SPECIALIZED NEUROSCIENCE RESEARCH PROGRAMS ON HEALTH DISPARITY: HIV AND THE NERVOUS SYSTEM Release Date: August 26, 1999 RFA: NS-99-007 National Institute of Neurological Disorders and Stroke Letter of Intent Receipt Date: November 30, 1999 Application Receipt Date: March 10, 2000 PURPOSE The National Institute of Neurological Disorders and Stroke (NINDS), a component of the National Institutes of Health (NIH), invites applications for Specialized Neuroscience Research Programs (SNRP) on Health Disparity awards. The purpose of this Request for Applications (RFA) is to augment and strengthen the research capabilities of faculty, students, and fellows at minority institutions by supporting the development of new, and/or the enhancement of ongoing basic and clinical neuro-AIDS related research projects and programs. These awards will be made to support individuals at minority institutions who collaborate with one or more established NIH supported investigators at research intensive organizations. The collaborative research program's focus should be on prevention of neurological complications of HIV infection. The NIH recognizes that minority institutions are an integral component of our national biomedical research agenda. Therefore, the NIH is offering programmatic assistance for the development of the technology and resources that are necessary to conduct state-of-the-art neuroscience research. The SNRP will help the awarded institutions prepare the next generation of neuroscience investigators. Beyond this, the SNRP will become regional resources that contribute to the NIH mission to find new knowledge that will improve the health of the American public. This competitive RFA is one mechanism that the NIH identifies and supports neuroscientists at eligible institutions. To this end, the long term goals are (1) to develop effective prevention and/or intervention strategies to reduce the burden and the neurological consequences of HIV/AIDS in socio-economically disadvantaged populations; (2) to ameliorate problems associated with AIDS-related dementia, peripheral neuropathy, and other neurological complications of HIV infection; and (3) to strengthen existing research, evaluation and prevention programs among research institutions, community-based organizations, and minority medical and graduate schools. In summary, the goals of this program are to establish new, or strengthen existing research collaborations with NIH-supported neuro-AIDS investigators, investigators at minority institutions, and health care providers to better deliver the benefits of research to Americans at increased risk for AIDS and the neurological complications associated with HIV infection. While awards under this program are exploratory and intended to enhance and/or extend pilot neuro-AIDS research projects among collaborating research institutions and scientists, it is expected that the projects supported will be mutually beneficial to advancing national efforts to disseminate medical information and technologies to better serve the health needs of the public in this major disease. Successful programs will be further supported to serve as the foundation for the development of more intensive and larger research studies to reduce the national burden of this disease. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Specialized Neuroscience Research Programs on Health Disparity: HIV and the Nervous System, is related to the priority area of neurological complications of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (Tel 202-512-1800), or at http://odphp.osophs.dhhs.gov/pubs/hp2000. ELIGIBILITY REQUIREMENTS Applications will only be accepted from domestic, public or private, non- profit, academic institutions that offer Ph.D., M.D., and/or equivalent health professional degrees, at which more than 50 percent of the students enrolled are from ethnic or racial minority groups. Each applicant institution must identify a collaborating institution that can be a domestic Federal or non- Federal, public or private, non-profit organization. Because the awardee will need continuous and substantial research collaborations to achieve the objectives of this RFA, the collaborating organization must be in the U.S., its possessions, or its territories. The principal investigator, who serves as SNRP Director, must be a U.S. citizen, permanent resident, or non-citizen national. An award pursuant to this RFA will not be made until and unless the institution appoints a Program Director who has the professional skills needed to direct the Program. The administrative leadership skills, quality of independent research and productivity, and ability to obtain and effectively use research support of the proposed Program Director will be assessed (see REVIEW CONSIDERATIONS). Participating applicant investigators from the minority organizations should have completed two or more years of postdoctoral neuroscience research and must be full-time employees of the applicant institution. Participating collaborating investigators from the research intensive institutions must be current NIH and/or NSF grantees (see RESEARCH OBJECTIVES). MECHANISM OF SUPPORT The Cooperative Agreement (U-series) award is the administrative mechanism for supporting activities in which the NIH collaborates substantially in scientific and/or programmatic matters with the awarded institution(s). The Specialized Center-Cooperative Agreement (U54) mechanism will be used to support the SNRP award. It is anticipated that collaborating neuroscientists will benefit from a broader range of research resources and interdisciplinary research approaches than are