FDA NEWS RELEASE

FDA Extends Comment Period for Proposed Sunscreen Rule
30-day extension to run through Dec. 26, 2007

The Food and Drug Administration today announced that it will be extending the comment period on the agency's proposed sunscreen regulation to Dec. 26, 2007. The comment period was set to expire on Nov. 26. Typically, comment periods for Federal rules is 90 days. The sunscreen rule, when finalized, will amend the 1999 FDA final rule on sunscreen products that protect against ultraviolet B (UVB) rays and incorporates new testing and labeling requirements for products that protect against ultraviolet A (UVA) rays.

On Aug. 27 the agency released to the public its proposed rule for over-the-counter (OTC) sunscreen products. FDA received nine requests to extend the comment period. One asked for an additional two months, eight for an additional nine months. The submissions cited the need for more time to complete laboratory testing and consumer studies on the proposed labeling system. By extending the comment period for 30 days, FDA is balancing industry concerns and the interests of public health to ensure that sunscreen products properly inform consumers of the level of protection they provide against UVA and UVB rays.

Comments must be identified with Docket No. 1978N-0038 and can be submitted electronically or in written form. Electronic submissions can be submitted at the following Web sites:

• Federal eRulemaking Portal: www.regulations.gov
• FDA Web site: www.fda.gov/dockets/ecomments

Written submissions can be submitted by fax or mail:

Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Fax 301-827-6870

For more information: 

• FDA Web site for OTC drug products:
  www.fda.gov/cder/Offices/OTC/consumer.htm

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