EXTRAMURAL ASSOCIATES SPONSORED RESEARCH INFRASTRUCTURE PROGRAM (SRIP) RELEASE DATE: April 28, 2004 RFA NUMBER: RFA-HD-04-008 October 7, 2011 - See Notice NOT-HD-11-026. The purpose of this Notice is to Close-out of the Extramural Associates Research Development Award (EARDA) Program and Clarification of the Eligibility of Current and Previous EARDA Grantees for Participation in the Biomedical/Biobehavioral Research Development (BRAD) Program (G11). (This RFA has been modified, see PAR-05-053) EXPIRATION DATE: June 18, 2004 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 Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.865 LETTER OF INTENT RECEIPT DATE: May 18, 2004 APPLICATION RECEIPT DATE: June 17, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The Extramural Associates (EA) Program, National Institute of Child Health and Human Development (NICHD), NIH, announces an initiative directed at scientific faculty and academic science administrators of women's colleges and of institutions with significant underrepresented minority (i.e., Black, Asian/Pacific Islander, Hispanic, or Native American) student populations. This RFA describes the Sponsored Research Infrastructure Program (SRIP) and is intended for eligible institutions that award the Master's or the Ph.D. degree in the biomedical and/or behavioral sciences and/or other health-related professional degrees. In addition, it is expected that these institutions already have a modest research base of health-related research. The goal of this initiative is to increase the participation of these institutions in biomedical and behavioral research and research training through an integrated residency and institutional grant support program. RESEARCH OBJECTIVES Background The EA Program was established in 1978 at the NIH to promote the entry and participation of women and underrepresented minority institutions into biomedical and behavioral research. Overall, the program accomplishes this mission by providing EAs from women's colleges and underrepresented minority institutions with the opportunity to come to the NIH to gain the necessary understanding of the processes utilized by the NIH as well as other Federal agencies to provide funding to support biomedical and behavioral research and research training. The five-month SRIP winter residency program is for institutions with an individual wishing to establish or augment an Office of Research Development for the purpose of enriching faculty and student participation in biomedical and behavioral research activities. A successful applicant institution receives an Extramural Associates Research Development Award (EARDA); the individual from the awardee institution who participates in the residency EA Program is known as the Extramural Associate (EA). Program Objectives The objective of the SRIP program, through its five-month residency experience at NIH, is to enhance the research capacity of the awardee institution by providing the following resources: (1) administrative support for the development of grant applications and/or contract proposals; (2) updated information about the availability of funds to support biomedical and behavioral research and research training; (3) grantsmanship seminars for faculty; and (4) the resources to develop approaches to encourage faculty and students to participate in biomedical and behavioral research. It is anticipated that the individuals participating in the residency program will be responsible for establishing or enhancing an office that provides administrative support for research and research training projects receiving external funding, and for implementing pilot studies that encourage faculty and students to engage in research from a broader perspective. Scope Candidates for the Extramural Associates Research Development Award (EARDA) must be full-time scientific faculty or academic science administrators at the applicant institution. If approved and invited to participate, they will be required to spend five months at the NIH in residency training. The program has the flexibility necessary to allow each EA to participate in activities that are consistent with the institution's concerns and interests in health- related research. Upon entering the program, EAs are assigned a preceptor and participate in the regular EA Program curriculum. The EA's preceptor, a senior NIH or Public Health Service (PHS) official, is available for guidance with respect to working assignments and related activities to assure consistency with the Institutional Plan presented in the EARDA application. EAs attend an initial series of orientation sessions as well as in-depth seminars that prepare them to use their time effectively at the NIH. Working assignments are intended to provide in-depth exposure to the administration of NIH and other Federal extramural research programs. EAs have the opportunity to learn about the Federal legislative and budgetary processes, to study administrative procedures, and to observe staff meetings and scientific review meetings. During the course of the residency program, they visit other Federal agencies, and a nearby university's office of sponsored research. Opportunities may also be provided to observe NIH site-visits to grantee institutions. Residency Training Curriculum The purpose of the residency training curriculum is to provide the EA with the skills needed to improve or enhance the research infrastructure at the participating institution. Toward this end, the curriculum will focus on eight core areas: (1) The Organization and Function of the NIH; (2) Extramural Program Policies and Procedures; (3) Extramural Scientific Review Policies and Procedures; (4) Compliance and Regulatory Issues; (5) Project Administration and Financial Management; (6) Extramural Funding Mechanisms and Opportunities; (7) Other Federal Funding Programs and Opportunities; and (8) Grantsmanship Workshops and Seminars. Individual training specific to needs of the EAs or their institutions will be provided by their assigned mentors. Upon completion of the program, the EAs have: (1) a comprehensive working knowledge of the range of Federal support of biomedical and behavioral research; (2) skills in preparation of research grant applications; (3) a plan to establish or expand the institution's "Office of Research Development;" (4) knowledge of the composition of an Advisory Committee with membership capable of reviewing, recommending for funding, and monitoring faculty pilot research projects; (5) a network of contacts to the NIH and other Federal agencies, so they can serve as a liaison for faculty and students to access NIH opportunities, as well as those of other Federal and private agencies; and (6) the embryonic stage of a meaningful partnership with a research intensive institution. Following the residency training, EARDA grant funds will be used for the purpose of improving the research infrastructure at participating institutions and providing seed money for faculty and student pilot research projects. MECHANISM OF SUPPORT This RFA will use the NIH Extramural Associate Research Development Award (G11) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. The anticipated award date is upon completion of the NIH residency training after December 1, 2004. FUNDS AVAILABLE The NICHD intends to commit approximately $189,000 in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2005 to support three to five new grants in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs of up to $35,000 in the first year and up to $85,000 per year in subsequent years. 