AGING THROUGH THE LIFE SPAN: LONGITUDINAL DATA ANALYSES RELEASE DATE: August 25, 2004 RFA Number: RFA-AG-05-004 EXPIRATION DATE: January 12, 2005 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov/) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute on Aging, (NIA) (http://www.nia.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.866 LETTER OF INTENT RECEIPT DATE: December 13, 2004 APPLICATION RECEIPT DATE: January 11, 2005 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 research grant (R01) applications that will utilize existing human longitudinal data and specimens, and/or conduct ancillary studies to longitudinal studies, to gain information and answers to important research questions regarding the progression and determinants of changes across all segments of the life span that affect health in old age; effects of age, disease stage, and comorbidity on the effects of risk factors; variability among and within individuals in rates of change with age in physiologic, pathologic, behavioral, social and functional characteristics; determinants of exceptionally healthy aging; and the health and physiologic effects in human aging of factors that influence aging in other species. This RFA is confined to ancillary studies to existing longitudinal studies, and/or analyses of previously acquired data or specimens from ongoing or completed longitudinal studies. RESEARCH OBJECTIVES The health and functional outcomes of individuals at advanced ages are at least in part a result of physiological events, behavioral, social and environmental influences occurring across the life span, possibly starting as early as fetal development. There are major gaps in our understanding of how changes with age in multiple organ systems and disease processes affect the health of individuals from one segment of life to the next (e.g., adolescence, young adulthood, mid- and late life). There are promising opportunities in aging research to apply data from existing longitudinal studies more extensively (i.e., ancillary projects and/or further analyses of existing biospecimen repositories and longitudinal data sets) to address a variety of research questions about the sequences of events and progressive processes in individuals that affect how they change with age. In particular, there are opportunities to address the following topics: Life-course pathways influencing health in mid- and late life: Many age-related conditions develop over a sequence of stages that span large segments of the life span, often with secondary complications overlying the original etiologic mechanisms. In many cases, these sequences may be initiated or affected by conditions or changes occurring as early as gestation. Many factors that change between youth and middle age may be early steps, essential precursors, or predisposing factors, in pathologic processes that do not become symptomatic until old age. Similarly, early life events may have consequences that do not become apparent until advanced age. Analyses of longitudinal data could delineate sequences and potential chains of causality, and distinguish them from other potential confounding early- and mid-life factors that are associated with, but not causally related to, future outcomes. A particular challenge is to establish the entire series of links between factors operating in early or mid-life origins and consequences that may occur several decades later. Though data from very long-term longitudinal studies are critical for this purpose, combined analyses of longitudinal data from two or more longitudinal studies on differing life segments (e.g., childhood to young adulthood, and young adulthood to middle age) may also be useful in clarifying causal sequences extending over their combined age ranges. Differences in risk factors for age-related conditions at different ages, at different stages of disease progression, and in the presence or absence of coexisting conditions: Relationships between physiologic factors and disease risk may not remain constant across ages or segments of life because of physiologic/metabolic differences between immature, mature and old individuals. In later life, differences in the effects of risk factors could also vary depending on the stage of disease progression, as well as in the presence or absence of co- morbidities, and on behavioral, social and environmental factors. Under such circumstances, the longitudinal analysis of interrelationships between risk factors could help to distinguish primary etiologic factors from other factors contributing to secondary conditions or complications. Longitudinal data that include effects of risk or protective factors in individuals spanning a sufficient age range and time interval could be used to explore whether particular trajectories of change over the life course in factors (e.g., consistently high, consistently low, consistently increasing, consistently decreasing, increasing then decreasing, decreasing then increasing) are associated with particularly favorable or adverse effects. Such trajectories of change may be better predictors of outcomes than simply the factors level at one age or their average level over some age interval. This approach may provide insights into effects of many physiologic factors, such as hormones, as well as behavioral and social factors that could be studied longitudinally. Such trajectories may also provide clues to the mechanisms responsible for the aging outcomes that they influence. Extent, causes and implications of variability among and within individuals in rates of change with age in physiologic, pathologic, behavioral, social, environmental and functional characteristics: The rates of progression of change with age in physiologic and pathologic factors affect many health outcomes directly. Rates of changes in such factors, even if they have no direct health effects, may also serve as markers of rates of progression of aging processes that do have health effects. Individuals vary considerably among one another in their rates of many age-related changes. In addition, rates of change within an individual are often not constant over time. Longitudinal data could be more fully utilized to characterize the extent, causes and health implications of this variability among and within individuals. For other factors, restricted variability among individuals in rates of change is also related to important issues. For some risk factors for age-related conditions, individuals tend to track (i.e., maintain their risk level relative to others in the population) as they age. Determining the extent of tracking is important both for predicting future outcomes and considering the causes of age-related changes. Determinants of exceptionally healthy aging: This refers to protective factors that prevent or slow common adverse age-related changes or events. Retrospective and other analyses of longitudinal data can also be used to identify protective factors contributing to maintenance of exceptionally good health through advanced ages. Phenotypes of interest for exceptionally healthy aging could include exceptional health span (i.e., survival in the absence of any of a defined set of pathologies), exceptionally good values of a set of physiologic or biochemical measures or disease risk factors or behaviors or SES status (e.g., hormone levels, bone density, immune system function, cognitive function) compared to their usual values at that age, or exceptionally slow rates of deleterious change with age in physiologic, biochemical, and/or behavioral/social traits (e.g., exceptionally slow bone loss or minimal changes in arterial calcification, cognitive decline). Knowledge from studies on exceptionally healthy individuals, even though they are rare, may provide insights that are applicable to many persons. These approaches need not be confined to the older age range: Studies of the long-term implications of exceptionally good values of specific physiologic and/or behavioral/social factors in youth and middle age could also make valuable contributions. Health and physiologic effects in human aging of factors that influence aging in other species: Aging studies in nonhuman species have identified factors that influence life span, the rate of aging changes, and the development of age-related conditions. It is clearly of interest to consider the potential relationship of such factors to human age-related changes and conditions. Longitudinal studies in humans offer potential opportunities to study predictive factors and outcomes suggested by data from life span studies of laboratory animals, cross-species comparisons, and studies on the effects of mutations and other genetic variants in nonhuman species. Longitudinal studies could address the role in humans of putative mechanisms of aging, such as oxidative protein and DNA damage, proliferative senescence, mitochondrial dysfunction, cell loss, depletion of precursor cells, and others. Analyses of longitudinal data could help to identify common mechanisms underlying a variety of aging changes, by studying correlations within individuals of the rates of groups of aging changes (or the levels of factors that predict these changes) using two approaches: hypothesis-based analyses of specified clusters that are thought to be regulated by a putative common aging mechanism, and hypothesis-generating analyses to identify clusters that may suggest a possible common cause. Comparisons of longitudinal data from diverse populations to distinguish aging changes that are shared among them from those specific to one or a few populations may help in distinguishing common fundamental aging changes from those specific to particular genotypes or environments. More extensive information and discussion of the above issues is available in the report of the first meeting of the NIA Longitudinal Data on Aging Working Group, on the NIA website at: http://www.nia.nih.gov/ResearchInformation/ConferencesAndMeetings/. Research Goals and Scope: This RFA invites applications for ancillary studies and/or analyses of available specimens and data to provide new information and answers to important research questions in one or more of the five research areas discussed above, i.e., o Life-course pathways influencing health in mid- and late life, including causal sequences of changes beginning in early or mid-life, and factors regulating their progression o Differences in risk factors for age-related conditions at different ages, at different stages of disease progression, and in the presence or absence of coexisting conditions. o Extent, causes and consequences of variability among and within individuals in rates of change with age in physiologic, pathologic, behavioral, social and functional characteristics, and extent, causes and consequences of tracking of risk factor levels over the life span. o Determinants of exceptionally healthy aging: protective factors (including behavioral, social and genetic) that prevent or slow common adverse age-related changes or events; and characteristics and prevalence of exceptionally healthy phenotypes o Health and physiologic effects in human aging of factors that influence aging in other species, including the role of putative mechanisms of aging (e.g., apoptosis, oxidative damage) in human age- related pathologies Applications on other topics will be considered non-responsive and will be returned to the applicant. Studies may include a moderate amount of new data collection, as well as analyses of already-collected data and specimens. However, new longitudinal data collection (i.e., at multiple time points on the same individual) is outside the scope of this RFA. Applications may include exploratory analyses to evaluate issues relating to the design of future studies requiring new longitudinal data collection, or extension or expansion of current data collection. Applications on the five above topics may also include proposed development of new analytical tools for longitudinal data (e.g., pooling of data from different age groups or different studies, analyses of rates of change) relevant to the proposed project. Applicants may choose any appropriate longitudinal study, data set, or specimen collection for their proposals. Inclusion and integration of multiple outcomes in proposed ancillary or secondary data analysis is strongly encouraged. Many, but by no means all, of these are listed on the following websites, which applicants may choose to review: An NIA website http://www.nia.nih.gov/ResearchInformation/ScientificResources/ and an NHLBI website: http://www.nhlbi.nih.gov/resources/deca/directry.htm. Additional websites of potential interest to applicants to this RFA are the: Cognitive and Emotional Health Project: http://trans.nih.gov/CEHP, the National Alzheimer’s Coordinating Center: http://www.alz.washington.edu and the Publicly Available Databases for Aging-related Secondary Analyses in the Behavioral and Social Sciences: http://www.nia.nih.gov/NR/rdonlyres/D2DC41DF-3608-4785-A9BA-62B1138EB520/0/datasets.pdf. We strongly recommend that applicants read and comply with the data distribution policies. Applications which propose to use any of the data sets available through the NHLBI must include a copy of the data distribution agreement, or the application will be considered incomplete and non-responsive. Other applications must include a letter of agreement from the appropriate study oversight committee. Proposals submitted in response to this RFA are strongly encouraged to include interdisciplinary research teams spanning the range of expertise needed to address the research questions being posed, such as geriatrics, other clinical specialties, gerontology, demography, genetics, physiology, molecular medicine, behavior and biostatistics, as well as epidemiology. Whenever feasible and scientifically appropriate (i.e., those studies proposing moderate amount of new data collection), the incorporation of non-invasive measures or biosensor technology to assess physiological endpoints in the proposed ancillary studies is strongly encouraged. MECHANISM OF SUPPORT This RFA will use the NIH R01 award mechanism. As an applicant 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 project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 15, 2005. 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 modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non-modular research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm. FUNDS AVAILABLE The NIA intends to commit approximately $ 2.5M in FY 2005 to fund approximately 7 to 10 new proposals submitted in response to this RFA. An applicant may request a project period of up to 4 years and a budget for direct costs up to $275,000 per year. NIH no longer counts F&A costs on subcontracts as direct costs when calculating total direct costs of applications. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html for further details. Applications requesting funds exceeding this level for any year will be returned to the applicant. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration 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(s) 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 o Faith-based or community-based organizations 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 Applicants must include a letter from the appropriate study oversight committees indicating approval for the ancillary project and/or proposed secondary analysis. Applications without an approval letter will be determined as non-responsive to this RFA. In addition, awardees from this RFA may meet periodically to exchange data and ideas in guiding future studies on determinants of aging and health across the life span. Funds for travel to the Washington D.C. area for the principal investigator (and a co-investigator, if appropriate) for a one-day meeting should be included in the budgets for each year. 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: Chhanda Dutta, PhD Geriatrics and Clinical Gerontology Program National Institute on Aging Gateway Building, Suite 3C-307 Bethesda, MD 20892 Telephone: (301) 435-3048 Email: chhanda.dutta@nih.hhs.gov o Direct your questions about peer review issues to: Ann Hardy, DrPH Center for Scientific Review 6701 Rockledge Drive, Room 3138 Bethesda, MD 20892 Telephone: (301) 435-0695 Email: hardyan@csr.nih.gov o Direct your questions about financial or grants management matters to: John Bladen Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Room 2N212 Bethesda, MD 20892-9205 Telephone: (301) 402-1472 Fax: (301) 402-3672 Email: bladenj@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 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 IC 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: Chhanda Dutta, PhD Geriatrics and Clinical Gerontology Program National Institute on Aging Gateway Building, Suite 3C-307 Bethesda, MD 20892 Telephone: (301) 435-3048 Email: chhanda.dutta@nih.hhs.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The D&B number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document 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. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step- by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. 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/labels.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and five 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) APPLICATION PROCESSING: Applications must be received on or before 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. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment 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 an 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 from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIA. Incomplete and/or nonresponsive 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 CSR 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 Council on Aging. 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 application’s overall score, 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 (if any)? 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 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 on 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 described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW 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: December 13, 2005 Application Receipt Date: January 11, 2005 Peer Review Date: April 2005 Council Review: September 2005 Earliest Anticipated Start Date: September 15, 2005 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable. 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 the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm SHARING RESEARCH DATA: Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. 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 "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 are 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. 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. 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 PA 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). 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 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 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems 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) 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 103-227, 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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