Notice Number: NOT-DA-18-062
Release Date: February 21, 2018
National Institute on Drug Abuse (NIDA)
The National Institute on Drug Abuse (NIDA) intends to solicit proposals from offerors having the capability to perform the following:
A. General Requirements:
Offerors must conduct systematic preclinical toxicology and safety pharmacology studies, and preclinical cardiovascular safety studies that support the development of pharmacotherapies as medications to reduce substance abuse. The preclinical studies shall adhere to Good Laboratory Practice for Nonclinical Laboratory Studies (GLP) guidelines as set forth by relevant Food and Drug Administration (FDA) guidance and regulations (Code of Federal Regulations Title 21, Chapter 1, Subchapter A, Part 58).
B. Specific Requirements:
1. Offerors must have on-site in vivo toxicology (rodent, rabbit, guinea pig, canine and non-human primate) and in vivo cardiovascular safety testing facilities with telemetric recording capability in conscious, unrestrained animals (rat, dog and non-human primate);
2. Offerors must have access to state-of-the-art equipment for performing in vitro tests on cardiac muscle (hERG channel assays and action potential duration tests), access to state-of-the-art equipment for performing mutagenicity and genotoxicity tests and access to state-of-the-art equipment for performing analytical testing of dosing solutions;
3. Offerors must be able to verify the identity of the bulk substance through High Performance Liquid Chromatography (HPLC), Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), Infrared Spectroscopy (IR) and Nuclear Magnetic Resonance Spectroscopy (NMR);
4. Offerors must possess experience conducting rodent, dog and non-human primate GLP studies designed to evaluate the safety of test compounds in the presence of common drugs of abuse, including ethanol, cocaine, methamphetamine and opiates;
5. Offerors must possess experience in preparing reports acceptable in format for both paper and electronic submission to the FDA;
C. Mandatory Evaluation Criteria:
To handle test substances under the Controlled Substances Act of 1970, and prior to award, each offeror must possess a U.S. Drug Enforcement Administration (DEA) Registration for Schedules II to V. In addition, each offeror must either possess, or demonstrate the ability to obtain prior to award, DEA Registration for Schedule I controlled substances.
After the Request for Proposals (RFP) is issued, and prior to award, each offeror must:
Please direct all inquiries to: