Document ID: FDA-2018-N-3458-0008
Agency: fda
Document Type: Notice
Title: Food Handler Antiseptic Drug Products for Over-the-Counter Human Use; Request for Data and Information; Reopening of the Comment Period
Posted Date: 2019-04-24T04:00Z

[Federal Register Volume 84, Number 79 (Wednesday, April 24, 2019)]
[Notices]
[Pages 17171-17172]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08251]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3458]

Food Handler Antiseptic Drug Products for Over-the-Counter Human 
Use; Request for Data and Information; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for data and information; reopening of the 
comment period.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
reopening the comment period provided in the notice entitled ``Food 
Handler Antiseptic Drug Products for Over-the-Counter Human Use; 
Request for Data and Information'' that appeared in the Federal 
Register of December 7, 2018. That notice announced the establishment 
of a docket to obtain data, information, and comments that will assist 
the Agency in assessing the safety and effectiveness of food handler 
antiseptic drug products (i.e., antiseptic hand washes or rubs intended 
for use in food handling settings) for over-the-counter human use. The 
Agency is taking this action to allow interested persons additional 
time to submit comments, data, or information.

DATES: FDA is reopening the comment period on the notice published on 
December 7, 2018 (83 FR 63168). Submit either electronic or written 
comments by July 23, 2019.

ADDRESSES: You may submit comments, data, or information as follows. 
Please note that late, untimely filed comments will not be considered. 
Electronic comments must be submitted on or before July 23, 2019. The 
https://www.regulations.gov electronic filing system will accept 
comments until 11:59 p.m. Eastern Time at the end of July 23, 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'').

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-2018-N-3458 for ``Food Handler Antiseptic Drug Products for Over-
the-Counter Human Use; Request for Data and Information; Reopening of 
Comment Period.'' 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

[[Page 17172]]

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: Pranvera Ikonomi, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 5418, Silver Spring, MD 20993-0002, 240-
402-0272.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 7, 2018 
(83 FR 63168), FDA published a notice entitled ``Food Handler 
Antiseptic Drug Products for Over-the-Counter Human Use; Request for 
Data and Information'' with a 60-day comment period to obtain data, 
information, and comments relating to the safety and effectiveness of 
food handler antiseptics. Following publication of the December 7, 
2018, notice, FDA received a request to allow interested persons 
additional time to comment. FDA is reopening the comment period until 
July 23, 2019. The Agency believes that an additional 90 days will 
allow adequate time for interested persons to respond to FDA's specific 
requests for comments.

    Dated: April 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-08251 Filed 4-23-19; 8:45 am]
BILLING CODE 4164-01-P