Navigating the Latest NIH Omnibus Solicitations: Key Changes and Updates

As of July 3, 2024, The PHS 2024-2 omnibus solicitations of the NIH, CDC, and FDA for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grant applications have been released. The first application due date is Thursday, September 5, 2024, so start preparing your application today.

These solicitations—PA-24-246, PA-24-245, PA-24-247, and PA-24-248 —introduce several notable changes and updates that applicants should be aware of. Here’s what you need to know to stay ahead.

See all solicitations by NIH here – 👉 https://seed.nih.gov/small-business-funding/find-funding/sbir-sttr-funding-opportunities

Clinical Trials: Required or Not?

The most significant distinction between these solicitations lies in the requirement for clinical trials:

This clear demarcation allows applicants to tailor their proposals based on the nature of their research and development activities, ensuring they align with the solicitation’s requirements.

Streamlined Submission Process

The NIH continues to offer flexibility in the application process, maintaining several submission options:

  1. NIH ASSIST: This system facilitates the preparation, submission, and tracking of applications online.
  2. Institutional System-to-System (S2S) Solutions: These are institutional tools that submit applications to Grants.gov and track them via eRA Commons.
  3. Grants.gov Workspace: A widely-used platform for preparing and submitting applications, with tracking capabilities through eRA Commons​ (NIH Grants)​.

By offering these varied submission methods, NIH ensures that applicants can choose the most convenient and efficient means to submit their proposals.

Budget Increases

The maximum total funding support has increased for both Phase I and Phase II awards:

  • Phase I: From $295,924 to $306,872.
  • Phase II: From $1,972,828 to $2,045,816​ (NIH Grants)​.

Submission Deadlines

The proposal submission system will stop accepting proposals at 5:00 p.m. “submitting organization’s local time.” This is a firm deadline (no grace period). Proposers are strongly urged to submit well before the deadline.

  • September 05, 2024
  • January 05, 2024
  • April 05, 2025

Big differences between each of the four solicitations

PA-24-246 and PA-24-245 are for SBIR applications, with the former requiring clinical trials and the latter not allowing them. PA-24-247 and PA-24-248 are for STTR applications, with the former not allowing clinical trials and the latter requiring them. Each solicitation supports different phases of research and development efforts to commercialize innovations in health and technology.

  • PA-24-246: PHS 2024-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required).
    • Objective: This solicitation requires that the SBIR applications propose at least one clinical trial. It supports small businesses in conducting research and development with strong commercialization potential that aligns with the missions of the NIH and CDC.
    • Phases: It includes Phase I, Phase II, Direct to Phase II, Fast-Track, and Phase IIB
    • Learn More here – 👉 https://grants.nih.gov/grants/guide/pa-files/PA-24-246.html
  • PA-24-245: PHS 2024-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed).
    • Objective: This solicitation is for SBIR applications that do not propose any clinical trials. It also aims to support small businesses in research and development efforts with a focus on commercialization potential.
    • Phases: Similar to PA-24-246, it includes Phase I, Phase II, Direct to Phase II, Fast-Track, and Phase IIB.
    • Learn More here – 👉 https://grants.nih.gov/grants/guide/pa-files/PA-24-245.html
  • PA-24-247: PHS 2024-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed).
    • Objective: This solicitation focuses on the STTR program, which fosters technology transfer through cooperative research and development between small businesses and research institutions. Clinical trials are not allowed under this announcement.
    • Phases: Includes Phase I and Phase II.
    • Learn More here – 👉 https://grants.nih.gov/grants/guide/pa-files/PA-24-247.html
  • PA-24-248: PHS 2024-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required).
    • Objective: This solicitation also pertains to the STTR program but requires that the applications propose at least one clinical trial. It aims to support research and development efforts that require clinical trials and foster partnerships between small businesses and research institutions.
    • Phases: Includes Phase I and Phase II.
    • Learn More here – 👉 https://grants.nih.gov/grants/guide/pa-files/PA-24-248.html

Staying updated on the latest changes to the NIH Omnibus solicitations is crucial for small businesses looking to leverage SBIR and STTR funding. The new solicitations highlight the NIH’s ongoing efforts to enhance these programs, ensuring that small businesses can effectively contribute to and benefit from federal R&D initiatives.

By understanding these updates and aligning proposals accordingly, small businesses can maximize their chances of securing funding and advancing their innovative projects. Of course, for best results, it is always advisable to hire a proposal preparation subject matter expert to provide you with the most competitive proposal possible.


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