This Program Announcement expires on January 3, 2004 unless reissued. HIV PATHOGENESIS IN WOMEN"S INTERAGENCY HIV STUDY (WIHS) Release Date: April 26, 2001 PA NUMBER: PA-01-084 National Institute of Allergy and Infectious Diseases (http://www.niaid.nih.gov) National Institute of Child Health and Human Development (http://www.nichd.nih.gov) National Institute on Drug Abuse (http://www.nida.nih.gov) National Institute of Dental and Craniofacial Research (http://www.nidcr.nih.gov) National Institute of Diabetes and Digestive and Kidney Diseases (http://www.niddk.nih.gov) National Institute of Neurological Disorders and Stroke (http://www.ninds.nih.gov) Office of Research on Women"s Health (http://www4.od.nih.gov/orwh) National Center for Complementary and Alternative Medicine (http://www.nccam.nih.gov) Application Receipt Dates: May 1, 2001, September 1, 2001, January 2, 2002 THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA. PURPOSE The National Institute of Allergy and Infectious Diseases NIAID), the National Institute of Child Health and Human Development (NICHD), the National Institute on Drug Abuse (NIDA), the National Institute of Dental and Craniofacial Research (NIDCR), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Neurological Disorders and Stroke (NINDS), the Office of Research on Women"s Health (ORWH), and the National Center for Complementary and Alternative Medicine NCCAM), National Institutes of Health (NIH), invite applications for highly focused basic research integrated with the Women"s Interagency HIV Study (WIHS) scope and structure. This PA is a renewal of PA-97-105, which was published in the NIH Guide on 09/05/1997. Applications are expected to utilize the WIHS study population, a large cohort of HIV-infected women in the U.S., to formulate specific hypotheses concerning HIV/AIDS pathogenesis in women. The WIHS cohort is followed in five large metropolitan areas (New York, Washington DC, Chicago, Los Angeles and San Francisco). 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 Program Announcement (PA), HIV PATHOGENESIS IN WOMEN"S INTERAGENCY HIV STUDY (WIHS), is related to the HIV focus area. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) research project grant (R01) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed four years. Applications submitted in response to Program Announcements are assigned according to established PHS referral guidelines. When the subject of an application is of interest to more than one component of NIH, dual assignments are made. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. A notice of modification and update (OD-00-046) regarding modular grants was released on 7/24/00 and can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-046.html. RESEARCH OBJECTIVES A. Background 1. HIV IN WOMEN HIV in women is increasing globally. Women constitute over 45% of the approximately 36 million people estimated to be living with AIDS worldwide in 2000 and 47% of the nearly 5 million adults who were newly infected with HIV during the year 2000. In the United States (U.S.), the epidemic began expanding among women in the late 1980s. As of June 2000, the Centers for Disease Control and Prevention (CDC) estimated that the cumulative number of AIDS cases in adults and adolescents women in the U.S. was 124,911 (approximately 17% of all AIDS cases)- with 10,469 AIDS cases reported in the 12- month period July 1999-June 2000. In the same 12-month period, 6,984 HIV infections were reported among adult and adolescent women. In this group, self-identified exposure categories included heterosexual contact with HIV-infected men (41%), injection drug use (20%), other/risk not reported (38%) and receipt of blood transfusions or blood components (1%). In addition, the impact of HIV/AIDS in the U.S. has been particularly severe in minority populations and, recently, among young people. In the 36 geographic areas with name-based HIV reporting, 78% of new HIV infections in women between July 1999 and June 2000 occurred among African American and Hispanic women. Among men, these minorities represented 59% of new HIV infections. In the same 12-month period, young people aged 13 to 24 accounted for 16% of newly reported AIDS cases, evenly divided between women and men. Since the widespread introduction of highly active antiretroviral therapy, the death rate in persons with AIDS has decreased dramatically nationwide. As a result, among women 25 to 44 years old, AIDS has dropped from the third leading cause of death in 1995 to the fifth leading cause of death in 1998. However, the reduction in AIDS deaths among women has not been as marked as the death reduction among men. At the current stage of the HIV/AIDS epidemic, new paradigms have emerged that are likely to influence the direction of future research on HIV/AIDS. Marked gender differences may exist in HIV disease progression, response to antiretroviral therapy and complications of therapy. Differences in HIV pathogenesis may be the basis for gender specific differences in health outcomes. Women with HIV/AIDS suffer from a variety of conditions unique to women such as human papilloma virus abnormalities, vulvar and vaginal carcinomas and pelvic inflammatory disease. In addition, HIV-infected women have a higher prevalence of recurrent yeast infections, genital ulcer disease, and severe herpes infections than their male counterparts. Studies have demonstrated a wide variety of adverse conditions associated with antiretroviral therapy and these conditions affect many organ systems. Women infected with HIV may develop complications that are different from those in men. Since highly active antiretroviral therapy may extend HIV seropositive women’s lives, in depth studies are necessary to investigate the factors and mechanisms underlying the pathogenesis of HIV disease and the pathogenesis of such chronic toxicities. Studies of HIV/AIDS in women can play a unique role in testing new biological or socio-behavioral hypotheses at the population level and in linking basic science findings and laboratory methods to epidemiologically well-defined populations and communities. 2. WIHS The Women"s Interagency HIV Study (WIHS), a multicenter, prospective study, was established in 1993 to carry out comprehensive investigations of the impact of HIV infection in women. A total of 2,641 women (2066 HIV positive and 575 negative), 80% of minority background, were enrolled. In addition to NIAID, other NIH institutes currently fund different components of the WIHS. These Institutes include: the National Institute of Child Health and Human Development (NICHD), the National Institute on Drug Abuse (NIDA), the National Institute of Dental and Craniofacial Research (NIDCR), and the National Cancer Institute (NCI). The WIHS has interacted with the community from the outset, by soliciting the community"s input to better identify problems and to pursue research opportunities. Community involvement through the individual WIHS sites and the Community Advisory Board (CAB) continues to be encouraged to foster women"s participation and understanding of research scope and results. The WIHS was established to investigate the clinical, laboratory and psychosocial aspects of HIV infection in women, in a multi-site, prospective fashion. The WIHS is well positioned to contribute key information on many aspects of HIV infection and disease in women particularly in the era of combination antiretroviral therapy. Such aspects include the history of HIV treatment and its virologic and immunologic characteristics, gender differences in biologic markers of HIV, gynecologic manifestations, and socio-behavioral patterns. During the course of the study, progress in HIV/AIDS research will require flexibility in modifying goals and adjusting the infrastructure to reflect new knowledge and state-of-the-art methodology. Research in the WIHS is able to correspond to changes in HIV/AIDS research partly because clinical care and research activities for WIHS participants are carried out at the same health facilities. This allows for real-time clinical observation and laboratory testing of participants. The rapid implementation of new research protocols will be facilitated by close coordination between investigators proposing studies under this Program Announcement and the WIHS Executive Committee and Working Groups. B. Research Objective and Scope Applicants are invited to propose studies focused on basic mechanisms of HIV infection and disease in women. Applications in response to this Program Announcement may include expansion of ongoing studies and new studies. In addition, studies may involve all WIHS sites or may be limited to defined subsets of the WIHS population, when special requirements exist, such as the need for more frequent participant visits. Studies may address, in detail, biological aspects of HIV infection and how such aspects affect women"s health. Proposed studies should emphasize investigations predicated upon specific hypotheses. Applications may focus on investigations in the specific areas of interest of the collaborating NIH Institutes, as outlined below. Important areas of investigation include, but are not limited to, the following subjects: NIAID: grant applications in the areas of molecular basis of HIV infection and disease progression in women in the antiretroviral era, including the interplay of host and viral characteristics, characterization of HIV in cervico-vaginal mucosa and its relationship with HIV in blood, HIV virologic and immunologic factors and their relationship with endocrinologic factors in HIV infected women, characterization of viral reservoirs and their role in HIV-infected, antiretroviral-treated women. NICHD: grant applications in the areas of endocrinologic factors (including both endogenous and common exogenous hormonal exposures), HIV expression, and disease progression, interactions between pregnancy and HIV infection, and fertility-related behaviors among HIV- seropositive women. NIDA: grant applications investigating direct and indirect effects of drug use and associated infectious co- morbidities, such as chronic hepatitis C, metabolic complications such as wasting, lipid and glucose disorders, the impact of drug use, HIV and HIV therapies on peri- and post- menopausal co-morbidities and biological markers, drug-drug interactions and hepatotoxic effects of pharmacotherapies, viral strain variation in association with ongoing drug injection and development of viral resistance to anti-retroviral therapy. NIDCR: grant applications investigating the in vivo role and mechanism of action of oral antiviral factors (salivary and mucosal), the influence of oral co-infections on HIV infection and disease pathogenesis, the role of the oral pharyngeal region as a reservoir of HIV infection, oral diagnostics and therapeutics, the role of host response in candida infections, and characterization of salivary molecules exhibiting anti-candida activities. NIDDK: grant applications to elucidate the pathogenesis of lipodystrophy (lipoatrophy and lipohypertrophy) in HIV patients, studies of abnormalities of insulin sensitivity, glucose homeostasis, lipoproteins, and other components of the "Metabolic Syndrome" or "Syndrome X" in patients with HIV, studies of the AIDS wasting syndrome (AWS), including the effects of HIV on endocrine and gastrointestinal function, metabolism, appetite and diet, physical activity, and body composition, studies of the pathogenesis and natural history of endocrine, gastrointestinal and renal dysfunction in HIV-positive women, including mechanisms of hepatic and renal toxicity. NINDS: grant applications investigating the pathogenesis of central and peripheral nervous system abnormalities caused directly or indirectly by HIV infection in HIV-positive women. Such research could include the role of genetic factors, immune status, and hormonal function in women at risk for AIDS-related neurological disorders. NCCAM: grant applications to investigate the use of complementary and alternative medicine (CAM) therapies among women in the cohort, with attention to comparisons between women using and not using a specific CAM modality. Applications to evaluate the effect of CAM on disease markers, symptoms, progression, and sequelae, the influence of CAM on medication side effects, and clinical outcomes will be considered. ORWH: ORWH will be providing partial funding to selected grants awarded by the Institutes identified above, contingent upon the availability of funds. Grant applications investigating the racial/ethnic differences during early HIV infection and HIV disease progression. Two areas of particular interest are differences in high-risk behaviors (sexual or drug-related) and racial/ethnic differences during early HIV infection and HIV disease progression across a woman’s life span. In addition to addressing the aspects described above in the main study population (approximately 2000 HIV seropositive women), focused studies may be conducted in the approximately 500 HIV seronegative women who are currently under active follow-up. These HIV negative women represent a critical control population for research in areas such metabolic changes under highly active antiretroviral therapy and aging. C. Research Structure BIOLOGICAL SPECIMENS Scientific questions addressed by studies submitted under this Program Announcement may utilize biological specimens already collected and banked or specimens to be collected prospectively. Stringent monitoring of specimen utilization will occur throughout the study duration to permit specimen use by a broad number of investigators. Use of WIHS specimens will be restricted to the use stated in the grant. To address any peer-review concerns regarding specimen access, applicants are advised to provide a letter of support with their application from the WIHS Executive Committee demonstrating the establishment of a collaboration with the WIHS investigators. Inquiries on this matter should be directed to the Program staff of the participating NIH Institutes. 