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

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