2011-23479. 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.

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.

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: [phone].
• 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.