October 28, 2021
PAR-22-068- Continuation or Revision of NIDCR Clinical Trial Implementation Cooperative Agreement (UH3 Clinical Trial Required)
RFA-HD-23-020 - Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) Scientific Leadership Center (UM2 Clinical Trial Optional)
RFA-HD-23-021 - Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) Operations and Collaborations Center (UM2 Clinical Trial Optional).
PAR-21-356 - Limited Competition: Research Resource for the National Swine Resource and Research Center (U42 Clinical Trial Not Allowed)
NOT-OD-21-169 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022
NOT-OD-21-170 - Updates: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements
RFA-HG-22-001-Supporting Talented Early Career Researchers in Genomics (R01 Clinical Trial Optional)
NATIONAL INSTITUTES OF HEALTH (NIH)
AGENCY FOR HEALTHCARE RESEARCH AND QUALITY (AHRQ)
U.S. FOOD AND DRUG ADMINISTRATION (FDA)
This Notice reminds the applicant and recipient community that applicants must use FORMS-G application packages for due dates on or after January 25, 2022 and must use FORMS-F application packages for due dates on or before January 24, 2022 (see NOT-OD-21-169 for details).
Applicants are encouraged to submit early to allow time to work through any unforeseen issues. Also, applicants are encouraged to use the contact information below to address questions and challenges.
For a transition period, both FORMS-F and FORMS-G application packages will be active simultaneously. Applicants must choose the appropriate application package for their due date when presented with both FORMS-F and FORMS-G application packages on the same FOA (see table below).
|If your intended due date is...||You must use...|
On or before January 24, 2022, including:
|FORMS-F application package|
On or after January 25, 2022, including:
|FORMS-G application package|
Applications submitted using the incorrect application package for their due date may be withdrawn and removed from funding consideration.
Updates to Required Registrations
As part of the federal-wide transition from the DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number to the new government-owned Unique Entity Identifier (UEI), applicants will be required to have a UEI to apply for federal grants or cooperative agreements. The System for Award Management (SAM) will become the central repository for the new UEI that will be incorporated into an institution’s SAM registration. Although agencies are not required to fully transition until April 2022, NIH, AHRQ, and FDA will transition for due dates on or after January 25, 2022 to align with standard application and review cycles. See NOT-OD-21-170 for more information.
Additional NIH and AHRQ Implementation Details
Effective immediately, the following updated registration language applies to all active FOAs, and those issued on or after the date of this Notice:
Section III. Eligibility Information
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.
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) to register in SAM.
Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, after obtaining a DUNS number, applicant organizations 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.
eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; 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 to complete the Grants.gov registration.
Section IV. Application and Submission Information
7. Other Submission Requirements and Information
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit 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.
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile application 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. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the unique entity identifier (DUNS number or UEI as required) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Please direct all NIH inquiries to:
NIH Office of Policy for Extramural Research Administration (OPERA)
Systems Policy Branch
Please direct all AHRQ inquiries to:
Agency for Healthcare Research and Quality, HHS
Division for Policy, Coordination and Analysis
Office of Extramural Research, Education, and Priority Populations
Please direct all FDA inquiries to:
Food and Drug Administration (FDA)
Office of Acquisitions and Grants Services (OAGS)
Grants Management Branch