[Federal Register Volume 72, Number 228 (Wednesday, November 28, 2007)]
[Proposed Rules]
[Pages 67264-67265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-5853]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 347 and 352

[Docket No. 1978N-0038] (formerly 78N-0038)
RIN 0910-AF43


Sunscreen Drug Products for Over-The-Counter Human Use; Proposed 
Amendment of Final Monograph; 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 
December 26, 2007, the comment period for the August 27, 2007, proposed 
rule to amend the final monograph for over-the-counter (OTC) sunscreen 
drug products (72 FR 49070). The comment period for the proposed rule 
was to end on November 26, 2007. The agency is taking this action in 
response to requests for an extension to allow interested persons 
additional time to submit comments.

DATES: Submit written or electronic comments by December 26, 2007.

ADDRESSES: You may submit comments, identified by Docket No. 1978N-0038

[[Page 67265]]

and RIN number 0910-AF43, by any of the following methods:

Electronic Submissions

Submit electronic comments in the following ways:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
    <bullet> Agency Web site: http://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.

Written Submissions

    Submit written submissions in the following ways:
    <bullet> FAX: 301-827-6870.
    <bullet> Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal or the agency Web site, as described in the 
Electronic Submissions portion of this paragraph.
    Instructions: All submissions received must include the agency 
name, docket number and regulatory information number (RIN) for this 
rulemaking. All comments received may be posted without change to 
http://www.fda.gov/ohrms/dockets/default.htm, including any personal 
information provided. For additional information on submitting 
comments, see the ``Request for Comments'' heading of the SUPPLEMENTARY 
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm 
and insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Matthew R. Holman, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 5414, Silver Spring, MD 20993, 301-796-
2090.

SUPPLEMENTARY INFORMATION:

I. Discussion

    In the Federal Register of May 21, 1999 (64 FR 27666), FDA 
published the final monograph for OTC sunscreen drug products in part 
352 (21 CFR part 352) with an effective date of May 21, 2001. Issues 
concerning active ingredients, labeling, and test methods for products 
intended to provide ultraviolet A (UVA) protection were deferred for 
future regulatory action because more time was required to review 
comments from interested parties. In the Federal Register of June 8, 
2000 (65 FR 36319), FDA reopened the administrative record of the 
rulemaking for OTC sunscreen drug products to allow for specific 
comment on high sun protection factor (SPF) and UVA radiation testing 
and labeling issues. FDA also extended the effective date for the final 
monograph to December 31, 2002.
    In the Federal Register of December 31, 2001 (66 FR 67485), FDA 
stayed the December 31, 2002, effective date of the final monograph for 
OTC sunscreen drug products in part 352 pending further notice from FDA 
in a future issue of the Federal Register. FDA took this action because 
we planned to amend part 352 to address formulation, labeling, and 
testing requirements for both ultraviolet B (UVB) and UVA radiation 
protection. The existing stay of the effective date for part 352 
remains in effect at this time.
    In the Federal Register of August 27, 2007 (72 FR 49070), FDA 
issued a proposed rule that would amend the final monograph for OTC 
sunscreen drug products to address both UVB and UVA testing and 
labeling requirements for sunscreen and sunscreen-skin protectant 
combination drug products. FDA requested comments on the proposed 
amendments. FDA also requested comments on issues related to OTC 
sunscreen drug products containing alpha hydroxy acids or titanium 
dioxide and zinc oxide formulated in particle sizes as small as a few 
nanometers. The comment period on the proposed rule was scheduled to 
end on November 26, 2007.

II. Extension of the Comment Period

    The agency has received requests for an extension of the comment 
period for the proposed rule. Each request conveyed concern that the 
current 90-day comment period does not allow sufficient time to develop 
a meaningful or thoughtful response to the proposed rule.
    FDA has considered the requests and is extending the comment period 
for the proposed rule for 30 days, until December 26, 2007. The agency 
believes that a 30-day extension allows adequate time for interested 
persons to submit comments without significantly delaying rulemaking on 
these important issues.
    In response to several requests to extend the comment period, we 
are extending the comment period for 30 days, until December 26, 2007.

III. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on this document. Submit 
a single copy of electronic comments or two paper copies of any mailed 
comments, except that individuals may submit one paper 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 Division 
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
    Please note that in January 2008, the FDA Web site is expected to 
transition to the Federal Dockets Management System (FDMS). FDMS is a 
Government-wide, electronic docket management system. After the 
transition date, electronic submissions will be accepted by us through 
the FDMS only. When the exact date of the transition to FDMS is known, 
we will publish a Federal Register notice announcing that date.

IV. References

    The following references are on display in the Division of Dockets 
Management (see ADDRESSES) under Docket No. 1978N-0038 and may be seen 
by interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Comment No. EXT10.
    2. Comment No. EXT11.
    3. Comment No. EXT12.
    4. Comment No. EXT13.
    5. Comment No. EXT14.
    6. Comment No. EXT15.
    7. Comment No. EXT16.
    8. Comment No. EXT17.
    9. Comment No. EXT18.

    Dated: November 21, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. 07-5853 Filed 11-26-07; 9:25 am]
BILLING CODE 4160-01-S