Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)

Components of Participating Organizations
National Institute on Aging (NIA), http://www.nia.nih.gov
National Institute on Alcohol Abuse and Alcoholism (NIAAA), http://www.niaaa.nih.gov
National Institute on Deafness and Other Communication Disorders (NIDCD), http://www.nidcd.nih.gov
National Institute on Drug Abuse (NIDA), http://www.nida.nih.gov
National Institute of Dental and Craniofacial Research (NIDCR) http://www.nidcr.nih.gov/
National Institute of Mental Health (NIMH), http://www.nimh.nih.gov
National Institute of Neurological Disorders and Stroke (NINDS), http://www.ninds.nih.gov
Office of Dietary Supplements (ODS),
http://ods.od.nih.gov

Title: Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral Fellows (F31)

Announcement Type
This is a reissue of PA-04-032 that was previously released December 8, 2003.

Note: The PHS 416-1 (rev. 9/2008) must be used for December 2008 application receipt dates. See also: NOT-OD-09-004.

Update: The following updates relating to this announcement have been issued:

Looking ahead: As part of the Department of Health and Human Services' implementation of e- Government during FY 2006, the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts. Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) are required. Investigators should consult the NIH Forms and Applications Web site for the most current information when preparing a grant application.

Program Announcement (PA) Number: PA-07-002

Catalog of Federal Domestic Assistance Number(s)
93.866, 93.272, 93.286, 93.173, 93.279, 93.282, 93.853

Key Dates
Release Date: October 6, 2006
Application Receipt Date(s): Standard dates for Individual Kirschstein-NRSA awards apply: see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
AIDS Application Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS for details.
Peer Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
Council Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
Earliest Anticipated Start Date(s): see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
Expiration Date: New Date June 12, 2009 (per issuance of PA-09-208) Original Date: January 3, 2008 - (New Expiration Date January 8, 2010 per NOT-OD-08-069)
(Extended to August 9, 2008 per NOT-OD-08-011)
(now January 8, 2008 per NOT-OD-07-093)

Due Dates for E.O. 12372
Not applicable

Additional Overview Content

Executive Summary

The objective of this funding opportunity announcement is to help ensure that highly trained scientists will be available in adequate numbers and in appropriate research areas to carry out the Nation’s biomedical, behavioral, and clinical research agenda. The participating Institutes of the National Institutes of Health (NIH) provide individual predoctoral research training fellowship awards to promising doctoral candidates who have the potential to become productive, independent investigators in research fields relevant to the missions of these participating NIH Institutes and Centers.

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Training Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Training Objectives

The purpose of the Ruth L. Kirschstein National Research Service Award Act (NRSA) is to help ensure that diverse pools of highly trained scientists will be available in adequate numbers and in appropriate research areas to carry out the Nation's biomedical, behavioral, and clinical research agendas. The objective of the Kirschstein-NRSA Individual Predoctoral Fellowship (F31) is to provide support for promising doctoral candidates who will be performing dissertation research and training in scientific health-related fields relevant to the missions of the participating NIH Institutes during the tenure of the award. The Kirschstein-NRSA for Individual Predoctoral Fellows will provide up to five years of support for research training which leads to the Ph.D. or equivalent research degree, the combined M.D./Ph.D. degree, or another formally combined professional degree and research doctoral degree in the biomedical, behavioral, or clinical sciences.

Research Training Program

Applicants for the Kirschstein-NRSA F31 award must propose a dissertation research project and training program that fall in a research area within the scientific mission of the participating Institutes. The proposed predoctoral research training must offer an opportunity to enhance the fellow's understanding of the health-related sciences and extend his/her potential for a productive, independent research career. The application should document the need for the proposed research training and the expected value of the proposed fellowship experience as it relates to the individual’s goals for a career as an independent researcher.

Fellowship awardees are required to pursue their research training on a full-time basis, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies. An NRSA fellowship may not be used to support studies leading to the M.D., D.O., D.D.S., D.V.M., or other similar professional/clinical doctoral degree.

The sponsoring institution must have adequate faculty and facilities available to provide a suitable research environment for a high-quality research training experience. The proposed research training experience must enhance the applicant’s conceptualization of research problems and research skills. The sponsor should be an active investigator in the proposed area of research, and be committed both to the research training of the applicant and to the direct supervision of the applicant’s research. Applicants are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research and training program. In such cases, one individual must be identified as the principal sponsor who will oversee and coordinate the applicant’s research training program. The primary sponsor, or a member of the mentoring team, should have a successful track record in mentoring predoctoral students. The research training should occur in a research-intensive environment that has appropriate human and technical resources and is demonstrably committed to research training in the particular program proposed by the applicant.

Each participating NIH Institute has a unique scientific purview and different program goals and initiatives that evolve over time. Prior to preparing an application, it is critical that all applicants consult the appropriate Institute website (listed with each Institute's name at the beginning of this announcement) for details of research areas supported by that Institute and contact the appropriate Institute representative listed in Section VII (http://grants.nih.gov/archive/grants/guide/contacts/pa-07-002_contacts.htm to obtain current information about Institute-specific program priorities and policies. This action is of utmost importance because applications that do not fall within the current mission interests of the participating Institutes will not be accepted.

See Section VIII, Other Information - Required Federal Citations for policies related to this announcement.

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the Ruth L. Kirschstein NRSA individual predoctoral fellowship award mechanism (F31). As an applicant, the candidate, together with his/her sponsor and institution, are jointly responsible for planning, directing, and executing the proposed project.

A Kirschstein-NRSA 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., D.V.M., Psy.D or other similar professional degree unless it is part of a combined degree program such as the M.D./Ph.D.

2. Funds Available

Although the financial plans of the participating IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the receipt of a sufficient number of meritorious applications, the program priorities of the participating NIH Institutes, and the availability of funds.

This NRSA mechanism provides a stipend, tuition and fees, and an institutional allowance. For information see: http://grants.nih.gov/training/nrsa.htm, NIH Notice NOT-OD-06-026, released January 9, 2006, and NIH Notice NOT-OD-06-093, released August 18, 2006.

Stipends: Ruth L. Kirschstein-NRSA F31 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. At the time of release of this announcement, the predoctoral stipend for Fiscal Year (FY) 2006 was $20,772. The current stipend schedule can be found at http://grants.nih.gov/training/nrsa.htm and the NIH Notice NOT-OD-06-026 released January 9, 2006. The awarding NIH Institute will adjust awards on the anniversary date of the fellowship award to ensure consistency with the stipend schedule in effect at that time. No departure from the published Kirschstein-NRSA stipend schedule may be negotiated between the institution and the fellow.

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 contribute to the combined cost of tuition and fees at the rate in place at the time of award. Beginning with competing individual NRSA awards made in FY2007, the NIH will provide an amount per individual fellow equal to 60% of the level requested by the applicant institution, up to $16,000 per year for individuals enrolled in a doctoral degree program and up to $21,000 per year for those individuals enrolled in a dual degree (e.g. M.D./Ph.D.) program. Tuition, for the purposes of this policy, means the combined costs of tuition and fees. A full description of the tuition policy is contained within the NRSA section of the Grants Policy Statement at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600187 and NOT-OD-06-093.

Institutional Allowance: Beginning with competing individual NRSA awards made in FY2007, the institutional allowance category will be modified to include health insurance as an allowable expense. Predoctoral fellows will receive an institutional allowance of $4,200 per 12-month period to nonfederal or nonprofit sponsoring institutions (domestic or foreign) to help defray fellowship expenses such as health insurance, research supplies, equipment, books, and travel to scientific meetings. 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 applied consistently to all persons in a similar training status regardless of the source of support. 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 six months of the award year, only one-half of that year's allowance may be charged to the grant.

At the time of publication of this funding opportunity announcement, NIH will provide an institutional allowance of up to $3,100 for fellows sponsored by Federal laboratories or for-profit institutions for expenses associated with health insurance, travel to scientific meetings and books. For fellows at for-profit institutions, the $3,100 will be paid to the institution for disbursement to the fellow.

Funds are not available to cover the costs of travel between the fellow’s place of residence and a training institution. However, in an individual case of extreme hardship, a one-way travel allowance may be authorized by the sponsoring institution. Such travel must be paid from the institutional allowance.

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 Kirschstein-NRSA stipends at http://grants.nih.gov/training/nrsa.htm.

Other Training Costs: Additional funds may be requested by the institution when the training of a 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 (ADA). In all cases, the additional funds requested 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 in the application.

Applications that include 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 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.

Facilities and Administrative Costs: Facilities and administrative 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 in accordance with its own formally established policies governing stipend support. These policies must be consistently applied to all individuals in a similar status, regardless of the source of funds. 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 full-time research training activities. In addition, compensation may not be paid from a research grant supporting the fellow's research training experience.

A full description of the policy for stipend supplementation and compensation is located in the NIH Grants Policy Statement at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

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.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

The sponsoring institution must have adequate faculty and facilities available on site to provide a suitable environment for performing high-quality research training.

Applicants requesting fellowship support for foreign research training must demonstrate in the application that the foreign institution and sponsor offer unique opportunities and clear scientific advantages that are not currently available in the United States. Only if there is a clear scientific advantage will foreign training be supported.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research training is invited to work with his/her sponsor and institution to develop an application for support. Individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds may also be eligible to apply for the Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral Fellowships (F31) to Promote Diversity in Health-Related Research (PA-06-481).

The applicant must be at the dissertation research stage of their training and must show evidence of both high academic performance in the sciences and substantial interest in a research area of high priority to the participating Institutes.

Participating Institutes may have different eligibility requirements for individuals applying for a Kirschstein-NRSA F31 award. Additional information and requirements specific to a particular Institute are located at the F31 contact website (http://grants.nih.gov/archive/grants/guide/contacts/pa-07-002_contacts.htm ).

Citizenship: By the time of award, the individual applicant must be a citizen or a non-citizen national of the United States or have been lawfully admitted 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 Kirschstein-NRSA 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: An applicant must have a baccalaureate degree and be currently enrolled in a Ph.D. or equivalent research degree program (e.g., Eng.D., D.N.Sc., Dr. P.H., D.S.W., Pharm.D., Psy.D., Sc.D.), a formally combined M.D./Ph.D. program, or other combined professional/clinical doctoral/research Ph.D. graduate program (e.g., D.D.S./Ph.D.) in the biomedical, behavioral, or clinical sciences at an accredited domestic or foreign institution. With the exception of the combined degree programs described above, the Kirschstein-NRSA F31 may not be used to support studies leading to the M.D., D.D.S., or other clinical, health-professional training (e.g., D.C., D.M.D., D.N.P., D.O., D.P.M., D.V.M., N.D., O.D.).

Students seeking support for pursuit of a combined degree program (e.g. M.D./Ph.D.) may be eligible to apply for the Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral MD/PhD Fellows (F30) (PA-05-151).

2. Cost Sharing or Matching

There is no required cost sharing.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

An individual may not have two or more competing NIH fellowship applications pending review concurrently. In addition, the Center for Scientific Review (CSR) will not accept for review any application that is essentially the same as one already reviewed. This does not preclude the submission of a revision of an application already reviewed, but such applications must include an Introduction addressing the previous critique.

Duration of Support: Individuals may receive up to five years of aggregate Kirschstein-NRSA support at the predoctoral level, including any combination of support from an institutional training grant (e.g., T32 or T90) and an individual fellowship award (F31). However, it is not possible to have concurrent Kirschstein-NRSA support from two different sources (e.g., F31 and T32). Applicants must consider any prior Kirschstein-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 the time of award. The duration of support requested should be appropriate for the applicant’s proposed research training program. While individuals are eligible to receive up to five years of predoctoral Kirschstein-NRSA support, applicants typically request, and review committees generally recommend, two or three years of support during the phase of dissertation research and training.

Fellowship awardees are required to pursue their research training on a full-time basis, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies.

Continuation of the fellowship award for each subsequent year beyond the first award period is based upon evidence of satisfactory progress in the predoctoral research training program.

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 submitting a justification. Any waiver will require a detailed justification of the need for additional research training. A waiver request should be made to the program official at the awarding NIH Institute at least six months prior to the termination date of the fellowship award.

Sponsor: Before submitting a fellowship application, the applicant must identify a sponsoring institution and an individual who will serve as the applicant’s sponsor (also called mentor or supervisor) and who will supervise the training and research experience. The sponsor should be an active investigator in the proposed area of research, and be committed both to the research training of the applicant and to the direct supervision of the applicant’s research. The sponsor must document the availability of sufficient research support and facilities for high-quality research training at the institution. The sponsor, or a member of the mentoring team, should have a successful track record of mentoring predoctoral students. Applicants are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research and training program. In such cases, one individual must be identified as the principal sponsor who will oversee and coordinate the applicant’s research training program. The applicant must work with his/her sponsor(s) in preparing the application.

Sponsoring Institution: The sponsoring institution must have appropriate faculty and facilities available on site to provide a suitable environment for performing high-quality research training.

Foreign Training: Applicants requesting foreign research training are required to provide detailed justification for the foreign training, including the reasons why the facilities, the sponsor, or other aspects of the proposed experience are more appropriate than training in a domestic setting. The justification is evaluated in terms of the scientific advantages of the foreign training as compared to the training available domestically. Foreign training will be considered for funding only when unique opportunities and the scientific advantages are clear. Applicants seeking training abroad are encouraged to contact the relevant participating Institute prior to preparing an application (http://grants.nih.gov/archive/grants/guide/contacts/pa-07-002_contacts.htm).

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 416-1 (Rev. 10/2005) application instructions are available at http://grants.nih.gov/grants/funding/416/phs416.htm#forms in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. Note that the PHS 416-1 has been restructured (Rev. 10/2005) and the instructions have been significantly modified. See the NIH Notice released December 9, 2005.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the Ruth L. Kirschstein National Research Service Award Individual Fellowship Application Form PHS 416-1 (Rev. 10/2005). 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 D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 13b of the face page of the PHS 416-1 form (Rev. 10/2005).

The title and number of this funding opportunity must be typed on line 3 of the face page of the application form.

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 should 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.

Additionally, the following must be included with the application at the time of submission. Failure to include any of these items may delay review of the application.

3. Submission Dates and Times

Applications must be mailed on or before the receipt dates as described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Application Receipt Date(s): Standard dates for individual Ruth L. Kirschstein-NRSA applications apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
AIDS Application Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS for details.
Peer Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
Council Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
Earliest Anticipated Start Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm for details.

3.A.1. Letter of Intent

A letter of intent is not required.

3.B. Sending an Application to the NIH

Applications must be prepared using the Ruth L. Kirschstein National Research Service Award Individual Fellowship Form as described above. Following the instructions on page I-30 of the PHS 416-1 (Rev. 10/2005), 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 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 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

Certification Procedure: 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

3.C. Application Processing

Applications must be submitted on or before the application receipt dates described above (Section IV.3.A.). Upon receipt, applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed. At least three, sealed letters of reference must be submitted with the application.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a revision of an application already reviewed, but such application must include an Introduction section addressing the previous critique.

Information on the status of an application should be checked by the applicant in the eRA Commons.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement (see also Section VI.3. Reporting).

Kirschstein-NRSA awards are also subject to the NRSA policies.

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: Internal Revenue Code Section 117 applies to the tax treatment of all scholarships and fellowships. The Tax Reform Act of 1986, Public Law 99-514, impacts on the tax liability of all individuals supported under the NRSA program. Under that section, non-degree candidates are required to report as gross income all stipends and any monies paid on their behalf for 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 IRS and Treasury Department released regulations in January 2005 (Revenue Procedure 2005-11) clarifying the student exception to the FICA (Social Security and Medicare) taxes for students employed by a school, college, or university where the student is pursuing a course of study. Our understanding is that these final regulations do not apply to or impact Kirschstein-NRSA programs or awards. An NRSA stipend is provided by the NIH as a subsistence allowance for Kirschstein-NRSA fellows and trainees to help defray living expenses during the research training experience. NRSA recipients are not considered employees of the Federal government or the grantee institution for purposes of the award. We must note that the NIH takes no position on the status of a particular taxpayer, nor does it have the authority to dispense tax advice. The interpretation and implementation of the tax laws are the domain of the IRS. Individuals should consult their local IRS office about the applicability of the tax laws to their situation and for information on their tax obligations.

Future Year Support: Funds for continuation beyond the initial year are determined by the progress described in the continuation application (PHS 416-9, Rev. 10/2005), the timely submission of all required forms, and the availability of funds.

Service Payback: Recipients of Kirschstein-NRSA predoctoral support do not incur service payback.

6. Other Submission Requirements

Applicants are advised to pay special attention to the instructions in the PHS 416-1 (Rev. 10/2005). Please note several important changes and reminders on pages 1 and 2 and the new biographical sketch format page.

Sponsor: The applicant’s sponsor/mentor, who will directly supervise the applicant’s research, should be an active investigator in the area of the proposed research and meet the eligibility requirements in Section III. The sponsor and any co-sponsors must describe in detail his/her commitment to, and proposed role in, guiding the individual applicant during the research training experience. The sponsor and any co-sponsors are also expected to provide an assessment of the applicant’s qualifications and potential for a research career.

Training Plan: The training plan is an important component of the Kirschstein-NRSA F31 application. The sponsor(s) must provide a tailored research training plan for the applicant. Describe planned activities such as coursework, seminars, scientific conferences, opportunities for interaction with other groups and scientists, and any special or unique training opportunities for the applicant that are available in the training environment. Training in career skills, e.g. grant-writing and presentation skills, are strongly encouraged. Indicate the relationship of the proposed research training to the applicant’s career goals. Describe the skills and techniques that the candidate will learn as they relate to the applicant's career goals and relate these to the applicant’s career aspirations.

The research environment and the availability and quality of needed research facilities and research resources (e.g., equipment, laboratory space, computer time, available research support, etc.) must also be described.

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).

If the sponsoring institution is a foreign institution, information must be provided describing how the institution and sponsor offer unique opportunities for research training not currently available in the United States.

Research Proposal: Describe the broad, long-term objectives and Specific Aims, making reference to the health relatedness of the research (page 2 of the application PHS 416-1, rev. 10/05). The applicant must describe concisely the Specific Aims, the background leading to the proposed research, the research design and methods for achieving these Aims, the rationale, and expected/alternative outcomes of the proposed studies. It may be beneficial to include pertinent preliminary data obtained by the applicant in the dissertation laboratory.

Doctoral Dissertation and Other Research Experience: Advanced graduate students must include a narrative of their doctoral dissertation (may be preliminary) and any other prior research experience under item 27, Form Page 5. While the PHS 416-1 instructions direct predoctoral fellows to omit this section, the information is required of advanced graduate students who will be performing dissertation research. All graduate students should include any applicable research experience under item 27.

Training Potential: The application must include statements that address the planned value of the proposed fellowship experience and research training program, and how these relate to the applicant’s needs in preparation for a career as an independent researcher. Applicants should provide evidence of their potential for a productive and successful research career based upon the quality of their previous research training and academic record.

Instruction 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.

Human Subjects Research: If the proposed research involves human subjects, the applicant must be responsive to the instructions in the current version of the PHS 416-1. 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. Consult the Decision Tree for Inclusion of Children in Human Subjects Research for the exemptions that apply.

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the applicant must be responsive to the instructions in the current version of the PHS 416-1. The adequacy of plans for the care and use of vertebrate animals is assessed as part of the fellowship evaluation (see Additional Review Criteria below).

Biohazards: The investigator and the sponsoring institution are responsible for protecting the environment and research personnel from hazardous conditions. If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, the procedures to be taken in order to ensure adequate protection must be described (see Additional Review Criteria below).

Plan for Sharing Research Data

Not applicable

Sharing Research Resources

Sharing Model Organisms: For many individual fellowships, it is anticipated that plans of this nature would have already been reported to the NIH by the sponsor in his/her research application. When this has occurred, indicate so in this section and include the appropriate grant number. However, if the development of a new model organism is anticipated, applicants will include a description of a specific plan for sharing and distributing unique model organism research resources or will state appropriate reasons why such sharing is restricted or not possible. For additional information on this policy, see Sharing Model Organisms Policy (PHS 416-1). If model organisms are not part of the planned research training plan, omit this section. This description is not included in the Research Training Plan page limits.

Section V. Application Review Information


1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the participating ICs on the basis of established PHS referral guidelines.

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

Applications receive two sequential levels of review. The first level is an assessment of the merit of the research training by a Scientific Review Group (SRG), composed primarily of non-government scientists selected for their competence in research and research training in a scientific area related to 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. Staff within the assigned funding Institute provides a second level of review.

As part of the initial merit review, applications:

The goal of the Kirschstein-NRSA individual predoctoral fellowship (F31) program is to train future generations of outstanding scientists who are committed to research careers in scientific health-related fields relevant to the missions of the participating NIH Institutes. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research training will have a substantial impact on the pursuit of this goal. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. The scientific review group will use information in the letters of reference in consideration of the review criteria. Note that an application does not need to be strong in all categories to merit a high priority score. The final priority score will reflect the overall evaluation of the entire application. Note also that relevance to an Institute’s mission priorities is not evaluated as part of the peer review process but by Institute program staff. This programmatic evaluation may influence funding decisions independent of the peer review evaluation. Therefore, it is imperative that applicants consult the appropriate Institute representative listed in Section VII (http://grants.nih.gov/archive/grants/guide/contacts/pa-07-002_contacts.htm) to obtain current information about Institute-specific program priorities and policies prior to submission.

Review Criteria

Applicant/Fellow

Sponsor(s) and Training Environment

Research Training Plan

Training Potential

2.A. 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:

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).

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).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described on page 1-26 of the PHS 416-1 fellowship application Part I instructions (rev. 10/2005) will be assessed (see http://grants.nih.gov/grants/forms.htm).

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, the adequacy of the proposed protection will be assessed.

2.B. Additional Review Considerations

Responsible Conduct of Research: Every NRSA fellow must receive instruction in the responsible conduct of research (http://grants.nih.gov/grants/guide/notice-files/not92-236.html). Applications must include the sponsoring institution’s plans to provide and 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. The plan will be discussed after the overall determination of merit, so that the review panel's evaluation of this plan will not be a factor in the determination of the priority score. The plan will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note in the summary statement. Regardless of the priority score, an application with an unacceptable plan will not be funded until the applicant provides an acceptable plan. Staff in the NIH awarding component will judge the acceptability of the revised plan.

2.C. Sharing Research Data

Not applicable

2.D. Sharing Research Resources

Sharing Model Organisms: For many individual fellowship applications, it is anticipated that plans for sharing model organisms will have already been reported to the NIH by the sponsor in his/her research application. When this has occurred, applicants will indicate so and will provide the appropriate grant number. However, if the development of a new model organism is anticipated, applicants will include a description of a specific plan for sharing and distributing unique model organism research resources or will state appropriate reasons why such sharing is restricted or not possible.

The reviewers will assess the adequacy of plans for sharing model organisms and will describe their assessment of the sharing plan in an administrative note. Their assessment will not be a factor in the overall priority score. The adequacy of the resources sharing plan will be considered by Program staff of the funding Institute when making recommendations about funding applications. Program staff may negotiate modifications of the resources sharing plans with the applicant before recommending funding of an application. The final version of the negotiated resources sharing plan will become a condition of the award of the fellowship.

3. Anticipated Announcement and Award Dates

Not applicable

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the applicant/fellow will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons. Refer to the NIH eRA Commons System (COM) Users Guide for additional information regarding registration in the NIH eRA Commons. Direct questions regarding Commons registration to the eRA Commons Help Desk at: commons@od.nih.gov or by telephone: 301-402-7469 or 866-504-9552 (Toll Free).

If the application is under consideration for funding, NIH will request “just-in-time” information from the applicant. A request for just-in-time information should not be interpreted as an indication that an award will be issued.

A formal notification in the form of a Notice of Research Fellowship Award (NRFA) will be provided to the sponsoring organization. This notification signed by the grants management officer is the authorizing document. The Notice of Research Fellowship Award will be sent electronically to the designated institutional business official listed on the face page of the application or may be retrieved by the institution and the applicant/fellow through the eRA Commons.

Activation: Selection of an application for award is not an authorization to begin performance. No funds may be disbursed until the fellow has started training under the award, and an Activation Notice (PHS 416-5, Rev. 10/2005) has been submitted to the NIH. A fellow has up to six 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, countersigned by the sponsor and an institutional official.

2. Administrative and National Policy Requirements

Fellowships must be administered in accordance with the current NRSA section of the Grants Policy Statement (http://grants.nih.gov/grants/policy/policy.htm) and any terms and conditions specified on the Notice of Research Fellowship Award.

Service Payback: Recipients of Kirschstein-NRSA F31 awards do not incur a service payback obligation.

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 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: While Kirschstein-NRSA awardees are required to pursue research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies, 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.

Certification Requirements: Individuals admitted to the United States as Permanent Residents must submit notarized evidence of legal admission prior to the award.

Inventions: Fellowships made primarily for educational purposes are exempted from the PHS invention requirements. Kirschstein-NRSA F31 awards will not contain any provision giving PHS rights to inventions made by the awardee.

Publication and Sharing of Research Results: NIH supports the practical application and sharing of outcomes of funded research. Therefore, fellows should make the results and accomplishments of their Kirschstein-NRSA fellowship activities available to the research community and to the public at large. The grantee organization should assist fellows in these activities, including the further development of discoveries and inventions for furthering research and benefiting the public. No restrictions should be placed on the publication of results in a timely manner.

Fellows are encouraged to submit reports of their findings for publication to the journal of their choice. Responsibility for direction of the project should not be ascribed to the NIH. However, NIH support must be acknowledged by a footnote in language similar to the following: “This investigation was support by the National Institutes of Health under Ruth L. Kirschstein National Research Service Award (number).” In addition, federal funding must be acknowledged as provided in “Public Policy Requirements and Objectives-Availability of Information-Acknowledgment of Federal Funding.”

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.

3. Reporting

Forms may be found at http://grants.nih.gov/grants/forms.htm.

Activation Notice: An awardee has up to six months from the issue date on the Notice of Research Fellowship Award to activate the award using the Ruth L. Kirschstein National Research Service Award Individual Fellowship Activation Notice (PHS 416-5, Rev. 10/05). Under unusual circumstances, an NIH Institute may grant an extension of the activation period upon receipt of a specific request from the fellow. Such a request must be countersigned by the sponsor and an authorized institutional official.

Application for Continued Support: An awardee will be required to submit the form PHS 416-9, Rev. 10/05, Continuation of an Individual National Research Service Award, annually as required in the NIH Grants Policy Statement. The report is due two months before the beginning date of the next budget period. The progress report must describe the current year's progress as well as the research and training plans for the coming year.

Termination Notice: When support ends, the fellow must submit a Termination Notice (PHS 416-7, Rev. 10/05) to the NIH within 30 days following termination.

Section VII. Agency Contacts


Each participating NIH Institute has a unique scientific purview and different program goals and initiatives that evolve over time. Prior to preparing an application, it is critical that all applicants consult the appropriate Institute website (listed with each Institute’s name at the beginning of this announcement) for details of research areas supported by that Institute. Applicants should also contact the appropriate Institute scientific/research contact (see below) to obtain current information about specific program priorities and policies. This action is of utmost importance because applications with marginal or no relevance to the participating Institutes will not be accepted for review.

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Applicants should refer to the (http://grants.nih.gov/archive/grants/guide/contacts/pa-07-002_contacts.htm) to obtain participating NIH Institute scientific/research contact information.

2. Peer Review Contacts:

Not applicable

3. Financial or Grants Management Contacts:

Applicants should refer to the (http://grants.nih.gov/archive/grants/guide/contacts/pa-07-002_contacts.htm) to obtain participating NIH Institute grants management contact information.

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

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 (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

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). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

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 (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). 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.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

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 access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Kirschstein-NRSA awards are made under the authorization of Section 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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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