Part I Overview Information

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Department of Health and Human Services

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

Components of Participating Organizations
National Eye Institute (NEI), (http://www.nei.nih.gov)
National Heart, Lung and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov)
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 of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov)
National Institute of Biomedical Imaging and Bioengineering (NIBIB), (http://www.nibib.nih.gov)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www.niddk.nih.gov)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov)
National Center for Complementary and Alternative Medicine (NCCAM), (http://www.nccam.nih.gov)
National Center for Research Resources (NCRR), (http://www.ncrr.nih.gov)
Office of Dietary Supplements (ODS) , (http://ods.od.nih.gov)

Title: Ruth L. Kirschstein National Research Service Award Short-Term Institutional Research Training Grants (T35)

Announcement Type
This is a reissue of PA-05-117.

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

• November 27, 2009 - This PA has been reissued as (PA-10-037).
• July 24, 2009 - See Notice NOT-EB-09-002 Effective May 25, 2010, NIBIB will accept one receipt date per year.
• February 10, 2009 - See Notice (NOT-OD-09-049) Notice of Re-issuance of Kirschstein-NRSA T32.

Program Announcement (PA) Number: PA-08-227

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

Catalog of Federal Domestic Assistance Number(s)
93.173, 93.142, 93.272, 93.213, 93.233, 93.279, 93.286, 93.398, 93.837, 93.838, 93.839, 93.849, 93.856, 93.859, 93.865, 93.389, 93.866, 93.867

Key Dates
Standard dates apply (http://grants1.nih.gov/grants/funding/submissionschedule.htm). Please note that some participating NIH Institutes and Centers (ICs) do not accept T35 applications for all three receipt dates. Therefore, applicants are strongly encouraged to refer to the T35 Contact Table (See: http://grants.nih.gov/archive/grants/guide/contacts/pa-08-227_contacts.htm) associated with this funding opportunity announcement to determine Institute or Center (IC) specific submission dates.

• Release Date: August 1, 2008
• Letters of Intent Submission Date(s): Not applicable
• Application Submission Date(s): Standard dates apply (http://grants1.nih.gov/grants/funding/submissionschedule.htm), except as noted in the IC Contact Table (see above).
• AIDS Application Submission Date(s): Standard dates apply (http://grants1.nih.gov/grants/funding/submissionschedule.htm), except as noted in the IC Contact Table (see above).
• Peer Review Date(s): Standard dates apply (http://grants1.nih.gov/grants/funding/submissionschedule.htm), except as noted in the IC Contact Table (see above).
• Council Review Date(s): Standard dates apply (http://grants1.nih.gov/grants/funding/submissionschedule.htm), except as noted in the IC Contact Table (see above).
• Earliest Anticipated Start Date(s): Standard dates apply (http://grants1.nih.gov/grants/funding/submissionschedule.htm), except as noted in the IC Contact Table (see above).
• Additional Information To Be Available Date (Url Activation Date): Not applicable
• Expiration Date: (Now Expired January 8, 2010 per issuance of PA-10-037) September 8, 2011

Due Dates for E.O. 12372

Not Applicable.

Additional Overview Content

Executive Summary

• Purpose: The National Institutes of Health (NIH) will award Ruth L. Kirschstein National Research Service Award (NRSA) Short-Term Institutional Research Training Grants (T35) to eligible institutions to develop or enhance research training opportunities for individuals interested in careers in biomedical, behavioral and clinical research. Many of the NIH Institutes and Centers (ICs) use this grant mechanism exclusively to support intensive, short-term research training experiences for students in health professional schools during the summer. In addition, the Short-Term Institutional Research Training Grant may be used to support other types of predoctoral and postdoctoral training in focused, often emerging scientific areas relevant to the mission of the funding IC. The proposed training must be in either basic, behavioral or clinical research aspects of the health-related sciences. This program is intended to encourage graduate and/or health professional students to pursue research careers by exposure to and short-term involvement in the health- related sciences. The training should be of sufficient depth to enable the trainees, upon completion of the program, to have a thorough exposure to the principles underlying the conduct of research.
• Mechanism of Support: This Funding Opportunity Announcement (FOA) will utilize the Ruth L. Kirschstein National Research Service Award (NRSA) Short-Term Institutional Research Training Grants (T35).
• Funds Available and Anticipated Number of Awards: The number of applications funded will vary and depend upon the number of meritorious applications determined by the official review process.
• Budget and Project Period: Awards for T35 Short-Term institutional NRSA research training grants may be for project periods up to five years in duration and are renewable. Trainees selected for short-term training are required to pursue research training for 2-3 months on a full-time basis More information may be found in Section III, 3.
• Eligible Institutions/Organizations: Institutions/organizations listed in Section III, 1.A. are eligible to apply
• Eligible Program Director(s)/Principal Investigator(s) (PD/PI): An eligible Training PD/PI is any individual with the skills, knowledge, successful past training record, and available resources necessary to carry out the proposed research training program. The PD/PI should be an established basic, behavioral, and/or clinical researcher at the sponsoring institution. The PD/PI will be responsible for the selection and appointment of eligible trainees to the NRSA training grant, for the overall direction, management and administration of the research training program, program evaluation, and the submission of all required forms in a timely manner. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
• Number of Applications: Applicants may submit more than one application, provided the research training programs are scientifically distinct.
• Application forms (PHS 398) and NRSA instructions are available at: http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact Grants Info, Telephone (301) 710-0267, Email: [email protected]
• Resubmissions: Resubmission applications will be accepted. Such application must include an Introduction addressing the previous peer review critique (Summary Statement).
• Renewals: Applicants may submit a renewal application.
• Hearing Impaired: Telecommunications for the hearing impaired: TTY (301) 451-5936.

