Full Text HD-92-06 COOPERATIVE CONTRACEPTIVE DEVELOPMENT RESEARCH CENTERS PROGRAM RFA: HD-92-06 P.T. 04 Keywords: Contraceptives Chemical Synthesis Chemistry, Organic Human Reproduction/Fertility Pharmacology Biomedical Research, Multidiscipl National Institute of Child Health and Human Development Letter of Intent Receipt Date: January 31, 1992 Application Receipt Date: April 24, 1992 OVERVIEW The National Institute of Child Health and Human Development (NICHD) invites applications from investigators willing to participate with the NICHD, under a cooperative agreement, in establishing a Centers program designed to conduct comprehensive research on the development of new contraceptive products. It is anticipated that ultimately three Centers will participate in this program and that the award period will be five years. Two Centers were funded under a prior Request for Applications (RFA) and one Center will be funded as the result of the present RFA. The aim of these Centers will be to conduct a wide range of research activities that, with time, may result in the development of clinically useful modalities. The Center should have, or should be able to develop, a broad range of research activities that are classified as a research and development (R&D) program. It is understood that certain activities may have to be conducted outside a specific Center via arrangements with other Centers or other institutions. By utilizing the framework of an interdisciplinary approach, the Centers can conduct R&D activities that are beyond the capabilities of individual investigators. The Chief of the Contraceptive Development Branch (CDB) will serve as the Research Coordinator for the Centers' program and will cooperate with the Principal Investigator (PI) of the selected Center in the identification of research priorities and the implementation of the required steps in the overall process of product development. The Chief of the CDB may ask on occasion for participation of other CDB staff members in the interactive process if and when their scientific and managerial skills can contribute to effective program management. 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 Contraceptive Development Research Centers Program, is related to the priority area of family planning. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "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). BACKGROUND The NICHD has supported contraceptive development research for the past two decades. The program focused on the development of methods of fertility regulation that were reversible and acceptable to various segments of the American public. The retrenchment of the American pharmaceutical industry in the area of contraceptive development has had a negative effect on research and on the availability of products for the American people. A recent report from the National Research Council/Institute of Medicine entitled "Developing New Contraceptives - Obstacles and Opportunities" identified several problems facing the overall area. Among the subjects discussed were the low funding levels for applied research in contraceptive development and the scarcity of institutions conducting research in this area. Congressional committees have directed NICHD to establish a Contraceptive Development Centers program as a way of promoting research in this complex field. The Senate Appropriations Committee report stated: "The Committee has added $6,000,000 to create five new centers, two focused on infertility research and three focused on contraceptive research. The Committee considers this to be an adequate amount to initiate all five of these centers and expects to provide additional funding for these centers in subsequent years." The Committee report went on to say: "Research and development problems within the complex field of fertility cannot be solved by an individual investigator working alone; to create a new contraceptive method or treatment for infertility, the concerted efforts of highly skilled scientists from a variety of disciplines are required. Without specialized centers, promising new leads may never be translated effectively into new methods or ever made available to the public." The Committee concluded: "By establishing these new research centers, the Committee is taking an affirmative step to regain the United States' rightful position while at the same time reaffirming its commitment to those who are trying to plan their families." Thus, the intent of the Congressional mandate and the needs of the field support the concept that the Centers program should assume a leadership role in contraceptive development. Each Center will coordinate the research conducted by the Center's investigators and will attempt to interact with the pharmaceutical industry in order to bring the newly developed technologies to the public. The intent of the program is to develop an organizational infrastructure that has the scientific and administrative capabilities to address the broad issue of the development of methods of contraception. The proposed research should encompass ongoing and new projects in contraceptive development. Approaches to both male and female fertility regulation are encouraged. Innovative approaches that show promise for effective fertility regulation, but are in early developmental stages, will be considered for any of the broad categories of family planning methods other than those related to abortion. The scope of the proposed program must involve the concurrent development of at least three projects. The investigators should have a clear understanding of the complexities of the R&D process. However, a single institution need not be capable of conducting all of the necessary phases of product development. Consortium arrangements that utilize the capabilities of other research organizations may be proposed. The proposed investigational approaches may represent different phases of R&D. Thus the overall program can present a variety of approaches representing the early phases of R&D, such as synthesis of new compounds, and the more advanced stages, such as clinical studies. Although the initial funding is limited and can support only a part of the projected activities of each Center, each application must provide sufficient detail with respect to the research activities that will be implemented when additional funding becomes available from NICHD (see Budget section). The new or expanded projects that are proposed must be fully described since they will be subjected to the initial peer review. Projects funded by other sources may be incorporated into the overall concept of the Center if they are related to the projects for which NICHD funding is requested. Projects able