Part I Overview Information

Department of Health and Human Services

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

Components of Participating Organizations
National Institute on Aging (NIA), http://www.nia.nih.gov/
National Institute on Alcohol Abuse and Alcoholism (NIAAA), http://www.niaaa.nih.gov
National Institute on Deafness and Other Communication Disorders (NIDCD), http://www.nidcd.nih.gov/
National Institute of Dental and Craniofacial Research (NIDCR) http://www.nidcr.nih.gov/
National Institute on Drug Abuse (NIDA), http://www.nida.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 Center for Complementary and Alternative Medicine (NCCAM), http://www.nccam.nih.gov
Office of Dietary Supplements (ODS), http://ods.od.nih.gov/

Announcement Type
This is a reissue of PA-07-002.

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

• February 16, 2010 - This PA has been reissued as (PA-10-108).
• October 16, 2009 - See Notice NOT-OD-10-004 This notice amends the institutional eligibility for Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowships.
• July 2, 2009 - See Notice NOT-AT-09-005 Change of Funding Opportunity Announcement.

Program Announcement (PA) Number: PA-09-208

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF 424 Research and Related (R&R) forms and the SF 424 (R&R) Individual Fellowship Application Guide for use by NIH and AHRQ applicants.

APPLICATIONS MAY NOT BE SUBMTTED IN PAPER FORMAT.

This FOA must be read in conjunction with the individual fellowship application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission, and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.866, 93.272, 93.173, 93.279, 93.282, 93.853, 93.121, 93.213

Key Dates
Release Date: June 12, 2009
Opening Date: July 8, 2009 (Earliest date an application may be submitted to Grants.gov)
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Letter of Intent Receipt Date(s): Not Applicable
Application Due Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
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(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Expiration Date: Now Expired February 17, 2010 (per issuance of PA-10-108)September 8, 2012

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 Training Objectives

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

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

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application Electronically 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. 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 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 NIH-supported Ruth L. Kirschstein National Research Service Awards programs is to help ensure that a diverse pool of highly trained scientists are available in adequate numbers and in appropriate research areas to address the Nation's biomedical, behavioral, and clinical research needs.

The purpose of the predoctoral fellowship (F31) award is to provide support for promising doctoral candidates who will be performing dissertation research and training in scientific health-related fields relevant to the missions of the participating NIH Institutes during the tenure of the award. The Kirschstein-NRSA for Individual Predoctoral Fellows will provide up to five years of support for research training which leads to the PhD or equivalent research degree, the combined MD/PhD degree, or another formally combined professional degree and research doctoral degree in the biomedical, behavioral, or clinical sciences.

Applicants for the Kirschstein-NRSA F31 award must propose a dissertation research project and training program that fall in a research area within the scientific mission of the participating Institutes. The proposed predoctoral research training must offer an opportunity to enhance the fellow's understanding of the health-related sciences and extend his/her potential for a productive, independent research career. The training should provide the applicant with the opportunity to interact with members of the scientific community at appropriate scientific meetings and workshops (including NIH-sponsored meetings, where available). The application should document the need for the proposed research training and the expected value of the proposed fellowship experience as it relates to the individual’s goals for a career as an independent researcher.

Each NIH Institute and Center (IC) has a unique scientific purview and different program goals and initiatives that evolve over time. Prospective Fellowship Applicants are encouraged to contact the relevant NIH staff for IC-specific programmatic information: Table of Institute and Center Contacts.

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

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the Ruth L. Kirschstein NRSA individual predoctoral fellowship award mechanism (F31). As a Fellowship Applicant, the individual, together with his/her sponsor and institution, are jointly responsible for planning, directing, and executing the proposed research training program.

2. Funds Available

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

2.A. Allowable Costs

Stipends: 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 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. No departure from the published Kirschstein-NRSA stipend schedule may be negotiated between the institution and the fellow. For the current stipend levels, see: NOT-OD-09-075.

For fellows sponsored by domestic non-federal institutions, the stipend will be paid through the sponsoring institution. For fellows sponsored by Federal or foreign institutions, the monthly stipend payment will be deposited in the fellow's U.S. bank account or paid directly to the fellow by U.S. Department of Treasury check.

Tuition and Fees: The NIH will contribute to the combined cost of tuition and fees at the rate in place at the time of award. Currently, the NIH will provide an amount per individual fellow equal to 60% of the level requested by the applicant institution, up to $16,000 per year for individuals enrolled in a doctoral degree program and up to $21,000 per year for those individuals enrolled in a dual degree (e.g. MD/PhD) program. Tuition, for the purposes of this policy, means the combined costs of tuition and fees. For additional information, see: NOT-OD-06-093.

Institutional Allowance: Predoctoral fellows sponsored by nonfederal or nonprofit institutions (domestic or foreign) will receive an institutional allowance of $4,200 per 12-month period 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 is an allowable cost for fellows at the 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 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. The Notice of Award will be revised and the balance must be returned to the NIH.

NIH will currently 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 for fellows at Federal laboratories will be disbursed from the awarding IC.

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: As part of this award, additional funds may be requested. 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.

• Reasonable accommodations: Additional funds may be requested by the sponsoring institution to make changes or adjustments in the academic or research environment that will make it possible for an otherwise qualified individual with disabilities to perform the work necessary to meet the requirements of the degree program in which he/she is enrolled. Individuals with disabilities are defined as those with a physical or mental impairment that substantially limits one or more major life activities (see: Americans with Disabilities Act Home Page). The accommodations requested under this program must be directly related to the work required to meet the requirements as regards to both course work and laboratory experience, and must be appropriate to the special needs of the applicant. Some types of accommodations that might be provided under this award include, but are not limited to: specialized equipment, assistive devices, and personnel such as readers, interpreters, or assistants. This award is not meant to relieve the sponsoring institution of its obligation to provide reasonable accommodations as defined by the Americans with Disabilities Act. NIH will not provide funds for infrastructure alterations such as lowering countertops, widening doorways, etc.
• Off-site research training: Additional funds may be requested by the sponsoring institution if the research training of a fellow involves extraordinary costs for travel to field sites remote from the sponsoring institution.
• Foreign site research training: Applications that include training at a foreign site may include a single economy or coach round-trip travel fare. No allowance is provided for dependents. U.S. flag carriers must be used to the maximum extent possible when commercial air transportation is available for travel between the United States and a foreign country or between foreign countries.

Indirect Costs: These costs also known as Facilities and Administrative (F&A) costs, are not allowed for 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 may either 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. See also: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm#_Toc54600200.

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.

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.

NIH Grants Policy: 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:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education
• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• For-Profit Organizations (Other than Small Businesses)
• Non-domestic (non-U.S.) Entities (Foreign Organizations)
• Other(s):

• Eligible Agencies of the Federal Government

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

Foreign sponsorship: An individual may request support for training abroad. In such cases, the applicant is required to provide detailed justification for the foreign training, including the reasons why the facilities, the mentor, 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.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research training is invited to work with his/her sponsor and institution to develop an application for support. Individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds may also be eligible to apply for the Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral Fellowships (F31) to Promote Diversity in Health-Related Research (PA-09-209).

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

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). 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: A Fellowship Applicant must have a baccalaureate degree and be currently enrolled in a PhD or equivalent research degree program (e.g., EngD, DNSc, Dr PH, DSW, PharmD, PsyD, ScD), a formally combined MD/PhD program, or other combined professional/clinical and research doctoral (e.g., DDS/PhD) in the biomedical, behavioral, or clinical sciences at an accredited domestic or foreign institution. With the exception of the combined degree programs described above, the Kirschstein-NRSA F31 may not be used to support studies leading to the MD, DDS, or other clinical, health-professional training (e.g., DC, DMD, DNP, DO, DPM, DVM, ND, OD, AuD). Neither may these awards be used to support the clinical years of residency training.

Students seeking support for pursuit of a combined degree program (e.g. MD/PhD, or DO/PhD, or DDS/PhD) may be eligible to apply for the Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral MD/PhD Fellows (F30) (PA-09-207).

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Number of Applications: An individual may not have two or more competing NIH fellowship applications pending review concurrently.

Resubmission(s): Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new and competing renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

Renewals: Awards are generally not renewable and are not transferable from one PD/PI to another. Fellowship awardees requiring further research training should contact the NIH awarding component to see if they may submit a renewal application.

Duration of Support: Individuals may typically receive up to 5 years of aggregate Kirschstein-NRSA support at the predoctoral level, including any combination of support from an institutional training grant (e.g., T32 or T90) and an individual fellowship award (F31). However, it is not possible to have concurrent Kirschstein-NRSA support from two different sources (e.g., F31 and T32). Applicants must consider any prior Kirschstein-NRSA predoctoral research training in determining the duration of fellowship support requested. Accurate information regarding previous Kirschstein-NRSA support must be included in the application and will be considered at the time of award.

Training beyond the 5-year aggregate limit may be possible under rare and exceptional circumstances, but a waiver from the NIH awarding component is required. Individuals seeking additional Kirschstein-NRSA support beyond the fifth year are strongly advised to consult with relevant NIH staff before submitting a justification. Any waiver will require a detailed justification of the need for additional research training. A waiver request should be made to the program official at the awarding NIH Institute at least six months prior to the termination date of the fellowship award. A request for a waiver cannot be made prior to the issuance of the initial award.

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. Support for subsequent years of the fellowship award beyond the first budget period is based upon evidence of satisfactory progress in the predoctoral research training program which is determined by the NIH Program staff review of information documented in the progress report.

3.A. Special Requirements

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: Before submitting a fellowship application, the applicant must also identify a 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 and be demonstrably committed to research training in the particular program proposed by the applicant.

Foreign Training: Applicants requesting foreign research training are required to provide detailed justification for the foreign training, including the reasons why the facilities, the sponsor, or other aspects of the proposed experience are more appropriate than training in a domestic setting. The justification is evaluated in terms of the scientific advantages of the foreign training as compared to the training available domestically. Foreign training will be considered for funding only when the scientific advantages are clear.

Foreign Organizations: Several special provisions apply to applications submitted by foreign organizations. Additional information regarding foreign grants is available in the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_TOc54600260).

To download a SF424 (R&R) Application Package and SF424 (R&R) Individual Fellowship Application Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both: (see 2.2 Registration Process in the Application Guide)

• Grants.gov (http://www.grants.gov/applicants/get_registered.jsp) and
• eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

The PD/PI (Fellowship Applicant) should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

• Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
• If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
• The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
• Direct questions regarding Grants.gov registration to:
  Grants.gov Customer Support
  Contact Center Phone: 800-518-4726
  Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
  Email [email protected]

2) Organizational/Institutional Registration in the eRA Commons

• To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in eRA Commons.
• Direct questions regarding the Commons registration to:
  eRA Commons Help Desk
  Phone: 301-402-7469 or 866-504-9552 (Toll Free)
  TTY: 301-451-5936
  Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
  Email [email protected]

3) Project Director/Principal Investigator (PD/PI) Registration in the eRA Commons: Refer to the eRA Commons System (COM) Users Guide.

• The individual (fellow) submitting the application for support is the PD/PI.
• The individual designated as PD/PI on the application must be registered also in the eRA Commons prior to the submission of the application.
• The PD/PI must hold a PD/PI account in the Commons. The Fellowship Applicant should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an Internet Assisted Review (IAR) role, both roles should exist under one Commons account.
• This registration/affiliation must be done by the AOR/SO or his/her designee who is already registered in the Commons.

The PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Several of the steps of the registration process could take four weeks or more. Therefore, the Fellowship Applicant should immediately check with his/her business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

NOTE: Fellowship Applicants who are submitting an Individual Fellowship application with a different sponsoring organization should refer to NIH Notice Number: NOT-OD-07-003 Guidance to Applicant Organizations about Registering Research Fellows in the eRA Commons for guidance; see http://grants.nih.gov/grants/guide/notice-files/not-od-07-003.html. Additional instructional information is in the SF-424 (R&R) Individual Fellowship Application Guide for NIH and AHRQ applicants, 2.2 Registration Process.

1. Request Application Information

Fellowship Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Individual Fellowship Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo -- Telephone 301-710-0267, Email: [email protected].

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Individual Fellowship Application Guide for this FOA through Grants.gov/Apply. Note the PHS Supplemental Form Pages that must be included in the application.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. In addition to these components, NIH and AHRQ Fellowship applicants must also complete supplemental components listed as PHS Fellowship Supplemental Form in the table below: A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person Profile(s)
PHS Fellowship Supplemental Form

Optional Component:
PHS398 Cover Letter

Specific instructions related to each of the components are included in the Individual Fellowship Application Guide located at Grants.gov/APPLY.

Foreign Organizations (Non-domestic [non-U.S.] Entities)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

Applications from Foreign organizations must:

• Request budgets in U.S. dollars;
• Comply with Federal/NIH policies on human subjects, animals, and biohazards; and
  
• Comply with Federal/NIH biosafety and biosecurity regulations (see Section VI.2., Administrative and National Policy Requirements )

Proposed research training should provide special opportunities for training through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States (U.S.) or that augment existing U.S. resources.

3. Submission Dates and Times

See Section IV for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: July 8, 2009 (Earliest date an application may be submitted to Grants.gov)
Letter of Intent Receipt Date(s): Not Applicable.
Application Due Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
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(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See above for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.

• If everything is acceptable, no further action is necessary. The application will automatically move forward to the Division of Receipt and Referral in the Center for Scientific Review for processing after two weekdays, excluding Federal holidays.
• Prior to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if it is determined that some part of the application was lost or did not transfer correctly during the submission process, the AOR/SO will have the option to Reject the application and submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to ensure that the issues are addressed and corrected. Once rejected, applicants should follow the instructions for correcting errors in Section 2.12, including the requirement for cover letters on late applications. The Reject feature should also be used if you determine that warnings are applicable to your application and need to be addressed now. Remember, warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.
• If the two-day window falls after the submission deadline, the AOR/SO will have the option to Reject the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.
• If the AOR/SO chooses to Reject the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted, but it will be subject to the NIH late policy guidelines and may not be accepted (see: NOT-OD-05-030). The reason for this delay should be explained in the cover letter attachment.
• Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two days.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgment of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PD/PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

The NIH will not accept any application in response to this FOA 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. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

Citizenship: Fellowship Applicants must meet the citizenship/residency requirements as described in the Eligibility section of this announcement (see Section III) at the time of award.

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. Note that the NIH takes no position on the status of a particular taxpayer, nor does it have the authority to dispense tax advice. The interpretation and implementation of the tax laws are the domain of the IRS. Individuals should consult their local IRS office about the applicability of the tax laws to their situation and for information on their tax obligations.

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

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

6. Other Submission Requirements

R&R PD/PI Credential (e.g., Agency Login): The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.

Organizational DUNS: The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Cover Letter: Applicants are encouraged to include a cover letter with the application. For example, applicants may request assignment (referral) to a particular NIH Institute or Center, as well as a specific Scientific Review Group. See SF 424 Individual Fellowship Application Guide, Section 5.2, for additional information.

All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

6.A. Fellowship Applicant Information and Research Training Plan

The following information must be included in the application in accordance with the Application Guide Instructions for Individual Fellowships in the SF424 (R&R):

Sponsor(s): The 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. The sponsor and any co-sponsors must describe in detail his/her commitment to, and proposed role in, guiding the individual applicant during the research training experience. The sponsor should describe the research training plan for the applicant (coordinated with the applicant’s own research training plan; see below). The sponsor and any co-sponsors are also expected to provide an assessment of the applicant’s qualifications and potential for a research career. The research environment and the availability and quality of needed research facilities and research resources (e.g., equipment, laboratory space, computer time, available research support, etc.) must also be described. The description should include items such as classes, seminars, and opportunities for interaction with other groups and scientists. Training in career skills, e.g. grant-writing and presentation skills are strongly encouraged.

Note: The Sponsor(s) section must be attached as part of Other Attachments under Other Project Information Component.

Research Training Plan: The Fellowship Applicant should describe the research training plan which is an important component of the Kirschstein-NRSA F31 application. Describe planned activities such as coursework, seminars, scientific conferences, opportunities for interaction with other groups and scientists, and any special or unique training opportunities for the applicant that are available in the training environment. Indicate the relationship of the proposed research training to the applicant’s career goals. Describe the skills and techniques that the Fellowship Applicant will learn as they relate to the applicant’s career goals and relate these to his/her career aspirations. The applicant’s plan should be coordinated with the sponsor’s plan (see above), and should include substantive detail that adds to the information about time allocations requested. The applicant must describe concisely the Specific Aims, the background leading to the proposed research, the significance of the research, the research design and methods for achieving the Specific Aims, the rationale, and expected/alternative outcomes of the proposed studies. It is beneficial to include pertinent preliminary data obtained by the applicant in the dissertation laboratory.

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

Note: Items 2-5 of the Research Training Plan is limited to 10 pages.

Doctoral Dissertation and Other Research Experience: Advanced graduate students must include a narrative of their doctoral dissertation (may be preliminary) and any other prior research experience. All graduate students should include any applicable research experience. Please note that while the instructions direct Predoctoral Fellows to omit this section, the information is required of advanced graduate students who have successfully completed their comprehensive examinations or the equivalent by the time of award and will be performing dissertation research. All graduate students should include any research experience, if applicable.

Note: The Doctoral Dissertation and Other Research Experience section (#10) must be attached as part of C. Additional Information under 5.3. PHS Fellowship Supplemental Form.

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

Note: Training Potential section must be attached as part of Other Attachments under Other Project Information Component.

Institutional Environment and Commitment to Training: The application should describe the quality and appropriateness of the training environment for the applicant’s development including the strength of the institutional commitment to fostering the fellows training. Describe the quality and availability of facilities and resources (e.g. equipment, laboratory space, computer time, subject populations) for the proposed training. Additionally, the quality of the facilities and related resources (e.g., equipment, laboratory space, computer time, available research support, etc.) must be described.

Note: Institutional Environment and Commitment to Training section must be attached as part of Other Attachments under Other Project Information Component.

Additional Educational Information Required: Applicants must also provide scores for the Graduate Record Examination (GRE), if available. MD/PhD applicants should provide MCAT scores, if available.

• 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 Fellowship Applicant 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 combined 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.

Note: Additional Educational Information Required section must be attached as part of Other Attachments under Other Project Information Component.

Human Subjects Research: If the proposed research involves human subjects, the applicant must be responsive to the instructions in the SF 424 (R&R) Application Guide. The adequacy of plans to include appropriate human subjects is included in the fellowship evaluation (see Additional Review Criteria below). Note that NIH defines children as individuals under 21 years of age. Consult the Decision Tree for Inclusion of Children in Human Subjects Research for the exemptions that apply: 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 follow the instructions in the SF 424 (R&R) Application Guide. A Fellowship application needs to provide a complete Vertebrate Animal section that fully addresses each of the five key points of animal research listed in the instructions, below. The adequacy of plans for the care and use of vertebrate animals is assessed as part of the fellowship evaluation (see Additional Review Criteria below).

1. Provide a detailed description of the use of animals in the work previously outlined in the experimental design and methods section. Identify species, strains, ages, sex, and numbers of animals to be used.

2. Justify the use of animals, choice of species, and number of animals to be used.

3. Provide information on veterinary care for the animals involved.

4. Describe procedures for ensuring that discomfort, distress, pain, and injury will be limited to that which is unavoidable to conduct scientifically sound research. Describe the use of analgesic, anesthetic, and tranquilizing drugs and comfortable restraining devices, where appropriate, to minimize discomfort, distress, pain, and injury.

Describe any euthanasia method to be used and the reasons for its selection. State whether this method is consistent with the recommendations of the Panel on Euthanasia of the American Veterinary Medical Association. If not, present a justification for not following the recommendations.

Instruction in the Responsible Conduct of Research: Applications must include the sponsoring institution’s plan to provide and the potential fellow’s plans for obtaining instruction in the responsible conduct of research. The rationale, subject matter, appropriateness, format, frequency and duration of instruction must be described. 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.

Note: Instruction in the Responsible Conduct of Research section must be attached as part of Other Research Training Plan Section under PHS Fellowship Supplemental Form.

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

Select Agent Research: If any of the activities proposed in the application involve the use of Select Agents at any time during the proposed project period, either at the applicant organization or at any other Project/Performance Site, refer to application instructions for addressing this item.

6.B. Letters of Reference

Electronic submission of reference letters is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons and do not use Grants.gov. Therefore, candidates must follow the Supplemental Instructions in the SF424 R&R Individual Fellowship Application Guide for specific instructions (Part 5.4). Letters of reference are an important component of the application for fellowship support. Applicants for this fellowship must arrange to have at least three (but no more than five) letters of reference submitted on their behalf to the eRA Commons Web site at https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new. The letters should be from well-established scientists (referees) addressing the qualities of the applicant fellow as well as his/her potential to develop research skills needed in preparation for a productive research career in scientific areas related to the mission of one of the participating Institutes. These letters should be from individuals not directly involved in the application, but who are familiar with the candidate’s qualifications, training, and interests, including advisory committee members (if applicable). Resubmission applications will require new letters of reference.

Letters of reference may be submitted any time after the FOA opens and no later than 5 business days after the application due date.

Applications that are missing the required letters of reference may be delayed in the review process or not accepted.

6.C. Citizenship and Certification Procedures

If the applicant has been lawfully admitted to the United States for permanent residence, the appropriate item should be checked on the PHS Fellowship Supplemental form. Applicants who have applied for and have not yet been granted admission as a permanent resident should check the Permanent Resident of U.S. Pending block. A notarized statement documenting legal admission for permanent residence must be submitted prior to the issuance of an award.

Individuals admitted to the United States as Permanent Residents will be required to submit notarized evidence of legal admission prior to the award.

All application instructions outlined in the SF 424 (R&R) Individual Fellowship Application Guide are to be followed.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).

(a) Data Sharing Plan: Not Applicable.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications in which the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible (see Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

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

(c) Genome Wide Association Studies: Not Applicable.

Foreign Applications (Non-domestic [non-U.S.] Entities)

Indicate how the proposed research training project has specific relevance to the mission and objectives of the NIH/IC and has the potential for significantly advancing the health sciences in the United States

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF 424 (R&R) Individual Fellowship Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations of the Research Training Plan. An application that does not comply with the required page limitations may be delayed in the review process.

1. Criteria

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

2. Review and Selection Process

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

Applications that are complete will be evaluated for scientific and technical merit by Scientific Review Groups convened in accordance with the NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.

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 Official (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 the appropriate NIH Institute. Staff within the assigned funding Institute provides a second level of review.

As part of the initial merit review, applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.
• Will receive a second level of review by appropriate staff within the assigned NIH Institute or Center.

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 purpose of the predoctoral fellowship (F31) program is to train future generations of outstanding scientists who are committed to research careers in scientific health-related fields relevant to the missions of the participating NIH Institutes. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research training will have a substantial impact on the pursuit of this goal. 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 overall impact/priority score. The overall impact/priority score will reflect the overall evaluation of the entire application. Note also that relevance to an Institute’s mission priorities is not evaluated as part of the peer review process but by Institute program staff. This programmatic evaluation may influence funding decisions independent of the peer review evaluation.

Individual Fellowship Review Criteria

Overall Impact: Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood that the fellowship will enhance the candidate’s potential for, and commitment to, a productive independent scientific research career in a health-related field, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).

Core Review Criteria: Reviewers will consider each of the five criteria below in determining scientific and technical merit and will give a separate score for each. An application does not need to be strong in all categories to be judged likely to have a major impact.

Fellowship Applicant:

• Are the applicant’s academic record and research experience of high quality?
• Does the applicant have the potential to develop as an independent and productive researcher?

Sponsor(s), Collaborator(s), and Consultant(s):

• Are the sponsor’s research qualifications (including successful competition for research support) and track record of mentoring appropriate for the proposed fellowship?
• Are there (1) evidence of a match between the research interests of the applicant and the sponsor (including an understanding of the applicant’s research training needs) and (2) a demonstrated ability and commitment of the sponsor to assist in meeting these needs?
• Are the qualifications of any collaborator(s) and/or consultant(s), including their complementary expertise and previous experience in fostering the training of fellows, appropriate for the proposed research project?

Research Training Plan:

• Is the proposed research plan of high scientific quality, and does it relate to the applicant’s training plan?
• Is the training plan consistent with the candidate’s stage of research development?
• Does the research plan address scientific significance, originality, and feasibility?
• Will the research training plan provide the applicant with individualized and supervised experiences that will develop research skills needed for his/her research career?

Training Potential:

• Does the proposed research training have the potential to serve as a sound foundation that will lead the fellow to a productive career?
• Does the proposed research training plan have the potential to provide the fellow with the requisite individualized and supervised experiences that will develop his/her research skills?

Institutional Environment and Commitment to Training:

• Is the institutional environment for the scientific development of the applicant of high quality, and is there appropriate institutional commitment to fostering the fellows training?
• Are the research facilities, resources (e.g. equipment, laboratory space, computer time, subject populations), and training opportunities adequate and appropriate?

Additional Review Criteria

In addition to the above criteria, the following items may be considered in the determination of scientific merit and the overall impact/priority score:

Resubmission Applications: When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Applications from Foreign Organizations: Reviewers will assess whether the research training presents special opportunities and clearly described scientific advantages for the applicant, through the use of talent (e.g. mentor), resources, populations (if applicable), or training environment that are not readily available in the United States or augment existing U.S. talent and/or resources.

Protection of Human Subjects from Research Risk: For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, SRGs will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities and Children in Research: When human subjects are involved in the proposed clinical research, the SRG will also evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children in clinical research.

Care and Use of Vertebrate Animals in Research: As part of the peer review process, the SRG will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

Biohazards: Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Select Agent Research: Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

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 fellow'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 overall impact/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 overall impact/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.

Budget and Period of Support: Reviewers will assess the appropriateness of the requested period of support in relation to the proposed fellowship training.

Resource Sharing Plan(s)

(a) Data Sharing Plan: Not Applicable.

(b) 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 impact/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.

(c) Genome Wide Association Studies (GWAS): Not Applicable.

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 Fellowship Applicant will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to the eRA Commons System (COM) Users Guide for additional information regarding registration in the eRA Commons. Direct questions regarding Commons registration 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 may request just-in-time information from the applicant. Applicants are advised to submit just-in-time information only when requested by the awarding component. Guidance for submitting this information will be provided at the time of the request. Alternatively, this information may be submitted using the Just-In-Time feature of the eRA Commons found in the Status section. For information on the Commons see: https://commons.era.nih.gov/ commons/index.jsp.

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 Award (NoA) will be provided to the sponsoring organization. This notification signed by the grants management officer is the authorizing document. The Notice of 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 Fellowship Applicant through the eRA Commons. The NoA 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. A fellow has up to six months from the issue date on the NoA 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) has been submitted to the NIH. A fellow has up to six months from the issue date on the award notice to activate the award. Under unusual circumstances, an NIH Institute may grant an extension of the activation period upon receipt of a specific request from the fellow, countersigned by the sponsor and an institutional official.

2. Administrative and National Policy Requirements

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_Part14.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions of 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 (http://grants.nih.gov/grants/policy/policy.htm) and any terms and conditions specified on the Notice of 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 the same paid leave for this purpose and the use of parental leave is approved by the program director (see NOT-OD-08-064).

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.

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

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 fellow.

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

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

Copyrights: Except as otherwise provided in the terms and conditions of the award, the recipient is free to arrange for copyright without approval when publications, data, or other copyrightable works are developed in the course of work under a PHS grant-supported project or activity. Any such copyrighted or copyrightable works shall be subject to a royalty-free, nonexclusive, and irrevocable license to the Government to reproduce, publish, or otherwise use them, and to authorize others to do so for Federal Government purposes.

3. Reporting

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

Activation Notice: The fellowship award recipient has up to six months from the issue date on the Notice of 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.

Payback Agreement: Recipients of Kirschstein-NRSA F31 awards do not incur service payback.

Application for Continued Support: The fellow will be required to submit the form PHS 416-9, 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 describing the current year's progress as well as the research and training plans for the coming year. Note that the instructions request a listing of all courses and publications completed during the past 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

Each participating NIH Institute has a unique scientific purview and different program goals and initiatives that evolve over time. Prior to preparing an application, it is important that applicants consult the appropriate Institute website (listed with each Institute’s name at the beginning of this announcement) for details of research areas supported by that Institute. Applicants should also contact the appropriate Institute scientific/research contact (see below) to obtain current information about specific program priorities and policies. 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 Table of Institute and Center Contacts to obtain participating NIH Institute scientific/research contact information.

2. Peer Review Contacts:

Not applicable.

3. Financial or Grants Management Contacts:

Applicants should refer to the Table of Institute and Center Contacts to obtain participating NIH Institute grants management contact information.

Section VIII. Other Information

Required Federal Citations

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

Human Subjects Protection:
Federal regulations (45 CFR 46) 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 institutional review board (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. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal 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 SF424 (R&R) application; 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 each person identified as Senior/key Personnel involved in the design or conduct of research involving human subjects. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html and http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-054.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.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). 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 (HHS) 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 HHS 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) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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/.