COOPERATIVE CONTRACEPTIVE RESEARCH CENTERS Release Date: April 2, 2001 RFA: RFA-HD-01-011 (This RFA has been reissued, see RFA-HD-06-014) National Institute of Child Health and Human Development (http://www.nichd.nih.gov) Letter of Intent Receipt Date: August 15, 2001 Application Receipt Date: September 26, 2001 PURPOSE The National Institute of Child Health and Human Development (NICHD) invites applications from investigators interested in participating with NICHD in an ongoing multicenter cooperative research program termed the Cooperative Contraceptive 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, both basic and applied, with the ultimate goal of developing knowledge that may lead 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 research to discover and/or develop promising new leads in regulating fertility. The focus of individual projects may include basic, preclinical or clinical research or a combination of these areas. The Centers will also serve as a national resource for career development of young scientists electing to pursue research in fertility regulation. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This Request for Applications (RFA) is related to one or more of the priority areas. Potential applicants may obtain "Healthy People 2010" at http://www.health.gov/healthypeople. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, non-profit and for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, and units of State or local governments and eligible agencies of the Federal government. The need for continuous and active communication among sites dictates that only institutions in the United States are eligible to apply. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Applications prepared for this competition may propose multi-institutional consortium arrangements. Applications eligible for award include those for new Cooperative Contraceptive Research Centers or for renewal of existing Centers. MECHANISM OF SUPPORT The RFA will use the National Institutes of Health (NIH) specialized cooperative research center (U54) award mechanism, 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 studies to be funded under cooperative agreements are discussed below under Terms and Conditions of Award. Potential applicants may obtain the NICHD U54 Specialized Cooperative Research Center Grant Guidelines at http://www.nichd.nih.gov/funding/mechanism/u54_guide.cfm. FUNDS AVAILABLE The NICHD intends to commit approximately $5.9 million in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2002 to fund up to three new and/or competing continuation awards in response to this RFA. An applicant for a competing continuation grant may request a project period of up to five years and a budget for direct costs of up to120 percent of the direct costs awarded for the final competitive segment of the preceding project period as stated in the Notice of Grant Award. Applications exceeding the budgetary limits specified above will be returned to the applicant without peer review. Because the nature and scope of the research proposed may vary, it is anticipated that the size of the awards will also vary. Although the financial plans of the NICHD provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, it is not known if the RFA will be reissued. RESEARCH OBJECTIVES Background Over 50 percent of pregnancies in the United States are unintended. Thus, there is a critical need for fertility regulation that fits the needs of women and men throughout their reproductive lives. The ideal contraceptive should be safe and highly effective. 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 Research Program described in this RFA is to identify new leads for regulation of fertility. There are three phases to development of new contraceptive methods: basic discovery, proof of concept, and clinical development. New products are needed that act not only as contraceptives, but that prevent or limit transmission of sexually transmitted diseases 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 fertility regulation. Approaches to both male and female targets are encouraged. Research on abortion will not be funded. Research Scope Research projects can be directed to male or female targets of fertility regulation. The Center should consist of projects and/or core facilities 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 projects. Examples of possible projects include, but are not limited to: o Research on a particular gamete-specific target for drug design. o The definition of the transcriptome or proteome of gametes. o Development of genomic or proteomic screens designed to identify and define the functional role of proteins in fertilization. o The characterization of a macromolecule(s) involved in fertilization, the perturbation of which with a pharmacological reagent results in reversible infertility. o Research on the processes of gamete maturation with the goal of defining specific targets involved in control of fertility. o Hormonal or pharmacologic methods that control gamete production or maturation. 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 a novel formulation or delivery vehicle (implant, transdermal patch, vaginal ring, microsphere, etc.) to deliver contraceptive drugs would be considered a separate project. A Center application can build its research strategy primarily on one broad approach to fertility regulation within which the projects are embedded. 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 a Center as described in this RFA are as follows: o Competent and experienced Principal Investigator to oversee cooperation within the Center and to coordinate career development opportunities within the Center. o Competent and experienced investigators to direct individual research projects or core facilities 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 Research environment conducive for the development of new investigators in contraceptive research. 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 Minimum Application Requirements The Centers are expected to work together in a cooperative manner. It is expected that access to the core facilities will be open to all of the Centers. Meetings of the Steering Committee 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. Each Center should provide career development opportunities for new investigators to encourage research in fertility regulation. The research priorities of the projects within the approved research scope will be established after discussions between the awardee and the NICHD Research Coordinator. 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 will interact throughout the duration of the award in order to facilitate progress and resolve any problems that may arise. A response to this RFA 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 Center’s career development opportunities to encourage new investigators to participate in research directly related to fertility regulation. The description should include a justification of the plan, the goals of the program, the anticipated number of participants, eligibility criteria for participants, selection criteria, budget, 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 past funding period. A description of how the Center has met the special cooperative agreement terms and conditions of award, including its interaction with other Centers and the NICHD Research Coordinator, should be included. Meetings An annual meeting of the Centers will be conducted and applicants are advised to include funds for travel to these meetings in the budget request. The purpose of the meeting is to exchange scientific information and to discuss collaborations within and between Centers. It is expected that Principal and Project Investigators from each of the participating Centers will attend the annual meeting. In addition, core supervisors and research fellows participating in the projects should attend the meeting. Terms and Conditions of Award The following Terms and Conditions of Award and details of the arbitration procedures pertaining to the scope and nature of the interaction between the NICHD staff and the participating awardees will be incorporated into the Notice of Grant Award and provided to the Principal Investigator and the institutional official at the time of award. These procedures will be in addition to the customary programmatic and financial negotiations that occur in the administration of grants. Cooperative agreements are assistance mechanisms subject to the same administrative requirements as grants. The special Terms and Conditions 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 and procedures. 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. Facilities and Administrative Cost (indirect cost) award procedures will apply to cooperative agreement awards in the same manner as for grants. The administrative and funding instrument used for this program is 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. 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 Research Coordinator. 1. Awardee Rights and Responsibilities 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 primary responsibilities of the awardees are to: o Define the research objectives, o Design the necessary research protocols, o Conduct specific studies, o Analyze and interpreting research data, o Modify protocols as required, o Interact with the FDA concerning clinical investigations, o Provide information to the NICHD Research Coordinator concerning progress: o Maintain career development opportunities to encourage new investigators to work in the field of fertility control. 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. 2. NICHD Staff Responsibilities NICHD Research Coordinator: The NICHD Research Coordinator will have substantial scientific-programmatic involvement during the conduct of this activity, through technical assistance, advice and coordination above and beyond normal program stewardship for grants. The degree of involvement by the NICHD Research Coordinator will include the following: o Assist in setting research priorities and in avoiding unwarranted duplication of effort, o Review and comment on critical stages in the research program before subsequent stages are implemented, o Assist in the interaction between the awardee and the FDA, o Assist in the interaction between the awardee and investigators of other institutions as well as between the awardee and potential commercial sponsors, o Retain 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 Retain the option to recommend additional research endeavors within the constraints of the approved research and negotiated budget. NICHD Project Officer: NICHD will appoint a Project Officer, apart from the Project Scientist, who will: o Have the option to withhold support to a participating institution if technical performance requirements are not met. o Carry out continuous review of all activities to ensure objectives are being met. 3. Collaborative Responsibilities Overall coordination of the Program, consistent with the stated intent of the RFA, will be done by a Steering Committee consisting of the Principal and Project Investigators from each of the participating Centers and one NICHD staff member from the CRHB, CPR, NICHD, who will be the Research Coordinator. A member of the NICHD grants management staff will serve as a nonvoting advisor to the Committee. The Steering Committee meetings will be convened at least once yearly. The purpose of these meetings is to assess scientific progress, identify new research opportunities, establish priorities, and discuss strategies that will accelerate the translation of preclinical findings into clinical applications. Outside consultants/experts may be asked to participate in these discussions as nonvoting advisors. 4. Arbitration Process When agreement between an awardee and NICHD staff cannot be reached on scientific/programmatic issues that may arise after the award is made, an arbitration panel will be formed. The arbitration panel will consist of one person selected by the Principal Investigators of the three Centers, one person selected by the NICHD, and a third person selected by both NICHD staff and the Principal Investigators. The decision of the arbitration panel, by majority vote, will be binding. The special arbitration procedure in no way affects the right of an awardee to appeal adverse action 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 sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate to NIH-defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and/or ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects," published in the NIH Guide for Grants and Contracts, March 6, 1998, and available at: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff also may provide additional relevant information concerning the policy. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary for the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of this RFA. Although 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 NICHD staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to Dr. Diana Blithe at the address listed under INQUIRES, below, by August 15, 2001. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research, on the Internet at http://grants.nih.gov/grants/funding/phs398/phs398.html, and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, Telephone 301-710-0267, E-mail: GrantsInfo@nih.gov. Application Instructions Applications for the U54 grant are to be prepared in a manner consistent with the information presented in the NICHD U54 Cooperative Specialized Research Center Grant Guidelines, available from the contacts listed under INQUIRIES, below, and at: http://www.nichd.nih.gov/funding/mechanism/u54_guide.cfm. Submission Instructions The RFA label available in the PHS 398 (rev. 4/98) application form must be stapled to the bottom of the face page of the application and must display the RFA number HD-01-011. A sample RFA label is available at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note this is in the pdf format. 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 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: CENTER FOR SCIENTIFIC REVIEW 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 should be sent to: L.R. Stanford, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E03, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) Applications must be received by September 26, 2001. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) 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 CSR 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 the CSR and for responsiveness to this RFA by the NICHD. Incomplete and/or nonresponsive 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 NICHD in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the National Advisory Child Health and Human Development (NACHHD) Council. A site visit is not a required part of the review process. Applicants should ensure that their applications are complete as written and can stand on their own. Review Criteria The scientific and technical merit peer review focuses on three areas: (1) review of the component research subprojects, (2) review of the core units, and (3) review of the overall center as an integrated effort. Applications submitted in response to this RFA will be evaluated according to the review criteria described in the NICHD U54 Cooperative Specialized Research Center Grant Guidelines, available from the contacts listed under INQUIRIES, below, and at http://www.nichd.nih.gov/funding/mechanism/u54_guide.cfm. SCHEDULE Letter of Intent Receipt Date: August 15, 2001 Application Receipt Date: September 26, 2001 Peer Review Date: February/March 2002 Council Review: June 2002 Earliest Anticipated Start Date: June 2002 AWARD CRITERIA Criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Diana Blithe, Ph.D. Contraception and Reproductive Health Branch, National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B13, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6990 FAX: (301) 480-1972 Email: blithed@nih.gov Direct inquiries regarding fiscal matters to: Kathy Hancock Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17M, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5482 FAX: (301) 402-0915 Email: kathy.hancock@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.864. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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 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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