The National Institutes of Health (NIH), including the following NIH Institutes and Centers (ICs): NEI, NHLBI, NHGRI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDCD, NIDCR, NIDDK, NIDA, NIEHS, NIGMS, NIMH, NINDS, NINR, NIMHD, NLM, NCCIH, NCATS, ORIP, NCI and ORWH, along with the Centers for Disease Control (CDC), and the Food and Drug Administration (FDA), intends to publish a Notice of Funding Opportunity (NOFO) to invite eligible United States small business concerns (SBCs) to submit Small Business Innovation Research (SBIR) Phase I, Phase II, Direct to Phase II (NIH Only), Fast-Track (NIH only), and Phase IIB (NIH only) grant applications. Applications are not being solicited at this time. Publication of this solicitation is contingent upon reauthorization and extension of the SBIR program. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This NOFO will utilize the R43/R44 activity code. United States small businesses that have the research capabilities and technological expertise to contribute to the R&D mission(s) of the NIH, CDC, and FDA awarding components identified in this NOFO are encouraged to begin to consider applying for this new NOFO. In addition, collaborative investigations combining expertise will be encouraged, and these investigators should also begin considering applying for this application.