Department of Health and Human Services
National Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (http://www.niams.nih.gov/)
Title: Ruth L. Kirschstein National Research Service Awards for Individual Postdoctoral Fellowships in Muscular Dystrophy Research (F32)
This Funding Opportunity Announcement (FOA) is a reissue of PA-05-052.
Update: The following update relating to this announcement has been issued:
Announcement (PA) Number: PA-11-075
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.
Catalog of Federal Domestic Assistance Number(s)
Release/Posted Date: December 10, 2010
Opening Date: March 8, 2011(Earliest date an application may be submitted to Grants.gov)
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Not Applicable to Fellowships
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: January 8, 2014
Dates for E.O. 12372
Table of Contents
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Training Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria
Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
2. Review and Selection Process
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
Section VII. Agency Contacts
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
Section VIII. Other Information - Required Federal Citations
1. Research Training Objectives
The objective of NIH-supported Ruth L. Kirschstein National Research Service Awards programs is to help ensure that a diverse pool of highly trained scientists are available in adequate numbers and in appropriate research areas to address the Nation's biomedical, behavioral, and clinical research needs.
Purpose of this FOA
NIAMS provides individual fellowship awards to promising applicants with the potential to become productive investigators in basic, translational or clinical research on the muscular dystrophies. This FOA is issued in recognition of the urgent need for highly skilled, interactive investigators who are able to integrate various disciplines and levels of expertise to successfully address the increasing challenges in the current research environment of the muscular dystrophies. This FOA supports individual postdoctoral fellowships with the expectation that these training opportunities will increase the number of future investigators in basic, translational and clinical research on muscle diseases.
The Action Plan for the Muscular Dystrophies states “The National Institutes of Health and other funding agencies are aware of the dearth of clinical investigators and the need to increase the number and scope of individuals pursuing translational research as well as basic and clinical research in muscular dystrophy. Despite having a spectrum of training opportunities for medical and graduate students, fellows, and more established researchers the number of new investigators is lagging behind the need and opportunities.” The MD-CARE Act directs the NIH to “expand and intensify programs…with respect to research and related activities concerning various forms of muscular dystrophy.” Because the demand for translational and clinical investigators in the dystrophies is expected to rise, the pipeline of newly trained investigators needs to be expanded.
Action Plan for the Muscular Dystrophies: http://www.ninds.nih.gov/find_people/groups/mdcc/MDCC_Action_Plan.pdf
MD-CARE Act: http://www.cdc.gov/ncbddd/duchenne/documents/MD%20CARE%20Act.pdf
NIAMS is interested in stimulating and supporting research in the muscular dystrophies including, but not limited to, Duchenne, myotonic, facioscapulohumeral, and congenital muscular dystrophies. For a more complete description of specific areas of muscle disease research covered by NIAMS please visit our website at: http://www.niams.nih.gov/About_Us/Mission_and_Purpose/long_range.asp#muscle .
Postdoctoral fellows with diverse scientific interests are invited to apply their expertise to enhance our understanding of the pathogenesis and treatment of muscular dystrophies. Prior experience of the trainee in muscle disease or muscle biology research is not necessary, providing that the mentor/sponsor has appropriate expertise. Applicants are encouraged to develop innovative and novel approaches for studying and treating these diseases. Examples that illustrate possible areas of research are presented below. They are intended only to provide a broad direction for research and should be considered illustrative and not restrictive. General examples of appropriate research topics include, but are not limited to:
The field of muscular dystrophy research needs investigators who can integrate various disciplines and levels of expertise to effectively address the increasing level of complexity in the interplay between genetic, epigenetic, environmental and socioeconomic factors. Investigators must become familiar with the knowledge base and the methods of a wider variety of disciplines than is presently the case. Investigators must develop a different and more diverse set of competencies, including the ability to function effectively in interdisciplinary research teams. The need for training clinical scientists in muscular dystrophy research is especially high. These awards should provide the opportunity for trainees to develop these skills and should promote successful research career transitions and pathways. This training will ensure a larger pool of investigators with more diverse expertise that will be prepared to carry out basic, translational, and clinical research in muscular dystrophy.
VIII, Other Information - Required Federal Citations, for policies related to
Section II. Award Information
This funding opportunity will use the Kirschstein-NRSA F32 individual fellowship award mechanism. As a Fellowship Applicant, the individual, together with his/her sponsor and institution, are jointly responsible for planning, directing, and executing the proposed research training program.
This mechanism is intended for candidates that will have received a Ph.D., M.D., D.O., D.C., D.D.S., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr. P.H., DNSc., N.D.(Doctor of Naturopathy), Pharm.D., D.S.W., Psy.D., or equivalent doctoral degree from an accredited domestic or foreign institution prior to activation of the award. Additional information and detailed requirements for this NRSA award mechanism can be found at: https://grants.nih.gov/training/nrsa.htm.
Because the nature and scope of the proposed research training will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIAMS 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 ICs, and the availability of funds.
Facilities and Administrative (F&A) costs are not allowed for fellowship awards.
Stipends: Kirschstein-NRSA awards provide stipends to fellows as a subsistence allowance to help defray living expenses during the research and clinical training experiences. The awards are not provided as a condition of employment with either the Federal government or the sponsoring institution. For the most recent stipend levels, see the following website: http://grants2.nih.gov/training/nrsa.htm. The NIAMS will adjust awards on the anniversary date of the fellowship award to ensure consistency with the stipend level in effect at that time. No departure from the published Kirschstein-NRSA stipend schedule may be negotiated between the institution and the fellow.
Fellows with less than one full year of postdoctoral experience at the time of award will receive initial support at the zero level. Relevant experience may include research (including research in industry), teaching, internship, residency, clinical duties, or other time spent in full-time studies in a health-related field beyond that of the qualifying doctoral degree. The NIAMS will adjust awards on the anniversary date of the fellowship award to ensure consistency with the stipend schedule in effect at that time. No departure from the published Kirschstein-NRSA stipend schedule may be negotiated between the institution and the fellow. The stipend for each subsequent year of Ruth L. Kirschstein-NRSA support is the next level of experience using the stipend schedule 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 institutions, the monthly stipend payment will be deposited in the fellow's U.S. bank account or paid directly to the fellow by U.S. Department of Treasury check.
Tuition and Fees: The NIH will contribute to the combined cost of tuition and fees at the rate in place at the time of award. Tuition, for the purposes of this policy, means the combined costs of tuition and fees. For the most recent tuition/fees levels, see the following website: http://grants2.nih.gov/training/nrsa.htm.
Institutional Allowance: Fellows sponsored by nonfederal or nonprofit institutions (domestic or foreign) will receive an institutional allowance to help defray fellowship expenses such as health insurance, research supplies, equipment, books, and travel to scientific meetings. Self-only health insurance (available to fellows without families) or family health insurance is an allowable cost for fellows at the sponsoring institution only if such self or family health insurance is applied consistently to all persons in a similar training status and regardless of the source of support. This allowance is intended to cover training-related expenses for the individual fellow 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 Award will be revised and the balance must be returned to the NIH.
NIH provides an institutional allowance to fellows sponsored by Federal laboratories or for-profit institutions for expenses associated with health insurance, travel to scientific meetings and books. For fellows at for-profit institutions, the institutional allowance will be paid to the institution for disbursement to the fellow. Funds for fellows at Federal laboratories will be disbursed from the awarding Institute or Center.
Funds are not available to cover the costs of travel between the fellow’s place of residence and a training institution. However, in an individual case of extreme hardship, a one-way travel allowance may be authorized by the sponsoring institution. Such travel must be paid from the institutional allowance. For the most recent institutional allowance levels, see the following website: http://grants2.nih.gov/training/nrsa.htm.
Other Training Costs: As part of this award, additional funds may be requested. In all cases, the additional funds requested must be reasonable in relationship to the total dollars awarded under the fellowship and must be directly related to the approved research training experience. Such additional funds shall be provided only in exceptional circumstances that are fully justified and explained by the sponsoring institution in the application.
Supplementation of Stipends, Compensation, And Other Income: The sponsoring institution is allowed to provide funds to the fellow in addition to the stipend paid by the NIH. 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. See also: https://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm#_Toc54600200.
Stipend Supplementation: Supplementation, or additional support to offset the cost of living, may be provided by the sponsoring institution. Supplementation does not require additional effort from the fellow. DHHS funds may not be used for supplementation under any circumstances. Additionally, no funds from other Federal agencies may be used for supplementation unless specifically authorized by the NIH and the other Federal agency.
Compensation: The sponsoring institution may provide additional funds to a fellow in the form of compensation (as salary and/or tuition remission) for services such as teaching or serving as a research assistant. A fellow may receive compensation for services as a research assistant or in some other position on a Federal research grant, including a DHHS research grant. However, compensated services should occur on a limited, part-time basis apart from the normal research training activities, which require a minimum of 40 hours per week. In addition, compensation may not be paid from a research grant supporting the fellow's research training experience.
Educational Loans or G.I. Bill: An individual may make use of Federal educational loan funds and assistance under the Veterans Readjustment Benefits Act (G.I. Bill). Such funds are not considered supplementation or compensation.
NIH Grants Policy: NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
1. Eligible Applicants
The sponsoring institution must have staff and facilities available on site to provide a suitable environment for performing high-quality research training. The research training should occur in a research-intensive environment that has appropriate human and technical resources and is demonstrably committed to research training in the particular program proposed by the applicant.
Foreign sponsorship: An individual may request support for training abroad. In such cases, the applicant is required to provide detailed justification for the foreign training, including the reasons why the facilities, the 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.
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her 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.
Citizenship: By the time of award, the individual Fellowship Applicant must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status). Non-citizen nationals are generally persons born in outlying possessions of the United States (i.e., American Samoa and Swains Island). Individuals on temporary or student visas are not eligible. Individuals may apply for the award in advance of admission to the United States as a Permanent Resident recognizing that no award will be made until legal verification of Permanent Resident status is provided.
Degree Requirements: Before a Ruth L. Kirschstein-NRSA postdoctoral fellowship award can be activated, the individual must have received a PhD, MD, DO, DC, DDS, DVM, OD, DPM, ScD, EngD, Dr PH, DNSc, ND (Doctor of Naturopathy), PharmD, DSW, PsyD, or equivalent doctoral degree from an accredited domestic or foreign institution (it is the responsibility of the sponsoring institution to determine if a foreign doctoral degree is equivalent). Certification by an authorized official of the degree-granting institution that all degree requirements have been met is also acceptable. A Ruth L. Kirschstein-NRSA fellowship may not be used to support studies leading to the MD, DO, DDS, DVM, or other similar health-professional degrees. Neither may these awards be used to support the clinical years of residency training. However, these awards are appropriate for the research fellowship years of a research-track residency program. 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.
Sharing or Matching
This program does not require cost sharing as defined in the current NIH Grants Policy Statement.
3. Other-Special Eligibility Criteria
Number of Applications. An individual may not have two or more competing NIH fellowship applications pending review concurrently.
Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Only a single amendment (A1) is permitted
Renewals. Awards are generally not renewable and are not transferable from one PD/PI to another.
Duration of Support: 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), and up to 3 years of aggregate Kirschstein-NRSA support at the postdoctoral level, including any combination of support from institutional training grants (e.g. T32) and an individual fellowship award. However, it is not possible to have concurrent NRSA support from two different sources (e.g., Individual F and T32). Fellowship Applicants must consider any prior NRSA 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.
Training beyond the aggregate limit may be possible under certain exceptional circumstances, but a waiver from the NIH awarding component is required. Individuals seeking additional Kirschstein-NRSA support beyond the third year are strongly advised to consult with relevant NIH staff before preparing a justification. Any waiver will require a detailed justification of the need for additional research training. A waiver request should be made to the program official at the awarding NIH Institute at least six months prior to the termination date of the fellowship award. A request for a waiver cannot be made prior to the issuance of the initial award.
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. Support for subsequent years of the fellowship award beyond the first budget period is based upon evidence of satisfactory progress in the predoctoral research training program which is determined by the NIH Program staff review of information documented in the progress report.
Sponsor: 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. 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 (coordinated with the applicant’s research strategy). The sponsor and any co-sponsors are also expected to provide an assessment of the applicant’s qualifications and potential for a research career. The research environment and the availability and quality of needed research facilities and research resources (e.g., equipment, laboratory space, computer time, available research support, etc.) must also be described. The description should include items such as classes, seminars, and opportunities for interaction with other groups and scientists. Training in career skills, e.g. grant-writing and presentation skills are strongly encouraged.
Sponsoring Institution: Before submitting a fellowship application, the applicant must also identify a sponsoring institution. The sponsoring institution must have appropriate staff and facilities available on site to provide a suitable environment for performing high-quality research training and be demonstrably committed to research training in the particular program proposed by the applicant.
