Toxicological Evaluation of Potential Medications to Treat Drug Addiction

Notice Number: NOT-DA-08-025

RFP Available: N01DA-8-8880

Key Dates
Release Date:  March 3, 2008

Issued by
National Institute on Drug Abuse (NIDA), ( )

The National Institute on Drug Abuse plans to solicit proposals from qualified offerors with the in-house capacity to conduct systematic preclinical toxicology studies and preclinical cardiovascular safety studies that support the development of potential pharmacotherapies for the treatment of drug addiction.  The preclinical studies shall adhere to Good Laboratory Practices (GLP) guidelines as set forth by relevant Food and Drug Administration (FDA) guidance and regulations (e.g. CFR Title 21).

Offerors must have on-site in vivo toxicology (rodent, canine and nonhuman primate) and in vivo cardiovascular safety testing facilities with telemetric recording (dog and nonhuman primate), access to state-of-the-art equipment for performing in vitro tests on cardiac muscle (hERG channel assays and APD tests) and access to state-of-the-art equipment for performing analytical testing of dosing solutions and verification of identity of the bulk substance (HPLC, GC/LC-MS, IR and NMR).  Offerors must show experience in preparing reports in acceptable format for submission to the FDA.    

In order to handle substances under the Controlled Substances Act of 1970, it is mandatory that offerors possess a DEA Research Registration for Schedules II to V and demonstrate the capability to obtain a DEA registration for Schedule I controlled substances.  All offerors must comply with NIH guidelines on the care and use of laboratory animals.    

We anticipate the award of one cost reimbursement contract for a period of five years with additional annual option quantities.  NIDA anticipates release of this solicitation (RFP No. N01DA-8-8880) on or about March 13, 2008, with responses due to be received in the NIDA R&D Contracts Management Branch 45 calendar days thereafter.  You can access the RFP through the FedBizOpps website (URL: ) or through the NIDA website (URL: ).   Award of this contract is anticipated on or about September 1, 2008.  NIDA will consider proposals submitted by all responsible offerors.  This advertisement does not commit the Government to award a contract.     See Note 26.


Robin Jeffries, Contracting Specialist
National Institute on Drug Abuse, NIH
NIDA R&D Contracts Management Branch
6101 Executive Blvd., Room 260, MSC 8402
Bethesda, Maryland  20892-8402
Telephone: (301) 443-6677
Fax:  (301) 443-7595

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