Key Dates

Related Announcements

• May 09, 2022 - Limited Competition: Clinical and Translational Science Award (CTSA) Program: Collaborative and Innovative Acceleration Award (UG3/UH3 Clinical Trial Optional). See NOFO PAR-22-167.

Issued by

National Center for Advancing Translational Sciences (NCATS)

Purpose

This Notice informs potential applicants that the U.S. Food and Drug Administration (FDA) is participating, effective immediately, in notice of funding opportunity (NOFO) PAR-22-167, " Limited Competition: Clinical and Translational Science Award (CTSA) Program: Collaborative and Innovative Acceleration Award (UG3/UH3 Clinical Trial Optional)."

The following sections of PAR-22-167 were modified:

Part 1. Overview Information

Participating Organization(s)

Currently Reads:

National Institutes of Health (NIH)

Modified to Read (changes shown in bold italics):

National Institutes of Health (NIH)

U.S. Food and Drug Administration (FDA)

Assistance Listing Number(s)

Currently Reads:

93.350, 93.859, 93.121, 93.865, 93.307, 93.313, 93.846

Modified to Read (changes shown in bold italics):

93.350, 93.859, 93.121, 93.865, 93.307, 93.313, 93.846, 93.103

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

This section was modified to add:
U.S. Food and Drug Administration (FDA)

Regulatory science encompasses the development of tools, standards, and methods to evaluate the safety, efficacy, quality, and performance of FDA-regulated products, spanning medical devices, drugs, biologics, combination products, veterinary medicine, food, cosmetics, dietary supplements, and tobacco products. Beyond these areas, FDA strives to address innovative cross-cutting domains such as digital health, artificial intelligence, data science, and patient-centered outcomes. This initiative, facilitated by the Centers of Excellence in Regulatory Science and Innovation (CERSI) Program led by the Office of Regulatory Science and Innovation (ORSI), seeks to advance regulatory science individually and collectively through collaboration with FDA experts and funding offices. Specifically, the FDA targets innovation to benefit and advance the health of the following demographic groups and populations with clinical characteristics which may frequently preclude their participation in clinical research: racial & ethnic minorities, sex and gender minorities, women, children and adolescents, older adults, persons from rural geographies, persons who are immunocompromised, persons who are pregnant and lactating, persons with HIV infection, persons receiving gender-affirming medical interventions, persons with disabilities, persons with cancer, persons with rare diseases, and populations that include patients from multiple groups, like persons with rare cancers.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

This section was modified to add:
FDA Eligible Grants are funded under the following Funding Opportunity Announcement:

• Centers of Excellence in Regulatory Science and Innovation Program (RFA-FD-23-004 and subsequent reissues)

Section VII. Agency Contacts

This section was modified to add:

Scientific/Research Contact(s)

Tracy Chen, Ph.D., DABT
Senior Advisor, Regulatory Science Collaborative Community, OCS/ORSIOffice of Regulatory Science and Innovation (ORSI)
Office of the Chief Scientist (OCS)
Office of the Commissioner (OC)
U.S. Food and Drug Administration
Phone: (301) 796 - 3597
e-Mail: Tracy.Chen@fda.hhs.gov

Inquiries

Please direct all inquiries to:

Soju Chang, M.D., M.P.H.
National Center for Advancing Translational Sciences (NCATS)
Telephone: (301) 827-9206
E-mail: soju.chang@nih.gov