In most cases, the fellowship supports research training experiences in new settings in order to maximize the acquisition of new skills and knowledge. However, in unusual circumstances, applicants may propose postdoctoral training experiences at their doctorate institution or at the institution where they have been training for more than a year. In such cases, the applicant must carefully document the opportunities for new research training experiences specifically designed to broaden his/her scientific background.
Foreign Training: While the sponsoring institution must be domestic, an individual may request support for foreign training. In such cases, applicants 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 will be 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 opportunities and the scientific advantages are clear.
Foreign Organizations: Several special provisions apply to applications submitted by foreign organizations. Additional information regarding foreign grants is available in the NIH Grants Policy Statement (https://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_T0c54600260).
download a SF424 (R&R) Application Package and SF424 (R&R) Application
Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for
Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered “on-time” (see 3.C.1 for more information about on-time submission).
A one-time registration is required for institutions/organizations at both:
The PD/PI should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.
Several additional separate actions are required before an applicant can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered http://www.grants.gov/applicants/get_registered.jsp
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.
Request Application Information
Applicants must download the individual fellowship SF424 (R&R) application forms and the individual fellowship SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package
directly attached to a specific FOA can be used. You will not be able to use
any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA),
although some of the "Attachment" files may be useable for more than
For further assistance, contact GrantsInfo -- Telephone 301-710-0267, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY: (301) 451-5936
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (https://grants.nih.gov/grants/funding/424/index.htm).
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”
The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS Fellowship Supplemental Form
PHS398 Cover Letter File
Specific instructions related to each of the components are included in the Individual Fellowship Application Guide SF424 (R&R).
Foreign Organizations (Non-domestic [non-U.S.] Entities)
NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: https://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from Foreign organizations must:
Proposed research training should provide special opportunities for training through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States (U.S.) or that augment existing U.S. resources.
3. Submission Dates and Times
See Section IV.3.A for details.
3.A. Submission, Review, and
Anticipated Start Dates
Opening Date: March 8,2011 (Earliest date an application may be submitted to Grants.gov)
Application Due Date(s): Standard dates apply, please see https://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Not Applicable to Fellowships
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
3.B. Submitting an Application Electronically to the
To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered “on-time”:
Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.
Submission to Grants.gov is not the last step – applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!
3.C.2 Viewing an Application in the eRA Commons
Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday – Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons: https://commons.era.nih.gov/commons/. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.
4. Intergovernmental Review
This initiative is not subject to intergovernmental review.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
These awards are also subject to the NRSA Policies. For more information see: http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm.
Citizenship: Fellowship Applicants must meet the citizenship/residency requirements as described in the Eligibility section of this announcement (see Section III) at the time of award.
Concurrent Awards: A Kirschstein-NRSA fellowship may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of this award.
Tax Liability: Internal Revenue Code Section 117 applies to the tax treatment of all scholarships and fellowships. The Tax Reform Act of 1986, Public Law 99-514, impacts on the tax liability of all individuals supported under the NRSA program. Under that section, non-degree candidates are required to report as gross income all stipends and any monies paid on their behalf for course tuition and fees required for attendance. Degree candidates may exclude from gross income (for tax purposes) any amount used for tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization.
The IRS and Treasury Department released regulations in January 2005 (Revenue Procedure 2005-11) clarifying the student exception to the FICA (Social Security and Medicare) taxes for students employed by a school, college, or university where the student is pursuing a course of study. Our understanding is that these final regulations do not apply to or impact Kirschstein-NRSA programs or awards. An NRSA stipend is provided by the NIH as a subsistence allowance for Kirschstein-NRSA fellows and trainees to help defray living expenses during the research training experience. NRSA recipients are not considered employees of the Federal government or the grantee institution for purposes of the award. Note that the NIH takes no position on the status of a particular taxpayer, nor does it have the authority to dispense tax advice. The interpretation and implementation of the tax laws are the domain of the IRS. Individuals should consult their local IRS office about the applicability of the tax laws to their situation and for information on their tax obligations.
Future Year Support: Funds for continuation beyond the initial year are determined by the progress described in the continuation application, the timely submission of all required forms, and the availability of funds.
As required by the NIH Revitalization Act of 1993, postdoctoral fellows incur a service obligation of 1 month for each month of support during the first 12 months of the Ruth L. Kirschstein-NRSA postdoctoral support. The 13th and subsequent months of Ruth L. Kirschstein-NRSA support are acceptable postdoctoral payback service. Thus, individuals who continue under the award for 2 years will have paid off their first year obligation by the end of the second year.
