The Centers for Disease Control and Prevention, CDC/NIOSH/HELD/ACIB,  1600 Clifton Rd. NE, Atlanta, GA, 30333, hereby announces its intent to issue a sole source contract in accordance with FAR 6.302-1 to Enthalpy, 1104 Windfield Way, El Dorado Hills, CA, 95762, to fully understand the potential for dermal penetration and the health risks from exposure to PFAS through the dermal route.

The primary objective of the proposed procurement is the acquisition of PFAS distribution analysis data of mouse skin, lung, liver and spleen samples. Previous results have shown that these compounds are absorbed through the skin, where they distribute/accumulate in the skin, spleen and lungs, and potentially contribute to systemic toxicity. Additional information is needed about the toxicokinetics of the tissue distribution. This purchase order will support the PFAS analysis of samples that will be collected as part of a 2022 large NORA project.

The vendor will provide PFAS analysis of skin, lung, spleen and liver samples that have been collected from mice exposed to individual PFAS. Resultant PFAS analysis data will be made available by the vendor.

TASKS TO BE PERFORMED

Task 1: Skin, spleen, liver and lungs will be collected from mice following PFAS exposure. All subsequent steps will be performed by the proposed vendor. Resultant PFAS analysis data will then be made available from the vendor.

Task 2: Submitted samples will be analyzed using UPLC-MS/MS according to the unique and highly specialized method of the vendor.

Per- and polyfluoroalkyl substances (PFAS) are a group of synthetic chemicals (over 5,000) that have been used in industry and consumer products, worldwide, since the early 1950’s. Due to their physical and chemical properties, PFAS have been integrated extensively into consumer products and industrial applications, such as stain resistant textiles and carpeting, food-handling materials, medical devices, fire-fighting foam, and construction materials. Over the past few decades there has been growing concern over health effects associated with PFAS. Since there is potential for dermal exposure to PFAS occupationally and in the environment, it is important to fully understand the potential for dermal penetration, tissue distribution and the health risks from exposure to PFAS through the dermal route. Previously PFAS analysis in mouse spleen, skin, liver and lung samples has shown that these compounds distribute/accumulate in these organs and potentially contribute to systemic toxicity. Additional studies are required to determine the toxicokinetics of dermal exposure. Currently, this technology is not available within NIOSH. Enthalpy provides analytical detection of occupationally relevant PFAS in small volumes of mouse serum and urine. Additionally, the turnaround time is less than one month which is critical for the time-sensitive nature of the studies being conducted. This vendor has been used in the past and continued service is necessary for consistency of results. The vendor utilizes a proprietary UPLC-MS/MS technology for PFAS detection with isotype dilution.

No other vendors have been identified as being capable of providing PFAS analysis of mouse serum of limited volume.

The statutory authority permitting other than full and open competition is 41 U.S.C. 3304(a)(1) as cited in FAR 6.302-1, " Only one responsible source and no other supplies or services will satisfy agency requirements."

Responsible sources that believe they possess the expertise and capabilities identified above are encouraged to submit to the Contracting Officer within 15 days from the posting date of this notice, their written capabilities statement which shall be considered by the agency. Please forward the capability statement to Maria Shamburger, [email protected], Contracting Officer, Reference 2024-0430, Centers for Disease Control, Office of Acquisition Services, District at Chamblee, Building #2900, 2900 Woodcock Blvd, MS TCU-4, Atlanta, GA 30341. All vendors must be registered in the System for Award Management (SAM) prior to an award of a federal contract. The website is: www.sam.gov.

The Government will review any/all capabilities statements information submitted and determine if other qualified sources do exist that could provide this requirement. Information received in response to this announcement will be used solely for the purpose of determining whether to conduct a competitive procurement.

If no affirmative responses are received within 15 days, negotiations will be conducted with Enthalpy, as the only source and a contract will be issued without any additional notices being posted.