COOPERATIVE SPECIALIZED INFERTILITY RESEARCH CENTERS Release Date: November 7, 2000 RFA: HD-01-001 National Institute of Child Health and Human Development (http://www.nichd.nih.gov) Letter of Intent Receipt Date: February 15, 2001 Application Receipt Date: July 10, 2001 PURPOSE The National Institute of Child Health and Human Development (NICHD) invites applications from investigators willing to participate with the NICHD under a cooperative agreement in a multicenter cooperative research program termed the National Cooperative Program for Infertility Research (NCPIR). The objective of this program is to expedite the development of new approaches for the diagnosis and treatment of human male or female infertility. Recognizing that the complexity of infertility research severely limits the progress that can be achieved by individual investigators working alone, the NICHD will support at least two Centers comprising biomedical research projects and technical service core facilities, organized to conduct accelerated preclinical and clinical research and development studies on promising new leads in human infertility research. The Centers will also serve as national resources for the career development of young scientists electing to pursue research in high priority areas of infertility research. The efforts of the NCPIR centers will be enhanced by interaction within and among them, as well as with other NICHD- supported cooperative research programs such as the Specialized Cooperative Centers Program in Reproduction Research and the National Cooperative Reproductive Medicine Network. The benefit of this activity will be to the infertile couples, their health-care providers, and the public. 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 priority areas. Potential applicants may obtain Healthy People 2010" at http://www.health.gov/healthypeople/. 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. The need for continuous and active communication among sites dictates that only institutions in the United States are eligible to apply. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This 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 stimulate the recipients activity by involvement in the activity and otherwise working jointly with the award recipients in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships and governance of the 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 NICHD intends to commit $3.0 million in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2002 to fund up to two new and/or competing continuation grants in response to this RFA. An applicant for a new center may request a project period of up to five years and a budget for direct costs of up to $1.0 million for the first year, excluding F & A costs on consortium arrangements, with incremental increases not exceeding three percent in each subsequent year. 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 awards also will vary. Although the financial plans of 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. The anticipated award date is April 2, 2002. This RFA is a one-time only solicitation for the purpose of the present competition. At this time, the NICHD has not determined whether or how this program will be continued beyond the present solicitation. In addition to new applications received in response to this solicitation, up to two competing continuation (renewal) applications are expected to compete for these two Center awards. RESEARCH OBJECTIVES Background Infertility is a major public health problem, affecting 7.1 percent, or 2.1 million married couples in the United States, according to the latest available data of the National Center for Health Statistics. The same data show that 6.2 million women aged 15-44 have some degree of impaired fecundity, of whom 2.7 million have sought medical help. Categorizing human infertility is not an exact science, but it is generally attributed to female factors (40 percent), male factors (40 percent), combined male and female factors (10 percent) or so-called unexplained infertility (10 percent). For couples in whom a definitive diagnosis can be made, such as ovulation dysfunction or tubal disease, treatment may be chosen accordingly. In many cases, however, treatment is empirical. In recent years, assisted reproductive technologies (ART) have rapidly expanded the possibilities of infertility treatment, but many questions remain, not the least of which is the inherent potential to transmit chromosomal aberrations that in themselves may have been responsible for fertility failure. The NICHD is considering these issues in a number of ways. A workshop was held in April 2000 on Outcomes of Children Born as a Result of Intracytoplasmic Sperm Injection (ICSI). As part of the NICHD Strategic Plan 2000: From Cells to Selves, developed with the help of outside experts and the public, the NICHD identified as a scientific goal: Pursue Research Leading to Improved Outcomes in Assisted Reproductive Technologies as part of the section, Reproductive Health for the 21st Century (http://www.nichd.nih.gov/strategicplan/cells/). Infertility and its treatment, however, involve much more than the pragmatic, and often invasive, approaches of ART. Anywhere along the chain of events that result in the birth of a healthy child, abnormalities can occur that impair fertility. The hypothalamic-pituitary-gonadal axis, germ cell production and maturation, steroid hormone production and function, the reproductive tract, fertilization, implantation and early development -- all are vulnerable steps. Reducing the use of hysterectomy in treating reproductive-aged