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MALARIA VACCINE DEVELOPMENT: UNDERSTANDING MALARIAL ANEMIA Release Date: January 30, 2001 RFA: RFA-AI-01-007 National Institute of Allergy and Infectious Diseases (http://www.niaid.nih.gov/default.htm) Letter of Intent Receipt Date: April 20, 2001 Application Receipt Date: May 22, 2001 THIS RFA 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 RFA. PURPOSE The Division of Microbiology and Infectious Diseases of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, invites applications for research grants to support multidisciplinary research in the areas such as tropical medicine, hematology, immunology, and genetics relevant to understanding the pathogenesis of severe malarial anemia. Studies should be designed to elucidate the mechanisms underlying severe malarial anemia in individuals who are naturally exposed to infection, and/or to clarify the pathophysiology of malarial anemia reported in non-human primates following immunization and challenge infection. Clinical studies will be expected to incorporate substantial research at institutions located in areas where malaria is endemic. Applications proposing studies to be conducted in murine malaria models will not be considered responsive to this Request For Applications (RFA)unless they are logically coupled to clinical studies or studies in non-human primates, with the clinical and/or primate studies comprising the major component of the application. To enhance capability strengthening for malaria research, NIAID and the Fogarty International Center (FIC) have frequently integrated research and training programs for foreign investigators. FIC plans to release a Request for Applications for a training program on malarial anemia complementary to this NIAID RFA for research projects on this subject. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS led national activity for setting priority areas. This RFA, "Malaria Vaccine Development: Understanding Malarial Anemia" is related to one or more of the focus areas. 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 institutions, 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 The mechanism of support will be the individual research project grant (R01). The total requested project period for an application submitted in response to this RFA may not exceed four years. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. This RFA is a one-time solicitation. Future competing renewal applications will compete with all investigator-initiated applications and will be reviewed according to customary referral and review procedures. 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 (NOT-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. FUNDS AVAILABLE The estimated total funds (direct and facilities and administrative (F&A) costs) available for the first year of support for all awards made under this RFA will be $1,000,000. In fiscal year 2002 the NIAID plans to fund approximately 3 to 4 awards. The usual NIH policies governing grants administration and management will apply. Although this program is provided for in the financial plans of the NIAID, awards pursuant to this RFA are contingent upon the availability of funds for this purpose and the receipt of a sufficient number of applications of high scientific merit. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. RESEARCH OBJECTIVES Background Malaria is an infectious disease caused by protozoan parasites of Plasmodium spp. (primarily P. falciparum and P. vivax). Malaria claims an estimated 1 to 3 million lives annually, and accounts for untold morbidity in the approximately 300 to 500 million people infected annually. It is becoming increasingly recognized that severe anemia contributes substantially to malaria-related mortality, especially in young children living in endemic regions. In P. falciparum malaria, anemia may develop acutely or chronically, and may range from mild to severe. In the case of life-threatening anemia, a feature of severe and complicated malaria, the only effective treatment currently available is blood transfusion, which carries risks for transmission of other blood-borne pathogens. According to the World Health Organization (Management of Severe Malaria, 2nd edition), need for blood transfusion should be considered in malaria positive patients if the packed cell volume falls below 20% or hemoglobin concentration falls below 7g/dl. Children meeting these criteria would be considered high-risk if accompanied by respiratory distress, impaired consciousness, or hyperparasitemia, or if the packed cell volume reaches 12% or hemoglobin concentration reaches 4g/dl. Severe malarial anemia is multifactorial, involving increased erythrocyte destruction as well as decreased erythrocyte production. Factors reported to contribute to severe anemia include hemolysis of uninfected as well as parasitized red cells, erythrophagocytosis, bone marrow suppression, ineffective erythropoiesis and dyserythropoiesis, inadequate erythropoietin production, and concomitant infections. The mechanisms underlying severe malaria anemia are poorly understood, apparently involving humoral (e.g. antibody and/or complement) as well as cellular (e.g. cytokine) immune responses. The immunologic basis of severe malarial anemia is of particular interest to NIAID because of its potential relevance to malaria vaccine development (see NIAID"s malaria vaccine research activities at http://www.niaid.nih.gov/dmid/malaria/). Recent observations of severe anemia developing in non-human primates (Aotus) following vaccination with blood-stage antigens and challenge infection, or after repeated P. falciparum infection and drug cure, suggest that improved understanding of the pathogenesis of severe malarial anemia will be an important factor in the development of safe and effective vaccines. Research Objectives and Scope This RFA seeks to support multidisciplinary research, in areas such as tropical medicine, immunology, hematology, and genetics, to increase our understanding of the pathogenesis of severe