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RFA-HD-02-029: SPECIALIZED COOPERATIVE CENTERS PROGRAM IN REPRODUCTION RESEARCH SPECIALIZED COOPERATIVE CENTERS PROGRAM IN REPRODUCTION RESEARCH RELEASE DATE: September 27, 2002 RFA: HD-02-029 National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov) LETTER OF INTENT RECEIPT DATE: May 21, 2003 APPLICATION RECEIPT DATE: June 18, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute of Child Health and Human Development (NICHD), through the Reproductive Sciences Branch (RSB) in the Center for Population Research (CPR), provides funding for a limited number of research centers in the reproductive sciences. These centers provide an arena for multidisciplinary interactions among basic and clinical scientists interested in establishing high quality research programs in the reproductive sciences. Accordingly, the purpose of this RFA is to announce the annual recompetition of the Specialized Cooperative Centers Program in Reproduction Research. Applications are sought from investigators willing to participate with the NICHD under a cooperative agreement in a multicenter cooperative research program. Center investigators will be expected to work with NICHD staff in facilitating research collaborations and interactions within and between centers. Such a cooperative program will form a national network that fosters communication, innovation, and research excellence with the ultimate goal of improving human reproductive health through accelerated transfer of basic science findings into clinical practice. RESEARCH OBJECTIVES Background The ultimate goal of biomedical research supported by the RSB is to develop new knowledge leading to clinical applications that will enable men and women to control their own fertility choices with methods that are safe, effective, inexpensive, reversible, and acceptable to various population groups. Such research aims to develop new leads for contraception, procedures for alleviating infertility, and fertility-preserving treatments for reproductive disorders that threaten fertility. The present day need for the availability of contraceptive options acceptable to diverse populations remains globally unmet. Among the 600 million women of reproductive age in today"s world, as many as 228 million women are at risk of unintended pregnancy. Up to 64 percent of all worldwide pregnancies are unintended (mistimed or completely unwanted). Over 50 million abortions occur worldwide each year with minimal estimates of at least 100,000 abortion-related deaths annually. In the U.S., three million unintended pregnancies--57 percent of all pregnancies--occur annually, with half resulting in abortion as an outcome. In half of the 1.3 million abortions occurring in the U.S. each year, a contraceptive method being used failed to prevent pregnancy. Families, family values, and family planning form the cultural essence and cohesiveness of our existence as human societies. One of the most basic of human rights--the right to procreate--is frustrated or denied by the occurrence of infertility in a couple desiring children. It has been estimated that infertility affects between 37 and 70 million married couples around the world. In U.S. studies described nearly 50 years ago, it was stated that up to 10 percent of married couples were "sterile," with the remaining 90 percent having varying degrees of fertility. More recent and technically rigorous U.S. survey studies have conservatively identified that there are about 2.3 million infertile couples, which is about nine percent of the domestic married couple population base with wives aged 15-44. In addition, such studies found that about 4.9 million U.S. women in this age range had an impaired ability to have children. At least 30-50 percent of infertility is attributable to male factor infertility for which the pathophysiology is either not understood at all or, at best, poorly understood. The prognosis for male infertility treatment outcomes is extremely poor at present. Indeed, whereas 80 percent of infertile women can be successfully treated, male infertility can be treated in only 10-20 percent of such men. However, the widespread use of assisted reproductive technologies such as intracytoplasmic sperm injection (ICSI) and its variants have enabled otherwise infertile men to father children, although possible genetic causes of the infertility are likely transmitted to the progeny. While analyses of the U.S. population base have not found alarming annual increases in the overall number of infertile couples or the overall prevalence of infertility, significant age-related increases in infertility, coupled with delayed childbearing in the contemporary couple population base, have been found in such studies. Physician office visits reflecting current societal life style requirements for infertility services have markedly increased in the U.S. from 1968 (600,000) to 1988 (1,350,000) and are estimated to approach two million visits in 2000. Of the infertile couples seeking treatment for infertility, it has been estimated that up to one-half will be unsuccessful in achieving their desired outcome. In concert with the increased medical assistance sought, U.S. infertility service costs have risen to exceed a billion dollar annual medico-economic impact in the U.S. Reproductive disorders affecting fertility are associated with significant morbidity and a degree of mortality in some specific instances that cannot be ignored. During the past two decades, the incidence of ectopic pregnancy has increased from 4.5 to 16.1 per 10,000 pregnancies. The rate appears to be increasing particularly in young women aged 15-19, perhaps in relationship to the U.S. factors of earlier age of menarche and initiating sexual activity leading to encountering tubal disease factors earlier. In 1989, it was reported that 88,400 women experienced an ectopic pregnancy and 34 of them died as a direct consequence. While improved diagnostic procedures and early intervention protocols have resulted in markedly reducing mortality, surviving women are left with an eight-fold risk of reoccurrence and a 20 percent lowered