women with gynecologic diseases preserves their fertility potential. Safety, acceptability, and economics also figure in the development of improved treatment. For example, prevention of high-order multiple gestation, with its attendant morbidity and cost, has become an issue in infertility treatment. There remains a need for better understanding of the basic and applied human biology that forms the foundation for understanding, diagnosing, and treating infertility. Objectives of the Program The cooperative research program described in this RFA is designed to meet the nationally identified need for coordinated infertility research to expedite the translation of promising preclinical or clinical leads into new or improved practice available to the public. The need for accelerated basic, translational, and clinical research on the diagnosis, prevention, and treatment of infertility, as documented in a number of relevant reports, provided the original impetus for the NCPIR ( Infertility: Medical and Social Choices, Office of Technology Assessment of the Congress of the United States, Publication OTA-BA-358, May 1988; Infertility in America: Why is the Government Ignoring a Major Health Problem? Report of the House Committee on Government Operations, December 1989; Medically Assisted Conception: An Agenda for Research, Report of the Institute of Medicine of the National Research Council, 1989). Much has been learned since the inception of the NCPIR, but the NICHD continues to emphasize infertility research as an ongoing need. The Research Agenda for the Reproductive Sciences Branch of the NICHD devoted major sections to research progress and unmet needs in male and female infertility. In addition, the document entitled NICHD Special Emphasis Areas for Discretionary Funding lists, among its 14 key topic areas, four directly relating to infertility (http://grants.nih.gov/grants/guide/notice-files/not98-073.html). The NCPIR originated when legislative directives included in the deliberations of the 101st Congress stressed the need to enhance support for research on the diagnostic and therapeutic aspects of infertility alleviation (Resolution HJ 173, Bill HR 2956). Such directives were restated in the respective appropriation committee reports issued by the 102nd Congress. The NIH Reauthorization Act of 1993, issued from the 103rd Congress and enacted on June 10, 1993, as PL 103-43 (Title X, Subtitle A, Section 1001), authorized the Director, NICHD, to make grants or contracts for the operation of two Centers to conduct activities for the purpose of improving methods of diagnosis and treatment of infertility and to provide for the coordination of the Centers assisted under this section. The terms of PL 103-43 acknowledge that infertility research and development problems are so complex that they cannot be solved by individual investigators working alone and that without specialized centers, promising new leads may never be translated into new methods or ever made available to the public. The FY 2001 Senate Appropriations Committee Report language relating to infertility and contraceptive research encourages NICHD to continue aggressive activities in this area, specifically including support of the Centers. Research Scope The scope of the research projects proposed in a Center’s research plan should address infertility as a result of female factor, male factor, or both. Although the overall NCPIR cooperative research program may be expanded by one or more Centers in the future to accommodate a broadened range of studies, the two Centers to be awarded from this RFA are expected to include projects that will lead to early diagnosis and/or therapy of those female factors that most contribute to infertility (endometriosis, ovulatory dysfunction, uterine dysfunction) or those male factors associated with ineffective sperm production (quality or quantity) or function. Research proposals for projects or cores directly involving human in vitro fertilization and/or embryo transfer must be in compliance with NIH policies for such research and should not, therefore, include efforts or activities that create human embryos solely for research purposes (http://stemcells.nih.gov/index.asp). As a cardinal principle, each Center organization should consist of a multidisciplinary set of projects and/or cores capable of interacting in a coordinated, cooperative fashion. Applicants should note that it is not the intent of this cooperative research program to fund a collection of diverse, noninteractive projects. Awards will not be made for applications with research activities focused exclusively on basic research or on clinical research. It is not intended for the Centers to conduct epidemiological research or large clinical trials. Applicants should particularly note that the NICHD currently supports a separately established cooperative research program, called the National Cooperative Reproductive Medicine Network, for conducting national clinical trials, including male and female infertility treatment, and it is not the intent of the present NCPIR cooperative research program to support additional large-scale, long-term clinical trials. It is anticipated, however, that findings from NCPIR Centers may form the basis for protocols to be developed and conducted by the Reproductive Medicine Network, with collaboration from the NCPIR. Each Center should organize its overall research plan to include a mix of patient-oriented research, clinical research in the broader sense of involving human material, and closely related basic research activities. Within the NICHD requirement for a minimum of three