to attract industrial cosponsorship are encouraged. Provision of financial assistance from the NICHD, together with other funding sources, should permit these new Centers to assume a leadership role in contraceptive development. ORGANIZATION OF CENTERS AND RESEARCH SCOPE The NICHD invites applications from investigators based in institutions that can provide a scientific and administrative framework conducive to research directed toward development of new technologies for fertility regulation. The minimum requirements for a Center application will be: o Commitment of a PI with experience in the area of contraceptive development. This experience may be in research conducted at the different stages of the overall R&D process. Consequently, the PI may be either a clinician experienced in the development of fertility regulation methods or a non-clinician who is familiar with the preclinical aspects of contraceptive research. o Availability of other staff who will be responsible for both the research and administrative aspects of the Center. o Evidence of ongoing applied contraceptive research projects that, together with new initiatives, represents a minimum of three distinct fundable projects (see below for project description). This research may be represented by any one of several R&D phases. Projects involving clinical studies must provide assurance of implementation of NIH policies concerning inclusion of women and minorities in study populations. o Ability to attract and train other investigators for a comprehensive contraceptive development program. o Availability of facilities to conduct research leading to product development. o Institutional commitment to the project and flexibility for implementation of interactions within the organization and with outside resources. Each Center must focus on a mix of research activities that are classified as applied R&D, as distinguished from basic research. The proposed program must involve research endeavors that represent a minimum of three distinct fundable projects. With respect to the Centers program, a project is defined as an activity involving, for example: o Research dealing with 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 Research dealing with the development of a new spermicide based on a compound would be construed as a single project. o Development of a transdermal patch or a vaginal ring to deliver contraceptive drugs would be considered a single project. These examples of research activities should not be construed as indicating a preference on the part of NICHD in these areas of research. Investigators are invited to propose development of methods, other than abortion, that can be made available to the American public. A Center application can build its research strategy primarily on one broad approach to fertility regulation within which the three projects are embedded. For example, a Center could devote its energies to the development of barrier methods of contraception. Under these circumstances the three Center projects could be comprised of: o New spermicide development o Development of devices to block the cervix and deliver the new spermicide o Development of formulations for more effective delivery of spermicides Alternatively, a Center application may be structured to represent research from different approaches to fertility regulation. There could be a project involving drug development and two projects dealing with barrier methods. The overall Center plan must stress internal priorities and be focussed on opportunities for progress. In structuring the Center application, investigators must take into account two important aspects of the program: o Projects that require funding from the proposed Center grant o Projects that are part of the program but do not require funding from the proposed grant since it is available from other sources It must also be kept in mind that the NICHD is currently involved in funding research in the following areas: o Synthesis and biological evaluation of antagonists of gonadotrophic releasing hormone o Condom development and clinical evaluation o Isolation of peptides that can influence reproductive processes o Development of contraceptive vaccines It is not the intent of the NICHD that the Centers should allocate fiscal resources to duplicate research areas listed above. On the other hand, fiscal resources may be allocated to research that represents a programmatic progression from what is currently being supported by the NICHD. For example, if funding is already provided for synthesis and biological evaluation, funds may be requested for toxicology or clinical evaluation. Because phase III multicenter clinical trials require a substantial investment of funds, they should not be proposed for funding during initial phases of the Center program. CONTENT OF APPLICATIONS Each research project that is proposed for inclusion in the Center must be described independently using the PHS 398 application format. The page limitations stated in PHS 398 instructions must be followed for each individual sub-project. The overall Center application must also use the PHS 398 format to summarize the Center's organization and cumulative budgeting for the various budget categories. All essential information necessary for the evaluation of the Center application must appear in the body of the application rather than as appendixes. In view of the fact that the overall Center evaluation process will not include site visits, investigators must provide sufficient details for the assessment of scientific and technical merit. The application must include the following information: 1. Center Staffing Provide a complete description of the qualifications of the PI and the research staff who will be responsible for the Center's activities. Specify past and current involvement of the staff in applied research directed toward the development of new fertility regulation technology. Specify the extent of the commitment that each investigator can make to the Center's program. Indicate possible staff additions in the event of program expansion. If actual individuals cannot be specified, indicate the nature of expertise that is needed. 2. Center Research Activities Provide information concerning the details of the proposed Center program. Provide a five-year research plan for activities that may result in the development of new contraceptive products. The plan must include: o Information concerning current projects or, in their absence, information on projects that will become part of the Center o Evidence of understanding of the research that must be in place for successful implementation of a goal oriented program o Phasing of new studies based on an increase in fiscal resources to be provided by NICHD (Consideration must be given to budgetary expansion in succeeding years (see Budget Section) o Provision for activities for young investigators interested in contraceptive development 3. Facilities Describe the nature of facilities that will be made available to the Center. Describe availability of essential core facilities and indicate major equipment needs. 4. Departmental and Institutional Commitment Provide letters of commitment from all individuals and departments that are not currently directly affiliated with the PI. Provide letters of commitment from the institution to the Center. 5. Collaboration Describe past and current collaborative studies that have been conducted by the PI and the proposed Center staff. Indicate which projects may require collaboration with other departments or institutions. 6. Center Management Provide information concerning the scientific and administrative management of the Center. Indicate what decision-making processes will be utilized in order to optimize successful progression of research. MECHANISM OF SUPPORT The funding mechanism to be used will be the Specialized Center Cooperative Agreement (U54) between the Center and the NICHD. It is expected that one application will be funded for a five-year period, contingent upon the receipt of a sufficient number of meritorious applications, within the total cost limit of $750,000 available for the first year of this award. The major difference between a Cooperative Agreement and a research grant is that there will be a substantial programmatic involvement of NICHD Research Coordinator (Chief of CDB or designee) above and beyond the levels required for traditional program management of grants. Specifically, the awardee will proceed with peer reviewed and approved projects that result from discussions and subsequent agreement between the awardee and NICHD. Recognizing that the available funding may be below the level needed to support all of the peer reviewed and approved projects, research priorities will be established after in-depth discussions between the awardee and the 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. Awardees will retain custody and rights to the data developed under these awards subject only to the Government rights of access consistent with current HHS, PHS, and NIH policies. 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 Food and Drug Administration (FDA) concerning clinical investigations o Providing information to the NICHD Research Coordinator concerning progress The involvement of the NICHD Research Coordinator will be: o Assistance in setting research priorities and in avoiding unwarranted duplication of effort o Review and comment on critical stages in the R&D program before subsequent stages are implemented o Assistance in the interaction between the awardee and the FDA o Assistance in the interaction between the awardee and investigators of other institutions and between the awardee and potential commercial sponsors o Retains the option to recommend 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 Retains the option to recommend additional research endeavors The specific terms and conditions of the award and details of arbitration procedures pertaining to the scope and nature of the interactions between the NICHD and the participating sites will be incorporated into the Notice of Grant Award. These procedures will be in addition to the customary programmatic and financial negotiations that occur in the administration of grants. 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 PI of each of the three Centers and one person selected by the NICHD. 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. The above Terms of Award are in addition to, and not in lieu of, otherwise applicable Office of Management and Budget administrative guidelines, HHS grants administration regulations at 45 CFR Part 74, and other HHS, PHS, and NIH grants administration policies. Cooperative agreements are subject to the administrative requirements outlined in pertinent OMB, HHS, PHS, and NIH guidelines, with particular note of HHS regulations at 42 CFR Part 52 and 45 CFR Part 74. The indirect cost award procedures will apply to cooperative agreement awards in the same manner as for grants. SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group, together with a rationale for its choice. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Section 2, A-D of the Research Plan AND summarized in Section 2, E, Human Subjects. Applicants/offerors are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognize that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. REVIEW PROCEDURES AND CRITERIA Review Procedure A preliminary review will be conducted by NICHD staff upon receipt of the application. Any application that does not meet the minimum requirements (see ORGANIZATION AND SCOPE, above) of this RFA will be returned to the applicant without technical review. Applications meeting the minimum requirements will be reviewed as a group on a competitive basis with each other and in accordance with the usual NIH peer review procedures for research grants. Projects proposing clinical studies must ensure that adequate representation of minorities and women are included in the study population in accord with NIH policy. Failure to comply with this policy may result in the application being returned without review (see above). Responsive applications may be subjected to a triage by a peer-review group to determine their scientific merit relative to the other applications received in response to this RFA. NIH will withdraw from competition those applications judged to be non-competitive, and notify the Principal Investigator and institutional official. The review will be conducted for scientific and technical merit by a special review committee convened specifically for this purpose by the Division of Scientific Review, NICHD. This will be followed by a second-level review by the National Advisory Child Health and Human Development Council. Criteria for Review of Applications Applications meeting the minimum requirements will be evaluated on scientific and technical merit according to the criteria listed below. 1. Scientific, Technical and Programmatic Merit of the Proposed Research o Clear understanding of the relationship of the proposed research to the future of fertility regulation o Description of the experimental plan, including phasing, that may maximize progress o Appreciation of potential problems that may be encountered in the conduct of research and how they may be resolved 2. Qualifications, Experience, and Commitment of Key Personnel o Scientific, clinical, and administrative abilities of the PI and other team members o Knowledge and experience in areas relevant to the conduct of potential studies in contraceptive development o Commitment of staff time for the satisfactory conduct of the study o Experience and qualifications of team members who would be responsible for internal coordination of activities 3. Adequacy of Facilities and Availability of Equipment and volunteer population o Present facilities o Facilities necessary to meet future needs o Availability of suitable volunteer population for clinical investigation 4. Nature of Departmental and Institutional Commitment Institutional assurance to provide support for the study in such areas as fiscal administration, personnel management, space allocation, procurement, planning, and budgeting 5. Nature of Potential Arrangements Outside of Center o Willingness to work with other organizations in the conduct of contraceptive research o Information on the implementation of these arrangements 6. Appropriateness of budget METHOD OF APPLYING Letter of Intent Prospective applicants are asked to submit a letter of intent that includes the names of the Principal and Co-Investigators, identify the cooperating institutions, and indicate whether the application will be for a Field Center, Coordinating Center, or both. The NICHD requests such letters only for the purpose of providing an indication of the number and scope of applications to be received and, usually does not acknowledge their receipt. 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 applications. This letter of intent is to be received no later than January 31, 1992, and is to be sent to: Application Procedures Applications must be submitted on form PHS 398 (revised 10/88, reprinted 9/89), that is available in most institutional business offices and from: Division of Research Grants Office of Administrative Management Office of Grants Inquiries National Institutes of Health Westwood Building, Room 449 Bethesda, MD 20892 Telephone: (301) 496-7441 Applications must be identified by checking the "yes" box in Item Number 2 on the face page of the application, and typing in the words, "Cooperative Contraceptive Development Research Centers Program RFA HD-92-06." In addition, the RFA label available in the 10/88 revision of application form PHS 398 must be affixed to the bottom of the face page and 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. The original and four copies must be received by the Division of Research Grants no later than April 24, 1992. Applications must be sent or delivered to: Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** In addition, two copies of the application must be simultaneously sent to: Laurance Johnston, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development National Institutes of Health Executive Plaza North, Room 520 Bethesda, MD 20892 Applicants from institutions must 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 clinical research. In such a case, a letter of agreement from either the GCRC program director or PI must be included with the application. Budget The instructions for budget estimates provided with the research grant application form (PHS 398) must be followed. Indirect costs will be awarded in the same manner as for research project grants (R01). Budgets will be reviewed on the basis of appropriateness for the work proposed. Allowable costs and policies governing the research grants programs of the NIH will prevail. In planning the budget section of the application investigators should submit detailed budget estimates for each project. It should be kept in mind that the requested budget for the first year may far exceed the total funds ($750,000) made available for this award. Consequently, the peer-reviewed and approved projects will be subject to negotiations between the Center and the NICHD to bring the overall funding level in line with allocated funds. The NICHD may be in position to negotiate the second year budget at a higher level, two-fold, but this will depend on appropriations for this program. For subsequent years (3, 4, and 5) budgetary increases of up to 20 percent may be negotiated, but these will also depend on appropriations for the Center's program. All budgetary negotiations between the Center and the NICHD will be based strictly upon projects that have been peer reviewed. A summary of sources of actual and pending support for each investigator participating in the study, with grant or other award number identification and percent effort, must be in the application. The intent of the Contraceptive Development Centers program is to establish scientific/administrative organizations capable of undertaking the various phases of the R&D process leading to the development of improved methods of fertility regulation for men and women. It is not the intent of this program to enable the awardee to merely shift the funding currently available from a variety of sources to other projects and to reallocate the Center's funds to the ongoing projects. The Center's funds may be used to supplement ongoing projects if such supplementation is programmatically justifiable. Funds may be used in any one of the accepted budget categories. With respect to travel, the budget must include funds for at least one trip to Bethesda per year and a cost estimate for a yearly meeting of Center PIs. It is anticipated that no more than three individuals from any one of the Centers will participate in these meetings. Deadline for Submission The deadline for receipt of applications by the NIH Division of Research Grants is April 24, 1992. Applications received after this date will be returned to the applicant. TIMETABLE Application Receipt Date: April 24, 1992 Review by Initial Review Group: June 1992 Review by NICHD Advisory Council: September 1992 Earliest Award Date: September 1992 Additional Information For further information, investigators are encouraged to contact the NICHD staff members listed below. Program/Scientific Matters: Gabriel Bialy, Ph.D. Contraceptive Development Branch National Institute of Child Health and Human Development Executive Plaza North, Room 600 Bethesda, MD 20892 Telephone: (301) 496-1661 Administrative Policy: Ms. Melinda Nelson Office of Grants and Contracts National Institute of Child Health and Human Development Executive Plaza North, Room 505 Bethesda, MD 20892 Telephone: (301) 496-5481 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance NO. 93,864, Population Research. Awards will be made under the authority of the Public Health Service Act 301 (42 USC 241) and 441 (USC 289d) and administered under PHS Grants Policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. .
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