Required Application Instructions

It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide or PHS 398 Application Guide, as appropriate) 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.

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

This funding opportunity announcement (FOA) is specifically and exclusively for use with the following three NINDS R25 Research Education Programs:

• NINDS Research Education Programs for Residents and Fellows in Neurology, Neurosurgery, Neuropathology, Neuroradiology and Emergency Medicine (R25) (PAR-13-384)
• NINDS Research Education Programs for Residents and Fellows in Neurology, Neurosurgery, Neuropathology and Neuroradiology (R25) (RFA-NS-10-002)
• NINDS Research Education Programs for Residents and Fellows in Neurology and Neurosurgery (R25) (RFA-NS-09-001)

The goal of the three NINDS R25 programs is to facilitate the ability of dedicated, outstanding physician scientists in the above named specialties to develop into independently funded researchers who will conduct highly impactful research within the NINDS mission. The purpose of administrative supplements to these R25 programs is to support additional residents and fellows in neurology, neurosurgery, neuroradiology, neuropathology and emergency medicine to develop a research project, and receive the education necessary for them to obtain individual mentored career development (K) awards. All research areas within the NINDS mission, including basic, clinical and translational approaches, are eligible for support. All research education plans, and associated research projects, including basic, clinical and translational, should adhere to best practices of experimental design and rigor (see also NOT-NS-11-023).

Supplemental support for R25 programs may be requested for either a resident or a fellow. In order for a fellow to be supported, however, he/she must have been funded by this R25 mechanism for a minimum of 6 months during residency. Supplemental support occurs in increments. Each increment (or period) of funding occurs between July 1 and June 30, in order to coincide with clinical schedules. The first increment of funding, which must occur during residency, may be for 6 to 12 months in duration. A second increment of funding may be requested for support during a second residency year or during a fellowship year. The duration of the second period of support, combined with the duration of the first period of support, must total a minimum of 18 months. For participants whose second period of support occurs during a fellowship year, a third and final increment of support may be requested for a second fellowship year. Thus, up to 24 months support may be obtained during fellowship years. However, to obtain more than 24 months of total support by this R25 program, participants must submit a competitive, individual mentored K award application within the first 24 months of total R25 support. A typical, but not required, support path, might be 6 months during residency, then 12 months during a first fellowship year and 12 months during a second fellowship year. However, the last 6 months of support during this example 30 month path would be contingent on submission of a high quality, individual mentored K award application during the first 18 months of post-residency R25 support.

A one to two year gap in time between the support during residency and support during fellowship is acceptable if the gap is required to obtain clinical fellowship training. Research activity between a second and third period of support must be continuous. Funds may not be used for those in faculty positions.

Participants must devote 80% effort (4 full days during the Monday-Friday workweek) to the research education program during each period of support. (Neurosurgeons must also devote 80% effort during the first 12 month period of support. Consistent with the NINDS policy for mentored K awards, neurosurgeons may devote a minimum of 50% effort during subsequent periods of support).

In addition to the on-site research education participants will receive, they are expected to attend national and/or international meetings to present their work and network with other researchers in their fields. In addition, participants are expected to attend a special NINDS workshop designed for this program once for each period of funding that they receive.

Each R25 program may obtain support for multiple residents and fellows. However, a separate supplement application is necessary for each participant for whom support is requested.

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.

All organizations administering an eligible parent award may apply for a supplement under this announcement.

The only eligible institutions are those that were funded under the following three specific R25 FOAs:

• NINDS Research Education Programs for Residents and Fellows in Neurology, Neurosurgery, Neuropathology, Neuroradiology and Emergency Medicine (R25) (PAR-13-384)
• NINDS Research Education Programs for Residents and Fellows in Neurology, Neurosurgery, Neuropathology and Neuroradiology (R25) (RFA-NS-10-002)
• NINDS Research Education Programs for Residents and Fellows in Neurology and Neurosurgery (R25) (RFA-NS-09-001)

This announcement is for supplements to existing projects. To be eligible, the parent award must be active and the research proposed in the supplement must be accomplished within the competitive segment. The proposed supplement must be to provide for an increase in costs due to unforeseen circumstances. All additional costs must be within the scope of the peer reviewed and approved project.

IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Individual(s) must hold an active grant, and the activities proposed in the supplement must be accomplished within the competitive segment of the active award. Individuals are encouraged to work with their organizations to develop applications for support.

For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award. Do not use this administrative supplement application to add, delete, or change the PDs/PIs listed on the parent award. Visit the Multiple Program Director/Principal Investigator Policy in the SF424 (R&R) Application Guide for more information.

