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

A. Objectives:

The National Institute on Drug Abuse (NIDA) intends to solicit proposals under full and open competition from qualified and capable offerors having the ability to perform the following services:

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 testing of drug substances and/or drug products;
4. Determination of stability of drug substances and/or finished dosage forms according to the FDA Guidance for Industry: Q1A (R2) Stability Testing of New Drug Substances and Products;
5. Provision 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) documentation.

Independently and not as an agent of the Government, the Contractor shall furnish all necessary labor, facilities, materials (except experimental bulk drugs and drug products), supplies, equipment, and services (except as otherwise specified herein) and perform the work as generally described above. Bulk drug substances will generally be provided by the Government at the time of approval of the delivery schedule by the Contracting Officer’s Representative.

This is a follow-on procurement to Contract Number 75N95019C00042 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.

B. Mandatory Criteria: 

This acquisition includes the following special or unique performance or capability requirements:

DEA RESEARCH REGISTRATION

This project involves the use of scheduled drugs under the Controlled Substances Act of 1970. Due to the nature of the compounds which will be evaluated under this contract, it is mandatory that the Offeror (prime and/or subcontractor) possess a DEA Research Registration for Schedules II to V in order to handle substances under the Controlled Substances Act of 1970. In addition, the successful Offeror (prime and/or subcontractor) must either possess, or demonstrate the ability to obtain, a DEA registration for Schedule I controlled substances, as well as the ability to distribute, import and export controlled substances.

cGMP Compliance

All manufacturing facilities (prime and/or subcontractor) must comply with the FDA’s current Good Manufacturing Practices (cGMP). A copy of the most recent FDA cGMP inspection report (and/or a table referencing the inspection history by the FDA and if findings were noted) for all proposed manufacturing facilities must be included with Offeror’s proposal. Facilities must include a DEA approved vault securely to store controlled drug substances/products.

C. Additional Information:

RFP No. 75N95024R00045 will be available electronically on or about February 12, 2024. You can access the RFP through the beta.SAM.gov or through the NIDA website: (URL: https://nida.nih.gov/funding/nida-office-acquisitions-contracting#RFP). 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 approximately 45 days from the release date. 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.