Full Text HD-96-001 COOPERATIVE CONTRACEPTIVE DEVELOPMENT RESEARCH CENTERS NIH GUIDE, Volume 25, Number 4, February 16, 1996 RFA: HD-96-001 P.T. 34 Keywords: Contraceptives Human Reproduction/Fertility National Institute of Child Health and Human Development Letter of Intent Receipt Date: April 1, 1996 Application Receipt Date: July 17, 1996 PURPOSE The National Institute of Child Health and Human Development (NICHD) invites applications from investigators interested in participating under a Cooperative Agreement (U54) with NICHD in an ongoing multicenter cooperative research program termed the Cooperative Contraceptive Development Research Centers program. This program is designed to expedite the development of new methods to regulate fertility. The aim of the program is to conduct a wide range of research leading to clinically useful products. Recognizing that the complexity of contraceptive development can severely limit progress achieved by individual investigators working alone, the NICHD will support three Centers composed of research projects and technical service core facilities that are interactively organized to conduct preclinical and clinical research and development studies on promising new leads in contraceptive development. The Centers will also serve as a national resource for career development of young scientists electing to pursue research in contraception. 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 Contraceptive Development Research Centers, is related to the priority area of Family Planning. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Domestic non-profit and for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, and units of state or local governments are eligible to apply for these Centers. Applications prepared for this competition may propose multi-institutional consortium arrangements. The need for continuous and active communications and interactions among the awarded sites dictates that only institutions in the Continental United States may apply for these Center grant awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Applications eligible for award include those for new U54 Centers or for renewal of existing Centers. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U54), 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 study 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 may not exceed five years. The anticipated award date is March 1, 1997. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of the awards will vary also. Awards and level of support depend on receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NICHD, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. NICHD has not determined whether or how this program will be continued beyond the present solicitation. Any future NICHD determination in this regard will be publicly announced. FUNDS AVAILABLE The estimated funds (total indirect and direct costs) available for the first year of support for the entire program are $4,080,000. Three awards are anticipated, either new or competing continuation. RESEARCH OBJECTIVES Background Over 50 percent of pregnancies in the United States are unintended. Thus, there is a critical need for contraception that fits the needs of women and men throughout their reproductive lives. Whether dissatisfaction with the current methods leads to misuse or abandonment of effective methods, or whether available methods are too inconvenient or difficult to use, too expensive or too complicated is not clear. The ideal contraceptive should be highly effective, safe, long-acting but readily reversible, virtually free of side effects, should reduce the spread of sexually transmitted diseases and, preferably, not be associated with sexual intercourse. A variety of contraceptive methods are needed to address the needs of people of different ethnic, cultural, and religious values; those with inadequate access to services; and those with changing needs related to age. The primary objective of the Cooperative Contraceptive Development Program described in this RFA is to develop new contraceptives. It is recognized that adverse reactions may occur with use of presently available contraceptives and there is concern about long-term safety and expense of currently available methods. Because the acquired immunodeficiency syndrome (AIDS) can be a sexually transmitted disease, new products are needed that act not only as contraceptives, but prevent or limit such transmission as well. The intent of this program is to establish or maintain an organizational infrastructure that has the scientific and administrative capabilities to address the broad issue of contraceptive development. The proposed research should encompass ongoing projects in contraceptive development, as well as the initiation of new projects. Approaches to both male and female fertility regulation are encouraged. Innovative approaches that show promise, but which are in the early developmental stages, will be considered for any of the broad categories of family planning methods, other than those related to abortion. Research Scope Research projects can be directed to male and/or female methods of contraception. The Center should consist of multidisciplinary projects and/or cores capable of interacting in a coordinated, cooperative fashion. It is expected that activities may require collaboration with other institutions or other Centers. By using the framework of an interdisciplinary approach, the Centers can conduct activities that are beyond the capabilities of individual investigators or institutions. Each Center should organize its overall research plan to include a minimum of three highly meritorious research and development (R&D) projects. Examples of possible projects include: o The pharmacology of a single drug. Even if this pharmacological assessment involves animal and clinical studies, it would still be classified as a single project. o The development of a new spermicide would be construed as a single project even though it would require formulation and preclinical and clinical studies. o The development of an