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

Applicant organizations may submit more than one application, provided that each is sufficiently distinct from any other administrative supplement currently under consideration by the awarding NIH Institute or Center.

A separate administrative supplement application must be submitted for each participant for whom support is requested (i.e. each administrative supplement application may request a single participant). Each R25 program, however, may submit multiple supplement requests, either for residents or continuation fellows.

Applicants must prepare applications using current forms in accordance with the Application Guide.

For electronic submissions, applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this announcement, or use the eRA Commons streamlined submission process.

All forms must be completed for the supplemental activities only and must not reflect funding or activities for the previously awarded parent award.

It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide or PHS 398 Application Guide, as appropriate) including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

All page limitations described in the Application Guide and the Table of Page Limits must be followed. Although the allowable page limit is 25 pages, it is not expected that the full 25 pages will be necessary.

Electronic submission of request for administrative supplements is only available for single-project activity codes for which competing applications are submitted electronically. Visit the list of single-project Activity Codes Processed Electronically by eRA to determine if the single-project activity code of the parent award has transitioned to electronic submission.

Applicants may either (A) submit using the SF424 (R&R) Application Forms and Grants.gov/Apply, or (B) submit using the streamlined submission process of eRA Commons. Applicants are strongly encouraged to use option B, submission using the streamlined submission process of eRA Commons, if possible.

Instructions for Submissions using Grants.gov/Apply for electronic-based submissions

For single project grants with activity codes that have transitioned to electronic submission using the SF424 (R&R) application forms, administrative supplement requests may be submitted electronically as a Revision application type on the R&R Cover Form. Prepare applications using the SF424 (R&R) application forms associated with this announcement. Please note that some forms marked optional in the application package are required for submission of applications for this announcement. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate required and optional forms.

Special Instructions for Streamlined Submissions using the eRA Commons for electronic-based submissions

NIH now offers a streamlined system through the eRA Commons for submitting administrative supplements. Login to the eRA Commons, identify the parent award, and prepare an administrative supplement request. A User s Guide for submitting through this system is available.

Include the Research Strategy and any other required documentation (described below) as a PDF file using the Add Other Attachments function. Budget information should be entered for the grantee institution in the fields provided.

PHS 398 Research Plan

Research Strategy: The Research Strategy section must include a summary or abstract of the funded parent award or project. In addition, the following information should be provided for the proposed participant.

• A 3 page (maximum) description of the research education and research plan (this should be written by the proposed participant and signed by both the proposed participant and the proposed mentor). This description should make clear the career goals of the participant and how the proposed plan is expected to lead to a future NIH K award or equivalent (i.e. a connection should be made between the proposed research and research education plan and a projected K award project).
• A brief description of the qualifications of the proposed mentor(s), with reference to their experience related to the research education plan and track record in mentoring clinician and non-clinician scientists.
• A statement, written by the proposed mentor, which describes his/her qualifications to mentor the applicant in the proposed research education plan, the applicant's suitability for the research education plan and the mentoring and overall research education plan for this participant. The mentor should discuss a plan by which the participant will become ready to submit an application for an NIH Career Development (K) award or equivalent, and the expected timeline for this to occur. An important component of this plan is how the proposed research is expected to lead to a larger project suitable for a K award. In addition, the mentor should describe how the participant's specific research project, whether basic, clinical or translational, will adhere to the best principles of experimental design and rigor.
• If the request is to continue support during a fellowship (or second residency) period for a participant who was previously supported, a brief description of progress made during the previous period(s) of support must be included (3 page maximum, written by the participant). Depending on when the participant started in residency and when the continuation request is made, there may have been little or no progress made at the time of supplement request submission. If this is the case, this should be stated along the dates during which the participant was supported during residency.
• If the request is to continue support for a participant previously supported by this R25 program, the PD/PI should confirm that the proposed participant was supported for at least 6 months during residency by this research education program. If applicable, the PD/PI should also state how long during a fellowship period this participant was supported, and for all periods of support, that the resident devoted a minimum of 80% effort to research education program while supported.

All instructions in the Application Guide must be followed, with the following additional instructions:

• Include the primary site where the proposed supplement activities will be performed.
• If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.

All instructions in the Application Guide must be followed, with the following additional instructions:

• List the PD/PI as the first person (regardless of their role on the supplement activities).
• List the participant for whom additional funds are being requested and the participant's mentor(s). Include a biographical sketch for the participant and all mentors.

All budgets should be submitted using the R&R Detailed Budget form, regardless of the form used for the parent award, and should only include funds requested for the additional supplement activities.

