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AIDS INTERNATIONAL TRAINING AND RESEARCH PROGRAM Release Date: December 14, 1999 RFA: TW-00-003 Fogarty International Center Letter of Intent Receipt Date: January 21, 2000 Application Receipt Date: February 25, 2000 PURPOSE The Fogarty International Center (FIC), National Institutes of Health (NIH), invites applications from non-profit private or public U.S. institutions with interest in working with foreign colleagues to build global HIV/AIDS and related tuberculosis (TB) research capacity to prevent HIV transmission and TB. This RFA describes the process by which new and competing renewal applicants can apply for funding under the AIDS International Training and Research Program (AITRP) and also describes opportunities listed on the AITRP website for existing programs to apply for competing supplements for geographic and programmatic expansions. AITRP supports HIV/AIDS and related TB international training and research for foreign health scientists, clinicians, and allied health workers from developing countries and emerging democracies. Countries in Central and Eastern Europe and the former Soviet Union are eligible to participate, as are countries in Africa, the Americas, Asia and the Pacific Region. Under AITRP, scientists are trained to address the global HIV/AIDS and related TB epidemic through research. AITRP helps to: (1) establish critical biomedical and behavioral science expertise in developing countries affected by HIV/AIDS and TB; (2) facilitate new prevention research efforts which supplement or complement NIH and other U.S. AIDS and TB research; (3) establish long-term cooperative relationships between U.S. and foreign research groups; and (4) support cooperation between U.S. academic research centers and foreign scientists. Applicants are strongly encouraged to relate training to ongoing prevention research efforts in developing countries and emerging democracies supported by NIH and other organizations. In October 1996, the FIC convened a panel of scientists to conduct a comprehensive review of AITRP (final report at FIC AITRP website (http://www.nih.gov/fic/opportunities/aitrp/aitrp.html). Based upon that review, the FIC adopted the following mission and goal statement for the program: “The mission of the AITRP is to train international health professionals in research on prevention of HIV infection.” The interpretation of this mission statement is broad and encompasses not only prevention of HIV transmission and infection, but also prevention of progression of HIV infection to AIDS. This RFA reflects most recommendations of the panel and also supports the NIH efforts to develop a coordinated and comprehensive Prevention Science Agenda that includes and combines biomedical, behavioral, and social interventions. It refocuses AITRP from an emphasis on epidemiology to prevention research involving multiple biomedical and behavioral science disciplines. Applicants are strongly encouraged to propose multidisciplinary training in one or more areas in each of these two broad fields, in addition to a core component of data management and analysis. Programs should ensure that trainees receive a range of experiences in biomedical and behavioral activities such that taken together, they would likely lead to a sustainable research and public health capacity to prevent HIV transmission. The AITRP website contains additional information of interest to applicants: o Opportunities for existing AITRP programs to propose competing supplements under expanded activities; o Future areas of program interest, subject to availability of funds; and o Answers to frequently asked questions. The FY 2001 NIH Plan for HIV-Related Research, available at http://www.nih.gov/od/oar/updates/updates.htm, describes overall NIH HIV research priorities. Applicants are encouraged to review and consider these documents in preparing their applications. Research and public health capacity is built in large part through individuals participating in the research process and, therefore, AITRP programs are strongly encouraged to link training with NIH-supported and other research programs. Training and research should mutually reinforce each other. AITRP is not expected to necessarily be active in all countries with significant HIV or TB incidence or prevalence. Rather, the demonstrated capacity and/or potential to achieve sustained research and training efforts within a country will be the priority. The emphasis in AITRP will be depth, not breadth; programs that focus on a relatively few sites or countries would likely have a greater impact than those that dilute their resources across many countries. Given the interrelationship between the occurrence of HIV and TB and the high mortality rate in persons infected by both HIV and TB, including multiple drug resistant TB, up to 50 percent of requested funds for new awards can be for tuberculosis provided that the proposed program is linked to a current or expected future epidemic of HIV/AIDS. An applicant whose primary capabilities are in the area of TB can collaborate with another FIC AITRP working in the same country to provide the necessary expertise related to HIV/AIDS. Applicants are strongly encouraged to develop TB training and capacity building in collaboration with or in support of projects funded by the National Institute of Allergy and Infectious Diseases (NIAID), Centers for Disease Control and Prevention (CDC), United States Agency for International Development (USAID), and the International Union Against Tuberculosis and Lung Disease (IUATLD). 