RUTH L. KIRSCHSTEIN NATIONAL RESEARCH SERVICE AWARDS FOR INDIVIDUAL PREDOCTORAL FELLOWS (F31) RELEASE DATE: December 08, 2003 PA NUMBER: PA-04-032 (Reissued as PA-07-002 as of October 6, 2006) (see NOT-EB-06-004 for policy clarification) EXPIRATION DATE: October 6, 2006 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) ( COMPONENTS OF PARTICIPATING ORGANIZATION: National Institute of Neurological Disorders and Stroke (NINDS) ( National Institute on Alcohol Abuse and Alcoholism (NIAAA) ( National Institute of Biomedical Imaging and Bioengineering (NIBIB) ( National Institute on Deafness and Other Communication Disorders (NIDCD) ( National Institute on Drug Abuse (NIDA) ( National Institute of Mental Health (NIMH) ( CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.272 (NIAAA), 93.286 (NIBIB), 93.173 (NIDCD), 93.278 (NIDA), 93.282 (NIMH), and 93.853 (NINDS) This program announcement supersedes PA-00-125, which appeared in the NIH Guide on July 25, 2000. THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose o Research training Objectives o Mechanism of Support o Eligibility Requirements o Eligible Sponsoring Institutions o Allowable Costs o Supplementation of Stipends, Compensation, and Other Income o Tax Liability o Service Payback o Leave Policies o Part Time Training o Other 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 The National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute of Biomedical Imaging and Bioengineering (NIBIB), the National Institute on Deafness and Other Communication Disorders (NIDCD), the National Institute on Drug Abuse (NIDA), the National Institute of Mental Health (NIMH), and the National Institute of Neurological Disorders and Stroke (NINDS) provide Ruth L. Kirschstein National Research Service Awards (Kirschstein-NRSA) to individuals for doctoral-level training. These Institutes award Kirschstein-NRSA individual predoctoral fellowships (F31) to promising applicants with the potential to become productive, independent investigators in their scientific mission areas. Each Institute has a unique scientific purview and different program goals and initiatives that evolve over time. Therefore, it is critical that all applicants consult the appropriate Institute website and contact the appropriate Institute office, both listed under Where to Send Inquiries, prior to preparing an application to obtain current information about each Institute's program priorities and policies with regard to fellowships. This action is of utmost importance since applications with marginal or no relevance to NIAAA, NIBIB, NIDCD, NIDA, NIMH, or NINDS programs will not be accepted for review or funding by the participating Institutes. RESEARCH TRAINING OBJECTIVES This program will provide predoctoral training support for doctoral candidates who have successfully completed their comprehensive examinations or the equivalent by the time of award and will be performing dissertation research and training. The applicant should provide evidence of potential for a productive research career based upon the quality of previous research training and academic record. The applicant must propose a dissertation research project and training program which falls into a research area within the scientific mission of the NIAAA, NIBIB, NIDCD, NIDA, NIMH, or NINDS. The research training experience must enhance the applicant’s conceptualization of research problems and research skills, under the guidance and supervision of a committed mentor who is an active and established investigator in the area of the applicant's proposed research. The research training program should be carried out in a research environment that includes appropriate human and technical resources and is demonstrably committed to the research training of the applicant in the program he/she proposes in the application. The application must include evidence that current and ongoing instruction in the principles of responsible conduct of research will be incorporated into the proposed research training plan (see below: Instructions in the Responsible Conduct of Research). MECHANISM OF SUPPORT The mechanism of support is the Kirschstein-NRSA individual predoctoral fellowship (F31) which is intended to provide biomedical or behavioral research training experiences to individuals committed to pursuing a career in research within the scientific missions of the participating Institutes. Women, minorities, and individuals with disabilities are encouraged to apply. Fellowship awardees are required to pursue their research training on a full- time basis, devoting at least 40 hours per week to the training program. The F31 fellowship supports research training applied toward preparation of a dissertation and does not support study leading to the M.D., D.O., D.D.S., Psy.D., or similar professional degrees unless it is part of a combined degree program such as the M.D./Ph.D. For those students who are pursuing a combined degree program, see the following programs: o NIDCD DUAL-DEGREE INDIVIDUAL PREDOCTORAL FELLOWSHIPS FOR TRAINING PHYSICIAN- SCIENTISTS: PA-01-122 o For NIAAA, NIDA, and NIMH: INDIVIDUAL PREDOCTORAL NATIONAL RESEARCH SERVICE AWARDS FOR M.D./PH.D. FELLOWSHIPS: PA-99-089 