Zoetis Inc., Withdrawal of Approval of New Animal Drug Applications; Chlortetracycline; Sulfathiazole; Penicillin, 15541 [2014-05882]
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Federal Register / Vol. 79, No. 54 / Thursday, March 20, 2014 / Rules and Regulations
The NADAs listed were identified as
being affected by guidance for industry
(GFI) #213, ‘‘New Animal Drugs and
New Animal Drug Combination
Products Administered in or on
Medicated Feed or Drinking Water of
Food-Producing Animals:
Recommendations for Drug Sponsors for
Voluntarily Aligning Product Use
Conditions with GFI #209’’, December
2013.
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and redelegated to the Center for
Veterinary Medicine, and in accordance
with § 514.116 Notice of withdrawal of
approval of application (21 CFR
514.116), notice is given that approval
of NADA 039–077, ANADA 200–140,
and ANADA 200–167, and all
supplements and amendments thereto,
is hereby withdrawn, effective March
31, 2014.
Elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to reflect the voluntary
withdrawal of approval of these
applications.
Dated: March 12, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014–05883 Filed 3–19–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
DATES:
ehiers on DSK2VPTVN1PROD with RULES
This rule is effective March 31,
2014.
[Docket No. FDA–2014–N–0002]
FOR FURTHER INFORMATION CONTACT:
Zoetis Inc., Withdrawal of Approval of
New Animal Drug Applications;
Chlortetracycline; Sulfathiazole;
Penicillin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect the
withdrawal of approval of a new animal
SUMMARY:
David Alterman, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–453–6843.
Zoetis
Inc., 333 Portage St., Kalamazoo, MI
49007 has requested that FDA withdraw
approval of the following NADA and
two ANADAs because the products are
no longer manufactured or marketed:
SUPPLEMENTARY INFORMATION:
Proprietary name
CSP 250 (chlortetracycline, sulfathiazole, and penicillin) Type A medicated article.
AUREOZOL (chlortetracycline, sulfathiazole, and penicillin) Type A medicated article.
AUREOZOL 500 Granular (chlortetracycline, sulfathiazole, and penicillin) Type A medicated article.
The NADAs listed were identified as
being affected by guidance for industry
(GFI) #213, ‘‘New Animal Drugs and
New Animal Drug Combination
Products Administered in or on
Medicated Feed or Drinking Water of
Food-Producing Animals:
Recommendations for Drug Sponsors for
Voluntarily Aligning Product Use
Conditions with GFI #209’’, December
2013.
Elsewhere in this issue of the Federal
Register, FDA gave notice that approval
of NADA 039–077, ANADA 200–140,
and ANADA 200–167, and all
supplements and amendments thereto,
is withdrawn, effective March 31, 2014.
As provided in the regulatory text of
this document, the animal drug
regulations are amended to reflect these
voluntary withdrawals of approval.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 558 is amended as follows:
DEPARTMENT OF VETERANS
AFFAIRS
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
RIN 2900–AO85
1. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
§ 558.4
2. In § 558.4(d), in the ‘‘Category II’’
table, remove the entry for
‘‘Sulfathiazole’’ and its respective
following entries.
■
§ 558.155
■
[Removed]
3. Remove § 558.155.
Dated: March 12, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014–05882 Filed 3–19–14; 8:45 am]
BILLING CODE 4160–01–P
14:19 Mar 19, 2014
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38 CFR Part 17
VA Dental Insurance Program—
Federalism
Department of Veterans Affairs.
Direct final rule; confirmation of
effective date.
AGENCY:
ACTION:
[Amended]
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
VerDate Mar<15>2010
drug application (NADA) and two
abbreviated new animal drug
applications (ANADAs) for three-way,
fixed-ratio combination drug Type A
medicated articles containing
chlortetracycline, sulfathiazole, and
penicillin. This action is being taken at
the sponsor’s request because these
products are no longer manufactured or
marketed.
21 CFR Part 558
NADA/ANADA
039–077 ..............................
200–140 ..............................
200–167 ..............................
15541
The Department of Veterans
Affairs (VA) published a direct final rule
in the Federal Register on October 22,
2013, amending its regulations related
to the VA Dental Insurance Program
(VADIP), a pilot program to offer
premium-based dental insurance to
enrolled veterans and certain survivors
and dependents of veterans.
Specifically, this rule adds language to
clarify the limited preemptive effect of
certain criteria in the VADIP
regulations. VA received no comments
concerning this rule or its companion
substantially identical proposed rule
published in the Federal Register on
October 23, 2013. This document
confirms that the direct final rule
became effective on December 23, 2013.
In a companion document in this issue
SUMMARY:
E:\FR\FM\20MRR1.SGM
20MRR1
]]>Agencies
[Federal Register Volume 79, Number 54 (Thursday, March 20, 2014)]
[Rules and Regulations]
[Page 15541]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05882]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2014-N-0002]
Zoetis Inc., Withdrawal of Approval of New Animal Drug
Applications; Chlortetracycline; Sulfathiazole; Penicillin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect the withdrawal of approval of a new animal
drug application (NADA) and two abbreviated new animal drug
applications (ANADAs) for three-way, fixed-ratio combination drug Type
A medicated articles containing chlortetracycline, sulfathiazole, and
penicillin. This action is being taken at the sponsor's request because
these products are no longer manufactured or marketed.
DATES: This rule is effective March 31, 2014.
FOR FURTHER INFORMATION CONTACT: David Alterman, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-453-6843.
SUPPLEMENTARY INFORMATION: Zoetis Inc., 333 Portage St., Kalamazoo, MI
49007 has requested that FDA withdraw approval of the following NADA
and two ANADAs because the products are no longer manufactured or
marketed:
------------------------------------------------------------------------
NADA/ANADA Proprietary name
------------------------------------------------------------------------
039-077................................... CSP 250 (chlortetracycline,
sulfathiazole, and
penicillin) Type A
medicated article.
200-140................................... AUREOZOL (chlortetracycline,
sulfathiazole, and
penicillin) Type A
medicated article.
200-167................................... AUREOZOL 500 Granular
(chlortetracycline,
sulfathiazole, and
penicillin) Type A
medicated article.
------------------------------------------------------------------------
The NADAs listed were identified as being affected by guidance for
industry (GFI) 213, ``New Animal Drugs and New Animal Drug
Combination Products Administered in or on Medicated Feed or Drinking
Water of Food-Producing Animals: Recommendations for Drug Sponsors for
Voluntarily Aligning Product Use Conditions with GFI 209'',
December 2013.
Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of NADA 039-077, ANADA 200-140, and ANADA 200-167, and
all supplements and amendments thereto, is withdrawn, effective March
31, 2014. As provided in the regulatory text of this document, the
animal drug regulations are amended to reflect these voluntary
withdrawals of approval.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is
amended as follows:
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
1. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.4 [Amended]
0
2. In Sec. 558.4(d), in the ``Category II'' table, remove the entry
for ``Sulfathiazole'' and its respective following entries.
Sec. 558.155 [Removed]
0
3. Remove Sec. 558.155.
Dated: March 12, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-05882 Filed 3-19-14; 8:45 am]
BILLING CODE 4160-01-P