Applicants accepting an award for the first 12 months of a Ruth L. Kirschstein-NRSA postdoctoral support must sign a payback agreement (PHS Form 6031) in which they agree to engage in health-related research training, research, and/or teaching for 12 months.
Those who do not pay back their obligation through continued Ruth L. Kirschstein-NRSA supported training may satisfy their obligation by serving in a position in which health-related research, research training, or teaching are the primary activities. Such individuals must engage in research, research training, or teaching at a rate of 20 or more hours per week averaged over a full work-year. Payback service may be conducted in an academic, governmental, commercial, or nonacademic environment, in the United States or in a foreign country. Examples of acceptable payback service include research associateships/assistantships, postdoctoral research fellowships, and college or high school science teaching positions. Examples of unacceptable payback service include clinical practice and administrative responsibilities not directly related to scientific research.
Payback service positions are arranged by the individual, not by the NIH. The NIH will review and approve the activity at the end of the year in which it occurs. Service to satisfy any outstanding obligation must be initiated within 2 years after termination of Ruth L. Kirschstein-NRSA support, and must be performed on a continuous basis. For individuals who fail to fulfill their service obligation, the United States is entitled to recover the total amount of Ruth L. Kirschstein-NRSA funds paid to the individual for the obligated period plus interest at a rate determined by the Secretary of the U.S. Department of Treasury. Financial payback must be completed within 3 years, beginning on the date the United States becomes entitled to recover such amount.
Under certain conditions, the Secretary, DHHS, may extend the period for starting service, permit breaks in service, extend the period of repayment, or otherwise waive the payback obligation when compliance would constitute a substantial hardship against equity and good conscience.
Policies regarding the Ruth L. Kirschstein-NRSA payback obligation are explained in the Ruth L. Kirschstein-NRSA Section of the NIH Grants Policy Statement available at https://grants.nih.gov/grants/policy/policy.htm.
Specific questions may appear in a list of Frequently Asked Questions that appears on the Web at https://grants.nih.gov/training/faq_fellowships.htm. For questions on payback see: http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part10.htm
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”
Cover Letter (Section 5.2 of the SF424 (R&R) Individual Fellowship Application Guide)
Fellowship Applicants are required to attach a cover letter to the PHS Cover Letter component of the application. The cover letter must contain the same list of referees (including name, departmental affiliation, and institution) that is included in the Other Project Information Component Item 12, Other Attachments. In addition, applicants may request assignment (referral) to a particular NIH Institute or Center, as well as a specific Scientific Review Group. See SF 424 Individual Fellowship Application Guide, Section 5.2, for additional information.
PHS Fellowship Supplemental Form (Section 5.3 of the SF424 (R&R) Individual Fellowship Application Guide)
All application instructions outlined in the SF424 (R&R) Individual Fellowship Application Guide are to be followed (see: http://grants2.nih.gov/grants/funding/424/index.htm), taking into consideration the following additional instructions (Note that only selected items are emphasized below; see SF 424 (R&R) Individual Fellowship Application Guide, Section 5.3, for additional information):
Research Training Plan
Introduction (Item 1): Required for a resubmission or revision application. This section is limited to 1 page.
Specific Aims (Item 2): The Fellowship Applicant must describe concisely the Specific Aims, broad, long-term objectives and the goal of the proposed research to test a stated hypothesis. The Specific Aims section is required for all Fellowship applications and is limited to 1 page.
Research Strategy (Item 3):
This section, including tables, graphs, figures, diagrams, and charts, is limited to 6 pages. See Table of Page Limits. This section should address the Significance of the proposed studies, including the background leading to the present application; and the Approach (including preliminary studies, if any) to provide experimental support of the proposed hypothesis.
Fellowship Applicants 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 to date. Describe the skills and techniques that the candidate will learn during the award period, and discuss the relationship of the proposed research training to the applicant’s career goals. The applicant’s plan should be coordinated with the sponsor’s plan (see below), and should include substantive detail that adds to the information about time allocations requested. The applicant 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 (see above), the rationale, and expected/alternative outcomes of the proposed studies. It is beneficial to include pertinent preliminary data obtained by the applicant in the current or prior laboratory.
If the sponsoring institution is a foreign institution, information must be provided describing how the institution and sponsor offer clear scientific advantages for research training not currently available in the United States.Other Research Training Plan Sections
(a) Data Sharing Plan: Not Applicable.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (go to NOT-OD-07-088, and https://grants.nih.gov/grants/gwas/.)
Respective Contributions (Item 17): The Fellowship Applicant and his/her sponsor/mentor should describe how they have collaborated to develop the current research training proposal. This section is limited to 1 page.
Selection of Sponsor and Institution (Item 18): The Fellowship Applicant should discuss how he/she arrived at selecting the sponsor(s) and the institution. This section is limited to 1 page.
Training in the Responsible Conduct of Research (Item 19): Applications must include a plan to obtain instruction in the responsible conduct of research. This section should document prior instruction in responsible conduct of research during the applicants current career stage (including the date of last occurrence) and propose plans to receive instruction in responsible conduct of research. Such plans must address five instructional components, format, subject matter, faculty participation, duration of instruction, and frequency of instruction, as outlined and explained in NOT-OD-10-019. The plan may include career stage-appropriate, individualized instruction or independent scholarly activities that will enhance the applicants understanding of ethical issues related to their specific research activities and the societal impact of that research. The role of the sponsor/mentor in responsible conduct of research instruction must be described. Applications lacking a plan for instruction in responsible conduct of research will be considered incomplete and may be delayed in the review process. The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019. This section is limited to 1 page.
Goals for Fellowship Training and Career (Item 7): The Fellowship Applicant should provide details of his/her overall career goals for training, and explain how the proposed research will enable the attainment of these goals. This section is limited to 1 page.
Activities Planned Under This Award (Item 8): The Fellowship Applicant should provide a detailed description of all planned activities under the proposed research training plan, such as coursework, seminars, scientific conferences, opportunities for interaction with other groups and scientists, and any special or unique training opportunities for the applicant that are available in the training environment. Give a year-by-year accounting including an estimate the percentage of time to be devoted to each activity. This section is limited to 1 page.
Doctoral Dissertation and Other Research Experience (Item 9): The Fellowship Applicant should provide a summary of his/her research experience to date and discuss how the proposed research training plan will add to this experience. This section is limited to 2 pages.
Citizenship (Item 10): Applicants who have applied for and have not yet been granted admission as a permanent resident should check the Permanent Resident of U.S. Pending block. A notarized statement documenting legal admission for permanent residence must be submitted prior to the issuance of an award. Individuals admitted to the United States as Permanent Residents will be required to submit notarized evidence of legal admission prior to the award.
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Individual Fellowship Application Guide (See https://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations. An application that does not comply with the required page limitations may be delayed in the review process.
Other Project Information Component (Section 4.4 of SF424 (R&R) Individual Fellowship Application Guide) – Other Attachments (Item 12)
Important Note: The following attachments must be included for Fellowship applications. Submit each attachment separately using the Other Attachments section of the Other Project Information Component.
Sponsor and any Co-Sponsor(s) Information (Limited to 6 pages):
a) Research Support Available. The sponsor(s) who will directly supervise the applicant’s research must currently be funded to conduct independent research in the area of the proposed research training (e.g., Principal Investigator on an R01 or equivalent).
b) Sponsor’s/Co-Sponsor’s Previous Fellows/Trainees. The sponsor(s) must describe past experience in the guidance of other research trainees and fellows.
c) Training Plan, Environment, Research Facilities. The sponsor(s) must describe in detail his/her commitment to and proposed role in guiding the individual applicant during the research training experience. The sponsor(s) should describe the research training plan for the applicant (coordinated with the applicant’s own research training plan). The description should include items such as classes, seminars, and opportunities for interaction with other groups and scientists. Training in career skills, e.g. grant-writing and presentation skills are strongly encouraged. The description should also elaborate on the research environment and available research facilities and equipment, and discuss the relationship of the proposed research training to the applicant's career.
The application should describe the quality and appropriateness of the training environment for the applicant’s development including the strength of the institutional commitment to fostering the fellows’ training. Describe the quality and availability of facilities and resources (e.g. equipment, laboratory space, computer time, subject populations) for the proposed training. Additionally, the quality of the facilities and related resources (e.g., equipment, laboratory space, computer time, available research support, etc.) must be described.
d) Number of Fellows/Trainees to be Supervised During the Fellowship. The sponsor(s) should provide information on other trainees they will be supervising during the period of this fellowship award.
e) Applicant’s Qualifications and Potential for a Research Career. The sponsor(s) are also expected to provide an assessment of the applicant’s qualifications and potential for a research career. The application must include statements that address the planned value of the proposed fellowship experience and research training program, and how these relate to the applicant’s needs in preparation for an independent research career. Applicants should provide evidence of their potential for a productive and successful research career based upon the quality of their previous research training and academic record.