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 Request for Applications, AIDS International Training and Research Program (AITRP), is related to the priority area of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000. ELIGIBILITY REQUIREMENTS The grantee institution must be a U.S. nonprofit private or public institution capable of meeting the objectives in this RFA. Only one D43 application will be allowed under this program from each U.S. institution. Institutions that currently hold an award are not eligible to submit a second application. Institutions currently awarded an NIH Centers for AIDS Research (CFAR) program but which do not currently hold an AITRP award are encouraged to apply. Applicants are also encouraged to collaborate with CFAR programs at other institutions and thereby take advantages of the CFAR expertise in the basic and the clinical sciences. Collaboration with CFAR programs is expected to be on a cost sharing basis. For example, in one joint program, AITRP could support training of foreign scientists in the United States and in their home country and the CFAR could support other costs in the United States and support of U.S. scientists at the foreign institution, including support for U.S. postdoctoral scientists to receive international research career development opportunities. Within allowable limits, and with some cost sharing, research and training collaborations can include other industrialized nations in addition to the United States when the purpose of that collaboration is to facilitate and/or support activities in a common developing country or emerging democracy. MECHANISM OF SUPPORT Grants will be made as D43 awards for a total project period of five years. Supplements to existing AITRP grants are limited to the time remaining on the existing award. Continued support during this period depends on satisfactory performance as judged by annual progress reports; site visits and meetings of program directors; indicators such as career progress of trainees (e.g., positions occupied, first author publications, presentations, research undertaken and research awards received); and impact on developing country capacity for research and prevention. FUNDS AVAILABLE (New Starts and Competing Renewals) The FIC intends to commit approximately $2,500,000 (total costs), availability of funds permitting, to fund an estimated 6-7 new starts or competing renewal awards (including recompeting TB supplements linked to competing renewals), depending upon the quality of recommended applications. The total (direct and Facilities and Administrative [F&A;]) cost per grant for the first year of recompeting programs must not exceed $500,000 (and $625,000 including a recompeting TB supplement). First year total costs for new programs must not exceed $300,000. FUNDS AVAILABLE (Competing Supplements) Existing programs (not including competing renewals) may request funds for competing supplements for expanded activities as described in more detail at the AITRP website. Approximately $1,250,000 is designated for this purpose, availability of funds permitting, to support an estimated 20 competing supplements. Competing supplement requests in aggregate cannot exceed $300,000 (total costs). Although new and competing renewal applicants are not permitted to apply for supplemental funds, they are encouraged to address the types of activities described under "Expanded Activities" as part of their proposals. RESEARCH OBJECTIVES The primary goal of this program is to build research capacity. This program is intended to complement ongoing HIV/AIDS and TB research efforts of the NIH and, to the extent possible, of other government, non-government and international organizations. A strong research infrastructure results in a good training experience. Programs are thus encouraged to develop human resources in those developing and other participating countries that currently are or are likely to be sites of HIV/AIDS-related research on HIV and/or TB vaccines, anti-HIV and TB drugs, and other HIV and TB interventions. Training Plan Emphasis should be given to U.S.-based, long-term (usually a minimum of two years) training either leading to an advanced degree or to provide postdoctoral training. Long-term training could include degrees in any relevant HIV prevention or TB research field. This RFA will allow short-term training targeted toward specific needs such as learning laboratory techniques required to conduct a research study or designing behavioral interventions and initial activities to establish relationships in countries where none currently exist. Types of Training 1. Training in biomedical and behavioral HIV/AIDS-related prevention and related TB research disciplines as well as data management and analysis in support of that research which may lead to a M.S. or Ph.D. degree for individuals with previous research experience. Duration of training is estimated from about two to four years. Academic courses will be taken in the United States. Research could be conducted in the United States, but is encouraged to take place in the trainees’ home country. 2. Training (generally two years in duration) in biomedical and behavioral HIV/AIDS-related prevention and related TB research disciplines, which may lead to a M.S. degree for individuals without prior research experience. Academic courses will be taken in the United States; research would ordinarily be conducted in the trainees' home country. 3. Postdoctoral research experiences (generally two years in duration) for foreign health scientists (in the United States) and for U.S. health scientists overseas. 4. Training (approximately three to six months in duration) conducted in the United States in laboratory procedures and research techniques in support of specific HIV/AIDS prevention and related TB research (for example, development of pilot biomedical and behavioral studies); for individuals with M.S. and Ph.D. degrees. 5. In-country, practical and applied short-term training (up to three weeks) in support of HIV/AIDS prevention and related TB research for professionals, technicians and allied health professionals, including training to support local participation in institutional review boards (research ethics committees), data and safety monitoring boards and community advisory boards. 6. Advanced research training (approximately one to two years in duration) for current and/or former trainees, including re-entry grants for in-country prevention research projects such as interventions to prevent the further spread of HIV/AIDS and to prevent and treat TB. 7. Support to enable U.S. faculty to be involved in advanced research training activities conducted in-country. 