Implantation or Injectable Dosage Form New Animal Drugs; Ivermectin and Clorsulon, 27733-27734 [E7-9517]
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Federal Register / Vol. 72, No. 95 / Thursday, May 17, 2007 / Rules and Regulations
control number was not available when
the final rule was published, thus
necessitating publication of this notice.
The FAA request was approved by OMB
without change and expires on April 30,
2010.
Title 49 U.S.C. 106(g), 40113, 40119,
41706, 44101, 44701–44702, 44705,
44709–44711, 44713, 44716–44717,
44722, 46105, grants authority to the
Administrator to publish this notice.
The final rule (71 FR 75616) became
effective on February 13, 2007 and the
compliance date for information
collection requirements in §§ 460.5,
460.7, 460.9, 460.19, 460.45, and 460.49
is May 17, 2007.
Issued in Washington, DC on May 8, 2007.
Pamela Hamilton-Powell,
Director, Office of Rulemaking Aviation
Safety.
[FR Doc. E7–9480 Filed 5–16–07; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Pimobendan
AGENCY:
Food and Drug Administration,
HHS.
cprice-sewell on PROD1PC71 with RULES
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a new animal drug
application (NADA) filed by Boehringer
Ingelheim Vetmedica, Inc. The NADA
provides for the veterinary prescription
use of pimobendan chewable tablets in
dogs for the management of the signs of
congestive heart failure.
DATES: This rule is effective May 17,
2007.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7540, email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Boehringer Ingelheim Vetmedica, Inc.,
2621 N. Belt Hwy., St. Joseph, MO
64506–2002, filed NADA 141–273 that
provides for the veterinary prescription
use of VETMEDIN (pimobendan)
Chewable Tablets in dogs for the
management of the signs of mild,
moderate, or severe (modified New York
Heart Association Class II, III, or IV)
congestive heart failure due to
VerDate Aug<31>2005
15:37 May 16, 2007
Jkt 211001
atrioventricular valvular insufficiency
or dilated cardiomyopathy; for use with
concurrent therapy for congestive heart
failure as appropriate on a case-by-case
basis. The NADA is approved as of
April 30, 2007, and the regulations in 21
CFR part 520 are amended by adding
§ 520.1780 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)(i) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(i)), this
approval qualifies for 5 years of
marketing exclusivity beginning on the
date of the approval.
The agency has determined under 21
CFR 25.33(d)(1) 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 520
Animal drugs.
I 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 520 is amended as follows:
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
I
2. Add § 520.1780 to read as follows:
§ 520.1780
Pimobendan.
(a) Specifications. Each chewable
tablet contains 1.25, 2.5, or 5 milligrams
(mg) pimobendan.
(b) Sponsor. See No. 000010 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Administer orally at a total
daily dose of 0.23 mg per pound (0.5 mg
per kilogram) body weight, using a
suitable combination of whole or half
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
27733
tablets. The total daily dose should be
divided into two portions administered
approximately 12 hours apart.
(2) Indications for use. For the
management of the signs of mild,
moderate, or severe (modified New York
Heart Association Class II, III, or IV)
congestive heart failure due to
atrioventricular valvular insufficiency
or dilated cardiomyopathy; for use with
concurrent therapy for congestive heart
failure as appropriate on a case-by-case
basis.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
Dated: May 7, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–9516 Filed 5–16–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs; Ivermectin
and Clorsulon
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 an abbreviated new animal
drug application (ANADA) filed by
Norbrook Laboratories, Ltd. The
ANADA provides for the use of an
ivermectin and clorsulon solution by
subcutaneous injection in cattle for
control of various internal and external
parasites.
DATES: This rule is effective May 17,
2007.
John
K. Harshman, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0169, email: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Norbrook
Laboratories, Ltd., Station Works,
Newry BT35 6JP, Northern Ireland, filed
ANADA 200–436 that provides for use
of NOROMECTIN Plus (ivermectin and
clorsulon) Injection for Cattle by
subcutaneous injection in cattle for
control of various internal and external
parasites. Norbrook Laboratories, Ltd.’s
NOROMECTIN Plus Injection for Cattle
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\17MYR1.SGM
17MYR1
27734
Federal Register / Vol. 72, No. 95 / Thursday, May 17, 2007 / Rules and Regulations
is approved as a generic copy of Merial,
Ltd.’s IVOMEC Plus Injection for Cattle,
approved under NADA 140–833. The
ANADA is approved as of April 23,
2007, and the regulations are amended
in 21 CFR 522.1193 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.
