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Stability Testing for ManNAc Drug Product produced in Campaigns 5 and 6. Stability testing will occur under regulatory compliance

Updated Oct 29, 2026

Presolicitation from the National Institutes of Health, for work in Bethesda, Maryland. Due Nov 9, 2026, 9:00 AM (UTC-5), 11 days left.

Solicitation number	75N98027Q00040
Agency	National Institutes of Health
Office	National Institutes of Health Olao
Notice type	Presolicitation
Set-aside	None
Trade (NAICS)	Testing Laboratories and Services (541380)
Product or service code	R499
Place of performance	Bethesda, Maryland
Posted	Oct 28, 2026
Response deadline	Nov 9, 2026, 9:00 AM (UTC-5) (11 days left)
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Federal prevailing wage rates for this place: Maryland Davis-Bacon and SCA wage determinations.

Description

Introduction this is a PRE-solicitation non-competitive (notice of intent) synopsis to award a contract or purchase order without providing for full or open competition (including brand-name). The National Institutes of Health (NIH) intends to negotiate and award a contract without providing for full and open competition (Including brand-name) to: Alcami Corporation 2320 Scientific Park DR Wilmington, North Carolina 28405-1800 NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541380 with a Size Standard $16.6M. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2026-01, March 13, 2026.

This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($350,000). STATUTORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold.

Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. GENERAL INFORMATION Title: Stability Testing for ManNAc Drug Product produced in Campaigns 5 and 6. Stability testing will occur under regulatory compliance Background Information: NHGRI was gifted 48kg of unlabeled drug ManNAc (powder-in-sachet) in September 2025, and agreed to take over the FDA-required, mandatory, stability testing program of this drug that has been ongoing at Alcami Corporation since June 2024.

The gifted drug was produced in 2 campaigns, Campaign 5 (C5, June 2024) and Campaign 6 (C6, September 2024). NHGRI plans to use the donated clinical grade drug for upcoming clinical trials. CLOSING STATEMENT This synopsis is not a request for competitive proposals.

However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include a technical proposal, a cost-price proposal, the period of performance, the Unique Entity ID (UEI), the Taxpayer Identification Number (TIN), and the certification of business size.

All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All responses must be received by November 9, 2026 at 9:00 AM Eastern time and must reference solicitation number 75N98027Q00040. Responses may be submitted electronically to Mr. James Law, Contracting Officer at [email protected]. Fax responses will not be accepted.

"All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.”

Contracting contact

Law, James B · [email protected]

As published on the official notice. Ask questions in writing and before any questions deadline the notice sets.

Is your business small enough?

For NAICS 541380, a business counts as small if it has no more than $19.0 million in average annual receipts (SBA size standard). This notice is not set aside, but the size decides your small business status on it. SBA table, current as of Oct 15, 2026.

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About the buyer

The National Institutes of Health awarded $5.8 billion in contracts in the last 12 months; its biggest suppliers were Leidos Biomedical Research Inc, M. A. Mortenson Company and Deloitte Consulting LLP. See what NIH is buying now.

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There are 42 open government contract opportunities in this trade (NAICS 541380), 17 posted in the last 7 days; 55% are set aside for small businesses. The agencies buying the most are Department of Veterans Affairs, Department of the Army and Department of the Navy. Most of the work with a stated place is in District of Columbia, Illinois and California. A notice in this trade gives a median of 14 days from posting to deadline; this one gives 12 days.

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