From owner-sci-resources@net.bio.net Wed Jun 02 23:00:00 1993 Path: biosci!mrc-crc.ac.uk From: smercer@mrc-crc.ac.uk (Mr. S.J. Mercer) Newsgroups: sci.bio.technology,sci.med,bionet.announce,bionet.general,bionet.genome.chromosomes,bionet.sci-resources Subject: The Chromosome Abnormality Database Keywords: Chromosome Database Gene Mapping Syndrome Message-ID: <1993Jun3.143619.21453@crc.ac.uk> Date: 3 Jun 93 14:36:19 GMT Sender: kristoff@net.bio.net Followup-To: poster Organization: MRC Human Genome Resource Centre Lines: 30 Approved: bionews-moderator@net.bio.net Xref: biosci sci.bio.technology:355 sci.med:15949 bionet.announce:567 bionet.general:5063 bionet.genome.chromosomes:26 bionet.sci-resources:748 Nntp-Posting-Host: tin THE CHROMOSOME ABNORMALITY DATABASE The Chromosome Abnormality Database (CAD) is a centralised repository of records of human chromosome abnormalities, and is available for researchers to search free of charge. Established in early 1991, the CAD now contains nearly forty thousand records of acquired and constitutional chromosome abnormalities contributed by over forty cytogenetics laboratories throughout the United Kingdom. Although there is a considerable bias towards recent cases, the data stretch back over twenty years and include information on the availability of cell lines and other stored material. Searches of the database may be performed free of charge by contacting the database manager, Dr Mercer at the address below, or directly by the researcher through the computing facilities maintained by the UK Human Genome Mapping Program. Dr S. Mercer, The Chromosome Abnormality Database, Oxford Medical Genetics Laboratory, Churchill Hospital, Headington, OXFORD OX3 7LJ ENGLAND Tel: +44 865 226003 Fax: +44 865 226006 Email: simon@bioch.ox.ac.uk From owner-sci-resources@net.bio.net Wed Jun 02 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 20, pt. 1, 4 June 1993 Message-ID: Date: 3 Jun 93 20:43:32 GMT Sender: kristoff@net.bio.net Lines: 1507 Approved: biosci-moderator@net.bio.net NOTE: The NIH Guide may be split into more than one mail message to avoid truncation during e-mail distribution. The first message always begins with the RFP/RFA summary sections followed by the appended texts of the full RFP/RFAs. ---------------------------------------------------------------------- $$XID NIHGUIDE 19930604 V22N20 P1O2 ************************************ X-comment: RFAS described: AI-93-013, DE-93-005, CA-93-028, DK-93-024, PA-93- 091 NIH GUIDE - Vol. 22, No. 20 - June 4, 1993 $$INDEX BEGIN ******************************************************* NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 09/08/93 ************************************************* GENE THERAPY FOR HIV-1 INFECTION: PRECLINICAL DEVELOPMENT (RFA AI-93-013) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R2 09/10/93 ************************************************* SHORT-TERM TRAINING FOR MINORITY AND WOMEN DENTAL STUDENTS (RFA DE-93-005) National Institute of Dental Research INDEX: DENTAL RESEARCH $$INDEX R3 09/23/93 ************************************************* CLINICAL CORRELATIVE STUDIES IN BREAST TUMORS (RFA CA-93-028) National Cancer Institute INDEX: CANCER $$INDEX R4 11/18/93 ************************************************* SILVIO O. CONTE DIGESTIVE DISEASES RESEARCH CORE CENTERS (RFA DK-93-024) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** SUPPORT OF SCIENTIFIC MEETINGS (PA-92-089) National Eye Institute INDEX: EYE $$INDEX P2 ********************************************************** BASIC RUBELLA RESEARCH LEADING TO IMPROVED RUBELLA VACCINES (PA-93-090) National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases INDEX: ALLERGY, INFECTIOUS DISEASES; ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES $$INDEX P3 ********************************************************** GENOME SCIENCE AND TECHNOLOGY CENTERS (PA-93-091) National Center for Human Genome Research INDEX: HUMAN GENOME RESEARCH This publication is also available electronically to institutions via BITNET or INTERNET. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details, or send an E-mail message to ZNS@NIHCU. $$INDEX END ********************************************************* NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN AI-93-013 FULL-TEXT ************************************** GENE THERAPY FOR HIV-1 INFECTION: PRECLINICAL DEVELOPMENT NIH GUIDE, Volume 22, Number 20, June 4, 1993 RFA AVAILABLE: AI-93-013 P.T. 34; K.W. 0715008, 1002045, 0745032 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: July 1, 1993 Application Receipt Date: September 8, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE This RFA is designed to support applied preclinical development studies for gene therapy systems targeting HIV; such studies are vital for the transition from basic research to experimental clinical evaluation in infected individuals. Studies in response to this RFA may propose to optimize to refine: viral vectors for in vivo delivery, physical methods for in vivo transduction, and expression of anti-HIV or anti-cellular genes for maximal virus inhibition in PBL challenged with clinical HIV isolates. Studies listed above are examples only, and are not intended to be exclusive or comprehensive. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Gene Therapy for HIV-1 Infection: Preclinical Development, is related to the priority area of HIV Infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone (202) 783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, private and public institutions such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The support mechanism for this program is the research project grant (R01) award. The anticipated award date is March 1994. This RFA is a one-time solicitation. Future unsolicited applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE The National Institute of Allergy and Infectious Diseases (NIAID) has set aside $0.6 million (total costs) for first year funding of applications received in response to this RFA. Three to four awards are anticipated. The final number and specific amounts of awards to be made will depend on the scientific quality, merit and scope of the applications received, relevance to programmatic priorities, and availability of funds. The total project period for applications submitted in response to this RFA may not exceed four years. RESEARCH OBJECTIVES The objective of this RFA is to support 'post discovery' HIV gene therapy studies and to propel promising, state-of-the-art therapies closer to clinical evaluation. Studies to be funded under this RFA are restricted to those that are directly related to HIV infection from investigators with ongoing gene therapy projects who demonstrate a commitment to the advanced preclinical development and translation of a defined gene approach to clinical evaluation. Applications proposing a unique strategy for gene delivery are responsive to the RFA provided the proposed preclinical optimization studies focus on application to HIV infection. Examples of advanced preclinical development projects responsive to this RFA include o Optimization of existing viral vectors (including HIV-1 vectors) for antiviral gene delivery to target cells, gene stability, expression levels, purity and yield of recombinant vector stock, and other parameters relevant to vector design and application; o Optimization of non-viral delivery vehicles (liposomes, receptor-ligand, other) for anti-HIV genes; o Comparative assessment in relevant in vitro and/or animal models of different anti-HIV genes, cis-acting regulatory elements, or cellular functions critical for HIV gene expression for maximal virus inhibition. Examples of intracellular molecular inhibitors include: transdominant negative mutants; RNA decoys; multivalent ribozymes; and Tat, Rev, TAR and RRE binding proteins. Multi-pronged targeting for enhanced inhibition and reduction of viral load are encouraged. o Refinement of vectors that provide stable, persistent expression in mature and stem cell derived differentiating cells susceptible to HIV infection; o Development of efficient and safe methods to enhance infection of target cells (T-cells, stem cells, other) by recombinant vectors resulting in minimization of ex vivo manipulations; o Safety assessment of HIV gene therapy strategies in appropriate animal models. o Optimization of 'naked' DNA delivery strategies for the induction of MHC-dependent CTL response as a form of immune augmentation in HIV infected individuals; SPECIAL CHARACTERISTICS The NIAID will organize one to two meetings a year focusing on gene therapy for HIV infection to which the Principal Investigators and other key personnel will be invited to attend. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of minorities and women in study populations. If women and minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by July 1, 1993, a letter of intent that includes a descriptive title of the proposed research, brief description of the proposed research, the name, address (including institution), telephone and FAX numbers of the Principal Investigator and other key personnel, and the number and title of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the review of the application, the information that it contains allows NIAID to estimate the potential workload for reviewers and to avoid possible conflict of interest in the review progress. The letter of intent is to be sent to Dr. Madelon Halula at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. This form is available at most institutional offices of sponsored research and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-594-7248. Applications not received by September 8, 1993, will be considered unresponsive and returned to the applicant without review. REVIEW CONSIDERATIONS Applications will be reviewed by Division of Research Grants (DRG) for completeness and by NIAID staff to determine responsiveness to this RFA. Incomplete and non-responsive applications will be returned to the applicant without further consideration or review. The NIAID will remove from further competition those applications judged to be noncompetitive for award and will notify the applicant and the institutional business official. Those applications judged to be competitive for award will be further reviewed for scientific and technical merit by an appropriate review committee. A second level of review will be provided by the NIAID Council in February 1994. REVIEW CRITERIA Factors to be considered in the evaluation of each application will be similar to those used in review of traditional research grant applications. AWARD CRITERIA This anticipated date of award is March 1994. Awards decisions will be based on technical merit, responsive to RFA, and availability of funds. Three to four awards are anticipated under this RFA. The number and specific amount to be awarded will depend upon the scientific merit and scope of the applications received and on the availability of funds. INQUIRIES It is essential that prospective applicants obtain a copy of the RFA before preparing an application. Written and telephone inquiries from prospective applicants will provide NIAID staff the opportunity to clarify issues or questions about the RFA. Direct requests for the RFA and inquiries regarding programmatic or scientific issues to: Dr. Nava Sarver Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2C11 Bethesda, MD 20892 Telephone: (301) 496-8197 Direct inquiries regarding the review of applications and address the letter of intent to: Dr. Madelon Halula Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C10 Bethesda, MD 20892 Telephone: (301) 402-2636 Email: MHalula@exec.niaid.pc.niaid.nih.gov Direct inquiries regarding fiscal matters to: Ms. Jane Unsworth Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B22 Bethesda, MD 20892 Telephone: (301-496-7075) Schedule Letter of Intent Receipt Date: July 1, 1993 Application Receipt Date: September 8, 1993 Anticipated Award Date: March 1994 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, 93.856 -Microbiology and Infectious Diseases Research and 93.855 - Immunology, Allergic and Immunological Diseases Research. Grants are awarded under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under the PHS grants policies and Federal Regulations, most specifically at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of the Executive Order 12372 or Health Systems Agency review. $$R1 END ************************************************************ $$R2 BEGIN DE-93-005 FULL-TEXT ************************************** SHORT-TERM TRAINING FOR MINORITY AND WOMEN DENTAL STUDENTS NIH GUIDE, Volume 22, Number 20, June 4, 1993 RFA AVAILABLE: DE-93-005 P.T. 44, FF, II; K.W. 0715148 National Institute of Dental Research Letter of Intent Receipt Date: August 10, 1993 Application Receipt Date: September 10, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE The National Institute of Dental Research (NIDR) invites applications proposing short-term, institutional training programs for minority and women dental students in basic and clinical oral health research. The NIDR has found that there is a paucity of minority and women investigators in oral health research. The primary objective of this training program is to provide women and minority dental students an opportunity to obtain a research experience during their professional training. This will encourage the selection of research careers and help them to develop into clinical investigators. These programs must involve collaborative funding among the NIDR, the applicant institution, and/or other public or private sources. Proposed training must be relevant to the goals of the NIDR, as described in the NIDR Long-Range Research Plan for the Nineties, "Broadening the Scope." Availability of this publication is described under the section on INQUIRIES. The NIDR supports research on the causes, epidemiology, prevention, diagnoses, and treatments of dental caries, periodontal and oral soft tissue diseases, craniofacial anomalies and orofacial pain. This includes normal and abnormal craniofacial development; the structure and function of teeth, jaws, oral mucosa, bone, connective tissue, salivary glands and other organs and tissues of the craniofacial complex; trigeminal neurobiology; the relationship of behavioral, social, economic and cultural factors to oral diseases and conditions; dental biomaterials; and the role of fluoride and nutrition in oral health and disease. The Institute emphasizes the need for research on older Americans, minority groups, and individuals with medical and handicapping conditions or who are otherwise at high risk for oral health problems. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Short-Term Training for Minority and Women Dental Students, is related to the priority area of oral health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted from domestic, public, and private institutions and the applicant institution must have, or be able to develop, the staff and facilities for the proposed program. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) National Research Service Award (NRSA) Short-Term Institutional Research Training Grant (T35). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to this RFA may not exceed five years; awards may be renewable upon the completion of a successful competing application. Trainees may receive up to three months of support per year. FUNDS AVAILABLE The NIDR expects to make up to four institutional training awards in response to this RFA. This level of support is dependent on the receipt of a sufficient number of applications of high scientific and educational merit. Although this program is provided for in the financial plans of the NIDR, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES The training program must provide opportunities for minority and women dental students to carry out supervised biomedical or behavioral oral health research and develop research skills. Clinical programs must have strong relationships with basic research to assure students the opportunity to acquire the necessary experience to pursue basic and clinical research training. The program will be a collaborative funding effort among the NIDR, the applicant institution, and other public and/or private sources. Stipends and other training costs will be provided by the NIDR. Other support sources will provide room and board for the time the dental students are on the short-term training grant, if necessary. If students require funds to travel from their home base to the applicant institution to participate on this training grant, the program director and the awardee institution must obtain the necessary resources to do this. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by August 10, 1993, a letter of intent that includes a descriptive title of the proposed research training program, the name, address, and telephone number of the Program Director, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIDR staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Thomas Valega at the address listed under INQUIRIES. APPLICATION PROCEDURES It is strongly recommended that prospective applicants contact Dr. Valega early in the planning phase of application preparation. Such contact may help ensure that applications are responsive to this RFA. Applications must be submitted on form PHS 398 (rev. 9/91). Application forms are available at most institutional offices of sponsored research; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248; and from the NIDR program administrator listed under INQUIRIES. To identify the application as a response to this RFA, check "yes" on item 2a of page AA of the application and enter "RFA: DE-93-005, SHORT-TERM TRAINING FOR MINORITY AND WOMEN DENTAL STUDENTS." The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. This RFA is for a single competition. Applications must be received by September 10, 1993. If an application is received after that date or deemed non-responsive to the RFA, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Applications will be evaluated for scientific and technical merit by the NIDR Special Grants Review Committee, a standing NIH initial review group. Applicant interviews or site visits may be involved. Secondary review will be by the National Advisory Dental Research Council. Review and Award Schedule Applications will be processed according to the following schedule: Application Receipt Date: Sep 10, 1993 Initial Review Group Meeting: Feb/Mar 1994 Council Meeting: May/Jun 1994 Earliest Award Date: Sep 1, 1994 AWARD CRITERIA The earliest award date will be September 1, 1994. The NIDR will notify the applicant of the Council's action shortly after its meeting. Funding decisions will be made based on the Special Grants Review Committee and Council recommendations, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues and requests for the RFA to: Thomas M. Valega, Ph.D. Special Assistant for Manpower Development and Training National Institute of Dental Research Westwood Building, Room 503 Bethesda, MD 20892 Telephone: (301) 594-7617 FAX: (301) 594-7616 Direct inquiries regarding fiscal and policy matters to: Theresa Ringler Extramural Program National Institute of Dental Research Westwood Building, Room 510 Bethesda, MD 20892 Telephone: (301) 594-7629 Copies of the NIDR Long-Range Research Plan for the Nineties, "Broadening the Scope," are available by a written request to NIDR, P.O. Box 54793, Washington, DC 20032 AUTHORITY AND REGULATIONS NRSA Institutional Research Training Grants are made under the authority of Section 487 of the Public Health Service (PHS) Act as amended (42 USC 288), Title 42 of the Code of Federal Regulations, Part 66, is applicable to this program. This program is also described in the Catalog of Federal Domestic Assistance No. 93.121. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R2 END ************************************************************ $$R3 BEGIN CA-93-028 FULL-TEXT ************************************** CLINICAL CORRELATIVE STUDIES IN BREAST TUMORS NIH GUIDE, Volume 22, Number 20, June 4, 1993 RFA AVAILABLE: CA-93-028 P.T. 34; K.W. 0715035, 0785035, 0755015, 0755010, 0760020 National Cancer Institute Letter of Intent Receipt Date: July 23, 1993 Application Receipt Date: September 22, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE The Cancer Therapy Evaluation Program (CTEP) of the Division of Cancer Treatment (DCT) and the Cancer Diagnosis Branch (CDB) of the Division of Cancer Biology, Diagnosis and Centers (DCBDC) at the National Cancer Institute (NCI) invite applications for cooperative agreements (U01) from institutions or consortia, such as DCT Clinical Trials Cooperative Groups, capable of and interested in performing clinical correlative studies with new prognostic factors ready for large scale evaluation. These factors must be relevant to the cancer treatment or clinical outcome of patients with breast cancer. It is essential for institutions to have access to sufficient numbers of patients on phase III clinical protocols to be able to test correlative hypotheses. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Clinical Correlative Studies in Breast Tumors, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit and for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications may be submitted from a single institution or may include arrangements with one or more additional institutions, if appropriate. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Support of this program will be through the Cooperative Agreement (U01), an assistance mechanism in which substantial NCI programmatic involvement with the recipient during performance of the planned activity is anticipated. The nature of NCI staff involvement is described in the RFA. Applicants will be responsible for the planning, direction, and execution of the proposed project. The total project period for applications submitted in response to the present RFA may not exceed four years. Except as otherwise stated in this RFA, awards will be administered under PHS grants policy as stated in PHS Grants Policy Statement DHHS Publication No. (OASH) 90-50-000, revised October 1, 1990. It is anticipated that the average amount of the total direct costs per year for each award will range from $140,000 to $180,000. This RFA is a one-time solicitation. However, if it is determined that there is a sufficient continuing program need, the NCI will invite recipients of awards under this RFA to submit competitive continuation cooperative agreement applications for review. FUNDS AVAILABLE Approximately $1,000,000 in total costs per year for four years will be committed to specifically fund applications submitted in response to this RFA. It is anticipated that four to five awards will be made. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is also contingent upon the continuing availability of funds for this purpose. RESEARCH GOALS AND SCOPE The objectives of this RFA are to foster collaborations and interactions between basic researchers and clinical investigators to advance therapeutic clinical research and conduct correlative studies on new prognostic factors that are ready for large scale evaluation. The CTEP and the CDB invite cooperative agreement applications (U01) from institutions or consortia, such as the DCT Clinical Trials Cooperative Groups and the NCI Cancer Centers, capable of and interested in performing clinical correlative studies relevant to cancer treatment or clinical outcome in patients with breast cancer. The correlative studies should be based on strong and testable hypotheses. A clear rationale should be given for the experimental design and technical methodologies selected. The hypotheses tested must relate to potential clinical applications such as development of new treatment strategies or identification of patient subsets for specific treatment approaches. Preliminary data from appropriate tumor models or analysis of patient specimens should be provided to support the feasibility of each study. Assays must have already been demonstrated to be applicable to tissue samples and/or body fluids. The laboratory assays must utilize tumor specimens from patients receiving defined treatments in large clinical trials such as phase III clinical protocols. Applications will be considered responsive only if investigators have access to sufficient numbers of patient specimens. All investigators are encouraged to work with multi-center organizations or form a consortium of institutions in order to access sufficient numbers of patients and clinical information to test the proposed hypotheses. To coordinate the above activities, each Institution must have access to a Central Operations Office and Statistical Center as defined in the RFA. The cooperative approach outlined in this RFA allows for interactions among successful applicants and is designed to optimize use of patient resources, tissues, reagents and methods. Applicants must describe how they might interact with NCI and other awardees in the sharing of data and improvements in laboratory techniques and study design methodologies. SPECIAL REQUIREMENTS The RFA describes the complete terms and conditions of award for this cooperative agreement including terms of cooperation, nature of participation by NCI staff, responsibilities of the awardees and the arbitration process to resolve disputes. Special instructions for preparation of cooperative agreement applications are also included. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by July 23, 1993, a letter of intent that includes a descriptive title of the proposed research, the name and address of the principal investigator, the names of other key personnel, the participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, it is requested in order to provide an indication of the number and scope of applications to be reviewed. The letter of intent is to be sent to Ms. Diane Bronzert at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications must be received by September 22, 1993. If an application is received after that date, it will be returned. The research grant application form PHS 398 (rev. 9/91) is to be used in applying for cooperative agreements. These forms are available at most institutional offices of sponsored research; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594- 7248; and from the NCI program staff listed under INQUIRIES. REVIEW CONSIDERATIONS Upon receipt, applications will be initially reviewed by the Division of Research Grants (DRG) for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA is an NCI program staff function. Applications that are judged non-responsive will be returned by the NCI. Questions concerning the responsiveness of proposed research to the RFA are to be directed to program staff (see Inquiries). INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA, inquiries regarding programmatic issues, and address the letter of intent to: Ms. Diane Bronzert Division of Cancer Treatment National Cancer Institute Executive Plaza North, Room 734 Bethesda, MD 20892 Telephone: (301) 496-8866 FAX: (301) 480-4663 Dr. Sheila E. Taube Division of Cancer Biology, Diagnosis, and Centers National Cancer Institute Executive Plaza North, Room 513 Bethesda, MD 20892 Telephone: (301) 496-1591 FAX: (301) 402-1037 Direct inquiries regarding fiscal matters to: Ms. Barbara A. Fisher Grants Administration Branch National Cancer Institute Executive Plaza South, Room 242 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 29 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No 93.395, Cancer Treatment Research. Awards are made under the authorization of the Public Health Service Act, Title IV Sections 301, 410, and 411, Part A (Public Law 78-410, 42 USC 241 as amended, Public Law 99-158, 42 USC 285a) and administered under PHS grants policies and Federal Regulations at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R3 END ************************************************************ $$R4 BEGIN DK-93-024 FULL-TEXT ************************************** SILVIO O. CONTE DIGESTIVE DISEASES RESEARCH CORE CENTERS NIH GUIDE, Volume 22, Number 20, June 4, 1993 RFA AVAILABLE: DK-93-024 P.T. 04; K.W. 0715085, 0710030, 0760025, 0745032 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: October 15, 1993 Application Receipt Date: November 18, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES BELOW. PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for Silvio O. Conte Digestive Diseases Core Center grants. NIDDK anticipates the award of four competitive Silvio O. Conte Digestive Diseases Core Center Grants (P30s) in Fiscal Year 1995. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS led national activity for setting priority areas. This RFA, Digestive Diseases Research Core Centers, is related to the priority area of diabetes and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic (not foreign) for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Minority individuals and women are encouraged to submit as Principal Investigators. Applicant institutions must have an adequate base of established programs of high quality in laboratory and/or clinical digestive diseases related research. MECHANISM OF SUPPORT Support of this program will be through the NIH core center (P30) award. Responsibility for the planning, direction, and execution of the proposed center will be solely that of the applicant. Except as otherwise stated in this announcement, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement. This RFA is a one-time solicitation. The receipt of four competing continuation applications is anticipated. These applications will compete for the awards along with new applications received in response to this RFA. The total project period for applications submitted in response to the present RFA may not exceed five years. The earliest possible award dates will be December 1994 for three center grants and January 1995 for the other grant. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or a Principal Investigator must be included with the application. FUNDS AVAILABLE For FY 1995, up to $3,000,000 in total costs will be committed to fund applications submitted in response to this RFA. It is anticipated that four awards will be made with an average size of approximately $750,000 per year, total costs; however, this funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. In order to help meet NIDDK goals for managing the costs of biomedical research, applicants must limit their requests to not more than $700,000 direct costs for the initial budget period. Included in this $700,000 are funds with a limit of $100,000 for the pilot and feasibility program. Future budget period escalations should not exceed a four percent increase over the previous budget period. Although this program is provided for in the financial plans of the NIDDK, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES The objective of the Digestive Diseases Core Centers is to bring together clinical and basic science investigators from relevant disciplines to enhance and extend the effectiveness of research related to digestive diseases and their complications. There must be an existing peer reviewed and funded program of excellence in this area. At least one half of the research must have a central theme or focus. Examples of a central theme or focus include, but are not restricted to, inflammatory bowel disease, peptic ulcer disease, liver disease, pancreatic disease, pediatric gastrointestinal disease, GI hormones, GI motility, AIDS in gastrointestinal disease, or gene therapy. Core facilities which enhance productivity or in other ways benefit a group of investigators working in digestive diseases centers to accomplish the stated goals of the center will be supported. Two other activities may also be supported with center funding: (1) a pilot and feasibility grant program which may include temporary salary support for one Named New Investigator and (2) an enrichment program including for example, seminars, visiting scientists, consultants, and workshops. Close cooperation, communication, and collaboration among all involved personnel of all professional disciplines are ultimate objectives. SPECIAL REQUIREMENTS At least 50 percent of the already funded research base in a new application must be supported by NIDDK. In competing continuation applications the percent may be less than 50 percent due to, for example, a growing research base of investigators entering digestive diseases from other fields. The appropriateness of the research base will be determined by the initial review group. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by October 15,1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIDDK staff to estimate the potential review workload and to avoid conflict of interest in the review. Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Telephone: (301) 594-7515 FAX: (301) 594-7503 APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91), available in the office of sponsored research of most academic or research institutions and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page. In addition, the RFA title and number must be typed on line 2a of the face page of the application and the YES box must be marked. Detailed instructions on submission procedures are described in the RFA. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated by an appropriate peer review group convened by the NIDDK in accordance with the usual NIH peer review procedures. Following review, the applications will be given a second level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council unless not recommended for further consideration by the initial review group. Applications that are incomplete or unresponsive to the RFA will be returned to the applicant. Review Criteria are given in the RFA. INQUIRIES Written and telephone inquiries are encouraged. It is imperative that the RFA and the pamphlet "Administrative Guidelines for Silvio O. Conte Digestive Diseases Research Core Centers" be obtained before an application is prepared. These documents and information about programmatic issues may be obtained from: Dr. Judith M. Podskalny Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A15 Bethesda, MD 20892 Telephone: (301) 594-7539 Inquiries regarding fiscal matters may be directed to: Ms. Nancy Dixon Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 5333 Westbard Avenue, Room 637A Bethesda, MD 20892 Telephone: (301) 594-7543 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.848. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R4 END ************************************************************ ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PA-93-089 ************************************************ SUPPORT OF SCIENTIFIC MEETINGS NIH GUIDE, Volume 22, Number 20, June 4, 1993 PA NUMBER: PA-93-089 P.T. 42; K.W. 1002046, 1014006 National Eye Institute PURPOSE The National Eye Institute (NEI) is announcing its intention to support future investigator-initiated scientific meetings by the conference cooperative agreement mechanism (U13), in most instances, rather than the traditional conference grant mechanism (R13). This is not an announcement of a new program or initiative. ELIGIBILITY REQUIREMENTS The NEI will consider applications submitted by U.S. institutions, including scientific or professional societies, eligible to receive grants from Public Health Service agencies. In the case of an international conference, the U.S. representative organization of an established international scientific or professional society is the eligible applicant. The NEI will not accept applications from foreign institutions. MECHANISM OF SUPPORT The rules and regulations that apply to conference cooperative agreements (U13) are the same as those that apply to conference grants (R13). The difference is that, after award, NEI extramural program staff will be substantially involved in the planning and conduct of the scientific meeting, assisting the Principal Investigator according to specific Terms and Conditions. These Terms and Conditions are given below and will be included in each Notice of Grant Award. In exceptional circumstances, it may not be practical or necessary for NEI staff to participate substantially in the planning or conduct of the meeting, and NEI will use the traditional conference grant (R13) to support such activities. SPECIAL REQUIREMENTS Terms and Conditions of Cooperative Agreement Award o The Principal Investigator will have the primary authority and responsibility to define objectives and approaches; plan, publicize, and conduct the scientific meeting; and publish the results of the meeting. o The Principal Investigator will retain custody of and have primary rights to information developed under the cooperative agreement, subject to Government rights of access, consistent with current DHHS, PHS, and NIH policies. o The appropriate NEI extramural program Branch Chief will assist, but not direct, the Principal Investigator in the planning and conduct of the scientific meeting to ensure that the meeting is relevant and responsive to NEI scientific program goals and key research questions identified in "Vision Research - A National Plan: 1994-1998," a report of the National Advisory Eye Council. This will include assisting the Principal Investigator in finalizing the meeting format and agenda, selecting topics for discussion, publicizing the meeting, selecting speakers and other meeting participants, and publishing the meeting proceedings. o Publication and copyright agreements, and the requirements for financial status reports, retention of records, and terminal progress reports will be as stated in the NIH publication, "Support of Scientific Meetings" (August, 1992). o An independent, third-party individual, acceptable to both the Principal Investigator and NEI will be asked to serve as an arbitrator of any serious differences of opinion on scientific and programmatic issues that may arise during the planning and conduct of the scientific meeting. This special arbitration process will in no way affect the rights of the recipient to appeal an adverse action in accordance with PHS regulations of 42 CFR Part 50, Subpart D and DHHS regulations of 45 CFR Part 16. o These special Terms and Conditions of Cooperative Agreement Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, DHHS grant administrative regulations at 45 CFR Parts 74 and 92, and other DHHS, PHS, and NIH grant administration policies. APPLICATION PROCEDURES Potential applicants are strongly encouraged to contact NEI staff prior to the preparation and submission of an application concerning possible NEI interest in supporting a particular scientific meeting. Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grant Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD, 20892, telephone 301/594-7248. The NIH publication, "Support of Scientific Meetings" (August, 1992), should be obtained, because it provides important information and supplemental instructions for completing the application. In addition, this publication states NIH policy regarding the application, receipt, assignment, review, award, administration, and reporting requirements when funds are requested and awarded for the support of scientific meetings. For item 2b on the Face Page, enter the code "U13," if conference cooperative agreement funds will be requested. In the Research Plan section of the application, describe the relevance of the proposed scientific meeting to the NEI program goals and key research questions identified in "Vision Research - A National Plan: 1994-1998." The applicant, in addition, should provide a statement acknowledging and agreeing to NEI staff post-award involvement in planning and conducting the scientific meeting, and should describe plans to accommodate this involvement. The complete and signed original application and five exact copies, in one package with any appendices, must be mailed or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW PROCEDURES Applications will be assigned by the Division of Research Grants on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific merit by an initial review group in accordance with standard NIH peer review procedures. The following criteria will be considered when assessing the scientific merit of applications: o the importance of the proposed scientific meeting to investigators in the area and to the general biomedical community; o timeliness and need for the proposed scientific meeting; o adequacy of the scope and content of the proposed scientific meeting; o qualifications of the conference organizers and the proposed participants o adequacy of the applicant's efforts and plans to seek out and encourage the participation of women and underrepresented minorities; o appropriateness of the proposed format for achieving the stated goals; o adequacy of plans to disseminate the information generated by the scientific meeting; and o appropriateness of the budget. Second level program and policy review for applications assigned to NEI will be conducted by the National Advisory Eye Council. AWARD CRITERIA The following will be considered in making funding decisions for applications assigned to the NEI: o scientific merit of the proposed scientific meeting as determined by peer review, o relevance to NEI program goals and key research questions identified in "Vision Research - A National Plan: 1994-1998," and o availability of funds. INQUIRIES Potential applicants are strongly encouraged to telephone Dr. Ralph J. Helmsen, NEI Research Resources Officer, at (301) 496-5301 for general information regarding this notice and for referral to the appropriate extramural program Branch Chief or Grants Management Specialist. The NEI publication, "Vision Research - A National Plan: 1994-1998," is available from: Office of Science Policy and Legislation National Eye Institute Building 31, Room 6A25 Bethesda, MD 20892 Telephone: (301) 496-4308 The NIH publication, "Support of Scientific Meetings" (August, 1992), is available from the Office of Grants Inquiries. AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance No. 93.867, Vision Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. Applications are not subject to the intergovernmental review requirements of Executive Order 12372 as implemented through Department of Health and Human Services regulations at 45 CFR part 100 or Health Systems Agency review. $$P1 END ************************************************************ $$P2 BEGIN PA-93-090 ************************************************ BASIC RUBELLA RESEARCH LEADING TO IMPROVED RUBELLA VACCINES NIH GUIDE, Volume 22, Number 20, June 4, 1993 PA NUMBER: PA-93-090 P.T. 34; K.W. 0740075, 0715125, 1002045, 0710070 National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invite investigator-initiated research grant applications to pursue the development of safer vaccines to protect women against rubella infection (German measles). Multidisciplinary approaches, including basic research in virology and molecular immunology, are needed to identify and characterize the rubella virus gene products that are required for induction of durable immunity and those that are associated with adverse effects, particularly manifestations of joint disease. Research in this area also might lead to an understanding of the high female/male incidence ratio of adverse reactions in adults. In addition to vaccines with fewer adverse side-effects, a further goal is to develop safe vaccines that can be used in pregnant women to prevent fetal infection and congenital rubella syndrome (CRS). HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program announcement (PA), Basic Rubella Research Leading to Improved Rubella Vaccines, is related to the priority area of immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Research grant applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Applications from minority individuals and women are encouraged. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) (R29) award. MECHANISMS OF SUPPORT Applications considered appropriate responses to this announcement are the investigator-initiated research project grant (R01) and the FIRST award (R29). RESEARCH OBJECTIVES Background Until the introduction of a live attenuated vaccine in 1970, rubella was a common febrile disease of childhood. The most serious effects of rubella--abortions, miscarriages, stillbirths and fetal anomalies--follow infection during early pregnancy. The average cost of a single case of CRS, caused by infection of the fetus with rubella, is estimated to be well over $200,000. The current licensed vaccine works well in children. By blocking the spread of rubella, it has been effective in dramatically reducing, but not eliminating, the yearly incidence of CRS in the United States. >From 1970 to 1989, there was a steady reduction in the number of annual cases of rubella. However, compared to 1988, the yearly incidence of rubella cases and rubella in patients 15 years of age or older, increased twofold in 1989, and threefold in 1990. Although the total number of cases was still small (0.4 cases per 100,000 in 1990), this re-emergence of natural rubella led to a campaign to increase vaccination coverage in all age groups, and thus more and more adult women are being immunized against rubella. Unfortunately, as a public health tool, the current vaccine has some deficiencies. This live vaccine, like natural rubella, causes transient joint symptoms in a significant proportion of women vaccinees. Historical reports of natural epidemics also mention increased arthropathy predominantly in adult women. Currently in the U.S., an increasing percentage of women entering child-bearing age have not been immunized against rubella. When these adult women receive rubella vaccine, acute joint complaints are common, occurring in up to 25 percent of previously seronegative vaccinees. These symptoms usually last from one day to three weeks. Investigators in Canada recently reported that 5 to 11 percent of adult female vaccinees develop a more severe, persistent or recurring arthropathy. There also have been reports that these complications increase with the age of the vaccinee, and/or the presence of low or incomplete rubella immunity (perhaps representing a waning antibody response from an earlier childhood immunization). Another limitation of the current vaccine is that it is not recommended for use in women who may be pregnant, because the vaccine virus can be transmitted to the fetus. Research Objectives and Experimental Approaches Basic research on rubella is now at a low level in the U.S. Our primary objective is to stimulate research on rubella so that data are available to develop improved vaccines which would protect women of childbearing age without causing undesirable side effects and without fear of fetal infection. Success in this endeavor will require basic research in virology, immunology, genetics, and pathogenesis. Studies are needed to identify and characterize rubella virus gene products required for induction of durable immunity, and those associated with adverse effects. Research is encouraged to discover the role of viral components, and the importance of the response of the host, in the induction of inflammation and symptoms of acute and persistent arthritis. Studies would include genetic analysis of clinically characterized vaccine strains to determine if strain-specific variation leads to a propensity for growth in human synovial cells and association with persisting joint symptoms in adult vaccinees. Research in this area also might provide an understanding of the high female/male incidence ratio of adverse reactions in adults. Research projects are sought which investigate topics including, but not limited to those listed below. o Establishment of the quantitative and qualitative differences between vaccine-induced and naturally-induced immunity against rubella. o Determination of which rubella antigens are required to safely elicit long-lasting protective humoral and cellular immunity. o Characterization of the viral correlates of virulence and attenuation. o Elucidation of those factors contributing to vaccine-induced adverse events. Analysis of the host and viral factors that contribute to immune and inflammatory responses associated with arthritis, and establishment of the molecular and cellular mechanisms causing joint inflammation. o Development of an animal model of rubella which parallels human disease, and allows elucidation of viral and host factors contributing to immunity and immunization-induced adverse events. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions that disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Sections 1-4, of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups must be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the review will be deferred until the information is provided. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications are to be submitted on the research grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines February 1, June 1 and October 1. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594.7248. The title and number of the announcement must be typed in Section 2a on the face page of the application. The original and five legible copies of the application must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** FIRST (R29) applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or Principal Investigator could be included with the application. REVIEW CONSIDERATIONS Applications in response to this announcement will be assigned on the basis of established PHS Referral Guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, and in accordance with the standard NIH peer review procedures. Following scientific-technical review of the applications considered to have significant and substantial merit, a secondary review will be by the appropriate national advisory council or board. AWARD CRITERIA Applications will compete for available funds with all other R01 and R29 applications considered to have significant and substantial merit. The following will be considered when making funding decisions: relative scientific merit, program relevance, availability of funds. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. James M. Meegan Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A16 Bethesda, MD 20892 Telephone: (301) 496-7453 FAX: (301) 496-8030 Dr. Susana A. S. Sztein Rheumatic Diseases Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 405 Bethesda, MD 20892 Telephone: (301) 594-9953 FAX: (301) 594-9673 Direct inquiries regarding fiscal matters to: Mr. Todd Ball Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B35 Bethesda, MD 20892 Telephone: (301) 496-7075 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.856, Microbiology and Infectious Disease Research. Grants will be awarded under the authority of the Public Health Service Act, Title From owner-sci-resources@net.bio.net Wed Jun 02 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 20, pt. 4, 4 June 1993 Message-ID: Date: 3 Jun 93 20:47:24 GMT Sender: kristoff@net.bio.net Lines: 657 Approved: biosci-moderator@net.bio.net $$XID RFA CA93028 CA-93-028 P1O1 *************************************** CLINICAL CORRELATIVE STUDIES IN BREAST TUMORS NIH GUIDE, Volume 22, Number 20, June 4, 1993 RFA: CA-93-028 P.T. 34; K.W. 0715035, 0785035, 0755015, 0755010, 0760020 National Cancer Institute Letter of Intent Receipt Date: July 23, 1993 Application Receipt Date: September 22, 1993 PURPOSE The Cancer Therapy Evaluation Program (CTEP) of the Division of Cancer Treatment (DCT) and the Cancer Diagnosis Branch (CDB) of the Division of Cancer Biology, Diagnosis and Centers (DCDBC) at the National Cancer Institute (NCI) invite applications for cooperative agreements (U01) from institutions or consortia, such as DCT Clinical Trials Cooperative Groups and the NCI Cancer Centers, capable of and interested in performing clinical correlative studies with new prognostic factors ready for large scale evaluation. These factors must be relevant to the cancer treatment or clinical outcome of patients with breast cancer. It is essential for institutions to have access to sufficient numbers of patients on phase III clinical protocols to be able to test correlative hypotheses. Awards will be made as cooperative agreements, which create an assistance relationship with substantial NCI programmatic involvement with the recipients during the performance of the project, as outlined in this RFA. The cooperative agreement mechanism is used when the NCI wishes to stimulate investigator interest and proposes to advise or assist in an important and opportune area of research. Although this project is provided for in the financial plans of the NCI, the award of cooperative agreements pursuant to this RFA is contingent on the availability of funds appropriated in fiscal year 1994. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Clinical Correlative Studies in Breast Tumors, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit and for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications may be submitted from a single institution or may include arrangements with one or more additional institutions, if appropriate. Applications from minority individuals and women are encouraged. It is essential for teams to have access to sufficient numbers of patients on phase III clinical protocols to be able to test correlative hypotheses. The study team must have access to a Central Operations Office and a Statistical Center for coordination of research activities and data analysis as defined below (see SPECIAL REQUIREMENTS, Definitions). The Central Operations Office and the Statistical Office need not reside at the Principal Investigator's institution. MECHANISM OF SUPPORT Support of this program will be through the Cooperative Agreement (U01), an assistance mechanism in which substantial NCI programmatic involvement with the recipient during performance of the planned activity is anticipated. The nature of NCI staff involvement is described in the section entitled SPECIAL REQUIREMENTS, Teams and Conditions of Award, Nature of Participation by NCI Staff. Applicants will be responsible for the planning, direction, and execution of the proposed project. The total project period for applications submitted in response to the present RFA may not exceed four years. Except as otherwise stated in this RFA, awards will be administered under PHS grants policy as stated PHS Grants Policy Statement, DHHS Publication No. (OASH) 90-50-000, revised October 1, 1990. It is anticipated that the average amount of the total direct costs per year for each award will range from $140,000 to $180,000. This RFA is a one-time solicitation. However, if it is determined that there is a sufficient continuing program need, the NCI will invite recipients of awards under this RFA to submit competitive continuation cooperative agreement applications for review according to the procedures described in Review Considerations. FUNDS AVAILABLE Approximately $1,000,000 in total costs per year for four years will be committed to specifically fund applications submitted in response to this RFA. It is anticipated that four to five awards will be made. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is also contingent upon the continuing availability of funds for this purpose. RESEARCH OBJECTIVES A. Background Insights into the biologic function and clinical relevance of growth factors, genes that promote and suppress neoplasia, mechanisms of treatment sensitivity and resistance, and functions of the immune system provide important new clinical research opportunities for investigators studying patients with solid tumors. While advances have been made relating biological studies to clinical behavior of hematologic malignancies, fewer clinical correlations have been explored for solid tumors. Historically, prognostic factors have played a major role in assisting clinicians in the selection of appropriate therapeutic interventions. In the case of breast cancer, estrogen receptor and progesterone receptor status are now commonly used as prognostic and treatment indicators. Currently, several well defined laboratory tests are ready for inclusion in clinical correlative studies to determine their clinical relevance and value. For example, HER-2/neu, cathepsin D and stress response proteins are currently being evaluated in adjuvant breast cancer studies. New technological advances in methodologies such as Polymerase Chain Reaction (PCR), flow cytometry, immunohistochemistry, and in situ hybridization allow laboratory investigators to do numerous analyses on tumor specimens and study tumor heterogeneity in a variety of tumor types. Many opportunities exist for conducting correlative laboratory studies that can be expected to be immediately relevant to cancer treatment. The NCI supports an extensive network of clinical and laboratory research studies related to cancer therapy through contracts, grants and cooperative agreements. CTEP supports a program of integrated national networks of clinical investigators and institutions (Clinical Trials Cooperative Groups) for the conduct of large scale, multi-institutional clinical trials. The primary goal of these trials is the definitive evaluation of clinical treatment programs. Presently, the Clinical Trials Cooperative Groups (CTCG) conduct approximately 500 clinical trials evaluating more than 23,000 patients per year. The CTCG have access to tumor specimens from large numbers of patients with solid tumors. They maintain statistical databases and are capable of correlating laboratory data with the clinical outcome of patients. The NCI also supports Cancer Centers that conduct phase III clinical trials and which have access to statistical operations, headquarters, and consortia arrangements with other institutions and hospitals. This RFA is designed to promote collaborations and interactions between basic researchers and clinical investigators to advance research on clinical correlations that can improve therapeutic approaches. NCI is seeking to encourage correlative laboratory studies linked to large scale clinical trials so that markers that correlate with prognosis and response to treatment can be studied simultaneously. In many instances the laboratory investigators are already recipients of R01 or P01 support for their basic research and have developed preliminary data supporting a large scale analysis of a new prognostic factor. Likewise, many clinical investigators are supported through Cancer Centers (P30) and the Clinical Trials Cooperative Group mechanism (U10) for clinical research and have access to patient specimens with clinical follow-up. The Cancer Diagnosis Branch, DCBDC, is establishing a Cooperative Breast Cancer Tissue Registry that will enable participating organizations to inventory their tissue collections and to establish a database for existing associated clinical and outcome data. This registry does not include funds for conducting correlative studies but it can serve as a resource for additional tissues. This initiative proposes to link these activities and provides a mechanism to obtain definitive data on the relationship of biological features and the clinical behavior of the tumors. B. Research Goals and Scope The objectives of this RFA are to foster collaborations and interactions between basic researchers and clinical investigators to advance therapeutic clinical research and conduct correlative studies on new prognostic factors that are ready for large scale evaluation. The CTEP and the CDB invite cooperative agreement applications (U01) from institutions or consortia, such as the DCT Clinical Trials Cooperative Groups and the NCI Cancer Centers, capable of and interested in performing clinical correlative studies relevant to cancer treatment or clinical outcome in breast cancer patients. Applicants may propose to undertake several correlative studies during the grant funding period (up to four years). An individual scientist or a consortia of institutions may be included on more than one application. The correlative studies should be based on strong and testable hypotheses. A clear rationale should be given for the experimental design and technical methodologies selected. The hypotheses tested must relate to potential clinical applications such as development of new treatment strategies or identification of patient subsets for specific treatment approaches. Preliminary data from appropriate tumor models or analysis of patient specimens should be provided to support the feasibility of each study. This RFA is for developing assays that have already been demonstrated to be applicable to tissue samples and/or body fluids. The laboratory assays must utilize tumor specimens from patients receiving defined treatments in large clinical trials such as phase III clinical protocols. Proposals must include a statistical section describing plans for analysis of data designed to test the hypotheses. Applications will be considered responsive only if investigators have access to sufficient numbers of patient specimens. All investigators are encouraged to work with multi-center organizations or form a consortium of institutions in order to access sufficient numbers of patients and clinical information to test the proposed hypotheses. To coordinate the above activities, each Team must have a Central Operations Office and Statistical Center as defined below (see SPECIAL REQUIREMENTS, Definitions). Examples of therapeutic laboratory correlates of interest include but are not limited to: (1) phenotypic or genotypic alterations which appear to correlate with the development of drug-, radiation-, or hormone-resistance; (2) loss or inactivation of tumor suppressor genes related to prognosis; (3) analysis of basal membrane factors related to tumor invasion and metastases; (4) studies of chromosomal rearrangements or deletions that may be used as prognostic indicators; (5) correlation of tumor growth factors or oncogenies with response to therapies; (6) characterization of tumor associated antigens that may lead to new immunotherapies; and (7) evaluation of use of serum or tumor markers that correlate with tumor progression. The cooperative approach outlined in this RFA allows for interactions among successful applicants and is designed to optimize use of patient resources, tissues, reagents and methods. Applicants must describe how they might interact with NCI and other awardees in the sharing of data and improvements in laboratory techniques and study design methodologies. SPECIAL REQUIREMENTS A. Definitions o Cooperative Agreement - An assistance mechanism in which substantial NCI programmatic involvement with the recipient is anticipated during performance of the planned activity. o Study Team - A Study Team may be a single institution or a consortium of institutions. A Study Team functions as an integrated unit with a common goal and is under the guidance and direction of a single Principal Investigator. Each Study Team is composed of investigators with expertise in clinical investigations and laboratory analyses. Each Study Team must have access within its institution or consortia to an Operations Office and Statistical Center. In this RFA, the terms Study Team and Team are used synonymously. o Principal Investigator (PI) - The person who submits the single application in response to this RFA and who is responsible for performance of the key personnel and the Study Team as a whole. A consortium of institutions must agree to work together with a single Principal Investigator under a single cooperative agreement. The Principal Investigator is responsible for coordinating the Study Team's activities scientifically and administratively. o Central Operations Office - An administrative unit that coordinates all Team activities. Responsibilities include coordinating protocol development, study conduct, and quality control and study monitoring. Each Study Team must have a Central Operations Office but it need not be at the PI's institution. o Statistical Center - The Study Team must have a Statistical Center for collection and analysis of patient and laboratory data. Responsibilities will include participation in the planning and coordination of study design methodologies, data management and analysis, data monitoring, and reporting of data. Each Study Team must have a Statistical Center but it need not be at the PI's institution. o NCI Program Directors - The Program Director, CTEP, Division of Cancer Treatment and the Chief, CDB, Division of Cancer Biology Diagnosis and Centers who will be coordinating their Division's interactions and providing guidance for the overall program within the NCI. o NCI Coordinator - The Breast Cancer Clinical Research Scientist, Medicine Section, Clinical Investigations Branch, CTEP, DCT who interacts scientifically with the Institutions. B. Terms and Conditions of Award Under the cooperative agreement, a partnership will exist between the recipient of the award and the NCI, with assistance from the NCI in carrying out the planned activity. The following terms and conditions pertaining to the scope and nature of the interaction between the NCI and the investigators will be incorporated in the Notice of Award. These terms will be in addition to the customary programmatic and financial negotiations which occur in the administration of grants. The "Nature of Participation by NCI Staff" and "Responsibilities of Awardees" described in this section are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines; DHHS grant administration regulations 45 CFR 74; DHHS grant administration regulations 45 CFR 92; other DHHS, PHS, and NIH grant administration policy statements; and other NCI administrative terms of award. The cooperative agreements will require cooperation between an NCI Coordinator and the Principal Investigators of the Teams. The NCI Coordinator will assist in coordinating the activities of the Teams as defined below and in facilitating exchange of information. 1. Nature of Participation by NCI Staff The role of the Program Director CTEP and the Chief CDB staff as described throughout these terms of cooperation is to assist and facilitate but not to direct research activities. The NCI Coordinator will interact scientifically with all the Institutions. Two levels of coordination are anticipated. The first level involves interactions between the NCI Coordinator and the individual Team. During the period of the award, the awardees institutions(s) will have primary authority to determine research priorities and statistical needs. The NCI Coordinator may provide appropriate assistance by participating in the design of research activities, review of protocols, coordination of the tissue utilization, establishment of priorities, and review of progress. The NCI Coordinator can assist in this process by providing information on other ongoing studies and on NCI priorities. Protocols will be provided to the CTEP Protocol Review Committee and the Diagnosis Decision and Implementation Committee for review to facilitate coordination of research activities throughout NCI. Although the Team(s) are responsible for statistical analysis of data, computer processing and statistical evaluations may be provided from NCI resources if requested by the awardee. The second level of coordination involves interactions between the NCI Coordinator and the various Teams funded for research on breast cancer. The NCI Coordinator will coordinate activities among the Teams such as the sharing of patient specimens, new reagents, improved laboratory techniques, data, and study design methodologies. Although investigators will have to demonstrate that they have access to the necessary numbers of patients and/or specimens to answer specific questions, other important correlations identified during the course of the funded research may require patient resources from more than one Team. Priorities would need to be set for the most effective use of available specimens since tumor specimens are often small in size. The NCI Coordinator can assist in this process by providing information on other ongoing studies and on NCI priorities. 2. Responsibilities of Awardees The Study Team is responsible for the proposing research projects to advance the goals of the RFA and to define its approaches to attain these goals. It is the primary responsibility of the PI to state clearly the objectives of the Team, to direct the research stipulated in the application, and to ensure that the results obtained are published in a timely manner. It is anticipated that decisions in all activities will be reached by consensus of the collaborators of a Team under the leadership of the PI and that the NCI Coordinator will have the opportunity to offer input to this process. Awardees are required to have access to appropriate tumor tissue and clinical follow-up on patients receiving defined treatments in phase III clinical trials. Awardees must have the appropriate clinical and laboratory expertise to accomplish their objectives within the Study Team. The NCI Coordinator and all Awardees funded for breast cancer research in this RFA will meet initially to discuss research activities and establish priorities among the Awardees. Subsequent periodic meetings will be scheduled to review progress and coordinate new research activities. Sharing of data and reagents will be expected among Awardees. In addition, new studies that may require the sharing of patient specimens and the prioritization of research studies among the Awardees is envisioned. Therefore, each Awardee should anticipate the need to attend two meetings per year with the NCI Coordinator and other Awardees to coordinate activities. The Government, via the NCI Coordinator, will have access to data generated under this cooperative agreement and may periodically review the data. However, the awardee will retain custody of primary rights to their data developed under these awards, and timely publication of major findings by the Team members is encouraged. Publication or oral presentation of work done under this agreement will require appropriate acknowledgement of NCI support. 3. Arbitration Committee An arbitration panel of external consultants will be created as needed to resolve any irreconcilable differences of opinion between the NCI coordinator and the Team(s) related to scientific/programmatic matters or implementation of a proposed operating policy. The panel will include one member selected by the Team(s), one member selected by the NCI, and a third member chosen by the other two members of the arbitration panel. The NCI arbitration process for the cooperative agreement in no way affects the rights of awardees to appeal selected post award administrative decisions in accordance with PHS regulations at 42 CFR part 50, subpart D and HHS regulations at 45 CFR part 16. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by July 23, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information is helpful in planning for the review of applications. It allows NCI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Ms. Diane Bronzert at the address listed under INQUIRES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for cooperative agreements. These forms are available at most institutional offices of sponsored research; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248; and from the NCI program staff listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA number and title must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Ms. Toby Friedberg, Referral Officer Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 650 6130 Executive Boulevard Bethesda, MD 20892 Applications must be received by September 22, 1993. If an application is received after that date, it will be returned. The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Special Instructions for Preparation of Cooperative Agreement Applications The grant application form PHS 398 (rev. 9/91) must be used for the cooperative agreement application. The general instructions, e.g., for format and budget issues, included in the application packet must be followed. Because the Terms and Conditions of Award discussed in the SPECIAL REQUIREMENTS section will be included in all awards issued as a result of this RFA, it is critical that each applicant include specific plans for responding to these terms. Plans must describe how the applicant will comply with staff involvement. Teams should anticipate the need to attend two meetings per year to share data and to coordinate activities. Travel funds for two representatives from a Team (one basic researcher and one clinician, one of whom must be the PI) should be included in the budget. This budget item will be negotiable. REVIEW CONSIDERATIONS A. Review Procedures Upon receipt, applications will be reviewed by the DRG for completeness. Incomplete applications will be returned to the applicant without further consideration. Applications that are judged non-responsive will be returned by the NCI. An application judged to be non-responsive to this RFA may be submitted as an investigator- initiated regular research grant (R01) or program project grant (P01) at the next receipt date. The application would require modification in accordance with either the R01 or P01 guidelines. The new application would not be considered an application for a Cooperative Agreement, nor would it be considered a response to an RFA. Questions concerning the relevance of proposed research to the RFA may be directed to program staff listed under INQUIRIES. Applications may receive a preliminary scientific peer review (triage) by an NCI scientific peer review group on the basis of relative competitiveness. The NCI will withdraw from further competition those applications judged to be noncompetitive for award and notify the applicant and institutional business official. Those applications judged to be both competitive and responsive will be further evaluated, using the review criteria stated below, for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review will be provided by the National Cancer Advisory Board. B. Review Criteria o Scientific merit and feasibility of the proposed research. o Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research. o Adequacy of plans for effective collaboration between laboratory, clinical, and statistical investigators. o Qualifications, demonstrated expertise in both the appropriate basic and clinical sciences, and proposed responsibilities of the Principal Investigator and key personnel. o Demonstration of availability of and access to appropriate patients receiving defined treatments on phase III clinical trials and/or to human tissue with the associated pathological data and clinical follow-up. o Scientific plans and timetable for implementing the proposed research program. o Adequacy of the available facilities and data management resources. Evidence of the competence of the Central Operations Office and statistical center with regard to the mechanisms for quality control, study monitoring, data management and reporting, and data analysis. o Plans for effective interaction and coordination among cooperating institutions within the Study Team, with other Teams working on the same solid tumor, and with the NCI. o Adequacy of provisions for the protection of human subjects. o Adequacy of the plans for inclusion of females and minorities. o Adequacy of the proposed budget and duration in relation to the proposed research. AWARD CRITERIA The anticipated date of award is July 1, 1994. In addition to the technical merit of the application, NCI will consider how well the applicant institution meets the goals and objectives of the program as described in the RFA, availability of resources, and study populations. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA and inquiries about whether or not specific proposed research would be responsive are strongly encouraged and may be directed to program staff listed below. The program staff welcome the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues and address the letter of intent to: Ms. Diane Bronzert Division of Cancer Treatment National Cancer Institute Executive Plaza North, Room 734 Bethesda, MD 20892 Telephone: (301) 496-8866 FAX: (301) 480-4663 Dr. Sheila E. Taube Division of Cancer Biology, Diagnosis, and Treatment National Cancer Institute Executive Plaza North, Room 513 Bethesda, MD 20892 Telephone: (301) 496-1591 FAX: (301) 402-1037 Direct inquiries regarding fiscal matters to: Ms. Barbara A. Fisher Grants Administration Branch National Cancer Institute Executive Plaza South, Room 242 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 29 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No 93.395, Cancer Treatment Research. Awards are made under the authorization of the Public Health Service Act, Title IV Sections 301, 410, and 411, Part A (Public Law 78-410, 42 USC 241 as amended, Public Law 99-158, 42 USC 285a) and administered under PHS grants policies and Federal Regulations at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. From owner-sci-resources@net.bio.net Wed Jun 02 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 20, pt. 3, 4 June 1993 Message-ID: Date: 3 Jun 93 20:46:43 GMT Sender: kristoff@net.bio.net Lines: 1153 Approved: biosci-moderator@net.bio.net $$XID RFA DK93024 DK-93-024 P1O1 *************************************** SILVIO O. CONTE DIGESTIVE DISEASES RESEARCH CORE CENTERS NIH GUIDE, Volume 22, Number 20, June 4, 1993 RFA: DK-93-024 P.T. 04; K.W. 0715085, 0710030, 0760025, 0745032 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: October 15, 1993 Application Receipt Date: November 18, 1993 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for Silvio O. Conte Digestive Diseases Core Center grants. The NIDDK anticipates the award of four competitive Digestive Diseases Core Center Grants (P30s) in Fiscal Year 1995. The Silvio O. Conte Digestive Diseases Research Core Centers are part of an integrated program of digestive diseases-related research support provided by the NIDDK. The Centers currently funded in this program have provided a focus for increasing collaboration and improving the cost-effectiveness of supported research among groups of successful investigators at institutions with an established comprehensive digestive diseases research base. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS led national activity for setting priority areas. This Request for Applications (RFA), Digestive Diseases Research Core Centers, is related to the priority area of diabetes and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic (not foreign) for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Minority individuals and women are encouraged to submit as Principal Investigators. Applicant institutions must have an adequate base of established programs of high quality in laboratory and/or clinical digestive diseases-related research. The quality of the programs must be evident from the fact that they have been awarded support through peer reviewed competition, such as NIDDK research project grants (R01), program project grants (P01), FIRST (R29) awards, cooperative agreements, and contracts or peer reviewed and funded through other Federal Agencies or non-federal groups. MECHANISM OF SUPPORT Support of this program will be through the NIH core center (P30) award. Responsibility for the planning, direction, and execution of the proposed center will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement. This RFA is a one-time solicitation. The receipt of four competing continuation applications is anticipated. These applications will compete for the awards along with other applications received in response to this RFA. The total project period for applications submitted in response to the present RFA may not exceed five years. The earliest possible award dates will be December 1994 for three center grants and January 1995 for the other grant. Applicants must limit their requests to not more than $700,000 direct costs for the initial budget period. Included in this $700,000 may be funds with a limit of $100,000 for the pilot and feasibility program. Future budget period escalations may not exceed a four percent increase over the previous budget period. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or a Principal Investigator must be included with the application. FUNDS AVAILABLE For FY 1995, up to $3,000,000 in total costs will be committed to fund applications submitted in response to this RFA. It is anticipated that four awards will be made with an average size of approximately $750,000 per year, total costs; however, this funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIDDK, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES The objective of the Core Centers is to bring together investigators from relevant disciplines to enhance and extend the effectiveness of research related to digestive diseases and their complications. A Core Center must be an identifiable unit within a single university medical center or a consortium of cooperating institutions, including an affiliated university. The overall goal of the Core Center is to bring together clinical and basic science investigators in a manner that will enrich the effectiveness of digestive diseases research. An existing program of excellence in biomedical research in the area of digestive diseases disorders is required. This research must be in the form of NIH funded research projects, program projects, or other peer reviewed research that is already funded at the time of submission of a Center grant application. Close cooperation, communication, and collaboration among all involved personnel of all professional disciplines are ultimate objectives. The Core Centers must have a central focus of research investigation. The central focus must be a digestive disease, group of diseases or functional studies relating to digestive diseases; at least half of the research must relate to this central focus. Examples of a gastrointestinal disease-related central focus of research investigation include (but are not restricted to) inflammatory bowel disease, peptic ulcer disease, pancreatic disease, liver disease, pediatric gastrointestinal disease and AIDS in gastrointestinal disease. Examples of functional studies as the central focus include (but are not restricted to) gastrointestinal motility, gastrointestinal hormones, or gene therapy for digestive diseases. Applicants should consult with NIDDK staff concerning plans for the development of the Center and the organization of the application. Silvio O. Conte Digestive Diseases Research Core Centers are based on the core concept. Five or six cores are usually included in a Center. Cores are defined as shared resources that enhance productivity or in other ways benefit a group of investigators working in digestive diseases centers to accomplish the stated goals of the Center. Examples of such resources include electron microscope, tissue culture, and radioimmunoassay facilities. Centers are encouraged to include a clinical component or core that deals with patients. This clinical component can exist as a stand alone core or part of another core such as the administrative core. Besides leading to a better understanding of disease etiology and natural history of disease, such cores might provide biostatistical support, enhance clinical study design, enhance collaboration among researchers and recruitment of subjects for clinical studies, provide for epidemiological studies in areas of digestive diseases or provide modest funding for tissue, DNA, or serum storage. In addition, a clinical or epidemiology core may more effectively address NIH policies concerning issues of women and ethnic minority participation in clinical studies. Two other types of activities may also be supported with Center funding: a pilot and feasibility (P/F) program and an enrichment program. The P/F program provides modest support for new initiatives or feasibility research studies. This program is directed at new investigators, at investigators established in other research disciplines with expertise that may be applied to digestive disease research, and, occasionally, at investigators already working in digestive diseases but who wish to make a substantial change in the direction of their research. In addition, temporary salary support for one Named New Investigator in a specified area of research with a defined P/F study may be requested for up to 24 months, with subsequent individuals to be named by the Center Director and approved by the Center's External Advisory Board and the NIDDK. The Core Center grant may include limited funds for program enrichment such as seminars, visiting scientists, consultants, and workshops. SPECIAL REQUIREMENTS At least 50 percent of the already funded research base in a new application must be supported by the NIDDK. In competing continuation applications the percent may be less than 50 percent due to, for example, a growing research base of investigators entering digestive diseases from other fields. The significance of the research base will be determined by the initial review group. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by October 15, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIDDK staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to: Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Telephone: (301) 594-7515 FAX: (301) 594-7503 APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91), available in the office of sponsored research of most academic or research institutions and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. Administrative Guidelines for Silvio O. Conte Digestive Diseases Research Core Centers may be requested from the NIDDK program staff listed under INQUIRIES below. The RFA label available in the application form must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and check the YES box. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, two additional copies of the application must also be sent under separate cover to: Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Applications must be received by November 18, 1993. If an application is received after that date, it will be returned to the applicant. The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications previously reviewed. Such applications must not only include an introduction addressing the previous critique but also be responsive to this RFA. REVIEW CONSIDERATIONS Upon receipt, applications will be initially reviewed by the DRG for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA is an NIDDK staff function. If the application is not responsive to the RFA, NIDDK staff will contact the applicant to determine whether it should be returned to the applicant. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIDDK. If the number of applications is large compared to the number of awards to be made, a preliminary scientific peer review may be conducted to withdraw applications from further competition if they are not competitive for the award. The NIDDK will notify the applicant and institutional official of this action. Those applications judged to be competitive will be reviewed for scientific and technical merit in accordance with the usual NIH peer review procedures by an initial review group specifically convened for this RFA. Applications are unlikely to be reviewed by a site visit team; therefore, the written application must be complete to facilitate review without a site visit. Following this review, the applications will be given a second level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council unless not recommended for further consideration by the initial review group. Review criteria for RFAs generally include those for unsolicited research grant applications: o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; and o if an application involves activities that could have an adverse effect upon humans, animals, or the environment, the adequacy of the proposed means for protecting against or minimizing such effects. Specific review criteria for Digestive Diseases Core Centers include: o The scientific excellence of the Center's research base (its strengths, its breadth and depth) as well as the relevance and interrelation of these separately funded research projects to the central theme(s) or focus of the Center and the likelihood for meaningful collaboration among Center investigators. The existence of a base of established, independently supported biomedical research of high quality is a prerequisite for the establishment of a Digestive Diseases Core Center and is the most important component of the review. (The results of previous peer reviews of its content will weigh heavily in the application's overall strength as a potential recipient of an award.) o The qualifications, experience, and commitment of the Center investigators responsible for the individual research projects, and their willingness to interrelate with each other and contribute to the overall objectives of the Digestive Diseases Core Center. o The appropriateness and relevance of the proposed Cores and their modes of operation (such as how usage will be prioritized), facilities, and potential for contribution to ongoing research. Competing continuation applications must document the use, utility, quality control and cost effectiveness of each Core requested to continue as part of the Center. Progress will be judged in part on the list of publications arising from the cores. At least two users are required to establish a core. However, a greater number of users generally can be evaluated as more cost effective. o For new and competing continuation applications, four or five P/F studies may be submitted for evaluation as part of the review of the P/F program. o In general for new applications, the proposed P/F projects will be examined to assess: the eligibility of the P/F applicant, i.e., whether they fit the three eligibility categories (1) new investigator, (2) an investigator bringing a different expertise into digestive diseases, or (3) an established investigator making a substantial change in direction in digestive diseases; the reasonableness of the hypothesis; and scientific and technical feasibility of projects for which funds are requested. The P/F program also will be judged as a whole. o In addition, in the case of new applications, the P/F studies should be presented as the Centers' best selection. The internal selection process should be described. In competitive continuation applications, the P/F studies should have been selected by using the existing internal evaluation mechanisms. o For competing continuation applications, the P/F program also will be assessed as a whole, including past accomplishments indicated by publications arising from P/F studies, peer reviewed funded grants arising from P/F studies, and investigators remaining in academic research even if they have moved to another research or academic environment; management of the program; and the general scientific merit of past, ongoing, and proposed P/F studies as a group. The quality of these P/F studies is an indication of how well the internal selection mechanism has been working. o In each case (new and competing continuation), the effectiveness of the proposed P/F program will be evaluated. However, in the case of the competing continuation, the progress of the established program will also serve as a basis for recommendations concerning the level at which P/F studies will be supported throughout the grant award period. o The Named New Investigator, when identified in the application, must be reviewed separately. The associated pilot study must be evaluated in a manner similar to the P/F studies in general. In a competing continuation application only, the progress of previous Named New Investigators should also be evaluated: whether or not their P/F projects led to publications, grant awards, and whether or not the investigator has remained in digestive diseases related research in that research environment or elsewhere. o Efficient and effective use and/or planned use of the limited enrichment funds, including the contribution of these activities in enhancing the objectives of the Center. o The scientific and administrative leadership abilities of the proposed Center Director and Associate Director and their commitment and ability to devote adequate time to the effective management of the program. o The administrative organization proposed for the following: (a) Coordination of ongoing research between the separately funded projects and the Center, including mechanisms for internal monitoring. (b) Establishment and maintenance of internal communication and cooperation among the Center investigators. (c) Mechanism for selecting and replacing professional or technical personnel within the Core Center. (d) Mechanism for reviewing the use of and administering funds for the P/F program. The general quality of P/F studies selected for the application. These funds are restricted and thus can only be used for this program. (e) Management capabilities that include fiscal administration, procurement, property and personnel management, planning, budgeting, and other appropriate capabilities. o The institutional commitment to the program, including lines of accountability regarding management of the Center grant and the institution's contribution to the management capabilities of the Center. o The academic environment and resources in which the activities will be conducted, including the availability of space, equipment, facilities, and the potential for interaction with scientists from other departments and institutions. o The institutional commitment to new individuals responsible for conducting essential Center functions. o The institutional commitment to establishing new positions specifically designed to enhance the operation of the Center. o The appropriateness of the budgets for the proposed and approved work to be done in Core facilities, for P/F studies (these are restricted funds and are capped at $100,000), and for enrichment in relation to the total Center program. Total Direct Costs are limited to $700,000 (including the P/F program). In competing continuation applications, consideration must be taken for reductions instituted in FY 1987 in accordance with NIDDK administrative policy. Ongoing Center grants incurred negotiated budget reductions averaging approximately 20 to 25 percent per year in addition to the Initial Review Group recommended reductions indicated in the summary statements. AWARD CRITERIA The anticipated date of award is December 1994 for three center grants and January 1995 for one additional center grant. Applications recommended for further consideration by the National Diabetes and Digestive and Kidney Diseases Advisory Council will be considered for funding on the basis of overall scientific and technical merit of the research as determined by peer review, program needs and balance, and availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. It is strongly suggested that the pamphlet "Administrative Guidelines for Silvio O. Conte Digestive Diseases Research Core Centers" be obtained before an application is prepared. Inquiries regarding programmatic issues and requests for the Administrative Guidelines may be directed to: Dr. Judith M. Podskalny Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A15 Bethesda, MD 20892 Telephone: (301) 594-7539 Inquiries regarding fiscal matters may be directed to: Ms. Nancy Dixon Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 637A Bethesda, MD 20892 Telephone: (301) 594-7543 Schedule Letter of Intent Receipt Date: October 15, 1993 Application Receipt Date: November 18, 1993 Initial Review: March 1994 Second Level Review: May 1994 Anticipated Date of Awards: December 1994 and January 1995 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.848. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$XID RFA PA93091 PA-93-091 P1O1 *************************************** GENOME SCIENCE AND TECHNOLOGY CENTERS NIH GUIDE, Volume 22, Number 20, June 4, 1993 PA AVAILABLE: PA-93-091 P.T. 34; K.W. 1215018, 0755045, 1002058 National Center for Human Genome Research PURPOSE The purpose of this program announcement is to solicit new or renewal applications for large-scale projects in genomic research. The announcement describes a reformulated, flexible program for support of research efforts designed to complete the initial five-year goals of the research program of the National Center for Human Genome Research (NCHGR) and to progress beyond them toward the ultimate goal of determining the complete sequence of human DNA. The new program, which is called the Genome Science and Technology Centers (GESTEC) program, will support large-scale, multidisciplinary genomic studies under the P50 and P01 grant mechanisms. The GESTEC program is intended to develop the technologies needed to accomplish the goals of the Human Genome Program and to apply them to the large-scale generation of mapping and sequencing information. Improved informatics solutions to data management will be a vital component to realizing success in these efforts. While primary focus will be on the mapping and sequencing objectives, it is also appropriate to address the need for better methods of annotating the maps and sequences, e.g., techniques for identifying and mapping all of the genes and/or other functional elements in a large genomic region. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. While a single institution must be the applicant, multi-institutional arrangements (consortia) are possible if there is a compelling reason for them and if there is clear evidence of close interaction among the participants. Applications from foreign institutions will not be accepted. However, subcontracts to foreign institutions are allowable, with sufficient justification. Applications from minority individuals and women are encouraged. Industrial/academic collaborations are also encouraged. In such collaborations, the respective contributions should be well-integrated into the design and operation of the center, to encourage cross-fertilization of ideas and rapid application of the research to practical purposes. MECHANISM OF SUPPORT Grants in the GESTEC program may be supported by specialized center grants (P50) or program project grants (P01). The P50 mechanism will be used for broad, complex, multidisciplinary programs that address the goals of the Human Genome Project. The P01 mechanism will be used for programs that support a minimum of three research components with a well-defined central research focus. RESEARCH OBJECTIVES Background The National Institutes of Health (NIH) is currently engaged, along with several other federal, private, and international organizations, in a 15-year research program designed to characterize the human genome and the genomes of selected model organisms. This research program, the Human Genome Project (HGP), has the following interrelated goals: (1) the construction of high-resolution genetic linkage maps; (2) the development of physical maps; (3) the determination of the complete nucleotide sequence of the genomes of selected organisms, including the human; (4) the development of the capability to collect, store, distribute and analyze the data and materials produced; (5) the development of appropriate new technologies to achieve these goals; and (6) the identification of major issues related to the ethical, legal and social implications (ELSI) of genome research, and the development of policy options to address them. The product of the Human Genome Project will be a set of information and material resources available to the entire research community that will facilitate further research as to the prevention, diagnosis, and therapy of disease, as well as a further understanding of human biology. In 1990, the NCHGR and the Department of Energy (DOE) jointly published a plan "Understanding Our Genetic Inheritance - The U.S. Human Genome Project: The First Five Years FY 1991-1995" that set out specific goals to be achieved in the first five-year phase of the U.S. human genome program. As of October 1993, the NCHGR will begin the fourth year of operation under that plan, with the prospect that many of the goals will be achieved on schedule. Anticipating the attainment of the initial set of goals, the NCHGR is currently engaged in developing goals for the second five-year period. At the same time, the NCHGR centers program, which has supported several large-scale, multidisciplinary projects that have made significant contributions to recent achievements, is also in transition, and a number of the grants awarded initially are scheduled for recompetition during the next year. The NCHGR intends to build upon the success of the current program and the lessons that have been learned from it, by establishing a reformulated centers program, the Genome Science and Technology Centers (GESTEC) program. This announcement solicits applications for new and continuing projects that propose to finish the goals of the first five-year component of the HGP and to address the further needs of the project, leading toward complete sequencing of the human genome and the genomes of selected model organisms. Progress and Future Needs in Mapping For the genetic linkage map, several current efforts, both genome-wide or on an individual chromosome level, are expected to achieve the timely completion of the 2 to 5 centimorgan genetic map called for in the Five-year Plan. Similarly, recent progress in physical mapping has been very rapid, with contiguous for long genomic regions, including two human chromosomes and parts of many others, having been assembled. While much work remains to be done in order to complete physical maps of the resolution called for in the Five-Year Plan (with a "sequence-tagged site" (STS) every 100 kb across most of the genome and with much of the genome in large physical contiguous of cloned DNA), there is a good possibility that this goal also will be largely attained by 1995. Even after the goals set forth for the first five years have been completed, however, continued technology development will be necessary to ensure progress toward sequencing the entire human genome. For example, it has not yet been convincingly demonstrated that any of the currently available cloning vectors allow reliably faithful cloning of mammalian genomic DNA. Thus, new techniques or strategies will be needed to generate "sequence-ready" physical maps, comprised of DNA that can be readily sequenced. In the next several years, strategies for creating maps and reducing them to nucleotide sequences will have to be thoughtfully and carefully integrated. Better methods of annotating genetic and physical maps, e.g., with genes and other functional elements, on a genomic scale are also needed. Progress and Future Needs in DNA Sequencing Progress has also been rapid toward the long-term goal of the Human Genome Program, i.e., determining the complete sequence of the DNA of certain model organisms and the human. In 1990, the cost of sequencing in laboratories devoted to DNA sequencing was estimated to be about $5 per finished base. At the same time, the rate at which finished sequence could be generated was relatively low. Since its inception, the NCHGR has supported several efforts designed to test and refine current methods in large-scale projects or develop entirely new approaches to DNA sequencing that offer substantial improvements over current methods. Through these efforts, a number of advanced sequencing laboratories are within reach of being able to generate contiguous finished sequence at a rate of megabases per year and the cost is now projected to be approximately $1 per finished base pair. Several interesting regions of both non-human and human DNA have been sequenced in these projects. To build on this significant progress, multidisciplinary centers will be needed to develop and implement visionary, integrated strategies that will optimize the several aspects of DNA sequencing, including sample preparation, band resolution and detection, sequence assembly and finishing, and annotation. The efforts in the GESTEC centers will need to be carefully balanced between technology development and actual testing in a production mode in order that the new technology developed is effective and well-suited to achieving the ambitious goals of the Human Genome Program. It is expected that, through previous feasibility studies, applicants for GESTEC program grants will have demonstrated their ability to sequence at high throughput in a cost effective manner and to manage a large-scale sequencing effort. Objectives and scope The GESTEC program is intended to foster and support innovative projects in which technology development and cost effectiveness are expected to push the limits of current capabilities. The GESTEC program is NOT intended to fund projects in which existing technology is simply applied to large-scale production or projects that involve a consortium of investigators whose research interests are only loosely united by a common theme. To achieve the ambitious goals that this program is intended to attain, it is anticipated that a Genome Science and Technology Center must be: o mission-oriented, addressing in a highly integrated way, a major, quantifiable goal(s) of the HGP, including completion of the initial genome program goals and/or going beyond those by addressing the ultimate goal of the HGP -- the first complete sequence of a human genome; o creative and innovative in terms of the proposed strategy and development of new technology for achieving its goal(s); o readily adaptable to new technology and new scientific developments; o focused, on an on-going basis, on issues of increased efficiency as evidenced by a plan for improvements in the rate of output of data and materials; at the same time, attention must be paid to maintaining or improving the quality of the techniques, data, and materials developed; o attentive to the needs of the larger scientific community, as demonstrated by the inclusion of an outreach program that will allow the center to act as a hub for collaboration and as a source for materials and information; the study of ELSI issues and outreach to the general public through education programs can be a component of such an outreach activity. Allowable Components of Gestec Grant Applications Genomic research is defined, in part, by its emphasis on technology development and on a high rate of data production. Because of these inherent characteristics, investigators in the field have occasionally found standard organizational structures other than those prescribed by traditional multi-component grant mechanisms, i.e., research projects and technical cores each managed by a differed principal investigator, to be more effective in managing and effecting large-scale genome research projects. In order to facilitate the most rapid progress and efficient use of limited resources, applicants will not be required to use the standard organizational format. Rather, each applicant is encouraged to divide the program into units that will best accomplish the scientific goals of the proposed project. Each proposed organizational component must have an identified leader, although no minimum number of different leaders is required. For example, the Principal Investigator of the entire grant may also serve as leader of several, or even all, of the components, if such an arrangement is scientifically justified and adequate supervision of the project can be assured. The selection of the leader for each component should be justified in terms of the scientific and management needs of that component and the experience of the proposed leader. The following is a discussion of the activities most frequently found in multicomponent, genome research projects. Each of these will, in some way, be integral to GESTEC programs and the organizational plan developed by the applicant must address each of these activities. Thus, while the form of the components may differ dramatically among grants in the GESTEC program, it is essential that the scientific and management structure (organizational plan) be clearly presented in the application, both for the overall program and for the individual activities. It is also essential that the requested budget correspond directly to the organizational plan. The proposed plan will be considered as an indication of the quality of the management of the project. Research activities There are four primary activities that are usually part of a GESTEC grant: scientific research, technology development, technical support of either of the preceding, and outreach to the scientific community. Additionally, a GESTEC grant may have administrative and management elements as well as request alterations and renovations. In a traditionally organized program project or center, research and technology development activities are normally organized as individual "research projects", while technical support and outreach activities are presented as "technical cores." It has been the experience, however, in some large-scale genome projects that it is more efficient and productive to organize and manage efforts in others ways, for example, by combining certain research and support activities into a single unit. In a proposal for a GESTEC project, the applicant may design activities to accomplish the scientific objectives most effectively. Technology development The development of new and better technology needed to achieve the objectives of the Human Genome Project is considered to be one of the most important aspects of a GESTEC project. Funds for technology development may be requested to support (1) the design and development of prototypes for equipment needed to increase the rate and efficiency of data production and analysis, (2) pilot projects to take advantage of scientific opportunities that present themselves during the course of the project, and (3) the development of technology to meet unanticipated needs of the research and support activities of the project. In some cases, it may be possible to present, in the application, a detailed description of plans and justification for the particular technology development projects envisioned. Applicants are encouraged to fully describe and justify plans to the extent possible. However, it is also recognized that unanticipated needs may arise as the project develops and, thus, a complete description of all technology development plans may not be possible. In the latter case, the request for technology development funds must be justified by the inclusion of a strategy for making decisions about the use of such funds, e.g., the planning process for the use of the funds, alternative logistical plans for development of a variety of technologies, and the process for evaluating projects to be supported by technology development activities. In an application for renewal of currently-funded NCHGR grants, the justification for technology development funds must include a description of the use(s) to which such funds were put during the previous grant period. Technical support activities An applicant may request shared facilities or equipment that will be required by more than one element of the proposed research program. Each applicant should examine the needs of the proposed program and request those technical facilities that would be required to support the proposed research in the most efficient and cost-effective manner. Outreach Activities GESTEC projects are expected to have an interest in and a sense of responsibility for outreach to the greater scientific community. At a minimum, effective and rapid distribution of data and/or materials generated by a GESTEC project to external investigators is an essential and expected activity of each center. Accordingly, the proposal must include a full description of plans for accomplishing this goal. The joint NIH-DOE Advisory Committee on the Human Genome has recently issued a set of Guidelines for Access to Data and Material Resources, which is available from the program administrators listed below and which would form the basis of an acceptable plan, although investigators are encouraged to go beyond these guidelines whenever possible. Funding to support data and materials distribution may be requested in a GESTEC grant application. Other means of distribution, such as through a commercial vendor are also acceptable. Beyond such distribution activities, GESTEC projects are also encouraged to provide outreach to the larger community by acting as a hub of genomic collaboration through activities such as providing additional services to the community, for example, visitor laboratories or library screening services. Beyond outreach to the scientific community, development of public education outreach programs and demonstration of interest in ELSI issues are also desirable. Applications for renewal of currently-funded NCHGR center grants must document their accomplishments in the outreach area as part of their justification for continued support. Administrative and Management Activities Funds to support overall management of the GESTEC grant may be requested. As the GESTEC program allows for flexibility in management to fit the scientific purpose of the application, it is essential that the applicant adequately describe and justify both the overall management strategy proposed, as well as a plan for the management of each of the activities. Management of a scientific enterprise as complex as a GESTEC center will require a significant amount of attention and effort. Therefore, the proposed center director must serve on a full-time or significant part-time basis. He or she should have authority over appointments and space within the center. The portion of the salaries of the principal investigator and other key individuals corresponding to the percentage of time devoted to center administration can be included as an allowable cost. Costs of advisory committees, steering committees, and/or consultants can also be included as an administrative activity. Such committees are not required, but it is strongly recommended that an effective mechanism be proposed for obtaining independent advice to ensure guidance of the center toward the attainment of its stated goals. In some cases, and at the request of the investigator, NCHGR may appoint an oversight committee for the center in order to monitor progress and the appropriate funding level. It will not be necessary for applicants to identify external advisory committee members before review of the application. Alterations and Renovations Funds needed for renovation of existing space may be requested, if such space is needed to house core facilities or new or expanded research activities. According to the Public Health Service (PHS) Grants Management Policy Statement, detailed justification of the need, and plans for, the use of the renovated space must be provided in the application and renovation plans must be approved by NIH before funds for this purpose can be released. In order to ensure that any renovations or alterations are done in a timely manner, (1) the request for alterations and renovations must include a timetable, (2) the renovation plans must be received by NCHGR no later than three months after the date of funding of the grant, and (3) the work must be finished within one year from the date of NIH approval of the plan. The application must also outline any plans for accommodating the project during the expected renovation period. Such a plan should take into account any need for accommodation of the program in temporary space while the renovations are being done. The University administration's commitment to the proposed plan must be well documented. PHS policy also limits the dollar amount for alterations and renovations to the lesser of $150,000 or 25 percent of total direct costs over a three year period. Waivers to exceed this amount may be sought by the NCHGR in exceptional cases. Costs of equipping renovated laboratories may be included in the request if the items are directly related to the research being conducted in the center. Term of Support The term of support for GESTEC programs is normally five years. Post Award Management During the course of the grant period and as progress toward the goals of the Human Genome Project is made, the focus of the GESTEC grant will likely change. In order to ensure that GESTEC projects funded for five years remain focused on appropriate goals and make sufficient progress, frequent scientific and programmatic reviews will be conducted. Yearly meetings of the Directors of GESTEC projects and NCHGR staff will be held to discuss recent achievements and expected future directions. It is expected that Pis of GESTEC grants will make the necessary adjustments in scientific direction and management structure to accommodate to changing requirements. In the case of five-year awards, applications for competitive renewal of support will be due at the first submission date after the beginning of the fourth year. In the event that the review of this application is not favorable, this will allow sufficient time for submission and review of a revised application or for orderly phase-out of the grant. Further support will be for a three- to five-year period. As noted above, GESTEC projects are encouraged to use advisory committees as a means to obtain independent advice. In renewal applications, continued support of this activity must be justified by the demonstration that the advisory committee mechanism has been used effectively. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH and policy requires that applicants for NIH clinical research grants and cooperative agreements include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study; special emphasis must be placed on the need for inclusion of minorities and subjects of appropriate gender in studies of diseases, disorders, and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear, compelling scientific rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to carefully assess the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). Rationale must be provided for studies on single minority population groups. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders, or conditions including, but not limited to, clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include tissue from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the review will be deferred until the information is provided. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available from most institutional offices of sponsored research from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The title and number of the announcement must be typed in Section 2a on the face page of the application. The completed original and three legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Additionally, two copies of the application must also be sent to: Office of Scientific Research National Center for Human Genome Research Building 38A, Room 604 Bethesda, MD 20892 REVIEW PROCEDURES Upon receipt, applications will be reviewed for completeness by DRG staff. Incomplete applications will be returned to the applicant without further consideration. The regular NIH receipt dates for center grant and program project applications and renewals are: February 1, June 1, and October 1. Applications will be evaluated for scientific merit by the Genome Research Review Committee (GRRC) or an appropriate NCHGR review committee constituted for the purpose of evaluating GESTEC grant applications. Site visits may be conducted as part of the review process. However, applicants should present a complete and well-justified written proposal and not depend on site visits to amplify their application. Review criteria will include: o Significance and originality of the research and methodological approaches; o Feasibility of the research and adequacy of the experimental design; o Training, experience, research competence and commitment of the investigator(s); o Adequacy of the facilities and resources; o Provisions for the protection of human subjects, the humane care of animals and biosafety conditions. Subsequent to evaluation by the initial review group, applications will be reviewed by the appropriate National Advisory Council. AWARD CRITERIA The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review; o Value of the proposed research and of the proposed technology development for achieving the goals of the Human Genome Program; o Adequacy of the proposed management structure; o Nature and extent of the outreach program, including the adequacy of any plans proposed for sharing and distributing data and resources in a timely manner; o Balance among projects within the NCHGR's grant portfolio; o Availability of funds. INQUIRIES Written and telephone inquiries are strongly encouraged. The GESTEC grant proposal guidelines should be requested before preparing the grant application. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquires regarding the GESTEC program may be directed to: Jane L. Peterson, Ph.D. Research Centers Branch National Center for Human Genome Research Building 38A, Room 610 Bethesda, MD 20892 Telephone: (301) 496-7531 Specific questions regarding DNA sequencing/technology development may be directed to: Robert L. Strausberg, Ph.D. Technology Development Program National Center for Human Genome Research Building 38A, Room 610 Bethesda, MD 20892 Telephone: (301) 496-7531 Inquiries regarding fiscal matters may be directed to: Ms. Jean Cahill Grants Management Officer National Center for Human Genome Research Building 38A, Room 613 Bethesda, MD 20892 Telephone: (301) 402-0733 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.172. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. From owner-sci-resources@net.bio.net Wed Jun 02 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 20, pt. 2, 4 June 1993 Message-ID: Date: 3 Jun 93 20:45:37 GMT Sender: kristoff@net.bio.net Lines: 1220 Approved: biosci-moderator@net.bio.net $$XID NIHGUIDE 19930604 V22N20 P2O2 ************************************ III, Section 301 (Public Law 78-410, as amended; 42 USC 241) and administered under PHS grants policies and Federal Regulations at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P2 END ************************************************************ $$P3 BEGIN PA-93-091 FULL-TEXT ************************************** GENOME SCIENCE AND TECHNOLOGY CENTERS NIH GUIDE, Volume 22, Number 20, June 4, 1993 PA AVAILABLE: PA-93-091 P.T. 34; K.W. 1215018, 0755045, 1002058 National Center for Human Genome Research THE PROGRAM ANNOUNCEMENT (PA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE PA FROM THE CONTACT NAME IN INQUIRIES, BELOW. PURPOSE The purpose of this program announcement is to solicit new or renewal applications for large-scale projects in genomic research. The announcement describes a reformulated, flexible program for support of research efforts designed to complete the initial five-year goals of the research program of the National Center for Human Genome Research (NCHGR) and to progress beyond them toward the ultimate goal of determining the complete sequence of human DNA. The new program, which is called the Genome Science and Technology Centers (GESTEC) program, will support large-scale, multidisciplinary genomic studies under the P50 and P01 grant mechanisms. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Multi-institutional arrangements (consortia) are possible if there is a compelling reason for them and if there is clear evidence of close interaction among the participants. Applications from foreign institutions will not be accepted. However, subcontracts to foreign institutions are allowable, with sufficient justification. Applications from minority individuals and women are encouraged. Industrial/academic collaborations are also encouraged. MECHANISM OF SUPPORT Grants in the GESTEC program may be supported by specialized center grants (P50) or program project grants (P01). The P50 mechanism will be used for broad, complex, multidisciplinary programs that address the goals of the Human Genome Project. The P01 mechanism will be used for programs that support a minimum of three research components with a well-defined central research focus. The term of a GESTEC grant is normally for five years. RESEARCH OBJECTIVES Background The National Institutes of Health (NIH) is currently engaged, along with several other federal, private, and international organizations, in a 15-year research program designed to characterize the human genome and the genomes of selected model organisms. This research program, the Human Genome Project (HGP), has the following interrelated goals: (1) the construction of high- resolution genetic linkage maps; (2) the development of physical maps; (3) the determination of the complete nucleotide sequence of the genomes of selected organisms, including the human; (4) the development of the capability to collect, store, distribute and analyze the data and materials produced; (5) the development of appropriate new technologies to achieve these goals; and (6) the identification of major issues related to the ethical, legal and social implications (ELSI) of genome research, and the development of policy options to address them. The product of the Human Genome Project will be a set of information and material resources available to the entire research community that will facilitate further research as to the prevention, diagnosis, and therapy of disease, as well as a further understanding of human biology. In 1990, the NCHGR and the Department of Energy (DOE) jointly published a plan "Understanding Our Genetic Inheritance - The U.S. Human Genome Project: The First Five Years FY 1991-1995" that set out specific goals to be achieved in the first five-year phase of the U.S. human genome program. As of October 1993, the NCHGR will begin the fourth year of operation under that plan, with the prospect that many of the goals will be achieved on schedule. Anticipating the attainment of the initial set of goals, the NCHGR is currently engaged in developing goals for the second five-year period. At the same time, the NCHGR centers program, which has supported several large-scale, multidisciplinary projects that have made significant contributions to recent achievements, is also in transition, and a number of the grants awarded initially are scheduled for recompetition during the next year. The NCHGR intends to build upon the success of the current program and the lessons that have been learned from it, by establishing a reformulated centers program, the Genome Science and Technology Centers (GESTEC) program. This announcement solicits applications for new and continuing projects that propose to finish the goals of the first five-year component of the HGP and to address the further needs of the project, leading toward complete sequencing of the human genome and the genomes of selected model organisms. Progress and Future Needs in Mapping For the genetic linkage map, several current efforts, both genome-wide or on an individual chromosome level, are expected to achieve the timely completion of the 2 to 5 centimorgan genetic map called for in the Five-year Plan. Similarly, recent progress in physical mapping has been very rapid, with contiguous for long genomic regions, including two human chromosomes and parts of many others, having been assembled. Continued technology development will be necessary to ensure progress toward sequencing the entire human genome, e.g., new techniques or strategies will be needed to generate "sequence-ready" physical maps, comprised of DNA that can be readily sequenced. Better methods of annotating genetic and physical maps, e.g., with genes and other functional elements, on a genomic scale are also needed. Progress and Future Needs in DNA Sequencing Progress has also been rapid toward the long-term goal of the Human Genome Program, i.e., determining the complete sequence of the DNA of certain model organisms and the human. In 1990, the cost of sequencing in laboratories devoted to DNA sequencing was estimated to be about $5 per finished base and the rate at which finished sequence could be generated was relatively low. Through a number of efforts, advanced sequencing laboratories are generating contiguous finished sequence at a rate projected to be a megabase per year and a cost of $1 per finished base pair by the end of the first five years. Multidisciplinary centers will be needed to develop and implement visionary, integrated strategies that will optimize the several aspects of DNA sequencing, including sample preparation, band resolution and detection, sequence assembly and finishing, and annotation. Objectives and Scope The GESTEC program is intended to develop the technologies needed to accomplish the goals of the Human Genome Program and to apply them to the large-scale generation of mapping and sequencing information. Improved informatics solutions to data management will be a vital component to realizing success in these efforts. While primary focus will be on the mapping and sequencing objectives, it is also appropriate to address the need for better methods of annotating the maps and sequences, e.g., techniques for identifying and mapping all of the genes and/or other functional elements in a large genomic region. The GESTEC program is NOT intended to fund projects in which existing technology is simply applied to large-scale production or projects that involve a consortium of investigators whose research interests are only loosely united by a common theme. To achieve the ambitious goals that this program is intended to attain, it is anticipated that a Genome Science and Technology Center must be: (a) mission-oriented, addressing in a highly integrated way, a major, quantifiable goal(s) of the HGP; (b) creative and innovative in terms of the proposed strategy and development of new technology for achieving its goal(s); (c) readily adaptable to new technology and new scientific developments; (d) focused on issues of increased efficiency as evidenced by a plan for improvements in the rate of output of data and materials; and (e) attentive to the needs of the larger scientific community, as demonstrated by the inclusion of an outreach program that will allow the center to act as a hub for collaboration and as a source for materials and information; the study of ELSI issues and outreach to the general public through education programs can be a component of such an outreach activity. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available from most institutional offices of sponsored research and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The title and number of the announcement must be typed in Section 2a on the face page of the application. The completed original and three legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Additionally, two copies of the application must also be sent to: Office of Scientific Research National Center for Human Genome Research Building 38A, Room 604 Bethesda, MD 20892 REVIEW PROCEDURES Upon receipt, applications will be reviewed for completeness by the Division of Research Grants. Incomplete applications will be returned to the applicant without further consideration. The regular NIH receipt dates for center grant and program project applications and renewals are: February 1, June 1, and October 1. Applications will be evaluated for scientific merit by the Genome Research Review Committee (GRRC) or an appropriate NCHGR review committee constituted for the purpose of evaluating GESTEC grant applications. Site visits may be conducted as part of the review process. However, applicants should present a complete and well-justified written proposal and not depend on site visits to amplify their application. Review criteria will include: (1) significance and originality of the research and methodological approaches; (2) feasibility of the research and adequacy of the experimental design; (3) training, experience, research competence and commitment of the investigator(s); (4) adequacy of the facilities and resources; and (5) provisions for the protection of human subjects, the humane care of animals and biosafety conditions. Subsequent to evaluation by the initial review group, applications will be reviewed by an appropriate National Advisory Council. AWARD CRITERIA The following will be considered in making funding decisions: (1) quality of the proposed project as determined by peer review; (2) value of the proposed research and of the proposed technology development for achieving the goals of the Human Genome Program; (3) adequacy of the proposed management structure; (4) nature and extent of the outreach program, including the adequacy of any plans proposed for sharing and distributing data and resources in a timely manner; (5) balance among projects within the NCHGR's grant portfolio; and (6) availability of funds. INQUIRIES Written and telephone inquiries are strongly encouraged. The program announcement and GESTEC grant proposal guidelines should be requested before preparing the grant application. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding the GESTEC program and requests for the program announcement may be directed to: Jane L. Peterson, Ph.D. Research Centers Branch National Center for Human Genome Research Building 38A, Room 610 Bethesda, MD 20892 Telephone: (301) 496-7531 Specific questions regarding DNA sequencing/technology development may be directed to: Robert L. Strausberg, Ph.D. Technology Development Program National Center for Human Genome Research Building 38A, Room 610 Bethesda, MD 20892 Telephone: (301) 496-7531 Inquiries regarding fiscal matters may be directed to: Ms. Jean Cahill National Center for Human Genome Research Building 38A, Room 613 Bethesda, MD 20892 Telephone: (301) 402-0733 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.172. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P3 END ************************************************************ $$XID RFA AI93013 AI-93-013 P1O1 *************************************** GENE THERAPY FOR HIV-1 INFECTION: PRECLINICAL DEVELOPMENT NIH GUIDE, Volume 22, Number 20, June 4, 1993 RFA: AI-93-013 P.T. 34; K.W. 0715008, 1002045, 0745032 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: July 1, 1993 Application Receipt Date: September 8, 1993 PURPOSE This Request For Application (RFA) is designed to support applied preclinical development studies for gene therapy systems targeting HIV; such studies are vital for the transition from basic research to experimental clinical evaluation in infected individuals. Studies in response to this RFA may propose to refine: viral vectors for in vivo delivery; physical methods for in vivo transduction (liposomes, receptor-ligand, naked DNA); expression of anti-HIV genes or anti-cellular factors (negative transdominants, RNA-decoys, ribozymes) for maximal virus inhibition in PBL challenged with clinical HIV isolates. Studies listed above are examples only, and are not intended to be exclusive or comprehensive. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Gene Therapy for HIV-1 Infection: Preclinical Development, is related to the priority area of HIV Infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone (202) 783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, private and public institutions such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The support mechanism for this program is the individual research project grant (R01) award. It is the responsibility of the applicants to plan, direct, and execute the proposed projects in accord with their ongoing commitment to the development of gene therapy as a treatment for HIV infected individuals. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of the awards will also vary. The anticipated award date is March 1994. This RFA is a one-time solicitation. Future unsolicited applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE The National Institute of Allergy and Infectious Diseases (NIAID) has set aside $0.6 million (total costs) for first year funding of applications received in response to this RFA. Three to four awards are anticipated. The final number and specific amounts of awards to be made will depend on the scientific quality, merit and scope of the applications received, on relevance to programmatic priorities, and on the availability of funds. The total project period for applications submitted in response to this RFA may not exceed four years. RESEARCH OBJECTIVES Background Acquired Immune Deficiency Syndrome (AIDS) is a disease that destroys the body's capacity to mount an effective immune response against a variety of infections. As of March 31, 1993, 289,320 cases of AIDS had been reported in the United States by the Centers for Disease Control (CDC) and more than 182,275 of these patients (63%) had died. Recent projections indicate that between 1,000,000 to 1,200,000 persons in the United States may already be infected with HIV, the infectious virus associated with AIDS. To date, three drugs, AZT, ddI, and ddC, all targeted to the viral reverse transcriptase, have been approved by the FDA for HIV therapy. Despite the advances in treating HIV infection with nucleoside analogues, these agents have a limited duration of activity; further, the emergence of drug-resistant isolates upon prolonged treatment limit their indefinite use. Several drugs, including non-nucleoside reverse transcriptase inhibitors (NNRTI) and those targeted against unique steps in HIV replication (protease inhibitors, Tat-inhibitor) are currently undergoing clinical evaluation. Not with standing these efforts, the rapid emergence of HIV resistant variants to certain NNRTI in vitro and in clinical trials, reports of in vitro emergence of resistant isolates to protease inhibitors, and uncertainties regarding the efficacy of newer drugs, point to the urgent need to develop anti-HIV therapeutic strategies based on state-of-the-art technological advances. While these may involve greater research risk than traditional antiviral approaches, they offer the potential to effect long lasting therapeutic benefit. Gene therapy - the process by which new genetic information is introduced into patients' cells with a resulting therapeutic benefit - is a cutting-edge strategy potentially applicable for the treatment of HIV infection. Gene therapy is not a single antiviral strategy but rather a conglomerate of discrete, yet diverse manipulative steps resulting in the endowment of target cells with an antiviral 'protective' capability. Principal steps involved in an anti-viral gene therapy strategy include: o Selecting the target for intervention (viral or host function); o Designing, constructing, and expressing the inhibitory gene (RNA decoys, transdominant negative gene product, catalytic RNA, others); o Selecting the vehicle for gene delivery: defective viral vectors [retroviral (retV), HIV, adenoassociated virus (AAV), others]; liposomes; receptor-ligand mediated; other; o Selecting the mode of intervention: ex vivo modification and manipulation of target cells or direct injection of genetic information ('naked' DNA) into accessible tissue for augmenting immune responses. Comprehensive preclinical studies for gene therapy strategies in vitro are already underway. Moreover, a clinical trial that uses one form of gene therapy is in progress: HIV patients with AIDS-associated lymphomas which have received allogeneic bone marrow are treated post transplantation with a combination of chemoradiotherapy, AZT, and adoptive transfer of modified CD8+ T cells [containing fused genes of herpes virus thymidine kinase (tk) and bacterial hygromycin (hgh)] to minimize infection of donor- derived cells. In most cases, however, once a promising gene therapy strategy is identified at the basic research level, funding to support preclinical development work essential for the transition to applied clinical phase is lacking. This initiative will support applied, advanced preclinical development studies of gene therapy for HIV, thereby bridging the gap between the early basic research ('discovery' phase) and applied clinical phases. [Concomitant with strategies to abate HIV gene expression/replication, there is an urgent need for therapeutic strategies that augment/restore immune functions in the immune compromised individual. These two facets of HIV infection - viral gene expression/replication and a gradual deterioration of the immune system - must be controlled to prevent the onset/exacerbation of AIDS. A separate RFA (AI-93-12) for 'Complete Immune Reconstitution of HIV-1 Infected Individuals' focuses on hematopoietic stem cell biology that may be exploited to restore immune functions to HIV positive subjects. Research objectives and scope The objective of this RFA is to support 'post discovery' HIV gene therapy studies and to propel promising, state-of-the-art therapies closer to clinical evaluation. The many aspects in this transition process are responsive to this RFA, including optimization of intracellular delivery/expression of antiviral genes as well as optimization of in vivo transduction methods capable of enhancing immune parameters in HIV infected individuals. Studies to be funded under this RFA are restricted to investigators with ongoing gene therapy projects which are directly related to HIV infection. Investigators must demonstrate a commitment to the advanced preclinical development and translation of a defined gene approach to clinical evaluation. Applications proposing a unique strategy for gene delivery are responsive to the RFA provided the proposed preclinical optimization studies focus on application to HIV infection. Examples of advanced preclinical development projects responsive to this RFA include: o Optimization of existing viral vectors [retV, HIV, AAV, herpes simplex virus (HSV), others] for antiviral gene delivery to target cells. This includes gene stability, expression levels, tissue specific promoters if required, purity and yield of recombinant vector stock, stringent assessment for "leakiness" of helper-free virus, and other parameters relevant to vector design and application. o Optimization of non-viral delivery vehicle (liposomes,receptor-ligand, other); o Comparative assessment in relevant in vitro and/or animal models of different anti-HIV genes, cis-acting regulatory elements, or cellular functions critical for HIV gene expression for maximal virus inhibition. Examples of intracellular molecular inhibitors include: transdominant negative mutants (tat, rev, gag, others); RNA decoys (RRE, TAR, psi); multivalent ribozymes; antisense molecules; transdominant mutants of NFkB; and Tat, Rev, TAR and RRE binding proteins. Multi-pronged targeting of unique viral functions for enhanced inhibition and reduction of viral load are encouraged. o Refinement of vectors that provide stable, persistent expression in mature and stem cell derived differentiating cells susceptible to HIV infection; o Development of efficient and safe methods to enhance infection of target cells (T-cells, stem cells, other) by recombinant vectors and reduce ex vivo manipulations; o Development of anti-HIV strategies for the induction of cytolytic T lymphocytes (CTL) and humoral response in HIV infected individuals. Encouraging data in animal models using in vivo delivery of HIV-gp120 gene suggest the feasibility of inducing MHC-dependent CTL response as a form of immune augmentation in HIV infected individuals; o Safety assessment of HIV gene therapy strategies in appropriate animal models including toxicity studies. Relationship to Ongoing Programs A complementary RFA for immune reconstitution of HIV-infected patients with multi-potent stem cells engineered to resist HIV infection is available. Studies on gene therapy for the treatment of HIV infection funded or supported under other RFAs or other programs, which have overlapping specific aims or objectives, are not responsive to this RFA. SPECIAL REQUIREMENTS The NIAID will organize one to two meetings a year to which the Principal Investigators and other key personnel will be invited to attend. This meeting will serve to promote interaction/collaboration among awardees, discuss scientific issues bearing on preclinical/clinical development of gene therapy strategies, and feasibility of planned approaches. Other investigators with ongoing programs in gene therapy strategies for HIV infection will be invited to further promote exchange of information and ideas. Funds for travel to this meeting should be included in the budget. For budgetary purposes, applicants should assume travel costs for one meeting to the Washington DC area or vicinity. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study populations must be described in terms of gender and racial/ethnic group, together with a rationale for its choice. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans including American Indians or Alaskan Natives, Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign populations groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants that do not comply with these policies. NOTE: Peer review groups need adequate information about the composition of proposed study populations in all applications involving human subjects. To avoid delays in review of such applications, the NIAID therefore requires that, as a minimum, the application must contain demographic data about the clinic and/or in-patient population from which study subjects (including clinical samples, materials, or fluids) will be drawn: average hospital admissions and/or clinic visits per year; percentage distribution of black/hispanic/other minority/non-minority populations; gender; etc. Studies using non-hospital populations, such as community-based studies, should provide similar data about populations in the area or region from which the study subjects will be drawn. In the absence of current data, historical demographic information and/or previous recruitment data for similar studies from the proposed study sites should be provided. LETTER OF INTENT Prospective applicants are asked to submit, by July 1, 1993 a letter of intent that includes a descriptive title of the proposed research, the names and affiliation(s) of the Principal Investigator and other key personnel, and the number and title of this RFA. Although the letter of intent is not required, is not binding, and does not enter into subsequent peer review deliberation, it provides NIAID staff with information on the number and scope of applications to be expected, allows estimation of the potential review workload, and avoids conflict of interest in the review. The letter of intent is to be sent to Dr. Madelon Halula at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, Telephone (301) 594-7248. The deadline for receipt of application in response to this RFA is September 8, 1993. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center of Research Resources may wish to identify the Center as a resource for conducting the proposed research. If so, a letter of agreement from the GCRC Program Director must be included in the application material. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title 'Gene Therapy for HIV-1 Infection: Preclinical Development' and number (RFA AI-93-013) must be typed on line 2a of the face page of the application, and the 'Yes' box marked. Submit, in one package, a signed typewritten original of the application including the Checklist, and three signed, exact single-sided photocopies, to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission to DRG, two additional, exact copies must be sent to Dr. Madelon Halula at the address indicated under INQUIRIES, below. Applications received after the receipt date will be returned without review. Alternatively, late applicants will be contacted and given the option of having the application returned or having it submitted for review in competition with unsolicited applications for the next DRG cycle. The DRG will not accept an application in response to this RFA which is essentially the same as one pending initial review, unless the applicant withdraws the pending application. DRG will not accept an application which is essentially the same as one already reviewed. This does not preclude the submission of a revised application already reviewed. Revised application, however, must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications and supporting material will be reviewed by DRG for completeness, and by NIAID staff to determine administrative and programmatic responsiveness to this RFA. If the application is judged to be not responsive, NIAID staff will contact the applicant and present the same options for handling the application as in late submission, above. Applications may be triaged by an NIAID peer group on the basis of relative competitiveness among applications responsive to this RFA. The NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the Principal Investigator and institutional official. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate review committee convened by the NIAID. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council. Review Criteria Review criteria for assessing the merit of submitted applications include: o documented primary observations of an identified gene therapy strategy with high potential for development of effective anti-HIV therapy (e.g., use of specific antiviral gene); o preliminary data indicating feasibility of the strategy to be developed; o likelihood for high therapeutic potential payoff that justifies greater than usual risk level; o originality and adequacy of the experimental approach for developing the identified strategy; o scientific and technical merit of the proposed research; o qualification and research experience of the Principal Investigator and staff, specifically but not exclusively in the area of gene therapy; o availability of resources necessary to perform the studies; o appropriateness of the proposed budget and duration in relation to the proposed budget. AWARD CRITERIA The anticipated date of award is March 1994 The primary criterion for award is the scientific and technical merit of the application as judged by peer reviewers and reflected in priority score. Additional award criteria are the availability of funds, receipt of a sufficient number of scientifically meritorious applications that are responsive to this RFA, and overall programmatic relevance and priority. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged; the opportunity to clarify issues and questions from prospective applicants is welcome. Direct inquiries concerning the programmatic and scientific aspects of this RFA to: Nava Sarver, Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2C11 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-8197 FAX: (301) 402-3211 Direct inquiries regarding matters pertaining to the review of applications and address the letter of intent to: Madelon Halula, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C10 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 402-2636 FAX: (301) 402-2638 Email: MHalula@exec.niaid.pc.niaid.nih.gov Direct inquiries regarding fiscal matters to: Ms. Jane Unsworth Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B22 Bethesda, MD 20892 Telephone: (301) 496-7075 FAX: (301) 480-3780 Schedule Letter of Intent Receipt Date: July 1, 1993 Application Receipt Date: September 8, 1993 Scientific Review Date: November 1993 Advisory Council Date: February 1994 Anticipated Award date: March 1994 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, 93.856 - Microbiology and Infectious Diseases Research and 93.855 - Immunology, Allergic and Immunological Diseases Research. Grants are awarded under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under the PHS grants policies and Federal Regulations, most specifically at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of the Executive Order 12372 or Health Systems Agency review. $$XID RFA DE93005 DE-93-005 P1O1 *************************************** SHORT-TERM TRAINING FOR MINORITY AND WOMEN DENTAL STUDENTS NIH GUIDE, Volume 22, Number 20, June 4, 1993 RFA: DE-93-005 P.T. 44, FF, II; K.W. 0715148 National Institute of Dental Research Letter of Intent Receipt Date: August 10, 1993 Application Receipt Date: September 10, 1993 PURPOSE The National Institute of Dental Research (NIDR) invites applications proposing short-term, institutional training programs for minority and women dental students in basic and clinical oral health research. The NIDR has found that there is a paucity of minority and women investigators in oral health research. The primary objective of this training program is to provide women and minority dental students an opportunity to obtain a research experience during their professional training. This will encourage the selection of research careers and help them to develop into clinical investigators. These programs must involve collaborative funding among the NIDR, the applicant institution, and/or other public or private sources. Proposed training must be relevant to the goals of the NIDR, as described in the NIDR Long-Range Research Plan for the Nineties, "Broadening the Scope." Availability of this publication is described under the section on INQUIRIES. The NIDR supports research on the causes, epidemiology, prevention, diagnoses, and treatments of dental caries, periodontal and oral soft tissue diseases, craniofacial anomalies and orofacial pain. This includes normal and abnormal craniofacial development; the structure and function of teeth, jaws, oral mucosa, bone, connective tissue, salivary glands and other organs and tissues of the craniofacial complex; trigeminal neurobiology; the relationship of behavioral, social, economic and cultural factors to oral diseases and conditions; dental biomaterials; and the role of fluoride and nutrition in oral health and disease. The Institute emphasizes the need for research on older Americans, minority groups, and individuals with medical and handicapping conditions or who are otherwise at high risk for oral health problems. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Short-Term Training for Minority and Women Dental Students, is related to the priority area of oral health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). Eligibility Requirements Applications may be submitted from domestic, public, and private institutions and the applicant institution must have, or be able to develop, the staff and facilities for the proposed program. Applications will be accepted to provide training for women and minority dental degree students for a short-term research experience, during the summer months, with a minimum period of two months. Trainees must be enrolled in a program leading to a D.D.S. or equivalent degree. Trainees must be citizens or non-citizen nationals of the United States or have been lawfully admitted for permanent residence (i.e., in possession of the Alien Registration Receipt Card I-551 or I-151) at the time of appointment. Individuals on temporary or student visas are not eligible. Minority trainees may be any of the following: American Indian or Alaskan Native (a person having origins in any of the original peoples of North America, and who maintains cultural identification through tribal affiliation or community recognition); Black (not of Hispanic origin) (a person having origins in any of the black racial groups of Africa); Hispanic (a person of Mexican, Puerto Rican, Cuban, Central or South American or other Spanish culture or origin regardless of race); Pacific Islander (a person having origins in any of the original peoples of Hawaii; the U.S. Pacific Territories of Guam, American Samoa, and the Northern Marianas; the U.S. Trust Territory of Palau; the islands of Micronesia and Melanesia; or the Philippines). If the applicant institution determines that Asians are underrepresented at their institution in the sciences in which training will be offered, they may be appointed to this training grant. An Asian is defined as a person having origins in any of the original peoples of East Asia, Southeast Asia, or the Indian subcontinent. This area includes, for example, China, India, Indonesia, Japan, Korea, and Vietnam. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) National Research Service Award (NRSA) Short-Term Institutional Research Training Grant (T35). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to this RFA may not exceed five years; awards may be renewable upon the completion of a successful competing application. Trainees may receive up to three months of support per year. FUNDS AVAILABLE The NIDR expects to make up to four institutional training awards in response to this RFA. This level of support is dependent on the receipt of a sufficient number of applications of high scientific and educational merit. Although this program is provided for in the financial plans of the NIDR, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. An institution may hold two NIDR NRSA Short-Term Training Grants, one conventional, short-term training grant and one in response to this RFA. BACKGROUND The NIDR is committed to increasing the number of women and members of minority groups that are underrepresented in oral health research. A variety of mechanisms are used to encourage women and minorities to consider careers in oral health research and obtain the necessary training. The NIDR cofunds oral health related projects in the Minority Biomedical Research Support (MBRS) and Minority Access to Research Careers (MARC) programs sponsored by the National Institute of General Medical Sciences. The MBRS program awards grants to educational institutions with substantial minority enrollments to support research by faculty members, strengthen the institutions' biomedical research capabilities, and provide opportunities for students to work as part of a research team. The MARC program provides special research training opportunities for faculty and students at 4-year colleges, universities and health professional schools, in which substantial student enrollments are drawn from minority groups. NIDR staff work closely with the Office of Research on Women's Health, NIH, to encourage the participation of women in oral health research and to provide research supplements to enable women and men to reenter an active research career after taking time off to attend to pressing family responsibilities. Applications for all institutional training and career development programs must include formal plans for the recruitment of women and minorities; recruitment records are evaluated critically when renewal applications are reviewed for funding. In 1992, almost 30 percent of individuals receiving training under the Career Development Award program (K awards) were women; almost 40 percent of individuals supported by the NRSA program were women. Minorities constituted only 11 and 15 percent of individuals supported by the Career Development and NRSA training programs, respectively. However, NIDR Research Supplements for Underrepresented Minorities provide another approach to research training for minorities. In 1992, supplements to research project, program project and center grants allowed 33 minority university faculty, postdoctoral fellows, graduate students, undergraduates and high school students, to participate in NIDR sponsored research. Clearly, additional efforts are needed to encourage minorities and women to consider careers in oral health research. One proven strategy is to provide an opportunity for these individuals to experience research first-hand under the mentorship of an investigator active in oral health research. An opportune time to participate in such an experience is during dental school training when students are considering career choices. Awards resulting from this RFA will provide such opportunities. Program Characteristics The training program must provide opportunities for minority and women dental students to carry out supervised biomedical or behavioral oral health research and develop research skills. Clinical programs must have strong relationships with basic research to assure students the opportunity to acquire the necessary experience to pursue basic and clinical research training. The training program director will be responsible for the selection and appointment of trainees and for the overall direction of the program. In addition, the program director and awardee institution will be expected to track the career paths of all the trainees for a period of ten years after they receive their dental degree. The program director will provide the NIDR with these data annually. Applicants may request as many trainee positions as can be justified, with a minimum of four trainees per year. The program will be a collaborative funding effort among the NIDR, the applicant institution, and other public and/or private sources. Stipends and other training costs will be provided by the NIDR. Other support sources will provide room and board for the time the dental students are on the short-term training grant, if necessary. If students require funds to travel from their home base to the applicant institution to participate on this training grant, the program director and the awardee institution must obtain the necessary resources to do this. Stipends and Other Training Costs The stipend for trainees is $734 per month ($8,800 per year). Institutions may supplement the stipends with non-Federal funds. Federal funds may be used for stipend supplementation only if specifically authorized under the terms of the program from which the supplemental funds are derived. An individual may make use of Federal educational loan funds or Department of Veterans' Affairs benefits when permitted by those programs. Under no circumstance may the condition of stipend supplementation detract from or prolong the training. The Tax Reform Act, Public Law 99-514, impacts on the tax liability of all individuals supported under the NRSA program. The NIH is not in a position to advise students or institutions about their tax liability. In any event, the taxability of stipends in no way affects the relationship between NRSA trainees and institutions. NRSA stipends are not now, and never have been, salaries. Trainees supported under the NRSA are not in an employer-employee relationship with the NIH or the institution at which they are pursuing research training. Institutional costs of $125 per month per trainee may be requested to defray the cost of training related expenses. Indirect costs based on eight percent of total NIH allowable direct costs, or actual indirect costs, whichever is less, may be requested. Applications from state and local government agencies may request full indirect cost reimbursement based upon the NIH allowable direct costs awarded. Payback Provisions All recipients of NRSA support must sign an agreement that they will fulfill payback requirements. They must agree to engage in biomedical or health-related behavioral research and/or teaching for a period equal to any period of cumulative NRSA support in excess of 12 months. In calculating payback indebtedness, the period of support from these short-term training programs will be added to any subsequent periods of support from NRSA programs such as institutional training programs (T32) or individual postdoctoral fellowships (F32, F33, F35). Trainees must undertake the obligated service on a continuous basis within two years after termination of support. Individuals who fail to fulfill the obligation through service must pay back the total amount of funds paid to the individual for the obligation period plus interest at a rate determined by the Secretary of the Treasury. Financial payback must be completed within three years of the date the United States becomes entitled to recover such amount. Under certain conditions, the Secretary of Health and Human Services may extend the period for starting service or for repayment, permit breaks in the period of service or repayment, or otherwise waive or suspend the payback obligation of an individual. Officials of the applicant organization responsible for recruitment of trainees should familiarize themselves with the terms of the payback service requirement and explain them carefully to prospective trainees before an appointment to the training grant is offered. For additional information, including the grounds for approving extensions of support and payback provisions, refer to the announcement in the NIH Guide for Grants and Contracts, "National Research Service Awards - Guidelines for Individual Awards - Institutional Grants," Special Edition, Volume 13, No. 1, January 6, 1984. LETTER OF INTENT Prospective applicants are asked to submit, by August 10, 1993, a letter of intent that includes a descriptive title of the proposed research training program, the name, address, and telephone number of the Program Director, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIDR staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr.Thomas M. Valega at this address listed under INQUIRIES. APPLICATION PROCEDURES It is strongly recommended that prospective applicants contact Dr. Valega early in the planning phase of application preparation. Such contact may help ensure that applications are responsive to this RFA. Applications must be submitted on form PHS 398 (rev. 9/91). Application forms are available at most institutional office of sponsored research; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248, and from the NIDR program administrator listed under INQUIRIES. To identify the application as a response to this RFA, check "yes" on item 2a of page AA of the application and enter "RFA: DE-93-005, SHORT-TERM TRAINING FOR MINORITY AND WOMEN DENTAL STUDENTS." The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892-4500** At the time of submission, two additional copies of the application must also be sent to: H. George Hausch, Ph.D. Scientific Review Section National Institute of Dental Research Westwood Building, Room 519 Bethesda, MD 20892 Telephone: (301) 594-7632 This RFA is for a single competition. Applications must be received by September 10, 1993. If an application is received after that date or deemed non-responsive to the RFA, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Applications will be evaluated for scientific and technical merit by the NIDR Special Grants Review Committee, a standing NIH initial review group. Applicant interviews or site visits may be involved. The following review criteria will be applied: o Procedures for recruiting women and individuals from minority groups: a plan must be included for the recruitment of these individuals. No awards will be made to applications lacking this component. o Procedure for the selection of trainees: availability of high quality candidates; how the candidates will be selected; how the trainees are assigned to preceptors. o The proposed research training and program design; the manner in which individual guided research activities will be selected; procedures for monitoring trainee progress; the existence of a true training program, as contrasted with fellowship training for an individual trainee; the appropriateness of the proposed number of trainees; the unique and/or innovative nature of the training program; resources and facilities. o The qualifications of the program director and participating faculty including the roles of specific preceptors, their time commitment, ability to compete successfully for research support, current and pending research grant holdings and experience in graduate research training. o Training environment: institutional commitment, the quality of the facilities, and the availability of research support; level of ongoing fundamental and clinical research activity; availability of equipment, facilities, and clinical resources. o The funding commitment from the institution to provide room and board and from private sources to provide funds for trainee travel to the institutional training site. o The methods by which the trainees will be exposed to career path options in oral health research. o The methods by which the program director will track the career paths of the trainees supported by this training grant. Secondary review will be by the National Advisory Dental Research Council. Review and Award Schedule Applications will be processed according to the following schedule: Application Receipt Date: Sep 10, 1993 Initial Review Group Meeting: Feb/Mar 1994 Council Meeting: May/Jun 1994 Earliest Award Date: Sep 1, 1994 AWARD CRITERIA The earliest award date will be September 1, 1994. The NIDR will notify the applicant of the Council's action shortly after its meeting. Funding decisions will be made based on the Special Grants Review Committee and Council recommendations, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Thomas M. Valega, Ph.D. Special Assistant for Manpower Development and Training National Institute of Dental Research Westwood Building, Room 503 Bethesda, MD 20892 Telephone: (301) 594-7617 FAX: (301) 594-7616 Direct inquiries pertaining to fiscal and policy matters to: Theresa Ringler Extramural Program National Institute of Dental Research Westwood Building, Room 510 Bethesda, MD 20892 Telephone: (301) 594-7629 Copies of the NIDR Long-Range Research Plan for the Nineties, "Broadening the Scope," are available by a written request to NIDR, P.O. Box 54793, Washington, DC 20032 AUTHORITY AND REGULATIONS NRSA Institutional Research Training Grants are made under the authority of Section 487 of the Public Health Service (PHS) Act as amended (42 USC 288), Title 42 of the Code of Federal Regulations, Part 66, is applicable to this program. This program is also described in the Catalog of Federal Domestic Assistance No. 93.121. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. From owner-sci-resources@net.bio.net Sun Jun 06 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 6 June 1993 Message-ID: Date: 7 Jun 93 18:39:52 GMT Sender: kristoff@net.bio.net Lines: 44 Approved: biosci-moderator@net.bio.net ------------------------------------------------------------------------ There were no new documents on STIS this week. ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet) or stisinfo@NSF (BITNET). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserv@nsf.gov (Internet) or stisserv@NSF (BITNET). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve nsf9110, the text of your message should be as follows: get nsf9110 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf9110, you would enter: ftp> get nsf9110 WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "firstop@nsf.gov" (Internet) or "firstop@nsf" (BITNET). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet) or "stis@NSF" (BITNET). From owner-sci-resources@net.bio.net Tue Jun 15 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 13 June 1993 Message-ID: Date: 16 Jun 93 03:13:26 GMT Sender: kristoff@net.bio.net Lines: 152 Approved: biosci-moderator@net.bio.net ** NEW DOCUMENTS ON STIS ** Document Type: Bulletin Title: NSF Bulletin June, July, August (Vol.20; No. 10) File size (bytes): 38442 STIS Filename: bul9306 Document Type: Letter Title: Nationwide search for Engineers File size (bytes): 4098 STIS Filename: leng9302 Title: NSF93-80 Undergraduate Chemistry Education File size (bytes): 9214 STIS Filename: nsf9380 Document Type: Press Release Title: NSF PR 93-46 File size (bytes): 4289 STIS Filename: pr9346 Title: NSF PR 93-47 File size (bytes): 4427 STIS Filename: pr9347 Title: NSF PR 93-48 File size (bytes): 5873 STIS Filename: pr9348 Title: NSF PR 93-49 File size (bytes): 5289 STIS Filename: pr9349 Title: NSF PR 93-50 File size (bytes): 3285 STIS Filename: pr9350 Title: NSF PR 93-51 File size (bytes): 2189 STIS Filename: pr9351 Title: NSF PR 93-52 File size (bytes): 7482 STIS Filename: pr9352 Title: NSF PR 93-53 File size (bytes): 5769 STIS Filename: pr9353 Document Type: Program Guideline Title: NSF 93-71 (SBER) File size (bytes): 34154 STIS Filename: nsf9371 Title: Instrumentation Grants for Research in Computer and Information Sciences and Engineering NSF 93-72 File size (bytes): 14382 STIS Filename: nsf9372 Title: NSF 93-77 - NSF-NATO Postdoctoral Fellowships- Outreach to East Europe File size (bytes): 18072 STIS Filename: nsf9377 Document Type: Recruit Title: National Environmental Policy Act Compliance Manager File size (bytes): 5334 STIS Filename: vex9320 Title: Biologist (NEPA Compliance Manager) File size (bytes): 5991 STIS Filename: vgm9361 Title: Environmental Engineer (NEPA Compliance Manager) File size (bytes): 6009 STIS Filename: vgm9362 Document Type: Report Title: NSF 93-22 - National Conference on Diversity in the Scientific and Technological Workforce File size (bytes): 271425 STIS Filename: nsf9322 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Phone Book Title: NSF Alphabetical Listing File size (bytes): 90639 STIS Filename: phnalpha Title: NSF Alphabetical Listing File size (bytes): 90639 STIS Filename: phnalpha Title: NSF Organizational Directory File size (bytes): 95954 STIS Filename: phnorg Title: NSF Organizational Directory File size (bytes): 95954 STIS Filename: phnorg ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet) or stisinfo@NSF (BITNET). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserv@nsf.gov (Internet) or stisserv@NSF (BITNET). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve phnorg, the text of your message should be as follows: get phnorg Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnorg, you would enter: ftp> get phnorg WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "firstop@nsf.gov" (Internet) or "firstop@nsf" (BITNET). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet) or "stis@NSF" (BITNET). From owner-sci-resources@net.bio.net Thu Jun 17 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 21, pt. 1, 11 June 1993 Message-ID: Date: 18 Jun 93 17:16:16 GMT Sender: kristoff@net.bio.net Lines: 1506 Approved: biosci-moderator@net.bio.net NOTE: The NIH Guide may be split into more than one mail message to avoid truncation during e-mail distribution. The first message always begins with the RFP/RFA summary sections followed by the appended texts of the full RFP/RFAs. ---------------------------------------------------------------------- $$XID NIHGUIDE 19930611 V22N21 P1O3 ************************************ X-comment: RFAs described: HD-93-014, CA-93-027, AI-93-018, CA-93-029 NIH GUIDE - Vol. 22, No. 21 - June 11, 1993 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NOTICE OF UPDATE OF THE NIH RESEARCH RESOURCES DATABASE National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N2 ********************************************************** STANDARD PROCEDURES FOR REPORTING PROGRAM INCOME National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** EXTENSION OF COOPERATIVE AGREEMENTS ON MATCHING PATIENTS TO ALCOHOLISM TREATMENTS National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM $$INDEX N4 ********************************************************** EXTENSION OF COOPERATIVE AGREEMENTS ON THE GENETICS OF ALCOHOLISM National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM $$INDEX N5 ********************************************************** CONFERENCE ON PLAGIARISM AND THEFT OF IDEAS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N6 ********************************************************** NICHD TRANSGENIC MOUSE DEVELOPMENT FACILITY National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX N7 ********************************************************** AVAILABILITY OF PROGRAM PROJECT GUIDELINES National Cancer Institute INDEX: CANCER $$INDEX N8 ********************************************************** NIH REGIONAL SEMINAR IN GRANTS ADMINISTRATION National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N9 ********************************************************** THE HUMAN BRAIN PROJECT: PHASE I FEASIBILITY STUDIES (PA-93-068) National Institute of Mental Health National Institute on Drug Abuse National Science Foundation National Institute on Aging National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Center for Research Resources National Library of Medicine Office of Naval Research National Aeronautics and Space Administration INDEX: MENTAL HEALTH; DRUG ABUSE; NATIONAL SCIENCE FOUNDATION; AGING; CHILD HEALTH, HUMAN DEVELOPMENT; DEAFNESS, COMMUNICATION DISORDERS; RESEARCH RESOURCES; NATIONAL LIBRARY OF MEDICINE; NAVAL RESEARCH; AERONAUTICS, SPACE ADMINISTRATION NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** SYNTHETIC PEPTIDES: PURITY DETERMINATION, STABILITY TESTING AND QUANTITATION (RFP N01DA-3-7402) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX R2 ********************************************************** TERRY BEIRN COMMUNITY PROGRAMS FOR CLINICAL RESEARCH ON AIDS (RFP NIH-NIAID-DAIDS-94-11) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R3 ********************************************************** INFORMATION SERVICES IN SUPPORT OF CANCER RESEARCH (RFP NCI-CM-37844-37) National Cancer Institute INDEX: CANCER $$INDEX R4 ********************************************************** DEVELOPMENT AND PERIODIC UPDATING OF CLINICAL PRACTICE GUIDELINES FOR THREE MEDICAL CONDITIONS (RFP 282-93-0029) Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY, RESEARCH $$INDEX R5 ********************************************************** CLINICAL TRIALS OF BIOLOGICAL RESPONSE MODIFIERS (RFP NCI-CM-47001-64) National Cancer Institute INDEX: CANCER $$INDEX R6 ********************************************************** LARGE SCALE AUTOMATED DNA SEQUENCING OF HUMAN GENES INVOLVED IN NEUROLOGICAL DISORDERS (RFP NIH-NINDS-93-11) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE $$INDEX R7 09/09/93 ************************************************* ETHNIC MINORITY FAMILIES WITH RETARDED MEMBERS (RFA HD-93-014) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R8 09/22/93 ************************************************* MINORITY ENHANCEMENT AWARDS (RFA CA-93-027) National Cancer Institute INDEX: CANCER $$INDEX R9 11/16/93 ************************************************* PROGRAM PROJECTS ON AUTOIMMUNITY (RFA AI-93-018) National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases INDEX: ALLERGY, INFECTIOUS DISEASES, ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES $$INDEX R10 12/07/93 ************************************************ CLINICAL STUDIES OF SYSTEMIC THERAPIES (RFA CA-93-029) National Cancer Institute INDEX: CANCER ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** NICHD CLINICAL INVESTIGATOR DEVELOPMENT AWARD (PA-93-082) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX P2 ********************************************************** CHILD AND ADOLESCENT DEVELOPMENT AND PSYCHOPATHOLOGY RESEARCH CENTERS (PA-93-092) National Institute of Mental Health INDEX: MENTAL HEALTH $$INDEX P3 ********************************************************** EXPLORATORY/DEVELOPMENTAL GRANTS FOR PSYCHOSOCIAL TREATMENT RESEARCH (PA-93-093) National Institute of Mental Health INDEX: MENTAL HEALTH $$INDEX P4 ********************************************************** RESEARCH ON THE EFFECTS OF MICROGRAVITY ON THE MUSCULOSKELETAL SYSTEM (PA-93-094) National Institute of Arthritis and Musculoskeletal and Skin Diseases INDEX: ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES $$INDEX P5 ********************************************************** RESEARCH ON RELATIONSHIPS BETWEEN ALCOHOL AND VIOLENCE (PA-93-095) National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM This publication is also available electronically to institutions via BITNET or INTERNET. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details, or send an E-mail message to ZNS@NIHCU. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** NOTICE OF UPDATE OF THE NIH RESEARCH RESOURCES DATABASE NIH GUIDE, Volume 22, Number 21, June 11, 1993 P.T. 16; K.W. 1004017 National Institutes of Health The National Institutes of Health (NIH) Research Resources subfile (NIHRES) of the DIRLINE (Directory of Information Resources Online) database has been recently revised and updated. This database is available on the National Library of Medicine's (NLM) computer and includes biomedical resources supported by NIH funds that are available to researchers throughout the country. Investigators conducting biomedical research frequently develop unique resources such as specialized laboratories, materials, substances, organisms, databases, and equipment, which may be valuable to other scientists in the course of their work. The NIH provides support, through grants and contracts, to many of these resources, including electron microscopy facilities, primate colonies, specialized laboratories, and cell culture collections. These resources are often difficult to identify and locate. The NIHRES files was established to communicate information about the availability of these unique or novel research resources to the scientific community. The Institutes, Centers and Divisions (ICDs) of NIH, including the National Center for Research Resources (NCRR), have contributed information about these valuable resources to the DIRLINE database. It is the policy of the Public Health Service (PHS) to make available to the public the results and accomplishments of the activities it supports. DIRLINE, and the NIHRES component, may be accessed by a variety of terminals or microcomputers connected to NLM's computer facility. Connection is established via direct telephone line, the TELENET, TYMNET or CompuServe nationwide telecommunications networks, or the Internet. DIRLINE is also available using GRATEFUL MED, NLM's user- friendly software for IBM-compatible PCs or Macintosh computers. This software, available for $29.95 through the National Technical Information Service (NTIS), allows novice users to access the NLM system and the NIHRES subfile of DIRLINE to easily obtain the information they need. For further information about DIRLINE access contact the MEDLARS Management Section of NLM at (800) 638-8480. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** STANDARD PROCEDURES FOR REPORTING PROGRAM INCOME NIH GUIDE, Volume 22, Number 21, June 11, 1993 P.T. 34; K.W. 1014006 National Institutes of Health This notice provides detailed instructions for reporting grant- related program income on NIH grants and cooperative agreements using the long form version of the Financial Status Report (FSR). It is intended to clarify questions and concerns raised regarding reporting requirements. All general program income must be reported on the long form version of the FSR. With the exception of royalty or equivalent income earned from patents or inventions, certain special categories of program income described in 45 CFR Subpart F must also be reported on the FSR. The specific reporting requirements applicable to most NIH research grants and cooperative agreements for each type of program income is described below. General Program Income - As defined in 45 CFR Part 74, general program income is all program income accruing to a grantee during the period of grant support or to a subgrantee during the period of subgrant support, other than the special categories of program income listed below. General program income subject to the deduction alternative must be reported on line 10c, "Program income used in accordance with the deduction alternative," and line 10q, "Disbursed program income shown on lines c and/or g above." General program income subject to the additional costs alternative must be reported on lines 10r, "Disbursed program income using the addition alternative," and 10s, "Undisbursed program income," as appropriate. Total program income realized should be reported on line 10t as instructed. General program income subject to a combination of these alternatives must be reported accordingly, i.e., the first $25,000 should be reported on lines 10r and 10s, and income in excess of $25,000 should be reported on lines 10c and 10q. Costs (both direct and indirect) associated with generating program income which are deducted from the program income receipts when such costs are not already charged to the project should not be reported on the FSR. Proceeds from the Sale of Real Property and from Sale of Equipment and Supplies Acquired for Use - o Sale of Property - Section 74.134 of Subpart O, "Property," states that the disposition instructions of the granting agency shall be followed when real property is no longer to be used by the grantee or transferred to an eligible third party. o Sale of Equipment - Grantees subject to the requirements in 45 CFR 74.139, "Disposition of equipment," shall reflect income earned from the sale of equipment on the FSR if the grantee's project or program for which equipment was acquired is still receiving grant support. If authorized by the awarding unit, grantees may use the income for allowable costs of the project. This income would be reported on lines 10c/10q, 10r, or 10s in accordance with awarding unit authorized disposition. There are no reporting requirements for nonprofit institutions of higher education or nonprofit organizations whose primary purpose is the conduct of scientific research since they are not subject to the requirements in 45 CFR 74.139. o Unused Supplies - Grantees subject to the requirements in 45 CFR 74.141, "Unused supplies," should reflect any credit to the grant on lines 10c and 10q of the FSR. There are no reporting requirements for non-profit institutions of higher education or non-profit organizations whose primary purpose is the conduct of scientific research since they are not subject to the requirements in 45 CFR 74.141. Royalties and Other Income Earned from a Copyrighted Work - Where the terms of the Notice of Grant Award (NGA) do not specify disposition, no reporting of income is required on the FSR. Where the terms of the NGA govern disposition, this kind of income would be reported on FSR lines 10c/10q, 10r, or 10s in accordance with awarding unit authorized disposition. Royalties or Equivalent Income Earned from Patents or from Inventions - Where the terms of the NGA do not specify disposition, this kind of income should be reported to the Extramural Inventions Office, Office of Policy for Extramural Research Administration, on the annual utilization report. Where the terms of the NGA govern disposition, this kind of income would be reported on FSR lines 10c/10q, 10r, or 10s in accordance with awarding unit authorized disposition, as well as to the Extramural Inventions Office on the annual utilization report. Income After Grant or Subgrant Support Not Otherwise Treated - Unless specified in the terms of the NGA there are no reporting requirements for income accrued after the period of grant support ends. Questions regarding these instructions may be directed the Grants Management Office of the awarding NIH Institute or Center. The Long Form Financial Status Report is available upon request from the Federal Assistance Accounting Branch, National Institutes of Health, (301) 496-5287. $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** EXTENSION OF COOPERATIVE AGREEMENTS ON MATCHING PATIENTS TO ALCOHOLISM TREATMENTS NIH GUIDE, Volume 22, Number 21, June 11, 1993 P.T. 34; K.W. 0404003, 0745070 National Institute on Alcohol Abuse and Alcoholism The National Institute on Alcohol Abuse and Alcoholism (NIAAA) has an active interest in the support of research projects addressing issues of the effective matching of alcoholism patients to specific treatments based on their individual characteristics. In 1989, NIAAA issued Requests for Applications (RFAs) for clinical research units, and a coordinating center, respectively, for Cooperative Agreements on Matching Patients to Alcoholism Treatments. The first five years of support for these awards will end in 1994. The NIAAA intends to extend this cooperative agreement program for an additional three years and to limit competition to investigators from the current clinical research units and the coordinating center. This limitation of eligibility is based on the current awardees' unique access to the study population and data derived therefrom, and unique expertise with respect to the assessment instruments developed specifically for this study. Although competition for this cooperative agreement study extension is limited, NIAAA wishes to call attention to its ongoing program announcement entitled "Research on Alcoholism Patient-Treatment Matching" (PA-92-75) dated May 1992. Research grant applications are encouraged under this program announcement without any limitation on eligibility. INQUIRIES Additional information on either of these alcoholism treatment matching research programs may be obtained from: John Allen, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 14C-20 Rockville, MD 20857 Telephone: (301) 443-0796 FAX: (301) 443-8774 $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** EXTENSION OF COOPERATIVE AGREEMENTS ON THE GENETICS OF ALCOHOLISM NIH GUIDE, Volume 22, Number 21, June 11, 1993 P.T. 34; K.W. 0404003, 1002019 National Institute on Alcohol Abuse and Alcoholism The National Institute on Alcohol Abuse and Alcoholism (NIAAA) has an active interest in the support of research projects addressing the genetic aspects of alcoholism. In 1989, NIAAA issued Requests for Applications (RFAs) for extramural research groups and a coordinating center, respectively, for Cooperative Agreements on the Genetics of Alcoholism. The first five years of support for these awards will end in 1994. The NIAAA intends to continue this cooperative agreement program for an additional five years and to limit competition to investigators from current extramural research groups and the coordinating center. This limitation of eligibility is based on the current awardees' unique access to the study probands and their biological relatives, and unique expertise with respect to interviewer training in the use of assessment instruments developed specifically for this study. Although competition for extension of this cooperative agreement is limited, NIAAA calls attention to its program announcement entitled "Genetic Studies in Alcohol Research" (PA-93-086) issued on May 21, 1993. Research grant applications are encouraged under this program announcement without any limitation on eligibility. INQUIRIES Additional information on the extension of the cooperative agreement may be obtained from: Helen Chao, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism Parklawn Building, Room 16C-06 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-2530 FAX: (301) 227-8673 Additional information on the genetics research program may be obtained from: Robert W. Karp, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 16C-05 Rockville, MD 20857 Telephone: (301) 443-4223 FAX: (301) 227-8673 $$N4 END ************************************************************ $$N5 BEGIN ********************************************************** CONFERENCE ON PLAGIARISM AND THEFT OF IDEAS NIH GUIDE, Volume 22, Number 21, June 11, 1993 P.T. 42; K.W. 1014006 National Institutes of Health The Office of Research Integrity/American Association for the Advancement of Science (ORI/AAAS) Conference on Plagiarism and Theft of Ideas will be held on June 21 from 8:00 am to 5:00 pm and on June 22 from 8:00 am to 1:00 pm in Lister Hill Auditorium, Building 38A, National Institutes of Health. INQUIRIES For more information, contact: Dr. Alan Price or Ms. Karen Gorirossi Office of Research Integrity 5515 Security Lane, Suite 700 Rockville, MD 20852 Telephone: (301) 443-5330 FAX: (301) 227-0039 $$N5 END ************************************************************ $$N6 BEGIN ********************************************************** NICHD TRANSGENIC MOUSE DEVELOPMENT FACILITY NIH GUIDE, Volume 22, Number 21, June 11, 1993 P.T. 34; K.W. 1002002, 1002019, 0760053 National Institute of Child Health and Human Development The NICHD Transgenic Mouse Development Facility (NTDF) is a research resource that develops transgenic mice for investigators requiring these services. It was established to provide reliable and affordable transgenic mice primarily to biomedical research grantees. Specifically, the NTDF supports basic biomedical research by providing investigators with the following customized services: o Analyzing constructs for microinjection. o Microinjecting constructs into fertilized one-cell mouse eggs and reimplanting into pseudopregnant recipient females. o Testing potential founders for DNA integration. o Producing at least two integration-positive transgenic mice. Applications for services should be requested from the Director, NTDF. Completed applications are submitted anytime to the NICHD Project Officer for review. All applications are handled confidentially and those constructs approved are microinjected at the NTDF. The Investigator is charged a non-refundable fee for initial analysis of the constructs. An additional fee is assessed if two or more integration-positive transgenic mice are produced. The NTDF is supported by a contract award from the National Institute of Child Health and Human Development, NIH. INQUIRIES Direct programmatic inquiries regarding this research resource to: Allan Lock, D.V.M. NTDF Project Officer National Institute of Child Health and Human Development Building 6100, Room 4B01 Bethesda, MD 20892 Telephone: (301) 496-5541 Direct requests for applications and resource inquiries to: Mark Swanson, Ph.D. Director, NICHD Transgenic Mouse Development Facility 303B College Road East Princeton, NJ 08540 Telephone: (609) 520-0300 FAX: (609) 520-9864 $$N6 END ************************************************************ $$N7 BEGIN ********************************************************** AVAILABILITY OF PROGRAM PROJECT GUIDELINES NIH GUIDE, Volume 22, Number 21, June 11, 1993 P.T. 34; K.W. 0715035, 1014006 National Cancer Institute The National Cancer Institute (NCI) announces the availability of updated guidelines for program project (P01) applications that are likely to be assigned to the NCI for review and funding. Investigators anticipating submission of a P01 should request a copy of the guidelines, which explain NCI policies and procedures relating to the preparation, submission and review of P01 applications. INQUIRIES Investigators may obtain copies of the guidelines and referrals for information regarding programmatic interests in such applications from: Referral Office, Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 Bethesda, MD 20892 Telephone: (301) 496-3428 FAX: (301) 402-0275 $$N7 END ************************************************************ $$N8 BEGIN ********************************************************** NIH REGIONAL SEMINAR IN GRANTS ADMINISTRATION NIH GUIDE, Volume 22, Number 21, June 11, 1993 P.T. 42; K.W. 1014006 National Institutes of Health PLEASE NOTE: THE DEADLINE FOR REGISTERING HAS BEEN EXTENDED TO JUNE 18, 1993 A regional conference covering topics related to grants administration at the National Institutes of Health (NIH) has been scheduled for Monday and Tuesday, June 28-29, 1993, at the Sheraton Hotel in Augusta, Georgia. The seminar, hosted by the Medical College of Georgia, is located to attract research administrators from the southern region of the United States -- Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia, and West Virginia. Those interested from other states are also invited. In addition, staff from small and minority colleges, for-profit research organizations, hospitals, universities and medical centers are encouraged to attend. This two-day conference will be of interest to both new and senior grant administrators and Principal Investigators. Discussions of current issues that affect NIH funding and grant administration will be included to give conference participants a comprehensive, up-to- date view of NIH-sponsored research. Topics for discussion will include the fundamentals of conducting business with NIH (application preparation, peer review, budget analysis, and award determination) and contemporary topics (strategic and financial management plans, indirect costs, and effective administration between NIH and recipients). The format for this conference will include case studies, group discussions, and formal presentations. Time will be available for conference participants to meet informally with NIH representatives to discuss topics of special interest. Mr. Geoffrey Grant, Director, Office of Policy for Extramural Research Administration at NIH, and representatives from the Grants Policy Office, Division of Research Grants, and grants management and program staff from several awarding components of NIH will be featured speakers. DATE: June 28-29, 1993 LOCATION Sheraton Hotel 2651 Perimeter Parkway Augusta, GA Telephone: (706) 855-8100 Participants must make hotel reservations directly, and should mention the regional seminar when doing so. COST OF WORKSHOP: $125 REGISTRATION AND INQUIRIES The deadline for advance registration has been extended to June 18, 1993. Conference space is limited to the first 250 registrants. For registration materials, send a FAX that provides your name, institution, address, telephone number, and anticipated number of registrants to Ms. Becky Jones, Physician's Practice Group. FAX (706) 724-1600. Allow 7 to 10 days for receipt of the materials. If you have any questions, you may call Ms. Jones at (706) 828-6422. $$N8 END ************************************************************ $$N9 BEGIN ********************************************************** THE HUMAN BRAIN PROJECT: PHASE I FEASIBILITY STUDIES NIH GUIDE, Volume 22, Number 21, June 11, 1993 PA NUMBER: PA-93-068 P.T. 34; K.W. 0705010, 1002030, 1004017 National Institute of Mental Health National Institute on Drug Abuse National Science Foundation National Institute on Aging National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Center for Research Resources National Library of Medicine Office of Naval Research National Aeronautics and Space Administration For the information of those intending to apply in response to the program announcement, "The Human Brain Project: Phase I Feasibility Studies" (PA-93-068; NIH GUIDE, Vol. 22, No. 13, April 2, 1993), add the following sentence to the REVIEW CONSIDERATIONS Section: "Applications deemed by the Division of Research Grants to be inappropriate for this program announcement will be assigned to the appropriate agencies, institutes and centers according to their goals and designs and in accordance with standard referral guidelines." $$N9 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN N01DA-3-7402 ********************************************* SYNTHETIC PEPTIDES: PURITY DETERMINATION, STABILITY TESTING AND QUANTITATION NIH GUIDE, Volume 22, Number 21, June 11, 1993 RFP AVAILABLE: N01DA-3-7402 P.T. 34; K.W. 1003006, 0760060, 0404009 National Institute on Drug Abuse The National Institute on Drug Abuse (NIDA) is soliciting proposals for the analysis of the chemical optical purity of a number of peptides and development of analytical methodology for a few selected peptides (especially opioid peptides). Offerors should be experienced in synthesis of peptides by conventional and solid phase methods. It is anticipated that a five year, incrementally funded cost reimbursement type contract will be awarded. Request for Proposals (RFP) No. N01DA-3-7402 was issued on May 17, 1993, and responses are due to be received in the Contracting Office approximately 45 calendar days thereafter. INQUIRIES Only written or facsimile requests for this RFP will be accepted. Forward all requests to: Ms. Johnnie L. Rice, Contract Specialist National Institute on Drug Abuse Parklawn Building, Room 10-49 5600 Fishers Lane Rockville, MD 20857 FAX: (301) 443-7595) $$R1 END ************************************************************ $$R2 BEGIN NIH-NIAID-DAIDS-94-11 ************************************ TERRY BEIRN COMMUNITY PROGRAMS FOR CLINICAL RESEARCH ON AIDS NIH GUIDE, Volume 22, Number 21, June 11, 1993 RFP AVAILABLE: NIH-NIAID-DAIDS-94-11 P.T. 34; K.W. 0715008, 0785035 National Institute of Allergy and Infectious Diseases The Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), has a requirement for the continuation of the Terry Beirn Community Programs for Clinical Research on AIDS (TB CPCRA). The purpose of these contracts is to expand and strengthen the HIV clinical research effort, support community participation in HIV research, enhance the participation of women, minorities and injection drug users in HIV clinical research and to ensure the prompt translation of research findings to primary care providers. This is a recompetition of an ongoing program. Proposals must describe the offeror organization and document the availability of patient population, recruitment and follow-up plans appropriate for the conduct of community-based trials. The offeror must be able to initiate a minimum of three, but not to exceed a maximum of ten community based research projects per year, depending on size and complexity and designed in conjunction with NIAID staff. Offerors are expected to enroll at least 30 to 50 patients into studies. These may be investigator-initiated or NIAID-initiated multicenter collaborative trials. All CPCRA research must be approved by the DAIDS Clinical Trials Review Committee prior to being implemented. The successful offerors to this Request for Proposal (RFP) must have the demonstrated or potential ability to implement and manage a clinical research program based in primary care settings. Proposals will be accepted from domestic organizations made up of licensed physicians and nurses with access to a substantial patient population infected with HIV. Particular emphasis will be given to organizations which serve minorities, women at risk for HIV infection and persons who use IV drugs and/or organizations composed of women and minorities. Evidence of substantial experience by the members of the organization in the care and treatment of persons with HIV infection must be documented in the proposal. Mandatory Criterion: Offeror's must document, e.g., by including letters of commitment from the organization, that, with respect to the CPCRA scientific and clinical issues, the overall direction and decision processes rest with the primary care clinicians. Proposals must also demonstrate support from the community served by the offering organization, such as endorsement by relevant community organizations, and community participation in the decision process of the provision of clinical care, clinical management or research priorities and conduct of research. Offerors must demonstrate relationships with community health care facilities such as hospitals, public health departments, and regional tertiary care centers, to ensure integration of the offeror clinicians within the local medical care structure. This must include affiliations with local hospitals so participating patients can be followed by offeror physicians if hospitalization is required. Offerors must have access to a clinical laboratory competent to perform the studies required for community-based clinical trials. Offerors in cities that include one or more AIDS Clinical Trial Unit (ACTU), must describe a formalized communication link with an NIAID supported ACTU(s). This should include relevant researchers, clinicians, and/or administrators of both the community organization and the ACTU and should provide a forum for discussion of goals, protocols, and entry criteria of clinical research at both the ACTU and the Community Program for Clinical Research on AIDS. This is an announcement for an anticipated RFP. RFP NIH-NIAID-DAIDS- 94-11 will be available on or about June 30, 1993 and proposals will be due by 4:30 p.m., local time, on November 3, 1993. It is anticipated that fifteen to twenty contracts will be awarded as a result of this solicitation. It is expected that the contract will have a five year period of performance, and a completion cost- reimbursement type contract is anticipated. INQUIRIES To receive a copy of the RFP, provide this office with five self- addressed mailing labels. Telephone inquiries will not be honored and all inquiries must be in writing. A short-form version of the RFP will be provided first, which includes only the Statement of Work, Reporting Requirements and the Evaluation Criteria to be used for selection of the awardees. After examining this, a full-text version of the RFP must be requested, in writing, for those offerors interested in responding. FAX requests are acceptable for the full text versions of the RFP only. Requests