[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]
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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.
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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
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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) * * *
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Firm name and address Drug labeler code
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* * * * *
Nicholas Piramal India Ltd. UK, 1st Floor, 066112
Alpine House, Unit II, Honeypot Lane,
London, NW99RX, England, UK.
* * * * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * * *
066112 Nicholas Piramal India Ltd. UK, 1st Floor,
Alpine House, Unit II, Honeypot Lane,
London, NW99RX, England, UK
* * * * *
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PART 529--OTHER DOSAGE FORM NEW ANIMAL DRUGS
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3. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
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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