PAR-00-039: ESTABLISHED INVESTIGATOR AWARD IN CANCER PREVENTION, CONTROL, BEHAVIORAL AND POPULATION RESEARCH (K05)

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ESTABLISHED INVESTIGATOR AWARD IN CANCER PREVENTION, CONTROL, BEHAVIORAL AND POPULATION RESEARCH (K05) Release Date: January 10, 2000 (see replacement PAR-03-149) PA NUMBER: PAR-00-039 National Cancer Institute PURPOSE The purpose of the National Cancer Institute (NCI) Established Investigator Award in Cancer Prevention, Control, Behavioral and Population Research(K05) is to provide established investigators protected time to devote to research and to act as mentors for new investigators. The target candidates are outstanding established scientists who have demonstrated a sustained, high level of productivity, research accomplishments, and contributions to cancer prevention, control, behavioral and population CANCER research; and who can demonstrate the need to sustain an intensive research focus that will enhance the progress of their own research and provide them greater opportunity to serve as mentors to new scientists. The award provides salary support for an award period up to five years, and is renewable for one additional five year period. The NCI is especially interested in training and retaining scientists who conduct high-quality research in cancer prevention, control, behavioral and populations sciences. Accordingly, this award forms an important part of the NCI Strategic Training Plan to relieve researchers from administrative responsibilities and/or clinical responsibilities in order to help them focus on research and mentoring. Examples of disciplines relevant to this Program Announcement (PA) include any aspect of human cancer prevention (modifiable risk factors, new animal models and extrapolation of these models to human cancer, genetic predisposition to cancer and detection of precursor lesions, chemoprevention trials in human populations, and behavioral research and behavioral intervention trials in cancer prevention), epidemiology (biochemical, genetic, molecular), biostatistics, human cancer genetics, human nutrition, behavioral and social sciences, health promotion, health services and health policy research; and medical decision analysis, survivorship and quality of life as they relate to cancer; and basic and applied research in the behavioral sciences that independently or in combination with biomedical approaches, reduces cancer risk, incidence, morbidity, and mortality across the lifespan and over the entire process of carcinogenesis from primary behavioral prevention in youth, to screening, treatment, and survivorship. 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 PA, Established Investigator Award in Cancer Prevention, Control, Behavioral and Population Research, is related to the priority areas of cancer and human resource development. Potential applicants may obtain a copy of "Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000 . ELIGIBILITY REQUIREMENTS Candidates must be established CANCER scientists with a strong track record of publications and successful competition for cancer research support. Candidates must have peer-reviewed, independent research support at the time of and during the entire duration of the award. This support could include National Institutes of Health (NIH) awards (e.g., R01) or awards from other sources, as long as they are equivalent to NIH R01 type grants in complexity and duration. Individuals holding small grants (e.g., R03s) or developmental grants (e.g., R21s) are not eligible. However, scientists whose work is primarily theoretical may apply for this award in the absence of research grant support, if the institutional commitment includes stability of salary and research support. Candidates must have a record of supervising junior researchers. Finally, candidates for this award must be able to demonstrate the need for protected time to advance their research careers and mentoring activities. Applications may be submitted on behalf of candidates by domestic, non-Federal organizations, public or private, such as medical, dental, or nursing schools or other institutions of higher education. Racial/ ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Candidates must be U.S. citizens or noncitizen nationals, or must have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-551) or some other verification of legal admission as a permanent resident. Noncitizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states but under U.S. sovereignty, jurisdiction or administration. Individuals on temporary or student visas are not eligible. A candidate for this award may not concurrently apply for any other PHS award that duplicates the provisions of this award. MECHANISM OF SUPPORT The Established Investigator Award in Cancer Prevention, Control, Behavioral and Population Research is a special NCI modification of the NIH Senior Scientist Award or K05 grant mechanism. Planning, direction, and execution of the program will be the responsibility of the candidate on behalf of the applicant institution. However, the institution must demonstrate a commitment to the candidate and the candidates goals for career development. The project period may be for up to five years (at least three years are required) . Awards are renewable for one additional five year period if the candidate still meets the stated requirements. RESEARCH OBJECTIVES A. Background: In 1998, the National Cancer Institute completed major external reviews of its cancer prevention and control sciences programs. The scientific experts conducting these reviews recommended strengthening the NCI-supported cancer prevention program by increasing support of research on modifiable risk