Expired PA-07-106: Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral Fellowships (F31) to Promote Diversity in Health-Related Research

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

Participating Organization
National Institutes of Health (NIH), (http://www.nih.gov/)
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov)

Title: Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral Fellowships (F31) to Promote Diversity in Health-Related Research

Announcement Type
This funding opportunity announcement (FOA) revises and replaces PA-06-481 that was previously released on July 21, 2006. This revision changes the application receipt dates, amends the submission requirements as described in NOT-OD-07-025, and updates the Tuition/Fees, and Institutional Allowance as detailed in NOT-OD-06-093.

Looking ahead: As part of the Department of Health and Human Services' implementation of e- Government, during FY 2006, the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) are 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)
93.272, 93.173, 93.279, 93.894, 93.282, 93.853, 93.866, 93.361,93.847, 93.848,93.849,93.855,93.856, 93.286, 93.865, 93.121, 93.867, 93.859, 93.233, 93.837, 93.838, 93.839, 93.172, 93.389, 93.225

Key Dates
Release Date: December 12, 2006
Application Receipt Date(s): April 13, August 13, December 13
Peer Review Date(s): June-July, October-November, February-March
Earliest Anticipated Start Date(s): December, April, July
Expiration Date: New Date June 12, 2009 (per issuance of PA-09-209) Original Date: April 14, 2010

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

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

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

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

The Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral Fellowships to Promote Diversity in Health-Related Research will provide up to five years of support for research training leading to the Ph.D. or equivalent research degree, the combined M.D./Ph.D. degree; or another formally combined professional degree and research doctoral degree in biomedical, behavioral, health services, or clinical sciences. These fellowships will enhance the diversity of the biomedical, behavioral, health services, and clinical research labor force in the United States by providing opportunities for academic institutions to identify and recruit students from diverse population groups to seek graduate degrees in health-related research and apply for this fellowship. The overall goal of this program is to increase the number of scientists from diverse population groups who are prepared to pursue careers in biomedical, behavioral, social, clinical, or health services research.

The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral and clinical sciences research workforce. The NIH expects that efforts to diversify the workforce to lead to:

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. This announcement seeks to stimulate the participation of individuals from the following groups:

C. individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research.

See Section III for additional information regarding eligibility for this program.

Fellowship awardees are required to pursue their research training on a full time basis, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies. An NRSA fellowship may not be used to support studies leading to the MD., D.O., D.D.S., D.V.M., or other similar health-professional degrees. Neither may these awards be used to support the clinical years of residency training. Research clinicians must devote full time to their proposed research training and confine clinical duties to those activities that are part of the research training program.

The sponsoring institution must have adequate faculty and facilities available to provide a suitable environment for a high-quality research training experience. The research training should occur in a research-intensive environment that has appropriate human and technical resources and is demonstrably committed to research training in the particular program proposed by the applicant. The applicant’s research training should be guided and supervised by a committed sponsor who is an active and established investigator in the area of the applicant’s proposed research and who will be committed to the research training of the individual. The sponsor must also document the availability of sufficient staff, research support, and facilities for high-quality research training.

Each NIH Institute and Center has a unique scientific purview and different program goals and initiatives that evolve over time. Prior to preparing an application, it is critical that all applicants consult the appropriate Institute website (listed with each Institute's name at the beginning of this announcement) for details of research areas supported by that Institute. In addition, applicants should contact the appropriate Institute program representative listed in the linked F31 Web site (http://grants.nih.gov/archive/grants/guide/contacts/PA-07-106_contacts.htm) prior to preparing an application to obtain current information about Institute specific program priorities and policies. This action is of utmost importance because applications with marginal or no relevance to the participating Institutes will not be accepted for review or possible funding

This funding opportunity will use the Ruth L. Kirschstein NRSA individual predoctoral fellowship (F31) award mechanism. As an applicant, the candidate together with his/her sponsor/mentor and institution are jointly responsible for planning, directing, and executing the proposed project. Information for participating Institute contacts and any IC mission-specific initiatives for F31 programs may be found in (http://grants.nih.gov/archive/grants/guide/contacts/PA-07-106_contacts.htm).

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

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

Ruth L. Kirschstein-NRSA awards provide stipends to predoctoral fellows as a subsistence allowance to help defray living expenses during the research training experience. The awards are not provided as a condition of employment with either the Federal government or the sponsoring institution. The current stipend level can be found on the NIH website at http://grants.nih.gov/training/nrsa.htm . The awarding NIH Institute will adjust awards on the anniversary date of the fellowship award to ensure consistency with the stipend level in effect at that time.

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

The NIH will offset the combined cost of tuition and fees costs at the rate in place at the time of the award. The rate currently in place, as indicated in the NIH Guide announcement NOT-OD-06-093 released August 18, 2006, will provide an amount per fellow equal to 60% of the level requested by the applicant institution, up to $16,000 per year. If the program supports formal combined dual degree training (e.g., M.D.-Ph.D.) the amount provided will be 60% of these costs up to $21,000 per year. The current policy can be located at: NOT-OD-06-093.

The NIH provides an institutional allowance to help offset expenses such as research supplies, equipment, health insurance (either self-only or family as appropriate), and travel to scientific meetings. At the time of publication of this funding opportunity announcement (and as indicated in the NIH Guide Notice NOT-OD-06-093), F31 fellows receive an institutional allowance of $4,200 per 12-month period to non-federal, or nonprofit or foreign sponsoring institutions. Self-only health insurance (available to fellows without families) or family health insurance (available to fellows with families) is an allowable cost for fellows at the awardee or sponsoring institution only if such self or family health insurance is required of all persons in a similar training status regardless of the source of support. This allowance is intended to cover training-related expenses for the individual awardee and is not available until the fellow officially activates the award. If an individual fellow is enrolled or engaged in training for less than six months of the award year, only one-half of that year's allowance may be charged to the grant. The Notice of Research Fellowship Award will be revised and the balance must be returned to the NIH.

NIH will currently provide an institutional allowance of up to $3,100 for F31 fellows sponsored by Federal or for-profit institutions for expenses associated with travel to scientific meetings, health insurance, and books. For fellows at for-profit institutions, the $3,100 will be paid to the institution for disbursement to the fellow. Funds for fellows at Federal laboratories will be disbursed from the awarding IC.

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

The Institutional Allowance is adjusted from time-to-time. Prospective applicants are advised to check for the current Institutional Allowance in the most recent documentation related to NRSA stipends at http://grants.nih.gov/training/nrsa.htm.

Additional funds may be requested by the institution when the training of a fellow involves exceptional circumstances. In all cases, the additional funds requested must be reasonable in relationship to the total dollars awarded under the fellowship and must be directly related to the approved research training experience. Such additional funds shall be provided only in exceptional circumstances that are fully justified and explained by the sponsoring institution in the application.

Facilities and administrative costs are not allowed on individual fellowship awards.

The sponsoring institution is allowed to provide funds to the fellow in addition to the stipend paid by the NIH in accordance with its own formally established policies governing stipend support. These policies must be consistently applied to all individuals in a similar status, regardless of the source of funds. Such additional amounts either may be in the form of an augmented stipend (supplementation) or in the form of compensation, provided the conditions described below are met. Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the fellow's approved Kirschstein-NRSA training program.

Supplementation, or additional support to offset the cost of living, may be provided by the sponsoring institution. Supplementation does not require additional effort from the fellow. DHHS funds may not be used for supplementation under any circumstances. Additionally, no funds from other Federal agencies may be used for supplementation unless specifically authorized by the NIH and the other Federal agency.

The sponsoring institution may provide additional funds to a fellow in the form of compensation (as salary and/or tuition remission) for services such as teaching or serving as a research assistant. A fellow may receive compensation for services as a research assistant or in some other position on a Federal research grant, including a DHHS research grant. However, compensated services should occur on a limited, part-time basis apart from the normal full-time research training activities. In addition, compensation may not be paid from a research grant supporting the fellow's research training experience.

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.

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

The sponsoring institution must have staff and facilities available on site to provide a suitable environment for performing high-quality research training. An applicant must include in the application the name of his/her sponsor who will supervise the training and research experience.

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

For the purpose of this announcement, institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. As discussed, 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 are eligible for support under 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.

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 Professions 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. Eligibility related to a disadvantaged background is most applicable to high school and perhaps to undergraduate candidates, but would be more difficult to justify for individuals beyond that level of academic achievement.

By the time of award, the individual applicant applying for the Kirschstein-NRSA fellowship award must be a citizen or non-citizen national of the United States, or must have been lawfully admitted to the United States for Permanent Residence (i.e., possess a currently valid Alien Registration Receipt Card I-551, or other legal verification of such status). Non-citizen nationals are generally persons born in outlying possessions of the United States (i.e., American Samoa and Swains Island). Individuals on temporary or student visas are not eligible. Individuals may apply for the F31 in advance of admission to the United States as a Permanent Resident recognizing that no award will be made until legal verification of Permanent Resident status is provided.

An applicant must have a baccalaureate degree and be currently enrolled in a Ph.D. or equivalent research degree program (e.g., Eng.D., D.N.Sc., Dr. P.H., D.S.W., Pharm.D., Psy.D., Sc.D.) , a formally combined M.D./Ph.D. program, or other combined professional doctorate/research Ph.D. graduate program (e.g., D.D.S./Ph.D.) in the biomedical, behavioral, health services, or clinical sciences, or have been accepted by and agreed to enroll in such a graduate program in the academic year for which funds are being sought. With the exception of the combined degree programs described above, the F31 may not be used to support studies leading to the M.D., D.D.S., or other clinical, health-professional training (e.g., D.C., D.M.D., D.N.P., D.O., D.P.M., D.V.M., N.D., O.D.,).

An individual may not have two or more competing NIH fellowship applications pending review concurrently. In addition, CSR will not accept for review any application that is essentially the same as one already reviewed.

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

Individuals are required to pursue their research training on a full-time basis, normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies. Continuation of the fellowship award for each subsequent year beyond the first award period is based upon evidence of satisfactory progress in the graduate program.

Before submitting a fellowship application, the applicant must identify a sponsoring institution and an individual who will serve as a sponsor (also referred to as mentor or supervisor) who will supervise the training and research experience. The sponsor should be an active investigator in the area of the proposed research who is committed to the research training of the individual and who will directly supervise the candidate's research. The sponsor must also document the availability of sufficient staff, research support, and facilities for a high-quality research training experience. The applicant must work with his/her sponsor in preparing the application.

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

Applicants requesting foreign training are required to provide detailed justification for the foreign training, including the reasons why the facilities, the sponsor, or other aspects of the proposed experience are more appropriate than training in a domestic setting. The justification is evaluated in terms of the scientific advantages of the foreign training as compared to the training available domestically. Foreign training will be considered for funding only when the scientific advantages are clear. Applicants seeking training abroad are encouraged to contact the relevant participating Institute or Center or AHRQ prior to preparing an application (http://grants.nih.gov/archive/grants/guide/contacts/PA-07-106_contacts.htm).

The fellowship application instructions are available at PHS 416-1 in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected]. Note that the PHS 416-1 has been restructured (Rev. 10/05), and the instructions have been significantly modified. See the NIH Notice NOT-OD-07-002 released October 5, 2006.

Applications must be prepared using the Ruth L. Kirschstein National Research Service Award Individual Fellowship Application Form (PHS 416-1(Rev. 10/05). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 13b of the face page of the PHS 416-1 form (Rev. 10/05)

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

If the applicant has been lawfully admitted to the United States for Permanent Residence, the appropriate item should be checked on the face page of the application. Applicants who have applied for but have not yet been granted admission as a permanent resident should check the Permanent Resident block on the face page of the PHS 416-1 application, and should also write in the word "pending." A notarized statement documenting legal admission for permanent residence must be submitted prior to the issuance of an award.

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

3. Submission Dates and Times

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

Application Receipt Date(s): April 13, August 13, December 13
Peer Review Date(s): June-July, October-November, February-March
Earliest Anticipated Start Date(s): December, April, July

3.A.1. Letter of Intent

Applications must be prepared using the Ruth L. Kirschstein National Research Service Award Individual Fellowship Form as described above. Following the instructions on page I-30 of the PHS 416-1, submit a signed, typewritten original of the application (including the Checklist, Personal Data form, at least three, sealed reference letters, and all other required materials) and two exact, clear, single-sided photocopies of the signed application. The applicant must follow the instructions for submitting the application and Appendix materials, 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)

No application will be accepted without the applicant signing the certification block on the face page of the application. Individuals admitted to the United States as Permanent Residents must submit notarized evidence of legal admission prior to the award.

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

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

A Kirschstein-NRSA fellowship may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of this award.

Internal Revenue Code Section 117 applies to the tax treatment of all scholarships and fellowships. The Tax Reform Act of 1986, Public Law 99-514, impacts on the tax liability of all individuals supported under the NRSA program. Under that section, non-degree candidates are required to report as gross income all stipends and any monies paid on their behalf for course tuition and fees required for attendance. Degree candidates may exclude from gross income (for tax purposes) any amount used for tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization.

The IRS and Treasury Department released regulations in January 2005 (Revenue Procedure 2005-11) clarifying the student exception to the FICA (Social Security and Medicare) taxes for students employed by a school, college, or university where the student is pursuing a course of study. Our understanding is that these final regulations do not apply to or impact Kirschstein-NRSA programs or awards. An NRSA stipend is provided by the NIH as a subsistence allowance for Kirschstein-NRSA fellows and trainees to help defray living expenses during the research training experience. NRSA recipients are not considered employees of the Federal government or the grantee institution for purposes of the award. We must note that the NIH takes no position on the status of a particular taxpayer, nor does it have the authority to dispense tax advice. The interpretation and implementation of the tax laws are the domain of the IRS. Individuals should consult their local IRS office about the applicability of the tax laws to their situation and for information on their tax obligations.

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

Applicants are advised to pay special attention to the following important items in the PHS 416-1 (Rev. 10/05). Please note several important changes and reminders on pages 1 and 2, and the new biographical sketch format page. Applicants should follow the most up-to-date PHS 416-1 application form and instructions at the time of application.

The applicant’s sponsor/mentor, who will directly supervise the applicant’s research, should be an active investigator in the area of the proposed research and meet the eligibility requirements in Section III. The sponsor must describe in detail his/her commitment to and proposed role in guiding the individual applicant during the research training experience and describe the research training plan for the applicant.

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

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

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

A description of the broad, long-term objectives and specific aims, making reference to the health relatedness of the research proposal must be included (page 2 of the application PHS 416-1, Rev. 10/05). Advanced graduate students, who have successfully completed their comprehensive examinations or the equivalent by the time of award and will be performing dissertation research, must describe concisely the specific aims, research design and methods for achieving the project goals, as well as the rationale, techniques planned to pursue these goals, and expected outcomes (anticipated results). Beginning graduate students who have not yet developed a dissertation research proposal should include a detailed and well-articulated description of research interests and how these relate to career objectives.

Advanced graduate students (ONLY) must also include a narrative of their doctoral dissertation (may be preliminary) and any other research experience under item 27, Form Page 5. Please note that while the instructions direct Predoctoral Fellows to omit this section, the information is required of advanced graduate students who have successfully completed their comprehensive examinations or the equivalent by the time of award and will be performing dissertation research. All graduate students should include any research experience, if applicable.

The application must include statements addressing the planned value of the proposed fellowship experience and research training program, and how these relate to the applicant’s needs in preparation for a career as an independent researcher.

Applications must include the sponsoring institution’s plans to provide and the candidate's plans for obtaining instruction in the responsible conduct of research, including the rationale, subject matter, appropriateness, format, frequency and duration of instruction. The amount and nature of faculty participation must be described. Although the NIH has not established specific curriculum or format requirements for this training, it is suggested that the following topics be covered: conflict of interest, data sharing, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal subjects, and data management. Applications without plans for training in responsible conduct of research will be considered incomplete and may be returned without review. No award will be made if an application lacks this component.

If the proposed research involves human subjects, the applicant must be responsive to the instructions in the current version of the PHS 416-1. The adequacy of plans to include appropriate human subjects is included in the fellowship evaluation (see Additional Review Criteria below). Note that NIH defines children as individuals under 21 years of age. Consult the decision tree for the exemptions that apply: http://grants.nih.gov/grants/peer/tree_children_hs.pdf.

If vertebrate animals are to be used in the project, the applicant must be responsive to the instructions in the current version of the PHS 416-1. The adequacy of plans for the care and use of vertebrate animals is assessed as part of the fellowship evaluation.

The investigator and the sponsoring institution are responsible for protecting the environment and research personnel from hazardous conditions. If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, please describe the procedures to be taken in order to ensure adequate protection.

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

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

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

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

Applications receive two sequential levels of review. The first level is an assessment of the merit of the research training by a Scientific Review Group (SRG), composed primarily of non-government scientists selected for their competence in research and research training in a scientific area related to the application. After the SRG meeting, the Scientific Review Administrator (SRA), a designated Federal official who coordinates the review of applications for the SRG, prepares a written summary of the review of each application and forwards it to the appropriate NIH Institute or AHRQ. Staff within the assigned funding Institute or Center or AHRQ provides a second level of review.

The goal of this F31 individual predoctoral fellowship program is to promote diversity in the biomedical, behavioral and clinical research workforce by supporting predoctoral students committed to pursuing research careers relevant to the missions of the participating NIH Institutes. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research training will have a substantial impact on the pursuit of this goal. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. The scientific review group will use information in the letters of reference in consideration of the review criteria. Note that an application does not need to be strong in all categories to merit a high priority score. The final priority score will reflect the overall evaluation of the entire application.

An assessment of the quality of the academic record and the prior research experience of the applicant. The latter is especially important for advanced graduate students.
An assessment of the applicant’s potential for independent contribution to scientific knowledge

2. Sponsor and Training Environment

An assessment of the qualifications of the sponsor as a mentor, including training track record, and as an active researcher, including successful competition for research support
Evidence of a match between the research interests of the applicant and the research advisor/sponsor, including an understanding of the applicant's research training needs and a demonstrated ability, on the part of the sponsor, to assist in meeting these needs
An assessment of the quality of the training environment including the institutional commitment to research training of predoctoral fellows and trainees, the quality and availability of facilities and related resources (e.g. equipment, laboratory space, computer time, subject populations), and the availability of research support
If applicable, an assessment of the quality and appropriateness of special and unique opportunities for research training at a foreign site that are not currently available in the United States

3. Research Training Plan

The merit and quality of the scientific proposal and research training plan
Potential of the proposed research training to serve as a sound foundation that will lead the candidate to a productive research career in scientific areas related to the mission of one of the participating NIH Institutes
For advanced graduate students, scientific significance, originality, and feasibility of the proposed research
For beginning graduate students, quality and clarity of stated research interests

4. Training Potential

An assessment of the value of the proposed fellowship experience as it relates to the applicant's needs in preparation for a research doctoral degree
Potential of the research training plan to provide the fellow with the individualized and supervised experiences that will develop his/her research skills

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:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see criteria included in the section on Federal Citations, below).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see inclusion criteria in the section on Federal Citations, below).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described on page 1-26 of the PHS 416-1 fellowship application Part I instructions (rev. 10/05) will be assessed.

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

2.B. Additional Review Considerations

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

2.C. Sharing Research Data

Not applicable

2.D. Sharing Research Resources

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

The reviewers will assess the adequacy of plans for sharing model organisms, and will describe their assessment of the sharing plan in an administrative note, but will not include their assessment in the overall priority score. The adequacy of the resources sharing plan will be considered by Program staff of the funding IC when making recommendations about funding applications.

3. Anticipated Announcement and Award Dates

Not applicable

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

Activation: No funds may be disbursed until the fellow has started training under the award and an Activation Notice (PHS 416-5, Rev. 10/05) has been submitted to the NIH. A fellow has up to 6 months from the issue date on the award notice to activate the award. Under unusual circumstances, an NIH Institute may grant an extension of the activation date upon receipt of a specific request from the fellow, countersigned by the sponsor and an institutional official.

2. Administrative and National Policy Requirements

All NIH grants and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part14.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions of Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

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

Leave Policies

In general, fellows may receive stipends during the normal periods of vacation and holidays observed by individuals in comparable training positions at the sponsoring institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training and is not considered to be a vacation or holiday. Fellows may receive stipends for up to 15 calendar days of sick leave per year. Sick leave may be used for medical conditions related to pregnancy and childbirth. Fellows may also receive stipends for up to 30 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable training positions at the grantee institution have access to paid leave for this purpose and the use of parental leave is approved by the program director.

A period of terminal leave is not permitted, and payment may not be made from fellowship funds for leave not taken. Fellows requiring periods of time away from their research training experience longer than specified here must seek approval from the NIH awarding component for an unpaid leave of absence.

Part-time Training

While Kirschstein-NRSA awardees are required to pursue research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies, under unusual and pressing personal circumstances, a fellow may submit a written request to the awarding component to permit less than full-time training. Such requests will be considered on a case-by-case basis. They must be approved by the awarding NIH Institute or Center in advance for each budget period. The nature of the circumstances requiring the part-time training might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission for part-time training will not be approved to accommodate other sources of funding, job opportunities, clinical practice, clinical training, or for other responsibilities associated with the fellow's position at the institution. In each case, the fellow must submit a written request countersigned by the sponsor and an appropriate institutional business official that includes documentation supporting the need for part-time training. The written request also must include an estimate of the expected duration of the period of part-time training, an assurance that the fellow intends to return to full-time training when that becomes possible, and an assurance that the trainee intends to complete the proposed research training program. In no case will it be permissible for the fellow to be engaged in Ruth L. Kirschstein-NRSA supported research training for less than 50 percent effort. Individuals who must reduce their commitment to less than 50 percent effort must take a leave of absence from Kirschstein-NRSA fellowship support. The notice of research fellowship award will be reissued and the stipend will be pro-rated during the period of any approved part-time training.

Certification Requirements

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

Inventions

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

Publication and Sharing of Research Results

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

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

Copyrights

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

Reporting

All forms were revised in October 2005 for immediate use, see NIH Notices: NOT-OD-06-017 and NOT-OD-06-018 which were released December 9, 2005 for additional details. As indicated in NIH Notice NOT-OD-07-002 released October 5, 2006, revised instructions and Form pages have been posted on the NIH Forms Page at: http://grants1.nih.gov/grants/funding/416/phs416.htm.

Activation Notice

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

Application for Continued Support

An awardee will be required to submit the form PHS 416-9, Rev. 10/05, Continuation of an Individual National Research Service Award, annually (http://grants.nih.gov/grants/funding/416-9/phs416-9.htm) as required in the NIH Grants Policy Statement. The report is due two months before the beginning date of the next budget period and must include information related to the current year's progress as well as the plans for the coming year.

Termination Notice

When support ends, the fellow must submit a Termination Notice (PHS 416-7, Rev. 10/05) to the NIH within 30 days following termination. Forms may be found at http://grants.nih.gov/grants/forms.htm.

Section VII. Agency Contacts

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

We encourage your inquiries concerning this funding opportunity announcement 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 (http://grants.nih.gov/archive/grants/guide/contacts/PA-07-106_contacts.htm). to obtain NIH Institute and Center scientific/research contact information.

2. Peer Review Contacts

Most fellowship applications are reviewed in Fellowship Study Sections convened by the Center for Scientific Review (see: http://www.csr.nih.gov/Roster_proto/Fellowship_section.asp). However, some ICs review their own fellowships. Please refer to (http://grants.nih.gov/archive/grants/guide/contacts/PA-07-106_contacts.htm) for further information on IC s-specific review of F31 applications.

3. Financial or Grants Management Contacts

Applicants should refer to (http://grants.nih.gov/archive/grants/guide/contacts/PA-07-106_contacts.htm) to obtain NIH Institute and Center grants management contact information.

Section VIII. Other Information

Required Federal Citations

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

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

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

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

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

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

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

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

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

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

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

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

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

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

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

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Kirschstein-NRSA awards are made under the authorization of Section 487 of the Public Health Service Act as amended (42 USC 288 and under Federal Regulations 42 CFR 66). For AHRQ, awards are made under the authorization of Title IX of the Public Health Service Act (42 USC 299-299c-6), under Federal Regulations 42 CFR 67 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices