From owner-sci-resources@net.bio.net Fri Nov 04 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-95-003 - V23(39) 11/04/94 Date: 5 Nov 1994 12:35:11 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 915 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <39gq9v$l9@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA95003 CA-95-003 P1O1 *************************************** COOPERATIVE FAMILY REGISTRY FOR EPIDEMIOLOGIC STUDIES OF BREAST CANCER NIH GUIDE, Volume 23, Number 39, November 4, 1994 RFA: CA-95-003 P.T. 34; K.W. 0715036, 0785055, 0780030 National Cancer Institute Letter of Intent Receipt Date: November 30,1995 Application Receipt Date: February 17, 1995 PURPOSE The Extramural Programs Branch, Epidemiology and Biostatistics Program, Division of Cancer Etiology, National Cancer Institute (NCI) invites cooperative agreement applications from investigators to participate, with the assistance of the NCI, in a network of organizations constituting a Cooperative Family Registry for Breast Cancer (CFRBC). The purpose of the proposed awards is to stimulate a cooperative effort to: 1. Collect pedigree information, epidemiological data and related biological specimens from patients with a family history of breast cancer in order to provide a registry resource for interdisciplinary studies on the etiology of breast cancer, and to encourage translational research in this area. 2. Identify a population at high risk for breast cancer that could benefit from new preventive and therapeutic strategies. This Request for Applications (RFA) responds to Congressional language instructing the Director of the National Cancer Institute to conduct and support research to expand the understanding of the cause of, and find a cure for, breast cancer. 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, Cooperative Family Registry for Epidemiologic Studies of Breast Cancer Studies, relates to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign non-profit and for-profit institutions, public and private, such as colleges, universities, hospitals, research laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority and women investigators are encouraged. MECHANISM OF SUPPORT Support of this program will be through the cooperative agreement (U01), an assistance mechanism in which substantial NCI scientific and programmatic involvement with the recipients during performance of the planned activity is anticipated. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the awardee in a partner role, but is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationship, and governance of the study to be funded under cooperative agreements are discussed later in this document under the section "Terms and Conditions of Award." The total project period for applications submitted in response to the present RFA may not exceed four years. The anticipated award date is December 1995. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. Awards and level of support depend on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. This RFA is a one-time solicitation. At this time, the NCI has not determined whether or how this solicitation will be continued beyond the present RFA. FUNDS AVAILABLE Approximately $2 million in total costs per year for four years will be committed to specifically fund applications that are submitted in response to this RFA. It is anticipated that two to five awards will be made. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. RESEARCH OBJECTIVES Background According to 1993 Surveillance, Epidemiology and End Results (SEER) Registry data, breast cancer is the second leading cause of cancer death among women in the United States, second only to lung cancer, and its incidence is increasing at a rate of approximately two percent per year. Breast cancer is a highly complex disease, and the natural history of primary breast cancer varies considerably from patient to patient. The genetic heterogeneity and etiologic complexity of breast cancer limit identification of high-risk populations. Family studies of breast cancer indicate that the genetic contribution to breast cancer risk is an important component of the heterogeneity of this disorder. The compelling need for validated screening procedures (especially among young women) and for the identification of risk factors and predictors contributing to the rising incidence of this disease have prompted Congress and the scientific community to place high priority on research in breast cancer etiology and on the development of preventive and therapeutic strategies. Recommendations from a conference on "Genetic Epidemiology of Cancer: an Interdisciplinary Approach," sponsored by NCI in 1992, indicate that extended families with high incidence of cancer or cancer syndromes provide a unique research resource for epidemiologic, molecular genetics, and prevention studies. Epidemiologic and interdisciplinary studies of major cancer genes are based on the ascertainment of families with high incidence of cancer. Large, informative families are useful for identifying and characterizing susceptibility genes involved in the etiology of cancer, and elucidating gene-environment interactions. Moreover, members of cancer-prone families represent a population at high risk that could benefit from novel preventive and therapeutic efforts. Early ascertainment of cancer-affected families is needed particularly for tumors with high mortality rates, such as early-onset breast cancer and breast/ovarian cancer. In addition, the selection of rare families with multiple cases of male breast cancer, or affected by familial cancer syndromes that include breast cancer could offer a substantial contribution to the study of this disease. The meeting report specifically recommends a concerted effort to identify such families and avoid their loss to follow-up. The meeting participants indicated that it is impractical, expensive and scientifically unproductive to collect only a few families at a time and that it is timely to develop larger registries of families at high risk for cancer. Such registries should include the collection of epidemiologic and clinical data and of blood and biological specimens, which would be used in future epidemiologic and biologic studies. This research has the potential to be translated into clinical applications and public health measures to address the pressing needs of at-risk populations. Many different approaches to breast cancer research will be able to take advantage of family registry resources, as new knowledge and molecular tools become available. The existence of an established cooperative breast cancer family registry would enhance the cost- effectiveness of: (1) the identification and follow-up of high-risk individuals for the purpose of preventive intervention; (2) the evaluation of the effectiveness of optional treatment strategies as they become available; (3) molecular epidemiology studies generating and testing etiologic hypotheses; and (4) the integration of laboratory studies into the biological mechanisms underlying breast cancer with epidemiologic and genetic data. Current epidemiologic studies of familial breast cancer are limited by the feasibility and expense of collecting a sufficient number of high-risk families to define the genetic heterogeneity of the familial disorder. Moreover, as new statistical approaches become available to explore the interaction between genetic and environmental factors in the etiology of familial breast cancer, the collection of appropriate epidemiologic data on exposure to potential risk factors in these same families becomes extremely important. Other limitations are the lack of archival or fresh-frozen tissue specimens and blood samples, and the difficulty in collecting and validating clinical and epidemiologic data. Efforts made to identify breast cancer-prone families have focused on the localization and mapping of a putative gene for early onset- breast cancer and breast/ovarian cancer, or BRCA1, using molecular markers for a defined area on chromosome 17q. Although an uncertain fraction of familial breast cancer is attributable to BRCA1, the risk for breast cancer of women inheriting this gene is extremely high (up to 85 percent lifetime risk), while the risk for ovarian cancer is also elevated. Testing for the BRCA1 gene is currently limited to very rare families being analyzed for research purposes. However, since the BRCA1 gene has been recently identified, and the mapping and cloning of other possible breast cancer genes are being pursued, it will be extremely important to identify and appropriately counsel the individuals at high risk and their families on preventive and therapeutic options. A family registry for breast cancer would greatly facilitate this process. Research Goals and Scope The purpose of this RFA is to stimulate cooperative efforts for the establishment of a comprehensive family registry for epidemiologic and interdisciplinary studies of individuals at high risk for breast cancer. The establishment of a population-based selection process that could utilize already existing resources, such as SEER or other cancer registries, is strongly encouraged. The CFRBC will enable participant organizations to: identify individuals with a family history of breast cancer, breast-ovarian cancer syndrome, male breast cancer, and various familial syndromes that include breast cancer; collect and define the related pedigrees; and collect clinical (tumor type, stage at diagnosis, hormonal evaluation, etc.), epidemiologic (age at diagnosis, sociodemographic status, etc.), and other relevant data (such as dietary history) to correlate with the pedigree information. Support for the collection of related biological specimens, such as blood samples, paraffin blocks and fresh-frozen tissue, will be included. This registry is not intended to directly support research on the mapping and cloning of the gene(s) for breast or breast/ovarian cancer, but to assist investigators funded through other sources by providing the data and biological specimens that can be used for a variety of purposes, including etiologic studies and prevention and treatment-oriented translational research. The applicants should demonstrate the capability for developing common protocols including, but not limited to: o ascertainment of breast cancer families; o epidemiologic and clinical data collection, validation and management (statistical support); o collection and banking of biological specimens (blood and tissues); o limited follow-up for outcome, recurrence and mortality; and o counseling of family members on risk and possible preventive or therapeutic interventions. Each application must have an Operation Core for statistical and logistic support, capable of providing the necessary coordination for specimen and data collection, and functioning as a central facility at the applicant's institution for data and specimens management and storage. Applicants must address coordination of quality control among awardees with regard to collection and storage of data and specimens. The establishment of the CFRBC resource will promote the availability of epidemiological and clinical data and the related specimens necessary for multidisciplinary and translational studies on the etiology of breast cancer. The awardees will provide to the research community at large pedigree information, epidemiological data, and biological specimens for high priority research studies. It is anticipated that prioritization of the research study proposals requesting access to the CFRBC's resources will be made by an Advisory Committee (AC), and will be based on scientific validity criteria established by the Steering Committee (SC) (for composition and duties of AC and SC see below under special requirement). The NCI will help to coordinate and promote this process through the Program Coordinator's membership in the AC and SC. Of the funds provided by this RFA, at least 90 percent of the total cost proposed in each application must be directed to the basic CFRBC activities (accrual of families, data and specimen collection, management, and retrieval). Up to 10 percent of the total cost, or $50,000 per year (whichever is smaller, starting from the second year of the cooperative agreement), can be requested for pilot or feasibility studies utilizing the family registry resources. Pilot/feasibility studies should be designed to obtain sufficient data to form the foundation for future R01 research grant applications, to help identify new areas where additional investigations are warranted, and to promote interdisciplinary and translational breast cancer research. SPECIAL REQUIREMENTS Definitions AWARDEE The organization to which a cooperative agreement is awarded and that is responsible and accountable to NCI for the use of funds provided and for performance of the project supported by the cooperative agreement. PRINCIPAL INVESTIGATOR (PI) The single individual at the Awardee's Institution designated by the Awardee in the cooperative agreement application, who is responsible for the scientific and technical direction of the project. OPERATION CORE (OP) The central site at the Applicant/Awardee Institution that handles the epidemiological and pedigrees data and the biological specimens. All the data and specimens from each Applicant/Awardee Institution will be coordinated and located at one central location within the awardee's own Institution. The PI serves as the head of the Coordination Site. NCI PROGRAM COORDINATOR The Extramural Programs Branch (EPB) Program Director who will be interacting scientifically and administratively with the Applicant/Awardee Institutions and providing guidance for the overall program for NCI. STEERING COMMITTEE (SC) A committee whose membership includes the NCI Coordinator, the PI and one other investigator from each awarded cooperative agreement, and one research scientist with expertise in translational breast cancer research who is not affiliated with any of the Awardee Institutions. This research scientist on the SC will be appointed by mutual agreement of the NCI Program Coordinator and the PIs. The SC will serve as the governing board of the CFRBC (for its functions, see under "Terms and Conditions of Award). ADVISORY COMMITTEE (AC) A committee composed of six to eight senior scientists with experience in multidisciplinary and translational breast cancer research. The members of the panel will evaluate all research proposals (those of the awardees as well as proposals from the research community at-large) proposing to utilize the CFRBC's resources according to the evaluation and the review criteria provided by the SC. The AC will provide a recommendation to the SC regarding the priority of the proposed research. The membership of the AC may vary, depending on the specific areas of the proposed breast cancer research to be reviewed. All AC members will be selected by the SC (see under "Terms and Conditions of Award" for function of the AC). The NCI Program Coordinator will function as a non-voting liaison member between the AC and the SC, and attend the AC meetings. Study Organization and Function The overall structure of the CFRBC will consist of two to five funded Institutions (awardees) that are governed and coordinated through the SC. Each awardee unit will be composed of one funded site, an Operation Core at the funded site, and a PI providing the scientific and administrative leadership for the unit and serving as the Head of the Operation Core. The overall function of the CFRBC is to promote multidisciplinary and translational research in the framework of studies in the genetic epidemiology of breast cancer, by serving as a national resource to the research community at large. Requests for specimen and data from the awardees and their collaborators will be reviewed, prioritized by the AC, and approved by the SC along with all other requests from investigators in the research community at-large. The Terms and Conditions of Award, below, will be included in all awards issued as a result of this RFA. It is critical that each applicant include specific plans for responding to these terms. 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 part 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program 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 performance of the activity. Under the cooperative agreement, the NIH 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 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 NCI Program Coordinator. 1. Awardee Rights and Responsibilities Awardees will have primary rights and responsibilities to define projects and approaches and to plan and conduct the project, including: o The Awardee's PI will participate as a permanent member in the SC and designate a second investigator from his/her institution to be a permanent member of such committee. o The Awardee will work together with the other Awardees through the SC to establish the registry operating policies, uniform collection procedures, and quality control procedures for specimens and data. The Awardee will be required to accept and implement the common policies and procedures approved by the SC. o The Awardee must agree to provide access to both specimens and data to investigators both within and outside the awardee's institutions, based on the prioritization of the research proposals set by the AC and final approval by the SC. The Awardee will abide by the decisions of the SC based on recommendations from the AC. o The Awardee will retain custody of, and have primary rights to, the data developed under this awards, subject to the Government rights of access consistent with current HHS, PHS, and NIH policies. o Each awardee will need to implement and comply with the common study protocols as established by the SC, but additional elements could be appended by individual institutions to address issues of unique interest or capabilities in each center. o The Awardee must provide an annual progress report to the EPB, DCE, NCI, and a copy to the chairperson of the SC, in a format that is compatible with the annual progress report of the other awardees. Information on the operation of the registry as well as performance and progress on pilot studies are to be included. o Collaboration among awardees in the reporting of findings originated from this initiative is encouraged. Collaborative publications among awardees and NCI are anticipated. Immediately after the notification of award, the successful applicant should also provide the name of one scientist not affiliated with his/her Institution as a potential member of the SC. In addition, each applicant should provide the names and qualifications of two scientists not affiliated with his/her Institution as potential members of the AC. Letters of commitment from the potential members of the AC and SC should be attached. 2. National Cancer Institute Staff Responsibilities The NCI Program Coordinator will be designated by the Chief, Extramural Programs Branch, EBP, DCE, NCI. He/she will have substantial scientific-programmatic involvement during conduct of this activity through participation in the SC and AC activities. The Program Coordinator will provide technical assistance, advice and coordination, assure that the SC and the AC follow the NIH guidelines on conflict of interest issues, and play a critical role in promoting the availability and use of the registry. The role of the Program Coordinator is to assist and facilitate, but not to direct, the activities supported by the CFRBC. The NCI Program Coordinator will: o Lend his/her expertise and overall knowledge of the NCI- and NIH- sponsored breast cancer research to facilitate the selection of scientists non-affiliated with the awardees institutions who are to serve in the AC and SC. o Serve as liaison, helping to coordinate activities among the awardees; act as a liaison to the NCI, and as an information resource about extramural multidisciplinary cancer research activities in the area of genetics and molecular epidemiology. o Attend the SC meetings as a voting member, assist in developing operating guidelines, quality control procedures, and consistent policies for dealing with recurrent situations that require coordinated action. o Serve as liaison between the SC and the AC, attending AC meetings in a non-voting liaison member role, lending a degree of continuity between AC and SC, as the ad hoc AC composition may change depending on the expertise required to review the submitted research applications. o Serve on subcommittee of the SC and the AC as required. o Assist in the monitoring of field data collection, helping to ensure standardization in methods across study centers; and assist in the interpretation and reporting of the collected information. This will be necessary because of the complexity of this multi-site structure, requiring a high degree of coordination and program involvement to achieve adequate standardization of procedures. o Assist by providing advice in the management and technical performance of the investigation. The Program Coordinator will serve as scientific liaison between the awardees and other program staff at NCI who have previous experience in the establishment of cancer registries and tumor bank. o Assist in promoting the availability of the CFRBC resources to the scientific community at large, for use in translational and prevention-oriented breast cancer research, as stated in this RFA goals. The National Cancer Institute reserves the right to reduce the budget, to withhold support, and to suspend, terminate or curtail a study or an award in the event of substantial shortfall in specimen accrual, data reporting, inadequate quality control in specimens or clinical data collection, other major breach of the protocol, or substantial failure to comply with the terms of the award. 3. Collaborative Responsibilities a. Steering Committee The SC will serve as the main governing board of the CFRBC (see "Terms and Conditions of Award"). The SC membership includes the NCI Coordinator, the PI, one other investigator from each awarded cooperative agreement, and one research scientist with expertise in the field of multidisciplinary and translational breast cancer research that is not affiliated with any of the awardees institutions. This last member will be appointed by mutual agreement of the NCI Coordinator and the PI's. Additional members can be added by action of the SC. Other appropriate NCI staff may need to attend the SC meetings if their expertise is required, to participate in specific discussions. The SC will be responsible for reviewing the plans for development of the CFRBC proposed in the individual applications of the awardees. This Committee will develop uniform procedures for data collection and management, tissue collection, processing and distribution, and quality control. The SC will develop the criteria for review and prioritization of research proposals requiring the use of the CFRBC's resources. The NCI Program Coordinator will assist the other members of the SC in all these tasks. Furthermore, the NCI Program Coordinator will serve as the scientific liaison between the awardees and the other program staff of NCI who have previous experience in the establishment of family cancer registries. Awardees will be required to accept and implement the common guidelines and procedures approved by the SC. The first meeting of the SC will be called by the NCI Program Coordinator shortly after award of the cooperative agreements. At this initial meeting, the Committee will elect a Chairperson (someone other than the Program Coordinator). The Chair of the SC is responsible for coordinating the Committee's activities, for preparing meeting agendas, and for scheduling and chairing meetings. The Program Coordinator attends and participates in all meetings of the SC, and should be informed of any major interactions. Subsequent meetings will be planned and scheduled at this meeting. Two additional meetings will be held during the first year of operation, and there will be two meetings a year thereafter, one of which with the AC. The meetings will be held in Bethesda or at another convenient location. Accordingly, respondents must request sufficient funds within the submitted budgets to accommodate travel expenses for the PI and his designee. Subcommittees will be established by the SC as it deems appropriate. The SC is responsible for providing documentation as to the availability and accessibility of specimens and data for the use of investigators with approved research proposals requesting the use of the registry resources. In no circumstance will the SC overturn the recommendation of the AC, except when specimens and/or data are not available. The SC will select members for the AC. The SC in the conduct of all business matters will pay particular attention to conflict of interest issues, especially in actions regarding recommended prioritization of the AC. b. Advisory Committee The AC is responsible for reviewing, evaluating and approving research proposals submitted by investigators from the research community at large, as well as from the awardees, for the use of the registry resources. A recommendation in terms of priority of the proposed research should be provided to the SC. The only occurrence in which the SC can overturn the recommendation of the AC is the unavailability of the requested specimens and/or clinical data. The AC will meet with the SC at least once yearly, at one of the two scheduled SC meetings. The AC will be composed of six to eight senior scientists with expertise in multidisciplinary and translational research in the field of breast cancer, which may include epidemiologists, laboratory researchers, clinicians, or other expertise that the SC deems needed. The membership of the AC may vary, depending on the scientific areas of the proposed research to be reviewed and evaluated. All members will be selected by the SC. The Program Coordinator will function as a non-voting liaison member between the AC and the SC, and attend the AC meetings. The members of the AC will evaluate all research proposals (those of the awardees as well as from the research community at large) proposing to utilize the CFRBC resources, according to the evaluation and review criteria provided by the SC. The review of proposals can be conducted either in person, by conference call or by mail at least twice a year. All reviews will be conducted according to rules pertaining to the conduct of reviews for NIH grants, contracts, and cooperative agreements, paying special attention to issues of conflict of interest, whether real or apparent. The AC will provide a recommendation to the SC as of the priority of the proposed research. The Chair of the AC will forward the final recommendation to the SC. 4. Arbitration Procedures Any disagreement that may arise on scientific/programmatic matters (within the scope of the award) between the award recipients and the NCI may be brought to arbitration. An arbitration panel will be composed of three members, one selected by the SC (without the vote of the Program Coordinator) or by the individual awardee in the event of an individual disagreement, a second member selected by the NCI, and the third member selected by the two prior selected 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 regulation 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 subpopulation 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 and 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 on the Inclusion of Women and Minorities as Subjects in Clinical Research," which was printed in the Federal Register of March 28, 1994 (59 FR 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 requested to submit, by November 30, 1994, a letter of intent that includes a descriptive title of the proposed research, the name and address of the Principal Investigator, the names of other key personnel, the participating institution(s), and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NCI staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to Daniela Seminara, Ph.D., M.P.H., at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on 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, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248, and from the NIH program administrator listed under INQUIRIES. The format and instructions applicable to research grant applications must be followed. It is critical that applicants clearly describe plans to accommodate stated criteria and staff involvement as listed in the Terms and Conditions of Award, and in the Review Criteria Section. Applicants must propose detailed plans for how to organize the CFRBC in the most cost-effective and scientifically sound manner. Applicants are encouraged to submit and describe their own ideas on how to best meet the goals of this RFA. Advantages and disadvantages of the proposed approaches should be discussed, and the plans for establishing collaborations should be described. Plans should describe resources, including information on number of probands available and reasonable estimate of the expected number and quality of pedigree information and related epidemiological data and biological specimen available. The Operation Core should be adequately described, including the facilities for data collection and storage and specimen storage, as well as the investigators' experience in this area. The applicants must provide details on appropriate facilities and biohazard precautions and comply with the applicable Federal, State, and Local regulations, laws and finances in the operation of the Registry. Information on the nature of the data collected at baseline and follow-up should be provided. Examples of data forms, epidemiologic questionnaire, medical records and abstracting procedures, and software that may be appropriate for the use of the registry should be included in the appendix Methods should be proposed to retrieve and establish an inventory of biological specimens, such as blood, fresh-frozen tissue, tissue blocks and slides. Appropriate data retrieval and data management procedures and quality control methods for the epidemiological and clinical data should be detailed. The applicants must state a willingness to cooperate with other awardees in developing policies for quality control and to share data with other awardees. The applicants must state a willingness and should discuss their approach to cooperate with the SC and the AC in evaluating research proposals utilizing the CFRBC resources, and to abide by the decisions of the AC in prioritizing such proposals, after final approval by the SC based on data and specimen availability. The applicant should provide the name and qualifications for the second investigator from his/her Institution to be designed as member of the SC. As the principal investigators of the funded applications and one designee will be members of a SC that will meet three times in the first year and twice in each subsequent year, travel funds for these meetings should be set aside as a budget item. As the AC will meet with the SC once a year, funds should also be included to support travel by one member of the AC to one SC meeting once a year, plus any additional travel anticipated for AC members. Applicants seeking up to 10 percent of the total cost, or up to $50,000 per year for three years (whichever is smaller, starting from the second year of the cooperative agreement), for pilot studies utilizing the CFRBC resources, should document their ability to conduct breast cancer research and document any of their ongoing work in this area. The research hypothesis, background and rationale and design of the pilot study should be described as part of the research plan, keeping within the allowed page limits. The SC and the AC will review the pilot studies proposed in the application in response to this RFA even if the studies received approval under peer review. Moneys for pilot studies will be restricted until the AC gives these pilot studies high priority ratings, and the requested specimens and/or data are available and have been released by the SC. The review of these pilot studies will occur along with the review and prioritization of other requests submitted by investigators in the research community at large. The pilot studies will begin no sooner than year two of the cooperative agreement. However, if the AC does not rank the pilot project as a high priority, a new pilot study that is rated as high priority by the AC can be substituted. The RFA label available in the application form PHS 398 (rev. 9/91) must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the number and title of the RFA must be typed on line 2a of the face page of the application and YES must be checked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact, clear and single-sided photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must be sent to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Rockville, MD 20852 (if hand delivered or delivery service) Bethesda, MD 20892 (if using U.S. Postal Service) It is important to send these copies at the same time that the original and three copies are sent to DRG; otherwise, the NCI cannot guarantee that the application will be reviewed in competition with other applications received by the designated receipt date. Applications must be received by February 17, 1995. If an application is received after that date, it will be returned to the applicant without review. If the application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS General Considerations All applications will be judged on the basis of the scientific merit of the proposed project and the documented ability of the investigators to meet the RESEARCH OBJECTIVES of the RFA. Although the technical merit of the proposed protocol is important, it will not be the sole criterion of evaluation of a study. Other considerations, such as the importance and timeliness of the proposed study, access to patients, and multidisciplinary and translational nature of the studies, will be part of the evaluation criteria. Review Method Upon receipt, applications will be reviewed for completeness by the DRG and responsiveness by the NCI. Incomplete applications will be returned to the applicant without further consideration. Also, if NCI 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 NCI 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. Review Criteria Applicants are encouraged to submit and describe their own ideas about how to best meet the goals of the cooperative study and their specific protocols, and are expected to address issues identified under SPECIAL REQUIREMENTS of the RFA. The review group will assess the scientific merit of the protocols and related factors, including: o extent to which the application addresses the goals and objectives of the RFA o adequacy of the applicant's plans for addressing the special scientific and technical program requirements presented in the RFA; o merit of the proposed activities and organizational plans for implementing the CFRBC; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o time availability of the PI and staff o availability of, and access to, a suitable patient population; o adequacy of existing physical facilities and resources of the applicants' Institutions. o demonstrated ability to carry out common protocol; o adequacy of plans for effective cooperation and coordination among participating awardees and the NCI Program Coordinator, as per Special Requirements of the RFA; o adequacy of proposed number of study subjects to be recruited 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 adequacy of proposed data to be collected and procedures for data handling, managing, and preparing for analyses; o evidence that appropriate steps have been taken to insure the rights of human subjects. o the scientific and technical significance or originality of the proposed pilot studies in the field of translational breast cancer research. It is to be noted that the review of this part of the grant application will be given much less weight relative to the review of the registry facilities, procedures and epidemiological data base, as no more than 10 percent of the total cost, or up to $ 50,000 per year for three years (whichever number is smaller, starting the second year of the Cooperative Agreement) may be requested for these studies. The review group will also examine the proposed budget and will recommend an appropriate budget and period of support for each application that is recommended for further consideration. The second level of review by the National Cancer Advisory Board considers the special needs of the NCI and the priorities of the National Cancer Program. AWARD CRITERIA The earliest anticipated date of award is December 1, 1995. The following will be considered for making funding decisions: o scientific and technical merit of the proposed project as determined by peer review; o availability of funds; o program balance among research areas. INQUIRIES Inquiries concerning the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct inquiries regarding programmatic issues to: Dr. Daniela Seminara Division of Cancer Etiology National Cancer Institute Executive Plaza North, Suite 535 6130 Executive Boulevard MSC 7395 Bethesda, MD 20892-7395 Telephone: (301) 496-9600 FAX: (301) 402-4279 EMAIL: SeminarD@NIHCDCE1.GOV Direct inquiries regarding fiscal matters to: Ms. Kelli Newball Grants Management Specialist National Cancer Institute 6120 Executive Boulevard Executive Plaza South, Suite 243 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 61 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.393, Cancer Cause and Prevention 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 Part 52 and 45 CFR Part 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service 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 Fri Nov 04 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-95-008 - V23(39) 11/04/94 Date: 5 Nov 1994 12:35:03 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 417 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <39gq9n$kn@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HL95008 HL-95-008 P1O1 *************************************** HUMAN STEM CELL SOURCES AND TRANSPLANTATION BIOLOGY NIH GUIDE, Volume 23, Number 39, November 4, 1994 RFA: HL-95-008 P.T. 34; K.W. 0710125, 0780015, 1002004 National Heart, Lung, and Blood Institute National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: February 13, 1995 Application Receipt Date: March 16, 1995 PURPOSE The Cellular Hematology Scientific Research Group, Blood Diseases Program, Division of Blood Diseases and Resources, NHLBI and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) announce the availability of a Request for Applications (RFA) on the above subject. The purpose of this initiative is to encourage research aimed at providing a better understanding of the differences between stem/progenitor cells from different sources such as bone marrow, peripheral circulation of children and adults and placental/cord blood. Important studies to be pursued entail the characterization of stem/progenitor cells for self-renewal, proliferation, and expansion and the mechanisms involved in these processes. Also to be studied are the immune cells present in the different tissue sources, and the mechanisms of their action in graft vs. host disease, and in graft vs. leukemia effect. The ultimate goal is to identify the most appropriate cell populations capable of sustaining long-term hematopoiesis in humans treated for malignant and non-malignant 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 initiative, Human Stem Cell Sources and Transplantation Biology, is related to the priority area of maternal and infant health and cancer. Potential applicants may obtain a copy of Healthy People 2000 (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-782-3238). 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 or local governments, and eligible agencies of the Federal government. Awards in response to this RFA will be made to foreign institutions only for research of very unusual merit, need, and promise, and in accordance with PHS policy governing such awards. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research project grant (R01) and FIRST (R29) award and is a one-time solicitation. Applicants, who will plan and execute their own research programs, are requested to furnish their own estimates of the time required to achieve the objectives of the proposed research project. For R01 grants, up to four years of support may be requested. FIRST (R29) awards must be for five years. At the end of the official award period, renewal applications may be submitted for peer review and competition for support through the regular grant program of the NHLBI or the NIDDK. It is anticipated that support for the present program will begin in September 1995. Administrative adjustments in project period and/or amount of support may be required at the time of the award. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded in response to this RFA. FUNDS AVAILABLE Fiscal Year 1995 financial plans for the NHLBI include $1.5 million for this program. The NIDDK plans to allocate an additional $500,000. However, award of grants pursuant to this RFA is contingent upon receipt of funds for this purpose. It is anticipated that the NHLBI will award approximately five new grants under this program and the NIDDK about two. The specific amount to be funded will, however, depend on the merit and scope of the applications received and on the availability of funds. Since a variety of approaches would represent valid responses to this RFA, it is anticipated that there will be a range of costs among individual grants awarded. If collaborative arrangements involve sub-contracts with other institutions, the NHLBI Grants Management Staff (tel: 301-594-7436) should be consulted regarding procedures to be followed. Designated funding levels and/or project period duration are subject to change at any time prior to award, due to unforeseen budgetary, administrative and/or scientific developments. RESEARCH OBJECTIVES The major objective of this initiative is to encourage research aimed at providing a better understanding of the differences between stem/progenitor cells from different sources such as bone marrow, peripheral circulation of children and adults and placental/cord blood. Recent studies suggest that there may be important differences between the various sources of transplantable hematopoietic stem/progenitor cells. Important studies to be pursued entail the characterization of stem/progenitor cells for self- renewal, proliferation, and expansion and the mechanisms involved in these processes. Also to be studied are the immune cells present in the different tissue sources, and the mechanisms of their action in graft vs. host disease, and in graft vs. leukemia effect. The ultimate goal is to identify the most appropriate cell populations capable of sustaining long-term hematopoiesis in humans treated for malignant and non-malignant diseases. Circulating Stem/Progenitor and Immune Cells Studies of over 45 cord blood transplants performed so far for a number of malignant (AML, ALL, CML, JCML, solid tumor) and non- malignant (Fanconi anemia, aplastic anemia, inborn errors of metabolism, Wiscott-Aldrich, x-linked lymphoproliferative disease, and beta thalassemia) diseases in children suggest that graft vs. host disease (GVHD) has been very low with this source of engrafting cells. Additionally, growth factor- and/or chemotherapy mobilized adult peripheral blood stem/progenitor cells are fast becoming a source of transplantable autologous, and to a lesser extent, allogeneic stem/progenitor cells. Therefore, a comparative assessment of the utility of cord blood, bone marrow and mobilized peripheral blood, in both autologous and related/unrelated allogeneic transplantation, are important studies to be pursued. The assessment would include characterization of potential differences in the quality of stem and progenitor cells from these different sources in terms of their capacity for proliferation, self-renewal, expansion, and their responsiveness to cytokines and stromal cells. Studies of the mechanisms of GVH and graft vs. leukemia (GVL) effects of subsets of blood lymphocytes, natural killer cells, and lymphokine-activated killer cells from the various tissue sources are needed. Future efforts in the area of chemotherapy- and/or growth factor- induced mobilized adult peripheral blood stem/progenitor cells should include: (a) optimization of mobilization techniques, better characterization of the cells mobilized and whether the use of different growth factors, at various doses and times will differentially recruit different subsets of stem and progenitor cells; (b) determination of whether or not the earliest long-term marrow engrafting cells are present in mobilized adult peripheral blood; and (c) determination of whether long-term engraftment is due to the infused cells, or if the infused population only contains shorter-term repopulating cells, which allow the donor/recipient time for repopulation by endogenous, non-transplanted cells. This latter possibility has not been adequately studied, and may result from the less myeloablative regimens used for autologous, as compared to allogeneic transplantation. Efforts here would require marking, perhaps using retroviral vectors, of the mobilized, removed and autologously transplanted cells. Of considerable importance would be to study the capacity of these different sources of stem and progenitor cells, such as cord blood versus bone marrow, to serve as cellular vehicles for gene therapy. Efforts aimed at the comparative efficacy of gene transduction of subsets of these cells, especially those of the most immature populations, including long-term marrow repopulating cells, could hasten the use of gene therapy for the treatment of malignant and non-malignant diseases. Comparative cellular, molecular biological and transplantation immunological studies of these cell sources could provide critical information required to engineer the graft product to provide the maximum therapeutic benefit in a variety of clinical diseases states. The above examples of research approaches are not meant to be all inclusive or restrictive. Investigators are encouraged to develop their own innovative approaches to achieve the goals of this initiative. However, the proposed studies should focus on cells of human origin but xenogeneic animal models for growth of human cells can be considered as possible models for study of the earliest human stem cells. Exclusions Epidemiological studies, large-scale clinical trials, and large multi-project grant applications (program project grants) are specifically excluded from this RFA. SPECIAL REQUIREMENTS Upon initiation of the program, the NHLBI and the NIDDK will sponsor annual meetings to encourage an exchange of information among investigators who participate in this program. In preparing the budget for the grant application, applicants should request additional travel funds for one meeting each year to be held in Bethesda, Maryland. Applicants should also include a statement in the application indicating their willingness to participate in such meetings. 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 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 may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by February 13, 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. Such letters are requested only for the purpose of providing an indication of the number and scope of applications to be received; therefore their receipt is usually not acknowledged. A letter of intent is not binding, will not enter into the review of any application subsequently submitted, nor is it a necessary requirement for the application. The letter of intent is to be sent to: Dr. James Scheirer Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 557A Bethesda, MD 20892 Telephone: (301) 594-7478 FAX: (301) 594-7407 email: James_Scheirer@NIH.Gov APPLICATION PROCEDURES Application Receipt Date: March 16, 1995 Applications are to be submitted on the research grant application form PHS 398 (rev. 9/91). This form is 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. Use the conventional format for research- project grant applications and ensure that the points identified in the section REVIEW CONSIDERATIONS are fulfilled. FIRST 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. The RFA label available in the PHS 398 application kit must be affixed to the bottom of the face page of the original copy 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. To identify the application as a response to this RFA, check "YES" on Item 2a of page 1 of the application and enter the title and RFA Number: HUMAN STEM CELL SOURCES AND TRANSPLANTATION BIOLOGY RFA HL-95-008. Send or deliver the completed application and three signed, exact photocopies of it to the following, making sure that the original application with the RFA label attached is on top: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Send an additional two copies of the application to the Chief, Review Branch at the address listed under LETTER OF INTENT. It is important to send these two copies at the same time as the original and three copies are sent to the Division of Research Grants (DRG). Otherwise the NHLBI cannot guarantee that the application will be reviewed in competition for this RFA. Applications must be received by March 16, 1995. An application not received by this date will be returned to the applicant without review. The 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 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. Although this RFA is a co-sponsored by the NHLBI and the NIDDK, the National Institute of Allergy and Infectious Diseases (NIAID) and the National Cancer Institute (NCI) also have an interest in research focused at better understanding the differences between stem/progenitor cells from different sources, including peripheral blood. The NCI also has an interest in research focused on immune functions and graft-versus leukemia mechanisms. Therefore, the NIAID or the NCI may be given an institute assignment, as appropriate, in accordance with NIH referral guidelines. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness and responsiveness by the NIH. Grant applications will be assigned according to standard referral guidelines. Incomplete applications and applications deemed not responsive to the RFA 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 NHLBI 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/program director and the official signing for the applicant organization will be promptly notified. The criteria used in evaluating the scientific merit of each application will be similar to those used in the review of traditional research project grant applications, including the novelty, originality, and feasibility of the approach; the training, experience and research competence of the investigator(s); the adequacy of the experimental design; the suitability of the facilities; the appropriateness of the requested budget to the work proposed; and the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Applications should be prepared so that they can be reviewed without the necessity of interaction between applicants and reviewers since no site visit or reverse site visit will be part of the technical merit review. AWARD CRITERIA The anticipated award date is September 1995. Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program needs and balance, and the availability of funds. Awards in response to this RFA will be made to foreign institutions only for research of very unusual merit, need, and promise, and in accordance with PHS policy governing such awards. Designated funding levels are subject to change at any time prior to award, due to unforeseen budgetary, administrative and/or scientific developments. In order to more evenly distribute administrative workload and reduce the number of awards with July 1 or September 30 start dates, ten months of time and money will be awarded for the first competing budget period of this project. This action results in a project period of 46 months rather than 48 months for R01 applications. Investigators should plan their research projects and budgets within these time frames. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Helena O. Mishoe, Ph.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute Federal Building, Room 5A12 Bethesda, MD 20892 Telephone: (301) 496-5911 FAX: (301) 496-9940 Email: Helena_Mishoe@NIH.Gov David G. Badman, Ph.D. Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A05 Bethesda, MD 20892 Telephone: (301) 594-7541 FAX: (301) 594-7501 Email: davidb@dvsgate.niddk.nih.gov Direct inquiries regarding fiscal matters to: Ms. Jane R. Davis Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 4A11 Bethesda, MD 20892 Telephone: (301) 594-7436 FAX: (301) 594-7492 Email: Jane_Davis@NIH.Gov AUTHORITY AND REGULATIONS The programs of the Division of Blood Diseases and Resources, NHLBI, are described in the Catalog of Federal Domestic Assistance No. 93.839. Awards are made under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under PHS grant policies and Federal regulations, most specifically 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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. From owner-sci-resources@net.bio.net Fri Nov 04 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 39, pt. 1of1, 4 November 1994 Date: 5 Nov 1994 12:34:56 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 563 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <39gq9g$kc@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19941104 V23N39 P1O1 ************************************ X-comment: RFAs described: HL-95-009, CA-95-003, HL-95-008 NIH GUIDE - Vol. 23, No. 39 - November 4, 1994 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NIH GUIDE PUBLICATION DATES $$INDEX N2 ********************************************************** PEER REVIEW APPEAL PROCESS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** CHANGE OF ADDRESS FOR THE OFFICE FOR PROTECTION FROM RESEARCH RISKS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N4 ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOP National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** CLINICAL TRIALS OF ANTIFUNGAL THERAPIES (RFP NIH-NIAID-DMID-96-04) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R2 01/24/95 ************************************************* CYTOKINE EFFECTS ON HEMATOPOIESIS IN AIDS ANIMAL MODELS (RFA HL-95-009) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R3 02/17/95 ************************************************* COOPERATIVE FAMILY REGISTRY FOR EPIDEMIOLOGIC STUDIES OF BREAST CANCER (RFA CA-95-003) National Cancer Institute INDEX: CANCER $$INDEX R4 03/16/95 ************************************************* HUMAN STEM CELL SOURCES AND TRANSPLANTATION BIOLOGY (RFA HL-95-008) National Heart, Lung, and Blood Institute National Institute of Diabetes and Digestive and Kidney Diseases INDEX: HEART, LUNG, BLOOD; DIABETES, DIGESTIVE, KIDNEY DISEASES THIS PUBLICATION IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET 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 ********************************************************** THE NIH GUIDE FOR GRANTS AND CONTRACTS WILL NOT BE PUBLISHED ON NOVEMBER 11, 1994. THE NEXT ISSUE OF THE NIH GUIDE WILL BE ON NOVEMBER 18, 1994. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** PEER REVIEW APPEAL PROCESS NIH GUIDE, Volume 23, Number 39, November 4, 1994 P.T. 34; K.W. 1014006 National Institutes of Health The National Institutes of Health (NIH) provide an applicant who feels that some aspect of the handling or peer review of his/her grant application has been inappropriate, biased, or wrong with two sequential opportunities (respectively referred to as "rebuttals" and "appeals") to have his/her concerns addressed. The first opportunity is after receipt of the summary statement that documents the results of the initial review of an application's scientific and/or technical merit. If the applicant submits a letter rebutting the review to the program administrator who is responsible for the application, that letter will usually be made available to the National Advisory Council/Board of the relevant NIH Institute/Center/Division (ICD) for consideration, if the ICD staff cannot handle the concerns administratively. The Council may recommend that the application be deferred and rereviewed, if the applicant's objections are deemed to have merit. However, should the Council not recommend deferral and rereview but concur with the initial review and deem that it should stand, then the applicant has a second opportunity to have his/her concerns heard, by submitting a formal appeal of the Council's decision. "The PI and the applicant institution, represented by the institutional official authorized to sign applications, must jointly sign an appeal and send it to the NIH Peer Review Appeals Officer. The official representative's signature indicates that the applicant institution endorses both form and substance of the appeal" (ref: NIH Manual Chapter 4518). The appeal letter must explain fully the reasons for the disagreement, append supporting documentation, and be sent to: NIH Appeals Officer Office of the Director National Institutes of Health Building 1, Room 328 Bethesda, MD 20892 Two points that are important for applicants considering an appeal to weigh for themselves concern the possible outcomes and the timing of the appeal process. The most favorable possible outcome for an applicant in an appeal case can only be a decision that the application in question be rereviewed, since appeals cases examine only whether there were any flaws in the peer review process. The other possible outcome is that the review of the application was not substantially flawed and any minor flaws in the review did not affect the recommendation regarding the application. In that case, the review would stand and the application would not be rereviewed. As the conduct of an appeal case involves several steps of process and review, it may take at least four months (or one review cycle) to complete. Thus, given, the possible outcomes and the timing of the appeal process, an applicant may wish to consider whether deficiencies in the review of his/her application were substantive enough to have had a major deleterious effect on the review of the application and, if not, to revise and resubmit the application instead. Applicant concerns about the acceptance for review, responsiveness to a Request for Applications, other receipt issues, or the referral of their application, when submitted prior to the initial review, are entirely the responsibility of the Division of Research Grants (DRG) or of the ICD assigned to review the application (as indicated on the computer-generated notice of assignments sent to applicants). This DRG or ICD process also provides two opportunities for applicant concerns to be addressed. As they are actions that are external to the peer review process, decisions regarding the funding of applications may not be appealed. INQUIRIES For additional information about the peer review appeal process or to discuss a particular matter, contact Dr. Janet Cuca at 301/496-5358. $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** CHANGE OF ADDRESS FOR THE OFFICE FOR PROTECTION FROM RESEARCH RISKS NIH GUIDE, Volume 23, Number 39, November 4, 1994 P.T. 34; K.W. 1014006 National Institutes of Health Effective November 7, 1994, the address for the Office for Protection from Research Risks (OPRR) is: Office for Protection from Research Risks National Institutes of Health 6100 Executive Boulevard, MSC 7507 Rockville, MD 20892-7507 The address for express or hand-delivered mail is: Office for Protection from Research Risks National Institutes of Health 6100 Executive Boulevard, Suite 3B01 Rockville, MD 20852-7507 $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOP NIH GUIDE, Volume 23, Number 39, November 4, 1994 P.T. 42; K.W. 0201011, 1014003 National Institutes of Health The National Institutes of Health, Office of Extramural Research, Office for Protection from Research Risks, is co-sponsoring a National Animal Welfare Education Workshop with the Medical University of South Carolina on December 1-2, 1994. The topic is "NEW FRONTIERS IN SURGERY." The workshop will be held at the Sheraton Inn, 170 Lockwood Drive, Charleston, SC 29403, telephone (800) 968-3669 or (803) 723-3000. The cut-off date for reservations is November 15, 1994. Accommodations should be made as soon as possible since hotel space is at a premium in Charleston. The day and a half program will focus on state-of-the-art surgical procedures as it applies to the use of animals in biomedical and behavioral research. An exceptional slate of speakers will address Xenographic Procedures; Fetal Intervention; Transgenic Technologies; Orthopedic Biomaterials; IACUC Issues and Ethical Issues in Surgical Research and Development. The workshop is 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 institutional animal care and use programs. Ample opportunities will be provided to exchange ideas and interests through question and answer sessions and informal discussions. The registration fee is $150.00 before November 15; $175.00 after that date and at the registration desk. The registration fee includes workshop materials, two continental breakfasts, refreshment breaks, one buffet lunch, and a reception. INQUIRIES To register for this workshop, contact: M. Michael Swindle, D.V.M. Comparative Medicine, MUSC 171 Ashley Avenue, Room 704-BSB Charleston, SC 29425-2216 Telephone: (803) 792-3625 FAX: (803) 792-9067 For information concerning future NIH/OPRR Animal Welfare Education Workshops, contact: Mrs. Roberta Sonneborn Office for Protection from Research Risks National Institutes of Health 6100 Executive Boulevard, MSC 7507 Rockville, MD 20892-7507 Telephone: (301) 496-7163 FAX: (301) 402-2803 $$N4 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN NIH-NIAID-DMID-96-04 ************************************* CLINICAL TRIALS OF ANTIFUNGAL THERAPIES NIH GUIDE, Volume 23, Number 39, November 4, 1994 RFP AVAILABLE: NIH-NIAID-DMID-96-04 P.T. 34; K.W. 0755015, 0715103 National Institute of Allergy and Infectious Diseases The Bacteriology and Mycology Branch, Division of Microbiology and Infectious Diseases of the National Institute of Allergy and Infectious Diseases (NIAID) has a requirement for a collaborative clinical trials group for serious fungal infections to include those caused by Candida, Aspergillus, Cryptococcus, Coccidioides, Histoplasma, and Blastomyces. A clinical trials program will be designed to facilitate advances in antifungal therapy by rigorously determining the efficacy and safety of new therapeutic regimens for serious mycotic diseases. The program will be driven by a scientific agenda with proposed studies that will address the most important gaps in treatment, the appropriate fungal pathogens and risk groups. Risk groups of emphasis are HIV infected patients, neutropenic cancer patients, bone marrow and organ transplant patients, and surgical trauma patients. Provision should also be made for the key management problems with the endemic mycoses in immunocompetent hosts. This group will conduct Phase II and Phase III clinical trials to evaluate antifungal therapies including, but not limited to new agents, formulations, dosing regimens, drug combinations, as well as immunebased therapeutics. Request for Proposals (RFP) No. NIH-NIAID-DMID-96-04 will be available on or about November 15, 1994. Responses will be due at close of business February 15, 1995. It is anticipated that one, cost reimbursement, completion contract will be awarded for a period of five years. All interested offerors are encouraged to submit a proposal. Any responsible offeror may submit a proposal that will be considered by the Government. INQUIRIES To receive a copy of the RFP, supply this office with two self- addressed mailing labels. Telephone inquiries will not be honored and all inquiries must be in writing and addressed to: Mr. Anthony J. Murray Contract Management Branch National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard MSC 7610 Solar Building, Room 3C07 Bethesda, MD 20892-7610 Interested organizations should request either a streamlined or full RFP package. If no selection is made, a streamlined version of the RFP will be provided, which includes only the Statement of Work, deliverable and reporting requirements, special requirements and mandatory qualifications, if any, and the Technical Evaluation Criteria. After examination of the abbreviated document, any organization interested in responding to the RFP must request the entire RFP in writing or by FAX request (301) 480-5253. This advertisement does not commit the Government to award a contract. $$R1 END ************************************************************ $$R2 BEGIN HL-95-009 FULL-TEXT ************************************** CYTOKINE EFFECTS ON HEMATOPOIESIS IN AIDS ANIMAL MODELS NIH GUIDE, Volume 23, Number 39, November 4, 1994 RFA AVAILABLE: HL-95-009 P.T. 34; K.W. 0715008, 0755020, 1002004 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: December 16, 1994 Application Receipt Date: January 24, 1995 PURPOSE The Cellular Hematology Scientific Research Group, Blood Diseases Program, Division of Blood Diseases and Resources, National Heart, Lung, and Blood Institute (NHLBI) announces the availability of a Request for Applications (RFA) on the above subject. The purpose of this initiative is to study animal models of human acquired immunodeficiency syndrome (AIDS) to increase our understanding of clinical consequences and/or efficacy of hematopoietic factors used in HIV-1 infected persons. The complexity of HIV disease makes it difficult to assess cytokine effects exclusively in the patient. Thus, this initiative will primarily focus on animal models of human AIDS that could be directly related to future human clinical studies. However, focused cytokine studies in HIV-1 infected persons will be considered. This RFA will use the National Institutes of Health (NIH) research project grant (R01) and First Independent Research Support and Transition (FIRST) (R29) awards. The NHLBI has set-aside $1.5 million dollars to fund approximately six new grants under this 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 RFA, Cytokine Effects on Hematopoiesis in AIDS Animal Models, is related to the priority area of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-782-3238). 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. Helena O. Mishoe, Ph.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute Federal Building, Room 5A12 Bethesda, MD 20892 Telephone: (301) 496-5911 FAX: (301) 496-9940 Email: Helena_Mishoe@NIH.Gov $$R2 END ************************************************************ $$R3 BEGIN CA-95-003 FULL-TEXT ************************************** COOPERATIVE FAMILY REGISTRY FOR EPIDEMIOLOGIC STUDIES OF BREAST CANCER NIH GUIDE, Volume 23, Number 39, November 4, 1994 RFA AVAILABLE: CA-95-003 P.T. 34; K.W. 0715036, 0785055, 0780030 National Cancer Institute Letter of Intent Receipt Date: November 30, 1995 Application Receipt Date: February 17, 1995 PURPOSE The Extramural Programs Branch, Epidemiology and Biostatistics Program, Division of Cancer Etiology, National Cancer Institute (NCI) invites cooperative agreement applications from investigators to participate, with the assistance of the NCI, in a network of organizations constituting a Cooperative Family Registry for Breast Cancer (CFRBC). The purpose of the proposed awards is to stimulate a cooperative effort to: 1. Collect pedigree information, epidemiological data and related biological specimens from patients with a family history of breast cancer in order to provide a registry resource for interdisciplinary studies on the etiology of breast cancer, and to encourage translational research in this area. 2. Identify a population at high risk for breast cancer that could benefit from new preventive and therapeutic strategies. The CFRBC will enable participant organizations to: identify individuals with a family history of breast cancer, breast-ovarian cancer syndrome, male breast cancer, and various familial syndromes that include breast cancer; collect and define the related pedigrees; and collect clinical (tumor type, stage at diagnosis, hormonal evaluation, etc.), epidemiologic (age at diagnosis, sociodemographic status, etc.), and other relevant data (such as dietary history) to correlate with the pedigree information. Support for the collection of related biological specimens, such as blood samples, paraffin blocks and fresh-frozen tissue, will be included. This registry is not intended to directly support research on the mapping and cloning of the gene(s) for breast or breast/ovarian cancer, but to assist investigators funded through other sources by providing the data and biological specimens that can be used for a variety of purposes, including etiologic studies and prevention and treatment-oriented translational research. Approximately $2 million in total costs per year for four years will be committed to specifically fund applications which are submitted in response to this RFA. It is anticipated that two to five awards will be made. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. 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 Family Registry for Epidemiologic Studies of Breast Cancer, relates to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or 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) via the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Dr. Daniela Seminara Division of Cancer Etiology National Cancer Institute Executive Plaza North, Suite 535 6130 Executive Boulevard MSC 7395 Bethesda, MD 20892-7395 Telephone: (301) 496-9600 FAX: (301) 402-4279 EMAIL: SeminarD@NIHCDCE1.GOV $$R3 END ************************************************************ $$R4 BEGIN HL-95-008 FULL-TEXT ************************************** HUMAN STEM CELL SOURCES AND TRANSPLANTATION BIOLOGY NIH GUIDE, Volume 23, Number 39, November 4, 1994 RFA AVAILABLE: HL-95-008 P.T. 34; K.W. 0710125, 0780015, 1002004 National Heart, Lung, and Blood Institute National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: February 13, 1995 Application Receipt Date: March 16, 1995 PURPOSE The Cellular Hematology Scientific Research Group, Blood Diseases Program, Division of Blood Diseases and Resources, NHLBI and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) announce the availability of a Request for Applications (RFA) on the above subject. The purpose of this initiative is to encourage research aimed at providing a better understanding of the differences between stem/progenitor cells from different sources such as bone marrow, peripheral circulation of children and adults and placental/cord blood. Important studies to be pursued entail the characterization of stem/progenitor cells for self-renewal, proliferation, and expansion and the mechanisms involved in these processes. Also to be studied are the immune cells present in the different tissue sources, and the mechanisms of their action in graft vs. host disease, and in graft vs. leukemia effect. The ultimate goal is to identify the most appropriate cell populations capable of sustaining long-term hematopoiesis in humans treated for malignant and non-malignant diseases. This RFA will use the National Institutes of Health research project grant (R01) and First Independent Research Support and Transition (FIRST) (R29) award. Approximately $1.5 million dollars from the NHLBI and $500,000 from the NIDDK has been set-aside to award five to seven grants. 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 initiative, Human Stem Cell Sources and Transplantation Biology, is related to the priority area of maternal and infant health and cancer. Potential applicants may obtain a copy of Healthy People 2000 (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-782-3238). 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. Helena O. Mishoe, Ph.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute Federal Building, Room 5A12 Bethesda, MD 20892 Telephone: (301) 496-5911 FAX: (301) 496-9940 email: Helena_Mishoe@NIH.Gov David G. Badman, Ph.D. Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A05 Bethesda, MD 20892 Telephone: (301) 594-7541 FAX: (301) 594-7501 email: davidb@dvsgate.niddk.nih.gov $$R4 END ************************************************************ From owner-sci-resources@net.bio.net Fri Nov 04 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-95-009 - V23(39) 11/04/94 Date: 5 Nov 1994 12:35:17 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 522 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <39gqa5$li@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HL95009 HL-95-009 P1O1 *************************************** CYTOKINE EFFECTS ON HEMATOPOIESIS IN AIDS ANIMAL MODELS NIH GUIDE, Volume 23, Number 39, November 4, 1994 RFA: HL-95-009 P.T. 34; K.W. 0715008, 0755020, 1002004 National Heart, Lung, and Blood Institute (NHLBI) Letter of Intent Receipt Date: December 16, 1994 Application Receipt Date: January 24, 1995 PURPOSE The Cellular Hematology Scientific Research Group, Blood Diseases Program, Division of Blood Diseases and Resources, NHLBI announces the availability of a Request for Applications (RFA) on the above subject. The purpose of this initiative is to study animal models of human acquired immunodeficiency syndrome (AIDS) to increase our understanding of clinical consequences and/or efficacy of hematopoietic factors used in HIV-1 infected persons. The complexity of HIV disease makes it difficult to assess cytokine effects exclusively in the patient. Thus, this initiative will primarily focus on animal models of human AIDS that could be directly related to future human clinical studies. However, focused cytokine studies in HIV-1 infected persons will be considered. 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 initiative, Cytokine Effects on Hematopoiesis in AIDS Animal Models, is related to the priority area of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-782-3238). 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 or local governments, and eligible agencies of the Federal government. Awards in response to this RFA will be made to foreign institutions only for research of very unusual merit, need, and promise, and in accordance with PHS policy governing such awards. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research project grant (R01) and FIRST (R29) award and is a one-time solicitation. Applicants, who will plan and execute their own research programs, are requested to furnish their own estimates of the time required to achieve the objectives of the proposed research project. Up to five years of support may be requested. At the end of the official award period, renewal applications may be submitted for peer review and competition for support through the regular grant program of the NHLBI. It is anticipated that support for the present program will begin in August 1995. Administrative adjustments in project period and/or amount of support may be required at the time of the award. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded in response to this RFA. FUNDS AVAILABLE Fiscal Year 1995 financial plans for the NHLBI include $1.5 million for this program. However, award of grants pursuant to this RFA is contingent upon receipt of funds for this purpose. It is anticipated that the NHLBI will award approximately six new grants under this program. The specific amount to be funded will, however, depend on the merit and scope of the applications received and on the availability of funds. Since a variety of approaches would represent valid responses to this RFA, it is anticipated that there will be a range of costs among individual grants awarded. If collaborative arrangements involve sub-contracts with other institutions, the NHLBI Grants Management Staff (tel: 301-594-7436) should be consulted regarding procedures to be followed. Designated funding levels are/or project period duration are subject to change at anytime due unforeseen budgetary administrative and/or scientific developments. RESEARCH OBJECTIVES AIDS remains among the most important public health challenges in the United States and abroad. The disease has managed to affect every segment of the population including the fetus and the newborn. Current estimates of HIV-1 prevalence place the number of HIV-1 infected individuals around one million. Early this fall, the Centers for Disease Control plans to release a new estimate of the prevalence of HIV-1 infection in the United States. The natural history of HIV infection is characterized by an abundance of hematologic complications. Anemia is the most frequent abnormality and is manifest at presentation in up to 20 percent of patients. By end-stage disease, 75 to 100 percent of patients become anemic (1,2). Thrombocytopenia and diminished marrow production are seen throughout all stages of AIDS. Leukopenia, consisting of monocytopenia. neutropenia, and lymphopenia, correlates with the stage of disease and as seen in anemia, is worsened with azidothymidine (3). Zidovudine, trimethoprim sulfamethoxazole, and ganciclovir all can produce or contribute to cytopenias. Reduced marrow reserves and cytopenias complicate treatment for not only HIV but also HIV related malignancies and opportunistic infections. The past decade has witnessed the cloning and characterization of multiple hematopoietic growth factors and cytokines. As a result, cytokines have been used clinically in HIV-1 infection to treat persons with HIV-related cytopenias resulting in improved management of these complications. Although cytokines have generally been well tolerated in clinical use, a number of important questions still remain regarding their use in HIV-1 infected individuals. Granulocyte macrophage colony stimulating factor (GM-CSF) and granulocyte colony stimulating factor (G-CSF) are very frequently used to manage HIV-1-related neutropenia. In phase I trials, GM-CSF has produced an increase in peripheral neutrophils and eosinophils and a slight rise in monocytes when it was administered to individuals with AIDS-related neutropenia (4,5). Although some investigators have reported that neutrophil function improves in these patients (6), others have reported that neutrophils released from the bone marrow after administration of the drug are dysfunctional (7). Also of some concern to clinicians, is the demonstration that in vitro, GM-CSF potentiates HIV-1 replication (8,9). G-CSF has also been used in the treatment of individuals with HIV-1 infection. Unlike GM-CSF, G-CSF has not been shown to increase the activity of HIV-1 in monocytes and macrophages (10) and also elicits fewer toxicities than GM-CSF (11). Although G-CSF has been shown to increase circulating neutrophils in patients with HIV infection (12), it is not clear if this response translates into fewer infections or increased survival. Other cytokines including M-CSF and interleukin-3 (IL-3) have also been characterized, but few studies detail their clinical use. M-CSF induces proliferation of mononuclear cells and has been shown to potentiate the infection of HIV-1 (13). Additionally, IL-3 has been shown to stimulate multiple hematopoietic cell lines (14), but it too has been associated with an increase in HIV proliferation in vitro by infected macrophages and monocytes. Alpha interferon has been reported to have an anti-viral effect when administered to individuals with HIV infection (15). Important questions still remain regarding the use of cytokines in HIV-1 infected individuals. Cytokine effects on hematopoietic cells and stromal elements have been primarily demonstrated in vitro with very little information available about their effects in vivo. Since these factors typically have multiple actions, some of these actions may be undesirable in a given case. In fact, when one gives a single factor, no less than three general events occur: (a) the blood level of the factor increases and the biological activity of that factor is exerted; (b) the factor induces auxiliary cells to release other cytokines; and (c) the administered factor will act synergistically with at least some of the endogenous factors it induces. Thus, the current view that hematopoietic growth factors simply stimulate the production of more white cells or the proliferation and/or differentiation of stem/progenitor cells, may inappropriately trivialize the physiologic events that take place in HIV-1 infected individuals when cytokines are administered. The many and complex opportunistic infections, neoplasms, and drug treatments, both prophylactic and active, make it difficult to unravel the pathogenesis of HIV disease. These phenomena significantly contribute to the difficulties in assessing the advantages and disadvantages of the use of cytokines in AIDS patients. Therefore, to gain insight into this important area, this RFA will focus primarily on the use of animal models of human AIDS. Recently, studies have demonstrated differences between the levels of viral burden and virus replication in peripheral blood versus lymphoid organs (16). Animal models could potentially provide a unique opportunity to assess these differences with larger numbers and to determine the impact of the use of cytokines on virus replication. In addition, animal models will undoubtedly continue to prove useful for studies of anti-HIV gene therapy strategies. The utility of animal models to study the pathogenesis of AIDS has been extensively reviewed (17,18). This RFA encourages applications that propose studies designed to better assess the use of hematopoietic factors in HIV-1 infected individuals. The primary focus of this RFA is to conduct the above assessment in animal models of human AIDS. The proposed studies should be directly related to evolution to future human clinical studies. Moreover, in vitro studies proposed should have an in vivo endpoint. Also, recent PCR technology would allow focused cytokine studies to be conducted in HIV-1 infected persons. Therefore, appropriate studies assessing the effects of cytokines in HIV-1 infected individuals will be considered. Research approaches that would be considered responsive to the program would include studies to (a) develop new animal models of human AIDS to better assess cytokine use in HIV-1 infected persons; (b) evaluate the effect(s) of cytokines used clinically in HIV-1 infected persons on viral burden, viral persistence, and viral infectivity of stem/progenitor cells and stromal elements; (c) evaluate the interplay of exogenously added cytokines and endogenous cytokines induced by HIV infection; (d) assess the different compartments of HIV-1 virus replication (i.e., peripheral blood vs. lymphoid tissue) and determine the impact of the use of cytokines on viral replication; and (e) evaluate the effects of cytokines on potential anti-HIV gene therapy treatment approaches (i.e., genetically altered stem/progenitor cell transplantation). The above examples of research approaches are not meant to be all inclusive or restrictive. Investigators are encouraged to develop their own innovative approaches to achieve the goals of this initiative. Exclusions Epidemiological studies, large-scale clinical trials, and large multi-project grant applications (program project grants) are specifically excluded from this RFA. Also, research focused on testing the effectiveness of vaccines for HIV infection is excluded. SPECIAL REQUIREMENTS Upon initiation of the program, the NHLBI will sponsor annual meetings to encourage an exchange of information among investigators who participate in this program. In preparing the budget for the grant application, applicants should request additional travel funds for one meeting each year to be held in Bethesda, Maryland. Applicants should also include a statement in the application indicating their willingness to participate in such meetings. 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 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 December 16, 1994, 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. Such letters are requested only for the purpose of providing an indication of the number and scope of applications to be received; therefore their receipt is usually not acknowledged. A letter of intent is not binding, it will not enter into the review of any application subsequently submitted, nor is it a necessary requirement for the application. This letter of intent is to be sent to: Dr. James Scheirer Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 557A Bethesda, MD 20892 Telephone: (301) 594-7478 FAX: (301) 594-7407 Email: James_Scheirer@NIH.Gov APPLICATION PROCEDURES Application Receipt Date: January 24, 1995 Applications are to be submitted on the research grant application form PHS 398 (rev. 9/91). This form is available in 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. Use the conventional format for research project grant applications and ensure that the points identified in the section REVIEW CONSIDERATIONS are fulfilled. FIRST 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. The RFA label available in the PHS 398 application kit must be affixed to the bottom of the face page of the original copy 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. To identify the application as a response to this RFA, check "YES" on Item 2a of page 1 of the application and enter the title and RFA Number: CYTOKINE EFFECTS ON HEMATOPOIESIS IN AIDS ANIMAL MODELS RFA HL-95-009. Send or deliver the completed application and three signed, exact photocopies of it to the following, making sure that the original application with the RFA label attached is on top: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Send an additional two copies of the application to the Chief, Review Branch at the address listed under LETTER OF INTENT. It is important to send these two copies at the same time as the original and three copies are sent to the Division of Research Grants (DRG). Otherwise the NHLBI cannot guarantee that the application will be reviewed in competition for this RFA. Applications must be received by January 24, 1995. An application not received by this date will be returned to the applicant without review. The 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 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. Although this is an RFA from the NHLBI, the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) also have an interest in research focused on the role of cytokines in AIDS and the development of AIDS animal models. In addition, the National Cancer Institute (NCI) has an interest in the role of cytokines in AIDS pathogenesis particularly, in the development of AIDS- associated malignancies. Therefore, the NIAID, the NCI or the NIDDK may be given an institute assignment in accordance with NIH referral guidelines. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness and responsiveness by the National Institutes of Health (NIH). Incomplete applications and applications deemed not responsive to the RFA 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 NHLBI 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/program director and the official signing for the applicant organization will be promptly notified. The criteria used in evaluating the scientific merit of each application will be similar to those used in the review of traditional research-project grant applications, including the novelty, originality, and feasibility of the approach; the training, experience and research competence of the investigator(s); the adequacy of the experimental design; the suitability of the facilities; the appropriateness of the requested budget to the work proposed; and the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Applications should be prepared so that they can be reviewed without the necessity of interaction between applicants and reviewers since no site visit or reverse site visit will be part of the technical merit review. AWARD CRITERIA The anticipated date of award is August 1995. Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program needs and balance, and the availability of funds. Awards in response to this RFA will be made to foreign institutions only for research of very unusual merit, need, and promise, and in accordance with PHS policy governing such awards. Designated funding levels are subject to change at any time prior to award, due to unforeseen budgetary, administrative and/or scientific developments. In order to more evenly distribute administrative workload and reduce the number of awards with July 1 or September 30 start dates, the NHLBI will award ten months of time and money for the first competing budget period of this project. This action results in a project period of 58 months rather than 60 months for R01 applications. Investigators should plan their research projects and budgets within these timeframes. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Helena O. Mishoe, Ph.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute Federal Building, Room 5A12 Bethesda, MD 20892 Telephone: (301) 496-5911 FAX: (301) 496-9940 Email: Helena_Mishoe@NIH.Gov Direct inquiries regarding fiscal matters to: Ms. Jane R. Davis Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 4A11 Bethesda, MD 20892 Telephone: (301) 594-7436 FAX: (301) 594-7492 Email: Jane_Davis@NIH.Gov AUTHORITY AND REGULATIONS The programs of the Division of Blood Diseases and Resources, NHLBI, are described in the Catalog of Federal Domestic Assistance number 93.839. Awards are made under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under PHS grant policies and Federal regulations, most specifically 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. References 1. Spivak JL, Bender BS, Quinn TC. Hematologic abnormalities in the acquired immune deficiency syndrome. Am J Medicine 77:224-228, 1974. 2. Zon, LI, Arkin C, Groopman JE. Hematologic Manifestations of human immune deficiency virus (HIV). Br J Haematol 66:251-256, 1987. 3. Fischl MA, Ricnman DD, Hansen N, Collier AC, Carey JT, Para MF, Hardy D. Dolin R. Powderly WG, Allan JD, Wong B, Merigan TC, McAuliffe VJ, Hyslop NE. Rhame FS, Balfour HH, Spector SA, Volberdino P, Pettinelli C, Anderson J. The safety and efficacy of zidovudine (AZT) in the treatment of subjects with mildly symptomatic human immunodeficiency virus type 1 (HIV) infection. Annals Internal Med 112:727-737, 1990. 4. Groopman JE, Granulocyte-macrophage colony-stimulating tor in human immunodeficiency virus disease. Semin Hematol 27:8-14, 1990. 5. Groopman JE, Mitsuyasu RT, DeLeo MY, et al. Effect of recombinant human granulocyte-macrophage colony-stimulating factor on myelopoiesis in the acquired immunodeficiency syndrome. N Engl J Med 317:533-598, 1987. 6. Baldwin GC, Gasson JC, Quan SG, et al. Granulocyte-macrophage colonystimulating factor enhances neutrophil function in acquired immunodeficiency syndrome patients. Proceedings of the National Academy of Sciences of the USA 85:2763-2766, 1988. 7. Peters WP, Stuart A, Affronti MI, Kim KS, Coleman R. Neutrophil migration is defective during recombinant GMCSF infusion after autologous bone marrow transplantation in humans. Blood 72:1310-1315, 1988. 8. Perno CF, Yarchoan R, Cooney DA, et al. Replication of human immunodeficiency virus in monocytes; granulocyte/macrophage colonystimulating factor (GM-CSF) potentiates viral production yet enhances the antiviral effect mediated by 3'-azido-2'3'-dideoxythymidine (AZT) and other dideoxynucleoside congeners of thymidine. J Exp Med 169:933-951, 1989. 9. Pluda JM, Yarchoan R, Smith PD, et al. Subcutaneous recombinant granulocyte-macrophage colony-stimulating factor used as a single agent and in an alternating regimen with azidothymidine in leukopenic patients with severe human immunodeficiency virus infection. Blood 76:463-472, 1990. 10. Koyanagi Y, O'Brien WA, Zhao JQ. Cytokines alter production of HIV-1 from primary mononuclear phagocytes. Science 241:1673-1675, 1988. 11. Davey RT, Davey V, Zurol J. A phase I/II trial of zidovudine interferon alpha and granulocyte-macrophage colony stimulating factor in treatment of HIV infection. 6th Int Conf on AIDS, San Francisco, June 11-24, 1990. 12. Miles SA, Milsuyasu R, Fink N. Recombinant G-CSF and recombinant erythropoietin may abrogate the neutropenia and anemia of AIDS and allow resumption of AZT. 5th Int Conf on AIDS, Montreal, June 4-9, p. 550, 1989. 13. Perno CF, Yarchoan R, Cooney DA, et al. Differential modulation of HIV replication and AZT activity in monocyte/macrophages by GM- CSF, M-CSF, G-CSF. 5th Int Conf on AIDS, Montreal, June 4-9, p. 536, 1989. 14. Alter R, Welniak LA, Jackson JD, Garrison L, Weisenburger DD, Kessinger, A. In vitro clonogenic monitoring of peripheral blood stem cell collections following interleukin-3 administration. Blood 76(10) Supplement 1:129a, 1990. 15. Lane HC, Davey V, Kovacs JA, et al. Interferon-alpha in patients with asymptomatic human immunodeficiency virus (HIV) infection. Ann Intern Med 112:805-811, 1990. 16. Pantaleo G, Grazios C, Demarest JF, Butini L, HIV infection is active and progressive in lymphoid tissues during the clinically late stage of the disease. Nature 362(6418): 355-358, 1993. 17. Fultz P. Nonhuman primate models for AIDS. Clinical Infectious Diseases 17 (suppl 1): S230-S235, 1993. 18. Letvin, N. Animal models for the study of human immunodeficiency virus infections. Current Opinions in Immunology 4:481-485, 1992. From owner-sci-resources@net.bio.net Mon Nov 07 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 6 November 1994 Date: 7 Nov 1994 19:10:48 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 138 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <39mq7o$95j@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: Press Release Title: ULTRAFAST LASERS PRODUCE ‘PICTURE’ OF BIOLOGICAL PROCESSES IN MOLECULES File size (bytes): 2777 STIS Filename: pr9469 Title: NSF AWARDS FIRST METACENTER REGIONAL ALLIANCE GRANTS File size (bytes): 8907 STIS Filename: pr9470 Document Type: Program Guideline Title: Guidelines for the NSF Graduate Research Traineeship Program (NSF 94-140) File size (bytes): 32463 STIS Filename: nsf94140 Title: NSF 94-151 - Sensor and Sensor Systems for Power Systems and Other Dispersed Civil Infrastructure Systems File size (bytes): 21979 STIS Filename: nsf94151 Title: NSF 94-152 - GLOBAL LEARNING AND OBSERVATIONS TO BENEFIT THE ENVIRONMENT (GLOBE) File size (bytes): 42694 STIS Filename: nsf94152 Title: NSF 94-154 - Research on Composite and Hybrid Structures File size (bytes): 14474 STIS Filename: nsf94154 Title: NSF 94-156 Academic Research Infrastructure (ARI) Program Instrumentation Development and Acquisition Solicitation File size (bytes): 36676 STIS Filename: nsf94156 Document Type: Recruit Title: Director, Division of Ocean Sciences File size (bytes): 7684 STIS Filename: vep951c Title: Director, Division of Ocean Sciences File size (bytes): 5249 STIS Filename: vep951i Title: Director, Division of Ocean Sciences File size (bytes): 7446 STIS Filename: vep951l Title: Cooperative Education Program (CO-OP) File size (bytes): 3957 STIS Filename: vgs9523 Document Type: SRS Report Title: NSF 94-307 Characteristics of Doctoral Science & Engineers in the United States- 1991 File size (bytes): 3940 STIS Filename: nsf94307 Also available: nsf94307.zip ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 8722 STIS Filename: cmpublic Title: NSF Advisory Committee Meetings File size (bytes): 8722 STIS Filename: cmpublic Document Type: Letter Title: Current List of REU Sites File size (bytes): 84502 STIS Filename: reulist Document Type: Phone Book Title: NSF Alpha Telephone File size (bytes): 94597 STIS Filename: phnalpha Title: NSF Organizational Directory File size (bytes): 99980 STIS Filename: phnorg ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). 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, the text of your message should be as follows: get phnorg Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnorg, you would enter: ftp> get phnorg WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "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 Nov 08 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: No NIH Guide for 11/11/94 Date: 8 Nov 1994 18:32:40 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 3 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <39pcc8$1r6@net.bio.net> NNTP-Posting-Host: net.bio.net $$MAIL BEGIN *********************************************************** The NIH Guide will not be published on 11/11/94. $$MAIL END************************************************************** From owner-sci-resources@net.bio.net Wed Nov 16 22:00:00 1994 Path: biosci!biosci!not-for-mail From: amcgough@bcm.tmc.edu (Amy McGough) Newsgroups: bionet.announce,bionet.jobs,bionet.sci-resources Subject: Computational Biology Undergraduate Fellowships Date: 16 Nov 1994 16:57:19 -0800 Organization: Baylor College of Medicine, Houston, Tx Lines: 45 Sender: biohelp@net.bio.net Approved: bionews-moderator@net.bio.net Distribution: world Message-ID: <3ad8ee$hjr@gazette.bcm.tmc.edu> NNTP-Posting-Host: net.bio.net Keywords: Computational Biology Fellowships Xref: biosci bionet.announce:1582 bionet.jobs:6346 bionet.sci-resources:1161 National Science Foundation-supported Undergraduate Training Opportunities at the W.M. Keck Center for Computational Biology The W. M. Keck Center for Computational Biology Undergraduate Research Training Program Science and engineering are in the process of being transformed by the power of new computing technologies. Our goals is to train a new kind of scientist -- one poised to seize the advantages of a national supercomputing prowess in solving important problems in biology. The W.M. Keck Center for Computational Biology offers studies in Computational Biology through three partner institutions: Baylor College of Medicine, Rice University, and the University of Houston. The Program emphasizes algorithm development, computation, and visualization in the areas of biology, biochemistry, and biophysics. The Keck Center draws on the intellectual and technological resources of its partner institutions, including the High Resolution Electron Microscopy Center and the Human Genome Center at Baylor College of Medicine, The Center for Research on Parallel Computation and the Institute of Bioscience and Bio-engineering at Rice University, and the Institute of Molecular Design and the Texas Center for Advanced Molecular Computation at University of Houston The research groups involved in the Keck Center are at the forefronts of their respective areas, and their laboratories are outstanding settings for the training program. The faculty have been chosen to represent the fields necessary for the development and deployment of new computational tools in modern biology. The subject areas encompass the intellectual activities needed to ask incisive questions, develop appropriate algorithms to approach the problems, and to execute the methods on modern computational architectures. Trainees will have mentors to guide them in taking advantage of interdisciplinary approaches. The Keck Center Undergraduate Research Fellowships, provide a stipend of $1500, are available for either during the academic year (for nine months) or during the summer (for three months). To obtain an application form, contact Marc Archambault, Executive Director of the W.M. Keck Center for Computational Biology, by Email at compbio@rice.edu, by phone at (713) 527-4752, or fax at (713) 527-4659. From owner-sci-resources@net.bio.net Mon Nov 21 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 20 November 1994 Date: 21 Nov 1994 18:24:43 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 118 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3arkpb$kjg@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: General Publication Title: NSF 94-116 -- The Alan T. Waterman Award File size (bytes): 18469 STIS Filename: nsf94116 Document Type: Letter Title: NATIONAL SBIR/FEDERAL HIGH TECH CONFERENCE IN SAN JOSE, CA NOVEMBER 14-16,1994 File size (bytes): 1618 STIS Filename: ltrsbir Document Type: Press Release Title: SPRING INAUGURATES NEW SEASON OF ANTARCTIC RESEARCH File size (bytes): 9743 STIS Filename: pr9474 Document Type: Program Guideline Title: NSF 94-150 Engineering Research Centers File size (bytes): 42231 STIS Filename: nsf94150 Document Type: Recruit Title: Director, Division of Mathematical Sciences File size (bytes): 8191 STIS Filename: vep9422c Title: Director, Division of Mathematical Sciences File size (bytes): 5735 STIS Filename: vep9422i Title: Director, Division of Mathematical Sciences File size (bytes): 7887 STIS Filename: vep9422l Title: Science Assistant, AD-1 File size (bytes): 4929 STIS Filename: vex9445 Title: Secretary (Office Automation) File size (bytes): 4994 STIS Filename: vgs9524 Title: Secretary (Office Automation) File size (bytes): 5917 STIS Filename: vgs9527 Title: Senior Program Assistant (Office Automation) File size (bytes): 5695 STIS Filename: vgs9528 Title: Computer Specialist File size (bytes): 9230 STIS Filename: vgs9532 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Phone Book Title: NSF Alpha Telephone File size (bytes): 94702 STIS Filename: phnalpha Title: NSF Organizational Directory File size (bytes): 100076 STIS Filename: phnorg ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). 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, the text of your message should be as follows: get phnorg Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnorg, you would enter: ftp> get phnorg WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "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 Nov 22 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 13 November 1994 Date: 22 Nov 1994 16:07:46 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 107 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3au14i$23u@net.bio.net> NNTP-Posting-Host: net.bio.net [Note from the moderator - my apologies for the delay, this was lost in the backlog from my recent trip.] 