Notice of Intent to Award to a Single Source

Closed Special Notice Posted

Solicitation number
PCA-NHGRI-10510
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Place of performance
Bethesda, Maryland 20814, United States

Notice details come from SAM.gov. Updated .

About this opportunity

The National Human Genome Research Institute issued a Notice of Intent to Award to a single source on September 10, 2026, with a capability statement due date of September 16, 2026, for procurement of a Meridian Breath ID replacement unit on an other-than-full-and-open competition basis under 41 U.S.C. 3204(b)(2).

NHGRI requires replacement of an existing non-operational Meridian BreathID instrument to continue ongoing patient history studies and support an upcoming clinical trial. The instrument performs propionate oxidation breath tests that measure whole body enzyme activity in patients with rare genetic disorders affecting the mitochondrial pathway. The replacement unit must be the same model to maintain consistency in sample analysis, instrument performance, data collection, and study procedures. The procurement includes a four-year extended warranty.

Meridian BioScience, 3471 River Hills Drive, Cincinnati, Ohio 45244, is identified as the owner and developer of the required product and is the intended awardee. The Government recognizes that Meridian BioScience is the sole source available based on compatibility requirements with existing research operations.

Vendors who believe they can provide a comparable product capable of fully meeting the Government's requirement may submit a written capabilities statement, including past performance, addressing factors created by continuing ongoing research studies with a non-Meridian BioScience product. Documentation must be submitted prior to the notice closing date to the identified point of contact, referenced as PCA-NHGRI-10510. The Government will evaluate submissions solely to determine whether to conduct the procurement on a competitive basis; a decision not to compete remains solely within the Government's discretion. This is not a request for proposal.

Notice text

Notice of Intent to Award to a Single Source - Meridian Bioscience Breath ID Replacement (ongoing studies)

This is a Notice of Intent (NOI), not a request for proposal. The National Human Genome Research Institute intends to negotiate on an other-than-full-and-open competition basis with Meridian BioScience, 3471 River Hills Drive, Cincinnati, OH  45244, USA. for a Meridian Breath ID unit to replace an existing, malfunctioning unit in order to continue ongoing research studies and provide a 4-year extended warranty for the unit. 

While this pre-solicitation does not constitute a solicitation, interested vendors may identify their interest and capability to satisfy this requirement. The Government understands that Merdian BioScience is the owner and developer of the required product currently being utilized by NHGRI per compatibility requirements. However, vendors who believe that they can provide the capability required to fully meet the Government's requirement may submit a capabilities statement, including past performance, in writing to the identified point of contact prior to the closing date and time of this notice. Interested parties should fully and clearly address factors created by continuing ongoing research studies with a non-Meridian Bioscience product.  Such documentation shall be evaluated solely for the purpose of determining whether or not to conduct this procurement on a competitive basis. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Interested parties may identify their interest and capability to respond to the requirement by referencing “PCA-NHGRI-10510.”

The statutory authority for this sole source requirement is 41 U.S.C. 3204(b)(2) as implemented by FAR Overhaul 12.102(a) only one source is available. THIS IS NOT A REQUEST FOR PROPOSAL.

All responsible sources that could provide comparable products may submit a capability statement via email to Christine Biser at:

ChristineBi@mail.nih.gov by 12:00 pm EASTERN Daylight Time, Wednesday, September 16, 2026.

Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.

Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to Christine Biser at ChristineBi@mail.nih.gov.

Files

File Type Posted
A.3 Award Notice.docx DOCX document
B.1.4 NOI PCA-NHGRI-10510 Statement of Need .docx DOCX document

Notice history

Notice Type Posted
This notice Latest special notice Special Notice
Notice of Intent to Award to a Single Source Original Pre-Solicitation

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