Proposed Rule2022-00475
Scientific Data and Information Related to the Residue of Carcinogenic Concern for the New Animal Drug Carbadox; Public Hearing; Request for Comments
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 13, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 9 (Thursday, January 13, 2022)</title>
</head>
<body><pre>
[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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 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:
<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-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 <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
[[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 <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: Kelly Covington, Center for Veterinary
Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, <a href="/cdn-cgi/l/email-protection#94d7f5e6f6f5f0fbecc4e1f6f8fdf7dcf1f5e6fdfaf3a6a4a6a6d4f2f0f5bafcfce7baf3fbe2"><span class="__cf_email__" data-cfemail="c380a2b1a1a2a7acbb93b6a1afaaa08ba6a2b1aaada4f1f3f1f183a5a7a2edababb0eda4acb5">[email protected]</span></a>, 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, <a href="https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room">https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room</a>.) 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 <a href="https://fda.zoomgov.com/j/1600135012?pwd=MFdjMW9FRXg4RGllc3FHWVhkWVAyZz09">https://fda.zoomgov.com/j/1600135012?pwd=MFdjMW9FRXg4RGllc3FHWVhkWVAyZz09</a> by March 9, 2022. If
you have any questions, you can contact
<a href="/cdn-cgi/l/email-protection#c98aa8bbaba8ada6b199bcaba5a0aa81aca8bba0a7aefbf9fbfb89afada8e7a1a1bae7aea6bf"><span class="__cf_email__" data-cfemail="a7e4c6d5c5c6c3c8dff7d2c5cbcec4efc2c6d5cec9c095979595e7c1c3c689cfcfd489c0c8d1">[email protected]</span></a> (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
<a href="/cdn-cgi/l/email-protection#4e0d2f3c2c2f2a21361e3b2c22272d062b2f3c2720297c7e7c7c0e282a2f6026263d60292138"><span class="__cf_email__" data-cfemail="36755744545752594e6643545a5f557e5357445f58510406040476505257185e5e4518515940">[email protected]</span></a>. 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 <a href="/cdn-cgi/l/email-protection#317250435350555e496144535d585279545043585f5603010303715755501f5959421f565e47"><span class="__cf_email__" data-cfemail="2f6c4e5d4d4e4b40577f5a4d43464c674a4e5d4641481d1f1d1d6f494b4e0147475c01484059">[email protected]</span></a> 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 <a href="https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/part-15-public-hearing-scientific-data-and-information-related-residue-carcinogenic-concern-new">https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/part-15-public-hearing-scientific-data-and-information-related-residue-carcinogenic-concern-new</a>.
Transcripts: Please be advised that as soon as a transcript of the
public hearing is available, it will be accessible at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/part-15-public-hearing-scientific-data-and-information-related-residue-carcinogenic-concern-new">https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/part-15-public-hearing-scientific-data-and-information-related-residue-carcinogenic-concern-new</a>.
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on January 13, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.