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

The Office of Research on Women's Health (ORWH) and participating Institutes and Centers (ICs) of the National Institutes of Health (NIH) announce the continuation of the program for administrative supplements to research grants to support individuals with high potential to re-enter an active research career after taking time off for family responsibilities or other qualifying circumstances. The aim of these supplements is to encourage such individuals to re-enter research careers within the missions of all the program areas of NIH. This program will provide administrative supplements to existing NIH research grants for the purpose of supporting full-time or part-time research by these individuals to update their existing research skills and knowledge, while contributing to the scope of the original project. It is anticipated that at the completion of the supplement, the re-entry scientist will be in a position to apply for a career development (K) award, a research award (R), or some other form of research support.

This program is designed to offer opportunities to women and men who have interrupted their research careers as described in Section III, "Eligible Candidates for the Supplement Program." The supplement aims to provide an opportunity for these individuals in reestablishing their careers in biomedical, behavioral, clinical or social science research.

In all cases, the proposed research experience must be an integral part of the approved, ongoing research of the parent award, and it must have the potential to contribute significantly to the research career development of the candidate. The individual supported under this supplemental award must be afforded the opportunity to act as a full participant in the research project and must be given an opportunity to update and enhance her or his research capabilities. This will allow the candidate to begin the process of establishing or re-establishing a career as a productive, competitive research investigator. Supplemental awards are expected to strengthen the existing research program and reflect the overall programmatic balance and priorities of the funding program of the NIH.

Note: This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary study to a clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.

Special Note: Because NIH ICs may have varying degrees of flexibility in interpreting and implementing the Re-entry program, potential applicants should consult with the contact at the NIH awarding component at the earliest possible stage to discuss his or her unique situation (see Table of IC-Specific Information, Requirements and Staff Contacts).

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 from this FOA.

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.. 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 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. 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.

In addition, subproject directors on multi-component research grants (e.g., P01, P50, U54) may request supplements to their project through the overall PD/PI of the grant.

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

A parent grant may support only one individual on a supplement. Candidates may receive support from only one supplement program at a time, but may be supported by more than one supplement during the development of their research careers.

Eligible Candidates for the Supplement Program

Candidates must have a doctoral degree, such as M.D., D.D.S., Ph.D., O.D., D.V.M., or equivalent; and must have been accepted in a postdoctoral or faculty position at the time they left active research. All candidates must be planning a career in biomedical, behavioral, clinical, or social science research. Candidates who have begun the re-entry process through a fellowship, traineeship, or similar mechanism are not eligible for this program. Awards will be limited to citizens or non-citizen nationals of the United States or to individuals who have been lawfully admitted for permanent residence (i.e., in possession of a Permanent Resident Card, Form I-551) at the time of award.

Eligibility Circumstances: In general, the duration of the career interruption should be at least one year and no more than eight years. Examples of qualifying interruptions would include a complete or partial hiatus from research activities for child rearing; an incapacitating illness or injury of the candidate, spouse, partner, or a member of the immediate family; relocation to accommodate a spouse, partner, or other close family member; pursuit of non-research endeavors that would permit earlier retirement of debt incurred in obtaining a doctoral degree; and military service. The program is not intended to support additional graduate training and is not intended to support career changes from non-research to research careers for individuals without prior research training. Generally, the candidate should be in complete or partial hiatus from research activities at the time of application, and should not be engaged in full-time paid research activities. Preference will be given to candidates with a complete hiatus from research activities.

Because NIH ICs may have varying degrees of flexibility in interpreting and implementing the Re-entry program, potential applicants should consult with the contact at the NIH awarding component at the earliest possible stage to discuss his or her unique situation (see Table of IC-Specific Information, Requirements and Staff Contacts).

Eligible Awards

For eligible awards, see the listing of Activity Codes under "Part 1. Overview Information." PD(s)/PI(s) at domestic institutions who hold an active grant or cooperative agreement may be eligible to submit a request for an administrative supplement to the awarding component of the parent grant. The P20, P30, and P60 award mechanisms are eligible for supplements only if they contain research components. In all cases, the mechanism of support under this program is the supplemental award.

Expected Time Commitment

Administrative supplements provided under this program may be for either part-time or full-time (equivalent to 12 person-months) support for the candidate, and all supported time is to be spent updating and enhancing research skills. Proposed part-time appointments may not be less than 50% effort (equivalent to 6 person-months).

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

You must access, prepare, and submit a full set of forms using one of the submission options listed above in the Table of Contents Part 1 of this FOA or take advantage of the eRA Commons streamlined submission method described below. Since your institution may have a preferred submission method (i.e., system to system), please consult with your administrative office for instructions before initiating an application.

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). 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.

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

Applicants submitting paper applications must use the PHS 398 Application Forms and the PHS 398 Application Guide.

Instructions for Electronic Application Submission through the NIH ASSIST system, an institutional system-to-system (S2S) solution, or Grants.gov Workspace

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. Applications for supplements must include a plan for the candidate to interact with other individuals on the parent grant, to contribute intellectually to the research, and to enhance her/his research skills and knowledge regarding the selected area of biomedical, behavioral, clinical or social sciences science. The application must also provide evidence that the re-entry research experience is intended to provide opportunities for the candidate's development as a productive researcher, and that the PD(s)/PI(s) is willing to provide appropriate mentorship to facilitate the research and career development of the candidate.
• Project/Performance Site Locations 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.
• Senior/Key Personnel Profile (Expanded) form: List the PD/PI as the first person (regardless of their role on the supplement activities). List the candidate proposed to be added through this supplement.
• Note: Candidates for re-entry supplement support must have an eRA Commons account and the candidate's Commons Username must be entered in the Credential field. Do not list any other senior/key personnel on this form.
• Biographical Sketch: Include a biographical sketch. The personal statement of the candidate's biographical sketch should address:

o Research objectives and career goals

o Research experience prior to onset of hiatus

o Length of and reason for career hiatus

o A description of how the candidate has kept current or attempted to keep current in her/his field

o Identification of any steps already taken toward re-entry (if any, such as attending scientific meetings)

• Budget forms (e.g., R&R Budget, PHS 398 Training Budget): Only include funds requested for the additional supplement activities. Additional funds up to $10,000 may be requested for the total materials and supplies, domestic travel, and publication costs relevant to the proposed research.
• 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.
• Candidate Eligibility Statement: A signed statement from the PD(s)/PI(s) and an institutional official establishing the eligibility of the candidate for support under this program that must include clearly presented information on citizenship. The strength of this statement will be considered by the NIH administrative review committee along with all other material provided.
• Home Institution Approval: Under unusual circumstances where the applicant and mentor would be at a site other than the grantee institution, an appropriately signed letter from the institution where the research is to be conducted must also be submitted. The request must be signed by the PD/PI, the re-entry candidate, and the appropriate institutional business official.
• PHS Human Subjects and Clinical Trials Information form: Only include a new or revised human subjects study record if these items do not change the scope of the approved project (e.g., new clinical trials cannot be added through an administrative supplement). If new recruitment or use of an additional existing dataset or resource is proposed in the supplement application, Section 2.4 should be revised and new Inclusion Enrollment Reports created, as appropriate.

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:

• After initiating the administrative supplement request form, answer "Yes" to the question, "Is this request for a diversity or re-entry supplement?"
• Provide the candidate's eRA Commons ID
• Attach a PDF of the candidate's biosketch, eligibility statement, and the research strategy in the locations indicated. Follow the guidance below in developing these attachments:
• Budget information should be entered for the grantee institution in the tabs provided for each selected budget period. Additional funds up to $10,000 may be requested for the total materials and supplies, domestic travel, and publication costs relevant to the proposed research.
• Since there is no template or form available for subaward budget information, all subaward information must be included as a PDF attachment in the Subrecipient Budgets section showing the funds requested (by budget period) and using the same categories provided for the grantee institution. The attachment must also include any related budget justification information.
• Use the "Add Other Attachments" function to include the following PDF documents:
• Research Experience Plan: Include a summary or abstract of the funded parent award or project. Applications for supplements must also include a plan for the candidate to interact with other individuals on the parent grant, to contribute intellectually to the research, and to enhance her/his research skills and knowledge. The application must also provide evidence that the re-entry research experience is intended to provide opportunities for the candidate's development as a productive researcher, and that the PD(s)/PI(s) is willing to provide appropriate mentorship.
• Biographical Sketch: Provide a biographical sketch for the candidate proposed to be added through this supplement, or for whom additional funds are being requested through this supplement. The personal statement of the candidate's biographical sketch should address:

o Research objectives and career goals

o Research experience prior to onset of hiatus

o Length of and reason for career hiatus

o A description of how the candidate has kept current or attempted to keep current in her/his field

o Identification of any steps already taken toward re-entry (if any, such as attending scientific meetings)

