In this proposed rule, we are proposing to establish conditions under which OTC antiseptic products intended for use by health care professionals in a hospital setting or other health care situations outside the hospital are generally recognized as safe and effective. The Food and Drug Administration (FDA) is issuing this proposed rule to amend the 1994 tentative final monograph or proposed rule (the 1994 TFM) for over-the-counter (OTC) antiseptic drug products. Start Preamble Start Printed 66 AGENCY:įood and Drug Administration, HHS. Summary of Preliminary Regulatory Impact Analysis Review of Available Data for Each Antiseptic Active Ingredient Studies To Evaluate the Potential Impact of Antiseptic Active Ingredients on the Development of Resistance Studies To Characterize Maximal Human Exposure Studies To Support a Generally Recognized as Safe Determination Safety (Generally Recognized as Safe) Determination Current Standards: Studies Needed To Support a Generally Recognized as Effective Determination Effectiveness (Generally Recognized as Effective) Determination Summary of Proposed Classifications of OTC Health Care Antiseptic Active Ingredients Ingredients Previously Proposed as Not Generally Recognized as Safe and Effective Polyhexamethylene Biguanide Benzalkonium Cetyl Phosphate Cetylpyridinium Chloride Salicylic Acid Sodium Hypochlorite Tea Tree Oil Combination of Potassium Vegetable Oil Solution, Phosphate Sequestering Agent, and Triethanolamine Eligibility of Certain Active Ingredients for Certain Health Care Antiseptic Uses Under the OTC Drug Review Active Ingredients With Insufficient Evidence of Eligibility for the OTC Drug Review Public Meetings Relevant to This Proposed Rule Significant Rulemakings Relevant to This Proposed Rule This Proposed Rule Covers Only Health Care Antiseptics Proposed, Tentative Final, and Final Monographs Terminology Used in the OTC Drug Review Regulations Summary of the Major Provisions of the Regulatory Action in Question.This repetition of headings to form internal navigation links Headings within the legal text of Federal Register documents. This table of contents is a navigational tool, processed from the Provide legal notice to the public or judicial notice to the courts. Rendition of the daily Federal Register on does not Until the ACFR grants it official status, the XML Legal research should verify their results against an official edition of The official SGML-based PDF version on, those relying on it for The material on is accurately displayed, consistent with While every effort has been made to ensure that Regulatory information on with the objective ofĮstablishing the XML-based Federal Register as an ACFR-sanctioned The OFR/GPO partnership is committed to presenting accurate and reliable Register (ACFR) issues a regulation granting it official legal status.įor complete information about, and access to, our official publications Informational resource until the Administrative Committee of the Federal This prototype edition of theĭaily Federal Register on will remain an unofficial Each document posted on the site includes a link to theĬorresponding official PDF file on. The documents posted on this site are XML renditions of published Federal Register, and does not replace the official print version or the official It is not an official legal edition of the Federal This site displays a prototype of a “Web 2.0” version of the dailyįederal Register.
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