Source: https://www.federalregister.gov/documents/2019/02/08/2019-01529/agency-information-collection-activities-submission-for-office-of-management-and-budget-review
Timestamp: 2019-02-17 15:55:36
Document Index: 384747253

Matched Legal Cases: ['§\u2009201', 'art 201', 'art 201', '§\u2009201', 'art 201', '§\u2009201', '§\u2009201', '§\u2009201', '§\u2009201', '§\u2009201', '§\u2009201', '§\u2009201']

Federal Register :: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Sun Protection Factor Labeling and Testing Requirements for Over-the-Counter Sunscreen Drug Products
This document has a comment period that ends in 22 days. (03/11/2019) Submit a formal comment
https://www.federalregister.gov/d/2019-01529 https://www.federalregister.gov/d/2019-01529
In the Federal Register of June 17, 2011 (76 FR 35620), we published a final rule establishing labeling and effectiveness testing requirements for certain OTC sunscreen products containing specified active ingredients without approved applications (2011 sunscreen final rule; § 201.327 (21 CFR 201.327)). In addition to establishing testing requirements, the 2011 sunscreen final rule lifted the delay of implementing the prior 1999 sunscreen final rule (published in the Federal Register of May 21, 1999 (64 FR 27666), and stayed in the Federal Register of December 31, 2001 (66 FR 67485), from complying with the 1999 Drug Facts labeling final rule (published in the Federal Register of March 17, 1999 (64 FR 13254)), in which we amended our regulations governing requirements for human drug products to establish standardized format and content requirements for the labeling of all marketed OTC drug products in part 201 (21 CFR part 201). Specifically, the 1999 Drug Facts labeling final rule added new § 201.66 (21 CFR 201.66) to part 201. Section 201.66 establishes content and format requirements for the Drug Facts portion of OTC drug product labels. We specifically exempted OTC sunscreen products from complying with the 1999 Drug Facts labeling final rule until we lifted the stay of the 1999 sunscreen final rule. The 2011 sunscreen final rule became effective December 17, 2012, for sunscreen products with annual sales of $25,000 or more and December 17, 2013, for sunscreen products with annual sales of less than $25,000 when we published an extension date notice in the Federal Register of May 11, 2012 (77 FR 27591) (2012 extension date notice).
In the Federal Register of June 17, 2011 (76 FR 35678), we published a 60-day notice requesting public comment on the collection of information regarding SPF labeling and testing requirements for OTC sunscreen products containing specified ingredients and marketed without approved applications (2011 60-day notice). In that notice, we stated that § 201.327(a)(1) requires the principal display panel (PDP) labeling of a sunscreen covered by the 2011 sunscreen final rule to include the SPF value determined by conducting the SPF test outlined in § 201.327(i). Therefore, that provision resulted in an information collection with a third-party disclosure burden for manufacturers of OTC sunscreens covered by the 2011 sunscreen rule. We determined that products need only complete the testing and labeling required by the 2011 sunscreen rule once and then continue to use the resultant labeling (third-party disclosure) going forward without additional burden. This one-time testing would need to be conducted within the first 3 years after publication of the 2011 sunscreen final rule for all OTC sunscreens covered by that rule.
Because the 2011 sunscreen final rule also lifted the delay of implementing the Drug Facts regulations (§ 201.66) for OTC sunscreens, the rule also modified the information collection associated with § 201.66 (currently approved under OMB control number 0910-0340) and added a third-party disclosure burden resulting from requiring OTC sunscreen products to comply with Drug Facts regulations. In the 1999 Drug Facts labeling final rule, we amended our regulations governing requirements for human drug products to establish standardized format and content requirements for the labeling of all marketed OTC drug products, codified in § 201.66. This section establishes requirements for the Drug Facts portion of labels on OTC drug products requiring such labeling, to include uniform headings and subheadings, Start Printed Page 2879presented in a standardized order with minimum standards for type size and other graphical features. Therefore, OTC sunscreen products already on the market at that time incurred a one-time burden to comply with the requirements in § 201.66(c) and (d). In the 60-day notice, the burden was estimated as 43,200 hours for existing sunscreen SKUs and 720 hours for new sunscreen SKUs.
[New sunscreens] 1
[Drug facts labeling] 1
Request for Drug Facts exemption or deferral § 201.66(e) 1 0.125 0.125 (7 minutes) 24 3