and Human Services (HHS)
EXPIRED
NIBIB RESEARCH SUPPLEMENTS TO PROMOTE CLINICAL RESIDENT RESEARCH EXPERIENCES RELEASE DATE: August 12, 2004 PA NUMBER: PAR-04-140 (Reissued as PAR-06-531) (Clinical fellows now eligible for support, see NOT-EB-05-009)(Program extended, see NOT-EB-05-006) EXPIRATION DATE: February 22, 2006, unless reissued. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.286 LETTER OF INTENT RECEIPT DATES: September 21, 2004 and January 17, 2005 (See revised dates, NOT-EB-05-006) APPLICATION RECEIPT DATES: October 21, 2004 and February 14, 2005 (See revised dates, NOT-EB-05-006) THIS PAR CONTAINS THE FOLLOWING INFORMATION o Purpose of the PAR o Research Objectives o Mechanism of Support o Eligible Institutions o Individuals Eligible to Receive Supplement Funding o Special Requirements o Where to Send Inquiries o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PAR The purpose of this Program Announcement is to provide a 1-2 year period of research experience for physicians in a residency program through supplements to existing NIBIB grant awards. The program targets applicants who have demonstrated the potential for productive research in an area of interest to the candidate and of relevance to the mission of the NIBIB. The National Institute of Biomedical Imaging and Bioengineering (NIBIB) seeks to improve human health by supporting research and training aimed at developing imaging, engineering, and bioinformatics tools with broad medical utility in the diagnosis, treatment, and prevention of disease. To this end, the institute will fund the research and/or training of creative and insightful clinicians to work in interdisciplinary research teams. Furthermore, cognizant of the importance of translating research findings to health benefits, NIBIB considers facilitation of the translation of discoveries from the laboratory to the clinical setting a cornerstone of its mission. This PAR aims specifically to enhance the fundamental knowledge and research skills of clinical residents interested in research careers in areas related to the mission of the NIBIB. PROGRAM OBJECTIVES The intent of this initiative is to attract outstanding clinicians into research careers related to the mission of the NIBIB. This initiative is not intended to support clinical residency training. The NIBIB anticipates that by providing research opportunities for these individuals during their residency, the number entering and remaining in NIBIB-focused research careers will increase. It is expected that individuals selected for this research experience will continue in research and subsequently apply for career development awards and/or research project grants. MECHANISM OF SUPPORT This PAR will use the NIH competitive supplement award mechanism. The supplement may be awarded to any of the following active NIBIB research project grant mechanisms: R01, R37, P01, P41, P50 (For additional details see the SPECIAL REQUIREMENTS section). The PI is solely responsible for planning, directing, and executing the proposed project. The proposed research experience must be related to the ongoing research of the parent grant and have the potential to contribute significantly to the research career development of the candidate. As part of this research experience, the candidate and the PI must describe a plan by which the candidate will have the opportunity to interact with other individuals on the parent grant, to contribute intellectually to the research, and to enhance her/his research skills and knowledge regarding the particular area of biomedical science. Furthermore, the PI must demonstrate an understanding that the purpose of the award is to enhance the research capability of the clinical resident and that the research experience is intended to provide opportunities for development as a productive research investigator, and demonstrate willingness to provide appropriate mentorship. Supplement awards will be consistent with the goal of strengthening the existing research program and with the overall programmatic balance and priorities of the NIBIB. A supplement award does not preclude the institution's use of funds from other sources to supplement the award. Each parent grant may support up to two clinical residents. A separate supplemental application is required for each resident. Support under the supplement program is not transferable to another individual or transportable to another institution. This program has been designed to attract individuals into research careers and is not intended to provide an alternative or additional means of supporting individuals who already receive support from a research grant or a research training grant or any other DHHS funding mechanism. Individuals who are supported by a National Research Service Award (NRSA) Institutional research training grant or NRSA Individual Fellowship may not be transferred to supplemental support prior to the completion of their appointed period of training. Individuals may not be transferred to a supplement to increase the availability of funds to the parent grant for other uses. This PAR uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). The budget format of the supplemental application must be the same as that of the parent grant. Specifically, if the parent grant has direct costs in each year of $250,000 or less, use the modular budget format for the supplement. Otherwise follow the instructions for non-modular budget 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. 