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1 NIH, CDC, and FDA Program Descriptions and Research Topics i DEPARTMENT OF HEALTH AND HUMAN SERVICES PHS 2021 OMNIBUS SOLICITATION OF THE NATIONAL INSTITUTES OF HEALTH, CENTERS FOR DISEASE CONTROL AND PREVENTION, AND FOOD AND DRUG ADMINISTRATION FOR SMALL BUSINESS INNOVATION RESEARCH (SBIR) AND SMALL BUSINESS technology TRANSFER (STTR) GRANT APPLICATIONS NIH, CDC, and FDA Program Descriptions and Research Topics SUBMISSION DATE S SEPTEMBER 7, 2021, JANUARY 5, 2022, AND APRIL 5, 2022 NATIONAL Institutes of Health (SBIR and STTR) Centers for Disease Control and Prevention (SBIR) Food and Drug Administration (SBIR) NIH, CDC, FDA, and ACL Program Descriptions and Research Topics ii F u n d ing Op p ortu nity Ann ouncements, App lication In st ructions, an d Appendices are contained in separate files.

2 Follow the links below to view these documents. FUNDING OPPORTUNITY ANNOUNCEMENTS REMINDER: ALL APPLICATIONS MUST BE SUBMITTED IN RESPONSE TO A FUNDING OPPORTUNITY ANNOUNCEMENT THROUGH PHS 2021-02 OMNIBUS SOLICITATION OF THE NIH, CDC, AND FDA FOR SMALL BUSINESS INNOVATION RESEARCH GRANT APPLICATIONS (PARENT SBIR [R43/R44] CLINICAL TRIAL NOT ALLOWED) [ ] PHS 2021-02 OMNIBUS SOLICITATION OF THE NIH FOR SMALL BUSINESS technology TRANSFER GRANT APPLICATIONS (PARENT STTR [R41/R42] CLINICAL TRIAL NOT ALLOWED) [ PHS 2021-02 OMNIBUS SOLICITATION OF THE NIH FOR SMALL BUSINESS INNOVATION RESEARCH GRANT APPLICATIONS (PARENT SBIR [R43/R44] CLINICAL TRIAL REQUIRED) [ ] PHS 2021-02 OMNIBUS SOLICITATION OF THE NIH FOR SMALL BUSINESS technology TRANSFER GRANT APPLICATIONS (PARENT STTR [R41/R42] CLINICAL TRIAL REQUIRED) [ ] ADDITIONAL SPECIAL ANNOUNCEMENTS FOR SMALL BUSINESS RESEARCH OPPORTUNITIES APPLICATION INSTRUCTIONS SF424 (R&R) APPLICATION INSTRUCTIONS AND ELECTRONIC SUBMISSION INFORMATION ( ) NIH, CDC, FDA, and ACL Program Descriptions and Research Topics iii TABLE OF CONTENTS NIH, CDC, AND FDA PROGRAM DESCRIPTIONS AND RESEARCH TOPICS PROGRAM DESCRIPTIONS AND RESEARCH GRANT TOPICS.]

3 V NATIONAL INSTITUTES OF HEALTH (NIH) v NATIONAL Institute on Aging (NIA) 1 NATIONAL Institute on Alcohol Abuse and Alcoholism (NIAAA) 6 NATIONAL Institute of Allergy and Infectious Diseases (NIAID) 11 NATIONAL Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) 25 NATIONAL Institute of Biomedical Imaging and Bioengineering (NIBIB) 28 NATIONAL Cancer Institute (NCI) 33 Eunice Kennedy Shriver NATIONAL Institute of Child Health and Human Development (NICHD) 38 NATIONAL Institute on Drug Abuse (NIDA) 51 NATIONAL Institute on Deafness and Other Communication Disorders (NIDCD) 60 NATIONAL Institute of Dental and Craniof acial Research (NIDCR) 63 NATIONAL Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 71 NATIONAL Institute of Environmental Health Sciences (NIEHS) 82 NATIONAL Eye Institute (NEI) 92 NATIONAL Institute of General Medical Sciences (NIGMS) 95 NATIONAL Heart, Lung, and Blood Institute (NHLBI) 104 NATIONAL Human Genome Research Institute (NHGRI) 109 NATIONAL Institute of Mental Health (NIMH) 113 NATIONAL Institute on Minority Health and Health Disparities (NIMHD) 123 NATIONAL Institute of Neurological Disorders and Stroke (NINDS) 126 NATIONAL Institute of Nursing Research (NINR) 130 NATIONAL Center For Advancing Translational Sciences (NCATS) 133 NATIONAL Center for Complementary and Integrative Health (NCCIH)