o NINDS MEDICAL STUDENT DUAL-DEGREE MD/PHD OR MD/MPH FELLOWSHIPS: PA-01-100 ELIGIBILITY REQUIREMENTS Citizenship: By the time of award, candidates for the predoctoral Kirschstein-NRSA fellowship award must be citizens or non-citizen nationals of the United States, or must 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. Individuals may apply for the F31 in advance of admission to the United States as a Permanent Resident recognizing that no award will be made until legal verification of Permanent Resident status is provided. Degree Requirements: Applicants must have received, as of the activation date of the award, a baccalaureate degree and must be enrolled in a program leading to a research doctorate such as the Ph.D. or D.Sc. Duration of Support: Individuals may receive up to 5 years of aggregate Kirschstein-NRSA support at the predoctoral level, including any combination of support from institutional training grants (T32) and individual fellowship awards (F31). However, it is not possible to have concurrent NRSA support (e.g., F31 and T32) during the same time period. Applicants must consider any prior NRSA predoctoral research training in determining the duration of fellowship support requested. Accurate information regarding previous Kirschstein-NRSA support must be included in the application and will be considered at time of award. Requests for support and recommendations of review committees are generally for two or three years of support for individual fellows conducting dissertation research and training. Training beyond the 5-year aggregate limit may be possible under rare and exceptional circumstances, but a waiver from the NIH awarding component is required. Individuals seeking additional Kirschstein-NRSA support beyond the fifth year are strongly advised to consult with relevant NIH staff before preparing a justification. Any waiver will require a detailed justification of the need for additional research training. Waiver requests should be made to program officials at the respective sponsoring NIH Institute prior to the termination date of the fellowship. Sponsor: 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 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 research support and facilities for high-quality research training. Foreign Sponsorship: Applicants requesting predoctoral fellowship support for foreign research training must show in the application that the foreign institution and sponsor offer unique opportunities and clear scientific advantages over positions currently available in the United States. ELIGIBLE SPONSORING INSTITUTIONS The sponsoring institution may be any of the following: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies and labs of the Federal government including NIH intramural labs o Domestic or foreign ALLOWABLE COSTS Stipends: Kirschstein-NRSA awards provide stipends to predoctoral fellows as a subsistence allowance to help defray living expenses during the research training experience. The awards are not provided as a condition of employment with either the Federal government or the sponsoring institution. For the current stipend levels, see the NIH website at The awarding NIH institute will adjust awards on the anniversary date of the fellowship award to ensure consistency with the stipend level in effect at that time. For fellows sponsored by domestic non-federal institutions, the stipend will be paid through the sponsoring institution. For fellows sponsored by Federal or foreign institutions, the monthly stipend payment will be deposited in the fellow's U.S. bank account or paid directly to the fellow by U. S. Department of Treasury check. Tuition and Fees: The NIH will reimburse 100 percent of the cost of tuition up to $3,000 and 60 percent of tuition costs above $3,000 for the predoctoral fellow. Tuition, for the purposes of this policy, means the combined cost of tuition, fees, and health insurance (see below). A full description of the tuition policy is contained within the NRSA section of the Grants policy statement at Health Insurance: Self only health insurance (available to fellows without families) or family health insurance (available to fellows with families) is an allowable cost for fellows at the awardee or sponsoring institution only if such self or family health insurance is required of all persons in a similar training status regardless of the source of support. Health insurance for predoctoral fellows who are eligible for this coverage is included in the calculation of the combined tuition, fees, and health insurance. Institutional Allowance: At the time of publication of this program announcement, predoctoral fellows receive an institutional allowance of $2,750 per 12-month period to nonfederal, nonprofit, or foreign sponsoring institutions to help defray such awardee expenses as research supplies, equipment, books, and travel to scientific meetings. This allowance is intended to cover training related expenses for the individual awardee, and is not available until the fellow officially activates the award. If an individual fellow is enrolled or engaged in training for less than 6 months of the award year, only one-half of that year's allowance may