Implantation or Injectable Dosage Form New Animal Drugs; Boldenone, 70997-70998 [05-23295]

Download as PDF 70997 Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Rules and Regulations 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 New Animal Drugs; Change of Sponsor’s Name AGENCY: 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 510 is amended as follows: I PART 510—NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 510 continues to read as follows: I Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. 2. Section 510.600 is amended in the table in paragraph (c)(1) by revising the entry for ‘‘Schering-Plough Animal Health Corp.’’; and in the table in paragraph (c)(2) by revising the entry for ‘‘000061’’ to read as follows. I § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. * * (c) * * * (1) * * * * * Firm name and address * * * Schering-Plough Animal Health Corp., 556 Morris Ave., Summit, NJ 07901. * * * Drug labeler code * 000061 * * * (2) * * * Drug labeler code * 000061 * * * Food and Drug Administration 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. * DEPARTMENT OF HEALTH AND HUMAN SERVICES Firm name and address * * * Schering-Plough Animal Health Corp., 556 Morris Ave., Summit, NJ 07901 * * * Dated: November 15, 2005. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 05–23296 Filed 11–23–05; 8:45 am] BILLING CODE 4160–01–S Food and Drug Administration, HHS. ACTION: Final rule. § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. List of Subjects in 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. I 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 510 is amended as follows: 21 CFR Part 522 PART 510—NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 510 continues to read as follows: 12:24 Nov 23, 2005 Jkt 208001 2. Section 510.600 is amended in the table in paragraph (c)(1) by removing the entries for ‘‘Phoenix Pharmaceutical, Inc.’’ and ‘‘Phoenix Scientific, Inc.’’, and by alphabetically adding a new entry for ‘‘IVX Animal Health, Inc.’’; and in the table in paragraph (c)(2) by removing the entry for ‘‘057319’’ and by revising the entry for ‘‘059130’’ to read as follows: I The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor’s name from Phoenix Scientific, Inc., to IVX Animal Health, Inc. In order to improve the accuracy of the regulations, erroneous entries for Phoenix Pharmaceutical, Inc., are also being removed at this time. DATES: This rule is effective November 25, 2005. 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, email: david.newkirk@fda.gov. SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503, has informed FDA that it has changed its name to IVX Animal Health, Inc. Accordingly, the agency is amending the regulations in § 510.600 (21 CFR 510.600) to reflect the change. In addition, FDA has noticed that Phoenix Pharmaceutical, Inc., is no longer a sponsor of an approved new animal drug application. At this time, § 510.600 is amended to remove entries for this sponsor. This action is being taken to improve the accuracy of the regulations. 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. SUMMARY: I VerDate Aug<31>2005 Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 * * * (c) * * * (1) * * * * * Firm name and address * * * IVX Animal Health, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503. * * * Drug labeler code * 059130 * * * (2) * * * Drug labeler code * 059130 * * * Firm name and address * * * IVX Animal Health, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503 * * * Dated: November 15, 2005. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 05–23297 Filed 11–23–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Implantation or Injectable Dosage Form New Animal Drugs; Boldenone AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Fort Dodge Animal Health. The supplemental NADA provides for E:\FR\FM\25NOR1.SGM 25NOR1 70998 Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Rules and Regulations revised labeling for the veterinary prescription use of injectable boldenone solution in horses. This rule is effective November 25, 2005. DATES: FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for Veterinary Medicine (HFV–110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–7543, email: melanie.berson@fda.gov. Fort Dodge Animal Health, A Division of Wyeth Holdings Corp., P.O. Box 1339, Fort Dodge, IA 50501, filed a supplement to NADA 34–705 that provides for veterinary prescription use of EQUIPOISE (boldenone undecylenate) by injection in horses. The supplemental NADA provides for a revised indication and food safety warning on labeling. The supplemental NADA is approved as of October 7, 2005, and the regulations are amended in 21 CFR 522.204 to reflect the approval and a current format. Approval of this supplemental NADA did not require review of additional safety or effectiveness data. Therefore, a freedom of information summary is not required. FDA has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. 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 the 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: I PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 522 continues to read as follows: I Authority: 21 U.S.C. 360b. 2. Section 522.204 is revised to read as follows: I VerDate Aug<31>2005 12:24 Nov 23, 2005 Jkt 208001 § 522.204 Boldenone. (a) Specifications. Each milliliter of solution contains 25 or 50 milligrams (mg) boldenone undecylenate. (b) Sponsor. See No. 053501 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. 0.5 mg per pound body weight by intramuscular injection. Treatment may be repeated at 3-week intervals. (2) Indications for use. As an aid for treating debilitated horses when an improvement in weight, hair coat, or general physical condition is desired. (3) Limitations. Do not administer to horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Dated: November 15, 2005. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 05–23295 Filed 11–23–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 522 and 556 New Animal Drugs; Flunixin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The supplemental NADA provides for the veterinary prescription use of flunixin meglumine solution by intramuscular injection for the control of pyrexia associated with swine respiratory disease. DATES: This rule is effective November 25, 2005. FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for Veterinary Medicine (HFV–130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.gov. SUPPLEMENTARY INFORMATION: ScheringPlough Animal Health Corp., 1095 Morris Ave., Union, NJ 07083, filed a supplement to NADA 101–479 that provides for the veterinary prescription use of BANAMINE-S (flunixin meglumine) Injectable Solution by intramuscular injection for the control PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 of pyrexia associated with swine respiratory disease. The supplemental NADA is approved as of November 1, 2005, and the regulations are amended in 21 CFR 522.970 and 556.286 to reflect the approval. The basis of approval is discussed in the freedom of information summary. In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval qualifies for 3 years of marketing exclusivity beginning November 1, 2005. FDA has determined under § 25.33(d)(5) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. 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 522 Animal drugs. 21 CFR Part 556 Animal drugs, Foods. 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 522 and 556 are amended as follows: I PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 522 continues to read as follows: I Authority: 21 U.S.C. 360b. 2. Section 522.970 is amended by adding paragraph (e)(3) to read as follows: I § 522.970 Flunixin. * * E:\FR\FM\25NOR1.SGM * 25NOR1 * *

Agencies

[Federal Register Volume 70, Number 226 (Friday, November 25, 2005)]
[Rules and Regulations]
[Pages 70997-70998]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-23295]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Boldenone

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a supplemental new animal drug 
application (NADA) filed by Fort Dodge Animal Health. The supplemental 
NADA provides for

[[Page 70998]]

revised labeling for the veterinary prescription use of injectable 
boldenone solution in horses.

DATES: This rule is effective November 25, 2005.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7543, e-mail: 
melanie.berson@fda.gov.

SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, A Division of 
Wyeth Holdings Corp., P.O. Box 1339, Fort Dodge, IA 50501, filed a 
supplement to NADA 34-705 that provides for veterinary prescription use 
of EQUIPOISE (boldenone undecylenate) by injection in horses. The 
supplemental NADA provides for a revised indication and food safety 
warning on labeling. The supplemental NADA is approved as of October 7, 
2005, and the regulations are amended in 21 CFR 522.204 to reflect the 
approval and a current format.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data. Therefore, a freedom of 
information summary is not required.
    FDA has determined under 21 CFR 25.33(a)(1) that this action is of 
a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.
    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 the 
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.

0
2. Section 522.204 is revised to read as follows:


Sec.  522.204  Boldenone.

    (a) Specifications. Each milliliter of solution contains 25 or 50 
milligrams (mg) boldenone undecylenate.
    (b) Sponsor. See No. 053501 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. 0.5 mg per pound body 
weight by intramuscular injection. Treatment may be repeated at 3-week 
intervals.
    (2) Indications for use. As an aid for treating debilitated horses 
when an improvement in weight, hair coat, or general physical condition 
is desired.
    (3) Limitations. Do not administer to horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

    Dated: November 15, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 05-23295 Filed 11-23-05; 8:45 am]
BILLING CODE 4160-01-S

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.