Notice to Inform the Applicant Community that NIDDK Will Not Accept Clinical Trial Applications in Response to Current Small Business Announcements

Notice Number: NOT-DK-16-030

Key Dates
Release Date:  October 4, 2016

Related Announcements

PA-16-303
PA-16-302
PAR-16-027
PAR-16-026
PA-15-077
PA-15-076
PAR-14-088
PA-14-059
PA-14-058
PA-14-054
PA-14-055
PA-14-204

Issued by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Purpose

Effective January 5, 2017, NIDDK will no longer accept clinical trial applications to the PHS 2016-02 Omnibus Solicitation of the NIH, CDC, FDA, and ACF for the Small Business Innovation Research (SBIR) PA-16-302, and Small Business Technology Transfer (STTR), PA-16-303 programs, or to any small business Funding Opportunity Announcement (FOA) in which NIDDK currently participates (see Related Announcements above) including the Direct Phase II or Commercialization Readiness Pilot (CRP) solicitations, wherein an intervention (drugs, biologics, or devices, as well as surgical, behavioral or rehabilitation therapies) is being evaluated (e.g., for safety or efficacy) in human subjects. This includes Phase I, Phase II, Fast-Track, and Phase IIB applications. The NIDDK will allow SBIR clinical trial applications through specific funding opportunities to be announced shortly. The NIDDK will not allow STTR clinical trials at this time. For the NIH Clinical Trial Definition, please see NOT-OD-15-015.

Inquiries

Please direct all inquiries to:

Daniel Gossett, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7723
Email: daniel.gossett@nih.gov