Notice Number: NOT-AA-19-029

Key Dates
Release Date: October 24, 2019
First Available Due Date: January 5, 2020
Expiration Date: January 8, 2022

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

Purpose

This NOSI announces the availability of funds for Administrative Supplements to active NIAAA funded SBIR/STTR (R41/R42/R43/R44/U44) grants for regulatory support and to encourage an early meeting or communication with the US Food and Drug Administration (FDA). These funds are intended to provide support for the time, expertise, and personnel costs associated with interacting early and often with the FDA to validate development plans and minimize or eliminate the need to repeat expensive and time-consuming studies which can exhaust limited resources. The funds may be used to obtain regulatory support from a Contract Research Organization or other regulatory expert.

NIAAA is interested in supporting administrative supplement applications where submission of an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application to the US Food and Drug Administration (US FDA) is proposed in the parent grant award.

Application and Submission Information:

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent , through January 7, 2022.

• PA-18-591 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-18-591 must be followed, with the following modifications: .

• Requests may be for one year of support only.
• The Research Strategy section of the application is limited to 6 pages.
• The NIAAA active grants using the mechanisms listed below are eligible:
  • R41 Small Business Technology Transfer (STTR) Grant - Phase I only
  • R41/R42 Small Business Technology Transfer (STTR) Grant - Phase I, Phase II, and Fast-Track
  • R42 Small Business Technology Transfer (STTR) Grant - Phase II only
  • R43 Small Business Innovation Research (SBIR) Grant - Phase I only
  • R43/R44 Small Business Innovation Research (SBIR) Grant - Phase I, Phase II, and Fast-Track
  • R44 Small Business Innovation Research (SBIR) Grant - Phase II only
  • U44 Small Business Innovation Research (SBIR) Cooperative Agreements - Phase II and Fast-Track
  • UT2 Small Business Technology Transfer (STTR) Cooperative Agreement Fast Track
• Individual requests can be no more than $25,000 in direct costs exclusive of Facilities and Administrative costs on sub-contracts for each year of the parent award. Active awards with project end dates in FY 2020 or later are eligible.
• For funding consideration, applicants must include NOT-AA-19-028 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
• Administrative supplements to support the parent grants that are in no cost extension or going into no cost extension are not eligible.
• The process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.
• Applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award that a request has been submitted in response to this FOA in order to facilitate efficient processing of the request.
• All applicants are strongly encouraged to discuss potential requests with their program official and the contact named below to discuss if a project idea falls within the scope of the parent project.

Inquiries

Please direct all inquiries to:

Megan Ryan, M.B.A.
National Institute on Alcohol Abuse and Alcoholism
Telephone: 301-443-4225
Email: [email protected]