Implantation or Injectable Dosage Form New Animal Drugs; Florfenicol and Flunixin, 54018-54019 [2010-22039]
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54018
Federal Register / Vol. 75, No. 171 / Friday, September 3, 2010 / Rules and Regulations
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 520 is amended as follows:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
21 CFR Part 520
[Docket No. FDA–2010–N–0002]
Oral Dosage Form New Animal Drugs;
Praziquantel and Pyrantel
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental new animal
drug application (NADA) filed by Bayer
HealthCare LLC. The supplement
provides for two new sizes of
praziquantel and pyrantel pamoate
tablets used in cats and kittens for the
removal of various internal parasites
and for a revised kitten age and weight
restriction.
DATES: This rule is effective September
3, 2010.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8337,
email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Bayer
HealthCare LLC, Animal Health
Division, P.O. Box 390, Shawnee
Mission, KS 66201, filed a supplement
to NADA 141–008 for DRONTAL
(praziquantel and pyrantel pamoate)
Tablets used in cats and kittens for the
removal of various internal parasites.
The supplement provides for two new
tablet sizes and for a revised kitten age
and weight restriction. The
supplemental NADA is approved as of
June 15, 2010, and 21 CFR 520.1871 is
amended to reflect the approval.
FDA has determined under 21 CFR
25.33 that this action is of a type that
does not individually or cumulatively
have a significant effect on the human
environment. Therefore, neither an
environmental assessment nor an
environmental impact statement is
required.
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.
erowe on DSK5CLS3C1PROD with RULES
SUMMARY:
List of Subjects in 21 CFR Part 520
Animal drugs.
■ Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
VerDate Mar<15>2010
14:12 Sep 02, 2010
Jkt 220001
1. The authority citation for 21 CFR
part 520 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
2. In § 520.1871, in paragraph (b)(1),
remove ‘‘tablet’’ and in its place add
‘‘tablets’’; and revise paragraphs (a)(1),
(d)(1)(i), and (d)(1)(iii) to read as
follows:
■
§ 520.1871
Praziquantel and pyrantel.
(a) * * *
(1) Each tablet contains 13.6
milligrams (mg) praziquantel and 54.3
mg pyrantel base (as pyrantel pamoate),
18.2 mg praziquantel and 72.6 mg
pyrantel base (as pyrantel pamoate), or
27.2 mg praziquantel and 108.6 mg
pyrantel base (as pyrantel pamoate).
*
*
*
*
*
(d) * * *
(1) * * *
(i) Dosage. Administer a minimum
dose of 2.27 mg praziquantel and 9.2 mg
pyrantel pamoate per pound of body
weight according to the dosing tables on
labeling. May be given directly by
mouth or in a small amount of food. Do
not withhold food prior to or after
treatment. If reinfection occurs,
treatment may be repeated.
*
*
*
*
*
(iii) Limitations. Not for use in kittens
less than 2 months of age or weighing
less than 2.0 pounds. Consult your
veterinarian before giving to sick or
pregnant animals.
*
*
*
*
*
Dated: August 31, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 2010–22043 Filed 9–2–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA–2010–N–0002]
Implantation or Injectable Dosage
Form New Animal Drugs; Florfenicol
and Flunixin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
List of Subjects in 21 CFR Part 522
Animal drugs.
Final rule.
Frm 00014
Fmt 4700
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental new animal
drug application (NADA) filed by
Intervet, Inc. The supplemental NADA
adds Mycoplasma bovis to the bovine
respiratory disease (BRD) pathogens for
which use of an injectable solution
containing florfenicol and flunixin
meglumine is an approved treatment.
DATES: This rule is effective September
3, 2010.
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, e-mail:
cindy.burnsteel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet,
Inc., 56 Livingston Ave., Roseland, NJ
07068, filed a supplement to NADA
141–299 that provides for use of
RESFLOR GOLD (florfenicol and
flunixin meglumine), a combination
drug injectable solution. The
supplement adds M. bovis to the BRD
pathogens for which the use of this
product is approved. The supplemental
NADA is approved as of June 7, 2010,
and the regulations in 21 CFR 522.956
are amended to reflect the approval.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
data and information submitted to
support approval of this application
may be seen in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday.
Under section 512(c)(2)(F)(iii) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(iii)), this
supplemental approval qualifies for 3
years of marketing exclusivity beginning
on the date of approval.
The agency has determined under 21
CFR 25.33 that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
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.
SUMMARY:
Sfmt 4700
E:\FR\FM\03SER1.SGM
03SER1
54019
Federal Register / Vol. 75, No. 171 / Friday, September 3, 2010 / Rules and Regulations
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 522 is amended as follows:
■
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
2. In § 522.956, revise paragraph (d)(2)
to read as follows:
■
§ 522.956
Florfenicol and flunixin.
*
*
*
*
*
(d) * * *
(2) Indications for use. For treatment
of bovine respiratory disease (BRD)
associated with Mannheimia
haemolytica, Pasteurella multocida,
Histophilus somni, and Mycoplasma
bovis, and control of BRD-associated
pyrexia in beef and non-lactating dairy
cattle.
