Purity Specifications, Storage and Distribution for Medications Development

Notice Number: NOT-DA-07-020


Key Dates
Release Date:  November  8 , 2006

Issued by
National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov)

The National Institute on Drug Abuse is soliciting proposals from qualified individuals or organizations having the capability to act as a centralized repository for compounds from domestic and international investigators, commercial sources, and pharmaceutical companies.     The contract shall involve the receipt, purchase, storage and analysis of compounds from various sources, and the shipment of these compounds to domestic and international test sites, as well as maintenance of an extensive inventory and tracking system. The major goal of this project is to provide NIDA with a holding site which has the capability to inventory, analyze and store compounds, prepared under both non-GMP and GMP conditions, in amounts ranging from milligram quantities to several kilograms.     Because some compounds may be scheduled under the Controlled Substances Act, proper DEA registration and adequate security is required. All studies must be carried out under pertinent FDA regulations, such as current Good Clinical Practice (cGCP) and current Good Laboratory Practice (cGLP) regulations. To handle substances under the Controlled Substances Act of 1970, DEA Research Registration for Schedules II to V will be required.     NIDA may also require a DEA registration for Schedule I controlled substances. The pertinent FDA's guidelines/guidance shall be followed.     It is estimated that a five year incrementally funded completion type contract with additional option quantities will be awarded. RFP No.     N01DA-7-8873 will be available electronically on or about November 3, 2006.     You can access the RFP through the FedBizOpps http://www.fedbizopps.gov or through the NIDA website at the following address: http://www.nida.nih.gov/RFP/RFPList.html. The electronic RFP contains all information needed to submit a proposal. No printed version of the solicitation document or source list is available. NIDA will consider proposals submitted by any responsible offeror. Proposals will be due on or about December 20, 2006. This advertisement does not commit the Government to award a contract.


Amy Sheib, Contract Specialist
National Institute on Drug Abuse, NIH
Contracts Management Branch, OPRM
6101 Executive Blvd., Room 260, MSC 8402
Bethesda, Maryland  20892-8402
E-mail: ap370t@nih.gov
Telephone: (301) 443-6677
Fax:  (301) 443-7595

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