[Federal Register Volume 60, Number 97 (Friday, May 19, 1995)]
[Proposed Rules]
[Pages 26853-26854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-12399]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 201

[Docket No. 92N-0311]


Topical Drug Products Containing Benzoyl Peroxide; Required 
Labeling; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to July 
17, 1995, the comment period for the proposed rule to include 
additional labeling (warning and directions) for all topically-applied 
acne treatment drug products containing benzoyl peroxide, which 
appeared in the Federal Register of February 17, 1995 (60 FR 9554). FDA 
is taking this action in response to a request to extend the comment 
period.

DATES: Written comments by July 17, 1995.

ADDRESSES: Submit written comments 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.

 [[Page 26854]] SUPPLEMENTARY INFORMATION: In the Federal Register of 
February 17, 1995 (60 FR 9554), FDA issued a proposed rule to include 
additional labeling (warning and directions) for all topically-applied 
acne treatment drug products containing benzoyl peroxide. Interested 
persons were given until May 18, 1995, to submit written comments on 
the proposal.
    In response to the proposal, the Nonprescription Drug Manufacturers 
Association (NDMA) requested a 2-month extension of the comment period. 
NDMA states that the request was on behalf of member companies who 
manufacture and distribute over-the-counter (OTC) acne drug products 
containing benzoyl peroxide. NDMA indicated that it intended to comment 
on FDA's proposal to require additional labeling on acne drug products 
at the request of its Benzoyl Peroxide Study Group. NDMA stated that it 
needed more time to document fully questions about certain facts 
included in the proposal. NDMA added that the precedent-breaking nature 
of the agency's proposal demanded careful scrutiny and thoughtful 
consideration and that coordination of the Benzoyl Peroxide Study 
Group's efforts in these regards was time-consuming.
    FDA has carefully considered the request and acknowledges the 
uniqueness of the proposal. The agency believes that additional time 
for comment is in the public interest and will be of assistance in 
establishing labeling that will help consumers safely use drug products 
containing benzoyl peroxide for the treatment of acne. Accordingly, the 
comment period is extended to July 17, 1995.
    Interested persons may, on or before July 17, 1995, submit to the 
Dockets Management Branch (address above) written comments regarding 
the proposal. Three copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.

    Dated: May 16, 1995.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 95-12399 Filed 5-18-95; 8:45 am]
BILLING CODE 4160-01-F