chance of ever conceiving again. Accompanying the human costs of morbidities of reproductive tract disorders, as noted above, are the attendant substantial costs to the U.S. health care system involving the diagnosis, treatment, and follow-up services provided to the patients, as well as the added costs to the patient and the U.S. economy of lost employment and family service hours. In reproductive age couples, the obstructive sequelae of male accessory gland infections account for eight to 12 percent of male partner diagnostic costs for fertility impairment. In reproductive age females, it has been estimated that the general incidence of endometriosis is five to 15 percent. The incidence of endometriosis in females being surgically treated for infertility is known to be 30 to 50 percent. Among infertile females with no other known cause of their infertility, the incidence of endometriosis has been reported to be 40 to 70 percent. A diagnosis of severe endometriosis often leads to hysterectomy-associated treatment. While the causative role of endometriosis in infertility remains poorly understood and its optimal diagnosis and treatment remain a goal--not an accomplishment--of contemporary medicine, the morbid impact of the associated pelvic pain has significant human cost as well as national economic costs. Similarly, the role of dysfunctional uterine bleeding, either in the presence or the absence of uterine leiomyomata (fibroids), is not well understood despite its common occurrence and decades of research. It is a significant factor in noncompliant contraceptive use or discontinuance and, therefore, in the unintended pregnancy problem. Uterine myomata occur in nearly 20 percent of all reproductive age women, are the single most common diagnosis in gynecological hospital admissions, may be the only abnormality observed in an infertile couple, and represent the most common medical indication for an unintended and often unwanted hysterectomy that prematurely ends a female"s reproductive options. Polycystic ovary syndrome (PCOS) is a major cause of female infertility, as well as other reproductive system, and other tissue and organ system morbidities. Identified more than 60 years ago by Stein and Leventhal, the etiology of PCOS remains misunderstood despite 60 years of research. This insidious disease is currently the most common endocrine disorder of women of reproductive age. Recent prevalence rate estimates suggest that between five and 10 percent of the reproductive age population of U.S. women suffers the full-blown syndrome of hyperandrogenism, chronic anovulation, and polycystic ovaries. Also poorly understood is the pathogenesis of premature ovarian failure that affects one in 100 women by age 40. Interestingly, 16 percent of women carrying the fragile X pre-mutation present with premature ovarian failure. It is becoming increasingly apparent that some conditions of male and female infertility may be genetically based. In males, there is considerable evidence from breeding studies and gene knockout experiments in animals that mutation of over 100 separate genes results in infertility. More limited studies in humans show that a number of inherited diseases are associated with abnormal sperm morphology and function. These data suggest that a significant number of men with infertility may have one or more mutations that predispose to their condition. However, it is currently not possible to determine which men have genetic infertility. Similarly, it is estimated that 15-20 percent of human pregnancies are chromosomally abnormal as a result of division errors during oocyte meiosis or early embryonic cleavage. Such errors not only are the leading cause of birth defects, but also may be the single most important factor contributing to human infertility. Recognizing that the interactive needs of basic and clinical research necessary to address the above and related problems may be so complex that they cannot be solved by individual investigators working alone without the intellectual and fiscal resources of a cooperative specialized center program, it is the intention of the RSB, contingent upon the availability of funds, to continue and maintain organized, multi-component reproductive extramural research programs of high quality that focus on topics of high priority and significance because of their critically important relationship to the mission of the RSB. Objectives The objectives of this Centers Program are to support specialized reproductive research programs of high quality, and to facilitate and accelerate bidirectional transfer of knowledge between the laboratory and clinic. This RFA is specifically designed to stimulate the reproductive sciences research community to organize and maintain research-based centers of outstanding quality that, serving as national research resources, form a cooperative network with NICHD that fosters communication, innovation, and high quality reproductive research. Such networking as afforded by the cooperative nature of this Centers Program will ensure that the reproductive research community remains in the forefront of the development and utilization of new technologies that can be used to diagnose, treat, and ameliorate reproductive disorders, as well as to identify novel leads for fertility regulation. Research Scope The Specialized Cooperative Centers Program in Reproduction Research (SCCPRR) is composed of research-based center grants designed to support interactive groups of research projects and supporting core service facilities. The research activities included in these center grants must comprise, by definition, a multidisciplinary approach to biomedical problems addressing the specific research topic areas announced in this RFA (see below). These centers may have more than one theme, focus or emphasis, but all of the subprojects involved must be responsive to one or more of the specific research areas of reproduction supported by the RSB. Furthermore, the translational objective of this Program requires that one of the subprojects be entirely or predominantly clinical. The following is a list of topics that are considered to be responsive to the research mission areas of the RSB. Additionally, these topics identify areas where research at the basic/clinical interface is deemed essential to the potential development of new leads or approaches to fertility regulation, as well as of diagnostic tools and procedures for the detection, treatment, and effective management of reproductive disorders that impact on reproductive competence. o Reproductive Developmental Biology -- origins and differentiation of germ cells, the endocrine, paracrine, and physiologic mechanisms involved in gametogenesis, including germ cell-somatic cell interactions, germ cell proliferation and apoptosis, and germ cell transplantation, fertilization, including sperm motility and capacitation, zona pellucida binding, and mechanisms to block polyspermy, pre-implantation embryonic development including zygotic gene activation, and mechanisms regulating embryonic stem cell differentiation and maintenance of stem cell pluripotency. o Reproductive Tract Biology and Physiology -- folliculogenesis, including studies addressing intraovarian control of follicle selection and atresia by growth factors, cytokines, and their respective binding proteins and receptor antagonists, luteogenesis and luteolysis, including intraovarian mechanisms that control luteal life span, implantation, including cell-to-cell interactions regulating implantation, structure, function, and regulation of the epididymis. o Reproductive Endocrinology and Neuroendocrinology -- fundamental mechanisms of hormone synthesis, secretion, regulation, and action in the context of reproduction, including intrapituitary mechanisms governing gonadotropin secretion, and intraneuronal mechanisms and glia-neuron interactions controlling pulsatile GnRH secretion, identification of elements and factors controlling gene transcription including co-activators and co- repressors, and identification of signaling molecules and pathways mediating hormone action, interaction of the immune and neuroendocrine systems in controlling fertility, mechanisms by which nutritional modification alters the hypothalamo-pituitary-gonadal endocrine axis. o Reproductive Genetics -- genetics of sex determination including clarification of the functional interactions between the known sex determination genes, role of inheritance and expression of parental alleles in reproduction including genes and mechanisms important in imprinting and methylation during gametogenesis and embryogenesis, and elucidation of the genes and genetic mechanisms responsible for normal and skewed X chromosome inactivation. o Reproductive Medicine -- etiology, pathophysiology, prevention, diagnosis and treatment of male or female infertility with particular emphasis on defining those conditions which are genetically based, relation of endometriosis to infertility, treatment of benign gynecologic diseases, research leading to improved outcomes across the spectrum of assisted reproductive technologies, as well as development of new approaches for assisted reproduction. Because this list is not meant to be all-inclusive, prospective applicants preparing either a new or competing continuation center grant application are encouraged to discuss program relevance issues with the program staff contact cited under WHERE TO SEND INQUIRIES, below. However, applicants should note that the research scope of this RFA does not include studies in the area of reproductive oncology, reproductive toxicology or reproductive epidemiology or studies dealing with post-implantation pregnancy and parturition. These topic areas are outside the scope of research supported by the RSB and, therefore, will be deemed non-responsive to this RFA. Further, applications proposing research activities focused exclusively on clinical research or exclusively on basic research, or applications or components thereof proposing epidemiological or large-scale clinical trial research, will not be considered responsive to this RFA. Guidance and Management Structures Overall coordination of the Centers Program, consistent with the stated objectives set forth in this RFA (see Objectives), will be done by a Steering Committee consisting of all Center Principal Investigators and an NICHD Staff Research Coordinator from the RSB, CPR. The Steering Committee will employ a consensus decision process to guide the Centers Program in evaluating the progress of member Center programs, their proposed new research initiatives within the general scope of the approved program, the need to provide the entire Center network with access to new technologies, the need for collaborations either within or outside the Center network, and the need to redirect certain efforts of member Centers 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. In addition to the Steering Committee, smaller cooperative groups will be formed that consist of research components of member centers having common research interests addressing a specific basic and/or clinical research problem. These research focus groups will perform coordinated research activities as recommended by the Steering Committee. In turn, progress of the focus groups will further guide the Steering Committee in decision-making regarding changes in specific research directions, translational activities, and collaborative research initiatives. The research focus group will consist of an NICHD Staff Research Coordinator from the RSB, CPR, and Key Investigators of the relevant subproject and/or Core Directors. Further details of the guidance and management structures and processes may be found under "Cooperative Agreement Terms and Conditions of Award," below. MECHANISM OF SUPPORT This RFA will use the NIH Specialized Cooperative Research Center (U54) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. At this time, the NICHD plans to reissue this RFA on an annual basis. The anticipated award date is April 1, 2004. The NIH U54 is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award." FUNDS AVAILABLE The NICHD intends to commit approximately $4.9 million in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2004 to fund up to four 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 $900,000 for the first year, excluding F & A costs on consortium arrangements, with incremental increases for recurring costs (i.e., personnel, consultants, supplies, travel and other expenses) not to exceed 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 to $900,000 in the first year or 120 percent of the direct costs awarded for the final competitive segment of the preceding project period as stated in the Notice of Grant Award, whichever is higher. 