Analytical Chemistry and Stability Testing of Treatment Drugs

Notice Number: NOT-DA-09-023

RFP Available: N01DA-9-8890

Key Dates
Release Date: December 16, 2008
Proposal Due Date:  February 10, 2009

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

The National Institute on Drug Abuse plans to procure services soliciting proposals from qualified organizations having the capability to carry out the work for the development and validation of analytical methods, preparation of reference standards, carrying out quality control tests, storage and distribution of drug substances and drug products, and performing stability studies for the compounds and dosage forms to be used in the medications development program.  The NIDA Division of Pharmacotherapies and Medical Consequences of Drug Abuse (DPMC) will use the data produced by this acquisition in the preparation of Drug Master File (DMF), Investigational New Drug (IND) or New Drug Application (NDA) submitted by NIDA or NIDA supported investigators to the FDA.

In order to handle substances under the Controlled Substances Act of 1970, the successful offeror must possess a current DEA registration for Schedules II-V substances for both narcotics and non-narcotics, and demonstrate the capability to obtain DEA Registration for Schedule I controlled substances.  In addition, the successful offeror must also possess DEA registrations for distribution, importation and exportation of controlled substances.  The offeror must have a vault for Schedules I and II and Schedules III-V raw materials and finished products that meets standards described in 21 CFR Part 1301.72.  The vault should have a minimum of 300 square feet in area and refrigerators and freezers located inside the vault.  The offeror must have a computerized shipment tracking system.

We anticipate the award of one cost reimbursement contract for a period of three years and 2 one-yr options.  There are also options for increase in quantity.  RFP No. N01DA-9-8890 will be available electronically on or about December 19, 2008.  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. Response to the RFP will be due on or about February 10, 2009.  NIDA will consider proposals submitted by any responsible offeror.  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.  


Point of Contact:

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  
Fax:  (301) 443-7595

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