Development of a Hazard and Risk Assessment Protocol for CFSAN

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. This is a Request for Quotes (RFC) for commercial items in accordance with the procedures of FAR Part 12 Acquisition of Commercial Items and Part 13 Simplified Acquisition Procedures The associated North American Industry Classification System (NAICS) Code is 5416111 -- Administrative Management and General Management Consulting Services. This is a small business set-aside solicitation in accordance with FAR Subpart 19.5 Set-asides for Small Business. Background The Food and Drug Administration (FDA) is responsible for providing regulatory oversight of the safety and proper labeling of cosmetics. In furtherance of its mission, FDA is developing protocols for assessing the safety of cosmetic product ingredients and now seeks to elaborate on its existing efforts. The present SOW focuses on expanding the existing protocol in order to assess hazards and risks of areas that were excluded from the previous protocol and updating the existing protocols which will help FDA to improve its approach for evaluating the safety of cosmetic product ingredients. Information from related work previously done by FDA will be shared by the COR, at least in part, with the Contractor to help facilitate completion of the requirements in this SOW. Purpose The primary purpose of this requirement is to acquire a hazard and risk assessment protocol that requires special consideration to include 1) unique biological characteristics which may have an impact in the evaluation of ingredients in cosmetic products used by subpopulations such as infants and children, the elderly, people of color, and immunosuppressed individuals, 2) unique physiochemical characteristics which may have an impact in the evaluation of certain ingredients such as engineered nanomaterials used in cosmetic products. In addition, the requirement includes updating and improving the existing hazard and risk assessment protocol. This requirement also includes an option year that consists of updating an existing aggregate risk assessment protocol and an existing education and training program. Objectives The primary objective of this requirement is for FDA to obtain a protocol that can be used to assess the hazards and risks by considering 1) the unique biological characteristics which may have an impact in the evaluation of ingredients in cosmetic products used by subpopulations such as infants and children, the elderly, people of color, and immunosuppressed individuals, 2) the unique physicochemical characteristics which may have an impact in the evaluation of certain ingredients such as engineered nanomaterials used in cosmetic products. In addition, the primary objective includes updating and improving the existing hazard and risk assessment protocol that will be shared, at least in part, by FDA. Optional objectives of this requirement include 1) updating an existing protocol of aggregate risks presented from a single ingredient used in multiple cosmetic products via multiple routes of exposure, and 2) updating an existing education and training program that can be used to facilitate adherence to the protocols and conduct outreach about the protocol use by FDA, with stakeholders. Scope To assist FDA in the oversight of cosmetic safety and labeling, for the primary requirement, the Contractor shall develop a protocol that can assess the hazards and risks by considering 1) the unique biological characteristics which may have an impact in the evaluation of ingredients in cosmetic products used by subpopulations such as infants and children, the elderly, people of color, and immunosuppressed individuals, 2) the unique physicochemical characteristics which may have an impact in the evaluation of certain ingredients such as engineered nanomaterials used in cosmetic products. In addition, the requirement also includes updating and improving the existing hazard and risk assessment protocol to incorporated newer information from data published in the literature and making necessary modifications to the existing protocol based on FDA's needs. The Contractor shall update and improve an existing aggregate risk assessment protocol by incorporating updated scientific approaches/methods and demonstrate the practicality of the protocol by providing examples of aggregate risk assessment for a single ingredient used in multiple cosmetic products as well as via multiple routes of exposure. In addition, the Contractor shall update an existing education and training program for FDA to train its reviews and educate stakeholders.