NIH Entrepreneurship News: Navigating America’s Seed Fund at NIH, NIH SBIR/STTR Commercialization Readiness Pilot Funding Opportunities

National Institutes of Health Office of Extramural Research sent this bulletin at 07/31/2023 03:50 PM EDT

July 31, 2023

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Upcoming Events

Navigating America’s Seed Fund at NIH

You may be familiar with America’s Seed Fund, also known as the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) program, which offers small business entrepreneurs in the life sciences more than $1.3 billion in non-dilutive funding. But did you know there have been changes to the program?

Attend this informational webinar on Tuesday, August 8, at 1:00 p.m. ET to learn about these changes, which include increased minimum performance standards, pre-and-post-award foreign disclosure requirements, and changes to the peer review process. You’ll also learn about open funding opportunities, including the current Omnibus grant solicitations, and how to apply.

There will be a live Q&A session following the presentation.

Speaker: HHS Small Business Program Lead Stephanie Fertig

Moderator: NIH Small Business Policy Manager Adam Sorkin

Can’t make it? The webinar will be recorded and posted online about seven business days after the event.

Register Now

Applicant Assistance Program Webinar

Are you in need of Phase I SBIR/STTR application preparation support? The Applicant Assistance Program (AAP) offers biotech innovators assistance from grant specialists to help write a more competitive Phase I Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) application.

If this opportunity interests you, attend this webinar on Tuesday, August 8, at 2:00 p.m. ET. Program experts will give a detailed explanation of the program before opening up the event for questions. Register today to receive insights on how AAP can help you move forward with your commercialization journey!

Register Now

There's still time...

Ongoing

Accepting Requests: SEED Company Showcase Program

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News

NIH SBIR/STTR Commercialization Readiness Pilot Funding Opportunities

The new Commercialization Readiness Pilot (CRP) Program funding announcements have been released. These opportunities are for those with NIH SBIR or STTR Phase II or Phase IIB contract or grant awards from one of the participating NIH Institutes or Centers within the last 36 months.

PAR-23-219: SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development - Clinical Trial Not Allowed
PAR-23-220: SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development - Clinical Trial Required

Key updates

All applicants should submit a new application (Type 1) regardless of whether the Phase II award is active or has ended.
The standard resubmission policy applies as long as applicants have a qualifying Phase II application.
Applicants seeking technical assistance only should use PAR-23-219.

The next receipt date is Tuesday, September 5, 2023.

Learn More

Foreign disclosure requirements for SBIR/STTR applications received on/after September 5, 2023

When the SBIR, STTR, and related pilot programs were reauthorized for FY2023-2025, the SBIR and STTR Extension Act of 2022 made several changes to the SBIR and STTR programs. Policy changes were announced June 12 through this Notice: Implementation of the NIH SBIR and STTR Foreign Disclosure Pre-award and Post-Award Requirements (NOT-OD-23-139).

Key elements include:

disclosure requirements regarding ties to foreign countries,
a requirement for federal agencies that manage SBIR and STTR programs to establish a due diligence program to assess security risks posed by applicants, and
denial of award and recovery authority provisions when ties to foreign countries of concern pose a significant risk.

This policy applies to all NIH, CDC, FDA, and ACL competing applications for SBIR or STTR funding on or after September 5, 2023. More information and resources will be provided in the near future.

Learn more about this policy in the Notice.

Phase I Awardees - Request Your TABA Needs Assessment Report Today!

Recent Phase I NIH SBIR or STTR awardees (grant, contract, or Fast-Track) may request a free Technical and Business Assistance (TABA) Needs Assessment Report provided by RTI Innovation Advisors that provides an assessment of your project’s progress in four technical and business areas:

Market Needs/Competitive Advantage
Intellectual Property/Barriers to Entry
Business Model Profitability
Manufacturing, Regulatory, and/or Clinical Plan

The Needs Assessment Report helps companies strategize for their project’s next steps. There is no cost for this report and the time commitment for participation is minimal.

Learn More

Funding Opportunities

NIH SBIR & STTR Grant Funding Opportunities

The NIH Small Business Program is accepting applications for SBIR & STTR funding. Learn more about these open opportunities.

Learn how to apply and what to do if you encounter systems issues.

Next receipt date: Tuesday, September 5, 2023.

New NIDA Small Business Funding Opportunity for Point-of-Need Diagnostics and Treatments

NIDA recently released a new funding opportunity that is soliciting proposals for the development of approaches and technologies that can potentially lower the barriers to diagnosis and treatment at any stage of the patient journey through substance use disorder (SUD).

There are significant hurdles individuals face in receiving diagnosis and treatment for SUD, for example, living in a low-resource setting or in a rural area, traveling to multiple in-person visits for diagnosis and treatment, and encountering stigma during the process. You can find more information about the Field-Deployable, Low-Cost Point-of-Need Approaches and Technologies to Lower the Barriers to Substance Use Disorders (SUD) Diagnosis and Treatment funding opportunities here: RFA-DA-24-018 (SBIR); RFA-DA-24-017 (STTR).

You may also contact NIDASBIR@nih.gov if you are interested in a technical assistance meeting with a program officer.

Application Deadline: Friday, November 10, 2023.

Learn more about current funding opportunities.

NIDA Soliciting Regulated Therapeutic and Diagnostic Solutions for Opioid and/or Stimulants use Disorders (OUD/StUD)

NIDA is seeking to fund the development of novel pharmacotherapeutics and medical therapeutic and diagnostic devices, including software as a medical device, to help overcome the current drug crisis that has seen an increase in overdose deaths from opioids and psychostimulants. While there are some FDA-approved pharmacotherapeutics and medical devices, there are no approved medications for stimulant use disorder (StUD), and there are barriers to treatment and retention in treatment for opioid use disorder (OUD). Investigators and developers of biomedical technologies that lead to the prevention, monitoring, diagnosis, and treatment of OUD/StUD are highly encouraged to apply. More information can be found here: RFA-DA-23-021 (SBIR); RFA-DA-24-038 (STTR).

You may also contact NIDASBIR@nih.gov if you are interested in a technical assistance meeting with a program officer.

Application deadlines: Tuesday, August 15, 2023; Wednesday, February 14, 2024; Tuesday, August 13, 2024.

Learn more about current funding opportunities.

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