Document ID: FDA-1978-N-0018-0706
Agency: fda
Document Type: Proposed Rule
Title: Sunscreen Drug Products for Over-the-Counter Human Use: Request for Data and Information Regarding Dosage Forms; Extension of Comment Period
Posted Date: 2011-09-14T04:00Z

[Federal Register Volume 76, Number 178 (Wednesday, September 14, 2011)]
[Proposed Rules]
[Pages 56682-56683]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23479]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 352

[Docket No. FDA-1978-N-0018] (formerly Docket No. 1978N-0038)
RIN 0910-ZA40

Sunscreen Drug Products for Over-the-Counter Human Use; Request 
for Data and Information Regarding Dosage Forms; Extension of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking; request for data and 
information; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period for the advance notice of proposed rulemaking (ANPRM) 
that published on June 17, 2011. The ANPRM is requesting data and 
information on certain dosage forms of over-the-counter (OTC) sunscreen 
drug products marketed without approved applications. The comment 
period for that ANPRM will end on September 15, 2011. This document 
extends the comment period to October 17, 2011.

[[Page 56683]]

DATES: Submit either electronic or written data and information by 
October 17, 2011.

ADDRESSES: You may submit comments, identified by Docket No. FDA-1978-
N-0018 (formerly Docket No. 1978N-0038) and/or RIN number 0910-ZA40, by 
any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Fax: 301-827-6870.
     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.
    Instructions: All submissions received must include the Agency 
name, Docket No. FDA-1978-N-0018, and RIN 0910-ZA40 for this 
rulemaking. All comments received may be posted without change to 
http://www.regulations.gov, including any personal information provided 
if not marked as confidential. 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.regulations.gov, 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: Reynold Tan, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 5411, Silver Spring, MD 20993-0002, 301-
796-2090.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 17, 2011 (76 FR 35669) (the June 
17, 2011, ANPRM), FDA published an ANPRM that requested data and 
information on OTC sunscreen products marketed without approved 
applications that are formulated in certain dosage forms. FDA requested 
these data to help establish OTC monograph conditions, including dosage 
form specifications, for OTC sunscreen drug products. Among the data 
requested is data necessary to resolve specific questions about the 
effectiveness and safety of OTC sunscreens in spray dosage forms.

II. Extension of the Comment Period

    In response to the June 17, 2011, ANPRM, three submissions (Refs. 
1, 2, and 3) requested an extension of the comment period, which will 
end on September 15, 2011. Two of the submissions requested that FDA 
extend the comment period by 30 days so that the comment period totals 
4 months (Refs. 1 and 2). The other submission requested that FDA 
extend the comment period by 90 to 180 days so that the comment period 
totals 6 to 9 months (Ref. 3). The submissions cited the need for 
additional time to evaluate their available data and to organize and 
submit the data and information that best addresses FDA's request while 
simultaneously implementing the new requirements for their sunscreen 
products imposed by the Labeling and Effectiveness Testing final rule 
that published in the Federal Register of June 17, 2011 (76 FR 35620).
    FDA is extending the comment period to end on October 17, 2011. A 
total comment period of 4 months is sufficient for the public to submit 
comments to the ANPRM.

III. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments, data, and 
information by October 17, 2011. It is only necessary to submit one set 
of comments, data, and information. It is no longer necessary to two 
copies of mailed comments, data, and information. Identify submissions 
with the docket number found in brackets in the heading of this 
document, and may be accompanied by supporting information. Received 
submissions may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday. Information submitted after the 
closing date will not be considered except by petition under 21 CFR 
10.30.

IV. References

    The following references are on display in the Division of Dockets 
Management (see ADDRESSES) under Docket No. FDA-1978-N-0018 and may be 
seen by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday.
    1. Comment No. FDA-1978-N-0018-DRAFT-5225.
    2. Comment No. FDA-1978-N-0018-DRAFT-5227.
    3. Comment No. FDA-1978-N-0018-DRAFT-5228.

    Dated: September 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23479 Filed 9-13-11; 8:45 am]
BILLING CODE 4160-01-P