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Federal Register / Vol. 70, No.

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
Administrative practice 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
AGENCY: Food and Drug Administration,
■ 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
(c) * * *
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
BILLING CODE 4160–01–S
* * * * * 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
code
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
BILLING CODE 4160–01–S
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:

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