07-5853. 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.

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

Electronic Submissions

Submit electronic comments in the following ways:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
• 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:

• 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.

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.