Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

NATIONAL INSTITUTES OF HEALTH (NIH)

National Eye Institute (NEI)

National Heart, Lung, and Blood Institute (NHLBI)

National Human Genome Research Institute (NHGRI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Institute on Drug Abuse (NIDA)

National Institute of Environmental Health Sciences (NIEHS)

National Institute of General Medical Sciences (NIGMS)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

National Institute of Nursing Research (NINR)

National Institute on Minority Health and Health Disparities (NIMHD)

National Library of Medicine (NLM)

National Center for Complementary and Integrative Health (NCCIH)

National Center for Advancing Translational Sciences (NCATS)

Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)

Office of Strategic Coordination (Common Fund)

National Cancer Institute (NCI)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Data Science Strategy (ODSS)

Funding Opportunity Title
Change of Recipient Organization (Type 7 Parent Clinical Trial Optional)
Activity Code

Change of Recipient Organization

Change of Recipient Organization applications must be submitted on paper for multi-project and complex activity codes, including but not limited to the following activity codes:

G12 Research Centers in Minority Institutions Award
P01 Research Program Projects
P20 Exploratory Grants
P30 Center Core Grants
P40 Animal (Mammalian and Nonmammalian) Model, and Animal and Biological Material Resource Grants
P41 Biotechnology Resource Grants

P42 Hazardous Substances Basic Research Grants Program
P50 Specialized Center
P51 Primate Research Center Grants
P60 Comprehensive Center
P2C Resource-Related Research Multi-Component Projects and Centers

PM1 Program Project or Center with Complex Structure

PN2 Research Development Center
S06 Research-Related Programs
U10 Cooperative Clinical Research Cooperative Agreements
U19 Research Program Cooperative Agreements
U2C Resource-Related Research Multi-Component Projects & Centers

Cooperative Agreements

U41 Biotechnology Resource Cooperative Agreements
U42 Animal (Mammalian and Nonmammalian) Model, and Animal and Biological Materials Resource Cooperative Agreements
U45 Hazardous Waste Worker Health and Safety Training Cooperative Agreements
U54 Specialized Center- Cooperative Agreements
U56 Exploratory Grants Cooperative Agreements
UC2 High Impact Research and Research Infrastructure Cooperative Agreement Programs
UC3 Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN) Cooperative Agreement Program
UC7 National Biocontainment Laboratory Operation Cooperative Agreement
UG4 National Network of Libraries of Medicine

UH4 Hazmat Training at DOE Nuclear Weapons Complex

UL1 Linked Specialized Center Cooperative Agreement

UM2 Program Project or Center with Complex Structure Cooperative Agreement

Change of Recipient Organization applications may be submitted electronically for single project activity codes, including but not limited to the following activity codes:

C06 Research Facilities Construction Grant
D43 International Training Grants in Epidemiology
D71 International Training Program Planning Grant
DP1 NIH Director’s Pioneer Award (NDPA)
DP2 NIH Director’s New Innovator Awards
DP3 Type 1 Diabetes Targeted Research Award
DP4 NIH Director’s Pathfinder Award- Multi-Yr Funding
DP5 Early Independence Award

DP7 NIH Director’s Workforce Innovation Award
F05 International Research Fellowships
F30 Individual Predoctoral NRSA for MD/PhD Fellowships
F31 Predoctoral Individual National Research Service Grant Award
F32 Postdoctoral Individual National Research Service Award
F33 National Research Service Awards for Senior Fellows

F99/K00 Pre-doc to Post-doc Transition Award/ Post-doctoral Transition Award
G08 Resources Project Grant (NLM)
G13 Health Sciences Publication Support Awards (NLM)
G20 Grants for Repair, Renovation and Modernization of Existing Research Facilities
K01 Research Scientist Development Award - Research & Training
K02 Research Scientist Development Award Research
K05 Research Scientist Award
K06 Research Career Awards
K07 Academic/Teacher Award (ATA)
K08 Clinical Investigator Award (CIA)
K12 Physician Scientist Award (Program) (PSA)
K18 Career Enhancement Award
K22 Career Transition Award
K23 Mentored Patient-Oriented Research Career Development Award
K24 Midcareer Investigator Award in Patient-Oriented Research
K25 Mentored Quantitative Research Career Development Award
K26 Midcareer Investigator Award in Biomedical and Behavioral Research
K43 International Research Career Development Award

K76 Emerging Leaders Career Development Award

K99/R00 Career Transition Award/Research Transition Award
KL2 Mentored Career Development Award
KM1 Institutional Career Enhancement Awards

RC2 High Impact Research and Research Infrastructure Programs

RC3 Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN) Program

RC4 High Impact Research and Research Infrastructure Programs Multi-Yr Funding

RM1 Research Project with Complex Structure
R00 Research Transition Award

R01 Research Project Grant
R03 Small Grant Program
R13 Support for Conferences and Scientific Meetings
R13/U13 Support for Conferences and Scientific Meetings
R15 Academic Research Enhancement Award (AREA)
R18 Research Demonstration and Disseminations Projects
R21 Exploratory/Developmental Research Grant Award
R21/R33 Phased Innovation Award
R24 Resource-Related Research Projects

R25 Education Projects
R33 Exploratory/Developmental Grants Phase II
R34 Clinical Trial Planning Grant Program
R35 Outstanding Investigator Award
R36 Dissertation Award
R37 Method to Extend Research in Time (MERIT) Award
R41 Small Business Technology Transfer (STTR) Grant - Phase I only
R41/R42 Small Business Technology Transfer (STTR) Grant - Phase I, Phase II, and Fast-Track
R41/R42 Small Business Technology Transfer (STTR) Grant - Phase I and Phase II
R42 Small Business Technology Transfer (STTR) Grant - Phase II only
R43 Small Business Innovation Research (SBIR) Grant - Phase I only
R43/R44 Small Business Innovation Research (SBIR) Grant - Phase I, Phase II, and Fast-Track
R43/R44 Small Business Innovation Research (SBIR) Grant - Phase I and Phase II
R44 Small Business Innovation Research (SBIR) Grant - Phase II only

R61/R33 Exploratory/Developmental Phased Award

RC1 NIH Challenge Grants and Partnerships Program Phase I

RC2 High Impact Research and Research Infrastructure Programs

RC3 Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN) Program

RC4 High Impact Research and Research Infrastructure Programs Multi-Yr Funding

RM1 Research Project with Complex Structure

S07 Biomedical Research Support Grants
S10 Biomedical Research Support Shared Instrumentation Grants
S11 Minority Biomedical Research Support Thematic Project Grants
S21 Research and Institutional Resources Health Disparities Endowment Grants Capacity Building
SB1 Commercialization Readiness Program

SC1 Research-Enhancement Award
SC2 Pilot Research Project
SC3 Research Continuance Award
T14 Conferences
T15 Continuing Education Training Grants
T32 Institutional National Research Service Award (NRSA)
T34 MARC Undergraduate NRSA Institutional Grants
T35 National Research Service Award (NRSA) Short -Term Research Training
T36 MARC Ancillary Training Activities Grant
T37 Minority International Research Training Grants

T42 Educational Resource Center Training Grants
T90/R90 Interdisciplinary Research Training Award/Interdisciplinary Regular Research Training Award
TL1 Linked Training Award
U01 Research Project Cooperative Agreements

U13 Conferences Cooperative Agreements
U18 Research Demonstration Cooperative Agreements
U2R International Training Cooperative Agreement
U24 Resource-Related Research Projects Cooperative Agreements U34 Clinical Planning Grant Cooperative Agreement

U44 Small Business Innovation Research (SBIR) Cooperative Agreements - Phase II
UB1 Commercialization Readiness Program - Cooperative Agreement

UC4 High Impact Research and Research Infrastructure - Cooperative Agreement Programs
UG1 Clinical Research Cooperative Agreements - Single Project

UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement

UH2 Exploratory/Developmental Cooperative Agreement Phase I
UH2/UH3 Phase Innovation Awards Cooperative Agreement
UH3 Exploratory/Developmental Cooperative Agreement Phase II

UM1 Multi-Component Research Project Cooperative Agreements

UP5 Cooperative Agreement

Announcement Type
Reissue of PA-21-268
Related Notices
  • May 10, 2022 - Updated Requirements for NIH Notification of Removal or Disciplinary Action Involving Program Directors/Principal Investigators or Other Senior/Key Personnel. See Notice NOT-OD-22-129.
Funding Opportunity Number (FON)
PA-24-254
Companion Funding Opportunity
None
Number of Applications

See Part 2, Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.173, 93.310, 93.350, 93.307, 93.847, 93.846, 93.351, 93.352, 93.859, 93.279, 93.172, 93.242, 93.286, 93.113, 93.879, 93.121, 93.865, 93.867, 93.233, 93.837, 93.838, 93.839, 93.840, 93.853, 93.866, 93.855, 93.213, 93.361, 93.353, 93.393, 93.394, 93.395, 93.396, 93.397, 93.398, 93.399, 93.273
Funding Opportunity Purpose

The National Institutes of Health (NIH) hereby notifies recipient organizations holding specific types of NIH grants, listed within the Activity Code section above, that applications for change of recipient organization may be submitted to this NOFO. This assumes such a change is programmatically permitted for the particular grant. Applications for change of recipient organization are considered prior approval requests (as described in Section 8.1.2.7 of the NIH Grants Policy Statement) and will be routed for consideration directly to the Grants Management Specialist named in the current award.

Although requests for change of recipient organization may be submitted through this NOFO, there is no guarantee that an award will be transferred to the new organization. All applicants are encouraged to discuss potential requests with the awarding IC before submission.

Key Dates

Posted Date
July 12, 2024
Open Date (Earliest Submission Date)
July 12, 2024
Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

A change of recipient organization request must be made before the anticipated start date at the new organization and preferably several months in advance.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Not Applicable

Advisory Council Review

Not Applicable

Earliest Start Date

Earliest start dates may vary by awarding IC. Contact awarding IC for further guidance.

Expiration Date
July 13, 2027
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Change of Recipient Organization requests for single-project activity codes can be submitted using either paper or electronic submission processes. Change of Recipient Organization 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.

Change of Recipient Organization actions generally require the submission of multiple applications and can involve awards from numerous NIH ICs. Therefore, the recipient should contact the lead NIH awarding IC before submitting applications through this NOFO.

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

Section II. Award Information

Funding Instrument

The funding instrument will be the same as the parent award.

Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.

Other: A mechanism that is not a grant or cooperative agreement. Examples include access to research resources or pre-applications.

Application Types Allowed

Revision

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s)

Change of recipient organization applications may not propose changes to the overall human subjects or clinical trial designation of the award.

 

Funds Available and Anticipated Number of Awards

The amount of an award is contingent upon the submission of an acceptable application and, unless otherwise instructed by the awarding IC, the direct costs relinquished by the original recipient organization.

Award Budget

Unless otherwise instructed by the awarding IC, application budgets are limited to the direct costs relinquished by the original recipient organization, plus applicable F&A costs for the new organization. Budgets must reflect actual needs of the proposed project.

Award Project Period

The project period should not exceed the amount of time remaining in the original project period.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this Notice of Funding Opportunity (NOFO).

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

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

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
  • Non-domestic (non-U.S.) Entities (Organizations)

If the original NOFO under which an award was funded includes special requirements for applicant eligibility, those may need to be maintained by the new organization. Prospective recipients should contact the awarding IC to discuss any special applicant eligibility requirements that may exist.

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

Foreign Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registration in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement 2.3.9.2 Electronically Submitted Applications for additional information.

  • System for Award Management (SAM) – 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.
    • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. 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 SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

Generally a Change of Organization request should include the same PD/PI(s) as on the currently funded award. 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 awards that include multiple PD(s)/PI(s), the Change of Organization request may be submitted by the PD(s)/PI(s) who will be transferring to the new applicant organization (in accordance with the existing leadership plan). Do not use this Change of Organization application to add, delete, or change the PD(s)/PI(s) listed on the current award. Visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms

3. Additional Information on Eligibility

Number of Applications

Applicant organizations must submit one application for each active award for which a change of recipient organization is being requested.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must prepare applications using current forms in accordance with the How to Apply - Application Guide.

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions for their submission option and the How to Apply - Application Guide, as appropriate except where instructed in this NOFO 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.

Page Limitations

 

All page limitations applicable to the parent award as described in the Application Guide and the Table of Page Limits for the activity code of the parent award must be followed.

Instructions for Application Submission

Prior to submission, applicants are encouraged to contact the awarding IC to discuss potential Change of Recipient Organization requests.

Change of Recipient Organization requests for single-project activity codes can be submitted using either paper or electronic submission processes. Change of Recipient Organization 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.

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:

SF 424 (R&R) Cover Form:

Change of recipient organization applications submitted electronically must include the institute and serial number of the grant number (e.g., CA987654) of the current award entered in field 4a (Federal Identifier). In field 8 (Type of Application), select "Revision" and then mark "E. Other" and insert "Change of Recipient Organization" in the corresponding text field.

R&R Other Project Information form:

Human Subjects section: If applicable, attach PDF documents in the Other Attachments field indicating the Office of Human Research Protections (OHRP) assurance number and IRB approval for the new organization. Name the documents "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;

Vertebrate Animals section: If applicable, provide the Office of Laboratory Animal Welfare (OLAW) assurance number and Institutional Animal Care and Use Committee (IACUC) approval for the new organization. Name the documents "IACUC Documentation.pdf";

Facilities & other Resources: Include probable effect of the move on the project;

Equipment: Include detailed list of any equipment purchased with grant funds to be transferred to the new organization (inclusion of this list in the transfer application from the new organization indicates its acceptance of title to that equipment).

Senior/Key Person Profile (Expanded) Form:

Include updated biographical sketches for the PD/PI and existing senior/key personnel, and biographical sketches for any proposed new senior/key personnel.

R&R Budget form:

The R&R Detailed Budget form must be used, regardless of the form used for the initial application for current award for all research and career mechanisms. The budget should be based on the direct costs relinquished by the original recipient organization, unless otherwise instructed by the awarding IC.

Even if the budget for the original award was submitted in a modular format, the R&R Detailed Budget form must be used for an electronic application for change of recipient organization. For these awards, recipients may either complete all of the fields in the R&R Detailed Budget as appropriate or, they may complete only the costs for the PD/PI (Section A), and include the remainder of the direct costs under Section F (Other Direct Costs), and Section H (Indirect Costs).

PHS 398 Training Budget Form:

Budgets for all NIH Training (T-series and D-series) applications should be submitted using the R&R Training Budget and R&R Detailed Budget forms (as appropriate), and should be based on the direct costs relinquished by the original recipient organization, unless otherwise instructed by the awarding IC.

Research Plan form (i.e., PHS 398 Research Plan Form, PHS 398 Career Development Award Supplemental Form, PHS 398 Research Training Program Plan Form, or PHS Fellowship Supplemental Form, as applicable):

Include a statement indicating whether the overall research/research training plans/aims have changed from the original submission. If the overall research/research training plans/aims have changed, provide updated information. If the overall research/research training plans/aims have not changed, provide the original research/research training plans/aims.

If transferring on the anniversary date, include the progress report for the current year that includes a statement regarding the goals for the upcoming year. If transferring during the budget period (i.e., a mid-year transfer), contact the awarding IC to determine if a progress report is required. If required, the progress report should be included in the Research Strategy section.

As outlined in NOT-OD-20-124 and the NIH Grants Policy Statement in 8.1.2.7, NIH also expects that requests for change in recipient institution should include mention whether the change in recipient organization is related to concerns about safety and/or work environments (e.g., due to concerns about harassment, bullying, retaliation, or hostile working conditions) involving the PD/PI. If applicable, this statement should be provided within the Introduction to Application attachment in the Introduction section.

Other Plan(s): Applicants must address a Data Management and Sharing (DMS) Plan based on the policy applicability and requirements of the parent award and are required to comply with the instructions for DMS Plans accordingly, as provided in the How to Apply - Application Guide. If applicable (i.e., when the parent award is already subject to the DMS Policy and the Change of Recipient Organization results in updates to the DMS Plan), an updated DMS Plan must be provided to the NIH awarding IC prior to award.

PHS Human Subjects and Clinical Trials Information:

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a delayed onset study record.

Other Requested Information: Include a statement indicating whether the study records have changed from the original submission as an Other Requested Information attachment. If the study records have changed, provide that updated information as new study records. If the study records have not changed, provide the original study records and/or delayed onset study records.

Study Record:

PHS Human Subjects and Clinical Trials Information: All instructions in the How to Apply - Application Guide must be followed.

Delayed Onset Study:

All instructions in the How to Apply - Application Guide must be followed. 

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

Applications must be prepared using either the PHS 398 research grant application forms and instructions or PHS 416-1 fellowship grant application forms and instructions.

For fellowships, refer to the Instructions for a Change of Sponsoring Institution Application for NRSA Fellowships (F30, F31, F32 and F33) and non-NRSA Fellowships.

Foreign Organizations

Foreign (non-U.S.) Organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the How to Apply - Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and Times. 

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and 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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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. Failure to register in the eRA 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 unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.

Mandatory Disclosure

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov

Post Submission Materials

Not Applicable

Section V. Application Review Information

1. Criteria

Change of Recipient Organization applications do not receive peer review (including objective peer review for applicable mechanisms). Instead, the administrative criteria described below will be considered in the administrative evaluation process. NIH may request additional information necessary to accomplish its administrative review of the change of recipient organization request.The following general criteria will be used:

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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 individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research. 

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

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

2. Review and Selection Process

Change of Recipient Organization 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.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

NIH will issue formal approval of a Change of Recipient Organization in the form of a revised Notice of Award (NoA) to the original recipient reflecting the revised budget/project period end dates, deletion of any future-year support, and deobligation of remaining funds, if applicable. A deobligation of funds will be based on the estimated grant expenditures through the relinquishment date, as determined from the relinquishing statement.

Concurrently, NIH will issue a NoA to the new recipient reflecting the direct cost balance reported on the relinquishing statement plus applicable F&A costs, if funds are available. This amount is subject to change as a result of the closeout of the original grant and may be adjusted downward. If the change of recipient organization occurs on the anniversary date of the project, the NoA to the new recipient will reflect the previously committed direct cost level plus applicable F&A costs if funds are available. The NoA is the official authorizing notification of a Change of Recipient Organization showing the transferee as the recipient of record and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions. 

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Any application awarded in response to this NOFO 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. 

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support

Cooperative Agreement Terms and Conditions of Award

Any Change of Recipient Organization to Cooperative Agreements will be subject to the same Cooperative Agreement terms and conditions as the original award.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

For any scientific or research-related questions on this Change of Recipient Organization announcement please contact the Program Officer listed on NoA of the most recent award.

Peer Review Contact(s)

Not Applicable

Financial/Grants Management Contact(s)

For any financial or grants management questions on this Change of Recipient Organization announcement, please contact the Grants Management Specialist or Grants Management Officer listed on the NoA of the most recent award

Section VIII. Other Information

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

Authority and Regulations

Change of Recipient Organization awards are made under appropriate authorities as referenced in a specific Notice of Award. For reference to specific authorities, refer to the original NOFO used for the last competing application and/or the most recent Notice of Award.
 

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