[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
