Justia Regulation Tracker

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[Federal Register: March 6, 2009 (Volume 74, Number 43)]
[Rules and Regulations]               
[Page 9766-9767]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06mr09-4]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 529

[Docket No. FDA-2009-N-0665]

 
New Animal Drugs; Change of Sponsor; Methoxyflurane

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 a change of sponsor for a new animal drug 
application (NADA) from Schering-Plough Animal Health, Inc., to Medical 
Developments International, Ltd.

DATES: This rule is effective March 6, 2009.

FOR FURTHER INFORMATION CONTACT:  David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail: 
david.newkirk@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 556 
Morris Ave., Summit, NJ 07901, has informed FDA that it has transferred 
ownership of, and all rights and interest in, NADA 14-485 for ANAFANE 
(methoxyflurane) Volatile Liquid for Inhalation Anesthesia to Medical 
Developments International, Ltd., P.O. Box 21, Sandown Village, 3171 
VIC Australia.
    Medical Developments International, Ltd., is not currently listed 
in the animal drug regulations as a sponsor of an approved application. 
In addition, FDA has noticed that this new animal drug has not been 
previously codified in 21 CFR part 529. Accordingly, the regulations 
are amended in 21 CFR 510.600(c) to add entries for Medical 
Developments International, Ltd., and in 21 CFR part 529 to add this 
new animal drug.
    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.

[[Page 9767]]

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 529

    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 parts 510 and 
529 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. In Sec.  510.600, in the table in paragraph (c)(1) alphabetically 
add an entry for ``Medical Developments International, Ltd.''; and in 
the table in paragraph (c)(2) numerically add an entry for ``025245'' 
to read as follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
            Firm name and address                  Drug labeler code
------------------------------------------------------------------------
                                * * * * *
Medical Developments International,           025245
 Ltd.,P.O. Box 21, Sandown Village, 3171 VIC
 Australia
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                 Firm name and address
------------------------------------------------------------------------
                                * * * * *
025245.....................  Medical Developments International,
                              Ltd.,P.O. Box 21, Sandown Village, 3171
                              VIC Australia
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 529 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

0
4. Add Sec.  529.1455 to read as follows:

Sec.  529.1455  Methoxyflurane.

    (a) Specifications. Methoxyflurane liquid.
    (b) Sponsor. See No. 025245 in Sec.  510.600 of this chapter.
    (c) Conditions of use--(1) Amount. The amount of methoxyflurane 
used depends on the weight of the patient, the depth of anesthesia, and 
the type of equipment used. Anesthesia may be induced with 
methoxyflurane alone, or by the intravenous administration of a short-
acting general anesthetic or by inhalation of another anesthetic agent.
    (2) Indications for use. For the induction and maintenance of 
general anesthesia.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: March 3, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E9-4758 Filed 3-5-09; 8:45 am]

BILLING CODE 4160-01-S