Source: https://de.scribd.com/document/2831150/Rule-Animal-drugs-feeds-and-related-products-Boldenone
Timestamp: 2019-12-08 16:18:13
Document Index: 165782111

Matched Legal Cases: ['art 510', 'art 510', '§ 510', 'art 510', 'ART 510', 'art 510', '§ 510', '§ 510', '§ 510', 'art 510', 'art 522', 'art 510', 'ART 510', 'art 510', '§ 522', '§ 510', '§ 25', 'arts 522', 'art 522', 'art 556', 'art 522', 'arts 522', 'ART 522', 'art 522', 'ART 522', 'art 522', 'art 522', '§ 522']

Rule: Animal drugs, feeds, and related products: Boldenone | Food And Drug Administration | Prescription Drugs
Rule: Animal drugs, feeds, and related products: Boldenone, 70997-70998 [05-23295] Food and Drug Administration
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Food Packaging and Food Safety Modernization Act 14
226 / Friday, November 25, 2005 / Rules and Regulations 70997
Therefore, it is not subject to the DEPARTMENT OF HEALTH AND Authority: 21 U.S.C. 321, 331, 351, 352,
congressional review requirements in 5 HUMAN SERVICES 353, 360b, 371, 379e.
U.S.C. 801–808. ■ 2. Section 510.600 is amended in the
Food and Drug Administration table in paragraph (c)(1) by removing
List of Subjects in 21 CFR Part 510 the entries for ‘‘Phoenix Pharmaceutical,
21 CFR Part 510 Inc.’’ and ‘‘Phoenix Scientific, Inc.’’, and
by alphabetically adding a new entry for
procedure, Animal drugs, Labeling, New Animal Drugs; Change of ‘‘IVX Animal Health, Inc.’’; and in the
Reporting and recordkeeping Sponsor’s Name table in paragraph (c)(2) by removing
requirements. the entry for ‘‘057319’’ and by revising
■ Therefore, under the Federal Food, HHS. the entry for ‘‘059130’’ to read as
Drug and Cosmetic Act and under ACTION: Final rule. follows:
authority delegated to the Commissioner § 510.600 Names, addresses, and drug
of Food and Drugs and redelegated to SUMMARY: The Food and Drug
labeler codes of sponsors of approved
the Center for Veterinary Medicine, 21 Administration (FDA) is amending the applications.
CFR part 510 is amended as follows: animal drug regulations to reflect a
change of sponsor’s name from Phoenix * * * * *
Scientific, Inc., to IVX Animal Health, (c) * * *
PART 510—NEW ANIMAL DRUGS (1) * * *
Inc. In order to improve the accuracy of
■ 1. The authority citation for 21 CFR the regulations, erroneous entries for Drug labeler
Phoenix Pharmaceutical, Inc., are also Firm name and address
part 510 continues to read as follows: code
being removed at this time.
Authority: 21 U.S.C. 321, 331, 351, 352, DATES: This rule is effective November * * * * *
353, 360b, 371, 379e. 25, 2005. IVX Animal Health, Inc., 059130
3915 South 48th Street
■ 2. Section 510.600 is amended in the FOR FURTHER INFORMATION CONTACT:
Ter., St. Joseph, MO
table in paragraph (c)(1) by revising the David R. Newkirk, Center for Veterinary 64503.
entry for ‘‘Schering-Plough Animal Medicine (HFV–100), Food and Drug * * * * *
Health Corp.’’; and in the table in Administration, 7500 Standish Pl.,
paragraph (c)(2) by revising the entry for Rockville, MD 20855, 301–827–6967, e- (2) * * *
‘‘000061’’ to read as follows. mail: david.newkirk@fda.gov.
SUPPLEMENTARY INFORMATION: Phoenix Drug labeler Firm name and address
§ 510.600 Names, addresses, and drug Scientific, Inc., 3915 South 48th Street code
labeler codes of sponsors of approved Ter., St. Joseph, MO 64503, has
applications. * * * * *
informed FDA that it has changed its 059130 IVX Animal Health, Inc.,
* * * * * name to IVX Animal Health, Inc. 3915 South 48th Street
Accordingly, the agency is amending Ter., St. Joseph, MO
the regulations in § 510.600 (21 CFR 64503
(1) * * * 510.600) to reflect the change. * * * * *
In addition, FDA has noticed that
Drug labeler Phoenix Pharmaceutical, Inc., is no
Firm name and address Dated: November 15, 2005.
code longer a sponsor of an approved new Steven D. Vaughn,
animal drug application. At this time,
* * * * * Director, Office of New Animal Drug
§ 510.600 is amended to remove entries Evaluation, Center for Veterinary Medicine.
Schering-Plough Animal 000061
Health Corp., 556 Morris
for this sponsor. This action is being
[FR Doc. 05–23297 Filed 11–23–05; 8:45 am]
Ave., Summit, NJ 07901. 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
(2) * * * it is a rule of ‘‘particular applicability.’’ DEPARTMENT OF HEALTH AND
Therefore, it is not subject to the HUMAN SERVICES
Drug labeler congressional review requirements in 5
Firm name and address Food and Drug Administration
U.S.C. 801–808.
* * * * * List of Subjects in 21 CFR Part 510 21 CFR Part 522
000061 Schering-Plough Animal
Health Corp., 556 Morris Administrative practice and Implantation or Injectable Dosage
Ave., Summit, NJ 07901 procedure, Animal drugs, Labeling, Form New Animal Drugs; Boldenone
* * * * * Reporting and recordkeeping
requirements. AGENCY: Food and Drug Administration,
■ Therefore, under the Federal Food, HHS.
Dated: November 15, 2005. ACTION: Final rule.
Drug, and Cosmetic Act and under
Steven D. Vaughn, authority delegated to the Commissioner
Director, Office of New Animal Drug SUMMARY: The Food and Drug
of Food and Drugs and redelegated to
Evaluation, Center for Veterinary Medicine. Administration (FDA) is amending the
the Center for Veterinary Medicine, 21
[FR Doc. 05–23296 Filed 11–23–05; 8:45 am] animal drug regulations to reflect
CFR part 510 is amended as follows:
approval of a supplemental new animal
PART 510—NEW ANIMAL DRUGS drug application (NADA) filed by Fort
Dodge Animal Health. The
■ 1. The authority citation for 21 CFR supplemental NADA provides for
part 510 continues to read as follows:
VerDate Aug<31>2005 12:24 Nov 23, 2005 Jkt 208001 PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 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 § 522.204 Boldenone. of pyrexia associated with swine
prescription use of injectable boldenone (a) Specifications. Each milliliter of respiratory disease. The supplemental
solution in horses. solution contains 25 or 50 milligrams NADA is approved as of November 1,
(mg) boldenone undecylenate. 2005, and the regulations are amended
DATES: This rule is effective November
(b) Sponsor. See No. 053501 in in 21 CFR 522.970 and 556.286 to reflect
§ 510.600(c) of this chapter. the approval. The basis of approval is
FOR FURTHER INFORMATION CONTACT: (c) Conditions of use in horses—(1) discussed in the freedom of information
Melanie R. Berson, Center for Veterinary Amount. 0.5 mg per pound body weight summary.
Medicine (HFV–110), Food and Drug by intramuscular injection. Treatment In accordance with the freedom of
Administration, 7500 Standish Pl., may be repeated at 3-week intervals. information provisions of 21 CFR part
Rockville, MD 20855, 301–827–7543, e- (2) Indications for use. As an aid for 20 and 21 CFR 514.11(e)(2)(ii), a
mail: melanie.berson@fda.gov. treating debilitated horses when an summary of safety and effectiveness
improvement in weight, hair coat, or data and information submitted to
SUPPLEMENTARY INFORMATION: Fort general physical condition is desired. support approval of this application
Dodge Animal Health, A Division of (3) Limitations. Do not administer to may be seen in the Division of Dockets
Wyeth Holdings Corp., P.O. Box 1339, horses intended for human Management (HFA–305), Food and Drug
Fort Dodge, IA 50501, filed a consumption. Federal law restricts this Administration, 5630 Fishers Lane, rm.
