Addition of SBIR Direct-to-Phase II Application Type to NIAAA PA-18-578 "Investigational New Drug (IND)-enabling Development of Medications to Treat Alcohol Use disorder and Alcohol-related disorders (U44 - Clinical Trial Optional)"

Notice Number: NOT-AA-18-013

Key Dates
Release Date: December 4, 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 flexbility' 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 isnotavailable to the STTR program andnotavailable for the CDC, FDA, and ACL SBIR progams.

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-18-578 " Investigational New Drug (IND)-enabling Development of Medications to Treat Alcohol Use disorder and Alcohol-related disorders Clinical Trial Optional - U44", to allow SBIR Direct-to-Phase II submissions.

Section below in PA-18-578 is modified to include the indicated sub-section:

Section III. Eligibility Information.

1. Eligible Applicants

SBIR Direct-to-Phase II submissions

NIAAA stronglyencourages small businesses to contact the FOA Program contact early in their application planning process.

An updated SBIR/STTR Application Guide with additional instructions for SBIR Direct Phase II application preparation and submission will be posted by November 26, 2018.

All other aspects of PA-18-578remain unchanged.



Please direct all inquiries to:

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