AGING INTERVENTION TESTING PROGRAM RELEASE DATE: April 9, 2002 RFA: AG-02-005 - (Reissued as RFA-AG-09-013) National Institute on Aging (NIA) (http://www.nih.gov/nia/) LETTER OF INTENT RECEIPT DATE: August 9, 2002 APPLICATION RECEIPT DATE: September 12, 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 OF THIS RFA The National Institute on Aging (NIA) invites applications for cooperative agreements (U01s) from groups of investigators capable of, and interested in, becoming components of an Aging Intervention Testing Program (also referred to below as the Testing Program). The main purpose of this program is to test, under standardized conditions in multiple sites, potential intervention strategies which may decelerate the rate of aging in mammals. Awards will be made to groups of investigators whose scientific and technical expertise and facilities will enable them to age mice in specific pathogen-free environments, and perform pathological, biochemical, physiological, cognitive and other behavioral assessments of functional status. Whereas longitudinal assessment is generally preferred, when necessary, invasive assessments will have to be done cross-sectionally. The assessment approaches used will reflect the blend of experience and creativity of the component groups, although standardized protocols will ultimately be developed by participants in the Testing Program. It is anticipated that positive results could be followed up with clinical trials to establish safety and efficacy in an appropriate human population, but not as a component of this Testing Program. A secondary goal is to identify interventions that are not safe or are not effective in delaying at least one significant adverse aspect of aging in mice, such knowledge would be highly relevant in assessing appropriate candidates for clinical trials. Potential applicants are directed to the following publication for further discussion of this initiative: Warner HR, et al., 2000. Meeting report: Program for testing biological interventions to promote healthy aging. Mech. Ageing Dev. 115: 199-208. RESEARCH OBJECTIVES Objectives The objectives of this Program are: 1) to choose interventions which have either already been shown in peer-reviewed reports to have some potential to extend life span in an animal model system and/or postpone age-related pathology or disability, or are promising candidates based on well-accepted hypotheses about aging mechanisms, 2) to perform phase 1 studies, including survival analysis and longitudinal body weight analysis to 50% survivorship, plus gross pathology assessment at time of death, and based on these results, determine which interventions to elevate to phase 2 studies, 3) to perform phase 2 studies for comprehensive evaluation, which may include some invasive endpoints, including drawing blood. Detailed objectives include: 1. Identifying interventions that increase mean life expectancy by at least 10% in phase 1 studies which may be terminated at 50% survivorship. Applicants should indicate how many mice will be used per group to achieve at least 80% power in this analysis. This survival analysis must be accompanied by longitudinal body weight measurements, and gross pathology assessment at time of death, following other age-sensitive traits in this phase is optional. These studies should be carried out with both males and females to detect whether effects are gender-specific. Caloric intake must be monitored to determine whether the intervention alters food intake. 2. Carrying out phase 2 studies that must include a complete survival analysis, accompanied by assessment of at least 5 age-sensitive endpoints per intervention, plus pathology assessment at time of death. Examples of endpoints include, but are not limited to: various measures of behavior, cognitive or sensory function, motor activity, T-cell subset analysis and other immune responses, indicators of stress, particularly oxidative stress, and resistance to stress, protein glycation or other protein modification, and changes in gene expression. The absence of actual validated biomarkers of aging requires that the Testing Program must rely on "best judgment" of informative age-sensitive traits to use as surrogate biomarkers. Applicants should propose a variety of such endpoints and provide justification for the endpoints chosen to evaluate interventions, and details of the methodologies to be used, although consensus about the actual protocols to be used across sites will be developed by the Steering Committee early in the program. Whereas longitudinal studies are preferred, in some cases cross-sectional studies may be necessary. 3. Because the purpose of the program is to not only identify effective and safe interventions, but also eliminate from further study interventions that are not effective and safe, publication of all results by the PI(s) in a scientific journal are strongly encouraged. The research plan Grants funded under this program must be interdisciplinary efforts. It is expected that applicants will have experience in biogerontology, and either have, or have access to, a specific pathogen-free facility. In their research plan, applicants should provide a cross-disciplinary team approach to fulfill the objectives of this RFA. Applicants should detail all the unique and specialized facilities, equipment, research expertise and core resources and services that are available to evaluate the effect of interventions on age-related changes and the development of age-related pathology. An animal pathologist must be included among the personnel. If facilities and expertise other than those at the applicant institution are required, applicants should thoroughly describe them and obtain the appropriate assurances. The research plan should also include information about how many animals would be used in a survival analysis, and details about what would be included in both a gross and comprehensive pathology assessment. Although how the proposed tests will be performed should be briefly described, actual details about the interventions to be tested, and the details such as dosage to be used, manner of administration, frequency and manner of sampling will be determined by the Steering Committee, based on recommendations forwarded to it by the Access Panel (see SPECIAL REQUIREMENTS). Applicants should indicate their willingness to collaborate and share data freely, and to participate in the required meetings with members from the other sites involved in the Testing Program. Before preparing their applications, applicants should review the SUPPLEMENTAL INSTRUCTIONS under SUBMITTING AN APPLICATION. MECHANISM OF SUPPORT This RFA will use the NIH cooperative agreement (U01) award mechanism. As an applicant you are solely responsible for planning, directing, and executing the proposed project. The anticipated award date is April 1, 2003. 