Notice Number: NOT-DA-12-030
Release Date: March 1, 2012
National Institute on Drug Abuse (NIDA)
The National Institute on Drug Abuse (NIDA) intends to issue a solicitation seeking qualified businesses with the capability to conduct clinical studies to determine the pharmacokinetics (PK) and pharmacodynamics (PD) of new medications for the treatment of substance use disorders. A solicitation will be released through the Federal Business Opportunies website( URL: https://www.fbo.gov/ ). The RFP will be released on or about February 28, 2012 and proposals will be due approximately 45 days thereafter.
Research Initiative Details
A major mission of NIDA is to develop new medications for the treatment of substance use disorders. Medication development is a long and complex process. It involves the design of new drugs, preclinical evaluations, pharmaceutical development, and clinical evaluations. A critical aspect of the clinical evaluations involves determination of clinical PK and PD of new medications under development. PK which describe the relationships between dose, plasma concentration, and effect, are essential for the understanding of drug action. PK and PD data are necessary for the design of safe and effective pharmacotherapies and PK/PD studies are required by the FDA in every phase of medication development.
All clinical studies must be carried out in compliance with the FDA's current Good Clinical Practice regulations (cGCP). The data and documentation generated should be acceptable to the FDA for support the filing of INDs and NDAs.
Offerors shall demonstrate possession of a Drug Enforcement Administration (DEA) Research Registration for Schedules II to V, and shall demonstrate either possession of or ability to obtain a DEA Research Registration for Schedule 1 under the Controlled Substances Act of 1970.The offerors must have a Federal Wide Assurance (FWA) currently accepted and approved by OHRP (Office for Human Research Protections). The offerors must comply with the requirements in the HHS Protection of Human Subjects regulations at 45 CFR Part 46 and must have a board certified physician on the project.
Please direct all inquiries to:
Brian H. O’Laughlin
NIDA R&D Contracts Management Branch
Office of Acquisitions, NIDA
National Institutes of Health
6001 Executive Blvd., Room 4211 (MSC 9559)
Bethesda, MD 20892-9559
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