funded projects to constitute a Center award, there are various options for a Center’s organization of its projects. An applicant’s research plan might, for example, include a set of clinical research projects and related basic or animal model projects to study infertility-related aspects of a specific disease or disorder, e.g., endometriosis. Alternately, an applicant’s research design strategy may include projects involving clinical and preclinical investigations integrating management of more than one infertility factor. Yet another orientation of scope might encompass comparative clinical and preclinical experimental evaluations of ART protocols. These examples are only indicative of general strategy designs and should not be taken as an inclusive or exclusive preference of the NICHD. Guidance and Management Structures The National Cooperative Program for Infertility Research (NCPIR) will include two Centers supporting an aggregate of research projects and, when appropriate, technical service cores. At least one patient-oriented research project and an administrative core will reside in the sponsoring department of the grantee institution awarded a Center grant. Centers may include one consortium-based, research project (excluding developmental projects) located at a domestic U.S. institution other than the grantee institution. A Steering Committee consisting of the investigators responsible for each project (excluding developmental project investigators), the Principal Investigator of each Center, and an NICHD staff Research Coordinator, will assist and guide the conduct of the research performed by the Centers. A nonvoting member of the NICHD grants management staff will serve as an advisor to the Committee. The Steering Committee will employ a consensus decision process to assist the Centers in evaluating the progress of Center projects, proposed new research initiatives, the need for extra-Center collaborations, and the need to redirect certain Center efforts due to either sufficient data acquisition to permit conclusion, the acquisition of data supporting an alternative study initiative or experience proving that the proposed research is no longer feasible. An NICHD Program Official (not the Research Coordinator) will provide administrative oversight and monitor progress of the NCPIR. Further details of the guidance and management structures and processes may be found under Terms and Conditions of Award, below. SPECIAL REQUIREMENTS Description of a Center The minimal requirements for a Center described in this RFA are as follows (see sections on REVIEW PROCEDURES and Award Criteria below): o An administrative core unit that provides oversight to the Center, located at the applicant institution and accessed only by budgeted Center subprojects and cores. o A research plan that is responsive to the objectives of the Centers Program set forth in this RFA (see RESEARCH OBJECTIVES). o At least three research projects (not including developmental projects) that thematically address one or more research areas listed under Research Scope. It is required that at least one project involve patient-oriented research. o At least one developmental research project directly related to the overall research emphasis of the Center, the budget of which cannot exceed 10 percent of the center grant’s first-year direct cost budget, inclusive of the portion budgeted for developmental projects, or $100,000 per year, whichever amount is smaller. The Principal Investigator (PI) of a developmental project must be a new investigator, i.e., an investigator who has not been the PI of a funded NIH or comparable research project other than a small grant (R03), an Academic Research Enhancement Award (R15), an exploratory/developmental grant (R21), or certain research career awards directed principally to clinicians at the beginning of their research career (K01, K08, K22, and K23). The PI can reside at either the grantee institution or a participating consortium institution. A minimum of 50 percent effort must be expended on the project by the new investigator. Support for a developmental project is limited to a two-year period which can be extended by one year with NICHD approval. If a developmental project is favorably recommended, funds will be included each year for the full duration of support of the parent grant. Funds in the outyears will be contingent upon review and approval of additional developmental projects by the Steering Committee and NICHD. A developmental project should be an opportunity for its PI to progress toward research independence. As such, the project proposal should explicitly include plans for mentoring by one or more established Center investigators. o Funds to support a collaborative project with another Cooperative Specialized Infertility Research Center or Specialized Cooperative Center in Reproduction Research. These funds, not to exceed $50,000 in direct costs, will be requested as part of the Administrative Core budget, and will be restricted for use to support collaborative projects pending an external peer review of the project and approval by the NCPIR Steering Committee, by the Steering Committee of the Specialized Cooperative Centers Program in Reproduction Research, if appropriate, and by NICHD. o A competent and experienced Principal Investigator who is committed to and directly involved in human infertility research. o Availability of competent and experienced scientific experts to direct individual research projects or cores associated with the proposed Center. o Availability of the technical resources and facilities necessary for the conduct of the research. o