SOLICITATION NOTICE
B -- Evaluation of the Allergenicity and Sensitization Potential of Cosmetic Ingredients / mixtures based on Survey of Scientific Literature - FDA-SOL-1169640
- Notice Date
- 7/13/2016
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SOL-1169460
- Archive Date
- 8/26/2016
- Point of Contact
- Lisa K. Yaw, Phone: 2404024018
- E-Mail Address
-
lisa.yaw@fda.hhs.gov
(lisa.yaw@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- To acquire services to evaluate allergenicity and sensitization potential of cosmetic ingredients/mixtures based on survey of scientific literature. Please see attached document for details. Background: The Food and Drug Administration (FDA) is responsible for providing regulatory oversight of the safety and proper labeling of cosmetics. FDA is interested in evaluating the safety data of up to twenty-five (25) cosmetic ingredients/mixtures in cosmetic products, specifically from dermal and inhalation routes of exposure. In order to develop a regulatory position that is based on the most relevant scientific literature, the FDA needs a review and an evaluation of the existing published data that supports the safety (or lack thereof), of these cosmetic ingredients/mixtures, in particular when exposure is via the dermal and inhalation routes. Specifically, toxicological endpoints related to allergenicity and sensitization potential for these cosmetic ingredients/mixtures are of most interest to FDA. FDA will determine if the published scientific data support the conclusion that these cosmetic ingredients/mixtures warrant being identified as allergens or whether the data do not support such a conclusion. In addition, FDA needs a determination of whether these cosmetic ingredients/mixtures meet the definition of “allergen” and/or “sensitizer” as defined by consensus in the published scientific literature or by international regulatory bodies. To this end, the FDA will commission a literature survey that includes a summary and evaluation of the scientific data related to the allergenicity and/or sensitization potential of up to twenty-five (25) cosmetic ingredients/mixtures listed in the table below and an analysis of whether these ingredients/mixtures meet the definition of “allergen” and/or “sensitizer.” This survey asks for a review and summary of data relevant to toxicological endpoints of concern, based on the dermal and inhalation routes of exposure. The review and summary will be based on a systematic and critical review of the previous and most recent published scientific literature, as well as the review of any literature previously reviewed by international regulatory bodies that have developed and published a regulatory position on these cosmetic ingredients/mixtures. Objective : The objective is to conduct a literature survey and then review and summarize the data in order to obtain a better understanding of the potential hazards associated with cosmetic ingredients/mixtures.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-1169460/listing.html)
- Place of Performance
- Address: The US Food and Drug Administration, 4300 River Road - University Station, College Park, MD 20740, United States
- Zip Code: 20740
- Zip Code: 20740
- Record
- SN04180652-W 20160715/160713234440-203a3cd56e8e54ce25f78e30ba0b5498 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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