This Funding Opportunity Announcement (FOA), issued by the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA), invites eligible United States small businesses to submit Small Business Innovation Research (SBIR) grant applications. United States small businesses that have the research capabilities and technological expertise to contribute to the R and D mission(s) of the NIH, CDC, and FDA awarding components identified in this FOA are encouraged to submit SBIR grant applications in response to identified topics (see PHS 2021-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA. This Parent Funding Opportunity Announcement does not accept clinical trials.

This Funding Opportunity Announcement (FOA) aims to explore the role of adaptive immunity in Alzheimers disease and Alzheimers disease-related dementias (AD/ADRD). Specifically, the FOA seeks an understanding of brain immune surveillance, the generation of CNS-directed immune responses in neurodegenerative disorders, and the functional role of adaptive immunity in AD/ADRD onset and progression.

This funding opportunity announcement (FOA) encourages applications for the Chronic, Non-Communicable Diseases and Disorders Across the Lifespan: Fogarty International Research Training Award (NCD-LIFESPAN) D43 program for institutional research training programs in low-and middle-income countries (LMICs, as defined by the World Bank classification system). Applications may be for collaborations between institutions in the U.S and an eligible LMIC or may involve just LMIC institutions if there is a previous track record of externally funded research and/or research training programs by the lead LMIC institution. The proposed institutional research training program is expected to sustainably strengthen the NCD research capacity of the LMIC institutions, and to train in-country experts to develop and conduct research on NCDs across the lifespan, with the long-range goal of developing and implementing evidence-based interventions relevant to their countries. The main focus of research training covered in the application must be relevant to the interests of at least one of the participating NIH ICs as stated by each in this FOA. Other NCD topics may be included as secondary and complementary focus areas. This Funding Opportunity Announcement (FOA) allows support of trainees as the lead investigator of an independent clinical trial; or a separate ancillary study to an existing trial; or to gain research experience in a clinical trial led by another investigator, as part of their research and career development.

This Funding Opportunity Announcement (FOA) encourages small business applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing clinical studies. Diseases chosen for study should be based on the NINDS strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm). Successful applicants will be given access to the NeuroNEXT infrastructure. Following peer review, NINDS will prioritize and order trials that are given access to the NeuroNEXT infrastructure. The NeuroNEXT Clinical Coordinating Center (CCC) will work with the successful applicant to efficiently implement the proposed study. The NeuroNEXT Data Coordinating Center (DCC) will provide statistical and data management support. The NeuroNEXT clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol. Applicants do not need to be part of the existing NeuroNEXT infrastructure.