Hello! Thank you for posting your questions.
1) For NSF, the Phase I SBIR budget cap is $256,000 for Phase I and $1,000,000 for Phase II. These are hard caps, and NSF does not offer budget waivers (as is the case for NIH).
For NIH, the Phase I SBIR budget cap is $256,580 for Phase I and $1,710,531 for Phase II. However, NIH applicants may be eligible for additional funding if their project aligns with a published budget waiver topic. Refer to this document for Institute-specific information on budget waiver limits. The budget waiver topics are included in the appendix, or can be viewed separately here. We recommend conferring with an NIH Program Officer to confirm whether your project aligns with a budget waiver topic.
2) Both NSF and NIH fund biomedical/health projects through the SBIR program, but NSF does not support drug development and they generally do not support clinical trials, clinical validation of information technologies or medical devices, or studies performed primarily for regulatory purposes. Limited studies with human subjects may be acceptable to the extent that they are performed with the goal of establishing feasibility of early-stage technologies. If you have difficulty determining whether your technology aligns best with NIH or NSF, we recommend reaching out to a Program Officer/Director to discuss your technology and scope of work.
Please feel free to reach out if you’d like additional clarification!