SB_SSN.pdf

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SOURCES SOUGHT NOTICE

Title: Development and Manufacture of Pharmaceutical Dosage Forms for Treatment of Substance Abuse

Disorders

Description.

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations.

The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small 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; (3) their size classification relative to the North

American Industry Classification System (NAICS) code for the proposed acquisition; and (4) availability of domestic sources manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality.

For equipment/supply requirements, responses must include the place of manufacturing (i.e., address if supply/equipment is a domestic end product and include country of manufacture). For equipment/supply requirements, small businesses must also address the size status of the manufacturer under the applicable

NAICS code (i.e., address Non-Manufacturer Rule).

Your responses 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 should not submit a response to this notice.

This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be 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.

Background.

The National Institute on Drug Abuse (NIDA) is soliciting proposals from qualified organizations having the capability to carry out development of formulations, manufacture, quality control tests, stability studies and distribution of pharmaceutical drug products to be used in the medications development program for treating substance use disorders.

Development of medications for the treatment of substance use disorders is a major mission of NIDA. Some of the potential treatment drugs currently being investigated are new chemical entities and previously approved drug substances. The Government acquires these drug substances from private industries, Government contractors/grantees, or independent investigators. This contract is to provide the Government a resource for the development and manufacture of pharmaceutical dosage forms for use in preclinical and clinical studies.

The Contractor shall be responsible for carrying out pre-formulation studies on drug substances, developing and manufacturing dosage forms/drug products, developing and validating analytical methods, carrying out stability studies, packaging and delivering of the pharmaceutical drug products to the sites designated by the NIDA. In addition, the Contractor shall provide adequate facilities for the storage of bulk drug substances, including controlled substances and their finished dosage forms/drug products. The Contractor shall have appropriate DEA Registrations for Schedules II-V Controlled Substances in order to use the controlled substances in research and manufacture of dosage forms under the Controlled

Substance Act of 1970. The Contractor must either possess or demonstrate the ability to obtain

DEA Registrations for Schedule I Controlled Substances should the research and manufacture of the Schedule I drugs be required under this indefinite delivery, indefinite quantity (task order) type contract.

The Contractor shall carry out the tasks in compliance with the Food and Drug

Administration's (FDA) current Good Manufacturing Practice regulations (cGMP) and Good

Laboratory Practices (GLP). The data and documents prepared should be in a format acceptable to the FDA for inclusion in Drug Master Files (DMF), Investigational New Drugs

(IND), or New Drug Applications (NDA) submitted by NIDA or investigators supported by

NIDA.

Purpose and Objectives.

The National Institute on Drug Abuse (NIDA) is soliciting a Contractor providing services for developing and manufacturing dosage forms/drug products to be used for preclinical pharmacological/ toxicological evaluations and clinical trials in support of NIDA’s medication development programs. In brief, the objectives of this contract are: (1) pre-formulation studies on bulk drug substances and formulation studies to select a formulation(s); (2 ) manufacture and packaging of finished dosage forms/drug products and placebos; (3 ) analytical method development and validation for the dosage forms/drug products; (4) establishment of specifications for the dosage forms/drug products; (5) determination of stability of the finished dosage forms/drug products and the placebos under accelerated and/or long-term storage in compliance of the FDA guidance on stability of drug products; (6) maintenance of an adequate storage facility for drug substances and finished dosage forms/drug products including controlled substances; (7) shipment of drug substances and dosage forms/drug products to sites designated by the NIDA; and (8) generation of reports, data, and documents to be used by NIDA in the preparation of Investigational New Drug (IND), New Drug Application (NDA), and/or Drug

Master File (DMF).

Anticipated period of performance.

The anticipated period of performance will be five (5) years based on an IDIQ TO type contract.

Capability statement /information sought.

Companies that believe they possess the capabilities to provide the required products should submit documentation of their ability to meet each of the project requirements to the Contracting Officer.

The capability statement must specifically address each of the project requirements separately.

Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and

Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.

Interested companies are required to identify their type of business, applicable North American Industry

Classification System (NAICS) Code, and size standards in accordance with the Small Business

Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number.

Please note that NIMH is particularly interested in small business sources. If you are a small business, please state the type of small business (small business; HUBZone; service-disabled, veteran-owned; 8(a);

veteran-owned; woman-owned; or small disadvantaged businesses) and your 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.

In case domestic sources are available and capable of fulfilling the Government’s need, and a future solicitation is published, the Government will use evaluation preferences in accordance with FAR 25.

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 requirements and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required.

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

The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.

All responses to this notice must be submitted electronically to the Contract Specialist.

Facsimile responses are NOT accepted.

The response must be submitted to Scott Duernberger at e-mail address scott.duernberger@nih.gov.

The response must be received on or before March 4, 2026, 9:00am Eastern Time.

Disclaimer and Important Notes

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.

mailto:scott.duernberger@nih.gov

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 presolicitation synopsis and solicitation may be published in www.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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