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 NICHD 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 if your institution has any of the following characteristics: o Domestic, private and public women's colleges and educational institutions with significant underrepresented minority student populations that offer programs in the biomedical or behavioral sciences. o Eligible women's colleges and underrepresented minority institutions that have never had a faculty member participate in the EA Program. o Institutions that had EAs enrolled in the five-month NIH residency training program prior to 1994 and who have never received an EARDA grant are eligible to apply for this program. However, the proposed Principal Investigators from such institutions must agree to repeat the five-month NIH residency training program. Institutions that have received a Research Centers in Minority Institutions (RCMI) award, if successful in applying for this award, may have their budget requests reduced if there is significant overlap in funding for infrastructure components. Institutions that received an Extramural Associates Research Development Award (EARDA) in years 1994 through 2003 resulting from their response to RFAs OD-94-002, OD-94-003, OD-95-001, OD-96-001, OD-97-002, OD-98-004, OD-99-001, OD-00-001, HD-01-003, HD-02-007 or HD-03-07 are not eligible to apply under this announcement. 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 his/her 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. The Principal Investigator will serve as the Extramural Associate (EA) for the program. Full-time science faculty, i.e., faculty who have earned degrees in the life sciences (biomedical and or behavioral sciences) or in the physical sciences (chemistry, mathematics, physics or engineering) are eligible to become Principal Investigators. Academic science administrators, or mid-level and senior level faculty, are preferable so long as they have the flexibility to participate in the residency training and carry out the expectations outlined in the RFA after completing the residency training. SPECIAL REQUIREMENTS Institutional Commitment Institutions may nominate only one Principal Investigator per cycle for participation in the program. In nominating the EA candidate, the sponsoring institution is expected to commit adequate resources to formulate and implement an Institutional Plan, which will build upon the EA's residency training experience. For the five-month residency program, this may include: o a commitment to provide the EA with support, in the form of designated authority to develop or enhance an Office of Research Development upon his/her return to the institution. o a statement in the proposed plan describing how the institution plans to continue the developmental research activity once EARDA support expires. o the EA's residency training costs under the Intergovernmental Personnel Act (IPA). The institution should be prepared to provide advance travel and per diem for the EA during the first year of the EARDA. Absence During Training The EA and the institution must be fully committed to the EA residency training. Specifically, because of the time and effort expended in scheduling and conducting the training, only in extreme cases will the EA be excused from any part of the training to engage in institutional responsibilities incurred prior to or during the residency training. Allowable Costs Funding for the program may be used to support the activities of the EA upon returning to the home institution. Such activities include equipping an office, support of small pilot research studies, conduct of student/teacher seminars and workshops to enhance research interest, and the establishment of consortium research arrangements. Other purposes for which funds may be used include, but are not limited to, the following: o Purchase of office supplies and equipment o Administrative assistance (Support for administrative assistance can be requested up to, but must not exceed, 50 percent FTE. Any request for administrative assistance greater than 50 percent FTE will be denied.) o Travel expenses for the EA to gain additional experience in carrying out the functions of the office o Membership dues in one professional organization whose function is related to the goals of the EA Program. Salary support for the EA during the five-month residency program will be provided through an IPA agreement mechanism described below, not through or from the EARDA grant itself. Therefore, salary should be requested for only seven months in the first 12-month budget period of the EARDA. The costs for the residency program are entirely separate from the EARDA award. Selected EAs will come to the NIH for the assignment under the IPA. The IPA enables temporary appointments to the Federal government by employees from academic institutions. Cost sharing is required. The IPA provides partial support for the EA while he/she is at NIH. Under the IPA arrangement, up to 67 percent of the cost of the EA's salary, while at the NIH, is reimbursed. Similarly, per diem (food and lodging) costs are reimbursed at 75 percent by NIH and the institution contributes 25 percent. The cost of relocating the EA from the home institution and any other costs incurred that are related to the residency program are reimbursed at 100 percent. Included in related costs are expenses to return to the home institution, for a one-week period, approximately mid-way through the five-month residency to meet with institution officials and faculty to discuss plans for implementing the institutional plan upon the EA's return. Although