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 partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award". If this program is funded and appears to be successful, it is anticipated that a follow-up RFA will be issued to facilitate renewal of the Program in five years. FUNDS AVAILABLE The NIA intends to commit up to $900,000 in FY 2003 to fund up to 3 new awards to 3 different sites in response to this RFA. Budget requests should not exceed $200,000 direct costs in the first budget period. Should an applicant plan to include subcontracts to other institutions or organizations, only the direct costs associated with the subcontracts will be used to tally the direct costs that apply toward the first year cap of $200,000. The annual direct costs will increase each year to a maximum of about $500,000 in year 5. This program will not use modular budgets. Applications should provide 5-year budget requests based on the following target estimates of annual direct costs per site: Year 1: $200,000 Year 2: $275,000 Year 3: $375,000 Year 4: $500,000 Year 5: $500,000 The budget projections listed above are estimates and should be regarded as approximate targets in the application. The gradual escalation reflects the intent to start a limited number (up to 3) of phase 1 studies each year per site, with increases beginning in year 4 when phase 2 studies are initiated. It is assumed that only one or two out of every three phase 1 studies begun each year will eventually lead to phase 2 studies. Thus, for the first 3 years only phase 1 studies will be conducted. From year 4 onward, it is expected that both phase 1 and phase 2 studies will be ongoing at every site. Although the financial plans of the NIA provide support for this program, U01 awards pursuant to this RFA are contingent upon the availability of funds for this purpose in fiscal year 2003, 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 Applications may represent a single institution, or may involve several institutions or organizations. Applications will not be accepted from foreign institutions, however, foreign institutions may establish sub- contract arrangements with domestic applicant institutions. 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. SPECIAL REQUIREMENTS The following terms and conditions will be incorporated into the U01 award statement, and will be provided to the PI and the awardee institutional official at the time of award. Cooperative Agreement Terms and Conditions of Award These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for the applicants to this program is a cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient"s activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NIA Program Scientist through the Steering Committee. Awardee Rights and Responsibilities The PI of a U01 grant will have primary authority and responsibility to define objectives and approaches, and to plan, conduct, and analyze results, interpretations, and conclusions of studies conducted under the terms and conditions of the cooperative agreement award, provided these are not in conflict with the goals, priorities, procedures and policies agreed upon by the Steering Committee. The PI will coordinate project activities scientifically and administratively at the awardee institution, and at the other sites that may be supported by sub-contracts to this award. The PI will assume responsibility and accountability to the applicant organization officials and to the NIA for the performance and proper conduct of the research supported by the U01 in accordance with the terms and conditions of the award. The PI will attend meetings of, and serve as a voting member of, the Steering Committee. The PI will be responsible for accepting and implementing the goals, priorities, procedures, and policies agreed upon by the Steering Committee, for close coordination and cooperation with the other components of the Testing Program, the Steering Committee, and with the NIA staff. The PI will submit periodic progress reports in a standard format to both the Steering Committee and the NIA. The PI will also select an individual to serve on the Access Panel. Effective conduct of the Testing Program goals will require electronic communication of data and other information between the PI and the other Program components and the NIA.. 1. NIA Extramural Staff Responsibilities The NIA Program Scientist will exercise substantial scientific and programmatic involvement to assist, guide, coordinate and participate in the conduct of the Testing Program activities. The NIA Program Scientist will attend and participate in all meetings of the Steering Committee as a voting member, and will provide liaison between the Steering Committee and the NIA/NIH. The NIA Program Scientist will assist the Steering Committee in developing and drafting operating policies and policies for dealing with recurring situations that require a coordinated action. An NIA Health Scientist Administrator will be the Program Director for this award, and will be responsible for normal programmatic and administrative stewardship of the award, the NIA Program Director may also serve as this NIA Program Scientist. 