CLINICAL ONCOLOGY RESEARCH CAREER DEVELOPMENT PROGRAM Release Date: March 23, 1999 PA NUMBER: PAR-99-077 P.T. National Cancer Institute Letter of Intent Receipt Date: September 7, 1999, May 1, 2000, May 1, 2001 Application Receipt Date: October 1, 1999; June 1, 2000; June 1, 2001 This Program Announcement (PA) replaces RFA CA-97-008, Clinical Oncology Research Career Development Program, which was published in the NIH Guide, Vol. 26, No. 3, January 31, 1997. PURPOSE The purpose of the National Cancer Institute (NCI) Clinical Oncology Career Development Program is to increase the number of medical doctors (M.D. s, D.O. s) and doctorally degreed Oncology registered nurses who are motivated and properly prepared to: (1) communicate and coordinate clinical research activities with basic/behavioral research scientists in order to expedite the translation of basic/ behavioral research information into patient-oriented research; (2) perform independent clinical research that develops and tests rational scientific hypotheses based on fundamental and clinical research findings for improving the medical care of cancer patients; and (3) design and test innovative clinical protocols and manage all phases of clinical trial research. To achieve this purpose, awards are made to institutions for up to 5 years for the development and implementation of training programs providing clinicians with all of the information and training needed to design, implement and manage all phases of cancer clinical trials research. Clinicians would be appointed to the training program, and would likely have more than one mentor as they will be exposed to the basic sciences and to the many disciplines critical to the clinical sciences. Clinicians interested in an individual mentored research experience in basic research, which can include a translational research component, should refer to PA-95-053 "Mentored Clinical Scientist Development Award (K08)," published in the NIH Guide, Vol. 24, No. 15 April 28, 1995. 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, Clinical Oncology Research Career Development Program, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, Telephone (202) 512-1800, or at http://www.crisny.org/health/us/health7.html. ELIGIBILITY REQUIREMENTS Institution: Applications may be submitted by domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Applicant organizations should have well-established research programs with adequate peer-reviewed grant support and highly qualified faculty in clinical, behavioral and basic science departments. Principal Investigator and Clinician Candidates: The principal investigator and all clinician candidates must currently be physicians holding the M.D. or D.O. degrees, or be doctorally prepared oncology registered nurses; and must have completed their clinical training. Clinician candidates must be able to spend a minimum of 75 percent effort conducting research and research career development including taking courses during the period of the award. The clinician candidates must be U.S. citizens, nationals or lawfully admitted permanent residents of the U.S. Individuals admitted for permanent residence must be able to produce documentation of their immigration status such as an Alien Registration Receipt Card (I-151 or I-551) or some other verification of legal admission as a permanent resident. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible for this award. Ineligible individuals include current or former principal investigators on any NIH research grants or non-PHS peer reviewed grants that are over $70,000 direct costs per year, on any NIH mentored career development award that has supported a career development experience in clinical research ; or on any non-PHS career development award that essentially duplicates the provisions of the NIH mentored career development awards or the K12 program. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) Mentored Clinical Scientist Development Program (K12) mechanism. Applicants will be responsible for the planning, direction, and execution of the proposed project. Awards will administered under NIH grants policy as stated in the National Institutes of Health Grants Policy Statement, NIH Publication No. 99-8 October 1998. The total project period for an application submitted in response to this PA may not exceed five years. Awards are renewable. RESEARCH OBJECTIVES A. Background: In 1991 the National Cancer Institute (NCI) recognized the need for establishing formal training programs that would prepare the next generation of clinical scientists to participate more effectively in translational clinical research, which the NCI simply defines as the movement of discoveries in the laboratory into patient research settings, and observations in patient care settings into the research laboratory. The NCI abandoned its previous strategy of expecting M.D./Ph.D.s to do this alone and embarked on a pilot program initiative that would prepare clinical oncologists to be effective scientific partners in the translational research process. These well-trained clinical oncologist scientists would be expected to communicate, interact and collaborate with basic/behavioral scientists in the design and implementation of clinical trials that were hypothesis driven and based on an understanding of biological mechanisms. This pilot program initiative, announced through RFA CA-91-32, was founded on the following principles: (1) unlike career awards to individuals, these would be awards to institutions and the institution would appoint individuals to a formal training program; (2) rather than having a single mentor, the individuals on the program would likely have more than one mentor as they are exposed to the basic sciences and to the many disciplines critical to the clinical sciences; (3) the program would provide individuals with all of the information and training needed to design, implement and manage all phases of clinical trials research. The initial pilot program initiative was highly successful. The RFA announcement generated 31 applications, 17 (55%) of which were funded, ultimately providing support for the training of 62 Clinical Oncologists. The reissuance of the RFA (CA-97-008) in 1997 generated 28 applications of which almost one-half (13/28 or 46%) were funded, providing support for the training of 50 Clinical Oncologists. Significantly, 13 (46%) of the funded applications submitted in