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 of Aging (NIA), (http://www.nia.nih.gov)
National Institute of Alcohol Abuse and Alcoholism (NIAAA), (
http://www.niaaa.nih.gov)
National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov)|
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), (http://www.niams.nih.gov)
National Institute of Biomedical Imaging and Bioengineering (NIBIB), (http://www.nibib.nih.gov)
National Cancer Institute (NCI), (http://www.nci.nih.gov)
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov)
National Institute on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www.niddk.nih.gov)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov )
National Eye Institute (NEI), (http://www.nei.nih.gov)
National Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov/ )
National Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov)
National Human Genome Research Institute (NHGRI), (http://www.nhgri.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)
National Institute of Nursing Research (NINR), (http://www.ninr.nih.gov/)
National Center for Research Resources (NCRR), (http://www.ncrr.nih.gov)
Office of Dietary Supplements (ODS), (http://www.ods.od.nih.gov)

Title: Ruth L. Kirschstein National Research Service Awards (NRSA) for Individual Postdoctoral Fellows (F32)

Announcement Type
This is a reissue of PA-03-067 which was previously released February 6, 2003.

Update: The following update relating to this announcement has 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 (http://grants.nih.gov/grants/guide/index.html). Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.

Program Announcement (PA) Number: PA-06-373

Catalog of Federal Domestic Assistance Number(s)
93.866, 93.272, 93.855, 93.856, 93.286, 93.865, 93.173, 93.121, 93.847, 93.848, 93.849, 93.279, 93.894, 93.867, 93.859, 93.837, 93.838, 93.839, 93.233, 93.172, 93.282, 93.853, 93.361, 93.389

Key Dates
Release Date: April 27, 2006
Application Receipt Date(s): Standard dates for Individual Kirschstein-NRSA awards apply: see http://grants.nih.gov/grants/funding/submissionschedule.htm 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: December 12, 2006

Due Dates for E.O. 12372
Not applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research 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 and 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 objective of the National Research Service Award (NRSA) F32 program is to provide support to promising postdoctoral applicants who have the potential to become productive and successful independent research investigators in scientific health-related fields relevant to the missions of the participating NIH Institutes and Centers (ICs).

The purpose of the 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 National Institutes of Health (NIH) awards individual postdoctoral fellowships (F32) to promising applicants who have the potential to become productive, independent investigators in fields related to the mission of participating NIH Institutes and Centers. The proposed postdoctoral training must be within the broad scope of biomedical, behavioral, or clinical research or other specific disciplines relevant to the research mission of the participating NIH Institutes and Centers. The proposed training must offer an opportunity to enhance the fellow's understanding of the health-related sciences and extend his/her potential for a productive research career.

The NRSA legislation requires that the Nation’s overall needs for biomedical research personnel be taken into account by giving special consideration to physicians and other health professionals who propose to become active biomedical researchers and who agree to undertake a minimum of 2 years of biomedical, behavioral or clinical research. NIH recognizes the critical importance of training clinicians to become researchers and encourages them to apply. For those who have a research doctoral health professional degree, the proposed training may be used to satisfy a portion of the degree requirements for a master's degree, a doctoral degree or any other advanced research degree program. Individuals from diverse racial and ethnic groups and individuals with disabilities and individuals from disadvantaged backgrounds are always encouraged to apply for NIH support.

Postdoctoral applicants for this award must include a research training proposal that documents the need for the 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.

Research Training Program: 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. A Ruth L. Kirschstein-NRSA fellowship (F32) may not be used to support studies leading to the MD., D.O., D.D.S., D.V.M., or other similar health-professional degrees. Neither may these awards be used to support the clinical years of residency training. Research clinicians must devote full-time to their proposed research training and confine clinical duties to those activities that are part of the research training program.

The sponsoring institution must have adequate faculty and facilities available to provide a suitable environment for the high-quality research training experience. The applicant’s research training should be guided and supervised by a committed sponsor who is an active and established investigator in the area of the applicant’s proposed research. 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 NIH Institute and Center 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 the linked F32 Web site (http://grants.nih.gov/archive/grants/guide/contacts/pa-06-373_contacts.htm) to obtain current information about Institute 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 or possible funding.