factors, new animal models and extrapolation of these models to human cancer, genetic predisposition to cancer and detection of precursor lesions, chemoprevention trials in human populations, and behavioral research and behavioral intervention trials in cancer prevention. Recommendations made by the scientific experts for research areas of emphasis in cancer control included basic behavioral and social research, communications and informatics, rehabilitation and survivorship, quality of life, screening research , and applied cancer control research which includes health services and health policy research. These groups also recommended bringing senior scientists into the NCI for short periods of time to collaborate with the NCI researchers and program staff. The cancer prevention and cancer control review groups independently identified the current level of support for training in cancer prevention and cancer control as being inadequate to take advantage of the new opportunities for reducing cancer incidence, morbidity and mortality. The scientific experts on these review groups recommended expanding current NCI support of education/ training programs in cancer prevention and cancer control, and multidisciplinary training of basic and clinical scientists in highly interdisciplinary and collaborative environments. Similar recommendations have been made by other NCI advisory groups. The NCI Cancer Training Branch responded to these recommendations in 1998 with the NCI Strategic Training Plan. A major focus of this plan was to provide new training and career development opportunities for young investigators in the cancer prevention, control and population sciences. Additionally, to address the projected needs of the mentors for these young investigators, the strategic plan proposed the use of a career award grant mechanism to provide senior investigators protected time to stabilize their research programs and for mentoring new investigators. B. Program: The award provides five consecutive 12 month appointments. At least 25 percent and up to 50 percent of the recipient's full-time professional effort must be devoted to the program and the remainder devoted to other research-related and/or teaching pursuits consistent with the objectives of the award. C. Environment: The institution must have a well-established research and career development program in cancer prevention, control and the population sciences. The institution must be able to demonstrate a commitment to the candidate as a productive, independent investigator. The candidate and institution must certify that the candidate will be released from other duties and be able to devote up to 50 percent effort (at least 25 percent) to achieve the research and mentoring objectives of this award. The institution must also document an adequate pool of candidates for mentoring. D. Allowable Costs: 1. Salary: The NIH will provide salary for the award recipient of up to the current Federal salary rate limit plus commensurate fringe benefits for up to 50 percent effort. The institution may supplement the NIH contribution up to a level that is consistent with the institution's salary scale. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the award. Recipients of this award may derive additional compensation for the effort associated with other federal sources or awards provided the total salary derived from all Federal sources does not exceed the current Federal salary rate limit and their total percent effort on all awards does not exceed 100 percent. Direct salary is exclusive of fringe benefits and indirect costs/ facilities and administrative expenses. The total salary requested must be based on a full-time, 12-month staff appointment and the level of effort proposed. It must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. The award will also provide fringe benefits on the calculated base salary at the established institutional rate. 2. Research Development Support: It is expected that candidates for a K05 award will have active, independent research support at the time of the award (see ELIGIBILITY REQUIREMENTS). However, the K05 award provides additional funds up to $25,000 per year for the following expenses: (a) tuition, fees, and books related to career development; (b) research expenses, such as supplies, equipment and technical personnel; (c) statistical and computational services including personnel and computer time; and (d) travel to research meetings or training. 3. Ancillary Personnel Support: Salaries for secretaries, technical, administrative assistants and other ancillary personnel are not allowed. 4. Facilities and Administration Costs: These costs, which were formerly called indirect costs, will be reimbursed at 8 percent of modified total direct costs. E. Other Income: Fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research-related activities of this award may not be retained by the career award recipient. Such funds must be assigned to the grantee institution for disposition by any of the following methods: - The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution; - The funds may be used for health-related research purposes; - The funds may be paid to miscellaneous recipients of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Division of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for payment; - Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, or honoraria from other institutions for lectures or seminars, provided these activities remain incidental and provided that the retention of such pay is consistent with the policies and practices of the grantee institution. Usually, funds budgeted in an NIH-supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. The awarding component will give consideration to approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career award must receive prior written approval of the NIH awarding component. F. Evaluation: In carrying out its stewardship of human resource related programs, the NIH may request information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. G. Special Leave: Leave to another institution, including a foreign laboratory and to the NCI, may be permitted if directly related to the purpose of the award. Awardees planning a period of leave must submit a written request to the NCI in advance of the leave. This request must be countersigned by the appropriate business official at the new institution/facility. This request must include the reasons for the leave; and must provide a description of the provisions that will be made to ensure that the awardee will be able to continue meeting the special requirements of this award for a suitable research environment and for opportunities to mentor junior investigators during the period of leave. NCI staff will review the request and notify the principal investigator and the grantee and new institutions of the results of this evaluation. If the request is approved, support will continue during the leave period. Parental leave will be granted consistent with the policies of the NIH and the grantee institution. H. Termination or Change of Institution: When a grantee institution plans to terminate an award, the NCI must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. If the individual is moving to another eligible institution, career award support may be continued provided: A new application for a K05 award is submitted by the new institution; All conditions of the award are met at the new institution; The period of support requested is no more than the time remaining within the existing award period; and The new application is submitted far enough in advance of the requested effective date to allow the necessary time for NCI review. Review of these materials is usually carried out by NCI staff. However, depending upon the circumstances, the NCI may also require a review by an initial review group and/or the National Cancer Advisory Board. The NIH may discontinue an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, the Director of the NIH shall notify the grantee institution and career award recipient in writing of this determination, the reasons therefor, the effective date, and the right to appeal the decision. A final progress report, invention statement, and Financial Status Report are required upon either termination of an award or relinquishment of an award in a change of institution situation. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS For research projects 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 has been published in the Federal Register of March 28,1994 (FR 59 14508-14513), and in the NIH Guide For Grants And Contracts of March 18, 1994, Vol. 23, No 11. It is also available electronically at the following website address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html . Investigators may obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by NIH, unless there are clear and compelling scientific and ethical reasons not to include them. This policy applies to all applications submitted in response to this Program Announcement. 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 website address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. As part of the scientific and technical merit evaluation of the research plan, reviewers will be instructed to address the adequacy of plans for including children as appropriate for the scientific goals of the research, or justification for exclusion. APPLICATION PROCEDURES Applications are to be submitted using the modifications of the instructions (see below) for Research Career Awards starting on page IV of the Form PHS 398 (last revised 4/98) grant application kit. Applications will be accepted three times a year on or before the regular receipt dates for Research Career Awards, which are February 1, June 1 and October 1. The Form PHS 398 is available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, Phone (301) 435-0714, FAX: (301) 480-0525, Email: grantsinfo@nih.gov. Forms are also available on the following NIH website: http://grants.nih.gov/grants/funding/phs398/phs398.html. 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 (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-004.html). Submit a signed, typewritten original of the application with 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 or Bethesda, MD 20817-7710 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8062 MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) The special instructions in the Form PHS 398 application kit for Research Career Awards (pages IV-1 through IV-7 and page LL) are for mentored awards and do not entirely apply to the K05 award. Letters of Reference, information about the Career Development/Training Activities During Award, and Statement by Sponsor(s) are NOT REQUIRED. Accordingly, the instructions below have been adapted to accommodate the Form PHS 398 and the special needs of the K05 grant: 1. Face Page: Use page AA as instructed in the Form PHS 398. On line 1. provide a title of project that is representative of your research. For line 2, fill in the number and title of this program announcement. 2. Description of Personnel: Use page 2-BB and prepare as instructed. List only your name (i.e., the candidate/principal investigator) 3. Table of Contents (adapted from page LL to accommodate the K05) to be organized as follows: Content Page Number Section I: Basic Administrative Data a. Face Page b. Description/ Key Personnel c. Table of Contents d. Budget for Entire Proposed Period of Support (Form Page EE) e. Biographical Sketches (Form Page FF) - Principal Investigator - Others f. Other Support for Principal Investigator (Format Pages GG) g. Resources (Form Page HH) Section II: Specialized Information a. Introduction to Revised Application b. The Candidate - Candidate’s Research Background - Candidate’s Mentoring Background - Career Goals and Objectives: Scientific Biography c. Career Development Objectives and Justification of the Need for this Award d. Environment and Institutional Commitment to Candidate e. Research Plan (Current, future studies) Percent Effort on this grant (K05) to be committed to Research Currently Supported Research: - Statement of Hypotheses and Specific Aims - Background, Significance, and Rationale - Preliminary Studies and Results - Research Design and Methods New Research to be Specifically Supported by this Grant (K05) - Hypothesis and Specific Aims - Significance and Rationale - Research Design and Methods f. Mentoring Plan Percent Effort on this grant (K05) to be committed to Mentoring - kinds of and availability of candidates that will be recruited for mentoring - educational and research experiences that will be provided - specific role as mentor in preparing trainees for an independent research career in the prevention, control, behavioral and population sciences g. Human Subjects h. Vertebrate Animals i. Literature Cited j. Consortium/ Contractual Arrangements k. Consultants l. Appendix (Five collated sets. No page numbering necessary) Number of Publications (not to exceed six): List of key items: 3. Biographical Sketch: Since the K05 is an unmentored award, provide information for the candidate and other key personnel, using Form Page 6-FF and the Additional Instructions for the Form PHS 398 on Page IV-3. List all education, professional degree and specialty training. 4. Other Support (Form PHS 398, Page IV-3): Please note that because the NCI’s use of the K05 grant mechanism requires that candidates have research support an Eligibility Requirement, this grant is not subject to Just-in- Time reporting procedures. Therefore, a candidate for a K05 award must have active research support at the time of and for the duration of the award. A listing of all sources of active research support and pending research support for the candidate’s research must be provided, following the format on Page 7 (Page GG) of the general instructions for the Form PHS 398. 5. Candidate’s Background: See the modified Table of Contents above for topical headings. The reviewers must have a clear view of your research background and your experience as a mentor in the field or fields relevant to prevention, control, behavioral and population sciences. With regard to the latter, it would be helpful to the reviewers to provide the number of years of mentoring experience, the capacity in which you served as a mentor (i.e., research advisor, research mentor, etc.) and the number of trainees you have mentored. The reviewers would be able to develop a complete understanding of your success as a mentor if you describe the types of research that were conducted by the individuals you mentored and the proportion of individuals under your oversight who became independent investigators. 6. Career Development Objectives and Justification for a K05 Award: It is important to convey to the reviewers your reasons for needing protected time to continue a vital research program and continue to engage in the mentoring of new scientists. It should be clear that this award will allow you to spend more time on research and mentoring and less time on administrative and clinical responsibilities for the institution. 7. Environment and Institutional Commitment to the Candidate: Use the instructions in Form PHS 398, Page IV-5. Within this part of the application, it would be helpful to the reviewers to understand what duties and responsibilities in the institution that you are being relieved of to focus on research and mentoring AND how the institution will accommodate these activities with other staff. 8. Research Plan (PHS Form 398, Page IV-6 and General Instructions, Pages 15-16): It is important to indicate your percent effort on this K05 that will be devoted specifically to research. A Research Plan is a REQUIRED component of the application. a. For most applicants (see ELIGIBILITY REQUIREMENTS), ongoing, preferably peer-reviewed research support, is required at the time of and throughout the duration of the K05 award: There is no need to provide extensive detail with regard to ongoing, funded research. Enough information should be provided in the areas of Hypothesis and Specific Aims; Background, Significance and Rationale; Preliminary Studies and Results; and Research Design and Methods to permit the peer reviewers to evaluate the extent, special features and general quality of your research activities. b. Proposed new research activities: Describe in reasonable detail how this award will be used to help you refine your research skills and/or develop new directions for your research. This should be presented as a Statement of Hypothesis and Specific Aims; Background, Significance and Rationale; and Research Design and Methods. This is an important part of the application because it will provide the main rationale and justification for your need to have protected time for research. Although it is likely that most of the described research will be ongoing, when appropriate the candidate must ensure that the inclusion of women, members of minority groups and their subpopulations, and children, has been addressed in the development of the design for all ongoing research. The candidate must provide for each new research project proposed the information described in the General Instructions in PHS Form 398 on pages 16-17; and must provide documentation that these issues have already been adequately addressed in ongoing research. 