federal_register: 2020-28929
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2020-28929 | Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Consumer Antiseptic Rub Final Rule Questions and Answers." We are issuing this guidance in accordance with the Small Business Regulatory Enforcement Fairness Act to help small businesses understand and comply with the Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph (Consumer Antiseptic Rub FR). In the Consumer Antiseptic Rub FR, FDA established that 28 active ingredients used in nonprescription (also known as over-the-counter (OTC)) consumer antiseptic products intended for use without water (consumer antiseptic rubs) are not eligible for evaluation under FDA's OTC Drug Review, which was used to evaluate the safety and effectiveness of OTC drug products marketed in the United States on or before May 1972. The Consumer Antiseptic Rub FR also established that three active ingredients used in consumer antiseptic rubs are eligible for evaluation under the OTC Drug Review and granted requests to temporarily defer further rulemaking on these three eligible ingredients to allow for the development and submission of new safety and effectiveness data. | 2020-12-31 | 2020 | 12 | https://www.federalregister.gov/documents/2020/12/31/2020-28929/consumer-antiseptic-rub-final-rule-finding-of-ineligibility-for-inclusion-in-final-monograph | https://www.govinfo.gov/content/pkg/FR-2020-12-31/pdf/2020-28929.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Consumer Antiseptic Rub Final Rule Questions and Answers." We are issuing this guidance in accordance with the Small Business... |