supplement to NADA 34–705 that drug to use by or on the order of a 1061, Rockville, MD 20852, between 9
provides for veterinary prescription use licensed veterinarian. a.m. and 4 p.m., Monday through
of EQUIPOISE (boldenone Friday.
undecylenate) by injection in horses. Under section 512(c)(2)(F)(iii) of the
The supplemental NADA provides for a Steven D. Vaughn,
revised indication and food safety Director, Office of New Animal Drug (the act) (21 U.S.C. 360b(c)(2)(F)(iii)),
warning on labeling. The supplemental Evaluation, Center for Veterinary Medicine.
this supplemental approval qualifies for
NADA is approved as of October 7, [FR Doc. 05–23295 Filed 11–23–05; 8:45 am] 3 years of marketing exclusivity
2005, and the regulations are amended BILLING CODE 4160–01–S beginning November 1, 2005.
in 21 CFR 522.204 to reflect the FDA has determined under
approval and a current format. § 25.33(d)(5) that this action is of a type
DEPARTMENT OF HEALTH AND that does not individually or
Approval of this supplemental NADA HUMAN SERVICES
did not require review of additional cumulatively have a significant effect on
safety or effectiveness data. Therefore, a Food and Drug Administration the human environment. Therefore,
freedom of information summary is not neither an environmental assessment
required. 21 CFR Parts 522 and 556 nor an environmental impact statement
FDA has determined under 21 CFR
New Animal Drugs; Flunixin This rule does not meet the definition
25.33(a)(1) that this action is of a type
that does not individually or AGENCY: Food and Drug Administration, it is a rule of ‘‘particular applicability.’’
cumulatively have a significant effect on HHS. Therefore, it is not subject to the
the human environment. Therefore,
ACTION: Final rule. congressional review requirements in 5
neither an environmental assessment
nor an environmental impact statement SUMMARY: The Food and Drug
is required. Administration (FDA) is amending the List of Subjects
This rule does not meet the definition animal drug regulations to reflect 21 CFR Part 522
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because approval of a supplemental new animal
it is a rule of ‘‘particular applicability.’’ drug application (NADA) filed by Animal drugs.
Therefore, it is not subject to the Schering-Plough Animal Health Corp. 21 CFR Part 556
congressional review requirements in 5 The supplemental NADA provides for
the veterinary prescription use of Animal drugs, Foods.
flunixin meglumine solution by ■ Therefore, under the Federal Food,
List of Subjects in 21 CFR Part 522 intramuscular injection for the control Drug, and Cosmetic Act and under
of pyrexia associated with swine authority delegated to the Commissioner
Animal drugs. of Food and Drugs and redelegated to
■ Therefore, under the Federal Food, the Center for Veterinary Medicine, 21
Drug, and Cosmetic Act and under the CFR parts 522 and 556 are amended as
authority delegated to the Commissioner follows:
FOR FURTHER INFORMATION CONTACT: Joan
C. Gotthardt, Center for Veterinary PART 522—IMPLANTATION OR
Medicine (HFV–130), Food and Drug INJECTABLE DOSAGE FORM NEW
CFR part 522 is amended as follows:
Administration, 7500 Standish Pl., ANIMAL DRUGS
PART 522—IMPLANTATION OR Rockville, MD 20855, 301–827–7571, e-
INJECTABLE DOSAGE FORM NEW mail: joan.gotthardt@fda.gov. ■ 1. The authority citation for 21 CFR
ANIMAL DRUGS SUPPLEMENTARY INFORMATION: Schering- part 522 continues to read as follows:
Plough Animal Health Corp., 1095 Authority: 21 U.S.C. 360b.
■ 1. The authority citation for 21 CFR Morris Ave., Union, NJ 07083, filed a ■ 2. Section 522.970 is amended by
part 522 continues to read as follows: supplement to NADA 101–479 that adding paragraph (e)(3) to read as
provides for the veterinary prescription follows:
use of BANAMINE-S (flunixin
■ 2. Section 522.204 is revised to read meglumine) Injectable Solution by § 522.970 Flunixin.
as follows: intramuscular injection for the control * * * * *
VerDate Aug<31>2005 12:24 Nov 23, 2005 Jkt 208001 PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 E:\FR\FM\25NOR1.SGM 25NOR1
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