institutions with an existing Office of Research Development or similar office or with funding through programs such as the Research Centers in Minority Institutions (RCMI) may apply, adjustments in the final funding level for budgetary overlap will be made prior to the award. Change of Principal Investigator If a request to change the Principal Investigator (PI) of the EARDA is received at any time during the five-year grant, the NICHD may suspend support pending approval of a substitute Principal Investigator by the EA Program Director. Additionally, the new PI must attend a modified EA training course to be conducted by the EA Program staff. The expense for residency training for the new PI will be borne entirely by the grantee institution. Inclusion of Pilot Research Projects Please do not include in this application any descriptions of pilot studies that will be conducted by faculty at your institution. These pilot studies will not be considered by peer reviewers of your grant application; therefore, such information will not influence the evaluation. Detailed instructions for submitting pilot studies for evaluation of scientific and technical merit, human subjects protection and animal welfare, and the inclusion of women, minorities and children can be accessed at: http://www.nichd.nih.gov/RFA/HD-04-008/HD-04-008.htm. Post-Award Monitoring To insure the EA is making satisfactory progress in achieving the goals and objectives of the EA Program and is receiving appropriate institutional support, two EARDA assessments will be conducted during the five-year grant period. The first assessment will take place at the institution approximately 18 months after the EARDA is awarded. The second one, a grantee interview, will take place at the NIH during the latter part of the fourth year or early in the fifth year of the grant and will include the EA and one or two designated institutional officials. Applicants should include in their budget, funds necessary to participate in the grantee interview at NIH. These assessments will be carried out in addition to the normal requirement for submitting annual Progress Reports to the NICHD. 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: Matthew Kinnard, Ph.D. Director, Extramural Associates Program National Institute of Child Health and Human Development 6100 Executive Boulevard, 5E03, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-2736 FAX: (301) 480-0393 Email: email@example.com o Direct your questions about peer review issues to: Robert Stretch, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1485 FAX: (301) 402-4104 Email: firstname.lastname@example.org o Direct your questions about financial or grants management matters to: Ms. Myrtle Coleman Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 402-4572 FAX: (301) 402-7827 Email: email@example.com 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 NICHD 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: Matthew Kinnard, Ph.D. Director, Extramural Associates Program National Institute of Child Health and Human Development 6100 Executive Boulevard, 5E03, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-2736 FAX: (301) 480-0393 Email: firstname.lastname@example.org 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 https://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. SUPPLEMENTARY INSTRUCTIONS: The instructions accompanying Form PHS 398 (rev. 5/2001) must be followed, with the exceptions noted below: Special Instructions for Research Plan For section I.C.9, Specific Instructions - Research Plan, use Continuation Pages to provide information on the three parts described below. The total length for these three parts combined should not exceed 15 pages. The Research Plan for a SRIP application consists of three parts. These parts are required and it is imperative that applicants fully address each point described in the outline below because they are reflected in the review criteria. Part I: The Nominee This part pertains to the nominee's background and potential as an EA. It should be prepared by the nominee and must include: o Evidence of rapport with faculty and students, ability to motivate and advise others, and commitment to serve the institution. o A description of the nominee's commitment to increasing and strengthening involvement of women and underrepresented minorities in biomedical and behavioral research at the institution. This description also should address his/her interest in and commitment to the objectives of the EA Program, the benefits that will accrue to the institution from his/her participation in the program, and the nominee's availability to participate in the five-month residency program at the NIH. o The names, titles, addresses, telephone and fax numbers, and e-mail addresses of three colleagues who have consented to submit letters of reference to the NIH attesting to the personal qualifications and potential effectiveness of the nominee. The reference letters must be included in the appendix. One of these letters should be from the President of the applicant institution. Reference letters should accompany the two applications sent to the NICHD (see SENDING AN APPLLICATION TO THE NIH, below). The reference letters must be received in the same package with the EARDA application. Otherwise, the application is considered incomplete and will be returned to the applicant without further consideration. In order to comply with this requirement, it is recommended that all reference letters be obtained from the referring individuals as far in advance of the application deadline as possible. o A detailed description of the current status of the sponsored programs office or similar office at the institution and the nominee's plan to take the institution forward with regard to developmental research activities. Part II: The Institution This part pertains to the institution's mission and goals related to the EA Program. It should be prepared by institutional officials and must include the following: o Statement of interest in and plans to improve the health-related research capabilities of the institution. o If applicable, a description of a current Office of Research Development or similar institutional unit. o If applicable, a description of a current Sponsored Programs Office or similar institutional unit. o A letter from the head of the Sponsored Programs Office or similar office, signed and dated, should be included in the Appendix. The letter should state explicitly that he or she is committed to working cooperatively with the Office of Research Development once established