Development and Manufacture of Pharmaceutical Dosage Forms for Treatment of Substance Abuse Disorders
Closed Pre-Solicitation Posted
- Solicitation number
- 75N98026R00007SB
- Agency
-
National Institute on Drug Abuse
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Place of performance
- United States
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institute on Drug Abuse (NIDA), under the Department of Health and Human Services, is seeking qualified organizations to develop and manufacture pharmaceutical dosage forms for treating substance use disorders. The procurement encompasses pre-formulation studies, development and manufacturing of dosage forms and placebos, analytical method development and validation, stability studies, specification establishment, storage facility maintenance for bulk drug substances and finished products, packaging and shipping, and FDA-compliant documentation generation for Drug Master Files, Investigational New Drug applications, and New Drug Applications. Prospective contractors must demonstrate compliance with FDA Good Manufacturing Practice regulations and Good Laboratory Practices, maintain appropriate DEA registrations for Schedules II-V controlled substances with the ability to obtain Schedule I registrations, and possess qualified personnel capable of executing these technical requirements. The government is conducting this market research effort to identify capable sources and determine the appropriate acquisition strategy, including whether small business set-asides are feasible. Interested organizations must submit responses electronically to Scott Duernberger at scott.duernberger@nih.gov by March 4, 2026, at 9:00 a.m. Eastern Time in Microsoft Word or PDF format, limited to ten pages.
This pre-solicitation notice does not involve a set-aside designation and does not identify any current or potential incumbent contractors. No specific award value or budget range is disclosed in the pre-solicitation materials. The anticipated period of performance spans five years under an indefinite delivery, indefinite quantity task order contract structure. Responses must include company name, Unique Entity ID, physical address, NAICS code, small business classification, employee count, personnel qualifications, and technical and administrative points of contact. The government reserves the right to utilize any non-proprietary information submitted for future solicitations and will not issue a contract or make payments based on responses to this market research notice.
Notice text
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. Please see SSN attached.
Files
| File | Type | Posted |
|---|---|---|
| SB_SSN.pdf |
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| Opportunity | Agency | Set-aside | Responses due |
|---|---|---|---|
| Synthesis and Distribution of Drugs of Abuse and Related Compounds | National Institute on Drug Abuse | Total Small Business | |
| Synthesis and Distribution of Drugs of Abuse and Related Compounds | National Institute on Drug Abuse | No set-aside |
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