be charged to the grant. The Notice of Research Fellowship Award will be revised and the balance must be refunded to NIH. NIH will provide an institutional allowance of up to $1,650 for predoctoral fellows sponsored by Federal laboratories or for-profit institutions for expenses associated with travel to scientific meetings, health insurance, and books. For fellows at for-profit institutions, the $1,650 will be paid to the institution for disbursement to the fellow. Funds for fellows at Federal laboratories will be disbursed from the NIH awarding institute. The Institutional Allowance is adjusted from time-to-time. Prospective applicants are advised to check for the current Institutional Allowance in the most recent documentation related to NRSA stipends at Other Training Costs: Additional funds may be requested by the institution when the training of a predoctoral fellow involves extraordinary costs for travel to field sites remote from the sponsoring institution, or for accommodations for fellows who are disabled, as defined by the Americans With Disabilities Act. The funds requested for costs of this nature must be reasonable in relationship to the total dollars awarded under the fellowship and must be directly related to the approved research training experience. Such additional funds shall be provided only in exceptional circumstances that are fully justified and explained by the sponsoring institution. Awards for training at a foreign site may include a single economy or coach round-trip travel fare. No allowance is provided for dependents. U.S. flag air carriers must be used to the maximum extent possible when commercial air transportation is available for travel between the United States and a foreign country or between foreign countries. Funds are not provided to cover the cost of travel between the fellow's place of residence and a domestic training institution. However, in cases of extreme need or hardship, a one-way travel allowance may be authorized by the sponsoring institution. Such travel must be paid from the institutional allowance. Facilities and Administrative Costs. F&A (indirect) costs are not allowed on individual fellowship awards. SUPPLEMENTATION OF STIPENDS, COMPENSATION, AND OTHER INCOME The sponsoring institution is allowed to provide funds to the fellow in addition to the stipends paid by the NIH. Such additional amounts either may be in the form of augmented stipends (supplementation) or in the form of compensation, provided the conditions described below are met. Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the fellow's approved Kirschstein-NRSA training program. Stipend Supplementation: Supplementation or additional support to offset the cost of living may be provided by the sponsoring institution. Supplementation does not require additional effort from the fellow. DHHS funds may not be used for supplementation under any circumstances. Additionally, no funds from other Federal agencies may be used for supplementation unless specifically authorized by the NIH and the other Federal Agency. Compensation: The sponsoring institution may provide additional funds to a fellow in the form of compensation (as salary and/or tuition remission) for services such as teaching or serving as a research assistant. A fellow may receive compensation for services as a research assistant or in some other position on a Federal research grant, including a DHHS research grant. However, compensated services should occur on a limited, part-time basis apart from the normal research training activities, which require a minimum of 40 hours per week. In addition, compensation may not be paid from a research grant supporting the fellow's research training experience. Educational Loans or G.I. Bill: An individual may make use of Federal educational loan funds and assistance under the Veterans Readjustment Benefits Act (G.I. Bill). Such funds are not considered supplementation or compensation. Concurrent Awards: A Kirschstein-NRSA fellowship may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of this award. TAX LIABILITY Section 117 of the Internal Revenue Code applies to the tax treatment of all scholarships and fellowships. Under that section, non-degree candidates are required to report as gross income any monies paid on their behalf for stipends, or any course tuition and fees required for attendance. Degree candidates may exclude from gross income (for tax purposes) any amount used for tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization. The taxability of stipends, however, in no way alters the relationship between Kirschstein-NRSA trainees or fellows and their institutions. Kirschstein-NRSA stipends are not considered salaries. In addition, trainees supported under the Kirschstein-NRSA are not considered to be in an employee- employer relationship with the NIH or the awardee institution. It is therefore inappropriate and unallowable for institutions to charge costs associated with employment (such as FICA, workman's compensation, or unemployment insurance) to the fellowship award. It must be emphasized that the interpretation and implementation of the tax laws are the domain of the Internal Revenue Service (IRS) and the courts. The NIH takes no position on the status of a particular taxpayer, and it does not have the authority to dispense tax advice. Individuals should consult their local IRS office about the applicability of the law to their situation and for information on their tax obligations. SERVICE PAYBACK Recipients of Kirschstein-NRSA predoctoral support do not incur service payback. LEAVE POLICIES In general, fellows may receive stipends during the normal periods of vacation and holidays observed by individuals in comparable training positions at the sponsoring institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training and is not considered to be a vacation or holiday. Fellows may receive stipends for up to 15 calendar days of sick leave per year. Sick leave may be used for the medical conditions related to pregnancy and childbirth. Fellows may also receive stipends for up to 30 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable training positions at the grantee institution have access to paid leave for this purpose and the use of parental leave is approved by the program director. A period of terminal leave is not permitted and payment may not be made from fellowship funds for leave not taken. Fellows requiring periods of time away from their research training experience longer than specified here must seek approval from the NIH awarding component for an unpaid leave of absence. PART-TIME TRAINING Under unusual and pressing personal circumstances, a fellow may submit a written request to the awarding component to permit less than full-time training. Such requests will be considered on a case-by-case basis. They must be approved by the awarding NIH Institute or Center in advance for each budget period. The nature of the circumstances requiring the part-time training might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission for part-time training will not be approved to accommodate other sources of funding, job opportunities, clinical practice, clinical training, or for other responsibilities associated with the fellow's position at the institution. In each case, the fellow must submit a written request countersigned by the sponsor and an appropriate institutional business official that includes documentation supporting the need for part-time training. The written request also must include an estimate of the expected duration of the period of part-time training, an assurance that the fellow intends to return to full-time training when that becomes possible, and an assurance that the trainee intends to complete the proposed research training program. In no case will it be permissible for the fellow to be engaged in Kirschstein-NRSA supported research training for less than 50 percent effort. Individuals who must reduce their commitment to less than 50 percent effort must take a leave-of-absence from Kirschstein-NRSA fellowship support. The fellowship notice of award will be reissued and the stipend will be pro-rated during the period of any approved part-time training. OTHER SPECIAL REQUIREMENTS Fellowships must be administered in accordance with the current NRSA section of the Grants Policy Statement at, and any terms and conditions specified on the award notice. Certification and Reporting Procedures: No application will be accepted without the applicant signing the certification block on the face page of the application. Individuals admitted to the United States as permanent residents must submit notarized evidence of legal admission prior to the award. When support ends, the fellow must submit a Termination Notice (PHS 416-7) to the NIH. Forms may be found on the NIH Website at Inventions and Publications: Fellowships made primarily for educational purposes are exempted from the PHS invention requirements. F31 awards will not contain any provision giving the PHS rights to inventions made by the awardee. Copyrights: Except as otherwise provided in the terms and conditions of the award, the recipient is free to arrange for copyright without approval when publications, data, or other copyrightable works are developed in the course of work under a PHS grant-supported project or activity. Any such copyrighted or copyrightable works shall be subject to a royalty-free, nonexclusive, and irrevocable license to the Government to reproduce, publish, or otherwise use them, and to authorize others to do so for Federal Government purposes. WHERE TO SEND INQUIRIES Inquiries are strongly encouraged. Prospective applicants should visit each Institute's website in order to obtain current information about the scientific missions, program priorities, research topics of interest, and policy guidelines: NIAAA: NIBIB: NIDCD: NIDA: NIMH: NINDS: Direct inquiries regarding specific programmatic issues to the appropriate institute representative listed below: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM Laurie Foudin, Ph.D. Division of Metabolism and Health Effects National Institute on Alcohol Abuse and Alcoholism 6000 Executive Blvd., Room 402, MSC 7003 Bethesda, MD 20892-7003 Telephone: 301-443-0912 FAX: (301) 594-0673 Email: NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING Meredith D. Temple-O Connor, Ph.D. Acting Director, Division of Interdisciplinary Training National Institute of Biomedical Imaging and Bioengineering National Institutes of Health/DHHS 6707 Democracy Boulevard, Suite 200 Bethesda, MD 20892-5477 Telephone: (301) 451-4792 FAX: (301) 480-1614 Email: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS Daniel A. Sklare, Ph.D. Division of Scientific Programs National Institute on Deafness and Other Communication Disorders 6120 Executive Blvd., Room 400C, MSC-7180 Bethesda, MD 20892-7180 Telephone: (301) 496-1804 FAX: (301) 402-6251 Email: NATIONAL INSTITUTE ON DRUG ABUSE Suman A. Rao, Ph.D. Deputy Research Training Coordinator Office of Science Policy and Communications National Institute on Drug Abuse 6001 Executive Blvd. Room 5230, MSC 9591 Bethesda, MD 20892 301-443-6071 301-443-6277 (FAX) M. Beth Grigson Babecki, M.A. Deputy to Training Coordinator Division of Neuroscience and Behavioral Research National Institute on Drug Abuse 6001 Executive Blvd. Room 4282, MSC 9555 Bethesda, MD 20892 301-435-0899 301-594-6043 (FAX) Paul A. Coulis, Ph.D. Center on AIDS and other Medical Consequences of Drug Abuse (CAMCODA) National Institute on Drug Abuse 6001 Executive Blvd. Room 5199, MSC 9593 Bethesda, MD 20892 301-443-2105 301-594-6566 (FAX) Jamie Biswas, Ph.D. Chief, Medications Research Grants Branch National Institute on Drug Abuse 6001 Executive Blvd. Room 4123, MSC 9551 Bethesda, MD 20892 301-443-8096 301-443-9649 (FAX) Aria Crump, Sc.D. Division of Epidemiology, Services, and Prevention Research National Institute on Drug Abuse 6001 Executive Boulevard, Room 5153, MSC 9589 Bethesda, MD 20892-9589 Telephone: (301) 435-0881 FAX: (301) 480-2542 Email: NATIONAL INSTITUTE OF MENTAL HEALTH Mary F. Curvey Division of Neuroscience and Basic Behavioral Science National Institute of Mental Health 6001 Executive Boulevard, Room 7211, MSC 9647 Bethesda, MD 20892-9647 Telephone: (301) 443-3107 FAX: (301) 443-1731 Email: Nancy L Desmond, Ph.D. Division of Neuroscience and Basic Behavioral Science National Institute of Mental Health 6001 Executive Boulevard, Room 7197, MSC 9645 Bethesda, MD 20892-9645 Telephone: (301) 443-3563 FAX: (301) 443-1731 Email: Mark Chavez, Ph.D. Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6219, MSC 9621 Bethesda, MD 20892-9621 Telephone: (301) 443-9700 FAX: (301) 443-6000 Email: Fred Altman, Ph.D. Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6220, MSC 9621 Bethesda, MD 20892-9621 Telephone: (301) 443-9700 FAX: (301) 443-6000 Email: Enid Light, Ph.D. Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Room 7160, MSC 9635 Bethesda, MD 20892-9635 Telephone: (301) 443-3599 FAX: (301) 594-6784 Email: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE NINDS Training and Career Development Officer National Institute of Neurological Disorders and Stroke 6001 Executive Blvd., Room 2154 Bethesda, MD 20892-9531 Telephone: (301) 496-4188 FAX: (301) 402-4370 Email: Direct inquiries regarding fiscal matters to: Judy Fox Chief, Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Room 504, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4704 FAX: (301) 443-3891 Email: Florence Turska Grants Management Specialist Grants Management Branch National Institute of Biomedical Imaging and Bioengineering National Institutes of Health/DHHS 6707 Democracy Boulevard, Suite 900, MSC 5469 Bethesda, MD 20892-5469 Telephone: (301) 496-9314 FAX: (301) 480-4974 Email: Sherry Dabney Grants Management Branch Division of Extramural Activities National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400C 6120 Executive Blvd., MSC-7180 Bethesda, MD 20892-7180 (for regular mail) Rockville, MD 20852 (for express/courier mail) Telephone: (301) 402-0909 FAX: (301) 402-1758 Email: Daisey Parker Grants Management Specialist National Institute on Drug Abuse 6101 Executive Blvd, Suite 242, MSC 8403 Bethesda, MD 20892 Telephone: 301-443-6710 Fax: 301-594-6849 Overnight Delivery Address: 6101 Executive Blvd, Suite 242 Rockville, MD 20852 Rebecca Claycamp Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6122, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-2811 FAX: (301) 443-6885 Email: Michael Loewe Grants Management Branch National Institute of Neurological Disorders and Stroke 6001 Executive Blvd., Room 3290 Bethesda, MD 20892-9537 Telephone: (301) 496-9231 FAX: (301) 402-0219 Email: SUBMITTING AN APPLICATION Individuals must submit the application using the Ruth L. Kirschstein National Research Service Award Individual Fellowship Form (PHS 416-1, rev. 06/02) available at Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at The DUNS number should be entered on line 12 of the face page of the PHS 416-1 form. For further assistance contact GrantsInfo, telephone (301) 710-0267, email: APPLICATIONS MUST INCLUDE AT LEAST THREE SEALED LETTERS OF REFERENCE. APPLICATIONS WITHOUT AT LEAST THREE LETTERS OF REFERENCE MAY BE RETURNED OR DELAYED IN REVIEW. If the applicant has been lawfully admitted to the United States for permanent residence, the appropriate item should be checked on the Face Page of the application. Applicants who have applied for and have not yet been granted admission as a permanent resident should check the Permanent Resident block on the Face Page of the PHS 416-1 application, and also write in the word "pending." A notarized statement documenting legal admission for permanent residence must be submitted prior to the issuance of an award. The applicant should identify the number of this Program Announcement (PA) in Item 3. Instructions in the Responsible Conduct of Research: Applications must include the candidate's plans for obtaining instruction in the responsible conduct of research, including the rationale, subject matter, appropriateness, format, frequency and duration of instruction. The amount and nature of faculty participation must be described. Although the NIH has not established specific curriculum or format requirements for this training, it is suggested that the following topics be covered: conflict of interest, data sharing, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal subjects, and data management. Applications without plans for training in responsible conduct of research will be considered incomplete and may be returned without review. No award will be made if an application lacks this component. Instructions Regarding Human Subjects Research: If the proposed research involves human subjects, the applicant must be responsive to the instructions in the form PHS 416-1 (revised 6/02). The adequacy of plans to include appropriate human subjects is included in the fellowship evaluation (see Additional Review Criteria below). Note that NIH defines children as individuals under 21 years of age. To comply with the Inclusion of Children Policy, however, all relevant age groups need to be addressed. Hence, inclusion of individuals from 18-21 does not automatically satisfy the requirement to include children. Consult the decision tree for the exemptions that apply: APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates for individual NRSA fellowships described at (see also Schedule below). The Center for Scientific Review (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. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. Normally the complete review process takes between 5 and 8 months. Schedule: (NOTE: The earlier start date months in the range accommodate the NIDCD’s planned expedited review/award schedule) Application Receipt Dates: Apr 5 Aug 5 Dec 5 For AIDS Related Applications: May 1 Sept 1 Jan 2 Initial Review Dates: Jun/Jul Oct/Nov Feb/Mar Earliest Start Dates: Aug-Dec Dec-March April-June INCOMPLETE APPLICATIONS WILL NOT BE REVIEWED Submit a signed, typewritten original of the application (including the Checklist, Personal Data form, AT LEAST THREE SEALED REFERENCE LETTERS, and all other required materials) and two (2) exact, clear, single-sided photocopies of the signed application, 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) All applications submitted to the Center for Scientific Review must come via United States Postal Service or a recognized delivery/courier service. Individuals may not personally deliver packages to the building on Rockledge Drive. For further information please see Note: Applicants submitting applications that are within the scientific purview of the NIDCD should send, at the time of submission, one of these copies and all sets of appendix materials, if any, to: Chief, Scientific Review Branch Division of Extramural Research National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-C - MSC-7180 Bethesda, MD 20892-7180 Telephone: (301) 496-8683 ATTN: NRSA predoctoral fellowship PEER REVIEW PROCESS Complete applications will be assigned to the appropriate participating Institute and a suitable Scientific Review Group (SRG) in the Center for Scientific Review (CSR) or in the assigned NIH Institute or Center. Applicants will be notified by mail of their application's Institute and SRG assignment. Applications receive two sequential levels of review. The first level is an assessment of the merit of the research training by an SRG, composed primarily of non-government scientists selected for their competence in research and research training in a scientific area related to the application. Shortly after the SRG meeting, applicants will be notified by mail of the SRG recommendation and the name and phone number of the Institute program official responsible for the application. After the SRG meeting, the Scientific Review Administrator (SRA), a designated Federal official, who coordinates the review of applications for the SRG, prepares a written summary of the review of each application and forwards it to the appropriate NIH Institute. When the program official representing the Institute receives the written summary of the review, prepared by the SRA after the review meeting, a copy will be forwarded to the applicant. Staff within the assigned funding Institute or Center provides a second level of review. Following the second-level review, the program official will notify applicants within the funding range of the final disposition of the application. Any questions on SRG recommendations and funding possibilities should be directed to the appropriate Institute program official, not the Scientific Review Administrator of the SRG. REVIEW CRITERIA The F31 individual predoctoral fellowship is designed to train future generations of outstanding scientists committed to pursuing research careers relevant to the missions of the participating NIH Institutes. The review of an application will focus on the following: the applicant, the research training plan, the sponsor, and the institutional environment/commitment. Information from the letters of reference will be used by the review committee in their consideration of these factors, and the final priority score will reflect the overall evaluation of the entire application. Applicant: o the applicant's potential for, and commitment to, a productive scientific career. The reviewers may take into account the applicant's history as a student, as well as past and current involvement in research activities. Research Training Plan: o objectives, design, and direction of the proposed research program; o soundness and feasibility of the experimental approach and methodology proposed to carry out the research; o specificity and clarity of the description of the research skills and knowledge to be acquired; o overall coherence and potential of the research training plan to provide the fellow with individualized supervised experiences that will develop research skills; o clarity, completeness, originality, and significance of the goals of the proposed research training plan; o adequacy of knowledge and presentation of relevant literature and current methods in the proposed research area; o potential of proposed research training to serve as a sound foundation that will lead the applicant to a productive research career in scientific areas related to alcohol abuse and alcoholism, biomedical imaging and/or bioengineering, deafness and other communication disorders, drug abuse and addiction, mental health, or neurological disorders and stroke research; o adequacy of plans for the protection of human subjects, animals, or the environment, to the extent they may be adversely affected by the research proposed; o adequacy of plans to include women, children and minorities as subjects in research, if applicable; o adequacy of plans to provide training in the responsible scientific conduct of research. Sponsor: o caliber of the sponsor as a researcher, including successful competition for research support; o evidence of the proposed sponsor's understanding of and commitment to fulfilling the role of sponsor and mentor; o evidence of an understanding of the applicant's research training needs and a demonstrated ability, on the part of the sponsor, to assist in meeting those needs; o past research training record of the sponsor in terms of the rate at which former predoctoral trainees obtain their doctoral degree and go on to postdoctoral or other scientific careers. Institutional Environment/Commitment: o training environment, including the institutional commitment to research training and career development, the quality of the facilities and related resources (e.g., equipment, laboratory space, computer time, subject populations) and the availability of research support. Additional Review Criteria: In addition to the above criteria, the following items may be considered in the determination of scientific merit and the priority score: o Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). o Inclusion of Women, Minorities and Children in research: 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 will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). o Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described on page 21 of the PHS 416-1 fellowship application instructions (rev. 6/2002) will be assessed (see AWARD CRITERIA The responsibility for award decisions resides solely with authorized program staff of the Institutes. The following criteria will be used in making award decisions: (1) overall merit of the application; (2) relevance of the application to the research priorities and mission of the awarding institute and programs; and (3) availability of funds. Activation: No funds may be disbursed until the fellow has started training under the award and an Activation Notice (PHS 416-5) has been submitted to the NIH. An awardee has up to 6 months from the issue date on the award notice to activate the award. Under unusual circumstances, an NIH institute may grant an extension of the activation period upon receipt of a specific request from the fellow. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: 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 "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 (; a complete copy of the updated Guidelines is available at 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 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 HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at and at Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, 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 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 AUTHORITY AND REGULATIONS Kirschstein-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. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at 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 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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