Key Dates

Related Announcements

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Issued by

National Institute of General Medical Sciences (NIGMS)

Purpose

Introduction

NIGMS is soliciting input from the Institutional Development Award (IDeA) program community to help determine the best timelines for the submission and review of IDeA program post-award project (such as pilot and research project) prior approval requests. 

Background

Recipients of IDeA programs, including the IDeA Networks of Biomedical Research Excellence (INBRE), IDeA Clinical and Translational Research Programs (IDeA CTR) and the Centers of Biomedical Research Excellence (COBRE), submit over 600 post-award projects on a rolling basis every fiscal year, as part of the post-award prior approval process. While NIGMS aims to provide an approval/denial response within 30 days, there are several challenges with the prior approval process, including:

• High submission volume during Research Performance Progress Report (RPPR) periods and during the fourth quarter of the fiscal year.
• Incomplete or outdated submissions that require extensive follow-up. Examples of common issues include projects involving clinical trials or human subjects that are not compliant with NIH Federal-wide Assurance requirements and certifications, including: 
  • Expired or no IRB approval
  • Underspecified or missing Data and Safety Monitoring documentation
  • Missing Section 2.2 of the PHS Human Subjects and Clinical Trials Information form.
• Administrative oversight required to ensure that each project aligns with and is compliant with NIH priorities, policies, and regulations.

Implementation Considerations

NIGMS recognizes the importance of post-award projects in the IDeA program as a vehicle to build biomedical research capacity, as well as the importance of an efficient prior approval process. Accordingly, NIGMS seeks feedback on approaches to ensure a more efficient prior approval process for post-award projects. Below are two approaches to consider:

• One deadline window per fiscal year: 
  • INBRE: November 1 to December 31
  • IDeA-CTR: October 15 to January 15
  • COBRE: Four months after the start of the budget period 
    • Example: For a January 1 budget period start, the post award submission date would be May 1
  • This scenario accounts for NIGMS' programmatic and grant management cycles. Each complete and compliant prior approval request would be reviewed within 45 days of submission.
• Two deadlines per fiscal year:
  • INBRE and IDeA-CTR: September to November and February to April
  • COBRE: Four months after the start of the budget period 
    • Example: For a January 1 budget period start, the post award submission date would be May 1.
  • This scenario accounts for NIGMS' programmatic and grant management cycles. Each complete and compliant prior approval request would be reviewed within 45-60 days of submission, with longer review times for submissions approaching the fourth quarter when NIGMS prioritizes funding actions.

Regardless of the approach, a timely prior approval process is dependent on submissions that are complete and include all required materials as specified in the relevant NOFO and in the Notice of Award. 

As stewards of the taxpayers' investments in biomedical research, NIGMS must ensure that each post-award project is mission-appropriate research that helps build biomedical research capacity in IDeA states. 

Prior approval submissions for post-award projects that are incomplete or do not align with NIH priorities will be denied without a full programmatic review.

Information Requested

Comments are requested on potential approaches to ensure a more efficient prior approval process for post-award projects for IDeA programs. Response to this Notice is voluntary. Respondents are free to address any or all the topics listed below, or any other relevant topic for NIGMS to consider. Respondents should not feel compelled to address all items. 

• Advantages and disadvantages of the proposed approaches
• Possible unintended consequences
• Other approaches that should be considered

Submitting a Response

Comments should be submitted electronically to the email address below by December 4, 2026.

This Notice is for planning purposes only and should not be construed as a policy, solicitation of applications, or as an obligation on the part of the Government to provide support for any ideas identified in response to it. Please note that the Government will not pay for the preparation of any information submitted or for its use of that information. 

Responses will be compiled and may be shared publicly in unredacted form. Please do not include any proprietary, classified, confidential, or sensitive information in your response. The NIH may use information gathered by this Notice to inform the development of future guidance.

Inquiries

Please direct all inquiries to:

National Institute of General Medical Sciences (NIGMS)

Email: [email protected]