Document ID: FDA-2010-N-0002-0048
Agency: fda
Document Type: Rule
Title: Implantations or Injectable Dosages Form New Animal Drugs: Propofol
Posted Date: 2010-07-06T04:00Z

[Federal Register: July 6, 2010 (Volume 75, Number 128)]
[Rules and Regulations]               
[Page 38699-38700]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06jy10-4]                         

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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: 
melanie.berson@fda.hhs.gov.

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.

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. 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]
BILLING CODE 4160-01-S