Allowable costs include: 80% PGY salary for one participant for the duration of support between July 1 and June 30 of the fiscal year in which support is requested, up to $2,000 for travel to meetings, workshops and other educational activities for the supported participant and up to $1,000 for attendance at the NINDS R25 workshop for the supported participant.

The budget request should reflect the program requirements that the participant must devote 80% effort (4 full days during the Monday through Friday work week) during the period of support. Residents must be supported for a minimum duration of 6 months (at 80% effort). The budget requested for fellows must meet the requirement that the combined support during residency and first fellowship year of support equal a minimum of 18 months duration. The timeline of previous and requested support for the participant should be described in the budget justification.

All instructions in the Application Guide must be followed, with the following additional instructions:

Other Attachments:

IACUC Documentation and IRB Documentation: If applicable, include documentation that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects involvement is planned for the supplement component.

It would be best to provide this information with the supplement application. However, this information will be required before an award can be made.

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

Not Applicable

Not Applicable

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications as described above. 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 before the due date in the eRA Commons to ensure accurate and successful submission.

For electronic application submission, information on the submission process and a definition of on-time submission are provided in the SF424(R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted using the instructions specified above.

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:
For applications submitted electronically on the SF424 (R&R) Application forms, all PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form 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 (SAM). Additional information may be found in the Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and/or responsiveness by the awarding Institute or Center. Applications that are incomplete and/or nonresponsive will not be reviewed.

Not Applicable

Administrative Supplements do not receive peer review. Instead, the administrative criteria described below will be considered in the administrative evaluation process.

The staff of the NIH awarding component will evaluate requests for a supplement to determine its overall merit. The following general criteria will be used:

Budget and Period of Support

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

Overall Impact

NIH staff will consider the ability of the proposed supplement activities to increase or preserve the parent award’s overall impact within the original scope of award, and consider the following, in addition to programmatic needs:

• Will the administrative supplement increase or preserve the likelihood for the program to exert a sustained, powerful influence on the research field(s) involved?
• Is the participant for whom support is requested highly qualified to engage in the proposed research and research education plan?
• Is the participant's research and research education plan well thought-out, well-presented, feasible and suitable for a K award application on the intended timeline? Is there a plan in place to ensure that the research will adhere to the best practices of experimental design and rigor?
• Is the mentor highly qualified for the candidate's research education plan and does the mentor provide a thorough description of his/her role envisioned to help prepare the participant to obtain a future K award?
• Is the mentor well-funded, recently productive and experienced in fostering transition of clinician-scientists to mentored K awards? If the primary mentor is not a clinician, is there an individual included in the research education plan with the appropriate experience to provide career guidance in line with the participant's goal of succeeding in a dual clinical and research career?
• Is the proposed research education plan consonant with the candidate's career goals?
• Is the environment well suited for the proposed research education plan?

In addition, each of the following criteria will be evaluated as applicable for the proposed supplement.

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, NIH staff 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, NIH staff 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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

NIH staff 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

NIH staff 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.

Administrative supplement requests will undergo an administrative evaluation by NIH staff, but not a full peer review. Applications submitted for this funding opportunity will be assigned to the awarding component for the parent award and will be administratively evaluated using the criteria shown above.

Not Applicable

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. This may be as an NoA for the supplemental activities only; alternatively, it may be as either a revision to the current year NoA or included as part of a future year NoA. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s 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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website. When calculating the award for additional funds, NIH will 1) prorate funding if the requested budget period is adjusted at the time of award, and 2) use the institution’s current F&A rate; i.e., the rate in effect when the new funding is provided.

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.

Cooperative Agreement Terms and Conditions of Award

Any supplements to Cooperative Agreements will be subject to the same Cooperative Agreement terms and conditions as the parent award.

Reporting requirements will be specified in the terms and conditions of award as applicable to the supplemental activities. In most non-competing continuation applications, the progress report and budget for the supplement must be included with, but clearly delineated from, the progress report and budget for the parent award. The progress report must include information about the activities supported by the supplement even if support for future years is not requested. Continuation of support for the supplement activities in the remaining years of the competitive segment of the grant will depend upon satisfactory review by the NIH awarding component of progress for both the parent award and the supplement project, the research proposed for the next budget period, and the appropriateness of the proposed budget for the proposed effort. This information is submitted with the Non-Competing Grant Progress Report, PHS 2590 or RPPR, and financial statements as required in the NIH Grants Policy Statement.

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.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

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

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

Stephen Korn, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-4188
Email: korns@ninds.nih.gov

Not Applicable

Tijuanna DeCoster, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: decostert@ninds.nih.gov

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.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.