6204 Federal Register / Vol. 84, No. 38 / Tuesday, February 26, 2019 / Proposed Rules DEPARTMENT OF HEALTH AND the public. Similarly, if your submission 1978–N–0018 (formerly Docket No. HUMAN SERVICES includes safety and effectiveness data or FDA–1978–N–0038) for ‘‘Sunscreen information marked as confidential by a Drug Products for Over-the-Counter Food and Drug Administration third party (such as a contract research Human Use.’’ Received comments, those organization or consultant), you should filed in a timely manner (see 21 CFR Parts 201, 310, 347, and 352 either include a statement that you are ADDRESSES), will be placed in the docket [Docket No. FDA–1978–N–0018] (Formerly authorized to make the information and, except for those submitted as Docket No. FDA–1978–N–0038) publicly available or include an ‘‘Confidential Submissions,’’ publicly authorization from the third party viewable at https://www.regulations.gov RIN 0910–AF43 permitting the information to be or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday Sunscreen Drug Products for Over-the- publicly disclosed. If you submit data through Friday. Counter Human Use without confidential markings in response to this document and such • Confidential Submissions—To AGENCY: Food and Drug Administration, data includes studies or other submit a comment with confidential HHS. information that were previously information that you do not wish to be made publicly available, submit your ACTION: Proposed rule. submitted confidentially (e.g., as part of a new drug application), FDA intends to comments only as a written/paper SUMMARY: The Food and Drug presume that you intend to make such submission. You should submit two Administration (FDA or Agency) is data publicly available. copies total. One copy will include the issuing this proposed rule to put into information you claim to be confidential effect a final monograph for Electronic Submissions with a heading or cover note that states nonprescription, over-the-counter (OTC) Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS sunscreen drug products. This proposed following way: CONFIDENTIAL INFORMATION.’’ The rule describes the conditions under • Federal eRulemaking Portal: Agency will review this copy, including which FDA proposes that OTC https://www.regulations.gov. Follow the the claimed confidential information, in sunscreen monograph products are instructions for submitting comments. its consideration of comments. The generally recognized as safe and Comments submitted electronically, second copy, which will have the effective (GRASE) and not misbranded. including attachments, to https:// claimed confidential information It is being published as part of the www.regulations.gov will be posted to redacted/blacked out, will be available ongoing review of OTC drug products the docket unchanged. Because your for public viewing and posted on conducted by FDA. It is also being comment will be made public, you are https://www.regulations.gov. Submit published to comply with the Federal solely responsible for ensuring that your both copies to the Dockets Management Food, Drug, and Cosmetic Act (FD&C comment does not include any Staff. If you do not wish your name and Act), as amended by the Sunscreen confidential information that you or a contact information to be made publicly Innovation Act (SIA). third party may not wish to be posted, available, you can provide this information on the cover sheet and not DATES: Submit either electronic or such as medical information, your or in the body of your comments and you written comments. on the proposed rule anyone else’s Social Security number, or must identify this information as by May 28, 2019. Electronic comments confidential business information, such ‘‘confidential.’’ Any information marked must be submitted on or before May 28, as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed 2019. The https://www.regulations.gov that if you include your name, contact except in accordance with 21 CFR 10.20 electronic filing system will accept information, or other information that and other applicable disclosure law. For comments until 11:59 p.m. Eastern Time identifies you in the body of your comments, that information will be more information about FDA’s posting at the end of May 28, 2019. See section of comments to public dockets, see 80 XII for proposed effective and posted on https://www.regulations.gov. • If you want to submit a comment FR 56469, September 18, 2015, or access compliance dates of a final rule based the information at: https://www.gpo.gov/ on this document. with confidential information that you do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015- ADDRESSES: You may submit comments public, submit the comment as a 23389.pdf. as follows. Please note that late, written/paper submission and in the Docket: For access to the docket to untimely filed comments will not be manner detailed (see ‘‘Written/Paper read background documents or the considered. Comments received by Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments mail/hand delivery/courier (for written/ received, go to https:// paper submissions) will be considered Written/Paper Submissions www.regulations.gov and insert the timely if they are postmarked or the Submit written/paper submissions as docket number, found in brackets in the delivery service acceptance receipt is on follows: heading of this document, into the or before the closing date. • Mail/Hand Delivery/Courier (for ‘‘Search’’ box and follow the prompts Please be advised that safety and written/paper submissions): Dockets and/or go to the Dockets Management effectiveness data that are not available Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061, to the public cannot be relied on to Drug Administration, 5630 Fishers Rockville, MD 20852. establish conditions under which the Lane, Rm. 1061, Rockville, MD 20852. Submit comments on information OTC drugs described in this document • For written/paper comments collection issues under the Paperwork of proposed rulemaking are generally submitted to the Dockets Management Reduction Act of 1995 to the Office of recognized as safe and effective. Staff, FDA will post your comment, as Management and Budget (OMB) in the Accordingly, you should not submit, well as any attachments, except for following ways: and FDA generally does not intend to information submitted, marked and • Fax to the Office of Information and rely on, any evidence of safety and identified, as confidential, if submitted Regulatory Affairs, OMB, Attn: FDA effectiveness that bears a confidential as detailed in ‘‘Instructions.’’ Desk Officer, Fax: 202–395–7285, or mark unless you include a statement Instructions: All submissions received email to [email protected]. that the information may be released to must include the Docket No. FDA– All comments should be identified with VerDate Sep<11>2014 17:34 Feb 25, 2019 Jkt 247001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 E:\FR\FM\26FEP2.SGM 26FEP2 Federal Register / Vol. 84, No. 38 / Tuesday, February 26, 2019 / Proposed Rules 6205 the title, ‘‘Sunscreen Drug Products for B. Regulatory Status of Testing Entities changed conditions, including Over-the-Counter Human Use.’’ C. Generating and Maintaining Records of substantially increased sunscreen usage The Agency encourages commenters SPF and Broad Spectrum Testing and exposure and evolving information XVI. Federalism also to submit their comments on these XVII. Consultation and Coordination With about the potential risks associated with paperwork requirements to the Indian Tribal Governments these products since they were rulemaking docket (Docket No. FDA– XVIII. References originally evaluated. While these 1978–N–0018), along with their additional data are being developed and comments on other parts of the I. Executive Summary reviewed, FDA generally intends to proposed rule. A. Purpose and Coverage of the follow the enforcement approach FOR FURTHER INFORMATION CONTACT: Proposed Rule discussed in section III.B with regard to sunscreen products that contain those Kristen Hardin, Center for Drug The Food and Drug Administration Evaluation and Research, Food and (FDA or Agency) is publishing this sunscreen active ingredients included in Drug Administration, 10903 New proposed rule as part of the regulatory the Stayed 1999 Final Monograph. This proposed rule is also being Hampshire Ave., Bldg. 22, Rm. 5443, proceeding to put into effect a final published to comply with section 586E Silver Spring, MD 20993, 240–402– monograph 1 for nonprescription, OTC of the FD&C Act (21 U.S.C. 360fff–5), as 4246. sunscreen drug products under the OTC amended by the SIA (21 U.S.C. ch. 9, Drug Review. In 2011, FDA announced SUPPLEMENTARY INFORMATION: sub. 5, part I, enacted November 26, that ‘‘we are considering certain active Table of Contents ingredient safety issues further . In 2014). The SIA calls for FDA to issue a a forthcoming rulemaking, we intend to final OTC sunscreen monograph to be I. Executive Summary effective within 5 years of enactment of A. Purpose and Coverage of the Proposed request additional data regarding the Rule safety of the individual sunscreen active the SIA, or by November 26, 2019 B. Summary of the Major Provisions of the ingredients.’’ (‘‘Revised Effectiveness (section 586E(a) of the FD&C Act). If the Proposed Rule Determination; Sunscreen Drug final OTC sunscreen monograph does C. Legal Authority Products for Over-the-Counter Human not include provisions related to the D. Costs and Benefits Use’’ (Max SPF PR), 76 FR 35672 at effectiveness of various sun protection II. Table of Abbreviations/Commonly Used 35673, June 17, 2011). As described in factor (SPF) levels and address all Acronyms in This Document dosage forms known to FDA to be used III. Background further detail below, changed conditions in the nearly 20 years since publication in sunscreens marketed in the United A. FDA’s Current Regulatory Framework States without approved new drug B.