Key Dates

Related Announcements

• September 14, 2022 - Centers of Biomedical Research Excellence (COBRE) Phase 1 (P20 - Clinical Trial Optional). See NOFO PAR-22-250.

Issued by

National Institute of General Medical Sciences (NIGMS)

Purpose

The purpose of this Notice is to alert potential applicants to PAR-22-250 “Centers of Biomedical Research Excellence (COBRE) Phase 1 (P20 - 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)

Currently reads:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Updated to read (changes in bold italics):

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Other Plans: 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 include 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.

Because not all of the Research and Pilot projects and their associated data will be known at the time of application, a detailed DMS Plan is not required. Do not include separate DMS Plans for individual research projects or cores. Instead, submit one DMS Plan that includes 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.

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Part 2. Section VI. Award Administration Information.

3. 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.

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 FOAs 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 75.113and 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):

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.

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.

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 FOAs 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.

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

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 75.113and 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.

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

Inquiries

Please direct all inquiries to:

Federico Bernal, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: Federico.bernal@nih.gov