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PepMix COVID-19 Peptide Mixtures/Reagents

Waiver type - Procurement: Nonavailability

Agency: NATIONAL INSTITUTES OF HEALTH (7529) • Product Service Code (PSC) : 6505 | Last Modified: 05/03/2023

Procurement Summary

National Institute of Allergy & Infectious Diseases (NIAID)’s Vaccine Research Center (VRC) (collectively “Program”) is engaged in studies to understand the pathology, progression, and disease mechanisms of COVID-19 by better understanding the underlying immunologic response with the hope of justifying the use of specific vaccines and vaccine dosing regiments as well as dosing methods (intramuscular, intra-nasal, etc.) . These studies allow policy decisions to be made about future directions of research regarding changing vaccine formulation and boosting frequency. In order to accomplish this, certain types of reagents are used to examine blood and tissue derived immune cell subtypes and the cytokines they produce in animal studies where specimens have been exposed COVID-19. The samples acquired from these studies will be analyzed both pre- and post-vaccination and pre- and post-infection. In order to conduct this research, Program requires the PepMix COVID-19 Peptide Mixtures/Reagents biological reagents from JPT Peptide Technologies GmbH.

Waiver Rationale Summary

JPT biological items are not mined, produced, or manufactured in the United States in sufficient 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

DRUGS AND BIOLOGICALS

NAICS

325414 - Biological Product (except Diagnostic) Manufacturing

Date Submitted

04/28/2023

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