response to the reissued RFA were competing renewals of programs initiated in response to the first announcement of the initiative; the success rate of these applications was 61% (8/13). Based upon these successes, the NCI through its Cancer Training Branch is announcing the Clinical Oncology Research Career Development Program as an ongoing Program Announcement (PA) with a once-a-year submission date. Additionally, due to the critical complementary role of oncology nursing research in the cancer clinical research team in areas such as informatics, patient education, decision making, quality of life, symptom management, and survivorship, the PA extends eligibility to include doctorally prepared oncology registered nurses. It is anticipated that such a "multidisciplinary" approach during these formative years of clinical research training will promote the team approach necessary for conducting clinical oncology research and for optimum cancer patient care. The levels of salary and research support offered in the previous RFA’s have been increased in this PA to levels consistent with the support offered clinicians in the NCI administration of the NIH Mentored Research Scientist Career Development Award (K08) and the Mentored Patient-Oriented Research Career Development Award (K23). B. Program: The award provides support to institutions for five consecutive 12- month periods. Appointments of clinical candidates to the program are provided in 12-month increments. These appointments may be as long as seven years. The program provides research career development opportunities in more than one clinical oncology research discipline (e.g., medical oncology, surgical oncology, radiation oncology, oncology nursing, etc.). Both the didactic and the research phases of the award are expected to develop the necessary knowledge and research skills in scientific areas relevant to the career goals of the candidate in clinical research. Candidates lacking skills in data management, statistics, epidemiology, study design, clinical trial design, hypothesis development, drug development, etc. will be provided the opportunity to participate in courses designed to overcome these deficiencies. C. Environment: The institution must have a well-established research and clinical career development program, and faculty qualified in clinical research with an emphasis on patient-oriented research to serve as faculty for the program. The research environment should be one in which there are active basic/behavioral/clinical research collaborations that exemplify a dynamic two-way exchange of information and ideas between laboratory and clinical scientists. The research environment should also promote rapid translation of basic/behavioral/oncology research into clinical testing as well as stimulate new ideas and laboratory experiments, based on clinical observations and testing results. Finally, the institution must demonstrate a commitment to the development of trainees as productive, independent investigators. D. Allowable costs: 1. Salary: Clinical research candidates can be provided salary support of up to $75,000 each year, plus fringe benefits commensurate with the applicant institution's salary structure for persons of equivalent qualifications, experience, and rank. The institution may supplement the NCI contribution; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case, may PHS funds be used for salary supplementation. Institutional supplementation of salary may not require extra duties or responsibilities that would interfere with the purpose of this award. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution salary scale. The total salary requested must be based on a full-time, 12 month staff appointment. 2. Other Expenses: Up to $30,000 per candidate can be provided annually to partially support supplies, equipment, travel, tuition and other costs which are essential for the individual's clinical research development program. 3. Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc. is not allowed. 4. The total cost of the award may not exceed $499,000 in direct costs per annum. 5. Facilities and Administrative Costs: These costs, which were formerly called indirect costs, will be reimbursed at 8 percent of modified total direct costs. 6. 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 fees 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 receipts 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 the 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 NCI 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 NCI staff. E. Special Leave: Leave to another institution of a trainee, including a foreign laboratory, may be permitted if directly related to the purpose of the award. Only local, institutional approval is required if such leave does not exceed 3 months. For longer periods, prior written approval of NCI staff is required. To obtain prior approval, the trainee must submit a letter to NCI Program staff describing the plan, countersigned by his or her department head and the appropriate institutional official. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the award will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NCI and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Parental leave will be granted consistent with the policies of the NCI and the grantee institution. F. Termination: 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. G. Change of Institution: The Clinical Oncology Career Development Program (K12) cannot be transferred from one institution to another. H. Change of Program Director: If the program director moves to another institution or resigns from the position, support of the award may be continued with NCI prior approval provided: o The current program director or the awardee institution has submitted a written request for change of program director, countersigned by the appropriate institutional business official, to the NCI Program Director describing the reasons for the change. The biosketch of the proposed new program director, including a complete listing of active research grant support, is provided. The information in the request establishes that the specific aims of the original peer reviewed research program to be conducted under the direction of the new program director will remain unchanged, and that the new program director has the appropriate research and administrative expertise to lead the program; o The