NOT-GM-24-035: Clarification of Data Management and Sharing Plan Instructions in PAR-23-216 Limited Competition: Centers of Biomedical Research Excellence (COBRE) (Phase 3) - Transitional Centers (P30 Clinical Trial Optional)

Clarification of Data Management and Sharing Plan Instructions in PAR-23-216 “Limited Competition: Centers of Biomedical Research Excellence (COBRE) (Phase 3) - Transitional Centers (P30 Clinical Trial Optional)”

Notice Number:

NOT-GM-24-035

Key Dates

Release Date:

June 18, 2024

Related Announcements

July 11, 2023 - Limited Competition: Centers of Biomedical Research Excellence (COBRE) (Phase 3) - Transitional Centers (P30 Clinical Trial Optional). See NOFO PAR-23-216.

Issued by

National Institute of General Medical Sciences (NIGMS)

Purpose

The purpose of this Notice is to alert potential applicants to PAR-23-216 “Limited Competition: Centers of Biomedical Research Excellence (COBRE) (Phase 3) - Transitional Centers (P30 Clinical Trial Optional)” of a clarification to the instructions for the Data Management and Sharing (DMS) Plan.

Part 2. Section IV. Application and Submission Information

Overall Component

PHS 398 Research Plan (Overall)

Other Plan(s)

Currently reads:

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. Note: Any budget information for Data Management and Sharing Costs should be included in the Administrative Core Component, not the Overall Component.

Updated to read (changes in bold italics):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan (DMS Plan) will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the DMS Plan must be provided in the Overall component.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the DMS Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a DMS Plan. Note: Any budget information for Data Management and Sharing Costs should be included in the Administrative Core Component, not the Overall Component.

Accordingly, because research will be supported through the Pilot Project Program, applications must include a DMS Plan. Since the research projects and associated data are not known at the time of application, a detailed plan is not required. Applications should include general plans for complying with the DMS policy, including any foreseeable issues. These issues may include, but are not limited to, the following examples:

If projects involving American Indian/Alaska Native (AI/AN) participant data are anticipated, provide information on needed Tribal approvals, data sovereignty issues, and Tribal review.
Restrictions related to research that is also supported by the private sector that may result in proprietary data.
A commitment to identify appropriate methods/approaches and repositories for future scientific data resulting from the award that will make it findable and identifiable via a persistent unique identifier or other standard indexing tool.

The plan should also indicate a commitment to update the DMS Plan at the time of RPPR.

As a reminder, NIH policy requires a single plan for the entire application, so plans are expected to be general and should not exceed 2 pages.

Part 2. Section VI. Award Administration Information.

4. Reporting

Currently reads:

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. Recipients will provide updates at least annually on implementation of the PEDP.

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs 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 Part 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 and 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 75and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Update to read (changes in bold italics):

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, compliance with the approved Data Management and Sharing Plan (DMS Plan), and should notify NIH of serious adverse events and unanticipated problems.

In the event that new research supported by the Pilot Project Program is not covered by the current DMS Plan, an updated DMS Plan, not exceeding 2 pages, should be submitted as part of the RPPR.

All other aspects of this Notice of Funding Opportunity remain the same.

Inquiries

Please direct all inquiries to:

Crina Frincu, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]