and Human Services (HHS)
EXPIRED
NIA PILOT RESEARCH GRANT PROGRAM RELEASE DATE: January 16, 2003 PA NUMBER: PAR-03-056 EXPIRATION DATE: November 18, 2003 National Institute on Aging (NIA) (http://www.nia.nih.gov/) APPLICATION RECEIPT DATES: March 17, 2003; July 15, 2003; November 17, 2003 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Institute on Aging (NIA) is seeking small grant (R03) applications in specific areas to: (1) stimulate and facilitate the entry of promising new investigators into aging research, and (2) encourage established investigators to enter new targeted, high priority areas in this research field. This Small Grant (R03) Program provides support for pilot research that is likely to lead to a subsequent individual research project grant (R01) that is focused on aging and/or a significant advancement of aging research. This PA supercedes PAR-02-049. RESEARCH OBJECTIVES The topics in this announcement are grouped according to their relevance to the different priority areas within NIA's five-year strategic plan: http://www.nia.nih.gov/AboutNIA/StrategicPlan/. You may apply for a small grant in one of the numbered topics below. Applications for support in other areas will be returned to you without review. You should follow the instructions described under APPLICATION PROCEDURES to identify the topic on which the application is focused. Improve Health and Quality of Life of Older People: 1. HIV/AIDS and Aging: Behavioral, social, clinical, neuroscientific, and/or biological research on older people at risk for, or infected by, or affected by, HIV/AIDS. Social, economic, comorbid and other health risks and consequences of HIV/AIDS for older persons as parents and relatives of HIV infected adults, in both developed and developing countries. Prevention sciences research is encouraged, and both basic and applied research are welcomed. 2. Cardiovascular and Cerebrovascular Aging: Behavioral, clinical, social, cellular, and molecular studies of cardiovascular and cerebrovascular aging. 3. Drug Discovery for Cognitive Decline and Alzheimer's Disease: Studies for preclinical research in the discovery, design, development and testing of novel compounds aimed at immunological and other approaches to delaying decline in cognitive function, and to preventing, slowing the progression of, or delaying the onset of Alzheimer's disease. 4. Transmissible Spongiform Encephalopathies (TSEs): Research is encouraged on the development of methods for screening, diagnosis, and mechanisms of action of prions in the production of TSEs in the aging organism. Of special interest are understanding the susceptibility of the aging nervous system to these agents, and the roles played by the normal cellular forms of prions in the functioning of the aging brain. 5. Vaccine Development: Preliminary Basic and Clinical studies, and Therapeutic Trials of Vaccines for Use in Elderly Populations: Vaccines may be prophylactic or therapeutic in nature. These may include studies of methods to enhance the immune response in older persons including alternative administration schedules with existing vaccines, the use of adjuvants, and/or new vaccines. 6. Health-related Consequences of Female Reproductive Aging: Basic molecular and cellular research to elucidate underlying neuroendocrine, endocrine and physiologic mechanisms of the female reproductive aging process, especially 1) changes across the hypothalamic-pituitary- ovarian axis leading to menopause in women, 2) hormonal and other changes in the menopausal process associated with increased risk for peri- and postmenopausal health problems and conditions, and 3) age- related changes in the biology of hormone action and metabolism. 7. Protein Modification, Aggregation and Degradation in Aging and Age- related Diseases: Basic molecular, cellular, and physiological studies on age- and disease-related protein modification (e.g., oxidation), protein misfolding and repair (e.g., role of chaperones), protein aggregation, and protein degradation (e.g., proteasomes and lysosomes) in the heart, liver, nervous system and other organ systems. 8. Cancer in the Elderly: Studies in persons aged 70 years and older regarding incidence, survival, and clinical impact in cancers of the breast, prostate, colorectal, lung, ovarian, and pancreas are encouraged. Research topics include tumor-related tissue studies, autopsy investigations, characterization of cancer as it interfaces with pre-existing health conditions (i.e., comorbidity), overcoming the practical problems of acquiring data on this age segment of cancer patients, and quality of survival. Studies with a focus on home and/or nursing home settings are appropriate. Patterns of care and treatment, development of clinical evaluation tools specific for the elderly (e.g., prognostic indicators, geriatric assessment) that can be used by physicians to determine the patients' overall physical and physiologic health status are also included in this solicitation. 9. Basic Research in Behavioral Medicine: Pilot studies of basic processes in behavioral medicine are solicited. These may include bio- behavioral linkages, social and psychological risk factors of illness and disease, the role of social support, social networks, and social stressors in the etiology and epidemiology of disease, and processes leading to disease illness recognition. Pilot research in these areas is intended to develop basic principles, methods, and approaches for more generalizable research on behavioral medicine related topics. Multi-level approaches, integrating social, psychological, and biomedical concepts and approaches is especially solicited (see: New Horizons in Health: An Integrative Approach. National Academy Press, 2001). 