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Federal Register / Vol. 79, No. 20 / Thursday, January 30, 2014 / Notices we conclude that the petition presents substantial scientific information indicating that the petitioned action of listing
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Substantial scientific information refers to data, studies, research findings, or other relevant information that supports the safety, efficacy, or quality of a product.
Manufacturers or marketers of products may be required to file substantial scientific information with regulatory authorities.
Substantial scientific information can be filled out by providing detailed documentation, studies, research reports, and any other relevant data to support the claims of a product.
The purpose of substantial scientific information is to provide evidence-based support for the safety, efficacy, and quality of a product.
Information such as study results, research methodologies, data analysis, and conclusions must be reported on substantial scientific information.
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