RESPONSE TO THE PRESIDENTIAL VACCINE INITIATIVE - OVERCOMING THE TUBERCULOSIS LATENCY CHALLENGE Release Date: March 14, 2001 RFA: RFA-AI-01-009 National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov/) National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov) Letter of Intent Receipt Date: June 16, 2001 Application Receipt Date: July 16, 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. P01 GRANT APPLICATIONS IN RESPONSE TO THIS RFA MUST BE PREPARED USING A MULTI-PROJECT GRANT APPLICATION FORMAT; SPECIFIC INSTRUCTIONS FOR COMPLETING THE APPLICATION ARE IN THE NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS (August 2000) . PURPOSE The objective of this Request for Applications (RFA) is to stimulate investigator-initiated research to elucidate the mechanisms underlying persistent, asymptomatic infection (also referred to as latency ) with Mycobacterium tuberculosis. Of the 1.86 billion persons infected with M. tuberculosis worldwide, 90% harbor the bacterium but do not display symptoms. However, these latent infections may convert to active tuberculosis that renders patients infectious and capable of transmitting M. tuberculosis to others. The rate of conversion from latent to active tuberculosis depends on the immune status of the patients and may be as high as 10% per year in HIV co-infected persons, who constitute about 0.18% of the world population and 8% of all TB cases. The increased rate of conversion to active TB in HIV/TB co- infected persons also increases the potential for spread of tuberculosis and clearly contributes to the global threat from this disease. (The prevalence of HIV/TB co-infection is as high as 1194 cases per 100,000 individuals in some high burden countries.) In the US alone, it is estimated that 10-15 million people are infected with M. tuberculosis. A better understanding of persistent infection is an essential step toward developing improved intervention strategies to eliminate tuberculosis as a public health problem. 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 Request for Applications (RFA), Response to the Presidential Vaccine Initiative - Overcoming the Tuberculosis Latency Challenge , 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. Although foreign institutions are not eligible to apply for Program Project (P01) grants, they are permitted as subprojects. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA is being co-sponsored by NIAID and NHLBI. The mechanisms of support will be the individual research project grant (R01), Exploratory/Developmental Research Project Grant (R21) and the Program Project Grant (P01) for NIAID. NHLBI will support only R01 and R21 grant applications received in response to this RFA. The total requested project period for an application submitted in response to this RFA may not exceed five years for an R01, two years for an R21, and five years for a P01 grant. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. NIAID and NHLBI use R21 grants to provide short-duration support for preliminary studies of a highly speculative nature, which are expected to yield, within this time frame, sufficient information upon which to base a well-planned and rigorous series of further investigations. R21 applications in response to this RFA may not request more than $150,000 direct costs per year and the total requested project period may not exceed two years. P01 grant applications may be accepted by NIAID, but not by NHLBI in response to this RFA. The P01 grants are used to support broadly based multidisciplinary research programs that have a well-defined central research focus or objective. An important feature is that the interrelationships among the individual scientifically meritorious projects will result in a greater contribution to the overall program goals than if each project was pursued individually. The program project grant consists of a minimum of three interrelated individual research projects that contribute to the program objective. The award also can provide support for certain common resources termed cores. Such resources should be utilized by two or more projects within the award. A P01 application should be prepared using the guidance and instruction provided in the NIAID Information Brochure for Program Projects and Grants, available at: http://www.niaid.nih.gov/ncn/grants/multibron.htm. A P01 application in response to this RFA may not request more than $750,000 total costs without prior program staff approval (contact information listed in INQUIRIES section). 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. 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. FUNDS AVAILABLE The estimated total funds (direct and Facilities and Administrative (F&A) Costs) available for the first year, fiscal year 2002, of this RFA will be $1.5 million from NIAID and $0.5 million from NHLBI, a total of $2.0 million. In Fiscal Year 2002 the NIAID plans to fund approximately two to four grants and NHLBI plans to fund one to two grants (three to six grants total). The usual NIH policies governing grants administration and management will apply. Although this program is provided for in the financial plans of the NIAID and NHLBI, 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 As a response to the Presidential Millennium Vaccine Initiative, national and international agencies have committed to further development of TB, malaria and HIV vaccines. This RFA is part of the NIAID and NHLBI response to the vaccine initiative. Both NIAID and NHLBI intend to support research to increase our understanding of the biological mechanisms underlying human M. tuberculosis infection and host response. Persistent infection and reactivation of disease is an important, but poorly understood aspect of human TB. Understanding these aspects of TB is critical to developing new diagnostic tools and identifying potential new vaccine and/or therapeutic targets. The recent NIAID Workshop Addressing the Presidential Challenge , held May 22-23, 2000, identified the lack of appropriate animal models that accurately reflect human tuberculosis infection as a significant technical barrier to developing new or improved TB vaccines. The TB working group convened by NHLBI in September of 1999 and an NHLBI RFA grantees meeting in September of 2000 also emphasized the need for better animal models and more in vivo research to improve our understanding of host-mycobacterial interactions and the pathogenesis of tuberculosis, both for latency and reactivation. This type of research is an important aspect of vaccine development and testing. New and improved animal models not only would be instrumental in the early evaluation of vaccine and drug candidates before efficacy studies in humans are undertaken, but also would allow further characterization of latent mycobacterial infection in a nonhuman host. Previous attempts by NIAID and NHLBI to stimulate interest and opportunities in this research area have not been very successful due to the technical challenges and inherent slow pace of this research. However, the availability of the M. tuberculosis genome sequence has opened new avenues to exploring gene and protein expression during persistent infection and reactivation, and progress has begun in a number of laboratories towards developing and validating improved models of human latency . The primary goal of this RFA is to engage investigators in innovative pursuits that will further our understanding of latency and reactivation through the development of consistent, reliable animal models of persistent, asymptomatic human M. tuberculosis infection and reactivation. Research Objectives and Scope To pursue the above-described goal, we encourage applications in the following research areas: o Novel approaches, to characterizing mycobacterial physiology and gene expression