FDA has determined under 21 CFR
25.33(a)(1) 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.
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:
I
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
I
Dated: May 7, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–9517 Filed 5–16–07; 8:45 am]
Authority: 21 U.S.C. 360b.
2. Amend § 522.1193 as follows:
a. Revise the section heading and
paragraphs (a) and (b);
b. Redesignate paragraph (d) as
paragraph (e);
c. Add new paragraph (d); and
d. Revise newly redesignated
paragraph (e).
The revisions, redesignation, and
addition read as follows:
I
cprice-sewell on PROD1PC71 with RULES
§ 522.1193
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Ivermectin and clorsulon.
(a) Specifications. Each milliliter (mL)
of solution contains 10 milligrams (mg)
(1 percent) ivermectin and 100 mg (10
percent) clorsulon.
(b) Sponsors. See Nos. 050604 and
055529 in § 510.600(c) of this chapter
VerDate Aug<31>2005
for use as in paragraph (e) of this
section.
*
*
*
*
*
(d) Special considerations. See
§ 500.25 of this chapter.
(e) Conditions of use in cattle—(1)
Amount. Administer 1 mL (10 mg
ivermectin and 100 mg clorsulon) per 50
kilograms (110 pounds) by
subcutaneous injection.
(2) Indications for use. For the
treatment and control of gastrointestinal
nematodes (adults and fourth-stage
larvae) (Haemonchus placei, Ostertagia
ostertagi (including inhibited larvae), O.
lyrata, Trichostrongylus axei, T.
colubriformis, Cooperia oncophora, C.
punctata, C. pectinata,
Oesophagostomum radiatum,
Nematodirus helvetianus (adults only),
N. spathiger (adults only), Bunostomum
phlebotomum; lungworms (adults and
fourth-stage larvae) (Dictyocaulus
viviparus); liver flukes (adults only)
(Fasciola hepatica); grubs (parasitic
stages) (Hypoderma bovis, H. lineatum);
lice (Linognathus vituli, Haematopinus
eurysternus, Solenopotes capillatus);
mites (Psoroptes ovis (syn. P. communis
var. bovis), Sarcoptes scabiei var. bovis);
and for control of infections of D.
viviparus and O. radiatum for 28 days
afer treatment; O. ostertagi, T. axei, and
C. punctata for 21 days after treatment;
and H. placei and C. oncophora for 14
days after treatment.
(3) Limitations. For subcutaneous use
only. Not for intravenous or
intramuscular use. Do not treat cattle
within 49 days of slaughter. Because a
withdrawal time in milk has not been
established, do not use in female dairy
cattle of breeding age. Do not use in
other animal species because severe
adverse reactions, including fatalities in
dogs, may result. A withdrawal period
has not been established for this product
in preruminating calves. Do not use in
calves to be processed for veal.
15:37 May 16, 2007
Jkt 211001
21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs; Ivermectin
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00014
Fmt 4700
Sfmt 4700
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of an abbreviated new animal
drug application (ANADA) filed by
Norbrook Laboratories, Ltd. The
ANADA provides for use of a one
percent ivermectin solution by
subcutaneous injection in cattle, swine,
reindeer, and American bison for the
treatment and control of various internal
and external parasites.
DATES: This rule is effective May 17,
2007.
John
K. Harshman, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0169, email: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Norbrook
Laboratories, Ltd., Station Works,
Newry BT35 6JP, Northern Ireland, filed
supplemental ANADA 200–437 that
provides for use of NOROMECTIN
(ivermectin) Injection for Cattle and
Swine by subcutaneous injection in
cattle, swine, reindeer, and American
bison for the treatment and control of
various internal and external parasites.
