METABOLOMICS: APPLICATION TO ENVIRONMENTAL HEALTH RESEARCH RELEASE DATE: June 25, 2004 RFA Number: RFA-ES-04-008 EXPIRATION DATE: September 15, 2004 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 Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov/) National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov) CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.113, 93.114, 93.115 (NIEHS); 93.273 (NIAAA) LETTER OF INTENT RECEIPT DATE: August 13, 2004 APPLICATION RECEIPT DATE: September 14, 2004 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 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 of Environmental Health Sciences (NIEHS) and the National Institute of Alcohol Abuse and Alcoholism (NIAAA) invite research applications that use metabolomics technologies to study metabolic and regulatory pathways that are perturbed by environmental exposures and can lead to the development of toxicity and disease. The characterization of metabolic profiles in the context of molecular and biochemical changes resulting from environmental exposures provides an integrative approach to study more directly the relationships between exposure and disease. Ultimately, a metabolomic approach to studying biological systems should lead to (1) a better understanding of the mechanism(s) involved in the dysregulation of pathways by environmental agents, (2) the development of predictive biomarkers or surrogate endpoints of toxicity or clinical response and 3) a more rational approach for the development of disease intervention/prevention strategies. This initiative builds on and complements the 2003 NIH Roadmap Initiative in Metabolomics Technology Development which encourages the development of new technologies to identify and quantify cellular metabolites and their fluxes at high anatomical, spatial and temporal resolution. RESEARCH OBJECTIVES Background Metabolomics is an emerging field that involves the study of the metabolome, the complement of all metabolites expressed in a cell, tissue or organism during its lifetime. Metabolomics studies seek to define the levels, activities, regulation and interactions of all metabolites in a biological system and how these quantities or interactions change in response to external stimuli. Changes in the metabolome are directly influenced by environmental factors and genetic alterations. Consequently, metabolomics is an effective tool for studying the individual and combined effects of environmental and genetic factors on disease processes. The advent of new metabolomics technologies has provided to the research community the ability to assess changes in metabolites and their levels on a broad scale, providing a global perspective about how an organism responds to a specific stressor. This information can be used to define cellular pathways and networks of response, identify target molecules of toxicity, provide biomarkers and surrogate endpoints of disease, and establish a functional basis for defining the contribution of genetic polymorphism to individual susceptibility to environmental exposures and disease. Thus, the application of metabolomics provides a new approach for defining gene-environment interactions in disease and for monitoring and modulating the disease process. The importance of metabolomics research for environmental health sciences lies in linking metabolite changes with perturbations in the dynamic metabolic and regulatory processes that mediate cellular function, potentially leading to the development of new markers or surrogate endpoints of toxicity or clinical response. Understanding these changes could potentially lead to the development of new markers or surrogate endpoints of toxicity or clinical response. Because most environmentally related diseases are complex and multi-factorial, there are likely to be multiple markers or mechanistic endpoints that are intermediate between the exposure and the disease. Metabolomics offers a global approach to metabolite analysis that is appropriate for defining these markers for pathophysiological or clinical endpoints. Research Goals and Objectives The primary goal of this solicitation is to encourage hypothesis-driven research that focus on the use of metabolomic technologies to study the dynamics of cellular pathways and their perturbation by environmental factors. The NIEHS is specifically interested in studies that address either exogenous factors such as chemical and physical stressors or endogenous (physiological) stressors. The NIAAA is interested in studies that focus on alcohol as the environmental stressor. This solicitation builds on and complements the NIH Roadmap initiative in Metabolomics Technology Development (http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-04-002.html. The Roadmap initiative encourages the development of highly innovative and sensitive tools for characterizing cellular metabolites and their fluxes at high anatomical, spatial, and temporal resolution. This RFA should further advance the science of metabolomics by encouraging the use of these tools to address research needs in environmental health science. Examples of metabolomic research topics that may be proposed include, but are not limited to the following (not in order of priority): o Studies that link quantitative global metabolic changes with cellular pathway perturbation and disease progression resulting from environmental stressors. o Studies that use metabolomic profiling to define genetic and metabolic factors that contribute to differential individual susceptibility to toxicity or disease resulting from exposure to environmental factors. o Studies to assess changes in metabolite concentration, activity, or flux patterns in conjunction with biochemical functions at the tissue, organ or whole organism level that may be relevant to environmentally related disease or dysfunction (e.g., metabolic, neurological, renal, hepatic, cardiovascular, endocrine or reproductive function). o Studies conducted in clinical populations or as adjunct to ongoing epidemiological studies to quantify global metabolic changes that can be plausibly correlated with biological mechanism and/or potentially serve as markers or surrogate endpoints for environmentally related disease or dysfunction. o Functional and comparative studies that use quantitative metabolomic approaches to examine perturbation of specific metabolic or regulatory pathways by environmental factors in more than one animal model. These comparisons will allow us to elucidate pathways, networks and molecular cascades that are conserved and are of critical importance in normal and compensatory biological responses to environmental stressors. In vivo and in vitro experimental models are appropriate and include whole animal, organ or tissue culture systems. Animal models including naturally susceptible or genetically or pharmacologically manipulated models are acceptable. Human biological samples (e.g., blood or urine) that are derived from new or ongoing clinical investigations or epidemiological studies are specifically encouraged as a means of identifying metabolite changes that can be correlated with human disease progression and of establishing biomarkers and surrogate endpoints in translational and clinical settings. The proposed metabolomics approaches may be derived from existing technologies, such as NMR and mass spectroscopy, or involve new approaches for measuring cellular metabolomes or subsets (e.g., peptides, lipids). Applications that propose only to survey and catalog metabolite expression patterns in response to exposure to environmental agents will be considered non-responsive to this RFA. Rather, applications should focus on using metabolomics approaches to enhance our understanding of a particular environmentally responsive pathway by defining metabolite changes or markers that can be correlated with perturbation or disease progression. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01) award mechanism. The R01 grant mechanism supports a discrete, specified, circumscribed research project that is well- grounded on current knowledge and is to be performed by the named investigator(s) in an area of research representing his/her/their specific interest and competencies. 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 be reviewed according to the customary peer review procedures. The anticipated award date is July 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 budget 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 NIEHS intends to commit approximately $3.75 million in FY 2005 to fund six to ten new grants in response to this RFA. The NIAAA intends to commit up to $350,000 to fund one new grant specifically related to alcohol effects. An applicant may request a project period of up to five years and a budget for direct costs of up to $350,000 per year. Should an applicant plan to include subcontracts to other institutions or organizations, only the direct costs associated with the subcontracts will be used to tally the direct costs that apply toward the cap. (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html) Because the nature and scope of research proposed might vary, it is anticipated that the size of each award will also vary. Although the financial plans of the NIEHS and the NIAAA 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. At this time, it is not known if this RFA will be reissued. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o Domestic or foreign non-profit organizations. Applications will not be accepted from for-profit organizations; however, applicant organizations may establish subcontract arrangements with for-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 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 should request funds for one trip/year for an annual meeting of grantees to be held at NIEHS in Research Triangle Park, North Carolina. The purpose for these meetings is to discuss scientific advances and to discuss the potential for collaborations, data sharing, data repositories and other research opportunities. The policy of the PHS is to make available to the public results and accomplishments of activities that it funds. All awardees must adhere to PHS policy for distribution of unique research resources produced with PHS funding, which was published at http://ott.od.nih.gov/NewPages/xtramrl.html Public databases are being developed at NIEHS for the submission of genomics, proteomics and metabolomics data. Applicants may be requested to submit findings to these databases. 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: Brenda K. Weis, Ph.D. Scientific Program Administrator Center for Risk and Integrated Sciences Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-23 79 T.W. Alexander Drive, Building 4401 Research Triangle Park, NC 27709 Telephone: (919) 541-4964 FAX: (919) 316-4937 Email: weis@niehs.nih.gov Lorraine Gunzerath, Ph.D., MBA Health Scientist Administrator Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 409 6000 Executive Boulevard Bethesda, MD 20892-7003 Telephone: (301) 443-2369 Fax: (301) 443-6077 Email: lg72x@nih.gov o Direct your questions about peer review issues to: Teresa Nesbitt, D.V.M., Ph.D. Chief, Scientific Review Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-20 Research Triangle Park, NC 27709 Telephone: (919) 541-7571 Fax: (919) 541-2503 E-mail: nesbitt@niehs.nih.gov o Direct your questions about financial or grants management matters to: Ms. Lisa Archer Grants Management Specialist Grants Management Branch National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-22 79 T.W. Alexander Drive, Building 4401 Research Triangle Park, NC 27709 Telephone: (919) 541-0751 FAX: (919) 541-2860 Email: archer@niehs.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 staff at NIEHS and NIAAA 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: Teresa Nesbitt, D.V.M., Ph.D. Chief, Scientific Review Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-20 Research Triangle Park, NC 27709 Telephone: (919) 541-7571 Fax: (919) 541-2503 E-mail: nesbitt@niehs.nih.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 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 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 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: Teresa Nesbitt, D.V.M., Ph.D. Chief, Scientific Review Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-20 Research Triangle Park, NC 27709 Telephone: (919) 541-7571 Fax: (919) 541-2503 E-mail: nesbitt@niehs.nih.gov 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 previous 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 NIEHS and NIAAA. 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 NIEHS 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 the respective NIEHS and NIAAA advisory councils. 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. 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 have to be strong in all categories to be judged likely to have a 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 method? 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: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN AND 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 PHH 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: August 13, 2004 Application Receipt Date: September 14, 2004 Peer Review Date: February 2005 Council Review: May 2005 Earliest Anticipated Start Date: July 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 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 DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety 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. 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. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov) It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, 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 RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a Federal regulation under the Health Insurance Portability and Accountability Act (HIPPA) 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 HIPPA 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. Reviewers are cautioned 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 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 promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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