Access to properly managed animal facilities for projects conducting animal studies. o Access to inpatient and outpatient reproductive health care units providing adequate numbers of patients for clinical research projects that require patient participation. [Applications from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. In such a case, a letter of agreement from either the GCRC Program Director or Principal Investigator should be included with the application.] o A research environment conducive to the training of new investigators in infertility research. o Willingness to cooperate in a coordinated cooperative research program involving other Cooperative Specialized Infertility Research Centers, as well as other cooperative programs administered by the NICHD such as the Specialized Cooperative Centers Program in Reproduction Research and the National Cooperative Reproductive Medicine Network. o Substantive evidence of departmental and institutional support for and commitment to the proposed Center. Optional components of the Center organization include the mix of projects and cores to be included in the Center: The Principal Investigator may choose to organize the Center using collaborations of projects within the same institution. Centers may seek to maximize their scientific expertise and research capabilities by including in the application a project to be supported at another institution through subcontracted consortium arrangements. No more than one consortium project (excluding a developmental project) will be permissible in each center, however, portions of other projects may be subcontracted. The Principal Investigator of the Center may wish to incorporate into the application a highly relevant individual NIH research project that is currently ongoing and deemed appropriate for transfer into the Center. Such a project may be fully presented in the Center application as a renewal project and, contingent upon the peer review outcome, may become eligible for funding through the Center upon relinquishment of the prior awarded project grant. The Principal Investigator may choose one of two center structure options regarding access to technical service core facilities: o Closed Access Structure - In this center structure, administrative and all technical service cores will be utilized by budgeted center subprojects only. Consistent with NICHD guidelines for establishment of core facilities, utilization by three subprojects is required to justify a core technical service facility. Percent utilization by any one of the three subprojects justifying the core may not exceed 50 percent or be less than five percent. The percent utilization of additional subprojects requiring core services may be less than five percent. Costs necessary to use a particular core facility may be incorporated into the budget of the core unit, and not in the budgets of the research subprojects per se. No internal charge-back system would be required. o Open Access Structure - In this center structure, budgeted center subprojects as well as research projects external to the Center (e.g., R01, R03, P01 subproject) may have access to technical service cores. However, special consideration must be given to justification of a technical service core facility and the formal establishment of an effective charge-back system for all technical service cores. For each core service facility, at least one of the three projects used to justify a core must be a budgeted center subproject, while the remaining project(s) used in justifying the core must be externally funded NICHD projects administered by the Reproductive Sciences Branch (RSB). Percent utilization by any internally budgeted center subproject or externally-funded RSB project used to justify a particular core facility may not exceed 50 percent or be less than five percent. An additional seven federally-funded, peer-reviewed external research projects addressing program-relevant research areas of the RSB may access the core up to 100 percent of its service capacity. The 50/5 percent utilization requirement applies to this group of external projects. Centers must establish an internal management policy for evaluating the acceptability of proposed RSB program relevant external projects to access the core facilities. Approval of requests for core access privileges for external projects that would replace those described above must be made to RSB Program Staff who then will evaluate the extent to which the project is relevant to RSB mission research areas (see Research Scope), and render a decision accordingly. If centers choose to operate in an open access format, costs necessary to utilize a particular core facility by budgeted center subprojects must be incorporated into the budget of the subproject and not the core budget in order to accommodate participation in the required charge-back system. Core budgets will be justified and evaluated based on access by budgeted center subprojects and external, program-relevant research projects as described above. Above and beyond this arrangement, technology-based core units may offer services to additional external projects addressing any area of research regardless of funding source only on a full payback (fee-for-service or in- kind) basis. However, additional funds necessary to provide services to these external projects (e.g., technical support, supplies, etc.) must come from sources other than the center funding, such as the supply budgets of the external projects wishing to access the core facilities. In choosing to configure a center in an open-access center structure, the Principal Investigator