Analytical Chemistry and Stability Testing of Treatment Drugs for Substance Use Disorders

The National Institute on Drug Abuse (NIDA) plans to solicit proposals under full and open competition procedures from qualified organizations 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 Therapeutics and Medical Consequences (DTMC) 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. This is a follow-on procurement to Contract Number HHSN271201400054C titled "Analytical Chemistry and Stability Testing of Treatment Drugs for Substance Use Disorders." It is estimated that a cost reimbursement, level of effort type contract will result from this procurement which will include a one-year base period and four one-year options to extend performance. Additional option quantities will also be included. MANDATORY CRITERIA In order to handle substances under the Controlled Substances Act of 1970, it is mandatory that offerors possess a Drug Enforcement Administration (DEA) Registration for Chemical Analysis or 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. The proposed facility must meet cGMP compliance. NOTICE RFP No. 75N9502019R00003 will be available electronically on or about 15 days from the date of this posting. You can access the RFP through the FedBizOpps (URL: http://www.fbo.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 45 days from the release date. NIDA anticipates an award on or before August 2019. 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 or organizations 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.