9. Mentoring Plan: It is important to indicate the percent effort on this K05 award that will be devoted specifically to mentoring. A Mentoring Plan is a REQUIRED component of the application. This plan should include a description of the availability of clinicians for mentoring, the previous training and specialization of these individuals, plans for recruitment and supervision, the types of educational and research experiences that will be provided, and the capacity in which the applicant for the K05 award will serve as a mentor. REVIEW CONSIDERATIONS Applications will be assigned based on the established NIH referral guidelines. Applications will be reviewed for completeness by the Center for Scientific Review and for responsiveness to this Program Announcement by NCI staff. Incomplete and non-responsive applications will be returned to the applicant without further consideration. Applications that are not eligible (See ELIGIBILITY REQUIREMENTS), as judged by NCI staff, will be returned without further consideration. Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by a peer review group convened by the Division of Extramural Activities of the National Cancer Institute. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board to ensure that the proposed program meets the broad programmatic needs of the National Cancer Institute and the National Cancer Program. The following review criteria will be applied: Candidate: Quality of the candidate’s academic and research record, and track record as a leader of a productive research program. o A demonstrated record of mentoring or training of investigators, or a demonstration of the capability to provide mentoring to beginning investigators. o Evidence of ongoing high-quality research in the cancer prevention, control, behavioral or population sciences and the relationship of that research to the proposed K05 program. o A strong track record of obtaining research support in the cancer prevention, control, behavioral or population sciences. Career and research plan: o Appropriateness of the research plan as a vehicle for developing and refining skills and capabilities in cancer prevention, control, behavioral and population sciences research. Scientific and technical merit of the ongoing and newly proposed research. Likelihood of research contributing significantly to the scientific knowledge base o Appropriateness of the duration of the proposed research program. o Availability of adequate resources to conduct the research program. o Demonstration that the proposed program and protected time will relieve the candidate of existing administrative (and where appropriate, clinical) duties to permit additional time for research. o Appropriateness of proposed level of effort committed to the Research Plan. o Adequacy of the plan's attention to gender and minority issues associated with projects involving human subjects. o Adequacy of plans for including children as appropriate for the scientific goals of the research, or justification for exclusion. Mentoring Plan: o Experience and potential of the candidate to serve as a mentor. o Adequacy of the plans for mentoring or supervising junior investigators in cancer prevention, control, behavioral or population sciences research. o Appropriateness of the proposed level of effort committed to the Mentoring Plan. Environment and Institutional Commitment: o Applicant institution's commitment to the scientific development of the candidate and assurances that the institution intends the candidate to be an integral part of its research program. o Quality and relevance of the environment for scientific and professional development of the candidate and trainees pursuing research in cancer prevention, control, behavioral and the population sciences; Adequacy of the applicant institution's commitment to provide protected time for conduct of the research and mentoring programs. AWARD CRITERIA Applications will compete for available funds with all other scored career award applications received in response to this PA. Funding decisions will be made based on the recommendations of the initial review group and the National Cancer Advisory Board, the need for research personnel in specific program areas, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this PA are encouraged especially during the planning phase of the application. Below is a listing of the NCI staff in the program, grants management and review who are available for inquiries: Direct inquiries regarding scientific or programmatic issues to: Dr. Brian W. Kimes Cancer Training Branch Office of Centers, Training and Resources National Cancer Institute 6116 Executive Blvd, Suite 7001 MSC 8346 Bethesda, MD 20892-8345 FAX: (301) 402-0181 Email: bk34t@nih.gov Direct inquiries regarding fiscal or budget matters to: Ms. Catherine Blount Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301)-496-3179 FAX: (301)-496-8601 Email: cb136g@nih.gov Direct inquiries regarding review matters to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8062 MSC/8329 Bethesda, MD 20892-8329 Rockville, MD 20850 (express courier) AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.398, Cancer Research Manpower. 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 PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74 and Part 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or, in some cases, 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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