Tender Details

Country: USA
Summary: Notice of Intent to Award a Sole Source -ENDS Toxicological Studies
UST Ref No: 123056125
Deadline: 01 Aug 2025
Financier: Self Financed
Purchaser Ownership: Government
Tender Value: Refer Document
Notice Type: Tender
Document Ref. No.: 75F40125R00098
Purchaser's Detail:
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Description:
Description
The U.S. Food and Drug Administration (FDA) intends to solicit a 2-year, sole source, firm-fixed-price type contract from Lovelace Biomedical Research Institute; 2425 Ridgecrest Dr. SE; Albuquerque, NM 87108, in accordance with the authority under Federal Acquisition Regulation (FAR) 6.302-1 - Only one responsible source and no other supplies or services will satisfy agency requirements, and 15.101 Contracting by Negotiation. The North American Industry Classification System (NAICS) code is 541380 - Testing Laboratories. The anticipated period of performance consists of a 12-month base and one (1) 12-month options.
On June 22, 2009, President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) into law (Public Law 111-31). The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and granted the FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.
Premarket tobacco product applications (PMTAs) are submitted for any new tobacco product seeking an FDA marketing order under the FD&C Act. A PMTA is required to provide sufficient scientific evidence demonstrating that marketing of the new product is appropriate for the protection of public health (APPH). Scientific data must address, among other things, any health risks and benefits of the new product to the US population as a whole. This requirement includes a thorough toxicological assessment that directly addresses the health risks associated with a product. The final PMTA rule emphasizes detailed assessment of the toxicological profile from the use of or exposure to a new tobacco product. Electronic cigarettes are very recent additions to the United States tobacco market compared to conventional cigarettes. Sufficient time has not yet passed to directly assess the effects of electronic cigarettes in humans and yet there ar...
Documents:

Intent-to-Sole-Source-Lovelace-In-Vivo_Final_18Jul.pdf

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Notice of Intent to Award a Sole Source -ENDS Toxicological Studies - USA Tender

The HEALTH AND HUMAN SERVICES, DEPARTMENT OF | FOOD AND DRUG ADMINISTRATION, a Government sector organization in USA, has announced a new tender for Notice of Intent to Award a Sole Source -ENDS Toxicological Studies. This tender is published on USARFP under UST Ref No: 123056125 and is categorized as a Tender. Interested and eligible suppliers are invited to participate by reviewing the tender documents and submitting their bids before the deadline on 2025-08-01.

The estimated tender value is Refer Document, and full details, including technical specifications and submission requirements, are provided in the official tender documents. Ensure all submissions meet the criteria outlined to be considered for evaluation.