From owner-sci-resources@net.bio.net Fri Mar 03 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 24, no. 8, pt. 1of1, 3 March 1995 Date: 3 Mar 1995 16:47:15 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 621 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3j8daj$3fi@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19950303 V24N08 P1O1 ************************************ X-comment: RFAs described: AI-95-012 NIH GUIDE - Vol. 24, No. 8 - March 3, 1995 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT Department of Health and Human Services INDEX: DEPARTMENT OF HEALTH AND HUMAN SERVICE $$INDEX N2 ********************************************************** NATIONAL SURVEY OF LABORATORY ANIMAL USE, FACILITIES, AND RESOURCES CONDUCTED BY THE NCRR IN 1995 National Center for Research Resources INDEX: RESEARCH RESOURCES $$INDEX N3 ********************************************************** SMALL BUSINESS INNOVATION RESEARCH National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX N4 ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS National Institutes of Health Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH; FOOD AND DRUG ADMINISTRATION $$INDEX N5 ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOPS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** DYNAMICS OF HEALTH, AGING AND BODY COMPOSITION - COORDINATING UNIT (RFP NIH-AG-95-03) National Institute on Aging INDEX: AGING $$INDEX R2 ********************************************************** LABORATORY TESTS OF BLOOD AND URINE SAMPLES FROM THE CPEP CLINICAL TRIAL (RFP NICHD-DESPR-95-14) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R3 07/18/95 ************************************************* HEPATITIS C COOPERATIVE RESEARCH CENTERS (RFA AI-95-012) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES This publication is available electronically via BITNET or INTERNET, by subscription, and is also on the NIH GOPHER (gopher.nih.gov). 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. THE PUBLIC HEALTH SERVICE (PHS) STRONGLY ENCOURAGES ALL GRANT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 24, Number 8, March 3, 1995 P.T. 34; K.W. 1014004, 1014006 Department of Health and Human Services Notice is hereby given that the Office of Research Integrity (ORI) has made final findings of scientific misconduct in the following case: Aaron Apte, Stanford University: The Division of Research Investigations of the Office of Research Integrity (ORI), reviewed an investigation conducted by Stanford University into possible scientific misconduct on the part of Mr. Aaron Apte, a former technician in the Department of Cardiovascular Surgery. Mr. Apte and his research were supported by U.S. Public Health Service grants. ORI concluded that Mr. Apte fabricated data for research, by cutting >From a former coworker's notebook a scintillation counter printout, pasting it into his own notebook, and representing it as his own results from a different experiment on the binding of angiotensin to transfected cells. Mr. Apte has been debarred from eligibility for and involvement in grants as well as other assistance awards and contracts from the Federal Government for a period of three years. The fabricated research did not appear in any publications. INQUIRIES For further information, contact: Director Division of Research Investigations Office of Research Integrity 5515 Security Lane, Suite 700 Rockville, MD 20852 Telephone: (301) 443-5330 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** NATIONAL SURVEY OF LABORATORY ANIMAL USE, FACILITIES, AND RESOURCES CONDUCTED BY THE NCRR IN 1995 NIH GUIDE, Volume 24, Number 8, March 3, 1995 P.T. 34; K.W. 0404021, 0780000 National Center for Research Resources The National Center for Research Resources of the National Institutes of Health is conducting the "National Survey of Laboratory Animal Use, Facilities, and Resources" of all Public Health Service (PHS) awardee institutions. This survey was mailed to the Institutional Officials of all OPRR-assured institutions, at the address indicated on the assurance, in January 1995. Data requested includes information on the characteristics of the organization, the species and numbers of animals in the program, the facilities and personnel supporting the laboratories, and the costs of animal care. In order to maintain the confidentiality of the responses, the survey will be anonymous. The final report, which will be sent to each institution in late 1996, will contain aggregated data gathered from the responding institutions. The survey is being performed by Advanced Resource Technologies, Inc. During the survey response period, February 1 to March 17, staff of Advanced Resource Technologies, Inc. will maintain a toll free number -- 1-800-NIH-2494 -- to offer assistance to respondents with any questions about the survey. The survey information will be of great importance to the NIH in determining the impact of animal resource needs on biomedical research and the future funding of laboratory animal research, facility construction, and renovation programs. Each institution is strongly urged to participate in the survey process, since the value of aggregated information rests on a significant response from the PHS awardee institutions. INQUIRIES For toll free assistance with questions about the survey or guidance in filling out the form: Dr. Elizabeth Gard or Dr. Paul DiTullio Advanced Resource Technologies, Inc. Telephone: (800) NIH-2494 Ms. Carol Brown National Center for Research Resources Building 12A, Room 4047 Bethesda, MD 20892-5666 Email: carolb@od12A.ncrr.nih.gov $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** SMALL BUSINESS INNOVATION RESEARCH NIH GUIDE, Volume 24, Number 8, March 3, 1995 P.T. 34; K.W. 0750020, 1003006, 0740022, 0710070 National Institute of Child Health and Human Development One program description for the Omnibus Solicitation of the Public Health Service for Small Business Innovation Research (SBIR) Grant and Cooperative Agreement Applications (PHS 95-3) was inadvertently omitted. The text, as it appears under the heading "B. Contraceptive Development" pertains to "C. Contraceptive and Reproductive Evaluation". Thus, on page 63, under "Contraceptive Development", the text should read as follows: B. Contraceptive Development Research focussed on new and improved methods of fertility regulation, for men and for women, that are safe, effective, inexpensive, reversible, and acceptable. The objective of the research is to develop an array of methods that couples in various population groups can use successfully and safely. (1) Synthesis and testing of drugs that can influence male and female fertility and that have the potential of becoming useful contraceptives. (2) Development of methods of contraceptive drug administration that can improve the bioavailability from different routes of administration. (3) Isolation of antigens specific to the reproductive system that could be utilized for antifertility vaccine development. (4) Development of improved barrier contraceptives for men and women, including new spermicidal agents or new formulations that may reduce vaginal irritation and provide better protection against sexually transmitted diseases. (5) Development of simplified methods to quantify sperm counts, particularly for men with low sperm counts. (6) Developing leads to non-peptide GnRH analogs (agonists and antagonists), as potential contraceptive agents, via screening of libraries of compounds against the GnRH receptor. C. Contraceptive and Reproductive Evaluation INQUIRIES For further information regarding this program, contact: Ms. Hildegard Topper National Institute of Child Health and Human Development Building 31, Room 2A03 Bethesda, MD 20892-2425 Telephone: (301) 496-0104 FAX: (301) 402-1104 Email: ht20t@nih.gov $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOPS NIH GUIDE, Volume 24, Number 8, March 3, 1995 P.T. 42; K.W. 0201011, 1014003 National Institutes of Health The National Institutes of Health, Office for Protection from Research Risks is continuing to sponsor workshops on implementing the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Each of the workshops scheduled for Fiscal Year 1995 will focus on a specific theme. The workshops are open to institutional administrators, members of Institutional Animal Care and Use Committees, laboratory animal veterinarians, investigators and other institutional staff who have responsibility for high-quality management of sound institutional animal care and use programs. Ample opportunities will be provided to exchange ideas and interests through question and answer sessions and informal discussions. DATES: March 12-14, 1995 TOPIC: Animal Care and Research: Challenges and Changes for the Institutional Animal Care and Use Committee LOCATION San Diego Princess 1404 West Vacation Road San Diego, CA 92109-7994 Telephone: (619) 274-4630 or (1-800) 344-2626 FAX: (619) 581-5929 SPONSORS Tufts University School of Veterinary Medicine Public Responsibility in Medicine and Research REGISTRATION Ms. Danielle Demko Public Responsibility in Medicine and Research 132 Boylston Street Boston, MA 02116 Telephone: (617) 423-4112 FAX: (617) 423-1185 FEE: $300 DESCRIPTION: The Workshop will focus on revisions to the Institutional Animal Care and Use Committee Guidebook; assessment and reduction of pain and distress in animal research; occupational health risks ad biohazards; and a host of other regulatory and administrative issues that are central to the successful operation of laboratory animal care and research programs. Immediately preceding the Tufts University School of Veterinary Medicine/NIH/OPRR Workshop, Applied Research Ethics National Association (ARENA) will sponsor its annual animal issues meeting on Sunday, March 12, also at the San Diego Princess. INQUIRIES For further information concerning these workshops and future NIH/OPRR Animal Welfare Education Workshops, contact: Mrs. Roberta Sonneborn Office of Protection from Research Risks National Institutes of Health 6100 Executive Boulevard, MSC 7507 Bethesda, MD 20892-7507 Telephone: (301) 496-7163 FAX: (301) 402-2071 $$N4 END ************************************************************ $$N5 BEGIN ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS NIH GUIDE, Volume 24, Number 8, March 3, 1995 P.T. 42; K.W. 0783005 National Institutes of Health Food and Drug Administration The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are continuing to sponsor a series of workshops on responsibilities of researchers, Institutional Review Boards (IRBs), and institutional officials for the protection of human subjects in research. The workshops are open to everyone with an interest in research involving human subjects, and will be of special interest to those persons currently serving or about to begin serving as a member of an IRB. Issues discussed at these workshops are relevant to all Public Health Service agencies. The current schedule includes the following: DATES: May 4-5, 1995 TITLE: Contemporary Issues in Human Research Subject Protection in Vulnerable and Minority Populations: Sharing the Benefits and Burdens of Research LOCATION: Regal Riverfront Hotel, St. Louis, MO SPONSORS Washington University School of Medicine Jewish Hospital of St. Louis at Washington University Meharry Medical College REGISTRATION Barb Woodson Secretary, Research Administration Jewish Hospital of Saint Louis 216 South Kingshiway, Room 1768-69 Saint Louis, MO 63110 Telephone: (314) 454-8322 FAX: (314) 454-4241 REGISTRATION FEE: $150 DESCRIPTION: The HHS and FDA mandate to Institutional Review Boards is to protect the rights and welfare of human subjects while supporting scientific advancement. This protection is extended to all human subjects, but additional safeguards are provided by both the HHS/FDA regulations and basic ethical principles to protect the rights and welfare of vulnerable subjects who, by reason of their disability or illness, exhibit diminished personal autonomy. Neither the Federal regulations, nor ethical codes, including The Belmont Report, proscribe inclusion of vulnerable persons as research subjects, although special justification of any plan to involve vulnerable persons as research subjects is required. Women and members of certain racial groups -- particularly Afro-Americans and Hispanics -- have been excluded from research. Inasmuch as these groups have not been involved, they also are vulnerable -- vulnerable to exclusion and to the possibility of being deprived of proven new advances from research. This Conference will focus particularly on evolving concerns for the protection of vulnerable subjects from research risks, inappropriate or inadvertent exploitation, or discrimination by exclusion. Presentations will highlight FDA regulatory updates; explore the new guidelines for the inclusion of women and people of color and diverse racial and ethnic backgrounds in clinical research; examine the claims that women have been systematically excluded from research and potentially deprived thereby of proven diagnostic and therapeutic strategies; review current issues in research in vulnerable populations including unconscious patients in emergency rooms, AIDS patients, children, the elderly, and the cognitively-impaired. IRB challenges in research in psychiatry will be discussed, including the validity of initial and continuing informed consent for research in schizophrenic patients, justification for the use of a placebo, the social and medical implications of genetic screening for vulnerability to psychiatric disease, the ethical difficulties involved in research in child psychiatry, and the influence of cultural patterns on psychiatric research in minority populations. The Conference will include keynote addresses, panel presentations, facilitated forums, information exchanges, and active audience participation. An outstanding faculty of experts in each area of discussion has been selected on the basis of expertise and ability to communicate authoritatively and comprehensively. INQUIRIES For further information regarding these workshops and future NIH/FDA National Human Subject Protections Workshops, contact: Ms. Darlene Marie Ross Office for Protection from Research Risks National Institutes of Health 6100 Executive Boulevard, Suite 3B01 Rockville, MD 20892-7507 Telephone: (301) 496-8101 FAX: (301) 402-0527 $$N5 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN NIH-AG-95-03 ********************************************* DYNAMICS OF HEALTH, AGING AND BODY COMPOSITION - COORDINATING UNIT NIH GUIDE, Volume 24, Number 8, March 3, 1995 RFP AVAILABLE: NIH-AG-95-03 P.T. 34; K.W. 0710010, 0755018, 0404021, 0413000 National Institute on Aging The National Institute on Aging (NIA) has a contract requirement to operate the coordinating unit for an eight-year population-based observational study, the Dynamics of Health, Aging and Body Composition (HEALTH ABC). The coordinating unit will interact with two field centers that will recruit a total of 3,000 non- institutionalized White and African-American men and women aged 70-79. Change in physical function and incident disability are the major study outcomes. Assessment of participants will include baseline and follow-up interviews and examinations that include measurement of body composition using dual energy x-ray absorptiometry (DEXA); measures of anthropometry, strength, fitness and physical function; objective measures of weight-related health conditions, i.e., osteoarthritis, cardiovascular disease, osteoporosis, pulmonary disease, and diabetes, and collection of blood and other biologic samples. The coordinating unit will have the primary responsibility for: (1) providing reading centers for body composition studies and electrocardiograms; (2) establishing and maintaining a central storage facility for biologic specimens; (3) identifying and assessing candidate facilities for analysis of biologic specimens; and (4) managing the central storage facilities and analytic laboratories for biologic specimens, including coordinating the shipping, tracking, and analysis of samples. Responsibilities for data management and study administration include: (1) participating with the field centers in preparing the study protocols, reporting forms, and manuals of operations; (2) assisting in the preparation of materials for OMB clearance; (3) developing a distributed data entry system; (4) standardizing, printing and distributing reporting forms, the study protocol, and manuals of operations; (5) conducting training sessions for field center personnel on all aspects of data collection; (6) receiving, collecting, processing, editing, storing, providing quality control of, and analyzing data collected by the field centers; (7) coordinating, arranging, participating in, providing information for, and preparing minutes from committee meetings; (8) preparing and distributing periodic technical and statistical reports; (9) developing recruitment plans, informed consent materials, and educational materials for diverse study populations; (10) collaborating with the other study investigators and project officers in producing manuscripts for publication. Applicants should have previous experience in research projects involving the following: collection of data on body composition or bone mineral density and from electrocardiograms, establishing and maintaining a central storage facility for biologic specimens, and evaluating laboratories for analysis of these specimens. The solicitation is scheduled to be issued on or about March 3, 1995. Proposals will be due 60 days after the date of issuance of the solicitation. All responsible sources may submit a proposal that will be considered by the Government. INQUIRIES Copies of the solicitation may be obtained by sending a written request to: John P. DeCenzo Research Contracts Branch, DCG/OD National Institutes of Health 6100 Executive Boulevard, Room 6E01 - MSC 7540 Bethesda, MD 20892-7540 Telephone: (301) 496-4487 $$R1 END ************************************************************ $$R2 BEGIN NICHD-DESPR-95-14 **************************************** LABORATORY TESTS OF BLOOD AND URINE SAMPLES FROM THE CPEP CLINICAL TRIAL NIH GUIDE, Volume 24, Number 8, March 3, 1995 RFP AVAILABLE: NICHD-DESPR-95-14 P.T. 34; K.W. 0755015, 0780005 National Institute of Child Health and Human Development As a part of the Trial of Calcium for Preeclampsia Prevention (CPEP), the National Institute of Child Health and Human Development (NICHD) is planning to (1) compare urinary excretion of calcium and related nutrients in preeclamptic women before and after the diagnosis of preeclampsia to that in normal pregnant women at comparable gestational ages, and determine the effect of oral calcium supplementation on the excretion of these substances; (2) determine the presence or absence of proteinuria not previously ascertained in up to 125 urine specimens obtained from normal women and from women with gestational hypertension within seven days of documented hypertension; and (3) measure the quantity of elemental calcium in each of up to 100 study medication tablets for purposes of quality control. The comparison of urinary excretion of calcium and related nutrients will be a nested case control study using stored urine specimens collected at specified times during pregnancy and at the diagnosis of preeclampsia from pregnant women participating in CPEP. CPEP is a randomized clinical trial designed to determine whether oral calcium supplementation will prevent preeclampsia. The Contractor will be expected to measure calcium, sodium, potassium, chloride, magnesium, zinc, phosphorus, urea nitrogen, and creatinine in approximately 5912 urine specimens selected by the Project Officer over the course of one year. Measurements of protein and creatinine in up to 125 additional urine specimens and calcium content of up to 100 study medication tablets must also be completed within the same year. INQUIRIES This announcement is a new solicitation. The issuance of this Request for Proposals (RFP) will be on or about March 6, 1995, and proposals are due by 4:00 p.m. (local time), May 2, 1995. The short-form version of the RFP will be provided first, which includes only the Statement of Work, Technical Reporting Requirements, Background Information, and the Evaluation Criteria to be used for selection of the awardee. After examining this, a full-text version of the RFP must be requested, in writing, for those organizations interested in responding. FAX requests are acceptable. All requests must cite the RFP number and include two self-addressed mailing labels. All sources who consider themselves qualified are encouraged to submit a proposal. This advertisement does not commit the Government to make an award. Organizations desiring a copy of the short-form RFP may send a written request to: Mrs. Lynn Salo Office of Grants and Contracts National Institute of Child Health and Human Development Executive Building, Room 7A07 6100 Executive Boulevard MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-4611 FAX: (301) 402-3676 $$R2 END ************************************************************ $$R3 BEGIN AI-95-012 FULL-TEXT ************************************** HEPATITIS C COOPERATIVE RESEARCH CENTERS NIH GUIDE, Volume 24, Number 8, March 3, 1995 RFA AVAILABLE: AI-95-012 P.T. 34; K.W. 0715125, 1002045, 0765033, 0710030 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: April 7, 1995 Application Receipt Date: July 18, 1995 PURPOSE Applications are invited for Hepatitis C Cooperative Research Centers (HC CRCs) to perform innovative, systematic, collaborative basic and clinical research on hepatitis C virus (HCV). Using integrated approaches from multiple disciplines, the HC CRCs will serve as foci for generating the knowledge needed to further understanding of HCV infection, recovery, and pathogenesis. Building on this knowledge, HC CRCs will devise original preventive and therapeutic interventions. 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), Hepatitis C Cooperative Research Centers (HC CRCs), 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 Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). INQUIRIES This RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Dr. Leslye Johnson Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard - MSC 7630 Solar Building, Room 3A-22 Bethesda, MD 20892-7630 Telephone: (301) 496-7051 Email: lj7m@nih.gov $$R3 END ************************************************************ From owner-sci-resources@net.bio.net Fri Mar 03 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AI-95-012 - V24(08) 03/03/95 Date: 3 Mar 1995 16:47:29 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 717 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3j8db1$3gn@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AI95012 AI-95-012 P1O1 *************************************** HEPATITIS C COOPERATIVE RESEARCH CENTERS NIH GUIDE, Volume 24, Number 8, March 3, 1995 RFA: AI-95-012 P.T. 34; K.W. 0715125, 1002045, 0765033, 0710030 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: April 7, 1995 Application Receipt Date: July 18, 1995 PURPOSE The Enteric Diseases Branch of the Division of Microbiology and Infectious Diseases (DMID) of the National Institute of Allergy and Infectious Diseases (NIAID) invites applications for the establishment of high-quality Hepatitis C Cooperative Research Centers (HC CRCs). The purpose of this Request for Applications (RFA) is to stimulate multidisciplinary, multi-project, collaborative research on hepatitis C virus (HCV). Such clinical and basic research will further the understanding of early and mid, rather than late (liver failure or liver cancer), stages and manifestations of hepatitis C infection, disease, and recovery. The HC CRCs will build on new findings to develop vaccine and therapy strategies. 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, Hepatitis C Cooperative Research Centers (HC CRCs), 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 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 Research grant applications may be submitted by domestic non-profit and for-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 but may be part of a collaborative arrangement as described under STUDY POPULATIONS. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The administrative and funding mechanism to be used to undertake this program will be the Multi-component Cooperative Agreement (U19), an "assistance" mechanism, rather than an "acquisition" mechanism. The U19 must have a minimum of three inter-related research projects around a common theme as well as collaborative efforts and interactions among component investigator-initiated projects and their investigators to achieve a common goal. Further information can be found in NIAID's "Application Guidelines for Multiproject Research Awards, November 1994," which are available from the individuals listed under INQUIRIES. The Multi-component Cooperative Agreement differs from the Program Project in that the U19 anticipates substantial NIH scientific and/or programmatic involvement with the awardee during performance of the activity. Under the cooperative agreement, the NIH's purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role. However, NIH is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships, and governance of the study funded under agreement(s) are discussed later in this document under the section Terms and Conditions of Award. HC CRCs may involve collaboration among investigators at several institutions. These consortium arrangements should follow the NIH "Guidelines for Establishing and Operating Consortium Grants, January 1989." These are available from the individuals listed under INQUIRIES. The total requested period for applications submitted in response to this RFA may not exceed five years. At present, the NIAID is administratively limiting the duration of U19 agreements to four years; this administrative limitation may change in the future. At this time, the NIAID has not determined whether and how this solicitation will be continued beyond the present RFA. The earliest anticipated award date is May 1, 1996. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for the first year of support for awards under this RFA will be $1.5 million. In Fiscal Year 1996, the NIAID plans to fund two or three HC CRCs. The final number of awards to be made is dependent upon the availability of funds. The initial year's total costs, including direct and indirect costs, should not exceed $750,000 for each award. 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, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the agreement upon satisfactory progress during the preceding years and availability of funds. RESEARCH OBJECTIVES Background Hepatitis due to hepatitis C virus (HCV) is classified as an emerging infectious disease (IOM Report, 1992). Just six years ago, investigators identified HCV as an important etiological agent of non-A, non-B hepatitis and chronic liver disease through cloning and sequencing efforts. HCV infects close to 200,000 individuals each year in the U.S., affecting Hispanics and Afro-Americans disproportionately. The modes of transmission remain unidentified for an alarming 43 percent of cases. Recovery from infection is rare and at least 70 percent and quite possibly 90 percent of those infected become chronic carriers. Thus, 140,000 - 180,000 U.S. citizens become new chronic carriers each year. Even when the initial infection is asymptomatic, as it is in a high percentage of people, severe chronic liver disease with its concomitant high morbidity and mortality occurs. The CDC estimates that one to two percent of the people in the U.S., i.e., 2.5-5.0 million individuals, are chronically infected with HCV. The same one to two percent carrier rate is true around the world with the exception of a few high endemicity areas such as some inner city areas in the U.S., Egypt, the Sudan, and isolated villages in Asia. In the U.S. the total cost for HCV infection and chronic sequelae is estimated at $1.5 billion per year. Since identification of HCV considerable progress has been made. Molecular biological techniques have enabled investigators to: (1) clone and sequence many genotypes; (2) map the HCV genome and identify some of its functions; and (3) analyze structural and nonstructural proteins and the processes by which they are made. New diagnostics have been instrumental in: (1) verifying the agent causing liver disease in symptomatic patients as well as identifying asymptomatic patients; (2) preventing transmission in transfusion, transplantation and hemodialysis patients; and (3) identifying cofactors for infection and chronic disease. There have been efforts to define modes of transmission as well as affected and at risk population groups. Studies of (immuno)pathogenesis and viral replication are beginning. Despite these advances, infection and disease caused by HCV remain enigmatic, and prevention and treatment problematic. Mechanisms of liver disease and the host's role in viral persistence are largely unexplored. Significant gaps exist in the knowledge base regarding HCV's natural history and progression of disease. An obstacle to vaccine development stems from the inadequate immune response to natural infection -- viral clearance is exceedingly rare even though neutralizing antibodies have recently been detected. The large number of HCV genotypes and their high rate of mutation as well as the existence of genetic variants, i.e., "quasispecies," pose obstacles both to prevention and treatment. Alpha interferon, the only available therapy, is less than adequate and has associated toxicity. Additionally, sample sizes in human studies have often been inadequate to draw statistically significant conclusions. HCV indeed poses tough challenges for scientists and clinicians. Prevention of infection, e.g., through vaccination, and cure or amelioration of disease have the greatest promise for those at risk and affected respectively. For diseases like hepatitis B they have been shown to be highly cost-effective. Thus in this RFA, the NIAID is interested in research focused on acute and chronic disease rather than on liver failure or cancer. Objectives and Scope This RFA seeks to support state-of-the-art, innovative research on hepatitis C virus. Using integrated approaches from multiple disciplines, the HC CRCs will serve as foci for generating the knowledge needed to further understanding of HCV infection, recovery, and pathogenesis. And building on this knowledge, to devise original preventive and therapeutic interventions. The NIAID expects clinical issues and needs to be the driving forces for research performed by the HC CRCs. Relevant topics for research may include but are not limited to: o identify host responses to infection, e.g., correlates of immunity associated with prevention of infection and disease as well as recovery from acute and chronic infection; o explore host mechanisms involved in fostering and maintaining viral persistence; o identify mechanisms of pathogenesis which lead to and exacerbate liver disease; o develop small animal model and in vitro systems which are relevant for HCV vaccine, antiviral, and pathogenesis research; o develop infectious cDNA clones and utilize them in ways directly relevant to disease research; and o assess the impact of viral heterogeneity, e.g., genotypes and "quasispecies", on disease initiation and progression, the development of protective immunity, treatment outcome, etc.; o utilize findings to bridge the gaps between basic, applied, and clinical research by developing and evaluating intervention strategies, e.g., broaden or enhance protective immunity, subvert avoidance mechanisms. SPECIAL REQUIREMENTS Relevant Disciplines To foster multidisciplinary research, each HC CRC should include approaches from at least four disciplines such as virology, immunology, pathogenesis, the liver (cells, tissue, and organ) and changes (biology, biochemistry, etc.) in response to infection, clinical infection and disease, model system development, and applied research. HC CRC Collaborative Studies During the award period collaborative studies among HC CRCs may enhance research progress and increase the significance of HC CRC contributions. Examples include, but are not limited to, rapid accrual of patients or augmented access to samples. Hence, applicants should be willing to share samples as well as to participate in multicenter activities and common protocols. These will be encouraged and stimulated by the Scientific Coordinator through discussions with the Program Directors and at meetings and workshops scheduled as part of these awards. Steering Committee Meetings and Workshops To coordinate activities, facilitate interchanges, and develop collaborative opportunities, HC CRC Program Directors and the NIAID Scientific Coordinator will meet twice a year as a Steering committee. To enhance information exchange, Project Leaders will be expected to attend workshops in Years 1 and 3 of the award period. Clinical Capability To move forward with basic and clinical approaches, HC CRCs must have access to, and clinical experience with, well-characterized and diverse patient samples and populations representing different disease stages. The value of research and studies performed will be directly related to the care exercised in selection and characterization of cases and controls. Programs should include participation of human subjects to address research questions. NIAID encourages: (1) collaborative arrangements with ongoing studies or clinical care capable of providing patient populations, specimens and information; (2) applicants from institutions that have a General Clinical Research Centers (GCRC) funded by the NIH National Center for Research Resources to identify the GCRC as a resource for conducting the proposed research. In both cases letters of collaboration or agreement from the study's principal investigator and/or GCRC program director should be included in the application material. Access to and experience with patient populations also will be helpful should progress warrant studies with promising new vaccine and therapy candidates. In describing the clinical and laboratory facilities, the applicant should include specific information on present patient load, projections for patient involvement in future clinical investigations, history of recruitment and study of subjects, and disease category and prevalence as well as the availability of appropriate biohazard facilities and safety procedures. Budget and Related Issues Applications should budget appropriate funds to allow the Program Director of each HC CRC (also known as the HC CRC Director) to attend meetings in Bethesda, MD with the NIAID Scientific Coordinator twice each year and for all HC CRC Project Leaders to attend HC CRC workshops twice during the program period. Applicants should be aware that no additional travel monies will be awarded. Funds for travel to HC CRC meetings must be included in applicant's budget. (See below: SPECIAL REQUIREMENTS, Terms and Conditions of Award, 3. Collaborative Responsibilities.). Optional Developmental Fund for Pilot Studies Applicants may include a request for a Developmental Fund of up to $60,000 in direct costs to provide support for pilot projects. Such pilot projects might develop methods or resources capable of enhancing basic and clinical research progress, follow-up on new observations and hypotheses, or perform short term high risk - high benefit research. They should fit within the relevant disciplines listed above. It is envisioned that availability of funds for pilot studies will increase flexibility and responsiveness to important new scientific observations and medical reports and encourage the development of research investigators interested in hepatitis C. Pilot studies need not be restricted to the awardee institution. IT IS EMPHASIZED THAT PILOT STUDIES AWARDED FROM THE DEVELOPMENTAL FUND ARE DISTINCT FROM INDIVIDUAL HC CRC RESEARCH PROJECTS. Direct costs may not exceed $20,000 for any single pilot study and supplies and equipment expenditures may not exceed $7,000 annually per study. The duration of support for each study typically would be one year, but may be up to two years. In the event the study is independently funded through a traditional research project grant (R01) or a FIRST (R29) award prior to the end of the award period, the support of the pilot study from the Developmental Fund must be terminated, and unexpended funds must be returned to the Developmental Fund. Funds reserved for pilot projects may not be rebudgeted into other budget categories except in unusual circumstances and following approval from the Awarding Unit and the Scientific Coordinator. The HC CRC must maintain detailed records of disbursements and expenditures of the Developmental Fund. Potential awardees and specific research projects to be pursued need not be identified in the application. However, the application should include a one page description of the kind of project that might be funded under this mechanism and how it interdigitates with other CRC projects. Approval of the developmental funds portion of the application does not in any way commit the program directors to the execution of the sample project. It is anticipated that prior to the HC CRC Program Director proposing pilot studies to the NIAID Scientific Coordinator, these studies and their budgets will be reviewed and recommended by a local review committee. The application must provide a description of the review process and selection criterion for proposed projects. Examples of criteria are scientific merit of the proposal, medical relevance and need for data to advance the research objectives of the HC CRC. It is recommended that no one applying for a development pilot project be on the review committee. Studies involving Human Subjects will require prior approval by the Institutional Review Board like all other NIH supported projects. The $30,000 annual direct costs should be entered in the OTHER category in the Consolidated Budget (see pages 12 and 19 in the accompanying brochure). Terms and Conditions of Award The following terms and conditions will be incorporated into the award notice. These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is the agreement (U19), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the agreement, the NIH's purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Awards will be made to an institution on behalf of a Program Director who will be responsible for the coordination of HC CRC scientific and administrative activities. Support of all HC CRC activities will be coordinated through a Central Operations Office located within the applicant organization. 1. Awardee Rights and Responsibilities Awardees will have primary responsibility for defining the details for the project within the guidelines of the RFA and for performing the scientific activity, and agree to accept close coordination, cooperation, and participation of NIAID staff in those aspects of scientific and technical management of the project as stated below under NIAID Staff Responsibilities. Specifically, awardees have primary responsibilities as described below. Under the Cooperative Agreement, a partnership relationship exists between the recipient of the award and NIAID in which successful applicants are responsive to the guidelines and conditions set forth in the RFA. At the same time, investigators are expected to define research objectives and approaches in accord with their own interests and perceptions of novel and exploitable approaches to the research which ultimately is likely to result in improved prevention and control of hepatitis C. It is the primary responsibility of the HC CRC Program Director to clearly state the objectives and approaches of the research, to plan and conduct the research stipulated in the application, and to ensure that the results obtained are analyzed and published in a timely manner. The HC CRC Program Director also will propose pilot studies to the NIAID Scientific Coordinator after review of these studies and their budgets by a local review committee. NIAID may periodically review and generate internal reports from data and progress reports developed under this agreement. The data obtained will, however, be the property of the awardee. 2. NIAID Staff Responsibilities The NIAID will have substantial scientific/programmatic involvement during the conduct of this activity, through technical assistance, advice and coordination above and beyond normal program stewardship for grants, as described below. The NIAID will work closely with the Program Directors and shall be represented by the Scientific Coordinator (Program Officer). The Scientific Coordinator will be the Hepatitis Program Officer in the Enteric Diseases Branch of NIAID. During the award period, the NIAID Scientific Coordinator may provide appropriate assistance, advice, and guidance in: o overall design of studies, e.g., prospective or intervention, especially those undertaken jointly by the HC CRCs; o linkage to special populations and vaccine production facilities funded through NIAID contracts, NIAID's data collection and analysis contracts, and DMID staff capabilities with respect to IND filing; o coordination and facilitation of information, technology, reagent and pedigree specimen exchange between HC CRCs themselves and with other grantees; o assistance in review and selection of developmental fund awardees; and o technical and administrative activities of HC CRCs. However, it is again emphasized that the role of NIAID will be TO FACILITATE AND NOT TO DIRECT THE ACTIVITIES of the HC CRCs. It is anticipated that decisions in all activities outlined within this RFA will be reached by consensus of the investigators and that the NIAID Scientific Coordinator will be given the opportunity to offer input to this process. In the event that research supported by the Cooperative Agreement results in development of a therapeutic or other medical intervention, NIAID will retain the option to cross-file or independently file an application for investigational clinical trial (i.e., an Investigational New Drug Application [INDA]) to the United States Food and Drug Administration. To facilitate this, reports of data generated by the HC CRC or any of its members which are required for inclusion in INDs and Clinical Brochures and for cross-filing purposes will be submitted by the Program Director to the Scientific Coordinator upon request. Such reports will be in final draft form and include background information, methods, results, and conclusion. They will be subject to approval and revision by NIAID and may be augmented with test results from other Government sponsored projects prior to submission to the appropriate regulatory agency. 3. Collaborative Responsibilities The HC CRC Program Directors and NIAID Scientific Coordinator will form a Joint Steering Committee which will meet at the NIH in Bethesda, Maryland (or at a site designated by NIAID) twice a year. Its functions include, but are not limited to: tracking and reviewing activities/progress over the six months between meetings, planning for the next six months and beyond, maintaining focus, and developing collaborative efforts among HC CRCs. The Program Directors and Scientific Coordinator will have voting rights. Issues for discussion and agendas will be a collaborative responsibility. The first steering committee meeting will occur shortly Post Award. Twice during the project period and in conjunction with the semi-annual Steering Committee meeting, workshops for the Program Directors and Project Leaders will be convened to share hepatitis C research advances, to discuss research needs and opportunities, and to develop collaborations. It is likely that these workshops will be convened in Year 1 and Year 3 of the project period at the NIH in Bethesda, Maryland (or at a site designated by NIAID). 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award) between award recipients and the NIAID may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the Program Director, a second member selected by the NIAID, and the third member selected by the two prior members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations at 42 CFR part 50, subpart D, and HHS regulation at 45 CFR part 16. STUDY POPULATIONS A strong emphasis is placed on studying hepatitis C in racial/ethnic populations that are disproportionately affected. These populations include African-Americans and Hispanics. Subjects may be recruited or specimens obtained from domestic sites or through collaborations with foreign institutions if the collaboration is beneficial to the foreign country and offers the potential for collection of hepatitis C data that are pertinent to U.S. populations and could not be generated as effectively in the United States. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and printed in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from Dr. Johnson at the address listed under INQUIRIES. Dr. Johnson may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by March 1, 1995, a letter of intent that includes a descriptive title of the overall proposed research, the name, address, and telephone number of the Program Director, a list of the key investigators and their institution(s), and the number and title of this RFA. 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 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. Olivia Preble at the address listed under INQUIRIES. APPLICATION PROCEDURES It is highly recommended that potential applicants contract Dr. Leslye Johnson in the early stages of application preparation. Before preparing an application, the applicant should carefully read the information brochure, "NIAID APPLICATION GUIDELINES FOR MULTIPROJECT RESEARCH AWARDS," available from the contacts listed under INQUIRIES. Instructions for formatting the application as outlined in the brochure should be followed carefully. Failure to follow the instructions may result in unnecessary delays in the review process. Applications are to be submitted on the standard research grant application form PHS 398 (rev. 9/91). These application forms may be obtained from the institution's office of sponsored research or its equivalent and from the Office of Grants Information, 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 (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, exact, single-sided photocopies, in one package, to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (express mail) 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. Olivia Preble Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C-20 MSC 7610 6003 Executive Boulevard Bethesda, MD 20892-7610 Rockville, MD 20852 (express mail) Applications must be received by July 18, 1995. All components, subparts and sections of the application must be collated into the application, and the packages sent to the DRG and to the NIAID must each be complete in themselves. Applications that do not conform to the instructions contained in PHS 398 (rev. 9/91) application kit will be judged nonresponsive and will be returned to the applicant. Current NIH policy permits a component research project of a multiproject grant application to be concurrently submitted as a traditional individual research project (R01) application. If, following review, both the multiproject application and the R01 application are found to be in the fundable range, the investigator must relinquish the R01 and will not have the option to withdraw from the multiproject grant. This is an NIH policy intended to preserve the scientific integrity of a multiproject grant, which may be seriously compromised if a strong component project(s) is removed >From the program. Investigators wishing to participate in a multiproject grant must be aware of this policy before making a commitment to the Program Director and awarding institution. REVIEW CONSIDERATIONS Review Method Upon receipt, applications will be reviewed for completeness by the Division of Research Grants (DRG) for completeness and for responsiveness by NIAID staff. Incomplete and non-responsive applications will be returned to the applicant without further consideration or 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 will remove from competition those applications judged to be non-competitive for award and will notify the Program Directors 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. Review Criteria The standard review criteria are stated in the NIAID GUIDELINES FOR MULTIPROJECT RESEARCH AWARDS, which is available from the program staff listed under INQUIRIES. In addition, the following criteria will apply: o the scientific and technical significance, merit, and originality of the research projects and anticipated contributions to the understanding of HCV's immunology and disease; o the scientific expertise and experience of the Program Director, the Project Leaders and key project and core personnel; o documentation of a strong clinical capability, adequate and appropriate patient populations, disease prevalence, and historical success of recruitment and retention of subjects; o documentation of the sponsoring institution's commitment to the program and willingness to accept the participation and assistance of NIAID staff; o adequacy of proposed plan for coordination and communication within the applicant HC CRC and with NIAID and other HC CRCs; and o adequacy of proposed plan for selection of pilot studies. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program balance, and 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: Dr. Leslye Johnson Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A-22 MSC 7630 6003 Executive Boulevard Bethesda, MD 20892-7630 Telephone: (301) 496-7051 Email: lj7m@nih.gov Direct inquiries regarding review issues, address the letter of intent to, and mail two copies of the application and all five sets of appendices to: Dr. Olivia Preble Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C-20 MSC 7610 6003 Executive Boulevard Bethesda, MD 20892-7610 Rockville, MD 20852 Telephone: (301) 496-8208 Email: op2t@nih.gov Direct inquiries regarding fiscal matters to: Linda M. Shaw Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B-33 MSC 7610 6003 Executive Boulevard Bethesda, MD 20892-7610 Rockville, MD 20852 Telephone: (301) 496-7075 Email: lsl5k@nih.gov Schedule Letter of Intent Receipt Date: April 7, 1995 Application Receipt Date: July 18, 1995 Scientific Review Date: November 1995 Advisory Council Date: January 1996 Earliest Award Date: May 1, 1996 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.855 Immunology, Allergic and Immunological Diseases Research and 93.856 Microbiology and Infectious Diseases Research. Grants are awarded under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under 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. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Mar 06 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 5 March 1995 Date: 6 Mar 1995 17:21:32 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 160 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3jgces$pdh@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Letter Title: LMPS01 - Dear Colleague Letter File size (bytes): STIS Filename: lmps01.txt Document Type: Press Release Title: DIAL-A-SCIENTIST STUDYING EL NINO File size (bytes): STIS Filename: pr9514.txt Title: NSF-FUNDED RESEARCH WILL HELP NATURAL GAS INDUSTRY File size (bytes): STIS Filename: pr9515.txt Title: COMPUTATIONAL SCIENCE HIGHLIGHTS AVAIBABLE ON WORLD WIDE WEB File size (bytes): STIS Filename: pr9516.txt Document Type: Program Guideline Title: NSF 95-37 - Multi-User Biological Equipment and Instrumentation Resources Instrument Development for Biological Research File size (bytes): STIS Filename: nsf9537.txt Title: NSF 5-40 Program Description for Bioengineering and Environmental Systems File size (bytes): 27276 STIS Filename: nsf9540.txt Title: NSF 95-44 An Opportunity in the Environment and Global Change Research Initiative File size (bytes): STIS Filename: nsf9544.txt Title: NSF 95-44 An Opportunity in the Environment and Global Change Research Initiative File size (bytes): STIS Filename: nsf9544.txt Title: NSF 95-45 The National Science Foundation Global Change Research Program a component of the U.S. Global Change Research Program File size (bytes): STIS Filename: nsf9545.txt Title: NSF 95-47 NSF/DOE/NASA/USDA JOINT PROGRAM ON TERRESTRIAL ECOLOGY AND GLOBAL CHANGE File size (bytes): STIS Filename: nsf9547.txt Title: NSF 95-49 -- ENVIRONMENTAL GEOCHEMISTRY AND BIOGEOCHEMISTRY Research at the Interfaces of Geochemistry, Hydrology, Coastal Sciences, Chemistry, Microbial and Molecular Biology, Colloid and Transport Engineering, and Mathematics File size (bytes): STIS Filename: nsf9549.txt Title: NSF 95-52 -- CIVIL INFRASTRUCTURE SYSTEMS File size (bytes): STIS Filename: nsf9552.txt Title: NSF 95-54 -- NATIONAL CONSORTIUM FOR RESEARCH ON VIOLENCE File size (bytes): STIS Filename: nsf9554.