EXPIRED
NHLBI CAREER TRANSITION AWARD (K22) RELEASE DATE: August 26, 2002 PA NUMBER: PAR-02-154 (Reissued as PAR-07-317) (Expiration Date extended, see NOT-HL-06-119) (Expiration Date extended, see NOT-HL-05-120) EXPIRATION DATE: June 2, 2006 for New Applications January 22, 2007 for Revised Applications (see NOT-HL-06-119) National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The overall goals of the National Heart, Lung, and Blood Institute (NHLBI) Career Transition Award (K22) program are to enable outstanding individuals to obtain a research training experience in the NHLBI Division of Intramural Research and to facilitate their successful transition to an extramural environment as independent researchers. The award will provide up to three years of support for research training in an NHLBI intramural laboratory followed by two years of support for an independent research project in an extramural institution. It is anticipated that awardees will subsequently obtain research project grants such as the R01 to support the continuation of their work. RESEARCH OBJECTIVES The NHLBI intramural research environment has provided a unique opportunity for the training of new scientists who have subsequently entered the extramural biomedical research community and have become leaders in their fields of investigation. The goal of the NHLBI K22 program is to provide highly qualified new investigators with an opportunity to receive mentored research experience in the NHLBI Division of Intramural Research and then to provide them with bridge funding to facilitate the transition of their research programs to extramural institutions. To achieve these objectives, the NHLBI Career Transition Award will support two phases of research: an intramural phase and an extramural phase, for a total of four to five years of combined support. Transition from the intramural phase of support to the extramural phase is not automatic. Approval of the transition will be based on the success of the awardees" research program as determined by an NHLBI progress review, which will take place no later than the end of the second year of the Intramural Support Phase, and the evaluation of a research plan to be carried out at the extramural institution. The extramural institution must demonstrate a commitment to the candidate by providing protected research time and space needed to perform the proposed research. Matching funds from the extramural institution for equipment and supplies (and if necessary, salary) are encouraged. Awardees approved to proceed with the second phase of support will receive notification of approval in writing from the NHLBI. An application from the extramural institution on behalf of the candidate will be required for the NHLBI to process the second phase of the K22. NHLBI DIVISION OF INTRAMURAL RESEARCH The NHLBI provides leadership for a national program in diseases of the heart, blood vessels, blood, and lungs, and in the use of blood and the management of blood resources. It plans, conducts, fosters, and supports an integrated and coordinated program of research, investigations, clinical trials, and demonstration and education projects relating to the causes, prevention, methods of diagnosis, and treatment (including emergency medical treatment) of cardiovascular and cardiopulmonary diseases. The Division of Intramural Research conducts clinical research on the normal and pathophysiologic functioning of the cardiac, pulmonary, blood, and endocrine systems and basic research on normal and abnormal cellular behavior at the molecular level. The research activities of the laboratories and branches range from structural organic chemistry to cardiology. Major areas of interest include: Mechanisms of gene regulation, viral-mediated gene transfer and gene therapy, the molecular basis of lipoprotein dysfunctions and the atherogenic process, the molecular basis of diseases of the alveolar structures of the lung and the design of new therapeutic modalities, the cellular and molecular events underlying ischemic heart disease and myocardial hypertrophy, biochemical events associated with aging and certain pathologic processes, molecular, structural, and developmental aspects of muscle and nonmuscle contractile systems, cell and organelle movement, molecular and cellular processes for the conversion of metabolic energy into useful work, mechanisms of cardiac development, the molecular basis of transmembrane signaling, the pathophysiology of renal function at the cellular and molecular levels, the biochemistry of trace nutrients, enzyme kinetics, metabolic regulation, and protein chemistry, the cellular and molecular basis of toxicities induced by drugs and other foreign compounds, molecular immunology and cytokines, hematopoietic stem cell biology and bone marrow transplantation, pathophysiology of vascular diseases with emphasis on molecular genetic interventions, cardiac imaging through ultrasound and magnetic resonance imaging, as well as some aspects of cardiovascular devices, computational biophysics, and mass and optical spectroscopy. Animal medicine and surgery support is provided to both clinical and basic science by full-time NHLBI staff. MECHANISM OF SUPPORT Awards in response to this PA will use the K22 mechanism. Planning, direction, and execution of the candidate"s individual research and training program will be the responsibility of the candidate and his/her mentor. The total period of support is four or five years (two or three years intramural, plus two years extramural). Awards are not renewable. Total direct costs for the intramural phase are based on the candidate"s experience, not to exceed $150,000 per year, including salary, those for the extramural phase cannot exceed $150,000 including fringe benefits per year in direct costs or $300,000 for the two-year period. (For information about specific allowable costs, please see ALLOWABLE COSTS). The NHLBI anticipates making five awards per year. ALLOWABLE COSTS Intramural Support Phase: Support during the intramural phase will include a fellowship stipend, be based on the candidate"s years of postdoctoral experience, commensurate with the NHLBI intramural salary structure. Research expenses including personnel, consultants, equipment, supplies, and travel will be negotiated with the laboratory chief and will depend on the nature and scope of the research approved by peer review. Allowable costs will follow those specified for the Extramural Support Phase which follows. Extramural Support Phase: 1. Salary: The NIH NHLBI will provide salary for the award recipient of up to $75,000 per year plus commensurate fringe benefits for a minimum of 75 percent effort. Although a greater effort may be proposed, the maximum allowable salary is $75,000. The total salary requested must be based on a full-time, 12-month staff appointment. 