must have in place, and adequately describe in the application, management policies that ensure that budgeted center subprojects are given highest priority in receiving services provided by the core. Centers choosing to configure in an open-access center format may propose one or more technical service cores that will be utilized exclusively by budgeted center subprojects. These centers may, therefore, have a mix of open and restricted access technical service cores. On the other hand, administrative cores in open center structures may be accessed only by budgeted center subprojects. Once an award is made, centers configured as a closed-access center structure may, at a later time, choose to convert to an open access center structure by requesting such conversion in writing to the NICHD. Travel to Meetings Principal Investigators should request travel funds to support their participation in the annual Directors Meeting and two Steering Committee Meetings per year. Key Investigators of budgeted center projects and Directors of technical service cores should request travel funds to support participation at two Steering Committee Meetings per year. Terms and Conditions of Award Cooperative agreements are assistance mechanisms and are subject to the same administrative requirements as grants. The following Terms and Conditions of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS and NIH grant regulations, policies and procedures, with particular emphasis on HHS regulations at 45 CFR Parts 74 and 92. Business management aspects of these awards will be administered by the NICHD Grants Management Branch in accordance with HHS and NIH grant administration requirements. The purpose of these cooperative agreements is to support a coordinated research program of specialized centers that seek to establish new methods for the diagnosis, treatment and amelioration of human infertility. 1. Awardee Rights and Responsibilities The primary authorities and responsibilities of the awardees are to participate cooperatively with the Steering Committee in the following activities: o Determine objectives and experimental approaches; o Design protocols; o Conduct experiments and collect the resulting data; o Analyze, interpret, and present results and plans to the Steering Committee for approved activities; o Publish results, conclusions, and interpretation of the studies. The Awardees will agree to: (1) accept the coordinating role of the Steering Committee which includes evaluating objectives and research goals of the Centers Program, and recommending modification, deletion or addition of protocols within the Centers Program; and (2) follow any common protocols in which they participate for multicenter projects that are approved by the Steering Committee. Awardees will agree, when appropriate, to work cooperatively with other NICHD- supported cooperative programs, particularly those administered by the RSB such as the Specialized Cooperative Centers Program in Reproduction Research and the National Cooperative Reproductive Medicine Network. Examples of interaction with these programs may include providing reagents and access to research resources, and participation in research focus groups. Findings from NCPIR Centers may form the basis for protocols to be developed and conducted by the Reproductive Medicine Network, with collaboration from the NCPIR. Awardees will retain custody of and primary rights to their data developed under the award subject to current government policies regarding rights of access as consistent with current HHS, PHS, and NIH policies. 2. The degree of programmatic involvement of the NICHD Research Coordinator is as follows: o Participating in the overall coordination of the Centers Program with the Steering Committee. This includes setting research priorities, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted. The Research Coordinator will assist and facilitate the overall coordination of the Program, and not direct it. o Providing, as a member of the Steering Committee, assistance by reviewing and commenting on all transitional phases of the Centers activities prior to implementation to assure consistency with required program goals and compliance with research protocol priorities. This includes efforts to improve and strengthen inter- and intra-center cooperation amongst the research projects of the Centers. The Research Coordinator will also assist the research efforts of the Centers Program by facilitating access to fiscal and intellectual resources provided by industry, private foundations, and NIH intramural scientists. The Research Coordinator will, as required, help reprogram research efforts, including options to modify or terminate them, by mutual consent between the Centers Program and NICHD. In the event of disagreements among the Program participants, the Research Coordinator will assist in forming an arbitration panel as discussed below. o Interacting with each individual center awardee to evaluate objectives and research goals of that particular center, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted. The Research Coordinator will assist and facilitate this process and not direct it. The Research Coordinator will also provide assistance in reviewing and commenting on all major transitional changes of an individual center’s activities prior to implementation to assure consistency with required goals of the Centers Program. o Retaining the option to recommend the withholding of support from a Center project or core materially failing to meet the technical performance requirements established by the Program. This includes identifying jointly with participants the need to add additional research projects or service cores to Centers or to phase out a Center project or core when performance standards have not been met; and o Participating, where warranted, in data analyses, interpretations, and the dissemination of study findings to the research community and health care recipients including co-authorship of the publication of results of studies conducted by the Centers. 