Preparation and Distribution of Research Drug Products

Notice Number: NOT-DA-09-030

RFP Available: N01DA-10-7772

Key Dates
Release Date:  July 31, 2009
Proposals Due: August 10, 2009

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

The National Institute on Drug Abuse (NIDA) is soliciting proposals from qualified organizations able to analyze and characterize various cannabinoids and other drugs of abuse; produce drug dosage forms of cannabinoids and other drugs of abuse, such as delta-9-tetrahydrocannabinol ()9-THC); methadone, morphine, and naltrexone pellets; acquire, develop and produce reduced nicotine cigarettes of varying strengths and specifications; and maintain an inventory and supply of various DEA scheduled and unscheduled chemicals and drugs. The offeror must 1)possess extensive experience in the field of analytical and pharmaceutical chemistry, preparation of drug dosage forms, analysis and characterization of controlled drugs and drug compounds; 2) develop and manufacture of research cigarettes; 3) demonstrate extensive experience in handling and shipping of DEA controlled drug compounds and drugs within United States and other countries as well as the ability to obtain import and export permits;  4) possess suitable instruments for analytical work such as GC, GC-MS, LC-MS; 5) have a facility and equipment to house a safe and secure DEA approved storage vault for storing approximately 100 to 200 drug compounds & their various drug dosage forms, 200,000 to 1,000,000 research cigarettes under controlled temperature;  6) have a secure video monitored quality control shipping facility while having an expertise in controlled and hazardous materials handling and shipping.

NIDA anticipates the award of one cost reimbursement contract for a period of 5-years with option quantities.

MANDATORY REQUIREMENT: The successful offeror must indicate possession of a current Schedule I and II manufacturer license, Schedule I and II researcher license, Schedule I and II distributor license, and a Schedule I and II exporter and importer license. Offerors must possess these required licenses or demonstrate their ability to obtain them at the time of proposal submission. Award will not be made to any offeror who has not obtained the specified licenses. NIDA anticipates awarding a five year contract with quantity options.

RFP No. N01DA-10-7772 is available electronically.  You can access the RFP through the FedBizOpps (URL: or through the NIDA website: (URL: All information required for the submission of a proposal will be contained in or accessible through the RFP package.  Proposals are due August 10, 2009. Any responsible offeror may submit a proposal that will be considered by the Government.  Following proposal submission and the initial review, the Contracting Officer may require additional documentation from offerors in the competitive range. This advertisement does not commit the Government to award a contract.


Diane M. Loeb, Contract 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

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