PAR-98-025: NICHD CAREER TRANSITION AWARD

Department of Health
and Human Services (HHS)

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NICHD CAREER TRANSITION AWARD Release Date: Febuary 2, 1998 PA NUMBER: PAR-98-025 (This PA has been reissued, see PAR-06-078) P.T. National Institute of Child Health and Human Development PURPOSE The overall goals of this program are to enable outstanding individuals to obtain a research training experience in the National Institute of Child Health and Human Development (NICHD) Division of Intramural Research and to facilitate their successful transition to an extramural environment as independent researchers. The Career Transition Award will provide two years of support for research training in an NICHD 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 a research project grant (R01) to support the continuation of this work. 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 Program Announcement (PA), NICHD Career Transition Award, is related to the priority area of human resource development. 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). ELIGIBILITY REQUIREMENTS The candidate must have a research or a health-professional doctorate or its equivalent, and must have demonstrated the potential for highly productive research during doctoral training and the immediate postdoctoral period (i.e., the first three years of postdoctoral training). During the intramural phase of the award (i.e., the fourth and fifth year of postdoctoral training), the candidate is expected to spend his/her full time on research. During the extramural phase, the candidate must spend a minimum of 75 percent of full-time professional effort conducting research and research career development activities for the two years of the award. 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. Candidates may have completed the first three years of postdoctoral training at the NICHD or elsewhere to be eligible for the two-year intramural support phase. To progress to the extramural support phase, candidates must have a formal tenure-track (or equivalent) offer in an extramural institution. Current principal investigators on PHS research grants are not eligible. 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 years (two 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 $125,000; those for the extramural phase cannot exceed $125,000 plus fringe benefits per year in direct costs or $250,000 for the two- year period. FUNDS AVAILABLE It is anticipated that applications for the NICHD 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 1998, the NICHD anticipates making 2-3 awards. RESEARCH OBJECTIVES The NICHD 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 NICHD K22 program is to provide highly qualified young investigators (Research Scholars) with an opportunity to receive research and research training experience in the NICHD Division of Intramural Research and provide them with bridge funding to facilitate the transition of their research programs to extramural institutions. The NICHD Career Transition Award will consist of two phases: an intramural phase and an extramural phase. The total period of combined support at NICHD and at the extramural institution will be four years. Initially, two years of the research training program will be an Intramural Support Phase in which the salary of the Scholars will be commensurate with his/her level of experience. The final two years of the program, the Extramural Support Phase, will provide salary and funds for supplies, equipment and technical support through the NIH Career Transition Award (K22). 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 Scholar's research program as determined by a formal NICHD scientific 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. Scholars approved to proceed with the second phase of support will receive notification of approval in writing from the NICHD. 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 Institution for equipment and supplies (and if necessary, salary) are encouraged. Once an application has been received from the extramural institution on behalf of the candidate, the NICHD will process the K22. Intramural Research In The NICHD The NICHD's Division of Intramural Research, located on the Bethesda campus, is broadly concerned with the biological and neurobiological, medical and behavioral aspects of normal and abnormal human development. In addition to five major clinical research and training programs in the areas of genetics, endocrinology and maternal-fetal medicine, a diversity of developmental models are under study in eighteen fundamental research Laboratories and Branches, drawing upon observations in bacteria, Drosophila, plants (Arabidopsis), yeast, viruses, mollusks, zebrafish, frogs, rodents (including transgenic and gene knock-out mice), and subhuman primates. Disciplines employed in these studies include molecular biology, biochemistry, virology, immunology, pharmacology, genetics, cell and neuronal biology, biophysics, mathematical and theoretical biology, electrophysiology, reproductive physiology, structural biology, and developmental psychology. The Intramural Research Program is carried out mainly in five laboratory-building complexes on the Bethesda campus as well as the Poolesville (Maryland) Primatology Center and several other local research sites. The Division comprises about 100 independent research groups with a total staff of about 1,000. A brief description of the NICHD Intramural Research Program can be obtained from this web site: http://dir2.nichd.nih.gov/ A more complete description of the Program, as well as the Division's Annual Report, may be obtained by writing to: Arthur S. Levine, M.D. Scientific Director National Institute of Child Health and Human Development Building 31, Room 2A50 Bethesda, MD 20892-2425 FAX: (301) 402-0105 Email: levinea@exchange.nih.gov Allowable Costs Intramural Support Phase: The budget for the intramural support phase includes the fellowship stipend, determined by years of postdoctoral experience, and research expenses determined by the laboratory chief. Extramural Support Phase: 1. Salary: The NIH will provide up to $50,000 in salary plus fringe benefits for the K award recipient. 