and Human Services (HHS)
EXPIRED
GENETIC AND MOLECULAR BASIS OF LONGEVITY RELEASE DATE: July 10, 2003 RFA: AG-04-003 National Institute on Aging (NIA) (http://www.nia.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.866 LETTER OF INTENT RECEIPT DATE: September 22, 2003 APPLICATION RECEIPT DATE: October 22, 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 on Aging (NIA) invites applications for new and competing renewal applications for research project grants (R01) to support basic research on the genetic and molecular basis of longevity. The goals of the "Genetic and Molecular Basis of Longevity" Request for Applications (RFA) are to identify and functionally characterize genes that play a role in determining and modulating longevity and health span and determine the molecular mechanism(s) of action of these Longevity Assurance Genes (LAGs). Longevity Assurance Genes are operationally defined as genes that: determine, modulate or promote longevity and extend health span; maintain cell, tissue and/or organ function; and regulate and/or maintain organismal homeostasis. A multidisciplinary approach to the study of the complex traits of aging and longevity, including the application of genetic, molecular and biochemical approaches and techniques, has significantly accelerated research progress toward an in depth understanding of the genes, proteins, and biochemical pathways that modulate and play significant functional roles in aging and longevity in both invertebrate and mammalian species. Candidate LAGs that fit one or more of the above classifications have been identified in several invertebrates (Saccharomyces cerevisiae, Drosophila melanogaster, Caenorhabditis elegans), mice and humans. The continued development and application of multidisciplinary scientific approaches to the elucidation of the genetic and molecular basis of aging and longevity is strongly encouraged in applications submitted in response to this RFA. RESEARCH OBJECTIVES Research advances in several experimental models of aging and longevity including yeast, nematodes, fruit flies, mice, rats and humans have clearly established that aging and longevity are, in part, under genetic control. Furthermore, several biological processes have been implicated in the modulation/regulation of longevity in both invertebrates and mammals including insulin/IGF-I-like signaling pathways, antioxidant defenses, metabolic regulation/energy metabolism, chromatin stability and gene silencing. The multidisciplinary, interactive research approach outlined in this RFA is designed to integrate the genetic, molecular and biochemical analysis of various animal and human models of longevity with state-of-the-art biotechnology in a concerted effort to decipher and understand the fundamental mechanisms which contribute to longevity and aging. Enhanced knowledge of these crucial biological processes will guide and hasten the development of effective prevention and intervention strategies to promote human longevity and extend human health span. The scientific objectives of this RFA are: o to stimulate multidisciplinary research focused on discovery and functional characterization of the fundamental mechanisms that determine and/or regulate longevity and health span o to encourage the application of research advances in invertebrates and short-lived mammals to understanding the fundamental mechanism(s) of human aging and longevity o to develop and test experimental intervention strategies that promote longevity and extend health span MECHANISM OF SUPPORT This RFA will use the NIH R01 award mechanism. As the principal investigator you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this research project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is July 1, 2004. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. This RFA uses just-in-time concepts. It also uses the non-modular budgeting format (see http://grants.nih.gov/grants/funding/modular/modular.htm). This program does not require cost sharing as defined in the current NIH Grants policy statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE The NIA intends to commit approximately 6 million dollars in FY2004 to fund 15 to 20 new and/or competing renewal 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 $350,000. direct costs 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 the NIA 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 always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Annual Meetings of Investigators: Investigators receiving grant awards pursuant to this RFA will become members of the NIA Longevity Assurance Gene (LAG) Interactive Network. NIA program staff will schedule and organize yearly three-day meetings of the LAG Interactive Network to facilitate scientific interactions and data sharing among investigators and NIA program staff. Applicants to this RFA must include $2000 per year in the proposed travel budget to cover expenses related to attendance at the LAG Interactive Network meetings. Sharing of Unique Resources and Research Tools: Investigators receiving grants pursuant to this RFA must follow NIH guidelines pertaining to the sharing of unique resources, research tools and methodology with the scientific community. That is, unique resources, research tools and scientific methodology developed wholly, or in part, by NIH funds are to be made available to the scientific research community. Recipients are expected to manage interactions with third parties that have the potential to restrict Recipients' ability to disseminate research resources and tools developed with NIH funds. To avoid incurring obligations to a third party that conflict with Recipients' obligation to the NIH, grant recipients are encouraged to share these principles with potential co-sponsors of research projects and third party providers of materials. Recipients should take every reasonable step to streamline the process of transferring their own research tools freely to other academic research institutions and are encouraged to use the Simple Letter Agreement of the Uniform Biological Materials Transfer Agreement (UBMTA). The Appendix of the Principles and Guidelines (see below) contains an updated freestanding version of the Simple Letter Agreement that is strongly encouraged for transfers of unpatented research material among recipients. For assistance in implementation of these principles and guidelines, please refer to: "Sharing Biomedical Research Resources: Principles and Guidelines for the Recipients of NIH Research Grants and Contracts" at http://www.ott.nih.gov/policy/rt_guide_final.html or http://ott.od.nih.gov/NewPages/64FR72090.pdf. 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/grants management issues. o Direct your questions about scientific/research issues to: Anna M. McCormick, Ph.D. Chief, Genetics and Cell Biology Branch Genetics Program Director Biology of Aging Program National Institute on Aging Gateway Building, Suite 2C231 Bethesda, MD 20892-2292 Telephone: (301) 496-6402 FAX: (301) 402-0010 Email: mccormia@nia.nih.gov o Direct your questions about peer review issues to: Mary Nekola, Ph.D. Chief, Scientific Review Office National Institute on Aging Gateway Building, Suite 2C212 Bethesda, MD 20892-2292 Telephone: (301) 496-9666 FAX: (301) 402-0066 Email: nekolam@nia.nih.gov o Direct your questions about financial or grants management matters to: Linda Whipp Grants Management Officer National Institute on Aging Gateway Building, Suite 2N212 Bethesda, MD 20892-2292 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: whippL@nia.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 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 the subsequent application, the information that it contains allows NIA 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: Mary Nekola, Ph.D. Chief, Scientific Review Office National Institute on Aging Gateway Building, Suite 2C212 Bethesda, MD 20892-2292 Telephone: (301) 496-9666 FAX: (301) 402-0066 Email: nekolam@nia.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) 710-0267, 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 must be sent to: Dr. Mary Nekola Scientific Review Office National Institute on Aging Gateway Building, Suite 2C212 Bethesda, MD 20892-2292 Bethesda, MD 20814 (for express/courier service) APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of the RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignments within 8 weeks. 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to this RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state specifically how. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIA. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to this RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIA in accordance with the review criteria stated below. As part of the initial scientific 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 applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Advisory Council on Aging (NACA) 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 the 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 the overall score of the application, weighting them as appropriate for each application. The 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, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers involved? ENVIRONMENT: Does the scientific environment in which the 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, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section of Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, 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 in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items under Section f of the PHS 398 Research Grant Application Instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS 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 22, 2003 Application Receipt Date: October 22, 2003 Peer Review Date: February-March 2004 Council Review: May 2004 Earliest Anticipated Start Date: July 1, 2004 AWARD CRITERIA Award criteria that will be used to make award decision include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their subpopulations 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 for 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 "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/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 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. 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. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp 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 contain 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 publically 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 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLIATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary for the scientific 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 "Health People 2010", a PHS-led national activity for setting 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 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health System Agency Review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) (93.866) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. 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 103-257, 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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