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 10955 STIS Filename: cmmtg.txt Document Type: Phone Book Title: NSF Alpha Telephone File size (bytes): 97256 STIS Filename: phnalpha.txt Title: NSF Alpha Telephone File size (bytes): 97256 STIS Filename: phnalpha.txt Title: NSF Organizational Directory File size (bytes): 98642 STIS Filename: phnorg.txt Title: NSF Organizational Directory File size (bytes): 98642 STIS Filename: phnorg.txt Document Type: Program Guideline Title: NSF 5-40 Program Description for Bioengineering and Environmental Systems File size (bytes): 27276 STIS Filename: nsf9540.txt Document Type: Recruit Title: Senior Executive Service Nationwide Vacancy Listing File size (bytes): 31653 STIS Filename: sesvac.txt Title: Student Career Experience Program (SCEP) File size (bytes): 5255 STIS Filename: vgs9566.txt ------------------------------------------------------------------------ ** 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). 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 stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve vgs9566.txt, the text of your message should be as follows: get vgs9566.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve vgs9566.txt, you would enter: ftp> get vgs9566.txt 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 "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Tue Mar 07 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HS-95-003 - V24(09) 03/10/95 Date: 8 Mar 1995 15:07:48 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 966 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3jldc4$q0f@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HS95003 HS-95-003 P1O1 *************************************** CONSUMER ASSESSMENTS OF HEALTH PLANS STUDY NIH Guide, Volume 24, Number 9, March 10, 1995 RFA: HS-95-003 P.T. 34; K.W. 0404021, 0755018, 0730000 Agency for Health Care Policy and Research Letter of Intent Receipt Date: May 20, 1995 Application Receipt Date: June 20, 1995 PURPOSE The Agency for Health Care Policy and Research (AHCPR) invites applications for cooperative agreements to: (1) produce reliable, valid and rigorously tested survey protocols for collecting information from consumers regarding their assessments of health plans and services; (2) develop and test the effectiveness of different formats for conveying resulting information to consumers; (3) demonstrate the resulting survey protocols in real world settings; and (4) evaluate the usefulness of this information in assisting consumers, and purchasers acting on their behalf, in making informed selections of health care plans and services. The long term goal of this project is to strengthen the science base underlying the evolution and the use of consumer surveys within the health care industry. 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, Consumer Assessments of Health Plans Study (CAHPS), is related to the priority areas of access to and use of clinical preventive services, maternal and child health services, and health services related to major disease categories. 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 REQUIREMENTS Applications may be submitted by public and private non-profit private domestic organizations or associations, including universities, units of State and local governments, non-profit firms and foundations; or a consortium of organizations. If the application is submitted by a domestic, non-profit, public or private organization, a consortium may include other types of organizations, such as for-profits. Racial/ethnic minorities, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The administrative and funding instrument will be the cooperative agreement (U18), an "assistance" mechanism in which substantial AHCPR scientific and programmatic involvement with the awardee(s) is anticipated during the performance of the project. The total project period for each application submitted in response to this RFA may not exceed five years. The anticipated award date is September 30, 1995. Funding beyond the initial budget period will depend upon annual progress reviews by AHCPR and the availability of funds. FUNDS AVAILABLE The AHCPR expects to award up to $2 million for two projects not to exceed $1 million in total costs for each project for the first year. The number of awards is dependent on the number of high quality applications responding to this RFA. This is a one time solicitation. RESEARCH OBJECTIVES Background Public and private organizations are surveying consumers to collect information on access to care, use of health services, health outcomes, and patient satisfaction. The results of these surveys are being used by: consumers to inform their choices about health care plans; purchasers to assess the value of the services they buy; and health insurers, quality assurance managers and policy makers, to plan programs and services. Existing tools for obtaining information from health plan enrollees vary on several dimensions: content of the questions; characteristics of intended respondents; and fit to particular health care settings. The extent to which these instruments have been tested and the methods used to accomplish the testing also differ across surveys. Because of these variations, it is unlikely that any single existing instrument will produce accurate and useful assessments from (and for) consumers across different types of plans and health care settings. Potential survey users require responses to a range of critical questions including, but not limited to, the following: Are existing instruments capable of producing reliable and valid assessments of consumer evaluations of health care services? Do they include the full range of topics important to consumers? Can they be used to obtain information from the full range of audiences of interest, including high users of health care services; people insured under managed care as well as fee-for service plans; consumers with poor literacy skills; plan disenrollees; participants in publicly subsidized programs; and relatively healthy middle-class health care consumers? Even if reliability and validity can be demonstrated, will potential users, particularly inexperienced ones, know how to conduct a valid survey? Will different users collect data in a manner that allows valid comparison across a variety of health plans? And most importantly, if these efforts can be accomplished, will they yield the expected pay-off; that is, the production of accurate, understandable information that enables consumers and purchasers acting on their behalf to identify and select appropriate, high-quality health care coverage? In September 1994, AHCPR co-sponsored a conference with the Robert Wood Johnson (RWJ) Foundation, "Consumer Survey Information in a Reformed Health Care System." Conference papers and discussions identified no single instrument that could be used across a wide variety of consumer groups and within multiple service settings to obtain assessments of health plans and services. Some of these surveys are effective, though, for a specific purpose, population or service. Thus, these various instruments offer the possibility of constructing "question modules" -- sets of questions drawn from a variety of sources and relating to diverse concepts, consumers and delivery settings -- to use as the basis for activities to be performed under this agreement. The AHCPR is currently supporting a project with that goal: to construct question modules from existing survey instruments. This Survey Design Project, through contract to the Research Triangle Institute, is developing modules of consumer survey questions. These modules ask about the experiences of consumers regarding access to care, use of specific health services, health outcomes, and satisfaction with the care received. The goal of the project is to produce modules that are adaptable to a variety of health care settings. The Survey Design Project began with an extensive search for question modules and items. This search was guided by recent published and unpublished studies on consumer information needs. The contractor then developed an Adult Health Care Survey and began developing modules and items related to other areas of interest. Although validity and reliability studies were not within the scope of work, items in the modules were subjected to rigorous cognitive testing to ensure appropriate interpretation by respondents. Items in the modules were then revised as necessary to be understandable to consumers who receive care through different benefits arrangements (e.g., fee for service as well as managed care plans). Finally, this project's methods and products were reviewed by as many interested parties as could be identified. This review included two public meetings, one held at the beginning of the contract and one at the end. Draft modules and materials were circulated for comments to over 100 researchers, consumers and potential users. The project was also informed by a technical panel of researchers and representatives of health insurance organizations, managed care organizations, clinical associations and other groups. Because AHCPR wishes to provide rapid access to products from the Survey Design Project and to products resulting from CAHPS, we plan to disseminate both through the AHCPR User Group Initiative. This effort is being developed to respond to requests from potential users who wish to begin using consumer question modules as early as possible, even before the completion of the systematic demonstration called for in this RFA. Points at which grantees are expected to coordinate activities with the User Group Initiative are noted under RESEARCH OBJECTIVES, Study Design. The results of the Survey Design Project, including limited technical and operational instructions, will be placed in the public domain no later than March 30, 1995. The results of the Survey Design Project, the AHCPR/RWJ conference and other relevant efforts are being made available to potential applicants and others (see INQUIRIES). Objectives and Scope The objectives of this RFA are to: (1) produce reliable, valid and rigorously tested survey protocols for collecting information from consumers regarding their assessments of health plans and services; (2) develop and test the effectiveness of different formats for conveying resulting information to consumers; (3) demonstrate the resulting survey protocols in real world settings; and (4) evaluate the usefulness of this information in assisting consumers, and purchasers acting on their behalf, in making informed selections of health care plans and services. To save time and resources, applicants should select the best existing set of questions currently in the public domain and use it to accomplish objectives 1 and 2. For purposes of this RFA, the "best existing set of questions" is that which most successfully addresses the following questions and concerns: 1. Who are the critical consumers from whom to collect assessments of health care plans and services? Successful applicants will develop and test a core question module designed to obtain a basic assessment of plan features and services from relatively healthy, adult, middle-level socioeconomic status (SES) Americans who receive care through the predominant types of benefits plans and delivery settings (e.g., indemnity plans, managed care plans, etc). Grantees should develop and test additional modules, as time and budget permit, to obtain assessment data from some of the following types of consumers: a. Parents of young children, especially those of low SES, b. Racial and ethnic minorities, c. Participants in publicly subsidized health programs, such as Medicaid or State health programs, d. High users of health care services, such as the chronically ill, those suffering severe acute episodes of illness, and persons with disabilities, e. Persons living in rural areas, f. Persons with poor literacy skills, and g. Disenrollees from health plans. For which of these potentially important consumer groups should question modules be developed? After the core module is completed, what should be the sequence of module development? What rationale supports this prioritization? Applicants should address these questions as part of their application. If applicants discover that items or question modules for use with a consumer group perceived as high- priority do not exist, they should propose development of those modules as part of this project. 2. What information on access and quality do consumers want and need to assist in selecting health care plans and services? How do information needs vary by type of audience? Although a large-scale, fully developed needs assessment covering the entire range of topics and consumers may not exist, a number of qualitative (e.g., focus group studies by AHCPR and the National Committee on Quality Assurance in 1994) and quantitative (e.g., a survey by Consumers Union 1995) studies conducted recently provide information related to this question. If an applicant discovers an access or quality-related information need for which items/questions modules do not exist, the applicant may propose development of those modules as part of this project. 3. Through what types of benefits arrangements and delivery settings are the consumer groups of interest likely to receive services? Consumers may conceivably obtain health care services through fee for service plans, diverse types of managed care plans, public assistance programs or other types of benefits arrangements. These benefits may be offered through public or private employers, purchasing cooperatives, multi-state health plans, or public health clinics. This diversity of benefits and settings means that items, or the wording of items, from any given set of questions may not be appropriate for all consumers in all situations. In selecting their core questions module, applicants should consider that the overall goal of CAHPS is to produce modules (especially a core module) that will allow comparability across the greatest possible range of plans and benefits arrangements. Since it is unlikely that any existing module was designed with application to multiple settings in mind, applicants should discuss in their application the extent to which their selected module will require post-award testing to meet this goal. 4. What evidence exists to ensure that consumers interpret proposed survey items as the developers intended? As mentioned under RESEARCH OBJECTIVES, Background, a variety of instruments exist with which to obtain consumer perceptions about health care services. A limitation of some of these instruments is their lack of cognitive testing of survey items with members of the target audience. In selecting question modules for use in this RFA, applicants should obtain information about the extent to which item interpretation was tested and the methods used to accomplish this. Because the AHCPR wishes to build on existing work to the greatest extent possible and to accomplish objectives 1 and 2 rapidly, it is recommended that the results of the Survey Design Project form the basis for activities to be performed under this agreement. The modules developed in the Survey Design Project, to AHCPR's awareness, best satisfy the concerns discussed above. Although use of the modules from the Survey Design Project is recommended, itis anticipated that applicants may make revisions, additions, or other alterations to them. Changes or alternatives to the modules are acceptable and appropriate to the extent that they address the concerns discussed above. In any case, each applicant must: (a) specify instruments or question modules and (b) discuss their suitability for accomplishment of study objectives. Applicants' responses to the four preceding questions should form the basis for Phase 1 of this project as described in the next section. Study design Grantees will need to accomplish a number of objectives in two phases, a project planning phase (Phase 1) and a demonstration and evaluation phase (Phase 2). During both phases, grantees will collaborate with the AHCPR project officer (and the advisory committee, when appropriate) to define and respond to key questions and issues that will guide the development of CAHPS products. Grantees are expected to prepare interim reports and a final report that summarizes all Phase 1 and 2 activities. Elements of these reports will be determined jointly by the grantees and AHCPR. Phase 1: Project planning The major goals of Phase 1 include: (a) development and initial implementation of a project work plan, (b) production of survey protocols suitable for use in real-world settings, (c) development and testing of report formats for survey information, (d) development and initial implementation of a process and outcome evaluation plan, and (e) recruitment of demonstration sites and development of a demonstration time table. Phase 1 is expected to be completed within 15 months of the award date. Applicants should provide information that demonstrates their ability to accomplish the activities listed below. Applicants may include in appendices descriptions of prior projects that demonstrate their experience in performance of similar activities. 1. Develop a work plan. This should include specification of project activities, linked to a listing of products and a time table for their execution or development. 2. Propose advisory committee (see SPECIAL REQUIREMENTS). Applicants should discuss proposed composition of the advisory committee (i.e., types of expertise required) and ways in which the advisory committee may be used most effectively during the course of the project. 3. Characterize focal consumer populations. Applicants will have laid the groundwork for this step as part of their application. In Phase 1, grantees and AHCPR (with input from the advisory committee) should complete specification of focal consumer groups, as well as determine their quality-related information needs. As they make these decisions, the project team should keep in mind that products resulting from CAHPS must be appropriate for use in a variety of settings as discussed in RESEARCH OBJECTIVES, Objectives and Scope, number 1. 4. Refine the question modules. Applicants will have selected existing modules and identified items/modules that need to be developed as part of the application. As the grantees develop new items and modules, they should make critical decisions jointly with AHCPR and with input from the advisory committee. 5. Perform all activities related to production of survey protocols that are ready for use in real world settings. This includes: testing the validity and reliability of question modules for each consumer group of interest; performing cognitive testing, as necessary, to ensure that respondents will interpret items as intended; resolving all issues related to sampling strategies; preparing alternative versions of survey instruments for administration by telephone or mail; developing and implementing plans for data analysis and processing, and other issues. As part of the application, applicants should identify criteria for site selection for Phase 1 reliability, validity and cognitive testing and obtain letters of commitment from actual sites. Because the user demand for rigorously tested survey modules is great, grantees are expected to perform reliability, validity and cognitive testing on a module-by-module schedule, with priority given to modules that have the widest applicability. As each module is tested and revised, it will be released to the public through the AHCPR User Group Initiative. Though many important activities need to be accomplished within the 15 month Phase 1 time frame, grantees should sequence activities so that the testing of questionnaire modules occurs as early as possible. 6. Coordinate activities as appropriate with AHCPR User Group Initiative. The purposes of the User Group Initiative are to disseminate modules and segments of the user manual as they are completed, track efforts at implementing the modules at sites other than those included in this cooperative agreement, and provide technical assistance to these users. 7. Develop/revise user manual. The user manual should provide thorough, comprehensive documentation to guide users, whether unsophisticated or highly experienced, through all activities associated with survey administration, including mail and telephone administration. 8. Develop and test sample reporting formats. Many different types of consumers will ultimately use reports based on data collected through these instruments. To be optimally useful to consumers, characteristics of the data-based reports should be tailored to fit characteristics of the intended user. On the other hand, some potential survey administrators will not have the resources required to develop reports specifically tailored to consumer subgroups. These users will need to know how to select appropriate formats from a stock of sample reports and how to design and test their own materials for a heterogeneous group of users. 9. Develop a process and outcome evaluation plan. One of the grantee's most important responsibilities under this agreement will be the development of a comprehensive plan to evaluate CAHPS products, procedures, and outcomes. This involves at least three components: (a) developing and implementing a plan for the evaluation of report formats; (b) developing and implementing a plan for the process evaluation of CAHPS procedures (e.g., the usefulness of the operations manual to staff at demonstration sites); and (c) developing and implementing a plan for the evaluation of the effectiveness of data-based reports to consumers. Though all of the evaluation planning must occur in Phase 1, the only evaluation data expected to be collected in Phase 1 is that related to step "a." Applications should demonstrate the applicant's ability to: o Specify appropriate evaluation questions, identify appropriate outcome measures and appropriate respondents for each question, and specify times at which these questions should be asked. o Develop an appropriate evaluation design. The design should: (a) eliminate as many threats to validity as possible; and (b) result in a clear demonstration of usefulness of the data-based reports in assisting consumer decision-making in an open enrollment situation, as well as identification of factors related to product effectiveness or ineffectiveness. o Identify and use appropriate qualitative and quantitative data collection instruments. o Analyze data appropriately. Applicants should pay particular attention to strategies for analysis of qualitative data, as well as the issue of conveying information from quantitative evaluation analyses in a manner that is understandable by and useful to personnel at sites implementing the survey protocols. o Develop recommendations based on evaluation data that can be used to modify CAHPS projects or procedures. One component of the CAHPS evaluation plan should be the development of clearly written, user-friendly recommendations designed to promote data-based changes to products and procedures. 10. Recruit sites and develop a time table for Phase 2 demonstrations. o Identify selection criteria for and propose demonstration sites. AHCPR is interested in a range of diverse demonstration sites as discussed above in RESEARCH OBJECTIVES, Objectives and Scope, numbers 1 and 3. Applicants are not required to include all of those types of settings in their applications, but should provide examples of the types of settings they intend to include, a rationale for their choice, and evidence of recent experience in undertaking large-scale, multi-site demonstrations. If necessary, AHCPR will work with the awardee to identify appropriate organizations. Final selection of sites will take place in consultation with the AHCPR Project Officer. o Identify key personnel from each potential site and specify their roles. Also, as sites are selected, grantees will need to identify appropriate demonstration site staff to be added to the advisory committee (e.g., the lead contact at each site, consumer representatives, etc.). o Building on the work plan discussed above, develop a demonstration time table. This document should contain all the information sites will need to know in order to commit themselves to the demonstration. Phase 2: Demonstration and evaluation The goals of Phase 2 are to: (a) work with demonstration sites to implement the tested survey protocols; (b) assess the effectiveness of data obtained through these surveys in assisting consumers with their health plan selections; (c) continue implementation of the process and outcome evaluation; and (d) revise CAHPS products and procedures based on evaluation data. Applicants should provide information which illustrates their ability to plan and implement large-scale, multi-site demonstrations, including their ability to accomplish the following activities. 11. Develop a demonstration management plan. After each site commits to the demonstration, the grantee should develop an overall management plan which will serve as the master plan to guide all demonstration activities. The groundwork for this plan will have been laid by development of demonstration time tables discussed at the end of Phase 1 activities. The management plan should clearly specify both grantee and site personnel roles and responsibilities and should include a time table listing key decisions related to and dates for all demonstration components. 12. Assist sites in all phases of demonstration activity as specified in the management plan, including: selecting appropriate survey modules; collecting data; using the operations manual; developing, testing, and disseminating reports in formats appropriate for the audiences of interest; and other activities. 13. Coordinate activity among all demonstration sites and work with the AHCPR User Group Initiative. 14. Collect process and outcome evaluation data at all appropriate points. The grantee should analyze evaluation data and produce reports which include recommended revisions to CAHPS products and procedures. 15. Revise products and procedures based on data-based recommendations. Before making these revisions, the grantee should consult with AHCPR and obtain input from the advisory committee. Timetable Phase 1 of CAHPS should be completed 15 months from the date of award. The entire project may take four to five years. SPECIAL REQUIREMENTS To promote the development of this multi-site collaborative project, a number of additional issues must be addressed in applications responding to this RFA, as discussed below. Budget Applicants must develop a timeline for project activities, including percentage of effort for key staff for all years, as part of the budget justification. Project Organization Applicants, or principal members of the consortium qualified to participate in this agreement, must have experience in: field survey operations; testing and improvement of survey instruments; management of multiple collaborators; program planning and evaluation; and development and evaluation of health-related materials for consumer audiences. If a consortium of institutions responds to this RFA, the application must describe a practical structure for consortium decision-making and governance, and the mechanisms designed to ensure that effective collaboration will occur among sites. Unanticipated disagreements about methods, resource allocation, standardization, authorship, etc., may arise during the course of any project. The consortium must be able to make unified decisions on the merits of these issues, without dissolving or routinely relying upon outside arbitration. Confidentiality of Data Information obtained in the course of this study that identifies an individual or entity must be treated as confidential in accordance with section 903(c) of the Public Health Service Act. Applicants must describe in the Human Subjects section number 5 procedures for ensuring the confidentiality of information. This should include a discussion of who will be permitted access to the information, both the raw data and machine readable files, and how personal identifiers will be safeguarded. Terms and Conditions of Award This cooperative agreement anticipates substantial AHCPR scientific and programmatic involvement with the awardees throughout the planning, implementation, and close-out of CAHPS. 1. Awardee Responsibilities The awardee will have primary and lead responsibility for all activities including: o Formation of the advisory committee, including convening meetings and documenting activities, with committee membership approved by the AHCPR project officer; o Development and implementation of a comprehensive process and outcome evaluation design; o Selection, in collaboration with the AHCPR project officer, of items or question modules from the consumer survey instrument that will be tested; o Identification and implementation of techniques to test the modules for reliability, validity, consistency in interpretation, and comparability across different sites/subpopulations; o Development and implementation of a module-by-module testing schedule; o Identification and recruitment of Phase 1 testing sites for reliability, validity, etc. Applicants should submit letters of commitment with the application; o Identification of characteristics of appropriate Phase 2 demonstration sites and selection, in collaboration with the project officer, of actual sites possessing these characteristics; o Development of sample selection strategy and identification of potential associated methodological issues; o Identification of methodological issues associated with administration of the survey to the subpopulations and sites of interest; o Identification of potential confidentiality concerns of test sites and individual respondents and a strategy for implementing safeguards that address these concerns; o Identification of methodological issues associated with mode of administration of the questionnaire; o Identification and implementation of procedures that enhance response rates; o Development and implementation, with project officer approval, of an appropriate data coding, preparation and analysis plan; o Development and documentation of strategies to address all outlined methodological issues; o Development, testing and revision of a comprehensive survey operations, or "user", manual suitable for use by organizations with minimal as well as extensive experience in fielding large-scale, multi-site surveys; o Provision of training and technical assistance to all Phase 2 demonstration sites; o Preparation and testing, in collaboration with project officer, of understandable, usable reports that summarize survey results and which are tailored to the subpopulations of interest; o Preparation of agreed-upon interim and final reports, including a summary report to inform AHCPR of any difficulties encountered in the course of planning, implementing and evaluating the surveys; o Provision of AHCPR access to all data generated under this award as it is collected; and o Cooperation with other key parties in this project, particularly the AHCPR User Group; other CAHPS grantees; and other complementary projects. 2. AHCPR Staff Responsibilities The AHCPR Project Officer and other AHCPR staff will have substantial scientific and programmatic involvement during the conduct of this activity, through technical assistance, advice, and coordination beyond the usual program stewardship for grants. Collaboration on the development of the testing plan, evaluation design and survey protocol will occur after the award is made. Specifically, AHCPR's role in the cooperative agreement is to provide technical assistance, advice, and support to the PI and to ensure that all related AHCPR-supported projects complement one another. AHCPR will: o Work with the grantee to structure composition of the advisory committee; o Approve composition of advisory committee, management plan and plans for data collection and analysis; o Participate in all key project decisions, including but not limited to: identification of focal consumer groups, assessment of consumer information needs, selection of items/question modules to be tested, identification and resolution of methodological issues; o Work with the grantee to identify and negotiate with Phase 2 demonstration sites, with the AHCPR project officer retaining right of final approval; o Establish collaboration with and obtain project-related information from other Federal agencies and programs; o Disseminate tested question modules and other research findings as they become available; and o Participate in or coordinate strategy sessions with the grantees on at least four occasions in the first year and up to every four months thereafter to review progress; The AHCPR will require prior written approval for the addition or deletion of a participating or collaborating institution, site, or other organizational component. The AHCPR reserves the right to terminate or curtail the study in the event of: o Insufficient progress towards completion of study goals within an agreed-upon time frame; o Inability to identify and recruit demonstration sites that include members of the subpopulations and settings of interest; o Inability to work collaboratively with demonstration sites, the advisory committee, or other necessary organizations; o Inability to successfully address key methodological issues; and o Substantive changes in the agreed-upon protocol with which the AHCPR does not agree. These special Terms of Award are in addition to and not in lieu of otherwise applicable PHS grants policies and Federal regulations. Collaborative Responsibilities As discussed under Phase 1 activities, grantees must establish an Advisory Committee to provide overall policy guidance and technical expertise, and assist in conflict resolution. The membership of the Advisory Committee may include, in addition to the Principal and Co-Investigators, the AHCPR project officer, consumers, methodology experts in the fields of health care consumer survey research, social marketing (with experience in developing health information for consumers), health insurance and other health-related research areas; representatives of public and private groups from Phase 2 demonstration sites, including employers, unions, health plan administrators, and other health insurance providers; and local and national health service providers and institutions. SPECIAL INSTRUCTIONS TO APPLICANTS CONCERNING INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the AHCPR that women and members of minority groups be included in all AHCPR supported research projects involving human subjects, unless clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. A new NIH policy resulting from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) supersedes and strengthens NIH's previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which were in effect since 1990 and which AHCPR had adopted. The new NIH policy contains provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the AHCPR contractor, Global Exchange listed under INQUIRIES. AHCPR staff may also provide information concerning this policy. LETTER OF INTENT Prospective applicants are asked to submit, by May 20, 1995, a letter of intent that includes the name, address, and telephone number of the proposed Principal Investigator and other key personnel; the identities of proposed consortia members, including any other participating organizations or institutions; a descriptive title of the proposed demonstration project; and the number and title of the RFA. Although a letter of intent is not required, is not binding, and does not enter into the consideration of any subsequent application, the information allows AHCPR staff to estimate the potential review workload and avoid conflicts of interest in the review. The letter of intent is to be sent to the CAHPS project officer at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on research grant application form PHS 398 (rev. 9/91). State and local government applicants may use form PHS 5161, Application for Federal Assistance. These forms are available at most institutional offices of sponsored research; the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. For AHCPR, applications are available from Global Exchange Inc., 7910 Woodmont Avenue, Suite 400, Bethesda, MD 20814-3015, telephone (301) 656-3100, Fax (301) 652-5264. 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 on the face page of the application form and the YES box must be marked. Complete information must be submitted with the application. Consortium arrangements typically take the form of a formal agreement between an applicant and other organization(s). In the grant application, a separate budget page and budget justification must be included for each organization involved in the proposed consortium arrangement. Submit a signed, typewritten, original of the application, including the Checklist, and three signed legible copies (two copies when using the PHS 5161) in one package to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express mail or courier) Applications submitted under this RFA must be received by June 20, 1995, by the Division of Research Grants, NIH. If an application is received after that date, it will be returned to the applicant. At the time of submission, two additional copies of the application (one copy when using the PHS 5161) must be sent to the CAHPS project officer at the address under INQUIRIES. Conference for Prospective Applicants The AHCPR plans to convene a conference for prospective applicants on April 5, 1995 in Rockville, Maryland. Attendance is not a prerequisite to applying. Attendees must pay for their own travel and accommodation costs. For further information, contact (301) 594-1357 ext 105. REVIEW CONSIDERATIONS All applications will be judged on the basis of the scientific and technical merit of the proposed project and the documented ability of the investigator to meet the objectives of the RFA. Upon receipt, applications will be reviewed for completeness by the Referral Office, Division of Research Grants, NIH, and by AHCPR staff for responsiveness to the RFA. Incomplete and nonresponsive applications will be returned to applicants without further consideration. The determination of any application as nonresponsive will be the sole responsibility of AHCPR. All accepted applications will undergo peer review for scientific and technical merit by a special review group convened by the AHCPR. Review criteria for AHCPR grant applications are: significance and originality from a scientific and technical viewpoint; adequacy of the method; availability of data or proposed plan to collect data required for the project; qualifications and experience of the Principal Investigator and proposed staff; adequacy of the plan for organizing and carrying out the project; reasonableness of the proposed budget; and adequacy of the facilities and resources available to the applicant. Although the technical merit of the proposed protocol is important, it is not the sole criterion for selection of the awardee(s). Applications may undergo triage by the peer review group on the basis of relative scientific and technical competitiveness. The AHCPR will withdraw from further consideration those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. When an application is reviewed, the peer review committee may recommend further consideration or no further consideration. The committee also assigns priority scores to the applications for which further consideration is recommended. Recommendations of the peer review committee may be reviewed subsequently by AHCPR's National Advisory Council for Health Care Policy, Research, and Evaluation. The peer review process is rigorous, and only those applications judged to be of greatest merit will be recommended for further consideration. Special Review Criteria In addition to the review criteria noted above, the review committee will evaluate each application in response to this RFA against the following special scientific and technical review criteria: 1. Understanding of issues related to completing the activities outlined in OBJECTIVES AND SCOPE and STUDY DESIGN. 2. Understanding of all issues related to the measurement of consumer assessments of health care plans and services. 3. Understanding of the needs of various audiences who may use health care information (e.g., consumers, purchasers, plans, providers, payers, State and local-level health care organizations) and the ways in which they may use this information (selection of plans and providers; comparison of plan/provider performance; identification of local or multi-site quality problems). 4. Demonstrated experience in the performance of all aspects of fielding a large-scale, multi-site survey, including but not limited to: formulation of a methodologically sound design; performance of validity and reliability studies on large-scale survey instruments; identification and resolution of methodological issues associated with sample selection and sample size, and with administration of surveys to the subpopulations of interest and within a variety of health care delivery settings; identification and resolution of methodological issues associated with mode of administration. 5. Demonstrated ability to produce detailed survey operations manuals suitable for use by groups with minimal as well as extensive experience in fielding large-scale, multi-site surveys. 6. Demonstrated ability to cooperate with, provide technical assistance or training to, and/or monitor the progress of potential collaborating organizations or test sites; particularly, other groups such as consortium members, subgrantees, subcontractors, community-based organizations, data supplying organizations, respondents, and site representatives. 7. Demonstrated ability to collaborate with government agencies in the performance of research studies and demonstrations. 8. Demonstrated ability to develop and test attractive, understandable, usable health-related materials for a variety of consumers. 9. Demonstrated ability to design and implement process and outcome evaluations, including: specification of evaluation questions and outcome measures; use of quantitative and qualitative data collection methods; data analysis; development of data-based recommendations and use of the recommendations to improve products and procedures. AWARD CRITERIA Applications will compete for available funds with all other applications for this RFA. The following will be considered in making funding decisions: quality of the proposed project as determined by scientific and technical merit; program balance, including the likelihood of successful collaboration based upon sufficient compatibility of features; and availability of funds. The earliest anticipated date of award is September 30, 1995. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. Copies of this RFA and background documents are available from: Global Exchange Inc. 7910 Woodmont Avenue, Suite 400 Bethesda, MD 20814-3015 Telephone: (301) 656-3100 FAX: (301) 652-5264 Copies of the RFA without background materials can also be requested by e-mail at cahpsrfa@PO3.AHCPR.GOV, the NIH GOPHER (gopher.nih.gov), and AHCPR InstantFAX at (301) 594-2800, AHCPR Pub. No. 95-0044. To use InstantFAX, you must call from a fax machine with a telephone handset. Use the key pad on the receiver when responding to prompts >From InstantFAX. The RFA will be sent at the end of the ordering process. AHCPR InstantFAX operates 24 hours a day, 7 days a week. For questions about this service, call AHCPR's Division of Communications at (301) 594-1364 ext. 159. Direct inquiries regarding programmatic issues, including information on the policy of inclusion of women and minorities in study populations, to: Christine Crofton, Ph.D. CAHPS Project Officer Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 603 Rockville, MD 20852-4908 Telephone: (301) 594-1357 ext 105 Direct inquiries regarding fiscal matters to: Mr. Ralph L. Sloat Grants Management Officer, Office of Management Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 601 Rockville, MD 20852-4908 Telephone: (301) 594-1447 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.226. Awards are made under authorization of the Public Health Service Act, Title IX (42 U.S.C. 299-299c-6). Awards are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the phs mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Tue Mar 07 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HS-95-004 - V24(09) 03/10/95 Date: 8 Mar 1995 15:07:19 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 453 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3jldb7$pv6@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HS95004 HS-95-004 P1O1 *************************************** HEALTH SERVICES RESEARCH ON ADVANCE DIRECTIVES NIH Guide, Volume 24, Number 9, March 10, 1995 RFA: HS-95-004 P.T. 34; K.W. 0730021, 0730052 Agency for Health Care Policy and Research Letter of Intent Receipt Date: May 15, 1995 Application Receipt Date: June 20, 1995 PURPOSE The Agency for Health Care Policy and Research (AHCPR) is soliciting applications for research on advance directives. Research applications are invited for establishing and evaluating a pilot study of the effectiveness of a community focused, home-based approach to completion of advance medical care directives by individuals. 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. AHCPR urges applicants to submit grant applications with relevance to the specific objectives of this initiative. 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 REQUIREMENTS Applications may be submitted by domestic and foreign non-profit organizations, public and private, including universities, clinics, units of State and local governments, non-profit firms, and non-profit foundations. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This request for applications will use the research project grant (R01) mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. This is a one-time solicitation. The total requested project period may not exceed two years. FUNDS AVAILABLE The AHCPR expects to make one award of up to $700,000 (total cost) over a two-year period to meet the objectives of this RFA. Funding for the first year will not exceed $350,000 total cost. This is a one time solicitation, with the first year of funding to be awarded in Fiscal Year 1995. No award will be made if, as a result of the scientific and technical review, none of the applications is judged to be of high merit. Continuation of the grant for the second year will depend on evaluation of a one-year progress review by AHCPR, and the availability of funds. RESEARCH OBJECTIVES Definition and Significance An advance directive is a means of recording a person's preferences regarding future health care decisions while the person is fully competent. Such recorded preferences may be used to guide the actual decisions that are made at a later time, should the person become incompetent. Advance directives commonly take one of two forms. A living will records the person's health care preferences in the event he or she has a terminal illness. The other form, the durable power of attorney for health care, sometimes called "medical power of attorney," or "health care proxy," records the individual chosen by the person to make decisions on his/her behalf if necessary. Thus, one form of advance directive focuses on what health care will be chosen, while the other focuses upon who is most trusted by the patient to do the choosing. These goals are not mutually exclusive and combined forms of advance directives are increasingly common. Advance directives are designed to accomplish a number of functions. They protect an individual's right to choose or to refuse various forms of health care, even in the face of the development of decisional incapacity. They provide additional assurance that the care provided for an incompetent patient will actually match that patient's personal values. They transfer a critical health-care decision point from the time of a patient's decisional incapacity to an earlier time when the person is fully competent. Historical Background In the decade of the 1960s, medicine introduced a number of technologies capable of prolonging life in critically ill patients, including cardiopulmonary resuscitation, mechanical ventilation, and renal dialysis. For a time, the excitement over the initial success of these treatments displaced concerns about the negative impact of such technologies upon patient autonomy, or about the balancing of the value of life's quality with its quantity. In concert with these technological advances, the field of biomedical ethics expanded greatly between 1970 and 1985. Early biomedical ethics discussions focused upon the value of patient autonomy, and the right of the competent patient to choose or to refuse various forms of medical care, including life-prolonging therapy. Around 1970, the earliest form of "living will" was introduced. The importance of respect for informed consent as a guiding ethical principle was firmly entrenched by the time the President's Commission for the Study of Ethical and Legal Problems in Medicine and Biomedical and Behavioral Research issued its 1983 influential report, Deciding to Forego Life-Sustaining Treatment (U.S. Government Printing Office, Washington, DC Stock number: 040-000-00470-0). That report encouraged the use of advance directives and popularized use of the generic term. Concern about use of life-sustaining technologies was outlined in two Office of Technology Assessment reports (U.S. Congress, Office of Technology Assessment: Life-Sustaining Technologies and the Elderly, OTA-BA-306, Washington, DC, U.S. Government Printing Office (GPO), July 1987; and, Institutional Protocols for Decisions about Life-Sustaining Treatments--Special Report, OTA-BA-389, Washington, DC, GPO, July 1988). More recently, the value of advance directives has been generally assumed, and attention has been devoted to refining and improving the various forms or documents which can be used to record patient preferences. At the same time, empirical research has been conducted, and many more data are available about the prevalence and effectiveness of advance directives. AHCPR has funded much of the empirical research on this question, having 10 projects currently underway and 7 projects completed. Research has been conducted in hospitals, nursing homes, physicians' offices, and the community. The Patient Self-Determination Act In 1990, Congress, prompted by concerns similar to those expressed by the President's Commission report of 1983, and by the low rates of execution of directives among the population, passed the Patient Self-Determination Act. This law directs that all patients admitted to Medicare and Medicaid certified providers, including hospitals, nursing facilities, hospices, home health agencies, and pre-paid health plans must receive some form of counselling regarding their right to refuse medical treatment and their right to complete an advance directive under the laws of their State. Patients must be asked whether they already have an advance directive, and if they do, the directive must be made part of the medical record in a manner that assures easy retrieval in a later emergency. Institutions are also required to perform some type of public outreach and education around advance directives. Some have argued that passage of this law solved the advance directive "problem" and that further research is not needed to guide policy. However, the law does not mandate discussion of advance directives in most outpatient, primary care settings, where many experts feel that these discussions would optimally occur. Given the disappointing advance directive completion rates in studies where experienced primary care providers spent a good deal of time educating and counselling patients, it is reasonable to question whether the often perfunctory methods many hospitals have used to comply with the law, such as having the admitting clerk hand the patient a brochure, could possibly have any beneficial effect. Additionally, many providers have interpreted the Patient Self-Determination Act as if it were focused solely on do-not-resuscitate (DNR) orders. This points out the problem, that while an individual's plans may be for a broad scope and level of care at the end of his or her life, these plans may be reduced to the very narrow question of whether the patient is a "DNR" or "full code." Decisions may be made as if cardiopulmonary resuscitation were the only decision that matters, or cardiopulmonary arrest is the only medical contingency for which advance planning is desirable. Also, many practitioners do not discuss advance directives with their patients even though their patients may be willing to do so (Loewy EH, Carslon RW. Archives Internal Medicine 1994; 154:2265-7). While the Patient Self-Determination Act may have changed the practice environment in a positive direction, the need for research in advance directives persists. This was recognized by the Senate Appropriations Committee which directed AHCPR to support a study in this area (S.103-318). Future Research Needs A conference was held in September 1993, supported by AHCPR, the Greenwall Foundation, The Kornfeld Foundation, and the Walter and Elsie Haas Fund. The purpose of the conference was to assess the current state-of-knowledge about decision-making for incapacitated adults, giving special attention to the role of advance directives and aiming to establish priorities for further theoretical and empirical research in this area. This invitational working conference assembled 36 leading investigators to make recommendations on the priorities for both theoretical and empirical research in the wake of the Patient Self-Determination Act. Conference participants reached consensus that future research on advance directives should focus on a broad process of communication that participants called "advance care planning." The consensus statement derived from this conference was published in a Special Supplement to the Hastings Center Report (November-December 1994 issue) entitled "Advance Care Planning: Priorities for Ethical and Empirical Research." Potential applicants under this RFA are encouraged to read this report. It is available from the National Technical Information Service (NTIS) order number PB95-147740. A limited number of copies are available >From program staff listed under INQUIRIES. Specific Goals of this RFA Research under this RFA should address the issue of the low percentage of the general public who have completed an advance medical directive. Specifically, this RFA calls for a pilot project to assess the effectiveness of a community focused, home-based approach to encouraging the completion of advance medical directives, including bona fide advance directives documentation. The pilot project should be initiated in four geographic and ethnically diverse locations. It is desirable that the research should evaluate the validity of advance directives executed in this setting. Validity includes the concepts of accuracy and of stability. Accuracy in this context is the issue of how well the advance directive explains or is consistent with the person's true desires. Stability refers to how long the advance directive actually represents the person's desires. The research should address differences in motivational and procedural barriers to completing an appropriate living will or health care power of attorney. SPECIAL REQUIREMENTS 1. The AHCPR does not endorse, recommend or specify which or what particular documentation is to be used. However, it is expected that the applicant will specify and justify the advance directive documentation to be used with respect to validity, reliability, and stability of patient preferences for life sustaining treatment. 2. This pilot project should be administered by an organization with a demonstrated record of education achievements in adult learning and community involvement. The organization should affiliate with an academic institution experienced in this area. The research design must be rigorous. 3. The applicant's literature review should demonstrate evidence of substantive understanding of advance directives research supported by AHCPR as to avoid duplication and to enhance utilization of prior research. Applicants may obtain a listing of AHCPR supported projects from program staff listed under INQUIRIES. 4. The proposed research design should be sensitive to the consensus statement on behalf of the September 1993 conference participants that appears in the Special Supplement (pp S32-36) to that statement, noted above. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of AHCPR that women and members of minority groups must be included in all AHCPR supported health services research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. A new NIH policy resulting from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) supersedes and strengthens NIH's previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which were in effect since 1990 and which AHCPR had adopted. The new NIH policy contains some provisions that are substantially different from the 1990 policies. AHCPR plans to publish guidelines specific to AHCPR. In the interim, AHCPR will follow the NIH guidelines, as applicable. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of this policy from the AHCPR program staff listed under INQUIRIES. AHCPR program staff may also provide additional relevant information concerning this policy. LETTER OF INTENT Prospective applicants are asked to submit, by May 15, 1995, a letter of intent that includes a descriptive title of the proposed research; the name, address, and telephone number of the Principal Investigator, co-investigators and other key personnel; the applicant institution and other participating organizations or 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 consideration of any subsequent application, the information allows AHCPR staff to estimate the potential review workload and avoid conflicts of interest in the review. The letter of intent should be sent to: Julius Pellegrino Agency for Health Care Policy And Research 2101 East Jefferson Street, EOC/Suite 502 Rockville, MD 20852-4908 APPLICATION PROCEDURES Applications are to be submitted on research grant application form PHS 398 (rev. 9/91). State and local government agencies may use form PHS 5161 and follow those requirements for copy submission. These forms are available at most institutional offices of sponsored research; and the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892. Applications for AHCPR support are also available from Global Exchange Inc., 7910 Woodmont Avenue, Suite 400, Bethesda, MD 20814-3015, telephone 301-656-3100 (FAX 301-652-5264). The RFA label available in the form PHS 398 (rev. 9/91) must be affixed to the bottom of the face page of the original 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, type "RFA HS-95-004" in Section 2a on the face page of the application form and mark the "YES" box. 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 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express mail) At the time of submission, two additional copies of the application must be sent to: Julius Pellegrino Agency For Health Care Policy And Research 2101 East Jefferson Street, EOC/Suite 502 Rockville, MD 20852-4908 Applications submitted under this RFA must be received in the Division of Research Grants, NIH, by June 20, 1995. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the Referral Office, Division of Research Grants, NIH, for completeness, and by AHCPR staff for responsiveness to the RFA. Incomplete applications will be returned to the applicant without further consideration. Nonresponsive applications will be transferred to a standing AHCPR or other appropriate scientific review group convened by the AHCPR for review through routine mechanisms. The determination of any application as nonresponsive will be the sole responsibility of AHCPR. Applications may undergo advance review by the peer review group on the basis of relative scientific and technical competitiveness. The AHCPR will withdraw from further consideration those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. When an application is reviewed, the peer review committee may recommend further consideration or no further consideration. The committee also assigns priority scores to the applications for which further consideration is recommended. Recommendations of the peer review committee may be reviewed subsequently by AHCPR's National Advisory Council for Health Care Policy, Research, and Evaluation. The peer review process is rigorous, and only those applications judged to be of greatest merit will be recommended for further consideration. General Review Criteria The general review criteria for AHCPR grant applications are: o significance and originality from a scientific and technical viewpoint; o adequacy of the proposed method(s); o availability of data or proposed plan to collect data required for the project; o adequacy of the plan for organizing and carrying out the project; o qualifications and experience of the Principal Investigator and proposed staff; o reasonableness of the proposed budget; o adequacy of the facilities and resources available to the applicant; and o adequacy of plans to include both genders and minorities and their subgroups, as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of experimental subjects, and the safety of the research environments. Special Review Criteria In addition to the general review criteria noted above, the reviewers will assess applicants' treatment of the SPECIAL REQUIREMENTS of this RFA, i.e. documentation, organization, literature review, and consensus statement. AWARD CRITERIA Applications will compete for available funds with all other applications for this RFA. In making funding decisions, AHCPR will consider: quality of the proposed project as determined by peer review, availability of funds, and program balance. INQUIRIES The AHCPR welcomes the opportunity to clarify any issues or questions >From potential applicants. Direct inquiries regarding program matters to: Julius Pellegrino, Program Staff Agency For Health Care Policy and Research 2101 East Jefferson Street, EOC/Suite 502 Rockville, MD 20852-4908 Telephone: (301) 594-1357 Ext 138 FAX: (301) 594-3721 Email: JPELLEGR@po3.ahcpr.gov Direct inquiries regarding fiscal matters to: Ralph Sloat, Grants Management Officer Agency for Health Care Policy and Research 2101 East Jefferson Street, EOC/Suite 601 Rockville, MD 20852-4908 Telephone: (301) 594-1447 Email: RSloat@po7.ahcpr.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.226. Awards are made under authorization of the Public Health Service Act, Title IX, and are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR Part 67, Subpart A, and 45 CFR Part 74 (45 CFR Part 92 for State and local governments). This program is not subject to the intergovernmental review requirements of Executive Order 12372. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Tue Mar 07 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HG-95-005 - V24(09) 03/10/95 Date: 8 Mar 1995 15:07:33 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 519 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3jldbl$pvi@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HG95005 HG-95-005 P1O1 *************************************** PILOT PROJECTS FOR SEQUENCING OF THE HUMAN GENOME NIH GUIDE, Volume 24, Number 9, March 10, 1995 RFA: HG-95-005 P.T. 34; K.W. 1215018, 0755045 National Center for Human Genome Research Letter of Intent Receipt Date: June 1, 1995 Application Receipt Date: August 4, 1995 PURPOSE The National Center for Human Genome Research (NCHGR) invites applications to develop and implement pilot projects to test strategies that have the potential to lead to full-scale production sequencing of mammalian DNA, resulting in achieving the goal of the complete, accurate, finished sequence of human DNA by the year 2005. 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), Pilot Projects for Sequencing of Human DNA, is related to several priority areas, including cancer, heart disease and stroke, diabetes and chronic disability conditions, maternal and infant health, and others. 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 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 social/ethnic minority individuals, women, and persons with disabilities are encouraged. Applications from foreign institutions will not be accepted. However, subcontracts to foreign institutions are allowable, with sufficient justification. Collaborations and consortia are encouraged. In such collaborations, the respective contributions should be well-integrated into the design of the application to encourage cross-fertilization of ideas and rapid application of the research to practical purposes. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research project grant (R01), pilot project/feasibility study (R21), research program project (P01), exploratory grant (P20), and center grant (P50) mechanisms. The R21 mechanism is used to support highly creative approaches for which substantial preliminary data are not yet available. Each R21 award will be limited to $100,000 direct costs per year for a maximum of two years. The P20 mechanism is used to support groups of outstanding investigators who wish to develop interdisciplinary research programs. P20 awards will be limited to $750,000 direct costs per year for a maximum of three years. R21 and P20 grants are not renewable, but future project continuation is possible through other grant mechanisms such as R01 or P01. Responsibility for the planning, direction and execution of the proposed project 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. The total project period for an application submitted in response to this RFA may not exceed three years (with the exception of the R21 noted above). Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The anticipated award date is April 1, 1996. FUNDS AVAILABLE Given the importance of both further technology improvement for DNA sequencing and the need to gain more experience in large-scale sequencing of human DNA, the NCHGR is implementing a bipartite plan to advance the capability of large-scale sequencing of human DNA and to strike a balance between these two program areas. This RFA represents one part of this plan and solicits applications to initiate pilot projects for large-scale sequencing that will increase the experience in production issues such as improved strategies, substrate preparation, data analysis, and project management and organization. The complementary part of the plan is announced in RFA HG-95-004, "Improved Electrophoretic DNA Sequencing Technology." The scientific goals of these two RFAs are very different but awards applications submitted for either RFA will be funded out of a single set-aside of $20 million. Applicants may respond to both RFA, if desired, but should not address the two RFAs in a single application. The anticipated outcome of the plan is to support a set of applications that will provide the balance needed in the NCHGR program to enhance progress toward attainment of the sequence of the human genome. NCHGR anticipates that projects of widely varying size may be responsive to this RFA and therefore expects to consider for funding projects ranging in cost from $100,000 to several million dollars per year. Only applications found to be of high scientific merit will be considered for funding and all of the funds will not be spent if there are not enough highly meritorious applications. Funding in future years is subject to the availability of funds. RESEARCH OBJECTIVES Background The NCHGR sponsors basic and applied research concerned with the characterization and analysis of the human genome and the genomes of selected model organisms. The activities encompassed by the NCHGR program include genetic and physical mapping, DNA sequencing, informatics related to mapping and sequencing, gene identification and technology development that will facilitate all of these efforts. The NCHGR, in conjunction with the Department of Energy, recently formulated a new five-year plan (Science Vol. 262, pp. 43-46, 1993) in which the goals for DNA sequencing were two-fold: (1) development of new technologies to facilitate DNA sequencing and (2) the production of DNA sequence, primarily that of model organisms. In the past year, there has been significant progress in developing the capability for large-scale DNA sequencing. Several laboratories have generated at least one, and as many as ten, megabases of DNA sequence each. Through this experience, strategic and organizational lessons, such as how to manage large laboratory efforts devoted to rapid data production, have been learned. The capacity of automated sequencing instruments has increased, and newer, higher throughput sequencing instruments are close to a stage at which they could be introduced into a large-scale sequencing environment. However, sequencing technology and sequencing capability must still be improved considerably to achieve the DNA sequencing capability necessary to determine the sequence of the three billion base pairs of human DNA within the time and cost goals for the HGP. The technological progress and project management experience that have already been achieved warrant the initiation of human DNA sequencing at increased scale. Obtaining more experience in larger scale sequencing of human DNA is also necessitated by the recognition that important issues will be encountered in large-scale sequencing of human DNA that will not be addressed in current large-scale projects directed to sequencing non-human DNA. One such issue is the large-scale generation of sequencing substrates, which in most cases will be based on high resolution maps. The current human physical mapping goal calls for maps with STSs every 100 kb, on average. Current DNA sequencing methods require maps of considerably higher resolution but, except for relatively short intervals, such high resolution maps are not available for human DNA. The quantity and type of repetitive sequences present in human DNA, and the sheer size of the genome, will present challenges to map construction. Therefore, large-scale human DNA sequencing requires that strategies to convert low resolution maps to sequencing substrates be developed and tested. However, preparation of high resolution physical maps is not in and of itself, a goal of the NCHGR; for reasons of efficiency and quality control, it is noted in the extended five-year plan, that "preparation of sequence-ready sets of clones should be closely associated with an imminent intent to sequence". A second issue requiring study is the effect of highly conserved, highly repetitive sequences on the assembly of DNA sequence. Large data sets of human DNA sequence will be useful in studying this question. Such data sets will also be useful in developing improved base-calling algorithms. In recognition of the importance of both further technology improvement and the need to gain more experience in large-scale sequencing of human DNA, the NCHGR is implementing a bipartite plan to advance the capability of large-scale sequencing of human DNA and to strike a balance between these two program areas. This RFA represents one part of this plan and solicits applications to initiate pilot projects for large-scale sequencing that will increase the experience in production issues such as improved strategies, substrate preparation, data analysis, project management and organization. The other, complementary part of the plan is announced in RFA HG-95-004, "Improved Electrophoretic DNA Sequencing Technology". Its purpose is to invite applications for research projects to develop novel automated sequencing technology suitable for large-scale genomic sequencing through the reduction in scale and increased parallelization of existing methods that utilize Sanger sequencing reactions coupled with electrophoretic separation of fragments. Objectives and Scope The purpose of this RFA is to solicit applications for pilot projects to increase the capacity of the NCHGR program for the sequencing of human DNA, i.e., to develop realistic paths that have the potential to lead to full-scale production sequencing of human DNA, resulting in achieving the goal of the complete, accurate, finished sequence of human DNA by the year 2005. Applications are sought that will propose an integrated strategy that will span the entire large-scale sequencing problem, from the up-front preparation of sequencing substrates through the assembly and analysis of the data. The applicant must propose to sequence at least 1 Mb of contiguous DNA over the three year pilot project period. If the models tested in these pilot projects are to truly contribute to the ultimate goal of the HGP, they will have to be capable of scaling up effectively. Therefore, applicants should clearly address the question of how the proposed approach will scale for efficient, rapid large-scale human DNA sequencing. Importantly, the issues of organization and managing large-scale sequencing should be addressed in so far as is possible, i.e., the pilot project and a tentative plan for a scaled-up project should be presented. The primary focus of this RFA is to gain experience in sequencing human DNA. However, the inclusion of parallel sequencing of mouse DNA is acceptable, with appropriate justification. Applicants should address the following issues: o How the pilot-scale project will scale up and lead to the efficient, cost-effective sequencing of the human genome and attainment of the year 2005 goal; o The "up-front" aspects of high throughput sequencing, specifically, the preparation of sequencing substrate. At present, the density of the markers (STSs) on the human physical mapping varies widely on different chromosomes. The HGP goal for the physical map, to be completed by 1998, is to have one STS marker every 100 kb, on average. While such a map is extremely valuable for many uses, additional effort will be needed to either produce a much higher resolution map in regions to be sequenced or to develop a strategy that can use the low resolution map directly in order to generate the DNA substrates for sequencing. Thus it is critical for the applicant to address the transition from the relatively low resolution map information that is available now to a map of the resolution required to support sequencing, or to propose an alternative means of substrate (template) generation. The proposed strategy for doing so should be tested on a region of not less than 5 Mb of DNA. This requirement is intended to ensure that the problem of converting 100 kb maps to sequencing substrates will be done on a region large enough to provide information about the problems that will be encountered in dealing with large-scale substrate preparation. If, on the other hand, the project proposes to sequence regions where only minimal substrate preparation is needed, because the high resolution map has already been constructed, applicants must address how substrate preparation for sequencing the entire human genome will be accomplished. o New Technological Developments. Successful applications will need a clear-cut scientific and budgetary strategy for maintaining state-of-the-art sequencing capability. Applicants must address the ways in which the proposed strategy will allow incorporation of the new technological developments in DNA sequencing that will surely arise during the term of the grant. The exportability of any technology or strategies to be developed in the pilot project must also be addressed. o Sequence quality. While the ultimate goal of the HGP is to produce DNA sequence of high quality, some applicants may wish to propose, as a viable path toward attaining the final high quality sequence, scenarios that produce sequence that is of lower quality than that expected for the year 2005 product, such as sequence that has gaps and/or a relatively high error rate. In such cases, the applicants must indicate how the pilot project will contribute to attaining the ultimate goal of accurate and complete sequence. Applicants must also estimate the value of any such "lower accuracy" product to the community. Thus, an applicant's overall vision and strategy for how the HGP will accomplish its goal of producing an accurate and complete sequence, is of central importance. Additionally, the applicant must discuss the cost-effectiveness of a strategy that involves an investment in lower accuracy sequencing. Another aspect of sequence quality that applicants must address is the description of sequence accuracy for the sequence produced in the pilot project. o Cost factors. It is recognized that the cost of sequencing in different pilot projects will vary, depending upon several factors including the laboratory's strategy, state of the starting map, and current level of experience in sequencing. However, as the long-range vision of successful pilot projects must be toward sequencing the entire human genome, applicants must address both their costs through the life of the proposed (3 year) project and projected long-term costs, as part of their overall vision for efficiently accomplishing the goal of a complete and accurate human sequence. o Selection of the genomic region(s) to serve as substrate for the pilot project. Because of the small number of projects that will be funded, it will be important that the region(s) chosen for sequencing accurately represent the breadth of "problems" likely to be encountered in the sequence of the entire genome. The U.S. HGP has adopted a policy of encouraging rapid release of mapping and sequencing data into public databases. Guidelines developed by NCHGR and DOE advisors recommend that data be made publicly available within six months of the time they are verified. Applicants should fully describe their plans for data release. Post-Award Management During the course of the grant period, mapping and cloning technologies will improve, genomic technologies will evolve, and the rate of progress and focus of work supported by the grant(s) may change. It is expected that the Principal Investigator will make any necessary adjustment in scientific direction to accommodate the changing environment. In order to ensure that the project(s) remains focused on appropriate goals, incorporates new technological advances and makes sufficient progress, scientific and programmatic visits to the grantee will be conducted at a frequency to be negotiated with the awardee. LETTER OF INTENT Prospective applicants are asked to submit, by June 1, 1995, 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. Any applicant planning to submit an application for more than $500,000 direct cost per year must have contacted staff, listed under INQUIRIES, before submitting the application or it will be returned to the applicant. 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 NCHGR 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. Jane L. Peterson or Dr. Jeffery A. Schloss 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 Information, 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 (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 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express mail) At the time of submission, two additional copies of the application must also be sent to: Ms. Linda Engel Office of Scientific Review National Center for Human Genome Research Building 38A, Room 604 38 Library Drive MSC 6050 Bethesda, MD 20892-6050 Applications must be received by August 4, 1995. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and for responsiveness to the RFA by the NCHGR program staff. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NCHGR 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. 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 NCHGR. Site visits will not be performed as part of the initial review and applicant interviews will only be conducted in exceptional cases. Therefore, applicants must present a complete and well-justified written application. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. All applications will receive a second level of review by the National Advisory Council for Human Genome Research. Review criteria are the following: o scientific and technical merit of the proposed research to meet the objectives of this RFA, including: 1. novelty of the strategies and methods proposed; 2. exportability of the strategies and technologies under investigation, or quality of the plan describing how the genome will be sequenced if the strategies and technologies are not exportable; 3. plan for incorporating new technologies (e.g., a new base-calling instrument) at reasonable cost; o significance and originality of the research and methodological approaches; o feasibility of the research and adequacy of the experimental design; o likelihood that the pilot project will be able to scale to a successful system for sequencing the entire human genome; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o quality of integration of the proposed solutions to critical large-scale sequencing issues (upstream to base- calling to downstream); o quality of the management plan; o availability of the facilities, resources and technology necessary to perform the research, and the level of institutional commitment; and o appropriateness of the proposed budget and time-line in relation to the proposed research. Additional factors to be considered in the evaluation of competing renewal applications will be: o prior demonstrated success in increasing throughput, decreasing cost, and maintaining accuracy in DNA sequencing; o timeliness with which data have been placed in the public domain; AWARD CRITERIA The earliest anticipated date of award is April 1, 1996. Applications submitted in response to this RFA and RFA HG-95-004 will compete for the same pool of funds. Factors that will be used to make award decisions are as follows: o Quality of the proposed project as determined by peer review; o Promise of the proposed program to contribute to the goals of RFAs HG-95-004 and HG-95-005, and to the balance between further technology development and pilot sequence production in the NCHGR sequencing program; o Overall contribution of the pilot project to knowledge and experience required to sequence the human genome in its entirety; o Selection of region(s) for study that will present the array of problems likely to be encountered in sequencing the entire human genome; o Nature and extent of the plans for placing DNA sequence data in the public domain and disseminating information on technological developments in a timely manner; o 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: Jane L. Peterson, Ph.D. or Jeffery A. Schloss, Ph.D. Mammalian Genomics Branch National Center for Human Genome Research Building 38A, Room 610 38 Library Drive MSC 6050 Bethesda, MD 20892-6050 Telephone: (301) 496-7531 FAX: (301) 480-2770 Email: jane_peterson@nih.gov Email: jeff_schloss@nih.gov Direct inquiries regarding fiscal matters to: Ms. Jean Cahill Grants Management Officer National Center for Human Genome Research Building 38A, Room 613 38 Library Drive MSC 6050 Bethesda, MD 20892-6050 Telephone: (301) 402-0733 Email: jean_cahill@nih.gov 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. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the phs mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Tue Mar 07 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HG-95-004 - V24(09) 03/10/95 Date: 8 Mar 1995 15:07:40 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 493 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3jldbs$q02@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HG95004 HG-95-004 P1O1 *************************************** IMPROVED ELECTROPHORETIC DNA SEQUENCING TECHNOLOGY NIH Guide, Volume 24, Number 9, March 10, 1995 RFA: HG-95-004 P.T. 34; K.W. 1215018, 0755045 National Center for Human Genome Research Letter of Intent Receipt Date: June 15, 1995 Application Receipt Date: August 29, 1995 PURPOSE The National Center for Human Genome Research (NCHGR) invites applications for research projects to develop novel automated sequencing technology suitable for large-scale genomic sequencing through the reduction in scale and increased parallelization of existing approaches that utilize Sanger sequencing reactions coupled with electrophoretic separation of fragments. The Request For Applications (RFA) encompasses front end sample preparation, separation, detection, and data acquisition and handling. Technologies solicited include a spectrum of approaches ranging from capillary and ultrathin gel electrophoresis to microfabricated and microelectro mechanical systems (MEMS) that could yield reductions in scale and increased throughput. This RFA is a reissuance of RFA HG-95-001. 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, Improved Electrophoretic DNA Sequencing Technology, is related to several priority areas, including cancer, heart disease and stroke, diabetes and chronic disability conditions, maternal and infant health, and others. 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 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. Collaborations between scientists in academia and industry are encouraged, as are applications from minority individuals and women. Applications from foreign institutions will not be accepted. However, subcontracts to foreign institutions are allowable, with sufficient justification. Applications are particularly encouraged from scientists, such as engineers and physicists, and institutions, such as for-profit institutions and biotechnology companies, that have not traditionally requested research support from the NCHGR. Applicants whose expertise is primarily nonbiological are especially encouraged to interact closely with biologists during the development of the research plan. MECHANISM OF SUPPORT Support for this program will be through the National Institutes of Health (NIH) individual research project grant (R01), pilot project/feasibility study (R21), research program project (P01), and exploratory grant (P20) mechanisms. The R21 mechanism is used to support highly creative approaches for which substantial preliminary data are not yet available. Each R21 award will be limited to $100,000 direct costs per year and to a maximum of three years of support, although the funding limit may be waived under exceptional circumstances. The P20 mechanism is used to support groups of outstanding investigators who wish to develop interdisciplinary research programs. Each P20 awards will be limited to three years at $750,000 direct costs per year. R21 and P20 grants are not renewable, but future project continuation is possible through other grant mechanisms such as R01 or P01. The levels and time frames for support of R21 and P20 awards indicated here are specific to this solicitation. Responsibility for the planning, direction, and execution of the proposed project 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. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The total project period for applications submitted in response to the present RFA may not exceed three years. The anticipated award date is April 1, 1996. FUNDS AVAILABLE Given the importance of both further technology improvement and the need to gain more experience in large-scale sequencing of human DNA, the NCHGR is implementing a bipartite plan to advance the capability of large-scale sequencing of human DNA and to strike a balance between these two scientific areas. This RFA represents one part of this plan and invites applications for research projects to develop novel automated sequencing technology suitable for large-scale genomic sequencing through the reduction in scale and increased parallelization of existing approaches utilizing Sanger sequencing reactions coupled with electrophoretic separation of fragments. The complementary part of the plan announced in RFA HG-05-005, "Pilot Projects for Sequencing of the Human Genome," solicits applications to initiate pilot projects for large-scale sequencing that will increase the experience in production issues such as improved strategies, substrate preparation, data analysis, project management and organization. The scientific goals of these two RFAs are very different, but the applications for both RFAs will be competing for the same pool of available funds. The anticipated outcome of the plan is to support a set of applications that will provide the balance needed in these two areas of the NCHGR program to enhance progress toward attainment of the sequence of the human genome. It is anticipated that $20,000,000 (direct and indirect costs) per year for up to three years will be available for the combination of this RFA and RFA HG-95-005, beginning in fiscal year 1996. It is anticipated that approximately 15 awards will be made from the pool of applications received in response to this RFA and RFA HG-95-005, representing a mix of research topics and mechanisms. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of awards will also vary. The number of awards may be increased if a large number of highly meritorious applications are received and if funds are available. The number of awards made will be contingent upon the quality of applications received and the availability of funds. RESEARCH OBJECTIVES Background The NCHGR sponsors basic and applied research concerned with the development and application of new technologies for the characterization and analysis of the human genome and the genomes of selected model organisms. The activities encompassed by the NCHGR program include genetic and physical mapping, DNA sequencing, informatics related to mapping and sequencing, gene identification, and technology development that will facilitate all of these efforts. The NCHGR, in conjunction with the Department of Energy, recently formulated a new five-year plan (Science Vol. 262, pp. 43-46, 1993) that states that significant technological advances will need to be made in the area of DNA sequencing if the demanding goals of the Human Genome Project are to be met. A major long-term goal of the Human Genome Program is to identify all the genes encoded in the three billion base pairs of human DNA. The first step in this process is to assemble detailed genetic and physical maps of the human genome. Subsequently, the complete sequence of human DNA must be determined. In order to attain this second objective, DNA sequencing technology must be further developed so that the cost will be significantly decreased and the rate significantly increased. In 1994, the cost of sequencing performed by highly skilled researchers in laboratories devoted to genomic DNA sequencing was estimated to be about $1 per finished base. The state-of-the-art approach for large-scale sequencing includes isolation of sample DNA from a biological source followed by amplification of the DNA and the synthesis of fluorescently tagged replicate ladders of the template DNA in a Sanger sequencing reaction. Biochemistry for DNA sequencing is currently performed in volumes that range from multiple microliters to hundreds of microliters, and only modest parallelization and automation has been achieved. The DNA ladders are resolved on a separation medium through slab gel electrophoresis and ladder composition is evaluated by laser-based detection technology. Software tools are then utilized for identification of the four bases, assembly of contiguous sequences from individual reads, and sequence finishing, including resolution of ambiguities. Current sequence throughput from automated electrophoresis instruments is approximately 7,000,000 bases (raw) per instrument year. Use of these instruments in sequencing approaches based on a combination of shotgun and directed strategies results in a throughput of about 700,000 finished bases per year. Even at this relatively modest throughput, sequence assembly and finishing limitations result in a systems bottleneck. Current efforts to optimize genomic sequencing technology focus on the development of a fully automated, integrated, modular system, that accounts for sample flow in a way that eliminates bottlenecks and maximally utilizes each step of the system from the front end of sample isolation through to data collection and analysis. Recent advances suggest that dramatically improved DNA sequencing technology can be developed through the application of existing miniaturization and automation technologies to state-of-the-art genomic sequencing. A continuum of approaches exists that creates a path to a substantially reduced scale for sequencing devices with associated throughput increase and cost decrease. Further development of these approaches requires several technological advances that are expected to be addressable based on existing scientific principles. Capillary Electrophoresis and Ultrathin Gels Recent work in ultrathin (capillary or slab) gel electrophoresis has demonstrated the potential for greatly increased separation speed due to improved heat transfer. These approaches are also expected to yield cost savings by reduction in sample size if small volume robotic reaction systems are developed concurrently. Although preliminary data suggest that these formats will be successful in improving sequence throughput, technological challenges remain to the development of dependable, exportable systems. Remaining challenges include the need to identify new separation matrices that will allow for increased reproducibility of separation and easy manipulation in these formats, small volume loading technology, reduced volume sample preparation chemistry, improved detection technology, and systems automation to attain maximal sustainable throughput. Microfabricated Devices and MEMS It is anticipated that further reductions in scale and increases in throughput could be achieved through the application of existing microfabrication and MEMS to DNA sequencing. It is anticipated that successful application of this technology could increase the speed of sequencing by two to three orders of magnitude. Technological challenges that are likely to be encountered are related to the nature of the sample and include reduced volume sample preparation chemistries, improved sample loading technologies, optimizing surface chemistries to minimize sample and reagent loss, and microscale fluidics and detection issues. Systems Integration, Data Acquisition and Handling A key component of high-throughput automated systems will be improved software tools for base calling, sequence assembly, and sequence finishing, as well as for overall systems integration. Even in current approaches, sequence finishing is a bottleneck and requires manual intervention to achieve sequence closure as well as resolution of ambiguities. Therefore, if order of magnitude improvements in finished sequence throughput are to be achieved, this component will require substantial attention and creative approaches for full automation. Objectives The purpose of this RFA is to encourage applications from individuals and groups interested in developing novel automated sequencing technology suitable for large-scale electrophoresis-based genomic sequencing through the reduction in scale of existing approaches that utilize Sanger sequencing reactions coupled with electrophoretic separation of fragments. Applications are encouraged that will provide technology that can ultimately achieve the sequencing goals of the Human Genome Project. Therefore applications should address the development of sequencing technology that when fully developed will allow: o the large-scale sequencing of DNA at a cost significantly below 50 cents per base pair, and o increased large-scale genomic DNA sequence throughput, by at least 10-fold over current methods. Novel sequencing technologies based on reductions in scale that will be considered include, but are not limited to, capillary and ultrathin electrophoresis separation systems, and microfabricated and MEMS systems. Proposals to develop such systems should consider front-end sample preparation through separation and detection, aiming for a fully automated, integrated, modular system. Support for individual components of an integrated system will be considered, given indications of a vision towards a fully integrated system or appropriate collaborations. It is important for applicants to demonstrate an appreciation of bottlenecks that arise in the application of existing technology to large-scale genomic DNA sequencing, and to indicate how these bottlenecks will be overcome in the proposed system. In this context, collaboration with large-scale genomic sequencing efforts is encouraged. It is also important for applicants to discuss plans for export and support of the technology developed. As the development of a fully functional integrated system is largely dependent on successful data handling, it is anticipated that proposals will deal with this issue in detail. Applications for the development of improved tools for data acquisition, data handling, sequence assembly, and finishing are encouraged, as these steps represent the greatest bottlenecks in current systems and additional improvements in these areas are required to unleash the full power of systems with a capacity for higher throughput. It is crucial that the development of new data acquisition and handling tools be closely linked to large-scale sequencing efforts using current technology and existing data sets, and should also be well connected to ongoing efforts toward reductions in scale to ensure adaptability of ensuing products to higher throughput systems under development. Applications to pursue DNA sequencing projects using state-of-the-art techniques, or improved non-electrophoretic-based technology such as hybridization-based approaches or scanning probe microscopy will not be considered responsive to this request for applications. However, the NCHGR welcomes applications in those areas, as well as other new approaches to DNA sequencing, through program announcements PA-92-50 and PA-90-21. Applications that are solely directed toward the development of databases to support large-scale sequencing projects, or development of algorithms and analytical tools for the annotation of genomic information, should be submitted under program announcement PA-92-50. LETTER OF INTENT Because of the specialized interest of this NCHGR program it is strongly recommended that potential applicants contact NCHGR staff to discuss research objectives and appropriate mechanisms. Prospective applicants are asked to submit, by June 15, 1995, 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 NCHGR 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. Carol A. Dahl or Dr. Robert L. Strausberg 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 Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248; and from the NIH program administrator 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 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 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express mail) To expedite the review process, at the time of submission, please send two additional copies of the application to: Office of Scientific Review National Center for Human Genome Research Building 38A, Room 604 38 Library Drive MSC 6050 Bethesda, MD 20892-6050 Applications must be received by August 29, 1995. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and for responsiveness to the RFA by the NCHGR program staff. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NCHGR 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. 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 NCHGR. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. All applications will receive a second level of review by the National Advisory Council for Human Genome Research. Review criteria for this RFA are generally the same as those for unsolicited research grant applications, and are the following: 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 the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; Additional scientific/technical merit criteria specific to this RFA include: o likelihood that the proposed technology will serve as a technology that can support the completion of the goals of the Human Genome Project for sequencing of genomic DNA. o degree to which the project contributes to a fully integrated, automated, modular system for the sequencing of genomic DNA; o degree to which the proposed technology considers and effectively overcomes existing bottlenecks in large-scale sequencing of genomic DNA; o degree to which the proposed system addresses data acquisition and handling issues; o degree to which the proposal considers exportation and support of the ensuing technology; AWARD CRITERIA The anticipated date of award is April 1, 1996. The following criteria will be considered in making funding decisions. o the quality of the proposed project as determined by peer review; o balance among the projects in addressing the issues related to the development of a fully integrated, automated, miniaturized, highly parallel system for sequencing of genomic DNA with associated tools for data acquisition and handling, as specified in this RFA; o promise of the proposed program to contribute to the goals of RFA HG-95-004 and HG-95-005, and to the balance between further technology development and pilot sequence production in the NCHGR sequencing program; o 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: Carol A. Dahl, Ph.D., or Robert L. Strausberg, Ph.D. Sequencing Technology Branch National Center for Human Genome Research Building 38A, Room 610 38 Library Drive MSC 6050 Bethesda, MD 20892-6050 Telephone: (301) 496-7531 FAX: (301) 480-2770 Email: carol_dahl@nih.gov Email: robert_strausberg@nih.gov Direct inquiries regarding fiscal matters to: Jean M. Cahill Grants and Contracts Management Section National Center for Human Genome Research Building 38A, Room 613 38 Library Drive MSC 6050 Bethesda, MD 20892-6050 Telephone: (301) 402-0733 FAX: (301) 402-1951 Email: jean_cahill@nih.gov 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 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the phs mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Tue Mar 07 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 24, no. 9, pt. 1of1, 10 March 1995 Date: 8 Mar 1995 15:07:00 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 544 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3jldak$pu9@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19950310 V24N09 P1O1 ************************************ X-comment: RFAs described: HS-95-003, HS-95-004, HG-95-005, HG-95-004 NIH GUIDE - Vol. 24, No. 9 - March 10, 1995 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NEW ADDRESS FOR THE DIVISION OF RESEARCH GRANTS Division of Research Grants INDEX: DIVISION OF RESEARCH GRANTS $$INDEX N2 ********************************************************** RESPONSIBILITIES OF NIH AND AWARDEE INSTITUTIONS FOR THE RESPONSIBLE CONDUCT OF RESEARCH National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 06/20/95 ************************************************* CONSUMER ASSESSMENTS OF HEALTH PLANS STUDY (RFA HS-95-003) Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY RESEARCH $$INDEX R2 06/20/95 ************************************************* HEALTH SERVICES RESEARCH ON ADVANCE DIRECTIVES (RFA HS-95-004) Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY RESEARCH $$INDEX R3 08/04/95 ************************************************* PILOT PROJECTS FOR SEQUENCING OF THE HUMAN GENOME (RFA HG-95-005) National Center for Human Genome Research INDEX: HUMAN GENOME RESEARCH $$INDEX R4 08/29/95 ************************************************* IMPROVED ELECTROPHORETIC DNA SEQUENCING TECHNOLOGY (RFA HG-95-004) National Center for Human Genome Research INDEX: HUMAN GENOME RESEARCH This publication is available electronically via BITNET or INTERNET, by subscription, and is also on the NIH GOPHER (gopher.nih.gov). 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. THE PUBLIC HEALTH SERVICE (PHS) STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTING EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** NEW ADDRESS FOR THE DIVISION OF RESEARCH GRANTS NIH GUIDE, Volume 24, Number 9, March 10, 1995 P.T. 34; K.W. 1014006 Division of Research Grants The Division of Research Grants (DRG) is moving to a new location. Effective May 8, 1995, all COMPETING grant applications submitted to the National Institutes of Health must be sent to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for courier/overnight mail service) The telephone numbers for all offices within the DRG will also be changing. Essential telephone numbers at the new location and other information updates will be published in future issues of the NIH Guide for Grants and Contracts. Questions concerning this announcement may be directed to the Referral Office at (301) 594- 7250. This telephone number will be in operation until May 8, 1995. After May 8 the telephone number will be (301) 435-0715. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** RESPONSIBILITIES OF NIH AND AWARDEE INSTITUTIONS FOR THE RESPONSIBLE CONDUCT OF RESEARCH NIH GUIDE, Volume 24, Number 9, March 10, 1995 P.T. 34; K.W. 1014006, 1014004 National Institutes of Health This version of the notice replaces the version published in the NIH Guide for Grants and Contracts, Vol. 23, No. 44, December 16, 1994. Item number 5 has been clarified. The responsible conduct of research is an important public policy issue. Cases of misconduct in science present a serious threat to continued public confidence in the integrity of the scientific process and the stewardship of Federal funds. The Public Health Service (PHS) has set forth regulations and policies (42 CFR Part 50, Subpart A) for handling misconduct in science. The purpose of this notice is to provide guidance on the responsibilities of awardee institutions under current regulations when misconduct in science affects the design, conduct, or reporting of research funded by the NIH. DEFINITION Misconduct in science is defined as fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgements of data. (42 CFR 50.102) Copies of the regulation pertaining to misconduct in science are available from the Office of Research Integrity (ORI) at the address listed below. POLICY 1. It is the policy of PHS to maintain high ethical standards in research and investigate and resolve promptly and fairly all instances of alleged or apparent misconduct. The NIH places responsibility on awardee institutions to assure that each NIH funded program, function, or activity is progressing toward its respective goals (45 CFR 74.81) and that awarded funds are expended solely for the purpose of the award in accordance with the approved application and budget, applicable regulations, the terms and conditions of the award, and the applicable cost principles. These responsibilities must be carried out with extra care where misconduct in science has been found or where a misconduct in science investigation has been initiated. 2. Where a misconduct in science investigation has been initiated that involves alleged misconduct affecting an ongoing project, the awardee institution, consistent with its responsibilities under applicable regulations, is responsible for taking whatever steps are necessary to protect the scientific integrity of the project; protect human or animal subjects; provide reports to ORI; ensure that awarded funds are properly expended; and ensure the continuation of the project, to the extent such continuation is consistent with the foregoing objectives and the need to ensure a prompt, fair investigation. Affirmative obligations are imposed in each of these areas by 42 CFR 50.103 and 50.104. The institution should consult with the ORI and the funding agency as necessary to accomplish these objectives. Appointment of a qualified institutional official not previously connected with the research project to oversee the scientific and/or financial aspects of the project is an example of an action that may be necessary, depending upon the circumstances. 3. When a finding of misconduct in science has been made against an individual or individuals working on the funded project by the ORI, the awardee institution must assess the effect of that finding upon the qualifications of the Principal Investigator (PI) or other staff named in the application. Proposed changes must be reported promptly to the awarding agency. In accord with 42 CFR 52.2 and 52.5(a), the awarding agency may withdraw its approval of the PI or other staff named in the application against whom a finding of misconduct has been made, and require the appointment of acceptable substitutes before the project may continue. If PHS or HHS has imposed administrative actions based on an ORI finding of misconduct, such as debarment of an investigator from Federal funding, the awardee institution is expected to make any changes necessary on the funded project to comply with such actions. 4. A finding of misconduct in science that has a significant effect upon the conduct of a funded project may constitute grounds for the withholding of additional awards and the suspension and/or termination of current funding under 45 CFR 74.114 and 74.115. 5. Under 45 CFR 74.27, et seq., and the cost principles referenced therein, and the Public Health Service Grants Policy Statement, expenditures of awarded funds by the awardee or by the subrecipients for research that is invalid or unreliable because of misconduct in science may, on a case-by-case basis, be determined to be unallowable costs for which the awardee institution is liable for repayment to the awarding agency. This and any other determination of unallowable costs is appealable under 42 CFR Part 50, Subpart D and 45 CFR Part 16. Awardees should have procedures in place for the recovery of funds from subrecipients. 6. Where the validity or reliability of data has been affected by misconduct in science, the awardee institution and its employee authors are responsible for submitting a correction or retraction of data to a journal, as appropriate, and/or for republishing the corrected data. Such corrections or retractions may be required as a PHS administrative action. If the institution does not meet its responsibilities, the awarding agency may invoke its rights to access the data (45 CFR 74.211) and to use copyrightable material developed under the award (45 CFR 74.145), have the data reviewed, and submit the correction. COOPERATION AND TECHNICAL ASSISTANCE Staff of the ORI are available to assist awardee institutions in responding to misconduct in science. Staff of the NIH awarding agencies are available to provide technical assistance to protect funded projects from the adverse effects of misconduct in science. The joint responsibilities of the awarding agencies and the awardee institutions are the protection of human and animal subjects, proper stewardship of public funds, and ensuring the integrity of the scientific data from the project. INQUIRIES Written, telephone, and email requests for additional information or clarification of the issues addressed in this notice are welcome. Questions concerning technical assistance to protect funded projects should be directed to: NIH Agency Extramural Research Integrity Officer National Institutes of Health Building 1, Room 152 Bethesda, MD 20892 Telephone: (301) 496-5356 Email: gg9i@nih.gov Questions concerning the conduct of institutional or ORI inquiries or investigations should be directed to: Division of Research Investigations Office of Research Integrity 5515 Security Lane, Suite 700 Rockville, MD 20852 Telephone: (310) 443-5330 FAX: (301) 594-0039 Email: dmacfarlane@oash.ssw.dhhs.gov $$N2 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN HS-95-003 FULL-TEXT ************************************** CONSUMER ASSESSMENTS OF HEALTH PLANS STUDY NIH GUIDE, Volume 24, Number 9, March 10, 1995 RFA AVAILABLE: HS-95-003 P.T. 34; K.W. 0404021, 0755018, 0730000 Agency for Health Care Policy and Research Letter of Intent Receipt Date: May 20, 1995 Application Receipt Date: June 20, 1995 PURPOSE The Agency for Health Care Policy and Research (AHCPR) invites applications for cooperative agreements (U19) to: (1) produce reliable, valid and rigorously tested survey protocols for collecting information from consumers regarding their assessments of health plans and services; (2) develop and test the effectiveness of different formats for conveying resulting information to consumers; (3) demonstrate the resulting survey protocols in real world settings; and (4) evaluate the usefulness of this information in assisting consumers, and purchasers acting on their behalf, in making informed selections of health care plans and services. The long term goal of this project is to strengthen the science base underlying the evolution and the use of consumer surveys within the health care industry. The AHCPR expects to award up to $2 million for two projects not to exceed $1 million in total costs for each project for the first year. The number of awards is dependent on the number of high quality applications responding to this RFA. This is a one-time solicitation. 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, Consumer Assessments of Health Plans Study (CAHPS), is related to the priority areas of access to and use of clinical preventive services, maternal and child health services, and health services related to major disease categories. 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. INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Copies of this RFA and background documents are available from: Global Exchange Inc. 7910 Woodmont Avenue, Suite 400 Bethesda, MD 20814-3015 Telephone: (301) 656-3100 FAX: (301) 652-5264 Copies of the RFA without background materials can also be requested through email at cahpsrfa@PO3.AHCPR.GOV, the NIH GOPHER (gopher.nih.gov), through AHCPR InstantFAX at 301-594-2800, AHCPR Pub. No. 95-0044. To use InstantFAX, you must call from a fax machine with a telephone handset. Use the key pad on the receiver when responding to prompts from InstantFAX. The RFA will be sent at the end of the ordering process. AHCPR InstantFAX operates 24 hours a day, 7 days a week. For questions about this service, call AHCPR's Division of Communications at 301-594-1364 ext. 159. Direct inquiries regarding programmatic issues, including information on the policy of inclusion of women and minorities in study populations, to: Christine Crofton, Ph.D. CAHPS Project Officer Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 603 Rockville, MD 20852-4908 Telephone: (301) 594-1357 ext 105 $$R1 END ************************************************************ $$R2 BEGIN HS-95-004 FULL-TEXT ************************************** HEALTH SERVICES RESEARCH ON ADVANCE DIRECTIVES NIH GUIDE, Volume 24, Number 9, March 10, 1995 RFA AVAILABLE: HS-95-004 P.T. 34; K.W. 0730021, 0730052 Agency for Health Care Policy and Research Letter of Intent Receipt Date: May 15, 1995 Application Receipt Date: June 20, 1995 PURPOSE The Agency for Health Care Policy and Research (AHCPR) is soliciting applications for research on advance directives. Research applications are invited for establishing and evaluating a pilot study of the effectiveness of a community focused, home-based approach to completion of advance medical care directives by individuals. An advance directive is a means of recording a person's preferences regarding future health care decisions while the person is fully competent. Such recorded preferences may be used to guide the actual decisions that are made at a later time, should the person become incompetent. Research under this RFA should address the issue of the low percentage of the general public who have completed an advance medical directive. Specifically, this RFA calls for a pilot project to assess the effectiveness of a community focused, home-based approach to encouraging the completion of advance medical directives, including bona fide advance directives documentation. The pilot project should be initiated in four geographic and ethnically diverse locations. It is desirable that the research should evaluate the validity of advance directives executed in this setting. This request for applications will use the research project grant (R01) mechanism. The AHCPR expects to make one award of up to $700,000, total cost, over a two-year period to meet the objectives of this RFA. Funding for the first year will not exceed $350,000 total cost. 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. AHCPR urges applicants to submit grant applications with relevance to the specific objectives of this initiative. 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). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov), and by contacting the program staff listed below. Julius Pellegrino Agency For Health Care Policy and Research 2101 East Jefferson Street, Suite 502 Rockville, MD 20852-4908 Telephone: (301) 594-1357 ext. 138 FAX: (301) 594-3721 Email: JPELLEGR@po3.ahcpr.gov $$R2 END ************************************************************ $$R3 BEGIN HG-95-005 FULL-TEXT ************************************** PILOT PROJECTS FOR SEQUENCING OF THE HUMAN GENOME NIH GUIDE, Volume 24, Number 9, March 10, 1995 RFA AVAILABLE: HG-95-005 P.T. 34; K.W. 1215018, 0755045 National Center for Human Genome Research Letter of Intent Receipt Date: June 1, 1995 Application Receipt Date: August 4, 1995 PURPOSE The National Center for Human Genome Research (NCHGR) invites applications to develop and implement pilot projects to test strategies that have the potential to lead to full-scale production sequencing of mammalian DNA, resulting in achieving the goal of the complete, accurate, finished sequence of human DNA by the year 2005. This RFA will use the National Institutes of Health (NIH) individual research grant (R01), pilot project/feasibility study (R21), research program project (P01), exploratory grant (P20) and center (P50) grant mechanisms. $20 million has been set-aside to fund approximately 15 awards made under this RFA and RFA HG-95-004. 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), Pilot Projects for Sequencing of Human DNA, is related to several priority areas, including cancer, heart disease and stroke, diabetes and chronic disability conditions, maternal and infant health, and others. 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). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Jane L. Peterson, Ph.D. or Jeffery A. Schloss, Ph.D. Mammalian Genomics Branch National Center for Human Genome Research 38 Library Drive - MSC 6050 Bethesda, MD 20892-6050 Telephone: (301) 496-7531 FAX: (301) 480-2770 Email: jane_peterson@nih.gov Email: jeff_schloss@nih.gov $$R3 END ************************************************************ $$R4 BEGIN HG-95-004 FULL-TEXT ************************************** IMPROVED ELECTROPHORETIC DNA SEQUENCING TECHNOLOGY NIH GUIDE, Volume 24, Number 9, March 10, 1995 RFA AVAILABLE: HG-95-004 P.T. 34; K.W. 1215018, 0755045 National Center for Human Genome Research Letter of Intent Receipt Date: June 15, 1995 Application Receipt Date: August 29, 1995 PURPOSE The National Center for Human Genome Research (NCHGR) invites applications for research projects to develop novel automated sequencing technology suitable for large-scale genomic sequencing through the reduction in scale and increased parallelization of existing approaches that utilize Sanger sequencing reactions coupled with electrophoretic separation of fragments. The Request For Applications (RFA) encompasses front end sample preparation, separation, detection, and data acquisition and handling. Technologies solicited include, but are not limited to, a spectrum of approaches ranging from capillary and ultrathin gel electrophoresis to microfabricated and microelectro mechanical systems (MEMS) that could yield reductions in scale and increased throughput. This RFA is a reissuance of RFA HG-95-001. Support for this program will be through the National Institutes of Health (NIH) individual research project grant (R01), pilot project/feasibility study (R21), research program project (P01), and exploratory grant (P20) mechanisms. $20 million has been set-aside to fund approximately 15 awards made under this RFA and RFA HG-95-005. 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, Improved Electrophoretic DNA Sequencing Technology, is related to several priority areas, including cancer, heart disease and stroke, diabetes and chronic disability conditions, maternal and infant health, and others. 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). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Carol A. Dahl, Ph.D., or Robert L. Strausberg, Ph.D. Sequencing Technology Branch National Center for Human Genome Research Building 38A, Room 610 38 Library Drive - MSC 6050 Bethesda, MD 20892-6050 Telephone: (301) 496-7531 FAX: (301) 480-2770 Email: carol_dahl@nih.gov Email: robert_strausberg@nih.gov $$R4 END ************************************************************ From owner-sci-resources@net.bio.net Sun Mar 12 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 12 March 1995 Date: 13 Mar 1995 15:15:41 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 130 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3k2jmt$gu4@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Dir of Awards Title: NSF 95-6 The Advanced Technological Education (ATE) File size (bytes): 1994 Awards STIS Filename: nsf956.txt (NSF) Also available: nsf956.doc Document Type: International Document Title: INT 95-006 -General Outline of JFY 1995 Government Budget for S&T File size (bytes): STIS Filename: int95006.txt Document Type: Letter Title: LEHR9501 EPSCoR Newsletter File size (bytes): STIS Filename: lehr9501.txt Title: LMPS9501 - Dear Colleague Letter File size (bytes): 4067 STIS Filename: lmps9501.txt Document Type: Report Title: NSF 93-147 -- A Selected List of Fellowship and Other Support Opportunities for Advanced Education File size (bytes): STIS Filename: ns93147a.txt Title: NSF 93-147 -- A Selected List of Fellowship and Other Support Opportunities for Advanced Education File size (bytes): STIS Filename: ns93147b.txt Title: NSF 93-147 -- A Selected List of Fellowship and Other Support Opportunities for Advanced Education File size (bytes): STIS Filename: ns93147c.txt Title: NSF 93-147 -- A Selected List of Fellowship and Other Support Opportunities for Advanced Education File size (bytes): STIS Filename: ns93147d.txt Title: NSF 93-147 -- A Selected List of Fellowship and Other Support Opportunities for Advanced Education File size (bytes): STIS Filename: ns93147e.txt Title: NSF 93-147 -- A Selected List of Fellowship and Other Support Opportunities for Advanced Education File size (bytes): STIS Filename: ns93147f.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 13107 STIS Filename: cmmtg.txt Document Type: Letter Title: LMPS9501 - Dear Colleague Letter File size (bytes): 4067 STIS Filename: lmps9501.txt Document Type: News Title: MPSLECT -- Understanding or Memorization File size (bytes): Are We Teaching the Right Thing? STIS Filename: mpslect.txt (NSF) Document Type: Program Guideline Title: NSF 94-139 (Reprint)- Grant Opportunities for Academic Liaison with Industry (GOALI) File size (bytes): 21055 STIS Filename: nsf94139.txt ------------------------------------------------------------------------ ** 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). 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 stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve nsf94139.txt, the text of your message should be as follows: get nsf94139.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf94139.txt, you would enter: ftp> get nsf94139.txt 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 "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Wed Mar 15 22:00:00 1995 Path: biosci!biosci!not-for-mail From: "Len A. Poli" Newsgroups: bionet.sci-resources Subject: 9-12 biotechnology/molecular biology Date: 15 Mar 1995 22:45:11 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 19 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3k59vj$t4b@cello.gina.calstate.edu> NNTP-Posting-Host: net.bio.net I'm interested in communicating with high school science teachers/administgrators who would like to share ideas, protocols, laboratory investigations, etc. We in San Francisco Public Schools have a program called SF Base- (Biotechnology Alliance for Science Education). Our partners are UCSF, City College (CCSF) and San Francisco State (SFSU). We have connections with other Bay Area Partnerships such as The San Mateo County Biotechnology Partnership, the Sant Clara County Biotechnology Partnership and the Human Genome Education Project from Stanford. Currently we are doing experiments dealing with bacterial transformation, recombinant DNA, & DNA fingerprinting. We have several other ideas. If your interesed and/or whant to share let me know by e-mail, phone or US post. Len Poli Implementation Director, SF Base (San Francisco Biotechnology Alliance for Science Education -precollege-) 3045 Santiago Avenue (valid until May 1, 1995) San Francisco CA 94116 Voice (415) 759-2767 Fax (415) 556-1514 From owner-sci-resources@net.bio.net Wed Mar 15 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 24, no. 10, pt. 1of1, 17 March 1995 Date: 16 Mar 1995 15:29:22 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 688 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3kahki$mkh@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19950317 V24N10 P1O1 ************************************ X-comment: RFAS described: HD-95-006, HD-95-007, HD-95-008, AI-95-011, PA-95- 038, PA-95-039 NIH GUIDE - Vol. 24, No. 10 - March 17, 1995 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NEW ADDRESS FOR THE DIVISION OF RESEARCH GRANTS Division of Research Grants INDEX: DIVISION OF RESEARCH GRANTS $$INDEX N2 ********************************************************** ELIMINATION OF INTERNATIONAL GENOME RESEARCH PROGRAM FOR CENTRAL AND EASTERN EUROPE National Center for Human Genome Research INDEX: HUMAN GENOME RESEARCH $$INDEX N3 ********************************************************** ETHICAL AND POLICY ISSUES IN RESEARCH WITH CHILDREN AND ADOLESCENTS---A SYMPOSIUM National Institute of Child Health and Human Development National Institute of Mental Health INDEX: CHILD HEALTH, HUMAN DEVELOPMENT; MENTAL HEALTH $$INDEX N4 ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS National Institutes of Health Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH; FOOD AND DRUG ADMINISTRATION NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 06/15/95 ************************************************* COOPERATIVE MULTICENTER NEONATAL RESEARCH NETWORK (RFA HD-95-006) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R2 06/16/95 ************************************************* COOPERATIVE MULTICENTER NETWORK OF MATERNAL-FETAL MEDICINE UNITS (RFA HD-95-007) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R3 10/11/95 ************************************************* COOPERATIVE SPECIALIZED INFERTILITY RESEARCH CENTER PROGRAM (RFA HD-95-008) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R4 11/15/95 ************************************************* MUCOSAL AND SYNOVIAL GENE TRANSFER IN INFECTION/INFLAMMATION (RFA AI-95-011) National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases INDEX: ALLERGY, INFECTIOUS DISEASES; ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES $$INDEX P1 ********************************************************** NEUROSCIENCE RESEARCH OF NICOTINE AND NICOTINE ABUSE (PA-95-038) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX P2 ********************************************************** GENE TRANSFER FOR PRIMARY IMMUNE DEFICIENCY (PA-95-039) National Institute of Allergy and Infectious Diseases The Jeffrey Modell Foundation INDEX: ALLERGY, INFECTIOUS DISEASES; JEFFREY MODELL FOUNDATION This publication is available electronically via BITNET or INTERNET, by subscription, and is also on the NIH GOPHER (gopher.nih.gov). Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221); contact Dr. John James at 301/594- 7270 for details. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTING EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** NEW ADDRESS FOR THE DIVISION OF RESEARCH GRANTS NIH GUIDE, Volume 24, Number 10, March 17, 1995 P.T. 34; K.W. 1014006 Division of Research Grants The Division of Research Grants (DRG) is moving to a new location. Effective May 8, 1995, all COMPETING grant applications submitted to the National Institutes of Health must be sent to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for courier/overnight mail service) The telephone numbers for all offices within the DRG will also be changing. Essential telephone numbers at the new location and other information updates will be published in future issues of the NIH Guide for Grants and Contracts. Questions concerning this announcement may be directed to the Referral Office at (301) 594- 7250. This telephone number will be in operation until May 8, 1995. After May 8 the telephone number will be (301) 435-0715. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** ELIMINATION OF INTERNATIONAL GENOME RESEARCH PROGRAM FOR CENTRAL AND EASTERN EUROPE NIH GUIDE, Volume 24, Number 10, March 17, 1995 P.T. 34; K.W. 1215018 National Center for Human Genome Research Effective April 1, 1995, the National Center for Human Genome Research will discontinue the International Genome Research Program for Central and Eastern Europe, which includes the collaborative program (PA-92-067) and the research fellowship program (PA-92-068). No new applications will be accepted after that date. Commitments to ongoing grants will be honored, provided funds are available. INQUIRIES For further information contact: Bettie J. Graham, Ph.D. Chief, Mapping Technology Branch National Center for Human Genome Research Building 38A, Room 612 Bethesda, MD 20892-6050 Email: Bettie_Graham@nih.gov $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** ETHICAL AND POLICY ISSUES IN RESEARCH WITH CHILDREN AND ADOLESCENTS---A SYMPOSIUM NIH GUIDE, Volume 24, Number 10, March 17, 1995 P.T. 42, AA; K.W. 1014004 National Institute of Child Health and Human Development National Institute of Mental Health Symposium Dates: April 27 and 28, 1995 Symposium Location: Boston, Massachusetts Public Responsibility in Medicine and Research (PRIM&R) announces a symposium on the "Ethical and Policy Issues in Research with Children and Adolescents." The symposium is co-sponsored by Tufts University School of Medicine, the National Institute of Child Health and Human Development, the National Institute of Mental Health, the Society for Adolescent Medicine, the Association of Medical School Pediatric Department Chairmen, the American Pediatric Society, the Society for Pediatric Research, and the Boston Children's Hospital. The topics to be covered include: o Genetic research and gene therapy o Research on life-threatening conditions o Research in school-based clinics o Mental health research (including substance abuse and child abuse) o Contraceptive research o An examination of capacity, consent, and assent o Randomized trials The conference will include plenary addresses, panel discussions, and more than 24 workshops by a diverse faculty of experienced research, clinicians, institutional administrators, representatives of advocacy organizations and other professionals who conduct and review research with children and adolescents. Small discussion groups will facilitate productive attendee/faculty interaction and will provide a forum for the development of effective strategies to address common concerns. PRIM&R has set aside a limited number of auditor scholarships for full-time students and others demonstrating need. INQUIRIES Joan Rachlin, Esq. Executive Director, Public Responsibility in Medicine and Research 132 Boylston Street Boston, MA 02116 Telephone: (617) 423-4112 FAX: (617) 423-1185 $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS NIH GUIDE, Volume 24, Number 10, March 17, 1995 P.T. 42; K.W. 0783005 National Institutes of Health Food and Drug Administration The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are continuing to sponsor a series of workshops on responsibilities of researchers, Institutional Review Boards (IRBs), and institutional officials for the protection of human subjects in research. The workshops are open to everyone with an interest in research involving human subjects, and will be of special interest to those persons currently serving or about to begin serving as a member of an IRB. Issues discussed at these workshops are relevant to all Public Health Service agencies. The current schedule includes the following: DATES: May 4-5, 1995 TITLE: Contemporary Issues in Human Research Subject Protection in Vulnerable and Minority Populations: Sharing the Benefits and Burdens of Research LOCATION: Regal Riverfront Hotel, St. Louis, MO SPONSORS: Washington University School of Medicine; Jewish Hospital of St. Louis at Washington University; Meharry Medical College REGISTRATION Barb Woodson, Secretary, Research Administration Jewish Hospital of Saint Louis 216 South Kingshiway, Room 1768-69 Saint Louis, MO 63110 Telephone: (314) 454-8322 FAX: (314) 454-4241 REGISTRATION FEE: $150 DESCRIPTION: The HHS and FDA mandate to Institutional Review Boards is to protect the rights and welfare of human subjects while supporting scientific advancement. This protection is extended to all human subjects, but additional safeguards are provided by both the HHS/FDA regulations and basic ethical principles to protect the rights and welfare of vulnerable subjects who, by reason of their disability or illness, exhibit diminished personal autonomy. Neither the Federal regulations, nor ethical codes, including The Belmont Report, proscribe inclusion of vulnerable persons as research subjects, although special justification of any plan to involve vulnerable persons as research subjects is required. Women and members of certain racial groups -- particularly Afro-Americans and Hispanics -- have been excluded from research. Inasmuch as these groups have not been involved, they also are vulnerable -- vulnerable to exclusion and to the possibility of being deprived of proven new advances from research. This Conference will focus particularly on evolving concerns for the protection of vulnerable subjects from research risks, inappropriate or inadvertent exploitation, or discrimination by exclusion. Presentations will highlight FDA regulatory updates; explore the new guidelines for the inclusion of women and people of color and diverse racial and ethnic backgrounds in clinical research; examine the claims that women have been systematically excluded from research and potentially deprived thereby of proven diagnostic and therapeutic strategies; review current issues in research in vulnerable populations including unconscious patients in emergency rooms, AIDS patients, children, the elderly, and the cognitively-impaired. IRB challenges in research in psychiatry will be discussed, including the validity of initial and continuing informed consent for research in schizophrenic patients, justification for the use of a placebo, the social and medical implications of genetic screening for vulnerability to psychiatric disease, the ethical difficulties involved in research in child psychiatry, and the influence of cultural patterns on psychiatric research in minority populations. The Conference will include keynote addresses, panel presentations, facilitated forums, information exchanges, and active audience participation. An outstanding faculty of experts in each area of discussion has been selected on the basis of expertise and ability to communicate authoritatively and comprehensively. INQUIRIES Ms. Darlene Marie Ross Office for Protection from Research Risks National Institutes of Health 6100 Executive Boulevard, Suite 3B01 Rockville, MD 20892-7507 Telephone: (301) 496-8101 FAX: (301) 402-0527 $$N4 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN HD-95-006 FULL-TEXT ************************************** COOPERATIVE MULTICENTER NEONATAL RESEARCH NETWORK NIH GUIDE, Volume 24, Number 10, March 17, 1995 RFA AVAILABLE: HD-95-006 P.T. 34; K.W. 0775013, 0403020, 0730050, 0785035 National Institute of Child Health and Human Development Letter of Intent Receipt Date: April 1, 1995 Application Receipt Date: June 15, 1995 PURPOSE The National Institute of Child Health and Human Development (NICHD) invites applications from investigators willing to participate with the NICHD under a Cooperative Agreement in an ongoing multicenter clinical program designed to investigate the safety and efficacy of treatment and management strategies to care for newborn infants, particularly those related to management of low birth weight infants. The objective of this program is to facilitate evaluation of these strategies by establishing a network of academic centers that, by rigorous patient evaluation using common protocols, can study the required numbers of patients and can provide answers more rapidly than individual centers acting alone. The NICHD program staff will assist the principal investigators of the Neonatal Research Network and the Advisory Board in identifying research topics of high priority, and in designing protocols appropriate to the evaluation of optimal management in these areas. It is anticipated that approximately 12 or 13 awards for clinical centers will be made, with an estimated total cost of $3.5 million. 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 Application (RFA), Cooperative Multicenter Neonatal Research Network is related to the priority area of low birth weight. 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). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Linda L. Wright, M.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B03F - MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5575 FAX: (301) 496-3790 Email: WRIGHTL@HD01.NICHD.NIH.GOV $$R1 END ************************************************************ $$R2 BEGIN HD-95-007 FULL-TEXT ************************************** COOPERATIVE MULTICENTER NETWORK OF MATERNAL-FETAL MEDICINE UNITS NIH GUIDE, Volume 24, Number 10, March 17, 1995 RFA AVAILABLE: HD-95-007 P.T. 34; K.W. 0785135, 0775020, 0775025 National Institute of Child Health and Human Development Letter of Intent Receipt Date: April 1, 1995 Application Receipt Date: June 16, 1995 PURPOSE The National Institute of Child Health and Human Development (NICHD) invites applications from investigators willing to participate with the NICHD under a Cooperative Agreement (U10) in an ongoing multicenter clinical program designed to investigate problems in clinical obstetrics, particularly those related to prevention of low birth weight. The objective of this program is to facilitate resolution of these problems by establishing a network of academic centers that, by rigorous patient evaluation using common protocols, can study the required numbers of patients and can provide answers more rapidly than individual centers acting alone. The NICHD program staff will assist the principal investigators of the MFMUs and the Advisory Board in identifying research topics of high priority, and in designing protocols appropriate to the evaluation of optimum management in these areas. It is anticipated that approximately 12 or 13 clinical centers will be involved in the program. Awards will consist of base budgets, supplemented by capitated funding for patient recruitment to specific protocols. 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 Application (RFA), Cooperative MultiCenter Network of Maternal-Fetal Medicine Units (MFMUs), is related to the priority area of low birth weight. 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). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and e-mail from the program contact listed below. Donald McNellis, M.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B03 - MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5575 FAX: (301) 496-3790 Email: mcnellid@hd01.nichd.nih.gov $$R2 END ************************************************************ $$R3 BEGIN HD-95-008 FULL-TEXT ************************************** COOPERATIVE SPECIALIZED INFERTILITY RESEARCH CENTER PROGRAM NIH GUIDE, Volume 24, Number 10, March 17, 1995 RFA AVAILABLE: HD-95-008 P.T. 04; K.W. 0413002, 0710030, 0785035 National Institute of Child Health and Human Development Letter of Intent Receipt Date: May 15, 1995 Application Receipt Date: October 11, 1995 PURPOSE The National Institute of Child Health and Human Development (NICHD) invites applications from investigators willing to participate with the NICHD under a cooperative agreement (U54) in an ongoing multicenter cooperative research program termed the National Cooperative Program for Infertility Research (NCPIR). The objective of this Program is to expedite the development of new approaches for the diagnosis and treatment of human male or female infertility. It is anticipated that $3,040,000 (including indirect and direct costs) will be available for the entire program for the first year of the Program. It is planned that these funds will support at least two Center awards. In addition to new applications received in response to this solicitation, up to two competing continuation (renewal) applications are expected to compete for these two Center awards. 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), Cooperative Specialized Infertility Research Center Program, is related to the priority area of family planning. 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). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Michael E. McClure, Ph.D. Reproductive Sciences Branch National Institute of Child Health and Human Development Building 61E, Room 8B01 Bethesda, MD 20892 Telephone: (301) 496-6515 FAX: (301) 496-0962 Email: MCCLUREM@HD01.NICHD.NIH.GOV $$R3 END ************************************************************ $$R4 BEGIN AI-95-011 FULL-TEXT ************************************** MUCOSAL AND SYNOVIAL GENE TRANSFER IN INFECTION/INFLAMMATION NIH GUIDE, Volume 24, Number 10, March 17, 1995 RFA AVAILABLE: AI-95-011 P.T. 34; K.W. 1002008, 0745032, 0715026, 0715120 National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases Letter of Intent Receipt Date: July 15, 1995 Application Receipt Date: November 15, 1995 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invite submission of investigator-initiated research applications for basic and preclinical studies targeted at molecular methods for transferring genes into cells of mucosal membranes and synovial tissues to augment host defenses and alter inflammatory responses for the treatment or prevention of infectious and rheumatic and other immunologic diseases. The estimated funds available for the total (direct and indirect) first-year costs of all awards made under this RFA will be $950,000, $750,000 from the NIAID and $200,000 >From the NIAMS. In Fiscal Year 1996, the NIAID plans to fund approximately three to four research projects grants (R01s) and/or FIRST (R29) awards and the NIAMS plans to fund one R01/R29. 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), Mucosal and Synovial Gene Transfer in Infection/Inflammation, 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 Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone (202) 782-3238). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Howard B. Dickler, M.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A19 Bethesda, MD 20892-7640 Telephone: (301) 496-7104 FAX: (301) 402-2571 Email: hd7e@nih.gov $$R4 END ************************************************************ $$P1 BEGIN PA-95-038 FULL-TEXT ************************************** NEUROSCIENCE RESEARCH OF NICOTINE AND NICOTINE ABUSE NIH GUIDE, Volume 24, Number 10, March 17, 1995 PA AVAILABLE: PA-95-038 P.T. 34; K.W. 0404001, 0404019, 1002030, 0710085 National Institute on Drug Abuse PURPOSE The purpose of this program announcement is to encourage research to examine the many aspects of nicotine abuse/addiction in in vitro or in vivo systems, in animals, and in man. The research may be based upon behavioral, neurophysiologic, neurochemical, or other methods that will seek to explain nicotine use. The overall goal is to further the understanding of the brain mechanisms that underlie addictive processes, with an eventual target of developing specific treatments for the abuse/addiction of nicotine in man. HEALTHY PEOPLE 2000 The PHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This program announcement, Neuroscience Research of Nicotine and Nicotine Abuse, is related to the priority area of tobacco. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. David N. Johnson, Ph.D. Division of Basic Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-19 Rockville, MD 20857 Telephone: (301) 443-6975 Email: dj42n@nih.gov $$P1 END ************************************************************ $$P2 BEGIN PA-95-039 FULL-TEXT ************************************** GENE TRANSFER FOR PRIMARY IMMUNE DEFICIENCY NIH GUIDE, Volume 24, Number 10, March 17, 1995 PA AVAILABLE: PA-95-039 P.T. 34; K.W. 0745032, 0715120 National Institute of Allergy and Infectious Diseases The Jeffrey Modell Foundation Application Receipt Dates: June 1, and October 1, 1995, and February 1, 1996 PURPOSE The NIAID and the Jeffrey Modell Foundation (JMF) invite research grant applications specifically targeted to isolation and characterization of defective genes that cause primary immune deficiency diseases and development of the techniques and vectors necessary to transfer these genes into hematopoietic progenitors to correct the defects. The estimated funds available for the total (direct and indirect) first-year costs of awards made under this Program Announcement (PA) to applications assigned to NIAID will be $500,000 ($400,000 from the NIAID and $100,000 from the JMF). In Fiscal Year 1996, the NIAID and the JMF plan to fund approximately two to three R01 and/or R29 grants. HEALTHY PEOPLE 2000 The 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 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 Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-783-3238). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Howard B. Dickler, M.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A19 Bethesda, MD 20892-7640 Telephone: (301) 496-7104 Email: hd7e@nih.gov $$P2 END ************************************************************ From owner-sci-resources@net.bio.net Wed Mar 15 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-039 - V24(10) 03/17/95 Date: 16 Mar 1995 15:29:53 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 316 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3kahlh$mln@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95039 PA-95-039 P1O1 *************************************** GENE TRANSFER FOR PRIMARY IMMUNE DEFICIENCY NIH GUIDE, Volume 24, Number 10, March 17, 1995 PA NUMBER: PA-95-039 P.T. 34; K.W. 0745032, 0715120 National Institute of Allergy and Infectious Diseases The Jeffrey Modell Foundation Application Receipt Dates: June 1, and October 1, 1995 and February 1, 1996 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) and the Jeffrey Modell Foundation (JMF) invite investigator-initiated research grant applications specifically targeted to isolation and characterization of defective genes that cause primary immune deficiency diseases and development of the techniques and vectors necessary to transfer these genes into hematopoietic progenitors to correct the defects. 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), Gene Transfer for Primary Immune Deficiency, 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 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 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) (R29) award. MECHANISM(S) OF SUPPORT The mechanisms of support will be the individual research project grant (R01) and the FIRST (R29) award. The total project period for an application submitted in response to this PA may not exceed five years; a foreign application may not request more than three years of support. FUNDS AVAILABLE The estimated funds available for the total (direct and indirect) first-year costs of awards made under this PA, for applications assigned to the NIAID, will be $500,000 ($400,000 from the NIAID and $100,000 from the JMF). In Fiscal Year 1996, the NIAID and the JMF plan to fund two to three R01 and/or R29 grants. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. The usual PHS policies governing grants administration and management, including indirect costs, will apply. Although this program is provided for in the financial plans of the NIAID and the JMF, awards pursuant to this program announcement 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. New applications submitted for the June 1 and October 1, 1995 and February 1, 1996 receipt dates will be eligible for funding under this program announcement. Competing continuation applications for already funded projects will NOT be eligible for award from NIAID and JMF under this PA. Although the NIAID has a continuing interest in the research areas of this PA, the latest anticipated award date with set-aside funds is September 30, 1996. RESEARCH OBJECTIVES Background Research on the immune system and diseases that result from abnormalities of this system are part of the mission of the NIAID. Primary immune deficiency diseases are a heterogenous group of diseases in which immune system dysfunction causes such things as abnormal susceptibility to infection and abnormal inflammatory responses. There are more than 70 such diseases (e.g., Wiscott-Aldrich Syndrome, Ataxia-telangiectasia, Bare Lymphocyte Syndrome) and, although many are rare, it has been estimated that as many as 500,000 individuals in the United States are affected, of whom 5,000-10,000 (primarily children) are severely affected. The genes for most of these diseases have not yet been identified. Morbidity, mortality, medical, and social costs for severely affected individuals and their families are extremely high. The Jeffrey Modell Foundation was started by Vicki and Fred Modell in memory of their son Jeffrey, who died in 1986, at the age of 15, of an inherited immune deficiency. This research foundation provides funding to advance investigations, trials, diagnosis, and clinical services needed for those with primary immunodeficiency diseases. Advances in molecular biology and mapping the human genome provide the opportunity to isolate and clone the defective genes that cause primary immunodeficiency. These advances include isolation of large tracts of the human genome in cloned form, the development of novel strategies to detect genes, and the use of efficient methods of mutation detection. A recent successful example involves cloning of the gene responsible for x-linked agammaglobulinemia. This gene is a previously undescribed member of the SRC family of proto-oncogenes which encode protein-tyrosine kinases. Thus, not only has a gene responsible for a disease been identified, but a whole new area in tissue-specific signalling has been opened. In addition, recent advances in isolation of hematopoietic progenitors from peripheral blood greatly enhance the opportunity for successful gene transfer for correction of the defects in patients themselves. Scope The objective of this PA is to encourage innovative new research targeted at isolation and characterization of the genes that cause primary immune deficiency and development of the techniques and vectors necessary for gene transfer to correct these defects. Some examples of research topics that would be considered responsive to this solicitation include, but are not limited to, the following: o Application of advances in molecular biology and the human genome map to isolate defective genes that cause primary immune deficiency. o Characterization of the structure and function of the products of the defective genes and an indepth understanding of the biochemical and immunologic consequences of the genetic defect. o Development of vectors for efficient and successful transfer of normal versions of the genes that are defective in primary immune deficiency. o Development or improvement of techniques for isolating and growing hematopoietic progenitors and selecting those that have been successfully transfected. These areas of interest are not listed in any order or priority. They are only suggested examples of areas of research. Applicants are encouraged to propose other areas that are related to the objectives and scope of this PA as described above. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and printed in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted on the standard application deadlines as indicated in the application kit. Requests for continued funding of already funded projects (Type 2) will NOT be considered under this program announcement. Applications may be submitted for the following receipt dates only: June 1, and October 1, 1995 and February 1, 1996. Awards resulting from this program announcement will be made on or about April 1, July 1, and September 30, 1996. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. Each application must be identified by checking "YES" on line 2a of the PHS face page, and the number and title of this program announcement must be typed in section 2a. The completed original and five legible, single-sided copies of the application must be sent or delivered to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express mail or courier service) 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 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. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria 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 the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications assigned to the NIAID will compete for available set-aside funds provided by the NIAID and the JMF. The following will be considered when making funding decisions: quality of the proposed project as determined by peer review, program balance among research areas of the program announcement, and 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: Howard B. Dickler, M.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A19 Bethesda, MD 20892-7640 Telephone: (301) 496-7104 FAX: (301) 402-2571 Email: hd7e@nih.gov Direct inquiries regarding fiscal matters to: Maryellen Connell Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B28 Bethesda, MD 20892-7610 Telephone: (301) 496-7075 FAX: (301) 480-3780 Email: mc40u@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.855 - Immunology, Allergy and Transplantation 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. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the phs mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Wed Mar 15 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HD-95-008 - V24(10) 03/17/95 Date: 16 Mar 1995 15:30:20 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 789 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3kahmc$mmp@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HD95008 HD-95-008 P1O1 *************************************** COOPERATIVE SPECIALIZED INFERTILITY RESEARCH CENTER PROGRAM NIH GUIDE, Volume 24, Number 10, March 17, 1995 RFA: HD-95-008 P.T. 04; K.W. 0413002, 0710030, 0785035 National Institute of Child Health and Human Development Letter of Intent Receipt Date: May 15, 1995 Application Receipt Date: October 11, 1995 PURPOSE The National Institute of Child Health and Human Development (NICHD) invites applications from investigators willing to participate with the NICHD under a cooperative agreement in a multicenter cooperative research program termed the National Cooperative Program for Infertility Research (NCPIR). The objective of this Program is to expedite the development of new approaches for the diagnosis and treatment of human male or female infertility. Recognizing that the complexity of infertility research severely limits the progress that can be achieved by individual investigators working alone, the NICHD will support at least two Centers comprised of biomedical research projects and technical service core facilities that are interactively organized to conduct accelerated preclinical and clinical research and development studies on promising new leads in human infertility research. The Centers will also serve as national resources for the career development of young scientists electing to pursue research in high priority areas of infertility research. The benefit of this activity will be to the infertile couples, their health-care providers, and the public. 