[Federal Register Volume 59, Number 29 (Friday, February 11, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-3343]


[[Page Unknown]]

[Federal Register: February 11, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 352, 700, and 740

[Docket No. 78N-0038]
RIN 0905-AA06

 

Sunscreen Drug Products for Over-the-Counter Human Use; Tentative 
Final Monograph; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening to March 
21, 1994, the comment period on the notice of proposed rulemaking that 
would establish conditions under which over-the-counter (OTC) sunscreen 
drug products are generally recognized as safe and effective and not 
misbranded (May 12, 1993, 58 FR 28194). FDA is taking this action in 
response to a request to extend the comment period for an additional 40 
days to allow more time to comment on this proposal. This reopening of 
the comment period does not apply to comments on ultraviolet A (UVA) 
testing, protection, ingredients, and labeling. The comment period for 
these issues closed on November 8, 1993. Subsequently, the agency 
extended the comment period until February 7, 1994, in order to have a 
workshop on these subjects in the spring of 1994. A notice concerning 
this workshop will appear in a future issue of the  Federal Register. 
This proposal is part of the ongoing review of OTC drug products 
conducted by the FDA.

DATES: Written comments by March 21, 1994.

ADDRESSES: 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.

SUPPLEMENTARY INFORMATION: In the  Federal Register of May 12, 1993 (58 
FR 28194), FDA issued a notice of proposed rulemaking (tentative final 
monograph) to establish the conditions under which OTC sunscreen drug 
products are generally recognized as safe and effective and not 
misbranded. Interested persons were given until November 8, 1993, to 
submit comments on the proposal. In the  Federal Register of October 
15, 1993 (58 FR 53460), the agency extended the comment period until 
February 7, 1994, for all issues except those related to UVA testing, 
protection, ingredients, and labeling.
    On January 19, 1994, the Cosmetic, Toiletry, and Fragrance 
Association (CTFA), a trade association, requested that the comment 
period be further extended by approximately 40 days. CTFA stated that 
the extension is necessary to provide sufficient time for its board of 
directors to consider and decide positions that CTFA will take in its 
comments to the agency. CTFA explained that these issues were to be 
discussed at a meeting of its executive committee on January 19, 1994. 
However, the meeting was cancelled as a result of travel difficulties 
caused by inclement weather in the East and Midwest and the earthquake 
in Los Angeles. CTFA stated that its board of directors will meet on 
March 2, 1994, and will address the policy issues at that time. CTFA 
stated that until the meeting, it is impossible to complete comments to 
the many significant issues raised in the tentative final monograph. 
CTFA requested an additional 40 days to provide sufficient time to 
address the issues still outstanding.
    FDA has carefully considered the request and believes that this 
additional time for comment is in the public interest. Accordingly, the 
comment period is reopened to March 21, 1994.
    This reopening of the comment period does not apply to comments on 
UVA testing, protection, ingredients, and labeling. The comment period 
for these issues closed on November 8, 1993, in order to have a 
workshop on these subjects in the spring of 1994. Comments received on 
UVA issues will be used to formulate questions and subjects for 
discussion at the workshop. Prior to and following the workshop, the 
administrative record for the rulemaking for OTC sunscreen drug 
products will be reopened to allow additional submissions of comments 
and data on UVA issues.
    Interested persons may, on or before March 21, 1994, submit to the 
Dockets Management Branch (address above) written comments regarding 
all sunscreen drug product proposals with the exception of comments 
pertaining to UVA testing, protection, ingredients, and labeling. 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. Comments received 
may be seen in the office above between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: February 7, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-3343 Filed 2-9-94; 10:59 am]
BILLING CODE 4160-01-F