[Federal Register Volume 59, Number 219 (Tuesday, November 15, 1994)] [Unknown Section] [Page 0] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 94-28063] [[Page Unknown]] [Federal Register: November 15, 1994] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 333 and 369 [Docket No. 75N-183H] RIN 0905-AA06 Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products; Extension of Comment and New Data Periods AGENCY: Food and Drug Administration, HHS. ACTION: Notice of proposed rulemaking; extension of comment and new data periods. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is extending to June 19, 1995, the period for comments; to December 15, 1995, the period for new data; and to February 13, 1996, the period for comments on the new data for the notice of proposed rulemaking that was published in the Federal Register of June 17, 1994. That document proposed to establish conditions under which over-the-counter (OTC) topical health-care antiseptic drug products are generally recognized as safe and effective and not misbranded. FDA is taking this action in response to a request to extend these periods for an additional 6 months to allow interested persons adequate time to assess and respond to the proposal. DATES: Written comments by June 19, 1995; new data by December 15, 1995; and comments on the new data by February 13, 1996. ADDRESSES: Written comments or new data to the Dockets Management Branch (HFA-305), Food and Drug Administration, rm.1-23, 12420 Parklawn Dr., Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: William E. Gilbertson, Center for Drug Evaluation and Research (HFD-810), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-5000. SUPPLEMENTARY INFORMATION: In the Federal Register of June 17, 1994 (59 FR 31402), FDA issued a notice of proposed rulemaking in the form of an amended tentative final monograph to establish conditions under which OTC topical health-care antiseptic drug products are generally recognized as safe and effective and not misbranded. FDA issued this notice of proposed rulemaking to amend a previous notice of proposed rulemaking on topical antimicrobial drug products (43 FR 1210, January 6, 1978), after considering the public comments on that notice and other information in the administrative record for this rulemaking. Interested persons were given until December 14, 1994, to submit comments on the proposal; until June 19, 1995, to submit new data; and until August 17, 1995, to comment on the new data. In response to the proposal, the Cosmetic, Toiletry, and Fragrance Association (CTFA), the Soap and Detergent Association (SDA), and the Nonprescription Drug Manufacturers Association (NDMA) requested a 6- month extension of the comment and new data periods. (Although not specifically requested, a 6-month extension of the period for comments on the new data would result if these requests were to be granted.) CTFA, SDA, and NDMA noted their representation of the personal care products industry, manufacturers of products for cleaning and sanitation and the raw materials used in these products, and manufacturers of OTC drug products. The associations asserted that the proposal was broad in scope and raised numerous complex issues, particularly in the area of the effectiveness testing of these OTC drug products. The associations stated that more time is needed to assess fully the significant changes included in the proposal and to respond adequately to these issues. Observing that the agency's proposal was in the preparation stage for a considerable number of years, the associations stated their belief that it is reasonable for the agency to allow the additional time for comment and new data. FDA has carefully considered the request and acknowledges the broad scope of the proposal as well as the complexity of the issues it raises. The agency believes that additional time for comment and the submission of new data is in the public interest and will be of assistance in establishing conditions under which OTC topical health- care antiseptic drug products are generally recognized as safe and effective and not misbranded. Thus, the agency finds an extension of the periods for comments, new data, and comments on the new data to be appropriate. Interested persons may, on or before June 19, 1995, submit to the Dockets Management Branch (address above) written comments on the proposed regulation. New data may be submitted on or before December 15, 1995, and comments on the new data by February 13, 1996. Three copies of all data and comments are to be submitted, except that individuals may submit one copy. All data and comments are to be identified with the docket number found in brackets in the heading of this document. Received data and comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday. Dated: November 1, 1994. William K. Hubbard, Interim Deputy Commissioner for Policy. [FR Doc. 94-28063 Filed 11-14-94; 8:45 am] BILLING CODE 4160-01-F