Source: https://www.federalregister.gov/documents/2012/05/11/2012-11390/labeling-and-effectiveness-testing-sunscreen-drug-products-for-over-the-counter-human-use-delay-of
Timestamp: 2018-08-21 03:21:13
Document Index: 456632046

Matched Legal Cases: ['§\u2009201', '§\u2009310', '§\u2009201', '§\u2009201', '§\u2009201', '§\u2009201', '§\u2009201', '§\u2009201', '§\u2009310', '§\u2009201', '§\u2009201', '§\u2009310', '§\u2009310', '§\u2009310', '§\u200910', '§\u200910']

Federal Register :: Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Delay of Compliance Dates
27591-27593 (3 pages)
https://www.federalregister.gov/d/2012-11390 https://www.federalregister.gov/d/2012-11390
In the Federal Register of June 17, 2011, a final rule was published for OTC sunscreen products (hereafter referred to as “2011 final rule”). The 2011 final rule established labeling and effectiveness testing requirements for certain OTC sunscreen products containing specified active ingredients and marketed without approved applications, to be codified in the Code of Federal Regulations (CFR) at § 201.327 (21 CFR 201.327) (which is effective June 18, 2012). It also amended § 310.545 (21 CFR 310.545) to classify as new drugs, requiring premarket approval, sunscreens labeled with certain claims (claims for “instant protection” or protection immediately upon application, or claims for “all-day” protection or extended wear claims citing a specific number of hours of protection that is inconsistent with the directions for application in § 201.327). Finally, it lifted the delay of implementation of the Drug Facts regulation, § 201.66 (21 CFR 201.66), published at 69 FR 53801, September 3, 2004, requiring those products to comply with § 201.66 on the same date as they would be required to comply with § 201.327 (76 FR 35620 at 35629). The 2011 final rule had an effective date of June 18, 2012, which was 1 year following publication of the final rule. For OTC sunscreen products with annual sales of $25,000 or more, the 2011 final rule had a compliance date of June 18, 2012. For OTC sunscreen products with annual sales of less than $25,000, the 2011 final rule had a compliance date of June 17, 2013.
FDA concurs that the operational timeline included in the submission supports extending the implementation period by an additional 6 months. One of our primary objectives in the 2011 final rule is to provide labeling that will enable consumers to identify and select sunscreen products that provide broad spectrum protection as well as a minimum sun protection factor (SPF) of 15. These sunscreens are particularly important for the public health because, in addition to helping prevent sunburn, sunscreens with a broad spectrum SPF value of 15 or higher, if used as directed with other sun protection measures, decrease the risk of skin cancer and early skin aging caused by the sun. If the timeline for implementation discourages manufacturers from conducting broad spectrum testing, and instead prompts them to apply the labeling that the final rule establishes for products that have not been established to offer broad spectrum protection, a major public health goal of the rule will be undermined. For this reason, granting manufacturers additional time to complete testing and relabeling is in the public interest. Also, implementation of § 201.66, the general Drug Facts labeling requirements, has been intended to be coordinated with the implementation of the substantive labeling changes necessitated by § 201.327, which provide the specific content for the Drug Facts panel for sunscreens. We therefore conclude that the implementation periods for these rules should remain coordinated.
We also conclude that extension of the compliance dates for § 310.545(a)(29)(ii) should likewise be extended because it is claims in labeling, and not formulation, that defines what sunscreens are subject to this provision of the 2011 final rule. The claims that would necessitate submission of a new drug application (NDA), as defined by that provision of the rule, are claims that would be in conflict with the labeling required by § 201.327. We believe that in many cases the relabeling of products to comply with § 201.327 will remove claims that would otherwise bring the sunscreen within § 310.545(a)(29)(ii). We therefore intend to revise the compliance dates to be codified in § 310.545(d)(40), so as to avoid requiring sunscreens that bear the indicated claims to be removed from the market before their relabeled replacements are ready.
We find that there is adequate rationale to delay the compliance dates for the 2011 final rule. We are issuing this rule directly, without issuing a notice of proposed rulemaking or taking comments on this action, for good cause. Because manufacturers' plans depend on the date by which compliance is expected, and the original compliance date for most products is now imminent, we find that issuing notice and taking comments are impracticable, unnecessary, and contrary to the public interest with respect to this action. As already noted, without this extension of the time for implementation, manufacturers who do not anticipate being able to comply by the original compliance dates expressed in the final rule would be faced either with discontinuing distribution, or potentially confining themselves to the labeling for products that have not been established to be broad spectrum. This means that consumers would be deprived of the additional information to make informed choices regarding their sun protection options. With regard to § 310.545, in particular, we also find it is in the public interest to extend the compliance date prior to the effective date, to avoid the confusion that would likely ensue if the codified had already been incorporated into the CFR with the earlier compliance dates. Accordingly, 5 U.S.C. 553(b) and § 10.40(e)(1) (21 CFR 10.40(e)(1)) provide a statutory and regulatory basis for not issuing notice or taking comment prior to implementing the delay of the compliance dates for the 2011 final rule. In accordance with § 10.40(e)(1), however, interested parties may submit comments on whether the extension of compliance dates set forth in this document should subsequently be modified or revoked.
1. “Personal Care Products Council—Comment, FDA-2011-N-0449-0003, 10/06/2011,” http://www.regulations.gov.