It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide, eRA Commons Administrative Supplement User 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 NINDS R25 Research Education Program:

NINDS Research Education Programs for Residents and Fellows in Neurology, Neurosurgery, Neuropathology, Neuroradiology and Emergency Medicine (R25) (PAR-NS-13-984 and subsequent reissuances).

The goal of this NINDS R25 program is to facilitate the ability of dedicated, outstanding physician scientists in the named specialties to develop into independently funded researchers who will conduct highly impactful research within the NINDS mission. The purpose of administrative supplements to this R25 program 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-OD-15-103).

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. Whereas the R25 is intended to support fellows and not faculty, funds may be used for those in faculty positions when the faculty position immediately follows an R25 fellowship year. However, even if in a faculty position, the R25 will provide a PGY 7 level of salary support (the 80% effort requirement [see below] will remain and any salary differential between the PGY 7 salary and the faculty level salary will be expected to be made up by the institution.)

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.

Supplements may be used to support clinicians who enroll in a PHD program during fellowship.

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.

See Section VIII. Other Information for award authorities and regulations.

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 specific R25 FOA(s) associated with the NINDS Research Education Programs for Residents and Fellows in Neurology, Neurosurgery, Neuropathology, Neuroradiology and Emergency Medicine (PAR-13-384 and its reissuance)

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. Since administrative supplements are made against active grants and cooperative agreements, many of these registrations may already be in place. 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. Grants.gov registration is only required if you plan to submit using the 'Electronic Application Submission through Grants.gov' option.

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 or cooperative agreement, and the research 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.

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

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 for their submission option (SF424 (R&R) Application Guide, eRA Commons Administrative Supplement User 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 documented requirements 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 applicable to the parent award as described in the Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements. Although the allowable page limit is 25 pages, it is not expected that the full 25 pages will be necessary.

Administrative supplement requests for most single-project activity codes can be submitted using either paper or electronic submission processes. See Activity Code section in Part 1 to determine if electronic submission is an option for your activity code.

Instructions for Electronic Application Submission through Grants.gov

Use the Apply button(s) in Part I of this announcement to access the application forms package posted at Grants.gov. If presented with more than one form package, use the Competition ID and Competition Titles provided to determine the most appropriate application forms package for your situation.

Prepare applications using the SF424 (R&R) forms associated with the chosen package. 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, with the following additional guidance:

• R&R Cover form: Select Revision in the Type of Application field.
• Research Plan form: At a minimum, the Research Strategy section should be completed and must include a summary or abstract of the funded parent award or project. Other sections should also be included if they are being changed by the proposed supplement activities.
• Project/Performance Site Location form: 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.
• Sr/Key Personnel form: List the PD/PI as the first person (regardless of their role on the supplement activities). List any other Senior/Key Personnel who are being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each.
• Budget forms (e.g., R&R Budget, PHS 398 Training Budget): Only include funds requested for the additional supplement activities.
• R&R Other Project Information form: If applicable, attach PDF documents in the Other Attachments field indicating 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. Name the documents IACUC Documentation.pdf and/or IRB Documentation.pdf . 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.

PHS 398 Research Plans

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 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).

It is critical that the participant's work can be identified and clearly differentiated from, the work done by others in the laboratory or research environment. Participants are strongly encouraged to write in the first person singular narrative when discussing their ideas, their hypotheses and the research they will do and in the first person plural narrative only when discussing collaborative work between the participant and others. In addition, the work and ideas of others should be appropriately attributed.

The application should include 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 he/she will ensure that 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 (approximately 3 pages, written by the participant) in addition to the 3 page description of research/education plan. 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.

If the participant is enrolled in a PHD program, and is requesting support for costs associated with tuition payments, a comprehensive description of the program specific to the participant should be provided. This should include a detailed description of the formal education to be obtained in experimental design and statistics, as well as other didactic and programmatic content.

Project/Performance Site Locations

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.

Senior/Key Personnel Form

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.

R&R Budget Form

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 up to $1,000 for attendance at the NINDS R25 workshop for the supported participant. If the participant is simultaneously enrolled in a PHD-granting program, up to $12,800 may also be requested for costs associated with research activities associated with both R25 participation and the degree-granting program.

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.

Other Project Information

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.

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

NIH 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, with the following additional guidance:

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 Plans

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 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).

It is critical that the participant's work can be identified and clearly differentiated from, the work done by others in the laboratory or research environment. Participants are strongly encouraged to write in the first person singular narrative when discussing their ideas, their hypotheses and the research they will do and in the first person plural narrative only when discussing collaborative work between the participant and others. In addition, the work and ideas of others should be appropriately attributed.

The application should include 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 he/she will ensure that 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 (approximately 3 pages, written by the participant) in addition to the 3 page description of research/education plan. 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.

If the participant is enrolled in a PHD program, and is requesting support for costs associated with tuition payments, a comprehensive description of the program specific to the participant should be provided. This should include a detailed description of the formal education to be obtained in experimental design and statistics, as well as other didactic and programmatic content.

Project/Performance Site Locations

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.

Senior/Key Personnel Form

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.

R&R Budget Form

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 up to $1,000 for attendance at the NINDS R25 workshop for the supported participant. If the participant is simultaneously enrolled in a PHD-granting program, up to $12,800 may also be requested for costs associated with research activities associated with both R25 participation and the degree-granting program.

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.

Other Project Information

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.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

Part I. Overview Information contains information about Key Dates and Times. Applicants are encouraged to submit electronic applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Applicants are responsible for viewing their electronic 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.

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS 398 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 prior to submission. 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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission contact the Application Submission Contacts in Section VII.

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.

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 the 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 specific role of the participant in the proposed research plan clear?
• Is the anticipated path, including the planned research project, from the proposed research education plan to an individual mentored K award for the participant clear?
• 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.

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.

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.

NIH staff will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 Research Performance Progress Report (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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

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

Not Applicable

Tijuanna DeCoster, Ph.D
National Institute of Neurological Disease 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 Part 75.