Key Dates

Related Announcements

• June 15, 2021 - Large Health Services Research Demonstration and Dissemination Projects for Prevention of Healthcare-Associated Infections (R18). See PA-21-264.
• July 7, 2021- Large Research Projects for Prevention of Healthcare-Associated Infections (R01). See PA 21-265.
• October 21, 2021- Large Research Projects for Combating Antibiotic-Resistant Bacteria (CARB) (R01). See PA-22-047.
• October 21, 2021 - Large Health Services Research Demonstration and Dissemination Projects for Combating Antibiotic-Resistant Bacteria (CARB)(R18). See PA-22-048.

Issued by

AGENCY FOR HEALTHCARE RESEARCH AND QUALITY (AHRQ)

Purpose

This Notice serves to clarify two issues regarding applications submitted in response to PA-21-264, PA-21-265, PA-22-047, and PA-22-048 that propose to study or that include medical devices, diagnostics, therapeutics, or environmental agents: 1) need for review and approval by appropriate Federal agencies and 2) the need for inclusion of clinical outcomes in these studies.

Need for review and approval by appropriate Federal agencies:

AHRQ will not accept applications submitted in response to PA-21-264, PA-21-265, PA-22-047, and PA-22-048 that propose to study or that include medical devices, diagnostics, therapeutics, or environmental agents that have not already been reviewed and approved by the appropriate Federal agency. The purpose of these Notices of Funding Opportunity (NOFOs) is to fund research focused on improving integration of approved medical devices, diagnostics, therapeutics, and environmental agents into clinical care. Medical devices, diagnostics, and therapeutics intended to be used in applications submitted in response to these Notices of Funding Opportunity must have already been reviewed and approved by the FDA for commercial marketing.

Disinfectants and cleaning supplies not intended to be used on humans must comply with the appropriate EPA registration and labeling requirements.

Need for inclusion of clinical outcomes in these studies:

In order to be eligible for funding consideration, applications submitted in response to PA-21-264, PA-21-265, PA-22-047, and PA-22-048 that propose to study medical devices, diagnostics, therapeutics, or environmental agents must incorporate clinical outcomes, which may include but are not limited to infection rates, mortality, length of stay, readmission rates, and/or antibiotic prescription rates.

For further questions or clarifications, you may reach out to the point of contact for this Notice. AHRQ will review a draft statement of aims for eligibility under these NOFOs.

Inquiries

Please direct all inquiries to:

Leyi Lin, MD
Division of Healthcare Associated Infections, Center for Quality Improvement and Patient Safety
Telephone: 301-427-1333
Email: leyi.lin@ahrq.hhs.gov

Melissa Miller, MD, MS
Division of Healthcare Associated Infections, Center for Quality Improvement and Patient Safety
Telephone: 301-472-1107
Email: melissa.miller@ahrq.hhs.gov