available at any one institution. A SNRP award will support research and research development activities within the scope of the program priorities identified by the NINDS. The NIH will support and stimulate the activities of the awardee(s) by working as a partner. The NIH will not assume direction, take primary responsibility, or in any other way dominate the activity. The section TERMS AND CONDITIONS contains detailed descriptions of the responsibilities, relationships, and governance of the activities supported by the cooperative agreements for the Specialized Neuroscience Research Programs on Health Disparity. FUNDS AVAILABLE The NINDS plan to make up to four SNRP awards in Fiscal Year 2000. An applicant may request a project period of five or fewer years, and a budget for direct costs of up to $1,000,000 per year, excluding indirect costs on consortium arrangements. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the NINDS provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of applications of outstanding scientific and technical merit. At this time, it is not known if competing renewal applications will be accepted and/or if this RFA will be reissued. Applicants planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement (type 3), or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact institute program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the applicant must obtain agreement from NINDS staff that the institute will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any subsequent amendment (Refer to the NIH Guide for Grants and Contracts, March 20, 1998). Any application subject to this policy that does not contain the required information in a cover letter sent with the application will be returned to the applicant without review. RESEARCH OBJECTIVES Background The NINDS wants to foster an improved health status of and eliminate the health disparity experienced by Americans at increased risk for HIV/AIDS. Focused research and research career development programs such as the Specialized Neuroscience Research Programs are used to achieve those objectives. Secondly, the NIH recognizes the unique and essential contributions that minority institutions can make to fulfill the promise of the NIH research agenda. Therefore, the NIH has the responsibility to the Nation to ensure that minority and other 'non-research-intensive' institutions can develop the technology and other resources needed to conduct significant neuroscience research. Thirdly, the NIH can foster, by means of the SNRP and other programs, the collaborative research affiliations needed to address neuroscience research problems relevant to the communities and regions served by awarded institutions. The Specialized Neuroscience Research Programs will: (1) help minority institutions develop state-of-the-art neuroscience research programs; (2) create more opportunities for researchers employed by minority institutions to establish research collaborations and professional networks with NIH and/or NSF grantees employed by research intensive institutions; (3) increase the role of ongoing research in maintaining a vigorous, stimulating academic and intellectual milieu that will inspire and prepare students and fellows to pursue research careers in neuroscience; and (4) provide support for pilot research. This research is needed to polish the skills and abilities of investigators, to obtain preliminary data, and to publish in peer reviewed journals which can help ensure successful competition for traditional research grants and awards. . Research Objectives and Scope The NINDS strongly supports scientific investigations into the causes, prevention, diagnosis, and treatment of neurological diseases and stroke. An application for a SNRP in the area of neuro-AIDS could include proposals for basic and/or clinical research. Examples of relevant research include, but are not limited to the following: o Development of strategies to promote the dissemination and/or transfer of information on the neurological complications of HIV infection from research to service providers; o Development of strategies to prevent the spread of HIV infections in the CNS and PNS; o Establishment of population-based studies to evaluate promising new therapies that could impact the progression of AIDS-associated dementia; o Studies on mechanisms underlying the neurological and neurobehavioral aspects of HIV infection; o Identification of surrogate markers which will allow rapid measurement of neuropathogenic damage and treatment success; o Refinement of brain imaging techniques (CT, MRI, MR spectroscopy, functional MR, SPECT, and PET) in the diagnosis and treatment of HIV- associated neurological disease; o Elucidation of the role of the immune system, intracellular signaling pathways, receptors, and cytokines in HIV neuro-tropism and pathogenicity in HIV-associated dementia; o Investigations of signal transduction which may induce recruitment and proliferation of inflammatory cells and further cytokine/chemokine dysfunction; o Studies of drugs of abuse that result in neuro-AIDS complications; o Investigation of possible common links among neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, and HIV-dementia, where microglial activation is a common pathway for neural destruction. The research plan of an application for a SNRP award must contain the description of up to three multidisciplinary, collaborative, research projects that will be mutually beneficial to participating investigators through coordinated, cooperative interactions. Each of the proposed projects should effectively use the scientific and