SAM_Presol_Attachment NOI.pdf

U.S. Food & Drug Administration

NOTICE OF INTENT TO SOLE SOURCE

Systematic Review of Contaminant Composition of Human Milk and Infant Formula

This synopsis is hereby issued and posted in accordance with FAR Subpart 5.2 and FAR 6.302. The purpose of this synopsis is to announce the Food and Drug Administration's intent to negotiate a Labor Hour sole source award with Texas A&M Agrilife Research located at 2147 TAMU, College Station, TX 77843 for the project titled “Systematic Review of Contaminant Composition of Human Milk and Infant Formula.”

Under the authority of FAR 6.302-1, only one responsible source and no other type of services will satisfy agency requirements. The primary objective is to complete a systematic review by the Contractor on the availability and strength of the scientific data/evidence in the peer-reviewed literature on the composition of contaminants in human milk and infant formula.

Texas A&M Agrilife Research's Agriculture, Food, and Nutrition Evidence Center is the only evidence center of its kind that can combine expertise in evidence in agriculture with food and nutrition topics, capable of addressing the required topics. FDA consulted with leadership in the United State Department of Agriculture (USDA) Agricultural Research Service regarding the existence of institutions with expertise in conducting systematic reviews on food and agriculture contaminants. USDA specified that the Texas A&M Agrilife Research's Agriculture, Food, and Nutrition Evidence Center was established to fill this gap in capabilities and is the only Contractor able to fulfill the requirements of the acquisition. Other entities considered during market research did not include the required expertise related to contaminant composition of human milk and infant formula or toxicology; did not currently have the capability to conduct the required full scale systematic review in-house; did not conduct topics related to agriculture or food composition related to environmental contaminants; and/or did not conduct work in heavy metals in foods and did not cover contaminants in foods or agricultural practices.

Specifically, this procurement calls for the following tasks to be completed:

• Hold Kick-Off Meeting

• Project Management

• Scientific Review on Chemical Composition of Human Milk and Infant Formula

• Research Recommendations

• Study Report

THIS NOTICE IS NOT A REQUEST FOR COMPETITIVE QUOTATIONS; however, responsible sources may submit a capability statement in response to the above requirement with pricing information by 11:59pm (Eastern) on July 30, 2023 to the Contract Specialist, Noah Wills, at Noah.Wills@fda.hhs.gov.

mailto:Noah.Wills@fda.hhs.gov