2. Collaborative Responsibilities STEERING COMMITTEE: This Committee will be the main governing body of the Program. Its voting members will include the PI of each award, at least an equivalent number of biogerontologists covering a broad range of gerontological expertise who are not affiliated with the Testing Program, and the NIA Program Scientist. These additional members will be chosen by the PIs and the NIA Program Scientist. The primary roles of the Steering Committee are to prioritize the interventions recommended by the Access Panel, develop consensus on testing protocols to be employed in phase 2 studies, and decide which phase 1 studies will proceed to phase 2 studies. In carrying out these responsibilities, the Steering Committee should seek advice from outside experts as needed, and is encouraged to include the investigator(s) who either discovered or developed the potential intervention in their discussions as appropriate. These individuals, when present at Committee meetings, will be temporary non-voting members of the Committee. In addition, the Steering Committee will also review manuscripts to be submitted for publication. The Steering Committee will meet twice a year, or as needed. The initial meeting will take place at the NIA in Bethesda, MD, with subsequent meetings at a location the Committee selects, and with which the NIA concurs. The Steering Committee may, when it is deemed necessary, invite additional non- voting scientific advisors to the meetings. ACCESS PANEL: The function of the Access Panel is to nominate and review promising interventions to be tested in Phase 1 trials, these nominations may be made by anyone either within or outside of the Testing Program. Nominations should be accompanied by sufficient information, either published or unpublished, to permit the Access Panel to evaluate the potential efficacy of the intervention in mice. The Access Panel shall consist of one representative (not the PI) from each testing site, and at least three other scientists chosen by NIA staff from the biogerontology research community. The Panel will include one non-voting NIA representative. An intervention to be recommended for testing would require a majority vote of this panel. In evaluating the merit of a proposed intervention, the Access Panel should solicit relevant information from a wide range of experts, and use both published and unpublished data. Where appropriate, the Panel is encouraged to include the investigator(s) who discovered or developed a potential intervention in their discussions as temporary non-voting members of the Panel. Recommendations from this panel will be prioritized by the Steering Committee. The Panel will meet twice a year, although some meetings may be conducted by telephone conference calls and/or by email. Proceedings of the Access Panel"s meetings will be forwarded to the Steering Committee in writing, accompanied by appropriate supporting materials, and a priority rating, i.e. low, medium, high. The NIA may provide limited funds to permit the Access Panel to widely publicize the Testing Program, and solicit nominations on an annual basis. 3. Arbitration Panel The function of this ad hoc Panel is to review any scientific or programmatic disagreement (within the scope of the U01 award) between U01 awardees and the NIA. The panel will be composed of three members: one selected by the Steering Committee (without NIA staff voting), or by an individual U01 awardee in the event of an individual disagreement, a second member selected by the NIA, and, the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee"s right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CPR Part 50, subpart D and HHS regulation at 45 CPR 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: Huber R. Warner, Ph.D., Associate Director Biology of Aging Program National Institute on Aging 7201 Wisconsin Avenue Gateway Building, Suite 2C231 Bethesda, MD 20892 TEL: 301/496-4996 FAX: 301/402-0010 Email: firstname.lastname@example.org o Direct your questions about peer review issues to: Mary Nekola, Ph.D., Chief Scientific Review Office National Institute on Aging 7201 Wisconsin Avenue, Room 2C212 Bethesda, MD 20892-9205 TEL: 301/496-9666 Email: email@example.com o Direct your questions about financial or grants management issues to: Ms. Linda Whipp, Grants Management Officer Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue Gateway Building, Suite 2N212 Bethesda, MD 20892 TEL: 301/496-1472 FAX: 301/402-3672 Email: firstname.lastname@example.org 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 and 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 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: Huber R. Warner, Ph.D., Associate Director Biology of Aging Program National Institute on Aging 7201 Wisconsin Avenue Gateway Building, Suite 2C231 Bethesda, MD 20892 TEL: 301/496-4996 FAX: 301/402-0010 Email: email@example.com SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001) available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact Grants Info, Telephone: 301/710-0267, Email: firstname.lastname@example.org. SUPPLEMENTAL INSTRUCTIONS: For standardization of research protocols, applicants should prepare a research plan consistent with the following conditions: 1. Four-way cross, genetically heterogeneous mice generated by the NIA under contract to a commercial supplier are recommended for use in this Testing Program to ensure consistency and that results obtained will not be strain- specific. Such mice are produced by mating two F1 hybrid populations with each other so that each mouse will share a random 50% of its genes with its siblings. Currently the NIA is generating two F1 hybrid populations by crossing BALB/cJNia mice with C57BL/6JNia mice, and C3H/HeJNia mice with DBA/2JNia mice and then crossing these hybrids to obtain a genetically heterogeneous population of mice. These mice will be provided at 4 months of age through the NIA Office of Biological Resources and Resource Development (TEL: 301/496-0181) at the usual NIA-subsidized price. With scientific justification, other genotypes may be used with concurrence of the Steering Committee. However, budget limitations may preclude performing many tests on multiple strains. 2. The mice will have ad libitum access to sterilized NIH31 food and sterilized water, and will be maintained in a specific pathogen-free barrier facility on a 12/12 hr light-dark cycle. For these studies the mice must be maintained free of Helicobacter, Mycoplasma, Salmonella, Pasteurella, Bordetella, Pseudomonas, Citrobacter and Corynebacter. Mice must also be maintained virus-antibody free for MHV, Sendai, PVM, Reo3, TMEV GDVII, MVM, parvovirus, ectromelia, MAD, polyoma, rotavirus, LCM, Hantaan, K-virus, MCMV and E. Cunicuii. Mice must also be free of external parasites and pathological internal parasites. Sentinel mice housed in the same room(s) as the test mice must be submitted for health evaluation quarterly. Health assessments should include all of the above – mentioned organisms as well as Staphybococcus, Streptococcus and Klebsiella. Mice should be group housed, maximum of 4 per cage, with their original cage mates as shipped from the supplier. Cage sizes and all other husbandry issues not specifically addressed must conform to DHHS standards as published by ILAR in Guide for the Care and Use of Laboratory Animals, 1996, available online at http://www.nap.edu/catalog/5140.html. 3. Applicants are requested to propose age-sensitive endpoints to be measured, although the actual endpoints to be measured for each intervention, and standardized assay procedures for use in phase 2 studies, will eventually be established by the Steering Committee (see SPECIAL REQUIREMENTS) to facilitate reliable comparison of results among sites. 