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, compelling rationale, and justification are provided 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 research involving human subjects should read the UPDATED "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines are available at: http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate to NIH-defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. NIH POLICY AND GUIDELINES ON THE 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 are scientific and ethical reasons not to include them. This policy 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 which is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may provide additional relevant information concerning the policy. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits 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 301/710-0267, email: GrantsInfo@nih.gov. In addition, the application kits can be found on the following URL: http://grants.nih.gov/grants/forms.htm. Applicants planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement, 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 the Institute or Center (IC) program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the IC staff that the IC 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 or Center 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 such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-030.html SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative(F&A)costs] for the initial budget period Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET NARRATIVE JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. Under Personnel, provide budget narrative for ALL personnel by position, role and level of effort. This includes consultants and any to be appointed positions. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/ organizations with whom consortium or contractual arrangements have been made, the percent effort of all personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include a Letter of Commitment or Intent if there is or is to be a subcontract/ consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, including consultants, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page - List position(s) and any honors - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years - List selected peer-reviewed publications, with full citations o CHECKLIST - This page should be completed and submitted with the application. Applicant institutions should calculate the Facilities and Administration (F&A) costs using the current negotiated F&A rate, less exclusions, for the initial budget period and all future budget periods. It is not necessary to list the exclusions on the Checklist nor anywhere in the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. Applications not received as a single package on the receipt date or not conforming to the instructions, including page limitations and font size, contained in PHS 398 Application Kit (rev. 4/98) (as modified in, and superseded by, the special instructions below, for the purposes of this PA), will be judged non-responsive and will be returned to the applicant. Effective for the receipt dates beginning September 1, 2000, applications not in compliance with the modular application instructions will be returned to the applicant institution by the Center for Scientific Review (CSR). Applications revised and resubmitted to NIH in a timely manner may remain in the intended review cycle. (See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-046.html) The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the checklist, and five 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 (Use BETHESDA, MD 20817 for express/courier delivery) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established NIH referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will be evaluated as well. o The reasonableness of the proposed budget and duration in relation to the proposed research o The adequacy of the proposed protection for humans or the environment, to the extent they may be adversely affected by the project proposed in the application. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: NIAID: Paolo Miotti, M.D., M.P.H. Telephone: (301) 496-9176 FAX: (301) 402-3211 E-mail: pm122m@nih.gov NICHD: Heather Watts, M.D. Telephone: (301) 496-7339 FAX: (301) 496-8678 E-mail: hw59i@nih.gov NIDA: Henry Francis, M.D. Telephone: (301) 443-2146 FAX: (301) 443-4100 E-mail: hf23n@nih.gov NIDCR: Maryann Redford, D.D.S., M.P.H. Telephone: (301) 544-5588 FAX: (301) 480-8254 E-mail: mr48a@nih.gov NIDDK: Barbara Linder, M.D., Ph.D. Telephone: (301) 594-0021 FAX: (301) 480-3503 E-mail: linderb@extra.niddk.nih.gov NINDS: A.P. Kerza-Kwiatecki, PhD. Telephone: (301) 496-1431 FAX: (301) 402-2060 E-mail: ak45w@nih.gov NCCAM: Morgan N. Jackson, M.D., M.P.H. Telephone: (301) 402-1278 FAX: (301) 480-3621 E-mail: mj145m@nih.gov ORWH: Lisa Begg, Dr.P.H. Telephone: (301) 402-1770 FAX: (301) 402-1798 E-mail: beggl@od.nih.gov Direct inquiries regarding fiscal matters to: Ms. Theresa Mercogliano Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6700-B Rockledge Drive, Room 2261 Bethesda, MD 20892 (use Bethesda, MD 20817 for express/courier delivery) Telephone: (301) 402-5512 FAX: (301) 480-3780 E-mail: tm47o@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.856. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 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 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, and 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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