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Federal Register / Vol. 72, No.

95 / Thursday, May 17, 2007 / Rules and Regulations 27733

control number was not available when atrioventricular valvular insufficiency tablets. The total daily dose should be
the final rule was published, thus or dilated cardiomyopathy; for use with divided into two portions administered
necessitating publication of this notice. concurrent therapy for congestive heart approximately 12 hours apart.
The FAA request was approved by OMB failure as appropriate on a case-by-case (2) Indications for use. For the
without change and expires on April 30, basis. The NADA is approved as of management of the signs of mild,
2010. April 30, 2007, and the regulations in 21 moderate, or severe (modified New York
Title 49 U.S.C. 106(g), 40113, 40119, CFR part 520 are amended by adding Heart Association Class II, III, or IV)
41706, 44101, 44701–44702, 44705, § 520.1780 to reflect the approval. congestive heart failure due to
44709–44711, 44713, 44716–44717, In accordance with the freedom of atrioventricular valvular insufficiency
44722, 46105, grants authority to the information provisions of 21 CFR part or dilated cardiomyopathy; for use with
Administrator to publish this notice. 20 and 21 CFR 514.11(e)(2)(ii), a concurrent therapy for congestive heart
The final rule (71 FR 75616) became summary of safety and effectiveness failure as appropriate on a case-by-case
effective on February 13, 2007 and the data and information submitted to basis.
compliance date for information support approval of this application (3) Limitations. Federal law restricts
collection requirements in §§ 460.5, may be seen in the Division of Dockets this drug to use by or on the order of
460.7, 460.9, 460.19, 460.45, and 460.49 Management (HFA–305), Food and Drug a licensed veterinarian.
is May 17, 2007. Administration, 5630 Fishers Lane, rm. Dated: May 7, 2007.
Issued in Washington, DC on May 8, 2007. 1061, Rockville, MD 20852, between 9 Bernadette Dunham,
Pamela Hamilton-Powell,
a.m. and 4 p.m., Monday through
Deputy Director, Center for Veterinary
Friday. Medicine.
Director, Office of Rulemaking Aviation Under section 512(c)(2)(F)(i) of the
Safety. [FR Doc. E7–9516 Filed 5–16–07; 8:45 am]
Federal Food, Drug, and Cosmetic Act
[FR Doc. E7–9480 Filed 5–16–07; 8:45 am] (21 U.S.C. 360b(c)(2)(F)(i)), this BILLING CODE 4160–01–S
BILLING CODE 4910–13–P approval qualifies for 5 years of
marketing exclusivity beginning on the
date of the approval. DEPARTMENT OF HEALTH AND
DEPARTMENT OF HEALTH AND The agency has determined under 21 HUMAN SERVICES
HUMAN SERVICES CFR 25.33(d)(1) that this action is of a Food and Drug Administration
type that does not individually or
Food and Drug Administration cumulatively have a significant effect on 21 CFR Part 522
the human environment. Therefore,
21 CFR Part 520 neither an environmental assessment Implantation or Injectable Dosage
nor an environmental impact statement Form New Animal Drugs; Ivermectin
Oral Dosage Form New Animal Drugs;
is required. and Clorsulon
Pimobendan
This rule does not meet the definition
AGENCY: Food and Drug Administration, of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because AGENCY: Food and Drug Administration,
HHS. it is a rule of ‘‘particular applicability.’’ HHS.
ACTION: Final rule. Therefore, it is not subject to the ACTION: Final rule.
congressional review requirements in 5
SUMMARY: The Food and Drug U.S.C. 801–808. SUMMARY: The Food and Drug
Administration (FDA) is amending the Administration (FDA) is amending the
animal drug regulations to reflect List of Subjects in 21 CFR Part 520 animal drug regulations to reflect
approval of a new animal drug Animal drugs. approval of an abbreviated new animal
application (NADA) filed by Boehringer ■ Therefore, under the Federal Food, drug application (ANADA) filed by
Ingelheim Vetmedica, Inc. The NADA Drug, and Cosmetic Act and under Norbrook Laboratories, Ltd. The
provides for the veterinary prescription authority delegated to the Commissioner ANADA provides for the use of an
use of pimobendan chewable tablets in of Food and Drugs and redelegated to ivermectin and clorsulon solution by
dogs for the management of the signs of the Center for Veterinary Medicine, 21 subcutaneous injection in cattle for
congestive heart failure. CFR part 520 is amended as follows: control of various internal and external
DATES: This rule is effective May 17, parasites.
2007. PART 520—ORAL DOSAGE FORM DATES: This rule is effective May 17,
NEW ANIMAL DRUGS 2007.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary ■ 1. The authority citation for 21 CFR FOR FURTHER INFORMATION CONTACT: John
Medicine (HFV–110), Food and Drug part 520 continues to read as follows: K. Harshman, Center for Veterinary
Administration, 7500 Standish Pl., Medicine (HFV–104), Food and Drug
Authority: 21 U.S.C. 360b.
Rockville, MD 20855, 301–827–7540, e- Administration, 7500 Standish Pl.,
mail: melanie.berson@fda.hhs.gov. ■ 2. Add § 520.1780 to read as follows: Rockville, MD 20855, 301–827–0169, e-
SUPPLEMENTARY INFORMATION: § 520.1780 Pimobendan. mail: john.harshman@fda.hhs.gov.
Boehringer Ingelheim Vetmedica, Inc., (a) Specifications. Each chewable SUPPLEMENTARY INFORMATION: Norbrook
2621 N. Belt Hwy., St. Joseph, MO tablet contains 1.25, 2.5, or 5 milligrams Laboratories, Ltd., Station Works,
64506–2002, filed NADA 141–273 that (mg) pimobendan. Newry BT35 6JP, Northern Ireland, filed
provides for the veterinary prescription (b) Sponsor. See No. 000010 in ANADA 200–436 that provides for use
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use of VETMEDIN (pimobendan) § 510.600(c) of this chapter. of NOROMECTIN Plus (ivermectin and
Chewable Tablets in dogs for the (c) Conditions of use in dogs—(1) clorsulon) Injection for Cattle by
management of the signs of mild, Amount. Administer orally at a total subcutaneous injection in cattle for
moderate, or severe (modified New York daily dose of 0.23 mg per pound (0.5 mg control of various internal and external
Heart Association Class II, III, or IV) per kilogram) body weight, using a parasites. Norbrook Laboratories, Ltd.’s
congestive heart failure due to suitable combination of whole or half NOROMECTIN Plus Injection for Cattle