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 (excluding developmental project investigators), and one NICHD staff member from the RSB, 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 twice yearly. The purpose of these meetings is to share scientific information, assess scientific progress, identify new research opportunities, establish priorities that will accelerate the translation of preclinical findings into clinical applications, and conduct the business of the cooperative research program. 4. Arbitration When agreement between an awardee and NICHD staff cannot be reached on scientific/ programmatic issues that may arise after the award, an arbitration panel will be formed. The panel will consist of one person selected by the Principal Investigator, one person selected by NICHD staff, and a third person selected by these two members. The decision of the arbitration panel, by majority vote, will be binding. This special arbitration procedure in no way affects the right of an awardee to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. 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 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 on the Internet 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 may also 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 to 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 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 NICHD staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to Dr. Louis De Paolo at the address listed under INQUIRIES, below, by February 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. At minimum, an application in response to this RFA should include: o A description of a Cooperative Specialized Infertility Research Center consisting of multiple individual research subprojects, an Administrative Core, and, if applicable, one or more technology-based core service facilities. o A description of the capabilities of the Center to meet or exceed the minimal requirements for a Center stated in this RFA (see Description of a Center). o A proposed five-year research plan that presents the applicant's perception of the Center's organization and component functions. This plan should demonstrate the applicant's knowledge, ingenuity, practicality, and commitment in organizing a multi-project research infrastructure for conducting studies aimed at developing new approaches to the diagnosis and/or therapy of human infertility. The research plan for the Center and all component subprojects must address the Research Scope described above. o A statement describing the willingness of the Principal Investigator to cooperate in a coordinated cooperative centers program with the objective of developing research project and/or service core interactions between other Cooperative Specialized Infertility Centers, as well as with other NICHD- supported cooperative programs. o Substantive evidence of departmental and institutional support for and commitment to the proposed Center. o For competing renewal applications, evidence of having met the Terms and Conditions of the award during the previous funding period. All applicants must document their ability to meet or exceed the minimum requirements as set forth in this RFA. This specifically includes understanding of and commitment to the cooperative nature of this program, and willingness to meet the Terms and Conditions of Award. Submission Procedures 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-01-001. 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 July 10, 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 CSR and for responsiveness to the RFA by NICHD staff. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Any application that does not meet the minimum application requirements as set forth under SPECIAL REQUIREMENTS will be considered unresponsive to the RFA. Responsiveness includes, but is not limited to, the program relevance of the proposed research subprojects and external projects being proposed to access core facilities, as determined by NICHD. 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: February 15, 2001 Application Receipt Date: July 10, 2001 Peer Review: October/November 2001 Council Review: January 2002 Earliest Anticipated Award Date: April 2, 2002 AWARD CRITERIA Applications recommended by the NACHHD Council will be considered for award based on scientific and technical merit as determined by peer review; program balance; and availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues and address the letter of intent to: Louis V. DePaolo, Ph.D. Reproductive Sciences Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B01, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6970 FAX: (301) 496-0962 E-mail: ld38p@nih.gov Direct inquiries regarding fiscal matters to: Ms. Mary Ellen Colvin Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17M, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1304 FAX: (301) 402-0915 E-mail: mc113b@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.864, Population Research. 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 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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