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 institutions/organizations o Foreign institutions are not eligible to apply INDIVIDUALS ELIGIBLE TO RECEIVE SUPPLEMENT FUNDING Principal Investigators: Principal Investigators (PIs) holding an active R01, R37, P01, P41, or P50 from the NIBIB may apply for this program. Any individual who meets the criteria described below is invited to work with his/her institution and an identified mentor (PI holding an active R01, R37, P01, P41, or P50 from the NIBIB) 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. Candidate Eligibility: A candidate must have a health professional degree (M.D. or the equivalent) and be enrolled in an accredited clinical residency- training program in the United States. Candidates need not be citizens or permanent residents of the U.S. Individuals who received medical degrees at foreign sites, but are currently enrolled in an accredited U.S. residency- training program are eligible. Individuals who have already completed their residency training are not eligible; they should contact Dr. Meredith Temple- O Connor listed under WHERE TO SEND INQUIRIES, for other training/research opportunities. SPECIAL REQUIREMENTS The candidate must work with a mentor for the research experience who is the PI on an active NIBIB grant. Co-mentoring is encouraged for interdisciplinary projects. The duration of the supplement should be at least one year to provide the candidate with a meaningful research experience, and to prepare him/her for further research experiences. Supplements can be requested only for active NIBIB grants that have a minimum of one year of support remaining. Submit a supplemental application only for a period within the current period of support. (A supplement may not extend beyond the parent award period.) A maximum of two clinical residents (i.e., two supplements) will be allowed on any given parent grant award. Ideally, candidates may take time off from residency training to participate in this program on a full-time basis. However, candidates must be willing and able to dedicate at least 75% of their professional time to the research project. Up to $100,000 direct costs per year may be requested. Of that amount, residents may request funds for research costs and travel up to $25,000 direct costs per year of support. A maximum of $2000 per year can be allocated for travel. Salary and fringe benefits for the candidate should be consistent with the institution’s salary structure for the residency-training program. No funds may be requested to supplement the salaries of the PI or other personnel, or to purchase equipment. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PAR 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: Meredith D. Temple-O Connor, Ph.D. Acting Director, Division of Interdisciplinary Training National Institute of Biomedical Imaging and Bioengineering (NIBIB) National Institutes of Health/Dept. of Health and Human Services 6707 Democracy Boulevard, Democracy II, Suite 200, MSC 5477 Bethesda, MD 20892 Telephone: (301) 451-4792 FAX: (301) 480-4973 Email: [email protected] o Direct your questions about peer-review issues to: David T. George, Ph.D. Director, Office of Scientific Review National Institute of Biomedical Imaging and Bioengineering National Institutes of Health/DHHS 6707 Democracy Boulevard, Suite 920, MSC 5469 Bethesda, MD 20892-5469 (20817 for FedEx, UPS, and other courier services) Voice: (301) 496-8633 Fax: (301) 480-0675 Email: [email protected] o Direct your questions about financial or grants management matters to: Florence Turska Grants Management Specialist Grants Management Branch National Institute of Biomedical Imaging and Bioengineering National Institutes of Health/DHHS 6707 Democracy Blvd., Suite 900, MSC 5469 Bethesda, MD 20892 Telephone: (301) 496-9314 FAX: (301) 480-4974 Email: [email protected] 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 PAR A letter of intent is not required, is not binding, and does not enter into the review of a subsequent application. However, the information 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, and should be sent to David T. George, Ph.D. Director, Office of Scientific Review National Institute of Biomedical Imaging and Bioengineering National Institutes of Health/DHHS 6707 Democracy Boulevard, Suite 920, MSC 5469 Bethesda, MD 20892-5469 (20817 for FedEx, UPS, and other courier services) Voice: (301) 496-8633 Fax: (301) 480-0675 Email: [email protected] SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The D&B number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 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: [email protected]. The title and number of this Program Announcement must be typed on line 2 of the face page of the application form and the YES box must be checked. SUPPLEMENTARY INSTRUCTIONS The request for a supplemental award must include the following: 1. The supplemental application must have the same Principal Investigator/Program Director as the currently funded (parent) grant. 2. Supplements can be requested only for active NIBIB grants that have a minimum of one year of support remaining. Submit a supplemental application only for a period within the current period of support. (A supplement may not extend beyond the parent award period.) 3. A proposed budget related to the percent effort (where appropriate) for the research experience of the candidate during the first and future years. The budget format (modular or non-modular) must be the same as that of the parent grant. 4. The supplemental application must include an Introduction of not longer than one page. 5. Completed biographical sketch pages (for the candidate and updated for the mentor(s)), resources page (updated), and checklist page (updated). The biographical sketch of the candidate should include evidence of scientific achievement and/or interest. 