Development and Manufacture of Pharmaceutical Dosage Forms for Treatment of Substance Abuse Disorders
Closed Pre-Solicitation Posted
- Solicitation number
- 75N98026R00007
- 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), a component of the National Institutes of Health under the Department of Health and Human Services, is seeking qualified contractors to develop and manufacture pharmaceutical dosage forms for substance abuse disorder treatment medications. Contractors must possess capabilities in pre-formulation studies, dosage form development and manufacturing, analytical method development and validation, product specification establishment, stability testing under accelerated and long-term conditions, and storage facility management for bulk drug substances and finished products including controlled substances. All work must comply with FDA current Good Manufacturing Practice (cGMP) and Good Laboratory Practices (GLP) regulations, with deliverables formatted for Drug Master Files (DMF), Investigational New Drug (IND) applications, or New Drug Applications (NDA). Capability statements addressing each project requirement are the primary evaluation mechanism, and must include company information, key personnel qualifications, relevant GSA Schedule or GWAC contracts, and technical and administrative contact information. The deadline for submission is March 4, 2026, at 9:00 AM Eastern Time, with responses to be submitted electronically to Scott Duernberger at scott.duernberger@nih.gov.
This Pre-solicitation Notice contains no set-aside designation, though NIDA encourages responses from small businesses, including HUBZone, service-disabled veteran-owned, 8(a), veteran-owned, woman-owned, and small disadvantaged businesses. No incumbent contractors or current award values are identified in this sources sought notice. The anticipated contract vehicle is an Indefinite Delivery, Indefinite Quantity (IDIQ) task order contract with a five-year period of performance. Capability statements are limited to ten pages, excluding cover page, executive summary, and references, and must be submitted in Microsoft Word or Adobe PDF format with 11- or 12-point font. This notice is strictly for information-gathering purposes and does not obligate the Government to issue a solicitation or award a contract, nor will any costs incurred by respondents be reimbursed.
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. Pleas see SSN attached.
Files
| File | Type | Posted |
|---|---|---|
| OTSB_SSN.pdf |
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