Department of Health
and Human Services (HHS)
and Human Services (HHS)
February 18, 2021
PA-20-262 – PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] 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 April 5, 2021 receipt date, in PA-20-262 "PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] 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-20-262 have been modified (shown in boldface and in italics) to reflect the NIBIB's participation in this FOA:
Components of Participating Organizations
National Cancer Institute (NCI)
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 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 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 Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Center for Complementary and Integrative Health (NCCIH)
Center for Global Health (CGH/CDC)
National Center on Birth Defects and Developmental Disabilities (NCBDDD/CDC)
National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP/CDC)
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID/CDC)
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP/CDC)
National Center for Immunization and Respiratory Diseases (NCIRD/CDC)
National Center for Injury Prevention and Control (NCIPC/CDC)
National Institute for Occupational Safety and Health (NIOSH/CDC)
National Center for Environmental Health (NCEH/CDC)
Center for Preparedness and Response (CPR/CDC)
Center for Biologics Evaluation and Research (CBER/FDA)
Center for Drug Evaluation and Research (CDER/FDA)
Center for Food Safety and Applied Nutrition (CFSAN/FDA)
Center for Devices and Radiological Health (CDRH/FDA)
Center for Veterinary Medicine (CVM/FDA)
Office of Critical Path Programs (CPI/FDA)
Office of Orphan Products Development (OOPD/FDA)
Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.068; 93.073; 93.070; 93.084; 93.103; 93.113; 93.136; 93.172; 93.173; 93.213; 93.233; 93.242; 93.262; 93.273; 93.279; 93.286; 93.307; 93.316; 93.326; 93.361; 93.393; 93.394; 93.395; 93.396; 93.399; 93.837; 93.838; 93.839; 93.840; 93.847; 93.859; 93.865; 93.866; 93.867, 93.083
All other aspects of this Funding Opportunity Announcement are unchanged.
Ilana Goldberg, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-402-3465
Email: ilana.goldberg@nih.gov