Table of Contents

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Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Training Objectives

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

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

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

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

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Section I. Funding Opportunity Description

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1. Research Training Objectives

The objectives of the short-term research training (T35) program are to develop and/or enhance research training opportunities for individuals interested in careers in biomedical, behavioral and clinical research. The program may also be used to support other types of predoctoral and postdoctoral training in focused, often emerging scientific areas relevant to the mission of the NIH funding Institute or Center. The training program must be in either the basic, clinical, or behavioral research aspects of the health-related sciences, and should be of sufficient depth to enable selected trainees, upon completion of the program, to have a thorough exposure to the principles underlying the conduct of research. Each NIH Institute and Center has a unique scientific purview and different program goals and initiatives that evolve over time. The T35 program provides short-term support for a period of at least 8, but no more than 12 weeks in a grant year for full-time training experiences under the supervision of experienced researchers and exposes students to individuals with active research careers as well as providing them with knowledge about further research training and biomedical or behavioral research career opportunities.

This grant mechanism will help ensure that a diverse and highly trained workforce is available to carry out the Nation's biomedical and behavioral research agenda.

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

Section II. Award Information

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1. Mechanism of Support

This funding opportunity will use the Ruth L. Kirschstein National Research Service T35 award mechanism. Awards may be made for periods up to 5 years and are renewable.

The Training Program Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed research training program.

This funding opportunity announcement (FOA) uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application, following the instructions for preparing an NRSA institutional research training application.

2. Funds Available

Because the nature and scope of the proposed short-term research training program will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the ICs provide support for this program, the total amount awarded and the number of awards will depend upon the number, quality, duration, and costs of the applications received.

Grantees are expected to be familiar with and comply with applicable costs policies and the NRSA Guidelines (http://grant.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm). Funds may be used only for those expenses that are directly related and necessary to the research training not otherwise available and must be expended in conformance with OMB Cost Principles, the NIH Grants Policy Statement, and the NRSA regulations, policies, guidelines, and conditions set forth in this document.

2.A. Allowable Costs

Stipends: Stipends are provided as a subsistence allowance for trainees to help defray living expenses during the research training experience. The stipend is not provided as a condition of employment with either the Federal government or the grantee institution nor is it to be considered a payment for services performed. Stipends for short-term trainees will be based on a monthly proportion of the annual NIH stipend level at the time of award. The FY 2008 annual stipend level for a predoctoral trainee is $20,772, therefore the monthly stipend is $1,731. For postdoctoral trainees, the annual stipend is determined based on the number of full years of prior relevant postdoctoral experience at the time of the trainee's appointment. The FY 2008 range of annual postdoctoral stipend levels is $36,996 ($3,083 per month) to $51,036 ($4,253 per month). No departure from the established stipend schedule may be negotiated by the institution with trainees (see http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-08-036.html and http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-07-057.html for specific information).

Training Related Expenses (TRE): The applicant institution may request the proportion of the NIH standard annual NRSA Training Related Expenses to help defray other costs of the short-term training experience, such as research supplies, tuition, fees, certain types of travel, and other expenses. The FY 2008 amounts for TRE are $4,200 annually ($350 /month) for each predoctoral trainee and $7,850 annually ($654 /month) for each postdoctoral trainee. Health insurance is an allowable expense that may be charged to the Trainee Related Expenses budget category but only to the extent that the same health insurance fees are charged to non-Federally students and postdoctoral individuals.

Facilities and Administrative (F&A) Allowance: Grantees, other than State, local, or Indian tribal governments, will receive F&A costs at 8 percent of modified total direct costs (exclusive of tuition and fees, health insurance (when still awarded in the tuition and fees category), consortiums in excess of $25,000, and expenditures for equipment) rather than on the basis of a negotiated rate agreement. State, local, and Indian tribal government agencies are eligible for full F&A cost reimbursement. For this policy, State universities or hospitals are not considered governmental agencies.

Stipend Supplementation, Compensation, and Other Income: The grantee institution is allowed to provide funds to an individual in addition to the stipends paid by the NIH. Such additional amounts either may be in the form of augmented stipends (supplementation) or in the form of compensation, such as salary or tuition remission for services such as teaching or serving as a laboratory assistant, provided the conditions described below are met. Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the trainee's approved NRSA training program.

Supplementation: Grantees may supplement stipends from non-Federal funds provided the supplementation is without obligation to the trainee. An organization can determine what amount of stipend supplementation, if any, will be provided according to its own formally established policies governing stipend support. These policies must be consistently applied to all individuals in a similar training status regardless of the source of funds. Federal funds may not be used for stipend supplementation unless specifically authorized under the terms of the program from which funds are derived. An individual may use Federal educational loan funds or VA benefits when permitted by those programs. Under no circumstances may PHS funds be used for supplementation.

Compensation: Funds characterized as compensation may be paid to trainees only when there is an employer-employee relationship, the payments are for services rendered, and the situation otherwise meets all of the conditions and policies in the NIH Grants Policy Statement. Additionally, compensation must be in accordance with organizational policies consistently applied to both federally and non-federally supported activities and must be supported by acceptable accounting records that reflect the employer-employee relationship. An institution may provide additional funds to a trainee in the form of compensation (as salary and/or tuition remission) for services performed outside of the responsibilities of the full-time NRSA-supported training such as teaching or serving as a research assistant. A trainee 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 that supports the same research that is part of the trainee’s planned training experience as approved in the institutional training grant application. The Training PD/PI must approve all instances of employment on research grants to verify that the circumstances will not detract from or prolong the approved training program.

A full description of the NIH policy regarding NRSA supplementation and compensation can be found in the NIH Grants Policy Statement at: http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part11.htm.

Educational Loans or G.I. Bill: An individual may make use of Federal educational loan funds and assistance under the Veterans Readjustment Benefits Act (G.I. Bill). Such funds are not considered supplementation or compensation.

NIH Loan Repayment: Postdoctoral trainees in their first and third years of training may also be eligible to participate in the NIH Extramural Loan Repayment Program. Information about this program is available at: http://www.lrp.nih.gov/.

Section III. Eligibility Information

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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)
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribally Designated Organizations
• U.S. Territory or Possession
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Faith-based or Community-based Organizations

Only domestic, non-profit, private or public institutions may apply for grants to support National Research Service Award (NRSA) short-term research training programs. Foreign institutions are not eligible to apply. The applicant institution must have a strong and high quality research program in the area(s) proposed for the research training and must have the requisite staff and facilities on site to conduct the proposed research training program.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to organize and implement a high-quality research training program is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds are always encouraged to apply for NIH support.

The Training PD/PI should be an established basic, behavioral, and/or clinical researcher with skills, knowledge, a successful past training record, and available resources to conduct the proposed short-term research training program at the sponsoring institution. The PD/PI will be responsible for the selection and appointment of eligible trainees to receive short-term NRSA support, for the overall direction, management and administration of the program, program evaluation, and the submission of all required forms in a timely manner.

More than one Training PD/PI (or multiple PD/PIs), may be designated on the application for training programs that require a team approach and therefore clearly do not fit the single PD/PI model, e.g., interdisciplinary of multidisciplinary training. The decision to apply with a single PD/PI or a multiple PD/PIs is the responsibility of the investigators and applicant organizations, and should be determined and justified by the goals of the training program. Applications for grants with multiple PD/PIs require additional information. When considering multiple PD/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD/PI will be factored into the assessment of the overall scientific merit of the application. Multiple PD/PIs on a program share the authority and responsibility for leading and directing the training program, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization for the proper conduct of the program, including the submission of required reports.

Applications with multiple Training PD/PIs must provide a Leadership Plan that emphasizes how leadership by multiple PD/PIs will benefit the research training program and the trainees. A single Contact PD/PI must be designated for the purpose of communicating with the NIH, although other individuals may contact the NIH on behalf of the Contact PD/PI when necessary. Because training programs are intended to be coherent a single award will be made. NIH will not allocate the budget or training positions between multiple PD/PIs. Multiple PD/PI application should include reasonable numbers of PD/PIs and each should be included for a specific purpose. Multiple PD/PI applications should not include all mentors of the training grant as PD/PIs, except in unusual cases.

Additional instructional information associated with the multiple PD/PI option is located in the PHS 398 application, Part I, Section 4.1 (Face Page) and 4.2.3 (Senior/key Personnel) and 8.9.11 (Multiple PD/PI Leadership Plan). For background information on the Multiple PD/PI initiative, see http://grants.nih.gov/grants/multi_pi/index.htm.

2. Cost Sharing or Matching

Cost sharing is not required.

3. Other-Special Eligibility Criteria

Training Program: Trainees appointed to the short-term research training program must have the opportunity to carry out supervised biomedical, behavioral, or clinical research with the primary objective of developing or enhancing their research skills and knowledge in preparation for a health-related research career. Trainees must be able to commit full-time effort, normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies, to the program and its related research activities, consonant with NRSA guidelines. Within the full-time training period, research trainees who are also training as clinicians must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training experience.

A Kirschstein-NRSA institutional research training grant must be used to support a program of full-time research training. It may not be used to support studies leading to the M.D., D.D.S., or other clinical, health-professional training except when those studies are part of a formal combined research degree program, such as the M.D./Ph.D. Similarly, trainees may not accept NRSA support for clinical training that is part of residency training leading to clinical certification in a medical or dental specialty or subspecialty. It is permissible and encouraged, however, for clinicians to engage in NRSA-supported full-time postdoctoral research training even when that experience is creditable toward certification by a clinical specialty or subspecialty board.

Eligible Trainees: Trainee Eligibility Requirements: NRSA institutional short-term training grants are intended to introduce predoctorates and postdoctorates to research that would not otherwise be available through their regular course of graduate study. Short-term training is not intended, and may not be used, to support activities that would ordinarily be part of a research degree program. Positions on NRSA short-term institutional training grants may not be used for courses and study leading to an M.D., D.D.S. D.O., D.V.M., or other clinical, health professional degree, nor do they support residency training. Research elective credit may be granted for students who complete a short-term research training experience supported by the T35. The decision to award elective credit will be at the discretion of the sponsoring institution and must be consistent with the policies of the institution. Any additional costs associated with the decision to allow research elective credit may not be charged to the T35.

The training grant positions should not be used in lieu of regular graduate stipends. Trainees supported by NRSA funds are not considered to be in an employer-employee relationship with NIH or the institution at which they are pursuing research training.

Trainees are required to pursue research training for 2-3 months on a full-time basis devoting at least 40 hours per week or as specified by the sponsoring institution in accordance with its own policies, to the program. Within the full time training period, research trainees in clinical areas must devote their time to the proposed research training and must confine clinical and other duties to those that are an integral part of the research training experience. Successful trainees may be appointed for additional periods of short-term training, or when appropriate, they may be encouraged to enter an extended period of full-time training supported by an NRSA training grant or fellowship or an NIH career development award. Individuals currently supported by other Federal Funds are not eligible for duplicative trainee support from this program at the same time.

Trainee Citizenship: The individual to be trained must be a citizen or a noncitizen national of the United States or have been lawfully admitted for permanent residence at the time of appointment. Noncitizen nationals are people, who, although not citizens of the United States, owe permanent allegiance to the United States. They generally are people born in outlying possessions of the United States (e.g., American Samoa and Swains Island). Individuals who have been lawfully admitted for permanent residence must have a currently valid Permanent Resident Card (USCIS Form I-551) or other legal verification of such status. For example, if an individual has the proper validation on his/her passport, a notarized photocopy of the passport could suffice. Because there is a 6-month limitation on this validation, it is the grantee’s responsibility to follow up and ensure that the individual received the I-551 prior to the 6-month expiration date.

A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving Kirschstein-NRSA support. Individuals on temporary or student visas are not eligible for Kirschstein-NRSA support.

Predoctoral Trainees: Predoctoral trainees must have received a baccalaureate degree by the beginning date of the NRSA short-term appointment and must be training at the post baccalaureate level. Predoctoral trainees must be enrolled in a program leading to a Ph.D. in science or in an equivalent research doctoral degree program.

Trainees in Health Professional Schools: Trainees must be enrolled and in good standing and must have successfully completed at least one quarter or semester at an accredited school of medicine, optometry, osteopathy, dentistry, veterinary medicine, pharmacy, allied health professions, public health, audiology, or other accredited health professional schools such as schools of chiropractic or naturopathic medicine before participating in the program. In schools of pharmacy, only students who are candidates for Pharm.D. are eligible. An institution may support students enrolled at other institutions, provided that a feasible plan for evaluating and monitoring the short and long-term outcome of the students' research experiences is provided.

Postdoctoral Trainees: Postdoctoral trainees must have received, as of the beginning date of the NRSA appointment, a Ph.D., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign institution. Eligible doctoral degrees include, but are not limited to, the following: D.M.D., D.C., D.O., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr. P.H., D.N.Sc., D.P.T., Pharm.D., N.D. (Doctor of Naturopathy), D.S.W., and Psy.D., as well as a doctoral degree in nursing research. Documentation by an authorized official of the degree-granting institution certifying all degree requirements have been met prior to the beginning date of training is acceptable. Research training at the postdoctoral level must emphasize specialized training to meet national research priorities in the biomedical, behavioral, or clinical sciences that are with the scientific purview of the NIH ICs participating in the short-term research training program (see http://grants.nih.gov/archive/grants/guide/contacts/pa-08-227_contacts.htm).

Section IV. Application and Submission Information

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1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. 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

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applicants must follow the additional specific instructions for institutional NRSA applications, located in Section 8. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

3.A. Submission, Review and Anticipated Start Dates

Institutional NRSA T35 application submission/receipt/review dates vary among participating Institutes and Centers. See: http://grants.nih.gov/archive/grants/guide/contacts/pa-08-227_contacts.htm associated with this announcement.

Letter of Intent Submission Date: Not required for this funding opportunity.
Application Submission Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
http://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS; however, not all ICs use the T35 award mechanism, and not all participating ICs use all application Submission dates, see http://grants.nih.gov/archive/grants/guide/contacts/pa-08-227_contacts.htm for IC specific information.
Peer Review Date: http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward, except as noted in the IC Contact Table (see above).
Council Review Date: http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward except as noted in the IC Contact Table (see above).
Earliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward except as noted in the IC Contact Table (see above).

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application forms and the specific NRSA institutional research training grant application instructions that are located in Section 8. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

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

3.C. Application Processing

Applications must be submitted on or before the application submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm with attention to IC specific submission dates (see http://grants.nih.gov/archive/grants/guide/contacts/pa-08-227_contacts.htm).

Upon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.

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

Information on the status of an application should be checked by the Training PD/PI in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The National Research Service Award (NRSA) policies apply to this program.
Awards are contingent upon the availability of funds. Furthermore, the duration of the award and the number of funding training positions may be less than the levels recommended by the peer review group, based on programmatic and budgetary considerations.

Funds for continuation of support beyond the initial year are determined by the success as described in the annual progress report, the timely submission of required forms, and the availability of funds for continuation programs.

Pre-Award Costs: Pre-award costs are not allowable charges for stipends, tuition, or trainee travel on institutional training grants since these costs may not be charged to the grant before the trainee appointment is actually made. However, the policies governing the pre-award cost authority for the expenditure of the other funds provided as training-related expense in a training grant are those permitted as follows:

A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project.

Concurrent Awards: An NRSA may not be held concurrently with another federally sponsored fellowship, traineeship, or similar Federal award that provides a stipend or otherwise duplicates provision of the NRSA.

Taxability of Stipends: Section 117 of the Internal Revenue Code applies to the tax treatment of scholarships and fellowships. Degree candidates may exclude from gross income (for tax purposes) any amount used for course tuition and related expenses, such as fees, books, supplies, and equipment, required for courses of instruction at a qualified educational organization. Nondegree candidates are required to report as gross income any monies paid on their behalf for stipends or any course tuition and fees required for attendance.

The taxability of stipends in no way alters the relationship between Kirschstein-NRSA trainees and grantee organizations. Kirschstein-NRSA stipends are not considered salaries. In addition, trainees supported under Kirschstein-NRSA institutional research training grants are not considered to be in an employee-employer relationship with NIH or the grantee organization solely as a result of the Kirschstein-NRSA support. Interpretation and implementation of the tax laws are the domain of the IRS and the courts. NIH takes no position on what the status may be for a particular taxpayer, and it does not have the authority to dispense tax advice. Individuals should consult their local IRS office about the applicability of the law to their situation and for information on their tax obligations.

Service Payback: As specified in the NIH Revitalization Act of 1993, Kirschstein-NRSA recipients incur a service payback obligation for the first 12 months of postdoctoral support. Additionally, the Act specifies that the second year of postdoctoral Kirschstein-NRSA training support will serve to pay back a postdoctoral service payback obligation. (See Section VI.2. Administrative and National Policy Requirements for further details.)

6. Other Submission Requirements

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year:

Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;

2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and,

3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.

This policy applies to all investigator-initiated new (type 1), competing continuation (type 2 renewal), competing supplement, or any amended or revised version of these grant application types. For additional information on this policy, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html, released October 16, 2001.

NOTE: This requirement is in place for all NIH ICs except those indicated in the IC contact table and IC-specific information: http://grants.nih.gov/archive/grants/guide/contacts/pa-08-227_contacts.htm.

6.A. Special Program Requirements

Research Training Program: The program may provide didactic training as well as laboratory experience. This should include a plan for determining trainee experience and needs and monitoring progress to accomplish desired goals. The program should develop trainee skills in understanding research, applying their critical abilities to conduct research, identify problems in the process of conducting research, raise questions and propose solutions to resolving problems. Trainees should be prepared to take the information gleaned from the project to pursue future research. The program should provide information and career guidance (when applicable) describing the process of applying for future support.

Training Program Director/Principal Investigator (PD/PI): The Training PD/PI must possess the scientific background and leadership and administrative capabilities required to coordinate, supervise, and direct the proposed research training program. The PD/PI will be responsible for the selection and appointment of trainees to the approved research training program, and for the overall direction, management, administration, and evaluation of the program. The PD/PI must provide potential trainees information associated with NRSA programs and submit all required trainee forms in a timely manner. If multiple PDs/PIs are involved in the research training program, applicants must describe how the research training program and trainees will benefit from the arrangement. A Leadership Plan is required. See http://grants.nih.gov/grants/multi_pi/index.htm, and information in 8.9.11 of the PHS 398 application instructions.

Institutional Environment, Commitment, and Resource: The administration of the applicant institution as well as all participating units and departments should include information in the application that documents institutional support and commitment to the goals of the short-term research training program. The application should include a description of support (financial and otherwise) to be provided to the proposed program. This could include, for example, space, shared laboratory facilities and equipment, funds for curriculum development, release time for the PD/PI and/or participating faculty, support for additional trainees in the program, or any other creative ways to improve the climate for the establishment and growth of the research training program.

Training Program Evaluation: The application must describe an evaluation plan to review and determine the quality and effectiveness of the training program. This should include plans to obtain feedback from current and former trainees to help identify weaknesses in the training program and to provide suggestions for program improvements, as well as plans for assessing trainees career development and progression, including publications, degree completion, and post-training positions. Evaluation results should be included in future competing continuation (renewal) applications and as part of the Final Progress Report.

Recruitment Plan: Applicants must submit a recruitment plan for recruiting trainees from both outside and inside their sponsoring institutions. The application should describe any recruitment and outreach plan to increase the depth and diversity of the applicant pool including those underrepresented in the current scientific research workforce in the area of the proposed research training.

Recruitment and Retention Plan to Enhance Diversity: The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.

Accordingly the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27) In addition, it is recognized that under-representation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C. Individuals from disadvantaged backgrounds who are defined as:

1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professional Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career. Recruitment and retention plans related to a disadvantaged background are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.

Competing continuation and non-competing applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies, including aggregate information on the distribution of:

• Students or postdoctorates who applied for admission or positions within the department(s) relative to the training grant,
• Students or postdoctorates who were offered admission to or a position within the department(s),
• Students actually enrolled in the academic program relevant to the training grant,
• Students or postdoctorates who were appointed to the research training grant.

For those trainees who were enrolled in the academic program, the report should include information about the duration of research training and whether those trainees finished their training in good standing.

Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. For renewal applications, peer reviewers will evaluate whether the experience in recruitment during the previous award period has been incorporated into the formulation of the plan for the next award period. The review panel's evaluation will be included in an administrative note in the summary statement. If the recruitment and retention plan to enhance diversity is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. Staff within the NIH awarding component, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.

This Program Announcement requires all applicants to submit a recruitment and retention plan to enhance diversity. Applications without a description of diversity recruitment and retention plan will be considered incomplete and may be delayed in the peer review process. Additional information on the required Recruitment and Retention Plan to Enhance Diversity is available at Frequently Asked Questions Recruitment and Retention Plan to Enhance Diversity (http://grants1.nih.gov/training/faq_diversity.htm).

Training in the Responsible Conduct of Research:

Every trainee must receive instruction in the responsible conduct of research. Describe a plan to provide trainees with formal and informal instruction on scientific integrity and ethical principles in research. The plan must address the rationale for the instruction, the format and subject matter, the degree of faculty participation, trainee attendance, plans to assess the quality and the frequency of instruction. For Renewal applications, describe the type of instruction provided in the current project period, the degree of student participation, the results of any assessments and other relevant information.

There are no specific curriculum or format requirements for this instruction; however, it is strongly suggested that the instruction include: conflict of interest, responsible authorship and publication, peer review, policies for handling misconduct, policies regarding human subjects and live vertebrate animal subjects in research, data management, data-sharing, collaborative research and mentor-mentee relationships. Applicants may wish to consult the NIH web site at http://grants.nih.gov/training/responsibleconduct.htm and http://bioethics.od.nih.gov/researchethics.html for additional guidance.

Applications lacking a plan for instruction in the responsible conduct of research will be considered incomplete and will be returned to the applicant without review.

Trainees who will participate in research involving human subjects must meet the NIH policy requirement for education in human subjects protections (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html). Trainees participating in research with live vertebrate animals must also be enrolled in the institutional animal welfare training program for personnel who have contact with animals. The requirements for specific human subjects education and participation in the institutional animal welfare training program may be included as elements of required training in the Responsible Conduct of Research.

6.B. Resource Sharing Plans

Not Applicable

Section V. Application Review Information

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1. Criteria

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

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

2. Review and Selection Process

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

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

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 a priority score
• Will receive a written critique
• Will receive a second level of review by an appropriate national advisory council or board.

The following will be considered in making funding decisions:

• Scientific merit of the proposed project as determined by peer review
• Relevance to program priorities
• Availability of funds

The goals of NIH-supported research training programs are 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 scientific review group will determine the quality of the proposed research training program and consider whether the requested number of trainee positions is appropriate for the short-term program.

All short-term research training applications will be evaluated for merit by NIH initial review groups based on the following criteria:

Training Program: Are the objectives, design, direction, and quality of the proposed short-term research training program appropriate? Does the proposed program provide suitable training for the levels of trainees being proposed and the area of science to be supported by the program? Is the quality of proposed course contents and training experience appropriate for all levels of trainees to be included in the program? Does the program have access to candidates for short-term research training and the ability to recruit high quality, short-term trainees from the applicant institution or some other health-professional school? For competing continuation (renewal) applications, what is the success in attracting trainees back for multiple appointments?

Training Program Director/Principal Investigator (PD/PI): Does the Training PD/PI and participating preceptors as basic and clinical researchers have the scientific background, expertise, and experience appropriate to direct, manage, coordinate, and administer the proposed research training program? Does the PD/PI plan to commit adequate time to the program? Is the past training record of the PD/PI’s and preceptors appropriate? For applications designating multiple PD/PIs, is the leadership approach, including the designated roles and responsibilities, governance and organizational structure consistent with and justified by the aims of the research training program and the expertise of each of the PD/PIs? Does the PD/PI team bring complementary and integrated expertise to the proposed research training program? Does the leadership plan describe how multiple PD/PIs will benefit the program and the trainees?

Institutional Training Environment, Commitment, and Resources: Is the quality of the research environment for the proposed short-term research training program appropriate? Is the level of institutional commitment, quality of available facilities, courses and seminars, research and research training support suitable for the short-term training program?

Trainee Recruitment and Selection Plan: Are the quality of the applicant pool and plans for the selection of individuals appointed to the short-term training program appropriate? Specifically, what is the size and quality of the applicant pool? Are the recruiting procedures, and trainee selection criteria, appropriate and well defined? Are there advertising plans or other effective strategies to recruit high-quality trainees?

• For competing renewal applications: How successful has the program been in efforts to recruit individuals from diverse underrepresented populations?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Resubmission Applications: Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the PHS 398 research grant application instructions, Research Plan, section 5.5, item 8 on Human Subjects).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the PHS 398 research grant application instructions, Research Plan, section 5.5., items 9 and 11 on the Inclusion of Women and Minorities and the Inclusion of Children).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described in the PHS 398 research grant application instructions, Research Plan, section 5.5., item 12, will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed short-term research training program. The priority score should not be affected by the evaluation of the budget.

Training Program Evaluation: Does the application describe an evaluation plan to review and determine the quality and effectiveness of the training program? Are the plans for obtaining feedback from current and former trainees and monitoring trainees career development and progressions adequate to measure the quality and effectiveness of the research training program?

• For competing renewal applications: Are there plans to make changes to improve program performance and incorporate feedback from current and former trainees (e.g., new mentors, changes in courses, recruitment strategies, etc.)?
• Does the competing renewal application describe the program accomplishments to date, including information on trainee publications, degree completion, and post-training positions?

Recruitment and Retention Plan to Enhance Diversity: The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.

Accordingly the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.

Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The review panel’s evaluation will be included in an administrative note in the summary statement. If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. Staff within the NIH awarding component, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.

Training in the Responsible Conduct of Research: Peer reviewers will assess the applicant's plans for training in the responsible conduct of research on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction.

The plan will be discussed after the overall determination of merit, and the review panel's evaluation of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable, and the result will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides an acceptable, revised plan. Program staff will judge the acceptability of the revised plan. The relevant NIH staff will judge the acceptability of the revised plan.

2.C. Resource Sharing Plans

Not Applicable

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information

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1. Award Notices

After the peer review of the application is completed, the Training PD/PI will be able to access the written critique called a Summary Statement via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Award will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

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

Institutional NRSA training grants must be administered in accordance with the current NRSA section of the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm#_Toc54600204, and any terms and conditions specified in the NoA.

Special Administrative Requirements Associated with NRSA Programs:

Leave Policies: In general, trainees 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. Trainees may receive stipends for up to 15 calendar days of sick leave per year. Sick leave may be used for the medical conditions related to pregnancy and childbirth. Trainees 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 this level of paid leave for this purpose and the use of parental leave is approved by the Training PD/PI (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-064.html). A period of terminal leave is not permitted, and payment may not be made from traineeship funds for leave not taken. Trainees 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. Trainees supported by academic institutions should refer to the NIH Institutional NRSA training grant guidelines at: http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part11.htm for further guidance regarding vacations and requested leave.

Carryover of unobligated balances: Most of the NIH funding components require prior written approval for carryover of funds from one budget period to the next. . When required, such requests must include compelling justification including the status of trainee appointments to the program. If not stated on the Notice of Award, the Training PD/PI should contact the applicable IC's Grants Management contact to determine the funding IC's carryover policy.

Termination of award: NIH may terminate a Kirschstein-NRSA institutional research training grant before its normal expiration date if it determines that the grantee has materially failed to comply with the terms and conditions of the award or to carry out the purpose for which the award was made. If an award is terminated for cause, NIH will notify the grantee organization in writing of this determination, the reasons for the determination, the effective date, and the right to appeal the decision. NIH also may terminate an award at the request of the grantee.

An organization that wants to terminate a training grant before the scheduled termination date must notify the NIH awarding office immediately. In such cases, NIH will issue a revised NGA to specify the changed period of support and to show prorated trainee stipends, depending on the amount of time spent in training.

Change of institution: Kirschstein-NRSA institutional research training grants may not be transferred from one domestic organization to another except under the most unusual circumstances. Such a change generally will be approved by the NIH awarding office only if all of the major benefits attributable to the original grant can be transferred and there is no negative impact on trainees active in the program.

Change of Training Program Director/Principal Investigator (PD/PI): If change of a Training PD/PI is necessary, support of the award is not automatic but may be continued with prior written approval by the NIH funding component, provided that the following conditions are met. The current PD/PI or the grantee institution has submitted a written request for the change, countersigned by the appropriate institutional business official, to program staff at the NIH funding component describing the reasons for the change. The Biographical Sketch of the proposed PD/PI, including a complete listing of active research grant support, must be provided. The information in the request must establish that the specific aims of the original peer-reviewed program will remain unchanged under the direction of the new PD/PI and that the new PD/PI has the appropriate research and administrative expertise to lead the training program. This request must be submitted sufficiently in advance of the requested effective date to allow the necessary time for review.

Change of program: A rationale must be provided for any proposed changes in the original, peer-reviewed research training program objectives. Any change requires prior approval by program staff of the NIH funding component. If the new program does not satisfy this requirement, the award will be terminated.

Service Payback Provisions: As specified in the NIH Revitalization Act of 1993, Kirschstein-NRSA recipients incur a service payback obligation for the first 12 months of postdoctoral support. Additionally, the Act specifies that the second year of postdoctoral Kirschstein-NRSA training will serve to pay back a postdoctoral service payback obligation. Accordingly, the following guidelines apply:

Postdoctoral trainees in the first 12 months of postdoctoral Kirschstein-NRSA support must sign the Payback Agreement Form (PHS 6031) before initiating an appointment. Postdoctoral trainees in their first 12 months of support will incur a period of service payback obligation equal to the period of support.

Postdoctoral trainees in the 13th and subsequent months of NRSA postdoctoral support are not required to sign the payment agreement form and will not incur a service payback obligation for this period of support. In addition, the 13th and subsequent months of postdoctoral Kirschstein-NRSA support are considered acceptable payback service for prior postdoctoral support. For example, postdoctoral trainees who continue under that award for two years have fulfilled the obligation incurred during the first 12 months of support by the end of the second year.

Service payback obligations can also be paid back after termination of Kirschstein-NRSA support by conducting health-related research or teaching averaging at least 20 hours per week of a full work year. Payback service may be conducted in an academic, governmental, commercial, or nonacademic environment in the United States or in a foreign country. Examples of acceptable payback service include research associateships/assistantships, postdoctoral research fellowships, and college or high school science teaching positions. Examples of unacceptable payback service include clinical practice and administrative responsibilities not directly related to scientific research. Recipients with service obligations must begin to provide acceptable payback service on a continuous basis within two years of termination of Kirschstein-NRSA support. The period for undertaking payback service may be delayed for such reasons as temporary disability, completion of residency requirements, or completion of the requirements for a graduate degree. Requests for an extension must be made in writing to the NIH specifying the need for additional time and the length of the required extension.

Recipients of Kirschstein-NRSA support are responsible for informing the NIH of changes in status or address.

For individuals who fail to fulfill their obligation through service, the United States is entitled to recover the total amount of Kirschstein-NRSA funds paid to the individual for the obligated period plus interest at a rate determined by the Secretary of the Treasury. Financial payback must be completed within three years beginning on the date the United States becomes entitled to recover such amount. Under certain conditions, the Secretary, DHHS (or those delegated this authority), may extend the period for starting service or repayment, permit breaks in service, or in rare cases in which service or financial repayment would constitute an extreme hardship, may waive or suspend the payback obligation of an individual. Detailed information on the accrual and repayment of the Kirschstein-NRSA service payback obligation and waivers is available at: http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part11.htm#_Toc54600220

Officials at the grantee institution have the responsibility of explaining the terms of the payback requirements to all prospective trainees before appointment to the training grant. Additionally, all trainees recruited into the training program must be provided with information related to the career options that might be available when they complete the program. The suitability of such career options as methods to satisfy the NRSA service payback obligation must be discussed.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 (http://grants.nih.gov/grants/funding/2590/2590.htm), annually and annual financial statements as required in the NIH Grants Policy Statement. The NRSA program is not subject to SNAP.

The NRSA instructions for the Non-Competing Grant Progress Report in, Form 2590) should be followed. Note that a substitute budget page and a summary of trainee page are to be included in the request for continuation support. The non-competing budget page should list the names and levels of those trainees who are continuing in the research training program. Information on each trainee should also be included in the narrative portion of the Progress Report as described in the PHS Form 2590 instructions. Additional information that should be included in the annual progress report in concert with the PHS 2590 instructions:

• A brief introductory description of the program objective.
• Information describing which, if any, faculty and/or mentors have left the program and which, if any, new individuals have been added; for new faculty and/or mentors involved in the program, biographical sketches should be included in the application.
• A detailed account of experiences in recruiting individuals from under-represented groups during the previous funding period must be included. Information must be included on both successful and unsuccessful recruitment strategies. The report should provide aggregated information on the distribution of all applicants and those accepted and appointed. The aggregated report also should include information on individuals with disabilities and those from underrepresented groups and disadvantaged backgrounds. For those who were enrolled in the program, the report should include aggregated information about the duration of research training and whether those trainees completed their training in good standing.
• Any recommended changes to improve the program, including those resulting from feedback from current or former trainees (e.g. new mentors, changes in courses, recruitment strategies, etc.)

3.A. Additional Reporting Requirements

Financial Status Report (FSR): An annual FSR is required and must be submitted within 90 days of the end of each budget period. Continuation support will not be provided until the required form is submitted and reviewed.

Trainee Reporting Requirements: The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant. This Form must be submitted to the awarding IC at or before the start of each trainee’s appointment or reappointment. An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year. Additionally, a completed Payback Agreement Form (PHS 6031) must be submitted for each postdoctoral trainee in his or her first 12 months of support. No funds may be provided until such documents are submitted. A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving Kirschstein-NRSA support.

Within 30 days of the end of the total support period for each trainee, the institution must submit a Termination Notice (PHS 416-7) to the NIH. All trainees must submit a termination notice as part of the closeout process. If the trainee has a payback obligation, he or she must notify the NIH of any change in address and submit Annual Payback Activities Certification Forms (PHS 6031-1) until the payback service obligation is satisfied.

Failure by the grantee to submit the required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award. Forms may be found on the NIH Web site at http://grants.nih.gov/grants/forms.htm.

Publication and Sharing of Research Results: NIH supports the practical application and sharing of outcomes of funded research. Therefore, trainees should make the results and accomplishments of their Kirschstein-NRSA research training activities available to the research community and to the public at large. The grantee organization should assist trainees 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.

Trainees are encouraged to submit reports of their findings for publication to the journals of their choice. For each publication that results from a trainee’s research, NIH support should be acknowledged by a footnote in language similar to the following: This investigation was supported by the National Institutes of Health under Ruth L. Kirschstein National Research Service Award (number). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH. In addition, federal funding must be acknowledged as provided in Public Policy Requirements and Objectives-Availability of Information-Acknowledgment of Federal Funding.

Evaluation: In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this Program. Accordingly, NRSA participants should be notified that they may be contacted after the completion of their appointment for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the research training program.

Inventions: Traineeships made primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required for institutional training grants.

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.

Final Reports: A Final Progress Report and Financial Status Report are required at the end of the grant project period or upon relinquishment of an award. Evaluation results should be included as part of the Final Progress Report.

Human Embryonic Stem Cells (hESC): Only approved hESC lines listed on the NIH Human Embryonic Stem Cell Registry http://stemcells.nih.gov/registry/ may be used for research training activities. The abstract of the application must provide the registry identifying numbers of the HESC lines to be used.

Section VII. Agency Contacts

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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 NIH Web site http://grants.nih.gov/archive/grants/guide/contacts/pa-08-227_contacts.htm for information for each IC's scientific/research contact for this NRSA T35 program.

2. Peer Review Contacts:

Not Applicable

3. Financial or Grants Management Contacts:

Applicants should refer to the NIH Web site http://grants.nih.gov/archive/grants/guide/contacts/pa-08-227_contacts.htm for information for each IC's grants management contact for this NRSA T35 program.

Section VIII. Other Information

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Required Federal Citations

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

Human Subjects Protection: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan: Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data: Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local 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 new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

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

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

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

Human Embryonic Stem Cells (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

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

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

URLs in NIH Grant Applications or Appendices: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This 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 Section 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The 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.