4 138 NATIONAL Library of Medicine (NLM) 143 Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of Research Infrastructure Programs (ORIP) 145 CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) 150 Center For Global Health (CGH) 152 NIH, CDC, FDA, and ACL Program Descriptions and Research Topics iv NATIONAL Center on Birth Def ects and Developmental Disabilities (NCBDDD) 154 NATIONAL Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) 156 NATIONAL Center for Emerging and Zoonotic Infectious Diseases (NCEZID) 161 NATIONAL Center f or Environmental Health (NCEH) 164 NATIONAL Center f or HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) 167 NATIONAL Center for Immunization and Respiratory Diseases (NCIRD) 171 NATIONAL Center for Injury Prevention and Control (NCIPC) 172 NATIONAL Institute for Occupational Safety and Health (NIOSH) 179 FOOD AND DRUG ADMINISTRATION (FDA) 184 Center for Biologics Evaluation and Research (CBER) 184 Center for Drug Evaluation and Research (CDER) 185 Center for Food Safety and Applied Nutrition (CFSAN) 186 Center f or Devices and Radiological Health (CDRH) 187 Center for Veterinary Medicine (CVM)

5 188 Office of Critical Path Programs 189 Office of Orphan Products Development 190 NIH, CDC, FDA, and ACL Program Descriptions and Research Topics v PROGRAM DESCRIPTIONS AND RESEARCH GRANT TOPICS The research topics shown in this SOLICITATION represent program areas that may be of interest to s mall businesses and fall within the missions of the NIH, CDC, and FDA. Small businesses are encouraged to s ub mit SBIR and STTR grant applications in these areas. Information about the HHS SBIR and S TTR programs for applicants and awardees, including resources and programs available to HHS SBIR and STTR awardees, can be found at APPLICABLE TO NIH and CDC ONLY: SBIR and STTR grant applications will be accepted and considered in any area within the mission of the awarding components ( , Institutes and Centers (ICs)) identified in this SOLICITATION .

6 Applicants are strongly encouraged to subscribe to the NIH Guide for Grants and Contracts LISTSERV ( ) or query program administrators periodically via email to learn of new or emerging scientific interests of the NIH, CDC, and FDA awarding components. You may also subscribe to the SBIR-STTR LISTSERV list to get timely information about the NIH SBIR and S TTR P ro g ram s ( ). Additional information on each of the awarding components (ICs) and their research interests is available electronically on the home pages shown throughout the Research Topics section of the SOLICITATION . NATIONAL INSTITUTES OF HEALTH (NIH) NIH is the steward of medical and behavioral research for the Nation. Its mission is science in pursuit of f undamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability.

7 The goals of the agency are as f ollows: 1. to f oster fundamental creative discoveries, innovative research strategies, and their applications as a basis for ultimately protecting and improving health; 2. to develop, maintain, and renew scientific human and physical resources that will assure the Nation's capability to prevent disease; 3. to expand the knowledge base in medical and associated sciences in order to enhance the Nation's economic well-being and ensure a continued high return on the public investment in research; and 4. to exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science. In realizing these goals, the NIH provides leadership and direction to programs designed to improve the health of the Nation by conducting and supporting research: in the causes, diagnosis, prevention, and cure of human diseases; in the processes of human growth and development; in the biological effects of environmental contaminants; in the understanding of mental, addictive and physical disorders; and in directing programs for the collection, dissemination, and exchange of information in medicine and health, including the development and support of medical libraries and the training of medical librarians and other health information specialists.

8 In addition, the NIH sponsors training of research personnel; career development of new and established scientists; construction and renovation of research facilities and provision of other research resources. NIH, CDC, FDA, and ACL Program Descriptions and Research Topics vi Inf ormation about the NIH SBIR and STTR programs for applicants and awardees, including resources and programs available to NIH SBIR and STTR awardees, can be found at To carry out these responsibilities, the NIH is organized into awarding components (Institutes and Centers). Those components that have an extramural element, that is, those that provide funds for research and research training activities in organizations external to the NIH, are shown below.

9 The NIH makes every effort to finance worthy applications, including the co-funding of such applications by one or more awarding components having relevance in the projects. Total f unding support (direct costs, indirect costs, fees) normally may not exceed $259,613 for Phase I awards and $1,730,751 for the duration of the Phase II awards. However, this amount is subject to change and the most current information can be found on the Small Business Administration (SBA) SBIR web site. Awards exceeding these amounts may be made at the discretion of an Institute or Center for applications wit hin one of the SBA-Approved Waiver To pics. Applicants considering a requested budget greater than these limits are strongly encouraged to contact program staff before submitting an application.

10 Funding levels for projects are determined through the combined interaction among peer review, grants management, program, budget, and other Institute and/or Center staff. These levels are based on allowable costs that are consistent with the principles of sound cost management and in consideration of Institute or Center priorities, constraints on the growth of average grant costs, and the availability of f unds. Bef ore considering and/or preparing an application to the SBIR and STTR programs, all applicants are strongly encouraged to review the agencies and NIH Institutes and Centers websites and to contact the SBIR and STTR program coordinators listed below. The Fogarty International Center, which provides support only for conferences, postdoctoral fellowships for research in the United States and abroad, and senior scientist exchanges between the United States and other countries, does not participate in the SBIR and STTR program.