Document ID: FDA-2009-N-0665-0077
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Change of Sponsor; Isoflurane
Posted Date: 2009-12-28T05:00Z

[Federal Register: December 28, 2009 (Volume 74, Number 247)]
[Rules and Regulations]               
[Page 68529-68530]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28de09-21]                         

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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; 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, USP, from Nicholas 
Piramal India Ltd. UK, to Piramal Healthcare Ltd.

DATES: This rule is effective December 28, 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: Nicholas Piramal India Ltd. UK has informed 
FDA that it has transferred ownership of, and all rights and interest 
in, ANADA 200-237 for Isoflurane, USP, to Piramal Healthcare Ltd., 
Piramal Tower, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400 013, 
India. Accordingly, the regulations are amended in 21 CFR

[[Page 68530]]

529.1186 to reflect this change of sponsorship.
    Following this change of sponsorship, Nicholas Piramal India Ltd. 
UK is no longer the sponsor of an approved application. In addition, 
Piramal Healthcare Ltd. 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 Nicholas 
Piramal India Ltd. UK to add entries for Piramal Healthcare Ltd.
    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 ``Piramal Healthcare Ltd.'' and remove the entry for 
``Nicholas Piramal India Ltd. UK''; and in the table in paragraph 
(c)(2) remove the entry for ``066112'' and numerically add an entry for 
``065085'' 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
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------
Piramal Healthcare Ltd., Piramal Tower,       065085
 Ganpatrao Kadam Marg, Lower Parel, Mumbai -
 400 013, India
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
     Drug labeler code                  Firm name and address
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------
065085                       Piramal Healthcare Ltd., Piramal Tower,
                              Ganpatrao Kadam Marg, Lower Parel, Mumbai
                               400 013, India
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------

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.

Sec.  529.1186  [Amended]

0
4. In Sec.  529.1186, in paragraph (b), remove ``066112'' and in its 
place add ``065085''.

    Dated: December 17, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E9-30590 Filed 12-24-09; 8:45 am]

BILLING CODE 4160-01-S