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Labeling and Effectiveness Testing; I Vol. 76 Friday, No. 117 June 17, 2011 Part IV Department of Health and Human Services Food and Drug Administration 21 CFR Parts 201, 310, and 352 Sunscreen Drug Products for Over-the-Counter Human Use; Final Rules and Proposed Rules VerDate Mar<15>2010 18:47 Jun 16, 2011 Jkt 223001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\17JNR3.SGM 17JNR3 emcdonald on DSK2BSOYB1PROD with RULES3 35620 Federal Register / Vol. 76, No. 117 / Friday, June 17, 2011 / Rules and Regulations DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: regulatory actions associated with OTC HUMAN SERVICES Reynold Tan, Center for Drug sunscreen products, please refer to our Evaluation and Research, Food and Web site: http://www.fda.gov/Drugs/ Food and Drug Administration Drug Administration, 10903 New DevelopmentApprovalProcess/ Hampshire Ave., Bldg. 22, rm. 5411, DevelopmentResources/Over-the- 21 CFR Parts 201 and 310 Silver Spring, MD 20993, 301–796– CounterOTCDrugs/StatusofOTC [Docket No. FDA–1978–N–0018] (Formerly 2090. Rulemakings/ucm072134.htm. In the Federal Register of May 12, Docket No. 1978N–0038) SUPPLEMENTARY INFORMATION: 1993 (58 FR 28194), we published a RIN 0910–AF43 Table of Contents proposed rule for OTC sunscreen products that identified active Labeling and Effectiveness Testing; I. Overview of Document A. Rulemaking History ingredients we tentatively considered to Sunscreen Drug Products for Over-the- be generally recognized as safe and Counter Human Use B. Scope of This Document C. Issues Outside the Scope of This effective (GRASE), as well as associated AGENCY: Food and Drug Administration, Document labeling and sun protection factor (SPF) HHS. D. Enforcement Policy testing to be required for these OTC E. Summary of Major Revisions to the sunscreen products (the 1993 proposed ACTION: Final rule. Labeling and Testing Requirements rule). The SPF test and corresponding Included in the 2007 Proposed Rule labeling reflect the level of protection SUMMARY: The Food and Drug II. Administrative and Other Issues Administration (FDA) is issuing this III. Principal Display Panel (PDP) Labeling against sunburn, which is caused document to address labeling and A. SPF Statement primarily by UVB radiation. The 1993 effectiveness testing for certain over-the B. Broad Spectrum Statement proposed rule also explained the counter (OTC) sunscreen products C. Water Resistance Statement importance of protection against UVA containing specified active ingredients D. UVB and UVA Educational Statement radiation (58 FR 28194 at 28232 and and marketed without approved IV. Drug Facts Labeling 28233). The proposed rule referenced A. Active Ingredients/Purpose applications. This document addresses published UVA test methods but did not B. Uses propose a specific method (58 FR 28194 labeling and effectiveness testing issues C. Warnings raised by the nearly 2,900 submissions at 28248 to 28250). Rather, the proposed D. Directions rule stated that a sunscreen product that we received in response to the E. Constitutionality of Labeling Statements sunscreen proposed rule of August 27, Regarding Skin Cancer and Skin Aging could be labeled as ‘‘broad spectrum,’’ 2007 (2007 proposed rule). The F. Other Information or labeled with a similar statement, if it document also identifies specific claims G. Reduced Labeling protected against UVA radiation as that render a product that is subject to V. Miscellaneous Labeling Outside Drug demonstrated by one of the published this rule misbranded or would not be Facts UVA tests or a similar test. VI. SPF Test Parameters In April 1994, we reopened the allowed on any OTC sunscreen product A. Solar Simulator administrative record to allow marketed without an approved B. Sunscreen Standards additional submissions concerning application. The document does not C. Test Subjects UVA-related issues. We also announced address issues related to sunscreen D. Test Sites and Subsites a public meeting to be held in May 1994 active ingredients or certain other issues E. Finger Cot to discuss UVA testing procedures (59 regarding the GRASE determination for F. Application Amount FR 16042, April 5, 1994). We held the sunscreen products. The document G. Water Resistance VII. SPF Test Issues (Other Than Test public meeting to gather more requires OTC sunscreen products to information to help us determine the comply with the content and format Parameters) A. Pass/Fail (Binomial) SPF Test most appropriate UVA test method and requirements for OTC drug labeling B. Photostability labeling. contained in the 1999 Drug Facts final C. In Vitro SPF Test In November 1997, Congress enacted rule (published in the Federal Register D. Anti-Inflammatory Ingredients the Food and Drug Administration of March 17, 1999, by lifting the delay VIII. Broad Spectrum Test Modernization Act of 1997 (FDAMA), of implementation date for that rule that A. In Vivo Test Method: Not Required which addressed OTC sunscreen we published on September 3, 2004). B. In Vitro Test Method: Critical