SAM #75N98027R00006SB

NIDA Seeks Small-Business Drug Synthesis, Supply, and Distribution Services

NIH’s NIDA is seeking small-business capabilities to support its research drug supply program. - Government buyer: National Institutes of Health (NIH), through the National Institute on Drug Abuse (NIDA) and its Division of Therapeutics and Medical Consequences (DTMC). - Requested services: Synthesize or acquire, test, store, maintain, and distribute controlled and uncontrolled drugs and related research compounds, including cannabinoids, hallucinogens, narcotics and antagonists, stimulants, depressants, and peptides. - Inventory and researcher support: Manage an existing inventory of hundreds of compounds, including kilogram quantities; replenish supplies, identify new compounds, process researcher requests, maintain the Drug Inventory Supply Control System (DISCS), and prepare updated chemical data sheets. - Notable requirements: Maintain compounds at a minimum purity of 95%, with re-purification as needed; provide secure storage and shipment, including appropriate refrigeration; hold DEA Research Registration for Schedules II–V and demonstrate the ability to obtain Schedule I registration. - OEMs and vendors: No commercial OEMs or vendors are named in the notice, and no specific commercial products, part numbers, or quantities are identified. - Opportunity context: This is market research seeking small-business capability statements, not a request for proposals or a commitment to award.

Description

This is a SMALL BUSINESS SOURCES SOUGHT NOTICE. This is NOT a solicitation for proposals, proposal of abstracts or quotations. The purpose of this notice is to obtain information regarding: The availability and capability of qualified small business sources; Whether they are small businesses (e.g., 8(a), Veteran-owned small businesses, service-disabled Veteran-owned small businesses, HUBZone small businesses, small disadvantaged businesses, and women-owned small businesses); Their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition; and Whether commercial sources and services are available in the marketplace. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code 541715 should not submit a response to this notice.

This notice is issued to help determine the appropriate acquisition method, including small business socioeconomic set-aside possibilities, and to determine the availability of commercial or non-commercial companies technically capable of meeting the Government's potential requirement. It is not construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Furthermore, it should be noted that any future solicitations that may be issued as a result of this notice, or in response to this requirement, may be issued using a different solicitation number from the one identified above.

The National Institute on Drug Abuse (NIDA) Division of Therapeutics and Medical Consequences (DTMC) and National Institutes of Health (NIH) is seeking Capability Statements from Small Business organizations with the demonstrated capability of providing service to support NIDA DTMC with the synthesis and distribution of drugs of abuse and related compounds.

BACKGROUND AND OBJECTIVES The National Institute on Drug Abuse (NIDA) is seeking capability statements from small businesses with the capability to synthesize and distribute drugs of abuse and related compounds. The NIDA Drug Supply Program has played an important role in promoting and supporting substance use research by providing a wide variety of authentic, pure, controlled and uncontrolled drugs and other chemical compounds (both unlabeled and labeled with deuterium, tritium, carbon-14, and iodine-125 isotopes) to the drug abuse research community for basic research. To continue to supply authentic and pure drugs and research chemicals, NIDA maintains the drug supply inventory, periodically checks chemical purity, and supplies research investigators according to the NIDA drug supply guidelines.

Specifically, NIDA plans to continue to: Produce, acquire, synthesize and maintain several radio- and deuterium-labeled and unlabeled drugs of abuse and other chemical substances in its drug supply inventory and distribute them to research investigators upon approval; Analyze, test, establish, and maintain the purity of drugs of abuse and other chemical compounds in the NIDA drug supply inventory and produce updated chemical data sheets; Replenish existing drug supply inventory with depleted drugs and research compounds through the routine synthesis or acquisition of depleted drug/chemical substances; Identify, acquire, and update the drug supply inventory with newly discovered chemical compounds useful for drug abuse research; Use, maintain, and update the NIDA drug supply database, known as Drug Inventory Supply Control System (DISCS); Accept and process request packages from researchers; and Provide secure storage for all compounds and safe shipment of approved drugs/compounds to research investigators.

Capable vendors must demonstrate the capability to receive the current inventory of hundreds of DEA controlled and uncontrolled drugs, other chemical compounds including peptides (opioid and related neuropeptides) in several kilogram quantities for immediate storage. Many of these compounds will require refrigeration. Some substances are in solution form and therefore require appropriate and secure storage to meet DEA requirements.

Chemical compounds to be synthesized shall include new drugs, drug metabolites and other compounds as directed by NIDA. Specific compounds may include, but not be limited to, unlabeled compounds as well as compounds labeled with tritium, 125I, 14C, deuterium and 13C. Representative classes of compounds shall include cannabinoids, hallucinogens, narcotics and antagonists, stimulants, depressants, peptides (opioid and related neuropeptides).

All chemical compounds must be stored under optimum shelf-life conditions and their purity maintained at not less than 95%. Re-purification must be carried out if chemical or radiochemical deterioration occurs.

MANDATORY REQUIREMENTS To handle controlled substances under the Controlled Substances Act of 1970, it is mandatory that the successful capable vendors possess a DEA Research Registration for Schedules II to V and demonstrate the capability to obtain a DEA registration for Schedule I controlled substances.

INSTRUCTIONS Based on preliminary market research, the Government has determined that the requirements described herein do not meet the definition of a commercial product or commercial service as defined in RFO 2.101, and therefore, RFO Part 12 procedures are not applicable to this requirement. However, if a capable vendor believes that these services or products qualify as commercial under FAR 2.101, the vendor may submit a written justification for the Contracting Officer's consideration. Such submissions must be provided to the Contracting Officer no later than November 20, 2026 at 1:00 PM EST.

Respondents must provide clear and convincing documentation of their capability and experience with providing the personnel and services as specified in the tasks above. Also, information must be provided in sufficient detail regarding the respondents': Staff expertise, including availability, experience, formal and other training; Current capability to perform the work; Prior completed projects of similar nature; Corporate experience and other management capability; and Examples of prior completed Government contracts, references, and other related information.

Each capability statement must include the respondent's UEI number, organization name, and address. Each response should include the technical and administrative points of contact, with names, titles, addresses, telephone numbers, and e-mail addresses. The capability statement should clearly identify the size and type of business (e.g., 8(a), HubZone, Non-Profit, Other Than Small Business, etc.), pursuant to the applicable NAICS code, and any other information that may be helpful in developing or finalizing the acquisition requirements.

One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2″ x 11″ paper size, with 1″ top, bottom, left and right margins, and with single or double spacing.

The information submitted must be in an outline format that addresses each of the elements of the project requirement and the capability statement paragraphs stated herein. A cover page and an executive summary may be included but are not required.

The response is limited to ten (10) pages. The 10-page limit does not include the cover page, executive summary, resumes, or references, if requested.

Any business concerns that believe they possess the capability necessary to successfully undertake the work described above must SUBMIT CAPABILITY STATEMENTS ELECTRONICALLY to the Contract Specialist, Shaun Rostad, at Shaun.Rostad@nih.gov, NO LATER THAN 1:00 p.m. EST on November 20, 2026. The subject line for the submission should include this Sources Sought Number, SAM.gov Unique Entity Identifier (UEI), and organization name. NIDA will not accept paper or faxed capability statements.

THIS NOTICE IS NOT A REQUEST FOR PROPOSALS. This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

CONFIDENTIALITY No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

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