Scientific Data and Information Related to the Residue of Carcinogenic Concern for the New Animal Drug Carbadox; Public Hearing; Request for Comments, 2093-2095 [2022-00475]
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Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Proposed Rules
Environmental Review
The Proposed Amendment
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‘‘Environmental Impacts: Policies and
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In consideration of the foregoing, the
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List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference,
Navigation (air).
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
§ 71.1
[Amended]
2. The incorporation by reference in
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Airspace Designations and Reporting
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effective September 15, 2021, is
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■
Paragraph 6011 United States Area
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■
JOPES, AK TO CABGI, AK [NEW]
JOPES, AK
WP
WOMEV, AK
WP
JERDN, AK
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HALUS, AK
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FEMEP, AK
WP
JIGUM, AK
WP
Kotzebue, AK (OTZ)
VOR/DME
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*
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T–367
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*
Issued in Washington, DC, on January 3,
2022.
Scott M. Rosenbloom,
Acting Manager, Rules and Regulations
Group.
[FR Doc. 2022–00004 Filed 1–12–22; 8:45 am]
BILLING CODE 4910–13–P
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
AGENCY:
Food and Drug Administration,
HHS.
Notice of public hearing; request
for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is 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.
DATES: The public hearing will be held
virtually on March 10, 2022, from 1 p.m.
to 5 p.m., Eastern Time. Persons
interested in attending this public
hearing must register no later than 11:59
p.m. Eastern Time on March 9, 2022.
Persons interested in making oral
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SUMMARY:
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17:38 Jan 12, 2022
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(Lat.
(Lat.
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62°03′33.30″
62°18′43.29″
63°44′57.33″
64°41′43.78″
65°14′24.15″
65°59′34.37″
66°53′08.46″
68°52′16.94″
N,
N,
N,
N,
N,
N,
N,
N,
long.
long.
long.
long.
long.
long.
long.
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163°17′07.68″
162°57′55.67″
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162°04′03.53″
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161°56′53.01″
162°32′23.77″
166°04′50.37″
presentations and comments at the
public hearing must submit requests by
February 18, 2022. Submit either
electronic or written comments on this
hearing by April 11, 2022. See the
SUPPLEMENTARY INFORMATION section for
registration dates and information.
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 April 11,
2022. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of April 11, 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
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W)
W)
W)
W)
W)
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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; Public Hearing;
Request for Comments.’’ 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
E:\FR\FM\13JAP1.SGM
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2094
Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Proposed Rules
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
our 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-201509-18/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, CarbadoxPublic
Hearing2022@fda.hhs.gov, 240–402–
5661.
SUPPLEMENTARY INFORMATION:
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I. Background and Purpose of Hearing
Under the Delaney Clause (section
512(d)(1)(I) (21 U.S.C. 360b(d)(1)(I)) of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act)), FDA generally cannot
approve a new animal drug application
(NADA) if the drug that is the subject of
that application induces cancer in
humans or animals. An exception to this
general rule is commonly known as the
Diethylstilbestrol ‘‘DES’’ Proviso, which
allows for the approval of a carcinogenic
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new animal drug where FDA finds that
under the approved conditions of use:
(1) The drug will not adversely affect
the animals treated with the drug and
(2) no residues of the drug will be found
by an approved regulatory method in
any edible tissues of, or in any foods
yielded by, the animal (section
512(d)(1)(I) of the FD&C Act).
On July 20, 2020, the Agency
published a notice in the Federal
Register proposing an order to revoke
the approved method for detecting
residues of carbadox, a carcinogenic
new animal drug used in swine feed. (85
FR 43853, July 20, 2020; Docket No.
FDA–2020–N–0955, ‘‘Phibro Animal
Health Corp.; Carbadox in Medicated
Swine Feed; Revocation of Approved
Method.’’) The currently approved
method measures quinoxaline-2carboxylic acid (QCA) as a marker
residue to detect the presence of the
residue of carcinogenic concern.
(Determination of Carbadox (as
Quinoxaline-2-Carboxylic [QCA])
Residues in Swine Liver and Muscle
Tissues After Drug Withdrawal, https://
www.fda.gov/about-fda/centerveterinary-medicine/cvm-foia-electronic
-reading-room.) The proposal to revoke
the approved method for carbadox is
based on CVM’s determination that the
method is inadequate to monitor residue
of carcinogenic concern in compliance
with FDA’s regulations in part 500,
subpart E (21 CFR part 500, subpart E).
These regulations set out the
requirements for demonstrating that no
residues of the drug will be found by an
approved regulatory method in any
edible tissues of or in any foods
obtained from the animal, as required to
meet the requirements of the DES
Proviso. The purpose of the public
hearing is to gather additional data and
information related to the residue of
carcinogenic concern for the new
animal drug carbadox.
II. Notice of Hearing Under 21 CFR Part
15
This public hearing will be held in
accordance with part 15 (21 CFR part
15). Pursuant to § 15.1(a) and authority
delegated from the Commissioner of
Food and Drugs as referenced in the
FDA Staff Manual Guide
1410.21(1)(B)(6) and (1)(D), the FDA
Acting Chief Scientist concludes, as a
matter of discretion, that it is in the
public interest to permit persons to
present information and views at a
public hearing on this matter. The
hearing will be conducted by a
presiding officer, who will be
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accompanied by other United States
Government employees serving as a
panel in conducting the hearing. Under
§ 15.30(f), the hearing is informal, and
the rules of evidence do not apply. Only
the presiding officer and panel members
can pose questions; they can question
any person during or at the conclusion
of each presentation. To the extent that
the conditions for the hearing, as
described in this notice, conflict with
any provisions set out in part 15, this
notice acts as a waiver of those
provisions as specified in § 15.30(h).
III. Topics for the Public Hearing
We encourage public comments and
presentations at the public hearing. We
are particularly interested in receiving
comments, data, and information about
the topics listed below. In submitting
comments, data, and information to the
docket, please identify available
references for the data and information,
as well as the specific item number
listed below, if applicable. Please
reference, but do not resubmit, any
information already contained in Docket
No. FDA–2020–N–0955, ‘‘Phibro
Animal Health Corp.; Carbadox in
Medicated Swine Feed; Revocation of
Approved Method.’’
1. Data to inform our knowledge of
the residue of carcinogenic concern not
summarized in the Freedom of
Information summary for the 1998
supplemental approvals, including
additional data regarding the fraction of
noncarcinogenic residues in the total
radiolabeled residues of carbadox.
2. For any given concentration of a
marker residue, the corresponding
concentration of the residue of
carcinogenic concern.
3. Additional information not already
contained in Docket No. FDA–2020–N–
0955, ‘‘Phibro Animal Health Corp.;
Carbadox in Medicated Swine Feed;
Revocation of Approved Method’’
related to the adequacy of the current
approved method to measure QCA as a
marker residue for the residue of
carcinogenic concern for the new
animal drug carbadox.
4. Any method, other than the current
approved method, that demonstrates
‘‘no residue’’ for the new animal drug
carbadox in conformance with part 500,
Subpart E.
5. Detailed information on the
conduct and quality of studies
providing data to support the points
above, including information on the
extraction process and the stability of
residues being analyzed.
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Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Proposed Rules
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IV. Participating in the Public Hearing
Registration: To register to attend the
virtual public hearing, on ‘‘Scientific
Data and Information Related to the
Residue of Carcinogenic Concern for the
New Animal Drug Carbadox; Public
Hearing; Request for Comments’’ please
register at https://fda.zoomgov.com/j/
1600135012?
pwd=MFdjMW9FRXg4RGllc
3FHWVhkWVAyZz09 by March 9, 2022.
If you have any questions, you can
contact CarbadoxPublicHearing2022@
fda.hhs.gov (See DATES and ADDRESSES).
Please provide complete contact
information for each attendee, including
name, title, affiliation, address, email,
and telephone.
Request for Oral Presentations: During
online registration, you may indicate if
you wish to make a formal presentation
(with accompanying slide deck) or
present oral comments during the
public hearing session (with no slide
deck). If you decide you wish to make
a presentation after registering online,
you may submit a request to
CarbadoxPublicHearing2022@
fda.hhs.gov. All requests to make
presentations must be received by
February 18, 2022. FDA will do its best
to accommodate requests to make public
presentations. Individuals and
organizations with common interests are
urged to consolidate or coordinate their
presentations. FDA will determine the
amount of time allotted to each
presenter and the approximate time
each presentation is to begin and will
select and notify participants by
February 23, 2022.
If selected for a formal oral
presentation (with a slide deck), each
presenter must submit an electronic
copy of their presentation (PowerPoint
or PDF) to
CarbadoxPublicHearing2022@
fda.hhs.gov with the subject line
‘‘Scientific Data and Information
Related to the Residue of Carcinogenic
Concern for the New Animal Drug
Carbadox; Public Hearing; Request for
Comments’’ on or before March 4, 2022.
No commercial or promotional material
will be permitted to be presented or
distributed at the public hearing.
Persons notified that they will be
presenters are encouraged to be online
early. Actual presentation times may
vary based on how the hearing
progresses in real time. An agenda for
the hearing and any other background
materials will be made available no later
than 5 days before the hearing at https://
www.fda.gov/animal-veterinary/
workshops-conferences-meetings/part15-public-hearing-scientific-data-and-
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information-related-residuecarcinogenic-concern-new.
Transcripts: Please be advised that as
soon as a transcript of the public
hearing is available, it will be accessible
at https://www.regulations.gov. It may
also be viewed at the Dockets
Management Staff (see ADDRESSES). A
link to the transcript will also be
available on the Agency’s website at
https://www.fda.gov/animal-veterinary/
workshops-conferences-meetings/part15-public-hearing-scientific-data-andinformation-related-residuecarcinogenic-concern-new.
Dated: January 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–00475 Filed 1–12–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF THE INTERIOR
National Indian Gaming Commission
25 CFR Part 559
RIN 3141–AA76
Facility License; Correction
National Indian Gaming
Commission, Department of the Interior.
AGENCY:
ACTION:
Proposed rule; correction.
This document corrects the
preamble to a proposed rule published
in the Federal Register of December 1,
2021, regarding Facility Licenses. The
document contained incorrect dates for
submitting comments. This correction
clarifies that comments are due January
31, 2022.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Michael Hoenig, 202–632–7003.
SUPPLEMENTARY INFORMATION:
Correction
In the Federal Register of December 1,
2021, in FR Doc. 2021–25845, on page
68200, in the third column, change the
DATES caption to read:
DATES: Written comments on this
proposed rule must be received on or
before January 31, 2022.
Dated: January 6, 2022.
Michael Hoenig,
General Counsel.
[FR Doc. 2022–00625 Filed 1–12–22; 8:45 am]
BILLING CODE 7565–01–P
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2095
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R04–OAR–2021–0428; FRL–9374–01–
R4]
Finding of Failure To Attain the 2010
Sulfur Dioxide Standard; Tennessee;
Sullivan County Nonattainment Area
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
The Environmental Protection
Agency (EPA) is proposing to determine
that the Sullivan County, Tennessee
sulfur dioxide (SO2) nonattainment area
failed to attain the 2010 1-hour SO2
primary National Ambient Air Quality
Standard (NAAQS or standard) by the
applicable attainment date of October 4,
2018, based upon a weight of evidence
analysis of available quality-assured and
certified SO2 ambient air monitoring
data and SO2 emissions data from
January 2015 through December 2017. If
EPA finalizes this determination as
proposed, the State of Tennessee will be
required to submit revisions to the
Tennessee State Implementation Plan
(SIP) that, among other elements,
provide for expeditious attainment of
the 2010 SO2 standard.
DATES: Comments must be received on
or before February 14, 2022.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–R04–
OAR–2021–0428 at https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Once submitted, comments cannot be
edited or removed from Regulations.gov.
EPA may publish any comment received
to its public docket. Do not submit
electronically any information you
consider to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Multimedia submissions (audio, video,
etc.) must be accompanied by a written
comment. The written comment is
considered the official comment and
should include discussion of all points
you wish to make. EPA will generally
not consider comments or comment
contents located outside of the primary
submission (i.e., on the web, cloud, or
other file sharing system). For
additional submission methods, the full
EPA public comment policy,
information about CBI or multimedia
submissions, and general guidance on
making effective comments, please visit
https://www2.epa.gov/dockets/
commenting-epa-dockets.
FOR FURTHER INFORMATION CONTACT:
Evan Adams, Air Regulatory
SUMMARY:
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]]>Agencies
[Federal Register Volume 87, Number 9 (Thursday, January 13, 2022)]
[Proposed Rules]
[Pages 2093-2095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00475]
=======================================================================
-----------------------------------------------------------------------
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
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public hearing; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
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.
DATES: The public hearing will be held virtually on March 10, 2022,
from 1 p.m. to 5 p.m., Eastern Time. Persons interested in attending
this public hearing must register no later than 11:59 p.m. Eastern Time
on March 9, 2022. Persons interested in making oral presentations and
comments at the public hearing must submit requests by February 18,
2022. Submit either electronic or written comments on this hearing by
April 11, 2022. See the SUPPLEMENTARY INFORMATION section for
registration dates and information.
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 April 11, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 11, 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;
Public Hearing; Request for Comments.'' 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
[[Page 2094]]
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 our 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:
I. Background and Purpose of Hearing
Under the Delaney Clause (section 512(d)(1)(I) (21 U.S.C.
360b(d)(1)(I)) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)),
FDA generally cannot approve a new animal drug application (NADA) if
the drug that is the subject of that application induces cancer in
humans or animals. An exception to this general rule is commonly known
as the Diethylstilbestrol ``DES'' Proviso, which allows for the
approval of a carcinogenic new animal drug where FDA finds that under
the approved conditions of use: (1) The drug will not adversely affect
the animals treated with the drug and (2) no residues of the drug will
be found by an approved regulatory method in any edible tissues of, or
in any foods yielded by, the animal (section 512(d)(1)(I) of the FD&C
Act).
On July 20, 2020, the Agency published a notice in the Federal
Register proposing an order to revoke the approved method for detecting
residues of carbadox, a carcinogenic new animal drug used in swine
feed. (85 FR 43853, July 20, 2020; Docket No. FDA-2020-N-0955, ``Phibro
Animal Health Corp.; Carbadox in Medicated Swine Feed; Revocation of
Approved Method.'') The currently approved method measures quinoxaline-
2-carboxylic acid (QCA) as a marker residue to detect the presence of
the residue of carcinogenic concern. (Determination of Carbadox (as
Quinoxaline-2-Carboxylic [QCA]) Residues in Swine Liver and Muscle
Tissues After Drug Withdrawal, https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room.) The proposal to
revoke the approved method for carbadox is based on CVM's determination
that the method is inadequate to monitor residue of carcinogenic
concern in compliance with FDA's regulations in part 500, subpart E (21
CFR part 500, subpart E). These regulations set out the requirements
for demonstrating that no residues of the drug will be found by an
approved regulatory method in any edible tissues of or in any foods
obtained from the animal, as required to meet the requirements of the
DES Proviso. The purpose of the public hearing is to gather additional
data and information related to the residue of carcinogenic concern for
the new animal drug carbadox.
II. Notice of Hearing Under 21 CFR Part 15
This public hearing will be held in accordance with part 15 (21 CFR
part 15). Pursuant to Sec. 15.1(a) and authority delegated from the
Commissioner of Food and Drugs as referenced in the FDA Staff Manual
Guide 1410.21(1)(B)(6) and (1)(D), the FDA Acting Chief Scientist
concludes, as a matter of discretion, that it is in the public interest
to permit persons to present information and views at a public hearing
on this matter. The hearing will be conducted by a presiding officer,
who will be accompanied by other United States Government employees
serving as a panel in conducting the hearing. Under Sec. 15.30(f), the
hearing is informal, and the rules of evidence do not apply. Only the
presiding officer and panel members can pose questions; they can
question any person during or at the conclusion of each presentation.
