16222 Federal Register / Vol. 84, No. 75 / Thursday, April 18, 2019 / Proposed Rules 
8. On page 6270, in the third column, 
the formula under § 201.327(j)(7) is 
corrected to read: 
9. On page 6270, in the third column, 
the formula under § 201.327(j)(8) is corrected to read: 
Elsewhere in this issue of the Federal 
Register, FDA is extending the comment 
period on the proposed rule. 
Dated: April 12, 2019. 
Lowell J. Schiller, 
Principal Associate Commissioner for Policy. 
[FR Doc. 2019–07712 Filed 4–17–19; 8:45 am] 
BILLING CODE 4164–01–C 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
21 CFR Parts 201, 310, 347, and 352 
[Docket No. FDA–1978–N–0018 (formerly 
Docket No. FDA–1978–N–0038)] 
RIN 0910–AF43 
Sunscreen Drug Products for Over-the- 
Counter Human Use; Extension of Comment Period 
AGENCY : Food and Drug Administration, 
HHS. 
ACTION : Proposed rule; extension of 
comment period. 
SUMMARY : The Food and Drug 
Administration (FDA or the Agency) is extending the comment period for the proposed rule that appeared in the Federal Register of February 26, 2019. In the proposed rule, FDA requested 
comments on its proposals relating to the regulation of over-the-counter (OTC) sunscreen monograph products. These proposals described the conditions under which the Agency proposes that OTC sunscreen monograph products are 
generally recognized as safe and effective and not misbranded. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. 
DATES : FDA is extending the comment 
period on the proposed rule published February 26, 2019 (84 FR 6204). Submit either electronic or written comments by June 27, 2019. 
ADDRESSES : You may submit comments 
as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 27, 2019. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 27, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions 
Submit electronic comments in the 
following way: 
•Federal eRulemaking Portal: 
https://www.regulations.gov. Follow the 
instructions for submitting comments. 
Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to 
the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. 
•If you want to submit a comment 
with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). 
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Written/Paper Submissions 
Submit written/paper submissions as 
follows: 
•Mail/Hand Delivery/Courier (for 
written/paper submissions): Dockets 
Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 
•For written/paper comments 
submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ 
Instructions: All submissions received 
must include the Docket No. FDA– 1978–N–0018 (formerly Docket No. FDA–1978–N–0038) for ‘‘Sunscreen Drug Products for Over-the-Counter Human Use.’’ Received comments, those filed in a timely manner (see 
ADDRESSES ), will be placed in the docket 
and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. 
•Confidential Submissions—To 
submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit 
both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ 
fdsys/pkg/FR-2015-09-18/pdf/2015- 
23389.pdf. 
Docket: For access to the docket to 
read background documents or the electronic and written/paper comments received, go to https://
www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 
FOR FURTHER INFORMATION CONTACT : 
Kristen Hardin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5443, Silver Spring, MD 20993, 240–402– 4246. 
SUPPLEMENTARY INFORMATION : In the 
Federal Register of February 26, 2019, FDA published a proposed rule with a 90-day comment period to request comments on the Agency’s proposals relating to the regulation of OTC sunscreen monograph products. These proposals described the conditions under which the Agency proposes that OTC sunscreen monograph products are generally recognized as safe and effective and not misbranded. Comments on these proposals will inform FDA’s rulemaking to establish regulations putting into effect a final monograph for nonprescription, OTC sunscreen drug products. FDA also indicated in the proposed rule that the Agency would consider requests to defer further rulemaking with respect to 
specific sunscreen active ingredients to allow the submission of new safety and/ or effectiveness data to the record if such requests were submitted to the docket within the initial 90-day comment period. Elsewhere in this issue of the Federal Register, the Agency is 
publishing a correction to the proposed rule to clarify illegible graphics of equations. 
The Agency has received a request for 
a 60- to 90-day extension of the comment period for the proposed rule. This request conveyed concern that the current 90-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the proposed rule. 
FDA has considered the request and 
is extending the comment period for the proposed rule for 30 days, until June 27, 2019. The Agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues. We note that this 30-day extension applies both to comments and to requests for the Agency to defer further rulemaking with respect to specific sunscreen active ingredients. Dated: April 12, 2019. 
Lowell J. Schiller, 
Principal Associate Commissioner for Policy. 
[FR Doc. 2019–07710 Filed 4–17–19; 8:45 am] 
BILLING CODE 4164–01–P 
DEPARTMENT OF HOMELAND 
SECURITY 
Coast Guard 
33 CFR Part 100 
[Docket Number USCG–2019–0150] 
RIN 1625–AA08 
Special Local Regulation; Kailua Bay, 
Ironman World Championship, Kailua- Kona, Hawaii 
AGENCY : Coast Guard, DHS. 
ACTION : Notice of proposed rulemaking. 
SUMMARY : The Coast Guard is proposing 
to establish a recurring special local regulation for certain waters of Kailua Bay, Hawaii. This action is necessary to provide for the safety of life on these navigable waters located at Kailua-Kona, HI, during the swim portion of the Ironman World Championship Triathlon and practice swim held on consecutive Saturdays annually in October. This proposed rulemaking would prohibit persons and vessels from being in the regulated area each day of the event unless authorized by the Captain of the Port Honolulu. We invite your comments on this proposed rulemaking. 
DATES : Comments and related material 
must be received by the Coast Guard on or before May 20, 2019. 
ADDRESSES : You may submit comments 
identified by docket number USCG– 2019–0150 using the Federal eRulemaking Portal at https://www.regulations.gov. See the ‘‘Public 
Participation and Request for Comments’’ portion of the 
SUPPLEMENTARY INFORMATION section for 
further instructions on submitting comments. 
FOR FURTHER INFORMATION CONTACT : If 
you have questions about this proposed rulemaking, call or email Chief Jason Olney, Waterways Management Division, U.S. Coast Guard Sector Honolulu; telephone (808) 522–8265, email jason.r.olney@uscg.mil. 
SUPPLEMENTARY INFORMATION : 
I. Table of Abbreviations 
CFR Code of Federal Regulations 
COTP Captain of the Port DHS Department of Homeland Security FR Federal Register 
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