technical strengths of collaborating investigators to define a research plan appropriate to the requested duration that will advance scientific knowledge in the research areas identified above. Description of Key Elements in an Application for a Specialized Neuroscience Research Program Award: o Selection and appointment of an SNRP Director who has had experience with neuroscience research funding and research training; o Selection of one or more highly qualified applicant investigators at the minority institution to propose and direct meritorious research projects suited to their expertise. These investigators are required to devote a minimum of 50 percent time and effort to these projects; o Documentation of the nature and scope of the collaborative research projects with NIH and/or NSF grantees from research intensive institutions. Collaborators at the intensive research organizations must devote no less than 20 percent time and effort to the collaborative projects; o Evidence that the senior leadership at the applicant institution has addressed issues related to tenure, promotion, research release time, and other personnel matters pertaining to the scientific success of the SNRP Director and applicant investigators. In addition, evidence is required of institutional commitment and availability of technical and logistical resources for the long-term support of the SNRP. Features of the institutional environment that are relevant to effective accomplishment of the overall neuroscience program must be briefly described. As appropriate, available resources (e.g., clinical and laboratory facilities, patient populations, geographic distributions of space and personnel) and collaborative resources should be described. A letter of support from a senior institution official (e.g., President or Dean) should outline the commitment for resources to sustain and support the neuroscience program throughout the period of funding and beyond the performance period of this award; o The applicant must identify and outline plans for support staff (e.g., grants management, administrative, and technical) to ensure the timely ordering of research supplies, equipment, and other resources essential to the scientific productivity of the research award; o Eligible institutions must show evidence of an existing research infrastructure that can support the neuroscience research program. Previous (past five years) and current research support used for neuroscience research could be described. The existing research infrastructure and needed enhancements must be delineated; o Brief description of how the proposed activities will enhance the scientific capabilities of faculty, students and fellows in neuroscience, and strengthen the neuroscience curriculum; and o Description of the chain of responsibility for decision making and administration, beginning at the level of the institution's President and including all key staff (e.g., Sponsored Programs Administrator, Department Chair, and Dean), plans for day-to-day administration of the SNRP, program coordination, planning, and evaluation. The proposed relationship of SNRP to existing programs and, how the SNRP initiative will augment and strengthen the research infrastructure need to be described in detail. SPECIAL REQUIREMENTS The awardee will work to establish research priorities within the approved research scope of each SNRP award through discussions with the NINDS Office of Special Programs in Neuroscience. The NINDS reserves the right to include outside consultants/experts in these discussions. After the awardee and the NINDS have set the priorities, the awardee will be responsible for conducting the research activities. The awardee and the NINDS will interact in a cooperative manner throughout the duration of the award to facilitate progress and resolve any problems that may arise. TERMS AND CONDITIONS The following Terms of Award are in addition to otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Part 74 and 92, and other HHS, PHS, and NIH grant administration policies. Cooperative Agreements are subject to the administrative requirements outlined in pertinent OMB, HHS, PHS, and NIH guidelines, with particular emphasis on HHS regulations at 42 CFR Part 52 and 45 CFR Part 74. Indirect costs are calculated and awarded for cooperative agreement the same way as for grants. 1. The Awardee Rights and Responsibilities: o The awardee has primary authority and responsibility to define the scientific objectives and approaches, to plan, conduct, analyze, and publish results, interpretations, and conclusions of the studies; o The awardee has the primary responsibility for establishing effective and substantial research collaborations with NIH and/or NSF grantees from research intensive organizations. The scope and nature of the research on common protocols must be adequately documented and must ensure participation, collaboration, and sharing of methods and data among collaborating organizations; o The awardee has the primary responsibility for establishing an internal advisory committee of the collaborating neuroscientists. The committee will have the responsibility for directing and monitoring the progress of the research projects. Also, the committee must develop opportunities for information exchange, seminar presentations, and research training for students and fellows; o The awardee has the primary responsibility for establishing an external advisory committee of distinguished senior neuroscientists. Annually, the committee will assess the productivity of the SNRP, make recommendations for the future direction of the SNRP initiative, and provide advice and guidance about personnel matters and the allocation of resources to individual projects and investigators. The awardee will retain custody of, and primary rights to the data and intellectual property developed under the award, subject to current government policies regarding rights of access as consistent with current HHS, PHS, and NIH policies. The NINDS reserves the right to negotiate additional awardee terms and conditions based on recommendations from the Initial Review Group and the National Advisory Neurological Disorders and Stroke Council. 