Notice of Intent to Publish a Funding Opportunity Announcement for New Ways to Counteract Prescription Drug Diversion and Abuse (Small Business Innovation Research [SBIR R43/44])

Notice Number: NOT-DA-13-020

Key Dates
Release Date: April 2, 2013
Estimated Publication Date of Announcement: Summer 2013
First Estimated Application Due Date: Fall 2013
Earliest Estimated Award Date: Spring 2014
Earliest Estimated Start Date: Spring 2014

Issued by
National Institute on Drug Abuse (NIDA)

Purpose

The National Institute on Drug Abuse intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for research on new ways to counteract prescription drug diversion and abuse.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

NIDA also welcomes and strongly encourages all inquiries concerning this Notice from potential applicants. Early communication with Program Staff will provide an opportunity to clarify specific characteristics of the SBIR program goals and guidelines, and hone the scope of projects that are likely to be judged responsive.

The FOA is expected to be published in Summer 2013 with an expected application due date in Fall 2013.

This FOA will utilize the R43/44 activity code. Details of the planned Funding Opportunity Announcement (FOA) are provided below.

Research Initiative Details

Prescription drug diversion and abuse represent a continuing problem for the United States. This problem increasingly stems from the abuse of opioid drugs, such as hydrocodone, oxycodone, and codeine, prescribed by physicians to treat pain. Medications like these have a high potential for abuse, and abuse rates have more than quadrupled since 1990. Prescription drug diversion involves the unlawful channeling of regulated pharmaceuticals from legitimate sources to the illicit marketplace for the use different from prescribed, and can occur along all points in the drug delivery process, from the original manufacturing site to the wholesale distributor, the office of prescribing physician, the retail pharmacy, or the patient.

Opioid diversion and abuse varies significantly across different populations (e.g., experienced prescription opioid abusers, polydrug abusers, pain patient abusers, recreational users, etc.), indicating a variety of products is needed to more comprehensively counteract drug diversion and abuse. Accordingly, the impending FOA is intended to provide support to Small Business Concerns (SBCs) for the development of commercializable products that would serve to diminish (or eliminate) prescription drug diversion and abuse. For example, NIDA and US Food and Drug Administration (FDA) have been charged to “expedite research, through grants on the development of abuse-deterrent formulations (ADF) of opioid medications and other drugs with abuse potential.” While ADFs represent one way to address the problem, any technology that will mitigate diversion and abuse would be responsive to the forthcoming FOA.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:

Elena Koustova, PhD, MBA
Director, Office of Translational Initiatives and Program Innovations
National Institute on Drug Abuse (NIDA)
6001 Executive Blvd - Room 4292
Bethesda, MD 20892-9593
Telephone: 301-496-8768
Fax: 301-594-6043
Email: koustovae@nida.nih.gov