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), Cooperative Specialized Infertility Research Center Program, is related to the priority area of family planning. 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 REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, that meet the requirements stated in this RFA. Minority individuals, persons with disabilities, and women are encouraged to apply as Principal Investigators. The need for continuous and active communications and interactions among the awarded sites dictates that only institutions in the United States will be eligible for these Center grant awards. MECHANISM OF SUPPORT The funding mechanism to be used to assist the scientific community in undertaking this Program of applied human biology research will be the National Institutes of Health (NIH) cooperative specialized center (U54) mechanism. Funding will be provided by means of cooperative agreements established between the participating Centers and the NICHD. A cooperative agreement is not an "acquisition" mechanism. It is an "assistance" mechanism in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activities conducted by the awardee. Under a cooperative agreement, the NIH purpose is to support, stimulate, and expedite the recipient's activities by jointly being involved with them. NIH staff work cooperatively with the award recipients in a partner role and do not assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships, and governance of the activities to be funded under the cooperative agreements awarded for this Program are discussed later in this document under the section "Terms and Conditions." The total project period for an application submitted in response to this RFA may not exceed five years. The anticipated award date is September 1, 1996. 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. Awards and levels of support depend on the receipt of a sufficient number of applications of high scientific merit. Although the Program is provided for in the financial plans of the NICHD, awards pursuant to the RFA are contingent upon the availability of funds for this purpose. This RFA is a one-time only solicitation for the purpose of the present competition. At this time, the NICHD has not determined whether or how this Program will be continued beyond the present solicitation. Any future NICHD determination in this regard will be publicly announced. FUNDS AVAILABLE It is anticipated that an estimated total of $3,040,000 (including indirect and direct costs) will be available for the entire program for the first year of the Program. It is planned that these funds will support at least two Center awards. In addition to new applications received in response to this solicitation, up to two competing continuation (renewal) applications are expected to compete for these two Center awards. RESEARCH OBJECTIVES Background It has been estimated that infertility affects between 35 and 70 million married couples, who would like to have children, around the world (World Health Organization, 1988 data). In U.S. studies described nearly 50 years ago, it was stated that 10 percent of married couples were "sterile," while the remaining 90 percent possessed varying degrees of fertility. More recent studies (National Center for Health Statistics, 1988 and 1990 data) in the U.S. have conservatively indicated that there are 2.3 million infertile couples, about nine percent of the domestic married couple population base with wives aged 15 to 44. In addition, it has been observed that about 4.9 million U.S. women in this age range had an impaired ability to have children. While analyses of the U.S. population base has not found alarming increases in either the number of infertile couples or the overall incidence of infertility, physician office visits reflecting societal life style requirements for infertility services have markedly increased from 1968 (600,000) to 1988 (1,350,000) with a projected peak in 1995 approaching 1,800,000. Of the infertile couples seeking medical treatment for infertility, it has been estimated that up to one-half will be unsuccessful in achieving their desired outcome. Human infertility is generally accorded to female factors (40 percent), male factors (40 percent), male and female factors (10 percent) or unexplained infertility factors (10 percent). Current therapy results for male factor infertility have been discouraging. One earlier British study reported only a 20 percent chance of a successful pregnancy within two years and no significant improvement of this chance with the use of therapeutic insemination, husband (TIH). Potential applications of assisted reproductive technology aimed at male infertility alleviation, such as Intracytoplasmic Sperm Injection have not been well researched yet. Varicocele is a progressive disorder affecting 15 percent of pubertal boys. While evidence suggests many, but not all, of the men affected by this disorder experience infertility, the underlying pathophysiology and effective treatment approaches are not well understood. Ovulation failure has been reported to be the underlying cause for at least 25 percent of female factor infertility. A specific cause for anovulation is usually not able to be determined. Chronic anovulation predisposes the female to infertility and compromises fecundity if not detected and treated early. Recent findings also indicate that current ovulation inducing fertility drug treatments may carry, in certain circumstances, underappreciated risks to the female (hyperstimulation, ovarian cancer) and the child (multiple gestation, low birth weight prematurity consequences) associated with medically assisted conception procedures. In reproductive aged females, it has been estimated that the general incidence of endometriosis is 5 to 15 percent. For women being surgically treated for infertility, the incidence is 30 to 50 percent. Among infertile females with no other known cause of their infertility, the incidence has been reported at 40 to 70 percent. The causative role of endometriosis in infertility is poorly understood at present and optimal diagnosis and treatment of endometriosis has yet to be attained. The role of dysfunctional uterine bleeding, either in the presence or absence of uterine myomata, is not well understood with respect to infertility. Uterine myomata occur in nearly 20 percent of all reproductive aged women, are the single most common diagnosis >From gynecological hospital admissions, may be the only clinical abnormality observed in an infertile couple, and represent the most common medical indication for an often unwanted hysterectomy that prematurely ends a females reproductive option. Objectives It is the primary objective of the cooperative research program described in this RFA to meet the nationally identified need for a coordinated infertility research program that will accelerate the translation of promising new preclinical or clinical leads into new clinical methods available to the public. The need for accelerated basic and clinical research on the diagnostic and therapeutic aspects of infertility alleviation or cure has been extensively considered in a number of relevant reports ("Infertility: Medical and Social Choices," Office of Technology Assessment of the Congress of the United States, Publication OTA-BA-358, May 1988; "Infertility in America: Why is the Government Ignoring a Major Health Problem?," Report of the House Committee on Government Operations, December 1989; and "Medically Assisted Conception: An Agenda for Research," Report of the Institute of Medicine of the National Research Council, 1989.) Legislative directives included in the deliberations of the 101st U.S. Congress stressed the need to enhance support for research on the diagnostic and therapeutic aspects of infertility alleviation (Resolution HJ 173, Bill HR 2956). Such directives were restated in the respective appropriation committee reports issued by the 102nd U.S. Congress. The NIH Reauthorization Act of 1993 issued from the 103rd U.S. Congress and enacted on June 10, 1993, as PL 103-43 (Title X., Subtitle A., Section 1001) authorized the Director, NICHD, to make grants or contracts for the operation of two Centers to conduct activities for the purpose of improving methods of diagnosis and treatment of infertility and to provide for the coordination of the Centers assisted under this section. The terms of PL 103-43 acknowledge that infertility research and development problems are so complex that they can not be solved by individual investigators working alone and that "without specialized centers, promising new leads may never be translated into new methods or ever made available to the public." The operational requirements to be met by such Centers are further detailed in the subsequent section of this RFA. Research Scope The scope of the research projects expected to be pursued by a proposed Center's research plan should address studies organized with an orientation to either female factor or male factor infertility research. Although it is anticipated that the overall NCPIR cooperative research program may be expanded by one or more Centers in the future, to accommodate a broadened range of studies, the two Centers to be awarded from this RFA are expected to be oriented toward either research on the early diagnosis and/or therapy of those female factors that most contribute to infertility (endometriosis, ovulatory dysfunction, uterine dysfunction) or those male factors associated with ineffective sperm production (quality or quantity) or function. Research proposals for projects or cores directly involving human in vitro fertilization and/or embryo transfer must be in compliance with NIH policies for such research and should not, therefore, include efforts or activities that create human embryos solely for research purposes. As a cardinal principle, the current Center organization should consist of multidisciplinary projects and/or cores capable of interacting in a coordinated, cooperative fashion. Each Center should organize its overall research plan to include a mix of primary clinical and closely adjunctive preclinical research activities. Applicants should note that it is not the intent of this cooperative research program to fund a collection of diverse, noninteractive projects. Awards will not be made for applications with research activities focused exclusively on basic research or clinical research. It is not intended for the Centers to conduct epidemiological research or large clinical trials. Applicants should particularly note that the NICHD currently supports a separately established cooperative research program, called the Reproductive Medicine Clinical Trial Network (RMN) for conducting national clinical research trials of experimental protocols and it is not the intent of the present NCPIR cooperative research program to support additional large-scale, long-term clinical trials. It is anticipated, however, that progress achieved by the NCPIR Centers may lead to collaborating interactions with the existing RMN group. The scope of the Centers requested in the present RFA is expected to include a program of applied human biology involving clinical research projects and requisitely adjunctive preclinical projects and/or cores that may prove translational in moving research progress >From the bench into the clinic. Within the requirement for a minimum of three funded projects to constitute a Center award, an applicant's research plan might, for example, include a set of clinical research projects and related animal model projects to study infertility-related aspects of endometriosis. Alternately, an applicant's research design strategy may include projects involving clinical and preclinical animal investigations of several different types of infertility-associated ovulation failure. Another orientation might be toward male spermatogenesis failure. Yet another orientation of scope might encompass comparative clinical and preclinical experimental evaluations of in vitro fertilization and embryo transfer protocols. Research proposals for projects or cores directly involving human in vitro fertilization and/or embryo transfer must be in compliance with NIH policies for such research and should not, therefore, include efforts or activities that create human embryos solely for research purposes. These examples are only indicative of general strategy designs and should not be taken as an inclusive or exclusive preference of the NICHD. Guidance and Management Structures The National Cooperative Program for Infertility Research (NCPIR) will include two Centers supporting an aggregate of up to ten to twelve research projects and two or more technical service cores. At least one clinical project and an administrative core will reside in the sponsoring department of the grantee institution awarded a Center grant. As the Centers may be consortium-based, other research projects may be resident at domestic U.S. institutions other than the grantee institution. A Steering Committee consisting of the investigators responsible for each project, the Principal Investigator of each Center, an NICHD staff Research Coordinator, and a nongovernment chairperson designated by the Steering Committee will assist and guide the conduct of the research performed by the Centers. A nonvoting member of the NICHD grants management staff will serve as an advisor to the Committee. The Steering Committee will employ a consensus decision process to assist the Centers in evaluating the progress of Center projects, proposed new research initiatives, the need for extra-Center collaborations and the need to redirect certain Center efforts due to either sufficient data acquisition to permit conclusion, the acquisition of data supporting an alternative study initiative or experience proving that proposed research is no longer feasible. Further details of the guidance and management structures and processes may be found in the Terms and Conditions section below. Description of a Center The minimal requirements for the Centers described in this RFA are as follows (see also Review Criteria and Procedures below): o Competent and experienced principal investigator who is committed to and directly involved in human infertility research; o Availability of competent and experienced scientific experts to direct individual research projects or cores associated with the proposed Center; o Availability of the technical resources and facilities necessary for the conduct of the experiments; o Access to properly managed animal facilities for projects conducting animal studies; o Access to inpatient and outpatient reproductive health care units providing adequate numbers of patients for clinical research projects (Applicants from institutions which 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. In such a case, a letter of agreement from either the GCRC program director or principal investigator should be included with the application); o A research environment conducive to the training of new investigators in infertility research; o Willingness to cooperate in a coordinated cooperative research program involving two or more Centers with multiple interacting research projects, and if required, service cores; o Substantive evidence of departmental and institutional support for and commitment to the proposed Center. SPECIAL REQUIREMENTS Contents of Applications A response to this RFA should consist of a proposal that includes: o A description of a National Center for Infertility Research (NCIR) consisting of multiple individual research projects and, as justified, one or more core service facilities. For suggested formatting instructions see the document, "Suggested Format for NICHD U54 Grant Applications," available from the program staff listed under INQUIRIES. o A description of the capabilities of the Center to meet or exceed the minimal requirements stated earlier (see DESCRIPTION OF A CENTER above). o A proposed five-year research plan that presents the applicant's perception of the Center's organization and component functions. This plan should demonstrate the applicant's knowledge, ingenuity, practicality, and commitment in organizing a multiproject research infrastructure for conducting studies aimed at developing new approaches to the diagnosis and/or therapy of human infertility. The research plan for the Center and all component projects must address the "Research Scope" described earlier. For the 02 through 05 years of the overall Center research plan, the plan should include (for peer review evaluation) at least one and no more than two "New Program Development" (NPD) research projects directly related to the overall research emphasis of the Center, which will provide up to $75,000 total cost per annum to new investigators who have not been the Principal Investigator of a funded NIH (or comparable) research project grant award. The initial NPD project(s) should be presented as a two-year research project by a named new investigator. NPD project investigators may be resident at either the grantee or a participating consortium institution. For each successfully competed NPD project, the NICHD will include a full four years of budgeting support to permit renewal of a continuing project or replacement by a new NPD project in accord with the consensus decision process of the NCPIR Steering Committee. Optimal components of the Center organization include the mix of local and external projects or cores to be included in the Center as follows: o Principal investigators may consider organizing the Center to attack a problem from different disciplines using collaborations between institutions via consortium subcontract arrangements for projects at other institutions. Centers may thus seek to maximize their scientific expertise and research capabilities by including in the application new projects or technical service cores to be supported at other institutions through subcontracted consortium arrangements. o The Principal Investigator may choose to organize the Center using collaborations of projects within the same institution. o The Principal Investigator of the Center may wish to incorporate into the application a highly relevant individual NIH research project, which is currently ongoing and deemed appropriate for transfer into the Center. Such a project may be fully presented in the Center application as a renewal project and, contingent upon the review outcome, become eligible for funding through the Center upon relinquishment of the prior awarded project. Irrespective of the organizational mix selected by the Principal Investigator, each research project or core proposed for inclusion in the Center must be described independently using the PHS 398 application format as described in Appendix A of this RFA. For the individual projects or cores, the page limits stated in the PHS 398 instructions must be followed. The overall Center application must also use the PHS 398 format to provide at the beginning of the application an overall summary of the Center's organization and cumulative aggregate budgeting for the various budgetary categories. In both instances, all essential information for the evaluation of the application must appear in the body of the application rather than in an appendix. Terms and Conditions of Award The following terms and conditions of the award, and details of the arbitration procedures pertaining to the scope and nature of the interaction between the NICHD and the participating Centers will be incorporated into the Notice of Grant Award and provided to the Principal Investigator as well as the institutional official at the time of award. These procedures will be in addition to the customary programmatic and financial negotiations which occur in the administration of grants. 1. The purpose of these cooperative agreements is to establish new methods for the diagnosis or therapy of human infertility. 2. Planning and implementation of the studies will be done by a Steering Committee consisting of the Principal and Project Investigators from each of the participating Centers, one NICHD staff member from the Reproductive Sciences Branch, CPR, NICHD, who will be the Research Coordinator and Collaborator, and a nongovernment Chairperson, who will be a nonvoting member, as designated by the Steering Committee. A member of the NICHD grants management staff will serve as a nonvoting advisor to the Committee. The Steering Committee meetings will be convened at least twice yearly. The purpose of these meetings is to share scientific information, assess scientific progress, identify new research opportunities, establish priorities that will accelerate the translation of preclinical findings into clinical applications, and conduct the business of the cooperative research program. 3. The primary authorities and responsibilities of the awardees are to participate cooperatively with the Steering Committee in the following activities: o Determine objectives and experimental approaches; o Design protocols; o Conduct experiments and collect the resulting data; o Analyze results and interpret the results; o Present results and plans to the Steering Committee; o Publish results, conclusions, and interpretation of the studies; and o Modify, delete, or add protocols within the Program Awardees will retain custody of and primary rights to their data developed under the award subject to current government policies regarding rights of access as consistent with current HHS, PHS, and NIH policies. The awardees agree to accept the coordinating role of the Steering Committee and the cooperative nature of the group process. 4. The degree of programmatic involvement of the Research Coordinator is as follows: o Participation in the group process setting research priorities, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted. The Research Coordinator will assist and facilitate the group process and not direct it. o Providing, as a member of the Steering Committee, assistance by reviewing and commenting on all transitional phases of the Centers' activities prior to implementation to assure consistency with required program goals and compliance with research protocol priorities. This includes efforts to improve and strengthen inter- and intra-Center cooperation amongst the research projects of the Centers as well as interactions with industry. The Research Coordinator will, as required, help redirect program efforts, including options of modifications or terminations by mutual consent between the Program and NICHD. In the event of disagreements among the Program participants, the Research Coordinator will assist in forming an arbitration panel as discussed below; o Retaining the option to recommend the withholding of support from a Center project or core materially failing to meet the technical performance requirements established by the Program. This includes identifying jointly with participants the need to add additional research projects or service cores to Centers or to phase out a Center project or core when performance standards have not been met; and o Participating in data analyses, interpretations, and where warranted, co-authorship of the publication of results of studies conducted by a Center to the research community and health care recipients. 5. Arbitration When agreement between an awardee and NICHD staff cannot be reached on scientific/programmatic issues that may arise after the award, an arbitration panel will be formed. The panel will consist of one person selected by the Principal Investigators, one person selected by NICHD staff, and a third person selected by these two members. The decision of the arbitration panel, by majority vote, will be binding. This special arbitration procedure in no way affects the right of an awardee to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. 6. Cooperative agreements are assistance mechanisms and are subject to the same administrative requirements as grants. The above special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS, PHS, and NIH grant regulations, policies and procedures, with particular emphasis on HHS regulations at 45 CFR Part 74 and 92. Business management aspects of these awards will be administered by the NICHD Grants Management section in accordance with HHS, PHS, and NIH grant administration requirements. 7. The level of support recommended for future years is subject to negotiation and the availability of funds. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subject, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide further discussion concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by May 15, 1995, 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 NICHD 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. Michael E. McClure at the address listed under INQUIRIES. APPLICATION PROCEDURES All applicants must document their ability to meet or exceed the minimum requirements as set out in the DESCRIPTION OF A CENTER section and meet or exceed those in the SPECIAL REQUIREMENTS section as detailed above. This specifically includes understanding of and commitment to the cooperative nature of this Program. Any competing renewal application should include in the progress report section a description of how the Center has met the special cooperative agreement terms and conditions of the award, including its interaction with other NCPIR Center projects and the NICHD Research Coordinator. Applications 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 appropriate. If so, a letter of agreement >From either the GCRC program director or principal investigator could be included with the application. The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these awards. These forms are available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248. Additional suggestions for formatting the application into a Center grant application are provided in the document "Suggested Format for NICHD U54 Grant Applications," which is available from the 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 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, COOPERATIVE SPECIALIZED INFERTILITY RESEARCH CENTER GRANT, and number, RFA HD-95-008, must be typed on line 2a of the face page of the application form and the YES box must be checked. On line 2b, type U54. 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 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express mail or courier service) At the time of submission, two additional copies of the application must be sent to: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development Building 61E, Room 5E03 Bethesda, MD 20892 Applications must be received by October 11, 1995. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA 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. Schedule Letter of Intent Receipt Date: May 15, 1995 Application Receipt Date: October 11, 1995 Initial Review Group Peer Review: February/March 1996 NACHHD Council Review: June 4, 1996 Earliest Award Date: September 1, 1996 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by NICHD staff. Incomplete applications will be returned to the applicant without further consideration. Any application that does not meet the minimum requirements in the DESCRIPTION OF A CENTER and SPECIAL REQUIREMENTS sections of this RFA will be considered unresponsive to the RFA and returned to the applicant. Applications that are complete and responsive to the Request for Applications will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NICHD in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the National Advisory Child Health and Human Development Council. Review Criteria Evaluation of the applications will be based upon the following: 1. Qualifications, experience, and commitment of key personnel, particularly, but not exclusively, in the area of the proposed research o Scientific, clinical, and administrative abilities of the Principal Investigator and other key participants; o Knowledge and experience of the Principal Investigator and other key investigators in areas relevant to the conduct of the experiments proposed; o Documented commitment time for the proposed studies and the specifically stated and described willingness of the Principal Investigator and the key investigators to work and collaborate with other Centers and with NICHD assistance in the manner summarized in this RFA; 2. Protocols and Procedures o Scientific merit of the application and its component projects and cores, including ethical issues relating to human subjects o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o Responsiveness of the application to the research objectives of the Program outlined in this RFA; o Willingness to work and cooperate with other Centers and the NICHD in the manner summarized in this RFA. 3. Facilities and Management o Adequacy of administrative, clinical, and technical capabilities to conduct the research proposed; o Adequacy of animal facilities and appropriateness of animal care management where animal work is proposed; o Adequacy of clinical facilities and appropriateness of patient care management where clinical work is proposed; and o Institutional assurance to provide support to the Center in such areas as fiscal administration, personnel management, space allocation, procurement, planning, and budgeting. 4. Budgeting Appropriateness of the proposed budget and duration in relation to the proposed research. AWARD CRITERIA The anticipated date of award is September 1, 1996. Applications approved by the NACHHD Council will be considered for award based on scientific and technical merit; compatibility of features to make a successful collaborative program a reasonable likelihood; program balance; and availability of funds. In order to be eligible for an award, an application must have at least three fundable projects, at least two of which are entirely or predominately clinical research projects. If the consortium option described in this RFA is employed, at least one clinical research project and the administrative core must reside at the institution submitting the application. Awards will not be made for applications with research activities focused exclusively on clinical research or exclusively on basic research or for applications proposing epidemiological or large scale clinical trial research. 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: Michael E. McClure, Ph.D. Center for Population Research National Institute of Child Health and Human Development Building 61E, Room 8B01 Bethesda, MD 20892 Telephone: (301) 496-6515 FAX: (301) 496-0962 Email: MCCLUREM@HD01.NICHD.NIH.GOV Direct inquiries regarding fiscal matters to: Ms. Melinda Nelson Office of Grants and Contracts National Institute of Child Health and Human Development Building 61E, Room 8A17 Bethesda, MD 20892 Telephone: (301) 496-5481 FAX: (301) 402-0915 Email: NELSONM@HD01.NICHD.NIH.GOV AUTHORITY AND REGULATIONS This Program is described in the Catalog of Federal Domestic Assistance number 13.864, Population Research. Awards will be made under the authority of the Public Health Service Act, Title X, Section 1004 (Public Law 92-572, as amended; 42 USC 241) and Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241). These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Part 74, and other HHS, PHS, and NIH grant administration policies. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the phs mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Wed Mar 15 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-038 - V24(10) 03/17/95 Date: 16 Mar 1995 15:30:13 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 340 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3kahm5$mmc@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95038 PA-95-038 P1O1 *************************************** NEUROSCIENCE RESEARCH OF NICOTINE AND NICOTINE ABUSE NIH GUIDE, Volume 24, Number 10, March 17, 1995 PA NUMBER: PA-95-038 P.T. 34; K.W. 0404001, 0404019, 1002030, 0710085 National Institute on Drug Abuse PURPOSE The purpose of this program announcement is to encourage research to examine the many aspects of nicotine abuse/addiction in in vitro or in vivo systems, in animals, and in man. The research may be based upon behavioral, neurophysiologic, neurochemical, or other methods that will seek to explain nicotine use. The overall goal is to further our understanding of the brain mechanisms that underlie addictive processes, with an eventual target of developing specific treatments for the abuse/addiction of nicotine in man. 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, Neuroscience Research of Nicotine and Nicotine Abuse, is related to the priority area of tobacco. 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 REQUIREMENTS 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT The mechanism available for support of this program announcement is the regular research project grant (R01). Because the nature and scope of the research proposed in response to this program announcement may vary, it is anticipated that the size of an award will vary also. RESEARCH OBJECTIVES Background Throughout history, man has maintained the ubiquitous habit of smoking, ingesting, or otherwise using tobacco products. The most common usage is inhalation of the smoke, with approximately 27 percent of the United States population lighting up cigarettes, cigars, and pipes on a regular basis. (1) Nicotine, the major pharmacologic agent in tobacco, is widely accepted to be the primary cause of this habit (2,3). In the 1964 report of the Advisory Committee of the U.S. Surgeon General on Smoking and Health, (3) the WHO Expert Committee criteria were used as the basis for viewing tobacco as a "habit" rather than an addiction. The primary reasons for the decision to define smoking, even heavy or compulsive smoking, as a habit was because of the absence of clear-cut nicotine-induced signs of physical dependence (withdrawal) in animal models, and of the belief that symptoms observed when smokers stopped using tobacco were "secondary to the deprivation of a desired object" rather than a specific nicotine-induced withdrawal effect, and of the variable duration of these cessation symptoms. Furthermore, there was the belief that the obvious tolerance that smokers showed for tobacco was of "low grade," and that a variety of interventions that appeared to help the motivated smoker in quitting this "habit." In this historic document, it was implied many times (but never actually stated) that the primary reason that people smoked tobacco was to obtain nicotine. Subsequent reports from the Surgeon General and from other prestigious national and international forums (including the Royal College of Physicians, (4) the American Psychiatric Association and the World Health Organization have left little doubt as to the addictive nature of nicotine. These were summarized in the 1988 Surgeon General's Report which incorporated more than 2500 published papers and the contributions of more than 50 scientists, and presented three major conclusions: 1. Cigarettes and other forms of tobacco are addictive, 2. Nicotine is the drug in tobacco that causes addiction, and 3. The pharmacological and behavioral processes that determine tobacco addiction are similar to those that determine addiction to drugs such as heroin and cocaine. Because of the widespread use of cigarettes and other nicotine-containing products and the recent suggestion that nicotine may be "as addictive as cocaine", the National Institute on Drug Abuse (NIDA) is seeking additional research into the many different effects of nicotine. Areas of Research Areas of research interest in this program announcement range from the in vitro biochemical and neurochemical determinations of the effects of nicotine in model systems, to in vivo studies investigating the behavioral or physiologic effects of nicotine in animals and in man. In general, these may include: o An examination of the cholinergic mechanisms involved, both peripherally and centrally, in the effects of nicotine. o Further investigations of the subtypes of nicotinic cholinergic receptors (alpha, beta, delta and gamma), and their correlation with function. o Neurobiologic and/or neurochemical techniques that utilize the underlying mechanisms of nicotine to understand the use/abuse of this substance. o Studies of individual sensitivities of animal or human systems toward the behavioral or physiologic effects of nicotine. o The development of new animal models of smoking that correlate with the human pattern of nicotine self-administration. o A comparison of the neuroanatomical sites and the neurochemical substrates in the addictive behavior of nicotine. o Effects of nicotine on cognitive performance, perception, vigilance, memory and motor skills. o Neurotoxicologic effects of nicotine in animals and/or man. o Effects of prenatal nicotine on development and social behaviors in the offspring. o Human studies on the prevalence of nicotine addiction in society and its role in fostering attitudes towards other drugs of abuse. o Autoradiographic or computer imaging studies of tobacco smoking/nicotine administration. o A comparison of behaviors (craving/withdrawal/relapse) of nicotine and other abused drugs. These areas of research are not intended to be all-inclusive, but are designed to give the applicant some direction for the types of research that NIDA is interested in exploring in its search to understand the basic mechanism(s) of nicotine abuse, as well as other abused drugs. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff also provide additional relevant information concerning the policy. 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 at most institutional offices of sponsored research and may be obtained from the Office of Grant Information, 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 program announcement must be typed in Item 2a of face page of the application. 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. The completed original application and five legible copies of the application must be sent or delivered to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 If overnight delivery is used, the zip code is 20817. REVIEW CONSIDERATIONS Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate advisory council or board. Review Criteria: 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 proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; and o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animals subjects, and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the Institute. The following will be considered in making funding decisions: o quality of the proposed project as determined by peer review, o availability of funds, o programmatic priorities, i.e., o relevance to program goals and objectives as described in the Areas of Research Interest in the program announcement. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: David N. Johnson, Ph.D. Division of Basic Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-19 Rockville, MD 20857 Telephone: (301) 443-6975 FAX: (301) 594-6043 Email: dj42n@nih.gov Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: gfleming@aoada.ssw.dhhs.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of Section 301 of the Public Health Service Act (42 USC 241) and administered under PHS policies and Federal Regulations at Title 42 CFR 52 "Grants for Research Projects," Title 45 CFR Part 74 & 92, "Administration of Grants" and 45 CFR Part 46, "Protection of Human Subjects." This program is not subject to the inter- governmental review requirements of Executive Order 12372 or Health Systems Agency review. Sections of the Code of Federal Regulations are available in booklet form from the U.S. Government Printing Office. Grants must be administered in accordance with the PHS Grants Policy Statement, (rev. 4/94), which may be available from your office of sponsored research. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. Bibiolography 1. U.S. Dept. of Health and Human Services. National Household Survey on Drug Abuse: Main Findings 1990. DHHS Publication # (ADM) 91-1788. Washington, D.C. United States Government Printing Office, 1991. 2. Nicotine Psychopharmacology (eds: S. Wonnacott, M.A.H. Russell, I.P. Stolerman) Oxford Science Publications, p. 25, 1990. 3. Reducing the Health Consequences of Smoking: Nicotine Addiction. A Report of the Surgeon General. Rockville, MD. DHHS Publication # (CDC) 88-8406. Washington, DC United States Government Printing Office, 1988. 4. Henningfield, JE, C Cohen and JD Slade. Is nicotine more addictive than cocaine? Br. J. Addiction 86: 565-569, 1991. From owner-sci-resources@net.bio.net Wed Mar 15 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AI-95-011 - V24(10) 03/17/95 Date: 16 Mar 1995 15:30:01 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 428 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3kahlp$mm0@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AI95011 AI-95-011 P1O1 *************************************** MUCOSAL AND SYNOVIAL GENE TRANSFER IN INFECTION/INFLAMMATION NIH GUIDE, Volume 24, Number 10, March 17, 1995 RFA: AI-95-011 P.T. 34; K.W. 1002008, 0745032, 0715026, 0715120 National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases Letter of Intent Receipt Date: July 15, 1995 Application Receipt Date: November 15, 1995 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) of the National Institutes of Health (NIH) invite submission of investigator-initiated research applications for basic and preclinical studies targeted at molecular methods for transferring genes into cells of mucosal membranes and synovial tissues to augment host defenses and alter inflammatory responses for the treatment or prevention of infectious and rheumatic and other immunologic 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 Request for Applications (RFA), Mucosal and Synovial Gene Transfer in Infection/Inflammation, 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 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 Applications may be submitted by domestic and foreign, 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 institutions are not eligible to apply for First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The mechanisms of support will be the individual research project grant (R01) and the FIRST (R29) award. The total project period for an application submitted in response to this RFA may not exceed five years; a foreign application may not request more than three years of support. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. This RFA is a one-time solicitation. Future competing renewal applications will compete with all investigator-initiated applications and will be reviewed according to customary referral and review procedures. The National Heart, Lung, and Blood Institute (NHLBI) also has interest in supporting applications concerned with gene transfer to respiratory cells for the purpose of modulating host defense processes and inflammatory responses which may apply to treatment or prevention of infectious or inflammatory diseases. For applications of mutual interest, the NHLBI is likely to be given a secondary assignment in accordance with DRG Referral Guidelines. FUNDS AVAILABLE The estimated funds available for the total (direct and indirect) first-year costs of all awards made under this RFA will be $950,000, $750,000 from the NIAID and $200,000 from the NIAMS. In Fiscal Year 1996, the NIAID plans to fund approximately three to four R01s and/or R29s and the NIAMS plans to fund one R01/R29. The NIH is currently limiting annual inflationary increases to no more than four percent for future years of awards. 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 Background The pathogenesis of many infectious diseases involves a combination of mucosal colonization, production and release of toxins and invasion of tissue. Both host and microbial factors that may contribute to or limit infection are now being understood at molecular and genetic levels. Among these are microbial adhesins and virulence factors important for attachment and penetration of host tissues; opsonic factors and host cell surface molecules involved in microbial adherence and uptake; antimicrobial peptides of phagocytic and mucosal cells; host cellular factors that may alter microbial metabolism as well as microbial toxins that may mediate inflammation through effects on host cell metabolism. Gene transfer into mucosal cells offers the potential to modify the course of infectious diseases by altering the expression of factors that participate in host/pathogen interactions. Potential advantages might include an ability to change colonization and tissue invasion in clinical situations where effective antibiotics are lacking; providing antimicrobials in high concentrations at critical sites; and altering cell turnover in targeted tissues (increased resistance). The ability to transfer into mucosal cells genes that encode molecules that are anti-microbial, anti-inflammatory, or vaccine epitopes would confer enormous advantages in treating or preventing infectious and immunologic diseases. Mucosal gene transfer could be a useful adjunct in a variety of clinical situations including: (a) viral, bacterial, fungal or parasitic infections of the respiratory and gastrointestinal tracts; (b) infection of the genitourinary tract and sexually transmitted diseases (STDs); (c) intrabdominal and post surgical wounds as well as decubitus ulcers; (d) mucosal vaccination with recombinant immunogens; (e) noninfectious inflammatory disorders involving mucosal tissues such as asthma; and (f) introduction of self molecules into the gastrointestinal tract for induction of tolerance in autoimmune diseases. In the case of rheumatic diseases such as rheumatoid arthritis, delivery of genes to the synovial membranes may induce significant local changes to reduce inflammation and limit tissue destruction and disability. Advantages include: delivery of the active molecule to the optimal site; high concentrations of therapeutic agent; continuous presence of this molecule for days or weeks; and a defined end of exposure to the molecule (due to cellular turnover). In experimental systems of rheumatoid arthritis, the approach has shown promising results. Research Objectives and Scope While exciting advances have occurred in gene therapy, much of the work has focused on hematologic cells or the cells of solid organs and less effort has been focused on mucosal cells. The main work in the area concerns introducing the cystic fibrosis gene into respiratory epithelial cells. The aim of this RFA would be to support basic research leading to gene transfer intended to augment host defense at mucosal sites. Relevant research includes, but is not limited to, the following: o development and characterization of vectors that would efficiently transfer genes into various cells of the respiratory, gastrointestinal or genitourinary tracts and which are safe and suitable for use in humans; o modification and packaging for transfection of genes that encode molecules that are antimicrobials or anti-inflammatory and intended to modify host/pathogen interactions; o modification and packaging for transfection of genes that are useful as immunogenic or toleragenic epitopes for vaccines; o preclinical studies in cell lines and animal models that may prove useful in evaluation of safety and efficacy of such approaches; o modification and packaging for transfection of genes to alter mucosal levels of mediators specific or useful in the treatment of asthma, inflammatory bowel disease and other immunologically mediated disorders of unknown etiology. NOTE: This RFA is not intended to support studies of gene transfer in genetic deficiencies. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH- supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which has been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by July 15, 1995, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator, and the number and title of this RFA. 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 NIH 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. Christopher Beisel 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). These application forms may be obtained from the institution's office of sponsored research or its equivalent and from the Office of Grants Information, 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 (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. 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 "MUCOSAL AND SYNOVIAL GENE TRANSFER IN INFECTION/INFLAMMATION" must be typed in. FIRST award (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. It is highly recommended that the appropriate NIAID or NIAMS program contact be consulted before submitting the letter of intent and during the early stages of preparation of the application. (See program contacts under INQUIRIES). Submit a signed, typewritten original of the application, including the checklist, and three signed, exact, single-sided photocopies, in one package to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express mail or courier service) At the time of submission, two additional exact copies of the grant application and all five sets of the appendix must also be sent to Dr. Beisel at the address listed under INQUIRIES. Applications must be received by November 15, 1995. Applications received after the receipt date will be returned without review. Applications 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 Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. This does not exclude the submission of substantial revisions of an application already reviewed. These applications must, however, include an introduction addressing the previous critique. 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 staff. Incomplete and non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non- competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator and the official signing for the applicant organization will be promptly notified. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council and the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. Review, Council and award dates can be found in "SCHEDULE", below. Review Criteria 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 the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program priorities, 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 6003 Executive Boulevard Bethesda, MD 20892-7640 Telephone: (301) 496-7104 FAX: (301) 402-2571 Email: hd7e@nih.gov Susana A. Serrate-Sztein, M.D. Rheumatic Diseases Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS37G Bethesda, MD 20892-6500 Telephone: (301) 594-5032 FAX: (301) 480-4353 Email: arthrit@ep.niams.nih.gov Direct inquiries regarding review issues, mail two copies of the application and all five sets of appendices, and mail the letter of intent to: Christopher E. Beisel, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C03 6003 Executive Boulevard Bethesda, MD 20892-7610 Telephone: (301) 402-4596 FAX: (301) 402-2638 Email: cb45d@nih.gov Direct inquiries regarding fiscal matters to: Ms. Maryellen Connell Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B28 Bethesda, MD 20892-7610 Telephone: (301) 496-7075 FAX: (301) 480-3780 Email: mc40u@nih.gov Schedule Letter of Intent Receipt Date: July 15, 1995 Application Receipt Date: November 15, 1995 Scientific Review Date: March 1996 Advisory Council Date: May 1996 Earliest Award Date: August 1996 AUTHORITY AND REGULATIONS The program is described in the Catalog of Federal Domestic Assistance, No. 93.855 and No. 93.846. Awards will be made under the authority 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 CRF Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the phs mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Wed Mar 15 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HD-95-006 - V24(10) 03/17/95 Date: 16 Mar 1995 15:29:37 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 780 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3kahl1$mku@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HD95006 HD-95-006 P1O1 *************************************** COOPERATIVE MULTICENTER NEONATAL RESEARCH NETWORK NIH GUIDE, Volume 24, Number 10, March 17, 1995 RFA: HD-95-006 P.T. 34; K.W. 0775013, 0403020, 0730050, 0785035 National Institute of Child Health and Human Development Letter of Intent Receipt Date: April 1, 1995 Application Receipt Date: June 15, 1995 PURPOSE The National Institute of Child Health and Human Development (NICHD) invites applications from investigators willing to participate with the NICHD under a Cooperative Agreement (U10) in an ongoing multicenter clinical program designed to investigate the safety and efficacy of treatment and management strategies to care for newborn infants, particularly those related to management of low birth weight infants. The objective of this program is to facilitate evaluation of these strategies by establishing a network of academic centers that, by rigorous patient evaluation using common protocols, can study the required numbers of patients and can provide answers more rapidly than individual centers acting alone. The NICHD program staff will assist the principal investigators of the Neonatal Research Network and the Advisory Board in identifying research topics of high priority, and in designing and implementing protocols appropriate to the evaluation of optimal management in these areas. It is anticipated that approximately 12 or 13 clinical centers will be involved in the program. 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), Cooperative Multicenter Neonatal Research Network, is related to the priority area of low birth weight. 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 REQUIREMENTS Applications may be submitted by domestic non-profit organizations, public and private. Organizations should have academically-oriented divisions of neonatal medicine. The need for continuous and active communication among sites dictates that only institutions in the United States are eligible to apply. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U10), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activity by involvement in the activity and otherwise working jointly with the award recipients in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreements are discussed later in this document under the section "Terms and Conditions." The total project period for an application submitted in response to the present RFA may not exceed five years. The anticipated award date is April 1, 1996. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of awards will vary also. The number of awards and level of support depend on receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NICHD, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. At this time, the NICHD has not determined whether or how this solicitation will be continued beyond the present RFA. FUNDS AVAILABLE It is anticipated that 12 or 13 awards for Clinical Sites will be made, with an estimated total cost of $3,500,000 (including direct and indirect costs) for the entire program in the first year. Up to ten competing continuation awards and at least three new awards are expected. RESEARCH OBJECTIVES A. Background Modern neonatology medicine has introduced a number of principles of management and innovative methodologies without rigorous use of the controlled observation necessary for their objective evaluation. A major problem has been the balance between assuring prompt implementation of new technologies, procedures, treatments and drugs, and adequate evaluation of their safety and efficacy. Indeed, because of the urgent demands of sick infants, care is often based on limited knowledge of new modalities not subjected to critical studies prior to introduction and use. In a critically ill infant, an innovative idea may be tried which, if the infant's condition improves, may rapidly set a new trend, and become the standard of care. Therefore, the incorporation into the arsenal of therapies frequently is based on limited experience, and their efficacy and/or safety have not been evaluated scientifically. In an attempt to respond to the need for well-designed clinical trials in neonatal medicine, NICHD established a Neonatal Research Network in 1986. Seven university units were selected among respondents to an RFA. The Network Steering Committee, which consists of representatives from each Clinical Center, NICHD staff, and data center staff, evaluated several controversial issues for study. It then selected certain priority areas in which to develop protocols for randomized clinical trials. Protocols on the prevention of sepsis, intraventricular hemorrhage, pulmonary hypertension, surfactant administration, and outcome and resource requirements for very low birthweight (VLBW) infants were initiated. In addition, the Network established a generic data base of infants less than 1500 grams at birth. A Data Monitoring and Safety Committee advises NICHD on research design issues, data quality and analysis, and ethical and human subject protection aspects of protocols. During the second grant period of the Neonatal Research Network (1991-1996), clinical trials were initiated on the prevention or treatment of chronic lung disease, intraventricular hemorrhage, retinopathy of prematurity, and persistent pulmonary hypertension. Studies of VLBW maturity and postnatal growth, the sequelae of the fetal drug exposure, and a standardized follow-up program were also initiated. The NICHD expects that the ongoing clinical trials dealing with the prevention of intraventricular hemorrhage and retinopathy of prematurity, the treatment of persistent pulmonary hypertension, and the follow-up study will continue into the new grant period in existing centers. New protocols may be developed before the Network is refunded. Centers that join the Network in the next award period (beginning April 1, 1996) may participate in the protocols ongoing at that time. The NICHD intends to enable the Network to initiate new protocols within the first year of the next award period. The topics of these protocols will be decided cooperatively by the Steering Committee with advice from the Advisory Board. Areas of interest include all major areas of newborn pathophysiology: cerebral function, pulmonary physiology, gastrointestinal function and nutrition, immunology, etc. Also of interest are the evaluation of drugs in the newborn, the rapid transfer of new technologies to neonatal medicine, strategies to reduce the cost and preserve the quality of neonatal care, and long-term outcome. B. Objectives and Scope There are a number of controversial issues in neonatology that might be clarified by multicenter collaborative research. Funded principal investigators will cooperate with the NICHD program officer in identifying research topics of high priority and in designing protocols appropriate to the evaluation of superior, or even optimal management in these areas. The participating Neonatal Research Network members will be designated as "Clinical Centers" which will recruit, assess and treat subjects under the supervision of the respective Clinical Center principal investigator. The data center will have primary responsibility for data management and analysis for Network research in collaboration with the Steering Committee. C. Guidance and Management Structures The management of the Neonatal Research Network includes three committees whose functions are as follows: 1. A Steering Committee will be responsible for protocol development, assisted by the Advisory Board and the Data Safety and Monitoring Committee. The Steering Committee will have primary responsibility for the conduct of protocols and the preparation of publications. The Steering Committee will be composed of all principal investigators, one representative from the data center, and two NICHD staff. NICHD staff will comprise the Director of the Center for Research for Mothers and Children (CRMC) and a neonatologist from the Pregnancy and Perinatology Branch (Neonatal Research Network program officer). The Neonatal Research Network program officer will be the only voting NICHD staff member of the Steering Committee. An outside chairperson, who is not participating as a principal investigator, will be selected by the NICHD. 2. An Advisory Board will advise the Steering Committee in the identification and prioritization of topics for Network research. The Advisory Board, chosen by the NICHD with the advice of the Steering Committee, will be composed of individuals with expertise in clinical trials, biostatistics, epidemiology, perinatology, and neonatology; the Chairperson of the Steering Committee; and the Director of the CRMC and the Neonatal Research Network program officer. Additional members will participate based on the need for specific expertise. 3. A Data Safety and Monitoring Committee will monitor the safety of ongoing clinical trials and advise on their conduct. It will be established by NICHD and will represent expertise in clinical trial design and conduct, perinatology, neonatology, basic science, and ethics. In addition, the Network has established Policies and Procedures that govern its operations, including publications. These documents are under periodic review, and may be amended and supplemented at the discretion of the Steering Committee. SPECIAL REQUIREMENTS The NICHD invites applications both from current members of the Neonatal Research Network (competing renewal applications) and from prospective members (new applications). Minimum requirements for applicants are as follows (see also Review Criteria and Procedures, below): A. Requirements for Applicants 1. Academic Productivity Provide evidence of recent research productivity by the applicant Clinical Center in previous or present clinical trials, especially of a cooperative, multicenter nature. Specifically, contributions in key areas such as protocol design, patient recruitment, data analysis and interpretation, and publication are important. Applicants who are current Neonatal Research Network members should describe their participation in Network research during the current competitive segment in detail, i.e., studies in which they participated, subcommittee memberships and chairman, percentage of patients eligible for each study, and percentage of eligible patients who were recruited for each study. New applicants should describe their recent participation in at least one randomized clinical trial and one observational study, preferably of a multicenter nature, providing similar information to that requested from current Network members. 2. Neonatology Staffing Participants must be based in a level III neonatal intensive care unit that admits both inborn and outborn patients. Physician staffing of the Clinical Center should include at least four full-time board-certified neonatologists. Provide complete descriptions of their training and qualifications in both clinical care and research, and their previous and current involvement in clinical research. Specifically, the academic status and academic career development pathways should be described. The approximate percentage time protected for research by the academic department should be specified. 3. Available Population Applicant Clinical Centers must have at least 500 admissions per year currently in the unit. No more than 30 percent of admissions should be outborn. Large perinatal centers will be given preference over combined services composed of a small inborn unit and a transfer/tertiary care service. Applicants that have numbers of births near the minimum or have experienced a recent decline in annual admissions, should describe this decline and document efforts to maintain access to an adequate number of neonatal patients for research purposes. The patient population served by the Clinical Center should be characterized by demographics, obstetric parameters, and payment status. Indications should be given of the proportions of various subgroups, including minorities, that have been eligible, and have actually been randomized, in previous or current clinical trials (see also section on Inclusion of Women and Minorities). 4. Maternal Fetal Medicine Unit The Clinical Center should be located in an institution with a perinatal program that delivers high-risk pregnancies and has one or more perinatologists active in clinical research on staff. A history of cooperation between neonatology and obstetrics towards excellence in clinical care, maintenance of a data base, and research productivity should be documented. An obstetrician at the institution who has interest and experience in clinical research and is willing to participate in the Neonatal Research Network should be designated. Such individual(s) must commit to serve as a consultant and possible collaborator in Network research. The academic status and career development pathways of such individual(s) must be described. The organization and service load of the Maternal Fetal Medicine Units at the institution, including its research activities, must be included. 5. Facilities and Clinical Capabilities The applicant Clinical Center should have a full range of pediatric subspecialists, state-of-the-art facilities and clinical capabilities, and excellent support staff. The applicant Clinical Center should include a detailed description of facilities, equipment, and clinical capabilities; pediatric subspecialists and support staff; specialty clinics; laboratory facilities; and imaging capabilities. The availability of an institutional pharmacy and respiratory therapy program capable of supporting clinical research should also be documented. An established neonatal follow-up program with experience in following patients and a designated facility must be in place. The professional staff should include a developmental pediatrician or neonatologist with similar expertise. Specialists available to consult should include pediatric neurology, ophthalmology, orthopedics, surgery; physical and/or occupational therapy; and social services. A system of ongoing follow-up data collection must be documented, as well as established policies and procedures for conducting clinical research in these facilities. All applicants, both new and competing renewals, are also invited to describe briefly any special research strengths that may be relevant to Network research. Such strengths would represent state-of-the-art scientific capabilities that might be shared or made available to the Network, to expand the scientific productivity of the research. For example, an ongoing specialized registry or capabilities in areas such as PET scanning, prenatal diagnosis, molecular biology, and clinical pharmacology constitute some of the relevant strengths that could be included. Special administrative strengths may also be described. For example, both competing and new applications may present the availability of potentially collaborating neonatal units in medical centers with which affiliations have been developed by the applicant institution for clinical research. The same requirements (above) must be met by such affiliated institutions. 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 should be included with the application. A description of whether, and how, policies and procedures may have been modified to support neonatal clinical research in the past must be provided. 6. Perinatal Data System The Clinical Center must have an established neonatal/perinatal data system, preferably computerized, to collect and tabulate statistics. Applicants must provide a detailed description of the variables collected and the data quality and management activities. The applicant should also illustrate how the system has been used recently to plan and perform clinical research. All successful applicants must be willing to provide complete, accurate, and timely data to the Neonatal Research Network generic data base. 7. Research Nurse Staffing A research nurse must be designated for the full-time nurse coordinator position. Also, additional research nursing staff should be available. Provide descriptions of these individuals' training, experience, and involvement in clinical research. 8. Proposed Protocol Concept (new applicants only) To provide peer reviewers and NICHD an idea of the capabilities of investigators, only new applicants must submit a "concept" proposal, briefly (2-3 pages) summarizing a protocol that the applicant might submit to the Network for possible implementation at all Network centers. The proposed "concept" will serve as an indicator of the applicant's ability to participate in the development and design of cooperative protocols in the Network. The "concept" may not actually be performed by the Network, although it is anticipated that funded Neonatal Research Network centers will be invited to submit the "concepts" included in their applications to the Network Steering Committee. For purposes of this RFA only, the protocol "concept" should address ONE of the following topics: a. Strategies to improve the neurologic outcome of VLBW infants (including diagnosis and treatment of acute perinatal asphyxia). b. Treatments to reduce the risk of chronic lung disease. c. Strategies to reduce the cost while preserving the quality of neonatal care. The "concept" should also demonstrate use of the applicant's perinatal data system to estimate numbers of available patients eligible for the protocol at their institution. The "concept" should also address relevant ethical issues and the appropriate inclusion of minorities as subjects. 9. Intent to Participate There must be a clearly expressed intent to participate in a cooperative manner with other Neonatal Research Network Clinical Centers, the NICHD, and the data center, in all aspects of Network research, as outlined in this RFA. 10. Departmental and Institutional Commitments The departmental and institutional commitments to collaborative neonatal/perinatal research should be clearly documented by letters to the Principal Investigator, and by citing evidence of past support. 11. Acceptance of Budgetary Mechanism Assurance of cooperation with the policy of capitation of research costs for each individual protocol, in addition to a base budget, should be provided from the department and from the institutional office of sponsored research programs. B. Budget Preparation The instructions for budget requests provided with the research grant application form (PHS 398) should be followed. Indirect costs will be awarded in the same manner as for research project grants (RO1). Budgets will be reviewed on the basis of appropriateness for the work proposed. Allowable costs and policies governing the research grants programs of the NIH will prevail. In planning the budget section of the application each applicant should submit budget estimates for all years. The first-year budget at the time of application will be limited to a BASE BUDGET with maximum allowances as follows: Principal Investigator 10% effort Research Nurse Coordinator 100% effort Data Entry Clerk 50% effort Supplies and Small Equipment (itemized and justified) NTE $4,500 Travel (a total of 10 trips to Bethesda per Network team) as appropriate Other costs (itemized and individually justified) NTE $2,500 When an application has been favorably recommended and is being considered for funding, the applicant will be required to complete protocol budgets for those studies underway within the network. These budgets will consist of specific protocol-related costs and will be capitated on the anticipated number of subjects to be enrolled in the study at the applicant Clinical Center. Ongoing annual budgets of Neonatal Research Network members will be based on individual protocols, which will be funded through a capitation system. Each Clinical Center will be given base costs (listed above), in addition to a flat fee per patient successfully enrolled and completed. The principal investigator will be required to project patient enrollment for a specific protocol during a specified time frame; continuation and level of funding will be based on actual recruitment. Future years' budgets should be limited to base budget costs, with an annual increment not to exceed four percent. Terms of Agreement The funding mechanism to be used to assist the scientific community in undertaking this system of clinical investigation will be a Cooperative Agreement between the participating units and NICHD. The major difference between a Cooperative Agreement and a research grant is that there will be substantial programmatic involvement of NICHD staff above and beyond the levels required for traditional program management of grants. Specifically, the role of the NICHD Neonatal Research Network program officer will be to aid the awardees and the Steering Committee in the following ways. o Assistance in the identification of important areas of study. o Assistance in the development of study protocols. o Assistance in the development and review of capitation-based budgets, including the identification of study costs and special institutional needs. o Assistance in the review and evaluation of each stage of the program before subsequent stages are started, in conjunction with the Steering Committee, and the Advisory Board. o Assistance in reporting results in the community of investigators and health care recipients. Programmatic responsibility for review and oversight of these Cooperative Agreements will reside with the Neonatal Research Network program officer. This role will include the following: o Assurance of the scientific merit of the trials, including the option to withhold support of a participating center if technical performance requirements such as protocol compliance, enrollment targets, or randomization of subjects are not met. o Assistance in the efficient conduct of the trials, including ongoing review of progress; possible redirection of activities to improve performance and cooperation; and frequent communication with other members of the Steering Committee. o Initiation of a decision to modify or terminate a study based on the advice of the data center, Data Safety and Monitoring Committee, and Advisory Committee with the mutual consent of the Steering Committee. The responsibilities and authorities of the awardees will be as follows: o Identification of priority issues for research. o Development and implementation of common protocols. o Collection and transmission of accurate data in a timely manner. o Analysis of data and publication of results of the Neonatal Research Network studies. All parties will agree to accept the coordinating role of the group and the participatory and cooperative nature of the group process. The specific terms, conditions, and details of arbitration procedures pertaining to the scope and nature of the interaction between NICHD and the participating Neonatal Research Network units will be incorporated into the Notice of Grant Award. These procedures will be in addition to the customary programmatic and financial negotiations that occur in the administration of grants; they will be invoked only when agreement cannot be reached on issues that may arise after the award between the awardee and the Neonatal Research Network program officer. In that event, an arbitration panel will be formed consisting of one person selected by the principal investigators, one person selected by the Chief of the Pregnancy and Perinatology Branch, and a third person selected by these two members. The decision of the arbitration panel will be binding. Terms of Award of Cooperative Agreement are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, DHHS grant administration regulations at 45 CFR Part 74 and other DHHS, PHS, and NIH grant administration policies. The NICHD review procedure in no way affects the right of a recipient of a cooperative agreement to appeal an adverse determination under the terms of PHS regulations at 42 CFR Part 50, Subpart D, and DHHS regulations at 45 CFR Part 16. Business management aspects of these awards will be administered by the NICHD Office of Grants and Contracts in accordance with DHHS, PHS, and NIH grant administration requirements. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59-14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by April 1, 1995, 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 a subsequent application, the information that it contains allows the NICHD staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Linda L. Wright 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 Information, 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 (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, COOPERATIVE MULTICENTER NEONATAL RESEARCH NETWORK HD-95-006, 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 Institute of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20893-7710 Bethesda, MD 20817 (for express mail or courier service) At the time of submission, two additional copies of the application must be sent to: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development Executive Building, Room 5E03F 6100 Executive Boulevard, MSC 7510 Bethesda, MD 20892-7510 Applications must be received by June 15, 1995. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA 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. Schedule Letter of Intent Receipt Date: April 1, 1995 Application Receipt Date: June 15, 1995 NICHD Council Review: January 1996 Earliest Award Date: April 1, 1996 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NICHD. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Scientific Review, NICHD in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or noncompetitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Criteria for Review of Applications: a. Qualifications, experience, and commitment of key personnel. o Scientific, clinical, and administrative abilities and academic productivity of the principal investigator and other team members; o Knowledge and experience in areas relevant to the conduct of collaborative clinical research, especially randomized clinical trials, in neonatal medicine. This should include specific experience in research design; o Commitment of staff time for the satisfactory conduct of the study; o Experience and qualifications of team members who would be responsible for data quality and management activities; b. Protocols and Procedures o Quality of the Clinical Center's participation in either (1) (current Network members) Network protocols during the current grant period or (2) (new applicants) a randomized, clinical trial in the recent past; o Willingness to work and cooperate with other Neonatal Research Network units and the NICHD in the manner summarized in this RFA; o Quality of the proposed "concept" protocol designed to be undertaken by the Network (new applicants only); o Optional research strengths, as presented. c. Facilities and Management o Adequacy of administrative, clinical, and data organizational management facilities as described in the minimum requirements; o Institutional assurance to provide support to the study in such areas as fiscal administration, personnel management, space allocation, procurement, planning and budgeting; o Optional administrative strengths, such as affiliations with other research units. d. Budget - Appropriateness of the Proposed Budget The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. AWARD CRITERIA Applications recommended by the National Advisory Child Health and Human Development Council will be considered for award based primarily on scientific and technical merit. Program balance, that is, the scope and variety of research strengths to enable a successful collaborative program, will be considered. Final selection of Clinical Centers for funding may be partly based in the need for diversity in the study population. Availability of funds may also determine the awards made. INQUIRIES 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: Linda L. Wright, M.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development Executive Building, Room 4B03F 6100 Executive Boulevard, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5575 FAX: (301) 496-3790 Email: WrightL@HD01.NICHD.NIH.GOV Direct inquiries regarding fiscal matters to: Ms. Mary Ellen Colvin Office of Grants and Contracts National Institute of Child Health and Human Development Executive Building, Room 8A17G 6100 Executive Boulevard MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1303 FAX: (301) 402-0915 Email: COLVINM@HD01.NICHD.NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.3, 93.865. 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. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the phs mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Wed Mar 15 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HD-95-007 - V24(10) 03/17/95 Date: 16 Mar 1995 15:29:45 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 746 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3kahl9$mlb@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HD95007 HD-95-007 P1O1 *************************************** COOPERATIVE MULTICENTER MATERNAL-FETAL MEDICINE UNITS NETWORK NIH GUIDE, Volume 24, Number 10, March 17, 1995 RFA: HD-95-007 P.T. 34; K.W. 0785135, 0775020, 0775025 National Institute of Child Health and Human Development Letter of Intent Receipt Date: April 1, 1995 Application Receipt Date: June 16, 1995 PURPOSE The National Institute of Child Health and Human Development (NICHD) invites applications from investigators willing to participate with the NICHD under a Cooperative Agreement (U10) in an ongoing multicenter clinical program designed to investigate problems in clinical obstetrics, particularly those related to prevention of low birth weight. The objective of this program is to facilitate resolution of these problems by establishing a network of academic centers that, by rigorous patient evaluation using common protocols, can study the required numbers of patients and can provide answers more rapidly than individual centers acting alone. The NICHD program staff will assist the principal investigators of the MFMUs and the Advisory Board in identifying research topics of high priority, and in designing and implementing protocols appropriate to the evaluation of optimum management in these areas. It is anticipated that approximately 12 or 13 clinical centers will be involved in the program. 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), Cooperative Multicenter Maternal-Fetal Medicine Units Network, is related to the priority area of low birth weight. 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 REQUIREMENTS Applications may be submitted by domestic non-profit organizations, public and private. Organizations should have academically-oriented divisions of maternal-fetal medicine. The need for continuous and active communication among sites dictates that only institutions in the United States are eligible to apply. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U10), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activity by involvement in the activity and otherwise working jointly with the award recipients in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreements are discussed later in this document under the section "Terms of Agreement." The total project period for applications submitted in response to the present RFA may not exceed five years. The anticipated award date is April 1, 1996. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the sizes of awards will vary also. Awards and level of support depend on receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NICHD, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. At this time, the NICHD has not determined whether or how this solicitation will be continued beyond the present RFA. FUNDS AVAILABLE It is anticipated that 12 or 13 awards for Clinical Sites will be made, with an estimated total cost of $3,500,000 (including direct and indirect costs) for the entire program in the first year. Up to nine competing continuation awards and at least three new awards are expected. RESEARCH OBJECTIVES A. Background Modern obstetrical management, especially the management of high-risk pregnancies, has in some instances adopted principles of care, and at times employed pharmaceuticals and methodologies without rigorous use of the controlled observation necessary for their objective evaluation. Often the development of this medical specialty (and others as well) has been marked by the enthusiastic adoption of concepts and procedures followed by their modification or replacement, sometimes decades later, after extensive experience has failed to support their usefulness or shown unexpected consequences. Costs involved in instrument purchase and employment have often been large, and uncertainties embedded in such obstetrical practices have contributed at least partly to the rising incidence of cesarean delivery. Regional differences in practice have complicated the field. In an attempt to respond to the need for well-designed clinical trials in maternal-fetal medicine, NICHD established a Network of Maternal-Fetal Medicine Units in 1986. Seven university units were selected among respondents to an RFA. The Network Steering Committee, which consists of representatives from each clinical center, NICHD staff, and data coordinating center staff, evaluated several controversial issues for study. It then selected certain priority areas on which to develop protocols for randomized clinical trials. Trials were done on question of postterm pregnancy, management of preterm labor, and prevention of preeclampsia. A Data Monitoring and Safety Committee also advises NICHD on research design issues, data quality and analysis, and ethical and human subject protection aspects of protocols. During the second grant period of the MFMU Network (1991-1996), clinical trials were initiated on preterm premature rupture of membranes, prevention of preeclampsia in high-risk patients, predictors of preterm birth, obstetric predictors of neonatal survival, varicella in pregnancy, asthma in pregnancy, and bacterial vaginosis in pregnancy. The NICHD expects that ongoing clinical trials dealing with preterm labor, asthma and bacterial vaginosis will probably continue into the continuation grant period for existing centers. Centers that might join the Network in the next award period (beginning April 1, 1996) may participate in the protocols ongoing at that time. The NICHD intends to enable the Network to initiate new protocols within the first year of the next award period. The topics of these protocols will be decided cooperatively by the Steering Committee with advice from the Advisory Board. Areas of interest include: gestational diabetes mellitus, and techniques to reduce the risk of preterm labor and birth. B. Objectives and Scope There are a number of controversial issues in maternal-fetal medicine that might be clarified by multicenter collaborative research. Funded principal investigators will cooperate with the NICHD program officer in identifying research topics of high priority and in designing protocols appropriate to the evaluation of superior, or even optimal management in these areas. The participating maternal-fetal medicine units (MFMUs) will be designated as "clinical centers", and will recruit, assess and treat the subjects in the clinical research of the Network, with each MFMU being supervised by its respective principal investigator. The data center will have primary responsibility for data management and analysis for Network research in collaboration with the Steering Committee. C. Guidance and Management Structures The management of the MFMU Network includes three committees whose functions are as follows: 1. A Steering Committee will be responsible for protocol development, assisted by the Advisory Board and the Data Safety and Monitoring Committee. The Steering Committee will have primary responsibility for the conduct of protocols and the preparation of publications. The Steering Committee will be composed of all principal investigators, one representative from the data center, and three NICHD staff. NICHD staff will comprise the Director of the Center for Research for Mothers and Children (CRMC), an obstetrician >From the Pregnancy and Perinatology Branch (MFMU program officer), and a representative from the Epidemiology and Biometry Research Program. The MFMU program officer will be the only voting NICHD staff member of the Steering Committee. An outside chairperson, who is not participating as a principal investigator, will be selected by the NICHD. 2. An Advisory Board will advise the Steering Committee in the identification and prioritization of topics for network research. The Advisory Board, chosen by the NICHD with the advice of the Steering Committee, will be composed of individuals with expertise in clinical trials, biostatistics, epidemiology, perinatology, and neonatology; the Chairperson of the Steering Committee; the Director of the CRMC; and the MFMU program officer. Additional members will participate based on the need for specific expertise. 3. A Data Safety and Monitoring Committee will monitor the safety of ongoing clinical trials and advise on their conduct. It will be established by NICHD and will represent expertise in ethics, clinical trial design, perinatology, neonatology, and basic science. In addition, the Network has established Policies and Procedures that govern its operations, including publications. These documents are under periodic review, and may be amended and supplemented at the discretion of the Steering Committee. SPECIAL REQUIREMENTS The NICHD invites applications both from current members of the MFMU Network (competing renewal applications) and from prospective members (new applications). Minimum requirements for applicants are as follows (see also Review Criteria and Procedures, below): A. Requirements for Applicants 1. Academic Productivity Provide evidence of recent research productivity by the applicant Clinical Center in previous or present clinical trials, especially of a cooperative, multicenter nature. Specifically, contributions in key areas such as protocol design, patient recruitment, data analysis and interpretation, and publication are important. Applicants who are current MFMU Network members should describe their participation in Network research during the current competitive segment. New applicants should describe their recent participation in one randomized clinical trial, preferably of a multicenter nature. 2. Maternal-Fetal Staffing Physician staffing of the MFMU should include at least three maternal-fetal medicine subspecialists, each of whom would be available to take primary responsibility for one or more of the Network protocols at the unit. Provide complete descriptions of their training and qualifications in both clinical care and research, and their previous and current involvement in clinical research. Specifically, the academic status and academic career development pathways should be described. The approximate percentage time protected for research by the academic department should be specified. 3. Research Nurse Staffing A research nurse must be designated for the full-time nurse coordinator position. Also, additional research nursing staff should be available. Provide descriptions of these individuals' training, experience, and involvement in clinical research. 4. Available Population Applicant units must have at least 2,700 births per year currently in the unit, with a minimum of 30 percent documented to be high risk pregnancies. Applicants that have numbers of births near the minimum or which have experienced a decline in annual births in recent years, should document efforts to maintain access to an adequate number of obstetric patients for research purposes. A large majority of patients with obstetric complications who deliver in the MFMU must also receive prenatal care at the institution. The patient population served by the MFMU must be characterized by demographics, obstetric parameters, and payment status. Indications be given of the proportions of various subgroups, including minorities, that have been eligible, and have actually been randomized, in previous or current clinical trials (see also section on Inclusion of Women and Minorities). 5. Strengths of the MFMU A detailed description of the clinical attributes of the MFMU must be provided. This should include antenatal fetal testing, intrapartum diagnosis, laboratory testing, and perinatal pathology. Other institutional components related to the MFMU must also be described. In particular, the ambulatory facilities for prenatal and postpartum care must be presented, including the established policies and procedures for conducting clinical research in these facilities, in both low risk and complicated pregnancies. Also, the availability of an institutional pharmacy capable of supporting clinical research must be documented. Describe whether, and how, MFMU policies and procedures may have been modified, if necessary, to support clinical research in the past. 6. Perinatal Data System The MFMU unit must have an established perinatal data system, preferably computerized, to collect and tabulate perinatal statistics. Applicants must provide a detailed description of the variables collected, and the data quality and management activities. The applicant must also illustrate how the system has been used recently to plan and perform clinical research. 7. Neonatal Intensive Care Unit One or more neonatologists active in clinical research at the institution must be designated. Such individual(s) must commit to serve as a consultant and possible collaborator in Network research. The academic status and career development pathways of these individuals must be described. Describe the organization and service load of the NICU at the institution, including the existing newborn follow-up program and its research activities. 8. Proposed Protocol Concept (new applicants only) To provide peer reviewers and NICHD an idea of the capabilities of investigators, only new applicants must submit a "concept", briefly (2-3 pages) summarizing a protocol that the applicant might submit to the Network for possible implementation at all Network centers. The proposed "concept" will serve as an indicator of the applicant's ability to participate in the development and design of cooperative protocols in the Network. The "concept" or another design on the same topic, may or may not actually be performed by the Network. It is anticipated that funded MFMU centers will be invited to submit the "concepts" included in their applications to the Network Steering Committee. For purposes of this RFA only, the protocol "concept" must address ONE of the following topics: a. Tocolytics to prevent preterm birth after initial successful suppression of preterm labor. b. Morbidity associated with gestational diabetes mellitus. c. Antenatal steroids for preterm premature rupture of membranes (PROM). The "concept" should also demonstrate use of the applicant's perinatal data system to estimate numbers of available patients eligible for the protocol at the institution. The "concept" should also address relevant ethical issues and the appropriate inclusion of minorities as subjects. 9. Intent to Participate There must be a clearly expressed intent to participate in a cooperative manner with other MFMU units, the NICHD, and the data center, in all aspects of Network research, as outlined in this RFA. 10. Departmental and Institutional Commitments The departmental and institutional commitments to collaborative maternal-fetal research should be clearly documented by letters to the Principal Investigator, and by citing evidence of past support. 11. Acceptance of Budgetary Mechanism Assurance of cooperation with the policy of capitation of research costs for each individual protocol, in addition to a base budget, should be provided from the department and from the institutional office of sponsored research programs. B. Optional: Special Strengths Available to The MFMU Unit All applicants, both competing renewals and new, are also invited to describe briefly any special research strengths of the MFMU that may be relevant to Network research. Such strengths would represent state-of-the-art scientific capabilities that might be shared or made available to the Network, to expand the scientific productivity of the research, over what it might be otherwise. For example, capabilities in areas such as genetics, placental function, or clinical pharmacology, are examples of relevant strengths that could be included. Special administrative strengths may also be described. For example, both competing and new applications may also present the availability of potentially collaborating maternal-fetal medicine units in medical centers with which affiliations have been developed by the applicant institution for the purpose of clinical research. The same requirements (above) must be met by such affiliated institutions. Another example of an administrative strength would be linkage with ongoing, specialized registries. 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. C. Budget Preparation The instructions for budget requests provided with the research grant application form (PHS 398) should be followed. Indirect costs will be awarded in the same manner as for research project grants (RO1). Budgets will be reviewed on the basis of appropriateness for the work proposed. Allowable costs and policies governing the research grants programs of the NIH will prevail. In planning the budget section of the application each applicant should submit budget estimates for all years. The first-year budget at the time of application will be limited to a BASE BUDGET with maximum allowances as follows: Principal Investigator 10% effort Research Nurse Coordinator 100% effort Data Entry Clerk 50% effort Supplies and Small Equipment (itemized and justified) NTE $4,500 Travel (a total of 10 trips to Bethesda per Network team) as appropriate Other costs (itemized and individually justified) NTE $2,500 When an application has been favorably recommended and is being considered for funding, the applicant will be required to complete protocol budgets for those studies underway within the network. These budgets will consist of specific protocol-related allowances and will be capitated on the anticipated number of subjects to be enrolled in the study at the applicant MFMU. Ongoing annual budgets of MFMU Network members will be based on individual protocols that will be funded through a capitation system. Each MFMU Network member will be given base costs (listed above), in addition to a flat fee per patient successfully enrolled and completed. The individual members will be required to project patient enrollment for a specific protocol during a specified time frame; continuation and level of funding will be based on actual recruitment. Future years' budgets should be limited to base budget costs, with an annual increment not to exceed four percent. Terms of Agreement The funding mechanism to be used to assist the scientific community in undertaking this system of clinical investigation will be a Cooperative Agreement between the participating units and NICHD. The major difference between a Cooperative Agreement and a research grant is that there will be substantial programmatic involvement of NICHD staff above and beyond the levels required for traditional program management of grants. Specifically, the role of the NICHD Maternal-Fetal Research network program officer will be to aid the awardees and the Steering Committee in the following ways: o Assistance in the identification of important areas of study. o Assistance in the development of study protocols. o Assistance in the development and review of capitation-based budgets, including the identification of study costs and special institutional needs. o Assistance in the review and evaluation of each stage of the program before subsequent stages are started, in conjunction with the Steering Committee, and the Advisory Board. o Assistance in reporting results in the community of investigators and health care recipients. Programmatic responsibility for scientific review and oversight of these Cooperative Agreements will reside with the MFMU Network program official. This role will include the following: o Assurance of the scientific merit of the trials. The NICHD reserves the right to terminate support of a participating center if technical performance requirements such as protocol compliance, enrollment targets, or randomization of subjects are not met; if a study reaches a major endpoint substantially before schedule; or, if an ethical issue dictates premature termination. o Assistance in the efficient conduct of the trials, including ongoing review of progress; possible redirection of activities to improve performance and cooperation; and frequent communication with other members of the Steering Committee. o Initiation of a decision to modify or terminate a study based on the advice of the data center, Data Safety and Monitoring Committee, and Advisory Committee with the mutual consent of the Steering Committee. The responsibilities and authorities of the awardees will be as follows: o Identification of priority issues for research. o Development and implementation of protocols. o Collection and transmission of accurate data in a timely manner. o Analysis of data and publication of results of the MFMU trials. All parties will agree to accept the coordinating role of the group and the participatory and cooperative nature of the group process. The specific terms, conditions, and details of arbitration procedures pertaining to the scope and nature of the interaction between NICHD and the participating MFMUs will be incorporated into the Notice of Grant Award. These procedures will be in addition to the customary programmatic and financial negotiations that occur in the administration of grants; they will be invoked only when agreement cannot be reached between the awardee and the MFMU program officer on issues that may arise after the award. In that event, an arbitration panel will be formed consisting of one person selected by the principal investigators, one person selected by the Chief of the Pregnancy and Perinatology Branch, and a third person selected by these two members. The decision of the arbitration panel will be binding. Terms of Award of Cooperative Agreement are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, DHHS grant administration regulations at 45 CFR Part 74 and other DHHS, PHS, and NIH grant administration policies. The NICHD review procedure in no way affects the right of a recipient of a cooperative agreement to appeal an adverse determination under the terms of PHS regulations at 42 CFR Part 50, Subpart D, and DHHS regulations at 45 CFR Part 16. Business management aspects of these awards will be administered by the NICHD Office of Grants and Contracts in accordance with DHHS, PHS, and NIH grant administration requirements. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59-14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by April 1, 1995, 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 a subsequent application, the informtation that it contains allows the NICHD staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Donald McNellis 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 Information, 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 (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, COOPERATIVE MULTICENTER NETWORK OF MATERNAL-FETAL MEDICINE UNITS (MFMUs) HD- 95-007, 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 Institute of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20893-7710 Bethesda, MD 20817 (for express mail) At the time of submission, two additional copies of the application must be sent to: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development Executive Building, Room 5E03F 6100 Executive Boulevard, MSC 7510 Bethesda, MD 20892-7510 Applications must be received by June 16, 1995. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA 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. Schedule Letter of Intent Receipt Date: April 1, 1995 Application Receipt Date: June 15, 1995 NICHD Council Review: January 1996 Earliest Award Date: April 1, 1996 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NICHD. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Scientific Review, NICHD in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or noncompetitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Review Criteria a. Qualifications, Experience, and Commitment of Key Personnel. o Scientific, clinical, and administrative abilities and academic productivity of the principal investigator and other team members; o Knowledge and experience in areas relevant to the conduct of collaborative clinical research, especially randomized clinical trials, in maternal-fetal medicine. This should include specific experience in research design; o Commitment of staff time for the satisfactory conduct of the study; o Experience and qualifications of team members who would be responsible for data quality and management activities. b. Protocols and Procedures o Quality of the unit's participation in either (1) (new applicants) a randomized, clinical trial in the recent past, or (2) (current Network members) Network protocols during the current grant period; o Willingness to work and cooperate with other MFMUs and the NICHD in the manner summarized in this RFA; o Quality of the proposed "concept" protocol designed to be undertaken by the Network (new applicants only); o Optional research strengths, as presented. c. Facilities and Management o Adequacy of administrative, clinical, and data organizational management facilities as described in the minimum requirements; o Institutional assurance to provide support to the study in such areas as fiscal administration, personnel management, space allocation, procurement, planning and budgeting; o optional administrative strengths, such as affiliations with other research units. d. Budget - Appropriateness of the Proposed Budget o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications recommended by the NACHHD Council will be considered for award based primarily on scientific and technical merit. Program balance, that is, the scope and variety of research strengths to enable a successful collaborative program, will be considered. Final selection of Clinical Centers for funding may be partly based on the need for diversity in the study population. Availability of funds may also determine the awards made. INQUIRIES 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: Donald McNellis, M.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development Executive Building, Room 4B03 6100 Executive Boulevard, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5575 FAX: (301) 496-3790 Email: mcnellid@hd01.nichd.nih.gov Direct inquiries regarding fiscal matters to: Ms. Mary Ellen Colvin Office of Grants and Contracts National Institute of Child Health and Human Development Executive Building, Room 8A17G 6100 Executive Boulevard MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1303 FAX: (3010 402-0915 Email: colvinm@hd01.nichd.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.3, 93.865. 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. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the phs mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Sun Mar 19 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 19 March 1995 Date: 20 Mar 1995 10:52:54 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 141 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3kkiu6$shp@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Bulletin Title: BUL 95-04 NSF Bulletin April- Vol 22; no 8 File size (bytes): STIS Filename: bul9504.txt Document Type: General Publication Title: NSF 94-102 Research Instrumentation File size (bytes): Enabling the Discovery Process STIS Filename: nsf94102.txt (NSF) Document Type: News Title: TIP5310 - Media Tipsheet March 10, 1995 File size (bytes): STIS Filename: tip5310.txt Document Type: Press Release Title: REVOLUTION IN ATMOSPHERIC MONITORING COULD IMPROVE WEATHER FORECASTS, MEASURE GLOBAL WARMING File size (bytes): STIS Filename: pr9517.txt Title: ELECTRONIC ARCHIVE WILL SPEED SCIENTIFIC EXCHANGE File size (bytes): STIS Filename: pr9518.txt Document Type: Program Guideline Title: MEDLOFSC -- The National Medal of Science File size (bytes): STIS Filename: medlofsc.txt Title: NSF 95-60 - Instrumentation Grants for Research in Computer and Information Science and Engineering File size (bytes): STIS Filename: nsf9560.txt Document Type: Recruit Title: Head, Arctic Sciences Section File size (bytes): STIS Filename: vep959.txt Title: Head, Arctic Sciences Section File size (bytes): STIS Filename: vep959i.txt Title: Head, Arctic Sciences Section File size (bytes): STIS Filename: vep959l.txt Title: Biologist (Science Assistant) File size (bytes): STIS Filename: vex9522.txt Title: Geographer (Program Director) File size (bytes): STIS Filename: vex9523.txt Title: Office Automation Clerk (Part-time) File size (bytes): STIS Filename: vgs9568.txt Title: Audio-Visual Producation Specialist File size (bytes): STIS Filename: vgs9569.txt Document Type: Report Title: NSF 95-65 Restructuring Engineering Education File size (bytes): A Focus on Change STIS Filename: nsf9565.txt (NSF) ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Antarctic EAM Title: OPP94008 - Support of Long-Term Ecological Research Project File size (bytes): 36835 STIS Filename: opp94008.txt Document Type: Phone Book Title: NSF Alpha Telephone File size (bytes): 97691 STIS Filename: phnalpha.txt Title: NSF Organizational Directory File size (bytes): 98690 STIS Filename: phnorg.txt ------------------------------------------------------------------------ ** 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). 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 stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve phnorg.txt, the text of your message should be as follows: get phnorg.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnorg.txt, you would enter: ftp> get phnorg.txt 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 "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Mon Mar 20 22:00:00 1995 Path: biosci!biosci!not-for-mail From: Daniel.Drell@mailgw.er.doe.gov Newsgroups: bionet.sci-resources Subject: Notice of ELSI Biblio & Supp Date: 21 Mar 1995 14:36:27 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 11 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3knkdb$ngu@net.bio.net> NNTP-Posting-Host: net.bio.net Here's a notice of the bibliography and supplement for science postings: "ELSI Bibliography" and "1994 Supplement": These bibliographic resources provide a current and comprehensive topical listing of books and articles related to the ethical, legal and social implications (ELSI) of the Human Genome Project. The bibliography and supplement were developed with the support of the Office of Health and Environmental Research, U.S. Department of Energy, and are available, free on request, from the compiler: Michael S. Yesley, msy@lanl.gov or 505/665-4424 (fax). From owner-sci-resources@net.bio.net Thu Mar 23 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DE-95-003 - V24(11) 03/24/95 Date: 23 Mar 1995 21:20:42 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 609 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3ktkra$6r0@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA DE95003 DE-95-003 P1O1 *************************************** ORAL CANCER RESEARCH CENTERS NIH GUIDE, Volume 24, Number 11, March 24, 1995 RFA: DE-95-003 P.T. 34; K.W. 0715035, 0715148, 0785055, 0710070, 1002045 National Institute of Dental Research Letter of Intent Receipt Date: May 15, 1995 Application Receipt Date: August 22, 1995 PURPOSE The National Institute of Dental Research (NIDR) invites applications >From United States institutions for the support of Oral Cancer Research Centers. The goal of these centers is to support multidisciplinary basic and clinical research incorporating the range of parameters and academic disciplines necessary for reducing the morbidity and mortality due to oral cancer (e.g., epidemiology, behavioral sciences, nutrition, immunology, molecular biology, toxicology, and virology). Multifactorial, multistep approaches will be encouraged. Proposed centers should take full advantage of combined institutional strengths in various geographic locations. 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 Application (RFA), Oral Cancer Research Centers, 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 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, public and private organizations, such as dental and medical schools, universities, research institutions, hospitals, laboratories, units of state and local governments, and eligible agencies of the federal government. Applications from foreign institutions are not eligible. However, domestic applications may include international components. Although an application must be submitted from a single institution, it may include consortia arrangements with other institutions provided these arrangements are clearly delineated and confirmed. Applications with key personnel such as center directors or principal investigators who are members of a minority group and/or women are encouraged. To be eligible for a center grant under this program, the potential applicant institution must have an ongoing, independently supported basic and/or clinical research program in the area of oral cancer or the capacity and infrastructure to support such research. The current application must propose new research in this area including human clinical oral cancer research. MECHANISM OF SUPPORT Centers will be supported by the National Institutes of Health Specialized Center grant (P50) mechanism for a period of not more than five years. The earliest possible award date is April 1, 1996. Responsibility for the planning, direction, and execution of the proposed center will be solely that of the applicant. This RFA is a one-time solicitation. Issuance of a subsequent request for new and competing continuation applications will be contingent upon program needs and the availability of funds. FUNDS AVAILABLE Two to three awards are planned and up to $2,250,000 in total costs will be committed for the first year of support if sufficient applications of high scientific merit are received. Although this program is provided for in the financial plans of the NIDR, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. Applicants may request up to $500,000 in direct costs for the first year. Where indirect costs are assigned to a subcontract and counted as direct costs on the parent grant, the direct cost maximum of $500,000 may be exceeded by the amount of indirect costs assigned to the subcontract. Applications that exceed these limits will be returned without review. Budget increases of no more than four percent per year for recurring costs may be requested for each of the subsequent four years. RESEARCH OBJECTIVES Background The International Classification of Diseases defines oral cancer as cancer of the oral cavity and pharynx, including cancer of the lip, tongue, salivary glands, gum, floor and other areas of the mouth, oropharynx, nasopharynx, hypopharynx, pharynx and other buccal areas. The Programs Advisory Committee (PAC) of the NIDR has stressed the need for research exploring a range of factors involved in oral cancer. Research topics in the area of oral cancer include: studies on herpes simplex virus; tobacco and alcohol as potential synergistic etiological agents; head and neck radiation studies; environmental causes of oral cancer; the effect of nutrition on survival following treatment for cancer; the role of human papilloma virus in the development of oral cancer; molecular mechanisms of oral cancer; the synergistic roles of both x-rays and chemicals in the development of cancer; smoke and smokeless tobacco products; the role of antioxidants in preventing cancer; and the role of transforming growth factor alpha (TGF-alpha). Although there has been a reduction in total mortality over the past two decades, the five-year relative cancer survival rate for oral and pharyngeal cancer is one of the lowest. As reported by the NCI Surveillance Epidemiology and End Result (SEER) Program for 1983-1989, only 33 percent of black patients and 54 percent of white patients survive the five year period after detection of oral cancer. This five year survival rate falls far below the survival for many other cancers including cancers of the testis, skin melanoma, breast, colon, rectum and kidney. At the same time, the annual number of new cases for all cancers has increased, rising from an estimated 625,000 new cases and 331,000 deaths in 1970 to an estimated 1,170,000 cases and 526,000 deaths in 1993. A large portion of this increase is due to a 50 percent increase in the size of the population since 1970 coupled with an increase in the number of older Americans. The number of people 85 and older has more than doubled during this time. However, during the time period 1973-1990 the incidence of cancer of the oral cavity and pharynx has decreased slightly from approximately five percent to about four percent of all cancers for men and two percent for women while mortality has decreased by about 18 percent. It is reasonable to hypothesize that early detection and/or treatment have played a role in the greater reduction of mortality over incidence. As with other forms of cancer, both the mortality and incidence data reflect higher rates among men than women and blacks than whites. This RFA indicates a renewed and increased interest on the part of the NIDR in supporting research on oral cancer. Because of the interest and familiarity of dental professionals with the oral cavity, they may be the first to recognize and diagnose oral cancers. Oral cancers and precancerous lesions can often be visualized by the health care professional and are often easier than cancers in other sites to biopsy, treat, and follow during treatment. Goals of the Centers The primary goal of the centers is to accelerate and expand the development of basic, clinical, epidemiological and behavioral research as well as to translate research findings into improved clinical methods for prevention, early detection and therapy of oral cancer. Multifactorial, multidisciplinary and multistep approaches will be encouraged. It is assumed that the proposed centers will take full advantage of combined institutional strengths in various geographic locations. The following areas of research in oral cancer are encouraged but are not meant to be exclusive: o determination of molecular events that lead to the conversion of a normal oral epithelial cell to a malignant cell; o prospective and retrospective analysis of tissue samples to determine events that lead to oral cancer; o genetic basis for susceptibility to cancer development including gene changes, production of gene products, incorporation of a virus in the genome, and chromosomal alterations; o continued development of specific markers or probes that can enhance early detection and provide a better prognosis for premalignant oral lesions; o tobacco, alcohol, and candidiasis as risk factors for cancer of the buccal epithelium and other parts of the oral cavity; o studies of premalignant lesions in an effort to enhance early prevention, detection, and treatment; o use of animals or other experimental approaches to develop better means of prevention and treatment of mucosal diseases including oral cancer; o the nature and mode of action of antitumor agents including gene therapy; o enhance naturally occurring anticancer therapies including biological modifiers and salivary antivirals; o improvement in the understanding of the effects of anticancer therapies on oral mucosa and salivary glands; o development of procedures for reducing the untoward oral side effects (e.g., destruction of salivary gland) resulting from chemotherapy and radiation of oral and other cancers; o effects of nutrition or nutritional supplements on precancerous lesions and on recovery from radiation and chemotherapy; and o development and testing of interventions designed to reduce risk behavior factors (e.g., tobacco and alcohol use) for oral cancer and precancerous lesions; Center Characteristics Each research center must be a clearly defined organizational entity within a larger research institution with a director responsible for management of the center. Strong and effective scientific leadership must be provided. The application should specify provisions that will be made for replacement of the director with a suitably qualified alternative should circumstances require. The director will be responsible for the organization and operation of the center and for communication with the center internal and external advisory panels and with the NIDR on scientific and administrative matters. Directors will be responsible for maintaining high-quality research efforts and for ensuring effective collaboration among collaborating scientists. The center will consist of a cluster of related research projects, some of which may be basic while others may involve clinical and small epidemiological studies. These projects must not constitute a collection of individual, unrelated investigations more appropriately supported by individual research project grants or small grants, rather they should be related by a common research theme. Each center must include core units, each of which is shared by at least two research projects. One unit must be an administrative core. Funds for the center director and administrative staff will be provided. This core unit should ensure that participants are provided with shared support services that enhance their research. The director will be responsible for monitoring the overall quality and the scope of center activities. The administrative core may provide limited funds, not to exceed $25,000 in direct costs and not lasting for more than two years, to support pilot research projects. The goals of the pilot and feasibility studies are to provide start-up funds for new projects, to develop new investigators under the direction of experienced basic and clinical scientists, and to encourage established investigators to utilize recent research techniques in addressing novel areas of oral cancer concerns. Research plans for pilot and feasibility projects to be carried out during the first and second years of the award and detailed procedures for the review and selection of future such projects by advisory panels and the center director must be included in the application. The director will convene an advisory panel of experts from outside the applicant institution at least once a year to review center activities and provide a written report on the progress of the center. This report may be included in the center's annual progress report to the NIDR. A biostatistics, experimental design, data management and analysis core is also mandatory, although this function can be incorporated into the administrative core. The biostatistics core will provide the staff with resources needed to enhance research programs through the application of epidemiology, sampling, biostatistics, and related support methodologies. Specifically, it should foster and strengthen biostatistician-clinical investigator interaction in the design and conduct of clinical research. Evidence should be presented of the role played by proposed key staff from this core in the development of the application, in particular the design of the research and pilot projects. Other proposed cores must directly relate to ongoing and planned oral health research activities of the center: o A Diagnostics Core may provide and develop methods and/or instrumentation to detect early signs or markers of oral disease or dysfunction and to monitor the efficacy of treatments. o A Laboratory Core may provide resources and scientific expertise to carry out adjunct studies on clinical trial patients or general population samples. Animal resources may be included where appropriate. Laboratory cores could, for example, include: behavioral/social sciences, biomaterial sciences, pharmacology, microbiology, immunology, nutrition, or molecular biology. Core resources, such as animal facilities, computer services and equipment to be shared by investigators will be provided, although budgetary constraints preclude expenditures for very expensive items of equipment or major renovations. o A Unique Clinical Facilities Core may provide resources to facilitate research that cannot be carried out in conventional health-care settings, such as the use of mobile units for clinical studies involving elderly or physically disabled individuals or work-site based dental operatories for preventive interventions with employed adults. Any costs associated with patient care must be limited to procedures included in research protocols. The above descriptions are not intended to include the full range of possible activities. Cores may provide support for personnel, including the necessary expertise to direct cores, equipment, supplies, services, facilities, and limited travel. In addition, they may provide funds for the integration of activities with other research centers in the same or related biomedical or behavioral/social science areas for purposes of program enrichment. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the 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 should be included with the application. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by May 15, 1995, a letter of intent that includes a descriptive title for the oral cancer research center, each research project and each pilot and feasibility project and core; give the name, address, and telephone number of the center director; the identity of other key personnel and participating institutions and departments; and this RFA by number and title. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains is helpful in planning for the timely review of applications. It allows NIDR staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be addressed to Dr. Norman S. Braveman at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are due no later than close of business on August 22, 1995. Applications received after that time will be returned to the applicant without further consideration. Prospective applicants are encouraged to communicate with program and grants management staff of the NIDR's Extramural Program as early as possible in the planning phase of application preparation. Advice and suggestions by staff may materially assist applicants to ensure that the cancer center's objectives and structure and the budget format are acceptable. Applications are to be submitted on the grant application form PHS 398 (rev. 9/91), available at most institutional offices of sponsored research and from the Office of Grants Information, 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 kit must be affixed to the bottom of the face page of the original and the original must be placed on top of the entire package. 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, in order to identify the application as a response to this RFA, the RFA title "Oral Cancer Research Centers" and number "RFA DE-95-003" must be typed in item 2a of the face page of the application form and the YES box must be checked. The instructions accompanying form PHS 398 must be followed to the extent possible, but some modification will be necessary. For example, a new Table of Contents must be prepared giving page numbers for all items in the application. Pagination must be consecutive throughout the application. Each project, pilot feasibility project, and core unit must be identified by number and investigator. A consolidated budget for the complete oral cancer center for the entire project period must be presented (use page 5, form PHS 398). Separate detailed, annual and total budgets for the entire project period for each project and core must be presented (use pages 4-5, form PHS 398). In addition, a summary table must be included providing budget totals for each project and core and for the entire program, for all years of support. Direct and indirect costs are to be given. Funds may be requested for professional, technical, and administrative personnel, consultant services, equipment, supplies, travel, patient costs directly related to the research, minor renovations and other costs. Detailed justification of the budget requests will be required. Specific attention must be given to efforts to contain costs and ensure cost-competitive implementation of center goals. Accordingly, provide a summary of additional financial support from non-NIDR sources for activities that will complement and expand the program proposed for support by the NIDR. Explain how these activities will further the goals of the cancer center and make it more cost-effective. Awardees will be expected to update this information on an annual basis. Under Research Plan, describe the goals of the center and explain how each proposed research project, core and pilot/feasibility project will contribute toward achieving those goals. Describe the administrative structure, the responsibilities of the center director, individual investigators, advisory groups, and the proposed mechanisms for monitoring scientific progress. Describe the relationship of all existing and pending institutional research projects that may be relevant to the oral cancer center regardless of funding source. Each project and core unit must be presented as in a research grant application, that is, the instruction pages 19-24 of form PHS 398 must be followed. The 25-page limitation will apply to each core unit. Each pilot/feasibility study must be presented as in a small grant application, so that, the Research Plan may not exceed ten pages. Additional instructions and guidelines, in this connection, are to be found in the NIDR Small Grant Program announcement PA-91-36: NIH GUIDE, Vol. 20, No. 12, March 22, 1991, and in its modification by the notice that appeared in the NIH GUIDE, Vol. 22, No. 1, January 8, 1993. Abstracts (page 2, form PHS 398) must be completed for the entire application, each research project and core unit, and for each pilot and feasibility study proposed for initiation during the first two years of the award. Whenever appropriate, the application must: (a) delineate all consortia arrangements and formally and officially confirm them by signed statements from the responsible official(s) of each institution; (b) be accompanied by firm funding commitments that ensure that appropriate clinical research projects will be active at the time of the award; and (c) include a letter of agreement from either the GCRC program director or principal investigator should the applicant identify a GCRC as a resource for conducting the proposed research. 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 6705 Rockledge Drive, Suite 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express or courier service) At the time of submission, two additional copies of the application must also be sent to: Dr. H. George Hausch Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN-44F 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 Applications must be received by August 22, 1995. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NIDR. Incomplete applications or those that exceed the first year budget limit of $500,000 will be returned to the applicant without further consideration. Waivers of the receipt deadline and budget limitation will not be granted. If NIDR staff find that the application is not responsive to the RFA, it will be returned without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDR in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. Secondary review of the applications will be conducted by the National Advisory Dental Research Council. Major factors to be considered in the evaluation of the applications include: o The extent to which the center will promote advances in the area of oral cancer that could not be achieved or would be achieved more slowly if the component projects were funded separately. o The institutional environment, its commitment to the center, and evidence of an organizational structure that will promote multidisciplinary, collaborative research. The potential of the center to provide an environment for interaction between investigators including the opportunity to learn new technology and for investigators supported by other public and private funds. o The scientific merit, originality and feasibility of each project, the soundness of the methodology proposed, and the competence of the investigators. Availability of statistical and data analysis resources and evidence of their use in developing the research protocols. o The technical merit and justification for core resources requested. o The adequacy of laboratory and clinical facilities, and the availability of appropriate populations in clinical studies. o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The inclusion of clinical and basic research projects that are interrelated with adequate plans for interaction and communication of information and concepts among the collaborating investigators. o The scientific and administrative qualifications, experience and commitment of the center director and his/her ability to provide effective leadership. The arrangements for an assistant director to administer the center in the director's absence and replace the director should it become necessary. o Plans for monitoring research, and for reviewing changes in research direction. The composition and use of internal and external reviewing committees and future pilot studies. o Appropriateness of the period and budget requested for each project, core, pilot project and the entire center. The inclusion of projects deemed to have limited scientific merit or that are considered peripheral to the oral cancer center's objectives may be considered a reflection of the center director's judgement and may adversely affect the rating of the application. Component pilot projects lacking significant and substantial merit will not be recommended for further consideration. Pilot projects or cores with only adequate merit that are not deemed essential to success of the oral cancer center may be recommended for deletion. AWARD CRITERIA The earliest anticipated date of award is April 1, 1996. Applicants should be aware that, in addition to scientific merit, program priorities and program balance, the total cost of the Oral Cancer Center to the NIDR will be considered by NIDR staff and the National Advisory Dental Research Council in making funding recommendations. One consideration will be the extent to which complementary projects, supported from non-NIDR funds, will contribute to the cost-effectiveness of the proposed Oral Cancer Center. In circumstances in which applications have similar scientific merit, but vary in cost-competitiveness, the NIDR is likely to select the more cost-competitive application for funding. Funded oral cancer centers may undergo an interim peer review by NIDR to evaluate progress. 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: Dr. Norman S. Braveman Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN 24B 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2089 FAX: (301) 480-8318 Email: BravemanN@de45.nidr.nih.gov Direct inquiries regarding grants management issues to: Ms. Theresa Ringler Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AS-55 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-4800 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.121. 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. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the phs mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Thu Mar 23 22:00:00 1995 Path: biosci!biosci!not-for-mail From: Daniel.Drell@mailgw.er.doe.gov Newsgroups: bionet.sci-resources Subject: DOE ELSI Call for proposals Date: 23 Mar 1995 21:45:44 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 148 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3ktma8$7v9@net.bio.net> NNTP-Posting-Host: net.bio.net Attached is a file with the recent (March 13, 1995) Federal Register announcement of the DOE Human Genome Program ELSI announcement, for electronic distribution. thanks Dan Drell [6450-01-P] Department of Energy Office of Energy Research Energy Research Financial Assistance Program Notice 95-15: Human Genome Program - Ethical, Legal, and Social Implications AGENCY: Department of Energy (DOE) ACTION: Notice inviting grant applications. SUMMARY: The Office of Health and Environmental Research (OHER) of the Office of Energy Research (ER), U.S. Department of Energy (DOE), hereby announces its interest in receiving applications in support of the Ethical, Legal, and Social Implications (ELSI) subprogram of the Human Genome Program (HGP). The HGP is a coordinated, multidisciplinary, goal-oriented, research effort aimed at improving technologies that will lead to a detailed understanding of the human genome at the molecular level. This particular research notice encompasses research grants that address ethical, legal, and social issues that may arise from the use of information and knowledge resulting from the HGP. DATES: Formal applications submitted in response to this notice must be received by 4:30 p.m., E.D.T., July 13, 1995, to be accepted for merit review in September and to permit timely consideration for award in Fiscal Year 1996. ADDRESSES: Formal applications referencing Program Notice 95-15 should be forwarded to: U.S. Department of Energy, Office of Energy Research, Acquisition and Assistance Management Division, ER-64 (GTN), Washington, D.C. 20585, ATTN: Program Notice 95-15. The following address must be used when submitting applications by U.S. Postal Service Express Mail or any commercial mail delivery service, or when handcarried by the applicant: U.S. Department of Energy, Office of Energy Research, Acquisition and Assistance Management Division, ER-64, 19901 Germantown Road, Germantown, MD 20874. FOR FURTHER INFORMATION CONTACT: Dr. Daniel W. Drell, Office of Health and Environmental Research, ER-72 (GTN), Office of Energy Research, U.S. Department of Energy, Washington, D.C. 20585, (301) 903-6488. SUPPLEMENTARY INFORMATION: The DOE encourages the submission of applications to conduct multidisciplinary, empirical research on privacy issues from the creation, use, maintenance, and disclosure of genetic information. This may include (but is not limited to) issues of ownership and control of genetic information and the protection of the privacy of genetic information in various settings including the workplace. Applications should demonstrate knowledge of the relevant literature, and should include detailed plans for the gathering and analysis of factual information and the exploration of the specific issues of interest. All applications should include, where appropriate, detailed discussion of human subjects protection issues; e.g., storage of, manipulation of, and access to data. Where appropriate, provisions to ensure the inclusion of women, minorities, and potentially disabled individuals must be described, unless specific exclusions are scientifically necessary and justified in detail. All proposed research applications should address the issue of efficient dissemination of results to the widest appropriate audience. The DOE is also soliciting applications for the preparation and dissemination of educational materials in any appropriate medium that will enhance public understanding of both the scientific aspects and the ethical, legal, and social aspects of the HGP. In addition, the DOE is encouraging applications for the support of conferences focusing on specific issues or areas of concern related to the ethical, legal, and social implications of the HGP. This may include (but is not limited to) implications of advances in the genetic characterization of complex traits and diseases. Educational and conference applications should also demonstrate awareness of the relevant literature, and include detailed plans for the accomplishment of project goals, including, where appropriate, video productions. In the case of applications that propose the production of series for broadcast, audio-visuals or other educational materials, the DOE strongly recommends that samples of previous similar work by the producers and writers be submitted along with the application. In the case of all educational activities, the DOE strongly recommends inclusion of assessments of effectiveness of the proposed activities. In the case of all conferences, a fairly detailed and complete roster of committed speakers is necessary. At the completion of the conference, a summary or report is required. Educational and conference applications must also demonstrate awareness of the need to reach the widest appropriate audience. Potential applicants are strongly encouraged to submit a brief preapplication in accordance with 10 CFR 600.10(d)(2), that consists of two to three pages of narrative describing the research project objectives and methods of accomplishment. These will be reviewed relative to the scope and research needs of the DOE's Human Genome Program. Preapplications referencing Program Notice 95-15 should be received by April 13, 1995, and sent to Dr. Daniel W. Drell, Office of Health and Environmental Research, ER-72 (GTN), Washington, D.C. 20585. Telephone and FAX numbers are required parts of the preapplication, and electronic mail addresses are desirable. A response to the preapplications discussing the potential program relevance of a formal application generally will be communicated within 30 days of receipt. It is anticipated that approximately $700,000 will be available for grant awards in this area during FY 1996, contingent upon availability of appropriated funds. Multiple year funding of grant awards is expected, and is also contingent upon availability of funds. Previous awards have ranged from $60,000 per year up to $500,000 per year with terms from one to three years; most awards average about $200,000 per year for two or three years. Similar award sizes are anticipated for new grants. Information about development and submission of applications, eligibility, limitations, evaluation, selection process, and other policies and procedures may be found in the Application Guide for the Office of Energy Research Financial Assistance Program and 10 CFR Part 605. The Application Guide is available from the U.S. Department of Energy, Office of Health and Environmental Research, Health Effects and Life Sciences Research Division, ER-72 (GTN), Washington, D.C. 20585. Telephone requests may be made by calling (301) 903-6488. As part of its grant regulations, ER requires at 10 CFR 605.11(b) that a grantee funded by ER and performing research involving recombinant DNA molecules and/or organisms and viruses containing recombinant DNA molecules shall comply with the National Institutes of Health "Guidelines for Research Involving Recombinant DNA Molecules" (51 FR 16958, May 7, 1986), or such later revision of those guidelines as may be published in the Federal Register. The dissemination of materials and research data in a timely manner is essential for progress towards the goals of the DOE Human Genome Program. The OHER requires the timely sharing of resources and data. Applicants should, in their applications, discuss their plans for disseminating research results and materials that may include, where appropriate, publication in the open literature, wide-scale mailings, etc. Once OHER and the applicant have agreed upon a distribution plan, it will become part of the award conditions. Funds to defray the costs of disseminating results and materials are allowable; however, such requests must be sufficiently detailed and adequately justified. Applicants should also provide timelines projecting progress toward achieving proposed goals. The Catalog of Federal Domestic Assistance Number for this program is 81.049, and the solicitation control number is ERFAP 10 CFR Part 605. D. D. Mayhew Director, Office of Management Office of Energy Research [FRDoc. 95-6107 Filed 3-10-95; 8:45 am] Billing code 6450-01-P Published in the Federal Register, V. 60, No. 48, Monday, March 13, 1995, pp. 13433-13434 From owner-sci-resources@net.bio.net Thu Mar 23 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DE-95-004 - V24(11) 03/24/95 Date: 23 Mar 1995 21:20:57 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 711 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3ktkrp$6ri@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA DE95004 DE-95-004 P1O1 *************************************** HEALTH EFFECTS OF DENTAL AMALGAMS IN CHILDREN NIH GUIDE, Volume 24, Number 11, March 24, 1995 RFA: DE-95-004 P.T. 34; K.W. 0785040, 0750005, 1007009 National Institute of Dental Research Letter of Intent Receipt Date: May 22, 1995 Applications Receipt Date: August 24, 1995 PURPOSE The National Institute of Dental Research (NIDR) invites applications for cooperative agreements for a multidisciplinary clinical trial addressing the health effects of dental amalgams in children. Public concerns about the safety of dental amalgam fillings containing mercury continues despite assurances from the public health community. The general purpose of the trial is to investigate the possible relationship between lowdose exposure to mercury vapor from dental amalgam restorations and the occurrence of specific health conditions in children. To accomplish this the NIDR is interested in supporting a prospective, randomized clinical trial involving children from high risk caries populations needing restorative dental treatment with dental amalgam. 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), Health Effects of Dental Amalgams in Children, 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 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, non-profit, public and private organizations, such as dental or medical schools, universities and research institutions. Applications from foreign institutions are not eligible, however, applications may have international components. 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 should be included with the application. MECHANISM OF SUPPORT The administrative and funding mechanism to be used to undertake this program will be a cooperative agreement (U01), which is an assistance mechanism, rather than an acquisition mechanism. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by collaborating and otherwise working jointly with the award recipient in a partnership role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships and governance of a study funded under a cooperative agreement are discussed later in this document under the section "Terms and Conditions of Award." The cooperative agreement mechanism of support will be used because substantial NIDR programmatic staff involvement with the awardee is necessary to facilitate coordination of a multidisciplinary approach to the research topic, to assist in protocol development, particularly in the selection of appropriate health endpoints, in quality control procedures, and to play an active role in monitoring the safety of study participants. FUNDS AVAILABLE This RFA is a one-time solicitation. At least one application is expected to be funded as a result of this RFA. However, in the event that a multicenter trial is needed to obtain sufficient numbers of subjects and to provide standardized analysis of biological samples, additional awards will be made. In either case, the funds available for the first year of support for the RFA are expected to total no more than $500,000. This level of support is conditional upon the receipt of applications of high scientific merit. Awards are expected to be made in Fiscal Year 1996. Although the financial and programmatic plans of the NIDR provide for support beyond the initial five year award, awards pursuant to this RFA are also contingent upon the availability of funds. RESEARCH OBJECTIVES Background Dental amalgam, a mixture of approximately equal parts of elemental mercury and other metals including silver, tin, copper, zinc and palladium or indium, has been in continuous use as a dental restorative material for well over a century. It has been the material of choice in restoring posterior teeth because of its strength, durability and relative low cost. It is estimated that approximately one-half of the 200 million restorative procedures performed in 1990 utilized amalgam as the material of choice. Mercury is widely found in the environment with trace levels present in air, water, and food. The toxicity of elemental mercury and its compounds is widely recognized. Experimental studies on animals, and biopsy observations in humans based on occupational exposure to organic mercury can affect the immune system to produce a nephrotic syndrome. Research on animals indicate large strain differences in susceptibility to the autoimmune response to mercury. In humans signs and symptoms associated with mercury intoxication from elemental mercury include tremor, ataxia, personality change, loss of memory, insomnia, fatigue, depression, headaches, irritability, slowed nerve conduction, weight loss, appetite loss, psychological distress, and gingivitis. Several review articles have indicated that few large scale human studies have been conducted investigating the potential adverse effects of dental amalgams. One large study of Swedish women was reported in which none of the correlations between number of amalgam fillings and clinical symptoms or complaints were found to be positive. Most of the signs and symptoms of mercury toxicity have been associated with longterm occupational exposure to air concentrations of mercury greater than 50 fg/m3, reflected by urinary mercury concentrations greater than 100 ng/ml. While clinically significant effects have not been reported below air concentrations of 100 fg/m3, preclinical manifestations consisting of short term memory loss and slowed peripheral nerve conduction have been reported below this level. No clinical findings on impairment of kidney function have been found in persons exposed to airborne concentrations of mercury below 100 fg/m3. Purported public concerns over the release of mercury from dental amalgam fillings have been recurring for many years. However, recent concerns have intensified with the discovery that small amounts of mercury vapor may be released from amalgam restorations and eventually absorbed into body tissues. Although, with the exception of allergic or hypersensitive reactions in a small number of patients, no adverse health effects have been demonstrated following the placement of dental amalgam fillings in humans. Nevertheless, there is a concern over the margin of safety between known toxic levels of mercury, regardless of source, and those levels in individuals having numerous amalgam fillings. A Health Assessment Program sponsored by the American Dental Association (ADA) was initiated in 1975. Each year, at the annual ADA meeting, practicing dentists volunteer to participate in this screening program. Questionnaires are given to all volunteers and urinary samples are collected for mercury assays. Between 1975 and 1983 over 9400 dentists participated in this program. Urine specimens were collected from 4272 of these dentists, 3793 of whom were general dentists. Their average urinary mercury concentration was 14.2 ng/ml, 4.8% had concentration levels over 50 ng/ml, 1.3 percent levels over 100 ng/ml. A subsequent report of the findings for 19851986 showed a decrease in urinary mercury concentration, averaging 5.8 ng/ml and 7.6 ng/ml. Although some five percent to seven percent of these professionals had high urinary mercury concentrations (over 20 ng/ml) no abnormal glomerular or tubular kidney dysfunction was reported. In 1991, the ADA reported results of a survey of 1000 adults which showed that nearly one-half believed that health problems could develop from dental amalgam. In the same year, the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) separately convened panels of experts to evaluate the current state of knowledge regarding amalgam-related hazards. Both panels of experts agreed that current research information does not demonstrate a causal relationship between dental amalgam and a human health problem. Subsequent to these meetings the Swedish Medical Research Council held a scientific conference in 1992 on the biological consequences of mercury released from dental amalgam and reported that it does not, according to available data, contribute to systemic disease, toxicological or teratological effects. In contrast, a symposium on the toxicity of mercury vapor from dental amalgam, held in 1992 under the auspices of the Society of Toxicology, reported that more remains to be learned about the effects of chronic, low level mercury exposure associated with dental amalgams. Attendees called for more research in the areas of neurologic, reproductive, developmental and renal effects, and the mechanisms that underlie them. The need for additional research was echoed by the Public Health Service when in 1991, at the direction of the Assistant Secretary for Health, it brought together subject matter experts as well as specialists in risk and benefits assessment on the Committee to Coordinate Environmental Health and Related Programs (CCERHP) to reach an independent judgment about the degree of health risk, if any, posed by the use of dental amalgam as a restorative material. These experts determined that current research did not demonstrate a health hazard for the vast majority of individuals exposed to mercury vapor at levels commonly encountered. In a 1993 report from CCERHP, the Assistant Secretary for Health, reaffirmed the position enunciated earlier by PHS that there are no data to compel a change in the current use of dental amalgam. Nevertheless, given the available scientific evidence, the possible adverse health effects resulting from the use of dental amalgam cannot be fully discounted. The strongest evidence documenting any potential hazards of amalgam restorations would be obtained from prospective cohort clinical studies, especially a clinical trial involving an amalgam restorative material in children. In particular, given the current state of knowledge, information is needed to try to define more precisely the human dose response relationship of low dose mercury exposure from dental amalgam restorative materials. Children in the mixed dentition stage have been selected as the subjects of choice because of the importance of establishing a baseline in a group with little or no exposure to mercury. Further, the NIDR is interested in studying a population that experiences caries at a high rate, who have received little or no restorative treatment prior to entry into the prospective trial, and in which there is a high likelihood of need for amalgam restorations. Finally, a childhood population of this age group will allow at least seven years, and hopefully more, of followup, a period that should prove sufficient to detect even the most subtle effects, if any, of amalgam. Objectives and Scope The aims of this clinical trial are to investigate the following: 1. Potential neurological, psychological/behavioral, renal, endocrine or other relevant organ system impairments or dysfunctions in children that are attributable to exposure to amalgam restorations; 2. Degree to which Hg concentrations in urine, blood or other relevant tissues differ in children with and without exposure to amalgam restorations; and 3. Progression of Hg concentrations in urine, blood or other relevant tissues over time in children beginning with the time of the initial placement of amalgam restorations. It is anticipated that the clinical trial would be performed in populations at high risk for dental caries consisting of individuals