for the benefit of the entire institution. o Statement of the institution's demonstrated past and potential contributions to the advancement of minorities and/or women in biomedical and behavioral research and training. o Description of the current academic environment. This should include a history/accreditation, and profile of the student population, including a detailed categorization of the enrollment of minorities and women. o Description of the research environment. Include a description of the science faculty and the research capability as indicated by: (1) number of faculty members in biomedical and behavioral science disciplines; (2) number of faculty engaged in biomedical and behavioral science research; (3) number of faculty with external research support; (4) evidence of presentations at local, regional, and national meetings; (5) evidence of faculty research collaborations with investigators at other institutions; (6) faculty involved in peer review activities, as members of standing or ad hoc review committees; (7) current student population in the sciences and follow-up data (e.g., graduate and post-graduate career profiles); (8) current and planned facilities for scientific research and training; and (9) current and planned Federal and non-Federal research support. o Description of ongoing or planned cooperation and/or collaboration with other institutions or Federal or non-Federal organizations. Part III: Institutional Plan The EA selected to participate in the SRIP will submit a preliminary plan that describes the establishment or enhancement of the institution's Office of Research Development. This plan should describe an approach for enhancing the research capabilities of the institution using the skills to be gained by the nominee. The plan also should include details about steps to be taken for identifying, funding, and monitoring progress of scientifically meritorious pilot research studies, as well as the development of seminars and workshops, and plans to involve students in research activities. This section should be developed by both faculty and administrators and should include: o A statement of nominee's role, authority, and institution-wide accessibility upon return to the institution as well as a description of resources that will be made available to the nominee, including a detailed budget. o At least one advisory committee must be described and established. The purpose, function, and expectation of the committee should be described in the application, but specific members should not be appointed until after an award is made. This committee could serve as advisory to the EA in the establishment and maintenance of ongoing research development activities. This committee will also be responsible for the review, recommendation for funding, and monitoring of faculty pilot research studies. All other planned committees should be included in this section with a justification for the particular committee structure and function proposed and a description of the proposed membership. o A description of plans to initiate or expand local or regional cooperation/collaboration in research activities. Particular emphasis is placed on partnering with foundations and with private companies and businesses. o A preliminary plan, including the source of budgetary resources, for continuation of the program once NIH support expires. Special Instructions for Appendix The Appendix to the application should include the following items: o Reference letters from colleagues identified. o Letter from Director of Sponsored Programs Office. 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: https://grants.nih.gov/grants/funding/phs398/label-bk.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: Robert Stretch, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight 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 NICHD. Incomplete or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NICHD 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 National Advisory Child Health and Human Development Council. REVIEW CRITERIA I. The Nominee o Strength of personal qualifications as indicated by past training and experience; o Evidence of ability to enhance the institution's effectiveness in involving women and underrepresented minorities in health-related research; o Demonstrated interest and resourcefulness, and evidence that the nominee has the requisite experience and access to the science faculty and to the administration to accomplish the goals of the program; o Ability to commit himself or herself to function as the EA, preferably for the duration of the EARDA grant but, at a minimum, for three full years. II. The Institution In the context of the institution's history and stage of development: o Quality of science education and potential for research and/or research training in biomedical and behavioral sciences; o Evidence of commitment to preparing women and/or underrepresented minorities for careers in science; o Evidence of potential for developing research and research training infrastructure; o Strength and quality of faculty and students in health-related science departments; and o Potential for conducting collaborative sponsored research and research training projects. III. The Institutional Plan o Evidence of a strong institutional commitment to implementing the plan; o Evidence, as reflected in institutional statements and the budget, that the nominee will be provided sufficient resources to carry out the plan; o Evidence that the nominee will have sufficient authority to carry out the plan; o Coherence of the plan and evidence that there is adequate coordination among key faculty and administrators (i.e., composition and functioning of committees) in its development; o Adequacy of the proposed Advisory Committee to review, fund, and monitor pilot research studies; o The presence, strength, and viability of the proposed evaluation strategy; and o The justification for establishing or expanding an Office of Research Development. 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: May 18, 2004 Application Receipt Date: June 17, 2004 Peer Review Date: July/August 2004 Council Review: September 2004 Earliest Anticipated Start Date: After December 01, 2004 AWARD CRITERIA 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 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 https://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.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at https://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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