BRE-SPAD grantees submitting post-award pilot projects must follow the requirements outlined below. Projects that are not consistent with the NIH mission and priorities, involve dangerous gain-of-function research, or do not comply with the terms and conditions of the Notice of Award (NoA) will not be approved or permitted to proceed with BRE-SPAD support.

Projects Not Involving Human Subjects (HS) or Vertebrate Animals (VA)

For pilot projects that do not involve human subjects (HS) or vertebrate animals (VA), the Authorized Organization Representative (AOR) must submit all required documentation to NIGMS for review at least 30 business days before the anticipated project start date. NIGMS will confirm receipt of the documentation to the AOR. Projects may not begin before the 30-business-day review period has elapsed. If NIGMS does not request additional information within 30 business days after submission of all required documentation, the project may begin after that period. If NIGMS requests additional information during that period, the project may not begin until NIGMS has received and reviewed the requested information and notified the AOR that the project may proceed.

Failure to submit all required documentation at least 30 business days before initiating a pilot project may result in enforcement actions for noncompliance.

Projects Involving Human Subjects or Vertebrate Animals

For post-award projects that involve HS or VA research, all instructions outlined in the “Prior Approval of Pilot Projects” under Section VI (Award Administration Information) of the NOFO applicable to your application must be followed. Prior approval by NIGMS is required before initiating these projects.

Addendum and Streamlined Submission Process

NIGMS is streamlining the required documentation and submission process for post-award projects, including those with or without HS/VA research. To support this effort, NIGMS provides an Addendum, in a suggested format, that contains the information required for submission. A fully completed Addendum table constitutes a simplified and strongly encouraged method for ensuring compliance with NOFO requirements.

Updated BRE-SPAD Pilot Project Addendum

Notes for Addendum:

• Instructions for each column within the Addendum are available by hovering over the column title. Instructions will appear as a yellow note. 

• Awardees submitting multiple projects at the same time should use one addendum. If additional projects are submitted at a later date, awardees should use a new addendum. 

  ---

Submission Requirements

For projects involving HS or VA research:

• In accordance with NOT-OD-26-026, all required documents, including the Addendum, when applicable, must be submitted through the eRA Commons Prior Approval Module, effective February 20, 2026.
• If an Addendum is included, awardees must also email the Addendum to the Grants Management Specialist (GMS) and the Program Officer (PO) assigned to the parent award, with the complete grant number (e.g., 5UC2GM123456-03) included in the subject line.

For projects not involving HS or VA research:

• Awardees must submit the Addendum via email to the Grants Management Specialist (GMS) and the Program Officer (PO) assigned to the parent award, with the complete grant number (e.g., 5UC2GM123456-03) included in the subject line.
• Additional documentation may be required based on responses provided in the Addendum, as specified by the embedded instructions and the documentation provided. 

Comments and questions about this Process?

Please contact your assigned Program Officer with any questions.