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: General Publication Title: NSF 92-134 FACTS ABOUT THE US ANTARCTIC PROGRAM File size (bytes): 123040 STIS Filename: nsf92134 Document Type: Letter Title: NSF 94-158 ENGINEERING DEAR COLLEAGUE LETTER File size (bytes): 10601 STIS Filename: nsf94158 Document Type: News Title: Tip41107 - Media Tipsheet November 4, 1994 File size (bytes): 4926 STIS Filename: tip41107 Document Type: Press Release Title: PR 94-68 COLLABORATIVE RESEARCH IN PLANT BIOLOGY FUNDED THROUGH TRI-AGENCY PROGRAM File size (bytes): 6900 STIS Filename: pr9468 Document Type: Program Guideline Title: NSF 94-05 (Revised) Networking Infrastructure for Education File size (bytes): 34186 STIS Filename: nsf9405 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Form Title: FM 1030 - (Revised) GPG Summary Proposal Budget Form File size (bytes): 241 STIS Filename: fm1030 Also available: fm1030.ps Title: FM 1030 - (Revised) GPG Summary Proposal Budget Form File size (bytes): 241 STIS Filename: fm1030 Also available: fm1030.ps Document Type: Phone Book Title: NSF Organizational Directory File size (bytes): 100023 STIS Filename: phnorg Document Type: Recruit Title: Senior Executive Service Nationwide Vacancy Listing File size (bytes): 49557 STIS Filename: sesvac ------------------------------------------------------------------------ ** 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 sesvac, the text of your message should be as follows: get sesvac Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve sesvac, you would enter: ftp> get sesvac 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 Nov 23 22:00:00 1994 Path: biosci!biosci!not-for-mail From: Barbara Dorsey Newsgroups: bionet.sci-resources Subject: Hollaender Postdoctoral Fellowship Opportunity Date: 23 Nov 1994 17:26:16 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 24 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3b0q3o$p6l@net.bio.net> NNTP-Posting-Host: net.bio.net U.S. Department of Energy Office of Health and Environmental Research Alexander Hollaender Distinguished Postdoctoral Fellowship Program Research Opportunities in Energy-Related Life, Biomedical, and Environmental Sciences * Research In OHER-sponsored programs * Tenable at various laboratories * Stipends $37,500 * Doctoral degree received after April 30, 1993 * U.S. citizens or PRA eligible * Deadline date - January 15, 1995 Information and applications: Linda Holmes (holmesl@orau.gov) Barbara Dorsey (dorseyb@orau.gov) Phone number (615) 576-9975 or write to: Hollaender Postdoctoral Fellowships Science/Engineering Education Division Oak Ridge Institute for Science and Education P.O. Box 117 Oak Ridge, Tennessee 37831-0117 From owner-sci-resources@net.bio.net Sun Nov 27 22:00:00 1994 Path: biosci!biosci!not-for-mail From: Ray Dobert Newsgroups: bionet.sci-resources Subject: Solicitation announcement biotechnology risk assessment Date: 27 Nov 1994 19:18:00 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 451 Sender: kristoff@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3bbi58$gp2@net.bio.net> NNTP-Posting-Host: net.bio.net FYI Solicitation for USDA-CSREES Biotechnology Risk Assessment Research Grants program. Deadline for submission: JANUARY 13, 1995. DEPARTMENT OF AGRICULTURE (USDA) Agricultural Research Service (ARS) Cooperative State Research Service Extension Service DEPARTMENT OF EDUCATION Notice: Biotechnology Risk Assessment Research Grants Program; Fiscal Year 1995; Solicitation of Applications *Notices* (FEDREGISTER 59 FR 59348 11/16/94; 432 lines.) Item Key: 28840 --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- DEPARTMENT OF AGRICULTURE Agricultural Research Service COOPERATIVE STATE RESEARCH, EDUCATION, AND EXTENSION SERVICE Biotechnology Risk Assessment Research Grants Program; Fiscal Year 1995; Solicitation of Applications Purpose Proposals are invited for competitive grant awards under the Biotechnology Risk Assessment Research Grants Program (the "Program") for fiscal year 1995. The authority for the Program is contained in section 1668 of Public Law 101-624 (the Food, Agriculture, Conservation, and Trade Act of 1990, 7 U.S.C. 5921). The Program is administered by the Cooperative State Research, Education, and Extension Service (CSREES) and the Agricultural Research Service (ARS) of the U.S. Department of Agriculture. (The CSREES was established by Pub. L. 103-354, the Federal Crop Insurance Reform and Department of Agriculture Reorganization Act of 1994, and the functions of the Cooperative State Research Service were transferred to the CSREES by the Secretary of Agriculture's Memorandum 1010-1.) The purpose of the Program is to assist Federal regulatory agencies in making science-based decisions about the safety of introducing genetically modified plants, animals, and microorganisms into the environment. The Program accomplishes this purpose by providing scientific information derived from the risk assessment research conducted under it. Research proposals submitted to the Program must be applicable to the purpose of the Program to be considered. Proposals based upon field research and whole organism-population level studies are strongly encouraged. Awards will not be made for clinical trials, commercial product development, product marketing strategies, or other research not appropriate to risk assessment. Proposals should be applicable to current regulatory issues surrounding the ecological impacts of genetically modified organisms, with special emphasis on natural ecosystem consequences. Applicant Eligibility Proposals may be submitted by any United States public or private research or educational institution or organization. Available Funding The amount available for support of the Program in fiscal year 1995 is approximately $ 1.7 million. Pursuant to Section 712 of Public Law 103-330 (the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 1995), funds available in fiscal year 1995 to pay indirect costs on research grants awarded competitively by CSREES may not exceed 14 per centum of the total Federal funds provided under each award. In addition, pursuant to Sec. 719(b) of Public Law 103-330, in the case of any equipment or product that may be authorized to be purchased with the funds provided under this Program, entities are encouraged to use such funds to purchase only American-made equipment or products. Program Description Under the Program, USDA will competitively award research grants to support science-based biotechnology regulation and thus help address concerns about the effects of introducing genetically modified organisms into the environment and to help regulators develop policies concerning such introduction. Proposals are invited in the area of biotechnology risk assessment research as appropriate to agricultural plants, animals and microbes. Emphasis will be given to risk assessment research involving genetically modified organisms, but model systems using nongenetically modified organisms also will be considered if they can provide information that could lead to improved assessment of potential risks associated with the introduction of genetically modified organisms into the environment. Proposals will be evaluated by the Administrator assisted by a peer panel of scientists for science quality, relevance for current regulatory issues, and intent to advance the safe application of biotechnology to agriculture by providing new knowledge for science-based regulatory decisions. The development of better risk assessment methods for field testing genetically modified organisms will also be considered. Areas of Research to Be Supported in Fiscal Year 1995 Proposals addressing the following research topics are requested: 1. Development of new risk assessment methods (e.g., monitoring organism escape, measuring biological impacts), and risk assessment procedures (e.g., comparative analysis of ecosystems, models to predict risks) that could be used in risk assessment of genetically modified fungi, bacteria, viruses (including animal vaccines), plants, arthropods, fish, birds, and mammals. Applicants should address the need for, and development of, such new risk assessment methods in the course of addressing a specific and defined risk assessment issue, especially as pertains to genetically modified organisms. 2. Creation of information systems and computer models to support regulatory agency decision-making in regards to potential impacts to the environment over time (e.g., computer models to describe the interaction of environmental and organismal factors especially for establishment and dispersal of the organism). 3. Risk assessment of the environmental fate (e.g., survival, reproduction fitness, genetic stability, horizontal gene transfer) as correlated with effects (e.g., loss of genetic diversity, enhanced competition) of genetically modified fungi, bacteria, viruses, plants, arthropods, fish, birds and mammals introduced into the environment (i.e., not in a contained laboratory, greenhouse or building); and studies or identification of traits which may influence fate and effects. In response to requests to Program Directors and Federal regulatory agencies, as stipulated in the authorizing legislation for the Program, section 1668 of Public Law 101-624, the following specific areas of risk assessment research have been identified as eligible for competition as research topics for this year. 4. The bidirectional rates, effects of selection pressures, mechanisms and impact of gene transfer between currently genetically transformable crop species and existing North American wild relatives of those crops including studies of methods of mitigation of potential gene exchange. Species specifically identified by the Animal and Plant Health Inspection Service include rye, oats, barley, sorghum and turfgrasses. Research could rely on reanalysis of published information and/or laboratory/field studies. 5. The potential for recombination between plant viruses and plant- encoded noncapsid viral genes (e.g., replicase), especially for those viruses in supergroup B (carmovirus, tombusvirus, luteovirus, sobemovirus). Such studies should identify recombination potentials and, if demonstrated, define frequencies and effect on symptom expression. 6. The potential for plants to express nonviral genes using noncoding regulatory sequences (promoters, translational enhancers, termination sequences) derived from plant viruses that naturally infect the plants (e.g., cauliflower mosaic virus and Brassica spp.). The potential for changes in expression of introduced genes or other aspects of host physiology when the transgenic plant becomes infected with plant viruses, especially those from which the noncoding sequence was derived or from related viruses. 7. Changes in viral host ranges or the types of viral vectors as a result of the use of transgenic plants expressing viral genes. 8. The potential for nontarget effects of introduced plant-defense compounds expressed in genetically modified plant-associated microorganisms (e.g., compounds in phyllosphere or rhizosphere-inhabiting bacteria) or in plants (e.g., Bacillus thuringiensis delta-endotoxin), especially in regard to persistence of the organisms and material in the environment. 9. Identification of genes which can confer additional pathogenicity to animal pathogens. Pathogenic organisms specifically identified by the Animal and Plant Health Inspection Service as being of interest are Marek's disease virus, laryngo tracheitis virus, bovine leukemia virus, eastern equine encephalomyelitis virus, bovine diarrhea virus, Erysipelothrix rhusiopathiae and Haemophilus somnus. 10. Environmental risk analysis of large scale deployment of genetically engineered organisms, especially commercial uses of such organisms, with special reference to considerations that may not be revealed through small scale evaluations and tests. All research proposals submitted should include a statement describing the relevance of the proposed project to one or more of the research topics requested. When appropriate, detailed descriptions of statistical analyses to be done should be included in the proposal. The inclusion of statisticians as co-principal investigators or contractors is encouraged. Note: Individual investigators whose research projects are funded under the Program will be required to attend and present data on the results of their research at an Annual Conference. Attendance costs at such a conference do not need to be included in the budgets of proposed research projects; such costs will be paid from funds provided under a cooperative agreement between CSREES and the University of Maryland for an annual risk assessment symposium. Additionally, a final project report on research results will be required in a fixed protocol, electronic format, suitable for distribution by USDA on CD-ROM. Applicable Regulations This Program is subject to the administrative provisions found in 7 CFR part 3415 (58 FR 65646, December 15, 1993), which set forth procedures to be followed when submitting grant proposals, rules governing the evaluation of proposals, the awarding of grants, and post-award administration of such grants. Several other Federal statutes and regulations apply to grant proposals considered for review or to grants awarded under this Program. These include, but are not limited to: 7 CFR Part 1.1-USDA implementation of the Freedom of Information Act; 7 CFR Part 1c-USDA implementation of the Federal Policy for the Protection of Human Subjects; 7 CFR Part 3-USDA implementation of OMB Circular A-129 regarding debt collection; 7 CFR Part 15, Subpart A-USDA implementation of Title VI of the Civil Rights Act of 1964; 7 CFR Part 520-ARS implementation of the National Environmental Policy Act; 7 CFR Part 3015-USDA Uniform Federal Assistance Regulations, implementing OMB directives (i.e., Circular Nos. A-110, A-21, and A- 122) and incorporating provisions of 31 U.S.C. 6301-6308 (formerly, the Federal Grant and Cooperative Agreement Act of 1977, Pub. L. No.95-224), as well as general policy requirements applicable to recipients of Departmental financial assistance; 7 CFR Part 3016-USDA Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments; 7 CFR Part 3017, as amended-USDA implementation of Governmentwide Debarment and Suspension (Nonprocurement) and Governmentwide Requirements for Drug-Free Workplace (Grants); 7 CFR Part 3018-USDA implementation of New Restrictions on Lobbying. Imposes new prohibitions and requirements for disclosure and certification related to lobbying on recipients of Federal contracts, grants, cooperative agreements, and loans; 7 CFR Part 3051-Audits of Institutions of Higher Education and Other Nonprofit Institutions; 7 CFR Part 3407-CSREES implementation of the National Environmental Policy Act; 29 U.S.C. 794, section 504-Rehabilitation Act of 1973, and 7 CFR Part 15B (USDA implementation of the statute), prohibiting discrimination based upon physical or mental handicap in Federally assisted programs; 35 U.S.C. 200 et seq.-Bayh-Dole Act, controlling allocation of rights to inventions made by employees of small business firms and domestic nonprofit organizations, including universities, in Federally assisted programs (implementing regulations are contained in 37 CFR Part 401). Programmatic Contact For additional information on the Program, please contact: Dr. Ann Lichens-Park, Cooperative State Research, Education, and Extension Service, U.S. Department of Agriculture, Ag Box 2220, Washington, DC 20250-2220, Telephone: (202) 401-4892 or Dr. Robert M. Faust, Agricultural Research Service, U.S. Department of Agriculture, Room 338, Building 005, BARC-West, Beltsville, MD 20705, Telephone: (301) 504-6918 How to Obtain Application Materials Copies of this solicitation, the administrative provisions for the Program (7 CFR Part 3415), and the Application Kit will be made available upon request. The Application Kit contains required forms, certifications, and instructions for preparing and submitting grant applications. The administrative provisions include guidelines for proposal format. Copies of this solicitation, the administrative provisions, and the Application Kit may be obtained by contacting: Proposal Services Branch, Awards Management Division, Cooperative State Research, Education, and Extension Service, U.S. Department of Agriculture, Ag Box 2245, Washington, DC 20250-2245, Telephone Number: (202) 401-5048 Application materials may also be requested via Internet by sending a message with your name, mailing address (not e-mail) and telephone number to psb@csrees.esusda.gov which states that you wish to receive a copy of the application materials for the Fiscal Year 1995 Biotechnology Risk Assessment Research Grants Program. The materials will then be mailed to you (not e-mailed) as quickly as possible. Proposal Format The format guidelines for full research proposals, found in the administrative provisions for the Program at Sec. 3415.4(d), should be followed for the preparation of proposals under the Program in fiscal year 1995. (Note that the Department elects not to solicit preproposals nor conference grant proposals in fiscal year 1995). Compliance with the National Environmental Policy Act (NEPA) As outlined in 7 CFR Part 3407 and 7 CFR Part 520 (the CSREES and ARS regulations implementing the National Environmental Policy Act of 1969), environmental data for any proposed project is to be provided to CSREES and ARS so that CSREES and ARS may determine whether any further action is needed. The applicant shall review the following categorical exclusions and determine if the proposed project may fall within one of the categories. (1) Department of Agriculture Categorical Exclusions (7 CFR 1b.3) (i) Policy development, planning and implementation which are related to routine activities such as personnel, organizational changes, or similar administrative functions; (ii) Activities which deal solely with the funding of programs, such as program budget proposals, disbursements, and transfer or reprogramming of funds; (iii) Inventories, research activities, and studies, such as resource inventories and routine data collection when such actions are clearly limited in context and intensity; (iv) Educational and informational programs and activities; (v) Civil and criminal law enforcement and investigative activities; (vi) Activities which are advisory and consultative to other agencies and public and private entities; and (vii) Activities related to trade representation and market development activities abroad. (2) CSREES and ARS Categorical Exclusions (7 CFR 3407.6 and 7 CFR 520.5 Based on previous experience, the following categories of CSREES and ARS actions are excluded because they have been found to have limited scope and intensity and to have no significant individual or cumulative impacts on the quality of the human environment: (i) The following categories of research programs or projects of limited size and magnitude or with only short-term effects on the environment: (A) Research conducted within any laboratory, greenhouse, or other contained facility where research practices and safeguards prevent environmental impacts; (B) Surveys, inventories, and similar studies that have limited context and minimal intensity in terms of changes in the environment; and (C) Testing outside of the laboratory, such as in small isolated field plots, which involves the routine use of familiar chemicals or biological materials. (ii) Routine renovation, rehabilitation, or revitalization of physical facilities, including the acquisition and installation of equipment, where such activity is limited in scope and intensity. In order for CSREES and ARS to determine whether any further action is needed with respect to NEPA, pertinent information regarding the possible environmental impacts of a particular project is necessary; therefore, a separate statement must be included in the proposal indicating whether the applicant is of the opinion that the project falls within a categorical exclusion and the reasons therefor. If it is the applicant's opinion that the project proposed falls within the categorical exclusions, the specific exclusions must be identified. The information submitted shall be identified as "NEPA Considerations" and the narrative statement shall be placed after the coversheet of the proposal. Even though a project may fall within the categorical exclusions, CSREES and ARS may determine that an Environmental Assessment or an Environmental Impact Statement is necessary for an activity, if substantial controversy on environmental grounds exist or if other extraordinary conditions or circumstances are present which may cause such activity to have a significant environmental effect. Proposal Submission What to Submit An original and 14 copies of a proposal must be submitted. Each copy of each proposal must be stapled securely in the upper lefthand corner (DO NOT BIND). All copies of the proposal must be submitted in one package. Where and When to Submit Proposals submitted through the regular mail must be received by January 13, 1995, and must be sent to the following address: Proposal Services Branch, Awards Management Division, Cooperative State Research, Education, and Extension Service, U.S. Department of Agriculture, Ag Box 2245, Washington, DC 20250-2245, Telephone: (202) 401-5048 Hand-delivered proposals must be brought to the following address by c.o.b. (4:30 p.m.) on January 13, 1995 (note that the zip code differs from that shown above): Proposal Services Branch, Awards Management Division, Cooperative State Research, Education, and Extension Service, U.S. Department of Agriculture, Room 303, Aerospace Center, 901 D Street, S.W., Washington, DC 20024, Telephone: (202) 401-5048 Supplementary Information The Biotechnology Risk Assessment Research Grants Program is listed in the Catalog of Federal Domestic Assistance under No. 10.219. For reasons set forth in the final rule-related Notice to 7 CFR Part 3015, subpart V (48 FR 29115, June 24, 1983), this Program is excluded from the scope of Executive Order No. 12372 which requires intergovernmental consultation with State and local officials. Under the provisions of the Paperwork Reduction Act of 1980 (44 U.S.C. 3504(h)), the collection of information requirements contained in this Notice have been approved under OMB Document No. 0524-0022. Done at Washington, D.C., on this 7th day of November, 1994. Sarah J. Rockey, Acting Administrator, Cooperative State Research, Education, and Extension Service. Richard L. Dunkle, Acting Associate Administrator, Agricultural Research Service. [FR Doc. 94-28344 Filed 11-15-94; 8:45 am] GARY L. JENSEN Extension Service-USDA Ag Box 0916 Rm. 3863 South Building Washington, DC 20250-0916 tel: 202/720-5004 fax: 202/690-4869 internet: gjensen@esusda.gov From owner-sci-resources@net.bio.net Mon Nov 28 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA TW-95-002 - V23(40) 11/18/94 Date: 28 Nov 1994 21:10:17 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 564 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3bed3p$n1d@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA TW95002 TW-95-002 P1O1 *************************************** INTERNATIONAL RESEARCH AND TRAINING IN POPULATION AND HEALTH NIH GUIDE, Volume 23, Number 40, November 18, 1994 RFA: TW-95-002 P.T. 34; K.W. 0720005, 0413000, 0413002 Fogarty International Center National Institute of Child Health and Human Development Letter of Intent Receipt Date: January 16, 1995 Application Receipt Date: April 20, 1995 PURPOSE The Fogarty International Center (FIC), in collaboration with the National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health, invites applications from non- profit public or private institutions in the United States to support international research and training in population-related sciences. The intent of this program is to enable NIH grant recipients to extend the geographic base of research and training efforts to developing nations, in support of international population priorities. Broad objectives are to: o Enhance domestic population research programs through training and international collaborative studies related to population, including the study of reproductive processes, contraceptive development, contraceptive and reproductive evaluation, reproductive epidemiology, and social and behavioral factors that influence population dynamics. o Assist scientists from developing nations to contribute to global population research efforts and advance knowledge in support of population policies appropriate for their home countries and established international guidelines. 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), International Research and Training in Population and Health, is related to the priority area of family planning and maternal and infant health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS The grantee institution must be a U.S. non-profit private or public institution capable of meeting the objectives in this RFA. Applicant investigators (or co-investigators) must be either a U.S. Principal Investigator of at least one NIH-sponsored research project grant (R series) or a Project Director of an NIH-sponsored center grant, program project grant or cooperative agreement (P and U series) related to population that will be funded during at least one year of the proposed grant award period. On submission of an application, at least eighteen months of active research support must remain on the listed parent grant(s). Investigators may request five years of support in anticipation that a renewal application for the parent grant(s) will be submitted and awarded. Under certain circumstances, an NIH research contract will be considered as meeting the eligibility requirements. The application must demonstrate that the award is relevant to and will enhance the activities of the NIH-supported parent grant(s) and benefit the research needs of the host country or countries of participating scientists and health professionals. Within allowable limits, research collaborations can include other industrialized nations in addition to the U.S. MECHANISM OF SUPPORT International Research and Training in Population and Health (D43) will be available to U.S. investigators at a funding level not to exceed $150,000 per year in direct costs for the first year, for a maximum of five years. The application should describe both research and training objectives to be pursued in the United States and in the cooperating developing nation(s) of Africa, Asia and the Pacific region, the Middle East and Latin America (including the Caribbean). Applications may incorporate cooperative activities with scientists from one or several developing countries or regions, based on the research and training objectives of the program. However, applicants are encouraged to focus their efforts on a limited number of countries. Types of Training Research-related training programs for foreign scientists and health professionals may include the following elements: o Predoctoral training in research related to population; academic courses (which may lead to a degree) will be undertaken in the U.S. in disciplines that may include: demographic and behavioral science, endocrinology, pharmacology and toxicology, pharmaceutical development, cell and molecular biology, genetics, embryology, physiology, epidemiology and other population-related fields; research projects may be undertaken either at the U.S. host institution or in the trainee's home country; o Postdoctoral training in laboratory procedures and research projects and techniques related to population research, to be conducted at the host U.S. institutions or in the trainee's home country; o Participation in advanced research training conducted by U.S. faculty in the host country and also short-term in-country training for foreign scientists and health professionals in the host country. As part of the application, the applicant institution must describe recruitment and selection procedures for the foreign pre- and postdoctoral scientists. Allowable Costs Eligible costs include: travel and subsistence related to research and training conducted at a foreign site; support for short and long- term training of pre- and postdoctoral scientists and health professionals from developing nations; provision of research supplies and materials to the foreign site in support of joint activities; and limited support for relevant activities with institutions in industrialized nations which would provide scientific contributions. The following cost categories are eligible for reimbursement under this program. The stipends and allowances are maximums and applicants are encouraged to design the most cost-effective programs: For foreign scientists from developing nations: o Living allowance (stipend) comparable to scientist's professional level and compatible with established NIH guidelines, but not to exceed $45,000 per annum while undergoing training or conducting research in the U.S.; o Living allowance (stipend) for scientists to conduct in-country research at a level comparable to that received by similar professionals in-country, but also not to exceed $45,000 per annum; o Tuition and fees at the U.S. university; o Round trip economy class air fare between the U.S. and home country; o Allowance for the grantee institution of up to $600 monthly per scientist to cover health insurance, travel to scientific meetings, and incidental research expenses; o Additional research support of up to $15,000 per person to support training-related research or advanced research training in the developing country (the program director is expected to ensure that projects submitted for this funding are peer reviewed by the U.S. institution); For U.S. scientists affiliated with grantee institution: o Economy class travel and per diem for the program director and U.S. faculty colleagues to provide guidance to trainees conducting related field studies or advanced research training in their home countries; o Economy class travel and per diem for U.S. faculty presenting short-term courses in the foreign country; o Longer-term support (travel, per diem and pro-rated salary, up to 10 percent of annual salary or $10,000, whichever is less) to enable U.S. faculty to conduct advanced research training activities in- country; For administrative expenses: o Administrative expenses at the U.S. institution (secretarial expenses, etc.) not to exceed 10 percent of the direct costs of this award. It is expected that the portion of salary for the program director for the purpose of administering this award will be provided for under the parent grant(s) associated with this proposal. For related activities with other industrialized nations: o Support for travel and subsistence of U.S. or foreign investigator(s), and the exchange of data, materials and supplies, not to exceed 10 percent of direct costs of this award unless prior approval is secured from the FIC. As a condition of this special expenditure, the applicant must indicate that some form of cost- sharing will be provided by the counterpart institution in an industrialized nation. Requests for an administrative supplemental budget will be considered for increases of up to 10 percent of funded levels in a given budget year. These funds may be requested to meet special needs and take advantage of unusual opportunities. Such requests will be reviewed by FIC program staff in consultation with NICHD and support will depend upon availability of funds. The grantee institution may request an indirect cost allowance based on eight percent of the total allowable direct costs, exclusive of tuition and related fees and expenditures for equipment. Applicants should assume a budget increase of four percent per year for each succeeding year. The anticipated date of award is on or before September 30, 1995. FUNDS AVAILABLE It is anticipated that six to seven awards will be made, with an estimated total of $1,000,000 available for the entire program in the first year, with no single award exceeding $150,000 (in direct costs). RESEARCH OBJECTIVES Although world population growth peaked at 2.3 percent and began to decline in the late 1970's, the age structure of the present population will result in significant population increases well into the next century. According to projections of the United Nations (U.N.) Population Division, world population will increase to 8.5 billion over the next 35 years. Of the projected increase of some 3.2 billion, it is estimated that less than 200 million will occur in industrialized countries; at least 3 billion, or 95 percent, will be in the less developed countries. By the year 2025, 16 of the world's most populous cities will be situated in the developing world. This trend has significant ramifications for global health. In developing nations, high birth rates may impede sustainable economic development. Consequences may include increasing pollution and worsening sanitation, the spread and emergence of infectious diseases, over exploitation of land, destruction of natural ecosystems, unemployment, and inadequate access to health care and education. Where declines in growth rates have occurred, they are attributed to increased economic productivity and cultural change, including acceptance of and access to a wide choice of birth control methods, sustained improvements in child survival, and improvements in the education and societal status of women. Through international research and training efforts, NIH-supported institutions are positioned to advance technological and social adaptations needed to meet the challenge of unsustainable population growth. This program is designed to create and expand research partnerships between U.S. scientists and counterparts in developing regions of the world on population issues of mutual priority. It will assist to train a cadre of research and health professionals in developing nations who may contribute to the development of population policies that are based on scientific information and also are responsive to societal mores and values in their home countries. Emphasis will be placed on collaborative activities with countries and regions where population growth adversely impacts public health, the environment and economic progress. Examples of research and training topics include, but are not limited to, the following: o Studies on reproductive processes, including development of the reproductive system, male and female fertility, processes and mechanisms to include preimplantation embryo development and implantation; o Studies on contraceptive development, including natural or synthetic agents, products to reduce transmission of sexually-transmitted diseases, new contraceptive devices and reversible sterilization techniques; o Evaluative studies of contraceptive and fertility-related drugs and products for safety and efficacy; evaluation of safety of male and female sterilization; o Studies on social and behavioral factors that influence population growth and change, including contraceptive use and choice, operational research related to family planning, migration and spatial distribution of populations, family composition and parental roles, and population policies. SPECIAL REQUIREMENTS Before any funds may be expended on in-country research, the grantee institution must show evidence of formal approval from responsible authorities at the collaborating institution and the host government. These approvals should be included in the application. As part of proposed training programs, the applicants must describe their training in the responsible conduct of research, consistent with NIH policy (NIH Guide for Grants and Contracts, Volume 21, Number 43, November 27, 1992) to be part of the program. An award will not be made unless such a description is included. Protection of human subjects and laboratory animals Applicable provisions for the protection of human research subjects and laboratory animals in research and training activities must be met in both domestic and foreign settings. Title 45 CFR, Part 46, provides guidelines concerning Department of Health and Human Services regulations for the protection of human subjects and the Public Health Service Policy on Humane Care and Use of Laboratory Animals. These are available from the Office for Protection from Research Risks, National Institutes of Health, 6100 Executive Boulevard, Suite 3B01 Rockville, MD 20852. 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 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 (59 FR 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. LETTER OF INTENT Prospective applicants are asked to submit, by January 16, 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 NIH staff to estimate the potential review workload and avoid conflict of interest in the review as well as to provide important information to prospective applicants. The letter of intent is to be sent to: Dr. Kenneth Bridbord International Studies Branch Fogarty International Center 31 Center Drive MSC 2220 Bethesda, MD 20892-2220 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 RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must be sent to: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E03 Bethesda, MD 20892-7510 Applications must be received by April 20, 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 responsiveness by the FIC and the NICHD. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, the application will be returned to the applicant without review. 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 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 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 notified. The second level of review will be provided by the FIC Advisory Board in September 1995. Review criteria include those generally applicable to research training programs and research: o past research training record for both the program and designated preceptors in terms of the rate at which former trainees establish independent and productive research careers; o past research training record in terms of the success of former trainees in obtaining individual awards such as fellowships, career awards, and research grants for further development; o objectives, design, and direction of the research training program; o caliber of preceptors as researchers including the institutional commitment, the quality of the facilities, and the availability of research support; o training environment including the institutional commitment, the quality of the facilities, and the availability of research support; o recruitment and selection plans for appointees and the availability of high quality candidates; o the record of the research training program in retaining health professional postdoctoral trainees for at least two years in research training or other research activities; o when appropriate, the concomitant training of health- professional postdoctorates (e.g., individuals with the M.D., D.O., D.D.S.) with basic science postdoctorates (e.g., individuals with a Ph.D., Sc.D.) will receive special consideration. Where specific research protocols are proposed, additional review criteria, applicable to research grants, will be as follows: 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; The initial review group will also examine the provisions for the protection of human and animal subjects, the safety of the research environment, and the adequacy of plans for instruction in the responsible conduct of research. Additional factors to be considered in the scientific evaluation of each application include the likelihood that the applicant institution can meet the objectives stated in this RFA and specifically: o the expected scientific contribution of the proposed activity; o the strength of the research program in health sciences related to the proposed research and training; o quality of teaching and research facilities and resources of the U.S. institution, as well as the cooperating institution(s) in other countries including documentation of previous international collaboration with developing country scientists and institutions; o previous training experience at the pre- and postdoctoral levels and success in maintaining collaboration with former trainees; o demonstrated capacity or potential to provide in- country advanced research or technical training; o demonstrated capacity or potential to conduct future population- related research projects with collaborating scientists and institutions from developing nations. AWARD CRITERIA The most important factor to be considered in making funding decisions will be the quality of the proposed project as determined by peer review. The proposed instruction in the responsible conduct of research must rated adequate for an award to be made. In addition, FIC, in consultation with NICHD, will attempt to ensure a reasonable balance of basic, clinical, behavioral and demographic research training, as well as a geographic distribution among developing nations of Asia and the Pacific region, Africa, the Middle East and Latin America (including the Caribbean). The number and amount of the awards made under this program will depend upon the availability of funds and cost-effectiveness will be one of the factors considered in making funding decisions. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome and prospective applicants are strongly encouraged to discuss their proposals with program staff prior to submission. Direct inquiries regarding programmatic issues to: Dr. Kenneth Bridbord International Studies Branch Fogarty International Center 31 Center Drive MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-2516 FAX: (301) 402-2056 Email: sn5@cu.nih.gov Direct inquiries regarding fiscal matters to: Ms. Silvia Mandes International Research and Awards Branch Fogarty International Center 31 Center Drive MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1653 FAX: (301) 402-0779 Email: som@cu.nih.gov AUTHORITY AND REGULATIONS This general type of program is described in the Catalog of Federal Domestic Assistance No. 93.154. 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 to Health Systems Agency review. 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. From owner-sci-resources@net.bio.net Mon Nov 28 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA RR-95-002 - V23(40) 11/18/94 Date: 28 Nov 1994 21:09:48 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 713 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3bed2s$ms0@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA RR95002 RR-95-002 P1O1 *************************************** NATIONAL GENE VECTOR LABORATORIES NIH GUIDE, Volume 23, Number 40, November 18, 1994 RFA: RR-95-002 P.T. 34; K.W. 1002019, 0745032 National Center for Research Resources National Cancer Institute National Heart, Lung, and Blood Institute National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: December 15, 1994 Application Receipt Date: February 21, 1995 PURPOSE The National Center for Research Resources (NCRR), together with the National Cancer Institute (NCI), the National Heart, Lung, and Blood Institute (NHLBI), and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) as cosponsors, invite applications to establish National Gene Vector Laboratories to enhance research leading to successful gene therapy of single- and multiple-gene disorders. For purposes of this solicitation, the term "vector" is used in the broadest sense to refer to any vehicle designed to deliver genetic material into human somatic cells. The National Gene Vector Laboratories will provide shared resources to facilitate optimal vector production of clinical grade vectors for human gene therapy research. The overall goals are to provide vectors for the prevention, treatment, and cure of a wide variety of medical conditions through gene therapy. 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), National Gene Vector Laboratories, is related to many of the priority areas discussed in this publication. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202 783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, but not foreign, for profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and Local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Program Directors. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be the NIH Animal (Mammalian and Nonmammalian) Model, and Animal and Biological Materials Resource Cooperative Agreement (U42), 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/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. Details of the responsibilities, relationships, and governance of the projects to be funded under cooperative agreement(s) are discussed later in this document under the section "Terms and Conditions of Award." The total project period for applications submitted in response to the present RFA may not exceed five years. The anticipated award date is August 1, 1995. Because the nature and scope of the activity proposed in response to this RFA may vary, it is anticipated that the size of an award 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 NCRR and cosponsoring Institutes, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. This RFA is currently anticipated to be a one-time solicitation. However, if it is determined that there is a sufficient continuing need, the NCRR will invite new applicants and recipients of awards under this RFA to submit competitive new and/or competitive continuation cooperative agreement applications for review according to the procedures described in REVIEW CONSIDERATIONS. FUNDS AVAILABLE Approximately $3.5 million in total costs will be available in Fiscal Year 1995 for the first year of support of meritorious applications submitted in response to this RFA . It is anticipated that between one and three awards will be made. RESEARCH OBJECTIVES Background Recent understanding of molecular biology, combined with breakthroughs in virology and gene transfer techniques, have led to new approaches to the treatment of both inherited and acquired diseases. Diseases thought to be amenable to gene therapy include, but are not limited to, single gene disorders such as cystic fibrosis, Gaucher disease, adenosine deaminase deficiency, immune deficiencies, hemoglobinopathies, hemophilias, hyperlipidemias, and multifactorial disorders such as cancer, hypertension, diabetes, heart disease, and pulmonary diseases. In addition, diseases such as acquired immunodeficiency syndrome (AIDS) and malignancies require suitable vector development, production, and distribution to enhance research leading to effective treatment. Gene therapy for such diseases requires the development of suitable vectors to transfer new genetic material to target cells. Somatic cells such as lung, muscle, liver, neuronal, and bone marrow stem cells, as well as tumor cells, are important targets for gene therapy. An array of viral vectors are under investigation for use in such treatments. In addition, liposome formulations have been approved as vehicles for the delivery of DNA. The technical requirements and the expense of vector development, production, and safety testing have limited the capacity of clinical investigators to proceed with implementation of gene therapy. Just as collaborative efforts have facilitated the testing of gene therapy for cystic fibrosis, optimal progress in treatment of other diseases would be enhanced by national cooperation for the production and distribution of vectors for gene therapy. In addition, centralizing such facilities will reduce the cost barrier for the production of vectors and therefore, enhance development of vectors for rare disorders where commercialization is not cost effective. Objectives and Scope The objective of this RFA is to solicit applications for cooperative agreements to support national laboratories for vector production, maintenance, and distribution for use in gene therapy. The rapid advancements in the field of molecular genetics have led to the identification and characterization of many genes and their products. In addition, investigators are ready to initiate clinical trials for promising gene therapies and patients are anticipating being participants in these studies. There is difficulty in bringing these scientific breakthroughs to clinically applicable therapies. Failure to accommodate the urgent need for vector production and distribution constitutes a barrier to progress in the field of gene therapy. Through this cooperative agreement initiative, national laboratories will be supported to develop plans and methods to produce and distribute gene therapy vectors for protocols that have received FDA approval and/or have either been determined not to require or have been recommended for approval by the Recombinant DNA Advisory Committee (RAC) and received approval from the Director of the NIH. Highest priority for use of the facilities will be given to projects that have received peer-reviewed grant support. These vectors would have been developed and had preclinical testing supported by NIH funding. Facilities must demonstrate expertise in production of gene therapy vectors that meet FDA criteria for human use. Facilities must address which of the currently approved vectors including retroviral, adenoviral, adeno-associated viral, and/or cationic liposomes will be produced at the facility, and must address how they will incorporate new technologies in the future. Facilities must have the capability to produce several vectors simultaneously and provide information regarding maximal capabilities. SPECIAL REQUIREMENTS These cooperative agreements (U42s) will require cooperation among the NCRR scientific coordinator, the participating Institute and Center (IC) program administrators, and the Program Directors of each vector production facility in order to assure smooth interactions among awardee organizations. To promote the development of a collaborative program among the award recipients, a number of issues need to be addressed in their applications as discussed below. The following terms and conditions will be incorporated into the award statement and provided to the Program Director as well as the institutional official at the time of award. 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 for this program is a cooperative agreement (U42), 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/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. 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 project(s) will be shared among the awardees and the IC participants. 1. Awardee Rights and Responsibilities The Program Directors and an associate from each institution will plan and design the details of the project including appropriate methods for defining and operating the vector laboratories. They will retain primary responsibility for the performance of the activity. Program Directors and associates must form and agree to participate as members of the National Gene Vector Laboratories Steering Committee. Program Directors will appoint outside experts to balance the composition and size of the Steering Committee so that the total percentage of NIH representatives does not exceed 40 percent of the membership. Each member of the Steering Committee, including the outside experts, will have one vote. The Program Directors, in cooperation with the other Steering Committee members, are responsible for developing the details of the operating policies of the National Gene Vector Laboratories, including definition of objectives and approaches, planning, implementation, and interaction with other Program Directors, and assurance of scientific integrity. The Steering Committee will elect a Chairperson from among the participating Program Directors. Rules governing the selection and tenure of the Chairperson and outside experts will also be established by the Steering Committee. The facility represented by the elected chairperson will then be designated as the Coordinating Facility for purposes of submitting applications for use of all facilities. That facility will also be responsible for the paperwork involved in Steering Committee meetings including preparing meeting agendas, chairing meetings, writing and distributing minutes, and notifying successful and unsuccessful applicants for use of the resource of decisions made and providing the written rationale for such. The Chairperson of the Steering Committee must present an update of activities at each meeting. In order to accomplish this obligation, each Program Director is responsible for timely preparation and submission of his or her individual update to the Chairperson of the Steering Committee who will prepare a summary for presentation at the time of each Steering Committee meeting for incorporation into the minutes. 