malarial anemia, which will contribute to the development of safe and effective vaccines or other interventions to reduce morbidity and mortality due to malaria. Responsive applications will focus on clinical research involving naturally infected individuals living in malaria endemic regions and/or preclinical research in non-human primate models of malaria. Applications proposing studies to be conducted in murine malaria models will not be considered responsive to this RFA unless they are logically coupled to clinical studies or studies in non-human primates, as by exploration of a common hypothesis, with the clinical and/or primate studies comprising the major component of the application. Applications for clinical studies will be expected to include substantial involvement of institutions and investigators from malaria-endemic areas. Applications in response to this RFA will focus on severe, not mild or moderate, anemia. The definition of severe malarial anemia is not universally agreed upon (see Parasitology Today 16:469, 2000). For purposes of this RFA, severe malarial anemia will be clinically defined as hemoglobin < 7g/dl or packed cell volume < 20%, in the presence of malarial parasitemia of any density. Within the constraint of this overall guideline, applicants may choose to apply stricter criteria in the context of the particular region or population in which the research will be conducted. Applications for research in non-human primates should refer to recent vaccination studies in Aotus monkeys, where hematocrit readings less than 50% of the pre-trial level have been considered life threatening. Research proposals submitted in response to this RFA must demonstrate that they are relevant to one or more of the following objectives: o Characterization of the pathogenesis of severe malarial anemia in individuals (especially children) living in malaria endemic regions, particularly regarding the role of cytokines or other immunoregulators, antibody and complement o Elucidation of the risk factors associated with development of severe malarial anemia, particularly with regard to the roles of microbial co-infection and genetic predisposition o Determination of whether prevention of severe anemia would serve as a useful clinical endpoint for vaccine efficacy in future malaria vaccine trials o Characterization of the pathophysiology of severe anemia occurring in primate models of malaria following vaccination with malaria antigens and challenge infection or multiple reinfection and drug cure SPECIAL REQUIREMENTS Funds for travel of the Principal Investigator to one meeting in the Bethesda, MD, area should be included in the budgets for years two and four as part of the overall budget request. This meeting may occur in the context of the annual conference of NIAID"s International Centers for Tropical Disease Research (see http://www.niaid.nih.gov/ictdr/default.htm) or in conjunction with another meeting of NIAID-sponsored malaria research projects. Inclusion of funds for other key personnel to attend these meetings is at the discretion of the applicant. Sample clinical protocol(s) and consent form(s) must be submitted with the application for consideration by the Initial Review Group. Protocol documents should include, at minimum, the following sections: an introduction, including background and rationale, a statement of the study objectives, description of study design, criteria for selection of subjects and enrollment procedures, clinical and laboratory evaluations to be performed, statistical considerations, including general design issues, endpoints, sample size, accrual and power, and analysis plan, plans for data collection and management, and, plan for data and safety monitoring. TERMS AND CONDITIONS OF AWARD When clinical studies or trials are a component of the research proposed, NIAID policy requires that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. Terms and Conditions of Award will be included with awards. NIAID policy was announced in the NIH Guide on February 24, 2000 and is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-AI-00-003.html. The full policy, including terms and conditions of award, is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf Please note that NIAID approval of the clinical protocol is required prior to initiation of a study. Clinical protocols involving human subjects will be reviewed by NIAID for: scientific content, design, safety, feasibility, statistical and regulatory issues such as adverse experience reporting mechanisms and informed consent. 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 may obtain copies from these sources or from Dr. Stephanie James (listed in INQUIRIES below) who may also 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. LETTER OF INTENT Prospective applicants are asked to submit, by April 20, 2001, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator, and the number and title of this RFA. Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of a subsequent application, the information that it contains allows NIAID staff to estimate the potential review workload and to plan the review. The letter of intent is to be sent to Dr. Anna Ramsey-Ewing at the address listed under INQUIRIES. APPLICATION PROCEDURES Applicants are strongly encouraged to call NIAID program staff with any questions regarding the responsiveness of their proposed project to the goals of this RFA. 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: [email protected]. In addition, the application kits can be found on the following URL: http://grants.nih.gov/grants/forms.htm. 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. For purposes of this RFA, in order to accommodate the requirement for inclusion of clinical protocols (see SPECIAL REQUIREMENTS), the Research Plan section of the application may be expanded beyond the standard 25 page limitation, not to exceed 40 pages. For purposes of identification and processing, item 2a on the face page of the application must be marked "YES" and the RFA number "AI-01-007" and the words "MALARIA VACCINE DEVELOPMENT: UNDERSTANDING MALARIAL ANEMIA" must be entered on the face page. Applications must be received by May 22, 2001. 