for the RFP may be directed in writing to: Nancy Hershey Contract Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 3C07 6003 Executive Boulevard Bethesda, MD 20892 FAX: (301) 402-0972 All proposals from responsible sources will be considered by the NIAID. This advertisement does not commit the Government to award a contract. $$R2 END ************************************************************ $$R3 BEGIN NCI-CM-37844-37 ****************************************** INFORMATION SERVICES IN SUPPORT OF CANCER RESEARCH NIH GUIDE, Volume 22, Number 21, June 11, 1993 RFP AVAILABLE: NCI-CM-37844-37 P.T. 34; K.W. 0715035, 1004017, 0755018 National Cancer Institute The Division of Cancer Treatment (DCT), National Cancer Institute (NCI), intends to enter into negotiations with the Japanese Foundation for Cancer Research to provide information pertaining to cancer treatment research in Japan. The major objectives of this project are: (1) Monitor the advances in preclinical and clinical cancer therapy research in Japan; (2) provide preliminary results of all clinical trials and screening evaluations underway at the Cancer Chemotherapy Center of Japan involving investigational drugs sponsored by the NCI; (3) manage specific projects within the treatment area of the U.S. Japan Cooperative Cancer Research Program, including scientist exchanges and the organization of meetings; (4) attend all major scientific meetings in Japan related to contract objectives and report to the DCT the results presented; (5) provide to the DCT all titles of abstracts related to cancer therapy presented at Japanese scientific meetings (These titles are to be collated and translated into English. Titles of all scientific reports in this field that are published in Japan are to be translated and provided to DCT); and (6) establish a bilateral exchange of postdoctoral fellows between the U.S. and Japan. This initiative would fund up to 10 exchange fellowships throughtout U.S. or Japan for periods of two to three years. The Japanese Foundation proposes to cost share 50 percent of the fellows stipend and the other 50 percent will derive from this contract. Although this is a sole source contract with the Japanese Foundation for Cancer Research, the NCI will consider other proposals that may offer an advantage to the Government. INQUIRIES Requests for this Request for Proposals (RFP) must be in writing and reference RFP No. NCI-CM-37844-37. The RFP is due to be mailed out June 14, 1993 and responses will be due 45 days from that date. Requests must be addressed to: Patricia Lightner, Contract Specialist Research Contracts Branch, TCS National Cancer Institute Executive Plaza South, Suite 603 Bethesda, MD 20892 Telephone: (301) 496-8620 No collect calls will be accepted. $$R3 END ************************************************************ $$R4 BEGIN 282-93-0029 ********************************************** DEVELOPMENT AND PERIODIC UPDATING OF CLINICAL PRACTICE GUIDELINES FOR THREE MEDICAL CONDITIONS NIH GUIDE, Volume 22, Number 21, June 11, 1993 RFP AVAILABLE: 282-93-0029 P.T. 34; K.W. 0730050 Agency for Health Care Policy and Research The General Acquisition Branch of the Division of Acquisition Management, Public Health Service, on behalf of the Agency for Health Care Policy and Research, proposes to award contracts for the development and periodic updating of clinical practice guidelines, medical review criteria, standards of quality, and performance measures on: screening for colorectal cancer, management of chronic pain with special emphasis on headache pain, and nosocomial urinary tract infection. Three awards are anticipated. The proposed awards will be set-aside for public and non-profit organizations. Anticipated award date is September 1993. The period of performance is 38 months. INQUIRIES This is an announcement for an anticipated Request for Proposal (RFP). RFP No. 282-93-0029 is now available. A closing date is tentataively set for August 1, 1993. Requests for the RFP must be submitted in writing to: Michele Trotter, Division of Acquisition Management General Acquisition Branch Public Health Service 5600 Fishers Lane, Room 5-101 Rockville, MD 20857 $$R4 END ************************************************************ $$R5 BEGIN NCI-CM-47001-64 ****************************************** CLINICAL TRIALS OF BIOLOGICAL RESPONSE MODIFIERS NIH GUIDE, Volume 22, Number 21, June 11, 1993 RFP AVAILABLE: NCI-CM-47001-64 P.T. 34; K.W. 0715035, 0740015, 0755015 National Cancer Institute The National Cancer Institute (NCI) plans to award five-year incrementally funded contracts for the performance of multiple clinical trials of biological response modifiers. Offerors will be required to demonstrate their capability to perform, within appropriate timeframes, Phase I clinical trials of biological response modifiers. Emphasis should be on excellent patient accrual, trial design, and conduct of laboratory studies of biological correlates. A theoretical (sample) laboratory and clinical protocol will be required with the proposal. The contractors will design, write, and develop clinical protocols for the biological response modifiers identified for study. The NCI will supply agents for clinical trials and hold the investigational new drugs (INDs). All contract clinical protocols will require NCI approval. Contract clinical trials will be monitored by NCI's Clinical Trials Monitoring Services. These trials will focus on initial Phase Ia/Ib studies of new biological response modifiers and on studies specifically related to issues of mechanism of action. Each contractor will perform up to three clinical trials per year. Up to three awards are planned. At least one award will be devoted to monoclonal anti-bodies and targeting agents, and at least one award will focus on biological response modifiers such cytokines and growth/differentiation factors. Beginning with each contract protocol, the contractor will submit data to Clinical Trials Monitoring Service biweekly using NCI Case Report Forms or electronic data transfer. INQUIRIES Request for Proposals (RFP) NCI-CM-47001-64 will be issued on or about June 15, 1993 and offers will be due approximately six weeks later. No telephone requests will be accepted. This procurement is unrestricted. The Standard Industrial Classification (SIC) code is 8731. No collect calls will be accepted. Requests are to be addressed to: Mr. Carl A. Newman, Contract Specialist Research Contracts Branch, TCS National Cancer Institute Executive Plaza South, Room 603 Bethesda, MD 20892 Telephone: (301) 496-8620 $$R5 END ************************************************************ $$R6 BEGIN NIH-NINDS-93-11 ****************************************** LARGE SCALE AUTOMATED DNA SEQUENCING OF HUMAN GENES INVOLVED IN NEUROLOGICAL DISORDERS NIH GUIDE, Volume 22, Number 21, June 11, 1993 RFP AVAILABLE: NIH-NINDS-93-11 P.T. 34; k.w. 0755045, 0715138 National Institute of Neurological Disorders and Stroke The National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), has a requirement for the research and development of highly reproducible, rapid DNA template production and purification procedures. DNA must be of sufficient purity for highly accurate automated DNA sequence analysis. Additional requirements include screening and amplification of clones from lambda, cosmid or YAC libraries and biological samples. Libraries of plasmid subclones are to be made from the larger clones. Genetic typing with highly informative polymerase chain reaction (PCR) based markers is another requirement. Work under the proposed contract will support the mission objectives of the NINDS Core DNA Sequencing Facility. The Facility provides rapid DNA sequencing and other services to NINDS scientists for use in basic and clinical neuroscience projects. Prospective offerors should have expertise and experience in several areas of molecular biology and nucleic acid biochemistry. In particular, offerors shall have experience in DNA isolation and analysis techniques, basic microbiological techniques, growth of filamentous bacteriophage, use of restriction endonucleases and DNA modifying enzymes, bacterial transformation, DNA hybridization, and use of PCR. This requirement represents a recompetition of work currently being performed under NINDS Contract No. NO1-NS-0-2387, with Collaborative Research, Inc., Waltham, MA. It is expected that the incumbent Contractor will recompete. A single award is anticipated with the performance period not to exceed three years. This is not a Request for Proposals (RFP). RFP No. NIH-NINDS-93-11 will be issued on or about June 11, 1993, with responses due on or about July 31, 1993. INQUIRIES To receive a copy of the RFP, submit a written request and supply two self-addressed mailing labels to: Contracts Management Branch Division of Extramural Activities National Institute of Neurological Disorders and Stroke Federal Building, Room 901 7550 Wisconsin Avenue Bethesda, MD 20892 Reference: RFP No. NIH-NINDS-93-11 This announcement does not commit the NINDS to make an award. All responsible sources may submit a proposal that will be considered by the Government. $$R6 END ************************************************************ $$R7 BEGIN HD-93-014 FULL-TEXT ************************************** ETHNIC MINORITY FAMILIES WITH RETARDED MEMBERS NIH GUIDE, Volume 22, Number 21, June 11, 1993 RFA AVAILABLE: HD-93-014 P.T. 34, FF; K.W. 0715130, 0730050, 0710030 National Institute of Child Health and Human Development Letter of Intent Receipt Date: July 21, 1993 Application Receipt Date: September 9, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE The Mental Retardation and Developmental Disabilities Branch (MRDD), Center for Research for Mothers and Children (CRMC), of the National Institute of Child Health and Human Development (NICHD) invites research grant applications on ethnic minority families with mentally retarded or developmentally disabled members. The ethnic minority populations to be studied are: African-American; Hispanic; Asian-American, including Pacific-Island-Americans; and American-Indian, including Alaskan-Natives. High priority research topics include traditional beliefs, values, and responses to mental retardation and developmental disability of these ethnic groups, formal and informal support systems that are most likely to be used by families in these groups, and the impact of ethnicity on families' interactions with various types of service agencies. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Ethnic Minority Families with Retarded Members, centers on a high priority area, the health and well-being of several special populations: people with disabilities, and people in particular ethnic minority groups, many of whom have low incomes. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, laboratories, units of state and local governments, and eligible agencies of the Federal government. Minority investigators and women are encouraged to apply. It is suggested that applicants have research experience pertinent to the research agenda spelled out in the RFA. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) awards (R29). MECHANISM OF SUPPORT This RFA will use two funding mechanisms: the National Institutes of Health (NIH) individual research grant (R01) and the FIRST award (R29). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed five years. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE It is estimated that applications submitted in response to this announcement will compete for approximately $750,000 in direct costs that will be made available for the first year of support. It is expected that four awards will be made. The number of awards depends on the overall scientific merit of the applications. Although this program is provided for in the financial plans of the NICHD, awards pursuant to this RFA are also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES The purpose of this RFA is to encourage research on ethnic minority families with retarded or developmentally disabled members. High priority research topics include the following: A. Traditional beliefs, values, and responses to mental retardation and developmental disability of particular ethnic groups. B. Formal and informal support systems that are most likely to be used by members of families from various ethnic minority groups with retarded or developmentally disabled members. C. Variables to be considered in the development of appropriate models and instruments to assess family functioning and needs of individuals in ethnic minority families with retarded or developmentally disabled members. It is expected that applicants will focus on a limited number of variables that are important to the functioning of families from specific ethnic minority populations. No single research project is expected to address all of the topics above, to include all ethnic minority populations, or families with all types of retardation and disability. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES This RFA calls for research on ethnic minority families from four groups: African-American; Hispanic; Asian-American, including Pacific-Island-Americans; and American-Indians, including Alaskan-Natives. Applicants are encouraged to study both male and female family members. Family members of all ages may be studied. LETTER OF INTENT Investigators who expect to respond to this RFA may submit a letter of intent by July 21, 1993. The letter of intent should include a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the names of any other key personnel, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in evaluating relevance to the topic of the RFA and in planning for the review of applications. The letter of intent is to be sent to Dr. Phyllis W. Berman at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on Form PHS 398 (rev. 9/91). This application form is available in the office of sponsored research at most academic and research institutions and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. The receipt deadline for applications prepared in response to this RFA is September 9, 1993. Late applications will be returned to the applicant without review. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required numbered of reference letters will be considered incomplete and will be returned without review. The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for evaluation. Check "YES" in item 2a on the face page of the application and type "Ethnic Minority Families with Mentally Retarded Members, HD-93-014." The original and three copies of the application must be sent or delivered to: Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** In addition, two copies of the application must be sent under separate cover to: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E01 Bethesda, MD 20892 REVIEW CONSIDERATIONS Applications will be reviewed by the NICHD staff for completeness and responsiveness to the RFA. Incomplete applications and those deemed non-responsive will be returned to the applicant. In the event that an application is returned, the applicant has the option to resubmit the application to the Division of Research Grants as an unsolicited application during one of the three yearly review cycles (February 1, June 1, October 1). If the application submitted in response to this RFA is substantially similar to a grant application already submitted to the NIH for review, but not yet reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Applications may be triaged by and NICHD peer review group on the basis of relative competitiveness. The NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NICHD. The second level of review will be provided by the National Advisory Child Health and Human Development Council. o Scientific, technical, or medical significance and originality of proposed research. o Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research. o Qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research. o Availability of resources necessary to perform the research. o Appropriateness of the proposed budget and duration in relation to the proposed research. AWARD CRITERIA The earliest anticipated award date is April 1994. The following will be considered in making awards: o Quality of the proposed project as determined by peer review. o Availability of funds. o Program balance among research areas of the RFA. INQUIRIES Requests for additional information and inquiries concerning this RFA are encouraged. Direct inquiries about programmatic issues, requests for the RFA, and address the letter of intent to: Phyllis W. Berman, Ph.D. Mental Retardation and Developmental Disabilities Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B09D Bethesda, MD 20892 Telephone: (301) 496-1383 For fiscal and administrative inquiries regarding this announcement, potential applicants may contact: E. Douglas Shawver Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17F Bethesda, MD 20892 Telephone: (301) 496-1303 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865, Research for Mothers and Children. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99- 158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R7 END ************************************************************ $$R8 BEGIN CA-93-027 FULL-TEXT ************************************** MINORITY ENHANCEMENT AWARDS NIH GUIDE, Volume 22, Number 21, June 11, 1993 RFA AVAILABLE: CA-93-027 P.T. 34, FF; K.W. 0785035, 0715035, 0745070, 0710095 National Cancer Institute Letter of Intent Receipt Date: July 14, 1993 Application Receipt Date: September 22, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE The Comprehensive Minority Biomedical Program (CMBP), Division of Extramural Activities (DEA), National Cancer Institute (NCI), invites research grant applications from interested investigators with access to large or predominantly minority populations to promote minority group participation in cancer research with a special focus on cancer control research. Support provided by this initiative would broaden the operational base of each institution by: 1. Expanding cancer control and prevention efforts in early detection, prevention, screening, pre-treatment evaluation, treatment, continuation care, and rehabilitation; 2. Increasing the involvement of minority population primary care providers early in the course of clinical treatment research; 3. Promoting the involvement in treatment research at the institutional level with a focus on the development of treatment protocols for cancers that have a high incidence in minorities; 4. Supporting programs involving diet and nutrition cancer control research activities; 5. Coordinating the contributions of investigators from various relevant disciplines, psychology and nutrition; and 6. Promoting the inclusion of minority individuals at all levels in the conduct of the research with the increased recruitment of minority scientists into the research base of the institution as an expected outcome. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Minority Enhancement Awards, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or Healthy People 2000" (Summary report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone (202) 783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. Institutions are eligible if they can demonstrate the following: 1. Broad research capabilities in cancer prevention, cancer control and cancer treatment as evidenced by significant research support in these areas. This would include past and current examples of ability to design and implement strong clinical trials research programs. 2. An organizational infrastructure that promotes and sustains a strong interdisciplinary, interactive cancer research environment which links basic research effectively to research in patient and populations settings (e.g., NCI-designated Comprehensive Cancer Centers). 3. Clear access to large numbers of minorities who are representative of the minority populations in the communities and/or regions associated with the institution. 4. Demonstrated capability to work with minority populations in a research setting within communities and/or regions. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research grant (R01). Applicants will be responsible for the planning, direction, and execution of the proposed project. Except as otherwise stated in this RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. This RFA is a one-time solicitation. Generally, future unsolicited competitive continuation applications will compete with all investigator-initiated applications and be reviewed by the Division of Research Grants (DRG). However, should the NCI determine that there is a sufficient continuing program need, a request for competitive continuation applications will be announced. Only recipients of awards under this RFA will be eligible to apply. The average amount of direct costs expected per award is $200,000. FUNDS AVAILABLE Funding in the amount of $1,600,000 in total costs has been set aside for the first year to specifically fund applications which are submitted in response to this RFA. It is anticipated that six awards will be made. This funding level is dependent on the receipt of sufficient number of applications of high scientific merit. The total project period for applications submitted in response to the present RFA may not exceed three years. The earliest feasible start date for the initial awards will be April 1, 1994. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES General research objectives within the scope of this initiative include, but are not limited to, smoking behavior in minority youth; studies of communication strategies for presenting information to minorities about cancer and its prevention; investigations of patient perspectives of cancer risks; the design and evaluation of interventions to minimize and prevent distress of minority patients with cancer; the development of pilot studies for minority clinical prevention trials; and psychosocial studies and perception of cancer risk in minorities. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by July 14, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NCI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Lemuel Evans at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications must be received by September 22, 1993. The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 496-7441; and from the NCI Program Director named below. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: NCI Referral Office Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 Bethesda, MD 20892 REVIEW CONSIDERATIONS From owner-sci-resources@net.bio.net Thu Jun 17 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 21, pt. 2, 11 June 1993 Message-ID: Date: 18 Jun 93 17:17:35 GMT Sender: kristoff@net.bio.net Lines: 1499 Approved: biosci-moderator@net.bio.net $$XID NIHGUIDE 19930611 V22N21 P2O3 ************************************ Upon receipt, applications will be reviewed for completeness by DRG and for responsiveness by the NCI Program Staff. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NCI staff will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Review criteria for RFAs are generally the same as those for unsolicited research grant applications. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions concerning the objectives and scope of this RFA or inquiries about whether or not specific proposed research would be responsive is welcome. Direct inquiries regarding programmatic issues, requests for the RFA, and address the letter of interest to: Dr. Lemuel Evans Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 620 Bethesda, MD 20892 Telephone: (301) 496-7344 FAX: (301) 496-7911 For information regarding budgetary/administrative issues related to this RFA, contact: Ms. Carolyn Mason Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800, Extension 59 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.399, Cancer Control. Awards are made under the authorization of the Public Health Service Act, Title V, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R8 END ************************************************************ $$R9 BEGIN AI-93-018 FULL-TEXT ************************************** PROGRAM PROJECTS ON AUTOIMMUNITY NIH GUIDE, Volume 22, Number 21, June 11, 1993 RFA AVAILABLE: AI-93-018 P.T. 34; K.W. 0715015, 0755030, 0765033, 0411005, 0745027 National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases Letter of Intent Receipt Date: August 15, 1993 Application Receipt Date: November 16, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE The Division of Allergy, Immunology and Transplantation of the National Institute of Allergy and Infectious Diseases (NIAID) and the Rheumatic Diseases Branch of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invite studies aimed at elucidating the causes and mechanisms of tolerance and autoimmune diseases and at the application of this basic biomedical knowledge to the development and implementation of new preventive and treatment modalities for these diseases. This RFA invites applications from collaborating basic science and clinical research investigators who are interested in developing novel integrated studies on autoimmune diseases. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Program Projects on Autoimmunity, is related to the priority areas of diabetes and chronic disabling diseases, and immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-782-3238). ELIGIBILITY REQUIREMENTS Research grant applications may be submitted by domestic, for-profit and non-profit organizations, public and private institutions, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The mechanism of support will be the Program Project (P01) grant. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period may not exceed five years. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for the first year of support for awards under this RFA will be $2,300,000. In Fiscal Year 1994, the NIAID and the NIAMS plan to fund approximately three program projects. Applications may not request budgets in excess of $500,000 total direct costs in the first year or more than 4 percent annual inflationary increases for future years. An application with a first year requested amount in excess of $500,000 total direct cost will require written approval by senior NIAID or NIAMS officials via the program officer for acceptance of the application for processing. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. RESEARCH OBJECTIVES AND SCOPE The major goals of these program projects are: increased understanding of etiology and pathogenetic mechanisms involved in autoimmune diseases; generation of new information and the expansion of the current knowledge base; and the application of this knowledge to the development of new or improved measures of risk assessment, prevention, early diagnosis and treatment of a wide variety of autoimmune diseases and disorders in which the autoimmune response is a major contributor to pathogenesis. The NIAID and NIAMS are seeking innovative applications that address various aspects of the immune responses related to self reactivity which may include studies concerned with relevant areas of genetics, cell and molecular biology, biochemistry, physiology, microbiology, pathology and pharmacology. Of special interest are program projects that emphasize new ideas, novel approaches, and state-of-the-art technology in basic research that elucidates pathogenic mechanisms and shows promise for clinical application in the prevention, diagnosis, and treatment of autoimmune diseases. There is overwhelming evidence to implicate immune mechanisms in the pathogenesis of diseases of the skin, nervous system, endocrine system and gastrointestinal tract. Thus, in addition to studies of well-recognized autoimmune disorders such as systemic lupus erythematosus, rheumatoid arthritis, antibody-mediated thrombocytopenia and autoimmune hemolytic anemia, the NIAID and NIAMS encourage investigators to design and develop studies aimed at establishing the role of the immune system in the pathogenesis of endocrine, dermatologic, neurologic and gastrointestinal diseases and the development of new preventive and treatment modalities specific for these disorders through the manipulation of the immune response. Projects focused on the study of mechanisms of autoimmune diseases should be designed based on integrated and coordinated intra- institutional clinical investigations or experimental studies with demonstrated relevance to human autoimmune disease. Inclusion of basic research components utilizing samples from human source materials in in vitro procedures are encouraged, as are preclinical studies using appropriate animal models of human autoimmune disease. Inclusion of clinical investigative components drawing upon immunologically relevant areas in medicine, pediatrics, surgery, dermatology, neurology, pathology and their subspecialties is highly recommended. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical research, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit by, August 15, 1993, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Program Director, the number and title of this RFA, and a list of the key investigators and their institution(s). Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID and NIAMS staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Mark Rohrbaugh at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the standard research grant application form PHS 398 (rev. 9/91). For purposes of identification and processing, item 2a on the face page of the application must be marked "yes" and the RFA number and the words "PROGRAM PROJECTS ON AUTOIMMUNITY" must be typed in. These application forms may be obtained from the institution's office for sponsored research or its equivalent, and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, Maryland 20892, telephone (301) 594-7248. Applications must be received by November 16, 1993. REVIEW CRITERIA The general criteria for P01 grant applications are the review criteria for large, multicomponent, interdisciplinary program projects as outlined in the NIAID Brochure on Program Project and Center Grants. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program needs and balance, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues and requests for the RFA to: Howard B. Dickler, M.D. Division of Allergy, Immunology, and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A19 Bethesda, MD 20892 Telephone: (301) 496-7104 FAX: (301) 402-2571 Susana A. Serrate-Sztein, M.D. Rheumatic Diseases Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 405 Bethesda, MD 20892 Telephone: (301) 594-9953 FAX: (301) 594-9673 Direct inquiries regarding review issues (including the preparation of a program project application), address the letter of intent to, and mail two copies of the application and all five sets of appendices to: Mark Rohrbaugh, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C22 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-8424 FAX: (301) 402-2638 Direct inquiries regarding fiscal matters to: Mr. Jeffrey Carow Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B29 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7075 Schedule Letter of Intent Receipt Date: August 15, 1993 Application Receipt Date: November 16, 1993 Scientific Review Date: February 1994 Advisory Council Date: June 1994 Earliest Award Date: August 1994 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.855 - Immunology, Allergy and Transplantation Research and No. 93.846 - Arthritis and Musculoskeletal and Skin Diseases Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R9 END ************************************************************ $$R10 BEGIN CA-93-029 FULL-TEXT ************************************* CLINICAL STUDIES OF SYSTEMIC THERAPIES NIH GUIDE, Volume 22, Number 21, June 11, 1993 RFA AVAILABLE: CA-93-029 P.T. 34; K.W. 0715035, 0785035, 0745070 National Cancer Institute Letter of Intent Receipt Date: October 22, 1993 Application Receipt Date: December 7, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRES, BELOW. PURPOSE The Cancer Therapy Evaluation Program (CTEP) of the Division of Cancer Treatment (DCT) at the National Cancer Institute (NCI) invites Interactive Research Project Grant (IRPG) applications to perform research projects designed to conduct clinical studies of innovative systemic therapies investigating promising therapeutic approaches in a single tumor type or focused on a single class of novel compounds or a mechanism of action. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Clinical Studies of Systemic Therapies, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Domestic and foreign, for-profit and non-profit organizations, governments and their agencies are eligible to apply. Applications can be from single institutions and multiple institutions (collaborating institutions, consortia, cooperative groups). New and experienced investigators are encouraged to apply. Applications from minority individuals and women are encouraged. For the purpose of this RFA, each IRPG must consist of a minimum of three investigator initiated research grant applications (R01s). Amended applications from CA-92-25 are encouraged. An IRPG that received funding for one or more, but not all, of the applications in the original package may submit revised applications for those that were unfunded. IRPGs submitted under CA-92-25 can be submitted with less than three required independent R01s under CA-93-029. However, the number of applications currently funded under CA-92-25 plus revised applications submitted under CA-93-029 R01s. MECHANISM OF SUPPORT Support of this program will be by the traditional research project grant (R01) through the use of the IRPG program (see PA- 93-078, NIH Guide for Grants and Contracts, Vol. 22, No. 16, April 23, 1993). Except as otherwise stated in this RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. The total cost for each IRPG (consisting of three or more R01s) is limited to $750,000 per year. The average amount of direct cost per year for each R01 will range from $140,000 to $180,000. The total project period for applications submitted in response to the RFA may not exceed four years. The earliest feasible start date for the initial awards will be August 1994. This RFA is a one-time solicitation. If it is determined that there is a sufficient continuing program need, the NCI will invite recipients of awards under this RFA to submit competitive continuation applications for review according to the procedures described below. FUNDS AVAILABLE Approximately $2,000,000 in total costs per year for four years will be committed to fund applications submitted in response to this RFA. It is anticipated that three IRPGs will be funded in FY 94. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, the award of R01 grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background An unprecedented number of new therapeutic agents are ready for evaluation in pilot clinical studies at this time. In addition, insights into the biologic function and clinical relevance of growth factors, genes that promote and suppress neoplasia, mechanisms of treatment sensitivity and resistance, and function of the immune system provide important new clinical research opportunities for investigators. NCI is interested in expanding support for clinical research. Under this Interactive Research Project Grant (IRPG) RFA, the NCI seeks to encourage the coordinated submission of related research project grant applications from investigators who want to collaborate on a common cancer research theme, but do not require extensive shared physical resources or multiple core functions. This mechanism is not meant to replace the P01 mechanism but to provide an intermediate level of support between the P01 and that available through an individual R01. Research Goals And Scope The aims of this RFA are two-fold: (1) to provide support for translational research that brings innovative basic research findings into the clinic and (2) to foster the development of interactions between basic science laboratories of different disciplines and clinicians performing clinical trials to advance therapeutic clinical research. This RFA is soliciting applications to perform interactive research projects with the goal of developing new clinical studies involving systemic therapies with a therapeutic intent. The interactive research project grants may have as their key focus either: (1) clinical studies investigating promising therapeutic approaches in a single tumor type or (2) the development of new clinical treatment strategies focused on a single class of novel compounds or mechanism of action. Each project supported in the IRPG is expected to contribute to and be directly related to the common theme of the IRPG application. The application must clearly explain how the projected integrated R01 research grants can be expected to accomplish the stated goal more efficiently and effectively than they could without the anticipated interactions. At least one clinical trial protocol must be proposed in one of the grant applications. The clinical trials should be well integrated with the laboratory studies proposed within the same R01 grant or in separate R01 grants. SPECIAL REQUIREMENTS The RFA describes the roles and responsibilities of the Principal Investigator/Awardee and the Project Coordinator. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF FEMALES AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of females and minorities in study populations. If females or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by October 22, 1993, a letter of intent that includes a descriptive title of the proposed research, the names and addresses of the Principal Investigators, the names of other key personnel, the participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, it is requested in order to provide an indication of the number and scope of applications to be reviewed. The letter of intent is to be sent to Dr. Roy S. Wu at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications must be received by December 7, 1993. If an application is received after that date, it will be returned. The research grant application form PHS 398 (rev. 9/91) is to be used in applying for this RFA. These forms are available at most institutional offices of sponsored research; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248; and from the NCI Program Director named below. Special instructions for application are included in the RFA. REVIEW CONSIDERATIONS Upon receipt, applications will be initially reviewed by the Division of Research Grants (DRG) for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA is an NCI program staff function. Applications that are judged non-responsive will be returned by the NCI. Questions concerning the responsiveness of proposed research to the RFA are to be directed to program staff listed under Inquiries. AWARD CRITERIA The anticipated date of award is August 1, 1994. In addition to the technical merit of the application, NCI will consider how well the applicant institution meets the goals and objectives of the program as described in the RFA, availability of resources, and study populations. INQUIRIES Written and telephone inquires concerning the objectives and scope of this RFA and inquires about whether or not specific proposed research would be responsive are encouraged. The NCI Program Directors welcome the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issue, requests for the RFA, and address the letter of intent to: Dr. Roy S. Wu Division of Cancer Treatment National Cancer Institute Executive Plaza North, Room 734 Bethesda, MD 20892 Telephone: (301) 496-8866 FAX: (301) 480-4663 Direct inquire regarding fiscal matters to: Ms. Jennifer Edwards Grants Administration Branch National Cancer Institute Executive Plaza South, Room 242 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 57 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No 93.395, Cancer Treatment Research. Awards are made under the authorization of the Public Health Service Act, Title IV Sections 301, 410, and 411, Part A (Public Law 78-410, 42 USC 241 as amended, Public Law 99-158, 42 USC 285a) and administered under PHS grants policies and Federal Regulations at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R10 END *********************************************************** ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PA-93-082 ************************************************ NICHD CLINICAL INVESTIGATOR DEVELOPMENT AWARD NIH GUIDE, Volume 22, Number 21, June 11, 1993 PA NUMBER: PA-93-082 National Institute of Child Health and Human Development Effective as of October 1, 1993 PURPOSE The National Institute of Child Health and Human Development (NICHD) announces the availability of the Clinical Investigator Development Award (CIDA). The CIDA includes features of and replaces the Physician Scientist Award and the Clinical Investigator Award. It enables candidates seeking a research career to receive advanced training and the opportunity to investigate a well-defined problem under a sponsor competent to provide guidance in the chosen area of research. The CIDA is intended to provide greater flexibility in supporting a career development program suited to the experience and capabilities of the candidate. The objectives of the NICHD in utilizing the CIDA are to: o encourage clinically trained individuals to develop the technological and intellectual investigational skills that will allow them to pursue an independent research career in the mission areas of the NICHD; o increase the pool of medical scientists prepared to use state-of- the-art methods to address significant topics in population research, maternal and pediatric health and disease research, and medical rehabilitation research. ELIGIBILITY The CIDA provides research career development support for clinically trained individuals with a range of research experience, who are committed to developing careers as independent investigators. This award will allow candidates holding health professional doctoral degrees, such as the M.D., D.V.M., D.O., or equivalent degree, to undertake three to five years of advanced study and supervised research with the goal of developing into independent investigators. It is expected that candidates will have completed at least two years of professional experience following the doctoral degree at the time of award. Applications may be accepted from those who hold the Ph.D. degree in addition to the professional degree only if special circumstances can be shown, such as the Ph.D. degree earned in a field unrelated to biomedical science, or a substantial intervening period of clinical or nonresearch activities having occurred since completion of the Ph.D. degree. Such applications will be considered on a case-by-case basis. MECHANISM OF SUPPORT PROVISIONS OF THE AWARD 1. Environment. Applications will be accepted from domestic universities, medical schools, or comparable non-Federal institutions with strong, well-established research and research training programs, sufficient numbers of accomplished faculty in basic and clinical sciences, and a commitment and capability to provide guidance to clinically trained individuals in the development of research independence. Evidence of institutional commitment to the candidate's research and development must be provided in a plan that identifies personnel and other resources to be devoted to the candidate's career development program. 2. Program. Candidates must be nominated by an institution on the basis of qualifications, interests, accomplishments, motivation, and potential for performing quality research. The candidate's academic background, previous experience, and career goals should determine the necessary length and type of plan that is appropriate. The candidate and sponsor are jointly responsible for the preparation of the research development plan. The amount of course work, seminars, and other educational experiences will be expected to vary according to the previous level of experience of the candidate. All candidates must provide a full description of the research and career development plan for the period of the award. The proposed plan must include hands-on research experience for the entire three to five year period. Programs may include studies and research endeavors leading to a relevant Masters or Ph.D. degree, if the objective is the development of the candidate into an independent investigator. 3. Sponsor. Each candidate must identify a primary sponsor who is an accomplished investigator in the research area proposed and has experience in training new investigators. The sponsor must provide a written plan for the development of the candidate into an independent scientist, and provide guidance during the preparation of the application. A secondary sponsor may also be proposed for subsequent guidance in a special area of expertise, but the primary sponsor must continue to be involved throughout the award period. In some cases, candidates may choose to propose both a basic research sponsor and a clinical research sponsor. 4. Advisory Committee. A committee composed of the sponsor(s) and two or three other senior faculty members should be identified. This advisory committee should meet at least annually with the candidate to review the research development plan and project, to evaluate his or her progress, and to provide guidance for future scientific career development. A report from this committee should be included in the annual progress report submitted as part of the noncompeting continuation application. 5. Duration and Effort. The award is made for three, four or five years, depending on the needs of the candidate and the evaluation by the initial review group and the National Advisory Child Health and Human Development Council. It is nonrenewable and not transferable, but in extraordinary situations, change of sponsor and/or change of institution may be allowed with the prior approval of the NICHD. All funds must be used on behalf of the original candidate. A minimum of 75 percent effort must be devoted to the research program, and the applicant institution must provide assurance that at least 75 percent time will be available to the candidate for research. The remainder may be devoted to other clinical and teaching pursuits that are directly relevant to the program, i.e., the candidate's scientific career development or the maintenance of clinical and teaching skills necessary for an academic medicine career. The candidate must have a full-time appointment at the applicant institution. In general, candidates who have Department of Veterans' Affairs (VA) appointments may not consider part of the VA effort toward satisfying the "full-time" requirement at the applicant institution. Although exceptional cases may be approved, any such requests must be strongly justified, and must otherwise meet the intent of the guidelines. Under no circumstances will the CIDA be used to reimburse part of the VA Federal salary. It is permissible for all or part of the research program to be conducted in a VA laboratory, if, for example, the sponsor has a VA appointment, but the above conditions must be satisfied with respect to the CIDA candidate. 6. Allowable costs. a. Salary. Individual compensation is based on the institution's salary scale for individuals at an equivalent experience level. Funding from this award for salary may not exceed $50,000 per year plus commensurate fringe benefits for a full-time employee with at least 75 percent effort devoted to the research program. NIH policy permits supplementation of salary from non-Federal sources. b. Research and Development Support. A maximum of $10,000 per year may be requested for research costs such as technical personnel, supplies, small items of equipment, candidate travel, telecommunications, publication costs, and tuition for necessary courses. All budget items requested must be justified in the application. c. Indirect costs. Reimbursement of actual indirect costs may be requested at a rate up to, but not exceeding, eight percent of the total allowable direct costs of each award, exclusive of tuition, fees, and equipment purchases. 7. Concurrent Applications. CIDA applications may not be submitted or awarded concurrently with other NIH applications, including any other career development award, FIRST award, or research project grant. This includes support under an institutional physician scientist award. Other career development awards may not be applied for or awarded to a candidate for, or recipient of, the CIDA. Individuals who have been the principal investigator on an AREA grant (R15) or a small research grant (R03) may apply for the CIDA. 8. Subsequent Applications for NIH Research Support. Individuals holding the CIDA, during the later years of the award, are encouraged to apply for independent research support, such as the FIRST Award or other research project grants. Care should be exercised that costs requested on the research grants do not duplicate those on the CIDA. Consultation with NICHD staff is recommended. OBJECTIVES The award is intended to serve the research career development needs of clinically trained individuals by providing them with research opportunities appropriate for their academic background, previous research experience, and other past achievements. Candidates who have minimal or no research experience and need guided course work and supervised laboratory experiences are eligible to apply. Individuals who do not require additional courses but who need an intensive research experience under the guidance of an established scientist are also eligible to apply, as are those who, by the time of award, will have concluded training support under institutional training grants or individual fellowships from NIH or other sources. Women, minorities, and individuals with disabilities are encouraged to apply. Current or past Principal Investigators of an NIH grant (other than an R03 or R15) or the equivalent are not eligible. All programs should be carefully tailored to meet individual needs and must include a sponsor who is competent to provide appropriate research guidance. In certain cases it may be appropriate to include a secondary mentor with additional specific expertise. The CIDA can be integrated with the requirements of clinical training, and various approaches for doing so may be proposed. Individuals desiring subspecialty training may wish to complete their clinical fellowships before starting the CIDA. An alternative is interruption of the award to complete clinical training. For example, individuals with limited clinical and research training may propose a plan which includes a one to two year hiatus in the program to allow for the completion of subspecialty training, followed by resumption of the research development program. The period of interruption would be without award support and would not reduce the total length of time of support for which the individual is eligible. At the time of application, candidates must be either citizens or noncitizen nationals of the United States or have been lawfully admitted to the United States for permanent residence. An individual lawfully admitted for permanent residence must submit with the application a notarized statement indicating possession of the Alien Registration Receipt Card (I-151 or I-551). Individuals on temporary or student visas are not eligible. REPORTING REQUIREMENTS During the period of award, recipients, in conjunction with their sponsors, are required to submit a detailed annual progress report. Recipients must also provide a report to the National Institutes of Health annually for a period of five years subsequent to the completion of the CIDA, regarding time devoted to research, academic status attained, publications, and research support (Federal and non- Federal) obtained. APPLICATION PROCEDURES Supplemental instructions for completing and submitting the application must be obtained from program staff or the NICHD contact listed below: Applications are to be submitted on the research grant application form PHS 398 (rev. 9/91). This form is available at the applicant institution's office of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. Submit a signed original of the application and five signed copies in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda MD 20892** REVIEW CONSIDERATIONS Upon receipt, applications will be screened by NICHD staff for compliance with the eligibility criteria above. Applications not meeting these requirements will be returned to the applicant without review. Individuals with significant research experience in the proposed field of study may not be eligible for this award and should discuss other methods of research support with appropriate institute staff. Applications for the CIDA will be evaluated for scientific and technical merit by an NICHD Review Committee, in accordance with the usual NIH peer review procedure. Following the initial review, applications will undergo a second level review by the National Advisory Child Health and Human Development Council. REVIEW CRITERIA 1. Candidate. The candidate's overall competence as demonstrated by academic and clinical performance, potential for a career in independent research, and commitment to pursuing an academic research career. 