implant, transdermal patch, or vaginal ring to deliver contraceptive drugs would each be considered a separate project. o Research on a particular gamete antigen for contraceptive vaccine development would be considered to be a single project. A Center application can build its research strategy primarily on one broad approach to fertility regulation within which the projects are embedded. For example, a Center could devote its energies to immunocontraceptive development with projects on specific antigens and delivery systems. Alternatively, a Center proposal could be structured with research representing different approaches to fertility regulation. The overall Center plan should stress internal priorities and collaboration and be focused on opportunities for progress. Description of a Center The minimal requirements for Centers described in this RFA are as follows: o Competent and experienced principal investigator who is committed to and directly involved in research in contraceptive development; o Competent and experienced investigators to direct individual research projects or cores associated with the proposed Center; o Availability of the technical resources and facilities for the conduct of the proposed projects, including appropriate animal facilities; o Access to volunteers for clinical studies where appropriate. (Applicant 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); o Research environment conducive for the development of young investigators in contraceptive research, a teaching program should be in place; o Willingness to engage in a coordinated cooperative research program involving two or more Centers with multiple interacting research projects, and if required, service cores; o Substantive evidence of departmental and institutional support for and commitment to the proposed Center. SPECIAL REQUIREMENTS The centers are expected to work together in a cooperative manner. It is expected that access to the cores will be open to all of the centers. Meetings of the center directors and core leaders, as part of the annual meeting, will facilitate the development of a plan for core use by the center members. The three center directors will work together to minimize overlap and to facilitate research efforts, depending upon the research goals of the various funded projects. The research priorities of the projects within the approved research scope will be established after discussions between the awardee and NICHD. Outside consultants/experts may be asked to participate in these discussions. Once priorities have been agreed upon, the awardee will assume the responsibility for implementation of research activities. It is anticipated that the awardee and NICHD Research Coordinator (Chief of CDB or designee) will interact throughout the duration of the award in order to facilitate progress and resolve any problems that may arise. The following 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 policies. Cooperative Agreements are subject to the administrative requirements outlined in pertinent OMB, HHS, PHS, and NIH guidelines, with particular emphasis on HHS regulations at 42 CFR Part 52 and 45 CFR Part 74. Indirect cost award procedures will apply to cooperative agreement awards in the same manner as for grants. TERMS OF THE AWARD The administrative and funding instrument used for this program is a cooperative agreement (U54), and ~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 studies will be shared among the awardees and the NICHD Project Scientist. Awardees have primary authorities and responsibilities to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies. The awardees will be responsible for: o Defining the research objectives; o Designing the necessary research protocols; o Conducting specific studies; o Analyzing and interpreting research data; o Modifying protocols as required; o Interacting with the FDA concerning clinical investigations; o Providing information to the NICHD Research Coordinator concerning progress. Awardees will retain custody of and primary rights to their data and intellectual property developed under the award subject to current government policies regarding rights of access as consistent with current HHS, PHS, and NIH policies. The NICHD Research Coordinator will have substantial scientific-programmatic involvement during conduct of this activity, through technical assistance, advice and coordination above and beyond normal program stewardship for grants. The following lists the degree of involvement by NICHD Research Coordinator: o Assisting in setting research priorities and in avoiding unwarranted duplication of effort; o Reviewing and commenting on critical stages in the R & D program before subsequent stages are implemented; o Assisting in the interaction between the awardee and the FDA; o Assisting in the interaction between the awardee and investigators of other institutions as well as between the awardee and potential commercial sponsors; o Retaining the option of recommending termination of studies if technical performance falls below acceptable standards, or when specific lines of research cannot be effectively pursued in a timely manner; o Retaining the option to recommend additional research endeavors within the constraints of the approved research and negotiated budget. The following arbitration procedures will be invoked only when agreement cannot be reached on programmatic issues that may arise between (an) awardee(s) and the NICHD after the award has been made. In that event, an arbitration panel will be formed consisting of one person selected by the Principal Investigators of the three Centers, one person selected by the NICHD and one person selected by both NICHD and the Principal Investigators. The decision of the arbitration panel, by majority vote, will be binding. The process to resolve programmatic differences described above in no way affects the right of a recipient of a cooperative agreement assistance grant to appeal adverse determination in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. Adequate plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research must be included. Plans for recruitment and retention of subjects will be evaluated. 