2. I/C Staff Responsibilities One representative from the NCRR will be designated to serve as the NIH Scientific Coordinator to the cooperative agreement. The NIH Scientific Coordinator and one program administrator from each cosponsoring Institute will serve on the Steering Committee in order to bring that individual's unique perspective on a given categoric disease for which the individual oversees basic genetic research. In consultation with awardees, these individuals may convene workshops or sponsor seminars within existing meetings to update the Program Directors on advances in gene therapy accomplished through NIH support. While each of the four participating IC representatives will attend and have a vote on the Steering Committee, according to the organization of the Committee, their cumulative votes will never exceed 40 percent. As members of the Steering Committee, the NIH Scientific Coordinator and the other IC program administrators attend and participate in all meetings and assist in developing operating policies, quality control procedures, and consistent policies for dealing with recurring situations that require cooperative action. The NIH Scientific Coordinator will assist in coordinating the activities of the awardees and in facilitating exchange of information. The role of the NIH Scientific Coordinator and Institute program administrators, as detailed throughout these terms of cooperation, is to assist and facilitate, but not to direct activities of the National Gene Vector Laboratories. The NIH Scientific Coordinator and the Institute program administrators act as liaisons to the NIH and as information resources about research activities in gene identification and gene therapy. The NIH representatives may also act as "catalysts," bringing together groups with characterized vectors and groups with the requisite resources and expertise to implement high quality clinical research. The Steering Committee coordinates and facilitates the activities supported by these cooperative agreements. 3. Collaborative Responsibilities Steering Committee The members of the Steering Committee will establish the functions of the Steering Committee, its method of operation, quality control assurance, cooperation among Program Directors, the NIH, and users of the facilities. The Steering Committee will also make provisions for an arbitration panel as described below. Criteria for accession and discontinuance of use of the facility will also be delineated. The Committee will then reach a consensus on these issues and generate three documents: one outlining its functions, handling of quality control issues, mode of cooperation of among awardees, the NIH, and the users of the facilities, conflict of interest, and mode of operation; a second enumerating criteria and procedures for accession and discontinuance of use of the facility for a given vector; and a third which will serve as an application form for investigators wishing to use the facility. The Steering Committee will meet three times during the first year of the awards and twice annually, thereafter. Program Directors are also responsible for formulating consistent policies for dealing with recurring situations that require coordinated action through participation by the Program Directors and any other designated representatives at Steering Committee meetings. Steering Committee meetings should be scheduled in close sequence with RAC meetings in order to avoid unnecessary delays in setting priorities and approving vectors. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters within the scope of the award, between award recipients and the NIH may be brought to arbitration. An arbitration panel of external consultants will be created, and convened as needed, to resolve any irreconcilable differences of opinion related to scientific/programmatic matters among awardees and the NIH with respect to implementation of a proposed operating policy or other problems that may arise. The panel will include one member selected by the Program Directors, one member selected by the NIH representatives, and a third member chosen by the other two members of the arbitration panel. These special arbitration procedures in no way affect the awardee's right to appeal an adverse determination in accordance with PHS regulations at 42 CFR part 50, subpart D and HHS regulations at 45 CFR part 16. Applicants should anticipate probable areas of conflict and put forward an arbitration plan in their applications. 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 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 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 December 15, 1994, a letter of intent that includes a descriptive title of the proposed project, the name, address and telephone number of the Program Director, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information is helpful in planning for the review of applications. It allows IC staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Dorothy D. Sogn, M.D. General Clinical Research Centers Program National Center for Research Resources Westwood Building, Room 10A-07 5333 Westbard Avenue Bethesda, MD 20892-4500** Telephone: (301) 594-7945 FAX: (301) 594-7929 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these cooperative agreements. 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 20892-4500, telephone 301/594-7248; and from the program administrators listed under INQUIRIES. The general instructions for format, budget issues, etc., in the application packet should be followed except for the following. The Research Plan (Sections A-D) may not exceed 150 pages, and must address the issues 1. through 4. listed below as well as points discussed in the Review Criteria section of this RFA. The budget pages of the application must address points raised under item 6. below. Special Application Requirements 1. Resources a. A detailed description of the facility and its compliance with current Good Manufacturing Practices as put forth by the Food and Drug Administration should be included. Access to animal and virology facilities as well as any necessary computer facilities should be documented. For current FDA guidance related to facilities for gene therapy, contact: Division of Establishment Licensing 1401 Rockville Pike, HFM-205 Rockville, MD 20852-1448 Telephone: (301) 594-2049 For information about Good Manufacturing Practices refer to Title 21 of the Code of Federal Regulations (CFR), sections 210-211 and 610. For information about Good Laboratory Practices refer to the CFR Title 21, section 58. Pertinent portions of the CFR can be ordered from: The Government Printing Office Superintendent of Documents Washington, DC 20402 Telephone: (202) 783-3238 b. Documentation must be provided of the maximum number of vectors that may be produced and maintained simultaneously and per year. 2. Scientific Expertise and Experience in Vector Production a. Documentation of experience in vector production and expertise in virology and molecular genetics should be provided. An understanding of important trends in gene therapy research and incorporation of new technologies in the future should also be documented. b. Documentation should be provided regarding which of the current vector technologies (retroviral, adenoviral, adeno-associated viral, and/or liposome components) will be performed at the facility. A detailed description of vector production methodology should also be provided and should include plans to establish and maintain a master cell bank of a producer cell line. c. Knowledge of, and ability to adhere to, FDA guidelines for quality control and safety testing for microbial contamination, endogenous and recombinant replication-competent retroviruses, and other viral contaminants of vectors at all stages of development and maintenance (including post distribution monitoring) should be outlined. d. Methods of certification of supernatants and final products should be described and outside sources of safety testing should be identified. Human somatic cell gene therapy involves the administration to patients of materials considered biological products, and thus subject to regulation by the Center for Biologics Evaluation and Research (CBER), FDA. Investigational New Drug (IND) applications are filed concerning clinical use of such products. Investigators planning clinical studies in these areas or preclinical and animal studies in support of future applications should inform themselves concerning the types of preclinical studies that are appropriate for such biological products. CBER has prepared a document entitled, "Points to Consider in Human Somatic Cell Therapy (1991)," which provides guidance in this area. Other relevant Points to Consider documents should also be consulted. These may include: "Points to Consider in the Production and Testing of New Drugs and Biological Produced by Recombinant DNA technology (1985);" "Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (1987);" "Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use (1987);" and "Points to Consider in the Collection, Processing, and Testing of Ex- Vivo Activated Mononuclear Leukocytes for Administration to Humans (1989)." Copies of Points to Consider documents are available from: The Division of Congressional and Public Affairs CBER HFM-12 1401 Rockville Pike, Suite 200 N Rockville, MD 20852-1448 Telephone: (301) 594-0830 CBER staff are also available for questions about which types of therapies are covered, for consultation, or for arrangement of pre- IND meetings at (301) 594-0830. 3. Collaborative Abilities a. Applicants should propose detailed plans for how to organize the cooperative resource. The function of the Steering Committee, including its mode of operation and methods of handling quality control and conflicts of interest, should be described. Suggested requirements for access to, and termination of use of, the facilities should be elaborated. Include proposed methods to be used to apply for access to the resources, both to have a vector developed from a gene sequence and to petition to use a vector for clinical studies. Issues of intellectual property and authorship of and plans for publications should be addressed. b. Methods should be proposed for establishing an inventory of vectors and their respective stages of development, as well as procedures for maintaining and distributing products and tracking the status of clinical studies. c. Rules for access to the laboratory should be proposed and the relationship between users and investigators proposing studies defined. d. A description should be provided concerning how the availability of the resource will be made known to the scientific community (e.g., notices of availability in scientific journals, displays at national meetings, etc.). If necessary, costs for these activities should be included in the budget. e. Outside experts will be added to the Steering Committee to balance its composition. Applicants should describe the types of expertise, but not individuals, needed to balance the composition of the Steering Committee. 4. Adherence to Terms of Cooperation a. Because the Terms of Cooperation discussed above will be included in all awards issued as a result of the RFA, it is critical that each applicant include specific plans for responding to these terms. b. Plans should describe clearly how applicants plan to interact with the other awardees involved in the cooperative agreement and describe how they will comply with the involvement of the NIH representatives. c. The expertise required for an effective Steering Committee should be proposed as well as how the Steering Committee would function to identify priorities for accessing the resources. d. Plans should describe the role of the Steering Committee in coordinating activities of the cooperative laboratories, establishing policies and priorities, and reviewing progress. 5. Budget a. Minimal and maximal staffing patterns and budgets for operation must be outlined; the cost of producing, maintaining, and distributing a representative vector being budgeted separately. b. The Program Director of each funded application will be a member of a Steering Committee that will meet three times in the first year and twice in each subsequent year. Travel funds for Steering Committee meetings should be set aside as a budget line item. For planning purposes, either three trips to Washington DC or one East Coast, one West Coast and one Central U.S. trip in the first year may be proposed. c. In addition to travel funds for institutional personnel, funds should be included to support travel by one outside expert (per applicant) to the Steering Committee meeting twice per year, anticipated travel expenses for workshop/seminar participants, plus any additional travel anticipated for Steering Committee members. d. One awardee institution will be designated as the Coordinating Facility and will have responsibility for certain tasks outlined under Responsibilities of Awardees. Each applicant should provide a budget for these tasks, in the event of being designated the Coordinating Facility. The RFA label available in the application form PHS 398 (rev. 9/91) must be affixed to the bottom of the face page. Failure to use label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA number and title must be typed on line 2a of the face page of the application form. Submit a signed typewritten original of the application, including the checklist, and three signed exact, clear, single-sided photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892-4500** At the time of submission, send two additional copies of the application to: Dr. Mary Ann Sestili Director, Office of Review National Center for Research Resources Westwood Building, Room 10A-11 Bethesda, Md 20892 Applications must be received by February 21, 1995. Applications received after this date will be returned. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is 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 responsiveness by NCRR. Applications that are incomplete or unresponsive will be returned to the applicant without further consideration. Applications must adhere to the page limitations and Special Application Requirements noted under the section APPLICATION PROCEDURES above to be considered responsive. 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 Office of Review, NCRR, in accordance with the review criteria stated below. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory councils/boards. 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 Program Director and the official signing for the applicant organization will be notified. Review Criteria Reviewers will be asked to review the grant applications by considering the following criteria: 1. Scientific and technical merit of the proposed activities and organizational plans for implementing the proposed National Gene Vector Laboratories and the extent to which they address the overall goals and objectives of the RFA. 2. Availability and quality of facilities and resources required for this project. 3. Qualifications, experience, and proposed responsibilities of the Program Director and other key personnel. 4. Plans for effective cooperation and coordination among participating awardees and the NIH. 5. Plans for protection of the rights of human subjects and for inclusion of women and minorities and their subgroups as appropriate to the scientific goals of the activity. Reviewers will also judge the appropriateness of the proposed budget and duration for each meritorious application. AWARD CRITERIA The earliest anticipated date of award is August 1, 1995. Awards will be based primarily on the scientific merit, diversity of vector production capability, and programmatic priorities. Some consideration may also be given to geographic diversity. 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: Dorothy D. Sogn, M.D. General Clinical Research Centers Program National Center for Research Resources Westwood Building, Room 10A-07 Bethesda, MD 20892-4500 Telephone: (301) 594-7945 FAX: (301) 594-7929 Email: DorothyS@EP.NCRR.NIH.GOV Inese Z. Beitins, M.D. General Clinical Research Centers Program National Center for Research Resources Westwood Building, Room 10A-03 Bethesda, MD 20892-4500 Telephone: (301) 594-7945 FAX: (301) 594-7929 Email: IneseB@EP.NCRR.NIH.GOV Direct inquiries regarding fiscal matters to: Ms. Mary V. Niemiec Office of Grants and Contracts Management National Center for Research Resources Westwood Building, Room 849 Bethesda, MD 20892-4500 Telephone: (301) 594-7955 FAX: (301) 594-7910 Email: MaryN@EP.NCRR.NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.922. Awards are made under authorization of the Public Health Service Act, Title III, Part A (Public Law 78-410 as amended by public law 99-158, 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52, 45 CFR Part 74 and 45 CFR 92. This program may be subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service 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 Nov 28 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA TW-95-003 - V23(40) 11/18/94 Date: 28 Nov 1994 21:09:38 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 691 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3bed2i$mr0@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA TW95003 TW-95-003 P1O1 *************************************** INTERNATIONAL TRAINING AND RESEARCH IN ENVIRONMENTAL AND OCCUPATIONAL HEALTH NIH GUIDE, Volume 23, Number 40, November 18, 1994 RFA: TW-95-003 P.T. 34, 44; K.W. 0725000, 0725020 Fogarty International Center National Institute of Environmental Health Sciences National Institute for Occupational Safety and Health Letter of Intent Receipt Date: January 16, 1995 Application Receipt Date: April 20, 1995 PURPOSE The Fogarty International Center (FIC) of the National Institutes of Health (NIH), in collaboration with the National Institute of Environmental Health Sciences (NIEHS), NIH, and the National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC), invites applications from non- profit private or public U.S. institutions with interest in developing international training and research programs related to environmental health for foreign health scientists, clinicians, epidemiologists, toxicologists, engineers, industrial hygienists, chemists, and allied health workers from developing countries and emerging democracies. New applications are invited for institutional grant programs in both general environmental health and occupational health. These new programs are named in honor of the late Dr. Irving Selikoff of the Mount Sinai School of Medicine and Dr. Norton Nelson of New York University, in recognition of their lifelong commitment to the training of health professionals in the occupational and environmental health sciences. Dr. Selikoff was internationally recognized and an exceedingly strong proponent of international cooperation in the health sciences. These programs acknowledge the pivotal role of Dr. Selikoff as a founder of the Collegium Ramazinni and its Institute and build upon these efforts to promote international cooperation and collaboration in the fields of occupational and environmental health. Dr. Norton Nelson was internationally recognized for his leadership in the environmental health sciences. He was instrumental in efforts to establish both NIOSH and NIEHS and was widely sought for his advice and expertise. As we look toward the future, it is clear that environmental and worker safety and health research are becoming more and more dependent upon international collaboration. Because of the global magnitude of environmental and occupational health problems, a broad based program of international training and research in environmental and occupational health sciences would have significant benefits both locally in the collaborating countries as well as globally. Such a program is envisioned to cover general environmental health issues such as air and water pollution, hazardous wastes and injury control, as well as issues related to occupational safety and health. Global concerns such as climate change and ozone depletion could also be included among the various curricula offered. A major goal of the International Training and Research in Environmental and Occupational Health Program is to train scientists of other countries to deal effectively with environmental and occupational health through epidemiologic research, environmental monitoring, engineering control and prevention research programs. This program will help to (1) establish the necessary epidemiologic and related research, including engineering and industrial hygiene and medical expertise needed in countries affected by environmental or occupational health problems and facilitate new research efforts which supplement or complement U.S. research and (2) establish cooperative relationships between U.S. and foreign research groups and support cooperation, for example, between U.S. academic research centers and foreign scientists. Collaborations established through this effort will help to facilitate standardized assessment and monitoring of environmental and occupational health hazards and problems and prepare for the coordinated conduct of scientifically valid and ethically sound studies and interventions on an international basis. Applicants are encouraged to relate training to ongoing research efforts in collaborating countries. In this new program substantial emphasis will be placed on chronic disease prevention and the control of injuries. Subjects to be introduced as part of the environmental and occupational health training and research will, for example, include epidemiology, biomechanics, industrial hygiene, planning, design and engineering aspects of worker safety and health, air and water quality engineering, atmospheric chemistry, toxicology, risk assessment, hazardous waste disposal, environmental and occupational health organization and management, delivery of environmental and occupational health services, and evaluation of efficacy and effectiveness of intervention measures. Establishment of this new program will allow the accumulated knowledge and experience of U.S. environmental and occupational health experts to be available to assist and work with their colleagues on a global basis to address common global problems. While the major linkages under this program are expected to be between institutions in the U.S. and those in developing countries and emerging democracies, within allowable limits, research collaborations can include other industrialized nations in addition to the U.S. 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), International Training and Research in Environmental and Occupational Health, is related to the priority areas of environmental health and occupational safety and health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS The grantee institution must be a U.S., non-profit private or public institution capable of meeting the objectives in this RFA. Though most applications are envisioned to be from academic institutions, a non-academic non-profit institution may apply if there is evidence of support through NIEHS or NIOSH programs and that collaborating arrangements exist to satisfy the academic requirements of this RFA. Questions about eligibility and partnerships with colleagues and institutions in the U.S. and overseas should be referred to the individuals listed in this RFA. Only one application will be allowed under this program from each U.S. institution. While the major linkages under this program are expected to be between institutions in the U.S. and those in developing countries and emerging democracies, within allowable limits, research collaborations can include other industrialized nations in addition to the U.S. MECHANISM OF SUPPORT Grants will be made as international training grants in epidemiology (D43) institutional awards for a total project period of five years. Continued support depends on satisfactory performance as judged by annual progress reports, site visits, and meetings of program directors. Types of Training: 1. Training, for example, in epidemiology concepts and methods, environmental monitoring, industrial hygiene, field studies and other research related to environmental and occupational health that will lead to the M.S. or Ph.D. degree for individuals with previous field research experience; 2. Training, for example, in epidemiology, field studies, environmental monitoring, industrial hygiene, and research related to environmental and occupational health that will lead to the M.S. degree for individuals without prior field research experience; 3. Short-term comprehensive courses in epidemiology, toxicology, chemistry, industrial hygiene and environmental and safety engineering, with an emphasis on control of occupational injuries and illnesses, for health and safety professionals to be given in the U.S.; 4. Training in laboratory procedures and research techniques related to environmental and occupational health for individuals with the M.S. or Ph.D. degree to be given in the U.S.; and 5. Postdoctoral research training for foreign scientists who want to expand their abilities in the epidemiology, diagnosis, prevention and treatment of environmental and occupational disease and injury. Postdoctoral training can take place both in the U.S. and in foreign countries. Three other types of training should be offered in-country: 1. Practical and applied short-term training related to environmental and occupational health for professionals, technicians and allied health professionals, including worker health and safety representatives, faculty of worker training facilities and other safety health trainers; 2. Advanced research training for selected current and former trainees to enable them to continue this advanced training in their home country and to participate in in-country research projects. While applicants can plan to include such training (estimated to be of about two years duration) as part of competing applications, individual appointments must be approved in advance as a reprogramming request and be under the guidance of the program director and his or her faculty colleagues. 3. Support to enable U.S. faculty to be involved in advanced research and in training activities conducted in-country. Trainees: Trainees shall be foreign nationals who are not permanent U.S. residents and who are involved in or are expected to be involved in environmental or occupational health research and prevention activities in their home country. The following categories of individuals are eligible for training: 1. Foreign health professionals (M.D., Ph.D., or equivalent); 2. Foreigners with a bachelors or masters degree in a basic, physical, engineering or health science; 3. Technicians, worker safety and health specialists, and health care workers; 4. Professionals such as engineers, chemists and industrial hygienists; and 5. Current or former trainees involved in advanced research training in their home countries. Allowable Costs: U.S. investigators may request funds to support research projects in the trainees' home country that emanate from the M.S. and Ph.D. epidemiological and related training program. The research supported (1) must be one of the requirements in fulfillment of an M.S. or Ph.D. degree or part of research training, (2) be relevant to an environmental or occupational health problem in the trainee's country, and (3) may form the basis for a long term collaboration funded by future research grant support. The following cost categories are eligible for reimbursement under this program. It should be noted that the following stipends and allowances are maximums and applicant institutions are encouraged to design the most cost-effective programs generally at lesser amounts: o Living allowance (stipend) comparable to trainee's professional level and compatible with established NIH guidelines, but not to exceed $45,000 per annum while undergoing training in the U.S.; o Living allowance (stipend) while conducting in-country dissertation research or in-country advanced research training at a level comparable to that received by similar professionals in- country, but also not to exceed $45,000 per annum; o Tuition and fees at the U.S. university; o Round trip economy class air fare between the U.S. and home country (two trips for M.S. or Ph.D. candidates and advanced research trainees, one for all others); o Allowance for the grantee institution of up to $600 monthly per student to cover health insurance, travel to scientific meetings, and incidental research expenses; o Additional research support of up to $15,000 per trainee to facilitate the conduct of advanced research training in the home country conducted by current or former trainees; the program director is expected to have projects submitted for this funding peer reviewed by the U.S. institution; o Support of up to $10,000 for in-country field research in partial fulfillment of the M.S. or Ph.D training program; o Travel and per diem for the program director and U.S. faculty colleagues to provide guidance to students conducting dissertation-related field studies or advanced research training in their home countries; o Program director's salary (up to 10% of annual salary or $10,000, whichever is smaller); o Travel and per diem for U.S. faculty presenting short-term, in- country courses; o Support (travel, per diem and pro-rated salary, up to 10% of annual salary or $10,000, whichever is less), to enable U.S. faculty to be involved in advanced research training activities conducted in- country; and o In keeping with the intent to maintain a flexible program, requests for an administrative supplemental budget will be considered for increases of up to 20 percent of funded levels in a given budget year for the expansion of prior approved activities to meet special needs and take advantage of unusual opportunities. Such requests will be reviewed by program staff and support will depend upon availability of funds. For administrative expenses: o Administrative expenses at the U.S. institution (secretarial expenses, etc.) not to exceed 10 percent of the direct costs of this award. While a portion of salary (up to 10 percent) for the program director for the purpose of administering this award is allowable, it is encouraged that this be provided for under related grants or awards funded by the NIH and CDC. For related activities with other industrialized nations: o Support for travel and subsistence of U.S. or foreign investigator(s), and the exchange of data, materials and supplies, not to exceed 10 percent of direct costs of this award unless prior approval is secured from the FIC. As a condition of this special expenditure, the applicant must indicate that some form of cost- sharing will be provided by the counterpart institution in an industrialized nation. Only one application will be allowed under this program from each U.S. Institution. Grantee institutions may request an indirect cost allowance based on eight percent of the total allowable direct costs exclusive of tuition and related fees and expenditures for equipment. The total allowable cost (direct and indirect) per grant for the first year of this five year award must not exceed $150,000. Applicants should assume a budget increase of four percent per year for each succeeding year. While applicants may develop programs at or close to these limits, they are strongly encouraged to pursue the most cost- effective approaches for implementing these programs. The intent is to award four grants depending upon the quality of the approved grant applications and the availability of funds. As noted above, before any funds can be expended from this award, the grantee institution must show evidence of approval for collaborative research between the U.S. and foreign countries and institutions included in the program through an endorsement from the appropriate government officials as well as from the collaborating institutions. The anticipated date of award is on or before September 30, 1995. FUNDS AVAILABLE Approximately $500,000 (total costs) will be available for this program in FY 1995, reflecting support from the FIC the NIEHS, and the NIOSH. An estimated four awards will be made depending upon the quality of approved applications. It is anticipated that other public and private sector organizations will become collaborators in support of these programs. All collaborators would be so recognized for their contributions which could increase the number of awards made. The total (direct and indirect) cost per grant for the first year must not exceed $150,000. RESEARCH OBJECTIVES The objectives of this program are to train scientists from developing countries and emerging democracies to deal effectively with environmental and occupational health problems through epidemiologic research, environmental monitoring, engineering control and prevention research. Applications that include collaborations with countries in Central and Eastern Europe and Latin America are especially welcome and encouraged. The program is intended to support collaborative research between U.S. and foreign scientists who wish to enhance their knowledge and skills in the epidemiology, diagnosis and prevention of environmental and occupational health problems and to stimulate scientists from nations affected by such problems to cooperate and to share research and practical knowledge in combatting this global problem. This program is intended to complement ongoing environmental and occupational health research and training efforts of the NIH and other agencies of the Public Health Service and the U.S. government. Emphasis will be given to the development of human resources in those countries having or likely to have severe general environmental and occupational health problems. Specifically the program is designed to: o Increase expertise in epidemiology, engineering, and other components of environmental and occupational health through short-and long-term training at U.S. institutions, which may lead to M.S. or Ph.D. degrees in epidemiology, engineering, toxicology, and other related areas; o Increase laboratory expertise of technical assistants in foreign countries who are engaged in epidemiological and other studies related to environmental and occupational health through in- country, short-term, didactical, and technical training; and o Expand ongoing collaborative training and research in environmental or occupational health between U.S. and foreign scientists. SPECIAL REQUIREMENTS The primary effort of the program should be directed toward developing countries and emerging democracies that have, or are likely to have, population groups with a significant incidence of environmentally- and occupationally-related diseases and injuries. Countries in Central and Eastern Europe and Latin America are eligible to participate as are countries in Africa, Asia and the Pacific Region, the Middle East, and the former Soviet Union. The majority of candidates for training will be selected from those countries where the U.S. program director and colleagues either have well established in-country research efforts or a significant potential to develop such collaborative relationships as, for example, through a history of joint collaborations or publications. This does not preclude establishing new collaborative arrangements, for example, in countries or areas where environmentally- and occupationally-related diseases and injuries have not yet developed epidemic proportions. Trainees from industrialized countries may be allowed into the program only under special, well justified circumstances and with prior approval by the FIC as a reprogramming request to meet special training needs to support unique collaborative relationships. As part of proposed training programs, the applicants must describe their training in the responsible conduct of research, consistent with NIH policy (NIH Guide for Grants and Contracts, Volume 21, Number 43, November 27, 1992) to be part of the programs. An award will not be made unless such a description is included. Before any funds can be expended from this award, the grantee institution must show evidence of approval for collaborative research between the U.S. and foreign countries and institutions included in the program through an endorsement from the appropriate government officials as well as from the collaborating institutions. These approvals should be included in the application. The applicant institution must include a plan describing the recruitment and selection procedures for trainees as well as plans for continued collaboration with former trainees. Protection of human subjects and laboratory animals: Applicable provisions for the protection of human research subjects and laboratory animals in research and training activities must be met in both domestic and foreign settings. Title 45 CFR, Part 46, provides guidelines concerning Department of Health and Human Services regulations for the protection of human subjects and the Public Health Service Policy on Humane Care and Use of Laboratory Animals. These are available from the Office for Protection from Research Risks, National Institutes of Health, 6100 Executive Boulevard, Suite 3B01, Rockville, MD 20892. 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 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 (59 FR 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. LETTER OF INTENT Prospective applicants are asked to submit, by January 16, 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 NIH staff to estimate the potential review workload and avoid conflict of interest in the review as well as to provide important information to prospective applicants. The letter of intent is to be sent to: Dr. Kenneth Bridbord International Studies Branch Fogarty International Center 31 Center Drive MSC 2220 Bethesda, MD 20892-2220 U.S.A. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for this grant. These forms are available at most U.S. 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; and from the 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 Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must be sent to: Dr. Ethel B. Jackson Division of Extramural Research and Training National Institute for Environmental Health Sciences Post Office Box 12233 111 Alexander Drive (must include for express delivery) Research Triangle Park, NC 27709 Applications must be received by April 20, 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 responsiveness by the FIC in collaboration with the NIEHS and NIOSH. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, the application will be returned to the applicant without review. 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 NIEHS 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 notified. The second level review will be provided by the FIC Advisory Board in September 1995. The following criteria apply to all applicant institutions. Factors to be considered in the scientific evaluation of each application include: In general, the likelihood that the applicant institution can meet the objectives stated in this RFA and specifically: o The strength of the academic program in environmental and occupational health and depth of the faculty's experience in environmental and occupational health-related basic and physical science and engineering disciplines; o Quality of teaching and research facilities and resources including those at institutions in other countries; o Previous success in training epidemiologists, industrial hygienists and other environmental and occupational health specialists, and in maintaining collaboration with former trainees including assisting former trainees in obtaining support for their research; o The likelihood, based on accomplishments of current and former trainees, that individuals selected for the proposed training will contribute meaningfully to science and health progress following return to their home countries; o Demonstrated support for domestic and international environmental and occupational health, epidemiological and related research and training as evidenced by support from the NIH or other sources. Examples of such support include participation in or collaboration with the NIEHS research and training programs (e.g., environmental health research centers and superfund programs); participation in or collaboration with the NIOSH research and training programs (e.g., Educational Resource Centers, Centers for Agricultural Disease and Injury Research, Education and Prevention and NIOSH individual project training grants); as well as support from other NIH institutes; o Demonstrated capacity or potential to provide in-country research training, which involves support for the research and appropriate guidance for selected, highly qualified current and former trainees; o Demonstrated capacity or potential to help support in-country trials of engineering and other interventions; o Capacity to provide in-country courses and workshops for indigenous technical staff, and worker safety and health specialists, as well as the quality of proposed technical training, including training conducted by former trainees; o Demonstration of continued or future support for the program from governments and institutions and other non-governmental organizations from collaborating countries; and o Demonstrated capacity or potential to coordinate program activities with related efforts of other PHS programs, other federal agencies and international organizations, including the World Health Organization. AWARD CRITERIA The following will be considered in making funding decisions: o quality of the proposed project as determined by peer review; o cost-effectiveness of programs; o availability of funds; o program balance among critical research training areas of emphasis such as, but not limited to, occupational vs. general environmental health, essential industries such as agriculture, construction, mining and transportation; critical problem areas such as air, water pollution or hazardous waste; and vital disciplines such as epidemiology, toxicology, chemistry, industrial hygiene and engineering control technology. o geographic distribution among countries involved in applications under consideration including but not limited to countries in Central and Eastern Europe and Latin America; and o unique collaborative relationships such as affiliations with U.S. and international environmental organizations, U.S. and international worker organizations, U.S. tripartite relations with institutions in developed and developing countries, as well as unique cooperative arrangements involving both labor and management. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome and prospective applicants are strongly encouraged to discuss their proposals with program staff prior to submission. Direct inquiries regarding programmatic issues to: Dr. Kenneth Bridbord International Studies Branch Fogarty International Center 31 Center Drive MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-2516 FAX: (301) 402-2056 Email: sn5@cu.nih.gov Direct inquiries regarding fiscal matters to: Ms. Silvia Mandes International Research and Awards Branch Fogarty International Center 31 Center Drive MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1653 FAX: (301) 402-0779 Email: som@cu.nih.gov AUTHORITY AND REGULATIONS This general type of program is described in the Catalog of Federal Domestic Assistance No. 93.154. 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 to Health Systems Agency review. 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. From owner-sci-resources@net.bio.net Mon Nov 28 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AI-95-002 - V23(40) 11/18/94 Date: 28 Nov 1994 21:10:07 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 579 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3bed3f$mvc@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AI95002 AI-95-002 P1O1 *************************************** TROPICAL MEDICINE RESEARCH CENTERS NIH GUIDE, Volume 23, Number 40, November 18, 1994 RFA: AI-95-002 P.T. 04; K.W. 0715151, 0710030 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: December 19, 1994 Application Receipt: May 16, 1995 PURPOSE The Division of Microbiology and Infectious Diseases (DMID) of the National Institute of Allergy and Infectious Diseases (NIAID) invites applications for multiproject center grants from institutions in geographic areas where tropical infectious diseases are endemic. These centers of excellence, designated as Tropical Medicine Research Centers (TMRCs), will conduct interdisciplinary research on parasitic and other tropical infectious diseases, which will lead to the development, evaluation and deployment of new and/or improved intervention strategies to prevent and control these diseases. The intent of the TMRC program is to bring together relevant biomedical knowledge and technology to develop and evaluate new approaches for the detection, prevention and treatment of infectious diseases of recognized importance to the health of people living in tropical countries. It is envisioned that this program will enhance opportunities for relevant experience in tropical disease research and will promote scientific linkages and interaction between U.S. and foreign investigators. Each TMRC will be included as a component of the NIAID's network of International Centers of Tropical Disease Research (ICTDR). 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), Tropical Medicine Research Centers, is related to the priority areas of immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-782-3238). ELIGIBILITY REQUIREMENTS Organizations and institutions with facilities in or near an area, outside of the United States, where tropical diseases are endemic, are eligible to apply for center grants under this RFA and the research will be carried out in that area. Applications may be submitted by for-profit and non-profit organizations, public and private institutions, such as universities, colleges, hospitals, laboratories and government agencies in the host country. To achieve the goals identified in the application, subcontract or consortium arrangements are permitted with other overseas institutions. It will be necessary for each TMRC to demonstrate a working relationship with the appropriate government organization in the host country. It may also be convenient to develop a collaborative association with an organization such as Pan American Health Organization or the World Health Organization. Only institutions with strong ongoing research programs and resources that can focus on a multidisciplinary approach on tropical infectious diseases will be considered for TMRC support under the provisions of this RFA. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The mechanism of support will be the specialized center (P50) grant. This is a mechanism for the support of any phase of research activities ranging from basic to more applied field and clinical research and development aspects. This research may require ancillary activities such as protracted patient care necessary to support the primary research and/or research and development effort. The spectrum of activities comprises a multidisciplinary attack on a specific disease entity or biomedical problem area. Unless specifically stated to the contrary herein, all policies and requirements that normally govern the grant programs of the PHS will apply. The responsibility for leadership of each TMRC rests with the program director (PD) who must possess demonstrated scientific and administrative competence. The PD should be located at and affiliated with the institution at which the TMRC will reside. The PD must show a substantial commitment of time and effort to the program and exercise leadership in the maintenance of its quality control. If desired, a U.S. Co-PD may be designated. Each TMRC must consist of three or more scientifically meritorious projects whose interrelationships will result in a greater contribution to the program goals than if each project were pursued individually. There must be a unifying, well-defined goal or problem area of research to which each project relates and contributes, thereby producing a research environment that allows each research effort to share the creative strengths of the others. Each research project included in the application must, as assessed by peer review, stand on its own independent scientific merit, as well as complement the other projects whenever feasible. Each of the individual projects within the TMRC should be under the leadership of an established investigator who would be the principal investigator (PI) for the specific project. These multiple projects require the participation of investigators in several disciplines with special expertise in several areas of one discipline. All investigators must contribute to, and share in, the responsibilities of fulfilling the objective of the TMRC. Support for certain common resources (cores) may also be requested. Such resources (e.g., laboratory or clinical service facilities) should be utilized by two or more projects within the TMRC when such sharing facilitates the total research effort. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total requested period of support may not exceed five years. At this time, the NIAID is administratively limiting the duration of center grants to four years; this administrative limitation may change in the future. These P50 applications should not request budgets in excess of $550,000 total costs in the first year. Currently, NIAID awards no more than four percent annual inflationary increases for future years. It is the policy of the Public Health Service that indirect costs will not be paid to organizations located outside of the territorial limits of the United States. The earliest anticipated award date is April 1996. FUNDS AVAILABLE The estimated total funds available for the first year of support for this RFA will be $1.6 million. In fiscal year 1996, the NIAID plans to fund approximately three center grants related to this RFA. 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 grant will be contingent upon satisfactory scientific progress during the preceding years and availability of funds. Satisfactory progress will be assessed by NIAID staff, including their review of material presented in annual reports. At this time, the NIAID has not determined whether or how this solicitation will be continued beyond the present RFA. RESEARCH OBJECTIVES Background Infectious diseases represent a tremendous public health threat for people living in tropical and subtropical regions of the world and are responsible for limiting individual productivity and socioeconomic development. It is estimated that 20 percent of the world's population carries a helminthic parasite infection, and that 10 percent are infected with those parasites causing malaria, schistosomiasis, filariasis, leishmaniasis or trypanosomiasis. Enteric infections, caused by viruses, bacteria and protozoa, as well as mycobacterial infections, especially leprosy and tuberculosis, are responsible for immeasurable global morbidity and mortality. Childhood mortality rates in tropical developing countries are at least ten times higher than those in industrialized countries. This difference is to a large extent attributable to the prevalence of diarrheal and acute respiratory diseases. The magnitude of many tropical disease problems in endemic areas is increasing, due to changing ecological patterns and to the failure of currently available control measures, e.g., as a result of microbial drug resistance. Moreover, tropical diseases are of increasing global concern as tourism, trade, business travel, immigration and military activities extend the range of infectious agents and invertebrate vectors. An Institute of Medicine committee articulated these issues in its report entitled Emerging Infections: Microbial Threats to Health in the United States (National Academy Press, Washington DC, 1992) and recommended the support of increased research efforts on surveillance and applied disease control strategies. The report specifically identified expanding research efforts on diagnostics, vaccines, antimicrobial drugs and vector control. Advances in biomedical technology are opening up exciting possibilities for the development of vaccines, chemo- and immunotherapeutics, and transmission control methodologies for all the major tropical diseases. For example, there are now multiple defined antigens that have been shown to induce protective immunity in laboratory animals, which require further preclinical and clinical research to evaluate their vaccine potential. In addition, the use of cytokines as adjuvant therapy for infectious diseases is showing great promise in animal models. The need for sustained research support in these areas has never been greater, especially for those clinical and field efforts dependent upon access to populations of pathogens, patients and invertebrate vectors. The NIAID has long been the lead Federal agency for support of research and training on tropical infectious diseases, funding the development of new control strategies through a combination of investigator-initiated grants and special Institute-initiated programs designed to encourage more application-oriented work. In 1991, NIAID established a competitive program to fund institutions, in endemic areas, to carry out research on tropical diseases. The TMRC program was initiated to support the infrastructure and expertise necessary to develop and assess new approaches to the control of complex tropical infectious disease problems. Currently there are three TMRCs. Scope of Research The research to be supported by this RFA will focus on those infectious diseases primarily endemic in or which profoundly impact upon people living in the tropics. Diseases of interest include, but are not limited to, those resulting from infection with protozoa and helminth parasites, enteric bacteria and viruses, mycobacteria and arboviruses. Emphasis is placed on those diseases for which recent discoveries and developments, leading to new and/or improved control strategies, require facilities and infrastructure for further testing and evaluation in the field and in the clinic. Studies of human immunodeficiency virus (HIV) infections in developing countries are supported by other NIAID activities, and will not be considered in response to this solicitation. Studies of the impact of HIV infection on the clinical course and outcome of other tropical diseases and on control programs for these diseases will, however, be considered. Each TMRC should organize a multidisciplinary research effort that will bring together relevant biomedical knowledge and technology to achieve a greater understanding of the world's tropical infectious diseases and to develop and test new intervention strategies for these diseases. Relevant research activities for each TMRC may include projects on clinical, epidemiological and field aspects of tropical diseases as well as on supportive basic research areas related to the biology of host-infectious agent interactions, utilizing such disciplines as genetics, immunology, pharmacology, bacteriology, virology, parasitology and medical entomology. The goals of the research projects should be the development and evaluation of diagnostic tests, immunotherapeutic and immunoprophylactic measures, chemotherapeutic and chemoprophylactic methods, and vector control strategies as well as other approaches that may be deployed as part of disease control programs relevant to national control efforts on these diseases. Projects may involve collaboration among investigators at several institutions. Consortium arrangements should follow the NIH Guide outlined in "Guidelines for Establishing and Operating Consortium Grants, January 1989." These are available from the program staff listed under INQUIRIES. SPECIAL REQUIREMENTS Research at the applicant institution in the endemic area will be supported directly by NIAID. Fiscal and administrative arrangements for the transfer of funds and materials to the applicant institution and for the management of these funds and materials must be described in the application. Travel, salaries and fringe benefits will be subject to the applicant institution's rules and regulations. Successful TMRCs will be designated as components of the NIAID International Centers for Tropical Disease Research (ICTDR), which constitutes a network of NIAID-supported activities in tropical diseases (see Appendix). Each TMRC program director will represent his/her TMRC at the annual meeting of the ICTDR network organized by NIAID. These meetings will be held to share advances in tropical disease research among the TMRC projects and other NIAID-supported tropical disease research programs and activities, to discuss research needs and opportunities in this arena, and to facilitate the development of new collaborative protocols that may include multi- center studies. Provision should be made for the TMRC Program Director to travel to the annual meetings of the NIAID ICTDR network to be held in the Washington, DC area and generally lasting three days. Such anticipated travel costs should be identified in advance and built into the budget of the TMRC application. Other TMRC personnel are encouraged, but not required, to attend the ICTDR meetings, and travel support will be at their own discretion. Applications must also include a Visiting Investigator component, which should be described as a separate Core constituent. Under the terms of this Core, provision will be made by the TMRC for visiting investigators to spend up to one year in residence to study tropical disease problems of their own interest or participate in ongoing programs of the TMRC. This provision is intended to afford opportunities for tropical disease research experience at the TMRC primarily to U.S. scientists, although non-U.S. scientists may be eligible as conditions permit. The application should detail: the facilities available at the applicant institution to host visiting investigators, the procedures to be used to advertise the program and to recruit such visiting investigators, and the method by which their research projects will be evaluated and approved. Those selected will require the approval of NIAID program staff. Funds allotted to the visiting investigator core should not exceed $50,000 per year to cover the anticipated costs of travel, supplies, and salary. Funds initially designated for this core are restricted for this purpose and cannot be rebudgeted to other programs within the Center. Applicants must be aware of policies and procedures for the conduct and oversight of clinical research studies and of clinical trials. NIH defines all biomedical and behavioral research involving human subjects as clinical research. For the purposes of NIH policy, a clinical trial is defined as a broadly based prospective phase III clinical investigation that is designed to evaluate an experimental intervention in comparison with a standard or control intervention or to compare two or more existing treatments. NIAID's Division of Microbiology and Infectious Disease has developed guidelines for the establishment, responsibilities and operating procedures of data safety and monitoring boards (DSMBs) for clinical trials. A copy of these guidelines is available from Dr. Michael Gottlieb at the address listed under INQUIRIES. Applications must include details for the implementation of these guidelines where relevant in the proposed studies. Recent advances in satellite remote sensing technology and in computerized geographic information systems (GIS) have been applied to the study of infectious diseases and their distribution. These tools have provided predictive data for such purposes as identifying geographic areas where there is an increased risk of vector-borne disease transmission. Investigators seeking to employ remote sensing in their studies of tropical diseases should clearly indicate this fact in the application. In this regard, applicants should prepare a separate budget indicating the funds and resources required for the conduct of such studies. This budget should be clearly identified and should not be considered as part of the $550,000 limit indicated above. Applicants are strongly encouraged to contact Dr. Michael Gottlieb at the address listed under INQUIRIES for more information and assistance. 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. The NIH policy on inclusion of women in research conducted outside the U.S. is the same as that for research conducted in the U.S. With regard, however, to the population of the foreign country, the definition of the minority groups in foreign countries may be different than in the U.S. If there is a rationale for examining subpopulation group differences within the foreign population, investigators should consider designing their studies to accommodate these differences. 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 of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from Dr. Gottlieb at the address listed in INQUIRIES below, who may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by December 19, 1994, 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. Prospective applicants are also asked to submit a list of the key investigators and their institution(s). Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID 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 Applications are to be submitted on form PHS 398 (rev. 9/91), the standard application form for research grants. 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. Applicants must adhere to the format and requirements specified in the PHS 398 application kit. In addition, applicants for multicomponent grants are strongly advised to read the information brochure "NIAID Program Project Grants and Multiproject Cooperative Agreements," available from Michael Gottlieb at the address listed under INQUIRIES. For purposes of identification and processing, mark "YES" in item 2a on the face page of the application and type in the RFA number AI-95-002 and the title "TROPICAL MEDICINE RESEARCH CENTERS." 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. The signed, typewritten original of the application, including the Checklist, and three exact single-sided copies must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application and all five sets of appendices must also be sent to Dr. Olivia Preble at the address listed under INQUIRIES. To ensure their review, applications must be received by both the Division of Research Grants and Dr. Olivia Preble by May 16, 1995. Applications not received by May 16, 1995 will be considered non- responsive and will be returned to the applicant without review. Current NIH policy permits a component research project of a multi- project grant application to be concurrently submitted as a traditional individual research project (R01) application. If, following review, both the multi-project application and the R01 application are found to be in the fundable range, the investigator must relinquish the R0l and will not have the option to withdraw from the multi-project grant. This is an NIH policy intended to preserve the scientific integrity of a multi-project grant, which may be seriously compromised if a strong component project(s) is removed from the program. Investigators wishing to participate in a multi- project grant must be aware of this policy before making a commitment to the Principal Investigator and awarding institution. REVIEW CONSIDERATIONS Review Procedures Applications will be reviewed by DRG staff for completeness and by NIAID staff to determine administrative and programmatic responsiveness to this RFA. Those judged to be incomplete or non- responsive will be returned to the applicant without review. Those considered complete and responsive may be subjected to a triage review by an NIAID peer review group to determine their scientific merit relative to the other applications submitted in response to this RFA. The NIAID will withdraw from competition those applications judged by the triage peer review group, before or during the initial review group meeting, to be noncompetitive for award and will so notify the applicant investigator and the institutional business official. For applications found non-competitive, summary statements will be very brief and will generally contain unedited reviewers' comments, indicating the major reason(s) for the non- competitive rating. Those applications judged to be competitive for award will be 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 review criteria for P50 center grant applications are the same as review criteria for large, multicomponent, interdisciplinary program projects as outlined in the brochure, NIAID PROGRAM PROJECT GRANTS AND MULTIPROJECT COOPERATIVE AGREEMENTS. The distinguishing features of a multiproject center grant include: o A unifying well-defined goal or problem area of research to which each project relates and contributes, thereby producing a research environment that allows each research effort to share the creative strengths of others. o A program director who possesses recognized scientific and administrative competence; he/she must show a substantial commitment of time and effort to the center and exercise leadership in its quality control. o Each research project must, as assessed by peer review, stand on its own independent scientific merit, as well as complement other projects whenever feasible. o These multiple projects require the participation of established investigators in several disciplines, or investigators with special expertise in several areas of one discipline. All investigators must contribute to and share in the responsibilities of fulfilling the center's objective. In addition, the following criteria will be considered in the scientific review of the application: o Relevance of research approach, design, and methodology to the development and evaluation of intervention strategies for the control of tropical diseases. o Adequacy of appropriate facilities for laboratory, field and clinical studies. In studies involving clinical trials, this includes adequacy of procedures for the establishment and operation of a DSMB. o Mechanisms proposed for the visiting investigator component. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program needs and balance, and the availability of funds. It is the desire of NIAID to fund a group of applications that together will provide a broad spectrum of research opportunities for the development, evaluation and deployment of intervention strategies for the control of tropical infectious diseases. INQUIRIES Written, telephonic, and electronic inquiries concerning this RFA are strongly encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Requests for the NIAID Information Brochure "NIAID Program Project Grants and Multiproject Cooperative Agreements" and for the new "NIH GUIDELINES FOR INCLUSION OF WOMEN AND MINORITIES AS SUBJECTS IN CLINICAL RESEARCH" as well as inquiries regarding programmatic issues may be directed to: Michael Gottlieb, Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A12 6003 Executive Boulevard Bethesda, MD 20892-7630 Telephone: (301) 496-7115 FAX: (301) 402-0804 Email: mg35s@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: Olivia Preble, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C20 6003 Executive Boulevard Bethesda, MD 20892-7610 Telephone: (301) 496-8208 FAX: (301) 402-2638 Email: op2t@nih.gov Direct inquiries regarding fiscal matters to: Ms. Leslie Marsden Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B35 6003 Executive Boulevard Bethesda, MD 20892-7610 Telephone: (301) 496-7075 Email: leslie_marsden@exec.niaid.pc.niaid.nih.gov Schedule Letter of Intent Receipt Date: December 19, 1994 Application Receipt Date: May 16, 1995 Scientific Review Date: October 1995 Advisory Council Date: February 1996 Earliest Date of Award: April 1996 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.856 - Microbiology and Infectious Diseases 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 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. From owner-sci-resources@net.bio.net Mon Nov 28 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AA-95-001 - V23(40) 11/18/94 Date: 28 Nov 1994 21:09:57 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 588 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3bed35$msg@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AA95001 AA-95-001 P1O1 *************************************** HEALTH SERVICES RESEARCH ON ALCOHOL-RELATED PROBLEMS NIH GUIDE, Volume 23, Number 40, November 18, 1994 RFA: AA-95-001 P.T. 34; K.W. 0404003, 0730050 National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: February 6, 1995 Application Receipt Date: March 21, 1995 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks health services research and research training grant applications that are aimed at developing a knowledge base to improve the efficiency and effectiveness of services for alcohol-related problems. Such a knowledge base includes both treatment and preventive interventions. This Request for Applications (RFA) invites research applications related to improving the availability, accessibility, delivery, quality, cost effectiveness, impact, and outcomes of alcohol-related treatment and prevention services. The research objectives include, but are not limited to, four major areas: (1) determining impacts of financing and reimbursement mechanisms on alcohol-related health care program availability, accessibility, delivery, organization, content, quality, and outcomes; (2) assessing sources of variation in the utilization and cost of treatment services and prevention interventions for alcohol- related problems; (3) identifying and assessing the effectiveness and outcomes of alcohol-related treatment and preventive services; and (4) identifying factors that influence the organization, management, and delivery of treatment and prevention services for alcohol-related problems across regions, populations, and settings. 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 Services Research on Alcohol-Related Problems, is related to the priority areas of alcohol abuse reduction and alcoholism treatment. 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. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards or Institutional Research Training Grants (T32). MECHANISMS OF SUPPORT Research support may be obtained through applications for a regular research project grant (R01) or FIRST (R29) award. Applicants may also submit Investigator-Initiated Interactive Research Project Grants (IRPGs) under this RFA. Interactive Research Project Grants require the coordinated submission of related regular research project grant applications and, to a limited extent, FIRST award applications from investigators who wish to collaborate on research, but do not require extensive shared physical resources. The NIAAA also seeks to increase the pool of health services researchers who have expertise in the alcohol field. The NIAAA encourages interested institutions to undertake programs of research training and career development in the area of alcohol-related health services research. Under this RFA, up to $250,000 has been targeted to award one or two Institutional Research Training Grants (T32). A copy of the NIH announcement for National Research Service Awards for Institutional Research Training Grants, as published in the NIH Guide for Grants and Contracts, Vol. 23, No. 21, June 3, 1994, may be obtained from the program staff listed under INQUIRIES. Potential applicants may obtain copies of other NIAAA announcements from the National Clearinghouse for Alcohol and Drug Information, P.O. Box 2345, Rockville, Maryland, 20852, telephone: 301-468-2600 or 1-800-729-6686. Further information on grant mechanisms and areas of research interest may be obtained from the program staff listed under INQUIRIES. FUNDS AVAILABLE It is estimated that up to $4 million will be available for approximately 16 grant awards under this RFA in FY 1995. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. The NIAAA estimates that the average grant size will be approximately $250,000 in total costs for the first year. Although the financial plans of NIAAA provide for the support of this program, the award of grants pursuant to this RFA is contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES In June 1992, "The ADAMHA Reorganization Act" (Public Law 101-321) directed NIAAA to expand its program of health services research. Health services research is defined in the legislation as "research endeavors that study the impact of the organization, financing and management of health services on the quality, cost, access to and outcomes of care" (Section 409). Health services research also is concerned with identifying factors that influence the effectiveness of health services in "real world" settings. This RFA invites research grant applications related to understanding and improving the financing, utilization, effectiveness, and organization of health services for the prevention and treatment of alcohol-related problems. For the purposes of this RFA, health services research includes: (a) the assessment of the impact of health services and the effects of organizational and financing arrangements in "real world" clinical settings on the quality and outcomes of care provided to patients with alcohol abuse and alcoholism or with medical problems consequent to alcoholism and (b) the assessment of the effectiveness of prevention services as well as their financing, organization, management, implementation, cost, and utilization. As directed by subsequent legislation (P.L. 103-43), for the purposes of this RFA health services research does not include studies of the efficacy of specific preventive, diagnostic, and treatment services where the analysis is directed at the individual as distinct from the service system. Applications whose main objective is to establish and support treatment or prevention services are not eligible for funding under this RFA. Support for research-related treatment, rehabilitation, or prevention services and programs may be requested only for those particular costs and for that period of time required by the research. These costs must be justified in terms of research objectives, methods, and designs that promise to yield important generalizable knowledge and/or to make a significant contribution to theoretical concepts. Applicants should adopt the most carefully controlled and rigorous research designs feasible in conducting treatment and prevention services research and studies (see Lettieri 1992; Sechrest, Persin, and Bunker 1990; Cook and Campbell 1979). As elaborated in the "Review Criteria" section of this RFA, applications will judged on the basis of the scientific and technical merit of the proposed research as well as on the adequacy and appropriateness of the proposed methodology. Applicants may wish to consult generic publications in health services research as well as alcohol-specific examples of prevention and treatment research. The following list of research topics is for illustrative purposes. Topics not mentioned below that fall within the research objectives of this RFA will also be accepted. Financing and Reimbursement of Services o Investigating the impact of innovative financing and reimbursement approaches on the quality, cost effectiveness, and supply of alcohol treatment and/or prevention services as well as demand for and barriers to those services. o Assessing how alternative managed care systems affect availability, quality, cost, and outcomes of treatment and prevention services. o Developing uniform ways to measure insurance benefits and payments for treatment and prevention of alcohol-related problems in order to compare performance of alternative health plans. Alcohol-related problems include medical consequences of alcohol abuse and alcoholism such as alcohol poisoning, or cardiovascular, gastrointestinal and/or neurological disorders. o Identifying the impacts of changes in compensation incentives on: the behavior of consumers, clinicians, and institutions; treatment appropriateness and outcomes; and the nature and extent of prevention services within the health care system. o Modelling and assessing impacts of health care reform legislation and other policy changes on the organization, management, financing, availability, appropriateness, and cost of alternative alcohol-related health policies and treatment/prevention services. Utilization and Cost of Services o Identifying health service factors and individual characteristics influencing access to, or compliance with, treatment or preventive interventions for alcohol-related problems (including symptomatic medical problems), particularly among underserved, uninsured, and HIV-infected populations. o Identifying care-seeking behavior of people with alcohol problems, including utilization of informal resources (e.g., self-help groups) and alternative (e.g., acupuncture) health resources as well as general medical and specialty alcohol services. o Developing standardized criteria for identifying episodes of alcohol treatment to apply in longitudinal analyses of cost and utilization data. o Determining whether or not prevention programs have significant effects on the utilization and cost of treatment services. o Determining the extent to which costs of treatment or prevention services are offset by subsequent reductions in health care costs. For example, evaluating characteristics of individuals, programs, service systems, and insurance benefits associated with greater cost offsets and cost effectiveness. Effectiveness and Outcomes of Services o Developing and assessing criteria to classify and measure objectives, components, and processes involved in delivering major types of treatment services or prevention interventions for alcohol- related problems; examining linkages between treatment content, quality of care, and functional as well as alcohol-specific outcomes; and examining linkages (e.g., process evaluations) between prevention content, its method of delivery, and alcohol outcomes. o Assessing the effectiveness of brief interventions to treat or prevent problem drinking and its medical and social consequences. Health services treatment research may assess brief interventions in inpatient or outpatient acute and specialty as well as primary care settings. o Assessing adequacy and appropriateness of treatment and prevention services to meet needs and demands of different groups such as women, youth, minorities, rural residents, and the elderly. o Determining the impact of organization, financing, and management on the effectiveness of research-based treatment and prevention interventions when they are delivered to heterogeneous populations in natural rather than experimental settings. o Developing classification or measurement systems for use by clinicians to better assign patients to treatment modalities or to improve outcomes, particularly prevention and management of post- treatment relapse. o Applying cost effectiveness research to estimate the costs and effectiveness of particular alcohol-related health services (including treatment and prevention) from the perspective of consumers or their families as well as from the perspectives of payers, providers, or employers. o Assessing the effects of participation in Alcoholics Anonymous on treatment utilization, outcome, and cost. Service System Delivery, Organization, and Management o Examining organization and management of alcohol treatment and prevention services, including social, economic, demographic, geographic, legal or health policy, and other factors that may facilitate or impede effective and efficient linkage and delivery of those services. o Determining the impact of system-level, service integration initiatives on the coordination, comprehensiveness and continuity of alcohol treatment and prevention services. o Identifying different organizational models needed for delivery of alcohol treatment and prevention services to different subpopulations such as the elderly, youth, women, minorities, rural residents, or HIV-positive individuals. o Developing and testing innovative management approaches to improve productivity and efficiency in implementing treatment and prevention services. o Examining organizational, provider, and consumer responses to changes in the following areas: (a) financing and reimbursement policies, (b) structural aspects of managed care systems, (c) insurance coverage characteristics of populations in the service area, (d) number and characteristics of other organizations and providers in the area, and (e) demographic factors such as population density, and/or other factors that may lead to changes in organizational and provider behavior with ultimate consequences for access to and outcomes of treatment and prevention services. o Investigating factors that influence how preventive interventions or treatment services reach the appropriate target populations; are distributed to be accessible to those populations; are utilized in an effective manner; are adopted with sufficient commitment from policy makers to make them viable; and are implemented with adequate resources. 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 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 February 6, 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 NIAAA 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: Mark Green, Ph.D. Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Willco Building, Room 409 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4375 FAX: (301) 443-6077 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 NIAAA 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 and number must be typed on line 2a of the face page of the application form and the YES box must be marked. Applicants for support mechanisms other than R01 (i.e., T32 or R29) must cite the relevant program announcement on line 2a in addition to listing the current RFA. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Page limits and limits on size of type are strictly enforced. Non- conforming applications will be returned without being reviewed. Applicants from institutions that have a General Clinical Research Center (GCRC), funded by the NIH Division of Research Resources may wish to identify the Center 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 in the application material. Submit a signed, typewritten original of the application, including the checklist, and three signed, photo copies in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to Dr. Mark Green at the address listed under LETTER OF INTENT. Applications must be received by March 21, 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 by the NIAAA. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, DRG staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications 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 NIAAA 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 notified. The second level of review will be provided by the National Advisory Council on Alcohol Abuse and Alcoholism. Review Criteria Criteria to be used in the scientific and technical merit review of alcohol-related health services research grant applications will include the following: 1. The scientific, technical, health or medical significance, and originality of the proposed research to alcohol-related health services and the goals of this RFA. 2. The appropriateness and adequacy of the research design and methodology proposed to carry out the research. 3. The adequacy of the qualifications (including level of education and training) and relevant research experience of the principal investigator and key research personnel. 4. The feasibility of implementing the project (including recruitment of subjects, implementation of the intervention or innovation, cooperation of relevant organizations, and/or availability and quality of necessary data). 5. The availability of adequate facilities, general environment for the conduct of the proposed research, other resources, and collaborative arrangements necessary for the research. 6. The appropriateness of budget estimates and duration in relation to the proposed research. 7. 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 subjects and the safety of the research environment. The review criteria for FIRST Awards (R29) are contained in the FIRST program announcement (revised February 1994). The review criteria for Institutional Research Training Grant (T32) applications are contained in the NIH program announcement for National Research Service Awards for Institutional Research Training Grants dated June 3, 1994. AWARD CRITERIA Applications recommended for approval by the National Advisory Council on Alcohol Abuse and Alcoholism will be considered for funding on the basis of the overall scientific and technical merit of the application as determined by peer review, NIAAA programmatic needs and balance, and the availability of funds. NIAAA is interested in maintaining a portfolio of research activities that is balanced among the four major issues described in the RESEARCH OBJECTIVES section of this RFA. In order to expedite the achievement of such balance, special consideration will be given to applications that focus on: (a) Financing and Reimbursement of Services or (b) Service System Delivery, Organization, and Management. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct general inquiries regarding health services research to: Robert B. Huebner, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0786 FAX: (301) 443-8774 Email: bhuebner@willco.niaaa.nih.gov Direct inquiries regarding health services treatment research to: Harold I. Perl, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0788 FAX: (301) 443-8774 Email: hperl@willco.niaaa.nih.gov Direct inquiries regarding health services prevention research to: Michael Hilton, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-8753 FAX: (301) 443-8774 Email: mhilton@willco.niaaa.nih.gov Direct inquiries regarding health services epidemiologic research to: Harold Yahr, Ph.D. Division of Biometry and Epidemiology National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 594-6230 FAX: (301) 443-8614 Email: hyahr@willco.niaaa.nih.gov Direct inquiries regarding research training and career development opportunities to: Frances Cotter, M.P.H. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1207 FAX: (301) 443-8774 Email: fcotter@willco.niaaa.nih.gov Direct inquiries regarding fiscal matters to: Linda Hilley Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0915 FAX: (301) 443-3891 Email: lhilley@willco.niaaa.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.273. Awards are made under the authorization of the Public Health Service Act, Sections 301 and 464H, and administered under the PHS policies and Federal Regulations at Title 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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. References Cook, T.D. and Campbell, D.T. Quasi-Experimentation: Design and Analysis Issues for Field Settings. Boston: Houghton Mifflin, 1979. Lettieri, D.J. A Primer of Research Strategies in Alcoholism Treatment Assessment. DHHS Pub. No. (ADM) 92-1882. Rockville, MD: National Institute on Alcohol Abuse and Alcoholism, 1992. Sechrest, L.; Persin, E.; and Bunker, J., eds. Research Methodology: Strengthening Causal Interpretations of Nonexperimental Data. DHHS Pub. No. (PHS) 90-3454. Rockville, MD: Agency for Health Care Policy and Research, 1990. From owner-sci-resources@net.bio.net Mon Nov 28 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DE-95-001 - V23(40) 11/18/94 Date: 28 Nov 1994 21:10:27 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 663 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3bed43$n1u@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA DE95001 DE-95-001 P1O1 *************************************** ORAL HEALTH RESEARCH CLINICAL CORE CENTERS NIH GUIDE, Volume 23, Number 40, November 18, 1994 RFA: DE-95-001 P.T. 04; K.W. 0715148, 0755030, 0765033, 0785055, 0745027 National Institute of Dental Research Letter of Intent Receipt Date: January 13, 1995 Application Receipt Date: June 13, 1995 PURPOSE The National Institute of Dental Research (NIDR) invites grant applications for the support of Oral Health Research Clinical Core Centers (OHRCCCs). The primary goal of these centers is to enhance the nation's oral health clinical research capability and, thereby, facilitate the transfer from the laboratory to the clinic of fundamental knowledge of the etiology, pathogenesis, epidemiology, prevention, diagnosis and treatment of oral diseases and dysfunctions. This Request for Applications (RFA) consolidates under one umbrella and announces the first recompetition of all the NIDR clinical core center programs. 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, Oral Health Research Clinical Core 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 "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply. However, domestic applications may include international components. Applications with key personnel such as center directors or principal investigators who are minority individuals and/or women are encouraged. Although an application must be submitted from a single institution, it may include consortia arrangements with other institutions. Applicant institutions must provide clear evidence of having a suitable clinical research base to ensure appropriate utilization of the added resources that the NIDR would provide through the OHRCCC. This must include meritorious ongoing clinical research projects and/or the capability to develop such clinical research. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) center core grant (P30). 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. Subsequent support will be contingent upon program needs and availability of funds. The total project period for applications submitted in response to the present RFA must be five years. The earliest possible award date will be December 1, 1995. In addition to support for pilot and feasibility studies, support will be provided for shared resources and facilities (core units), the sharing of which will facilitate the total research effort. Each core unit must be utilized by at least two projects. Applicants must limit their requests to not more than $300,000 direct costs for the initial budget period. Where indirect costs are assigned to a subcontract and counted as direct costs, the direct cost maximum of $300,000 may be exceeded by the amount of the indirect costs assigned to the subcontract. Budget increases of no more than four percent per year for recurring costs may be requested for each of the subsequent four years. Included in the direct cost maximum of $300,000 are funds with a limit of $45,000 for the support of specified pilot and feasibility studies, each of which must not exceed $20,000 in direct costs per year and may last for a maximum period of two years. Applications that exceed these limits will be returned without review. Pilot and feasibility studies are the only research projects that will be directly supported by this mechanism. The OHRCCC will not provide direct funding for ongoing research projects. These must be funded through other sources or support mechanisms. FUNDS AVAILABLE It is anticipated that up to four to five awards will be made and up to $2,250,000 in total costs will be committed for the first year of support for the entire program, if a sufficient number of applications of high scientific merit are received. The receipt of three competing continuation applications is anticipated. These applications will compete for the awards along with other applications received in response to this RFA. 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 are encouraged to seek additional support from other public sources and private sector sources, including foundations and industrial concerns, for activities, including information transfer and outreach programs, that will complement and expand the OHRCCCs. A summary of the objectives and financial support for such activities must be included in the application. RESEARCH OBJECTIVES Background Establishment of the NIDR's Clinical Research Core Centers program was recommended by an expert panel and highlighted in a 1985 report, requested by Congress, on NIDR's use of the center and other large grant mechanisms. A number of additional advisory groups, including the National Advisory Dental Research Council, have reaffirmed the need for expansion in clinical research and the use of core centers to expedite the translation of new knowledge from the laboratory to the clinic. The NIDR initiated this program on October 20, 1989 by issuing an RFA on Clinical Dental Research Core Centers (CDRCCs). The primary goal of these centers was to facilitate clinical research relevant to the pathogenesis, diagnosis, early detection, prevention, control and treatment of oral diseases and dysfunctions. The intent of this program was to provide the resources and facilities necessary to develop and to conduct clinical research at the level of sophistication necessary to expedite the translation of basic scientific knowledge into new and better methods for improving the oral health of the nation. Two CDRCCs were funded on September 30, 1990. A second RFA on Clinical Core Centers for Oral Health Research (CCCOHR) was issued by NIDR on January 4, 1991. This type of center was intended to facilitate and stimulate clinical research to improve oral health in adults, senior citizens, and other groups at high risk for oral diseases. Such groups include individuals with systemic diseases (e.g., diabetes), undergoing medical treatments (e.g., chemotherapy or radiation), or having oral conditions (e.g., xerostomia) that increase the risk for oral diseases or tooth loss, and rural residents and members of minority groups who have not shared the gains in oral health seen in many segments of the U.S. population. One CCCOHR was funded on September 15, 1991. Another major objective of the clinical research core center programs was to encourage expanded funding from other public and private sector sources (e.g., industry, foundations, or other government agencies) for both ongoing and new clinical research projects utilizing the center core units, thereby contributing to the cost- effectiveness of these centers. In addition to support for core units, funds were available for pilot and feasibility studies. Moreover, it was expected that the applicant institution would have ongoing clinical research projects and/or the potential to develop, through complementary non-NIDR funding, clinical research projects which would utilize the core units. Preliminary data suggest that considerable progress already has been made toward the original goals of the existing centers. Highlights of progress include success in attracting substantial funds and in- kind contributions from other public and private sector sources, establishment of one or more training courses in clinical research methodology, and contributions to several significant research advances. The present RFA on OHRCCCs consolidates under one umbrella and announces the first recompetition of the original clinical research core center programs. Center Goals and Scope The primary goal of the OHRCCCs is to provide the shared resources and facilities necessary to develop and to conduct clinical research at the level of sophistication necessary to expedite the translation of basic scientific knowledge into new and better methods for improving the oral health of individuals of all ages and of all segments of the U.S. population irrespective of the afflicting oral disease or dysfunction. The centers, thereby, are intended to: provide nuclei around which additional clinical studies, funded through government or private sources, can be conducted; encourage increased collaboration among the various disciplines of oral health clinical research and among basic and clinical scientists with expertise relevant to this initiative; and serve as magnet organizations to foster productive research-related relationships with other institutions. The secondary goal of the OHRCCCs is to foster the development of clinical research scientists at all levels of career development by providing improved opportunities for collaboration and expanded environments for clinical research. The clinical research supported by these centers must be relevant to the attainment of the NIDR's objectives. Research areas of interest include, but are not limited to: the epidemiology, etiology, pathogenesis, diagnosis, prevention and treatment of dental caries, periodontal and soft tissue diseases, oral cancer and manifestations of AIDS, salivary gland disorders, craniofacial anomalies and orofacial pain; trigeminal neurobiology; the relationship of behavioral, social, economic and cultural factors to oral diseases; biomaterials, pulp biology and implants; the role of fluoride and nutrition in oral health and disease; and clinical research to improve oral health in the elderly, women, minorities, and other groups at high risk for oral diseases. Center Characteristics Each OHRCCC must be a clearly defined organizational entity within a dental school or dental 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. OHRCCC directors will be responsible for the organization and operation of the centers and for communication with the OHRCCC 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 OHRCCC scientists. It is essential that the various elements of the OHRCCC be interrelated and that their utilization facilitates an enhanced quality and quantity of clinical oral health research. Funding of an OHRCCC is intended to support shared resources and facilities (core units) that will enhance and extend the effectiveness of clinical research related to improving the oral health of the nation. Each center must include a minimum of three core units. One unit must be an administrative core. A biostatistics core unit also is mandatory. The biostatistics component may be incorporated into the administrative core. Other cores proposed must directly relate to ongoing and planned oral health clinical research activity of the center. Descriptions of core units include: o Administrative Core: Funds for the center director and administrative staff will be provided. This core unit should ensure that OHRCCC 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 to facilitate improved accrual of patient populations for pilot studies for subsequent studies supported through collateral funding. 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. The center director will be expected to utilize panel recommendations in guiding and strengthening OHRCCC activities. Pilot and feasibility studies also will be administered through the administrative core and will remain under the purview of the center director. o Biostatistics, Experimental Design, Data Management and Analysis Core: This core will provide the staff and other resources needed to enhance programs of clinical research 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. o 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 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 include, for example: behavioral/social sciences, biomaterial sciences, pharmacology, microbiology, immunology, nutrition, or molecular biology. The composition of the laboratory core(s) should reflect the resource needs and added research opportunities arising from ongoing clinical research activities. o 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 worksite-based dental operatories for preventive interventions with employed adults. The above descriptions are not intended to include the full range of possible activities. Inclusion of core units of all these types in a single proposed center is not required nor even necessarily advisable. In structuring OHRCCC proposals, applicants should consider their institution's areas of special clinical research potential, its profile of currently funded clinical research projects, and determine which areas present the greatest need for shared resources. 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 NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. This award also will provide up to $45,000 (i.e., no more than 15 percent of direct center costs) for pilot and feasibility studies. These are the only research projects that will be directly supported by this mechanism. The OHRCCC will not provide direct funding for ongoing research projects. These must be funded through other sources or support mechanisms. Each pilot or feasibility study must not exceed $20,000 in direct costs per year and must not extend for a period of more than two years. The goals of the pilot and feasibility studies are to provide start-up funds for new projects, to develop young investigators under the direction of experienced clinical scientists and to encourage established investigators to utilize recent research techniques in addressing areas of oral health 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. SPECIAL REQUIREMENTS Each OHRCCC will be expected to establish, as an integral component of its mandatory biostatistics core unit, a plan that includes offering a regularly scheduled workshop and/or intensive minicourse. This plan should foster training in clinical oral health research methodology for basic scientists and clinicians, either with or without prior postdoctoral research experience. This may be accomplished through utilization of OHRCCC resources and/or associated projects and training grants supported by the NIH or by other public or private sources. Applicants should provide details of this plan in their applications and include pertinent funds, if any, in their budget requests. 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, Vol. 23, No. 11, March 18, 1994. Investigators may obtain copies from these sources or 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 January 13, 1995, a letter of intent. This must include a descriptive title for the OHRCCC and each pilot and feasibility project and core, give the name, address, and telephone number of the center director and the identities of other key personnel and participating institutions and departments, and identify 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 conflicts of interest in the review. The letter of intent is to be addressed to Dr. G.G. Roussos at the address listed under INQUIRIES. APPLICATION PROCEDURES 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 OHRCCC's objectives and structure and the budget format are acceptable. Applications are to be prepared on 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 (DRG), 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 Health Research Clinical Core Centers" and number "DE-95-001" 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 as far as 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 pilot or feasibility project and core unit must be identified by number and investigator. A consolidated budget for the complete OHRCCC 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 should 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 OHRCCC 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 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 OHRCCC regardless of funding source. Each core unit must be presented as in a research grant application, that is, the instruction pages 19-24 of form PHS 398 should 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, that is, 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 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 an OHRCCC 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 Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Dr. H. George Hausch Extramural Program National Institute of Dental Research Natcher Building, Room 4AN-44F 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 Applications must be received by June 13, 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 the Division of Research Grants (DRG) and responsiveness by the NIDR. Incomplete applications will be returned to the applicant without further consideration. 