8. Support to enable new and minority U.S. health science students (including medical students and residents) to receive overseas health research experiences (generally of three to twelve months duration). Trainees Trainees shall be individuals involved in or expected to be involved in HIV/AIDS prevention and related TB research activities upon completion of training in their home country. The following categories of individuals are eligible for training: 1. Foreign health professionals (M.D., D.D.S./D.M.D., Ph.D., or equivalent); 2. Foreign professionals with a bachelors or masters degree in a basic or health science; 3. Medical technicians and health care workers; 4. Allied health professionals such as behavioral scientists, nurses, nurse midwives and social workers; 5. Current or former AITRP trainees involved in advanced research training in their home countries; and 6. U.S. health science students, medical residents and postdoctoral researchers (participating in collaborative research and research training with foreign colleagues). Programs are strongly encouraged to give special emphasis in selecting foreign trainees to include women and to ensure adequate representation of women and minorities in selecting U.S. trainees under this program. SPECIAL REQUIREMENTS Applicants are required to include training in responsible conduct of research as a part of the program. An award will not be made unless a description of such training is included. Before any funds can be expended for in-country activities, the grantee institution must show evidence of approval for collaborative research between the United States and foreign countries and institutions through an endorsement from the Minister of Health or other appropriate government officials as well as from the collaborating institutions. Recompeting programs are expected to update their prior agreements. Applicants must include a plan describing recruitment and selection procedures for trainees, for the peer review of training-related and advanced in-country research (re-entry grants) as well as plans for continued collaboration with former trainees. AITRP grant applications should clarify and completely specify: (a) criteria and procedures for the selection of trainees as, for example, by a committee composed of U.S. and foreign investigators at participating institution(s); and (b) a mechanism for internal peer review of applications to support in- country research projects with budgets generally not exceeding $25,000. As part of their obligations under this program, awardees are required to design and implement a system to fully track and document the long- term impact of this training program on: (1) careers of current and former trainees including whether or not they returned to their home country (and to what position) after completion of training; (2) research capacity in the home countries of trainees; (3) contributions to future NIH-supported international HIV/AIDS and related TB research efforts; and (4) impact on prevention activities in the home countries of trainees. Examples include how training allowed participants to assume more responsible positions upon returning home, how training resulted in funding of collaborative research projects for which trainees were either Principal or co-Principal Investigators, and publications in which trainees were first authors and which were supported by this program. This tracking system, to follow former trainees at least ten years, should be described in the application. Programs are strongly encouraged to collaborate with other AITRP and non-AITRP programs when working in common countries and/or regions. Programs are also encouraged to provide training and research capacity building in support of in-country projects funded by NIAID, NICHD, NCI, NIDCR, NIDA and NIMH. Collaboration also is strongly encouraged with international organizations and NGOs [e.g. Joint United Nations Programme on AIDS (UNAIDS), the Pan American Health Organization (PAHO), the Rockefeller INCLEN program, and the International Union Against Tuberculosis and Lung Disease (IUATLD). Communication FIC AITRP programs should endeavor to ensure that research results are accessible and to facilitate translation of results into clinical and public health practice by: (a) sponsoring in-country meetings for all trainees in a country; and (b) establishing a World Wide Web site for dissemination of new information and for less formal exchange of information among sites. In addition, grantees are encouraged to develop mechanisms to enhance medical informatics capability including enhancing access of their foreign collaborators to current published literature. Protection of Human Subjects and Laboratory Animals Applicable provisions for the protection of human research subjects and laboratory animals in research and training activities must be met in both domestic and foreign settings. Title 45 CFR, Part 46, provides guidelines concerning Department of Health and Human Services regulations for the protection of human subjects. The requirements for using animals are detailed in the Public Health Service Policy on Humane Care and Use of Laboratory Animals. These are available from the Office for Protection from Research Risks (OPRR), National Institutes of Health, 6100 Executive Boulevard, MSC 7508, Rockville, Maryland 20852- 7508. Applicants must be sure to meet the requirements of obtaining single project assurances from OPRR for all projects involving human subjects at foreign sites unless otherwise covered by a multiple project assurance. Applicants must also be sure to obtain the necessary assurances including review at both U.S. and foreign sites for research in which they are actively engaged by virtue of consultancy (for example, resulting in co-authorship) or for research conducted on biological samples obtained from scientific colleagues in collaborating countries, if the samples are individually identifiable to any of the scientists. 