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Federal Register / Vol. 71, No.

212 / Thursday, November 2, 2006 / Rules and Regulations 64451

to compete effectively in a global a generic copy of Fort Dodge Animal (2) Indications for use. As a
environment. Health’s, Division of Wyeth’s ROBINUL- preanesthetic agent.
This Statement of Policy has been V (glycopyrrolate), approved under (3) Limitations. Federal law restricts
developed as a means for the NADA 101–777. The ANADA is this drug to use by or on the order of
Commission to respond flexibly to the approved as of October 2, 2006, and the a licensed veterinarian.
challenges posed by the ongoing regulations are amended in 21 CFR Dated: October 23, 2006.
evolution in electronic access to global 522.1066 to reflect the approval and a Stephen F. Sundlof,
markets. The Commission will continue current format. The basis of approval is
Director, Center for Veterinary Medicine.
to monitor carefully, and review the discussed in the freedom of information
Policy Statement as necessary in light [FR Doc. E6–18444 Filed 11–1–06; 8:45 am]
of, the ongoing evolution of cross-border In accordance with the freedom of BILLING CODE 4160–01–S

electronic direct access and information provisions of 21 CFR part

intermediation in order to ensure that it 20 and 21 CFR 514.11(e)(2)(ii), a
does not adversely affect U.S. cash and summary of safety and effectiveness DEPARTMENT OF STATE
futures markets, market participants and data and information submitted to
customers, as well as the consumers support approval of this application 22 CFR Part 97
affected by those foreign market may be seen in the Division of Dockets [Public Notice 5602]
transactions. Management (HFA–305), Food and Drug
RIN 1400–AC19
Issued in Washington, DC, on October 27, Administration, 5630 Fishers Lane, rm.
2006 by the Commission. 1061, Rockville, MD 20852, between 9 Intercountry Adoption—Department
Eileen A. Donovan, a.m. and 4 p.m., Monday through Issuance of Certifications in Hague
Acting Secretary of the Commission.
Friday. Convention Adoption Cases
FDA has determined under 21 CFR
[FR Doc. E6–18513 Filed 11–1–06; 8:45 am] AGENCY: Department of State.
25.33(a)(1) that this action is of a type
that does not individually or ACTION: Final rule.
cumulatively have a significant effect on
the human environment. Therefore, SUMMARY: The Department of State (the
DEPARTMENT OF HEALTH AND neither an environmental assessment Department) is issuing a final rule to
HUMAN SERVICES nor an environmental impact statement implement the certification and
is required. declaration provisions of the 1993
Food and Drug Administration This rule does not meet the definition Hague Convention on Protection of
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because Children and Co-operation in Respect of
21 CFR Part 522 it is a rule of ‘‘particular applicability.’’ Intercountry Adoption (the Convention)
Therefore, it is not subject to the and the Intercountry Adoption Act of
Implantation or Injectable Dosage
congressional review requirements in 5 2000 (the IAA) with respect to adoption
Form New Animal Drugs;
U.S.C. 801–808. and custody proceedings taking place in
the United States, after review of public
List of Subjects in 21 CFR Part 522 comments received in response to the
AGENCY: Food and Drug Administration,
HHS. Animal drugs. Department’s June 16, 2006 issuance of
ACTION: Final rule. ■ Therefore, under the Federal Food, a proposed rule. This final rule governs
Drug, and Cosmetic Act and under the application process for Hague
SUMMARY: The Food and Drug authority delegated to the Commissioner Adoption Certificates and Hague
Administration (FDA) is amending the of Food and Drugs and redelegated to Custody Declarations in cases involving
animal drug regulations to reflect the Center for Veterinary Medicine, 21 emigration of a child from the United
approval of an abbreviated new animal CFR part 522 is amended as follows: States. It also establishes a process for
drug application (ANADA) filed by IVX seeking certification, for purposes of
Animal Health, Inc. The ANADA PART 522—IMPLANTATION OR Article 23 of the Convention, that an
provides for veterinary prescription use INJECTABLE DOSAGE FORM NEW adoption done in the United States
of glycopyrrolate solution as an ANIMAL DRUGS following a grant of custody in a
injectable preanesthetic agent in dogs Convention country of origin was done
■ 1. The authority citation for 21 CFR
and cats. in accordance with the Convention.
part 522 continues to read as follows:
DATES: This rule is effective November DATES: This rule is effective December 4,
Authority: 21 U.S.C. 360b.
2, 2006. 2006. Information about the date the
■ 2. Revise § 522.1066 to read as Convention will enter into force is
follows: provided in 22 CFR 96.17.
K. Harshman, Center for Veterinary
Medicine (HFV 104), Food and Drug § 522.1066 Glycopyrrolate. FOR FURTHER INFORMATION CONTACT: For
Administration, 7500 Standish Pl., (a) Specifications. Each milliliter of further information, contact Anna Mary
Rockville, MD 20855, 301–827–0169, e- solution contains 0.2 milligram Coburn at 202–736–9081. Hearing- or
mail: john.harshman@fda.hhs.gov. glycopyrrolate. speech-impaired persons may use the
SUPPLEMENTARY INFORMATION: IVX (b) Sponsors. See Nos. 000856 and Telecommunications Devices for the
Animal Health, Inc., 3915 South 48th 059130 in § 510.600(c) of this chapter. Deaf (TDD) by contacting the Federal
Street Ter., St. Joseph, MO 64503, filed (c) Conditions of use in dogs and Information Relay Service at 1–800–
ANADA 200–365 that provides for cats—(1) Amount. 5 micrograms per 877–8339.
veterinary prescription use of pound of body weight (0.25 milliliter
pwalker on PRODPC60 with RULES

Glycopyrrolate Injectable as a per 10 pounds of body weight) by
preanesthetic agent in dogs and cats. intravenous, intramuscular, or I. Background
IVX Animal Health, Inc.’s subcutaneous injection in dogs or by The Convention is a multilateral
Glycopyrrolate Injectable is approved as intramuscular injection in cats. treaty that provides a framework for the

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