patterns, as well as host response during persistent, asymptomatic human M. tuberculosis infection. These approaches should be based on human tissues and/or M. tuberculosis isolated from these tissues, whenever possible, take advantage of new genomic-, proteomic-, and/or nano-technologies, and potentially lead to development of surrogate microbiologic or immunologic markers for persistent infection in humans. The use of theoretical or mathematical models could be considered as a possible component of the proposed projects. o Development of consistent, reliable animal models that mimic persistent, asymptomatic human M. tuberculosis infection and reactivation. These models, once developed, should be useful for furthering our understanding of the mechanisms underlying these phenomena and/or serve as screening models for potential TB vaccines or drug candidates. Methods for validating these models should also be proposed where possible, including, for example, comparison of gene expression patterns between mycobacteria in model animal tissues and in tissues from humans with latent infection. Any investigators interested in developing drug therapies against persistent and/or reactivated tuberculosis may find the following program of interest: NIH Inter-Institute Pilot Program for the Development of AIDS-Related Therapeutics http://dtp.nci.nih.gov/ SPECIAL REQUIREMENTS NIAID and NHLBI plan to sponsor an annual meeting to encourage the exchange of information among investigators supported under this RFA, foster collaborative efforts, and identify resources that would enhance the productivity of this research program. For this purpose, travel funds for an annual one to two day meeting, to be held in the Washington DC area, should be included in the budget request. 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. he full policy, including terms and conditions of award, is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf Policies and guidance for clinical research funded by NHLBI can be found on the Institute web site located at: http://www.nhlbi.nih.gov/funding/policies/index.htm 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 the program staff (listed in INQUIRIES section) 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 June 16, 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, and does not enter into the review of a subsequent application, the information that it contains allows staff to estimate the potential review workload and to plan the review. The letter of intent is to be sent to Dr. Edward Schroder at the address listed under INQUIRIES. APPLICATION PROCEDURES Applicants are strongly encouraged to call NIAID and NHLBI program staff with any questions regarding the responsiveness of their proposed project to the goals of this RFA. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. 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. For purposes of identification and processing, item 2a on the face page of the application must be marked "YES" and the RFA number AI-01-009 and the words "Response to the Presidential Vaccine Initiative Overcoming the Tuberculosis Latency Challenge" must be typed in. 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. Applications must be received by July 16, 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 (rev. 4/98) Application Kit (as modified in, and superseded by, the NIAID brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS ), will be judged non-responsive and will be returned to the applicant. 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: Dr. Edward Schroder Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room Number 2151, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 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. 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. SPECIAL INSTRUCTIONS FOR COMPLETION OF P01 GRANT APPLICATIONS IN RESPONSE TO THIS RFA Applicants for P01 grants must follow special application guidelines in the NIAID brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI- PROJECT AWARDS (August 2000); this brochure is available via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm. The brochure presents specific instructions for sections of the PHS 398 (rev. 4/98) application form that should be completed differently than usual. For all other items in the application, follow the usual instructions in the PHS 398. A P01 application in response to this RFA may not request more than $750,000 total costs without prior program staff approval (contact information listed in INQUIRIES section). Concurrent submissions of a component research project of a multi- project (P01) grant application as a traditional individual research project (R01) to this RFA is prohibited. SPECIFIC INSTRUCTIONS FOR R01 and R21 GRANT APPLICATIONS R01 and R21 applications in response to this RFA should use the modular grant format. R21 applications in response to this RFA may not request more than $150,000 direct costs per year and the total requested project period may not exceed two years. 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. For grants at $250,000 and below, the total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions, which are described below: 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. REVIEW INFORMATION Review Procedures Upon receipt, applications will be reviewed for completeness by Center for Scientific Review and for responsiveness by NIAID and NHLBI staff. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Review Considerations 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 and the National Heart, Lung and Blood Advisory Council. The initial review group will examine: the appropriateness of the 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. Review Criteria for P01 Grant Applications The general criteria for P01 grant applications are presented in the NIAID brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS (August 2000). Review Criteria for R01 and R21 grant applications The criteria to be used in the evaluation of R01 and R21 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. R21 applications should be evaluated based more on innovation and/or potential significance for moving a field forward, than feasibility; preliminary data are not required for R21 applications. 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? Schedule Letter of Intent Receipt Date: June 16, 2001 Application Receipt Date: July 16, 2001 Scientific Peer Review Date: October, 2001 Advisory Council Date: February, 2002 Earliest Anticipated Award date: April, 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, 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: Christine Sizemore, Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Room 3131, MSC- 7630 6700-B Rockledge Drive Bethesda, MD 20892-7630 Telephone: (301) 496-5305 FAX: (301) 496-8030 E-Mail: cs390s@nih.gov Hannah H. Peavy, M.D. Division of Lung Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 10018, MSC 7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0222 FAX: (301) 480-3557 E-mail: peavyh@nih.gov 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: Edward Schroder, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2151, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Telephone: (301) 435-8537 FAX: (301) 402-2638 E-Mail: es170m@nih.gov Direct inquiries regarding fiscal matters to: Ms. Ann Devine Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2118, MSC-7614 6700-B Rockledge Drive Bethesda, MD 20892-7614 Telephone: (301) 402-5601 Fax: (301) 480-3780 E-mail: ad22x@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance No. 93.856 and No. 93.361. 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 72,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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