4. To reduce the possibility for bias, the animal handlers and researchers should be blinded with regard to treatment status of each animal. Applicants should construct a tentative budget that clearly outlines the costs of what they propose to do in each phase 1 and phase 2 trial. However, budgets will be adjusted by NIA staff, on an annual basis, to reflect 1) the resources available for this program, and 2) the composition of the studies anticipated each year at each funded site. Estimates should be provided for the anticipated average cost per given assay per animal to facilitate these adjustments of budgets each year, as required to reflect the number of interventions actually under study each year in both phase 1 and phase 2 studies. The PI must budget for travel and per diem expenses for a total of 4 Access Panel and Steering Committee meetings per year, at the rate of 1 person per meeting. 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, "Aging Intervention Testing Program", and number, RFA AG-02-005, must be typed on line 2 of the face page of the application form and the YES box must be marked. The sample 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 signed photocopies of the application must also be sent to: Chief of Review Scientific Review Office National Institute on Aging 7201 Wisconsin Avenue, Room 2C212 Bethesda, MD 20892-9205 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 a substantial revision of an application already reviewed, but such an application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR, and for responsiveness by the NIA. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. 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 the NIA in accordance with the review criteria stated below. There will be no site visits. Applications must be complete at the time of submission. The Scientific Review Office of the NIA will determine whether late materials will be accepted. If so, they will be limited to three typed pages, and the Scientific Review Administrator in charge of the review must authorize their submission. 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 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, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. Applicants are encouraged to submit and describe their own ideas about how best to meet the goals of the Testing Program, and are expected to address issues identified under "SPECIAL REQUIREMENTS". The peer review group will assess the merit of the applications and related factors, including: 1. SIGNIFICANCE: Are the age-sensitive endpoints proposed for evaluating interventions appropriate? 2. APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed and appropriate to the aims of the Testing Program? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are the parameters chosen to characterize interventions sufficient and appropriate? Would they be relevant to evaluating effectiveness in human clinical trials? 3. INNOVATION: Does the project employ novel concepts, approaches or methods? Is the project original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. INVESTIGATORS: Are the principal investigator and his/her collaborators appropriately trained and well suited to carry out this work? To what extent do these investigators have the necessary complementary skills? Have collaborations been established or consultants identified to provide the appropriate depth and breadth of scientific expertise required for the project? Will this team of investigators contribute unique skills to the Testing Program? Factors considered to be important for review include a multi-disciplinary team of collaborators, substantial interactions among collaborating researchers, demonstration of appropriate facilities and resources, willingness to share data and reagents freely. 5. ENVIRONMENT: Are the facilities for mouse maintenance and experimentation appropriate to support the endeavor? 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 and incorporate the best use of collaborative arrangements? Is there evidence of institutional support? 6. INTERACTION AND DATA SHARING: Are there adequate plans for effective interaction and coordination among Testing Program components and the NIA? Do the investigators state their willingness to collaborate extensively and share information fully? Do the investigators state their willingness to abide by the priorities and policies agreed upon by the Steering Committee? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: ANIMAL WELFARE: Are there adequate plans for protection of animals during the testing protocol? BUDGET: Does the apportionment of the budget among fundamental infrastructure, and intervention testing indicate that the applicants understand the requirements of managing this sort of enterprise? Is the budget reasonable? RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: August 9, 2002 Application Receipt Date: September 12, 2002 Council Review: January 2003 Earliest Anticipated Award Date: April 1, 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific and technical merit (as determined by peer review) o Availability of funds o Programmatic priorities REQUIRED FEDERAL CITATIONS 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 protection 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. URLS IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within the usual page limitations. Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Services (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. 93.866. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284), and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74 and Part 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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