B_Presolicitation Notice.pdf

Document Type: Presolicitation Notice

Solicitation No. 75N95024R00058 (NIDA ref # N01DA-24-8915)

Project Title: GMP Synthesis of Bulk Drug Substances

Classification Code: A—Research & Development

NAICS Code: 541715 – Research and Development in Physical, Engineering and Life Sciences (except Biotechnology)

The National Institute on Drug Abuse (NIDA) intends to solicit proposals using FULL AND OPEN COMPETITIVE procedures from qualified organizations certified under NAICS Code 541715; to manufacture bulk drug substances under Good Manufacturing Practices (GMP), using the regulations and guidelines listed in the Code of Federal Regulations (CFR), Food and Drugs, 21, Part 211, “Current Good Manufacturing Practice for Finished Pharmaceuticals.” These bulk drug substances will be used to support NIDA preclinical safety testing and subsequent safety and efficacy clinical trials.

Offerors must demonstrate the ability to manufacture bulk drug substances under both GMP following relevant Food and Drug Administration (FDA) guidance and regulations (e.g. Code of Federal Regulations (CFR) Title 21) and non-GMP. Offerors must also indicate experience in producing GMP and non-GMP drug substances and appropriately store GMP and non-GMP materials on site.

Additionally, offerors must show experience in preparing reports acceptable in format and substance for adaptation into a Chemistry, Manufacturing and Control (CMC) section for each drug substance for submission to the FDA in support of Investigational New Drug (IND) and New Drug Application (NDA) applications.

This acquisition includes special or unique performance or capability requirements. Due to the nature of the bulk drug substances being used to support NIDA preclinical safety testing and subsequent safety and efficacy clinical trials, it is mandatory that offerors’ facility is in good standing with the FDA. In addition, to handle substances or starting materials under the Controlled Substance Act of 1970, it is mandatory that offerors possess Drug Enforcement Administration (DEA) Research and Manufacturing Registrations for Schedules II to V controlled substances and demonstrate the capability to obtain DEA Research and Manufacturing Registrations for Schedule I controlled substances.

NIDA anticipates the award of a single, five-year, indefinite delivery, indefinite quantity (IDIQ) task order contract. NIDA may award either cost reimbursement and/or fixed price task orders under this contract. Individual Task Orders may include options to extend the period of performance and/or Options for Increased Quantity. If options or option quantities are utilized for an individual task order the will be clearly defined in the Task Order RFP and be determined and evaluated at the time of task order solicitation and award. NIDA anticipates that at least one or more task orders will be awarded with the contract. Future funding will be made through issuances of task orders and will be dependent on NIDA programmatic needs and availability of funds.

RFP No. 75N95024R00058 will be available electronically on or about March 20, 2024. You will be able to access the RFP through SAM.gov and the NIDA website at the following URL:

http://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps. All information required for the submission of an offer will be contained in or accessible through the RFP package. Responses to the RFP will be due on or about 45 days after release of the RFP. 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.

http://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps