INDIVIDUAL POSTDOCTORAL NRSA FELLOWSHIPS IN CLINICAL PHARMACOLOGY Release Date: March 30, 1999 PA NUMBER: PA-99-078 P.T. National Institute of General Medical Sciences PURPOSE Progress in drug and therapeutic development in recent years has increased the need for clinically trained scientists with an understanding and knowledge of drug action in humans. In response, the NIGMS announces the availability of individual NRSA postdoctoral fellowships to support high quality physicians seeking research training in the field of clinical pharmacology. These fellowships are intended to support up to three years of advanced training to individuals with the M.D. degree to qualify them to perform basic laboratory and/or clinical investigations of the effects and mechanisms of drug actions in humans, in the scientific areas consistent with the mission of NIGMS. One goal of this initiative is to promote high quality clinical pharmacology research training at academic health centers. Therefore, a special feature of this award is to encourage applicants at institutions with a General Clinical Research Center (GCRC) supported by the National Center for Research Resources (NCRR) to submit a letter of endorsement from the director of the training institution's GCRC. The intent is to promote interaction between the applicant and the staff and director of the GCRC, expose the applicant to the extensive resources and rich research environment of the GCRC, and to raise the visibility of this important area of translational research within the institution. 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), Individual Postdoctoral NRSA Fellowships in Clinical Pharmacology, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2000" at http://www.crisny.org/health/us/health7.html. ELIGIBILITY REQUIREMENTS Candidate: The candidate must have an M.D. degree or its equivalent, and must meet the criteria for the NIH National Research Service Awards For Individual Postdoctoral Fellows (F32) described in program announcement PA-99-025, available in the NIH Guide for Grants and Contracts (release date December 11, 1998; available at http://www.nih.gov/grants/guide/pa-files/PA-99-025.html). Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply. By the time of award, individuals must be citizens or non- citizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence (i.e., possess a currently valid Alien Registration Receipt Card I-551, or other legal verification of such status). Non-citizen nationals are generally persons born in outlying possessions of the United States (i.e., American Samoa and Swains Island). Individuals on temporary or student visas are not eligible. Sponsorship: Before submitting a fellowship application, the applicant must identify a sponsoring institution and an individual who will serve as a sponsor (also called mentor or supervisor) and will supervise the training and research experience. The sponsoring institution may be private (profit or nonprofit) or public, including the NIH Intramural Programs and other Federal laboratories. The applicant's sponsor should be an active investigator in the area of the proposed research who will directly supervise the candidate's research. The sponsor must document the availability of staff, research support, and facilities for high-quality research training. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) Individual Postdoctoral NRSA Fellowship Award (F32) mechanism. The total project period for an application submitted in response to this PA may not exceed a total of three years. The requested project period should be reduced by the amount of time a fellow has received support on any prior NRSA post-doctoral support, including Institutional NRSA Training Grants (e.g., T32s). For further information refer to the NIH Guidelines for the NIH National Research Service Awards for Individual Postdoctoral Fellows (F32) published in the NIH Guide for Grants and Contracts (PA-99-025) http://www.nih.gov/grants/guide/pa-files/PA-99-025.html RESEARCH OBJECTIVES The overall goal of this research training initiative is to increase the number of clinician scientists trained to investigate questions in clinical pharmacology, and to advance the scientific knowledge of this field. A secondary goal is to enhance the visibility of this discipline at U.S. academic health centers and encourage interaction of applicants with NIH-supported General Clinical Research Centers (GCRC). NIGMS supports individual postdoctoral fellowships in those areas covered by its research grant portfolio. More detailed information of research areas supported by the NIGMS can be found on the NIGMS homepage (http://www.nih.gov/nigms/). 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 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 available on the web at the following URL address: https://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 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 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 Applications are to be submitted on the form PHS 416-1 (rev. 8/95) available at: http://www.nih.gov/grants/forms.htm. Application kits are available from 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 20892-7710, telephone (301) 710-0267, email: grantsinfo@nih.gov. Information on the current stipend levels may be found at: http://www.nih.gov/grants/guide/notice-files/not98-161.html. Applications for fellowship awards must include at least three sealed letters of reference. Fellowship applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applicants at institutions with a NIH-supported GCRC are encouraged to include a letter of support from the GCRC program director with the application. All individual fellowship applications are on an expedited review schedule. Receipt dates for applications are April 5, August 5, and December 5 annually. The earliest dates that awards can be made are November, January, and May, respectively. The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. The original and two copies of the application must be submitted 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) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications submitted in response to this program announcement will be reviewed in accordance with the standard NIH peer review procedures. The following factors are considered in the review of fellowship applications: (1) the candidate's potential for a research career; (2) the scientific or scholarly merit and training potential of the research proposal; (3) the training environment and resources; and (4) assessment of the value of the proposed fellowship experience. The second level of review is performed by the appropriate oversight group of the NIH awarding component. AWARD CRITERIA Applications will compete for available training funds with all other approved fellowship applications. The following will be considered in making funding decisions: quality of the fellowship application as determined by peer review, availability of funds, and program priority. Applications with letters of support from GCRC directors will receive special consideration. INQUIRIES Inquiries are strongly encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Alison E. Cole, Ph.D. Division of Pharmacology, Physiology and Biological Chemistry National Institute of General Medical Sciences 45 Center Drive, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-1826 FAX: (301) 480-2802 Email: colea@nigms.nih.gov Direct inquiries regarding fiscal matters to: Ms. Antoinette Holland Grants Management Office National Institute of General Medical Sciences 45 Center Drive, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-5132 FAX: (301) 480-3423 Email: hollandt@nigms.nih.gov AUTHORITY AND REGULATIONS NRSA awards are made under the authority of Section 487 of the Public Health Service Act as amended (42 USC 288) and Title 42 of the Code of Federal Regulations, Part 66. The Catalog of Federal Domestic Assistance Number is 93.859. 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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