(Presolicitation Notice) Intent to Sole Source - Biol Specimens for Lenacapavir PEP
Closed Pre-Solicitation Posted
- Solicitation number
- PR97866
- Agency
-
CDC Office of Acquisition Services
Centers for Disease Control and Prevention, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 621511 Medical Laboratories
- Place of performance
- Atlanta, Georgia, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Centers for Disease Control and Prevention intends to sole-source a firm fixed price purchase order to Emory University for procurement and delivery of biological specimens from persons receiving weekly oral lenacapavir, with a response deadline of September 17, 2026. This sole-source action is justified under 41 U.S.C. 3304(a)(1) and RFO FAR 12.201-1 simplified procedures.
Emory's Atlanta location enables timely monthly specimen transport to the CDC Division of HIV Prevention Laboratory Branch, reducing cold-chain transit time, shipping variability, weather-related exposure, and risks to specimen integrity. The university maintains established HIV clinical-research infrastructure including prevention and treatment capabilities, documented prior experience performing CDC-supported clinical studies with extensive biological specimen collection and pharmacokinetic procedures, and prior CDC DHP contract performance. This prior experience with collection, processing, handling, and transfer of biological specimens provides continuity with CDC DHP laboratory methods and specimen-handling procedures, reducing technical risk in protocol implementation, specimen-processing method transfer, study start-up, and specimen integrity preservation.
The CDC reserves discretionary authority to decline competition based on responses received within 15 days of notice issuance. All quotations and responses submitted within that window will be considered, though the government's determination not to compete remains solely within its discretion.
NAICS 621511 (Medical Laboratories); PSC 6550 (In Vitro Diagnostic Substances, Reagents, Test Kits and Sets).
Notice text
The Centers for Disease Control and Prevention intends to award a sole source firm fixed price purchase order to Emory University for the procurement and delivery of biological specimens from persons receiving weekly oral lenacapavir. Emory maintains established HIV clinical-research infrastructure, including HIV prevention and treatment clinical-research capabilities, and has documented prior experience performing CDC-supported clinical studies involving extensive biological specimen collection and pharmacokinetic-related procedures.
Emory also has prior CDC DHP contract performance and documented experience with the collection, processing, handling, and transfer of biological specimens required for CDC-supported research. This established experience provides continuity with CDC DHP laboratory methods and specimen-handling procedures and reduces technical risk associated with protocol implementation, specimen-processing method transfer, study start-up, and preservation of specimen integrity.
In addition, Emory’s Atlanta-area location permits timely and predictable monthly transport of specimens to the CDC DHP Laboratory Branch. This proximity reduces cold-chain transportation time, shipping variability, weather-related exposure, and other risks that could adversely affect specimen integrity and comparability.
This contract action is for services for which the Government intends to solicit and negotiate with only one source under the authority of RFO FAR 12.201-1 simplified procedures pursuant to 41 U.S.C. 1901, and is justified under 41 U.S.C. 3304(a)(1). See note below.
This notice of intent is not a request for competitive quotations; however, all quotations/responses received within 15 of days of the issuance of this notice shall be considered by the government. 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. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Any quotation/response should be emailed to contract specialist at xmr1@cdc.gov, by the closing date of this posting.
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