*
*
*
*
*
Dated: August 31, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 2010–22039 Filed 9–2–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA–2010–N–0002]
New Animal Drugs for Use in Animal
Feed; Ractopamine
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
SUMMARY:
animal drug regulations to reflect
approval of two supplemental new
animal drug applications (NADAs) filed
by Elanco Animal Health, A Division of
Eli Lilly & Co. The supplemental
NADAs provide for administering a
Type C medicated feed containing
ractopamine hydrochloride as a top
dress on Type C medicated feeds
containing monensin, USP, or
monensin, USP, and tylosin phosphate
to cattle fed in confinement for
slaughter.
This rule is effective September
3, 2010.
FOR FURTHER INFORMATION CONTACT:
Suzanne J. Sechen, Center for Veterinary
Medicine (HFV–126), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8105, email: suzanne.sechen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco
Animal Health, A Division of Eli Lilly
& Co., Lilly Corporate Center,
Indianapolis, IN 46285, filed a
supplement to NADA 141–225 that
provides for use of OPTAFLEXX
(ractopamine hydrochloride) and
RUMENSIN (monensin, USP) Type A
medicated articles to formulate two-way
combination drug Type C medicated
feeds for cattle fed in confinement for
slaughter. Elanco Animal Health also
filed a supplement to NADA 141–224
that provides for use of OPTAFLEXX
(ractopamine hydrochloride),
RUMENSIN (monensin, USP), and
TYLAN (tylosin phosphate) Type A
medicated articles to formulate threeway combination drug Type C
medicated feeds for cattle fed in
confinement for slaughter.
The supplemental NADAs provide for
administering ractopamine
hydrochloride Type C medicated feeds
as a top dress on Type C medicated
feeds containing monensin, USP, or
monensin, USP, and tylosin phosphate
to cattle fed in confinement for
slaughter as the means by which the
two-way or three-way combinations will
be created. Supplemental NADA 141–
224 is approved as of June 7, 2010;
DATES:
erowe on DSK5CLS3C1PROD with RULES
Ractopamine in
grams/ton
Combination in
grams/ton
*
(xii) Not to exceed 800; to
provide 70 to 400 mg/
head/day.
*
*
Monensin 10 to 40 to
provide 0.14 to 0.42
mg monensin/lb of
body weight, depending on severity of
coccidiosis challenge,
up to 480 mg/head/
day.
VerDate Mar<15>2010
17:12 Sep 02, 2010
Jkt 220001
PO 00000
supplemental NADA 141–225 is
approved as of June 17, 2010; and the
regulations in 21 CFR 558.500 are
amended to reflect the approvals.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summaries of safety and effectiveness
data and information submitted to
support approval of these applications
may be seen in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday.
The agency has determined under 21
CFR 25.33 that these actions are of a
type that do not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
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 the
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
1. The authority citation for 21 CFR
part 558 continues to read as follows:
Authority: 21 U.S.C. 360b, 371.
2. In § 558.500, add paragraphs
(e)(2)(xii) and (e)(2)(xiii) to read as
follows:
■
§ 558.500
*
Ractopamine.
*
*
(e) * * *
(2) * * *
Indications for use
*
*
Limitations
*
*
*
Cattle fed in confinement for
Top dress ractopamine in a minslaughter: As in paragraph
imum of 1.0 lb of medicated feed
(e)(2)(i) of this section; for preduring the last 28 to 42 days on
vention and control of coccidiosis
feed. Not for animals intended for
due to Eimeria bovis and E.
breeding. See § 558.355(d).
zuernii.
Frm 00015
Fmt 4700
Sfmt 4700
E:\FR\FM\03SER1.SGM
03SER1
Sponsor
*
000986
]]>Agencies
[Federal Register Volume 75, Number 171 (Friday, September 3, 2010)]
[Rules and Regulations]
[Pages 54018-54019]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22039]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA-2010-N-0002]
Implantation or Injectable Dosage Form New Animal Drugs;
Florfenicol and Flunixin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Intervet, Inc. The supplemental NADA adds
Mycoplasma bovis to the bovine respiratory disease (BRD) pathogens for
which use of an injectable solution containing florfenicol and flunixin
meglumine is an approved treatment.
DATES: This rule is effective September 3, 2010.
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, e-mail:
cindy.burnsteel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet, Inc., 56 Livingston Ave.,
Roseland, NJ 07068, filed a supplement to NADA 141-299 that provides
for use of RESFLOR GOLD (florfenicol and flunixin meglumine), a
combination drug injectable solution. The supplement adds M. bovis to
the BRD pathogens for which the use of this product is approved. The
supplemental NADA is approved as of June 7, 2010, and the regulations
in 21 CFR 522.956 are amended to reflect the approval.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval
qualifies for 3 years of marketing exclusivity beginning on the date of
approval.
The agency has determined under 21 CFR 25.33 that this action is of
a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
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 522
Animal drugs.
[[Page 54019]]
0
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 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 522.956, revise paragraph (d)(2) to read as follows:
Sec. 522.956 Florfenicol and flunixin.
* * * * *
(d) * * *
(2) Indications for use. For treatment of bovine respiratory
disease (BRD) associated with Mannheimia haemolytica, Pasteurella
multocida, Histophilus somni, and Mycoplasma bovis, and control of BRD-
associated pyrexia in beef and non-lactating dairy cattle.
* * * * *
Dated: August 31, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2010-22039 Filed 9-2-10; 8:45 am]
BILLING CODE 4160-01-S
