Notice2023-24547
Phibro Animal Health Corp.; Proposal To Withdraw Approval of New Animal Drug Applications for Carbadox in Medicated Swine Feed; Opportunity for a Hearing
Primary source
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Published
November 7, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency), Center for Veterinary Medicine (CVM), is proposing to withdraw approval of all new animal drug applications (NADAs) providing for use of carbadox in medicated swine feed, for which Phibro Animal Health Corp., Glenpointe Centre East, Third Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666-6712, is the sponsor, and is announcing an opportunity for the holder of the NADAs to request a hearing on this proposal. This action is based on CVM's determination that there is no approved regulatory method to detect the residue of carcinogenic concern in the edible tissues of the treated swine.
Full Text
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<title>Federal Register, Volume 88 Issue 214 (Tuesday, November 7, 2023)</title>
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[Federal Register Volume 88, Number 214 (Tuesday, November 7, 2023)]
[Notices]
[Pages 76756-76760]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-24547]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-4742]
Phibro Animal Health Corp.; Proposal To Withdraw Approval of New
Animal Drug Applications for Carbadox in Medicated Swine Feed;
Opportunity for a Hearing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or the Agency), Center
for Veterinary Medicine (CVM), is proposing to withdraw approval of all
new animal drug applications (NADAs) providing for use of carbadox in
medicated swine feed, for which Phibro Animal Health Corp., Glenpointe
Centre East, Third Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck,
NJ 07666-6712, is the sponsor, and is announcing an opportunity for the
holder of the NADAs to request a hearing on this proposal. This action
is based on CVM's determination that there is no approved regulatory
method to detect the residue of carcinogenic concern in the edible
tissues of the treated swine.
DATES: The sponsor of the NADAs may submit a written request for a
hearing by December 7, 2023. Submit all data, information, and analyses
upon which a request for a hearing relies by December 7, 2023. Either
electronic or written comments on the notice must be submitted by
December 7, 2023.
ADDRESSES: The request for a hearing may be submitted by the sponsor of
the NADAs by either of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments to submit your request
for hearing. Your request for a hearing submitted electronically,
including any attachments to the request for hearing, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> will be posted to the docket unchanged.
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper request for
a hearing): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
[[Page 76757]]
<bullet> Because your request for a hearing will be made public,
you are solely responsible for ensuring that your request does not
include any confidential information that you or a third party may not
wish to be publicly posted, such as confidential business information
(e.g., a manufacturing process). The request for a hearing must include
the Docket No. FDA-2023-N-4742 for ``Phibro Animal Health Corp.;
Proposal to Withdraw Approval of New Animal Drug Applications for
Carbadox in Medicated Swine Feed; Opportunity for a Hearing.'' The
request for a hearing will be placed in the docket and publicly
viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
The sponsor of the NADAs may submit all data and analyses upon
which the request for a hearing relies in the same manner as the
request for a hearing except as follows:
<bullet> Confidential Submissions--To submit any data and analyses
with confidential information that you do not wish to be made publicly
available, submit your data and analyses only as a written/paper
submission. You should submit two copies total of all data and
analyses. 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
any decisions on this matter. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>
or available at the Dockets Management Staff between 9 a.m. and 4 p.m.,
Monday through Friday. Submit both copies to the Dockets Management
Staff. Any information marked as ``confidential'' will not be disclosed
except in accordance with 21 CFR 10.20 and other applicable disclosure
law.
Comments Submitted by Other Interested Parties: For all comments
submitted by other interested parties, submit comments as follows.
Please note that late, untimely filed comments will not be considered.
The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept
comments until 11:59 p.m. Eastern Time at the end of December 7, 2023.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are received on or
before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2023-N-4742 for ``Phibro Animal Health Corp.; Proposal to Withdraw
Approval of New Animal Drug Applications for Carbadox in Medicated
Swine Feed; Opportunity for a Hearing.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: Diane Heinz, Center for Veterinary
Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-402-5692.
SUPPLEMENTARY INFORMATION:
I. Approved NADAs for Use of Carbadox in Swine Feed
Carbadox, a quinoxaline derivative, is a synthetic organic acid
antimicrobial. Currently, there are three approved NADAs for use of
carbadox in medicated swine feed, either by itself or in combination
with other approved new animal drugs. Phibro Animal Health Corp.,
Glenpointe Centre East, Third Floor, 300 Frank W. Burr Blvd., Suite 21,
Teaneck, NJ 07666-6712, is currently the sponsor of all three approved
NADAs.
Carbadox is marketed as a Type A medicated article used to
manufacture complete Type C medicated feeds that are administered ad
libitum (available at all times) to swine. Carbadox is
[[Page 76758]]
indicated for the control of dysentery and bacterial enteritis, and for
growth promotion. A tolerance of 30 parts per billion (ppb) has been
established for residues of quinoxaline-2-carboxylic acid (QCA), the
marker residue, in liver of swine (21 CFR 556.100). The combination
products containing carbadox (carbadox and pyrantel, and carbadox and
oxytetracycline) are also approved for additional indications related
to the non-carbadox active ingredient.
The following three NADAs are approved for the use of carbadox:
NADA 041-061, originally approved in 1972 (37 FR 20683, October 3,
1972), provides for the use of MECADOX 10 (carbadox) Type A medicated
article to manufacture single-ingredient Type C medicated swine feeds
for the following conditions of use:
Carbadox at 10 to 25 grams per ton (g/ton) of feed for increased
rate of weight gain and improved feed efficiency; and
Carbadox at 50 g/ton of feed for control of swine dysentery
(vibrionic dysentery, bloody scours, or hemorrhagic dysentery); for
control of bacterial swine enteritis (salmonellosis or necrotic
enteritis caused by Salmonella choleraesuis); and for increased rate of
weight gain and improved feed efficiency.
In January 1998, CVM approved a supplemental application to NADA
041-061, which included the approved method.
In October 1998, CVM approved an additional supplemental NADA for
NADA 041-061, changing the withdrawal period for carbadox medicated
feeds from 70 days to 42 days.
Currently, the withdrawal period for these uses of carbadox is 42
days (Sec. 558.115(d)(1)(ii) and (d)(2)(ii) (21 CFR 558.115(d)(1)(ii)
and (d)(2)(ii))).
NADA 092-955, originally approved in 1975 (40 FR 45164, October 1,
1975), provides for the use of MECADOX 10 (carbadox) Type A medicated
article with BANMINTH (pyrantel tartrate) Type A medicated article to
manufacture two-way, combination drug Type C medicated swine feeds for
the following conditions of use:
Carbadox at 50 g/ton of feed plus pyrantel tartrate at 96 g/ton of
feed for control of swine dysentery (vibrionic dysentery, bloody
scours, or hemorrhagic dysentery); for control of bacterial swine
enteritis (salmonellosis or necrotic enteritis caused by Salmonella
choleraesuis); as an aid in the prevention of migration and
establishment of large roundworm (Ascaris suum) infections; and as an
aid in the prevention of establishment of nodular worm
(Oesophagostomum) infections.
The withdrawal period for the use of this drug combination is 70
days (Sec. 558.115(d)(3)(ii)).
NADA 141-211, originally approved in 2004 (69 FR 51173, August 18,
2004), provides for the use of MECADOX 10 (carbadox) Type A medicated
article with TERRAMYCIN 50, TERRAMYCIN 100, or TERRAMYCIN 200
(oxytetracycline) Type A medicated articles to manufacture two-way,
combination drug Type C medicated swine feeds for the following
conditions of use:
Carbadox at 10 to 25 g/ton of feed plus oxytetracycline at levels
in feed to deliver 10 mg oxytetracycline per pound of body weight for
treatment of bacterial enteritis caused by Escherichia coli and S.
choleraesuis susceptible to oxytetracycline; for treatment of bacterial
pneumonia caused by Pasteurella multocida susceptible to
oxytetracycline; and for increased rate of weight gain and improved
feed efficiency.
The withdrawal period for the use of this animal drug combination
is 42 days (Sec. 558.115(d)(4); Sec. 558.450(e)(3)(iii)).
II. Basis for Withdrawal of Approval
FDA is providing notice of an opportunity for a hearing (NOOH) on
CVM's proposal to withdraw approval of the NADAs providing for use of
carbadox in medicated swine feeds. New evidence demonstrates that the
Delaney Clause in section 512(d)(1)(I) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 360b(d)(1)(I)), which requires that
no residue of a carcinogenic drug can be found in any edible portion of
the animal after slaughter, applies because the Diethylstilbestrol
(DES) Proviso exception is no longer met (see section III).
Section 512(e)(1)(B) of the FD&C Act provides grounds for
withdrawal of approval of an NADA if new evidence not contained in such
application or not available until after such application was approved,
tests by new methods, or tests by methods not deemed reasonably
applicable when such application was approved, evaluated together with
the evidence available when the application was approved, shows that
the Delaney Clause, section 512(d)(1)(I) of the FD&C Act, applies to
the drug. Under the Delaney Clause, the Secretary shall not approve a
new animal drug application if ``such drug induces cancer when ingested
by man or animal or, after tests which are appropriate for the
evaluation of the safety of such drug, induces cancer in man or
animal'' (section 512 (d)(1)(I) of the FD&C Act). An exception to this
general rule, referred to as the ``DES Proviso,'' 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)(i) through
(ii) of the FD&C Act).
Evidence available at the time of the approvals showed that
carbadox was carcinogenic. At the time of the January 1998 supplemental
approval, CVM concluded that carcinogenic residues, including
desoxycarbadox (DCBX), a known carcinogenic metabolite of carbadox,
depleted quickly (within 72 hours) while QCA residues depleted more
slowly (Ref. 1). However, new evidence not available at the time of the
approval, including studies conducted by the sponsor and submitted to
FDA from 2005 to 2016 and a study conducted by a third party and
summarized in a publication in 2022,\1\ demonstrates that the residue
of carcinogenic concern persists longer than previously known (Refs. 2
to 4). Because there is no established relationship between
concentrations of QCA measured by the approved method and
concentrations of the residue of carcinogenic concern, the approved
regulatory method cannot be used to measure the residue of carcinogenic
concern.
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\1\ ``Metabolism and Tissue Depletion of Carbadox in Swine,
Broilers, and Rats,'' Jie Zhang, Wei Qu, Zongchao Wang, and Yuanhu
Pan, ACS Agricultural Science & Technology 2022 2 (3), 477-485.
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Elsewhere in today's Federal Register, FDA is publishing a final
order (Ref. 5) revoking the approved regulatory method for carbadox
that measures QCA as a marker residue to detect the presence of any
residue of carcinogenic concern (Ref. 6). Currently, therefore, there
is no approved regulatory method for carbadox, and the second prong of
the DES Proviso is not met.
III. Background Information Regarding the Regulation of Carcinogenic
New Animal Drugs
Under the Delaney Clause of the FD&C Act, the Secretary shall not
approve a carcinogenic new animal drug application unless the DES
Proviso applies (section 512(d)(1)(I)(i) through (ii) of the FD&C Act).
FDA has issued implementing regulations that set the requirements for
demonstrating that no residues of the drug will be found by an approved
regulatory method in any
[[Page 76759]]
edible tissues of or in any foods yielded from the animal (21 CFR part
500, subpart E). These regulations, referred to as the sensitivity of
the method regulations (SOM regulations), describe how FDA determines
whether the regulatory method proposed by a sponsor is sufficiently
sensitive to ensure that residues of carcinogenic concern in edible
tissues will not exceed concentrations that represent no significant
increase in the risk of cancer to humans.
Pursuant to these regulations, FDA determines for each drug and
each drug metabolite (on the basis of the results of chronic bioassays
and other information) whether the drug or any of its metabolites are
carcinogenic (Sec. 500.84(a) (21 CFR 500.84(a))). For the drug and
each metabolite determined to be carcinogenic, FDA calculates, based
upon submitted assays, the concentration of the test compound in the
total diet of the test animal that corresponds to a maximum lifetime
risk of cancer in the test animal of 1 in 1 million (Sec. Sec.
500.82(b) (21 CFR 500.82(b)) and 500.84(c)(1)). FDA designates the
lowest value thus calculated as the S<INF>o</INF> (Sec. Sec. 500.82(b)
and 500.84(c)(1)). The S<INF>o</INF> corresponds to a concentration of
residue of carcinogenic concern in the total human diet that represents
no significant increase in the risk of cancer to people (Sec.
500.82(b)). Residue of carcinogenic concern includes all compounds in
the total residue of a demonstrated carcinogen excluding any compound
judged by FDA not to present a carcinogenic risk (Sec. 500.82(b)). The
total residues of carcinogenic concern (the drug and all of its
metabolites less metabolites shown to be noncarcinogenic) are regulated
based on the most potent carcinogenic residue (Sec. 500.84(c)(1)).
This approach ensures that use of the drug does not present a
significant increase in the risk of cancer when considering all
residues in edible tissues.
Because the total diet is not derived only from food-producing
animals, the SOM regulations make adjustments for human food intake of
edible tissues and determine the concentration of residues of
carcinogenic concern in a specific edible tissue that corresponds to no
significant increase in the risk of cancer to the human consumer. FDA
assumes for purposes of these regulations that this value will
correspond to the concentration of residues in a specific edible tissue
that corresponds to a maximum lifetime risk of cancer in test animals
of 1 in 1 million. This value is termed the S<INF>m</INF> (Sec. Sec.
500.82(b) and 500.84(c)(1)).
Based on residue depletion data submitted by a sponsor, FDA selects
a target tissue (the edible tissue selected to monitor for residues in
the target animals) and a marker residue (a residue whose concentration
is in a known relationship to the concentration of the residues of
carcinogenic concern in the last tissue to deplete to the
S<INF>m</INF>) and designates the concentration of the marker residue
that the regulatory method must be capable of detecting in the target
tissue (Sec. 500.86(a) through (c) (21 CFR 500.86(a) through (c))).
This value, termed the R<INF>m</INF>, is the concentration of a marker
residue in the target tissue when the residue of carcinogenic concern
is equal to S<INF>m</INF> (Sec. 500.82(b)). When the marker residue is
at or below the R<INF>m</INF>, the residue of carcinogenic concern in
the human diet does not exceed S<INF>o</INF> (Sec. 500.86(c)). This
regulation ensures that when the marker residue is no longer
detectable, the residue of carcinogenic concern does not exceed
S<INF>m</INF> in any of the edible tissues (Sec. Sec. 500.82(b) and
500.86(c)).
A sponsor must submit a regulatory method that is able to detect
the marker residue at or below the R<INF>m</INF> (21 CFR 500.88(b) and
500.84(c)(2)) (``The LOD [Limit of Detection for the regulatory method]
must be less than or equal to R<INF>m</INF>.'')). If a method is not
developed that can detect the marker residue at or below the
R<INF>m</INF>, the requirements of the SOM regulations are not
satisfied, and FDA cannot approve the drug. The DES Proviso and FDA's
implementing regulations are satisfied where no marker residue is
detectable using the approved regulatory method under the proposed
conditions of use of the drug, including the proposed preslaughter
withdrawal period (Sec. 500.84(c)(3)).
IV. Notice of Opportunity for a Hearing
CVM is proposing to withdraw approval of the three NADAs that
provide for use of carbadox in swine feed because new evidence
demonstrates that the drug does not meet the DES Proviso exception to
the Delaney Clause. There is currently no approved regulatory method
for carbadox.
Therefore, notice is given to Phibro Animal Health Corp.,
Glenpointe Centre East, Third Floor, 300 Frank W. Burr Blvd., Suite 21,
Teaneck, NJ 07666-6712, and to all other interested persons, that the
Deputy Commissioner for Policy, Legislation, and International Affairs,
Office of Policy, Legislation, and International Affairs proposes to
issue an order under section 512(e) of the FD&C Act withdrawing
approval of all NADAs providing for use of carbadox in medicated swine
feed.
In accordance with section 512 of the FD&C Act and 21 CFR part 514
and under the authority delegated to the Deputy Commissioner for
Policy, Legislation, and International Affairs, Office of Policy,
Legislation, and International Affairs by the Commissioner of Food and
Drugs, Phibro Animal Health Corp., the sponsor, is hereby given an
opportunity for a hearing to show why approvals of NADA 041-061, 092-
955, and 141-211 should not be withdrawn.
If the sponsor, Phibro Animal Health Corp., wishes to request a
hearing, the sponsor must file the following: (1) a written notice of
participation and request for a hearing (see DATES and ADDRESSES) and
(2) the data, information, and analyses relied on to demonstrate that
there is a genuine and substantial issue of fact that requires a
hearing (see DATES and ADDRESSES). Any other interested person may also
submit comments on this notice. Procedures and requirements governing
this NOOH, a notice of appearance and request for a hearing, submission
of data, information, and analyses to justify a hearing, other
comments, and a grant or denial of a hearing, are contained in Sec.
514.200 (21 CFR 514.200) and 21 CFR part 12.
The failure of a holder of an approval to timely file a request for
a hearing as required by Sec. 514.200 constitutes an election by the
holder not to avail itself of the opportunity for a hearing and
constitutes a waiver of any contentions concerning the legal status of
any such drug product, and the Director of CVM will summarily enter a
final order withdrawing the approvals. Any new animal drug product
marketed without an approved NADA is subject to regulatory action at
any time.
A request for a hearing may not rest upon mere allegations or
denials but must set forth specific facts showing that there is a
genuine and substantial issue of fact that requires a hearing. If it
conclusively appears from the face of the data, information, and
factual analyses in the request for hearing that there is no genuine
and substantial issue of fact that precludes the withdrawal of approval
of the applications, or when a request for hearing is not made in the
required format or with the required analyses, the Commissioner of Food
and Drugs will enter summary judgment against the person who requests a
hearing, making findings and conclusions, and denying a hearing.
If a hearing is requested and is justified by the sponsor's
response to this NOOH, the issues will be defined,
[[Page 76760]]
a presiding officer will be assigned, and a written notice of the time
and place at which the hearing will commence will be issued as soon as
practicable.
This notice is issued under section 512 of the FD&C Act and under
the authority delegated to the Deputy Commissioner for Policy,
Legislation, and International Affairs, Office of Policy, Legislation,
and International Affairs.
V. Environmental Impact
The Agency has determined under 21 CFR 25.33(g) that this action is
of a type that does not individually or cumulatively have a significant
impact on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VI. References
The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Although FDA
verified the website addresses in this document, please note that
websites are subject to change over time.
1. FDA, Freedom of Information Summary, NADA 041-061, MECADOX 10
(carbadox) Type A medicated article, supplemental approval January
30, 1998. Available at <a href="https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/308">https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/308</a>.
2. Evaluations of the Joint Food and Agriculture Organization of the
United Nations/World Health Organization Expert Committee on Food
Additives (JECFA). Carbadox. 2021. Available at: <a href="https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/2176">https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/2176</a>.
3. Memorandum to File entitled ``CVM Response to Phibro Animal
Health Corporation's September 18, 2020 Comments on CVM's July 20,
2020 Proposed Order to Revoke the Regulatory Method for Carbadox''
(January 6, 2022).
4. Memorandum to File entitled ``CVM review of comments on the Zhang
article that Phibro references in the document submitted to the Part
15 Hearing docket under cover letter dated June 9, 2022, and
entitled, `Phibro Animal Health Corporation's Reply to the January
6, 2022 `CVM Response to Phibro Animal Health Corporation's
September 18, 2020 Comments on CVM's July 20, 2020 Proposed Order to
Revoke the Regulatory Method for Carbadox.' ' '' (October 30, 2023).
5. Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed;
Revocation of Approved Method (November 7, 2023).
6. ``Determination of Carbadox as Quinoxaline-2-carboxylic Residues
in Swine Liver and Muscle Tissues after Drug Withdrawal.'' Available
at <a href="https://www.fda.gov/media/136267/download">https://www.fda.gov/media/136267/download</a>.
Dated: November 1, 2023.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2023-24547 Filed 11-6-23; 8:45 am]
BILLING CODE 4164-01-P
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