Notice to allow SBIR Direct-to-Phase II Application Type for NIAAA-issued Funding Opportunity Announcement PAR-18-786, "Wearable Alcohol Biosensors (SBIR) (R43/R44- Clinical Trial Optional)"

Notice Number: NOT-AA-18-011

Key Dates
Release Date:October 15, 2018

Related Announcements

Issued by
National Institute on Alcohol Abuse and Alcoholism (NIAAA)


Section 5106 of the SBIR/STTR Reauthorization Act of 2011 authorized that NIH may ‘issue a Phase II award to a small business concern that did not receive a Phase I award for that research/research & development'. This 'phase flexibility' is called a ‘Direct-to-Phase II’ SBIR award. The original authority for this provision had expired on 9/30/2017. Recent legislation P.L. 115-232 re-instated this SBIR Direct Phase II provision through Fiscal Year 2022.

The SBIR Direct-to-Phase II authority is not available to the STTR program and not available for the CDC, FDA, and ACL SBIR programs.

As such, NIH is re-implementing the SBIR Direct-to-Phase II program. The prior program had specific SBIR Direct-to-Phase II funding opportunity announcements (FOAs). The transition to FORMS-E earlier this year now allows NIH to track SBIR Direct-to-Phase II applications at the Application level, as there is a new check-box on the SBIR/STTR Information Form for Direct Phase II.

As a result of this, NIH does not need to issue separate SBIR Direct-to-Phase II FOAs as before, but can offer Direct-to-Phase II as an allowable Application Type on any SBIR FOA.

NIAAA is therefore amending PA-18-786 "Wearable Alcohol Biosensors (SBIR [R43/R44] Clinical Trial Optional) ", to allow SBIR Direct-to-Phase II submissions.

NIAAA strongly encourages small businesses to contact the FOA Program contact early in their application planning process, as well as to read the SBIR/STTR Application Guide for instructions on grant application preparation and submission.

Section below in PA-18-786 has been updated to reflect the change:

currently reads:

Section II. Award Information

Application Types Allowed

New (Phase I, Fast-Track))
Renewal (Phase II* Direct Phase II not allowed)
Resubmission (all phases)
Phase IIB Competing Renewal (Phase IIB)

revised to read:

Section II. Award Information

Application Types Allowed

New (Phase I, Fast-Track)
New (Phase II - SBIR Direct Phase II)
Renewal (Phase II)
Resubmission (all phases)
Phase IIB Competing Renewal (Phase IIB)

All other aspects of PA-18-786 remain unchanged.


Please direct all inquiries to:

Megan Ryan, M.B.A.
Telephone: 301-443-4225