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Miltenyi Biotec’s autoMACS NEO Separator with MACS MiniSampler system

Waiver type - Procurement: Nonavailability

Agency: NATIONAL INSTITUTES OF HEALTH (7529) • Product Service Code (PSC) : 6640 | Last Modified: 08/16/2023

Procurement Summary

The National Institute of Allergy & Infectious Diseases (NIAID)’s Division of Intramural Research (DIR), Rocky Mountain Labs (RML) (collectively “Program”) is studying Coxiella burnetiid bacterium that causes the zoonosis Q fever. Program requires the autoMACS NEO Separator with MACS MiniSampler system for work related to C. burnetii infection modeling, vaccine design, and expansion of animal models of disease. The Miltenyi autoMACS NEO Separator was selected based on unique capabilities/features which satisfy Program’s requirements to standardize tissue dissociation and optimize downstream cellular quality. Research revealed that the needed items are only manufactured by this Miltenyi Biotec. Previous acquisitions of these items were awarded to this same company. Only these items can be used due to compatibility and technical requirements.

Waiver Rationale Summary

These items are not mined, produced, or manufactured in the United States insufficient and reasonably available commercial quantities and of satisfactory quality. Accordingly, the requirement of the Buy American Act that acquisitions be made from domestic sources, and that it be of domestic origin, is not applicable to this acquisition, since the referenced acquisition is within the non- availability exception stated in the Buy American Act.

Did / Will the solicitation include one of the standard BAA provisions announcing the agency’s intention to provide a price preference for domestic end products and construction material?

No

Was a sources sought or Request for Information issued?

No

OMB Determination

Consistent with Policy

Product

LABORATORY EQUIPMENT AND SUPPLIES

NAICS

334516 - Analytical Laboratory Instrument Manufacturing

Date Submitted

08/01/2023

Procurement Instrument Identifier (PIID)

Solicitation ID

N/A

Procurement Stage

Pre-solicitation

Expected Maximum Duration of the Proposed Waiver

Between 6 months and 1 year

Waiver Coverage

Individual Waiver

Funding Agency

NATIONAL INSTITUTES OF HEALTH