FEMALE HEALTH AND EGG QUALITY RELEASE DATE: June 13, 2002 RFA: HD-02-018 National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) LETTER OF INTENT RECEIPT DATE: September 16, 2002 APPLICATION RECEIPT DATE: October 16, 2002 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 The National Institute of Child Health and Human Development (NICHD) invites applications from investigators willing to participate in a multisite National Cooperative Program on Female Health and Egg Quality. This Program will utilize the cooperative agreement mechanism to try to better understand the impact of poor nutrition, extreme exercise, smoking, certain assisted reproductive technologies and other adverse health situations upon reproductive processes prior to and around the time of fertilization in females. The central focus of this Program will be to establish measurable or identifiable characteristics of high quality human and nonhuman eggs that have full developmental potential. It is thought that a high quality egg is an important starting point for the development of a healthy embryo, placenta and fetus. It is also thought that low egg quality can lead to certain forms of infertility, to abnormal embryonic and fetal development, to low birthweight as well as to longterm adult diseases and disorders in the offspring. The Barker Hypothesis on fetal origins of adult diseases suggests that there can be adverse in utero effects on the fetus that can lead to certain adult diseases such as heart attacks, diabetes and chronic high blood pressure. This present initiative is based upon the concept that the Barker Hypothesis may also pertain to adverse effects on the developing egg before and around the time of fertilization. Among the ultimate beneficiaries of this Program will be women who have difficulty attaining healthy pregnancies and producing healthy offspring owing to low egg quality. RESEARCH OBJECTIVES Background This initiative addresses the idea that low egg quality may be responsible for difficulties in attaining and maintaining a healthy pregnancy for a significant number of females. It also addresses the possibility that certain aspects of egg quality can be affected by adverse health situations in females prior to or around the time of fertilization. These situations can include poor nutrition, extreme exercise, smoking and other situations, including certain assisted reproductive technologies. Recent studies indicate that 10-15 percent of women of reproductive age seek fertility services in any given year. In addition, the incidence of infertility appears to be increasing. There are also data that suggest that numerous adult diseases and disorders such as heart attacks, diabetes and chronic high blood pressure may have their origins in low quality eggs owing to exposures of females to various adverse conditions including poor nutrition, extreme exercise, smoking and others. These exposures may occur long before fertilization and may have lasting effects upon egg quality. This research initiative will test various hypotheses as to the mechanisms that may cause low egg quality and most importantly, to develop measurable or identifiable characteristics that can be used to discriminate between eggs of high quality and eggs of low quality. If the idea is supported by future research, then it is anticipated that recommendations for female health could be used to prevent or alleviate some of the adverse outcomes of poor egg quality. Much of this research will need to be done in nonhuman organisms in order to be able to obtain sufficient numbers of eggs and also in order to conduct certain in vivo and in vitro experiments which cannot be done with humans for ethical reasons. The primary background information for this initiative comes from a conference held by NICHD on February 28, 2001 on "Effects of Maternal Health on Reproductive Events Leading to Adult Diseases and Disorders in Offspring." The distinguished panel of speakers concluded that the biology of human eggs is poorly understood and that the quality of these eggs may be affected by many risk factors in human females from their childhood through their reproductive years. As a result, the panel suggested that basic and clinical studies be done on the preconceptual and periconceptual health of girls and women and its potential impact upon egg quality. In addition, the panel felt that the impact upon egg quality should be followed for its effects on embryo and fetal development and even into adulthood. The panel also noted that decreased fertility, abnormal embryo and fetal development, low birthweight as well as diseases covered under the Barker Hypothesis, may also be caused by low quality eggs. There is evidence in support of this concept from nutritional studies in livestock and rodents as well as evidence on decreased fertility and fecundity in humans that is linked to poor nutrition, extreme exercise, smoking or other factors. The 2001 Surgeon General"s Report on Women and Smoking notes that women smokers may have certain unique problems related to reproductive health. These include increased risk of delayed time-to-pregnancy, and a moderately increased risk for ectopic pregnancies and spontaneous abortions. These risks may be related to egg quality that is compromised in women who smoke prior to or around the time of fertilization. There are other well-known risks of smoking during pregnancy to women and their fetuses. In this special program, major emphasis will be placed upon the determination of a number of measurable or identifiable characteristics that could be used to evaluate the quality of individual human oocytes or eggs. These characteristics will be used as baseline information in the study of the impact of a variety of preconceptual and periconceptual female health situations upon egg and preimplantation embryo quality and possible longterm effects of these situations. It is anticipated that this initiative will result in an increase in our knowledge of the genetics, cell and molecular biology of human and other mammalian oocytes and eggs. Substantial improvements in the culture conditions for the growth and development of immature oocytes into mature eggs are also expected. One important but largely unexplored feature of egg quality is the power of the egg cytoplasm to reprogram gamete or somatic cell nuclei. Using nonhuman species, there are significant opportunities within this program to study this impressive ability. Objectives of this Research Program o To establish measurable or identifiable characteristics of high quality human and nonhuman oocytes and eggs o To better understand how adverse female health situations can result in the formation of low quality oocytes, eggs and preimplantation embryos o To understand how low quality oocytes, eggs or preimplantation embryos can result in longterm adverse outcomes in offspring derived from those oocytes, eggs or preimplantation embryos o To determine whether nutritional or other behavioral approaches could be used to prevent or alleviate some of the causes of low quality eggs and preimplantation embryos Research Scope Examples of research and experimental approaches that are being sought to achieve the objectives include, but are not limited to, the following: o To develop baseline criteria that can be used to determine the quality of individual human oocytes or eggs o To reveal the elements or mechanisms in oocyte or egg cytoplasm that control nuclear reprogramming of gametes or somatic cells including nonhuman embryonic stem cells o To understand the roles of egg polarity and cytoplasmic localizations in the formation of high quality mammalian eggs and early embryos, or possible longterm effects of abnormal egg polarity o In vivo and in vitro experiments designed to test the hypothesis that poor nutrition or other adverse female health situations can lead to low quality oocytes and eggs that can have a longterm impact even into the adulthood of the offspring (nutrition, smoking, extreme exercise, certain assisted reproduction protocols, etc.) o Adverse preconceptual and periconceptual female health situations that may cause abnormal genomic imprinting with longterm effects, or gender specific effects o To study the impact of maternal diabetes upon egg quality o The study of oocytes raised or matured in vitro compared with naturally ovulated eggs o The improvement of oocyte and fertilization culture conditions o To obtain characteristic gene expression profiles of high and low quality oocytes and eggs o Investigation of adverse health situations that can lead to defects in the meiotic process in oocytes o The establishment of a panel of proteins or other measurable factors secreted by high quality and low quality oocytes, eggs or preimplantation embryos o Determine the role of companion somatic cells in the formation of healthy, developmentally competent oocytes o What are the egg properties that are essential for normal fertilization and egg activation? MECHANISM OF SUPPORT This RFA will use the NIH Cooperative Research Project (U01) award mechanism. As an applicant you will be solely responsible for planning, directing and executing the proposed project. The anticipated award date is September 1, 2003. This RFA uses just-in-time concepts. The NIH U01 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 scientific/programmatic partner with the Principal Investigator during the performance of the activity. Details of the responsibilities, relationships and governance of the studies to be funded under this cooperative agreement program are discussed below under "Cooperative Agreement Terms and Conditions of Award." It is not known at this time whether this RFA will be reissued in the future. FUNDS AVAILABLE The NICHD intends to commit approximately $2 million in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2003 to fund four to five new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs of up to $300,000 per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also 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. 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 or foreign 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 encouraged to apply. SPECIAL REQUIREMENTS Minimum Application Requirements o A competent, experienced Principal Investigator who is committed to investigation of these problems and who is willing to cooperate with the other Principal Investigators and the NICHD Research Coordinator o Agreement to participate in Steering Committee meetings that will be held three times a year o Experience with analyzing, characterizing, localizing, and/or measuring biological molecules and investigating oocytes, eggs and/or preimplantation embryos o Access to properly managed animal colonies with breeding capabilities and/or access to human specimens or tissues o For those with access to human specimens or tissues appropriate for this project, the applicant must be experienced with prospective and retrospective analyses of adverse health situations, having demonstrated knowledge of appropriate methodologies for clinical design and analyses Meetings Principal Investigators are expected to attend three Steering Committee meetings of two days each per year. Funds for attending these meetings should be included in the budget requests. The first meeting will be a planning meeting that will be held in Bethesda, Maryland in September, 2003. Cooperative Agreement Terms and Conditions of Award The following terms and conditions of the cooperative agreement award and details of the arbitration procedures pertaining to the scope and nature of the interaction between the NICHD and the participating awardees will be incorporated into the Notice of Grant Award and provided to the Principal Investigator and the institutional official at the time of award. The special Terms and Conditions of Award are in addition to, not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 42 CFR Parts 74 and 92, and other HHS, PHS and NIH grant administration policies. The administrative funding instrument used for this program will be the U01, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH scientific and/or programmatic involvement with the PI is anticipated during performance of the activities. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the PI"s activities by involvement in and otherwise working jointly with the PI in a partnership role, it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the PI for the project as a whole, although specific tasks and activities may be shared between the awardee and the NICHD Research Coordinator. Facilities and Administrative cost (indirect cost) award procedures apply to cooperative ageements in the same manner as for grants. Business management aspects of these awards will be administered by the NICHD Grants Management Branch in accord with HHS, PHS and NIH grant administrative requirements. 1. The Primary Rights and Responsibilities of the Awardees The PI will coordinate project activities scientifically and administratively at the awardee institution and at other sites that may be supported by subcontracts to this award. The PI will have primary responsibility for defining the details of the project within the guidelines of RFA HD-02-018, and for performing the scientific activities. The PI will agree to accept close coordination, cooperation and participation of the NICHD Research Coordinator and the Steering Committee in the scientific and technical management of the project. Specifically, the awardee will: o Determine experimental approaches, design protocols and direct experiments in consultation with the NICHD Research Coordinator and the Steering Committee and the awardee will constitute one vote in the group process, o Analyze and interpret the results o Present results and plans at Steering Committee meetings o Accept and implement the common guidelines and procedures approved by the Steering Committee o Publish results o Modify, delete or add protocols within the scientific scope of the project o Accept and participate in the cooperative nature of the group process Awardees will retain custody of, and primary rights to, their data developed under these awards, subject to Government rights of access consistent with current HHS, PHS and NIH policies. 2. NICHD Responsibilities NICHD Research Coordinator: The NICHD Research Coordinator will be a staff member of the Reproductive Sciences Branch. The Research Coordinator will have a substantial scientific/programmatic involvement that includes facilitating the partnership between NIH and the proposed research projects, helping to integrate the project"s activities with new and emerging research opportunities, and ensuring that the project"s activities are consistent with the mission of NICHD. The Research Coordinator will help to maintain scientific balance between accomplishing goals and addressing emerging research opportunities. The role of the NICHD Research Coordinator will be to facilitate, but not to direct activities. It is anticipated that decisions will be reached through consensus with the PI through the Steering Committee. The NICHD Research Coordinator will: o Ensure that Steering Committee meetings are held on schedule, attend those meetings and constitute one vote in the group process o Participate in the development of optional approaches and protocol designs (and adjustments of protocols and approaches when needed), the Research Coordinator will assist and facilitate the process, rather than direct it o Assist and review all phases of the study to assure consistency of protocol compliance, to improve and strengthen cooperation between the sites, and to help redirect efforts, or to recommend modification or termination of a site, when performance requirements are not met o Participate in data analyses, interpretations and, when warranted, publication of study results The above responsibilities are in addition to, not in lieu of, the levels of involvement normally required for program stewardship of grants. NICHD Project Officer: NICHD will appoint a Project Officer, apart from the Research Coordinator, who will: o Ensure that all regulatory, fiscal and administrative matters are handled according to NIH guidelines o Will evaluate requests for additional funds or for rebudgeting o Carry out continuous review of individual projects to evaluate progress o Perform other duties required for normal program stewardship of grants 3. Collaborative Responsibilities Guidance and Management Structure: The overall guidance and management of the program will be provided by a Steering Committee consisting of the Principal Investigators of each of the participating sites, one staff member of the Reproductive Sciences Branch, NICHD, who will serve as the Research Coordinator, and one of the Principal Investigators who will serve as a Chairperson for Steering Committee meetings. Each Principal Investigator will have one vote and the Research Coordinator will have one vote. The Steering Committee will be the main governing body of the projects to be funded by RFA HD-02-018. It will oversee and coordinate interactions among the projects, and will mediate interactions between the projects and the NIH. The Steering Committee will discuss scientific goals and progress, and recommend further research activities based upon research findings of ongoing projects. 4. Arbitration Process When agreement between an awardee(s) 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(s), 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 will not, in any way, affect 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. WHERE TO SEND INQUIRIES NICHD encourages inquiries concerning this RFA and welcomes 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: Richard J. Tasca, Ph.D. Center for Population Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B01, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6973 FAX: (301) 580-2389 Email: rt34g@nih.gov o Direct your questions about peer review issues to: Robert H. 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 FAX: (301) 402-4104 Email: rs365f@nih.gov o Direct your questions about financial or grants management matters to: Kathy Hancock Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5482 FAX: (301) 480-4782 Email: 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: Richard J. Tasca, Ph.D. Center for Population Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B01, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6973 FAX: (301) 580-2389 Email: rt34g@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 http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. 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: http://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 as well as any appendix material must be sent to: Robert H. 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) Telephone: (301) 496-1485 FAX: (301) 402-4104 Email: rs365f@nih.gov 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NICHD. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by 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 REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application o INCLUSION: The adequacy of plans to include appropriate subjects, all racial and ethnic groups (and subgroups), and children, as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: September 16, 2002 Application Receipt Date: October 16, 2002 Peer Review Date: February/March 2003 Council Review: June 2003 Earliest Anticipated Start Date: September 1, 2003 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 o Sufficient compatibility of features to enhance the likelihood of a successful collaborative program 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 (http://grants.nih.gov/grants/guide/notice- files/NOT-OD-02-001.html), a complete copy of the updated Guidelines is available at http://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 http://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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. BAN ON FUNDING OF HUMAN EMBRYO RESEARCH: In accord with directives derived from H.R. 2264 and S. 1061 and (Section 510) and included in the Labor, HHS and Education Fiscal Year 2002 Omnibus Appropriations Bill enacted into law (Public Law 107-116) on January 10,2002, funds provided for awards must only be used in compliance with the following directive: This section (510) continues the current ban that prohibits NIH from using appropriated funds to support human embryo research. Grant, cooperative agreement and contract funds may not be used for 1) the creation of a human embryo or embryos for research purposes, or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.208(a)(2) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). For purposes of this section, the term "human embryo" or "embryos" includes any organism not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated January 25, 2002, at http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-02-029.html HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://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 http://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 http://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 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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