EXPIRED
National Institutes of Health (NIH)
National Cancer Institute (NCI)
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)
Fogarty International Center (FIC)
National Center for Complementary and Integrative Health (NCCIH)
National Center for Advancing Translational Sciences (NCATS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers listed above. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.
Division of Program Coordination, Planning and Strategic
Initiatives, Office of Research Infrastructure Programs (ORIP)
Office of Strategic Coordination (Common
Fund)
Division of Program Coordination, Planning and Strategic Initiatives, DPCPSI
Office of Disease Prevention (ODP)
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Dietary Supplements (ODS)
Office of Research on Women’s Health (ORWH)
NIH Office of the Director (OD)
Change of Recipient Organization (Type 7 Parent Clinical Trial Optional)
Change of Recipient Organization
Change of Recipient Organization applications must be submitted on paper for 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 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)
G11
Extramural Associate Research Development Award (EARDA)
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
OT1 Pre-Application for an Other Transaction Award
OT2 Research Project - Other Transaction Award
OT3 Other Transaction Multiple-Component Research Award
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
Change of Recipient Organization applications may be submitted electronically for the following activity codes:
C06 Research Facilities Construction Grant
Reissue of PA-18-590
PA-21-268
None
93.350, 93.213, 93.398, 93.399, 93.397, 93.396, 93.395, 93.394, 93.393, 93.867, 93.172, 93.233, 93.837, 93.838, 93.839, 93.840, 93.866, 93.273, 93.855, 93.846, 93.286, 93.865, 93.279, 93.865, 93.121, 93.847, 93.113, 93.859, 93.242, 93.307, 93.853, 93.361, 93.879, 93.351, 93.313, 93.310
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 FOA. 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 FOA, 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.
It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide, PHS 398 Application Guide, or PHS 416-1 Instructions 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 consideration.
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
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 FOA.
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.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) 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.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
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.
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 SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations must submit one application for each active award for which a change of recipient organization is being requested.
Applicants must prepare applications using current forms in accordance with the 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 FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
It is critical that applicants follow the instructions for their submission option (SF424 (R&R) Application Guide, PHS 398 Application Guide, or PHS 416-1 Instructions as appropriate) except where instructed in this funding opportunity announcement to do otherwise. Conformance to documented requirements is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for consideration.
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.
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 4 (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).
Sr/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 grantee 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 grantee organization. For these awards, grantees 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) Item 8-10, 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.
PHS 398 Research Plan Form:
Include a statement indicating whether the overall research plans/aims have changed from the original submission. If the overall research plans/aims have changed, provide updated information. If the overall research plans/aims have not changed, provide the original research 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 as to whether the change in recipient institution 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.
PHS 398 Career Development Award Supplemental Form:
Include a statement indicating whether the overall research plans/aims have changed from the original submission. If the plans/aims have changed, provide updated information. If the overall research plans/aims have not changed, provide the original research 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 as to whether the change in recipient institution 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.
PHS 398 Research Training Program form:
Include a statement indicating whether the research training plans have changed from the original submission. If the research training plan has changed, provide updated information. If the overall training plans have not changed, provide the original training plans.
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.
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 as to whether the change in recipient institution 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.
PHS 398 Fellowship Supplemental Form:
Include a statement indicating whether the overall research plans/aims or research training plan have changed from the original submission. If either has changed, provide updated information. If the overall research plans/aims have not changed, provide the original research 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 as to whether the change in recipient institution 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.
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 SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed.
Delayed Onset Study:
All instructions in the SF424 (R&R) 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 (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the Application Guide.
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.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted using the instructions specified above.
Applicants must complete all required registrations prior to submission. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit 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 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.
Not Applicable
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 grantee organization request.The following general criteria will be used:
For research that involves human subjects but does not involve one of the 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 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 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.
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.
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.
Not Applicable
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 signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.
Recipients must comply with any funding restrictions described in Section IV.6. 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.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
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, Recipients, and Activities, including of note, but not limited to:
If a recipient is successful and receives a Notice of Award, 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 of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
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.
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.
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 and 2 CFR Part 200.206 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 Change of Recipient Organization to Cooperative Agreements will be subject to the same Cooperative Agreement terms and conditions as the original award.
Reporting requirements will be specified in the terms and conditions of award as applicable to the Change of Recipient Organization 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 Change of Recipient Organization even if support for future years is not requested. Continuation of support for 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 the parent award 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.
NIH FOAs 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 45 CFR Part 75.301 and 2 CFR 200.301.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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 the threshold. 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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and 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)
General Grants Information (Questions regarding application instructions,
application processes, and NIH grant resources)
Email: [email protected] (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: [email protected]
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.
Not Applicable
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
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.
Change of Grantee Organization awards are made under appropriate authorities as referenced in a specific Notice of Award. For reference to specific authorities, refer to the original funding opportunity announcement used for the last competing application and/or the most recent Notice of Award.