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 be 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 scientific merit of cores and pilot projects. This element involves, but is not limited to: (a) the availability of a base of meritorious ongoing clinical research projects or proposed projects with firm funding commitments permitting optimal utilization of OHRCCC resources; (b) the extent to which the center will expedite the translation of basic scientific knowledge into new and better methods for improving oral health; (c) the feasibility and relevance of plans for fostering training in clinical research methodology; (d) the scientific/technical merit and justification for requested core resources; (e) the scientific merit, appropriateness and relevance of pilot and feasibility projects proposed to be conducted during the first two years of the award; and (f) the ability to recruit individuals from appropriate study populations (i.e., women, subpopulations of minorities and disabled individuals) as defined by the NIH guidelines along with provisions for their protection from research risks and the humane treatment of any animal research subjects that may be used. o The experience of the director and key staff. This element involves, but is not limited to: (a) the scientific, clinical and administrative qualifications, experience and commitment of the center director and his/her ability to provide effective leadership as well as the provisions for selection of his/her replacement should it be necessary; and (b) the competence and commitment of the key center staff participating in core units and pilot/feasibility studies. o The scientific and administrative structure of the center. This element involves, but is not limited to: (a) the provisions for quality control during the development of the application and establishment of the center; (b) the procedures for monitoring the research; (c) the mechanisms for reviewing changes in research direction; (d) the composition and use of internal and external advisory committees; (e) the commitment of the institution to the proposed center; and; (f) the combination of the various projects and core units into an effective and cohesive program, and the adequacy of plans to ensure efficient collaboration, interaction, and dissemination of information among investigators. o The budget and period of support for the center. This element involves, but is not limited to: (a) the adequacy of the budget justification for each pilot and feasibility project and core resource as well as for the entire center; and (b) the extent to which complementary projects, supported from non- NIDR funds, will contribute to the cost-effectiveness of the proposed OHRCCC. o In the case of a competing continuation application, the progress made toward the original goals of the existing center in terms of: (a) success in attracting funds and in-kind contributions from other public and private sector sources; (b) establishment of one or more courses in clinical research methodology; and (c) contribution to significant research advances. The inclusion of pilot projects or cores deemed to have limited scientific merit or that are considered peripheral to the OHRCCC'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 or cores 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 OHRCCC may be recommended for deletion. AWARD CRITERIA The earliest anticipated date of award is December 1, 1995. Applicants should be aware that, in addition to scientific merit, program priorities and program balance, the total cost of the OHRCCC 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 OHRCCC. 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. Once funded, an OHRCCC may undergo an interim peer review by NIDR to evaluate progress. Funding for subsequent years may be contingent on successful outcome of this review. 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. G.G. Roussos Extramural Program National Institute of Dental Research Natcher Building, Room 4AN 18A 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-5500 FAX: (301) 480-8318 Email: roussosg@de45.nidr.nih.gov Direct inquiries regarding grants management issues to: Ms. Theresa Ringler Extramural Program National Institute of Dental Research Natcher Building, Room 4AS-55 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-4800 Email: rubinstein@de45.nidr.nih.gov 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 Public Health Service 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 Nov 28 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AI-95-004 - V23(40) 11/18/94 Date: 28 Nov 1994 21:09:05 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 429 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3bed1h$mos@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AI95004 AI-95-004 P1O1 *************************************** MATERNAL ANTIBODIES FOR PASSIVE INFANT IMMUNIZATION NIH GUIDE, Volume 23, Number 40, November 18, 1994 RFA: AI-95-004 P.T. 34; K.W. 0710070, 0705040, 0775025 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: January 15, 1995 Application Receipt Date: March 15, 1995 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) invites applications for basic studies on maternal immunization that will lead to passive, protective immunization of infants against infectious pathogens. The applications should present plans for altering the structure of antibody molecules, either by methods of protein chemistry or manipulation of antibody-encoding genes, that will (a) improve the efficiency with which antibody molecules are transported into the fetus via the placenta and/or into the newborn via breast milk; (b) prolong the metabolic half-lives of antibodies, both in mother and infant; and/or (c) improve the efficacy of antibodies to protect the infant from pathogenic microorganisms. Applications that deal with antibodies against known, critical antigens (those likely to elicit protective antibodies) of infant pathogens, or propose to identify such antigens, are of particular interest. 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), Maternal Antibodies for Passive Infant Immunization, is related to the priority areas of family planning, educational and community-based programs, maternal and infant health, HIV infection, sexually transmitted diseases, immunization and infectious diseases and clinical prevention services. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone (202) 782-3238). ELIGIBILITY REQUIREMENTS 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 or 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 applications submitted in response to this RFA may not exceed five years; foreign applications 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. FUNDS AVAILABLE The estimated funds available for the total (direct and indirect) first-year costs of all awards made under this RFA will be $500,000. In Fiscal Year 1995, the NIAID plans to fund approximately three R01/R29s. 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, 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. The National Institute of Child Health and Human Development (NICHD) is also interested in research concerned with protective immunization in infants. Applications that are of mutual interest may be given secondary assignment to the NICHD in accordance with Division of Research Grants (DRG) referral guidelines. RESEARCH OBJECTIVES Background Maternal immunization to elicit antibodies that can be transported to the fetus, and/or to the newborn via colostrum and breast milk, is an approach that has been utilized for years to prevent tetanus in infants, particularly in developing nations. Research performed in the 1950s and 1960s showed that maternal-to-fetal transfer of antibodies occurs in a variety of common domestic and laboratory animals, the exact route of transport varying with the type of placenta, the nature of the embryonic membranes and other factors. It was found that transplacental transport varies with the class of immunoglobulin, molecules of class IgG being most efficiently transported. In the case of colostrum immunoglobulins of classes IgA and IgG predominate. In recent years, there has been little additional research concerned with maternal-infant transfer of immunoglobulins except for a few studies on Fc receptors on cells of the trophoblast. Fc receptors involved in transport of immunologlobulins across gut epithelium of the infant have attracted attention recently. At the present time, NIAID supports research concerned with natural transfer of antibodies from mother to fetus and newborn, in particular: (1) maternal to fetal transfer of antibodies of different isotypes that are elicited by conjugated and unconjugated vaccines of Hemophilus influenzae type b, unconjugated pneumococcal polysaccharide vaccines, and group B streptococcal vaccines; and (2) transfer of antibodies in colostrum following maternal immunization with a subunit of respiratory syncytial virus. However, more attention is needed on methods of enhancing the efficiency of maternal-fetal and maternal-neonatal transfer of antibodies, prolonging the persistence of antibody molecules in both maternal and newborn circulation, and enhancing the efficacy of antibodies that enter the infant. In short, up-to-date approaches and methods of molecular and cellular immunology, along with progress in identifying and engineering key antigenic components of organisms responsible for infections in infants, are necessary to ensure that maternal immunization will result in protection of the newborn from infections. Research Objectives and Scope The objective of this RFA is to support basic research (in animal or human subjects) that will lead to procedures for active or passive maternal immunization to endow mothers with antibodies that: (a) persist in the maternal circulation, (b) are transported efficiently to the fetus and/or infant via the placenta and breast milk, and (c) provide strong protection against infection with microorganisms that are pathogenic in infants. Support will be provided for the development and pre-clinical testing of modified antibody molecules suitable for: (a) injection into pregnant women and efficient transfer across the placenta and into the fetus, (b) injection into lactating females and efficient transport into colostrum and thus into the newborn, and (c) oral administration to newborns and infants and efficient transport across intestinal epithelium and into the circulation. NOTE: Studies focused on the Human Immunodeficiency Virus (HIV) and its sequelae are NOT within the scope of this RFA. Progress in this area will require the application of modern molecular biology. Presumably, the combining sites of the antibody or antibody-like molecules should be derived from authentic human antibodies. Alternatively, combining sites of monoclonal murine antibodies that are minimally immunogenic in humans might be satisfactory. An example of a worthwhile approach might be the construction and expression of a gene that would encode single-chain molecules having: (a) Fv segments of heavy and light Ig chains, of the same or different epitope specificities at either end; (b) a linker segment consisting of an epitope of the key microbial antigen, or an analog of an adhesion molecule that would prevent attachment of antibody-coated microorganisms to epithelial cells. Such a molecule would require further refinement to, at least, ensure its efficiency of secretion or transplacental transfer and its non-immunogenicity. The ultimate objective of the research to be supported under this RFA is to obtain the knowledge needed to be able to prepare antibodies that are specific for key antigens of microbial pathogens and have the following properties: o are secreted into colostrum and breast milk and/or traverse the placenta with high efficiency; o possess combining sites of optimum affinity; o are microbicidal, prohibit growth of target microorganisms or interfere with their attachments (adherence) to host epithelial cells; o bear idiotopes (or introduced epitopes) that mimic one or more epitopes of the critical microbial antigen; o have prolonged metabolic half-lives both in the maternal and fetal or neonatal environment; o are, themselves, non-antigenic in humans; and o produce no harmful side-effects either in the pregnant or lactating female or in the fetus or newborn. 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 January 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. Olivia Preble at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the standard research grant application form PHS 398 (rev. 09/91). These application forms may be obtained from the institution's office for sponsored research or its equivalent, or from the Grants Information Office, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, Maryland 20892, telephone (301) 594-7248. 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 "MATERNAL ANTIBODIES FOR PASSIVE INFANT IMMUNIZATION" must be typed in. It is highly recommended that the appropriate NIAID program contact be consulted before submitting the letter of intent and during the early stages of preparation of the application. (See program contacts in INQUIRIES below.) Applications that do not conform to the instructions contained in PHS 398 (rev. 09/91) application kit, will be judged nonresponsive and will be returned to the applicant. The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. FIRST (R29) award 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. Applications must be received by March 15, 1994. Applications received after the receipt date will be returned 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. 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. 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 Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional exact copies of the grant application and all five sets of the appendix must also be sent to Dr. Olivia Preble at the address listed under INQUIRIES. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator could be included with the application. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the NIH Division of Research Grants (DRG) and for responsiveness by NIAID 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. 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: Joseph F. Albright, Ph.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A25 6003 Executive Boulevard Bethesda, MD 20892-7640 Telephone: (301) 496-1886 FAX: (301) 402-2571 Email: JA250@NIH.GOV Carole A. Heilman, Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3B06 6003 Executive Boulevard Bethesda, MD 20892-7630 Telephone: (301) 496-5305 FAX: (301) 496-8030 Email: CH25V@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: Olivia T. Preble, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C19 6003 Executive Boulevard Bethesda, MD 20892-7610 Telephone: (301) 496-8208 FAX: (301) 402-2638 Email: OP2T@NIH.GOV Direct inquiries regarding fiscal matters to: Mr. Carl Lucas Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B28 6003 Executive Boulevard Bethesda, MD 20892-7610 Telephone: (301) 496-7075 Email: CL37E@NIH.GOV Schedule Letter of Intent Receipt Date: January 15, 1995 Application Receipt Date: March 15, 1995 Scientific Review Date: June 1995 Advisory Council Date: September 1995 Earliest Award Date: September 1995 AUTHORITY AND REGULATIONS The NIAID program is described in the Catalog of Federal Domestic Assistance, No. 93.855 - Immunology, Allergy and Transplantation Research. Awards for NIAID 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 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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. From owner-sci-resources@net.bio.net Mon Nov 28 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-007 - V23(40) 11/18/94 Date: 28 Nov 1994 21:08:56 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 268 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3bed18$mod@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95007 PA-95-007 P1O1 *************************************** SMALL GRANT PROGRAM FOR THE NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS NIH GUIDE, Volume 23, Number 40, November 18, 1994 PA NUMBER: PA-95-007 P.T. 34; K.W. 0715050, 0715055, 0775005, 0775017 National Institute on Deafness and Other Communications Disorders PURPOSE This program announcement supersedes previous announcements of the National Institute on Deafness and Other Communication Disorders (NIDCD) Small Grant Program. This current Small Grant (R03) Program provides support for pilot research that is likely to lead to a subsequent individual research project grant (R01) or a First Independent Research Support and Transition (FIRST) (R29) award application. The research must be focused on areas within the mission of the NIDCD, that is, hearing, balance/vestibular, smell, taste, voice, speech, or language. 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, Small Grant Program for the NIDCD, is related to the priority area of clinical prevention services. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-11474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-11473-1) 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Foreign organizations and institutions are not eligible. Current and previous recipients of NIH research grants such as small grant (R03) research projects grants (R01), or FIRST (R29) awards are ineligible for this small grant program, as are Principal Investigators of research subprojects of P01/P50/P60 grants. Individuals who have received research support from the National Science Foundation (NSF) are considered ineligible. Recipients of NIH Academic Research Enhancement Awards (R15) or Clinical Investigator Development Awards (K08) are eligible for this small grant program. Participation in the program by investigators at minority institutions is strongly encouraged. Small grant funds may not be used to support thesis or dissertation research. MECHANISM OF SUPPORT Applicants may request up to $25,000 (direct costs) per year through the small grant (R03) mechanism. The grant may not exceed two years and is not renewable. Before completion of the R03, investigators are encouraged to seek continuing support for research through a research project grant (R01) or FIRST (R29) award. RESEARCH OBJECTIVES The Small Grant program is designed to support basic and clinical scientists who are at the beginning stages of their independent research careers. 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 of 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. APPLICATION PROCEDURES The submission, review, and award schedule for the Small Grant Program for FY 95 (these dates likely will differ for FY 96) is: Application Receipt Dates for FY95: 12/21/94 04/11/95 08/18/95 Institute Committee Review: Feb-Mar Jun-Jul Oct-Nov Council Review: May Oct Jan Earliest Funding: Jul Dec Apr Only one Small Grant application may be submitted by a principal investigator per receipt date. Applicants may not submit R01 or R29 applications on the same topic concurrently (to be considered at the same National Advisory Council cycle) with the submission of a Small Grant application. Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and prepared according to the directions in the application packet, with the exceptions noted below. 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. On the face page of the application: Item 2a Type "Small Grant Program NIDCD". Check the "YES" box. Sections 1-4: Do not exceed a total of five pages for the following sections: specific aims, background and significance, progress report/preliminary studies, and experimental design and methods. Tables and figures are included in the five page limitation. For revised applications, an additional introduction not to exceed one- half page is allowed. This introduction should respond to the comments and concerns of the Initial Review Group delineated in the summary statement. Applications that exceed the page limitation or NIH requirements for type size and margins (Refer to PHS 398 application for details) will be returned to the investigator. The five page limitation does not include Sections 5-9 (Human Subjects, Consortia, Literature cited). Appendix materials generally are not allowed. Use the mailing label in the application kit to mail the original and four copies of the application to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** To ensure that the application is received in sufficient time for the review, send one copy of the application to: Acting Chief, Scientific Review Branch National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-C 6120 Executive Boulevard MSC 7180 Bethesda, MD 20892-7180 REVIEW CONSIDERATIONS A review committee of the NIDCD will evaluate each Small Grant application in accordance with the usual NIH peer review procedures and criteria. Applications will be evaluated with respect to the following criteria: o Scientific, technical, or clinical significance and originality of the proposed research. o Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research. o Appropriateness of the statistical methods proposed to analyze the results. o Potential of the proposed studies to lead to more extensive research. o Qualifications and research experience of the principal investigator. o Availability of resources necessary for the research, including any needed to supplement the budget. o Appropriateness of the proposed budget and timetable in relation to the scope of the proposed research. o The adequacy of the proposed means for protecting against or minimizing potential adverse effects upon humans, animals, or the environment. o Adequacy of adherence to guidelines for including gender and minority representation in any study population. Applications subsequently will be reviewed by the National Deafness and Other Communication Disorders Advisory Council. AWARD CRITERIA The award of grants is contingent on the (1) receipt of applications of high scientific merit; (2) responsiveness to this program announcement, including the eligibility of investigators; (3) relevance to the mission of NIDCD; and (4) the availability of appropriated funds. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome Direct inquiries regarding programmatic issues to: Hearing Dr. Kenneth Gruber Telephone: (301) 402-3458\ Email: GruberK%NIDCD-EPS%NIH@fedtcp.ninds.nih.gov Balance/Vestibular Dr. Daniel Sklare Telephone: (301) 496-1804 Email: SklareD%NIDCD-EPS%NIH@fedtcp.ninds.nih.gov Smell/Taste Dr. Jack Pearl Telephone: (301) 402-3464 Email: PearlJ%NIDCD-EPS%NIH@fedtcp.ninds.nih.gov Smell/Taste Dr. Rochelle Small Telephone: (301) 402-3464 Email: SmallR%NIDCD-EPS%NIH@fedtcp.ninds.nih.gov Voice/Speech Dr. Beth Ansel Telephone: (301) 402-3461 Email: AnselB%NIDCD-EPS%NIH@fedtcp.ninds.nih.gov Language Dr. Judith Cooper Telephone: (301) 496-5061 Email: CooperJ%NIDCD-EPS%NIH@fedtcp.ninds.nih.gov The address and FAX number for all the above is: Division of Communication Sciences and Disorders National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-C 6120 Executive Boulevard MSC 7180 Bethesda, MD 20892 FAX: (301)402-6251 Direct inquiries regarding fiscal matters to: Sharon Hunt Grants Management Office National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-B 6120 Executive Boulevard MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 402-0909 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.173. 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 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. From owner-sci-resources@net.bio.net Mon Nov 28 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 40, pt. 2of2, 18 November 1994 Date: 28 Nov 1994 21:08:47 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1057 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3bed0v$mo4@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19941118 V23N40 P2O2 ************************************ biopsy procedures, equipment, and supplies; (3) during the conduct of the Trial, monitoring and optimizing all aspects of the Protocol related to colposcopy and biopsies including the design and conduct of experiments to assess the accuracy of colposcopic examinations, particularly the assessment of lesion severity and placement of biopsies; (4) ongoing participation in the overall supervision of the Trial via the Steering Committee and its subcommittees; and (5) cooperation with all Trial administrative functions, including reporting, data management, and proper handling of Trial-related biospecimens. Requests for this solicitation must be in writing and reference the RFP Number. INQUIRIES Requests for this solicitation must be in writing and reference the RFP Number, NCI-CN-55042-07. The RFP is tentatively scheduled for release on December 1, 1994 and proposals will be due approximately January 30, 1995. No collect calls will be accepted. Requests should be mailed to: Victor S. Buyny Research Contracts Branch, PCCS National Cancer Institute Executive Plaza South, Room 635 6120 Executive Boulevard, MSC 7226 Bethesda, MD 20892-7226 Telephone: (301) 496-8603 $$R3 END ************************************************************ $$R4 BEGIN NCI-CN-55043-05 ****************************************** PATHOLOGY QUALITY CONTROL GROUP FOR THE ASCUS/LSIL CLINICAL MANAGEMENT TRIAL NIH GUIDE, Volume 23, Number 40, November 18, 1994 RFP AVAILABLE: NCI-CN-55043-05 P.T. 34; K.W. 0715035, 0765035, 0755015 National Cancer Institute The National Cancer Institute, Division of Cancer Prevention and Control, is soliciting proposals for a Pathology Quality Control (QC) Group that will assure the reliable and accurate use of the Bethesda System for cytology and the cervical intra-epithelial neoplasia (CIN) scale for histopathology for a randomized clinical management trial among 3,600 women with the cervical cytologic diagnoses of "atypical squamous cells of undetermined significance" (ASCUS) and 3,600 women with "low-grade squamous intra-epithelial lesions" (LSIL). The Pathology QC Group shall be responsible for overseeing the quality of all aspects of the Trial involving cytology and histopathology. The general requirements include: (1) preparation with the other collaborators of the final protocols, data systems, and study forms; specifically, identifying the optimal protocol for the collection, fixation, staining, storing, and transport of cytologic and histologic specimens; (2) prior to enrollment, minimizing the intra- and inter-laboratory variability of cytologic and histologic diagnoses from the cooperating Pathology Laboratories used by the Clinical Centers during the Trial; (3) during the conduct of the Trial, continuing to monitor and optimize all aspects of the Protocol related to pathology, including review of all 7,200 referral cytology smears, all 7,200 enrollment smears, and a large sample (about 1,000 per year) of the follow-up cytology smears at the Clinical Centers; (4) review of all histology slides collected in the Trial (estimated for budgetary purposes at about 8,000 cases over the course of the study) to standardize clinical outcomes and provide quality control, including the design and conduct or masked quality control experiments; (5) ongoing participation in the overall supervision of the Trial via the Steering Committee and its subcommittees; and (6) cooperation with all Trial administrative functions, including reporting, data management, and proper handling of Trial-related biospecimens. INQUIRIES Requests for this solicitation must be in writing and reference the RFP Number, NCI-CN-55043-05. The RFP is tentatively scheduled for release on December 1, 1994. No collect calls will be accepted. Requests should be mailed to: Gary Topper Research Contracts Branch, PCCS National Cancer Institute Executive Plaza South, Room 635 6120 Executive Boulevard, MSC 7226 Bethesda, MD 20892-7226 Telephone: (301) 496-8603 $$R4 END ************************************************************ $$R5 BEGIN NCI-CN-55044-07 ****************************************** HPV QUALITY CONTROL GROUP FOR THE ASCUS/LSIL CLINICAL MANAGEMENT TRIAL NIH GUIDE, Volume 23, Number 40, November 18, 1994 RFP AVAILABLE: NCI-CN-55044-07 P.T. 34; K.W. 0715035, 1002045, 0755015 National Cancer Institute The National Cancer Institute, Division of Cancer Prevention and Control, is soliciting proposals for an HPV Quality Control (QC) Group that will be responsible for overseeing all aspects of HPV DNA testing for a randomized clinical trial among 3,600 women with the cervical cytologic diagnoses of "atypical squamous cells of undetermined significance" (ASCUS) and 3,600 women with "low-grade squamous intra-epithelial lesions" (LSIL). The HPV QC Group shall be responsible for maintaining the quality of the trial's HPV DNA testing. The general requirements include: (1) preparation with the other collaborators of the final protocols, data systems, and study forms; specifically, identifying the optimal means to collect, store, and transport cervical specimens for HPV DNA testing; (2) prior to enrollment, choosing optimal HPV DNA testing methods, assessing the qualifications of testing laboratories, preparing a list of approved laboratories, and validating the performance of participating laboratories before enrollment; (3) during the conduct of the trial, monitoring and optimizing all aspects of the Trial procedures manual related to HPV DNA testing including the design and conduct of masked quality control experiments and the performance of repeat "in-house testing of specimens; (4) ongoing participation in the overall supervision of the Trial via the Steering Committee and its subcommittees; (5) cooperation with all trial administrative functions, including reporting, data management, and proper handling of trial-related biospecimens; and (6) establishment of Data Management and Quality Assurance systems. INQUIRIES Requests for this solicitation must be in writing and reference the RFP Number, NCI-CN-55044-07. The RFP is tentatively scheduled for release on December 1, 1994 with proposals due approximately January 30, 1995. No collect calls will be accepted. Requests should be mailed to: Victor S. Buyny Research Contracts Branch, PCCS National Cancer Institute Executive Plaza South, Room 635 6120 Executive Boulevard, MSC 7226 Bethesda, MD 20892-7226 Telephone: (301) 496-8603 $$R5 END ************************************************************ $$R6 BEGIN NIH-NIDR-1-95-3R ***************************************** TARGETING ORAL HEALTH PROMOTION IN A MINORITY COMMUNITY: FEASIBILITY STUDY NIH GUIDE, Volume 23, Number 40, November 18, 1994 RFP AVAILABLE: NIH-NIDR-1-95-3R P.T. 34, FF; K.W. 0715148, 0745035 National Institute of Dental Research The National Institute of Dental Research (NIDR) has a requirement to develop, implement and evaluate community-based health interventions to reduce high rates of oral diseases and conditions within minority populations. The research is a feasibility study of a community- based health promotion strategy in a minority population. The proposed research will focus on one geographically defined community with one or more minority populations to assess the feasibility of a community's ability to define and manage its oral health. It is anticipated that one award will be made as a result of this solicitation. Solicitations will be available on or about December 2, 1994, with proposals due on or about February 10, 1995. INQUIRIES Verbal requests for the RFP will not be accepted; requests must be submitted in writing, addressed to: Marilyn R. Zuckerman Contracts Management Office National Institute of Dental Research Natcher Building, Room 4AN-44J 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 $$R6 END ************************************************************ $$R7 BEGIN NIH-NIAID-DMID-96-07 ************************************* MUCOSAL PATHOGENS RESEARCH UNITS NIH GUIDE, Volume 23, Number 40, November 18, 1994 RFP AVAILABLE: NIH-NIAID-DMID-96-07 P.T. 34; K.W. 0715125, 0760044 National Institute of Allergy and Infectious Diseases The Respiratory Diseases Branch and Enteric Diseases Branch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID) have a requirement for two Mucosal Pathogens Research Units (MPRU). These MPRUs will conduct basic research on host-pathogen interactions at mucosal surfaces, methods to maximize a protective mucosal immunity through the design of attenuated vectors or delivery systems, as well as Phase I and Phase II clinical trials to evaluate candidate vaccines and vaccine strategies and other preventive measures for infectious diseases of the enteric or respiratory systems. An MPRU provides volunteer populations, staff, facilities, and expertise to carry out such work that includes follow-up and focused epidemiologic-based studies. A variety of vaccine types (live-attenuated, inactivated, genetic, subunit, conjugated) for prevention of viral and bacterial illnesses are expected, as are vaccine strategies (use of adjuvants or delivery vehicles) designed to induce protective mucosal immunity. It is anticipated that two cost-reimbursement, level-of-effort type contracts will be awarded for a period of seven years. Of these two anticipated awards, one award is anticipated for an MPRU that will focus on enteric pathogens, and one award is anticipated for an MPRU that will focus on respiratory pathogens. The streamlined version of RFP NIH-NIAID-DMID-96-07 will be available on or about December 22, 1994 electronically through the NIH Gopher and Internet using the following electronic mail addresses and instructions: 1. To access the NIH Gopher: Point your gopher client to GOPHER@NIH.GOV PORT 70. 2. To access the NIH Grant Line (Internet): Configure your terminal emulator as: 1200 or 2400 baud, even parity, 7 data bits, 1 stop bit, Half Duplex. Using the procedure specified in your communication software, dial 1-301-402-2221. When you get a response indicating that you have been connected, then type ,GEN1 (the comma is mandatory) and press ENTER; you will be prompted by the NIH system for "INITIALS?". Type BB5 and press ENTER. You will then be prompted for "Account?". Type CCS2 and press ENTER. Please note that the RFP for this procurement has been streamlined to include only the Work Statement, deliverable and reporting requirements, special requirements and mandatory qualification, if any, the Technical Evaluation Criteria, and proposal preparation instructions. All information required for the submission of an offer will be contained in the streamlined RFP package. Following proposal submission and the initial review process, offerors comprising the competitive range will be requested to provide additional documentation (e.g., Representations and Certifications) to the Contracting Officer. PAPER COPIES OF THIS RFP WILL NOT BE DISTRIBUTED. INQUIRIES Any responsible offeror may submit a proposal that will be considered by the Government. Responses to this RFP will be due on April 14, 1995. This advertisement does not commit the Government to award a contract. Inquiries regarding this RFP may be directed to: Anthony Murray Contracts Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 3C07 Bethesda, MD 20892 Telephone: (301) 496-6424 $$R7 END ************************************************************ $$R8 BEGIN RR-95-002 FULL-TEXT ************************************** NATIONAL GENE VECTOR LABORATORIES NIH GUIDE, Volume 23, Number 40, November 18, 1994 RFA AVAILABLE: RR-95-002 P.T. 34; K.W. 1002019, 0745032 National Center for Research Resources National Cancer Institute National Heart, Lung, and Blood Institute National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: December 15, 1994 Application Receipt Date: February 21, 1995 PURPOSE The National Center for Research Resources (NCRR), together with the National Cancer Institute (NCI), the National Heart, Lung, and Blood Institute (NHLBI), and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) as cosponsors, invite applications to establish National Gene Vector Laboratories to enhance research leading to successful gene therapy of single- and multiple-gene disorders. For purposes of this solicitation, the term "vector" is used in the broadest sense to refer to any vehicle designed to deliver genetic material into human somatic cells. The National Gene Vector Laboratories will provide shared resources to facilitate optimal vector production of clinical grade vectors for human gene therapy research. The overall goals are to provide vectors for the prevention, treatment, and cure of a wide variety of medical conditions through gene therapy. The administrative and funding instrument to be used for this program will be the NIH Animal (Mammalian and Nonmammalian) Model, and Animal and Biological Materials Resource Cooperative Agreement (U42). Approximately $3.5 million in total costs will be available in Fiscal Year 1995 for the first year of support of meritorious applications submitted in response to this RFA . It is anticipated that between one and three awards will be made. 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), National Gene Vector Laboratories, is related to many of the priority areas discussed in this publication. 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 301-402-2231) and the NIH GOPHER (gopher.nih.gov) and by mail and email from the program contacts listed below. Dorothy D. Sogn, M.D. Medical Officer, General Clinical Research Centers Program National Center for Research Resources Westwood Building, Room 10A-07 Bethesda, MD 20892-4500** Telephone: (301) 594-7945 FAX: (301) 594-7929 Email: DorothyS@EP.NCRR.NIH.GOV $$R8 END ************************************************************ $$R9 BEGIN AI-95-004 FULL-TEXT ************************************** MATERNAL ANTIBODIES FOR PASSIVE INFANT IMMUNIZATION NIH GUIDE, Volume 23, Number 40, November 18, 1994 RFA AVAILABLE: AI-95-004 P.T. 34; K.W. 0710070, 0705040, 0775025 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: January 15, 1995 Application Receipt Date: March 15, 1995 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) invites applications for basic studies on maternal immunization that will lead to passive, protective immunization of infants against infectious pathogens. The applications should present plans for altering the structure of antibody molecules, either by methods of protein chemistry or manipulation of antibody-encoding genes, that will (a) improve the efficiency with which antibody molecules are transported into the fetus via the placenta and/or into the newborn via breast milk; (b) prolong the metabolic half-lives of antibodies, both in mother and infant; and/or (c) improve the efficacy of antibodies to protect the infant from pathogenic microorganisms. Applications that deal with antibodies against known, critical antigens (those likely to elicit protective antibodies) of infant pathogens, or propose to identify such antigens, are of particular interest. The mechanisms of support will be the individual research project grant (R01) and the First Independent Research Support and Transition (FIRST) (R29) award. The estimated funds available for the total (direct and indirect) first-year costs of all awards made under this RFA will be $500,000. In FY 95, the NIAID plans to fund approximately three R01s/R29s. 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, Maternal Antibodies for Passive Infant Immunization, is related to the priority areas of family planning, educational and community- based programs, maternal and infant health, HIV infection, sexually transmitted diseases, immunization and infectious diseases, and clinical prevention services. 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. Joseph F. Albright, Ph.D. Division of Allergy, Immunology, and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A25 Bethesda, MD 20892-7640 Telephone: (301) 496-1886 FAX: (301) 402-2571 Email: JA250@NIH.GO $$R9 END ************************************************************ $$R10 BEGIN AA-95-001 FULL-TEXT ************************************* HEALTH SERVICES RESEARCH ON ALCOHOL-RELATED PROBLEMS NIH GUIDE, Volume 23, Number 40, November 18, 1994 RFA AVAILABLE: AA-95-001 P.T. 34; K.W. 0404003, 0730050 National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: February 6, 1995 Application Receipt Date: March 21, 1995 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks health services research and research training grant applications that are aimed at developing a knowledge base to improve the efficiency and effectiveness of services for alcohol-related problems. Such a knowledge base includes both treatment and preventive interventions. This Request for Applications (RFA) invites research applications related to improving the availability, accessibility, delivery, quality, cost effectiveness, impact, and outcomes of alcohol-related treatment and prevention services. The NIAAA also seeks to increase the pool of health services researchers who have expertise in the alcohol field. The NIAAA encourages interested institutions to undertake programs of research training and career development in the area of alcohol-related health services research. Under this RFA, up to $250,000 has been targeted to award one or two Institutional Research Training Grants (T32). It is estimated that up to $4 million will be available for approximately 16 grant awards under this RFA in FY 1995. The research objectives include, but are not limited to: (1) determining impacts of financing and reimbursement mechanisms on alcohol-related health care program availability, accessibility, delivery, organization, content, quality, and outcomes; (2) assessing sources of variation in the utilization and cost of treatment services and prevention interventions for alcohol-related problems; (3) identifying and assessing the effectiveness and outcomes of alcohol-related treatment and preventive services; and (4) identifying factors that influence the organization, management, and delivery of treatment and prevention services for alcohol-related problems across regions, populations, and settings. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committee 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 Services Research on Alcohol-Related Problems, is related to the priority areas of alcohol abuse reduction and alcoholism treatment. 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. Harold I. Perl, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0788 Email: hperl@willco.niaaa.nih.gov $$R10 END *********************************************************** $$R11 BEGIN AI-95-003 FULL-TEXT ************************************* MECHANISMS UNDERLYING IMMUNOTHERAPY TRIALS IN AUTOIMMUNITY NIH GUIDE, Volume 23, Number 40, November 18, 1994 RFA AVAILABLE: AI-95-003 P.T. 34; K.W. 0715015, 0745045, 0755015 National Institute of Allergy and Infectious Diseases National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases Office of Research on Women's Health Letter of Intent Receipt Date: January 15, 1995 Application Receipt Date: March 21, 1995 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), and the Office of Research on Women's Health (ORWH) of the National Institutes of Health (NIH) invite applications for research into the basic mechanisms underlying new immunotherapies being tested for the prevention and treatment of various autoimmune diseases. Human clinical trials of new and innovative therapies for autoimmune disease are proceeding even though the exact mechanisms of the interventions being tested are unknown. The NIAID seeks studies that would expand the clinical evaluation of these experimental treatments by incorporating basic research on the molecular and immunologic mechanisms underlying these immune therapies. By augmenting the clinical investigations with research designed to elucidate specific mechanisms of action, assessment of clinical outcomes will be more meaningful and could facilitate the development of future therapeutic strategies. The mechanism of support will be the individual research project (R01) grant and the First Independent Research Support and Transition (FIRST) (R29) award. The estimated funds available for the total (direct and indirect) first-year costs of all awards made under this RFA will be $750,000 from NIAID, $250,000 from NIDDK, $250,000 from NIAMS, and $200,000 from ORWH. In Fiscal Year 1996, the NIAID plans to fund approximately four R01s/R29s. 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, Mechanisms Underlying Immunotherapy Trials in Autoimmunity, is related to the priority areas of diabetes and chronic disabling diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone (202) 782-3238). 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. Elaine Collier, M.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A20 Bethesda, MD 20892-7640 Telephone: (301) 496-7104 FAX: (301) 402-2571 Email: EC5X@NIH.GO $$R11 END *********************************************************** $$R12 BEGIN TW-95-002 FULL-TEXT ************************************* INTERNATIONAL RESEARCH AND TRAINING IN POPULATION AND HEALTH NIH GUIDE, Volume 23, Number 40, November 18, 1994 RFA AVAILABLE: TW-95-002 P.T. 34; K.W. 0720005, 0413000, 0413002 Fogarty International Center National Institute of Child Health and Human Development Letter of Intent Receipt Date: January 16, 1995 Application Receipt Date: April 20, 1995 PURPOSE The Fogarty International Center (FIC), in collaboration with the National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health, invites applications from non- profit public or private institutions in the United States to support international research and training in population-related sciences. The intent of this program is to enable NIH grant recipients to extend the geographic base of research and training efforts to developing nations, in support of international population priorities. Broad objectives are to: (1) enhance domestic population research programs through training and international collaborative studies related to population, including the study of reproductive processes, contraceptive development, contraceptive and reproductive evaluation, reproductive epidemiology, and social and behavioral factors that influence population dynamics; and (2) assist scientists from developing nations to contribute to global population research efforts and advance knowledge in support of population policies appropriate for their home countries and established international guidelines. It is anticipated that six to seven awards will be made, with an estimated total of $1,000,000 available for the entire program in the first year, with no single award exceeding $150,000 (in direct costs). The program provides support for stipends, travel and training related research. Applicants must be U.S. Principal investigators on at least one NIH-sponsored research grant, cooperative agreement or contract. Scientific review will be conducted by the NICHD. Awards will be made by the FIC. 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), International Research and Training in Population and Health, is related to the priority area of family planning and maternal and infant health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). 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. Kenneth Bridbord International Studies Branch Fogarty International Center 31 Center Drive MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-2516 FAX: (301) 402-2056 Email: sn5@cu.nih.gov $$R12 END *********************************************************** $$R13 BEGIN TW-95-003 FULL-TEXT ************************************* INTERNATIONAL TRAINING AND RESEARCH IN ENVIRONMENTAL AND OCCUPATIONAL HEALTH NIH GUIDE, Volume 23, Number 40, November 18, 1994 RFA AVAILABLE: TW-95-003 P.T. 34, 44; K.W. 0725000, 0725020 Fogarty International Center National Institute of Environmental Health Sciences National Institute for Occupational Safety and Health Letter of Intent Receipt Date: January 16, 1995 Application Receipt Date: April 20, 1995 PURPOSE This research training program is a collaborative effort among the Fogarty International Center (FIC), the National Institute of Environmental Health Sciences (NIEHS) and the National Institute for Occupational Safety and Health (NIOSH). A major goal of the International Training and Research in Environmental and Occupational Health Program is to train scientists of developing countries and emerging democracies to deal effectively with environmental and occupational health through epidemiologic research, environmental monitoring, engineering control, and prevention research programs. This program will help to (1) establish the necessary epidemiologic and related research, including engineering and industrial hygiene and medical expertise needed in countries affected by environmental or occupational health problems and facilitate new research efforts that supplement or complement U.S. research and (2) establish cooperative relationships between U.S. and foreign research groups and support cooperation, for example, between U.S. academic research centers and foreign scientists. Collaborations established through this effort will help to facilitate standardized assessment and monitoring of environmental and occupational health hazards and problems and prepare for the coordinated conduct of scientifically valid and ethically sound studies and interventions on an international basis. It is anticipated that four awards will be made, with approximately $500,000 (total costs) available for the program in the first year, with no single award exceeding $150,000 (in direct and indirect costs). The program provides support for stipends, travel and training related research. Scientific review will be conducted by NIEHS. Awards will be made by FIC. 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), International Training and Research in Environmental and Occupational Health, is related to the priority areas of environmental health and occupational safety and health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). 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 from the program contact listed below. Dr. Kenneth Bridbord International Studies Branch Fogarty International Center 31 Center Drive MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-2516 FAX: (301) 402-2056 Email: sn5@cu.nih.gov $$R13 END *********************************************************** $$R14 BEGIN DE-95-001 FULL-TEXT ************************************* ORAL HEALTH RESEARCH CLINICAL CORE CENTERS NIH GUIDE, Volume 23, Number 40, November 18, 1994 RFA AVAILABLE: DE-95-001 P.T. 04; K.W. 0715148, 0755030, 0765033, 0785055, 0745027 National Institute of Dental Research Letter of Intent Receipt Date: January 13, 1995 Application Receipt Date: June 13, 1995 PURPOSE The National Institute of Dental Research (NIDR) invites grant applications for the support of Oral Health Research Clinical Core Centers (OHRCCCs). The primary goal of these centers is to enhance the nation's oral health clinical research capability and, thereby, facilitate the transfer from the laboratory to the clinic of fundamental knowledge of the etiology, pathogenesis, epidemiology, prevention, diagnosis and treatment of oral diseases and dysfunctions. This Request for Applications (RFA) consolidates under one umbrella and announces the first recompetition of all the NIDR clinical core center programs. Support of this program will be through the National Institutes of Health center core grant (P30). It is anticipated that up to four to five awards will be made and up to $2,250,000 in total cost will be committed for the first year of support for the entire 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 RFA, Oral Health Research Clinical Core 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 "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). 