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27734 Federal Register / Vol. 72, No. 95 / Thursday, May 17, 2007 / Rules and Regulations

is approved as a generic copy of Merial, for use as in paragraph (e) of this ACTION: Final rule.
Ltd.’s IVOMEC Plus Injection for Cattle, section.
approved under NADA 140–833. The SUMMARY: The Food and Drug
* * * * *
ANADA is approved as of April 23, (d) Special considerations. See Administration (FDA) is amending the
2007, and the regulations are amended § 500.25 of this chapter. animal drug regulations to reflect
in 21 CFR 522.1193 to reflect the (e) Conditions of use in cattle—(1) approval of an abbreviated new animal
approval. Amount. Administer 1 mL (10 mg drug application (ANADA) filed by
In accordance with the freedom of ivermectin and 100 mg clorsulon) per 50 Norbrook Laboratories, Ltd. The
information provisions of 21 CFR part kilograms (110 pounds) by ANADA provides for use of a one
20 and 21 CFR 514.11(e)(2)(ii), a subcutaneous injection. percent ivermectin solution by
summary of safety and effectiveness (2) Indications for use. For the subcutaneous injection in cattle, swine,
data and information submitted to treatment and control of gastrointestinal reindeer, and American bison for the
support approval of this application nematodes (adults and fourth-stage treatment and control of various internal
may be seen in the Division of Dockets larvae) (Haemonchus placei, Ostertagia and external parasites.
Management (HFA–305), Food and Drug ostertagi (including inhibited larvae), O. DATES: This rule is effective May 17,
Administration, 5630 Fishers Lane, rm. lyrata, Trichostrongylus axei, T. 2007.
1061, Rockville, MD 20852, between 9 colubriformis, Cooperia oncophora, C. FOR FURTHER INFORMATION CONTACT: John
a.m. and 4 p.m., Monday through punctata, C. pectinata, K. Harshman, Center for Veterinary
Friday. Oesophagostomum radiatum, Medicine (HFV–104), Food and Drug
FDA has determined under 21 CFR Nematodirus helvetianus (adults only), Administration, 7500 Standish Pl.,
25.33(a)(1) that this action is of a type N. spathiger (adults only), Bunostomum Rockville, MD 20855, 301–827–0169, e-
that does not individually or phlebotomum; lungworms (adults and mail: john.harshman@fda.hhs.gov.
cumulatively have a significant effect on fourth-stage larvae) (Dictyocaulus SUPPLEMENTARY INFORMATION: Norbrook
the human environment. Therefore, viviparus); liver flukes (adults only) Laboratories, Ltd., Station Works,
neither an environmental assessment (Fasciola hepatica); grubs (parasitic Newry BT35 6JP, Northern Ireland, filed
nor an environmental impact statement stages) (Hypoderma bovis, H. lineatum); supplemental ANADA 200–437 that
is required. lice (Linognathus vituli, Haematopinus provides for use of NOROMECTIN
This rule does not meet the definition eurysternus, Solenopotes capillatus); (ivermectin) Injection for Cattle and
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because mites (Psoroptes ovis (syn. P. communis Swine by subcutaneous injection in
it is a rule of ‘‘particular applicability.’’ var. bovis), Sarcoptes scabiei var. bovis); cattle, swine, reindeer, and American
Therefore, it is not subject to the and for control of infections of D. bison for the treatment and control of
congressional review requirements in 5 viviparus and O. radiatum for 28 days various internal and external parasites.
