Document ID: FDA-1978-N-0018-1648
Agency: fda
Document Type: Proposed Rule
Title: Sunscreen Drug Products for Over-the-Counter Human Use; Extension of
Comment Period
Posted Date: 2019-04-18T04:00Z

[Federal Register Volume 84, Number 75 (Thursday, April 18, 2019)]
[Proposed Rules]
[Pages 16222-16223]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07710]

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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.

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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'').

[[Page 16223]]

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