request is submitted far enough in advance of the requested effective date to allow the necessary time for review. I. Changes of Program: Awards are made to a specific institution for a specific program under the guidance of a particular program director. Changes in any of these parameters requires prior approval by NCI Program staff. A scientific rationale must be provided for any proposed changes in the aims of the original peer reviewed program. The new program will be evaluated by NCI staff to ensure that the program remains within the scope of the original peer reviewed research program. If the new program does not satisfy this requirement, the award could be terminated. The Director of 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 program director in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision. J. Progress Reports: An Annual Progress Report for the grant is required. This report should provide a summary of the evaluation of the Advisory Committee and include a description of the research and career progress of each candidate, describing how laboratory and clinical research and practice are being integrated. These Annual Reports will be closely monitored by NCI staff to ensure that the grant is achieving the goals of this Clinical Oncology Research Career Development Program. 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. K. Evaluation: In carrying out its stewardship of human resource related programs, the NCI 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. SPECIAL REQUIREMENTS 1. The Program Director must assemble an Advisory Committee to provide an oversight function and annual evaluation of the clinical research development program as a whole. Clinical, basic and behavioral science departments, and oncology nursing departments participating in this program should be represented on the committee by clinical investigators from the various oncology disciplines such as medical oncology, surgical oncology, radiation oncology, oncology nursing and other oncology specialties as well as by basic and behavioral research investigators. The committee's responsibilities might include: selecting physician and oncology nurse candidates, assigning preceptors, approving each candidate's clinical research development plan, evaluating each candidate's progress, and monitoring the overall effectiveness of the program. A detailed description should be provided of the committee's composition, function, and frequency of meetings. A detailed report of the actions of the committee meetings must be provided in the annual progress report of the grant. Plans for an annual evaluation of the program by the Advisory Committee should be described. 2. The program must involve staff and clinical candidates representing at least two clinical oncology disciplines such as medical, surgical, radiation, pediatric, gynecologic oncology and oncology nursing. 3. The program should provide clinician candidates with the patient-oriented research skills that deal directly with aspects of cancer detection, diagnosis, prognosis, or treatment of cancer patients; and should provide the skills necessary for translating basic/ behavioral cancer research results into clinical experiments, procedures, and trials directly involving cancer patients in a clinical environment. It will not be sufficient within the scope of this initiative to use human cells and other clinical materials in an isolated basic laboratory setting as the total research development program. Basic laboratory/behavioral research experience is essential, but it must be properly integrated with patient-oriented clinical research, thereby affording the candidate actual experience in the application of their own basic research to clinical research. 4. The program should have the flexibility to accommodate clinical candidates with different levels of research competence. 5. The program should include a didactic component (e.g. formal courses, lecture series, seminars, and journal clubs). In those institutions with a Clinical Research Curriculum (K30) Award, the didactic component should link with and incorporate the new didactic programs developed though the K30 award. 6. Appointments of clinical candidates to the program should be for a minimum of two years. 7. A minimum of 75 percent effort must be devoted to the basic/clinical research program. The remaining 25 percent can be divided among other clinical and teaching activities only if they are consonant with the program goals, i.e. the candidate's development into an independent clinical investigator. 8. The institution must have a well-established research and clinical career development program, and faculty qualified in clinical research with an emphasis on patient-oriented research to serve as faculty for the program. The research environment should be one in which there are active basic/behavioral/clinical research collaborations that exemplify a dynamic two-way exchange of information and ideas between laboratory and clinical scientists. The research environment should also promote rapid translation of basic/behavioral/oncology research into clinical testing as well as stimulate new ideas and laboratory experiments, based on clinical observations and testing results. 9. The institution must demonstrate a commitment to the development of trainees as productive, independent investigators. 10. Where there already exists an active institutional (T32) National Research Service Award (NRSA) supporting a surgical or other clinical oncology research training program, the applicant must address the relationship between the existing T32 and proposed K12 programs. If there is significant overlap in the programs, the T32 award can be merged into the K12 program or modified to remove areas of substantial overlap. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification 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 "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research" which have been published in the Federal register of March 28, 1994 (FR 59 14508-14513), and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. It is also available electronically at URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html Investigators may also a obtain copy of the policy 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 initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH GUIDE FOR GRANTS AND CONTRACTS, March 6, 1998 and is available at the following URL address: http://www.nih.gov/grants/guide/notice-files/not98-024.html LETTER OF INTENT Prospective applicants are asked to submit, by the dates listed at the beginning of this PA, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the PA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NCI staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to the program staff listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) using the instructions in Section V of the application kit, and will be accepted on the receipt dates indicated at the beginning of this PA. Applications should follow Just-In-Time (JIT) procedures. Application kits are 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, telephone 301/435-0714, Email: grantsinfo@nih.gov. Applications kits are also available at: http://www.nih.gov/grants/forms.htm The title and number of the program announcement must be typed in Section 2 on the face page of the application and the YES box must be marked. Refer to the following URL for guidelines on modifications specific to this PA that must be incorporated into the organization and content of this application: http://cancertraining.nci.nih.gov/ The completed original application and three legible copies must be sent to or delivered to: CENTER FOR SCIENTIFIC RESEARCH NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (For express/courier service) At the time of submission, two additional copies must also be sent to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 636 Bethesda, MD 20892-7405 Rockville, MD 20852 (express/courier service) Applications will be accepted on October 1, 1999; June 1, 2000; and June 1, 2001. If an application is received after the deadline, it will be returned to the applicant without review. If the application submitted in response to this PA is substantially similar to a grant application already submitted to the NIH for review but 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. An application, therefore, cannot be submitted in response to this PA which is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. The information summarized below must be provided in this application in the suggested NCI-format found at http://camp.nci.nih.gov/public/ctb/main/grants.html o Career Development Plan for the clinical candidates; o Program Direction and Management; o Composition and role of the Advisory Committee; o Research funded activities, resources, facilities and mentors affiliated with the program; o Recruitment Strategies; o Protection of human subjects and vertebrate animals; o Plans for training in ethical conduct of research; o Budget. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review (CSR) and by the NCI for responsiveness. Applications that are complete and responsive to the PA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCI in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. Review Criteria The review criteria that will be applied to the application are briefly described here. The applicant should refer for additional details to the following URL: http://camp.nci.nih.gov/public/ctb/main/ o Adequacy and appropriateness of the plan for Career Development, and the focus of the plan on development of the translational and patient-oriented skills of the appointees to the Program; o Adequacy of the plan for Program Direction and Management; o Adequacy of the Advisory Committee to perform it’s required oversight, monitoring and evaluative functions; o (For institutions with an active K30 grant), appropriateness and adequacy of the linkage between the didactic component of the K12 program and the K30- derived curriculum; o Appropriateness and adequacy of the research funded activities, resources, facilities and mentors affiliated with the program; o Adequacy of Proposed Strategies for Recruitment of Clinicians into the Program; o Adequacy of the proposed means for protecting human subjects and vertebrate animals against hazardous or unethical research procedures and for protecting the privacy of human subjects; o Adequacy of plans for training in the ethical conduct of research; o Budget: The review group will critically examine the proposed budget and recommend an appropriate budget for each approved application within the guidelines stated above. The initial review group will also examine: the appropriateness of the proposed project duration; the adequacy of plans to include both genders and minorities in their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the adequacy of plans for including children as appropriate for the scientific goals of the research, or justification for exclusion; the provisions for the protection of human and animal subjects; and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other scored applications submitted in response to this PA. The following will be considered in making decisions: quality of the proposed project as determined by peer review, availability of funds and program priority. The NCI will notify the applicant of the National Cancer Advisory Board's (NCAB) action. SUPPLEMENTAL GUIDELINES The procedures for submission of a new or a competing renewal application are not applicable to applications for a non-competing renewal of an award. Applicants should refer for directions on preparing a non-competing renewal application for this award to the SUPPLEMENTAL GUIDELINES in the NCI-specific guidelines for this program at the following URL: http://camp.nci.nih.gov/public/ctb/main/ INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Lester S. Gorelic Training and Resources Program National Cancer Institute 6130 Executive Boulevard, MSC 7390 Bethesda, MD 20892-7390 Telephone: (301) 496-8580 FAX: (301) 402-4472 Email: lg2h@nih.gov Dr. Andrew Vargosko Training and Resources Program National Cancer Institute 6130 Executive Boulevard, MSC 7390 Bethesda, MD 20892-7390 Telephone: (301) 496-8580 FAX: (301) 402-4472 Email: av8b@nih.gov Direct inquiries regarding fiscal matters to: Ms. Catherine Blount Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 262 FAX: (301) 496-8601 Email: cb136g@nih.gov Direct inquiries regarding review issues to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 636, MSC 7399 Rockville, MD 20850 (express/courier service) Bethesda, MD 20892-7399 Telephone: (301) 496-3428 Fax: (301) 402-0275 Email: tf12w@nih.gov 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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