Norbrook Laboratories, Ltd.’s
NOROMECTIN Injection for Cattle and
Swine is approved as a generic copy of
Merial, Ltd.’s IVOMEC Injection for
Cattle and Swine approved under
NADA 128–409. The ANADA is
approved as of April 20, 2007, and the
regulations are amended in 21 CFR
522.1192 to reflect the approval and a
current format.
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.
FDA has determined under 21 CFR
25.33(a)(1) 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.
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\17MYR1.SGM
17MYR1
]]>Agencies
[Federal Register Volume 72, Number 95 (Thursday, May 17, 2007)]
[Rules and Regulations]
[Pages 27733-27734]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9517]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Ivermectin and Clorsulon
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 an abbreviated new animal drug
application (ANADA) filed by Norbrook Laboratories, Ltd. The ANADA
provides for the use of an ivermectin and clorsulon solution by
subcutaneous injection in cattle for control of various internal and
external parasites.
DATES: This rule is effective May 17, 2007.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail:
john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Norbrook Laboratories, Ltd., Station Works,
Newry BT35 6JP, Northern Ireland, filed ANADA 200-436 that provides for
use of NOROMECTIN Plus (ivermectin and clorsulon) Injection for Cattle
by subcutaneous injection in cattle for control of various internal and
external parasites. Norbrook Laboratories, Ltd.'s NOROMECTIN Plus
Injection for Cattle
[[Page 27734]]
is approved as a generic copy of Merial, Ltd.'s IVOMEC Plus Injection
for Cattle, approved under NADA 140-833. The ANADA is approved as of
April 23, 2007, and the regulations are amended in 21 CFR 522.1193 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.
FDA has determined under 21 CFR 25.33(a)(1) 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.
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. Amend Sec. 522.1193 as follows:
a. Revise the section heading and paragraphs (a) and (b);
b. Redesignate paragraph (d) as paragraph (e);
c. Add new paragraph (d); and
d. Revise newly redesignated paragraph (e).
The revisions, redesignation, and addition read as follows:
Sec. 522.1193 Ivermectin and clorsulon.
(a) Specifications. Each milliliter (mL) of solution contains 10
milligrams (mg) (1 percent) ivermectin and 100 mg (10 percent)
clorsulon.
(b) Sponsors. See Nos. 050604 and 055529 in Sec. 510.600(c) of
this chapter for use as in paragraph (e) of this section.
* * * * *
(d) Special considerations. See Sec. 500.25 of this chapter.
(e) Conditions of use in cattle--(1) Amount. Administer 1 mL (10 mg
ivermectin and 100 mg clorsulon) per 50 kilograms (110 pounds) by
subcutaneous injection.
(2) Indications for use. For the treatment and control of
gastrointestinal nematodes (adults and fourth-stage larvae) (Haemonchus
placei, Ostertagia ostertagi (including inhibited larvae), O. lyrata,
Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C.
punctata, C. pectinata, Oesophagostomum radiatum, Nematodirus
helvetianus (adults only), N. spathiger (adults only), Bunostomum
phlebotomum; lungworms (adults and fourth-stage larvae) (Dictyocaulus
viviparus); liver flukes (adults only) (Fasciola hepatica); grubs
(parasitic stages) (Hypoderma bovis, H. lineatum); lice (Linognathus
vituli, Haematopinus eurysternus, Solenopotes capillatus); mites
(Psoroptes ovis (syn. P. communis var. bovis), Sarcoptes scabiei var.
bovis); and for control of infections of D. viviparus and O. radiatum
for 28 days afer treatment; O. ostertagi, T. axei, and C. punctata for
21 days after treatment; and H. placei and C. oncophora for 14 days
after treatment.
(3) Limitations. For subcutaneous use only. Not for intravenous or
intramuscular use. Do not treat cattle within 49 days of slaughter.
Because a withdrawal time in milk has not been established, do not use
in female dairy cattle of breeding age. Do not use in other animal
species because severe adverse reactions, including fatalities in dogs,
may result. A withdrawal period has not been established for this
product in preruminating calves. Do not use in calves to be processed
for veal.
Dated: May 7, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-9517 Filed 5-16-07; 8:45 am]
BILLING CODE 4160-01-S