Letters of Reference (Section 5.4 of SF 424 (R&R) Individual Fellowship Application Guide)
Candidates must follow the Supplemental Instructions in the SF424 R&R Individual Fellowship Application Guide for Section 5.4 – Letters of Reference. 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 at https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new and do not use Grants.gov.
Letters of reference are an important component of the application for fellowship support. Applicants for this fellowship must arrange to have at least three (but no more than five) letters of reference submitted on their behalf to the eRA Commons Web site. The letters should be from well-established scientists (referees) addressing the qualities of the Fellowship Applicant as well as his/her potential to develop research skills needed in preparation for a productive research career as a physician-scientist or clinician-scientist in scientific areas related to the mission of one of the participating Institutes. These letters should be from individuals not directly involved in the application, but who are familiar with the candidate’s qualifications, training, and interests, including advisory committee members (if applicable). Resubmission applications will require new letters of reference.
Letters of reference may be submitted any time after the FOA opens and no later than 5 business days after the application due date. The Fellowship Reference Form can be submitted through eRA Commons at https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new prior to application submission through Grants.gov.
Applications that are missing the required letters of reference may be delayed in the review process or not accepted.
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications submitted for this funding opportunity will be assigned on the basis of established PHS referral guidelines for funding consideration.
Applications that are complete will be evaluated for scientific and technical merit by (an) appropriate scientific review group(s) in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.
As part of the scientific peer review, all applications will:
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
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.
Remember that the F programs are training awards and not research awards. Major considerations in the review are the candidate's potential for a productive career, the candidate's need for the proposed training, and the degree to which the research training proposal, the sponsor, and the environment will satisfy those needs.
Scored Review Criteria
Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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.
Sponsors, Collaborators, Consultants.
Research Training Plan.
Institutional Environment and Commitment to Training.
Additional Review Criteria
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, 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 Inclusion 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.
Resubmission. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewal. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.
Training in the Responsible Conduct of Research: Reviewers will evaluate plans for instruction in responsible conduct of research as well as the past record of instruction in responsible conduct of research, where applicable. Reviewers will specifically address the five Instructional Components (Format, Subject Matter, Faculty Participation, Duration of Instruction, and Frequency of Instruction) as detailed in NOT-OD-10-019. The review of this consideration will be guided by the principles set forth in NOT-OD-10-019. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE. Applications with unacceptable plans will not be funded until the applicant provides an acceptable, revised plan.
Applications from Foreign Organizations. Reviewers will assess whether the research training presents special opportunities and clearly described scientific advantages for the applicant, through the use of talent (e.g. mentor), resources, populations (if applicable), or training environment that are not readily available in the United States or augment existing U.S. talent and/or resources.
Select Agents 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 (Not applicable); 2) Sharing Model Organisms (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
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 training.
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. 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 NIH eRA Commons.
the application is under consideration for funding, NIH may request additional
information from the applicant. For details, applicants may refer to the NIH Grants Policy
Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.
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.
Activation: No funds may be
disbursed until the fellow has started training under the award, and an
Activation Notice (PHS 416-5) has been submitted
to the NIH. A fellow has up to six months from the issue date on the award
notice to activate the award. Under unusual circumstances, an NIH Institute may
grant an extension of the activation period upon receipt of a specific request
from the fellow, countersigned by the sponsor and an institutional official.
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.
Fellowships must be administered in accordance with the current NRSA section of the Grants Policy Statement (https://grants.nih.gov/grants/policy/policy.htm), and any terms and conditions specified on the Notice of Grant 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 60 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable training positions at the grantee institution have access to the same paid leave for this purpose and the use of parental leave is approved by the program director (see NOT-OD-08-064).
A period of terminal leave is not permitted, and payment may not be made from fellowship funds for leave not taken. Fellows requiring periods of time away from their research training experience longer than specified here must seek approval from the NIH awarding component for an unpaid leave of absence.
