N01DA-27-8961_Sources Sought Notice.pdf

Notice # 75N98026R00136

TITLE: Purity Specifications, Storage and Distribution for Medications Development

This is a Sources Sought notice. THIS IS NOT A REQUEST FOR PROPOSALS, ABSTRACTS, OR QUOTATIONS.

This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. The Government does not intend to award a contract based on responses under this announcement nor otherwise pay for preparing any information sent for the Government's use. Any proprietary information should be so marked.

The purpose of this notice is to obtain information regarding:

1. The availability and capability of qualified business sources;

2. Whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and

3. Their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition.

Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible.

The applicable NAICS code for this acquisition is 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

PROJECT REQUIREMENTS

The National Institute on Drug Abuse (NIDA) seeks capability statements from small businesses having the in-house capability to act as a centralized repository for compounds (i.e., chemical and biological) from domestic and international investigators, commercial sources, and pharmaceutical companies.

Specifically, the project requires the following tasks:

(1) Receive and store compounds from various sources:

• Store approximately 10,000 existing compounds ranging in quantity from milligrams to kilograms

• Store compounds in various conditions ranging from room temperature to -80° C; from inert atmosphere to desiccated atmosphere; and from high security storage to normal lock and key

• Receive and store new compounds received from various sources

• Obtain proper permits and coordinate logistics for receipt of compounds from foreign sources

• Dispose of compounds that may potentially be neurotoxins or biohazardous

(2) Analyze compounds received from various sources:

• Perform Thin Layer Chromatography (TLC) analysis

• Perform High Performance Liquid Chromatography (HPLC) analysis

• Perform Mass Spectrometry (MS) analysis

• Perform Gas Chromatography (GC) analysis

• Perform Nuclear Magnetic Resonance (NMR) analysis

• Perform Optical Rotation analysis

• Interpret and report results to the COR

(3) Ship compounds to domestic and international test sites:

• Package and ship compounds

• Prepare shipments as blinded samples

• Prepare shipments according to specified shipping conditions (i.e., dry ice, inert environment, desiccant, etc.)

(4) Record Keeping. Maintain an extensive, secure, web-based inventory and tracking system

• Maintain a centralized database tracking receipt, analysis, inventory coding, distribution, and other data for all compounds

• Update database on a daily basis

• Secure and maintain all records confidentially

• Meet DEA record keeping requirements for scheduled compounds

(5) Purchase commercially available compounds:

• Acquire compounds from commercial suppliers

• Obtain and transpose all analytical information (e.g., complete chemical structure, solubility, etc.) for purchased compounds

The major goal of this project is to provide NIDA and other NIH Institutes with a holding site which has the capability to inventory, analyze and store compounds, prepared under both non-GMP (Good Manufacturing Practices) and GMP conditions, in amounts ranging from milligram quantities to several kilograms. In accordance with the Controlled Substances Act of 1970, DEA Research Registration for Schedules II to V and potentially Schedule I controlled substances will be required.

CAPABILITY STATEMENT/INFORMATION SOUGHT:

The established NAICS code is 541715. Information sent should be relevant and specific in the technical area under consideration, on each of the following qualifications:

1) Experience: An outline of previous similar projects in the areas specified above and work in the field of drug abuse;

2) Personnel: Name, professional qualifications and specific experience in the work requested for scientists and/or technical personnel, particularly for those who may be assigned to key positions;

3) Mandatory Qualifications: Ability to handle Schedules II to V and potentially Schedule I controlled substances in accordance with the Controlled Substances Act of 1970; and,

4) Facilities: Availability and description of facilities and equipment required to conduct this type of work.

Any other specific and relevant information about this particular area of procurement that would improve our consideration and evaluation of the information presented is desirable.

Interested organizations must demonstrate and document, in any capability statements submitted, extensive experience with and the ability to perform the above tasks. Organizations should demonstrate capability to administer and coordinate interrelated tasks in an effective and timely manner.

Documentation may include, but not be limited to, contracts both Government and commercial the organization performed, references, i.e., names, titles, telephone numbers and any other information serving to document the organizations capability, e.g., awards, commendations, etc.

All capability statements must provide the following: 1) company name, address and UEI number; 2) point of contact, 3) phone/email; 4) NAICS Codes; 5) business size and status; 6) capability information in response to the requirement and qualifications identified in this notice; and 7) type of small business your organization classifies itself as.

Electronic capability statements will be accepted by the primary point of contact at polina.klimenkova@nih.gov with the subject line: “Capability Statement 75N98026R00136/N01DA-27- 8961” NO LATER THAN August 14th, 2026.

THIS NOTICE IS NOT A REQUEST FOR PROPOSALS. This notice is for information and planning purposes only and does not obligate the Government to award a contract or otherwise pay for the information provided in this response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. 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). 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 Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to the subsequent solicitation.

mailto:polina.klimenkova@nih.gov