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8290 Federal Register / Vol. 70, No.

33 / Friday, February 18, 2005 / Rules and Regulations

Authority: 21 U.S.C. 360b. basis of approval is discussed in the DEPARTMENT OF HEALTH AND
freedom of information summary. HUMAN SERVICES
§ 520.2260b [Amended]
■ 2. Section 520.2260b is amended in In accordance with the freedom of
Food and Drug Administration
paragraph (f)(1) by removing ‘‘000010’’ information provisions of 21 CFR part
and by adding in its place ‘‘059130’’. 20 and 21 CFR 514.11(e)(2)(ii), a
21 CFR Part 524
summary of safety and effectiveness
Dated: February 8, 2005.
data and information submitted to Ophthalmic and Topical Dosage Form
Steven D. Vaughn,
support approval of this application New Animal Drugs; Gentamicin
Director, Office of New Animal Drug
may be seen in the Division of Dockets Sulfate, Betamethasone Valerate,
Evaluation, Center for Veterinary Medicine.
Management (HFA–305), Food and Drug Clotrimazole Ointment; Technical
[FR Doc. 05–3178 Filed 2–17–05; 8:45 am]
Administration, 5630 Fishers Lane, rm. Amendment
BILLING CODE 4160–01–S
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through AGENCY: Food and Drug Administration,
Friday. HHS.
DEPARTMENT OF HEALTH AND Final rule; technical
ACTION:
HUMAN SERVICES The agency has determined under 21 amendment.
CFR 25.33(a)(1) that this action is of a
Food and Drug Administration type that does not individually or SUMMARY: The Food and Drug
cumulatively have a significant effect on Administration (FDA) is amending the
21 CFR Part 522 the human environment. Therefore, animal drug regulations to reflect
neither an environmental assessment approval of a supplemental abbreviated
Implantation or Injectable Dosage new animal drug application (ANADA)
nor an environmental impact statement
Form New Animal Drugs; Trenbolone filed by Phoenix Scientific, Inc. The
is required.
and Estradiol supplemental ANADA provides for a
This rule does not meet the definition
AGENCY: Food and Drug Administration, of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because new container size, a 20-gram dropper
HHS. bottle, from which gentamicin sulfate,
it is a rule of ‘‘particular applicability.’’
ACTION: Final rule. betamethasone valerate, clotrimazole
Therefore, it is not subject to the
ointment may be administered for the
SUMMARY: The Food and Drug congressional review requirements in 5
treatment of acute and chronic canine
Administration (FDA) is amending the U.S.C. 801–808.
otitis externa. The regulations are also
animal drug regulations to reflect List of Subjects in 21 CFR Part 522 being amended to correct the
approval of a supplemental abbreviated indications for use to agree with
new animal drug application (ANADA) Animal drugs. approved product labeling. This action
filed by Ivy Laboratories, Division of Ivy is being taken to improve the accuracy
■ Therefore, under the Federal Food,
Animal Health, Inc. The supplemental of the regulations.
Drug, and Cosmetic Act and under the
ANADA provides for an additional dose
authority delegated to the Commissioner DATES: This rule is effective February
of trenbolone acetate and estradiol
of Food and Drugs and redelegated to the 18, 2005.
implant for use in feedlot heifers for FOR FURTHER INFORMATION CONTACT:
increased rate of weight gain and Center for Veterinary Medicine, 21 CFR
part 522 is amended as follows: Lonnie W. Luther, Center for Veterinary
improved feed efficiency. Medicine (HFV 104), Food and Drug
DATES: This rule is effective February PART 522—IMPLANTATION OR Administration, 7519 Standish Pl.,
18, 2005. INJECTABLE DOSAGE FORM NEW Rockville, MD 20855, 301–827–8549, e-
FOR FURTHER INFORMATION CONTACT: ANIMAL DRUGS mail: lonnie.luther@fda.gov.
Lonnie W. Luther, Center for Veterinary SUPPLEMENTARY INFORMATION: Phoenix
Medicine (HFV–104), Food and Drug ■ 1. The authority citation for 21 CFR Scientific, Inc., 3915 South 48th St. Ter.,
Administration, 7519 Standish Pl., part 522 continues to read as follows: St. Joseph, MO 64503, filed a
Rockville, MD 20855, 301–827–8549, e- supplement to ANADA 200–287 for use
mail: lonnie.luther@fda.gov. Authority: 21 U.S.C. 360b.
of TRIPLEMAX (gentamicin sulfate,
SUPPLEMENTARY INFORMATION: Ivy ■ 2. Section 522.2477 is amended by U.S.P.; betamethasone valerate, U.S.P.;
Laboratories, Division of Ivy Animal revising paragraph (b)(1) to read as and clotrimazole, U.S.P. ointment) for
Health, Inc., 8857 Bond Street, Overland follows: the treatment of acute and chronic
Park, KS 66214, filed a supplement to canine otitis externa. The supplement
ANADA 200–346. The supplemental § 522.2477 Trenbolone acetate and provides for a new container size, a 20-
ANADA provides for the use of estradiol. gram dropper bottle. The supplemental
COMPONENT TE–200 (trenbolone * * * * * ANADA is approved as of January 21,
acetate and estradiol), a subcutaneous (b) * * * 2005, and the regulations are amended
implant containing 200 milligrams (mg) in 21 CFR 524.1044g to reflect the
trenbolone acetate and 20 mg estradiol (1) No. 021641 for products and uses approval. The basis of approval is
in heifers fed in confinement for described in paragraph (d) of this discussed in the freedom of information
slaughter for increased rate of weight section. summary.
gain and improved feed efficiency. Ivy * * * * * The regulations are also being
Laboratories’ COMPONENT TE–200 is Dated: February 8, 2005. amended to correct the indications for
approved as a generic copy of Intervet, use to agree with approved product
Inc.’s REVALOR–200, approved under Steven D. Vaughn,
labeling. This action is being taken to
NADA 140–992. The application is Director, Office of New Animal Drug improve the accuracy of the regulations.
approved as of January 14, 2005, and the Evaluation, Center for Veterinary Medicine. In accordance with the freedom of
regulations are amended in 21 CFR [FR Doc. 05–3107 Filed 2–17–05; 8:45 am] information provisions of 21 CFR part
522.2477 to reflect the approval. The BILLING CODE 4160–01–S 20 and 21 CFR 514.11(e)(2)(ii), a

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