Part-Time Training: While Kirschstein-NRSA awardees are required to pursue research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies, under pressing personal circumstances, a fellow may submit a written request to the awarding component to permit less than full-time training. Such requests will be considered on a case-by-case basis. They must be approved by the awarding NIH Institute or Center in advance for each budget period. The nature of the circumstances requiring the part-time training might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission for part-time training will not be approved to accommodate other sources of funding, job opportunities, clinical practice, clinical training, or for other responsibilities associated with the fellow's position at the institution. In each case, the fellow must submit a written request countersigned by the sponsor and an appropriate institutional business official that includes documentation supporting the need for part-time training. The written request also must include an estimate of the expected duration of the period of part-time training, an assurance that the fellow intends to return to full-time training when that becomes possible, and an assurance that the trainee intends to complete the proposed research training program. In no case will it be permissible for the fellow to be engaged in Kirschstein-NRSA supported research training for less than 50 percent effort. Individuals who must reduce their commitment to less than 50 percent effort must take a leave-of-absence from Kirschstein-NRSA fellowship support. The fellowship notice of award will be reissued and the stipend will be pro-rated during the period of any approved part-time training.
Certification Requirements: Individuals admitted to the United States as Permanent Residents must submit notarized evidence of legal admission prior to the award.
Service Payback: A Payback Agreement Form (PHS 6031) must accompany the Activation Notice for any award that occurs during the individual's initial 12 months of Ruth L. Kirschstein-NRSA postdoctoral support. When support ends, the fellow must submit a Termination Notice (PHS 416-7) to the NIH. If the fellow has a payback obligation, he or she must notify the NIH of any change in address and submit Annual Payback Activities Certification Forms (PHS 6031-1) until the payback service obligation is satisfied. Forms may be found on the NIH Website at https://grants.nih.gov/grants/forms.htm.
Inventions: Fellowships made primarily for educational purposes are exempted from the PHS invention requirements. Fellowship awards will not contain any provision giving PHS rights to inventions made by the fellow.
Publication and Sharing of Research Results: NIH supports the practical application and sharing of outcomes of funded research. Therefore, fellows should make the results and accomplishments of their Kirschstein-NRSA fellowship activities available to the research community and to the public at large. The grantee organization should assist fellows in these activities, including the potential commercialization of inventions. 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.
Activation Notice: The fellowship award recipient has up to six months from the issue date on the Notice of Award to activate the award using the Ruth L. Kirschstein National Research Service Award Individual Fellowship Activation Notice (PHS 416-5). Under unusual circumstances, an NIH Institute may grant an extension of the activation period upon receipt of a specific request from the fellow. Such a request must be countersigned by the sponsor and an authorized institutional official.
Payback Agreement: A Payback Agreement Form (PHS 6031) must accompany the Activation Notice for any award that occurs during the individual’s initial 12 months of Kirschstein-NRSA postdoctoral support.
Application for Continued Support: When multiple years are involved, awardees will be required to submit the Ruth L. Kirschstein National Research Service Award Individual Fellowship Progress Report for Continuation Support (PHS 416-9) annually as required in the NIH Grants Policy Statement. The report is due two months before the beginning date of the next budget period and must include information describing the current year's progress as well as the research and training plans for the coming year. Note that the instructions request a listing of all courses and publications completed during the past year.
Termination Notice: When support ends, the fellow must submit a Termination Notice (PHS 416-7) to the NIH within 30 days following termination.
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.
We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research (program), peer review, and financial or grants management issues:
1. Scientific/Research Contact(s):
Amanda Taylor Boyce, Ph.D.
6701 Democracy Blvd.
One Democracy Plaza, Suite 800
Bethesda, MD 20892-4872
Telephone: (301) 594-5055
2. Peer Review Contact(s):
3. Financial/Grants Management Contact(s):
Grants Management Specialist
6701 Democracy Blvd.
One Democracy Plaza, Suite 800
Bethesda, MD 20892-4872
Telephone: (301) 594-3505
Required Federal Citations
Use of Animals
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (https://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (https://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.
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety
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, https://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (https://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.
Policy for Genome-Wide
Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see https://grants.nih.gov/grants/gwas/
Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see https://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.
Access to Research Data through the Freedom of
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 https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.
Inclusion of Women And Minorities in Clinical
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” (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical
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 (https://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject
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 https://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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.
NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.
Standards for Privacy of Individually Identifiable
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
The 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/.
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