Request for Proposals (RFP) Notice: Analytical Chemistry & Stability Testing of Treatment Drugs for Substance Use Disorders

Notice Number: NOT-DA-14-041

Key Dates
Release Date: March 5, 2014

Related Announcements
None

Issued by
National Institute on Drug Abuse (NIDA)

Purpose

The National Institute on Drug Abuse intends to solicit proposals from qualified organizations (NAICS Code 541712) having the capability to perform: (1) development and validation of analytical methods for drug substances and/or finished dosage forms; (2) preparation of reference standards; (3) physical and chemical characterizations and quality control tests of drug substances and/or drug products; (4) determination of stability of drug substances and/or finished dosage forms under accelerated and long-term storage; (5) upkeep of an adequate storage facility for the drug substances and/or finished dosage forms; (6) shipment of drug substances and dosage forms to NIDA designated sites; and (7) maintenance of a database to track the shipment and storage of the drug substances and the finished dosage forms.   The NIDA Division of Pharmacotherapies and Medical Consequences of Drug Abuse (DPMC) will use the data produced by this contract in the preparation of Drug Master File (DMF), Investigational New Drug (IND) and New Drug Application (NDA) documentations.

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.  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 and inventory tracking system.

We anticipate that one (1) cost reimbursement, level of effort type contract will be awarded for a base period of one year and four one year options, additional option quantities will also be included.  RFP No. N01DA-14-8918 will be available electronically on or about March 14, 2014.  You can access the RFP through the FedBizOpps (URL: http://fedbizopps.gov) or through the NIDA website: (URL: http://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps).  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 on or about April 28, 2014. NIDA will consider proposals submitted by any responsible offeror.

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.

This advertisement does not commit the Government to award a contract. 

Inquiries

Please direct all inquiries to:

Ryan Cleary
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-6677
Email: clearyrc@mail.nih.gov

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