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. The institution may supplement the NIH contribution up to a level that is consistent with the institution"s salary scale, however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K22. If the grant is subject to streamlined non- competing application procedures (SNAP), institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution"s salary scale provided they do not exceed the current legislated maximum salary. 2. Research Support: The NHLBI will provide up to $75,000 per year for (a) research expenses, such as supplies, equipment, and technical personnel, (b) travel to research meetings or training, and (c) statistical services, including personnel and computer time. Total direct costs, including salary, fringe benefits and research support, may not exceed $150,000 per year. 3. Ancillary Personnel Support: Salary for secretarial and administrative assistance, etc., is not allowed. 4. Facilities and Administrative Costs (F&A): F&A costs will be reimbursed at eight percent of modified total direct costs. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any eligible individual with the skills and knowledge necessary to enter into the mentored training experience is invited to work with the Division of Intramural Research at NHLBI to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. The candidate must have a research or a health-professional doctorate or its equivalent, and must have postdoctoral research experience, during which the potential for highly productive basic or clinical research was demonstrated. During the intramural phase of the award, the candidate will spend full time on research. During the subsequent two-year extramural phase, the candidate must spend a minimum of 75 percent of full-time professional effort conducting research and research career development activities. The required research experience may have been completed in an intramural NIH laboratory or at an extramural institution. To obtain support for the extramural phase, candidates must have a formal tenure- track (or equivalent) offer in an extramural institution. Minorities, women, and persons with disabilities are encouraged to apply. 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. Individuals on temporary or student visas are not eligible. Former principal investigators on NIH research project (R01), FIRST Awards R29), SBIR/STTR awards, sub-projects of program project (P01) or center grants P50), K08 awards, or the equivalent, are not eligible. Former principal investigators of an NIH Small Grant (R03) or Exploratory/ Development Grants R21) remain eligible. A candidate for the NHLBI Career Transition Award may not concurrently apply for any other PHS award that duplicates the provisions of this award nor have another application pending award. SPECIAL REQUIREMENTS Acceptance into the NHLBI Career Transition Award Program does not convey any commitment or intent of the NHLBI to consider the awardee for a tenure track position within the NHLBI. The NHLBI Career Transition Award is specifically intended to help develop scientists who will pursue their careers in the extramural biomedical research community. However, the NHLBI K22 awardees are not explicitly precluded from applying for available tenure track positions at the NIH. If an awardee obtains an NIH position, the NHLBI Career Transition Award will be terminated. Once a K22 award is made, the awardee is expected to remain with the NHLBI Intramural Program for at least 18 months. Exceptions may be reviewed on a case-by-case basis. APPLICATION PROCEDURES: Individuals interested in applying for the NHLBI K22 Award must first identify a mentor within the Division of Intramural Research. The mentor should be in a position to offer a training experience that will enhance the candidate"s ability to conduct independent research. The NHLBI Office of Education can assist in identifying potential mentors within the Division of Intramural Research. Candidates wishing to take advantage of this assistance should contact the Office of Education at [email protected] and submit a curriculum vitae and a brief pre-application description of his/her past training, research experience and research interests as well as future research plans. Senior DIR staff will review this application for an intramural training position and attempt to identify appropriate mentors in the applicant"s area of interest who are willing to provide research training and provide this information to the applicant. The Office of Education may then arrange for the applicant to visit the NIH campus and meet with these investigators so that a prospective mentor can be selected. Once a mentor is identified, the candidate and mentor must work together to complete the application. The application must include information regarding the candidate"s long-term career plan, a research training plan, including descriptions of proposed formal course work, a research plan, and the mentor"s statement of support. The application should specifically address how training to be received in the Division of Intramural Research will enhance the candidate"s ability to achieve their career goals of becoming an independent investigator. The application must address the following issues: Candidate o The candidate"s commitment to a career in biomedical or behavioral research. o The candidate"s potential to develop into a successful independent investigator. o The candidate"s immediate and long-term career objectives, explaining how the research training under the award will contribute to their attainment. o Letters of recommendation. Three sealed letters of recommendation addressing the candidate"s potential for a research career must be included as part of the application. o Candidates must describe plans to receive instruction in the responsible conduct of research. These plans must detail the proposed subject matter, format, frequency, and duration of instruction, as well as the amount and nature of senior staff participation. No award will be made if an application lacks this component. Research Plan o Describe the research plan and the use of a basic or clinical approach to a biomedical or behavioral problem. The candidate must describe the research plan as outlined in form PHS 398 including sections on the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design and Methods. Mentor"s Training Plan (Intramural Phase) o The mentor must describe the elements of research training planned for the candidate, including any formal course-work, and specify how the candidate"s scientific independence and professional development will be promoted. Budget The applicant should work with the potential NHLBI mentor to devise a budget for the Intramural Phase. Budget information for TOTAL DIRECT COSTS and cost justifications should be developed in accordance with the Budget Information instructions in form PHS 398. For candidates who receive approval for transition to the Extramural Phase a budget will be submitted at that time as part of the form PHS 2590 (noncompeting application) as discussed below in EXTRAMURAL SUPPORT PHASE. WHERE TO SEND INQUIRIES E-mail and telephone inquiries concerning this PA are encouraged, especially during the planning phase of the application. The opportunity to clarify any issues or address questions from potential applicants is welcome. o Direct your questions about intramural programmatic issues to: Dr. Herbert M. Geller Director, Office of Education Division of Intramural Research National Heart, Lung, and Blood Institute 10 Center Drive, Room 8C104, MSC 1754 Bethesda, MD 20892-1754 Telephone: (301) 451-9440 FAX: (301) 594-8133 Email: [email protected] o Direct your questions about extramural programmatic issues to: Beth Schucker, M.A. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 9206, MSC 7940 Bethesda, MD 20892- 7940 Telephone: (301) 435-0535 FAX: (301) 480-1454 Email: [email protected] o Direct your questions about peer review issues and mail two copies of the completed application and any appendix material to: Anne Clark, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7214, MSC 7924 Bethesda, MD 20892-7924 Telephone: (301) 435-0270 FAX: (301) 480-0730 Email: [email protected] o Direct your questions about financial or grants management issues to: Dawn Walker Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7148, MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0171 FAX: (301) 480-3310 Email: [email protected] SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). (See additional instructions for preparing individual research career award applications on page IV-1) The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected]. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines for Career Development Awards which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to: o To identify the application as a response to this PA, on page 1 of the application, on item 2 check "YES", enter the number of this PA and "NHLBI Career Transition Award" as the title. Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application as well as five collated sets of Appendix material must be sent to Dr. Anne P. Clark at the address listed in the WHERE TO SEND INQUIRIES section. APPLICATION PROCESSING: Applications must be received by or mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened by NHLBI in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the appropriate national advisory council or board REVIEW CRITERIA The scientific review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. Intramural Support Phase (1) CANDIDATE: o Commitment to an independent research career. o Potential to develop as an outstanding scientist who will make significant contributions to the field. o All candidates for this award must have had previous research experience. Quality and breadth of prior scientific training and experience including, where appropriate, the record of previous research support and publications. (2) RESEARCH PLAN: o A sound research plan that is appropriate for the research training objectives of the candidate must be provided. o Appropriateness of the research plan as a vehicle for enhancing research skills necessary to fulfill the objectives of the career development plan, o Scientific and technical merit of the research question, design, and methodology, judged in the context of the candidate"s proposed career objectives, (3) CAREER DEVELOPMENT PLAN: o Appropriateness of the proposed training experience to the candidate"s career development, considering the candidate"s goals and prior experience. o Adequacy of plans to obtain instruction in the responsible conduct of research. (4) MENTOR: o Research qualifications and previous experience as a research supervisor. o Adequacy of the nature and extent of supervision that will occur during the proposed award period. o Appropriateness of the mentor"s research interests and qualifications to the career development needs of the candidate. o Adequacy of the proposed mentoring plan. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research (see Allowable Costs). AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities SELECTION PROCEDURES Intramural Support Phase Following peer review, applications will be considered by a NHLBI Selection Committee (NSC) consisting of Senior Scientists from the NHLBI Intramural Program convened by the Division of Extramural Affairs, NHLBI. Based on priority score ranking and programmatic needs, this committee will determine the final candidates to be selected. ACTIVATING THE EXTRAMURAL SUPPORT PHASE The candidate must receive approval in writing from the NHLBI and must be accepted by an extramural institution in order to activate the extramural support phase. The extramural institution will submit an application on behalf of the candidate for the extramural phase of support, using form PHS 2590, the noncompeting application. The application submitted by the awardee and the extramural institution for activation of the extramural phase of the program will be evaluated by NHLBI extramural staff for completeness and responsiveness to the program. EVALUATION Intramural Support Phase Each awardee will be evaluated for progress on an annual basis by the mentor, Laboratory Chief, and Scientific Director. Extramural (Transition) Support Phase The awardee will be required to submit a form PHS 2590 non-competing continuation application for the final years of extramural support. The application should provide a description of the research and career progress of the awardee, including: 1) publications in press or submitted, 2) current investigator-initiated research grant support, and 3) all applications submitted for investigator-initiated research grant support. After the completion of this award, periodic updates on various aspects of 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 may be solicited from awardees. REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research projects unless a clear and compelling justification is provided indicating 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 clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research, updated racial and ethnic categories in compliance with the new OMB standards, clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398, and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy 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 is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov/). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. 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. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. 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 PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.837, 93.838, and 93.839, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)(or other authorizations) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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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