E9-30590. 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, 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: [e-mail].

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 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

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

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.

2. In § 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:

§ 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, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400 013, India	065085
*    *    *    *    *

(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

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

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

§ 529.1186

[Amended]

4. In § 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.