U.S.C. 801–808. afer treatment; O. ostertagi, T. axei, and Norbrook Laboratories, Ltd.’s
C. punctata for 21 days after treatment; NOROMECTIN Injection for Cattle and
List of Subjects in 21 CFR Part 522 and H. placei and C. oncophora for 14 Swine is approved as a generic copy of
Animal drugs. days after treatment. Merial, Ltd.’s IVOMEC Injection for
■ Therefore, under the Federal Food, (3) Limitations. For subcutaneous use
Cattle and Swine approved under
Drug, and Cosmetic Act and under only. Not for intravenous or
NADA 128–409. The ANADA is
authority delegated to the Commissioner intramuscular use. Do not treat cattle
approved as of April 20, 2007, and the
of Food and Drugs and redelegated to within 49 days of slaughter. Because a
regulations are amended in 21 CFR
the Center for Veterinary Medicine, 21 withdrawal time in milk has not been
522.1192 to reflect the approval and a
CFR part 522 is amended as follows: established, do not use in female dairy
current format.
cattle of breeding age. Do not use in
In accordance with the freedom of
PART 522—IMPLANTATION OR other animal species because severe
information provisions of 21 CFR part
INJECTABLE DOSAGE FORM NEW adverse reactions, including fatalities in
20 and 21 CFR 514.11(e)(2)(ii), a
ANIMAL DRUGS dogs, may result. A withdrawal period
summary of safety and effectiveness
has not been established for this product
data and information submitted to
■ 1. The authority citation for 21 CFR in preruminating calves. Do not use in
support approval of this application
part 522 continues to read as follows: calves to be processed for veal.
may be seen in the Division of Dockets
Authority: 21 U.S.C. 360b. Dated: May 7, 2007. Management (HFA–305), Food and Drug
■ 2. Amend § 522.1193 as follows: Bernadette Dunham, Administration, 5630 Fishers Lane, rm.
a. Revise the section heading and Deputy Director, Center for Veterinary 1061, Rockville, MD 20852, between 9
paragraphs (a) and (b); Medicine. a.m. and 4 p.m., Monday through
b. Redesignate paragraph (d) as [FR Doc. E7–9517 Filed 5–16–07; 8:45 am] Friday.
paragraph (e); BILLING CODE 4160–01–S FDA has determined under 21 CFR
c. Add new paragraph (d); and 25.33(a)(1) that this action is of a type
d. Revise newly redesignated that does not individually or
paragraph (e). DEPARTMENT OF HEALTH AND cumulatively have a significant effect on
The revisions, redesignation, and HUMAN SERVICES the human environment. Therefore,
addition read as follows: neither an environmental assessment
Food and Drug Administration nor an environmental impact statement
§ 522.1193 Ivermectin and clorsulon. is required.
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(a) Specifications. Each milliliter (mL) 21 CFR Part 522 This rule does not meet the definition
of solution contains 10 milligrams (mg) of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
Implantation or Injectable Dosage
(1 percent) ivermectin and 100 mg (10 it is a rule of ‘‘particular applicability.’’
Form New Animal Drugs; Ivermectin
percent) clorsulon. Therefore, it is not subject to the
(b) Sponsors. See Nos. 050604 and AGENCY: Food and Drug Administration, congressional review requirements in 5
055529 in § 510.600(c) of this chapter HHS. U.S.C. 801–808.

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