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 RFA), will be judged non-responsive and will be returned to the applicant. The RFA label and line 2 of the application should both indicate the RFA number. The RFA label must be affixed to the bottom of the face page. 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 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. If the application submitted in response to this RFA is substantially similar to a grant application already submitted to the NIH for review, but that has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application that is essentially identical to one that has already been reviewed cannot be submitted in response to this RFA. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Submit a signed, typewritten original of the application, including the checklist, and three signed, exact, single-sided 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 mail or courier service) At the time of submission, two additional exact copies of the grant application and all five sets of any appendix material must be sent to: Anna Ramsey-Ewing, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2103, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Telephone: (301) 496-8536 FAX: (301) 402-2638 E-Mail: [email protected] For express mail carriers use zip code 20817 Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. 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. An application will be considered NON-COMPLIANT if: 1. The requested direct cost budget is not in modules of $25,000 for all years of support for requests up to $250,000 per year. 2. A detailed itemized categorical budget is provided. 3. The Budget Narrative Justification page includes an itemized justification for one or more of the following: equipment, supplies, travel, other expenses, etc. but the number of modules requested in each year is the same, or the information is not intended to explain the request for a different number of modules in one or more years. 4. OTHER SUPPORT pages are supplied, in addition to or in the absence of the section in the Biographical Sketch identifying "Research Projects Ongoing or Completed During the Last Three Years." 5. The Biographical Sketch lists "Current and Pending Support" instead of or in addition to the required information. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC Program Director or Principal Investigator should be included with the application. REVIEW CONSIDERATIONS Review Considerations Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review and for responsiveness by NIAID staff. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NIAID in accordance with the review criteria stated below. 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 the applications under review, will be discussed, assigned a priority score, and receive a second level of review provided by the National Advisory Allergy and Infectious Diseases Council. Review Criteria The criteria to be used in the evaluation of grant applications are listed below. To put those criteria in context, the following information is contained in instructions to the peer reviewers. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques 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 by the reviewers 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 a major scientific impact and thus deserve a high 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? 6. Focus. Does the proposed research emphasize clinical research and/or research in non-human primates, and address one or more of the specific objectives described above in RESEARCH OBJECTIVES AND SCOPE? 7. International Collaboration. For applications from U.S. institutions involving clinical studies, does the proposed research incorporate plans for meaningful collaboration with institutions and investigators from malaria-endemic regions? The initial review group will also examine: the appropriateness of proposed project budget and duration, the adequacy of plans to include children and both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, the provisions for the protection of human and animal subjects, and the safety of the research environment. Schedule Letter of Intent Receipt Date: April 20, 2001 Application Receipt Date: May 22, 2001 Scientific Peer Review Date: October, 2001 Advisory Council Date: February, 2002 Earliest Anticipated Award date: April 1, 2002 AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, programmatic priorities, and the availability of funds. The earliest anticipated date of award is April 1, 2002. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic (research scope and eligibility) issues to: Dr. Stephanie James Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Room 3101, MSC-7630 6700-B Rockledge Drive Bethesda, MD 20892-7630 Telephone: (301) 496-2544 FAX: (301) 402-0659 E-Mail: [email protected] Direct inquiries regarding review issues, address the letter of intent to, and mail two copies of the application and all five sets of appendices to: Anna Ramsey-Ewing, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2103, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Telephone: (301) 496-8536 FAX: (301) 402-2638 E-Mail: [email protected] For express mail carriers use zip code 20817 Direct inquiries regarding fiscal matters to: Celeste Kerner Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2248, MSC-7614 6700-B Rockledge Drive Bethesda, MD 20892-7614 Telephone: (301) 402-6213 Fax: (301) 480-3780 E-mail: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance No. 93.8__(Use appropriate program number. NIAID citations are Sec. 93.856, Microbiology and Infectious Diseases Research, and No. 93.855 - Immunology, Allergy, and Transplantation Research.) 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 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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