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 for the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by April 1, 1996, 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 the 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 staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Nancy J. Alexander at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev.5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: girg@drgpo.drg.nih.gov; and from the program administrator listed under INQUIRIES. Additional suggestions for formatting the application into a Center grant application are provided in the Supplemental Instructions for NICHD U54 Grant Applications, which are available from the program staff listed under INQUIRIES. A response to this Request for Applications must consist of an application that includes: o A description of the Center consisting of multiple individual research projects and justified core service facilities (three approved projects is the minimum for a Center). o A description of the capabilities of the Center. o A description of the career development program including a justification of the plan, the goals of the program, the anticipated number of participants, eligibility criteria for applicants, selection criteria, budget (no more than 10% of the grant), and other existing or pending sources of funding that will contribute to a substantial program. o A proposed five-year research plan that presents the applicant's perception of the Center's organization and component functions. The plan should identify the applicant~s knowledge, ingenuity, practicality, and commitment in organizing a multi-project research infrastructure for conducting studies aimed at developing new contraceptives. o Competing continuation applications should include a detailed report of research progress during the entire funding period. A description of how the Center has met the special cooperative agreement terms and conditions of the award, including its interaction with other Centers and the NICHD Research Coordinator should be included. An annual meeting of the centers will be conducted and applicants are advised to include such a plan in the budget request. The RFA label, available in the PHS 398 (rev.5/95) application, 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 number must be typed on line 2 of the face page of the application form and the Yes box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Susan Streufert, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development Building 6100, Room 5E03, MSC 7510 6100 Executive Boulevard Bethesda, MD 20892-7510 Rockville, MD 20854 (for express/courier service) Schedule Letter of Intent Receipt Date: April 1, 1996 Application Receipt Date: July 14, 1996 NACHHD Council Review: January 1997 Earliest Award Date: March 1, 1997 Applications must be received by July 14, 1996. 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 (NICHD). Incomplete or nonresponsive applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NICHD staff will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications may receive a preliminary scientific peer review to determine their relative competitiveness by an NICHD peer review group. The NIH will withdraw from further competition those applications judged to be non- competitive for award and notify the applicant Principal Investigator and institutional official. Those applications that are complete and responsive, and judged to be competitive in triage (if triage is used), will undergo further scientific merit review in accordance with an appropriate peer review group convened by the NICHD. The second level of review will be provided by the NACHHD Council. 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 for evaluation of the study. Other considerations,, such as the importance and timeliness of the proposed study or clinical trials, access to patients if appropriate, and multidisciplinary nature of the studies will be part of the evaluation criteria. The review criteria are listed below. o Scientific, technical, or medical significance and originality of proposed research of each project; o Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o Relevance and usefulness of each core; core should serve several projects, appropriate scientific expertise should be available; core should be cost effective; variations in funding requests based on anticipated load should be considered; o Qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o Plans for coordination and cooperation among projects where appropriate; o Ability to move research toward clinical trials and approval by the FDA; o Availability of the resources necessary to perform the research; o Evidence of a detailed plan for career development of young investigators in contraceptive research and development; o Appropriateness of the proposed budget and duration of the projects in relation to the proposed research; o For research involving human subjects, 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 based on scientific and technical merit as determined by the peer review group, the recommendations of the NACHHD Council, program balance 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: Nancy J. Alexander, Ph.D. Center for Population Research National Institute of Child Health and Human Development Building 6100, Suite 8B13G MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1661 FAX: (301) 480-1972 Email: AlexandN@hd01.nichd.nih.gov For information on budget and fiscal matters, contact: Ms. Melinda Nelson Office of Grants and Contracts National Institute of Child Health and Human Development Building 6100, Suite 8A17K MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5481 FAX: (301) 402-0915 Email: NelsonM@hd01.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 1 3.864, Population Research. Awards are made under authorization of the PHS Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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