Document ID: FDA-2021-N-1326-0001
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
Posted Date: 2022-01-13T05:00Z

[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]

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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; request for comments.

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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