[Federal Register Volume 85, Number 139 (Monday, July 20, 2020)]
[Notices]
[Pages 43852-43853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15245]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0832]


Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; 
Withdrawal of Notice of Opportunity for Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of opportunity for hearing; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA), Center for Veterinary 
Medicine (CVM), is announcing the withdrawal of a notice of opportunity 
for a hearing (NOOH), which proposed to withdraw the approved uses of 
carbadox, a carcinogenic animal drug intended for use in feeds for 
swine. FDA is publishing a proposed order that, if finalized, will 
revoke the current approved method for carbadox because it does not 
satisfy the statutory requirement that there be a method to ensure that 
no residue of carcinogenic concern remains in the edible tissues of 
treated swine. If that order is finalized, we intend to publish in the 
Federal Register an NOOH proposing to withdraw approval of all new 
animal drug applications for use of carbadox.

DATES: The NOOH is withdrawn as of July 15, 2020.

ADDRESSES: For access to the docket to read background documents or 
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: Diane Heinz, Center for Veterinary 
Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-5692, diane.heinz@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In an NOOH published in the Federal Register 
of April 12, 2016 (81 FR 21559; correction 81 FR 23499), we proposed to

[[Page 43853]]

withdraw approval of the new animal drug applications (NADAs) for 
carbadox. That proposed action was based on two grounds. First, 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. The DES Proviso exception allows such an animal drug to be 
approved if, among other things, no residue of such drug will be found 
by methods of examination prescribed or approved by the Secretary of 
Health and Human Services by regulations, in any edible portion of such 
animal after slaughter or in any food yielded by or derived from the 
living animals. Second, new evidence demonstrates that carbadox is not 
shown to be safe under the General Safety Clause (section 512(e)(1)(B) 
of the FD&C Act). FDA has reviewed information submitted by the drug 
sponsor, including some studies submitted in response to the April 2016 
NOOH, and determined that the current approved method for detecting 
residues of carcinogenic concern does not meet the requirements of part 
500, subpart E (21 CFR part 500, subpart E), to demonstrate that there 
is ``no residue'' of carbadox in any food derived by treated animals as 
required by section 512(d)(1)(I) of the FD&C Act.
    FDA is withdrawing the April 2016 NOOH, which proposed to withdraw 
the approved uses of carbadox. Elsewhere in this issue of the Federal 
Register, FDA is publishing a proposed order that, if finalized, will 
revoke the current approved method for carbadox that measures 
quinoxaline-2-carboxylic acid as the marker residue for carbadox. The 
proposed order is based on the inadequacy of the current approved 
method to monitor residue of carcinogenic concern in compliance with 
FDA's operational definition of ``no residue'' in part 500, subpart E, 
and the requirements in section 512(d)(1)(I) of the FD&C Act. If the 
proposed order to revoke the current approved method is finalized and 
the approved analytical method is revoked, we intend to publish in the 
Federal Register an NOOH proposing to withdraw all new animal drug 
applications for use of carbadox based on the lack of an approved 
method to demonstrate compliance with part 500, subpart E, and section 
512(d)(1)(I) of the FD&C Act.

    Dated: July 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15245 Filed 7-17-20; 8:45 am]
BILLING CODE 4164-01-P