products among other FDA issues. Wavelength DATES: Effective Date: This final rule is C. Critical Wavelength Test Parameters Section 129 of FDAMA stated that ‘‘not effective June 18, 2012. For additional IX. Analysis of Impacts later than 18 months after the date of information concerning this effective A. Final Regulatory Impact Analysis enactment of this Act, the Secretary of date, see section X in the preamble of B. Small Business Impact (Final Regulatory Health and Human Services shall issue this document. The incorporation by Flexibility Analysis) regulations for over-the-counter reference of a certain publication listed X. Paperwork Reduction Act of 1995 sunscreen products for the prevention in this rule is approved by the Director XI. Environmental Impact or treatment of sunburn.’’ We then of the Federal Register as of June 18, XII. Federalism determined that the GRASE active 2012. XIII. References ingredients, SPF testing requirements, Compliance Date: The compliance I. Overview of Document and related labeling were issues that we date for all products subject to this final could finalize within the timeframe set rule with annual sales less than $25,000 A. Rulemaking History by FDAMA. Because we had not is June 17, 2013. The compliance date This section of the document does not previously proposed specific UVA for all other products subject to this discuss every regulatory action testing and labeling requirements, we final rule is June 18, 2012. associated with OTC sunscreen did not have sufficient time to finalize Implementation date: FDA is lifting products. It highlights the major these UVA requirements within the the delay of implementation date for regulatory actions that are related to the FDAMA timeframe. § 201.66 as published at 69 FR 53801, regulatory actions being taken in this In the Federal Register of May 21, September 3, 2004. document. For a complete list of all 1999, we published a final rule for OTC VerDate Mar<15>2010 18:47 Jun 16, 2011 Jkt 223001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\17JNR3.SGM 17JNR3 emcdonald on DSK2BSOYB1PROD with RULES3 Federal Register / Vol. 76, No. 117 / Friday, June 17, 2011 / Rules and Regulations 35621 sunscreen products (64 FR 27666). The sunscreen products are appropriately products, this new section 21 CFR 1999 sunscreen final rule added the labeled and tested for both UVA and 201.327 includes requirements for sunscreen monograph (regulations) in UVB protection. In addition, the labeling and the effectiveness testing part 352 (21 CFR part 352) and included requirements in this final rule will help upon which it relies. Because we have an effective date of May 2001. The 1999 ensure the proper use of these not yet resolved all of the issues sunscreen final rule stated that we sunscreens and greater consumer regarding conditions under which would publish a proposed rule outlining protection from the damaging effects of sunscreens are GRASE and not UVA testing and labeling requirements UV radiation. This final rule also misbranded, the stay of 21 CFR part 352 at a future date. In 2000, we extended identifies claims that render a product remains in effect. Although we are not the effective date for the 1999 sunscreen that is subject to this rule misbranded or yet codifying these labeling and related final rule to December 2002 (65 FR are not allowed on any OTC sunscreen effectiveness testing provisions in the 36319, June 8, 2000). drug product marketed without an monograph regulation, they do embody In December 2001, we stayed the approved application. the agency’s current determination on December 2002 effective date of the As described in the previous section appropriate regulation of these aspects 1999 sunscreen final rule indefinitely. of this document, we issued the 2007 of sunscreens that were previously We took this action because we planned proposed rule as a proposed amendment identified as falling within the to revise part 352 to add UVA testing to the sunscreen monograph monograph in part 352, and supersede and labeling requirements so that OTC requirements in 21 CFR part 352 the prior approach embodied in the sunscreen products would be tested and primarily to establish UVA testing and never-effective provisions of 21 CFR labeled for both UVB and UVA radiation labeling requirements so that all OTC part 352 subparts C and D. While this protection. We included these revisions sunscreen products marketed under the rule does not lift the stay of part 352, we in a proposed rule that published in the sunscreen monograph would be tested are lifting the delay of implementation Federal Register of August 27, 2007 (72 and labeled for both UVB and UVA date for the Drug Facts labeling FR 49070). The 2007 proposed rule radiation protection. Sunscreen active requirements of 21 CFR 201.66. In identified UVA testing and labeling that ingredients, UVB testing, UVB labeling, we proposed should be required for all and other conditions under which addition, this rule codifies certain OTC sunscreen products.
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