• If applicable, attach documents 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. 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.
• Candidate Eligibility Statement: A signed statement from the PD(s)/PI(s) and an institutional official establishing the eligibility of the candidate for support under this program that must include clearly presented information on citizenship. The strength of this statement will be considered by the NIH administrative review committee along with all other material provided.
• Provide documentation of Home Institution Approval: Under unusual circumstances where the applicant and mentor would be at a site other than the grantee institution, an appropriately signed letter from the institution where the research is to be conducted must also be submitted. The request must be signed by the PD/PI, the re-entry candidate, and the appropriate institutional business official.
• Provide documentation of Sub-recipient Approval: If any of the research is to be conducted at an organization other than the grantee institution, an appropriately signed letter from the institution where the research is to be conducted must be submitted. The request must be signed by the re-entry candidate, the PD/PI, and the appropriate institutional business official.
• PHS Human Subjects and Clinical Trials Information form: Only include a new or revised human subjects study record if these items do not change the scope of the approved project (e.g., new clinical trials cannot be added through an administrative supplement). If new recruitment or use of an additional existing dataset or resource is proposed in the supplement application, Section 2.4 should be revised and new Inclusion Enrollment Reports created, as appropriate.

Instructions for Paper-based Submissions using the PHS 398 Application Forms

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application, with the following additional guidance:

• Checklist: Select "Revision" in the "Type of Application" field.
• Face Page (Form Page 1): On the face page of the application form, note that your application is in response to a specific program announcement, and enter the title and number of this announcement.
• Research Plan: 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. Applications for supplements must include a plan for the candidate to interact with other individuals on the parent grant, to contribute intellectually to the research, and to enhance her/his research skills and knowledge. The application must also provide evidence that the re-entry research experience is intended to provide opportunities for the candidate's development as a productive researcher, and that the PD(s)/PI(s) is willing to provide appropriate mentorship.
• Project/Performance Sites section (Form Page 2): 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 section (Form Page 2): List the PD/PI as the first person (regardless of their role on the supplement activities). List the candidate proposed to be added through this supplement.
• Note: Candidates for re-entry supplement support must have an eRA Commons account and the candidate's Commons Username must be entered in the Credential field. Do not list any other senior/key personnel on this form.
• Biographical Sketch: Provide a biographical sketch for each the candidate proposed to be added through this supplement, or for whom additional funds are being requested through this supplement. The personal statement of the candidate's biographical sketch should address:

o Research objectives and career goals

o Research experience prior to onset of hiatus

o Length of and reason for career hiatus

o A description of how the candidate has kept current or attempted to keep current in her/his field

o Identification of any steps already taken toward re-entry (if any, such as attending scientific meetings)

• Budget for Entire Proposed Project Period (Form Page 5): A proposed budget should be submitted using the PHS 398 budget forms and should only include funds requested for the additional supplement activities. Additional funds up to $10,000 may be requested for the total materials and supplies, domestic travel, and publication costs relevant to the proposed research.
• PHS Human Subjects and Clinical Trials Information form: Only include a new or revised human subjects study record if these items do not change the scope of the approved project (e.g., new clinical trials cannot be added through an administrative supplement). If new recruitment or use of an additional existing dataset or resource is proposed in the supplement application, Section 2.4 should be revised and new Inclusion Enrollment Reports created, as appropriate.
• Appendix: Include the following:
• If applicable, attach documentation in the Appendix section 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. 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.
• Candidate Eligibility Statement: A signed statement from the PD(s)/PI(s) and an institutional official establishing the eligibility of the candidate for support under this program that must include clearly presented information on citizenship. The strength of this statement will be considered by the NIH administrative review committee along with all other material provided.
• Home Institution Approval: Under unusual circumstances where the applicant and mentor would be at a site other than the grantee institution, an appropriately signed letter from the institution where the research is to be conducted must also be submitted. The request must be signed by the PD/PI, the re-entry candidate, and the appropriate institutional business official.
• Sub-recipient Approval: If any of the research is to be conducted at an organization other than the grantee institution, an appropriately signed letter from the institution where the research is to be conducted must be submitted. The request must be signed by the re-entry candidate, the PD/PI, and the appropriate institutional business official.

The grantee institution, on behalf of the PD/PI of the parent award, must submit the request for supplemental funds directly to the awarding component that supports the parent award. Contact the appropriate Scientific/Research Contact in Table of IC-Specific Information, Requirements and Staff Contacts for contact information for NIH staff to whom a signed, typewritten original of the application, including the checklist, should be submitted.

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.

For paper-based application submission, 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.

Awards are based on the current programmatic needs of the NIH awarding component, therefore investigators must contact their program officials at the NIH before applying (see Table of IC-Specific Information, Requirements and Staff Contacts). The decision to fund a supplement will take approximately ten weeks from receipt of a complete application.

In all cases, the proposed research must be directly related to the funded approved ongoing research of the parent grant or cooperative agreement. The re-entry candidate supported under this supplemental award must be afforded the opportunity to act as a full participant in the research project and must be given an opportunity to update and enhance her or his research capabilities. This will allow the candidate to begin the process of establishing or reestablishing a career as a productive, competitive research investigator. Supplemental awards will be consistent with the goals of strengthening the existing research program and with the overall programmatic balance and priorities of the funding program of the NIH. Administrative supplements provided under this program may be for either part-time or full-time support for the candidate, and all supported time is to be spent updating and enhancing research skills. Proposed part-time appointments may not be less than 50% effort.

A minimum of one year and a maximum of three years of supplemental support can be awarded under this program. In most cases, funds will be provided as an administrative supplement to the parent grant. In subsequent years, continued funding for the supplement is contingent on continued funding of the parent grant and cannot extend beyond the current competitive segment of the parent grant and the availability of funds. See Section VI.3. Reporting for more information.

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

The Program staff of the NIH awarding component will review requests for a supplement to determine their overall merit. Only the administrative review criteria described below will be considered in the review process:

• The qualifications of the re-entry candidate, including career goals, prior research training, research potential, relevant research experience prior to the onset of hiatus, and length and reason for career hiatus.
• The plan for the proposed research experience in the supplemental request and its relationship to the parent grant.
• Evidence from the PD(s)/PI(s) that the experience will enhance the research
• Potential, knowledge, and/or skills of the re-entry candidate.
• Evidence from the PD(s)/PI(s) that the activities of the re-entry candidate are an integral part of the project.
• Evidence of effort by the re-entry candidate to initiate the re-entry process, such as attending scientific meetings, or keeping current with journals.
• Evidence that proposed research will achieve the stated objectives of the re-entry supplements.
• Quality and appropriateness of the mentoring and career development plans, including consistency of the plan with the candidate's prior research experience and current and future research career goals.
• Appropriateness of the mentor's experience and mentoring track record for the applicant's career development needs, and the commitment of the mentor to the applicant's continued career development and independence.

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.

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

Within ten years of making awards under this program, NIH will assess the program's overall outcomes, gauge its effectiveness in enhancing re-entry, and consider whether there is a continuing need for the program. Upon the completion of this evaluation, NIH will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program.

In evaluating this program, NIH expects to use the following evaluation measures:

• Aggregate number and demographic characteristics of participants
• Subsequent educational/career progress of participants, including:
• Subsequent participation in research
• Subsequent employment in a research or research-related field
• Subsequent authorship of scientific publications in a STEM field
• Subsequent independent research grant support from NIH or another source

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: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Before submitting an application for a research supplement, applicants are strongly encouraged to contact their program official to discuss the program (see Table of IC-Specific Information, Requirements and Staff Contacts).

Not Applicable

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

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.