Document ID: FDA-2021-N-1326-1539
Agency: fda
Document Type: Proposed Rule
Title: Scientific Data and Information Related to the Residue of Carcinogenic Concern for the New Animal Drug Carbadox; Public Hearing; Request for Comments; Extension of Comment Period
Posted Date: 2022-03-31T04:00Z

[Federal Register Volume 87, Number 62 (Thursday, March 31, 2022)]
[Proposed Rules]
[Pages 18750-18751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06762]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 15

[Docket No. FDA-2021-N-1326]

Scientific Data and Information Related to the Residue of 
Carcinogenic Concern for the New Animal Drug Carbadox; Public Hearing; 
Request for Comments; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

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

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SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is 
extending the comment period for the notice of public hearing that 
appeared in the Federal Register of January 13, 2022. In the notice, 
FDA requested comments on scientific data and information related to 
the residue of carcinogenic concern for the new animal drug carbadox. 
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 notice published 
January 13, 2022 (87 FR 2093). Submit either electronic or written 
comments by June 10, 2022.

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 10, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 10, 2022. 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-2021-N-1326 for ``Scientific Data and Information Related to the 
Residue of Carcinogenic Concern for the New Animal Drug Carbadox.'' 
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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Kelly Covington, Center for Veterinary 
Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, [email protected], 240-402-
5661.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 13, 2022, 
FDA published a notice announcing a public hearing on scientific data 
and information related to the residue of carcinogenic concern for the 
new animal drug carbadox, a carcinogenic new animal drug used in swine 
feed, with a 90-day comment period.

[[Page 18751]]

    Interested persons were originally given until April 11, 2022, to 
comment on this hearing. The Agency has received a request to allow 
interested persons additional time to comment. The request conveyed 
concern that the current 90-day comment period does not allow 
sufficient time to develop comprehensive comments. We have concluded 
that it is reasonable to extend the comment period for 60 days. The 
Agency believes that this extension allows adequate time for interested 
persons to submit comments.

    Dated: March 25, 2022.
Andi Lipstein Fristedt,
Deputy Commissioner for Policy, Legislation, and International Affairs, 
U.S. Food and Drug Administration.
[FR Doc. 2022-06762 Filed 3-30-22; 8:45 am]
BILLING CODE 4164-01-P