Key Dates

Related Announcements

PAR-19-313 - Centers of Biomedical Research Excellence (COBRE) Phase 1 (P20 Clinical Trial Optional)

Issued by

National Institute of General Medical Sciences (NIGMS)

Purpose

The purpose of this Notice is to announce updated instructions for demonstrating the eligibility of the PD/PI and Research Project Leaders in PAR-19-313 “Centers of Biomedical Research Excellence (COBRE) Phase 1 (P20 Clinical Trial Optional)” by providing information on current, pending, and past support, as necessary.

All prior instructions in the FOA requesting information regarding current, pending, and past support in Section D. Research Support of the Biographical Sketch should be disregarded per NOT-OD-21-073 “Upcoming Changes to the Biographical Sketch and Other Support Format Page for Due Dates on or after May 25, 2021”.

The following sections of the FOA are revised accordingly:

Part 2. Section IV. Application and Submission Information

2. Content and Form of Application Submission

Overall Component

Research & Related Other Project Information (Overall)

Current language:

Follow standard instructions.

Revised language in italics:

Follow standard instructions, with the following additional instructions.

Other Attachments:The application must include an attachment titled “Current and Pending Support” with the following information about each PD/PI’s current and pending research grants:

• Project Number
• Source of Funding and Title of the Project (or Subproject)
• Role on the Project and Level of Effort (in calendar-months)
• Dates of Approved/Proposed Project
• Annual Direct Costs
• Project Goal

Applications missing this attachment for each PD/PI will be considered incomplete and will be withdrawn without review.

Research Project

Research & Related Other Project Information (Research Project)

Current language:

Human Subjects:Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals:Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Revised language in italics:

Human Subjects:Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals:Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Other Attachments:The application must include an attachment titled: “Current, Pending, and Prior Support”, with the following information about all prior, current and pending support for both research grants and non-research grants including fellowship, career development, and institutional support; and research grants and contracts for which the Research Project Leader made significant contributions but was not the PD/PI.

• Project Number
• Source of Funding and Title of the Project (or Subproject)
• Role on the Project and Level of Effort (in calendar-months)
• Dates of Prior/Approved/Proposed Project
• Annual Direct Costs
• Project Goal

Applications missing this attachment will be considered incomplete and will be withdrawn without review.

Part 2. Section VI. Award Administration Information

Post Award Program Requirements

Prior Approval of Pilot and Replacement Research Projects

Current language:

Replacement Research Projects:

Using PHS398 forms and instructions, only the following sections need to be submitted

• Face Page (signed by institutional signing official)
• Project Summary (Page 2)
• Research Strategy Section
• Updated Other Support (Research Project only)
• Biographical Sketch (Research Project only)
• Detailed budget and budget justification (Research Project only)
• Checklist Format Page with F&A cost breakdown (Research Project only)

External Advisory Committee approval - communication from the EAC chair (at a minimum) indicating that the EAC concurs with supporting the Research or Pilot Project.

Revised language in italics:

Replacement Research Projects:

Using PHS398 forms and instructions, only the following sections need to be submitted

• Face Page (signed by institutional signing official)
• Project Summary (Page 2)
• Research Strategy Section
• Updated Other Support - Current, Pending, and Prior Support Attachment (Research Project only)
• Biographical Sketch
• Detailed budget and budget justification (Research Project only)
• Checklist Format Page with F&A cost breakdown (Research Project only)
• External Advisory Committee approval - communication from the EAC chair (at a minimum) indicating that the EAC concurs with supporting the Research Project.

Current language:

Pilot Projects (see Notice NOT-GM-14-111 for details):

Using PHS398 forms and instructions, only the following sections need to be submitted    

• Face Page (signed by institutional signing official)
• Project Summary (Page 2)
• Research Strategy Section
• External Advisory Committee approval - communication from the EAC chair (at a minimum) indicating that the EAC concurs with supporting the Research or Pilot Project.

Revised language in italics:

Pilot Projects

Using PHS398 forms and instructions, only the following sections need to be submitted

• Face Page (signed by institutional signing official)
• Project Summary (Page 2)
• Research Strategy Section
• Biographical Sketch
• External Advisory Committee approval - communication from the EAC chair (at a minimum) indicating that the EAC concurs with supporting the Pilot Project.

All other aspects of this FOA remain the same.

Inquiries

Please direct all inquiries to:

Michele McGuirl, PhD
National Institute of General Medical Sciences (NIGMS)
Email:michele.mcguirl@nih.gov