PAR-99-154: NHLBI CAREER TRANSITION AWARD (K22)

Department of Health
and Human Services (HHS)

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NHLBI CAREER TRANSITION AWARD (K22) Release Date: August 23, 1999 PA NUMBER: PAR-99-154 National Heart, Lung, and Blood Institute PURPOSE 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. 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 Program Announcement (PA), Title of 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/ . ELIGIBILITY REQUIREMENTS The candidate must have a research or a health-professional doctorate or its equivalent, and must have some 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. 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. 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. 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. 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 plus 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). FUNDS AVAILABLE It is anticipated that applications for the NHLBI Career Transition Award will be solicited annually through the reissuance of this PA. Each annual solicitation will indicate the number of positions that will be sponsored in that year. For Fiscal Year 2000, the NHLBI anticipates making five awards. PROGRAM 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 research and research training 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 16 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; molecular and cellular processes for the conversion of metabolic energy into useful work; 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. 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 Ne 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. Under expanded authorities, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution’s salary scale provided they don t 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. Special Restrictions: 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. 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 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 was 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, available on the web at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and/or 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://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Individuals interested in applying for the NHLBI K22 Award must contact the Office of Education in the NHLBI Division of Intramural Research ( Ms. Nancy Curro at (301) 496-2116; email: curron@nih.gov). This contact is required to initiate the process of selecting a mentor and completing the application. Preliminary information on the NHLBI Intramural Program may be found on the web at: http://www.nhlbi.nih.gov/nhlbi/relab/relab.htm Following initial contact with the Office of Education of the NHLBI Division of Intramural Research, the applicant will submit a curriculum vitae and a brief pre-application describing his/her past training, research experience and research interests. Senior DIR staff will review this pre-application, identify 3-5 potential mentors in the applicant’s area of interest 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. Applications are to be submitted on form PHS 398 (rev. 4/98) (See additional instructions for preparing individual research career award applications on page IV-1) and will be accepted on the receipt deadlines indicated in the application kit. These forms 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. Both new and revised K22 applications are due on the first appropriate receipt date for each cycle (February 1, June 1, and October 1). 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 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. Submission Procedures o Identify the application as a response to this PA; check "YES" on item 2 of page 1 of the application and enter "PAR-99-154, NHLBI Career Transition Award." o Submit a signed, typewritten original of the application 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 BETHESDA, MD 20817 (for express/courier service) At the time of submission, send an additional two copies of the application to Dr. James Scheirer at the address listed under INQUIRIES. It is important to send these two copies at the same time as the original and three copies are sent to the Center for Scientific Review (CSR). These copies are used to identify conflicts and help ensure the appropriate and timely review of the application. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review (CSR) and responsiveness to the PA by the appropriate NHLBI staff. Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group, convened by the NHLBI, in accordance with the review criteria stated below. Review Criteria Intramural Support Phase 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. Research Plan o A sound research plan that is appropriate for the research training objectives of the candidate must be provided. o Usefulness 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; 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. o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. 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. Budget o Appropriateness of the budget for the scope of the research and training activities proposed (see Allowable Costs). 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. AWARD CRITERIA Funding decisions will be made based on the recommendations of the initial review group and secondary review by the National Heart, Lung, and Blood Advisory Council. 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. INQUIRIES Written 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. Address inquiries regarding intramural programmatic issues to: Ms. Nancy Curro Division of Intramural Research National Heart, Lung, and Blood Institute Building 10, Room 7N-214 Bethesda, MD 20892 Telephone: (301) 496-2116 Email: curron@nih.gov Address inquiries regarding 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: schuckeb@nih.gov Address inquiries regarding review issues and mail two copies of the completed application to: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7220, MSC 7924 Bethesda, MD 20892-7924 Telephone: (301) 435-0266 FAX: (301) 480-3541 Email: js110j@nih.gov Address inquiries regarding fiscal issues to: Robert Vinson, Jr. 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: rv7g@nih.gov 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. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.837, 93.838, and 93.839. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. 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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