2011-909. New Animal Drugs; Change of Sponsor; Follicle Stimulating Hormone

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 a new animal drug application (NADA) for follicle stimulating hormone from Ausa International, Inc., to Therio, Inc.

DATES:

This rule is effective January 18, 2011.

FOR FURTHER INFORMATION CONTACT:

Steven D. Vaughn, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, 240-276-8300, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Ausa International, Inc., Rt. 8, P.O. Box 324-12, Tyler, TX 75703 has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 141-014 for SUPER-OV (follicle stimulating hormone) to Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503. Accordingly, the Agency is amending the regulations in 21 CFR 522.1002 to reflect the transfer of ownership.

Following this change of sponsorship, Ausa International, Inc., is no longer the sponsor of an approved application. Accordingly, § 510.600 (21 CFR 510.600) is being amended to remove the entries for this firm.

In addition, Therio, Inc., is not currently listed in the animal drug regulations as a sponsor of an approved application. Accordingly, § 510.600 is being amended to add entries for this sponsor.

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 522

• 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 522 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), remove the entry for “Ausa International, Inc.”; and alphabetically add a new entry for “Therio, Inc.”; and in the table in paragraph (c)(2), remove the entry for “059521”; and in numerical sequence add a new entry for “052923” 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
*    *    *    *    *
Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503	052923
*    *    *    *    *

(2) * * *

Drug labeler code	Firm name and address
*    *    *    *    *
052923	Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503
*    *    *    *    *

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

3. The authority citation for 21 CFR part 522 continues to read as follows:

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

§ 522.1002

[Amended]

4. In paragraph (a)(2) of § 522.1002, remove “059521” and add in its place “No. 052923”.

Dated: January 12, 2011.

Steven D. Vaughn,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.