[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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DATES: The NOOH is withdrawn as of July 15, 2020.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, [email protected].
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