2. NINDS Staff Responsibilities: The NINDS will have substantial scientific/programmatic involvement during the award performance period by contributing to the planning and assessment activities and by providing technical assistance, advice and coordination beyond normal program stewardship for grants. (see INQUIRIES, below). o The NINDS will have primary responsibility for stewardship of the award and overall responsibility for monitoring the conduct, progress, and fiscal management of the research program; o The NINDS will help shape a comprehensive framework for the development of the SNRP and provide technical advice and expertise regarding scientific direction and program management; o The NINDS will help the applicant institution and SNRP Director establish reasonable time lines to achieve the developmental goals of the SNRP. The NINDS will facilitate interactions between the awardee and collaborating investigators; o The NINDS reserves the authority to recommend reductions in budget, withhold support, suspend and/or terminate the award if technical performance falls below acceptable standards for quality and timeliness; o The NINDS will actively participate as non-voting members in all meetings of the external advisory committee during the performance period of the award; o The NINDS reserves the authority to recommend additional research endeavors within the approved research and negotiated budgets; and o The NINDS reserves the right to include selected extramural and intramural staff as consultants/experts on scientific issues during the performance period of the award. 3. Arbitration Any disagreements about scientific/programmatic matters (within the scope of the award) between the awardee and the NINDS may be brought to an arbitration panel convened by the Director's of the co-sponsoring NIH components. The decision of the arbitration panel, by majority vote, will be binding. The process to resolve programmatic differences described above in no way affects the rights of a recipient of a cooperative agreement assistance grant to appeal an adverse determination in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS 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 biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. Adequate plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research must be included. Plans for recruitment and retention of subjects will be evaluated. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research, which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. This information is available on the Internet at http://grants.nih.gov/grants/guide/notice-files/not94-100.html. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH 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 is scientific or ethical reasons not to include them. This applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html LETTER OF INTENT Prospective applicants are asked to submit, by November 30, 1999, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the principal investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, it is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NINDS staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Dr. Alfred W. Gordon Director, Office of Special Programs in Neuroscience National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Suite 2149 Rockville, MD 20892-9535 APPLICATION PROCEDURE The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910; telephone (301) 435- 0714; Email: grantsinfo@nih.gov; and from the NIH program administrator listed under INQUIRIES. Application kits are also available on the Internet at http://grants.nih.gov/grants/forms.htm. An application for a SNRP award must include the following: o Competitive applications will develop new and/or strengthen existing collaborative projects with NIH and/or NSF grantees from research intensive institutions. Investigators must clearly define the nature and extent of the research collaboration, such that they fully explain the necessary administrative, fiscal, and scientific aspects in the application. o A research plan for up to five years that includes the proposed organization and functioning of the SNRP. The plan should demonstrate the applicant's knowledge, ingenuity, practicality, and commitment to developing a significant, productive, research program. o A description of, and justification for the proposed individual research projects and core service facilities. Applicants are required to propose up to three meritorious research projects, and must describe the nature and scope of scientific research collaborations. o A description of the research, training goals, and capabilities of the proposed SNRP. The Program Director and NINDS must establish a time line for supported applicant investigators to prepare and submit proposals for traditional research grant review during the performance period of the SNRP award; and o A description of the infrastructure for conducting studies aimed at developing a nationally competitive neuroscience research program. The RFA label, available in the PHS 398 (rev. 4/98) application kit, must be affixed to the bottom of the face page of the application. The RFA label and line 2 of the application should both indicate the RFA number. 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 number and title must be typed on line 2 of the face page of the application form and the "YES" box must be marked. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. 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 must be sent to: Dr. Lillian Pubols Scientific Review Branch National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Suite #3208 Bethesda, MD 20892 SCHEDULE Letter of Intent Receipt Date: November 30, 1999 Application Receipt Date: March 10, 2000 Council Review: September 14, 2000 Earliest Award Date: December 2000 Applications must be received by March 10, 2000. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept an application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. Also, the CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR, and responsiveness by NINDS staff. Applications that are incomplete and/or non- responsive to this RFA, or exceed the maximum first year direct cost limit of $1,000,000, excluding costs for consortium budgets, will be returned to the applicant without further consideration. A Special Emphasis Panel (SEP) convened by the NINDS will determine the scientific merit of each application. The NINDS will withdraw from further competition those applications judged by the SEP to be noncompetitive for an award and notify the applicant principal investigator and applicant organization. The review of the SNRP application is based not only on the traditional review criteria for research projects, but also considers the feasibility and potential for investigators to gain scientific independence. The following criteria will be used to evaluate the potential for productive collaborative research, and the overall potential for enriching the academic and intellectual milieu for doing research that will increase what is known about healthy and disordered nervous systems. o The significance, approach, and innovation of the proposed research projects and of the SNRP as a whole; o The scientific and administrative qualifications of the principal investigator to direct the SNRP; o The strengths of the applicant investigators and collaborating neuroscientists, particularly the academic qualifications, neuroscience research experience, expertise and research productivity; o Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research, considering the applicant and collaborator research backgrounds and their respective contributions in the development of the research proposal. The application must have scientific merit, but unlike a traditional research grant application, it must be evaluated in the context of the developmental goals and feasibility of the study; o The nature, scope, and effectiveness of the plans for coordination and cooperation among research project investigators; o Evaluate the facilities, resources, and environment of the applicant institution (including existing relevant equipment, animal, and/or computer resources, and departmental or interdepartmental cooperation); o Evidence of a detailed plan for career development of students and fellows in neuroscience research and other neuroscience related health professions; o The specific research goals to be accomplished, the hypotheses to be tested, and the likelihood that applicant investigators will produce the preliminary data and publications to be competitive for a traditional research grant during the performance period of the award; o Appropriateness of the proposed budget and duration, including the justification for requested items in terms of the aims and methods of the proposed research studies; o For research involving human subjects, adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. Reviewers should assess the age-appropriate inclusion or exclusion of children in the research project and evaluate the plans for conducting the research in accord with the NIH guidelines on the inclusion of children as participants in research involving human subjects; and o The adequacy of the proposed plan for animal welfare and biohazard safety in the research environment. AWARD CRITERIA Funding decisions will be based on the scientific and technical merit of the application as determined by the Initial Review Group and the National Advisory Neurological Disorders and Stroke Council, program balance, and the availability of funds. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Joana Rosario Office of Special Programs in Neuroscience National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Suite 2150 Bethesda, MD 20892 Telephone: (301) 496-5489 FAX: (301) 594-5929 Email: jr69z@nih.gov Dr. A.P. Kerza-Kwiatecki National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Suite 2115 Bethesda, MD 20892 Telephone: (301) 496-1431 FAX: (301) 402-4020 Email: ak45w@nih.gov For information on budget and fiscal matters, contact: Mr. Maurice Johnson Grants Management Branch National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Suite 3115 Bethesda, MD 20892 Telephone: (301) 496-7432 FAX: (301) 402-0219 Email: mj34w@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.854 (Biological Basis Research in the Neurosciences). Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under NIH grants policies and Federal Regulation 42 CFR 52 and 45 CFR Part 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace, and to 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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