Notice of Intent 3-7-22.docx

PRESOLICITATION NOTICE: INTENT TO AWARD A SOLE-SOURCE CONTRACT

INTENDED SOURCE: American Type Culture Collection– 10801 University BLVD Manassas, Virginia 20110-2204 ANTICIPATED PERIOD of PERFORMANCE: A base period of one (1) year and four (4) one (1) year option periods

DESCRIPTION OF REQUIREMENT:

Pursuant to the authority of 41 USC 3304(a)(1), as implemented by Federal Acquisition Regulation (FAR) Subpart 6.302-1, the U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grant Services (OAGS) intends to award a sole source contract to American Type Culture Collection. FDA has a need to store 5,145 vials of cell lines and virus cultures at ATCC’s facility and to distribute them to the designated consignees at the request of the FDA.

1. cGPM storage conditions: for cell lines used for vaccine manufacture (includes DBS-130/MRC-5 cells, WHO-VERO cells freeze 10-87, WI-38 cells)

2. Secure storage conditions: for oral poliovirus seed ampules (includes poliovirus type I, II, and III)

3. Regular LN storage conditions for other cell lines.

The contractor will distribute 5 domestic and 5 internal shipments per contract year and will submit semi-annual (2) reports with the inventory logs of the cell lines and viruses stored and distributed.

The cells included in this contract are very important to vaccine manufacturers and ATCC is the only source that houses them in the U.S. Just removing the cells out of the freezer and putting them into a different container for transport exposes the cells to a change in the temperature that may be deleterious. Additionally, there is also exposure to some temperature change when the cells are subsequently put into containers to be sent to the requestor of vaccine cells. Keeping them at the original location at ATCC will avoid an additional exposure to temperature change and any potential problems during transport. This can only be sourced to ATCC without major disruption to the ongoing international work coordinated with the World Health Organization

The applicable North American Industry Classification System (NAICS) code for this acquisition is 541990 " All Other Professional, Scientific, and Technical Services.”

The Government intends to solicit and negotiate directly with American Type Culture Collection and no solicitation will be issued. This notice of intent is not a request for competitive proposals or quotations; however, if any interested party believes they can meet the above requirement, it may submit a statement of capabilities. The statement of capabilities must be submitted in writing and must contain material in sufficient detail to allow the government to determine if the party can perform the requirement. A determination by the Government not to compete this proposed requirement based on responses to this notice is solely within the discretion of the Government. All interested parties must express their interest and capabilities in writing via email to Paige.Eyberg@fda.hhs.gov within fifteen (15) business days after the date of publication of this notice. No faxed documents will be accepted. If no responsive statements are received within fifteen (15) business days, an award will subsequently be made to American Type Culture Collection.

This is a federal contract opportunity; FDA-NOI-1253249 for services at Food and Drug Administration Office of Acquisitions and Grants Services - Beltsville, MD. Response Due NLT 10:00 AM EST March 28, 2022.