10. Impact of Research on Health or Public Policy: Studies are solicited that will assess the impact of research and its translation on, for example, public policy, and the health, well-being and economic status of the elderly in terms suggested by the Government Performance and Results Act (GPRA). Historical, bibliometric and econometric studies of the determinants and rate of progress in social and behavioral sciences related to aging are also welcomed. 11. Interventions: Studies to gather preliminary data needed to design studies of novel interventions to delay or reverse aging-related morbidity or disability. Analyses of data or specimens from previous or ongoing studies, as well as new data collection, may be proposed. 12. Factors Moderating Rate of Age-related Changes and Risk for Adverse Events with Increasing Age: Clinical or epidemiologic studies to explore risk factors or protective factors affecting rates of change with age in human tissues, organ systems, or metabolism, or factors affecting risk for morbidity, mortality, or disability in old age in humans. Analyses of data or specimens from previous or ongoing studies, as well as new data collection, may be proposed. Studies of genetic and other factors contributing to exceptional longevity and/or exceptional healthy aging (i.e., maintenance of health through very advanced ages) in humans are of particular interest. Understand Healthy Aging Processes: 13. Stem Cells, Tissue Repair, and Cell Replacement in Aging: Studies on the biology of stem cells as a function of aging and disease; genetic and environmental effects on tissue stem cells; stem cell plasticity; development of cell markers and imaging techniques to identify and monitor stem cells in vivo; and transplantation of stem cells to effect tissue repair. Of interest is research that focuses on various aging tissues or physiological systems, including cardiovascular, musculoskeletal, immune, urogenital, endocrine and nervous systems. NIH has published guidelines for research using human pluripotent and embryonic stem cells and procedures to be used in applying for NIH research funding for this activity. If you intend to use these cells please read the relevant federal citation at the end of this announcement. 14. Sensory and Motor Processing: Mechanisms underlying normal age- related declines and age-related disease changes in sensory and motor processing in the central nervous system. 15. Cognition in Context: Studies to understand how different contextual factors produce systematic variation in cognitive functioning and performance. Of particular interest is what happens in the contexts of school, workplace, or social networks to shape the mind and brain, bringing about differences in cognition that endure through the life span. Additional contextual factors of interest include early life experiences, physical and social characteristics of the environment at home, and the attitudes and beliefs of others about cognitive aging. 16. Executive Function: Studies to develop new measures that would better characterize and assess those cognitive processes termed "executive function" in humans and non-human primates. Of particular interest would be development of executive function measures that help distinguish between normal and pathological cognitive aging, such as Alzheimer's disease. Imaging studies, or other neuroanatomical or neurobiological studies, that would help bolster this cluster of functions as being distinct from other cognitive domains are encouraged. 17. Membranes, Extracellular Matrix and Cytoskeleton: Studies on age- related changes in the structure, content, or function of cell membranes, the extracellular matrix and cytoskeleton, including regulation of cell signaling cascades, intracellular transport mechanisms, cell motility and morphology, and cell death. 18. Functional Senescence: Genetic, physiological, cellular and biochemical mechanisms that underlie age-related changes leading to dysfunction in tissues, systems, or organs. 19. Caloric Restriction and Aging: Studies that explore whether intermediary metabolism changes with advancing age and/or caloric restriction, and whether there is a relationship between age-related and caloric restriction-related changes in metabolism. Studies on changes in neuroendocrine, neuropeptide or neurochemical pathways as possible mediators of caloric restriction effects 20. Basic Underlying Mechanisms of Musculoskeletal Aging (muscle, bone, cartilage, neuromuscular junction, peripheral nerve, and motor neuron). 21. Genetics, Behavior, Social Factors and Aging: Genetic studies to advance our understanding of behaviors that affect aging (e.g., response to interventions, health behaviors, personality, social functioning and coping, everyday functional competence, cognition) using humans or non-human models. Research is solicited that examines aging and behavior from diverse levels of genetic analysis and uses evolutionary, population, biodemographic, quantitative or molecular approaches. Innovative approaches are needed to: integrate research directions stemming from social and epidemiological research (e.g., health disparities) with genetic approaches; to develop and apply methodologies to study how genes influence behavior; to investigate gene-environment interplay in developmentally dynamic ways; to integrate quantitative and molecular levels of genetic analysis; and to investigate environmental measures and contexts that modify genetic risk and are of particular relevance for