Withdrawal of Approval of Part of a New Animal Drug Application; Procaine Penicillin, 37621-37622 [2014-15273]
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Federal Register / Vol. 79, No. 127 / Wednesday, July 2, 2014 / Rules and Regulations
§ 522.814
Eprinomectin.
*
*
*
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(d) * * *
(2) Indications for use. For the
treatment and control of the following
internal and external parasites:
Gastrointestinal roundworms (adults
and fourth-stage larvae) Bunostomum
phlebotomum, Cooperia oncophora, C.
punctata, C. surnabada,
Trichostrongylus axei, Ostertagia
ostertagi (including inhibited stage);
(adults) Haemonchus placei,
Oesophagostomum radiatum, O. lyrata,
T. colubriformis; lungworms (adults)
Dictyocaulus viviparus; cattle grubs
Hypoderma bovis; mites Sarcoptes
scabiei var. bovis. Prevents reinfection
with C. oncophora, C. punctata, and T.
axei for 100 days following treatment;
H. placei, O. radiatum, O. lyrata, and O.
ostertagi for 120 days following
treatment; and B. phlebotomum and D.
viviparus for 150 days following
treatment.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian. Animals
intended for human consumption must
not be slaughtered within 48 days of the
last treatment. This drug product is not
approved for use in female dairy cattle
20 months of age or older, including dry
dairy cows. Use in these cattle may
cause drug residues in milk and/or in
calves born to these cows. A withdrawal
period has not been established for preruminating calves. Do not use in calves
to be processed for veal.
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
13. The authority citation for 21 CFR
part 529 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
supply or as a static bath once per day
for 60 minutes on consecutive or
alternative days for three treatments.
(ii) Indications for use. For the control
of mortality in walleye due to external
columnaris disease associated with
Flavobacterium columnare.
(3) Freshwater-reared warmwater
finfish—(i) Amount. 20 mg/L water in a
continuous flow water supply or as a
static bath once per day for 60 minutes
on consecutive or alternative days for
three treatments.
(ii) Indications for use. For the control
of mortality in freshwater-reared
warmwater finfish due to external
columnaris disease associated with F.
columnare.
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
15. The authority citation for 21 CFR
part 556 continues to read as follows:
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■
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
16. Add § 556.118 to read as follows:
Food and Drug Administration
§ 556.118
Chloramine-T.
(a) Acceptable Daily Intake (ADI). The
ADI for total residues of chloramine-T is
5 micrograms per kilogram of body
weight per day.
(b) Tolerances—(1) Fish—(i) Muscle/
skin (target tissue). The tolerance for
para-toluenesulfonamide (marker
residue) is 0.90 parts per million.
(ii) [Reserved]
(2) [Reserved]
(c) Related conditions of use. See
§ 529.382 of this chapter.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
17. The authority citation for 21 CFR
part 558 continues to read as follows:
■
§ 558.4
(a) Specifications. Chloramine-T
trihydrate powder for solution.
(b) Sponsor. See No. 086009 in
§ 510.600(c) of this chapter.
(c) Related tolerances. See § 556.118
of this chapter.
(d) Conditions of use—(1) Freshwaterreared salmonids—(i) Amount. 12 to 20
milligrams per liter (mg/L) water in a
continuous flow water supply or as a
static bath once per day for 60 minutes
on consecutive or alternative days for
three treatments.
(ii) Indications for use. For the control
of mortality in freshwater-reared
salmonids due to bacterial gill disease
associated with Flavobacterium spp.
(2) Walleye—(i) Amount. 10 to 20 mg/
L water in a continuous flow water
Dated: June 25, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
Authority: 21 U.S.C. 342, 360b, 371.
Authority: 21 U.S.C. 360b, 371.
Chloramine-T.
‘‘No. 054771’’ and in its place add ‘‘Nos.
000986 and 054771’’;
■ c. In the table in paragraph (e)(2)(x),
in the ‘‘Limitations’’ column, remove
‘‘Nos. 054771 and 021641’’ and in its
place add ‘‘Nos. 000986 and 054771’’;
and
■ d. In the table in paragraphs (e)(2)(ix)
and (xiii), in the ‘‘Limitations’’ column,
add at the end of the entry
‘‘Ractopamine as provided by Nos.
000986 or 054771 with tylosin as
provided by No. 000986 in § 510.600(c)
of this chapter.’’ and in the ‘‘Sponsor’’
column, remove ‘‘000986’’ and in its
place add ‘‘000986, 054771’’.
■
14. Add 529.382 to read as follows:
§ 529.382
37621
[Amended]
18. In § 558.4, in paragraph (d), in the
‘‘Category I’’ table, remove the entry for
‘‘Niclosamide’’.
■
§ 558.500
[Amended]
19. Amend § 558.500 as follows:
a. In the table in paragraphs (e)(1)(ii),
(iii), and (iv), in the ‘‘Limitations’’
column, add at the end of the entry
‘‘Ractopamine as provided by No.
000986 with tylosin as provided by Nos.
000986 or 016592 in § 510.600(c) of this
chapter; or ractopamine as provided by
No. 054771 with tylosin as provided by
No. 000986 in § 510.600(c) of this
chapter.’’ and in the ‘‘Sponsor’’ column,
remove ‘‘000986’’ and in its place add
‘‘000986, 016592, 054771’’;
■ b. In the table in paragraph (e)(2)(viii),
in the ‘‘Limitations’’ column, remove
■
■
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21 CFR Part 558
[Docket No. FDA–2014–N–0002]
Withdrawal of Approval of Part of a
New Animal Drug Application;
Procaine Penicillin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
approval of those parts of a new animal
drug application (NADA) for a threeway, fixed-ratio, combination drug Type
A medicated article that pertain to use
of the procaine penicillin component for
growth promotion indications in swine.
This action is being taken at the
sponsor’s request because the three-way
Type A medicated article is no longer
manufactured.
DATES: Withdrawal of approval is
effective July 2, 2014.
FOR FURTHER INFORMATION CONTACT:
Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV–130), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 240–276–
8341, cindy.burnsteel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Zoetis Inc.
(Zoetis), 333 Portage St., Kalamazoo, MI
49007 has requested that FDA withdraw
approval of those parts of NADA 035–
688 for AUREOMIX Granular 500
(chlortetracycline, procaine penicillin,
and sulfamethazine) Type A medicated
article that pertain to use of the procaine
penicillin component for growth
SUMMARY:
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Federal Register / Vol. 79, No. 127 / Wednesday, July 2, 2014 / Rules and Regulations
promotion indications in swine. Zoetis
requested voluntary withdrawal of
approval of these indications for use
because AUREOMIX Granular 500 Type
A medicated article is no longer
manufactured.
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and redelegated to the Director of the
Center for Veterinary Medicine, and in
accordance with 21 CFR 514.116 Notice
of withdrawal of approval of
application, notice is given that
approval of those parts of NADA 035–
688 that pertain to use of procaine
penicillin for the production indications
of growth promotion and increased feed
efficiency in swine are hereby
withdrawn, effective July 2, 2014.
NADA 035–688 was 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 is amending the animal
drug regulations to reflect the
withdrawal of approval of these parts of
NADA 035–688.
Dated: June 25, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014–15273 Filed 6–30–14; 11:15 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA–2014–N–0002]
New Animal Drugs for Use in Animal
Feeds; Chlortetracycline and
Sulfamethazine; Chlortetracycline;
Procaine Penicillin; and
Sulfamethazine
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect the
withdrawal of approval of those parts of
a new animal drug application (NADA)
for a three-way, fixed-ratio, combination
drug Type A medicated article that
pertain to use of the procaine penicillin
SUMMARY:
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component for growth promotion
indications in swine and to reflect the
reformulation of the Type A medicated
article as a two-way, fixed-ratio,
combination drug product without
penicillin.
DATES:
This rule is effective July 2,
2014.
FOR FURTHER INFORMATION CONTACT:
Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV–130), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 240–276–
8341, email: cindy.burnsteel@
fda.hhs.gov.
Zoetis Inc.
(Zoetis), 333 Portage St., Kalamazoo, MI
49007 has requested that FDA withdraw
approval of those parts of NADA 035–
688 for AUREOMIX Granular 500
(chlortetracycline, procaine penicillin,
and sulfamethazine) Type A medicated
article that pertain to use of the procaine
penicillin component for growth
promotion indications in swine. Zoetis
requested voluntary withdrawal of
approval of these indications for use
because AUREOMIX Granular 500 Type
A medicated article is no longer
manufactured.