that have received little or no previous treatment and which are in need of restorative treatment. Such populations may come from within the U.S., outside of the U.S., or a combination of the two. It is anticipated that routine restorations of carious teeth supplemented by an aggressive caries prevention and education program consistent with appropriate standard of care would be instituted for the study population throughout the study period. Due to the nature of the trial, a multidisciplinary approach including the appropriate mix of experts from epidemiology, biostatistics, neurology, behavioral sciences/child psychology, toxicology, and other relevant specialties is believed to be essential to its success. To accomplish the objectives within the multidisciplinary context, substantive NIDR scientific input is viewed as essential during both the developmental and operational phases of the project. Consensus is necessary regarding specific neurological, psychological/behavioral, and/or other appropriate health endpoints as well as for the length of time, estimated to be in the range of five to seven years, for study subject followup during which even the most subtle psychological or physiological changes could be detected. SPECIAL REQUIREMENTS The organizational structure of the study may take one of several forms depending on the ability to recruit sufficient numbers of subjects, to perform analyses on biological samples, and to perform data entry and analysis. These functions may all be able to be performed at one institution or with subcontracts to individual centers under a single award. On the other hand, it may be necessary to fund multiple sites with individual awards. In the latter case, it may also be necessary to fund a coordinating center to insure efficient conduct of the trial. In the event that multiple sites are required to carry out the trial, it is imperative that principal investigators of the individual centers agree to follow a single clinical protocol as well as to make measurements in a uniform and prescribed manner. Specific rationale should accompany the suggested outcome measures recommended as primary response variables. The variables selected should be specific enough to pertain to mercury vapor exposure. If multiple primary outcome measures are recommended, the methodology for combining results should be addressed to avoid confusion regarding procedures used for interpreting statistically significant findings (i.e., explain how positives will be validated). The importance of identifying and documenting the availability of an adequate population of subjects for this trial cannot be overemphasized. The assumptions made in the calculation of sample size determination must be made explicit with supportive documentation provided whenever possible. Procedures for soliciting diverse subpopulations will be required as will specific procedures for monitoring and managing the trial, including any quality control procedures. If more than one country or cultural/ethnic group is involved, a detailed description of precautions that will be taken to ensure that all instruments used will be valid across the various subgroups is necessary. Administrative responsibility needs to be documented in detail including responsibility for recruitment and enrollment, eligibility requirements, and criteria for determining whether a field center qualifies for inclusion in the study. Special attention must be given to the potential attrition problem during the study period, indicating the methods that will be used to encourage subjects to remain in the study, the techniques used for monitoring dropout rates at individual study sites, and the possible corrective actions that will be employed. The method of providing restorative care for all participants at the conclusion of the study must be specified. Appropriate level of dental care will have to be provided to all participants requiring restorative care as a result of participating in this study or coincident to participating in the study. Terms and Conditions of Award These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used to undertake the project is a cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient in a partner role, but it is not to assume direction, prime responsibility or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NIDR Project Scientist who is the Assistant Director for Program Development, Extramural Program. Awardees will have the usual responsibilities of award recipients, including protocol development, participant recruitment and followup, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, and preparation of publications, as well as responsibilities for collaboration with other awardees, as appropriate, and collaboration with the NIDR Project Scientist. Awardees will have lead responsibilities for the project as a whole and it is anticipated that the awardees will have lead responsibilities in all joint tasks and activities, except it is anticipated that the NIDR Project Scientist(s) will have lead responsibilities in quality control and catalyzing interim monitoring of data and safety and may, consistent with publication policy to be adopted by the Steering Committee as well as NIH publication policy, have lead responsibilities in the preparation of some publications. Awardees will retain custody of and have primary rights to the data developed under these awards, subject to Federal government rights of access consistent with current HHS, PHS, and NIH policies. In addition to the NIDR Project Scientist, a representative from the Epidemiology and Oral Disease Prevention Program (EODPP) will have responsibilities in protocol development, quality control, interim data and safety monitoring, final data analysis and interpretation, preparation of publications, collaboration with awardees, and project coordination. The main governing body of the study will be the Steering Committee. The Committee will have primary responsibility for developing common protocols, facilitating the conduct and monitoring of studies, and reporting the study results. The composition of the Committee will depend on the final organization of the trial. For a multicenter trial, the Committee will be composed of the principal investigator, representatives from each of the recruitment centers, a representative of the coordinating center, representatives from each of the analytic centers, the NIDR Project Scientist and a representative of the EODPP. For a single center trial, the Committee will consist of the PI, representatives from any analytic centers, the NIDR Project Scientists and a representative of the EODPP. Each member of the Committee will have one vote except for representatives from the NIDR who, together, shall have only one vote. The Chairperson, who will be someone other than an NIDR staff member, will be selected by the Committee. Subcommittees will be established by the Steering Committee, as it deems appropriate. The collaborative protocol will be developed by the Steering Committee and followed by all awardees. This protocol may be reviewed by an external committee convened by NIDR. The protocol will be implemented only with the concurrence of the awardee(s) and NIDR. Data will be submitted centrally to the Coordinating Center. The protocol will define rules regarding access to data and publications. An independent Data and Safety Monitoring Board (DSMB), to be appointed by NIDR, will review progress at least annually and report to NIDR. The DSMB will examine data for any untoward effects of the treatment procedure or of Hg amalgam on subjects as well as for statistically significant increases in Hg between baseline and subsequent measurements. The DSMB will have the responsibility of reporting to the NIDR the occurrence of untoward effects of Hg amalgam, any human subject ethical issues, or if statistical significance is reached in one of the major study endpoints before the planned end of the trial. The NIDR reserves the right to terminate or curtail the study (or an individual award in the event of (a) failure to develop or implement a mutually agreeable collaborative protocol, (b) substantial shortfall in participant recruitment, follow up, data reporting, quality control, or other major breach of the protocol, (c) reaching a major study endpoint substantially before schedule with persuasive statistical significance, or (d) human subject ethical issues. Any disagreement that may arise in scientific/programmatic matters within the scope of the award, between award recipients and the NIDR may be brought to arbitration. An arbitration panel will be composed of three members one selected by the Steering Committee (with the NIDR members not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by the NIDR, and the third member selected by the two prior members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR part 50, Subpart D and HHS regulation at 45 CFR part 16. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492 of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators may obtain copies from these sources or from program staff or contact the person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTERS OF INTENT Prospective applicants are asked to submit, by May 22, 1995, a letter of intent that includes a descriptive title of the proposed center(s), the name, address and telephone number of the center director(s), the identities of 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 subsequent applications. It allows NIDR staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be addressed to Dr. Norman S. Braveman at the address listed under INQUIRIES. APPLICATION PROCEDURES Prospective applicants are advised to communicate with program and grants management staff of the NIDR as early as possible in the planning phase of application preparation. NIDR staff are available to assist applicants to ensure that the objectives, structure, and the budget format for the proposed study are acceptable. The research grant application form PHS 398 (rev. 9/91) is to be used in applying for this cooperative agreement. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248; and from the program administrator listed under INQUIRIES. The RFA label available in the form PHS 398 must be affixed to the bottom of the face page of the original 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 in item 2a of the face page of the application form and the YES box checked. The instructions accompanying form PHS 398 must be followed to the extent possible, but some modification will be necessary. For example, a new Table of Contents must be prepared giving page numbers for all items in the application. Pagination must be consecutive throughout the application. A consolidated budget for the complete project for the entire project period must be presented (see page 5, form PHS 398). Separate detailed, annual and total budgets for the entire project period for each center must be presented (use pages 4 and 5, form PHS 398). Direct and indirect costs are to be given. Funds may be requested for professional, technical, and administrative personnel; consultant services; equipment; supplies; travel; patient costs directly related to the research; minor renovations and other costs. Detailed justification of the budget requests will be required. Under Research Plan, describe the goals of the center(s) and discuss the background and significance of the topics being addressed. Explain how the proposed research will accomplish the objectives. Describe the organizational and administrative structure, the responsibilities of the principal investigator and other investigators, and the proposed mechanisms for monitoring scientific progress. Address issues raised under the "Special Requirements" and "Terms and Conditions" sections of the RFA. An abstract (page 2, form PHS 398) must be completed for the entire application. Submit a signed, original of the application, including the Checklist, and three signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express or courier service) At the time of submission, two additional copies also must be sent to: Dr. H. George Hausch Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN-44F 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 Applications must be received by August 24, 1995. If an application is received after that date, it will be returned to the applicant. REVIEW CONSIDERATIONS General Considerations All applications will be judged on the basis of the scientific merit of the proposed protocols and the documented ability of the PI and the research team to conduct the essential study components as broadly outlined in the RESEARCH OBJECTIVES of the RFA. Although technical merit of the application is important, it will not be the sole criterion for selection. Other considerations such as importance and timeliness of the proposed trial, access to patients, and multidisciplinary nature of the studies will be part of the evaluation criteria. Review Method Upon receipt, applications will be reviewed by NIH staff for completeness and responsiveness. Applications that are incomplete or nonresponsive to this RFA, or exceed the first year budget limit of $500,000 in direct costs, including any indirect costs associated with consortium arrangements, will be returned to the applicant without further consideration. Waivers of the receipt date deadline and budget limitation will not be granted. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific and technical merit by a special review committee convened by the NIDR Scientific Review Office. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and assigned a priority score. Applications judged to be noncompetitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Review Criteria Applicants are encouraged to submit and describe their own ideas on how best to meet the goals and objectives of the RFA. They are expected to address issues identified under SPECIAL REQUIREMENTS of the RFA. Applications will be judged primarily on the scientific quality of the application, the appropriateness, importance and timeliness of the proposed approach, adequacy of facilities, access to patients, the multidisciplinary nature of the study, the approach to cost containment, the discussion of considerations relevant to the RFA, the expertise of the investigators, their capability to perform the proposed research, and a demonstrated ability to work as part of a multidisciplinary team as well as with the NIDR project scientists. The review group will assess the scientific merit of the protocols and related major factors, including: 1. The rationale for and prioritization of the primary health outcome variables proposed for the trial. 2. The appropriateness of the study design regarding length of study, composition and size of study groups, anticipated number of centers needed, inclusion of appropriate control group(s), and entry criteria of subjects required at participating centers. 3. Documentation (e.g., pilot study results) relative to the feasibility of the study population proposed for use in the trial, including susceptibility to dental caries, need for restorative treatment, lack of previous exposure to amalgam fillings or exposure to mercury from other environmental or dietary sources. 4. The adequacy of the identified study population, including the potential for enrollment, participation by females and minorities as study subjects, participant access for the duration of the trial period, and stability of participants for the duration of the study. Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. 5. The scientific and administrative qualifications, experience and commitment of the identified investigators to conduct this study. The adequacy of the proposed interdisciplinary team to conduct this trial. The expertise and experience of the data management team identified by the applicant, including the quality control procedures suggested for data entry, editing, storage and processing procedures. The quality and thoroughness of the analytical plan suggested in the study protocol. 6. The extent to which the investigators have anticipated potential problems; the loss of a senior investigator, change of an administrative head at a study site controlling access to a large group of study participants, difficulties in recruiting participants, corrective actions for clinics experiencing difficulty during the study period. 7. The technical expertise, demonstrated experience and capabilities of the laboratory to perform the mercury assays at the sensitivity level required for this study. The technical merit and justification for other core resources requested and the appropriateness of the budget for each component. 8. The thoroughness and adequacy of quality control procedures for accuracy and reliability of the clinical and laboratory data, monitoring the adherence to the study protocol by all investigators, and safety of procedures used. 9. The strategy for conducting longterm followup of the study participants should this be desired later including provisions for treatment of exiting participants from the study, during or at its conclusion, including providing for any restorative treatment needs. AWARD CRITERIA The NIDR appreciates the value of complementary funding from other public and private sources, including foundations and industrial concerns, for activities that will complement and expand those supported by the NIDR. Such support is encouraged to supplement funding for this trial. Applications recommended for funding by the National Advisory Research Dental Council will be considered for award based upon: (a) scientific and technical merit as determined by peer review, importance of the proposed clinical trial, timeliness, multidisciplinary nature of the study, and the requirements explicitly stated in the RFA; (b) in the case of a multicenter trial, compatibility of the various elements to make a successful collaborative program a reasonable likelihood; and (c) availability of funds. Letter of Intent Receipt Date: May 22, 1995 Application Receipt Date: August 24, 1995 NARDC Review: January 1996 Anticipated Award Date: March 1996 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 scientific program issues to: Norman S. Braveman, Ph.D. Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN 24B 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2089 FAX: (301) 480-8318 Email: BravemanN@de45.nidr.nih.gov Direct inquiries concerning fiscal policy matters to: Ms. Theresa Ringler Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AS-55 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-4800 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.121. 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 Parts 74 and 92. [Part 92 applies when state and local governments are eligible to apply as "domestic organization."]. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the phs mission to protect and advance the physical and mental health of the american people. From owner-sci-resources@net.bio.net Thu Mar 23 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-95-041 - V24(11) 03/24/95 Date: 23 Mar 1995 21:20:50 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 527 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3ktkri$6ra@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PAR95041 PAR-95-041 P1O1 ************************************* RESEARCH AND DEMONSTRATION GRANTS IN OCCUPATIONAL SAFETY AND HEALTH NIH GUIDE, Volume 24, Number 11, March 24, 1995 PA NUMBER: PAR-95-041 P.T. 34, 12; K.W. 0725020 National Institute for Occupational Safety and Health PURPOSE The purpose of this grant program is to develop knowledge that can be used in preventing occupational diseases and injuries. The National Institute for Occupational Safety and Health (NIOSH) will support the following types of applied research projects: causal research to identify and investigate the relationships between hazardous working conditions and associated occupational diseases and injuries; methods research to develop more sensitive means of evaluating hazards at work sites, as well as methods for measuring early markers of adverse health effects and injuries; control research to develop new protective equipment, engineering control technology, and work practices to reduce the risks of occupational hazards; and demonstrations to evaluate the technical feasibility or application of a new or improved occupational safety and health procedure, method, technique, or system. Background Americans are now working more hours than ever before. The workplace environment profoundly affects health. Each person, simply by going to work each day, may face hazards that threaten one's health and safety. Risking a person's life or health should never be considered part of the job. In 1970, Congress passed the Occupational Safety and Health Act to ensure Americans the right to "safe and healthful working conditions," yet workplace hazards continue to inflict a tremendous toll in both human and economic costs. In 1992, employers reported 3.3 million disabling work injuries and 370,000 cases of occupational illness. According to the most current statistics an average of 17 American workers die each day from injuries on the job. Moreover, even the most conservative estimates find that about 137 additional workers die each day from workplace diseases. Medical payments under workers' compensation rose to almost $17 billion in 1991. Considering that workers' compensation is received by only 60 percent of injured workers and does not cover most cases of chronic occupational illness, medical costs alone for these conditions may total $30 to $40 billion. Occupational injury and disease creates needless human suffering, a tremendous burden upon health care resources, and an enormous drain on U.S. productivity (estimated to exceed $100 billion annually). Yet, to date, this mainstream public health problem has somehow escaped mainstream public attention. Workplace injury and disease is neither inevitable nor acceptable. The time has come to protect one of the nation's most valuable resources: the American worker. The philosophy of NIOSH is articulated in the NIOSH's vision statement: Delivering on the Nation's Promise: Safety and Health at Work for All People...Through Prevention. To identify and reduce hazardous working conditions, the NIOSH carries out disease, injury, and hazard surveillance and conducts a wide range of field and laboratory research. Additionally, NIOSH sponsors extramural research in priority areas to complement and expand its efforts. These are listed under RESEARCH OBJECTIVES. 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 to reduce morbidity and mortality and improve the quality of life. This program announcement, Research and Demonstration Grants in Occupational Safety and Health, is related to the priority area occupational safety and health. 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 REQUIREMENTS Eligible applicants include domestic and foreign non-profit and for-profit organizations, universities, colleges, research institutions, and other public and private organizations, including State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Exceptions: applicants for the Special Emphasis Research Career Award Grant or Small Grant programs must be citizens or persons lawfully admitted to the U.S. for permanent residence (resident alien) at the time of application and must be employed by a domestic institution. MECHANISM OF SUPPORT The types of grants NIOSH supports are described below. Applications responding to this program announcement will be reviewed by staff for their responsiveness to the following program requirements. Grants are funded for 12-month budget periods in project periods up to five years for research project grants and demonstration project grants; three years for SERCA grants; and up to two years for small grants. Continuation awards within the project period are made on the basis of satisfactory progress and on the availability of funds. 1. Research Project Grants (R01) A research project grant application should be designed to establish, discover, develop, elucidate, or confirm information relating to occupational safety and health, including innovative methods, techniques, and approaches for dealing with occupational safety and health problems. These studies may generate information that is readily available to solve problems or contribute to a better understanding of the causes of work-related diseases and injuries. 2. Demonstration Project Grants (R18) A demonstration project grant application should address, either on a pilot or full-scale basis, the technical or economic feasibility of implementing a new/improved innovative procedure, method, technique, or system for preventing occupational safety or health problems. The project should be conducted in an actual workplace where a baseline measure of the occupational problem will be defined, the new/improved approach will be implemented, a follow-up measure of the problem will be documented, and an evaluation of the benefits will be conducted. 3. Special Emphasis Research Career Award (SERCA) Grants (K01) The SERCA grant is intended to provide opportunities for individuals to acquire experience and skills essential to the study of work-related hazards, and in so doing create a pool of highly qualified investigators who can make future contributions to research in the area of occupational safety and health. SERCA grants are not intended either for individuals without research experience or for productive, independent investigators with a significant number of publications and of senior academic rank. Moreover, the award is not intended to substitute one source of salary support for another for an individual who is already conducting full-time research; nor is it intended to be a mechanism for providing institutional support. Candidates must: (1) hold a doctoral degree; (2) have research experience at or above the doctoral level; (3) not be above the rank of associate professor; (4) be employed at a domestic institution; and (5) be citizens or persons lawfully admitted to the U.S. for permanent residence (resident alien) at the time of application. This non-renewable award provides support for a three-year period for individuals engaged in full-time research and related activities. Awards will not exceed $50,000 per year in direct costs for salary support (plus fringe benefits), technical assistance, equipment, supplies, consultant costs, domestic travel, publications, and other costs. The indirect cost rate applied is limited to eight percent of the direct costs, excluding tuition and related fees and equipment expenses, or to the actual indirect cost rate, whichever results in the lesser amount. A minimum of 60 percent time must be committed to the proposed research project, although full-time is desirable. Other work in the area of occupational safety and health will enhance the candidate's qualifications, but is not a substitute for this requirement. Related activities may include research career development activities as well as involvement in patient care to the extent that it will strengthen research skills. Fundamental/basic research will not be supported unless the project will make an original contribution for applied technical knowledge in the identification, evaluation, and/or control of occupational safety and health hazards (e.g., development of a diagnostic technique for early detection of an occupational disease). Research project proposals must be of the applicants' own design and of such scope that independent investigative capability will be evident within three years. At the completion of this three-year award, it is intended that awardees should be better able to compete for individual research project grants awarded by NIOSH. SERCA grant applications should be identified as such on the application form. Section 2 of the application (the Research Plan) should include a statement regarding the applicant's career plans and how the proposed research will contribute to a career in occupational safety and health research. This section should also include a letter of recommendation from the proposed advisor(s). 4. Small Grants (R03) The small grant program is intended to stimulate proposals from individuals who are considering a research career in occupational safety and health; as such, the minimum time commitment is 10 percent. It is expected that a recipient would subsequently compete for a career development grant (K01 - see section H.3.) or for a traditional research project grant (R01 - see section H.1.) related to occupational safety and health. The award is not intended to supplement ongoing or other proposed research; nor is it intended to be a mechanism for providing institutional support. The small grant investigators must be U.S. citizens or persons lawfully admitted to the U.S. for permanent residence (resident alien) at the time of application who are predoctoral students, post-doctoral researchers (within three years following completion of doctoral degree or completion of residency or public health training), or junior faculty members (no higher than assistant professor). If university policy requires that a more senior person be listed as principal investigator, it should be clear in the application which person is the small grant investigator. Except for applicants who are assistant professors, there must be one or more named mentors to assist with the project. A biographical sketch is required for the small grant investigator, as well as for the supervisor and other key consultants, as appropriate. This non-renewable award provides support for project periods of up to two years to carry out exploratory or pilot studies, to develop or test new techniques or methods, or to analyze data previously collected. Awards will not exceed $25,000 per year in direct costs for salary support (plus fringe benefits), technical assistance, equipment, supplies, consultant costs, domestic travel, publications, and other costs. The indirect costs will be based upon the negotiated indirect cost rate of the applicant organization. An individual may not receive more than two small grant awards, and then, only if the awards are at different stages of development (e.g., doctoral student, post-doctoral researcher, or junior faculty member). FUNDS AVAILABLE For fiscal year (FY) 1995, the budget for research grants is $9,373,900. Of that amount, $5,300,000 is to support 44 non-competing continuation awards, and $4,073,900 is available for approximately 35 new and competing renewal awards, which includes $400,000 for Small Business Innovation Research grant awards. Within the $9,373,900 budget, there is emphasis for health and safety research within the construction industry, totaling $2,500,000. Of this figure, $1,850,000 is to support 10 non-competing continuation awards, and $650,000 is available for approximately six new and competing renewal awards. Grant applications should be focused on the research priorities described under RESEARCH OBJECTIVES in this announcement, which include several new research priorities. Grant applications in these new areas will compete for the available funds given above, as well as for funds announced through Requests for Applications that are anticipated in FY 1995 and FY 1996. RESEARCH OBJECTIVES The NIOSH program priorities, listed below, are applicable to all of the above types of grants listed under MECHANISMS OF SUPPORT. These priority areas represent both new areas and traditional diseases and injuries related to risks on the job. NIOSH intends to support projects that facilitate progress in understanding and preventing adverse effects among workers. The conditions or examples listed under each category are selected examples, not comprehensive definitions of the category. Investigators may also apply in other areas related to occupational safety and health, but the rationale for the significance of the research to the field of occupational safety and health must be presented in the grant application. Potential applicants with questions concerning the acceptability of their proposed work are strongly encouraged to contact Dr. Roy M. Fleming at the address under INQUIRIES. New Research Priorities are: o Surveillance: The ability to identify the occurrence and emergence of work-related injury and disease is vital for prevention. While some targeted surveillance efforts address specific conditions, such as adult lead poisoning, occupational lung disease, and carpal tunnel syndrome, a national surveillance system for occupational disease and injury does not exist. To broaden current surveillance systems, it is necessary to: (1) improve hazard surveillance by developing systems that identify hazardous work conditions, rather than cases of disease or injury; (2) evaluate new disease surveillance efforts to better fill the gaps in current reporting systems; (3) explore additional surveillance methods for nonfatal injury, including workplace violence; and (4) assess the economic burden of occupational conditions and potential economic benefits of their prevention. o Work Organization: Through surveillance and research, NIOSH and others have identified many physical and chemical hazards of work. However, there is growing evidence that the way work is organized, itself, affects the health and well-being of workers, both directly and in combination with other hazards. Investigations are needed on broad aspects of employment, including underemployment, overemployment, unemployment, shift-work, alternate work schedules, and job stress. Also encompassed are special risks that may result >From the ongoing evolution to a service economy; to a workforce that is increasingly comprised of women, minorities and older workers; and to conditions of employment and demands for productivity increasingly pressured by global market forces. o Control Technology and Intervention Research: NIOSH seeks to prevent work-related diseases and injuries by designing, implementing, and evaluating measures to reduce occupational hazards at their source. If prevention measures are not currently available, new technologies need to be developed for controlling hazardous exposures. Such new technologies must be evaluated to determine that the prevention measures are feasible, even for smaller businesses. Intervention research, of which control technology is a part, examines the utility and impact of new and existing preventive measures in the workplace. Assessments are needed of the effectiveness of regulations, educational efforts, government and private outreach programs, employer policies, worker training, and protective technology in preventing disease and injury. o Health Services Research: This area includes (1) assessing the adequacy of the supply of occupational safety and health professionals, including specialist or generalist physicians and nurses, industrial hygienists, safety specialists, and engineers; (2) evaluating the accessibility, availability, and delivery of occupational health services, the role of workers' compensation, and the integration of occupational health services and primary health care; (3) improving the quality of occupational health care, through clinical and preventive practice guidelines; (4) assessing the effectiveness of screening and treatment of select occupational conditions; and (5) evaluating the economics of treating and preventing occupational injuries and illnesses. Traditional research priorities are broadly intended for investigator-initiated research of emerging or reemerging issues, particularly those affecting a large number of workers. These areas include: occupational lung diseases, musculoskeletal injuries, occupational cancers (other than lung), severe occupational traumatic injuries and fatalities, cardiovascular disease, disorders of reproduction, neurotoxic disorders, noise-induced hearing loss, dermatologic conditions, and psychological disorders. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Applicants are required to give added attention (where feasible and appropriate) to the inclusion of minorities and/or women study populations for research into the etiology of diseases, research in behavioral and social sciences, clinical studies of treatment and treatment outcomes, research on the dynamics of health care and its impact on disease, and appropriate interventions for disease prevention and health promotion. Exceptions would be studies of diseases which exclusively affect males or where involvement of pregnant women may expose the fetus to undue risks. If minorities and/or women are not included in a given study, a clear rationale and justification for their exclusion must be provided. 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 Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/594-7248; and from the program administrator listed under INQUIRIES. The original and five copies of the PHS 398 must be submitted to the address below by the specified receipt dates also provided below. A mailing label is provided in the form PHS 398 application package. Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express or courier service) The timetable for receiving applications and awarding grants is given below. This is a continuous announcement, consequently, these receipt dates will be ongoing until further notice. Research and Demonstration Project Grants: Receipt Initial Secondary Earliest Possible Date* Review Review Start Date Feb 1 Jun/Jul Sep Dec 1 Jun 1 Oct/Nov Jan Apr 1 Oct 1 Feb/Mar May Aug 1 *Deadlines for competing continuation applications or revised applications are 1 month later. SERCA and Small Grants Receipt Initial Secondary Earliest Possible Date Review Review Start Date Mar 1 Jun/Jul Aug Nov 1 Jul 1 Oct/Nov Dec Mar 1 Nov 1 Feb/Mar Apr Jul 1 Applications must be received by the above receipt dates. To guard against problems caused by carrier delays, retain a legible proof-of-mailing receipt from the carrier, dated no later than one week prior to the receipt date. If the receipt date falls on a weekend, it will be extended to Monday; if the date falls on a holiday, it will be extended to the following work day. The receipt date will be waived only in extenuating circumstances. To request such a waiver, include an explanatory letter with the signed, completed application. No request for a waiver will be considered prior to receipt of the application. REVIEW CONSIDERATIONS Applications 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 in accordance with the NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level programmatic review by NIOSH. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and those applications assigned to the NIOSH will receive a second level review by the NIOSH programmatic review committee. Review Criteria The initial (peer) review is based on scientific merit and significance of the project, competence of the proposed staff in relation to the type of research involved, feasibility of the project, likelihood of its producing meaningful results, appropriateness of the proposed project period, adequacy of the applicant's resources available for the project, and appropriateness of the budget request. Demonstration grant applications will be reviewed additionally on the basis of the following criteria: o Degree to which project objectives are clearly established, obtainable, and for which progress toward attainment can and will be measured. o Availability, adequacy, and competence of personnel, facilities, and other resources needed to carry out the project. o Degree to which the project can be expected to yield or demonstrate results that will be useful and desirable on a national or regional basis. o Documentation of cooperation from industry, unions, or other participants in the project, where applicable. SERCA grant applications will be reviewed additionally on the basis of the following criteria: o The review process will consider the applicant's scientific achievements, the applicant's research career plan in occupational safety and health, and the degree to which the applicant's institution offers a superior research environment (supportive nature, including letter(s) of reference from advisor(s) which should accompany the application). Small grant applications will be given consideration to the fact that applicants do not have extensive experience with the grant process. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to NIOSH. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. In the secondary review, the following factors will be considered: o The results of the initial review. o The significance of the proposed study to the mission of NIOSH. (1) Relevance to occupational safety and health, by contributing to achievement of research objectives specified in Section 20(a) of the Occupational Safety and Health Act of 1970 and Section 501 of the Federal Mine Safety and Health Amendments Act of 1977, (2) Magnitude of the problem in terms of numbers of workers affected, (3) Severity of the disease or injury in the worker population, (4) Potential contribution to applied technical knowledge in the identification, evaluation, and/or control of occupational safety and health hazards, (5) Program balance, and (6) Policy and budgetary considerations. Questions regarding the above criteria may be addressed to Dr. Fleming at the address listed under INQUIRIES. INQUIRIES Inquiries are encouraged. The opportunity to clarify and issues or questions from potential applicants is welcome. Direct inquiries regarding technical or programmatic issues to: Roy M. Fleming, Sc.D. National Institute for Occupational Safety and Health Centers for Disease Control and Prevention 1600 Clifton Road, NE Building 1, Room 3053, Mail Stop D-30 Atlanta, GA 30333 Telephone: (404) 639-3343 FAX: (404) 639-2196 Email: rmf2@niood1.em.cdc.gov Direct inquiries regarding fiscal matters to: Ms. Georgia Jang Grants Management Branch, PGO Centers for Disease Control and Prevention 255 E. Paces Ferry Road, NE Room 321, Mail Stop E-13 Atlanta, GA 30305 Telephone: (404) 842-6814 FAX: (404) 842-6613 Email: glj2@opspgo1.em.cdc.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.262. This program is authorized under the Public Health Service Act, as amended, Section 301 (42 U.S.C. 241); the Occupational Safety and Health Act of 1970, Section 20 (a) (29 U.S.C. 669[a]); and the Federal Mine Safety and Health Amendments Act of 1977, as amended, Section 501 (30 U.S.C. 951). The applicable program regulations are in 42 CFR Part 52. This program is not subject to the Public Health Systems Reporting Requirements. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and to promote the nonuse of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. From owner-sci-resources@net.bio.net Thu Mar 23 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 24, no. 11, pt. 1of1, 24 March 1995 Date: 23 Mar 1995 21:20:26 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 350 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3ktkqq$6q6@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19950324 V24N11 P1O1 ************************************ X-comment: RFAs described: DE-95-003, DE-95-004, PAR-95-041, PA-95-042 NIH GUIDE - Vol. 24, No. 11 - March 24, 1995 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NEW ADDRESS FOR THE DIVISION OF RESEARCH GRANTS Division of Research Grants INDEX: DIVISION OF RESEARCH GRANTS NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 08/22/95 ************************************************* ORAL CANCER RESEARCH CENTERS (RFA DE-95-003) National Institute of Dental Research INDEX: DENTAL RESEARCH $$INDEX R2 08/24/95 ************************************************* HEALTH EFFECTS OF DENTAL AMALGAMS IN CHILDREN (RFA DE-95-004) National Institute of Dental Research INDEX: DENTAL RESEARCH $$INDEX P1 ********************************************************** RESEARCH AND DEMONSTRATION GRANTS IN OCCUPATIONAL SAFETY AND HEALTH (PAR-95-041) National Institute for Occupational Safety and Health INDEX: OCCUPATIONAL SAFETY, HEALTH $$INDEX P2 ********************************************************** NIAID/MODELL MINORITY FELLOWSHIPS IN PRIMARY IMMUNE DEFICIENCY (PA-95-042) National Institute of Allergy and Infectious Diseases The Jeffrey Modell Foundation INDEX: ALLERGY, INFECTIOUS DISEASES; JEFFREY MODELL FOUNDATION This publication is available electronically via BITNET or INTERNET, by subscription, and is also on the NIH GOPHER (gopher.nih.gov). 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. THE PUBLIC HEALTH SERVICE (PHS) STRONGLY ENCOURAGES ALL GRANT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** NEW ADDRESS FOR THE DIVISION OF RESEARCH GRANTS NIH GUIDE, Volume 24, Number 11, March 24, 1995 P.T. 34; K.W. 1014006 Division of Research Grants The Division of Research Grants (DRG) is moving to a new location. Effective May 8, 1995, all COMPETING grant applications submitted to the National Institutes of Health must be sent to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for courier/overnight service) The telephone numbers for all offices within the DRG will also be changing. Essential telephone numbers at the new location and other information updates will be published in future issues of the NIH Guide for Grants and Contracts. Questions concerning this announcement may be directed to the Referral Office at (301) 594- 7250. This telephone number will be in operation until May 8, 1995. After May 8 the telephone number will be (301) 435-0715. $$N1 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN DE-95-003 FULL-TEXT ************************************** ORAL CANCER RESEARCH CENTERS NIH GUIDE, Volume 24, Number 11, March 24, 1995 RFA AVAILABLE: DE-95-003 P.T. 34; K.W. 0715035, 0715148, 0785055, 0710070, 1002045 National Institute of Dental Research Letter of Intent Receipt Date: May 15, 1995 Application Receipt Date: August 22, 1995 PURPOSE The National Institute of Dental Research (NIDR) invites applications >From United States institutions for the support of Oral Cancer Research Centers. The goal of these centers is to support multidisciplinary basic and clinical research incorporating the range of parameters and academic disciplines necessary for reducing the morbidity and mortality due to oral cancer (e.g., epidemiology, behavioral sciences, nutrition, immunology, molecular biology, toxicology, and virology). Multifactorial, multistep approaches will be encouraged. Proposed centers should take full advantage of combined institutional strengths in various geographic locations. 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 Application (RFA), Oral Cancer Research Centers, 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 Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (301-402-2221) and the NIH GOPHER (gopher@nih.gov) as well as by mail and email from the program contact listed below. Dr. Norman S. Braveman Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN 24B 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2089 FAX: (301) 480-8318 Email: BravemanN@de45.nidr.nih.gov $$R1 END ************************************************************ $$R2 BEGIN DE-95-004 FULL-TEXT ************************************** HEALTH EFFECTS OF DENTAL AMALGAMS IN CHILDREN NIH GUIDE, Volume 24, Number 11, March 24, 1995 RFA AVAILABLE: DE-95-004 P.T. 34; K.W. 0785040, 0750005, 1007009 National Institute of Dental Research Letter of Intent Receipt Date: May 22, 1995 Applications Receipt Date: August 24, 1995 PURPOSE The National Institute of Dental Research (NIDR) invites applications for cooperative agreements (U01) for a multidisciplinary clinical trial addressing the health effects of dental amalgams in children. Public concerns about the safety of dental amalgam fillings containing mercury continues despite assurances from the public health community. The general purpose of the trial is to investigate the possible relationship between low-dose exposure to mercury vapor >From dental amalgam restorations and the occurrence of specific health conditions in children. To accomplish this the Institute is interested in supporting a prospective, randomized clinical trial involving children from high risk caries populations needing restorative dental treatment with dental amalgam. It is anticipated that one award will be made and up to $500,000 in total costs will be committed for the first year of support, if a sufficient number of applications of high scientific merit are received. 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, Health Effects of Dental Amalgams in Children, 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 Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line: 301-402-2221) and the NIH Gopher (gopher.nih.gov) and by mail and email from the program contact listed below. Dr. Norman S. Braveman Division of Extramural Research National Institute of Dental Research Natcher Building Room 4AN-24B 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2089 FAX: (301) 480-8318 Email: BravemanN@de45.nidr.nih.gov $$R2 END ************************************************************ $$P1 BEGIN PAR-95-041 FULL-TEXT ************************************* RESEARCH AND DEMONSTRATION GRANTS IN OCCUPATIONAL SAFETY AND HEALTH NIH GUIDE, Volume 24, Number 11, March 24, 1995 PA AVAILABLE: PAR-95-041 P.T. 34, 12; K.W. 0725020 National Institute for Occupational Safety and Health PURPOSE The purpose of this grant program is to develop knowledge that can be used in preventing occupational diseases and injuries. The National Institute for Occupational Safety and Health (NIOSH) will support the following types of applied research projects: causal research to identify and investigate the relationships between hazardous working conditions and associated occupational diseases and injuries; methods research to develop more sensitive means of evaluating hazards at work sites, as well as methods for measuring early markers of adverse health effects and injuries; control research to develop new protective equipment, engineering control technology, and work practices to reduce the risks of occupational hazards; and demonstrations to evaluate the technical feasibility or application of a new or improved occupational safety and health procedure, method, technique, or system. For fiscal year (FY) 1995, the budget for research grants is $9,373,900. Of that amount, $5,300,000 is to support 44 non-competing continuation awards, and $4,073,900 is available for approximately 35 new and competing renewal awards, which includes $400,000 for Small Business Innovation Research grant awards. Within the $9,373,900 budget, there is emphasis for health and safety research within the construction industry, totaling $2,500,000. Of this figure, $1,850,000 is to support 10 non-competing continuation awards, and $650,000 is available for approximately six new and competing renewal awards. 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 to reduce morbidity and mortality and improve the quality of life. This program announcement, Research and Demonstration Grants in Occupational Safety and Health, is related to the priority area occupational safety and health. 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). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Roy M. Fleming, Sc.D. National Institute for Occupational Safety and Health Centers for Disease Control and Prevention 1600 Clifton Road, NE Building 1, Room 3053, Mail Stop D-30 Atlanta, GA 30333 Telephone: (404) 639-3343 FAX: (404) 639-2196 Email: rmf2@niood1.em.cdc.gov $$P1 END ************************************************************ $$P2 BEGIN PA-95-042 FULL-TEXT ************************************** NIAID/MODELL MINORITY FELLOWSHIPS IN PRIMARY IMMUNE DEFICIENCY NIH GUIDE, Volume 24, Number 11, March 24, 1995 PA AVAILABLE: PA-95-042 P.T. 22; K.W. 0715120, 0755030, 0765033, 0745020, 0745070 National Institute of Allergy and Infectious Diseases The Jeffrey Modell Foundation Application Receipt Dates: April 5, August 5, and December 5, 1995 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) and the Jeffrey Modell Foundation (JMF) invite applications for Individual Postdoctoral Fellowships from racial/ethnic minority individuals, women, and persons with disabilities for research on the etiology, pathogenesis, diagnosis and/or treatment of prima