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
| Published date | 12 September 2019 |
| Citation | 84 FR 48150 |
| Record Number | 2019-19697 |
| Section | Notices |
| Court | Food And Drug Administration |
Federal Register, Volume 84 Issue 177 (Thursday, September 12, 2019)
[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