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 National Research Service Award (NRSA) for Individual Postdoctoral Fellows (F32) award mechanism. As an applicant, the candidate and his/her sponsor are jointly responsible for planning, directing, and executing the proposed project. Information for participating Institute contacts and any IC mission-specific initiatives for F32 programs may be found in the (http://grants.nih.gov/archive/grants/guide/contacts/pa-06-373_contacts.htm).

This mechanism is intended for candidates that will have received a Ph.D., M.D., D.O., D.C., D.D.S., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr. P.H., DNSc., N.D.(Doctor of Naturopathy), Pharm.D., D.S.W., Psy.D., or equivalent doctoral degree from an accredited domestic or foreign institution prior to activation of the award. Additional information and detailed requirements for this NRSA award mechanism can be found at: http://grants.nih.gov/training/nrsa.htm .

2. Funds Available

Although the financial plans of the NIH ICs 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 ICs, and the availability of funds.

This NRSA mechanism provides a stipend, tuition and fees, and an institutional allowance. For additional information see: http://grants.nih.gov/training/nrsa.htm

Stipends: Ruth L. Kirschstein-NRSA awards provide stipends to postdoctoral 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. The stipend level for the first year of Ruth L. Kirschstein-NRSA support is determined by the number of full years of relevant postdoctoral experience at the time the award is issued (not at the time of activation, see below). Fellows with less than one full year of postdoctoral experience at the time of award will receive initial support at the zero level. Relevant experience may include research (including research in industry), teaching, internship, residency, clinical duties, or other time spent in full-time studies in a health-related field beyond that of the qualifying doctoral degree. The current stipend schedule is on the NIH website at http://grants.nih.gov/training/nrsa.htm and the NIH Guide Notice released on January 9, 2006 located at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-026.html . The awarding NIH IC will adjust awards on the anniversary date of the fellowship award to ensure consistency with the stipend schedule in effect at that time.

The stipend for each subsequent year of Ruth L. Kirschstein-NRSA support is the next level of experience using the stipend schedule in effect at that time. Stipends will be adjusted on the anniversary date of the award and will not be changed mid-year to accommodate an increase in the level of experience. No departure from the published Ruth L. 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 offset the combined cost of tuition and fees at the rate in place at the time of award. The rate currently in place provides 100% of all costs up to $3,000 and 60% of costs above $3,000. Costs associated with tuition and fees are allowable only if they are required for specific courses in support of the research training experience supported by the fellowship. A full description of the tuition policy is contained within the NRSA section of the NIH Grants Policy Statement at

http://grants.nih.gov/grants/policy/policy.htm.

Institutional Allowance: At the time of publication of this funding opportunity announcement, fellows receive an institutional allowance of $7,000 per 12-month period to nonfederal, nonprofit, or foreign sponsoring institutions to help defray fellowship expenses such as research supplies, equipment, health insurance (either self-only or family as appropriate), and travel to scientific meetings. Support for health insurance is allowable only if it is applied consistently for all individuals in a similar research training status regardless of the source of support. This allowance is intended to cover training related expenses for the individual fellow, 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.

NIH will currently provide an institutional allowance of up to $5,900 for 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 $5,900 will be paid to the institution for disbursement to the fellow. Funds for fellows at Federal laboratories will be disbursed from the awarding IC.

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 Ruth L. 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). The funds requested for costs of this nature must be reasonable in relationship to the total dollars awarded under the fellowship, must be directly related to the approved research training experience, and must be specifically identified in the application. Such additional funds shall be provided only in exceptional circumstances which are fully justified and explained by the sponsoring institution in the application.

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 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, such as salary or tuition remission for services such as teaching or serving as a laboratory assistant, 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 Ruth L. 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/grants/policy/nihgps_2003/NIHGPS_Part10.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. Postdoctoral fellows may also be eligible to participate in the NIH Extramural Loan Repayment Program. Information on this program is available at http://www.lrp.nih.gov/.

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 staff 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 over positions 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 as well as individuals with disabilities are always encouraged to apply for NIH support.

Citizenship: By the time of award, the individual to be trained must be a citizen or a noncitizen 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 F32 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: Before a Ruth L. Kirschstein-NRSA postdoctoral fellowship award can be activated, the individual must have received a Ph.D., M.D., D.O., D.C., D.D.S., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr. P.H., DNSc., N.D.(Doctor of Naturopathy), Pharm.D., D.S.W., Psy.D., or equivalent doctoral degree from an accredited domestic or foreign institution. Certification by an authorized official of the degree-granting institution that all degree requirements have been met is also acceptable.

Research Training Program: 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. Research clinicians must devote full-time to their proposed research training and must restrict clinical duties within their full-time research training experience to activities that are directly related to the research training experience. A Ruth L. Kirschstein-NRSA fellowship (F32) may not be used to support studies leading to the MD., D.O., D.D.S., D.V.M., or other similar health-professional degrees. Neither may these awards be used to support the clinical years of residency training.

2. Cost Sharing or Matching

Cost sharing is not required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.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, CSR will not accept for review any application that is essentially the same as one already reviewed.

Duration of Support: Individuals may receive up to 3 years of aggregate Ruth L. Kirschstein-NRSA support at the postdoctoral level, including any combination of support from institutional training grants (T32) and individual fellowship awards (F32). Applicants must consider any prior Ruth L. Kirschstein-NRSA postdoctoral research training in determining the duration of fellowship support requested. Training beyond the 3-year aggregate limit may be possible under certain exceptional circumstances, but a waiver from the NIH awarding component is required. Individuals seeking additional Ruth L. Kirschstein-NRSA support beyond the third 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.

Sponsor: Before submitting a fellowship application, the applicant must identify a sponsoring institution and an individual who will serve as a sponsor (also referred to as mentor or supervisor) and will supervise the training and research experience. The sponsor should be an active investigator in the area of the proposed research who is committed to the research training of the individual and will directly supervise the candidate's research. The sponsor should document the availability of sufficient research support and facilities for high-quality research training. In most cases, the F32 supports research training experiences in new settings in order to maximize the acquisition of new skills and knowledge. Opportunities for the fellow to obtain additional guidance from other subject matter experts during the research training experience are encouraged.

However, in unusual circumstances, applicants may propose postdoctoral training experiences at their doctorate institution or at the institution where they have been training for more than a year. In such cases, the applicant must carefully document the opportunities for new research training experiences specifically designed to broaden his/her scientific background.

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.

Applicants requesting foreign 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 the scientific advantages are clear. Applicants seeking training abroad are encouraged to contact the relevant participating Institute or Center prior to preparing an application (http://grants.nih.gov/archive/grants/guide/contacts/pa-06-373_contacts.htm).

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 416-1 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. 10/05) and the instructions have been significantly modified. See the NIH Notice released December 9, 2005, located at: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-06-016.html

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. 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, 10/05).

The title and number of this funding opportunity must be typed on line 3 of the face page of the application form. If the fellowship application is submitted in response to a Program Announcement (PA) or Request for Application (RFA) from a particular NIH IC, the applicant should identify the number of the PA or RFA in Item 3.

Applications must include at least three sealed letters of reference using the PHS 416-1 reference page. Applications without at least three letters of reference may be delayed in review or returned to the applicant without review. Information applicable to the required references is located in the application instructions, Part 1 Preparing Your Application, E. Application Section III.

If the applicant has been lawfully admitted to the United States for permanent residence, the Permanent Resident of U.S. block should be checked on the Face Page of the PHS 416-1 application. Applicants who have applied for and have not yet been granted admission as a permanent resident should also insert the word "pending." A notarized statement documenting legal admission for permanent residence must be submitted prior to the issuance of an award.

3. Submission Dates and Times
Applications must be mailed on or before the receipt date 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.
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: see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.

3.A.1. Letter of Intent
A letter of intent is not required for this funding opportunity.

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 416 (Rev. 10/05) research fellowship grant application instructions and forms as described above.

Applicants must follow the instructions stated on pages 30 and 31 of the PHS 416-1 for submitting the application and any Appendix materials.

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’s 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.) and at http://grants.nih.gov/grants/dates.htm. 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 substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Information on the status of an application should be checked by the applicant in the eRA Commons at: https://commons.era.nih.gov/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. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (see also Section VI.3. Reporting).

These awards are also subject to the NRSA Policies. For more information see: http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm.

Concurrent Awards: A Ruth L. 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 Ruth L. Kirschstein-NRSA programs or awards. An NRSA stipend is provided by the NIH as a subsistence allowance for Ruth L. 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.

Service Payback: As required by the NIH Revitalization Act of 1993, postdoctoral fellows incur a service obligation of 1 month for each month of support during the first 12 months of the Ruth L. Kirschstein-NRSA postdoctoral support. The 13th and subsequent months of Ruth L. Kirschstein-NRSA support are acceptable postdoctoral payback service. Thus, individuals who continue under the award for 2 years will have paid off their first year obligation by the end of the second year.

Applicants accepting an award for the first 12 months of a Ruth L. Kirschstein-NRSA postdoctoral support must sign a payback agreement (PHS Form 6031) in which they agree to engage in health-related research training, research, and/or teaching for 12 months.

Those who do not pay back their obligation through continued Ruth L. Kirschstein-NRSA supported training may satisfy their obligation by serving in a position in which health- related research, research training, or teaching are the primary activities. Such individuals must engage in research, research training, or teaching at a rate of 20 or more hours per week averaged over a full work-year. Payback service may be conducted in an academic, governmental, commercial, or nonacademic environment, in the United States or in a foreign country. Examples of acceptable payback service include research associateships/assistantships, postdoctoral research fellowships, and college or high school science teaching positions. Examples of unacceptable payback service include clinical practice and administrative responsibilities not directly related to scientific research.

Payback service positions are arranged by the individual, not by the NIH. The NIH will review and approve the activity at the end of the year in which it occurs. Service to satisfy any outstanding obligation must be initiated within 2 years after termination of Ruth L. Kirschstein-NRSA support, and must be performed on a continuous basis. For individuals who fail to fulfill their service obligation, the United States is entitled to recover the total amount of Ruth L. Kirschstein-NRSA funds paid to the individual for the obligated period plus interest at a rate determined by the Secretary of the U.S. Department of Treasury. Financial payback must be completed within 3 years, beginning on the date the United States becomes entitled to recover such amount.

Under certain conditions, the Secretary, DHHS, may extend the period for starting service, permit breaks in service, extend the period of repayment, or otherwise waive the payback obligation when compliance would constitute a substantial hardship against equity and good conscience.

Policies regarding the Ruth L. Kirschstein-NRSA payback obligation are explained in the Ruth L. Kirschstein-NRSA Section of the NIH Grants Policy Statement available at http://grants.nih.gov/grants/policy/policy.htm.

Specific questions may appear in a list of Frequently Asked Questions that appears on the Web at http://grants.nih.gov/training/faq_fellowships.htm. Other questions on payback should be directed to the appropriate NIH institute contact, (http://grants.nih.gov/archive/grants/guide/contacts/pa-06-373_contacts.htm) or see: http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm .

Future Year Support: Funds for continuation beyond the initial year are determined by the progress described in the continuation application (PHS 416-9, rev. 10/05), the timely submission of all required forms, and the availability of funds.

6. Other Submission Requirements

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

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 must describe in detail his/her commitment to and proposed role in guiding the individual applicant during the research training experience.

Include items such as classes, seminars, and opportunities for interaction with other groups and scientists and how these will assist the applicant in achieving his/her research goals. Describe the research environment and available research facilities and equipment. Indicate the relationship of the proposed research training to the candidate's career goals. Describe the skills and techniques that the candidate will learn as they relate to the candidate's career goals.

The NIH strongly encourages NRSA postdoctoral fellows to obtain instruction and training in grant writing in order to apply successfully for future career development and research support. All postdoctoral NRSA fellows should also be provided with instruction in laboratory and project management.

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.

Additionally, the quality of the facilities and related resources (e.g., equipment, laboratory space, computer time, available research support, etc.) must be described.

Research Proposal: A description of the broad, long-term objectives and specific aims, making reference to the health relatedness of the research proposal must be included (page 2 of the application PHS 416-1, rev. 10/05). The applicant must describe concisely the research design and methods for achieving these goals, as well as the rationale and techniques planned to pursue these goals.

Training Potential: The application must include statements addressing 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.

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 the exemptions that apply: http://grants.nih.gov/grants/peer/tree_children_hs.pdf.

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.

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, please describe the procedures to be taken in order to ensure adequate protection.

Plan for Sharing Research Data

Not applicable

Sharing Research Resources

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

Not applicable.

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 or Center provides a second level of review.

As part of the initial merit review, applications:

The following will be considered in making funding decisions:

The goal of the NIH NRSA F32 program is to provide support to promising applicants with the potential to become productive and successful independent research investigators in scientific health-related fields relevant to the missions of the participating NIH Institutes and Centers. 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 favorable priority score. The final priority score will reflect the overall evaluation of the entire application.

Review criteria:

1. Candidate

2. Sponsor/Mentor and Training Environment

3. Research Training Proposal

4. 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 in I.C.7. of the PHS 416-1 fellowship application instructions (rev. 10/05) 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, determine if the proposed protection is adequate.

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 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 the 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 of the summary statement. Regardless of the priority score, an application with an unacceptable plan will not be funded until the applicant provides a revised 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 fellowships it is anticipated that plans for sharing model organisms would have already been reported to the NIH by the sponsor in his/her research application. When this has occurred, applicants will indicate so 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 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, but will not include their assessment in the overall priority score. The adequacy of the resources sharing plan will be considered by Program staff of the funding IC when making recommendations about funding applications.

3. Anticipated Announcement and Award Dates
Not applicable

Section VI. Award Administration Information


1. Award Notices

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 indicating that an award will be issued.

A formal notification in the form of a Notice of Research Fellowship Award (NRFA) will be provided electronically to the designated sponsoring institution business official listed on the face page of the application. The NRFA may also be retrieved by the institution through its eRA Commons account. The NRFA signed by the grants management officer is the authorizing document indicating that an award has been made.

Selection of an application for award is not an authorization to begin performance. An awardee has up to six months from the issue date on the NRFA to activate the award.

Activation: No funds may be disbursed until the fellow has started training under the award and an Activation Notice (PHS 416-5, Rev. 10/05) and a Payback Agreement (PHS 6031, Rev. 10/05) has been submitted to the NIH. A fellow 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.

2. Administrative and National Policy Requirements

Ruth L. Kirschstein NRSA Postdoctoral Fellowships require a payback agreement. For more information see Section IV.5. Funding Restrictions and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm

All NIH grants and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

Fellowships must be administered in accordance with the current NRSA section of the Grants Policy Statement at http://grants.nih.gov/grants/policy/policy.htm), and any terms and conditions specified on the award notice.

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: While Ruth L. 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 Ruth L. 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 Ruth L. 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. Part-time training may affect the rate of accrual or repayment of the service obligation for postdoctoral fellows.

Certification Requirements: Individuals admitted to the United States as Permanent Residents must submit notarized evidence of legal admission prior to the award. A Payback Agreement Form (PHS 6031, Rev. 10/05) must accompany the Activation Notice for any award that occurs during the individual's initial 12 months of Ruth L. Kirschstein-NRSA postdoctoral support. When support ends, the fellow must submit a Termination Notice (PHS 416-7, Rev. 10/05) to the NIH. If the fellow has a payback obligation, he or she must notify the NIH of any change in address and submit Annual Payback

Activities Certification Forms (PHS 6031-1, Rev. 10/05) until the payback service obligation is satisfied. Forms will be provided to awardees by the NIH awarding component. Forms may also be found on the NIH Website at http://grants.nih.gov/grants/forms.htm.

Inventions: Fellowships made primarily for educational purposes are exempted from the PHS invention requirements. F32 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 Ruth L. 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.

Fellows are encouraged to submit reports of their findings for publication to the journals 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 supported by 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

Please note that all forms have been revised for immediate use, see NIH Notices: NOT-OD-06-017 (http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-06-017.html) and NOT-OD-06-018 (http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-06-018.html) which were released December 9, 2005 for additional details.

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) available at http://grants.nih.gov/grants/forms.htm. 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.

Payback Agreement: A Payback Agreement Form (PHS 6031, Rev. 10/05) must accompany the Activation Notice for any award that occurs during the individual’s initial 12 months of Kirschstein-NRSA postdoctoral support.

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 (http://grants.nih.gov/grants/funding/416-9/phs416-9.htm as required in the NIH Grants Policy Statement. The report is due two months before the beginning date of the next budget period and must include information related to the current year's progress as well as the plans for the coming year. Note that the instructions request that a listing of all courses and publications completed during the past year be included in the application for continued support.

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. If the fellow has a payback obligation, he or she must notify the NIH of any change in address and submit Annual Payback Activities Certification Forms (PHS 6031-1, Rev. 10/05) until the payback service obligation is satisfied. Forms may be found at http://grants.nih.gov/grants/forms.htm.

Section VII. Agency Contacts


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-06-373_contacts.htm) for information for each IC’s scientific/research contact for this NRSA F32 program.

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-06-373_contacts.htm) for information for each IC’s grants management contact for this NRSA F32 program.

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).

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/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.

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.

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. 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 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. Awards are made under the authorization of Sections 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 NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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