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Preparation and Distribution of Research Drug Products

Solicitation Number: N01DA-15-7792
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Institute on Drug Abuse
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N01DA-15-7792
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Presolicitation
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Added: May 29, 2014 5:42 pm
The National Institute on Drug Abuse (NIDA) plans to solicit proposals under full and open competition procedures from qualified organizations having the capability to acquire, analyze, characterize, and ship various drugs of abuse including cannabinoids and other research chemicals; produce drug dosage forms such as delta-9-tetrahydrocannabinol (delta-9-THC), methadone, morphine, and naltrexone pellets; acquire, develop, and produce marijuana and nicotine research cigarettes of varying strengths and specifications; and maintain an inventory and supply of various Drug Enforcement Administration (DEA) scheduled and unscheduled chemicals and drugs. The offeror must possess extensive experience to carry out the project tasks and demonstrate the availability of adequate and secure facilities and equipment.

In brief, NIDA plans to perform the following through this contract:


(1). Acquire drugs and/or chemical compounds from domestic sources,


(2). Import and export drugs/chemical compounds from foreign sources,


(3). Determine the purity and stability of bulk drugs and other chemical compounds in the NIDA drug supply inventory periodically, or as required by the NIDA Contracting Officer's Representative (COR),


(4). Develop methods to prepare and analyze drug dosage forms, such as (but not limited to) pellets of morphine, naltrexone, methadone (of various strengths) with their placebo counterparts; cannabinoid preparations (such as, delta-8, and delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, cannabichromene); and/or any other drug of interest,


(5). Maintain active inventory of all required bulk drugs and other chemical compounds for research purposes,


(6). Store and supply bulk drugs and other chemical compounds for research as required by NIDA,


(7). Manufacture, analyze, store, and supply marijuana cigarettes as required by NIDA,


(8). Develop, analyze, store, and supply nicotine research cigarettes (NRCs) for research as required by NIDA, and


(9). Develop, prepare and amend current NIDA Drug Master File (DMF) on marijuana, and marijuana cigarettes and Tobacco Product Master File (TPMF) on NRCs annually or as needed by the NIDA COR.


The successful offeror must indicate possession of a current DEA 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 contract award. Award will not be made to any offeror who has not obtained the specified licenses.


NIDA anticipates the award of one cost reimbursement indefinite delivery indefinite quantity contract for a period of five years. NIDA anticipates awarding task orders as needed throughout the period of performance to maintain flexibility in issuing work. This award is a competitive renewal of HHSN271201000003C, titled "Preparation & Distribution of Research Drug Products."


RFP No. N01DA-15-7792 will be available electronically on or about June 13, 2014. You can access the RFP through the FedBizOpps (URL: http://fedbizopps.gov), through the NIDA website (URL: http://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps), or via the NIH Guide. All information required for the submission of a proposal will be contained in or accessible through the RFP package. Responses to the RFP will be due 45 days from the release date. NIDA anticipates a January 2015 award date. NIDA will consider proposals submitted by any responsible offeror. This advertisement does not commit the Government to award a contract.


Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the Contracting Officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice.

:
6001 Executive Boulevard
Room 4211 - MSC 9559
Bethesda, Maryland 20892
United States
:
Philip DeCastro,
Contract Specialist
Phone: 3014436677
:
Brian H O'Laughlin,
Contracting Officer
Phone: (301) 443-6677
Fax: (301) 443-7595