[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]


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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.

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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