[Federal Register Volume 76, Number 178 (Wednesday, September 14, 2011)]
[Proposed Rules]
[Pages 56682-56683]
From the Federal Register Online via the Government Publishing 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