[Federal Register Volume 84, Number 177 (Thursday, September 12, 2019)]
[Notices]
[Pages 48150-48151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19697]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3019]


Transit Times to Slaughter Facilities, Milking Frequency, and 
Interpretation of Zero-Day Withdrawal Periods and Zero-Day Milk Discard 
Times Assigned to New Animal Drugs; Request for Comments; Extension of 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments, extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is 
extending the comment period for the request for comments that appeared 
in the Federal Register of August 9, 2019. In that document, we 
requested comments on transit times to slaughter, milking frequency, 
and how

[[Page 48151]]

end users interpret zero-day withdrawal period, or zero-day milk 
discard times statements found on new animal drug labeling. We are 
taking this action in response to requests for an extension to allow 
interested persons additional time to submit comments.

DATES: FDA is extending the comment period on the request for comments 
published August 9, 2019 (84 FR 39340). Submit either electronic or 
written comments by January 6, 2020.

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 January 6, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of January 6, 2020. 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-2019-N-3019 for ``Transit Times to Slaughter Facilities, Milking 
Frequency, and Interpretation of Zero-Day Withdrawal Periods and Zero-
Day Milk Discard Times Assigned to New Animal Drugs.'' 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: Charli M. Long-Medrano, Center for 
Veterinary Medicine (HFV-150), Food and Drug Administration, 7500 
Standish Pl., Rm. E340, Rockville, MD 20855, 240-402-0850, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of August 9, 2019, 
FDA published a request for comments with a 60-day comment period to 
request comments on transit times to slaughter, milking frequency, and 
how end users interpret zero-day withdrawal period, or zero-day milk 
discard time statements found on new animal drug labeling. Comments on 
interpretation of these labeling statements will help to evaluate if 
our current approach to assigning zero-day withdrawal periods and zero-
day milk discard times to new animal drugs is appropriate.
    The Agency has received requests for a 90-day extension of the 
comment period for the request for comments. The requests convey 
concern that the current 60-day comment period does not allow 
sufficient time to develop a meaningful or thoughtful response to the 
request for comments.
    FDA has considered the requests and is extending the comment period 
for the request for comments for 90 days, until January 6, 2020. The 
Agency believes that a 90-day extension allows adequate time for 
interested persons to submit comments without significantly delaying 
rulemaking on these important issues.

    Dated: September 5, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19697 Filed 9-11-19; 8:45 am]
 BILLING CODE 4164-01-P