To reduce administrative burdens for COBRE awardees, NIGMS has begun streamlining the submission and review process for post-award pilot projects (PPs). Under this updated guidance, prior approval by NIGMS is no longer required for COBRE PPs that do not involve Human Subjects (HS) and/or Vertebrate Animals (VA) research provided that the required documentation is submitted in accordance with the new procedures outlined below. To support this streamlined process, NIGMS has developed a suggested Addendum that captures the information required for project review and notification of approval. This guidance applies only to COBRE PPs without HS or VA.

Pilot Projects Involving HS and/or VA and all COBRE Research Projects (RP)

All instructions outlined in the “Post-Award Program Requirements for Research/Pilot Projects” section of the NOFO applicable to your award must continue to be followed. Prior approval by NIGMS is still required before initiating these projects and must be submitted through the eRA Commons Prior Approval Module in accordance with existing NIH requirements.

Pilot Projects not Involving Human Subjects or Vertebrate Animals

Prior approval from NIGMS is no longer required for COBRE PPs that do not involve HS and/or VA research. The institution’s Authorized Organization Representative (AOR) must now submit the required documentation as outlined in the NOFO corresponding to the award at least 14 calendar days before the anticipated project start date. The AOR will receive confirmation from NIGMS that the required documentation has been received.

• If the AOR does not receive further requests for additional information from NIGMS within 14 calendar days after submission of all required documentation, the project may begin on the proposed project start date.
• If NIGMS requests additional information from the AOR within the 14-day window, no COBRE-supported work may begin until all matters raised by NIGMS have been resolved.

COBRE post-award projects that are not supported with NIGMS COBRE funds do not require notification or prior approval irrespective of the type of research supported and should not be reported in an RPPR.

Addendum and Streamlined Submission Process

NIGMS is streamlining the submission process for all post-award PPs. To support this effort, NIGMS has developed a suggested Addendum that outlines the information required for a complete project submission. Submitting a completely filled Addendum table with the PP package to NIGMS will help ensure compliance with NOFO requirements, enable more efficient review by NIGMS staff, and is strongly encouraged.

Updated COBRE Post-Award Project Addendum

Notes:

• Instructions on how to fill each column are available within the document by hovering over the column title. Instructions will appear as a yellow note.
• When preparing the Addendum, do not change the column names or their order.
• 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

PPs involving HS and/or VA research or any COBRE RPs:

• In accordance with NOT-OD-26-026, all required documents as outlined in the NOFO, including the Addendum, must be submitted through the eRA Commons Prior Approval Module, effective February 20, 2026.
• 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., 5P20GM123456-07) included in the subject line.

PPs not involving HS and/or VA research:

• Awardees may submit the Addendum, EAC/AC approval, and the pertinent documentation as outlined in the corresponding NOFO via email to the Grants Management Specialist (GMS) and Program Officer (PO) assigned to the Parent Award with the complete grant number (e.g., 5P20GM123456-07) 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 that arise.