[Federal Register Volume 75, Number 128 (Tuesday, July 6, 2010)]
[Rules and Regulations]
[Pages 38699-38700]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-16301]
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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; Propofol
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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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 Fort Dodge Animal Health, Division of Wyeth. The NADA
provides for veterinary prescription use of propofol as an anesthetic
in dogs and cats.
DATES: This rule is effective July 6, 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:
[email protected].
SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of Wyeth,
a wholly owned subsidiary of Pfizer, Inc., 235 East 42d St., New York,
NY 10017 filed NADA 141-303 that provides for veterinary prescription
use of PROPOCLEAR (propofol) in dogs and
[[Page 38700]]
cats for induction and maintenance of anesthesia and for induction of
anesthesia followed by maintenance with an inhalant anesthetic. The
application is approved as of May 21, 2010, and the regulations are
amended in 21 CFR 522.2005 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.
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.
Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for
3 years of marketing exclusivity beginning on the date of approval.
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.
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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
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1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
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2. In Sec. 522.2005, revise paragraphs (b) and (c) to read as follows:
Sec. 522.2005 Propofol.
* * * * *
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter.
(1) No. 059130 for use as in paragraphs (c)(1), (c)(2)(i), and
(c)(3) of this section.
(2) No. 000074 for use as in paragraphs (c)(1), (c)(2)(i), and
(c)(3) of this section.
(3) No. 000856 for use as in paragraphs (c)(1), (c)(2)(ii), and
(c)(3) of this section.
(c) Conditions of use in dogs and cats--(1) Amount. Administer by
intravenous injection according to label directions. The use of
preanesthetic medication reduces propofol dose requirements.
(2) Indications for use--(i) As a single injection to provide
general anesthesia for short procedures; for induction and maintenance
of general anesthesia using incremental doses to effect; for induction
of general anesthesia where maintenance is provided by inhalant
anesthetics.
(ii) For the induction and maintenance of anesthesia and for
induction of anesthesia followed by maintenance with an inhalant
anesthetic.
* * * * *
Dated: June 29, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-16301 Filed 7-2-10; 8:45 am]
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