RFA-DK-03-018: GENETIC STUDIES OF OBESITY-RELATED TRAITS IN MODEL ORGANISMS

Department of Health
and Human Services (HHS)

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GENETIC STUDIES OF OBESITY-RELATED TRAITS IN MODEL ORGANISMS RELEASE DATE: October 29, 2003 RFA Number: RFA-DK-03-018 (see addenda NOT-DK-04-004 and NOT-DK-04-006) Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATION: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov) National Heart, Lung and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov) National Institute on Aging (NIA) (http://www.nia.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S) 93.847, 93.848, 93.866, and 93.837. LETTER OF INTENT RECEIPT DATE(S): February 18, 2004 and February 17, 2005 APPLICATION RECEIPT DATE(S): March 17, 2004 and March 17, 2005 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Letter of Intent o Submitting an Application o Supplementary Instructions 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 Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute on Aging (NIA), and the National Heart, Lung, and Blood Institute (NHLBI) invite investigator-initiated research projects (R01 and R21) designed to identify and characterize genes influencing obesity-related phenotypes in fruit flies (Drosophila melanogaster), soil nematodes (Caenorhabditis elegans), and zebrafish (Danio rerio). Animals bearing alterations in these genes will be indispensable tools for understanding the pathogenesis of obesity and lipodystrophies, for testing therapeutics, and for discovering genes that can be tested in human studies for association with obesity and related co-morbidities such as cardiovascular disease. RESEARCH OBJECTIVES Background The rapid increase in the number of overweight and obese individuals world wide, including an alarming increase in overweight and obese children and adolescents, has highlighted the need to learn as much as possible about the pathways regulating the anatomical, physiological and behavioral phenotypes underlying obesity, such as body composition, fat distribution, adipocyte physiology, food consumption, physical activity, and metabolic rate. Genetic analysis of these phenotypes offers the possibility of identifying previously unknown steps in both known and novel pathways. Each step so discovered represents a potential target for intervention to prevent or treat obesity and its medical consequences. Although genetic studies in humans have identified the probable locations of a number of genes influencing body mass index and some of the major co- morbidities of obesity (type 2 diabetes and cardiovascular disease), these studies have not yet had much success in identifying the genes themselves. Studies in cultured mammalian adipocytes have been largely responsible for our current understanding of the detailed regulation of fat storage and utilization. Studies employing transgenic and knockout mice have similarly advanced our understanding of the regulation of food consumption, body composition, and metabolic rate. Until recently non-mammalian genetic model organisms such as fruit flies (Drosophila melanogaster), soil nematodes (Caenorhabditis elegans), and zebrafish (Danio rerio) have not been exploited for research on the physiology underlying obesity and its attendant co-morbidities such as atherosclerosis, hypertension, and cardiac hypertrophy. Identification of genes influencing specific phenotypes can be accomplished much more rapidly in these species than in mice or humans, owing to their short generation time, ease of breeding very large numbers of individuals, powerful resources for genetic mapping, and high-throughput methods for creation of mutants and phenocopies. The speed and power of genetics in these model organisms could thus be harnessed to identify genes influencing obesity-related phenotypes, and the mouse and human homologues of the genes so identified could then be tested for effects on the corresponding phenotypes in mammalian species. This strategy might afford a quicker route to identification of genes influencing phenotypes in humans than attempts to identify such genes by direct genetic analysis of mice or humans themselves. In order for this strategy to work, the biological pathways controlling these phenotypes must be evolutionarily conserved among the non-mammalian species and mice or humans. Although not much is known about regulation of obesity- related phenotypes in fruit flies, nematodes, or zebrafish, an important proof of the principle of conservation of genetic pathways across the wide evolutionary distance separating C. elegans and mammals has been established by the recent results of a genome-wide RNAi screen in nematodes. This screen has identified more than 400 genes which upon inactivation, result in either increased or decreased fat deposition. Some of these newly identified nematode fat regulatory genes have mammalian homologues that are known to function in lipid homeostasis. In addition, more than half of these genes have mammalian homologues not previously suspected of involvement in control of fat deposition in mammals. An independent study demonstrated that inhibition of the activity of homologues of three of these genes (or their products, previously unsuspected of a role in lipid homeostasis) prevented murine adipocytes from depositing fat when stimulated to differentiate in vitro. These studies support the concept that genetic studies in non- mammalian model organisms can make important contributions to elucidating the physiological basis of obesity-related phenotypes in mammals (including humans). Objectives and Scope This RFA encourages investigator-initiated projects using Drosophila melanogaster, Caenorhabditis elegans and Danio rerio as model systems to identify and characterize genes influencing obesity-related phenotypes. Appropriate topics for investigation under this RFA would include but are not limited to: o Development and use of inducible fluorescent lipid reporters to identify genes controlling lipid deposition and utilization o Development and implementation of mutagenesis-, RNAi-, morpholino-, or other antisense-based screens to study control of eating behavior, level of physical activity, or metabolic rate o Development and implementation of sensitized screens for enhancers and suppressors of obesity-related phenotypes o Identification of genetic polymorphisms underlying naturally-occurring variation in obesity-related phenotypes o Identification of genes that influence atherosclerosis and cardiovascular disease o Studies to identify genes involved in blood pressure control o Elucidation of gene networks contributing to maladaptation of the cardiovascular system o Studies to identify genes that effect changes in metabolism with aging MECHANISM OF SUPPORT This RFA will use the NIH investigator-initiated Research Project Grant (R01) and the Exploratory/Development Research Grant (R21) award mechanisms. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. The total requested project period for an application submitted in response to this RFA may not exceed 4 years for the R01 mechanism, and 2 years for the R21 mechanism. The anticipated award date(s) are September 30, 2004 and September 30, 2005. This RFA is a one-time solicitation. R21 grants will not be renewable; continuation of projects developed under this program will be through the R01 grant program. 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. R21 (Exploratory/Developmental) grants The R21 mechanism is intended to encourage new exploratory/ developmental research projects by providing support for the early stages of their development. Awards are made to demonstrate feasibility of a subsequent project and to obtain preliminary data testing innovative ideas. Therefore, these grants are not renewable. Continuation of projects developed under this program will be through the regular research project grant mechanism (for example, R01). These grants are not intended to support or supplement ongoing funded research of an established investigator, or to serve as an alternative mechanism of support for projects not receiving funding as competitive continuation applications. The NIH Grants Policy statement applies to these awards. R01 (Research) grants The R01 award represents an investigator-initiated research grant designed to support a discrete, specified research project performed by a principal investigator. This RFA uses just-in-time concepts. It also uses the modular budgeting format. (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 budget format. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE The participating IC(s) intend to commit approximately $2.0 million dollars in FY2004 and $2.5 million in FY2005 to fund a total of 10 to 12 new grants in response to this RFA. An applicant may request a project period of up to 4 years and a budget for direct costs of up to $250,000 per year for R01 applications. An applicant may request a project period of up to 2 years with a combined budget for direct costs of up to $275,000 for the 2 year period for R21 applications. (For example, you may request $100,000 in the first year and $175,000 in the second year.) The request should be tailored to the needs of your project. Normally, no more than $200,000 can be requested in a single year. 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 IC(s) 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 institutions/organizations 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 Restricted availability of unique research resources, upon which further studies are dependent, can impede the advancement of research and delivery of medical care. Sharing biomaterials, data, and software in a timely manner has been an essential element in the rapid progress that has been made in the genetic analyses of mammalian genomes. NIH policy requires that investigators make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication [NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps; Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice, December 1999 (http://www.ott.nih.gov/policy/rt_guide_final.html)]. Biomaterials (constructs, cell lines and strains, etc.) and other research resources that can be patented (e.g., software tools, expression data) that are produced in projects funded by this RFA are to be made available and distributed to the broader scientific community. Applications will be evaluated on the adequacy of the proposed plan to share data and unique resources such as monoclonal antibodies, mutant strains of flies, worms and fish, and RNAi libraries. Data and unique resource sharing are essential for expedited translation of research results into knowledge, products, and procedures to improve human health. Investigators responding to this RFA should include a description of how final research data and unique research resources will be shared, or explain why data and resource sharing is not possible. It is expected that the data and resource sharing discussion will be provided primarily in the form of a brief paragraph immediately following the Research Plan Section of the PHS 398 application form (i.e., immediately after I. Letters of Support), and would not count towards the application page limit. For more information on data sharing, please see the following websites: http://grants.nih.gov/grants/policy/data_sharing/ http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm#goals http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm. Reviewers will make an administrative comment on the adequacy of the data and resource sharing plan, but this comment will not contribute to the priority score of the application. The adequacy of the data and resource sharing plan will be considered by IC Program Staff when making recommendations about funding applications. IC Program Staff may negotiate modifications of the data and resource sharing plan with the Principal Investigator before recommending funding of an application. The final version of the data and resource sharing plan negotiated by the Principal Investigator and IC Program Staff will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of administrative review of each Non-competing Grant Progress Report (PHS 2590). 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: Carol Renfrew Haft, Ph.D. Program Director, Adipocyte Biology Division of Diabetes, Endocrinology and Metabolism National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd, Room 605 Bethesda, MD 20892-5460 Telephone: (301) 594-7689 FAX: (301) 480-3503 E-mail: cr84g@nih.gov Robert Karp, Ph.D. Program Director, Genetics and Genomics Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd, Room 671 Bethesda, MD 20892-5460 Telephone: (301) 451-8875 FAX: (301) 480-8300 E-mail: rk56v@nih.gov David Finkelstein, Ph. D. Biology of Aging Program National Institute on Aging 7201 Wisconsin Avenue, Suite 2C231 Bethesda, MD 20892-9205 Telephone: (301) 496-7847 FAX: (301) 402-0010 E-Mail: finkelsd@nia.nih.gov Pothur Srinivas, Ph. D., MPH Vascular Biology Research Program Division of Heart and Vascular Diseases National Heart, Lung and Blood Institute 6701 Rockledge Drive, 2 Rockledge Center-10188 Bethesda, MD 20892-7926 Telephone: (301) 435-0550 FAX: (301)480-2858 E-mail: ps241q@nih.gov o Direct your questions about peer review issues to: Francisco O. Calvo, Ph.D. Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 752 Bethesda, MD 20892-5456 Telephone: (301) 594-8897 FAX: (301) 480-3505 E-mail: fc15y@nih.gov o Direct your questions about financial or grants management matters to: Denise Payne Grants Management Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 733 Bethesda, MD 20892-5456 Telephone: (301) 594-8845 FAX: (301) 480-3504 E-mail: dp43@nih.gov Grace Poe Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 E-mail: poeg@nia.nih.gov Edward McGeehan Grants Operations Branch National Heart, Lung and Blood Institute 6701 Rockledge Drive, Room 7142 Bethesda, MD 20892-7926 Telephone: (301) 435-0148 E-mail: mcgeehae@nhlbi.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: Chief, Review Branch Division of Extramural Activities, NIDDK 6707 Democracy Boulevard, Rm. 752 MSC 5452 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) Telephone: (301) 594-8885 FAX: (301) 480-3505 SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms. 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 DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS 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 R21 APPLICATIONS All application instructions outlined in the PHS 398 application kit are to be followed, with the following requirements for R21 applications: 1. R21 applications will use the "MODULAR GRANT" and "JUST-IN-TIME" concepts, with direct costs requested in $25,000 modules, up to a combined budget for direct costs of up to $275,000 for the two year period. 2. Preliminary data for the actual studies proposed in the R21 application are not required. However, the PI should demonstrate that he/she has the appropriate expertise and resources on hand to perform the proposed experiments. If not evidenced by publications, this may require inclusion of preliminary data to demonstrate facility in the methodologies proposed. 3. Sections a-d of the Research Plan of the R21 application may not exceed 15 pages, including tables and figures. 4. R21 appendix materials should be limited, as is consistent with the exploratory nature of the R21 mechanism, and should not be used to circumvent the page limit for the research plan. Copies of appendix material will only be provided to the assigned reviewers of the application and will not be reproduced for wider distribution. The following materials may be included in the appendix: o Up to 5 publications, including manuscripts (submitted or accepted for publication), abstracts, patents, or other printed materials directly relevant to the project. These may be stapled as sets. o Surveys, questionnaires, data collection instruments, and clinical protocols. These may also be stapled as sets. o Original glossy photographs or color images of gels, micrographs, etc., provided that a photocopy (may be reduced in size) is also included within the 15 page limit of items a-d of the research plan. 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 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 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. Also indicate if the application in an R01 or R21. The RFA label is 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 three signed, photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to: Chief, Review Branch Division of Extramural Activities, NIDDK 6707 Democracy Boulevard, Rm. 752 MSC 5452 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) 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 NIDDK, NIA and NHLBI. Incomplete and/or nonresponsive applications will not be reviewed. 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 NIDDK in accordance with the review criteria stated below. As part of the initial merit review, all applications will: 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 written critique o Receive a second level review by an appropriate National Advisory Council or Board. 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 evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment 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 CONSIDERATIONS In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: RELEVANCE TO HUMAN OBESITY: What is the likelihood that the project will advance our understanding of the physiological or behavioral basis of obesity or its co-morbiditites such as cardiovascular disorders in humans? 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 will be assessed. ADDITIONAL REVIEW CONSIDERATIONS SHARING RESEARCH DATA: Applicants responding to this RFA must include a data and unique resources sharing plan in their application. The reasonableness of the sharing plan or the rationale for not sharing research data and unique research resources such as monoclonal antibodies, mutant strains of flies, worms and fish, and RNAi libraries will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. It is expected that the data and resource sharing discussion will be provided primarily in the form of a brief paragraph immediately following the Research Plan Section of the PHS 398 application form (i.e., immediately after I. Letters of Support), and would not count towards the application page limit. For more information on data sharing, please see the following websites: http://grants.nih.gov/grants/policy/data_sharing/. http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm#goals http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm SPECIAL REVIEW CONSIDERATIONS FOR R21 APPLICATIONS: The NIH R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools or technologies that have the potential to significantly advance our knowledge or the status of health- related research. Because the research plan is limited to 15 pages, an exploratory/developmental grant application need not have background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications. 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(s): February 18, 2004 February 17, 2005 Application Receipt Date(s): March 17, 2004 March 17, 2005 Peer Review Date(s): Summer 2004 Summer 2005 Council Review: September 2004 September 2005 Earliest Anticipated Start Date(s): September 30, 2004 September 30, 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. The adequacy of the data and resource sharing plan will be considered by NIDDK Program Staff when making recommendations about funding applications. NIDDK Program Staff may negotiate modifications of the data and resource sharing plan with the Principal Investigator before recommending funding of an application. The final version of the data and resource sharing plan negotiated by the Principal Investigator and NIDDK Program Staff will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of administrative review of each Non-competing Grant Progress Report (PHS 2590). 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 http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/. 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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