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. There should be no less than 75 percent effort devoted by the Scholar specifically to the proposed research program. 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. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the Career Transition Award. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. 2. Research Support: The NICHD 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. 3. Ancillary Personnel Support: Salary for secretarial and administrative assistance, etc., is not allowed. 4. Indirect costs: Indirect costs will be reimbursed at eight percent of modified total direct costs, or at the actual indirect cost rate, whichever is less. Special Restrictions: Acceptance into the NICHD Career Transition Award Program does not convey any commitment or intent of the NICHD to consider the Scholar for a tenure track position within the NICHD. The NICHD Career Transition Award is specifically intended to help develop scientists who will pursue their careers in the extramural biomedical research community. However, the NICHD K22 Research Scholars are not explicitly precluded from applying for available tenure track positions at the NIH. If a Scholar obtains an NIH position, the NICHD Career Transition Award will be terminated. 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 the NIH GUIDE FOR GRANTS AND CONTRACTS, Volume 23, Number 11, March 18, 1994. APPLICATION PROCEDURES Individuals interested in applying for the NICHD K22 must identify a mentor in the NICHD Division of Intramural Research prior to submitting an application for the first phase of this award. Candidates may have undertaken their first three years of postdoctoral training in an NICHD laboratory and will, in most cases, retain their original mentor. Candidates from other Institutes or elsewhere should consult the published descriptions of the NICHD's current intramural fellowship program and communicate directly with the mentors whose research complements their own interests. Both the candidate and mentor must complete the application to be submitted on their behalf by the NICHD Division of Intramural Research. The application must include information regarding the candidate's long-term career plan, a research training plan, a research plan, and the mentor's statement of support. Applications are to be submitted on form PHS 398 (rev. 5/95) 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: asknih@od.nih.gov). The application must address the following issues: Candidate o Establish the candidate's commitment to a career in biomedical or behavioral research. o Establish the candidate's potential to develop into a successful independent investigator. o Summarize 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 demonstrate how the candidate's scientific independence will be promoted. Budget o The applicant should work with the potential mentor to devise a budget for the intramural phase. Using continuation pages as needed, provide in a narrative format justification for the budgetary needs of the proposed research program, including personnel, consultants, equipment, supplies and travel. For candidates who receive approval for transition to extramural support, a budget will be submitted as part of the form PHS 2590 noncompeting application as discussed below in EXTRAMURAL SUPPORT PHASE. Submission Procedures To identify the application as a response to this PA, check "YES" on item 2 of page 1 of the application and enter "PA-98-025, NICHD Career Transition Award." Submit a signed, typewritten original of the application, including the 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 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E03, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20854 (for express/courier service) 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 NICHD 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 NICHD, 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 Quality and breadth of prior scientific training and experience including, where appropriate, the record of previous research support and publications. Research Plan All candidates for this award will have had previous research experience. A sound research plan that is consistent with the candidate's level of research development must be provided. o Usefulness of the research plan as a vehicle for enhancing existing research skills as described in the career development plan; o Scientific and technical merit of the research question, design and methodology, judged in the context of the candidate's previous training and experience; 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. 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. 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. Budget o Appropriateness of the budget for the scope of the research and training activities proposed (see Allowable Costs). Extramural Support Phase After the candidate receives approval in writing for the transition to extramural support, the extramural institution offering the candidate a tenure-track (or equivalent) position will submit a form PHS 2590 noncompeting application. The application should include the following: o A description of the proposed research; o Information about applicant institution's commitment to the candidate and to the candidate's scientific independence; o Description of research facilities; Budget o Justification of budget requests in relation to career development goals and research aims and plans. Position Description o Institution should offer a detailed description of the candidate's position, responsibilities, and duties. The institution's tenure-track policy should be defined, or a description should be provided of the equivalent arrangements for institutions without a formal tenure-track. The application for the Extramural Support Phase will be evaluated for scientific and technical merit by an appropriate peer review group, convened by the NICHD, in accordance with the following review criteria: o Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? o Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? o Innovation: Does the project employ novel concepts, approaches, or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? o Investigator: Is the investigator appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to the experience level of the investigator and other researchers (if any)? o Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? o Institutional Commitment: Is there evidence for the applicant institution's commitment to the candidate and to the candidate's scientific independence? Is there assurance that the institution intends the candidate to be an integral part of its research program? In addition to the above criteria, all applications will also be reviewed with respect to the following: o Adequacy of plans to include both genders and minorities, and their subgroups as appropriate for the scientific goals of the research. Plans for recruitment and retention of subjects will also be evaluated. o Reasonableness of the proposed budget and duration in relation to the proposed research. o Adequacy of the proposed plans for protection of humans, animals, and/or the environment. SELECTION PROCEDURES Intramural Support Phase Following peer review, the written evaluations and priority score assigned to the application by the initial review group will be sent to the candidate. The applications will be considered by a NICHD Selection Committee (NSC) consisting of Senior Scientists from the NICHD Intramural Program and the Chair of the NICHD Training Policy Committee (TPC). Based on priority score ranking and programmatic needs, this committee will identify the pool of highly meritorious candidates to be invited for an interview. Following interviews, a ranking and matching process considering both the candidates and the sponsoring intramural branches will be used to determine the final awards. Extramural Support Phase The NICHD will conduct a formal scientific progress review no later than the end of the second year of the intramural support phase (i.e., equivalent to fifth postdoctoral year) to determine whether or not the Scholar will be recommended for the extramural phase of support. This review will be conducted by an NICHD Progress Review Committee composed of members of the TPC, NSC, and the NICHD Board of Scientific Counselors, as well as other intramural and extramural scientists, as appropriate. The results of the review will constitute a final evaluation of the intramural phase and be presented in writing to the Scholar. Approval will result in eligibility for the extramural phase of funding of the Career Transition Award, and up to a third additional year of intramural support to facilitate the transition to an extramural laboratory. Approval of the transition to the extramural support phase could be made at any time prior to the end of the second year of the intramural support phase. Whenever review and approval occur, the Scholar remains eligible for up to one additional year of intramural support. However, any remaining unused portion of the intramural support phase will not be carried over into the two-year extramural support phase. The Scholar must be accepted by an extramural institution which will submit an application for the extramural phase of support, using form PHS 2590, noncompeting application. The application must include the information outlined above under Review Criteria, Extramural Support Phase. The application submitted by the Scholar and the extramural institution for activation of the extramural phase of the program will be evaluated by NICHD extramural staff for completeness and responsiveness to the program. It will then be evaluated for scientific merit as described above. Second level review will be carried out by the National Advisory Child Health and Human Development Council. AWARD CRITERIA Funding decisions will be made based on the recommendations of the initial review group and the Council, 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. The opportunity to clarify any issues or address questions from potential applicants is welcome. Address inquiries regarding intramural programmatic issues to: Arthur S. Levine, M.D. Scientific Director National Institute of Child Health and Human Development Building 31, Room 2A50 Bethesda, MD 20892-2425 FAX: (301) 402-0105 Email: levinea@exchange.nih.gov Address inquiries regarding extramural programmatic issues and fiscal matters to: Yvonne T. Maddox, Ph.D. Deputy Director National Institute of Child Health and Human Development Building 31, Room 2A03 Bethesda, MD 20892-2425 FAX: (301) 402-1104 Email: maddoxy@exchange.nih.gov EVALUATION Intramural Support Phase Each Scholar 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 year 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 The NICHD Career Transition Award is made under the authority of Title III, Section 301 of the Public Health Service (PHS) Act as amended (Public Law 78-410, as amended, 42 USC 241). The Code of Federal Regulations, Title 42 Part 52, and Title 45 part 74, are applicable to this program. This program is described in the Catalog of Federal Domestic Assistance No. 93.121. 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 routing 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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