Department of Health
and Human Services (HHS)
and Human Services (HHS)
April 21, 2021
PAR-19-312 - Limited Competition: Renewal of Centers of Biomedical Research Excellence (COBRE) (Phase 2) (P20 Clinical Trial Optional)
National Institute of General Medical Sciences (NIGMS)
The purpose of this Notice is to announce updated instructions for demonstrating the eligibility of the PD/PI and Research Project Leaders in PAR-19-312 “Limited Competition: Renewal of Centers of Biomedical Research Excellence (COBRE) (Phase 2) (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
Current language:
Research & Related Other Project Information (Overall)
Follow standard instructions.
Facilities and Other Resource: Applications must briefly describe the institutional environment and resources available to investigators and indicate how prior COBRE support has improved facilities or made available new and collaborative resources (e.g., laboratory facilities, patient populations, laboratory space and personnel).
Revised language in italics:
Research & Related Other Project Information (Overall)
Follow standard instructions.
Facilities and Other Resource: Applications must briefly describe the institutional environment and resources available to investigators and indicate how prior COBRE support has improved facilities or made available new and collaborative resources (e.g., laboratory facilities, patient populations, laboratory space and personnel).
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 for both Federal and non-Federal sources:
Applications missing this attachment for each PD/PI will be considered incomplete and will be withdrawn without review.
Part 2. Section IV. Application and Submission Information
2. Content and Form of Application Submission
Research Project
Current language:
Research & Related Other Project Information (Research Project)
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:
Research & Related Other Project Information (Research Project)
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.
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
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
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
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
All other aspects of this FOA remain the same.
Behrous Davani, PhD
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]