Expired PA-09-029: Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral Fellows in PharmD/PhD Programs (F31)

Department of Health
and Human Services (HHS)

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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 General Medical Sciences (NIGMS) (http://www.nigms.nih.gov)
NIH Office of Dietary Supplements (ODS) (http://dietary-supplements.info.nih.gov/)

Title: Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral Fellows in PharmD/PhD Programs (F31)

Announcement Type
New

Update: The following update relating to this announcement has been issued:

April 27, 2010 - This PA has been reissued as (PA-10-178).
July 2, 2009 - This FOA has expired. NIGMS will re-issue this FOA in time for December 8, 2009 application due date. (See NOT-OD-09-106)

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/files/electronic_submission_timeline_08.pdf. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).

Program Announcement (PA) Number: PA-09-029

Catalog of Federal Domestic Assistance Number(s)
93.859

Key Dates
Release Date: November 18, 2008
Letters of Intent Receipt Date(s): Not applicable
Application Submission Dates(s): Standard dates for Individual Kirschstein-NRSA awards apply: see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
AIDS Application Submission Dates(s): Standard dates apply, please see for http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS details.
Peer Review Date(s): Standard dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date: Standard dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: New Date June 12, 2009 (See NOT-OD-09-106) Original Date: January 8, 2012

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 PharmD/PhD graduates will be available in adequate numbers and in appropriate research areas to carry out the Nation’s biomedical, behavioral, and clinical research agenda.

The National Institute of General Medical Sciences (NIGMS) will provide individual predoctoral research training fellowship awards to promising pharmacy students who are enrolled in a PharmD/PhD degree program whose dissertation projects are in areas relevant to the research mission of NIGMS.
Applicants must have a baccalaureate degree and must be enrolled in a formally combined PharmD./PhD program in the biomedical, behavioral, or clinical sciences. Applicants must be at the dissertation research stage of their doctoral training. Applicants must also show evidence of both high academic performance in the sciences and substantial interest in areas of high priority to NIGMS. See Section III. Eligibility Information for definitions associated with specific eligibility requirements.
Applicants must identify a primary sponsor and are encouraged to include additional co-sponsors when appropriate. The applicant, together with his/her sponsor(s) and institution, are jointly responsible for planning, directing, and executing the proposed project.
It is expected that the time period requested for this F31 award will be 3 years or less. Fellowship awardees are required to pursue their research training on a full-time basis, devoting at least 40 hours per week to the training program or as specified by the sponsoring institution in accordance with its own policies.
The number of F31 awards that NIGMS expects to provide through this announcement will depend on the scientific merit of the applications received, their relevance to the program priorities of NIGMS, and the availability of funds. It is predicted that 4 to 6 awards will be made a year.
Eligible sponsoring organizations include domestic institutions/organizations; public or private institutions such as universities and colleges that issue the Doctor of Pharmacy Degree (PharmD).
Applicants must be citizens or non-citizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence. Non-citizen nationals are generally persons born in outlying possessions of the United States, i.e. American Samoa and Swains Island. Individuals on temporary or student visas are not eligible. Individuals may apply for the F31 in advance of admission to the United States as a Permanent Resident recognizing that no award will be made until legal verification of Permanent Resident status is provided. See Section III. Eligibility Information for definitions associated with specific eligibility requirements.
It is strongly recommended that applicants consult with the NIGMS representative listed in Section VII. Agency Contacts to obtain current information about Institute-specific program priorities and policies. Applications that do not fall within the current mission interests of the NIGMS will not be accepted.
An individual may not have two or more competing NIH fellowship applications pending review concurrently. In addition, the NIH 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 application must include an Introduction addressing the previous critique.
This funding opportunity announcement (FOA) uses the Ruth L. Kirschstein Individual Predoctoral National Research Service Award (NRSA) mechanism (F31).
The Kirschstein-NRSA individual fellowship application (PHS 416-1) is available at: http://grants.nih.gov/grants/funding/416/phs416.htm. The PHS 416-1 application form was restructured and the instructions were significantly modified, see: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-09-004.html, released October 14, 2008.
Applicants submitting resubmission applications must follow the instructions for revised applications in the current PHS 416-1. Only one resubmission application may be submitted.
Telecommunications for the hearing impaired is available at: TTY 301-451-5936

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 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 and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
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 Contacts
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 National Institute of General Medical Sciences (NIGMS) is one of 27 Institutes and Centers that comprise the National Institutes of Health (NIH). NIGMS is committed to increasing the number of pharmacy students who wish to pursue doctoral research in the pharmaceutical sciences. It recognizes that current career paths for Doctor of Pharmacy graduates have reduced the number of individuals who pursue academic research training. NIGMS’s intent in issuing this Funding Opportunity Announcement (FOA) is to provide individual research training fellowships to promising predoctoral applicants who are enrolled in PharmD/PhD programs in Schools of Pharmacy who desire to become productive and successful independent investigators whose research meets the mission of NIGMS. This F31 fellowship program will provide support for the dissertation stage of predoctoral students enrolled in joint PharmD/PhD programs. It is expected that the length of time for a F31 award will be 3 years or less.

NIGMS primarily supports basic research that lays the foundation for advances in biomedical research. NIGMS-funded researchers seek to answer important scientific questions in fields such as biological chemistry, bioinformatics, computational biology, molecular and cell biology, biophysics, molecular genetics, developmental biology, physiology, pharmacological sciences, and clinical pharmacology (in the areas of pharmacogenetics, pharmacokinetics, drug formulation, drug metabolism, drug transport, drug delivery and drug-induced adverse effects). NIGMS also supports research and training in the following clinical areas: anesthesiology, burn and trauma injury, and wound healing. For further details on the research areas supported by NIGMS, please see the following website: http://search.nigms.nih.gov/research/programs.htm.

Research Training Program

This fellowship award program will provide training support for the dissertation stage of PhD students enrolled in joint PharmD/PhD programs. The applicant must propose a research training program and dissertation research that is consistent with the scientific mission of the NIGMS. The research training experience must enhance the applicant's conceptualization of research problems and research skills, under the guidance and supervision of a committed mentor or mentors (when appropriate) who are active and established in the area of the applicant's proposed research. The research training program should be carried out in an environment that includes appropriate faculty and technical resources and is demonstrably committed to the research training of the applicant in the program he/she proposes in the application.

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

This award mechanism may not be used to support training of individuals who are in predoctoral programs in a pharmacy school but are not enrolled in a PharmD/PhD degree program. This NRSA fellowship may not be used to support studies leading to the PharmD or other similar professional/clinical doctoral degree. Awards will be administered under the National Institutes of Health (NIH) Grants Policy Statement, which includes the Kirschstein-NRSA Guidelines for Individual Awards found at http://grants.nih.gov/grants/policy/policy.htm.

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

Section II. Award Information

1. Mechanism of Support

This FOA 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 studies leading to the PharmD or other similar professional degree.

2. Funds Available

The financial plans of NIGMS provide support for this program, but the number of awards made pursuant to this funding opportunity are contingent upon the receipt of a sufficient number of meritorious applications, the program priorities of the NIGMS, and the availability of funds. It is expected that NIGMS will make four to six F31 awards a year.

This NRSA mechanism provides a stipend, tuition and fees, and an institutional allowance. For information see: http://grants.nih.gov/training/nrsa.htm and NOT-OD-07-057.html released March 14, 2007.

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. The current stipend schedule and information can be found at http://grants.nih.gov/training/nrsa.htm, NOT-OD-07-057.html released March 14, 2007, and NOT-OD-08-036.html released January 28, 2008.

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 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.This F31 fellowship will cover only the tuition costs during the dissertation phase of the program and will be limited to the amount established for the predoctoral tuition. 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/grants/policy/nihgps_2003/NIHGPS_Part10.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.

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/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.

This FOA uses Just-in-Time information concepts.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

For-profit organizations
Non-profit organizations
Domestic Institutions
Public or private institutions, such as universities, colleges, and hospitals
Units of State and local governments
Eligible Agencies of the Federal Government

Applications from foreign institutions will not be accepted. The sponsoring institution must be accredited to award the Doctor of Pharmacy (PharmD) degree. The sponsoring institution must have adequate faculty and facilities available on site to provide a suitable environment for performing high-quality research training.

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. The applicant must be enrolled in a PharmD/PhD program at the time of application and must show evidence of both high academic performance in the sciences and substantial interest in a research area of high priority to NIGMS. It is expected that individuals who apply for this program will have been exposed to a broad interdisciplinary curriculum to prepare them for a research career.

Individuals from diverse racial and ethnic groups, individuals with disabilities, and those from disadvantaged backgrounds are encouraged to apply. Individuals from diverse racial and ethnic groups, individuals with disabilities, and those from disadvantaged backgrounds may submit an application either in response to the current announcement or to the Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral Fellowships (F31) to Promote Diversity in Health-Related Research (PA-07-106) for support of predoctoral research training.

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 Permanent Resident Card (USCIS Form I-551), or other legal verification of such status). For example, if an individual has the proper validation on his/her passport, a notarized photocopy of the passport could suffice. Because there is a 6-month limitation on this validation, it is the grantee s responsibility to follow up and ensure that the individual received the I-551 prior to the 6-month expiration date. 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 formally combined PharmD/PhD program in the biomedical, behavioral, or clinical sciences at an accredited domestic School of Pharmacy. This grant program will provide predoctoral training support for students at the dissertation stage of their training. Students may submit their application prior to reaching the dissertation stage of their training, but they must meet award activation guidelines as described in Section VI. Award Administration Information. This Kirschstein-NRSA F31 may not be used to support studies leading to the PharmD.

Individuals who have already earned a PharmD degree and have enrolled in a Ph.D. granting program or wish to seek additional postdoctoral research and mentored training should view the Fellowship (http://grants.nih.gov/training/F_files_nrsa.htm) and Career Development or K (http://grants.nih.gov/training/careerdevelopmentawards.htm) Kiosks on the NIH Training and Career Development Websites for additional programs that may support their training.

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/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, 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 apply for up to three years of this Kirschstein-NRSA F31 support. Individuals may receive up to a total of 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). It is not permissible 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.

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 total five year aggregate Kirschstein-NRSA limit may be possible, but a waiver from the NIH awarding component is required. Individuals seeking additional Kirschstein-NRSA support beyond five years 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.

Section IV. Application and Submission Information

1. Address to Request Application Information

The fellowship application instructions are available at PHS 416-1 in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected]. Note that the PHS 416-1 has been restructured, and the instructions have been significantly modified. See the NIH Notice NOT-OD-09-004 released October 14, 2008.

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

2. Content and Form of Application Submission

Applications must be prepared using the current 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 12b of the face page of the PHS 416-1 form.

The title and program announcement 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. 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:

At least three completed references using the PHS 416-1 Reference Page. These reference letters must be submitted in sealed envelopes affixed to the original face page of the application. Applications without at least three letters of references may be delayed in review or returned to the applicant without review. Information applicable to the required references in located in the Application instructions, Part 2.7).
A listing of the applicant’s courses with grades from all undergraduate and graduate institutions in which the applicant is/has been enrolled must be included in the Applicant/Fellow Biographical Sketch Format Page. DO NOT include transcripts with the application (applicants may be asked to send transcripts prior to award).
A description of the graduate or formally combined and accredited degree program in which the applicant is enrolled must be included in the application.
A description of plans to receive instruction in the responsible conduct of research must be included in the application. No award will be issued if an application lacks this component.

3. Submission Dates and Times

Applications must be mailed on or before the receipt dates as described in Section 3.A. (see Section IV. Application and Submission Information)..

3.A. Submission, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): not required
Application Receipt or Submission 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://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): please 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 the funding opportunity.

3.B. Sending an Application to the NIH

Applications must be prepared using the most recent PHS 416-1 research training fellowship application as described above.

The applicant must follow the instructions stated in the PHS 416-1 for submitting the application (original and two copies) and Appendix materials, and letters of reference 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/submission 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 merit 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.

These awards are also subject to the NRSA policies (see http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm)

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.

Service Payback

There are no payback requirements for predoctoral NRSA support.

Future Year Support

Funds for continuation beyond the initial year are determined by the progress described in the continuation application, PHS 416-9, the timely submission of all required forms, and the availability of funds.

6. Other Submission Requirements and Information

Applicants must follow the current PHS 416-1 application form and instructions at the time of application. See NOT-OD-09-004.

Sponsor

The applicant’s sponsor, 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. Eligibility Information The sponsor must describe in detail his/her commitment to and proposed role in guiding the individual applicant during the research training experience and describe the research training plan for the applicant and how it will contribute to the applicant’s career as an independent investigator.

Training Plan

The sponsor must provide a tailored research training plan for the applicant. The plan must list experiences that are specifically planned for the fellow including classes, seminars, and opportunities for interaction with other groups and scientists. Describe the research environment and available research facilities and equipment. Indicate the relationship of the proposed research training to the applicant's career. Describe the skills and techniques that the applicant will learn. Relate these to the applicant's career aspirations.

Additionally, the availability and quality of the facilities and related resources necessary for the proposed research training experience (e.g., equipment, laboratory space, computer time, 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.

Other Research Experiences

Follow the special instructions for predoctoral fellows. Note that advanced graduate students (ONLY) must include a narrative of their doctoral dissertation (may be preliminary). However, all graduate students should include a description of any applicable research.

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 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. 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.

Resource Sharing Plans

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 (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 NIGMS 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 Officer (SRO), 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 NIGMS. Staff within the assigned funding Institute provides a second level of review.

As part of the initial merit review, applications:

Will receive a written critique
Will receive a second level of review by appropriate staff within NIGMS

The following will be considered in making funding decisions:

Overall scientific merit of the proposed project as determined by peer review
Relevance to program priorities and portfolio balance
Availability of funds

The goal of this Kirschstein-NRSA individual predoctoral fellowship (F31) program is to train future generations of outstanding scientists who are enrolled in joint PharmD/PhD programs and are committed to basic, translational and clinical research careers in scientific health-related fields relevant to the mission of NIGMS. 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 NIGMS’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 Institute representative listed in Section VII. Agency Contacts to obtain current information about Institute-specific program priorities and policies prior to submission.

Review Criteria

Applicant/Fellow

The quality of the academic record and research experience of the applicant
The applicant’s potential for independent contribution to scientific knowledge

Sponsor(s) and Training Environment

The qualifications and caliber of the sponsor(s) as researcher(s), including successful competition for research support, and mentor(s), including track record in training, for the proposed research training experience
Evidence of a match between the research interests of the applicant and the primary sponsor(s), including an understanding of the applicant s research training needs and a demonstrated ability and commitment of the sponsor(s) to assist in meeting these needs
The quality of the training environment including the institutional commitment to research training of predoctoral fellows and trainees, the quality and availability of facilities and related resources (e.g. equipment, laboratory space, computer time, subject populations), and the availability of research support

Research Training Plan

The merit of the scientific proposal
The quality of the research training plan
Scientific significance, originality, and feasibility of the proposed research
The coherence and potential of the research training plan to provide the applicant with individualized and supervised experiences that will develop research skills needed in preparation for his/her research career
Potential of the proposed research training to serve as a sound foundation that will lead the applicant to a productive career in scientific areas related to the mission of NIGMS.

Training Potential

The value of the proposed fellowship experience with respect to the applicant’s needs in preparation for a research doctoral degree

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 the PHS 416-1 fellowship application Part I instructions 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. Resource Sharing Plans

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. Additional information regarding registration for the NIH eRA Commons can be found in the NIH eRA Commons System (COM) Users Guide. Questions regarding Commons registration should be made to the eRA Commons Help Desk at: [email protected] 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, 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. An NIGMS fellowship may not be activated on or between October 1 and November 15.

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 60 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 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 supported 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. 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. An NIGMS fellowship may not be activated on or between October 1 and November 15.

Application for Continued Support: An awardee will be required to submit the form PHS 416-9, 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, to the NIH within 30 days following termination.

Section VII. Agency Contacts

We strongly 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:

Richard Okita, PhD
Division of Pharmacology, Physiology, and Biological Chemistry
National Institute of General Medical Sciences
45 Center Drive, 2AS.49A, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-3827
Fax: (301) 480-2802
Email: [email protected]

Dr. Mary Frances Picciano
NIH Office of Dietary Supplements
6100 Executive Blvd, Room 3B01
Bethesda MD 20892-7517
301-435-3605
[email protected]

2. Peer Review Contacts:

Not Applicable

3. Financial or Grants Management Contacts:

Ms. Lisa Moeller
Pharmacology, Physiology, and Biological Chemistry
National Institute of General Medical Sciences
45 Center Drive, , 2AN.50C MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-3914
Fax: (301) 480-2554
Email: [email protected]

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 Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

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.

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 funding opportunity 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.

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 Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html), investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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 FOA 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. 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/.