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. In the event that an application submitted in response to this RFA is not funded, one revision of the application may be submitted in response to a subsequent RFA. Requested budgets for revised applications must follow the recommendations of the peer review group who evaluated the initial submission unless the submission of a different budget request has been authorized in advance by the NICHD. If a revised competing continuation application is not selected for funding, the applicant institution may then submit only a new, substantially different application in response to a subsequent RFA that will be subject to the direct cost limit of $900,000. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic. Foreign institutions are not eligible to apply as an applicant institution, however, subcontracts from domestic entities to foreign sites are permitted INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. 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 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 subprojects that thematically address one or more research areas listed under Research Scope. It is required that at least one subproject be entirely or predominantly clinical in nature. For the purpose of this Centers Program, the definition of "clinical" includes studies that involve patients or use of cultured human cells or tissue. Although not required, it is strongly encouraged that at least one basic science subproject be in a similar scientific area as the clinical subproject in order to facilitate transfer of information from bench to bedside. Alternatively, a project may be proposed that incorporates both basic and clinical approaches to a particular problem. 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 competent and experienced Principal Investigator who is committed to and directly involved in research dealing with mammalian reproduction. 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 As appropriate, 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.] Optional components of the Center organization include the mix of subprojects and cores to be included in the Center: o The Principal Investigator may choose to organize the Center using collaborations of projects within the same institution. Alternatively, Centers may seek to maximize their scientific expertise and research capabilities by including in the application a subproject and/or a technical service core to be supported at other institutions through subcontracted consortium arrangements. No more than one consortium subproject and one consortium core service facility will be permissible in each Center. o Funds may be requested to provide support for one or more pilot projects relevant to the center"s goals. Support for a pilot project is limited to a two-year period. Funding may not exceed 10 percent of the center grant"s first-year direct cost budget, inclusive of the portion budgeted for pilot projects, or $90,000 per year, whichever amount is smaller. With NICHD staff approval, the period of support may be extended one additional year. Funds for pilot projects may be requested in new or competing continuation applications only. As such, the proposed research plan must be described in sufficient detail, comparable to the other subprojects submitted in the application, to permit evaluation of the project using the review criteria listed under REVIEW CONSIDERATIONS. If a pilot project is favorably recommended for an initial two-year period, funds will be included each year for the full five years. Funds in Years 03-05 will be contingent upon review and approval of additional pilot projects by NICHD staff. Funding levels in these out-years will be based on the level of funding for this purpose in Years 01 and 02. o The Principal Investigator may choose one of two center structure options regarding access to technical service core facilities. 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. 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 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 which 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 Steering Committee Meeting as well as one research focus group meeting. Key Investigators of budgeted center subprojects and Directors of technical service cores should request travel funds to support participation in two research focus group meetings. Cooperative Agreement 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 Part 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 pursuing high quality reproductive research with the ultimate goal of facilitating and accelerating translation of basic science knowledge into clinical applications that can be used to regulate fertility or diagnose and treat infertility or reproductive disorders that impact on fertility. 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 Pursue research objectives consistent with the research scope of the RFA and research favorably recommended by peer review, 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, 2) follow any common protocols in which they participate for multicenter projects that are approved by the Steering Committee, and 3) accept the cooperative nature of the group process, including the establishment, where appropriate, of smaller collaborative groups comprised of interacting subprojects and/or cores focused on a particular reproductive research topic area. 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 DHHS and NIH policies. 