2. Sponsor(s). The sponsor's accomplishments in the scientific research area(s) proposed by the candidate, appropriate experience and record in training investigators, and degree of commitment for the duration of a candidate's research development program. 3. Environment. The institution's commitment and ability to provide adequate facilities, resources, and opportunities necessary for the candidate's training; the institutional commitment to the candidate; the quality and extent of interaction among the faculty in the basic and clinical sciences; and the quality of the institution's research and research training environment. 4. Career Development Plan. The adequacy of the research career development plan, based on the candidate's past experience, training and career goals. (See Item II, above) 5. Research Plan. Scientific merit of a proposed research project, as described in the Supplemental Instructions, and its appropriateness as a vehicle for developing the candidate's research skills. 6. Advisory Committee. Appropriateness of the advisory committee to meet the research career evaluation needs of the candidate's program. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues and requests for the supplemental instructions to: Hildegard Topper Special Assistant to the Deputy Director National Institute of Child Health and Human Development Building 31, Room 2A03 Bethesda, MD 20892 Telephone: (301) 496-0104 Receipt dates of applications by the Division of Research Grants, NIH are as follows: Application NICHD Advisory Earliest Receipt Dates Council Review Start Date February 1 October December 1 June 1 January April 1 October 1 May July 1 AUTHORITY AND REGULATIONS The programs of the NICHD are described in the Catalog of Federal Domestic Assistance Nos. 93.864, 93.865, and 93.929. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12374 or Health Systems Agency review. $$P1 END ************************************************************ $$P2 BEGIN PA-93-092 ************************************************ CHILD AND ADOLESCENT DEVELOPMENT AND PSYCHOPATHOLOGY RESEARCH CENTERS NIH GUIDE, Volume 22, Number 21, June 11, 1993 PA NUMBER: PA-93-092 P.T. 04; K.W. 0404004, 0710105, 0710030 National Institute of Mental Health PURPOSE The National Institute of Mental Health (NIMH) seeks to expand the Nation's scientific capacity to conduct research on child and adolescent mental disorders by fostering the evolution of Child and Adolescent Development and Psychopathology Research Centers (CADPRC). These Centers are essential to enable the development of new approaches and research strategies to address key scientific problems that have heretofore impeded progress in the child and adolescent mental health/mental disorders field. Thus, this program announcement represents a major NIMH commitment to the advancement of the scientific understanding of the causes, consequences, prevention, and treatment of child and adolescent mental disorders. This announcement focuses on the development of research centers whose main goal is to bridge basic science, state-of-the-art methodologies, and clinical research approaches, in order to address pressing child psychopathology-related research problems that cannot otherwise be adequately addressed by less integrated research strategies. As such, this announcement is the second part of a two-pronged approach outlined under "The National Plan for Research on Child & Adolescent Mental Disorders." While the previously released program announcement, "Implementation of the National Plan for Research on Child and Adolescent Mental Disorders," outlines major areas of research focus and opportunities, this announcement focuses on the creation of necessary research centers to develop the research infrastructure and to advance the knowledge base in critical problem areas. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000" a PHS-led national activity for setting priority areas. This Program Announcement, Child and Adolescent Development and Psychopathology Research Centers (CADPRC), is related to the priority areas of suicide and mental disorders in children and adolescents. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone (202) 783-3238. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT The NIMH will support a maximum of two Centers in each of the first three years of the program. Funding for a Developing CADPRC (P20) (described below under RESEARCH OBJECTIVES) is for a single five-year period only. Funding for Mature Centers (P50) (described below) can be for a maximum project period of five years. Funds may be requested for core support related to the research program of the Center and for specific research and research training activities, including inpatient bed costs, outpatient costs, subject incentive fees, pilot studies, and costs of specialized consultation such as statistical and/or computer science. Training costs and service costs not related to the research program are not covered under Center grants. Actual amounts and years of support that may be approved and awarded will depend on the appropriate level of support necessary for the scientifically meritorious work that is proposed. RESEARCH OBJECTIVES A CADPRC provides research resources that are to be used by a multidisciplinary, cooperating group of researchers as the foundation for a major research program organized around a significant research question or theme. This theme should be directed toward a pressing research question that juxtaposes two or more alternative research paradigms and traditions (e.g., genetic versus environmental contributions to the development of a disorder or subclinical condition; categorical versus dimensional taxonomic approaches; preventive versus promotive interventions, etc.). These multidisciplinary teams should draw upon an expert cadre of researchers across both basic and clinical research disciplines in order to build optimal conceptual and methodologic bridges to address pressing (sometimes controversial and hotly disputed) research questions. Thus, a CADPRC's multidisciplinary team as a rule will consist of researchers from the basic sciences (e.g., developmental psychology, behavioral neuroscience, molecular genetics, etc.) and scientists from more applied, clinical research areas (psychopharmacology, child psychiatry, pediatrics, neuropsychology, clinical psychology, epidemiology, prevention, neuroimaging). Priority will be given to the creation of multidisciplinary research centers devoted to key problem areas of child and adolescent psychopathology research. In all instances, the CADPRC's main goal is to bridge state-of-the-art theories and methods from the basic sciences with pressing, clinically relevant research problems, in order to address child psychopathology research questions that could not otherwise be adequately addressed. Pilot studies pertaining to the etiology, epidemiology, development, diagnosis and classification, prevention, treatment, outcome, and rehabilitation of child and adolescent mental disorders may be supported as a part of a CADPRC, if these studies are clearly related to the thematic focus of the Center. There are two categories of grant applications under the CADPRC program: applications for "Developing Centers" and applications for "Mature Centers." The intent of these two categories is to encourage the development of research centers across a wide range of institutions at varying stages of research capacity development. Although there is no absolute criterion to distinguish who should apply in which category, the following guidelines apply: o The category of "Developing Centers" (P20) is appropriate for departments or other entities that aspire to and are in the process of developing the critical mass of research scholars necessary to conduct state-of-the-art research on child and adolescent development and psychopathology. Applicants in this category do not necessarily have strong track records in research but do show promise by virtue of the commitment of institutional resources, recruitment of research scholars to develop into fully functioning research centers. The funding cap for grants in this category is $300,000 per year, plus negotiated institutional indirect costs. This award is not renewable. o "Mature Centers" (P30) are fully developed entities or have the capacity to rapidly become mature, state-of-the-art research centers by virtue of previous commitments of institutional resources, recruitment and/or development of an existing critical mass of research scholars, the presence of substantial recent publications in peer-reviewed research journals, active research grants, etc. The funding cap for CADPRCs in this category is $1,000,000 per year, plus negotiated institutional indirect costs. Any Center application requesting more than the cap will be returned to the applicant without review. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include both women and minorities in study populations, so that research findings can be of benefit to all persons at risk of the diseases, disorder, or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups must be provided. For the purpose of the policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders, or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the review will be deferred until the information is provided. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants that do not comply with these policies. APPLICATION PROCEDURES Preapplication Consultation. Applicants are strongly encouraged to contact the Centers program staff very early in the planning process. Telephone conversations and meetings with NIMH staff can be especially helpful in the development of a competitive application. It is often of value to the potential applicant to send a preliminary plan, no longer than 12 pages, to the program at least 90 days prior to initial submission of an intended Center grant application. The plan should summarize the present state of planning and development for establishing the proposed Center. Applicants are to use the grant application form PHS 398 (rev. 9/91). The number and title of this Program Announcement, "Child and Adolescent Development and Psychopathology Research Centers, PA-93- ," must be typed in item number 2a on the face page of the PHS 398 application form. PHS regulations concerning application page-length apply to CADPRC applications. In general, 25 pages of text are allowed for each core and research component of the Center. Application kits containing the necessary forms and instructions may be obtained from business offices or offices of sponsored research at most universities, colleges, medical schools, and other major research facilities. If such a source is not available, the following office may be contacted for the necessary application material: Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-05 Rockville, MD 20857 Telephone: (301) 443-4414 The signed original and five legible copies of the completed application must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS The Division of Research Grants, NIH, serves as a central point for receipt of applications for most discretionary PHS grant programs. Applications received under this announcement will be assigned to an Initial Review Group (IRG) in accordance with established PHS referral guidelines. The IRGs, consisting primarily of non-Federal scientific and technical experts, will review the applications for scientific and technical merit. Notification of the review recommendations will be sent to the applicant after the initial review. Applications will receive a second-level review by the appropriate National Advisory Council whose review may be based on policy considerations as well as scientific merit. Only applications recommended for approval by Council may be considered for funding. Receipt Dates Applications will be reviewed according to the following regular schedule: New, Competing National Continuation, & Scientific/ Advisory Revised Applications Technical Council/Board Approximately Receipt Date Merit Review Review Start Date Feb 1 May/Jun Sep/Oct Dec 1 Jun 1 Sep/Oct Jan/Feb Mar 1 Oct 1 Jan/Feb May/Jun Jul 1 Applications received after the above receipt dates are subject to assignment to the next review cycle or may be returned to the applicant. AWARD CRITERIA Applications received in response to this announcement will compete with others submitted for funding. In granting awards, the following criteria are considered: o Program relevance and balance o Quality of application as documented by IRG and Council recommendations o Availability of funding o Institute priorities INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Peter S. Jensen, M.D, Chief Division of Clinical and Treatment Research National Institute of Mental Health Parklawn Building, Room 10-104 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-5944 For information regarding fiscal or grants management issues, applicants may contact: Diana Trunnell Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-15 Rockville, MD 20857 Telephone: (301) 443-3065 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance 93.242, Mental Health Research Grants. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This announcement is not subject to the intergovernmental review requirements of Executive Order 12372, as implemented through DHHS regulations at 45 CFR Part 100, or Health Systems Agency review. The National Institute of Neurologic Disorders and Stroke (NINDS) also funds basic and clinical research concerning the etiology, diagnosis, treatment, and prevention of neurodevelopmental disorders. For further information contact: Giovanna M. Spinella, M.D. Federal Building, Room 820 Bethesda, MD 20892 Telephone: (301) 496-5821 $$P2 END ************************************************************ $$P3 BEGIN PA-93-093 ************************************************ EXPLORATORY/DEVELOPMENTAL GRANTS FOR PSYCHOSOCIAL TREATMENT RESEARCH NIH GUIDE, Volume 22, Number 21, June 11, 1993 PA NUMBER: PA-93-093 P.T. 34; K.W. 0715129, 0415001, 0745060, 0414014 National Institute of Mental Health PURPOSE The National Institute of Mental Health (NIMH) is soliciting applications for exploratory developmental grants for research on psychosocial treatment. The ultimate goal is the development of standardized psychosocial treatments for specific mental disorders or mental health problems of public health significance for eventual testing in clinical trials or treatment efficacy studies. The intent of this program announcement is to stimulate clinical investigators to collect preliminary data on a psychosocial treatment that are prerequisite to the conduct of a clinical trial. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, Exploratory/Developmental Grants for Psychosocial Treatment Research, is related to the priority area of mental health and mental disorders. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone (202) 783-3238). ELIGIBILITY These grants are available to public and private, for-profit and non- profit, domestic and international institutions such as a universities, colleges, hospitals, laboratories, and community agencies; and units of State and local governments and authorized units of the Federal government. Women and minorities are encouraged to apply. MECHANISM OF SUPPORT The exploratory/developmental grant (R21) is limited to $100,000 in direct costs per year for up to three years. Annual awards will be made subject to continued availability of funds and progress achieved. RESEARCH OBJECTIVES Background A review of the relevant research literature on the treatment of mental disorders indicates that although there are effective symptom-focused treatments for acute episodes of a few mental disorders, there is a need for the development of treatments for a large number of other disorders, including new treatments for intractable disorders, maintenance treatments for recurring or chronic disorders, and the modification of a treatment found efficacious for one disorder so that it can be tested with additional disorders. Most of the existing efficacious treatments focus on the primary symptoms of mental disorders. There is, however, a need to develop new treatments to address the residual problems associated with any given mental disorder. These residual problems may include high levels of associated symptoms (e.g., the high level of generalized anxiety that usually remains after the successful treatment of panic disorder); social, interpersonal, daily living, and occupational difficulties and deficits; and dysfunctional cognitive and affective patterns that appear to be related to the symptoms of a particular disorder. In all of these instances, the need for treatment development research is patently clear. Psychosocial treatment refers to treatment that attempts to modify feelings, cognitions, attitudes, and behavior through psychological and social processes. These include, among others, psychodynamic, experiential, cognitive-behavioral, marital, family, and group approaches to psychosocial treatment. Exploratory/developmental research in this context refers to the early phases of standardizing and piloting a psychosocial treatment. This research may be appropriate: (1) when no effective treatments for a particular mental disorder exist; (2) when treatments that have been effective for some patient subgroups can be adapted, augmented, or extended to other contexts or subgroups (e.g., patients with comorbidity, culturally distinct groups); (3) when effective treatments should be extended in time to prevent relapse or recurrences; or (4) when current treatment is only partially effective (e.g., some symptoms are relieved but symptoms but there is still a significant level of disability). The primary objective of this announcement is to stimulate high caliber research on the early stages of the development of a new psychosocial treatment or adaptation of a known effective one that might be applied to other mental disorders. Examples of eligible types of studies include: o Treatment standardization research focused on the development and testing of a manual for a specific psychosocial treatment as well as the development of therapy adherence measures and therapist competency measures o Research on the development of an integrated psychosocial and pharmacologic treatment regimen for a specific disorder, paying particular attention to the establishment of principles underlying different sequences of psychosocial and pharmacologic treatments o Research on the development of a psychosocial treatment that integrates treatment strategies from different psychotherapeutic orientations o Development of psychotherapy process and outcome measures for eventual use in the standardization of a psychosocial treatment Different mental disorders require the development of treatments at different stages. The following are examples of disorders and the stage of treatment that merit attention: o New, developmentally appropriate treatments for childhood and adolescent disorders o New treatments for bipolar disorder in adulthood o New treatments for Axis II disorders o New treatments for post-traumatic stress disorder o New treatments for comorbid conditions occurring throughout the life cycle o New treatments for disorders that differentially affect women and ethnic minorities In preparing a research grant application, the applicant should consider the following issues: o Public health significance of the clinical disorder and its complications addressed by the proposed treatment o Creativity and innovativeness of the proposed treatment program or model o Familiarity with the relevant clinical and research literature o Clear statement of working procedures, including procedures for development and formulation of treatment model, illustration and communication of model and treatment procedures for pilot studies, and plans for review and revision, appropriate to stated aims o Procedures for establishing reliability and validity of monitoring, and quality control STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. ALLOWABLE COSTS Applicants may request funds for salary, research costs, consultants, patient costs, equipment and supplies, and appropriate indirect costs. Grants must be administered in accordance with the "PHS Grants Policy Statement (rev. 10/90)." Federal regulations at 42 CFR Part 52, "Grants for Research Projects," and Title 45 CFR Parts 74 and 92, generic requirements concerning the administration of grants, are applicable to these awards. APPLICATION PROCEDURES Applications are to be prepared on the grant application form PHS 398 (rev. 9/91), available from most institutional offices of sponsored research and from the Grants Management Branch, National Institute of Mental Health, 5600 Fishers Lane, Room 7C-05, Rockville, MD 20857, telephone (301) 443-4414. On item 2a of the application face page, applicants must enter the number and title of this program announcement (PA-93-093: Exploratory/Developmental Grants for Psychosocial Treatment Research). A completed original application and five copies must be sent to: Division of Research Grants National Institutes of Health Westbard Building, Room 240 Bethesda, MD 20892** Schedule All applications will be reviewed in accordance with the regular PHS review schedule: Receipt Dates Initial Advisory Earliest New/Renewal Review Council Review Start Date Jun 1/Jul 1* Oct/Nov Jan/Feb Apr 1 Oct 1/Nov 1* Feb/Mar May/Jun Jul 1 Feb 1/Mar 1* May/Jun Sep/Oct Dec 1 *Competing continuations, supplemental, and revised applications are to be submitted on these dates. Protection of Human Subjects The Department of Health and Human Services has regulations for the protection of human subjects and has developed additional regulations From owner-sci-resources@net.bio.net Thu Jun 17 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 21, pt. 3, 11 June 1993 Message-ID: Date: 18 Jun 93 17:19:03 GMT Sender: kristoff@net.bio.net Lines: 1088 Approved: biosci-moderator@net.bio.net $$XID NIHGUIDE 19930611 V22N21 P3O3 ************************************ for the protection of children. A copy of these regulations (45 CFR 46, Protection of Human Subjects) and those pertaining specifically to children are available from the Office of Protection from Research Risks, National Institutes of Health, Bethesda, Maryland 20892, telephone (301) 496-7041. Specific questions concerning protection of human subjects in research may be directed to NIMH staff members listed under "Inquiries" below. Researchers who apply for and receive a Certificate of Confidentiality may not be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings to identify the persons who are participating in the research covered by the certificate. For more information about the NIMH Certificate of Confidentiality, contact Anne W. Cooley, Division of Extramural Activities, Room 9-95, telephone (301) 443-4673. REVIEW PROCEDURES Upon receipt, applications will be reviewed for completeness and responsiveness. Incomplete and non-responsive applications will be returned to the applicant without further consideration. Applications in response to this announcement will be reviewed on a nationwide basis in accordance with the usual Public Health Service peer review procedures for research grant applications. They will be reviewed for scientific and technical merit by an initial review group (IRG) composed primarily of non-Federal scientific experts, and by the appropriate Advisory Council. Review by Council may be based on policy considerations as well as scientific and technical merit. Summaries of IRG recommendations are sent to applicants as soon as possible following completion of the IRG review. Review Criteria Applications will be judged on the criteria listed below: o Scientific significance and originality of proposed research o Appropriateness and adequacy of the design and methodology proposed to carry out the research o Qualifications and research experience of the Principal Investigator and staff, particularly but not exclusively in the area of the proposed research o Availability of resources necessary to perform the research o Appropriateness of budget estimates for the proposed research o Adequacy of procedures for the protection of human subjects of research o Conformance of the application to NIH policy on inclusion of women and minorities in study populations AWARD CRITERIA In making awards, the following criteria are considered: o Quality of application as determined by IRG and Council recommendations o Program relevance o Availability of funds INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Barry E. Wolfe, Ph.D. Division of Clinical and Treatment Research National Institute of Mental Health Parklawn Building, Room 18-105 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-4527 Direct inquiries regarding fiscal matters to: Diana Trunnell Grants Management Branch National Institute of Mental Health Parklawn Building, Room 7C-15 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-3065 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P3 END ************************************************************ $$P4 BEGIN PA-93-094 ************************************************ RESEARCH ON THE EFFECTS OF MICROGRAVITY ON THE MUSCULOSKELETAL SYSTEM NIH GUIDE, Volume 22, Number 21, June 11, 1993 PA NUMBER: PA-93-094 P.T. 34; K.W. 0705050, 0710020, 1002061, 0765033 National Institute of Arthritis and Musculoskeletal and Skin Diseases PURPOSE The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), in collaboration with the Life Sciences Division of the National Aeronautics and Space Administration (NASA), invites grant applications on basic, applied, and clinical research projects focusing on the effects of microgravity on the musculoskeletal system. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Research on the Effects of Microgravity on the Musculoskeletal System, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, non-profit and for-profit, public and private organizations, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) Award (R29). Applications from minority individuals and women are encouraged. MECHANISMS OF SUPPORT Support will be offered through regular research project grants (R01) and FIRST Awards (R29). Because the nature and scope of the research proposed in response to this PA may vary, it is anticipated that the size of an award will vary also. RESEARCH OBJECTIVES Space travel encompasses many technological challenges and opportunities. As the U.S. Space Program prepares for extended duration space flights on the Space Shuttle, Space Station Freedom, and on exploration missions to the Moon and Mars, it is important that life sciences research provide a thorough understanding of the many physiologic changes that occur in a microgravity environment. Prolonged exposure to weightlessness diminishes functional capacity, performance and endurance of the musculoskeletal system, even at submaximal loads, and thus elicits concern about the health and well-being of space travellers, especially as space flight is extended in time. This research should also lead to development of effective countermeasures to any effects that may be detrimental to the functional capacity, health, or well-being of crew members. The musculoskeletal system has the capacity to adapt its structural and functional properties in accordance with the type and degree of stimuli imposed on it. Prolonged space travel is essentially a period of significant unloading of the musculoskeletal system. Exposure to weightlessness results in structural and functional adaptations that place the musculoskeletal system on the low end of the continuum ranging from complete disuse to maximal load-bearing. Evidence from previous space flights and ground-based research indicates that the musculoskeletal system is functionally impaired with increasing duration of weightlessness. Space flight has been consistently accompanied by loss of bone and negative calcium balance. Bone density may decrease by as much as 10 percent per year. This change in bone density is preceded by significant and more rapid weakening and atrophy of skeletal muscle. A workshop on the "Effects of Space Travel on the Musculoskeletal System" was co-sponsored by the NIAMS and NASA in October 1990. The workshop provided state-of-the-art knowledge, identified research gaps and windows of opportunity, and recommended future directions for research on understanding the musculoskeletal system's adaptation to exposure to weightlessness, including development of adequate physiologic and performance-based countermeasures. Although there is a research base of some knowledge on the complex bone remodelling process and potential biological agents and factors that may be able to restore or prevent bone loss on earth, more research is required in space applications of these technologies. Considerably less information is available on understanding how force development by skeletal muscle is essential in maintaining bone integrity. Likewise, there is a strong science base regarding muscle physiology, but knowledge in microgravity environments is limited. A workshop summary, The Effects of Space Travel on the Musculoskeletal System, has been published (NIH Publication No. 93-3482, November 1992) and is available upon request from the Program Officials listed under INQUIRIES. The NIAMS, in collaboration with NASA, is interested in soliciting grant applications whose research focus is on the effects of microgravity on the musculoskeletal system. The major objective of this Program Announcement is to stimulate basic, applied, and clinical research on elucidating the effects of microgravity on the musculoskeletal system. Development of mechanism-related hypotheses encompassing both basic and applied science is desirable. While the research focus is on reduced gravity conditions, well justified studies on musculoskeletal responses to increased gravity conditions may be instrumental in understanding the pathogenesis of bone and skeletal muscle weakness and loss during exposure to microgravity environments. A key feature of the basic research component is understanding the cellular mechanisms whereby alterations in the musculoskeletal system are evoked in response to external loading and loading histories. For example, how does loading or lack of it affect cellular processes and regulatory factors that control turnover of matrix and contractile proteins? Basic research would focus on the physiologic changes of bone and skeletal muscle in cell and tissue cultures that occur in a low or high gravity environment. Applicants are also encouraged for appropriate applied/clinical studies addressing microgravity-induced osteopenia and skeletal muscle atrophy in whole animal and human experiments. Utilization of available technologies including, but not limited to, the following are encouraged: simulations of weightlessness (e.g., suspension limb model), centrifugation (alterations in 'g' forces), and bedrest. Applicants may collaborate with NASA scientists (based on availability of resources), especially in gaining access to hospital beds in a clinical setting and low or high gravity environment facilities. Special emphasis should be placed on elucidating the etiology of the pathogenesis of bone loss and skeletal muscle weakness during exposure to an altered gravity environment and on research activities that will address the important issues of prevention and treatment of bone and skeletal muscle loss from microgravity exposure. The research identified in this announcement is specifically targeted to the response of bone and muscle to alterations in environmental gravity that lead towards understanding the effects of space travel. Examples of research activities identified by the Workshop include, but are not limited to: o Quantification of rate, magnitude, and cellular origins of bone and skeletal muscle cell loss in conditions of altered gravity; o Influence of skeletal muscle second messengers on bone growth under microgravity environments; o Hormonal and growth factor effects on bone and muscle cell function and metabolism in relation to gravity effects; o Characterization of bone loading in bedrest subjects; o Bone and muscle cell responses to altered mechanical stress and gravity; o Evaluation of 3-D structure and integrity of the musculoskeletal system and constituent tissues in response to changes in gravity; o Bone and muscle cell expression, including characterization of cellular receptors, signal transduction and messengers in response to gravity changes; o Alterations in blood flow and its impact on cellular metabolism in microgravity; and o Development of therapeutic agents that restore bone loss and muscle weakness due to space travel. These areas of research are neither prioritized nor meant to be restrictive. Investigators are encouraged to submit applications in any meritorious area of research responsive to the general research objectives of this Program Announcement. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study. Special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, and Hispanics). The rationale for studies on single minority population groups must be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including, but not limited to, clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the review will be deferred until the information is provided. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications are to be submitted on grant application form PHS 398 (rev. 9/91). Applications will be accepted at the standard application deadlines indicated in the application kits. Application kits are available at most institutional offices of sponsored research and may also be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248. The title and number of the announcement must be typed in Section 2a on the face page of form PHS 398. The completed original application and five legible copies of Form PHS 398 must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW PROCEDURES Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit by initial review groups of the Division of Research Grants. Following scientific-technical review, applications will receive a second-level review by the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council or by other relevant advisory boards and/or councils. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following criteria will be considered in the making of funding decisions: o Quality of the proposed project as determined by peer review; o Availability of funds; and o Program balance among research areas of the announcement. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: Stephen L. Gordon, Ph.D. Musculoskeletal Diseases Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 407 Bethesda, MD 20892 Telephone: (301) 594-9951 Richard W. Lymn, Ph.D. Muscle Biology Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 403 Bethesda, MD 20892 Telephone: (301) 594-9959 Victor S. Schneider, M.D. Life Sciences Division National Aeronautics and Space Administration Code SBM 300 E Street, SW Washington, DC 20546 Telephone: (202) 358-2359 Direct inquiries regarding fiscal matters to: Ms. Diane M. Watson National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 732A Bethesda, MD 20892 Telephone: (301) 594-9965 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.846, Arthritis, Musculoskeletal and Skin Diseases Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 410, 78th Congress, as amended, 42 USC 241) and administered under PHS grants policies and Federal regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P4 END ************************************************************ $$P5 BEGIN PA-93-095 ************************************************ RESEARCH ON RELATIONSHIPS BETWEEN ALCOHOL AND VIOLENCE NIH GUIDE, Volume 22, Number 21, June 11, 1993 PA AVAILABLE: PA-93-095 P.T. 34; K.W. 0404003, 0404023 National Institute on Alcohol Abuse and Alcoholism THE PROGRAM ANNOUNCEMENT (PA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS SHOULD OBTAIN THE PA FROM A CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE Alcohol is present in a significant proportion of violent events, including between one-half and two-thirds of all homicides and serious assaults. Moreover, alcohol-related problems have been found disproportionately among both juvenile and adult criminal offenders. Nevertheless, understanding of the mechanisms by which alcohol influences violent behavior has been limited, largely because the causes are multifactorial. The National Institute on Alcohol Abuse and Alcoholism (NIAAA) invites research grant applications that advance understanding of the biological and psychosocial mechanisms underlying associations between alcohol consumption and interpersonal violence and that identify and test interventions to reduce and/or prevent alcohol related violence and the alcohol-related sequelae of such violence. Of primary interest are studies that identify: (1) individual and environmental conditions, situations, populations, and circumstances under which alcohol and violence are causally connected; (2) sequential processes by which alcohol intake may lead to violent behavior and vice versa; (3) physiological and neural mechanisms that mediate the relationship between alcohol and violence; (4) behavioral consequences of alcohol-related violence, including subsequent alcohol abuse and violent behavior; and (5) interventions that may effectively reduce alcohol-related violence. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, Research on Relationships Between Alcohol and Violence, is related to the priority areas of reducing violent and abusive behavior and decreasing morbidity and mortality associated with alcohol consumption 4). Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0, or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY Applications may be submitted by domestic and foreign non-profit and for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. Foreign applicants are not eligible for First Independent Research Support and Transition (FIRST) Awards (R29s). MECHANISM OF SUPPORT Research support may be requested through applications for a regular research grant (R01), Small Grant (R03), or FIRST Award (R29). Specialized announcements for the FIRST Award program (R29) and the Small Grant program (R03) are available from the National Clearinghouse for Alcohol and Drug Information (NCADI), P.O. Box 2345, Rockville, Maryland 20852, telephone: (301) 468-2600 or 1-800-729-6686. FUNDS AVAILABLE Applications received in response to this announcement will compete with others submitted for funding. The amount of funding available will depend on appropriated funds, quality of proposals, and program priorities at the time of the award. No specific funds are allocated for this program at this time. RESEARCH OBJECTIVES The NIAAA seeks studies that systematically explore linkages among psychological, situational, and sociocultural factors that may contribute to or reduce the occurrence of alcohol related violence. Diverse designs, methodologies, and disciplinary approaches are welcome. The use of multiple methods and development of multidisciplinary research teams are desirable. Prevention research not only measures the effectiveness of interventions, but includes domains of pre-intervention research related to the causes and nature of alcohol-related violence that may inform intervention research. Basic neurobehavioral research seeks to explore the neurobiological, pharmacological, and physiological mechanisms underlying violent behavior and effects of genetic and environmental factors on animal and human behavior in the presence of alcohol. Relevant research topics include, but are not limited to, the following areas: Basic Research on Biological and Physiological Mechanisms. o Controlled animal studies to identify the discrete brain mechanisms underlying distinct types of aggressive behavior and their relationship with genetic and environmental variables. o The role of neurotransmitter systems in specific types of alcohol-induced aggression and in various species. o The actions of alcohol on neuroendocrine events that control testosterone and adrenal hormones. o Gene-environment interactions using animals selectively bred for high alcohol preference or high levels of aggressive behavior. o The genetic linkage between antisocial personality, alcoholism, and violence. Pre-intervention Studies of Behavior, Cognition and Expectancies. o How alcohol modifies perceptions of cues interpreted as aggressive or its effect on affective responses. o Alcohol-expectancies and violence: how children develop expectancies that associate alcohol and violence; the effects of social institutions, demographic variables, individual drinking history, personality traits, and perceptions of victimization risk on expectancies regarding post-drinking aggression; and how drinking is used to justify violence or mitigate its punishment. o Experiments varying alcohol dose and type, subject characteristics, and contextual factors to assess differences in individual aggressive responses. o Observational studies of social interaction involving alcohol to distinguish violent and non-violent sequences and outcomes. o The contribution of alcohol to violence by persons with comorbid psychiatric symptoms. Pre-intervention Studies of the Social and Environmental Context. o Effects of such contexts as physical environment, group settings, interpersonal relationships and the role of witnesses on the intoxication-aggression relationship. o The salience of social controls: police attitudes and behavior toward drunken individuals and situations when they are likely to intervene; relationships between violence and the density of alcohol outlets. o The role of alcohol in abuse against children, spouses, and the elderly. Aggregate Level Studies of Legal and Policy Effects. o The impact of changes in the law and other public policies that affect alcohol-related violence such as changes in alcohol availability or shifts in levels of law enforcement. Prevention/Intervention Research. o Educational programs that address alcohol's effect on judgment and the increased likelihood of victimization after drinking. o Therapeutic interventions with relevant prison population. o Interventions involving server training, routine police patrol, and alteration of the drinking environment. o Community-wide campaigns and their assessment. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available from most institutional offices of sponsored research and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-594-7248. The number and title of the announcement must be typed in item number 2a on the face page of the application. FIRST (R29) applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original and five permanent, legible copies of the PHS 398 form must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW PROCESS Applications received under this announcement will be assigned to an Initial Review Group (IRG) in accordance with established PHS Referral Guidelines. The IRG, consisting primarily of non-Federal scientific and technical experts, will review the applications for scientific and technical merit. Applications will receive a second-level review by an appropriate National Advisory Council, whose review may be based on policy considerations as well as scientific merit. Small Grants (R03s) do not receive a second level review. REVIEW CRITERIA Research grant applications will be reviewed based on standard criteria for scientific/technical merit review of applications for regular research grants (R01). The review criteria for Small Grants (R03) and FIRST Awards (R29) are contained in their program announcements. AWARD CRITERIA Applications recommended by a National Advisory Council will be considered for funding on the basis of overall scientific and technical merit of the research as determined by peer review, program needs and balance, and availability of funds. INQUIRIES Written and telephone inquiries are encouraged to clarify any issues or questions from potential applicants. Direct inquiries regarding pre-intervention, prevention, and policy studies, and requests for the program announcement to: Susan E. Martin, Ph.D. Prevention Research Branch National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 13-C23 Rockville, MD 20857 Telephone: (301) 443-1677 Direct inquires regarding biological mechanisms to: Ellen D. Witt, Ph.D. Neuroscience and Behavior Research Branch National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 16-C05 Rockville, MD 20857 Telephone: (301) 443-4223 Direct inquiries regarding fiscal issues to: Elsie Fleming Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 16-86 Rockville, MD 20857 Telephone: (301) 443-4703 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.273. Awards are made under authorization of the Public Health Service Act, Sections 301 and 464H, and administered under PHS policies and Federal Regulations at Title 42 CFR Part 52, "Grants for Research Projects," and Title 45 CFR Parts 74 and 92, "Administration of Grants" and 45 CFR Part 46, "Protection of Human Subjects." This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P5 END ************************************************************ $$XID RFA HD93014 HD-93-014 P1O1 *************************************** ETHNIC MINORITY FAMILIES WITH RETARDED MEMBERS NIH GUIDE, Volume 22, Number 21, June 11, 1993 RFA: HD-93-014 P.T. 34, FF; K.W. 0715130, 0730050, 0710030 National Institute of Child Health and Human Development Letter of Intent Receipt Date: July 21, 1993 Application Receipt Date: September 9, 1993 PURPOSE The Mental Retardation and Developmental Disabilities Branch (MRDD), Center for Research for Mothers and Children (CRMC), of the National Institute of Child Health and Human Development (NICHD) invites research grant applications on ethnic minority families with mentally retarded or developmentally disabled members. The primary goal of this Request for Applications (RFA) is to stimulate research on the unique qualities of ethnic minority families with mentally retarded or developmentally disabled members. The ethnic minority populations to be studied are: African-American; Hispanic; Asian-American, including Pacific-Island-Americans; and American-Indian, including Alaskan-Natives. High priority research topics include traditional beliefs, values, and responses to mental retardation and developmental disability of these particular ethnic groups, formal and informal support systems that are most likely to be used by families in these groups, and the impact of ethnicity on families' interactions with various types of service agencies. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Ethnic Minority Families with Retarded Members, centers on a high priority research area, the health and well- being of several special populations: people with disabilities, and people in ethnic minority groups, many of whom have low incomes. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone: 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, laboratories, units of state and local governments, and eligible agencies of the Federal government. Minority investigators and women are encouraged to apply. It is suggested that applicants have research experience pertinent to the research agenda spelled out in the RFA. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) awards (R29). MECHANISM OF SUPPORT This RFA will use two funding mechanisms: the National Institutes of Health (NIH) individual research grant (R01) or the FIRST Award (R29). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed five years and may be renewed according to the conventional procedures that pertain to PHS grants. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE It is estimated that applications submitted in response to this announcement will compete for approximately $750,000 in direct costs that will be made available for the first year of support. It is expected that four awards will be made. The number of awards depends on the overall scientific merit of the applications and the availability of funds. RESEARCH OBJECTIVES With the recent trend to deinstitutionalization, retarded and developmentally disabled individuals are spending more of their childhood and adult years living with their families. The result is that there are increasing opportunities for reciprocal influences between retarded persons and other family members. In 1986 the MRDD Branch issued an RFA for research on families with retarded members. Since that time research in this area has grown rapidly. However, little attention has been given to ethnicity in research on families with retarded or developmentally disabled members. In fact, much of the research literature in this field fails to describe the ethnicity of the families studied. Although it is difficult to establish reliable statistics on the prevalence of mental retardation and developmental disability in ethnic minority populations, it is known that conditions associated with low birth weight, prenatal and postnatal insult from environmental toxins, lack of economic resources, deprivation, and inadequate medical care, have contributed to the incidence of disability, including mild to severe retardation, in selected groups within ethnic minority populations. Thus, while many ethnic minority families care for retarded or developmentally disabled family members, little is known about these families. For this reason the MRDD Branch of NICHD held a conference in Bethesda, Maryland in April 1992 to review the status of research on ethnic minority families with retarded and developmentally disabled members and to identify promising directions, as well as methodological problems, in this research. This RFA is intended to encourage researchers to focus on ethnic minority families with retarded or developmentally disabled members, to learn more about their unique circumstances and experiences, beliefs, goals, needs, resources, strengths, and sources of support. The families to be studied may be from one or more of the following groups: African-American; Hispanic; Asian-American, including Pacific-Island-Americans; and American-Indian, including Alaskan-Natives. High priority research topics include traditional beliefs, values, and responses to mental retardation and developmental disability of these particular ethnic groups, formal and informal support systems that are most likely to be used by families in these groups, and the impact of ethnicity on families' interactions with various types of service agencies. Research topics in need of attention include the following: A. What are the traditional values and responses to retardation and developmental disability in particular ethnic minority groups? What are common beliefs within groups about the nature and causes of disabilities, and the functions and value of retarded persons in the family and society? How are these beliefs transmitted from generation to generation? Within particular ethnic groups, to what degree are family members' beliefs and responses to disability affected by variables such as education, socioeconomic status, family composition, size, and type, for example, single-parent families, nuclear, or extended families? In the case of recently immigrated ethnic minority groups, how are beliefs and responses to retardation and disability affected by recency of immigration, lifestyle changes, such as employment, gender roles, and acculturation? B. What types of formal and informal support systems are most likely to be used by family members in different ethnic groups? What are the characteristics of effective support systems for various family members, and how do they function? Do the various family members, e.g., mothers, fathers, siblings, grandparents, use similar or different support systems? What is the impact of economic factors on access and receptiveness to various types of formal and informal support systems and forms of services? How do ethnicity, family characteristics, and economic resources interact to affect the above outcomes? C. What variables need to be considered in the development of appropriate models and instruments to assess family functioning and the needs of individuals in ethnic minority families with retarded or developmentally disabled members? All investigations must carefully consider the type and severity of retardation, and other behavioral characteristics of the retarded and developmentally delayed members of the families to be studied, as well as the presence of associated disabling conditions, such as epilepsy, cerebral palsy, and hyperactivity. It is not necessary to compare ethnic minority families with Euro-American families. Proposals that include families from two or more different ethnic minority groups are welcome; however, research on a single ethnic group, is also appropriate. Although researchers must necessarily limit the number of variables to be investigated, it is important to be aware of sources of heterogeneity within the populations to be studied, including ethnic subgroup, differences in language and acculturation; socioeconomic status; age, cohort, and/or stage in the family cycle; family structure and composition; and geographic region and characteristics of the local community, to cite a few examples. Research designs may be cross-sectional or longitudinal, and all stages of the life cycle may be investigated. Care should be taken that measures are appropriate for the populations to be studied. Qualitative, as well as quantitative methods, may be used. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS It is NIH policy that applicants for NIH clinical research grants (i.e., research involving human subjects) will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study. This RFA is for research on ethnic minority families in four groups: African-American; Hispanic; Asian-American, including Pacific-Island-Americans; and American-Indians, including Alaskan-Natives. The composition of the proposed study population must be described in terms of gender, as well as racial or ethnic group, and gender issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included on the grant application form PHS 398 in Sections 1-4 of the research plan and summarized in Section 5, (Human Subjects). All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or girls in a study design is inadequate to answer the scientific question(s) addressed and the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. LETTER OF INTENT Investigators who expect to respond to this RFA may submit a letter of intent by July 21, 1993. The letter of intent should include a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the names of any other key personnel, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in evaluating relevance to the topic of the RFA and in planning for the review of applications. The letter of intent is to be sent to Dr. Phyllis W. Berman at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91). This application form is available in the office of sponsored research at most academic and research institutions and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. The receipt deadline for applications prepared in response to this RFA is September 9, 1993. Late applications will be returned to the applicant without review. The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for evaluation. Check "YES" in item 2a on the face page of the application and type "Ethnic Minority Families with Mentally Retarded Members, HD-93-014." Applications for the FIRST Award (R29) must include at least three sealed letter of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The original and three copies of the application must be sent or delivered to: Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** In addition, two copies of the application must be sent under separate cover to: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E01 Bethesda, MD 20892 REVIEW CONSIDERATIONS Applications will be reviewed by NICHD staff for completeness and responsiveness to the RFA. Applications deemed non-responsive will be returned to the applicant. If an application is returned, the applicant may resubmit the application to the Division of Research Grants as an unsolicited application during one of the three yearly review cycles (February 1, June 1, October 1). If the application submitted in response to this RFA is substantially similar to a grant application already submitted to the NIH for review, but not yet reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Applications may be triaged by and NICHD peer review group on the basis of relative competitiveness. The NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NICHD. The second level of review will be provided by the National Advisory Child Health and Human Development Council. o Scientific, technical, or medical significance and originality of proposed research. o Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research. o Qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research. o Availability of resources necessary to perform the research. o Appropriateness of the proposed budget and duration in relation to the proposed research. AWARD CRITERIA The earliest anticipated award date is April 1994. The following will be considered in making awards: o Quality of the proposed project as determined by peer review. o Availability of funds. o Program balance among research areas of the RFA. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues and address the letter of intent to: Phyllis W. Berman, Ph.D. Mental Retardation and Developmental Disabilities Branch, National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B09D Bethesda, MD 20892 Telephone: (301) 496-1383 Direct inquiries regarding fiscal and administrative matters to: E. Douglas Shawver Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17F Bethesda, MD 20892 Telephone: (301) 496-1303 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865, Research for Mothers and Children. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. From owner-sci-resources@net.bio.net Thu Jun 17 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 21, pt. 4, 11 June 1993 Message-ID: Date: 18 Jun 93 17:22:40 GMT Sender: kristoff@net.bio.net Lines: 1349 Approved: biosci-moderator@net.bio.net $$XID RFA CA93027 CA-93-027 P1O1 *************************************** MINORITY ENHANCEMENT AWARDS NIH GUIDE, Volume 22, Number 21, June 11, 1993 RFA: CA-93-027 P.T. 34, FF; K.W. 0785035, 0715035, 0745070, 0710095 National Cancer Institute Letter of Intent Receipt Date: July 14, 1993 Application Receipt Date: September 22, 1993 PURPOSE The Comprehensive Minority Biomedical Program (CMBP), Division of Extramural Activities (DEA), National Cancer Institute (NCI), invites research grant applications from interested investigators with access to large or predominantly minority populations to promote minority group participation in cancer research with a special focus on cancer control research. Support provided by this initiative would broaden the operational base of each institution by: 1. Expanding cancer control and prevention efforts in early detection, prevention, screening, pre-treatment evaluation, treatment, continuation care, and rehabilitation; 2. Increasing the involvement of minority population primary care providers early in the course of clinical treatment research; 3. Promoting the involvement in treatment research at the institutional level with a focus on the development of treatment protocols for cancers that have a high incidence in minorities; 4. Supporting programs involving diet and nutrition cancer control research activities; 5. Coordinating the contributions of investigators from various relevant disciplines, psychology and nutrition; and 6. Promoting the inclusion of minority individuals at all levels in the conduct of the research with the increased recruitment of minority scientists into the research base of the institution as an expected outcome. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Minority Enhancement Awards, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or Healthy People 2000" (Summary report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone (202) 783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the federal government. Applications from minority individuals and women are encouraged. Institutions are eligible if they can demonstrate the following: 1. Broad research capabilities in cancer prevention, cancer control and cancer treatment as evidenced by significant research support in these areas. This would include past and current examples of ability to design and implement strong clinical trials research programs. 2. An organizational infrastructure that promotes and sustains a strong interdisciplinary, interactive cancer research environment which links basic research effectively to research in patient and populations settings (e.g., NCI-designated Comprehensive Cancer Centers). 3. Clear access to large numbers of minorities who are representative of the minority populations in the communities and/or regions associated with the institution. 4. Demonstrated capability to work with minority populations in a research setting within communities and/or regions. Applicants who do not adequately meet the above eligibility requirements of this initiative may have their applications returned. Thus, the NCI strongly encourages applicants to communicate with the appropriate NCI program official before submitting a letter of intent (see INQUIRIES section). MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research grant (R01). Applicants will be responsible for the planning, direction, and execution of the proposed project. Except as otherwise stated in this RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. This RFA is a one-time solicitation. Generally, future unsolicited competitive continuation applications will compete with all investigator-initiated applications and be reviewed by the Division of Research Grants (DRG). However, should the NCI determine that there is a sufficient continuing program need, a request for competitive continuation applications will be announced. Only recipients of awards under this RFA will be eligible to apply. The average amount of direct costs expected per award is 200,000. FUNDS AVAILABLE Funding in the amount of $1,600,000 in total costs has been set aside for the first year to specifically fund applications which are submitted in response to this RFA. It is anticipated that six awards will be made. This funding level is dependent on the receipt of sufficient number of applications of high scientific merit. The total project period for applications submitted in response to the present RFA may not exceed three years. The earliest feasible start date for the initial awards will be April 1, 1994. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES The NCI is committed to reducing the cancer mortality disparity between disadvantaged populations, which include African Americans, Hispanics and Native Americans, and the general population. One approach to achieving this objective is through the NCI DEA CMBP, which is committed to providing support to institutions for increasing their efforts to broaden minority involvement in programs developing the latest and most effective measures in cancer prevention, cancer control, and clinical treatment research. One primary goal is the delivery of state-of-the-art cancer prevention and control as well as treatment modalities to underserved and minority populations. Cancer survival statistics verify that certain segments of the population, African Americans for example, have substantially lower cancer survival rates than that of American Whites with the same disease. By targeting minority populations with the highest mortality in different regions of the country, it is hoped that this initiative will have significant impact on minority population cancer survival. This initiative is to encourage institutions to develop research programs in cancer prevention, cancer control and cancer treatment that will specifically benefit minority populations. General research objectives within the scope of this initiative include, but are not limited to, smoking behavior in minority youth; studies of communication strategies for presenting information to minorities about cancer and its prevention; investigations of patient perspectives of cancer risks; the design and evaluation of interventions to minimize and prevent distress of minority patients with cancer; the development of pilot studies for minority clinical prevention trials; and psychosocial studies and perception of cancer risk in minorities. Specific research strategies include: 1. Targeting and facilitating the involvement of minority populations in cancer control research. 2. Investigating the impact of cancer therapy and control advances on minorities in community medical practice settings. 3. Increasing the involvement of minority primary health care providers and other specialists in treatment and other cancer control research, thereby providing both educational opportunities for health providers and facilitating interchange of information about current advances in cancer control research. 4. Increasing the number of underserved patients entered into clinical cancer treatment protocols. 5. Delivery of state-of-the-art cancer treatment to underserved minority populations. 6. Significantly impacting minority population cancer treatment and survival. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups must be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including, but not limited to, clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by July 14, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NCI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Lemuel Evans at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248; and from the NCI Program Director named below. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: NCI Referral Office Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 Bethesda, MD 20892 Applications must be received by September 22, 1993. If the application submitted in response to this RFA is substantially similar to a grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and for responsiveness by the NCI Program Staff. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NCI staff will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications may receive a preliminary scientific peer review (triage) by an NCI peer review group on the basis of relative competitiveness. The NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NCI. The second level of review will be provided by the National Cancer Advisory Board. Review criteria for RFAs are generally the same as those for unsolicited research grant applications. o Extent to which the proposed research plan addresses the goals and objectives of the RFA; o Scientific, technical, or medical significance and originality of a proposed research; o Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o Qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o Availability of the resources necessary to perform the research; and o Appropriateness of the proposed budget and duration in relation to the proposed research. AWARD CRITERIA The earliest anticipated date of award is April 1, 1994. The following will be considered for making funding decisions: o quality of the proposed research project as determined by peer review o availability of funds o program balance among research areas o geographical distribution of awards INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA or inquiries about whether or not specific proposed research would be responsive are encouraged and may be directed to: Dr. Lemuel Evans Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 620 Bethesda, MD 20892 Telephone: (301) 496-7344 FAX: (301) 496-7911 For information regarding budgetary/administrative issues related to this RFA, contact: Ms. Carolyn Mason Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800, Extension 59 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, Number 93.399, Cancer Control. Awards are made under the authorization of the Public Health Service Act, Title V, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$XID RFA AI93018 AI-93-018 P1O1 *************************************** PROGRAM PROJECTS ON AUTOIMMUNITY NIH GUIDE, Volume 22, Number 21, June 11, 1993 RFA: AI-93-018 P.T. 34; K.W. 0715015, 0755030, 0765033, 0411005, 0745027 National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases Letter of Intent Receipt Date: August 15, 1993 Application Receipt Date: November 16, 1993 PURPOSE The Division of Allergy, Immunology and Transplantation of the National Institute of Allergy and Infectious Diseases (NIAID) and the Rheumatic Diseases Branch of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invite studies aimed at elucidating the causes and mechanisms of tolerance and autoimmune diseases and at the application of this basic biomedical knowledge to the development and implementation of new preventive and treatment modalities for these diseases. This Request for Applications (RFA) invites applications from collaborating basic science and clinical research investigators who are interested in developing novel integrated studies on autoimmune diseases. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Program Projects on Autoimmunity, is related to the priority areas of diabetes and chronic disabling diseases, and immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-782-3238). ELIGIBILITY REQUIREMENTS Research grant applications may be submitted by domestic, for-profit and non-profit organizations, public and private institutions, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The mechanism of support will be the Program Project (P01) grant. Multidisciplinary approaches that involve collaborative efforts among investigators in the fields of basic immunology, molecular biology, cell biology, biochemistry, genetics, and relevant medical specialties are strongly encouraged. The total project period for applications submitted in response to this RFA may not exceed five years. At this time, the NIAID is administratively limiting the duration of P01 grants to four years; this administrative limitation may change in the future. If, by the beginning of the last year of support, the NIAID and NIAMS have not announced intentions to readvertise the RFA, incumbents who wish to recompete may consider reapplying using the investigator-initiated Interactive Research Project Grant (IRPG) mechanism. Applicants should be alert to a program announcement concerning IRPGs published in the NIH Guide for Grants and Contracts, Volume 22, Number 16, April 23, 1993. In such instances, incumbents are strongly encouraged to contact NIAID Program Staff prior to submitting an application. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for the first year of support for awards under this RFA will be $2,300,000. In Fiscal Year 1994, the NIAID and the NIAMS plan to fund approximately three program projects. Applications may not request budgets in excess of $500,000 total direct costs in the first year or more than 4 percent annual inflationary increases for future years. An application with a first year requested amount in excess of $500,000 total direct cost will require written approval by senior NIAID or NIAMS officials via the program officer for acceptance of the application for processing. The usual PHS policies governing grants administration and management will apply. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIAID and the NIAMS, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. RESEARCH OBJECTIVES AND SCOPE The major goals of these program projects are: increased understanding of etiology and pathogenetic mechanisms involved in autoimmune diseases; generation of new information and the expansion of the current knowledge base; and the application of this knowledge to the development of new or improved measures of risk assessment, prevention, early diagnosis and treatment of a wide variety of autoimmune diseases and disorders in which the autoimmune response is a major contributor to pathogenesis. The NIAID and NIAMS are seeking innovative applications that address various aspects of the immune responses related to self reactivity, which may include studies concerned with relevant areas of genetics, cell and molecular biology, biochemistry, physiology, microbiology, pathology and pharmacology. Of special interest are program projects that emphasize new ideas, novel approaches, and state-of-the-art technology in basic research that elucidates pathogenic mechanisms and shows promise for clinical application in the prevention, diagnosis, and treatment of autoimmune diseases. There is overwhelming evidence to implicate immune mechanisms in the pathogenesis of diseases of the skin, nervous system, endocrine system, and gastrointestinal tract. Thus, in addition to studies of well-recognized autoimmune disorders such as systemic lupus erythematosus, rheumatoid arthritis, antibody-mediated thrombocytopenia and autoimmune hemolytic anemia, the NIAID and NIAMS encourage investigators to design and develop studies aimed at establishing the role of the immune system in the pathogenesis of endocrine, dermatologic, neurologic and gastrointestinal diseases and the development of new preventive and treatment modalities specific for these disorders through the manipulation of the immune response. Projects focused on the study of mechanisms of autoimmune diseases should be designed based on integrated and coordinated intra-institutional clinical investigations or experimental studies with demonstrated relevance to human autoimmune disease. Inclusion of basic research components utilizing samples from human source materials in in vitro procedures are encouraged, as are preclinical studies using appropriate animal models of human autoimmune disease. Inclusion of clinical investigative components drawing upon immunologically relevant areas in medicine, pediatrics, surgery, dermatology, neurology, pathology and their subspecialties is highly recommended. Preparation of the Application In preparing the application, the applicant should bear in mind the research objectives of this RFA. P01 applications should be prepared using the guidance and instructions provided in the NIAID Information Brochure for Program Project and Center Grants, which may be requested from Dr. Rohrbaugh at the address listed under INQUIRIES. Failure to follow these instructions may result in delays in the review or in an incomplete application. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy requires that applicants for NIH clinical research grants and cooperative agreements include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale MUST be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group, together with a rationale for its choice. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in items 1-4 of the Research Plan AND summarized in item 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations [i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics]. The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to, clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, clinical samples which may be coded for use by the applicant but could be identified by another source are not excluded. Every effort should be made and documented to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For studies in foreign populations, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the U.S. populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by August 15, 1993, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Program Director, the number and title of this RFA, and a list of the key investigators and their institution(s). Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID and NIAMS staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Mark Rohrbaugh at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the standard research grant application form PHS 398 (rev. 9/91). For purposes of identification and processing, item 2a on the face page of the application must be marked "YES" and the RFA number and the words "PROGRAM PROJECTS ON AUTOIMMUNITY" must be typed in. These application forms may be obtained from the institution's office for sponsored research or its equivalent, and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, Maryland 20892, telephone (301) 594-7248. It is highly recommended that the Chief of the Clinical Immunology Branch, NIAID Division of Allergy, Immunology and Transplantation, or the Chief of the NIAMS Rheumatic Diseases Branch be contacted in the early stages of preparation of the application. (See program contacts in INQUIRIES, below.) Applications must be received by November 16, 1993. Applications that are not received by November 16, 1993, or that do not conform to the instructions contained in PHS 398 (rev. 9/91) application kit, will be judged non-responsive and will be returned to the applicant. The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. Submit a signed, typewritten original of the application, including the checklist, and three signed, exact, single-sided photocopies, in one package to: Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional exact copies of the grant application and all five sets of appendix material must also be sent to Dr. Mark Rohrbaugh at the address listed under INQUIRIES. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or Principal Investigator could be included with the application. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the NIH Division of Research Grants (DRG) and for responsiveness by NIAID and NIAMS staff; those judged to be incomplete or non-responsive will be returned without review. Those applications that are complete and responsive may be subjected to a triage by a peer review group to determine their scientific merit relative to other applications received in response to this RFA. The NIAID and the NIAMS will withdraw from competition those applications judged to be non-competitive for award and will notify the applicant and institutional business officials. Those applications judged by the reviewers to be competitive for award will be further reviewed for scientific and technical merit by a review committee convened by the Division of Extramural Activities, NIAID. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council and/or the National Arthritis and Musculoskeletal and Skin Diseases Council. The factors to be considered in the evaluation of scientific merit of each application will be those used in the review of traditional research project grant applications, including: the novelty, originality, and feasibility of the approach; the training, experience, and research competence of the investigator(s); the adequacy of the experimental design; and the adequacy and suitability of the facilities. Additional review criteria used for program project applications are outlined in the NIAID Information Brochure on Program Project and Center Grants. While the following review factors do not usually influence the priority score, they are nonetheless carefully considered by the initial review group: the appropriateness of the requested budget to the work proposed; the adequacy of protection of human subjects and/or animals in research; and the adherence, whenever appropriate, to NIH guidelines concerning adequate representation of women and minorities in clinical research. Any documented concerns expressed by the initial review group about any of these factors on a given application may influence the recommendation of the Advisory Council concerning funding of that application. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program needs and balance, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Howard B. Dickler, M.D. Division of Allergy, Immunology, and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A19 Bethesda, MD 20892 Telephone: (301) 496-7104 FAX: (301) 402-2571 Susana A. Serrate-Sztein, M.D. Rheumatic Diseases Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 405 Bethesda, MD 20892 Telephone: (301) 594-9953 FAX: (301) 594-9673 Direct inquiries regarding review issues (including the preparation of a program project application), address the letter of intent to, and mail two copies of the application and all five sets of appendices to: Mark Rohrbaugh, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C22 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-8424 FAX: (301) 402-2638 Direct inquiries regarding fiscal matters to: Mr. Jeffrey Carow Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B29 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7075 Schedule Letter of Intent Receipt Date: August 15, 1993 Application Receipt Date: November 16, 1993 Scientific Review Date: February 1994 Advisory Council Date: June 1994 Earliest Award Date: August 1994 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.855 - Immunology, Allergy and Transplantation Research and No. 93.846 - Arthritis and Musculoskeletal and Skin Diseases Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$XID RFA CA93029 CA-93-029 P1O1 *************************************** CLINICAL STUDIES OF SYSTEMIC THERAPIES NIH GUIDE, Volume 22, Number 21, June 11, 1993 RFA: CA-93-029 P.T. 34; K.W. 0715035, 0785035, 0745070 National Cancer Institute Letter of Intent Receipt Date: October 22, 1993 Application Receipt Date: December 7, 1993 PURPOSE The Cancer Therapy Evaluation Program of the Division of Cancer Treatment at the National Cancer Institute (NCI) invites Interactive Research Project Grant (IRPG) applications to perform research projects designed to conduct clinical studies of innovative systemic therapies investigating promising therapeutic approaches in a single tumor type or focused on a single class of novel compounds or a mechanism of action. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Clinical Studies of Systemic Therapies, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Domestic and foreign for-profit and non-profit organizations, governments and their agencies are eligible to apply. Applications can be from single institutions and multiple institutions (collaborating institutions, consortia, cooperative groups). New and experienced investigators are encouraged to apply. Applications from minority individuals and women are encouraged. For the purpose of this RFA (CA-93-029), each IRPG must consist of a minimum of three investigator-initiated research grant applications (R01s). Amended applications from CA-92-25 are encouraged. An IRPG that received funding for one or more, but not all, of the applications in the original package may submit revised applications for those that were unfunded. IRPGs submitted under CA-92-25 can be submitted with less than three required independent R01s under CA-93-029. However, the number of applications currently funded under CA-92-25 plus revised applications submitted under CA-93-029 must be three or more R01s. MECHANISM OF SUPPORT Support of this program will be by the traditional research project grant (R01) through the use of the IRPG program (see Background, RESEARCH OBJECTIVES). Except as otherwise stated in this RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. The total cost for each IRPG (consisting of three or more R01s) is limited to $750,000 per year. The average amount of direct cost per year for each R01 will range from $140,000 to $180,000. The total project period for applications submitted in response to the RFA may not exceed four years. The earliest feasible start date for the initial awards will be August 1994. This RFA is a one-time solicitation. If it is determined that there is a sufficient continuing program need, the NCI will invite recipients of awards under this RFA to submit competitive continuation applications for review according to the procedures described below. FUNDS AVAILABLE Approximately $2,000,000 in total costs per year for four years will be committed to fund applications submitted in response to this RFA. It is anticipated that three IRPGs will be funded in FY 94. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, the award of R01 grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Investigator initiated grant support is by far the largest single entity in the National Cancer Institute (NCI) research budget. The NCI utilizes a range of funding mechanisms to support clinical research efforts of differing scale and scope. For the conduct of large scale, multi-institutional clinical trials, the Cancer Therapy Evaluation Program has established a program of integrated national networks of clinical investigators and institutions (Clinical Trials Cooperative Groups). The primary responsibility of the cooperative groups is to perform definitive evaluation of clinical treatment programs. These groups have limited involvement with pilot studies and ancillary laboratory studies, which bridge the gap between the laboratory and the clinic. Currently, translational research and preliminary clinical studies are supported by grants (R01, P01 and U01 awards) under the Research Project Grant category. This smaller scale clinical research is usually done within single institutions or in small consortia of institutions interested in a particular area of therapeutic investigation. These investigator initiated mechanisms support early clinical development of new therapeutic agents and treatment modalities. They support pharmacokinetics studies, studies of mechanisms of action and resistance of therapeutic agents, and all types of clinical correlative studies. This effort is the essence of translational research, which brings the basic science to the bedside and provides leads for definitive treatment trials. An unprecedented number of new therapeutic agents are ready for evaluation in pilot clinical studies. In addition, insights into the biologic function and clinical relevance of growth factors, genes that promote and suppress neoplasia, mechanisms of treatment sensitivity and resistance, and function of the immune system provide important new clinical research opportunities for investigators. The NCI is interested in expanding support for clinical research. Under this IRPG RFA, the NCI encourages the coordinated submission of related research project grant applications from investigators who want to collaborate on a common cancer research theme, but do not require extensive shared physical resources or multiple core functions. This mechanism is not meant to replace the program project (P01) mechanism but to support a level of collaboration between that of the P01 and that available through an individual R01. The IRPG is defined in PA-93-078 (NIH Guide for Grants and Contracts, Vol. 22, No. 16, April 23, 1993) as two or more investigator initiated research grant proposals that are reviewed for independent merit but that share a theme and resource(s), and that require concurrent funding to maximize the effectiveness of the resource or to allow maximal creative interaction between researchers. Applicants will benefit from use of the IRPG mechanism by establishing a larger framework of reference for the proposed work, facilitating formal collaborations tailored to achieving research objectives, providing a record of independently acquired awards credited to each funded investigator, and allowing retention of research autonomy by the named Principal Investigator on each of the interactive grants. Research Goals And Scope This RFA is soliciting applications to perform IRPGs with the goal of developing new clinical studies involving systemic therapies with a therapeutic intent. The IRPGs may have as their key focus either: (1) clinical studies investigating promising therapeutic approaches in a single tumor type or (2) the development of new clinical treatment strategies focused on a single class of novel compounds or mechanism of action. Each project supported in the IRPG is expected to contribute to and be directly related to the common theme of the IRPG application. The application must clearly explain how the projected integrated R01 research grants can be expected to accomplish the stated goal more efficiently and effectively than they could without the anticipated interactions. At least one clinical trial protocol must be proposed in one of the grant applications. The clinical trials should be well integrated with the laboratory studies proposed within the same R01 grant or in separate R01 grants. Support will be provided to institutions with established clinical, laboratory and statistical resources. Some examples of research areas that individual R01 grant applications would focus on include: (1) pre-clinical drug development studies, utilizing in vitro or in vivo models, leading to new clinical trials; (2) studies to elucidate or exploit the mechanism of action or resistance of therapeutic agents; (3) pharmacokinetics and pharmacodynamic studies of new agents or in combination; (4) clinical correlative studies designed to improve therapeutic approaches; (5) clinical trials of new systemic therapies utilizing therapeutic agents alone or in combination with other modalities. Investigators are not limited to the above examples of potential studies. The NCI encourages investigators to propose other scientific approaches that suit the interactive R01 mechanism and the requirements of this RFA. The aims of this RFA are two-fold: (1) to provide support for translational research that brings innovative basic research findings into the clinic and (2) to foster the development of interactions between basic science laboratories of different disciplines and clinicians performing clinical trials to advance therapeutic clinical research. Special Requirements Definitions Principal Investigator (PI) - The person who submits the single R01 grant application in response to this RFA and who is responsible to the applicant/awardee institution for the scientific and administrative direction and proper conduct of all aspects of the R01 grant. Project Coordinator - The person designated by the PIs of the interactive R01 grants who is responsible for the overall coordination of the scientific direction of the interactive R01 grants. Responsibilities of Each Awardee Each awardee is responsible for his/her own proposed research project(s) to advance the goals of the RFA and to define its approaches to attain these goals. It is the primary responsibility of the PI to state clearly the objectives of the research project, to direct the research stipulated in the application, and to ensure that the results obtained are published in a timely manner. It is anticipated that decisions on the overall scientific direction of the package of interactive R01s will be reached by consensus of the collaborating PIs. Responsibilities of the Project Coordinator In addition to the responsibilities stated above for each awardee, the Project Coordinator has the responsibility of providing coordination of the overall scientific direction of the interactive R01s. He/she will accomplish this role by facilitating scientific collaborations among the various investigators. The Project Coordinator will also be responsible for establishing mechanisms to facilitate regular communication and coordination among investigators. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF FEMALES AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and females in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and females in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If females or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group, together with a rationale for its choice. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in the Research Plan, 1-4, AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from females and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of females applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of females or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by October 22, 1993, a letter of intent that includes a descriptive title of the proposed research, the names and addresses of the Principal Investigators, the names of other investigators and key personnel, the participating institutions, and the number and title of the RFA in response to which the application may be submitted. Amended IRPGs should indicate which institutions are already funded, if applicable. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, it is requested in order to provide an indication of the number and scope of applications to be reviewed. The letter of intent is to be sent to Dr. Roy S. Wu at the address listed under INQUIRIES. APPLICATION PROCEDURES The PHS 398 (rev. 9/91) research grant application form is to be used in applying for this RFA. These forms are available at most institutional offices of sponsored research; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248; and from the NCI Program Director named below. The RFA label available in the PHS 398 research application form must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA number and title must be typed on line 2a of the face page of the application form. All the R01 applications constituting the proposed IRPG cohort must be submitted in a single package, whether or not the applications arise from the same institution. Each application within the package must be clearly identified and a cover letter must list the total number of applications submitted for the IRPG cohort, indicating the Principal Investigator of each. The various applications should not be collated into an IRPG "package." For each application, the original, three copies, and the appendix material must be packaged together and clearly identified. The IRPG package must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, send two additional copies of each application in the form of an IRPG package to: Ms. Toby Friedberg, Referral Officer Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 650 6130 Executive Boulevard Bethesda, MD 20892 Applications must be received by December 7, 1993. If an application is received after that date, it will be returned without review. If the application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Special Instructions Particular attention must be paid to completion of Section 7, Consultants and Collaborators, for each IRPG application. In addition to those collaborations that would be necessary to carry out the proposed research, whether or not the IRPG mechanism is involved, within Section 7, each application that is a component IRPG must provide an identical statement (titled "IRPG INTERACTIONS") regarding the IRPG collaboration. This section should list each application that is part of the IRPG, including title, Principal Investigator, and other participating scientists. The single Project Coordinator, responsible for coordinating the collaborative efforts among the research projects and for promoting interaction and communication among the Principal Investigators, should be identified here. This section should further discuss the intended interactions among the components of the IRPG and the perceived benefits of supporting all of the components of the IRPG as a combined effort. Requests for limited shared resources, if any, should be included in this part of Section 7. This should include costs and full budget justification. To further clarify the utilization of shared resources, additional succinct information is needed and it is suggested that two tables be included. Table I would be identical in all applications of the IRPG cohort. Table II will detail the distribution of effort for all of that application's personnel (professional, technical and clerical) on all shared activities and/or resources. A sample format for the Tables can be obtained from the NCI Program Director listed under INQUIRIES. The utilization of these resources by each IRPG will be evaluated independently by the study section and any appropriate modifications recommended. Special Instructions for Revised Applications from CA-92-25 All revised applications from CA-92-25 must follow instructions for revised applications contained in the PHS 398 kit. For those revised applications that are composed of IRPGs that received funding for one or more, but not all of the applications in the original response to CA-92-25, an expanded section 7 is recommended. In addition to the information requested above, the applicant(s) should provide the title, the name and institution of the Principal Investigator, the abstract and the specific aims of the funded components of the IRPG. A special effort should be made to describe and justify the nature of the interaction with the funded grant(s). The total costs for the funded grant(s) and the revised application(s) cannot exceed the $750,000 total cost limit set forth under MECHANISM OF SUPPORT. REVIEW CONSIDERATIONS Review Procedure Upon receipt, applications will be reviewed by the Division of Research Grants (DRG) for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA is an NCI program staff function. Applications that are judged non-responsive will be returned to the applicant. An application judged to be non-responsive to this RFA may be submitted as an investigator initiated IRPG at the next receipt date for unsolicited applications. Questions concerning the responsiveness of proposed research to the RFA are to be directed to program staff listed under INQUIRIES. If the number of applications submitted is large compared to the number of awards to be made, the NCI may conduct a preliminary scientific peer review to eliminate those that are clearly not competitive. The NCI will remove from competition those applications judged to be noncompetitive for award and notify the applicant and institutional business official. Those applications judged to be both responsive and competitive will be further evaluated according to the review criteria stated below for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review by the National Cancer Advisory Board considers the special needs of the Institute and the priorities of the National Cancer Program. Review Criteria The factors considered in evaluating the scientific merit of each application will be: o Extent to which the proposed research addresses the goals of the RFA o Scientific, technical, or medical significance and originality of proposed research within each R01 application; o Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o Research or clinical experience, training, time availability, and qualifications of the investigators involved; o Adequacy of plans for effective collaboration among laboratory, clinical, and statistical investigators within each R01; o Adequacy of the available resources and environment (e.g. facilities, equipment, statistical resources; patient population) o Adequacy of the mechanisms for quality control, study monitoring, data management and reporting, and data analysis; o Adequacy of provisions for the protection of human subjects; o Adequacy of the plans for inclusion of females and minorities. The reviewers will also judge the appropriateness of the proposed budget and duration in relation to the proposed research. For each application that is given a priority score, the review group will assign an adjectival descriptor that reflects the extent and effectiveness of its collaboration(s) with other applications included in the IRPG. This assessment will be documented in a brief administrative note in the summary statement to assist the NCI in making final decisions on each application in the context of the overall IRPG. AWARD CRITERIA The anticipated date of award is August 1, 1994. In addition to the technical merit of the application, the NCI will consider how well the applicant institution meets the goals and objectives of the program as described in the RFA, availability of resources, and study populations. Those applications involving breast cancer research will have priority. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA and inquiries about whether or not specific proposed research would be responsive are encouraged. The NCI Program Directors welcome the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues and address the letter of intent to: Dr. Roy S. Wu Division of Cancer Treatment National Cancer Institute Executive Plaza North, Room 734 Bethesda, MD 20892 Telephone: (301) 496-8866 FAX: (301) 480-4663 Direct inquires regarding fiscal matters to: Ms. Jennifer Edwards Grants Administration Branch National Cancer Institute Executive Plaza South, Room 242 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 57 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No 93.395, Cancer Treatment Research. Awards are made under the authorization of the Public Health Service Act, Title IV Sections 301, 410, and 411, Part A (Public Law 78-410, 42 USC 241 as amended, Public Law 99-158, 42 USC 285a) and administered under PHS grants policies and Federal Regulations at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. From owner-sci-resources@net.bio.net Mon Jun 21 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 20 June 1993 Message-ID: Date: 22 Jun 93 20:31:34 GMT Sender: kristoff@net.bio.net Lines: 96 Approved: biosci-moderator@net.bio.net ** NEW DOCUMENTS ON STIS ** Document Type: Program Guideline Title: NSF 93-51 - International Opportunities for Scientists and Engineers File size (bytes): 133205 STIS Filename: nsf9351 Title: NSF 93-81 - Agile Manufacturing Initiative File size (bytes): 32379 STIS Filename: nsf9381 Document Type: Recruit Title: Environmental Officer File size (bytes): 5369 STIS Filename: vex9321 Title: Biologist (Environmental Officer) File size (bytes): 5907 STIS Filename: vgs9366 Title: Environmental Engineer (Environmental Officer) File size (bytes): 5941 STIS Filename: vgs9367 Title: Physical Scientist (Environmental Officer) File size (bytes): 6069 STIS Filename: vgs9368 Title: Program Assistant (Office Automation) File size (bytes): 4778 STIS Filename: vgs9369 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 1126 STIS Filename: cmpublic Document Type: Phone Book Title: NSF Alphabetical Listing File size (bytes): 90826 STIS Filename: phnalpha Title: NSF Organizational Directory File size (bytes): 95945 STIS Filename: phnorg ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet) or stisinfo@NSF (BITNET). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserv@nsf.gov (Internet) or stisserv@NSF (BITNET). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve phnorg, the text of your message should be as follows: get phnorg Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnorg, you would enter: ftp> get phnorg WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "firstop@nsf.gov" (Internet) or "firstop@nsf" (BITNET). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet) or "stis@NSF" (BITNET). From owner-sci-resources@net.bio.net Sun Jun 27 23:00:00 1993 Path: biosci!net.bio.net From: kristoff@net.bio.net (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 22, pt. 4, 18 June 1993 Message-ID: Date: 28 Jun 93 19:59:42 GMT Sender: kristoff@net.bio.net Lines: 1235 Approved: biosci-moderator@net.bio.net $$XID RFA AI93014 AI-93-014 P1O1 *************************************** CENTER FOR AIDS RESEARCH/CORE SUPPORT GRANT NIH GUIDE, Volume 22, Number 22, June 18, 1993 RFA: AI-93-014 P.T. 04; K.W. 0715008, 0710030, 0404000, 0745027 National Institute of Allergy and Infectious Diseases National Institute of Mental Health Letter of Intent Receipt Date: July 16, 1993 Application Receipt Date: August 25, 1993 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) and National Institute of Mental Health (NIMH) invite the submission of applications for Centers for AIDS Research/Core Support Grants (CFAR/CSG) from institutions conducting high quality, multidisciplinary AIDS research. The purpose of the CFAR/CSG is to provide administrative and shared research support through Core facilities to synergistically enhance and coordinate high quality AIDS and AIDS-related research projects requiring resources or services not otherwise readily obtained through more traditional funding mechanisms. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000", a PHS-led national activity for setting priority areas. This RFA, Centers for AIDS Research/Core Support Grant (CFAR/CSG), is related to the priority area of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applicant institutions Applications may be submitted by domestic, non-profit and for-profit research institutions including universities, colleges, units of state and local governments and research institutes or laboratories. Both new applicants and competing renewal applicants are eligible to apply. Minority individuals and women are encouraged to submit as Principal Investigators. Foreign institutions are not eligible to apply. One CFAR per institution per funding institute CFAR/CSGs are awarded to research institutions already heavily committed to several individual programs in AIDS and AIDS-related research. In general, the purpose of the CFAR/CSG award is to enhance the impact of the unique spectrum of scientific expertise and research projects available within an institution. Thus, only a single CFAR will be supported at a given institution per funding institute, i.e., one institution may have a CFAR funded by NIAID and one funded by NIMH, but the institution will not have more than one CFAR funded by either institute. It is incumbent upon the applicant institution to demonstrate that there will be no duplication of effort, if an institution applies for a CFAR/CSG from NIAID and one from NIMH. For example, the two CFARs should not have any Cores that are the same and should not use the same grants to fulfill the Funded Research Base requirement (see below). The terms "applicant institution" and "parent institution" refer to a given location (campus). For example, institutions that are part of a larger system, such as UCLA and UC Davis, each a separate component of the university system of the state of California, could each be awarded a CFAR/CSG. See the document "CFAR/CSG Guidelines" for a list of separate organizations. However, institutions that have significant overlap in faculty, resources, and/or administration should submit only one application. Funded Research Base An applicant institution must have a continuing Funded Research Base of at least $800,000 in annual direct costs of peer-reviewed AIDS or AIDS-related research. In order to qualify for a CFAR/CSG award by the NIAID, the Funded Research Base must be NIAID-funded research. In order to quality for a CFAR/CSG award by the NIMH, 60 percent of the Funded Research Base must be from NIMH-funded research and 40 percent may be from other NIH Institutes or peer-reviewed funding from alternate sources. Both Institutes require that the Funded Research Base be distributed among at least six peer-reviewed AIDS and AIDS-related research awards when the CFAR/CSG is awarded and throughout the award period. The annual progress report (form PHS 2590) must include this information each year of the project period. Funding for an existing CFAR cannot be used to achieve any portion of the Funded Research Base. To assist NIH in the identification of centers that may be funded by NIAID or NIMH, applicants are urged to indicate, in the abstract that describes the overall proposed CFAR, how many projects which comprise the Funded Research Base are funded by NIAID and how many are funded by NIMH. Applicants are also encouraged to include a brief description of the type of research included in the Funded Research Base in the overall CFAR/CSG abstract. Qualifying Funding For all applicants: AIDS and AIDS-related research supported by the NIAID and NIMH: This includes all types of grants, cooperative agreements, and research contracts in which proposed research has been peer-reviewed and includes the following categories: P01, P50, R01, R03, R21, R29, R35, R37, U01, U10, K and F series awards, R18 (Research Demonstration and Dissemination Projects) and N01 (Research Contracts). For NIMH applicants: AIDS and AIDS-related research supported by other NIH Institutes and funding organizations outside of NIH: Funding by the latter organizations, which may not exceed the indicated percentage of the Funded Research Base (40 percent for NIMH awards), may be included if review processes for awards are substantially equivalent to those of NIH. It is the responsibility of the applying institution to demonstrate that, in these cases, the alternative peer-review mechanisms involved are equivalent to those in use at NIH and that the research so funded is of sufficient quality to warrant CFAR/CSG support. This verification may be accomplished by attaching to the application a one page document containing information provided by each alternate funding agency describing their review mechanisms and criteria for awarding funds. Excluded Funding The following should not be included in the total AIDS Funded Research Base A current CFAR, training grants including Institutional Training Grants (T32s), other P30 awards, awards from private industry, contracts and other awards that primarily fund the production of materials and/or services for support of research. MECHANISM OF SUPPORT CFAR/CSG awards will be made under the NIH Core Support Grant (P30) mechanism. This RFA is a one-time solicitation. Because the nature and scope of the research proposed in response to this RFA will vary, it is anticipated that the sizes of the awards will vary also. Responsibility for the planning, direction and execution of the proposed Center will be solely that of the applicant. The total project period for applications submitted in response to this RFA may not exceed five years of support. However, recommended support beyond the third year of the CFAR/CSG is subject to the determination by an ad hoc review committee that stated goals (milestones) have been sufficiently met. The progress report of the non-competing continuation application (PHS 2550) for the fourth year of support must demonstrate that stated CFAR/CSG goals have been met. Program staff will contact the Principal Investigator to request additional information, if required. The six milestones that must be met at the end of year three are: interdisciplinary coordination and collaboration, especially between clinical and basic research investigators; synergistic scientific collaboration; organizational capabilities of the CFAR; institutional commitment; developmental and educational commitment; and effective use of the charge back system. Additional information is provided under REVIEW CRITERIA. FUNDS AVAILABLE The NIAID has set aside a total of $7.2 million for the initial year's funding of this RFA. The NIAID anticipates making 9 to 11 awards. NIMH has set aside a total of $1.5 million and anticipates making two awards. The final number and specific amounts of awards will depend upon the scientific and technical merit, relevance to programmatic priorities and availability of funds. All applications are limited to requests for no more than $750,000 in total costs (direct plus indirect) in the first year. Increases of up to four percent are permitted for allowable recurring costs for each of the subsequent years. RESEARCH OBJECTIVES Background The human Acquired Immunodeficiency Disease Syndrome (AIDS) has reached epidemic proportions: 253,448 cases of AIDS in the United States had been reported by the Centers for Disease Control (CDC) as of February, 1993. A total of 169,623 individuals have died from this disease and its sequelae. In response to this emergency, the NIH and other research institutes are supporting studies consisting of basic and applied research concerning the AIDS epidemic. It is anticipated that these investigations will lead to achievement of disease prevention through development of effective vaccines, prevention and behavioral change strategies, and rational therapeutic strategies to control viral infection and the development of opportunistic infections and other sequelae of AIDS. The continually expanding epidemic nature of AIDS increases the urgency for critical basic and applied research in AIDS and AIDS-related projects and the timely transfer of basic research knowledge into efficacious patient treatment protocols. The genetic variability of HIV, the apparent complexity of its viral pathogenesis (still not yet fully understood), as well as the unique socio-epidemiological aspects of infection, dictate the need for implementation of a multidisciplinary approach involving the collaboration of teams of investigators possessing diverse and relevant state of the art expertise in research areas most useful for an understanding of AIDS and for the development of effective therapies. Most importantly, there is an imperative need for the timely application of new knowledge obtained in the basic research laboratory to the clinical setting as well as for the efficient translation of observations in AIDS clinics into questions which may be addressed and resolved by novel laboratory experimentation. It is precisely these aspects of AIDS research to facilitate through CFAR/CSG awards. During Fiscal Year 1988, the NIAID launched a new initiative intended to establish a number of Centers for AIDS Research (CFARs) at institutions committed to several high quality AIDS research projects, using funds specifically appropriated by Congress. Under this program, thirteen CFARs were funded for the purposes of enhancing and focusing high quality, peer-reviewed, AIDS and AIDS-related research in a synergistic manner with a resulting increase in the efficiency and effectiveness of a wide variety of research programs. In May 1992, an ad hoc Program Review Committee organized by NIAID commended the CFAR Program, and recommended several changes to enhance the Program's effectiveness in achieving its stated goals. These suggestions included: an increased emphasis on interdisciplinary cooperation and collaboration and the use of Cores by multiple, interactive groups; the establishment of at least one Clinical Core within each CFAR; maintenance of a critical level of high quality AIDS research consisting of several peer-reviewed awards; a continued demonstration of active support of the CFAR by the parent institution in terms of space, personnel, and other resources; a requirement that the CFAR Director be a Principal Investigator of peer-reviewed funded AIDS research and a leader in the field of AIDS research; encouragement of behavioral and prevention research, support of the enrollment of women and minorities in clinical trials, and support of minority investigators. The purpose of this RFA is to request new and renewal applications for the establishment of CFARs at parent institutions involved in critical, high impact AIDS and AIDS-related research projects. Funding will be provided to awardees to support the leadership and planning activities of the Center and to develop Cores of shared resources and services that will enhance and focus existing clinical and basic AIDS research in a cooperative and synergistic manner. This RFA will also provide funding for pilot projects for innovative, high risk investigations, and developmental support for new investigators in AIDS research. The goal of both of these aspects of CFAR support is to provide limited funding for development of sufficient data to enable investigators to apply for R01-type grants. Goals and Objectives of the Centers for AIDS Research The goal of the CFAR/CSG is to enhance and extend the effectiveness of groups of investigators conducting AIDS and AIDS-related research supported by peer-reviewed funding mechanisms. More specifically, the CFAR/CSG is intended to: o Encourage activities that will initiate, consolidate and focus high quality AIDS and AIDS-related research by establishing Core Support Facilities for ongoing projects funded through peer-reviewed awards. This RFA will foster multidisciplinary collaboration among scientists at the parent institution through coordinated administrative, resource and service Cores: o Promote effective synergistic collaborations and interactions especially among investigators participating in clinical and basic areas of AIDS research. Such interactions are intended to facilitate translation of information obtained in the laboratory to specifically address problems in the clinic and the field, and will enhance the possibility of observations in the clinic and the field being translated to the laboratory setting for further investigation. o Foster development of innovative and high quality research areas in AIDS research by providing support for investigators new to the field, and through the funding of pilot projects whose results can form the basis for competitive applications. o Support administration of the Center including activities such as seminars and workshops for CFAR/CSG members and AIDS investigators in general, education at all levels including community programs, and funding for the leadership responsible for organizing and sustaining the Center's activities. Scope, Restrictions and Exclusions Specifically, the CFAR/CSG will provide funding for the types of activities listed below. In general, those CFARs funded by the NIAID may have Core Facilities supporting research such as basic biology and pathogenesis of HIV, vaccine research and development, clinical trials and treatment research for HIV infection, drug development, epidemiology of HIV infection, and preclinical developmental therapeutic research for HIV and associated opportunistic infections. Those CFARs funded by NIMH may have Core Facilities supporting research such as CNS effects of HIV infection (neurobiological and behavioral studies), behavior change and preventive intervention studies, psychological and psychosocial response to HIV infection and AIDS and psychological and psychiatric treatment of persons with HIV infection and AIDS. Basic research in the area of behavioral change related to prevention of HIV infection is an area of joint interest and either NIAID or NIMH may fund Centers having Core Facilities supporting studies of this type. In addition, it is strongly encouraged that by the end of year 01 of the award and included in the non-competing, renewal application for year 02, and subsequent non-competing renewal applications, the CFAR will establish a plan of "Charge Back" for the remaining four years of funding. This will involve a gradual assumption, over the remaining period of the grant award, of greater fiscal responsibility by users of Core facilities through R01 funds and by the parent institution, with a corresponding decrease in support from CFAR/CSG funds for established Cores. (Note that the specific examples provided below are not intended to be all inclusive. Applicants are strongly encouraged to contact program staff from NIAID or NIMH listed under INQUIRIES for questions regarding the types of Cores that will be supported by NIAID or NIMH.) o Basic Science Cores. Centers are required to have at least three Basic Science Cores that support basic AIDS and AIDS-related research by investigators at the CFAR. The basic science Cores should be designed to foster collaboration among investigators representing various scientific approaches or disciplines, and should especially promote cooperation and collaboration between basic and clinical investigators. Applicants should indicate the mechanism that will be used to select users of Basic Science Cores, e.g., such as through an Internal Review Committee. Examples of such Cores that may be supported by the NIAID include, but are not limited to, Virus Culture in Biohazard Containment (BL3), Mass Spectrometry, Computer Modeling, Monoclonal Antibody Facilities, Peptide Synthesis and HPLC, DNA Synthesis and Sequencing, PCR, Transgenic and SCID/Hu Mice Facilities, Animal Models, and Flow Cytometry. Examples of such Cores that may be supported by NIMH include, but are not limited to, Mass Spectrometry, Computer Modeling, Monoclonal Antibody Facilities, PCR, Transgenic and SCID/Hu Mice Facilities, Animal Models, Flow Cytometry, Tissue Banks, Cell Line Repositories, Psychoimmunology, Neuroimmunology, and Neuroimaging. o Clinical Core. Centers are required to include a Clinical Core Support Facility that will support patient-based research. This Core should provide for collaborations with basic scientists and encourage rapid development of new clinical approaches. Activities that will not be supported by a CFAR/CSG Clinical Core include: routine screening of clinical specimens, diagnosis, treatment, or rehabilitation. Regardless of the specific type of activity performed within the Clinical Core, all activities should facilitate translation between basic and clinical research. Applicants should indicate the mechanism that the CFAR will use for selection of users of the Clinical Core, e.g., such as through an Internal Review Committee. If a Center has a clinical research entity, such as an ACTU, AVEU, CPCRA, DATRI site, or a Clinical Center, etc., the applicant institution must include information concerning all support for clinical research already in place, such as, but not limited to, biostatistical analysis, and database or repository establishment or maintenance. The types of activities that may be supported by a NIAID-funded Clinical Core include, but are not limited to biostatistical support, recruitment of subjects for clinical studies, support for epidemiological studies in areas of AIDS, community outreach, or provide modest funding for sample storage. The types of activities that may be supported by a NIMH-funded Clinical Core includes, but are not limited to biostatistical support, recruitment of subjects for clinical studies, support for epidemiological studies or behavioral epidemiological studies in areas of AIDS, neurobehavioral or psyco-sexual or psycho-social or treatment assessments, focus groups, ethnographic studies, community outreach, test development, and/or provide modest funding for sample storage. o Developmental Core. CFARs are encouraged to support three Developmental areas: Investigators New to AIDS Research, Pilot Projects, and Evolving Research Opportunities. o Administration Core. Support for the CFAR Director, who should be a recognized leader in the field of AIDS research and the Principal Investigator of at least one peer-reviewed grant, which is part of the Funded Research Base in AIDS or AIDS-related research. Support may also be requested for Core Directors, a senior administrator, an office that is a clearly separate entity to which individuals may come for information and other activities related to the CFAR, and a modest staff for support of Center activities. o The CFAR may provide salaries and limited funds for research costs for Investigators New to AIDS Research who have not previously received individual R01-equivalent support in this field. Funding will be provided until the investigator achieves independent support through a traditional research grant or equivalent, but will not exceed three years. Applicants should indicate the mechanism that the CFAR will use for selection of recipients of Developmental funding, e.g., such as through an Internal Advisory Committee. o Developmental funds may also be used for small feasibility studies, often of a risky nature, preparatory to the development of applications for independent peer-reviewed support. Examples include, but are not limited to, nurture of an especially innovative idea for which other funding is not available, exploration of an unconventional but potentially important hypothesis, and encouragement of basic/clinical, basic/prevention, and basic/behavioral research collaborations. Funding for the Pilot Projects will not exceed one year. Applicants should describe the mechanism they will use for identification and selection of Pilot Projects they will support through developmental funds. o Funding for Evolving Research Opportunities is designed to support rapidly arising, critical, evolving areas in the field of AIDS research which demand a rapid resolution. Funding for projects of this type will not exceed six months. Identification of a potential project may be brought to the attention of the CFAR from CFAR members, scientists outside of the CFAR as well as from the awarding institute. Applicants should describe the mechanism they will use for identification and selection of Evolving Research Opportunities they will support through Developmental Funds. No more than 25 percent of the total direct costs requested in the CFAR/CSG application may be for the combined salaries of the CFAR Director and Core Directors. No more than 10 percent of the total direct costs requested in the CFAR/CSG budget application may be allocated for all other categories in the administration core. o Additional Activities. Four additional activities of CFARs are encouraged. Specific examples are not meant to be all inclusive: o Identification of a Thematic area, i.e., a general area of scientific specialization that characterizes an individual Center and represents its unique contribution to the overall breadth and scope of the CFAR/CSG program. An applicant institution may already have an existing focus of research, such as Immune Reconstitution, X-ray Crystallography, Specific Animal Models, Models of Cell-Based Trafficking, Neurobehavioral Sequelae of HIV, or Behavior Change and Prevention, that can then form the focus for a Thematic Area encompassing AIDS or AIDS-related research. CFAR investigators whose AIDS or AIDS-related research is not included in the Thematic Area will be eligible to use Core Facilities, after approval by the standard internal review process developed by each CFAR, e.g., through the Internal Review Committee. o Development of minority scientists in the field of basic and clinical AIDS research through support of programs that result in the participation of minorities in high quality mainstream investigations in this area. The CFAR may: (1) fund minority investigators who are new to AIDS research as part of one or more CFAR developmental grants, and (2) facilitate development of collaborative AIDS research projects with minority investigators at other institutions which could include, but not be limited to, membership in the CFAR, training within a CFAR Core and utilization of a Core with facilities that would not otherwise be available to the minority investigators at their own institution; o The CFAR is encouraged to identify ways to use scientific knowledge gained in the laboratory and clinic to decrease the gaps in understanding AIDS among non-scientists. Support could be through Developmental funding of a project in this area. Activities in this area might include the development of a program similar to NIH's "Medicine for the Layman" at the parent institution, and outreach to community groups with information tailored to the unique needs of the particular population, supported through Developmental funds or through the Administration Core. o Finally, the CFAR is encouraged to support identification of solutions to problems regarding enrollment and maintenance of women and minority groups in AIDS clinical trials, an area that can be supported through Developmental funding or through the Clinical Core. Definitions AFFILIATED INSTITUTIONS - Affiliated Institutions are institutions that provide one or two Core Support Facilities for the CFAR. AIDS RESEARCH - AIDS research includes, but is not limited to, studies of HIV and related retroviruses; studies of the mechanism(s) by which HIV and related retroviruses infect host cells, establish productive infections and cause disease; host genetic resistance to HIV/AIDS; studies on in vivo and in vitro models of human HIV infection; epidemiologic studies on HIV and related retroviruses, including prevention and behavioral change research; preclinical studies targeted to development of therapy for HIV infection including drug design modeling; clinical trials involving therapy for HIV infection or its sequelae; clinical trials involving, or studies targeted to development of, vaccines, or other immunological or chemotherapeutic interventions to prevent HIV infection; studies concerned with diagnosis of HIV infection and AIDS; and viral detection and isolation methods. AIDS-RELATED RESEARCH - AIDS-related research refers primarily to research on opportunistic infections associated with AIDS, research on other sequelae of AIDS such as AIDS-related neoplasias and wasting syndrome. Research on opportunistic organisms must use a model system related to HIV infection and pathogenesis in humans and may include: (a) mechanisms of pathogenesis; (b) virulence factors; (c) immunoregulation, immunopathology, immunotherapy and immune prophylaxis; (d) therapeutic methods in general, (e) host resistance mechanisms; and (f) detection and assay. ALTERATIONS AND RENOVATIONS - Alteration and renovation (A&R) is defined as work required to change the interior arrangements or other physical characteristics of an existing facility or installed equipment. APPLICANT INSTITUTION - The Applicant Institution refers to the responsible university or institute applying for the CFAR/CSG award. CFAR OR CENTER - In this RFA, the terms CFAR and "Center" are interchangeable and refer to the organization of ongoing, innovative, critical, peer-reviewed AIDS and AIDS-related research through the use of Core Support Facilities. In a CFAR, these ongoing research projects and their scientific disciplines are united under a single scientific and administrative structure with a common goal: the synergistic cooperation and collaboration between AIDS investigators at the CFAR, and especially, between basic and clinical investigators involved in innovative research on AIDS and its sequelae. The definitive feature of a CFAR is the establishment of shared Core Support Facilities. Through a Developmental Core, the CFAR also supports the recruitment of new scientists into AIDS research, pilot projects, and critical evolving research requiring an unusually timely response. A CFAR may also identify a thematic area to facilitate collaboration and interaction, and may also support community outreach projects, the organization of lecture series in AIDS for scientists and non-scientists, and may place special attention to the participation of women and minorities at all levels of AIDS research and treatment through the Developmental Core. CFAR MEMBER - Individual approved by the CFAR Internal Advisory Committee to use Core Facility(s). CFAR SENIOR LEADERSHIP - CFAR senior leaders are those individuals who are involved in the overall direction of the CFAR, including the Center Director, Associate or Assistant Director(s), Core Directors and those Center Staff Investigators who are involved in the planning, implementation and evaluation of Center activities including the stimulation of scientific interactions, the recognition and pursuit of new research opportunities, the implementation of budgets and charge back systems in cores, the identification of new CFAR members, the initiation of seminars and training programs and the recruitment of faculty. CHARGE BACK SYSTEM - CFARs are encouraged to phase in a Charge Back System, a method of charging users of the Core Facility a fee commensurate with their usage of equipment, time, supplies (such as reagents) and personnel, if any, providing the service. The charge back costs would then be budgeted within the users' research grants, resulting in a gradual increase in funds from this source, and a decreased cost to the CFAR/CSG over the award period. These freed funds from the CFAR/CSG award, originally dedicated to establish the Core Support Facilities proposed in the initial application, could then be rebudgeted to the Developmental Core and/or be used to establish new Cores as the Center evolved. Applicants should be aware that program income may be generated. Institute staff will work with grantees on this issue. CORE SUPPORT FACILITY - A "Core Support Facility", or "Core", consists of a functional AIDS service unit, either clinical (including behavioral aspects) basic, developmental, or administrative, including personnel, a responsible Core Director, defined space, laboratory equipment, supplies, resources and services which is able to perform experimental procedures requiring a number of specialized techniques not available to already existing independent research projects. A primary function of the CFAR is to foster multidisciplinary approaches to collaborative research. Core Components of a CFAR must be shared by investigators participating in a variety of individual and collaborative projects. CORE DIRECTORS - Core Directors shall consist of individuals responsible for the overall technical excellence of a Core Facility including its state of readiness, its ability to perform Core activities in a timely and efficient manner, improvement or adoption of new techniques as they become available, maintenance of supplies and equipment (a function that may be delegated to appropriate personnel), supervision of personnel providing services, supervision of any training programs having to do with the core and provision of advice to an Internal Advisory Committee, if appropriate, about core membership. EVOLVING RESEARCH OPPORTUNITIES - Evolving Research Opportunities is a category within Developmental Funding that is designed to support critical, evolving areas in AIDS research which demand a rapid resolution. EXTERNAL ADVISORY COMMITTEE - An External Advisory Committee may include established investigators in the field of AIDS and AIDS-related research who are not members of the CFAR they advise, one of whom may be the Director of another CFAR. The committee should provide advice on the overall direction and progress of the CFAR, establishment of new Cores and whether the CFAR is maintaining its mission. This committee should meet at least once per year and its report should be part of the annual CFAR progress report submitted to the funding institute (NIAID or NIMH). FUNDED RESEARCH BASE - The Funded Research Base is comprised of the total amount of AIDS or AIDS-related funding received for peer-reviewed grants awarded by the NIAID, NIMH, or alternate funding agencies, including all other NIH Institutes, having review criteria and mechanisms equivalent to the NIH. See III - Eligibility Requirements. INTERNAL ADVISORY COMMITTEE - An Internal Advisory Committee of each CFAR may be comprised of the CFAR Director, Core Directors, and other investigators of the CFAR, as appropriate, who may review all applications for use of Core facilities, and may be the group having final decision upon recruitment and retention of investigators within a Core facility. Other functions of the Internal Advisory Committee may include advice concerning the necessity to establish additional Cores, and the approval of developmental grant awards. MINORITY INVESTIGATOR / MINORITY INDIVIDUAL - A minority investigator or minority individual is defined, for the purposes of this RFA, as a member of a recognized minority group that is either under-represented in biomedical research or is undeserved in terms of AIDS diagnosis and treatment. PARENT INSTITUTION - The Parent Institution is the research institution receiving a CFAR award. In exceptional cases, a CFAR award may include up to 2 core support facilities housed at a second, affiliated institution. It is the responsibility of the applicant institution to clearly demonstrate the need for a Core at a second institution. It is expected that CFAR/CSG funding will be primarily used to support investigators at the Parent Institution. PEER-REVIEWED FUNDED RESEARCH - Peer-reviewed funded research includes the following: awarded research grants, cooperative agreements and research contracts awarded by NIAID or NIMH including P01, R01, R03, R18, R21, R29, R35, R37, U01, U10, K, and F series awards, and contracts (N01). Peer-reviewed funding also includes the equivalent awards from other NIH institutes and awarded grants from the National Science Foundation as well as all other government and private institutes which meet the NIH standard for peer review. It is the responsibility of the applying institution to demonstrate that the latter funding sources, if projects with such support are submitted to fulfill the requirement for a minimum level of direct cost peer-reviewed research funding are equivalent to the NIH standard for peer review. THEMATIC AREA - A thematic area is a general area of scientific specialization that characterizes an individual Center and represents its unique contribution to the overall breadth and scope of the CFAR Program. If NIAID and NIMH each support a CFAR at an institution, the themes should be distinct and non-overlapping. SPECIAL REQUIREMENTS Reporting Procedure o Progress report As is required for all awards, Annual Progress Reports on the progress and achievements attributable to the CFAR must be submitted together with an expenditure report, using form PHS 2590. Charge back systems for the core facilities must also be clearly documented. A progress report should demonstrate the overall value of the CFAR to the field of AIDS research. This would normally include brief descriptions of the projects the CFAR/CSG has supported, the nature of the contribution of the CFAR/CSG to the project, and the overall significance of the research to which the CFAR/CSG contributed. CFAR Citation All publications including abstracts, journal articles, books, as well as internal publications reporting on research findings supported, at least in part, by CFAR/CSG funding must acknowledge this as follows: "This (project) was supported by the Center for AIDS Research/Core Support Grant (CFAR/CSG) number XX-XXXXXX from the NIAID (or NIMH)." The CFAR/CSG program should also be acknowledged in all presentations, as appropriate. Allowable Budget Items Items within the following categories of expenses may be allowed: o Shared Resources Supporting Clinical and Laboratory Research. The CFAR may include funds for clinical and/or laboratory facilities, equipment, and services that will be used by multiple staff for research supported by ongoing peer-reviewed grants and/or contracts. Specific examples of such resources include, but are not limited to, large shared equipment, biostatistics, animal facilities and services, cell culture, media preparation, glassware washing, biosafety equipment and services, photography and illustration services, secretarial pools, centralized word processing, clinical pharmacology and toxicology, immunology, virology, cell and molecular biology or immunoparameter testing services, special animal colonies, amino acid analysis, HPLC facilities, cell sorting, chemical and drug synthesis, NMR facilities, protein chemistry, radioisotope facilities, mass spectrometry labs, flow cytometry, electron microscopy, neuroimaging facilities, PCR facilities, neurobehavioral assessment. o Alterations and Renovations. Alteration and renovation of an existing structure to provide suitable facilities in which to conduct the programs of the AIDS Center may be funded by the CFAR/CSG within the limits set by PHS grants policy if there is adequate justification for such costs. Requests for alterations and renovations related to containment facilities must be consistent with and limited to the level of containment (i.e., BL2, BL2+, or BL3) that is actually required to conduct the research comprising the CFAR Funded Research Base, as described in accepted NIH guidelines for working safely with HIV. (See HHS publication No. (NIH) 88-8395, Biosafety in Microbiological and Medical Laboratories, J.H. Richardson and W.E. Barkley, eds., May 1988 (or current edition) which is available from the Government Printing Office, Washington, DC 20402 at a cost of $4.00 per copy. When ordering, refer to GPO stock number 017-40-508-3.) The policy of PHS permits up to 100 percent of the costs of alterations and renovations to be charged to a CFAR, if there is adequate justification for such renovation, in accordance with PHS policy. o Salaries. The requested percentage of an individual's salary may not exceed the percentage of effort devoted specifically to the Center. Information substantiating this level of effort must be included in the application. All requested personnel costs should be thoroughly justified in the CFAR/CSG application. o CFAR Director. This grant may provide partial salary of the Director of the CFAR. Requests for salary support are limited to 35 percent of the total salary. o Core Directors. Core Directors are CFAR members who are responsible for the maintenance of the Core facility with which they are charged. Partial salaries for Core Directors may be provided by this award. Requests for salary support are limited to 10 percent of the total salary. o Investigators Funded through Developmental Grants. CFAR investigators awarded a developmental grant may qualify for up to 50 percent full salary support by the CFAR Developmental award for a period of time not to exceed three years. Established investigators whose research is supported by R01-type funding, and who are awarded funding for small, pilot studies will not qualify for salary support by this mechanism. o Administrative, Secretarial, and Technical Support. A maximum of 1.5 FTE positions for a chief administrator and/or secretarial and/or administrative assistance for the CFAR office and Director (for matters pertaining to the CFAR) may be supported by the CFAR/CSG award. In addition, applicant institutions may also request salary support for technicians providing services to maintain a Core or to provide a service to investigators using the Core facility. o Other Administrative Costs This category includes the costs necessary for the central administration and fiscal management of the Center, including relevant and reasonable costs for reprints, graphics and publications, especially for developmental grantees. As per standard NIH policy, those costs may not duplicate or replace costs included in the parent institution's indirect cost base or already funded by another award. o Planning and Evaluation Limited costs for planning and evaluation of center activities are allowable, such as costs of an External Advisory Committee (see Special Instructions document, "Centers for AIDS Research/Core Support Grant (CFAR/CSG) - Special Instructions for Preparation of Competing Applications"), and ad hoc scientific and technical consultants. o Travel One meeting per year for all CFAR Directors and one senior scientist per Center will be held at the NIH (or at a site designated by NIAID and by NIMH) during which time improvements to Centers, problems, collaborations among Centers and significant findings will be discussed. Applicants should include travel funds specifically for this meeting when they prepare the CFAR administration core budget request. Applicants may request up to $5000 for travel beyond the funds required for the Annual Directors' Meeting for investigators funded under the Developmental Core, or other CFAR investigators. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy requires that applicants for NIH clinical research grants and cooperative agreements include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale MUST be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group, together with a rationale for its choice. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 in items 1-4 of the Research Plan AND summarized in item 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of U.S. racial/ethnic minority populations [i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, and Hispanics]. The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of disease, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, clinical samples which may be coded for use by the applicant but could be identified by another source are not excluded. Every effort should be made and documented to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific questions addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. NOTE: Peer review groups need adequate information about the composition of proposed study populations in all applications involving human subjects. To avoid delays in review of such applications, the NIAID advises that, as a minimum, the application should contain demographic data about the clinic and/or in-patient population from which study subjects will be drawn: average hospital admissions per year; percentage distribution of Black/Hispanic/other minority/non-minority populations; gender; etc. Studies using non-hospital populations, such as community-based studies, should provide similar data about populations in the area or region from which the study subjects will be drawn. In the absence of current data, historical demographic information and/or previous recruitment data for similar studies from the proposed study sites should be provided. LETTER OF INTENT Prospective applicants are requested to submit, by July 16, 1993, a letter of intent that includes a descriptive title of the proposed research, the names of key members of the proposed CFAR and their institutions, a descriptive title of each Core Components. Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID and NIMH staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter is to be sent to Dr. Dianne Tingley at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted using form PHS 398 (rev. 9/91), available in the office of sponsored research of most academic or research institutions and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. Applicants are encouraged to request the supporting document for the CFAR/Core Support Grant RFA "CENTERS FOR AIDS RESEARCH/CORE SUPPORT GRANT (CFAR/CSG) GUIDELINES - Special Instructions for Preparation of Competing Applications" for all information required for preparation of the CFAR/CSG application from DAIDS program staff listed under INQUIRIES. The RFA label available in the application form must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and "YES" must be checked. Applicants must submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, two additional copies of the application must also be sent under separate cover to Dr. Dianne Tingley at the address listed under INQUIRIES. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the Division of Research Grants (DRG) for completeness. Those judged to be incomplete will be returned to the applicant without further consideration. Those considered to be non-responsive by program staff will be returned without review. All applications received in response to this RFA will be assigned to the appropriate institute based on the referral guidelines and may be reviewed by separate scientific review groups formed by the NIAID and NIMH. Those applications that are complete and responsive may be subjected to a triage by a NIAID and/or NIMH peer review group to determine their scientific merit relative to other applications received in response to this RFA. The NIAID and NIMH will withdraw from competition those applications judged to be non-competitive for award and will notify the applicant and institutional business officials. Those applications judged to be competitive will be further reviewed for scientific and technical merit by a review committee convened by the Division of Extramural Activities, NIAID and/or NIMH. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council or the National Advisory Mental Health Council. Specific review criteria for the CFAR/CSG, as recommended by the May 1992 ad hoc Review Committee for the CFAR/CSG program include, in order of importance: 1. The scientific excellence of the Center's AIDS and AIDS-related, peer-reviewed Funded Research Base (its strengths, its breadth and depth). This includes the following: o The presence of a critical mass of AIDS-related research. The applying institution must have a level of funding not less than $800,000 (direct costs) which includes a minimum of six individual awards. This Funded Research Base must be from NIAID funded research if the CFAR/CSG award is made by NIAID and must be 60 percent NIMH funded research if the CFAR/CSG is made by NIMH. 2. Interdisciplinary coordination and collaboration. The applicant institution should provide at least four specific examples from existing individual basic and clinical research projects demonstrating how the CFAR will fulfill its mandate to promote interdisciplinary coordination and collaboration to maximize productivity, including how the CFAR will effectively: o Promote the timely development of basic discoveries into applications in the clinical setting; o Promote the translation of observations in the clinical environment back into the research laboratory; o Encourage the use of Cores by scientists representing several disciplines or approaches to AIDS or AIDS-related research. 3. The commitment of the parent institution to the objectives and goals of the CFAR. The CFAR should be recognized as a formal organizational component within the parent institution. This includes: o A demonstration of its institutional commitment to the success of the Center by providing resources for the CFAR including appropriate space and personnel. o A willingness to adapt the provided resources to adequately address the changing needs of the CFAR; 4. The qualifications, experience, and commitment of the CFAR Director and Core Directors. This includes: o The CFAR Director should currently be a Principal Investigator of one or more peer-reviewed, AIDS or AIDS-related research projects in the CFAR Funded Research Base. He/she should have administrative experience roughly equivalent to a department head. It is strongly suggested that the director devote at least 35 percent of his or her time to the leadership responsibilities of the CFAR. o Core Directors should have sufficient knowledge and experience to direct Core activities. 5. The appropriateness and relevance of the proposed Cores and their modes of operation (such as how usage will be prioritized), facilities, and potential for contribution to ongoing research. This includes: o The mechanism the CFAR will utilize to ensure fair and appropriate selection of Core users; o Documentation of the use, utility, quality control and cost effectiveness of each Core requested to continue as part of the Center (for competing continuation applications). o Progress will be judged in part on the list of publications arising from the research supported by the Cores. At least two users are required to establish a Core. However, a greater number of users generally can be evaluated as more cost effective. o The willingness of the CFAR to augment a Charge Back System for each Core by the end of year 01 of the award. Additional information will be provided to the awardees with the Notice of Grant Award. 6. The appropriateness and effectiveness of the academic environment and resources in which the activities will be conducted, including the availability of space, equipment, facilities, and the potential for interaction with scientists from other departments and institutions will be reviewed. 7. The organizational capabilities of the proposed CFAR. o Appropriate advisory groups should be proposed su