Key Dates

Related Announcements

RFA-AI-22-076 - Consortium for Food Allergy Research: Clinical Research Center (U01 Clinical Trial Required)

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

The purpose of this Notice is to alert potential applicants of a change to the Application and Submission Information in RFA-AI-22-076, “Consortium for Food Allergy Research: Clinical Research Center (U01 Clinical Trial Required)”, to remove the last bullet "Estimate the total cost of the trial including anticipated costs for the investigation product (if relevant) and the entire number of CRCs needed to complete the proposed trial. Do not include in this estimate the services that will be provided by the NIAID-DAIT Data, Clinical Safety, and Statistical Center(s).”

Currently Reads:

Section IV.  Application and Submission Information

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

Include funds with justification for the following:

• For single PD/PI applications, the PD/PI must commit 1 person-month for CoFAR network-wide projects in addition to a minimum of 1 person-month for CoFAR-CRC site-specific projects. For multi-PD(s)/PI(s) applications, one of the PD(s)/PI(s) must commit 1 person-month for CoFAR network-wide projects, in addition to a minimum of 1 person-month for CoFAR-CRC site-specific projects.
• Include costs for at least 12 person-months of clinical coordinator effort for the CoFAR network-wide projects.
• Include funds for travel and other expenses for CoFAR-CRC Senior/Key Personnel to attend two (2) one and a half (1.5) day CoFAR Steering Committee meetings per year in the Rockville, Maryland area.
• For the CoFAR-CRC center-specific research project(s), include the costs for the proposed center-specific project(s), including all support for additional personnel, materials and equipment, participant recruitment, retention and compensation, statistical design, data collection, analysis and management, data deposition into ImmPort or other public portals designated by NIAID, as well as costs for project management, adverse event collection, safety reporting, and quality assurance as applicable.
• Do not include costs for the CoFAR network-wide project proposed in this application. Other than the personnel costs specified above (12 person months for clinical coordinator and 1 person month for a PD(s)/PI(s)), protocol funds for all the CoFAR network-wide projects will be disbursed by the CoFAR-LC to the CoFAR-CRCs participating in each network-wide clinical research project and will not be determined until after all CoFAR awards are issued and the projects to be undertaken are determined.
• Estimate the total cost of the trial including anticipated costs for the investigation product (if relevant) and the entire number of CRCs needed to complete the proposed trial. Do not include in this estimate the services that will be provided by the NIAID-DAIT Data, Clinical Safety, and Statistical Center(s).

Modified to Read:

Section IV.  Application and Submission Information

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

Include funds with justification for the following:

• For single PD/PI applications, the PD/PI must commit 1 person-month for CoFAR network-wide projects in addition to a minimum of 1 person-month for CoFAR-CRC site-specific projects. For multi-PD(s)/PI(s) applications, one of the PD(s)/PI(s) must commit 1 person-month for CoFAR network-wide projects, in addition to a minimum of 1 person-month for CoFAR-CRC site-specific projects.
• Include costs for at least 12 person-months of clinical coordinator effort for the CoFAR network-wide projects.
• Include funds for travel and other expenses for CoFAR-CRC Senior/Key Personnel to attend two (2) one and a half (1.5) day CoFAR Steering Committee meetings per year in the Rockville, Maryland area.
• For the CoFAR-CRC center-specific research project(s), include the costs for the proposed center-specific project(s), including all support for additional personnel, materials and equipment, participant recruitment, retention and compensation, statistical design, data collection, analysis and management, data deposition into ImmPort or other public portals designated by NIAID, as well as costs for project management, adverse event collection, safety reporting, and quality assurance as applicable.
• Do not include costs for the CoFAR network-wide project proposed in this application. Other than the personnel costs specified above (12 person months for clinical coordinator and 1 person month for a PD(s)/PI(s)), protocol funds for all the CoFAR network-wide projects will be disbursed by the CoFAR-LC to the CoFAR-CRCs participating in each network-wide clinical research project and will not be determined until after all CoFAR awards are issued and the projects to be undertaken are determined.

 All other aspects of the NOFO remain unchanged.

Inquiries

Please direct all inquiries to:

Gang Dong, MD PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3508
Email: [email protected]