Implantation or Injectable Dosage From New Animal Drugs; Change of Sponsor; Repository Corticotropin Injection, 20582 [E9-10291]

Download as PDF 20582 Federal Register / Vol. 74, No. 85 / Tuesday, May 5, 2009 / Rules and Regulations 01803; e-mail: mark.riley@faa.gov; telephone (781) 238–7758; fax (781) 238–7199, for more information about this AD. the Center for Veterinary Medicine, 21 CFR part 510 is amended as follows: Material Incorporated by Reference (l) None. PART 510—NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 510 continues to read as follows: ■ Issued in Burlington, Massachusetts, on April 23, 2009. Peter A. White, Assistant Manager, Engine and Propeller Directorate, Aircraft Certification Service. [FR Doc. E9–10145 Filed 5–4–09; 8:45 am] 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 ‘‘IVX Animal Health, Inc.’’ and alphabetically add a new entry for ‘‘Teva Animal Health, Inc.’’; and in the table in paragraph (c)(2), revise the entry for ‘‘059130’’ to read as follows: ■ BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. 21 CFR Part 510 * [Docket No. FDA–2009–N–0665] * * (c) * * * (1) * * * New Animal Drugs; Change of Sponsor’s Name AGENCY: * Firm name and address 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’s name from IVX Animal Health, Inc., to Teva Animal Health, Inc. DATES: This rule is effective May 5, 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, email: david.newkirk@fda.hhs.gov. SUPPLEMENTARY INFORMATION: IVX Animal Health, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503, has informed FDA that it has changed its name to Teva Animal Health, Inc. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c) to reflect this change. 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 in 21 CFR Part 510 22:59 May 04, 2009 Jkt 217001 * 059130 * * * (2) * * * Drug labeler code * 059130 * * * Firm name and address * * * Teva Animal Health, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503 * * * Dated: April 29, 2009. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. E9–10262 Filed 5–4–09; 8:45 am] BILLING CODE 4160–01–S Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor’s name from Summit Hill Laboratories to Putney, Inc. DATES: This rule is effective May 5, 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, email: david.newkirk@fda.hhs.gov. Summit Hill Laboratories, P.O. Box 535, Navesink, NJ 07752, has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 8–760 for ADRENOMONE (repository corticotropin injection U.S.P.) to Putney, Inc., 400 Congress St., suite 200, Portland, ME 04101. Accordingly, the regulations are amended in 21 CFR 522.480 to reflect this change of sponsorship. 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. SUPPLEMENTARY INFORMATION: List of Subjects in 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 part 522 is amended as follows: ■ PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 522 continues to read as follows: ■ DEPARTMENT OF HEALTH AND HUMAN SERVICES Authority: 21 U.S.C. 360b. Food and Drug Administration § 522.480 21 CFR Part 522 ■ Implantation or Injectable Dosage From New Animal Drugs; Change of Sponsor; Repository Corticotropin Injection AGENCY: Food and Drug Administration, HHS. PO 00000 Frm 00024 [Amended] 2. In paragraph (a)(2) of § 522.480, remove ‘‘037990’’ and add in its place ‘‘026637’’. [Docket No. FDA–2009–N–0665] Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. ■ Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to VerDate Nov<24>2008 * * * Teva Animal Health, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503 * * * Drug labeler code ACTION: Dated: April 30, 2009. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. E9–10291 Filed 5–4–09; 8:45 am] BILLING CODE 4160–01–S Fmt 4700 Sfmt 4700 E:\FR\FM\05MYR1.SGM 05MYR1

Agencies

[Federal Register Volume 74, Number 85 (Tuesday, May 5, 2009)]
[Rules and Regulations]
[Page 20582]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-10291]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2009-N-0665]


Implantation or Injectable Dosage From New Animal Drugs; Change 
of Sponsor; Repository Corticotropin Injection

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's name from Summit Hill 
Laboratories to Putney, Inc.

DATES: This rule is effective May 5, 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: Summit Hill Laboratories, P.O. Box 535, 
Navesink, NJ 07752, has informed FDA that it has transferred ownership 
of, and all rights and interest in, NADA 8-760 for ADRENOMONE 
(repository corticotropin injection U.S.P.) to Putney, Inc., 400 
Congress St., suite 200, Portland, ME 04101. Accordingly, the 
regulations are amended in 21 CFR 522.480 to reflect this change of 
sponsorship.
    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 in 21 CFR Part 522

    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 part 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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


Sec.  522.480  [Amended]

0
2. In paragraph (a)(2) of Sec.  522.480, remove ``037990'' and add in 
its place ``026637''.

    Dated: April 30, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E9-10291 Filed 5-4-09; 8:45 am]
BILLING CODE 4160-01-S

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