Department of Health
and Human Services (HHS)
and Human Services (HHS)
February 18, 2021
PA-20-183 - Research Project Grant (Parent R01 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 5, 2021 receipt date, in PA-20-183 "Research Project Grant (Parent R01 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-20-183 have been modified (shown in bold italics) to reflect the NIBIB's participation in this FOA:
Components of Participating Organizations
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
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)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Center for Complementary and Integrative Health (NCCIH)
Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.213, 93.867, 93.172, 93.233, 93.286, 93.840, 93.837, 93.838, 93.839, 93.866, 93.273, 93.855, 93.846, 93.847, 93.279, 93.113, 93.859, 93.307, 93.853, 93.361, 93.242
All other aspects of this Funding Opportunity Announcement are unchanged.
Michael B. Wolfson, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Phone: 301-451-4778
Email: Michael.Wolfson@nih.gov