With the withdrawal of approval of
the production indications for procaine
penicillin, the product approved under
NADA 035–688 was reformulated as
AUREOMIX S Granular
(chlortetracycline and sulfamethazine)
Type A Medicated Article, a two-way,
fixed-ratio, combination drug Type A
medicated article that does not contain
penicillin procaine and is not labeled
for production indications.
The Agency has determined under 21
CFR 25.33(a)(3) and (g) that these
actions are categorically excluded from
the requirement to submit an
environmental assessment or an
environmental impact statement
because they are of a type that do not
individually or cumulatively have a
significant effect on the human
environment.
Elsewhere in this issue of the Federal
Register, FDA gave notice that the
approval of those parts of NADA 035–
688 pertaining to the procaine penicillin
component indications for growth
promotion and increased feed efficiency
in swine is withdrawn, effective July 2,
2014. As provided for in the regulatory
text of this document, the animal drug
regulations are amended to reflect this
partial withdrawal of approval and
subsequent product reformulation.
NADA 035–688 was identified as
being affected by guidance for industry
(GFI) #213, ‘‘New Animal Drugs and
New Animal Drug Combination
SUPPLEMENTARY INFORMATION:
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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.
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 Director of the Center for Veterinary
Medicine, 21 CFR part 558 is amended
as follows:
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
■
2. Revise § 558.140 to read as follows:
§ 558.140 Chlortetracycline and
sulfamethazine.
(a) Specifications. Type A medicated
articles containing:
(1) 35 grams (g) per pound (/lb) each,
chlortetracycline and sulfamethazine.
(2) 40 g/lb each, chlortetracycline and
sulfamethazine.
(b) Sponsors. See sponsors numbers
in § 510.600(c) of this chapter as follow:
(1) Nos. 054771 and 048164 for use of
product described in paragraph (a)(1) as
in paragraph (d)(1) of this section.
(2) No. 054771 for use of product
described in paragraph (a)(2) as in
paragraph (d)(2) of this section.
(c) Related tolerances. See §§ 556.150
and 556.670 of this chapter.
(d) Conditions of use—(1) Cattle. It is
used in feed for beef cattle as follows:
(i) Amount. 350 milligrams per head
per day each, chlortetracycline and
sulfamethazine.
(ii) Indications for use. Aid in the
maintenance of weight gains in the
presence of respiratory disease such as
shipping fever.
(iii) Limitations. Feed for 28 days;
withdraw 7 days prior to slaughter. A
withdrawal period has not been
established for this product in preruminating calves. Do not use in calves
to be processed for veal.
(2) Swine. It is used in swine feed as
follows:
(i) Amount. 100 g/ton each,
chlortetracycline and sulfamethazine.
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]]>Agencies
[Federal Register Volume 79, Number 127 (Wednesday, July 2, 2014)]
[Rules and Regulations]
[Pages 37621-37622]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15273]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2014-N-0002]
Withdrawal of Approval of Part of a New Animal Drug Application;
Procaine Penicillin
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of those parts of a new animal drug application (NADA) for a three-way,
fixed-ratio, combination drug Type A medicated article that pertain to
use of the procaine penicillin component for growth promotion
indications in swine. This action is being taken at the sponsor's
request because the three-way Type A medicated article is no longer
manufactured.
DATES: Withdrawal of approval is effective July 2, 2014.
FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8341,
cindy.burnsteel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Zoetis Inc. (Zoetis), 333 Portage St.,
Kalamazoo, MI 49007 has requested that FDA withdraw approval of those
parts of NADA 035-688 for AUREOMIX Granular 500 (chlortetracycline,
procaine penicillin, and sulfamethazine) Type A medicated article that
pertain to use of the procaine penicillin component for growth
[[Page 37622]]
promotion indications in swine. Zoetis requested voluntary withdrawal
of approval of these indications for use because AUREOMIX Granular 500
Type A medicated article is no longer manufactured.
Therefore, under authority delegated to the Commissioner of Food
and Drugs and redelegated to the Director of the Center for Veterinary
Medicine, and in accordance with 21 CFR 514.116 Notice of withdrawal of
approval of application, notice is given that approval of those parts
of NADA 035-688 that pertain to use of procaine penicillin for the
production indications of growth promotion and increased feed
efficiency in swine are hereby withdrawn, effective July 2, 2014.
NADA 035-688 was 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 is amending
the animal drug regulations to reflect the withdrawal of approval of
these parts of NADA 035-688.
Dated: June 25, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-15273 Filed 6-30-14; 11:15 am]
BILLING CODE 4164-01-P