6. Research and Career Plans: The description of the research and career plans must not exceed 10 pages. This section must be prepared by the candidate and the PI of the parent grant and must include: (a) A statement by the candidate outlining his/her overall career plans and a timeline for the research and career development experiences proposed in this supplement; (b) A statement by the PI of the parent grant (i.e., the mentor) addressing the eligibility of the candidate for support under this program, detailing any current or previous PHS research grant support the candidate has received, and outlining how mentoring will be provided to help expand and foster the research capabilities of the candidate. (c) A description of the specific aims of the original project, and how the research proposed under this supplement relates to the specific research goals and objectives of the parent grant. The review committee will not receive a copy of the parent grant. (d) A description of the candidate’s proposed research project including research design and methods section. If the candidate’s proposed project uses vertebrate animals and/or human subjects, the application must address the points of Section E (human subjects research, including inclusion of women, minorities, and children in the study population) and/or Section F (vertebrate animals) of the PHS 398 application instructions. 7. A letter of support from the director of the residency program or department chair specifically stating that the candidate will be able to devote time at the requested effort (at least 75%) to his/her research experience. 8. If any of the research is to be conducted at a site other than the grantee institution, an appropriately signed letter from the institution where the research is to be conducted must be submitted. The request must be signed by the candidate, the PI, and the appropriate institutional business official. 9. Appendix material: Up to 5 publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to this project may be included. SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: The budget format of the supplemental application must be the same as that of the parent grant. If the parent application requested up to $250,000 per year in direct costs, the budget for the supplement must be submitted in a modular budget grant format. The modular budget 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. 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 David T. George, Ph.D. Director, Office of Scientific Review National Institute of Biomedical Imaging and Bioengineering National Institutes of Health/DHHS 6707 Democracy Boulevard, Suite 920, MSC 5469 Bethesda, MD 20892-5469 (20817 for FedEx, UPS, and other courier services) Voice: (301) 496-8633 Fax: (301) 480-0675 Email: [email protected] APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this PAR. 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 PAR 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 NIBIB. Incomplete applications will not be reviewed. If the application is not responsive to the PAR, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. Applications that are complete and responsive to the PAR will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIBIB in accordance with the review criteria stated below. As part of the initial merit review, all applications will: As part of the initial merit review, all applications will: o Undergo a selection process in which all applications will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the National Institute of Biomedical Imaging and Bioengineering staff. REVIEW CRITERIA The goal of this PAR is to provide research experiences for physicians in a residency program through supplements to existing NIBIB grant awards. The NIBIB seeks to enhance the research experiences of creative and insightful clinicians in order to help facilitate the translation of research findings to health benefits. This PAR aims specifically to enhance the fundamental knowledge and research skills of clinical residents interested in research careers in areas related to the mission of the NIBIB. In the written comments, reviewers will be asked to evaluate the application 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. Candidate o Quality of the candidate's proposed research; o Quality of the candidate’s academic and clinical record; o Potential to develop as an independent researcher; o Commitment to a research career; and o Appropriateness of the candidate’s career development plan Research Plan o Scientific and technical merit of the research question, design and methodology; o Relevance of the proposed research to the parent grant Mentor/Co-Mentor o Quality and extent of mentor(s) proposed role in providing guidance and advice to the candidate; o Previous experience in fostering the development of researchers; Environment and Institutional Commitment o Applicant institution's commitment to an appropriate balance of research and clinical responsibilities including the level of effort proposed by the candidate. (A minimum of 75% effort is required.) 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). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE (See revised dates, NOT-EB-05-006) Letter of Intent Receipt Dates: September 21, 2004 and January 17, 2005 Application Receipt Dates: October 21, 2004 and February 14, 2005 Peer Review Date: Feb-March 2005 and May-June 2005 Council Review: May 2005 and October 2005 Earliest Anticipated Start Date: July 1, 2005 and December 1, 2005 AWARD CRITERIA The following will be considered in making funding decisions: o Merit of the proposed research and training experience as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as mandated by the Health research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable. HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 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). SHARING RESEARCH DATA: Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. Effective October 1, 2004, applicants are required to submit sharing plan for model organisms, see NIH GUIDE May 7 issue http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.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 "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 PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA 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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