federal_register: 94-2262
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 | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 94-2262 | Oral Health Care Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Oral Antiseptic Drug Products; Proposed Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES | Uncategorized Document | The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking in the form of a tentative final monograph that would establish conditions under which over-the-counter (OTC) oral antiseptic drug products (drug products used to help decrease the chance of infection in wounds in the mouth) are generally recognized as safe and effective and not misbranded. FDA is issuing this notice of proposed rulemaking after considering the report and recommendations of the Advisory Review Panel on OTC Oral Cavity Drug Products and public comments on an advance notice of proposed rulemaking that was based on those recommendations. This proposal is part of the ongoing review of OTC drug products conducted by FDA. DATES: Written comments, objections, or requests for oral hearing on the proposed regulation before the Commissioner of Food and Drugs by August 8, 1994. Because new testing procedures for OTC oral antiseptic drug products are included in this tentative final monograph, the agency is allowing a period of 180 days for comments and objections instead of the normal 60 days. New data by February 9, 1995. Comments on the new data by April 10, 1995. Written comments on the agency's economic impact determination by August 8, 1994. | 1994-02-09 | 1994 | 2 | https://www.federalregister.gov/documents/1994/02/09/94-2262/oral-health-care-drug-products-for-over-the-counter-human-use-tentative-final-monograph-for-oral | The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking in the form of a tentative final monograph that would establish conditions under which over-the-counter (OTC) oral antiseptic drug products (drug products used to help... |