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 subpopulations 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. 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 was 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 available on the web at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. 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 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. LETTER OF INTENT Prospective applicants for new, competing renewal or supplemental funding are asked to submit, by January 21, 2000, a letter of intent that includes a descriptive title of the proposed training and research programs; the name, address, and telephone number of the Principal Investigator; identities of other key personnel and participating institutions in collaborating countries; and the number and title of the RFA to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, this information allows NIH staff to estimate potential review workload and avoid conflict of interest in the review. The Letter of Intent should be submitted to Dr. Kenneth Bridbord listed at the address below under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the standard research grant application form PHS 398 (rev. 4/98), using the instructions and forms for Institutional National Research Service Awards. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, email: grantsinfo@nih.gov For purposes of identification and processing, item two on the face page of the application must be marked "YES" and the RFA number "TW-00-003" and words "AIDS International Training and Research Program” must be entered on the face page. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. The RFA number "TW-00-003" should be added to 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. The sample RFA label is 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 and five copies of any appendices must be sent to Dr. Hortencia Hornbeak listed in Inquires below. Applications must be received (not postmarked) by February 25, 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 any application that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude 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 by CSR for completeness and by FIC and NIAID for responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, the application will be returned without review. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by a peer review group, convened by NIAID, in accordance with the review criteria stated below. As part of the initial merit review, a process will be used by the initial review group in which applications 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 the applications under review, will be discussed, assigned a priority score, and receive a second level review by the FIC Advisory Board. Review Criteria The following criteria apply to new and competing renewal applications. Criteria for the review of competing supplements are described in the AITRP website under Expanded Activities. Factors to be considered in the scientific evaluation of each application include: In general, the success of the programs to date (for competing renewals) and/or the likelihood that the applicant institution can meet and sustain the goals and objectives stated in this RFA and specifically considering the following: (1) Significance o The demonstrated capacity to achieve the expected public health and scientific contributions of the proposed activity; o The demonstrated capacity and/or potential to achieve sustained research and training efforts within a country; o Adequacy of the academic program; and o Demonstrated previous success in training AIDS and TB-related scientists and in maintaining collaboration with former trainees including assisting former trainees in obtaining support for their research upon return to their home countries. (2) Approach o Adequate balance in the proposed training program to provide breadth of training opportunities in the fields of 1) biomedical and clinical prevention research; 2) social and behavioral research; and 3) data management and analysis; o Adequacy of the mix of long- and short-term training to achieve the goals of this RFA; o Adequacy of opportunities for trainees to become involved in research projects conducted in their home countries; o Adequacy of proposed procedures and criteria for 1) recruitment, review and selection of trainees and 2) peer review of research projects; o Demonstrated capacity and/or potential to collaborate with other institutions and to coordinate program activities with related efforts of other FIC and NIH programs, other federal agencies (e.g., CDC and USAID), international organizations (e.g., UNAIDS and PAHO), and NGOs [e.g., the International Union Against Tuberculosis and Lung Disease (IUATLD), and the Rockefeller INCLEN program]; o Demonstrated capacity and/or potential to provide overseas research experience for U.S. health science students and medical residents, including new and minority U.S. health scientists from AITRP and non- AITRP institutions, such as HBCUs, Minority International Research and Training Programs as well as plans to include an adequate representation of women among foreign and U.S. trainees; and o Adequacy of the proposed systems for documenting the long-term impact of the program on research and public health capacity in the home countries of trainees including the impact of the program on the careers of current and former AITRP trainees. (3) Innovation o Demonstrated overall creativity of the training and research plan; o Adequacy of plans for trainees to become involved in research projects conducted in their home countries; and o Adequacy and creativity of plans to use modern information technology to facilitate access to scientific information, distance learning, data management and analysis, as well as coordination and research collaboration. (4) Investigator(s) o Adequacy of qualifications of the program director to lead and the named faculty to participate in the proposed training and research program; o Demonstration of previous international collaboration with scientists from developing countries and emerging democracies and institutions included in the proposed program; o Adequacy of the program director’s and faculty’s experience in the fields of 1) prevention; 2) biomedical, social and behavioral research; and 3) data management and analysis; o Adequacy of research support of program director and participating faculty; and o Demonstration of career accomplishments of former trainees including extent of former trainees’ involvement in the proposed program. (5) Environment o Demonstration of continued or of future support for the program from governments and institutions and other non-governmental organizations from collaborating countries; o Demonstrated support for domestic and international AIDS and TB- related research and training as evidenced by support from the NIH or other sources. Examples include research support by NIAID, NICHD, NCI, NIDCR, NIDA and NIMH; o Adequacy of resources and training environment in-country as evidenced by 1) the quality of teaching and research facilities and other resources in-country; 2) the availability of high-quality candidates; and 3) past history of success in former trainees' returning to their home countries and their continued involvement in the program, for example, in advanced in-country research, as research collaborators with U.S. scientific colleagues and/or as faculty and mentors for new trainees; and o Adequacy of training environment in the United States including the institutional commitment, the caliber of preceptors, the quality of teaching and research facilities and resources. The initial review group will also examine the adequacy of the process for providing for protection of human and animal subjects and the safety of the research environment, as well as plans to include training in responsible conduct of research and training in the operations of IRBs, data and safety monitoring boards and community advisory boards. IRBs in the home countries of trainees will be responsible for determining adequacy of inclusion of women, children and minorities in research involving human subjects in their countries. Allowable Costs o Details concerning allowable costs are described within the AITRP website (http://www.nih.gov/fic/opportunities/aitrp/aitrp.html). Expanded Activities o Areas of interest for expanded activities (both geographic and programmatic) are described in detail on the AITRP website (http://www.nih.gov/fic/opportunities/aitrp/aitrp.html). Schedule Letter of Intent Receipt Date: January 21, 2000 Application Receipt Date: February 25, 2000 Review for Scientific Merit: June, 2000 Review by the FIC Advisory Board: September, 2000 Anticipated Award (Start) Date: September 29, 2000 AWARD CRITERIA The following will be considered in making funding decisions for new and competing renewal applications and supplemental proposals (as indicated): o quality of the proposed project as determined by peer review; o the extent and effectiveness of efforts made by applicants in developing multidisciplinary biomedical and behavioral research training programs necessary to support prevention research efforts in the home countries of trainees; o efforts made to collaborate with other AITRP and FIC/NIH programs and institutions and with other organizations; o the extent to which proposed training programs generally support and complement other NIH-funded international HIV research efforts (and specific NIH-funded research projects for competing supplements); o program balance among critical research training areas of emphasis such as, but not limited to, preparation for future prevention and related research efforts including trials of HIV vaccines, anti-HIV drugs, anti-TB drugs and other interventions (e.g., microbicides, behavioral interventions, nutritional supplementation, prevention of mother-to-child HIV transmission); o geographic distribution among countries included in applications under consideration, including the need for a given program to work in a specific country (such as linkage with another NIH-supported research project in that country); and o For competing supplements: Overall program priority and relevance for those proposals. The anticipated date of award is September 29, 2000. INQUIRIES Prospective applicants are strongly encouraged to discuss their applications, including proposed collaborating countries and institutions with FIC program staff (see below) before submitting formal applications. All programmatic and scientific inquiries should be directed to: Kenneth Bridbord, M.D. Director Division of International Training and Research Fogarty International Center National Institutes of Health Building 31, Room B2C39 31 Center Dr MSC 2220 Bethesda, MD 20892-2220 Phone: (301) 496-2516 FAX: (301) 402-2056 Email: bridbord@nih.gov Inquiries related to the review of these applications may be directed to: Hortencia Hornbeak, Ph.D. Associate Director for Scientific Review and Policy NIH/NIAID/DEA/SRP National Institutes of Health 6700-B Rockledge Dr, MSC 7616 Bethesda, MD 20892-7616 Telephone: (301) 496-2550 FAX: (301) 402-2638 Email: hh7g@nih.gov Inquiries regarding fiscal matters may be addressed to: Mrs. Silvia Mandes Grants Management Officer Division of International Training and Research Fogarty International Center National Institutes of Health Building 31, Room B2C39 31 Center Dr MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1653 FAX: (301) 402-0779 E-mail: Silvia_Mandes@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.154. 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 PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 79. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or to Health Systems Agency review. The Public Health Service 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, 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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