To the extent that the conditions for the hearing, as described in this
notice, conflict with any provisions set out in part 15, this notice
acts as a waiver of those provisions as specified in Sec. 15.30(h).
III. Topics for the Public Hearing
We encourage public comments and presentations at the public
hearing. We are particularly interested in receiving comments, data,
and information about the topics listed below. In submitting comments,
data, and information to the docket, please identify available
references for the data and information, as well as the specific item
number listed below, if applicable. Please reference, but do not
resubmit, any information already contained in Docket No. FDA-2020-N-
0955, ``Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed;
Revocation of Approved Method.''
1. Data to inform our knowledge of the residue of carcinogenic
concern not summarized in the Freedom of Information summary for the
1998 supplemental approvals, including additional data regarding the
fraction of noncarcinogenic residues in the total radiolabeled residues
of carbadox.
2. For any given concentration of a marker residue, the
corresponding concentration of the residue of carcinogenic concern.
3. Additional information not already contained in Docket No. FDA-
2020-N-0955, ``Phibro Animal Health Corp.; Carbadox in Medicated Swine
Feed; Revocation of Approved Method'' related to the adequacy of the
current approved method to measure QCA as a marker residue for the
residue of carcinogenic concern for the new animal drug carbadox.
4. Any method, other than the current approved method, that
demonstrates ``no residue'' for the new animal drug carbadox in
conformance with part 500, Subpart E.
5. Detailed information on the conduct and quality of studies
providing data to support the points above, including information on
the extraction process and the stability of residues being analyzed.
[[Page 2095]]
IV. Participating in the Public Hearing
Registration: To register to attend the virtual public hearing, on
``Scientific Data and Information Related to the Residue of
Carcinogenic Concern for the New Animal Drug Carbadox; Public Hearing;
Request for Comments'' please register at https://fda.zoomgov.com/j/1600135012?pwd=MFdjMW9FRXg4RGllc3FHWVhkWVAyZz09 by March 9, 2022. If
you have any questions, you can contact
[email protected] (See DATES and ADDRESSES). Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone.
Request for Oral Presentations: During online registration, you may
indicate if you wish to make a formal presentation (with accompanying
slide deck) or present oral comments during the public hearing session
(with no slide deck). If you decide you wish to make a presentation
after registering online, you may submit a request to
[email protected]. All requests to make
presentations must be received by February 18, 2022. FDA will do its
best to accommodate requests to make public presentations. Individuals
and organizations with common interests are urged to consolidate or
coordinate their presentations. FDA will determine the amount of time
allotted to each presenter and the approximate time each presentation
is to begin and will select and notify participants by February 23,
2022.
If selected for a formal oral presentation (with a slide deck),
each presenter must submit an electronic copy of their presentation
(PowerPoint or PDF) to [email protected] with the
subject line ``Scientific Data and Information Related to the Residue
of Carcinogenic Concern for the New Animal Drug Carbadox; Public
Hearing; Request for Comments'' on or before March 4, 2022. No
commercial or promotional material will be permitted to be presented or
distributed at the public hearing.
Persons notified that they will be presenters are encouraged to be
online early. Actual presentation times may vary based on how the
hearing progresses in real time. An agenda for the hearing and any
other background materials will be made available no later than 5 days
before the hearing at https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/part-15-public-hearing-scientific-data-and-information-related-residue-carcinogenic-concern-new.
Transcripts: Please be advised that as soon as a transcript of the
public hearing is available, it will be accessible at https://www.regulations.gov. It may also be viewed at the Dockets Management
Staff (see ADDRESSES). A link to the transcript will also be available
on the Agency's website at https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/part-15-public-hearing-scientific-data-and-information-related-residue-carcinogenic-concern-new.
Dated: January 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-00475 Filed 1-12-22; 8:45 am]
BILLING CODE 4164-01-P