healthy aging. Reduce Health Disparities Among Older Persons and Populations: 22. Racial/Ethnic Differences and Health Disparities: (a) Research leading to identification of underlying mechanisms, including cellular and molecular mechanisms, linked to racial/ethnic differences in late life function or disease e.g. cognition, Alzheimer's disease, cardiovascular disease, osteoporosis, cancer, infectious diseases, and diabetes. (b) Research to disentangle the effects of socio-economic status, social and environmental factors, health behaviors, and race and ethnicity on health; and (c) Research to develop and improve instruments and methods, including standardization across population groups, to measure disorders, disease and disability in minority groups that will lead to an understanding of the causes of these conditions. NIA's strategic plan for addressing health disparities is available from: http://www.nia.nih.gov/AboutNIA/StrategicPlan/. Enhance Resources to Support High Quality Research: 23. Tools and Models for Molecular, Cellular, and Genetic Research on Aging: Development of tools such as cDNA full length libraries, single nucleotide polymorphism (SNP) analysis, and conditional gene expression systems for studying the genetic basis of aging; and development of tools such as protein microarrays, antibody-based amplification methods, and fluorescent-based techniques for studies on proteomics (protein expression, modification, and interaction) of aging. Development of new and informative animal models for aging research, including genetically defined and or genetically altered animals. 24. Improved Measures and Methodologies: Improved measures are needed of adaptation to chronic and acute illnesses and associated disability, including the costs of adaptation and coping on well-being. Innovative methods are needed that reconcile changes in objective and subjective measures of well-being over the natural history of aging-related diseases. Summary measures of health and the burden of illness that can be used in a national health accounts system are badly needed. Measures of cumulative social, psychological and cultural advantage or adversity are also sought. Cross-national studies to harmonize and validate measures are also welcomed, as are innovative methods for melding laboratory, clinical or ethnographic approaches with large-scale population studies. The National Institute on Aging will modify the selected topic areas annually by reissuing the program announcement or by participating through a central NIH small grant announcement. Information on other initiatives supported by NIA may be found at the following internet address: http://www.nia.nih.gov/. MECHANISM OF SUPPORT This PA will use the NIH R03 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. You may request either $25,000 or $50,000 per year in direct costs for up to two years. These awards are not renewable. Before completion of the R03, you are encouraged to seek continuing support for research through a research project grant (R01). This PA uses just-in-time concepts. It also uses the modular budgeting format. (see http://grants.nih.gov/grants/funding/modular/modular.htm). Replacement of the Principal Investigator on this award is not permitted. Revisions of applications previously reviewed under this initiative will be accepted under this announcement provided that the submission is the first amendment of the prior application and that the topic remains active in the current announcement. Only one amendment of previously unfunded applications will be accepted. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic. (Foreign institutions are not eligible.) o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS New and established investigators with the skills, knowledge and resources necessary to carry out the proposed work are invited to work with your institutions to develop an application for support. (1) You are considered a new investigator when you are neither a current nor former principal investigator on an NIH research project (R01), FIRST Award (R29), sub-project of program project (P01) or center grant (P50), or the equivalent. If you are in the final stages of training you may apply for an R03 but no award will be made to someone who is still in training or fellowship status at the time of award (see reference to Biographical sketch under Application Procedures). (2) To be eligible as an established investigator you must propose research on a topic for which you have never received NIH support. Women, individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. An individual principal investigator may not submit more than one application in response to this announcement for a given receipt date. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA 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 with primary emphasis on the biology of aging to: Dr. David B. Finkelstein Biology of Aging Program National Institute on Aging 7201 Wisconsin Avenue, Suite 2C231, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-6402 FAX: (301) 402-0010 Email: BAPQuery@nia.nih.gov o Direct your questions about scientific/research issues with primary emphasis on behavioral and social research on aging to: Ms. Angie Chon-Lee Behavioral and Social Research Program National Institute on Aging 7201 Wisconsin Avenue, Suite 5C533, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 594-5943 FAX: (301) 402-0051 Email: BSRQuery@nia.nih.gov o Direct your questions about scientific/research issues with primary emphasis on the neuroscience and neuropsychology of aging to: Dr. Judy Finkelstein Neuroscience and Neuropsychology of Aging Program National Institute on Aging 7201 Wisconsin Avenue, Suite 350, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9350 FAX: (301) 496-1494 Email: NNAQuery@nia.nih.gov o Direct your questions about scientific/research issues with primary emphasis on geriatric and clinical gerontological research to: Mr. Michael Bone Geriatrics and Clinical Gerontology Program National Institute on Aging 7201 Wisconsin Avenue, Suite 480, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-6913 FAX: (301) 402-1784 Email: bonem@nia.nih.gov o Direct your questions about peer review issues to: Dr. Mary Nekola Scientific Review Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2C212, MSC 9205 Telephone: (301) 496-9666 FAX: (301) 402-0066 Email: NekolaM@nia.nih.gov o Direct your questions about financial or grants management matters to: Ms. Linda Whipp Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: WhippL@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. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the application deadlines indicated at the beginning of this announcement. Applications 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 responding to this PA request either one or two $25,000 modules per year for up to two years. 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. Abstract: The first line of the abstract must list the number and title of the particular research topic (see RESEARCH OBJECTIVES) being responded to. Biographical sketch: If you are in training or in fellowship status at the time of application you should list in your biographical sketch the position you will occupy at the time of award with the expected start date in that position. If the position is contingent on receipt of the award then you should describe it as "contingent on award". Research plan: Do not exceed a total of ten pages for the following parts (a-d): Specific Aims, Background and Significance, Preliminary Studies/Progress Report, and Research Design and Methods. Tables and figures are included in the ten page limitation. Applications that exceed the page limitation or PHS requirements for type size and margins (Refer to PHS 398 application for details) will be returned to you. The ten page limitation does not include parts e through i. (Human Subjects Research, Vertebrate Animals, Literature Cited, Consortium/contractual Arrangements, Consultants). Appendix: The only items that may be included in an appendix are original glossy photographs or color images of gels, micrographs, etc., provided that a photocopy (that may be reduced in size) is also included within the 10 page limit of items a-d in the research plan. No photographs or color images may be included in the appendix that are not also represented in the research plan. Do not include publications or preprints. Materials submitted after the receipt date. No additional materials pertaining to a particular application will be accepted after the receipt date for which the application is submitted. SENDING AN APPLICATION TO THE NIH: Submit a signed 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) In addition, to prepare for review of the application, submit two additional exact photocopies of the application directly to: Dr. Mary Nekola Scientific Review Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2C212, MSC 9205 Bethesda, MD 20892-9205 APPLICATION PROCESSING: Applications must be received by the date listed on the first page. The CSR will not accept any application in response to this PA 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 application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection 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. REVIEW CRITERIA The NIA R03 pilot grant program supports discrete well-defined projects that may be completed in up to two years, that focus on one of the numbered topics listed in this announcement, and that require the specified level of funding. Because the research plan is limited to 10 pages, a small grant application will not have as much detail as an R01 application. Accordingly, review will focus on the conceptual framework, degree of innovation, and general approach to the problem, placing less emphasis on methodological details and certain indicators traditionally used in evaluating scientific merit (e.g., supportive preliminary data). In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. INCLUSION: The adequacy of plans to include subjects from both genders, and all racial and ethnic groups (and subgroups), as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) DATA SHARING: The adequacy of the proposed plan to share data, if appropriate BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. OTHER REVIEW CRITERIA: The initial review group will also examine: the likelihood that the pilot project will lead to the development of an R01 application, or significant advancement of aging research AWARD CRITERIA Applications submitted in response to this PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines 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. 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://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this 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. 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 PA 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 and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92 The PHS strongly encourages all grant recipients to provide a smoke- free workplace and 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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