2. NICHD Responsibilities NICHD Research Coordinator: o Participating in the overall coordination of the Centers Program with the Steering Committee. This includes efforts to improve and strengthen inter- and intra-center cooperation amongst the research projects of the Centers, particularly as it pertains to translational research activities within and between centers. As a means of improving inter-center cooperation, the Research Coordinator will directly participate in the activities of the smaller collaborative groups established by the Steering Committee comprising subprojects and/or cores focused on a particular reproductive research topic area. 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 evaluating 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 subproject or core materially failing to meet the technical performance requirements established by the Centers Program. This includes identifying jointly with participants of the Steering Committee the need to add additional research subprojects or service cores to Centers or to phase out a Center subproject 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. NICHD Project Officer: NICHD will appoint a Project Officer, apart from the Research Coordinator, 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, and o Exercise the normal stewardship responsibilities of an NIH Program Officer. 3. Collaborative Responsibilities Overall Coordination of the Centers Program consistent with the stated intent of the RFA will be done by a Steering Committee consisting of the Principal Investigators from each of the participating Centers 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. A chairperson for the Steering Committee will be chosen by a majority vote of the Principal Investigators. The Steering Committee meetings will be convened at least once per year. The purpose of these meetings is to share scientific information, assess scientific progress, identify new research opportunities and potential avenues of collaborations such as with industry, private foundations and/or NIH intramural scientists, establish priorities that will accelerate the translation of preclinical findings into clinical applications, reallocate resources and conduct the business of the cooperative research program. In anticipation that some centers will have common research interests that address a specific basic and/or clinical research problem, it is envisioned that research focus groups will be formed to conduct coordinated research activities recommended by the Steering Committee. The Steering Committee will approve multicenter protocols on specific research activities. As needed, the Steering Committee will develop a publication policy regarding joint authorship of research reports derived from such collaborative efforts. 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 DHHS regulations at 45 CFR Part 16. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues 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 o Direct your questions about peer review issues to: Robert Stretch, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1485 Email: stretch@nih.gov o Direct your questions about financial or grants management matters to: Ms. 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) 480-4782 E-mail: kh47d@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o 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 by the date listed at the beginning of this document. The letter of intent should be sent 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 SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SUPPLEMENTAL 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 Specialized Center in Reproduction Research 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 basic and clinical studies in the reproductive sciences. 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 program involving multiple Centers with the objective of developing research project and/or service core interactions between Centers. 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. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: 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 must be sent to: Robert Stretch, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. 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. Only one revision of a new or competing continuation application submitted in response to this RFA may be submitted in response to a subsequent RFA. PEER REVIEW PROCESS 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: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Advisory Child Health and Human Development Council A site visit will not be 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. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: May 21, 2003 Application Receipt Date: June 18, 2003 Peer Review Date: October/November 2003 Council Review: January 2004 Earliest Anticipated Start Date: April 1, 2004 AWARD CRITERIA Award 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. REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research projects unless a clear and compelling justification is 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 clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 ( https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete copy of the updated Guidelines is available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research, updated racial and ethnic categories in compliance with the new OMB standards, clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398, and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy 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 that is available at https://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at https://grants.nih.gov/grants/stem_cells.htm and at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. 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. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. 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 RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.864, Population Research, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 described at https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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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