Department of Health
and Human Services (HHS)
and Human Services (HHS)
May 4, 2021
PA-20-194 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)
NOT-EB-21-005 - NIBIB Guidance for Support of Clinical Trial Applications
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
This Notice announces the participation of the National Institute of Biomedical Imaging and Bioengineering (NIBIB), effective for the June 16, 2021 due date, in PA-20-194 "NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)".
NIBIB funding of clinical trials will be in accordance with NOT-EB-21-005 "NIBIB Guidance for Support of Clinical Trial Applications" Briefly, NIBIB will only support mission-focused (see NIBIB's program areas) early stage clinical trial applications, i.e., feasibility, Phase I, first-in-human, safety, or other small clinical trials, that inform early stage technology development. NIBIB will not support applications proposing pivotal, Phase II, III, IV, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern. Also, mechanistic trials are not supported unless the primary focus of the project is on technology development.
The following sections of PA-20-194 have been modified (shown in italics) to reflect the participation of NIBIB in this Funding Opportunity Announcement.
Part 1. Overview Information
Components of Participating Organizations
NATIONAL INSTITUTES OF HEALTH (NIH)
National Eye Institute (NEI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Mental Health (NIMH)
National Institute of Nursing Research (NINR)
The following Institutes/Centers only accept mechanistic studies that meet NIH's definition of a clinical trial. See Related Notices section below.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Mental Health (NIMH)
Note: Not all NIH Institutes and Centers (ICs) participate in Parent Announcements. Applicants should carefully note which ICs participate in this announcement and view their respective areas of research interest at the R21 Clinical Trial Required IC-Specific Scientific Interests and Contact website. ICs that do not participate in this announcement will not consider applications for funding.
Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.867, 93.172, 93.866, 93.273, 93.855, 93.846, 93.279, 93.173, 93.113, 93.361, 93.242, 93.865, 93.286
All other aspects of the FOA remain unchanged.
Randy King, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Phone: 301-451-0707
Email: Randy.King@nih.gov