SAM #FDA_7162026

FDA Sole Source Environmental Review Services for Sunscreen Ingredients ZnO and TiO2

This opportunity is a sole source procurement by the FDA for environmental review services related to sunscreen active ingredients zinc oxide (ZnO) and titanium dioxide (TiO2). - Agency: Food and Drug Administration (FDA), Department of Health and Human Services (HHS) - Sole source vendor: Johnson, Mirmiran & Thompson Inc. (JMT) - Scope of work: - Revise and finalize a draft Environmental Assessment (EA) and technical appendices for ZnO and TiO2 - Option to prepare a full Environmental Impact Statement (EIS) if required - Support public involvement, respond to comments, and prepare decision documents (Finding of No Significant Impact or Record of Decision) - Compile and deliver project files and administrative records - NAICS code: 541620 (Environmental Consulting Services) - Contract type: Firm fixed price - Period of performance: One year, from September 1, 2026 to August 31, 2027 - No specific products or part numbers; the procurement is for specialized environmental review services - Commercial opportunity is limited due to sole source designation, but similar firms in environmental consulting may be interested in future FDA requirements

Description

The objective of this contract is to prepare and document an appropriate level of environmental review under NEPA, applicable regulations and guidance, prior to issuing the final Sunscreen OTC Monograph Order regarding ZnO and TiO2.  Specifically, the intent is to finalize the EA on ZnO and TiO2  including appendices or, if necessary, to exercise an option under this contract to prepare and finalize an EIS for these active ingredients. 

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