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. G.G. Roussos Extramural Program National Institute of Dental Research Natcher Building, Room 4AN18A 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-5500 FAX: (301) 480-8318 Email: roussosg@de45.nidr.nih.gov $$R14 END *********************************************************** $$R15 BEGIN AI-95-002 FULL-TEXT ************************************* TROPICAL MEDICINE RESEARCH CENTERS NIH GUIDE, Volume 23, Number 40, November 18, 1994 RFA AVAILABLE: AI-95-002 P.T. 04; K.W. 0715151, 0710030 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: December 19, 1994 Application Receipt Date: May 16, 1995 PURPOSE Applications are invited for multiproject center (P50) grants from institutions in geographic areas where tropical infectious diseases are endemic to conduct multidisciplinary research leading to the development and evaluation of new strategies to prevent and control tropical diseases. Approximately three awards are anticipated for a first year total cost of $1.6 million. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Tropical Medicine Research Centers, is related to the priority area of immunization and infectious diseases. [Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-782-3238). INQUIRIES This RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Michael Gottlieb, Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard Solar Building, Room 3A03 Bethesda, MD 20892-7630 Telephone: (301) 496-7115 FAX: (301) 402-0804 Email: mg35s@nih.gov $$R15 END *********************************************************** $$P1 BEGIN PA-95-005 FULL-TEXT ************************************** AIDS, DRUG ABUSE AND NEUROBIOLOGY NIH GUIDE, Volume 23, Number 40, November 18, 1994 PA AVAILABLE: PA-95-005 P.T. 34; K.W. 0404009, 0715008, 0715138, 1002008 National Institute on Drug Abuse PURPOSE The Acquired Immunodeficiency Syndrome (AIDS) is particularly prominent in populations of drug abusers. The onset and spread of HIV infection and the development of AIDS in this population is only superficially understood. Associated with the AIDS epidemic is the re-emergence of tuberculosis (TB) and other diseases not early recognized as associated with AIDS. The reduction in the immunologic competence of the abuser by various drugs may be important in the selection and progression of particular diseases. Also, many drugs of abuse are themselves neurotoxic and may initiate or enhance the development of dementia relative to HIV and otherwise compromise the central nervous system. To enhance knowledge regarding drug modulation of the HIV infectivity and progression to AIDS, neuroscientists, endocrinologists, immunologists, chemists, molecular biologists and others are collectively invited to submit research and conference grant applications (singly or jointly) to bring about an understanding of how drug abuse affects HIV-related disease states. 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, AIDS, Drug Abuse, and Neurobiology, is related to the priority area of alcohol and other drugs. 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 program, may be obtained electronically through the NIH Grant Line (date line 301-402-2221) and the NIH Gopher (gopher.nih.gov), and by mail and email from the project contact listed below. A copy of the program announcement may also be obtained from NIDA/Grants Management Branch, OPRM, 5600 Fishers Lane, Room 8A-54, Rockville, MD 20857, telephone 301-443-6710. Charles W. Sharp, Ph.D. Division of Basic Research National Institute on Drug Abuse Parklawn Building, Room 10A-31 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-1887 Email: csharp@aoada.ssw.dhhs.gov $$P1 END ************************************************************ $$P2 BEGIN PA-95-006 FULL-TEXT ************************************** BIOLOGY OF THE MENOPAUSE: CHANGE OF OVARIAN FUNCTION NIH GUIDE, Volume 23, Number 40, November 18, 1994 PA AVAILABLE: PA-95-006 P.T. 34; K.W. 0413002, 0705075, 1002004, 1002008 National Institute on Aging National Institute of Child Health and Human Development National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The National Institute on Aging (NIA), in collaboration with the National Institute of Child Health and Human Development (NICHD) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is interested in receiving R01, R29, and F32 applications to support research to elucidate the molecular and cellular mechanisms of the menopausal process. This program announcement addresses age- and menopause-related changes in the pituitary-ovarian axis that result in the dramatic hormonal changes experienced across the menopausal transition. These changes lead to the menopause-related increase in health problems associated with the cardiovascular, skeletal, and genitourinary systems. The primary focus of this program announcement is on understanding the biology of the processes involved in the change in ovarian function across the menopausal transition, using appropriate animal models, human cells or tissue specimens. To increase the number of individuals trained to conduct high quality molecular and cellular research in the combined aging- and reproductive biology-related research areas, the individual postdoctoral fellowship (F32) mechanism is included as eligible for support in this program announcement. 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 PA, Biology of the Menopause: Change of Ovarian Function, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). INQUIRIES The PA, 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 e-mail from the program contacts listed below. Frank Bellino, Ph.D. Biology of Aging Program National Institute on Aging Gateway Building, Suite 2C231 Bethesda, MD 20892-9205 Telephone: (301) 496-6402 FAX: (301) 402-0010 Email: fqb@cu.nih.gov Donna Vogel, M.D., Ph.D. Reproductive Sciences Branch National Institute of Child Health and Human Development Building 61E, Room 8B01 6100 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-6515 FAX: (301) 496-0962 Email: vogeld@hd01.nichd.nih.gov Philip Smith, Ph.D. Pituitary and Neuroendocrinology Research Program National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 621 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7531 FAX: (301) 594-9011 Email: phils@dvsgate.niddk.nih.gov $$P2 END ************************************************************ $$P3 BEGIN PA-95-007 FULL-TEXT ************************************** SMALL GRANT PROGRAM FOR THE NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS NIH GUIDE, Volume 23, Number 40, November 18, 1994 PA AVAILABLE: PA-95-007 P.T. 34; K.W. 0715050, 0715055, 0775005, 0775017 National Institute on Deafness and Other Communication Disorders PURPOSE This program announcement supersedes previous announcements of the National Institute on Deafness and Other Communication Disorders (NIDCD) Small Grant Program. This current Small Grant (R03) Program provides support for pilot research that is likely to lead to a subsequent individual research project grant (R01) or a First Independent Research Support and Transition (FIRST) (R29) award application. The research must be focused on areas within the mission of the NIDCD, that is, hearing, balance/vestibular, smell, taste, voice, speech, or language. 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, Small Grant Program for the NIDCD, is related to the priority area of clinical prevention services. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-11474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-11473-1) 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 program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov), and in print from the program contact listed below. Dr. Judith Cooper Division of Communication Sciences and Disorders National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-C 6120 Executive Boulevard MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 496-5061 FAX: (301) 402-6251 Email: cooperj%NIDCD-EPS%NIH@fedtcp.ninds.nih.gov $$P3 END ************************************************************ From owner-sci-resources@net.bio.net Mon Nov 28 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 40, pt. 1of2, 18 November 1994 Date: 28 Nov 1994 21:08:35 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1499 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3bed0j$mno@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19941118 V23N40 P1O2 ************************************ X-comment: RFAS described: RR-95-002, AI-95-004, AA-95-001, AI-95-003, TW-95- 002, TW-95-003, DE-95-001, AI-95-002, PA-95-005, P A-95-006, PA-95-007 NIH GUIDE - Vol. 23, No. 40 - November 18, 1994 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** CONSIDERATIONS FOR RECIPIENTS OF NIH RESEARCH GRANTS AND CONTRACTS -- RESPONSE TO COMMENTS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N2 ********************************************************** INCLUDING AIDS RESEARCH IN BEHAVIORAL THERAPIES DEVELOPMENT PROGRAM (PA-94-078) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX N3 ********************************************************** SUPPORT FOR NATIONAL RESEARCH SERVICE AWARDS National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX N4 ********************************************************** SUPPORT FOR MENTORED CAREER AWARDS (K20, K21) AND EXPEDITED REVIEW National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX N5 ********************************************************** NIAID AWARD AND APPLICATION POLICIES National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX N6 ********************************************************** NCI BRIEFING ON PROSTATE SPORE PROGRAM National Cancer Institute INDEX: CANCER $$INDEX N7 ********************************************************** NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES, EXTRAMURAL PROGRAMS National Institute of Arthritis and Musculoskeletal and Skin Diseases INDEX: ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** POTENTIAL FOR ENVIRONMENTAL AND THERAPEUTIC AGENTS TO INDUCE IMMUNOTOXICITY (RFP NIH-ES-95-22) National Institute of Environmental Health Sciences INDEX: ENVIRONMENTAL HEALTH SCIENCES $$INDEX R2 ********************************************************** RANDOMIZED TRIAL ON CLINICAL MANAGEMENT OF ASCUS AND LSIL OF THE UTERINE CERVIX - CLINICAL CENTERS (RFP NCI-CN-55040-05) National Cancer Institute INDEX: CANCER $$INDEX R3 ********************************************************** COLPOSCOPY QUALITY CONTROL GROUP FOR THE ASCUS/LSIL CLINICAL MANAGEMENT TRIAL (RFP NCI-CN-55042-07) National Cancer Institute INDEX: CANCER $$INDEX R4 ********************************************************** PATHOLOGY QUALITY CONTROL GROUP FOR THE ASCUS/LSIL CLINICAL MANAGEMENT TRIAL (RFP NCI-CN-55043-05) National Cancer Institute INDEX: CANCER $$INDEX R5 ********************************************************** HPV QUALITY CONTROL GROUP FOR THE ASCUS/LSIL CLINICAL MANAGEMENT TRIAL (RFP NCI-CN-55044-07) National Cancer Institute INDEX: CANCER $$INDEX R6 ********************************************************** TARGETING ORAL HEALTH PROMOTION IN A MINORITY COMMUNITY: FEASIBILITY STUDY (RFP NIH-NIDR-1-95-3R) National Institute of Dental Research INDEX: DENTAL RESEARCH $$INDEX R7 ********************************************************** MUCOSAL PATHOGENS RESEARCH UNITS (RFP NIH-NIAID-DMID-96-07) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R8 02/21/95 ************************************************* NATIONAL GENE VECTOR LABORATORIES (RFA RR-95-002) National Center for Research Resources National Cancer Institute National Heart, Lung, and Blood Institute National Institute of Diabetes and Digestive and Kidney Diseases INDEX: RESEARCH RESOURCES; CANCER; HEART, LUNG, BLOOD; DIABETES, DIGESTIVE, KIDNEY DISEASES $$INDEX R9 03/15/95 ************************************************* MATERNAL ANTIBODIES FOR PASSIVE INFANT IMMUNIZATION (RFA AI-95-004) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R10 03/21/95 ************************************************ HEALTH SERVICES RESEARCH ON ALCOHOL-RELATED PROBLEMS (RFA AA-95-001) National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM $$INDEX R11 03/21/95 ************************************************ MECHANISMS UNDERLYING IMMUNOTHERAPY TRIALS IN AUTOIMMUNITY (RFA AI-95-003) National Institute of Allergy and Infectious Diseases National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases Office of Research on Women's Health INDEX: ALLERGY, INFECTIOUS DISEASES; DIABETES, DIGESTIVE, KIDNEY DISEASES; ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES; WOMEN'S HEALTH $$INDEX R12 04/20/95 ************************************************ INTERNATIONAL RESEARCH AND TRAINING IN POPULATION AND HEALTH (RFA TW-95-002) Fogarty International Center National Institute of Child Health and Human Development INDEX: FOGARTY INTERNATIONAL CENTER; CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R13 04/20/95 ************************************************ INTERNATIONAL TRAINING AND RESEARCH IN ENVIRONMENTAL AND OCCUPATIONAL HEALTH (RFA TW-95-003) Fogarty International Center National Institute of Environmental Health Sciences National Institute for Occupational Safety and Health INDEX: FOGARTY INTERNATIONAL CENTER; ENVIRONMENTAL HEALTH SCIENCES; OCCUPATIONAL SAFETY, HEALTH $$INDEX R14 06/13/95 ************************************************ ORAL HEALTH RESEARCH CLINICAL CORE CENTERS (RFA DE-95-001) National Institute of Dental Research INDEX: DENTAL RESEARCH $$INDEX R15 05/16/95 ************************************************ TROPICAL MEDICINE RESEARCH CENTERS (RFA AI-95-002) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX P1 ********************************************************** AIDS, DRUG ABUSE AND NEUROBIOLOGY (PA-95-005) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX P2 ********************************************************** BIOLOGY OF THE MENOPAUSE: CHANGE OF OVARIAN FUNCTION (PA-95-006) National Institute on Aging National Institute of Child Health and Human Development National Institute of Diabetes and Digestive and Kidney Diseases INDEX: AGING; CHILD HEALTH, HUMAN DEVELOPMENT; DIABETES, DIGESTIVE, KIDNEY DISEASES $$INDEX P3 ********************************************************** SMALL GRANT PROGRAM FOR THE NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS (PA-95-007) National Institute on Deafness and Other Communications Disorders INDEX: DEAFNESS, OTHER COMMUNICATION DISORDERS This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. THE PUBLIC HEALTH SERVICE (PHS) STRONGLY ENCOURAGES ALL GRANT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** CONSIDERATIONS FOR RECIPIENTS OF NIH RESEARCH GRANTS AND CONTRACTS -- RESPONSE TO COMMENTS NIH GUIDE, Volume 23, Number 40, November 18, 1994 P.T. 34; K.W. 1014006 National Institutes of Health The following is a reprint of the Notice that was published in the Federal Register of November 8, 1994 (59 FR 55673). SUMMARY: The National Institutes of Health (NIH) published a proposed draft of "Developing Sponsored Research Agreements: Considerations for Recipients of NIH Research Grants and Contracts" (hereafter referred to as Considerations) in the Federal Register on June 27, 1994. The document is to provide recipients of NIH grants and contracts (hereafter referred to as Recipients) with issues and points to consider in developing sponsored research agreements with commercial entities, where such agreements may include research activities which are fully or partially funded by NIH. Comments on the document were requested by July 27, 1994. In response to that Notice, NIH received comments from 18 respondents, two of whom represented a large number of research intensive institutions. In general, the comments were favorable and supportive of the NIH's action to assist its grantees and contractors in administering their activities in accordance with public law and the terms of their awards. There were a number of minor editorial comments that have been given consideration and for the most part accepted. A summary of the comments and the NIH response are presented below. The full text of the final document is also presented. FOR FURTHER INFORMATION CONTACT: Theodore J. Roumel, Assistant to the Deputy Director for Science Policy and Technology Transfer, NIH, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804, (301) 496- 7057, ext. 203 (this is not a toll-free number). Dated: Daryl A. (Sandy) Chamblee, J.D. Acting Deputy Director for Science Policy and Technology Transfer, National Institutes of Health Summary of Comments In response to the June 27 Notice, NIH received 18 comments, including two from organizations representing a large number of research intensive institutions. Below are the substantive comments offered and NIH's response, broken down by the section of the Considerations to which they pertain. INTRODUCTION In order to limit confusion as to requirements that may apply to grantees and contractors, the term Grantee has been replaced by the term Recipient. One entity questioned the need for the issuance of the Considerations. As was stated in the document, the NIH, as a steward of Federal funds, has the responsibility to advise Recipients as to the requirements that attach to the receipt of NIH funds and to offer technical assistance in adhering to those requirements. Recipients have varying levels of sophistication in their technology transfer activities and the NIH is trying to assist those institutions in addressing substantive issues based on an extensive review of sponsored research agreements. In keeping with its belief that: "both the public and private sectors must work together to foster rapid development and commercialization of useful products to benefit human health, stimulate the economy, and enhance our international competitiveness, while at the same time protecting taxpayers' investment and safeguarding the principles of scientific integrity and academic freedom", the NIH has developed the Considerations to encourage Recipients to address issues such as fair and open competition, dissemination and commercialization of research results, and the maintenance of academic freedom in developing sponsored research agreements with commercial entities. PURPOSE Several institutions sought greater clarification as to the universe to which the Considerations were addressed, e.g., NIH awards, all Federal awards, or any sponsored program agreement. The Bayh-Dole Act applies to all Federal agencies. However, the NIH can only provide guidance to Recipients within its jurisdiction. The INTRODUCTION and PURPOSE sections of the document have been modified to clearly indicate that the requirements of the Bayh-Dole Act and its implementing regulations apply to all NIH sponsored research, whether fully or partially funded. The document provides information on the Act and the regulations and guidance to institutions when situations arise where NIH has fully or partially funded research activities that may be included in a sponsored research agreement. Three respondents commented on the definition of a sponsored research agreement. The existing definition in the INTRODUCTION section has been modified to more clearly state what is meant by the term. One respondent proposed that the definition be used with NIH funding only. This was not accepted because the term is one of general applicability while the guidance will deal with only those types of agreements that may involve NIH funded activities. One respondent urged that NIH point out that sponsored research agreements differ from one another and must be viewed on a case by case basis. While it was our opinion that we had provided that sense, we have modified the last paragraph of the PURPOSE section to reflect that proposed sponsored research agreements should be reviewed on a case by case basis and that provisions of those documents should be reviewed both individually and in their totality. BACKGROUND Several of the respondents raised concerns about individual situations and whether or not the Considerations should be used in those situations. In developing the Considerations, it was the intent of the NIH to provide some general guidance for developing agreements and not to specify how an agreement should be written, how an institution should respond in certain situations, or prescribe any special language that should be used other than that which is already required by law and existing policy applicable to NIH funded projects. In addition, it was not the intent of the guidance to interpret or otherwise explain the Bayh Dole implementing regulations, which were issued by the Department of Commerce. Issues regarding the regulations and its requirements need to be addressed to the Department of Commerce. One respondent questioned how far the Federal rights extend to sponsored activities not specifically funded by the Federal government. If research results from an NIH funded activity or a piece of equipment purchased under an NIH funding agreement was later used in a sponsored research agreement which was being funded solely by the sponsor and this led to the development of a new invention, would Federal rights apply to any new invention made under that sponsored research agreement? In general, Federal rights attach only if an invention is conceived or first actually reduced to practice under a Federal funding agreement. Mere use of equipment, data, or pre-existing inventions does not mean that all work under the sponsored research agreement is subject to the requirements of the Bayh Dole Act. UNIVERSAL POINTS FOR CONSIDERATION Dissemination of Research Results Several respondents commented on the time frames related to possible delays in disclosure of research findings and the period for consideration of a license option. Comments were mostly supportive, however, there were several comments that the time frames offered might be too tight. It is of the utmost importance to the NIH to have research results disseminated and innovations brought to commercialization as rapidly as possible. Time frames were provided as guidance to institutions which need to exert their best efforts to accommodate this important objective. The Considerations recognize that different situations may dictate a shorter or longer period of time. To protect intellectual property it may be necessary to grant longer periods of time. However, each situation must be reviewed on a case by case basis and the institution must determine the appropriateness of the time frames for those particular circumstances. On the basis of comments received, we have modified the time frame for review under Dissemination of Research Results to read thirty (30) to sixty (60) days, rather than thirty (30) days which was viewed by several respondents as being too constraining. Utilization One respondent agreed with the idea of providing a commercial sponsor of the research an option to license resulting intellectual property with no second chance to license. However, the respondent believes that it would seem appropriate that the sponsor should be given an equal opportunity with its competitors to make a bid on the license when the terms of the license offered to a competitor differed from the terms offered to the sponsor. The rationale for the language in the Considerations was that if negotiations, within a reasonable period of time, do not end in a license with the sponsor, the Recipient should be free to negotiate with others to ensure the rapid transfer of technology to commercialization. This would not preclude a Recipient, at its discretion, from entering into new negotiations with the sponsor, especially when the Recipient has modified the terms of the license being offered to a competitor from that which it previously offered to the sponsor. Notification Requirements and Records In response to one comment, the listing of timeliness considerations has been revised to reflect more accurately the language in the Bayh Dole Act and the implementing regulations. One additional consideration has been added, i.e., the specification in patent applications that the invention was made with government support. This is an important requirement which was omitted in the original document. Two respondents expressed concern over the requirement that a Recipient disclose an invention to the NIH prior to the publication of any description of the invention. One of those respondents stated that the language was incorrect. The language cited in the Considerations is a grants policy requirement, has been in place for a number of years, and is consistent with the Bayh Dole requirements for notification of inventions. However, since this appears to have raised a concern, we have deleted the subject sentence and inserted information stating the source of the requirement. The comments related to notification requirements and records reinforce the need for institutions to have adequate systems to meet Federal requirements. Those institutions which have separated their technology transfer activities from their sponsored research administration activities may have difficulty in assuring coordination of actions, submission of reports, and retention of appropriate records. Institutions need to ensure that they have systems in place which coordinate actions involving technology transfer and sponsored research administration to preserve the rights of the government and be responsive to requests for information and reporting. POINTS FOR SPECIAL CONSIDERATION Three respondents commented on their concern regarding the suggestion that Recipients should avoid any other unusual practice or stipulation that might generate public concern or undermine rather the serve the public interest. With innovation and creativity being a major part of the evolving field of technology transfer, it is not possible for this document to cover every specific problem, concern or consideration that may occur in the future. Therefore, this language was written to encourage institutions to be constantly alert in their review of potential agreements with special attention to conformity with the Bayh Dole Act, implementing regulations, and NIH funding requirements. OTHER POINTS FOR CONSIDERATION BY NON-PROFIT RECIPIENTS Three respondents expressed concern regarding the language on small businesses. One had general concerns about the small business preference and offered some additional language. A second also had apprehensions with the small business preference being interpreted as a "must use" requirement. A third respondent was concerned that the form and level of documentation be specified. In the section on special provisions for non-profit organizations, the regulation states that such organizations will make efforts to execute a license with small businesses and, in certain circumstances, provide a preference for such businesses. However, the decision to give a preference in any specific case is at the discretion of the Recipient. Additionally, the regulation states that Recipients must be satisfied that the small business firms have the capability and resources to carry out plans or proposals. Having documentation sufficient to support its decisions on small business preferences is a key Recipient responsibility. As noted above, these Considerations have been prepared for use by Recipients; the regulations implementing the Bayh-Dole Act are issued by the Department of Commerce and the NIH does not have authority to modify their content. The NIH appreciates the effort taken to provide comments on this document and is pleased that the document is viewed as being a valuable technical assistance tool. DEVELOPING SPONSORED RESEARCH AGREEMENTS: CONSIDERATIONS FOR RECIPIENTS OF NIH RESEARCH GRANTS AND CONTRACTS INTRODUCTION The National Institutes of Health (NIH) is the principal biomedical and behavioral research agency within the Federal Government. Its mission is to improve human health by increasing scientific knowledge related to health and disease through the conduct and support of biomedical and behavioral research. The NIH advances its mission through intramural research activity and the award of research grants and contracts to institutions of higher education, research institutes and foundations, and other non-profit and for-profit organizations (hereafter referred to as Recipients). Whenever a Recipient's research work is funded either in whole or in part through NIH research grants, contracts, and cooperative agreements, that activity is subject to the requirements of Public Law 96-517, known as the Bayh-Dole Act of 1980 (1) (hereafter referred to as "Bayh-Dole" or "the Act"). Those Recipients are required to maximize the use of their research findings by making them available to the research community and the public at large and through their timely and effective transfer to industry for development. Recipients also have interactions with industry which may take many forms, including industrial liaison programs, spinoff companies, consortia, commercial licenses, material transfers, consultations, and clinical trial agreements. This document addresses one form of Recipient/industry interaction, sponsored research agreements. The NIH has focused a substantial amount of its recent attention on this relationship when NIH funds may also be involved. The term sponsored research agreement means a written document which describes the relationship between Recipients and commercial entities in which Recipients receive funding or other consideration to support their research in return for preferential access and/or rights to intellectual property deriving from Recipient research results. Although Recipients are primarily responsible for the implementation of the Bayh-Dole requirements, NIH, as a steward of Federal funds, has a responsibility to provide guidance on issues which may place Recipients at odds with Federal law and/or NIH funding requirements. PURPOSE The purpose of this document is to provide Recipients with issues and points to consider in developing sponsored research agreements with commercial entities, where such agreements may include research activities which are fully or partially funded by NIH. The intent is to assist Recipients in ensuring that those agreements comply with the requirements of the Bayh-Dole Act and NIH funding agreements while upholding basic principles of academic freedom. This document represents the culmination of various activities, under the aegis of the NIH Task Force on Commercialization of Intellectual Property Rights from NIH Supported Extramural Research, which included the review and analysis of 375 sponsored research agreements from 100 Recipients, meetings with industry, academia, and other Government agencies, and a specially convened public forum involving subject matter experts from outside of the NIH. The NIH recognizes that sponsored research agreements are unique, creative devices which reflect the needs and interests of the parties involved and require a delicate balance of risks and benefits to all of the parties. Although this document identifies a number of points to consider, with some necessitating more scrutiny than others, no single point or issue is so dominant that it is likely to be fatal to an agreement. Rather, the juxtaposition of multiple factors or clauses in an agreement and their synergy needs to be assessed. Therefore, Recipients should review each proposed sponsored research agreement on a case by case basis, and the provisions both individually and in the context of the entire agreement. BACKGROUND While NIH policies on the use of research results have been in effect for some time, commercial development of research results took a major step forward with the passage of the Bayh-Dole Act. Congress passed the Act in response to significant concerns about the United States' competitiveness and data indicating that rights to many inventions developed under Federal grants and contracts and assigned to the Federal government were not being commercialized. In general, the Act authorizes Recipients to retain title to inventions resulting from their Federally funded research and to license such inventions to commercial entities for development. Specifically, the Act states that: "It is the policy and objective of the Congress to use the patent system to promote the utilization of inventions arising from Federally supported research or development; to encourage maximum participation of small business firms in Federally sponsored research and development efforts; to promote collaboration between commercial concerns and non-profit organizations, including universities; to ensure that inventions made by non-profit organizations and small business firms are used to promote free competition and enterprise; to promote the commercialization and public availability of inventions made in the United States by United States industry and labor; to ensure that the Government obtains sufficient rights in federally supported inventions to meet the needs of the Government and protect against nonuse or unreasonable use of inventions; and to minimize the costs of administering policies in this area."(2) The provisions of the Act have been implemented through regulations issued by the Department of Commerce and adopted by the Department of Health and Human Services (3). The Act serves the public not only by encouraging the development of useful commercial products such as drugs and clinical diagnostic materials, but also by providing economic benefits, and enhancing U.S. competitiveness in the global market place. Since its passage, the Bayh-Dole Act has been effective in promoting the transfer of technology from Recipients to industry as evidenced by the aggressive pursuit of patenting and licensing and the proliferation of university/industry collaborations.(4) In addition, the development of many new and important drugs and devices has been facilitated by increased industrial support for academic research (5) and the explosion in the licensing of university owned inventions (6). Furthermore, statistics indicate that the Act has provided significant economic benefits which are projected as increasing between 25 to 30 percent per year (7). RECIPIENT RESPONSIBILITIES In keeping with the objectives and policies of Bayh-Dole, it is incumbent upon Recipients to effectively and efficiently transfer technology to industry for commercial development. However, in doing so Recipients must also comply with the specific terms of the Act, its implementing regulations, and the terms and conditions of each NIH award and ensure that such compliance is reflected in their agreements with commercial entities. In carrying out that responsibility, at a minimum, Recipients need to concern themselves with issues involving maintenance of academic freedom for institutions and investigators, fair access to information, timeliness of notification and reporting requirements, rational licensing to commercial entities, and adherence to the specific requirements of the Act and NIH funding agreements. While sponsored research agreements frequently are used where basic research is involved and no invention exists to disclose nor intellectual property to license at the time the agreement is executed, Recipients should anticipate such issues and consider the following points in developing a sponsored research agreement. The first section, Universal Points for Consideration, highlights several requirements and issues that Recipients should consider in all proposed sponsored research agreements. The second section, Points for Special Consideration, delineates circumstances which suggest heightened scrutiny. The third section, Other Points for Consideration by Non-Profit Recipients, contains additional considerations which apply only to non-profit Recipients. UNIVERSAL POINTS FOR CONSIDERATION Academic Freedom Academic research freedom based upon social collaboration within the scientific community and the scrutiny of claims and beliefs by its members is at the heart of scientific advancement within the United States. Primarily through Federal funding, academic institutions have contributed to fundamental knowledge and techniques upon which current and future scientific discoveries and technological innovations depend. Therefore, the preservation of academic freedom for Recipient institutions and researchers is of considerable concern to the NIH. Recipients should be aware that their interest in the scientific endeavor covered by a sponsored research agreement and the interest of the industrial sponsor may not be totally consonant. As a result, in general, Recipients should ensure that sponsored research agreements preserve the freedom for academic researchers to select projects, collaborate with other scientists, determine the types of sponsored research activities in which they wish to participate, and communicate their research findings at meetings, and by publication and through other means (8). Academic researchers also should be made aware of any agreements executed by their institutions which may restrict their ability to pursue research activities and publish research results. Recipients also should maintain their independence to pursue their own mission without undue influence or restraint by their industrial sponsors. For example, an agreement which gives an industrial sponsor the ability to direct the research mission of a Recipient would be inappropriate. Dissemination of Research Results Recipients must ensure that the timely dissemination of research findings is not adversely affected by the conditions of a sponsored research agreement. For example, in the case of research grants, the PHS Grants Policy Statement, incorporated as a condition of each NIH research grant, details policies on publication of research results, responsibilities to disseminate information on unique research resources, and standards of conduct for the organization's employees. Although an industrial sponsor's consideration of the commercial applicability of specific research findings and/or the filing of a patent application to secure intellectual property rights may justify a need to delay disclosure of research findings, a delay of thirty (30) to sixty (60) days is generally viewed as a reasonable period for such activity. Depending upon the individual circumstances, Recipients could consider a shorter or longer period of time, as they deem appropriate. In addition to the timing, a sponsored research agreement which requires the disclosure of inventions and research findings developed with NIH funds to an industrial sponsor prior to submission of the invention disclosure to the NIH, may be inconsistent with the terms and conditions of the NIH grant or contract. Utilization The NIH also has a concern that Federally funded technology be developed and commercialized in an expedited and efficient manner. In deciding to enter into an agreement with an commercial entity, Recipients should consider whether the organization has the experience, capability, and commitment to bring its likely inventions to commercial status. Additionally, Recipients should not enter into sponsored research agreements that permit a sponsor to tie up the development of a technology by acquiring exclusive licensing rights to the product of given research results before deciding whether or not it will actively develop and commercialize that product. Recipients could provide a sponsor with an option to pursue licensing rights. It is reasonable for such options to be limited to no more than six (6) months after disclosure to the authorized representative of the sponsor. However, individual circumstances may dictate a shorter or longer period of time. After the option period expires, the technology should become available for licensing to other entities. Moreover, once a sponsor decides not to exercise its option, normally, the agreement should not provide for a second opportunity to obtain licensing rights by matching other parties' offers for the rights. Such actions enable Grantees to license to companies presenting a bona fide commercialization plan, thus expediting the availability of products to the public. In order to ensure that technology is developed rapidly and is not being subjected to delays, Recipients should also establish, maintain, and actively administer policies and procedures which ensure that licenses arising from sponsored research agreements contain due diligence requirements and benchmarks to monitor performance. When future rights to as yet undiscovered inventions are included in a sponsored research agreement, benchmarks for development of each such invention should be established as they become available for commercial development. In addition, Recipients should actively monitor licensees in accordance with those requirements and benchmarks to assure compliance with Recipient obligations under the Act. Recipients also need to ensure that they have internal systems to provide required utilization reports to the NIH on each invention. Those reports are required by Department of Commerce regulation and include such items as the status of development, first commercial sale, and amount of gross royalties received. Detailed information about the precise utilization report requirements can be obtained from the NIH Office of Extramural Research. U.S. Manufacture The Bayh-Dole Act requires that products developed with Federal funds and used and sold in the United States, be substantially manufactured here. In granting exclusive rights to use or sell any subject invention in the United States, Recipients must ensure that each agreement requires that any products embodying the subject invention or produced through the use of the subject invention will be manufactured substantially in the United States. In individual cases, a request for waiver may be considered by the NIH. A determination will be made based upon a showing by the Recipient that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible. In granting a waiver of the U.S. manufacture requirement, the NIH may consider other benefits conferred on the United States by the potential license including the rapid availability of a product of benefit to the health of the American people. Notification Requirements and Records In sponsored research agreements, as in other contexts, Recipients must also ensure that invention, patent and license notification requirements are adhered to in a timely manner. Timeliness considerations include prompt (1) employee notification to Recipient administrators of an invention made under NIH funding, (2) written disclosure to NIH in sufficient technical detail to adequately describe the invention, (3) written election to the NIH of whether or not the Recipient will retain title to such invention, (4) adherence to time frames for initial filing of patent applications in the United States and the filing of foreign patent applications, (5) execution and delivery of all instruments necessary to establish or confirm NIH rights throughout the world in the subject inventions to which the Recipient has elected to retain title, (6) notification to the NIH of any decision not to continue patent prosecution, pay fees, or defend the patent in a reexamination or opposition proceeding on a patent, in any country, (7) conveyance of title to NIH when requested, and (8) specification in any United States patent applications and any patent issuing thereon covering a subject invention that the invention was made with government support (9). Specifically, as conditions of NIH grants and cooperative agreements, Recipients must fully notify the NIH in a timely manner when an invention has been developed. In addition, PHS grants policy requires that when applying for continued funding in each subsequent funding period, the institution must also provide either a listing of all inventions made during the preceding budget period or a certification that no inventions were made during the applicable period. A final invention statement and certification listing all inventions that were conceived or first actually reduced to practice during the course of work under the funding agreement is required within ninety (90) days following the expiration or termination of support on an applicable project. Additionally, Recipients need to adhere to the specific requirements contained in the patent clauses of their contracts as well as the general provisions of the Federal Acquisition Regulations. Furthermore, Recipients must also document their compliance with the requirements of the Act, regulations, and terms and conditions of NIH awards, generally and as related to sponsored research agreements. Recipient records must be available for review by authorized Federal officials in accordance with the terms and conditions of the award. For example, concerning access and retention of records under NIH grants and cooperative agreements, regulations require grantees to retain financial and programmatic records, supporting documents, statistical records, and all other grantee records which may reasonably be considered pertinent to a grant or subgrant (10). POINTS FOR SPECIAL CONSIDERATION The NIH has identified several situations, outlined below, in which Recipients should exercise heightened sensitivity and scrutiny in the development of sponsored research agreements. Such an exercise should confirm that a sponsored research agreement does not adversely impact NIH funded activities and Recipient concerns such as academic freedom, or shift control of the Recipient's scientific activities, management, and independence into the hands of the sponsor. While there is no requirement that Recipients submit proposed sponsored research agreements to the NIH for review, at the discretion of the Recipient, the NIH Deputy Director for Extramural Research may be consulted for additional clarification in instances where special considerations warrant. First, Recipients should subject their sponsored research agreements to heightened scrutiny when one or more of the following threshold criteria apply: (a) the amount of financial support from the sponsor meets or exceeds $5 million in any one year, or, $50 million total over the total period of funding under the agreement; (b) the proportion of funding by the sponsor exceeds 20 per cent of the Recipient's total research funding; (c) the sponsor's prospective licensing rights cover all technologies developed by a major group or component of the Recipient organization, such as a large laboratory, department or center, or the technologies in question represent a substantial proportion of the anticipated intellectual output of the Recipient's research staff; or (d) the duration of the proposed agreement is for more than 5 years. If one or more of these criteria apply, it is more likely that the proposed sponsored research agreement will adversely affect open commercial access, especially for small businesses, to a Recipient's Federally funded research activities and may delay or impede the rapid development and commercialization of technology. Second, Recipients should be concerned if the scope of the sponsored research agreement is so broad that the subsequent exclusive licensing of technology under the agreement provides a single sponsor with access to a wide array of Recipient research findings and technologies that effectively exclude other organizations from reasonable access to a Recipient's technology. This type of arrangement can also delay commercialization if the sponsor does not have the interest or the capability to develop the technology. Third, if the sponsor's contribution of funds is to support a Recipient's general operations rather than specifically defined research projects, the Recipient should consider the amount of the sponsor's general funding in relation to funds from other sources when determining what prospective intellectual property rights the sponsor will obtain from the results of the Recipient research. There should be a reasonable relationship between the amount of money contributed by the sponsor and the rights that it is granted both to review and license resulting technology or inventions. Additionally, Recipients should also consider the level of risk that the sponsor will be assuming in order to obtain rights. In general, the greater the restrictions on a sponsor's rights, the higher the sponsor's risk in receiving benefit from its support. As an extreme example, a sponsor should not be able to provide 5 percent of the Recipient's total support, review 100 percent of the Recipient's inventions, and receive rights or a first option to 50 percent of the research results generated by the Recipient. Where general funding is involved, a Recipient may consider a number of alternative actions, including establishing some mechanism to limit the review and licensing rights of the sponsor to a particular segment or percentage of the inventions for a set period of time. For example, the Recipient may require the sponsor to select those research areas on projects to which its general funding rights would attach in advance, thereby freeing up research areas that may be of interest to other commercial entities. Because, by its nature, general funding is less directed and its results more imprecise, Recipients should carefully monitor the impact on open competition and fair access by small business of the sponsor's licensing practices for technology supported by general funding. Fourth, Recipients should avoid any other unusual practice or stipulation that might generate public concern or undermine rather than serve the public interest. OTHER POINTS FOR CONSIDERATION BY NON-PROFIT RECIPIENTS The following points are to aid non-profit Recipients in administering the Act and in complying with the requirements of NIH funding agreements. First, Recipients must ensure that the rights to inventions resulting from Federal funding are not assigned without NIH approval. An exception to this is when the assignment is made to an organization which has as one of its primary functions the management of inventions, in which case, the assignee will be subject to the same provisions as the Recipient. Second, Recipients must share royalties collected on NIH supported inventions with the inventors and the balance of any royalties or income earned, after payment of expenses, including payment to inventors and incidental expenses to the administration of subject inventions, must be utilized for the support of scientific research or education. Third, Recipients must employ reasonable efforts to attract licensees of subject inventions that are small business firms. Additionally, Recipients must provide a preference to small business firms when licensing a subject invention if Recipients determine that small business firms have plans or proposals for marketing the invention which, if executed, are equally as likely to bring the invention to practical application as any plans or proposals from applicants that are not small business firms. However, Recipients must be satisfied that the small business firms have the capability and resources to carry out plans or proposals. The decision whether to give a preference in any specific case is at the discretion of the Recipient. However, since sponsored research agreements typically provide exclusive licenses or options to such rights to the sponsor, Recipients should seriously consider and provide for these issues when negotiating such agreements. CONCLUSION Technology transfer is a vehicle through which the fruits of NIH funded research are transferred to industry to be ultimately developed into preventive, diagnostic and therapeutic products to advance human health. In a dynamic and multinational marketplace, if the United States is to remain a world leader in technological and scientific innovation, both the public and private sectors must work together to foster rapid development and commercialization of useful products to benefit human health, stimulate the economy, and enhance our international competitiveness, while at the same time protecting taxpayers' investment and safeguarding the principles of scientific integrity and academic freedom. It is in this spirit that the NIH encourages Recipients to address the issues and apply the points for consideration identified in this document when developing sponsored research agreements with commercial entities. FOOTNOTES 1. Public Law 96-517, enacted December 12, 1980, Chapter 18--Patent Rights in Inventions Made with Federal Assistance. 2. Public Law 96-517, Chapter 18, Patent Rights in Inventions Made With Federal Assistance, Sec. 200. 3. The Department of Commerce regulations are at 37 Code of Federal Regulations (CFR) Part 401 and supersede applicable portions of 45 CFR Parts 6 and 8. 4. Approximately one in every four university patents issued in the late 1980s was for a biomedical or health related invention. In the early 1970s, the ratio was one in eight. Source: Science and Engineering Indicators, 1993, National Science Foundation. 5. While still representing less than 10 percent of the total funding for academic research, it is estimated that nearly 2 percent of United States industry's expenditures for R&D now goes to academic institutions, as compared with less than 1 percent in 1971. Source: Science and Engineering Indicators, 1993, National Science Foundation. 6. Over 1000 licenses or options were executed in Fiscal Year 1992 by 260 academic institutions surveyed. The institutions also reported that they had over 5000 active licenses in place at the time of the survey. Source: Association of University Transfer Managers Licensing Survey FY 1991-1992, published October, 1993. 7. In FY 1992 sales and employment attributable to the Act were estimated to be as follows: between $9 and $13 billion in sales and 50-100,000 jobs, with an annual increase of between 25 and 30 percent. Source: Dr. Ashley J. Stevens, Director, Office of Technology Transfer, Dana-Farber Cancer Institute, Association of University Technology Managers Winter Meeting, 1994. 8. The NIH recognizes that there may be certain instances when it may be reasonable for a Grantee institution to agree to minimally restrict a researcher from collaborating with another industrial partner when the subject matter of such collaboration overlaps with that of the sponsored research agreement. 9. The regulation, 37 CFR 401.14(F)(4), requires that the following clause be used: "This invention was made with government support under (identify the grant, contract, or cooperative agreement) awarded by (identify the Institute or Center), National Institutes of Health. The government has certain rights in the invention." 10. The regulations are set forth at 45 CFR Part 74, Subpart D and 45 CFR Part 92.42. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** INCLUDING AIDS RESEARCH IN BEHAVIORAL THERAPIES DEVELOPMENT PROGRAM NIH GUIDE, Volume 23, Number 40, November 18, 1994 PA NUMBER: PA-94-078 P.T. 34; K.W. 0404009, 0715008, 0730050 National Institute on Drug Abuse For those investigators applying for grants under the Behavioral Therapies Development Program, this announcement is meant to supplement Program Announcement (PA-94-078) published in the NIH Guide, Vol. 22, No. 26, July 15, 1994, which is still in effect and should be consulted in conjunction with this addendum. PURPOSE The National Institute on Drug Abuse (NIDA) will support the study of behavioral therapies (including counseling, psychotherapies, behavior therapies, and skills training approaches) that will potentially have a significant impact on reducing AIDS risk behaviors. Therefore, the purpose of this addendum is to encourage the incorporation of HIV risk reduction strategies as an integral component in the development of behavioral therapies for drug abuse and dependence treatment. Also encouraged is the use of HIV risk measures and the provision of HIV testing and counseling to participating subjects. Development of or research on HIV risk reduction interventions that can be integrated into drug abuse treatment are potential areas of interest, i.e., (1) incorporation of risk reduction techniques into routine counseling or other behavioral interventions being studied; (2) strategies to enhance motivation to change for drug abusers at risk for HIV; (3) sexual risk reduction interventions; (4) new counseling strategies for the provision of HIV testing and counseling and the determination of the effective components of the counseling process; (5) approaches for distinct drug abusing patient populations sensitive to cultural characteristics or unique needs of specific subgroups; (6) interventions designed to teach effective harm reduction techniques; (7) strategies to improve HIV treatment compliance; or (8) interventions targeting drug treatment avoiders or treatment drop-outs. Applicants are strongly encouraged to: (1) collect data on all potential risk behaviors, including, drug administration and sexual practices; and (2) include clearly defined measures of the effect of the therapies on AIDS risk behaviors, e.g., improvement of condom use skills, and decrease in needle use frequency and high risk sexual behaviors. Applications must be submitted on the grant application form PHS 398 (rev. 9/91) using the receipt dates described in the form. AWARD CRITERIA The following funding considerations will be applied: o Incorporation of HIV relevant risk reduction strategies in the behavioral therapies or other treatments being developed and tested. o Inclusion of HIV risk assessment measures and discussion of the use/provision of HIV testing and counseling. INQUIRIES Direct inquiries regarding programmatic issues to: Ms. Debra Grossman or Dr. Elizabeth Rahdert Treatment Research Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-30 Rockville, MD 20857 Telephone: (301) 443-0107 Email: dgrossma@aoada.ssw.dhhs.gov $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** SUPPORT FOR NATIONAL RESEARCH SERVICE AWARDS NIH GUIDE, Volume 23, Number 40, November 18, 1994 P.T. 34; K.W. 0404009 National Institute on Drug Abuse PURPOSE The National Institute on Drug Abuse (NIDA) is interested in expanding the number of qualified researchers engaged in biomedical, behavioral and health services drug abuse and addiction research. To this end, NIDA has set-aside an additional $1 million for National Research Service Awards (NRSAs) in Fiscal Year 1995. NIDA anticipates this set-aside will bring the total amount of funding available for new and competing NRSAs to between $2 to $3 million in FY 95. NRSAs are available at the individual predoctoral (F30, F31) and postdoctoral (F32) levels, and for institutional training grants (T32). The NRSAs are offered in all areas of drug abuse research, however, priority areas for funding will include: o clinical neuroscience, o health services research, o molecular neurobiology, o perinatology/human development, o basic and clinical behavioral sciences, and o HIV/AIDS and drug abuse. Applications for Individual NRSA awards must be submitted on the form PHS 416-1 using the standard receipt dates for fellowships, i.e., April 5, August 5, and December 5. Institutional NRSA applications must be submitted on form PHS 398 using the standard receipt dates for institutional NRSA applications, i.e., January 10, May 10, and September 10. INQUIRIES Direct inquiries for programmatic issues to: Timothy P. Condon, Ph.D. Office of Science Policy, Education, and Legislation National Institute on Drug Abuse 5600 Fishers Lane, Room 10A55 Rockville, MD 20857 Telephone: (301) 443-6071 Email: tcondon@aoada.ssw.dhhs.gov Direct inquiries for administrative or financial issues to: Gary P. Fleming, J.D. Office of Planning and Resource Management National Institute on Drug Abuse 5600 Fishers Lane, Room 8A54 Rockville, MD 20857 Telephone: (301) 443-6710 Email: gfleming@aoada.ssw.dhhs.gov $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** SUPPORT FOR MENTORED CAREER AWARDS (K20, K21) AND EXPEDITED REVIEW NIH GUIDE, Volume 23, Number 40, November 18, 1994 P.T. 34; K.W. 0404009, 0710030 National Institute on Drug Abuse The National Institute on Drug Abuse (NIDA) is interested in expanding the number of qualified researchers, especially clinicians, engaged in biomedical and behavioral drug abuse and addiction research. To this end, NIDA has set aside an additional $1.7 million for mentored career awards (K20, K21) in Fiscal Year 1995. These programs give promising, new investigators the opportunity to work with established researchers for a period of up to five years. Due to NIDA's particular interest in attracting clinically trained individuals to the field of drug abuse and addiction research, most of the funding for this cycle will be awarded to the Scientist Development Award for Clinicians (K20). To enhance the number of applications that will be considered during this fiscal year, all K20 and K21 (AIDS and non-AIDS) applications received by the February 1, 1995 deadline will be reviewed through an expedited initial review process. Both the set-aside funds and the expedited review apply only to the K20 and K21 applications. In order to facilitate the expedited initial review of these applications, in addition to sending the original and four copies to the Division of Research Grants, a copy of each application must be sent directly to: Ms. Eleanor Friedenberg Office of External Program Review National Institute on Drug Abuse 5600 Fishers Lane, Room 10-42 Rockville, MD 20857 Both AIDS and non-AIDS K20 and K21 applications will be reviewed in order to permit the selection of applications for funding by the National Advisory Council on Drug Abuse in May and allow for funding by May 31, 1994. INQUIRIES Timothy P. Condon, Ph.D. Office of Science Policy, Education, and Legislation National Institute on Drug Abuse 5600 Fishers Lane, Room 10A55 Rockville, MD 20857 Telephone: (301) 443-6071 email: tcondon@aoada.ssw.dhhs.gov Contact for administrative and financial matters: Gary P. Fleming, J.D. Office of Planning and Resource Management National Institute on Drug Abuse 5600 Fishers Lane, Room 8A54 Rockville, MD 20857 Telephone: (301) 443-6710 email: gfleming@aoada.ssw.dhhs.gov $$N4 END ************************************************************ $$N5 BEGIN ********************************************************** NIAID AWARD AND APPLICATION POLICIES NIH GUIDE, Volume 23, Number 40, November 18, 1994 P.T. 34, 44; K.W. 1014006 National Institute of Allergy and Infectious Diseases Based on recommendations of its National Advisory Council, the National Institute of Allergy and Infectious Diseases (NIAID) is announcing new award and application policies for (1) competitive renewal investigator-initiated research grants and (2) institutional National Research Service Award (NRSA) training grants. In addition, NIAID will no longer accept for review or award investigator- initiated competing renewal program project grant applications unless they are in response to an NIAID Program Announcement, Re-issuance of an NIAID RFA, or have received specific approval from the Director, NIAID or his designee before their submission. 1. Award Limits for Competing Renewal Research Grants Because of inordinate cost increases for competing renewal grants, the direct costs awarded in the first year to a research project grant (R01) resulting from a competing renewal application will be limited to no more than a 10 percent increase over the direct costs awarded in the last non-competing year of that grant. This policy will be implemented for competing renewal applications submitted on or after the February 1, 1995 receipt date. 2. Limits on Trainees for Institutional NRSA Training Grants; Single Annual Receipt Date for Competing Applications Current commitments for institutional NRSA training grants consume a large proportion of the NIAID's training budget and have severely constrained the NIAID's ability to award new outstanding training grant applications. As a result the following changes will be made for Fiscal Year 1996: a. Training grants approved for five to six pre-doctoral trainees per year will be reduced by one trainee per year; those with seven or more will be reduced by two trainees. b. Training grants approved for four to six postdoctoral trainees will be reduced by one trainee; those with seven or more will be reduced by two trainees. c. For Fiscal Year 1996 funding, competing (new and continuation) training grant applications will be accepted by NIAID on two future receipt dates: January 10, 1995 and May 10, 1995. Thereafter, NIAID will accept competing applications for institutional training grants on one receipt date annually - January 10. 3. Competing renewal applications for RFA-based single and multi- project research grants and cooperative agreements The NIAID awards single research project grants (R01 and R29) and cooperative agreements (U01s) and multi-project grants (P01) and cooperative agreements (U19s) as well as other types of grants under requests for applications (RFAs). When the NIAID determines that an RFA will not be reissued and does not announce the continuation of an initiative under a Program Announcement, awardees should consult with NIAID program staff about submitting their applications for continuation of all or parts of their research program as regular research grants (R01s). Two or more related R01 applications may be submitted as Interactive Research Project Grant (IRPG) applications (see Program Announcement PA-94-086 Investigator-Initiated Interactive Research Project Grants NIH Guide, Vol. 23, No. 28, July 29, 1994). Under exceptional circumstances, the NIAID Director or his designee may permit exceptions from these policies. INQUIRIES John J. McGowan, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 3C20 Bethesda, MD 20892 Telephone: (301) 496-7291 FAX: (301) 402-0369 E-Mail: john_mcgowan@exec.niaid.pc.niaid.nih.gov $$N5 END ************************************************************ $$N6 BEGIN ********************************************************** NCI BRIEFING ON PROSTATE SPORE PROGRAM NIH GUIDE, Volume 23, Number 40, November 18, 1994 P.T. 34; K.W. 0715035, 0705075 National Cancer Institute The National Cancer Institute (NCI) plans to conduct a briefing session on the Prostate SPORE program on Wednesday, November 30, 1994 at the Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, Maryland. This briefing is for those who plan to submit a letter of intent in response to the RFA for SPOREs in Prostate Cancer (CA-94-031, NIH Guide, Vol. 23, No. 33, September 16, 1994). The briefing will begin at 8:30 a.m. and will adjourn by noon. There will be ample time for questions and answers. A summary of the proceedings of this meeting will be available upon request. The meeting is open to the public and all interested parties are invited to attend. Rooms for Tuesday night, November 29, are available at a government rate of $113. Reservations must be made directly to the hotel at (301) 897-9400. To receive the government rate, you must mention the National Cancer Institute SPORE meeting. INQUIRIES For further information, contact: Dr. Andrew Chiarodo Division of Cancer Biology, Diagnosis and Centers National Cancer Institute Executive Plaza North, Suite 512 6130 Executive Boulevard Bethesda, MD 20892-7386 Telephone: (301) 496-8528 $$N6 END ************************************************************ $$N7 BEGIN ********************************************************** NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES, EXTRAMURAL PROGRAMS NIH GUIDE, Volume 23, Number 40, November 18, 1994 P.T. 34; K.W. 1014006 National Institute of Arthritis and Musculoskeletal and Skin Diseases On November 17, 1994, the staff of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Extramural Programs (EP) and Office of Prevention, Epidemiology, and Clinical Applications (OPECA), moves to the new William H. Natcher Building on the main NIH campus. The mailing address is: (Name of staff member) National Institute of Arthritis and Musculoskeletal and Skin Diseases 45 Center Drive MSC 6500 Bethesda, MD 20892-6500 Telephone and FAX numbers are changing as well. Listed below are the new telephone numbers and room addresses for key contact persons. For the telephone number of an NIAMS EP or OPECA staff member who is not included in this list, call the person's old number (a recording will give the new number for several weeks) or call the office of the Acting Director, EP (301) 594-2463. Acting Director, EP, 5AS-13F -- (301) 594-2463 Arthritis Branch, Dr. Susana A.Serrate-Sztein, 5AS-37G--(301) 594-5032 Contracts Management Branch, Ms. Eileen Webster-Cissel, 5AS-13B-- (301) 594-2543 Muscle Biology Branch, Dr. Richard W. Lymn -- (301) 594-5128 Musculoskeletal Diseases Branch, Dr. Stephen L. Gordon, 5AS-25E -- (301) 594-4977 Skin Diseases Branch, Dr. Alan N. Moshell, 5AS-25L -- (301) 594-5017 Bone Biology and Bone Diseases Branch, Dr. Joan A. Mcgowan, 5AS-43E - - (301) 594-5055 Centers Program, Dr. Julia B. Freeman, 5AS-19F -- (301) 594-5052 Review Branch, Dr. Tommy L. Broadwater, 5AS-25U -- (301) 494-4952 Grants Management Branch, Ms. Diane M. Watson, 5AS-49F -- (301) 594-3535 Office of Prevention, Epidemiology and Clinical Applications, Dr. Stephen P. Heyse, 5AS-53 -- (301) 496- 0434 Natcher FAX number -- (301) 480-4543 $$N7 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN NIH-ES-95-22 ********************************************* POTENTIAL FOR ENVIRONMENTAL AND THERAPEUTIC AGENTS TO INDUCE IMMUNOTOXICITY NIH GUIDE, Volume 23, Number 40, November 18, 1994 RFP AVAILABLE: NIH-ES-95-22 P.T. 34; K.W. 1007009, 0710070, 1007003 National Institute of Environmental Health Sciences The National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), is soliciting proposals from offerors that have the capabilities and facilities to perform the following tasks: Task I, demonstrate proficiency in the performance of the Immune Testing Assays provided by the Environmental Immunology and Neurobiology Section (EINS) to detect chemical-induced immune alteration. The sub-task I-A Immunosuppression will involve Immunopathology, Humoral Mediated Immunity, Cell Mediated Immunity, Cell Quantification, Non-specific Immunity and Host Resistance Assays and sub-task I-B Hypersensitivity Assays will involve Mouse ear swelling test (MEST) and Local lymph node assay (LLNA). Task II-A, upon demonstration of proficiency, the contractor will test four xenobiotics per year using tests described in Task I-A. Task II-B, the contractor will test two xenobiotics per year thereafter. Task II-C the contractor will test two xenobiotics per year for their potential to produce skin hypersensitivity in the mouse. Task II-D, the contractor will test one xenobiotic per year for the potential to influence autoimmune disease. Task III - Development and/or Evaluation of New and Improved Technology will be conducted beginning in year two of the contract, e.g., to quantitate certain biomedical changes. The Government estimates that the project will require approximately 1.5 professional person-years, 1.8 senior technical person years and 1.0 technical person years per contract year. The estimated period of performance is five years. INQUIRIES All responsible sources may submit a proposal that will be considered by the Agency. Release of Request for Proposals (RFP) No. NIH- ES-95-22 is anticipated on or about November 9, 1994 with proposals due January 3, 1995. Requests must reference the RFP number and must be directed to: Howard Hill Contracts and Procurement Management Branch National Institute of Environmental Health Sciences 79 T.W. Alexander Drive, Building 4401 Research Commons P.O. Box 12874 Research Triangle Park, NC 27709 Telephone: (919) 541-4971 FAX: (919) 541-2712 $$R1 END ************************************************************ $$R2 BEGIN NCI-CN-55040-05 ****************************************** RANDOMIZED TRIAL ON CLINICAL MANAGEMENT OF ASCUS AND LSIL OF THE UTERINE CERVIX - CLINICAL CENTERS NIH GUIDE, Volume 23, Number 40, November 18, 1994 RFP AVAILABLE: NCI-CN-55040-05 P.T. 34; K.W. 0715035, 0755015, 0755018 National Cancer Institute The proposed project is a three-armed clinical trial of 6 years duration involving 7,200 females aged 16 and over. The subjects will be randomized to one of three arms, each containing 2,400 females. Each clinical center should be able to recruit a minimum of 1,200 randomized subjects within a maximum time period of 18 months. Of the 1,200 recruited subjects, 600 subjects shall have recently diagnosed LSIL (low-grade squamous intraepithelial lesion) and 600 subjects shall have ASCUS (atypical squamous cells of undetermined significance). The offeror must document their referral base of ASCUS/LSIL diagnosed patients for the past year (1993). The trial goals and major objectives are as follows: (1) to determine whether human papillomavirus (HPV) DNA testing can effectively triage women with a cytologic diagnosis of ASCUS or LSIL; (2) to develop clinical management guidelines and provide prognostic information for the ASCUS and LSIL diagnostic categories of the Bethesda System; and (3) to determine whether the cost of screening and treatment for the potential precursor lesions of cervical cancer can be reduced through improved triage. INQUIRIES Request for this solicitation must be in writing and must reference the RFP number, NCI-CN-55040-05. The RFP is tentatively scheduled for release on December 1, 1994 with proposals due approximately January 30, 1995. Four to six awards are anticipated. No collect calls will be accepted. Requests should be mailed to: Gary Topper Research Contracts Branch, PCCS National Cancer Institute 6120 Executive Boulevard Bethesda, MD 20892-7226 Telephone: (301) 496-8603 $$R2 END ************************************************************ $$R3 BEGIN NCI-CN-55042-07 ****************************************** COLPOSCOPY QUALITY CONTROL GROUP FOR THE ASCUS/LSIL CLINICAL MANAGEMENT TRIAL NIH GUIDE, Volume 23, Number 40, November 18, 1994 RFP AVAILABLE: NCI-CN-55042-07 P.T. 34; K.W. 0715035, 0735015, 0755015 National Cancer Institute The National Cancer Institute, Division of Cancer Prevention and Control, is soliciting proposals for a Colposcopy Quality Control (QC) Group that will be responsible for overseeing all aspects of randomized clinical trial involving colposcopy and the taking of cervical biopsies among 3,600 women with the cervical cytologic diagnoses of "atypical squamous cells of undetermined significance" (ASCUS) and 3,600 women with "low-grade squamous intra-epithelial lesions" (LSIL). The Colposcopy QC Group shall be responsible for overseeing the quality of all aspects of the Trial involving colposcopies and the taking of cervical biopsies. The general requirements include: (1) preparation with the other collaborators of the final protocols, data systems, and study forms; specifically, identifying the optimal means to assure the highest possible quality of colposcopic examinations and cervical biopsies; (2) prior to enrollment, optimizing and standardizing clinic colposcopic and From owner-sci-resources@net.bio.net Mon Nov 28 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DK-95-003 - V23(41) 11/25/94 Date: 28 Nov 1994 21:17:22 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 378 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3bedh2$nj7@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA DK95003 DK-95-003 P1O1 *************************************** CYSTIC FIBROSIS CORE CENTER NIH GUIDE, Volume 23, Number 41, November 25, 1994 RFA: DK-95-003 P.T. National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: June 22, 1995 Application Receipt Date: July 20, 1995 PURPOSE Cystic Fibrosis (CF) Core Centers provide shared resources to enhance research ranging from elucidation of the molecular pathogenesis of CF to development of new therapies for this disorder. Biomedical research cores are intended to enhance the efficiency of research and foster collaborations at institutions with strong existing bases of research relevant to CF. In addition to biomedical research cores, Centers provide support for pilot and feasibility studies and an enhanced environment for research training. 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), Cystic Fibrosis Core Center, is related to the priority area of chronic 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 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. An outstanding interdisciplinary program of CF research must be in existence at the applicant organization. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) core center grant (P30). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed five years. The maximum budget request is limited to $750,000 in direct costs in any annual budget period. The anticipated award date is April 1, 1996. This RFA is a one-time solicitation. FUNDS AVAILABLE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) anticipates funding one core center grant application submitted in response to this RFA, and will commit up to $1.1 million total costs in FY 1996 for this purpose. The receipt of one competing continuation application is anticipated, which will be in competition together with other applications received in response to this RFA. Although this program is provided for in the financial plans of the NIDDK, the award of a grant pursuant to this RFA is contingent upon the availability of funds for this purpose and upon the receipt of at least one application of high scientific merit. RESEARCH OBJECTIVES CF is the most common fatal genetic disease in caucasians, affecting approximately one in 2500 newborns. Since the cloning of the CF gene and identification of its protein product as a cAMP-regulated chloride channel, there has been impressive progress in the molecular understanding of this disorder. CF Core Centers are part of an integrated program of CF-related research support within the NIDDK directed at further defining the molecular mechanisms underlying CF and translating information about the molecular basis of the disease into new treatments. Continued progress will depend on multidisciplinary collaborations among clinical and basic scientists. Core centers provide a focus for enhancing such collaborations. Centers promote efficient management of resources, interaction and collaboration among scientists in multiple disciplines, and a multifaceted approach to a common goal. The objective of the core center is facilitation of progress in research on CF with the ultimate goal of developing new therapies for this disorder. CF Core Centers are designed to enhance the efficiency and effectiveness of an established, ongoing program of research through provision of core resources, support of pilot and feasibility studies, and support of program enrichment activities. Thus, an outstanding existing program of biomedical research in the area of CF is an essential prerequisite for a CF Core Center. This research should be in the form of NIH-funded research projects (R01 or R29), program projects (P01), Specialized Centers of Research (P50), or other peer-reviewed research such as that supported by the Cystic Fibrosis Foundation. This established research program must be in existence at the time of submission of a CF Core Center application. A CF Core Center is composed of shared resources (cores) that enhance productivity or in other ways benefit a group of investigators pursuing a multifaceted approach to significant problems related to the pathogenesis and treatment of CF. The CF Core Center is intended to improve the quality and efficiency of research on CF by providing shared access to specialized technical resources and expertise. Examples of cores that would be considered responsive to this RFA include the following: electrophysiology, cell morphology, microscopy, imaging, assay, tissue culture, protein expression, mutagenesis, transgenic, animal models, structural biology, vector, and clinical resources. Specific cores should be proposed based on the requirements of the investigators at the applicant institution. Two other types of activities may also be supported with center funding: a pilot and feasibility program and an enrichment program. The pilot and feasibility program provides modest support for initiatives by new investigators, established investigators entering CF research, or established CF investigators exploring a new research direction related to CF. The Center grant may also include limited funds for program enrichment such as, but not limited to, seminars, visiting scientists, consultants, and workshops. 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. SPECIAL REQUIREMENTS Applicants must be willing to participate in an annual centers directors meeting and are advised to include such travel in their budget request. 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 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 June 22, 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 NIDDK staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 6AS37E 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7515 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. Applicants should request supplemental guidelines for preparing a Core Center grant from the program administrator listed under INQUIRIES. These guidelines contain additional information and suggestions on the format, content, and review of applications. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 6AS37E 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Applications must be received by July 20, 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 responsiveness by the NIDDK. 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 NIDDK 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 notified. It is essential that the written application be in a form to be reviewed on its own merit, since no site-visit is anticipated. Additional information will be accepted after the official receipt date only if it is submitted at the request of the Scientific Review Administrator. Review Criteria o Scientific excellence of the Center's research base that must have a broad and central focus in CF. The separately funded research that will utilize the Core Center must be relevant to the Core Center objectives (see above), and the likelihood for meaningful collaboration among Center investigators must be demonstrated. o Potential of the cores for contribution to ongoing research, their appropriateness and relevance, their modes of operation, the scientific/technical merit of the proposed methodology, and the suitability of facilities. Renewal applications must address the use, utility, quality control, and cost effectiveness of the cores, and demonstrated progress of any developmental research in the shared resources. o Consideration of the potential impact of the Core Center activity on the national CF research effort and overall coordination and cooperation with other CF-related efforts. o For new applications, the pilot and feasibility program is judged on the basis of: (1) scientific merit of the studies as submitted and (2) the merit of the administrative process for selecting subsequent studies. In competing renewal applications, emphasis is accorded to the program as a whole, including past track record and management of the program. o Efficiency and effectiveness of use and/or planned use of enrichment funds. Although the Center does not specifically support research training, demonstration of accomplishments and future plans related to the training of investigators necessary to conduct research in CF will be considered in assessing the potential to meet Center objectives. The integration of these efforts into the overall Center, including core facilities is of particular importance. o Scientific and administrative leadership abilities of the CF Core Center Director and Associate Director and their commitment and ability to devote adequate time to the effective management of the Core Center, as well as the qualifications and research experience of the core directors 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 work. 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 Institutional commitment to the program, including lines of accountability regarding management of the CF Core Center grant and a commitment to establish new positions as necessary. 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 The anticipated date of award is April 1, 1996. Applications will compete for available funds with all other applications submitted in response to this RFA. Funding decisions will be based on the quality of the proposed Center as determined by peer review, overall balance in the CF Core Center program, and the availability of funds. 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: Judith Fradkin, M.D. Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 5AN24E 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7567 Email: JudithF@DVSGATE.NIDDK.NIH.GOV Direct inquiries regarding fiscal matters to: Donna Huggins Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 6AS49K 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7543 Email: DonnaH@DVSGATE.NIDDK.NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847. 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 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. From owner-sci-resources@net.bio.net Mon Nov 28 22:00:00 1994 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-006 - V23(40) 11/18/94 Date: 28 Nov 1994 21:09:28 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 492 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3bed28$mqe@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95006 PA-95-006 P1O1 *************************************** BIOLOGY OF THE MENOPAUSE: CHANGE OF OVARIAN FUNCTION NIH GUIDE, Volume 23, Number 40, November 18, 1994 PA NUMBER: PA-95-006 P.T. 34; K.W. 0413002, 0705075, 1002004, 1002008 National Institute on Aging National Institute of Child Health and Human Development National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The National Institute on Aging (NIA), in collaboration with the National Institute of Child Health and Human Development (NICHD) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), is interested in receiving applications to support research that elucidates the molecular and cellular mechanisms of the menopausal process. This program announcement addresses age- and menopause-related changes in the pituitary-ovarian axis that result in the dramatic hormonal changes experienced across the menopausal transition. These changes lead to the menopause-related increase in health problems associated with the cardiovascular, skeletal, and genitourinary systems. The primary focus of this program announcement is on understanding the biology of the processes involved in the change in ovarian function across the menopausal transition, using appropriate animal models, human cells or tissue specimens. To increase the number of individuals trained to conduct high quality molecular and cellular research in the combined aging- and reproductive biology-related research areas, the individual postdoctoral fellowship (F32) mechanism is included as eligible for support in this program announcement. 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 PA, Biology of the Menopause: Change of Ovarian Function, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Applicants for the individual postdoctoral fellowship (F32) must be U.S. citizens, noncitizen nationals or individuals who have been lawfully admitted to the U.S. for permanent residence. More information on eligibility requirements for, and features of, individual postdoctoral fellowships is available in the program announcement, "National Research Service Awards for Individual Postdoctoral Fellows", PA-94-055, NIH Guide for Grants and Contracts, Vol. 23, No. 15, April 15, 1994. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Support for this program will be by research project grants (R01), FIRST Awards (R29), and the individual postdoctoral fellowship (F32). RESEARCH OBJECTIVES Background The ovary of the premenopausal non-pregnant human female, as well as the ovary of various animal species, serves as the body's primary source of estradiol-17 beta (E2), the steroid hormone associated with protection of the premenopausal woman from a variety of potential postmenopausal health problems, such as increased risk for decline in cardiovascular, skeletal, and genitourinary system function, and for increased incidence of hot flashes. In addition to E2, the premenopausal ovary also secretes other steroid hormones, such as progestins and androgens. The ovary also produces the glycoprotein inhibin. Progestins, androgens and inhibin all have reasonably well- defined actions within the hypothalamic-pituitary-ovarian (H-P-O) axis but much less well-defined roles in the proper functioning of peripheral tissues. Entry into the climacteric period is associated with declining fertility. Many women experience menstrual cycle irregularity during this period. Early follicular phase FSH levels begin to rise about five years preceding the menopause, even in regularly cycling women. Inhibin, a potential biomarker of ovarian function in the pre- and perimenopausal woman, is reported to decline with an inverse relationship to rising serum FSH levels, although information regarding the roles and temporal relationships of specific forms of inhibin is lacking. There is evidence that pulsatile characteristics of pituitary gonadotropin secretion change in women in their 40s with normal cycles and hormonal levels, suggesting age-related changes in the P-O axis are likely to play an important role in the menopausal process. LH levels become elevated roughly one year prior to menopause. The forms of gonadotropins secreted during the climacteric and postmenopause are reported to differ from forms secreted during the premenopause; perhaps the functions of these alternate forms differ also. Data on the serum levels of E2 in the latter years of the climacteric are conflicting: some studies report a decline of serum E2 while others describe an elevation. Changes in the formation and function of the corpus luteum during the perimenopause are not well described. Following menopause, both serum E2 and progesterone levels decline. Thus, the time of menopause marks a dramatic change in ovarian function. Prior to menopause the ovary participates as a key component of the dynamic hormonal orchestration of the H-P-O axis resulting in the release of oocytes; subsequent to menopause the ovary functions as a relatively quiescent androgen-secreting organ in a hypergonadotropic environment. The molecular and cellular mechanisms involved in the rise in early follicular phase FSH, the development of menstrual cycle irregularity, the rise in LH late in the climacteric period, and the regulation of E2 and inhibin levels during the climacteric period are largely unknown. The change in ovarian function across the menopause is accompanied by the loss of virtually all of the primordial and developing follicles residing within the ovary. From a non-replenishable store of several million primordial follicles formed within the developing human ovary during gestation, approximately 25,000 follicles remain at the start of the last decade of menstrual cycling. These remaining follicles appear to undergo an accelerated rate of loss of over twice that of the first two decades of reproductive life. Consequently only several hundred or less gonadotropin-insensitive follicles remain in the ovary at the time of menopause, a number apparently too low to sustain the H-P-O interactions required for regular menstrual cyclicity. The molecular and cellular mechanisms responsible for this apparent acceleration of follicular loss are virtually unknown. Follicular atresia is the predominant fate of ovarian follicles. Of the millions of follicles initially present in the ovary, well over 99 percent are depleted over the woman's reproductive life span through atresia. Except for the single ovulatory follicle per month in a normally cycling woman, all of the growing pool of antral follicles are resorbed within the ovary by atresia. Even women not cycling due to oral contraceptive usage or pregnancy lose ovarian follicles at the same rate as cycling women. The underlying mechanism of atresia of antral follicles in diverse species, including humans, appears to involve apoptosis in the granulosa cell layer surrounding the oocyte. The molecular and cellular mechanisms through which these apoptotic processes are regulated are largely unexplored. Health- and biology-related issues of the menopausal process, from basic ovarian and neuroendocrine biology through clinical, psychosocial and biobehavioral aspects, were presented and discussed at the NIH Workshop on Menopause held in Bethesda, MD from March 22 to 24, 1993. Proceedings of this workshop are published in Experimental Gerontology (vol 29 (3/4), 1994). Goals of the Program Announcement This program announcement focuses on (a) the molecular and cellular regulatory mechanisms acting within and external to the pituitary- ovarian axis that are involved in the enhancement of the rate of ovarian follicular loss in the decade prior to the menopause, and (b) the identity, and molecular and cellular mechanisms regulating the levels and activities, of hormones,cytokines and growth factors secreted from the P-O axis of the climacteric woman that serve to maintain extra-ovarian tissue function. The goal is to increase the understanding of the molecular basis of the normal menopausal process occurring in women generally between the ages of 45 and 55. Premature ovarian failure, due either to iatrogenic or pathologic processes, is not within the scope of this program announcement. However, this restriction is not intended to exclude research with animal or other models in which ovarian follicular exhaustion is manipulated experimentally or genetically to explore relationships of reproductive aging with follicular number. In addition to research project grants, the individual postdoctoral fellowship (F32) mechanism is included as eligible for support in this program announcement in order to permit the training of postdoctoral investigators in the specific research areas outlined below. In particular, investigators trained in non-aging ovarian reproductive research related to this program announcement may bring their expertise to, and gain additional training in, a laboratory experienced in age-related reproductive research through the F32 fellowship. Alternatively individuals trained in reproductive aging research may conduct the appropriate work in a non-aging ovarian reproductive research laboratory, or in a laboratory focused on an appropriate animal model. An intended outcome is to increase the number of investigators interested in and qualified to conduct high quality molecular and cellular research appropriate for this program announcement. Applicants interested in the effect of menopause- and age-related changes on the hypothalamus and higher brain centers are referred to a complementary program announcement ("Neuroendocrinology of Aging", PA-94-087, NIH Guide for Grants and Contracts, Vol. 23, No. 28, July 29, 1994). Although molecular and cellular mechanistic approaches to the issues described in this program announcement are strongly desired, the acquisition of more baseline data may be necessary in some areas to formulate a mechanistic hypothesis. Research questions of interest include, but are not limited to, the following: o What regulates the process responsible for the enhanced rate of follicular loss in the last decade of menstrual cycling; what role do the hormonal interactions of the P-O axis play in this process; o How do the declining numbers of ovarian follicles, and associated changes in the secretory products, in the aging ovary influence the process of the P-O intercommunication to result in acyclicity and eventual cessation of menstruation; o How do paracrine and autocrine processes within the aging ovary influence its function, and how are these processes regulated by extra-ovarian tissues; o What is the role of age- and ovarian-related changes in the pattern of pulsatile hypothalamic GnRH secretion on gonadotropin synthesis and release; how do these changes affect ovarian function; o What changes occur in the secreted forms of gonadotropins, by what mechanisms do these changes occur, and how do these changes affect ovarian function; o Why are follicles remaining in the postmenopausal ovary apparently insensitive to the hypergonadotropic environment; o To what extent and by what mechanism(s) does normal peri- or postmenopausal ovarian stromal tissue, either alone or in combination with resorbed ovarian follicular and luteal tissues/cells, influence the autocrine, paracrine and endocrine interactions of the aging ovary with the P-O axis and other extra-ovarian tissues; o What ovarian secretory products other than estrogen are potential regulators of extra-ovarian tissues involved in decline of tissue function associated with the menopause, and how are the secretions and activities of these substances regulated by the ovary and other tissues during the menopausal process; o If age-related changes in vascular supply to the ovary play an important role in change of ovarian function across the menopause, what are the mechanisms for these changes and how do they influence ovarian function. Research Resources The ability to conduct definitive studies into the molecular and cellular mechanisms of the menopausal transition and the associated change in tissue function is restricted in women by ethical concerns as well as by issues of practicality and experimental design. Consequently, it is necessary to utilize appropriate experimental models of the human menopausal process and development of pathophysiologic sequelae associated with the menopause. Investigators are encouraged to develop and/or utilize appropriate animal models. A non-primate animal model of menopause may be acceptable for particular studies provided that the selection of the animal model is based on current and expanding knowledge available regarding (a) the human menopausal process and associated changes in tissue or organ function, and (b) characteristics and appropriateness of particular animal species to answer the research questions posed using relevant experimental approaches. For example, it may be possible to experimentally manipulate in a physiologic fashion ovarian follicle number or rate of follicular decline in order to explore their relationship to reproductive aging and associated tissue decline. Although extensive research experience and background data on female reproductive aging has been accumulated in the rodent, some features of reproductive aging in the female rodent are substantially different from the human menopausal process. Since for other species less extensive background data on female reproductive aging are available, more preliminary data from the investigator will be required if use of these animal species is proposed. An obvious choice for a model of the human menopause based both on the phylogenetic relationship of species and the known physiologic similarities is the non-human primate. From the limited data available, the rhesus monkey and baboon may be suitable animal models of both the menopausal process and the subsequent decline in tissue function due to both menopause and aging. Investigators may choose to utilize non-human primates, particularly in collaboration with established primate research centers, including the Regional Primate Research Centers (RPRC) supported by the National Center for Research Resources (NCRR), NIH. However, there are drawbacks to the extensive and immediate use of these species, such as the high cost of husbandry (which is partially offset by maintenance of groups of aging animals at the RPRC by the NIA), relatively long life span, limited availability, and the absence of substantial published baseline data on female reproductive aging in non-human primates. Efforts are currently underway to expand the baseline data available for female reproductive aging in non-human primates, thus making them more attractive to investigators planning molecular and cellular mechanistic studies of the menopausal process and associated changes in tissue or organ function. Other appropriate experimental models include (a) in vitro cell and tissue culture models using human tissues, or specimens derived from human tissues, (b) use of human post-mortem tissue where appropriate, and (c) implantation of relevant human tissues into pertinent animal species to approach questions regarding the behavior of that tissue under suitable experimental conditions. While clinical and epidemiologic studies are not strongly encouraged in response to this program announcement, the use of clinically derived data in characterizing the human tissues used for these studies would be appropriate. 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 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 9, 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. APPLICATION PROCEDURES Applications for R01 or R29 awards must 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. Individuals applying for the F32 postdoctoral fellowship must use PHS 416-1 (rev. 10/91) application forms. Application receipt dates for the F32 award are April 5, August 5, and December 5. Application kits are available at most institutional business offices 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. The title and number of the program announcement must be typed in Section 2a on the face page of the application. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original and five legible copies of the PHS 398 or the original and two copies of the PHS 416-1, must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications will be assigned to Initial Review Groups 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 standard NIH peer review procedures. Following scientific-technical review, R01 and R29 applications will receive a second-level review by the appropriate national advisory council. Second-level review for F32 applications will be carried out by institute staff. The following criteria will be used in evaluating R01 and R29 applications submitted in response to this program announcement: o Scientific and technical merit, significance, and originality of the proposed research; o Appropriateness and adequacy of the experimental approach and methodology to be used; o Qualifications of the principal investigator and staff in the area of research, and the principal investigator's prior research experience and record; o Adequacy of the available facilities. Criteria used in review of F32 postdoctoral fellowship awards are: o the applicant; o the research proposed (both its scientific merit and training potential; o the training resources and environment, including the sponsor. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following criteria will be considered when making funding decisions: o Scientific and technical merit of the application as determined by peer review; o Availability of funds; o Program balance. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries