This notice has expired. Check the NIH Guide for active opportunities and notices.

EXPIRED

Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute on Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Center for Complementary and Integrative Health (NCCIH formerly NCCAM)

Special Note: Applicants are cautioned that not all NIH Institutes and Centers (ICs) participate in this program, and that consultation with relevant IC staff prior to submission of an application is strongly encouraged. The participating ICs have different emphases and program requirements for this program. Therefore, a prospective applicant is urged to consult the Table of IC-Specific Information, Requirements and Staff Contacts to determine whether the planned research and training falls within the mission of one of the participating NIH ICs.

Funding Opportunity Title

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

Activity Code

F31 Predoctoral Individual National Research Service Grant Award

Announcement Type

Reissue of PA-10-109

Related Notices

  • March 7, 2014 - This PA has been expired and reissued as PA-14-148.
  • February 18, 2014 - See Notice NOT-OD-14-060. Notice of Intent to Publish the Reissuance of this FOA.
  • October 19, 2012 - See Notice NOT-AT-13-002. The purpose of this Notice is to inform potential applicants to the Ruth L. Kirschstein National Research Service Awards listed below that effective immediately, NCCAM will not accept applications to these programs proposing to conduct new, free-standing clinical trials or studies.
  • December 14, 2011 - See Notice NOT-OD-12-022 Ruth L. Kirschstein National Research Service Awards (NRSA) and Other Fellowship Applications: New Policy on Post-Submission Information on Sponsor’s Research Funding .
  • June 30, 2011 - Per Notice NOT-AT-11-004, NCCAM will no longer participate in PA-11-111 (Parent F31). NCCAM will still participate in the Parent F31 - Diversity, Parent T32 and Parent T35 funding opportunities.
  • April 1, 2011 - This Notice is being provided to clarify instructions in Section IV. Application and Submission Information. See NOT-OD-11-062.
  • February 24, 2011 - See Notice NOT-OD-11-046 Reminder of Requirement for Certification Letter for Applications in Response to this FOA and Deadline for Their Receipt.

Funding Opportunity Announcement (FOA) Number

PA-11-112

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.273, 93.173, 93.113, 93.282, 93.853, 93.866, 93.361, 93.847, 93.855, 93.856, 93.286, 93.865, 93.121, 93.233, 93.837, 93.838, 93.839, 93.172, 93.398, 93.213

FOA Purpose

The purpose of this individual predoctoral research training fellowship is to improve the diversity of the health-related research workforce by supporting the training of predoctoral students from groups that have been shown to be underrepresented. Such candidates include individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds.

Key Dates
Posted Date
Open Date (Earliest Submission Date)

March 13, 2011

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

Standard dates applyl

AIDS Application Due Date(s)

Standard dates apply

Scientific Merit Review

Standard dates apply

Advisory Council Review

Not applicable for Fellowships

Earliest Start Date(s)

Standard dates apply

Expiration Date

(Now Expired March 8, 2014 per issuance of PA-14-148), Originally May 8, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Individual Fellowship SF424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The overall goal of the NIH Ruth L. Kirschstein National Research Service Award (NRSA) program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. More information about NRSA programs may be found at the Ruth L. Kirschstein National Research Service Award (NRSA) website.

The purpose of the F31 predoctoral fellowship to promote diversity in health-related research is to provide up to five years of support for research training leading to the PhD or equivalent research degree, the combined MD/PhD degree (up to six years of support); 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 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:

A. Individuals from underrepresented racial and ethnic groups;

B. individuals with disabilities; and

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.

Special Note: Applicants are cautioned that not all NIH Institutes and Centers (ICs) participate in this program, and that consultation with relevant IC staff prior to submission of an application is strongly encouraged. The participating ICs have different emphases and program requirements for this program. Therefore, a prospective applicant is urged to consult the Table of IC-Specific Information, Requirements and Staff Contacts to determine whether the planned research and training falls within the mission of one of the participating NIH ICs.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Resubmission
Renewal: Individual fellowship awards are generally not renewable. In rare cases in which fellowship awardees require further fellowship support, they should consult with NIH staff to obtain advice regarding submission of a renewal application.

The OER Glossary and the SF 424 (R&R) Individual Fellowship Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

Award Budget

Award budgets are composed of stipends, tuition and fees, and institutional allowance, as described below.

Award Project Period

Individuals may receive up to 5 years of aggregate Kirschstein-NRSA support at the predoctoral level (up to 6 years for dual degree training, e.g., MD/PhD), including any combination of support from institutional training grants (e.g. T32) and an individual fellowship award. Fellowship awards are often limited to 2-3 years.

Other Award Budget Information
Stipends

Kirschstein-NRSA awards provide stipends as a subsistence allowance to help defray living expenses during the research and clinical training experiences.

The most recent stipend levels are described on the Kirschstein-NRSA webpage. NIH will adjust awards on the anniversary date of the award to ensure consistency with the stipend level in effect at that time.

Visit NIH Grants Policy Statement: Ruth L. Kirschstein National Research Service Awards for more information.

Tuition and Fees

NIH will contribute to the combined cost of tuition and fees at the rate in place at the time of award. The most recent tuition and fees levels are described on the Ruth L. Kirschstein National Research Service Award (NRSA) webpage. Visit NIH Grants Policy Statement: Ruth L. Kirschstein National Research Service Awards for more information.

Institutional Allowance

The application should include in the Award Budget the applicable Kirschstein-NRSA institutional allowance to help defray the cost of fellowship expenses such as health insurance, research supplies, equipment, books, and travel to scientific meetings. The most recent institutional allowance levels are described via a link on the Ruth L. Kirschstein National Research Service Award (NRSA) site. Requests for additional costs (such as to accommodate the disabilities of a fellow) must be explained in detail and justified in the application. Visit NIH Grants Policy Statement: Ruth L. Kirschstein National Research Service Awards for more information.

Indirect Costs

NIH does not separately reimburse indirect costs (also known as Facilitates & Administrative [F&A] Costs) for fellowships. Costs for administering fellowships are part of Institutional Allowance.

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

Section III. Eligibility Information

1. Eligible Applicants
Eligible Organizations

Higher Education Institutions:

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

Before submitting a fellowship application, the applicant fellow must identify a sponsoring institution. The sponsoring institution must have staff and facilities available on site to provide a suitable environment for performing high-quality research. The research training should occur in a research-intensive environment that has appropriate human and technical resources and is demonstrably committed to research training in the particular program proposed by the applicant fellow. The sponsoring institution may be private (profit or nonprofit) or public, including the NIH Intramural Programs and other Federal laboratories.

An individual may request support for training abroad. In such cases, the applicant fellow is 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.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

Any applicant fellow with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her sponsor and organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Multiple Principal Investigators are not allowed.

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).

For the purpose of this announcement, institutions are encouraged to identify Fellowship Applicants who will increase diversity on a national or institutional basis. As indicated in Section I, 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 data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the report Women, Minorities, and Persons with Disabilities in Science and Engineering, 2007, p. 262). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: African Americans, Hispanic Americans, American Indians, Alaska Natives, Native Hawaiians, and other Pacific Islanders. 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.

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 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 (C1 and C2) 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. Under extraordinary circumstances the PHS may, at its discretion, consider an individual beyond the undergraduate level to be from a disadvantaged background. Such decisions will be made on a case-by-case basis, based on appropriate documentation.

Certification Letter

Applicants are required to attach a letter from the institution certifying eligibility of the Fellowship applicant for this program. The certification letter must be on institutional letterhead and scanned so that an institutional official signature is visible. See instructions in the SF424 Individual Fellowship Application Guide.

The applicant fellow must show evidence of both high academic performance in the sciences and substantial interest in a research area of high priority to the participating Institutes.

The applicant fellow must have a baccalaureate degree and be currently enrolled in a PhD or equivalent research degree program (e.g., EngD, DNSc, Dr PH, DSW, PharmD, PsyD, ScD), a formally combined MD/PhD program, or other combined professional/clinical and research doctoral (e.g., DDS/PhD) in the biomedical, behavioral, or clinical sciences at a domestic or foreign institution. The Kirschstein-NRSA F31 may not be used to support studies leading to the MD, DDS, or other clinical, health-professional training (e.g., DC, DMD, DNP, DO, DPM, DVM, ND, OD, AuD).

Students seeking support for pursuit of a combined degree program (e.g. MD/PhD, or DO/PhD, or DDS/PhD) also may be eligible to apply for the Kirschstein-NRSA for Individual Predoctoral MD/PhD Fellows (F30).

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

Duration of Support

Individuals may not exceed the aggregate limit of NRSA support shown above in the Award Project Period. Applicant fellows must consider any prior NRSA research training in determining the duration of support requested. Information regarding previous Kirschstein-NRSA support must be included in the application and will be considered at the time of award.

Level of Effort

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.

Sponsor

Before submitting the application, the applicant fellow must identify a sponsor (sometimes called a mentor) who will supervise the proposed training and research experience. See Section IV below for more specific requirements for the Sponsor and any co-sponsor(s).

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Fellowship Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission. Follow the instructions in the SF 424 (R&R) to determine which components are required.

Page Limitations

All page limitations described in the SF424 (R&R) Individual Fellowship Application Guide and the Table of Page Limits must be followed.

Other Project Information Component

All instructions in the SF424 (R&R) Individual Fellowship Application Guide must be followed, with the following additional instructions:

Additional Educational Information Required (Uploaded via the Other Attachments Section)

This attachment must include: (see updated instructions per NOT-OD-11-062)

The filename provided for each Other Attachment will be the name used for the bookmark in the electronic application in eRA Commons.

PHS Fellowship Supplemental Form

All instructions in the SF424 (R&R) Individual Fellowship Application Guide must be followed, with the following additional instructions:

Research Strategy (Component of Research Training Plan)

Applicant fellows must describe a tailored research training plan, including a description of the research strategy (preferably hypothesis-driven) well-suited to the stage of his/her career development. Describe the skills and techniques that the applicant fellow will learn during the award period, and discuss the relationship of the proposed research training to the applicant fellow’s career goals. The applicant fellow must describe the background leading to the proposed research, the significance of the research, the research approach (design and methods) for achieving the Specific Aims, the rationale, and expected/alternative outcomes of the proposed studies. It is beneficial to include pertinent preliminary data obtained by the applicant fellow in the current or prior laboratory.

Doctoral Dissertation and Other Research Experience (Component of Additional Information)

The applicant fellow should discuss how the proposed research training plan will add to the fellowship experience. Advanced graduate students must include a narrative of their doctoral dissertation (may be preliminary) and any other prior research experience. All graduate students should include any applicable research experience. Please note that while the instructions direct Predoctoral Fellows to omit this section, the information is required of advanced graduate students who have successfully completed their comprehensive examinations or the equivalent by the time of award and will be performing dissertation research. All graduate students should include any research experience, if applicable.

Sponsor(s) and Co-Sponsor(s)

Before submitting a fellowship application, the applicant must identify a sponsor (also called 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 training and be committed both to the research training of the Fellowship Applicant and to the direct supervision the applicant’s research. The sponsor must document the availability of sufficient research support and facilities for high-quality research training. The sponsor, or a member of the mentoring team, should have a successful track record of mentoring predoctoral students. Applicants are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research and training program. In such cases, one individual must be identified as the principal sponsor who will coordinate the applicant’s research training program. The applicant must work with his/her sponsor(s) in preparing the application.

The sponsor should describe the research training plan for the applicant fellow (coordinated with the applicant fellow’s research strategy). The sponsor and any co-sponsors are also expected to provide an assessment of the applicant fellow’s qualifications and potential for a research career. The research environment and the availability and quality of needed research facilities and research resources (e.g., equipment, laboratory space, computer time, available research support, etc.) must also be described. The description should include items such as classes, seminars, and opportunities for interaction with other groups and scientists. Training in career skills, e.g. grant-writing and making effective presentations, is strongly encouraged.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, and Sharing Model Organisms) as provided in the SF424 (R&R) Application Guide.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Letters of Reference

Applicant fellows must carefully follow the SF424 (R&R) Individual Fellowship Application Guide, including the time period for when letters of reference will be accepted. Applications lacking the required reference letters may be delayed in review or not reviewed. Please note that the specified Fellowship Reference Form must be used. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Referee Information link and not through Grants.gov. Note that the sponsor and any co-sponsors may not submit a letter of reference.

Foreign Organizations

Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the SF424 (R&R) Individual Fellowship Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

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 National Research Service Award (NRSA) policies apply to this program. 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.

Pre-award costs are generally not allowable for Fellowships.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

Overall Impact/Merit

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood that the fellowship will enhance the candidate’s potential for, and commitment to, a productive independent scientific research career in a health-related field, in consideration of the scored and additional review criteria.

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Fellowship Applicant

Sponsors, Collaborators, and Consultants

Research Training Plan

Training Potential

Institutional Environment & Commitment to Training

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

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

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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

Biohazards

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

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Allowed.

Additional Review Considerations

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

Training in the Responsible Conduct of Research

Taking into account the circumstances of the fellow, including level of experience, the reviewers will address the following questions. Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework, and/or real-time discussion groups? Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety? Do the plans adequately describe the role of the sponsor/mentor or other faculty involvement in the fellow’s instruction? Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction every four years? Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. Applications rated UNACCEPTABLE will not be funded until the applicant provides an acceptable, revised plan. See also: NOT-OD-10-019.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; and 2) Sharing Model Organisms.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Groups (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate NIH Institute or Center. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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 and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

The taxability of stipends is described in the NIH Grants Policy Statement.

Inventions and Copyrights

Fellowships funded primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required. More details, including exceptions for fellows training at NIH are provided in the NIH Grants Policy Statement.

Leave Policies

The NIH Grants Policy Statement: Ruth L. Kirschstein National Research Service Awards describes NRSA leave policies. Applicant fellows may receive stipends for parental leave as described in NOT-OD-08-064.

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, recipients are hereby notified that they may be contacted after the completion of this award 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 program.

3. Reporting

When multiple years are involved, awardees will be required to submit a Kirschstein-NRSA Individual Fellowship Progress Report for Continuation Support (PHS 416-9) annually. The report is due two months before the beginning date of the next budget period and must include information describing the current year's progress as well as the research and training plans for the coming year.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

Other Fellowship Reporting Requirements:
Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Special Note: Applicants are cautioned that not all NIH Institutes and Centers (ICs) participate in this program, and that consultation with relevant IC staff prior to submission of an application is strongly encouraged. The participating ICs have different emphases and program requirements for this program. Therefore, a prospective applicant is urged to consult the Table of IC-Specific Information, Requirements and Staff Contacts to determine whether the planned research and training falls within the mission of one of the participating NIH ICs.

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

See Table of IC-Specific Information, Requirements, and Staff Contacts

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

See Table of IC-Specific Information, Requirements, and Staff Contacts

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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.


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