federal_register: 2010-13001
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2010-13001 | Drometrizole Trisiloxane Eligibility for Potential Inclusion in Sunscreen Monograph; Over-the-Counter Sunscreen Drug Products for Human Use; Request for Safety, Effectiveness, and Environmental Data | Notice | As part of our ongoing review of over-the-counter (OTC) drug products, we (Food and Drug Administration, FDA) are announcing a call- for-data for safety, effectiveness, and environmental information for drometrizole trisiloxane, in concentrations up to 15 percent, as a sunscreen single active ingredient and in combination with generally recognized as safe and effective (GRASE) sunscreen active ingredients found in the sunscreen monograph. We reviewed a time and extent application (TEA) for drometrizole trisiloxane and determined that it is eligible to be considered for inclusion in our OTC drug monograph system. We will evaluate the submitted safety and effectiveness data and information to determine whether drometrizole trisiloxane can be GRASE for its proposed OTC use. We also request data and information to assess the projected environmental effects of a potential GRASE determination in order to assist us in complying with the requirements of the National Environmental Policy Act of 1969 (NEPA). | 2010-06-02 | 2010 | 6 | https://www.federalregister.gov/documents/2010/06/02/2010-13001/drometrizole-trisiloxane-eligibility-for-potential-inclusion-in-sunscreen-monograph-over-the-counter | https://www.govinfo.gov/content/pkg/FR-2010-06-02/pdf/2010-13001.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | As part of our ongoing review of over-the-counter (OTC) drug products, we (Food and Drug Administration, FDA) are announcing a call- for-data for safety, effectiveness, and environmental information for drometrizole trisiloxane, in concentrations up to... |