Implantation or Injectable Dosage Form New Animal Drugs; Glycopyrrolate, 64451 [E6-18444]
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Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Rules and Regulations
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2006 by the Commission.
Eileen A. Donovan,
Acting Secretary of the Commission.
[FR Doc. E6–18513 Filed 11–1–06; 8:45 am]
BILLING CODE 6351–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs;
Glycopyrrolate
AGENCY:
Food and Drug Administration,
HHS.
pwalker on PRODPC60 with RULES
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 IVX
Animal Health, Inc. The ANADA
provides for veterinary prescription use
of glycopyrrolate solution as an
injectable preanesthetic agent in dogs
and cats.
DATES: This rule is effective November
2, 2006.
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, email: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: IVX
Animal Health, Inc., 3915 South 48th
Street Ter., St. Joseph, MO 64503, filed
ANADA 200–365 that provides for
veterinary prescription use of
Glycopyrrolate Injectable as a
preanesthetic agent in dogs and cats.
IVX Animal Health, Inc.’s
Glycopyrrolate Injectable is approved as
VerDate Aug<31>2005
16:15 Nov 01, 2006
Jkt 211001
a generic copy of Fort Dodge Animal
Health’s, Division of Wyeth’s ROBINULV (glycopyrrolate), approved under
NADA 101–777. The ANADA is
approved as of October 2, 2006, and the
regulations are amended in 21 CFR
522.1066 to reflect the approval and a
current format. The basis of approval is
discussed in the freedom of information
summary.
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.
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 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:
I
Authority: 21 U.S.C. 360b.
2. Revise § 522.1066 to read as
follows:
I
§ 522.1066
Glycopyrrolate.
(a) Specifications. Each milliliter of
solution contains 0.2 milligram
glycopyrrolate.
(b) Sponsors. See Nos. 000856 and
059130 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs and
cats—(1) Amount. 5 micrograms per
pound of body weight (0.25 milliliter
per 10 pounds of body weight) by
intravenous, intramuscular, or
subcutaneous injection in dogs or by
intramuscular injection in cats.
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
64451
(2) Indications for use. As a
preanesthetic agent.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
Dated: October 23, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6–18444 Filed 11–1–06; 8:45 am]
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Intercountry Adoption—Department
Issuance of Certifications in Hague
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Department of State.
Final rule.
AGENCY:
ACTION:
SUMMARY: The Department of State (the
Department) is issuing a final rule to
implement the certification and
declaration provisions of the 1993
Hague Convention on Protection of
Children and Co-operation in Respect of
Intercountry Adoption (the Convention)
and the Intercountry Adoption Act of
2000 (the IAA) with respect to adoption
and custody proceedings taking place in
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comments received in response to the
Department’s June 16, 2006 issuance of
a proposed rule. This final rule governs
the application process for Hague
Adoption Certificates and Hague
Custody Declarations in cases involving
emigration of a child from the United
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seeking certification, for purposes of
Article 23 of the Convention, that an
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Convention country of origin was done
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2006. Information about the date the
Convention will enter into force is
provided in 22 CFR 96.17.
FOR FURTHER INFORMATION CONTACT: For
further information, contact Anna Mary
Coburn at 202–736–9081. Hearing- or
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SUPPLEMENTARY INFORMATION:
I. Background
The Convention is a multilateral
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E:\FR\FM\02NOR1.SGM
02NOR1
]]>Agencies
[Federal Register Volume 71, Number 212 (Thursday, November 2, 2006)]
[Rules and Regulations]
[Page 64451]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-18444]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Glycopyrrolate
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 IVX Animal Health, Inc. The ANADA provides
for veterinary prescription use of glycopyrrolate solution as an
injectable preanesthetic agent in dogs and cats.
DATES: This rule is effective November 2, 2006.
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: IVX Animal Health, Inc., 3915 South 48th
Street Ter., St. Joseph, MO 64503, filed ANADA 200-365 that provides
for veterinary prescription use of Glycopyrrolate Injectable as a
preanesthetic agent in dogs and cats. IVX Animal Health, Inc.'s
Glycopyrrolate Injectable is approved as a generic copy of Fort Dodge
Animal Health's, Division of Wyeth's ROBINUL-V (glycopyrrolate),
approved under NADA 101-777. The ANADA is approved as of October 2,
2006, and the regulations are amended in 21 CFR 522.1066 to reflect the
approval and a current format. The basis of approval is discussed in
the freedom of information summary.
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. Revise Sec. 522.1066 to read as follows:
Sec. 522.1066 Glycopyrrolate.
(a) Specifications. Each milliliter of solution contains 0.2
milligram glycopyrrolate.
(b) Sponsors. See Nos. 000856 and 059130 in Sec. 510.600(c) of
this chapter.
(c) Conditions of use in dogs and cats--(1) Amount. 5 micrograms
per pound of body weight (0.25 milliliter per 10 pounds of body weight)
by intravenous, intramuscular, or subcutaneous injection in dogs or by
intramuscular injection in cats.
(2) Indications for use. As a preanesthetic agent.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Dated: October 23, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6-18444 Filed 11-1-06; 8:45 am]
BILLING CODE 4160-01-S
