[Federal Register Volume 71, Number 149 (Thursday, August 3, 2006)]
[Rules and Regulations]
[Page 43967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-12570]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 529


New Animal Drugs; Change of Sponsor; Isoflurane

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for an abbreviated new 
animal drug application (ANADA) for isoflurane, U.S.P., from Rhodia UK 
Ltd. to Nicholas Piramal India Ltd. UK.

DATES: This rule is effective August 3, 2006.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Rhodia UK Ltd., P.O. Box 46, St. Andrews 
Rd., Avonmouth, Bristol BS11 9YF, England, UK, has informed FDA that it 
has transferred ownership of, and all rights and interest in, ANADA 
200-237 for isoflurane, U.S.P., to Nicholas Piramal India Ltd. UK, 1st 
Floor, Alpine House, Unit II, Honeypot Lane, London, NW99RX, England, 
UK. Accordingly, the regulations are amended in 21 CFR 529.1186 to 
reflect this change of sponsorship and a current format.
    Following these changes of sponsorship, Rhodia UK Ltd. is no longer 
the sponsor of an approved application. In addition, Nicholas Piramal 
India Ltd. UK is not currently listed in the animal drug regulations as 
a sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is 
being amended to remove the entries for Rhodia UK Ltd. to add entries 
for Nicholas Piramal India Ltd. UK.
    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

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 ``Nicholas Piramal India Ltd. UK'' and remove the 
entry for ``Rhodia UK Limited''; and in the table in paragraph (c)(2) 
remove the entry for ``059258'' and numerically add an entry for 
``066112'' 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
------------------------------------------------------------------------
                                * * * * *
Nicholas Piramal India Ltd. UK, 1st Floor,    066112
 Alpine House, Unit II, Honeypot Lane,
 London, NW99RX, England, UK.
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                 Firm name and address
------------------------------------------------------------------------
                                * * * * *
066112                       Nicholas Piramal India Ltd. UK, 1st Floor,
                              Alpine House, Unit II, Honeypot Lane,
                              London, NW99RX, England, UK
                                * * * * *
------------------------------------------------------------------------

PART 529--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. In Sec.  529.1186, in paragraph (b), remove ``059258'' and 
numerically add ``066112''; and revise paragraph (a), the introductory 
text of paragraph (c), and paragraph (c)(3) to read as follows:


Sec.  529.1186  Isoflurane.

    (a) Specifications. The drug is a clear, colorless, stable liquid.
* * * * *
    (c) Conditions of use. Administer by inhalation:
* * * * *
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

    Dated: July 24, 2006.
Bernadette A. Dunham,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. E6-12570 Filed 8-2-06; 8:45 am]
BILLING CODE 4160-01-S