Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin Sulfate, Betamethasone Valerate, Clotrimazole Ointment, 38261 [E6-10496]

Download as PDF Federal Register / Vol. 71, No. 129 / Thursday, July 6, 2006 / Rules and Regulations million; freight forwarding firms are small if their annual receipts are less than $6 million, and deep sea freight transport firms are small if they have not more than 500 workers. According to the 2002 Economic Census, there were 9,177 trucking firms, 5,840 freight forwarders, and 383 deep sea freight transport companies. Over 99 percent of trucking firms, 90 percent freight forwarders, and 70 percent of deep sea freight transport firms are considered to be small. Although the majority of these establishments are small entities, the effect of this rule will be negligible. Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities. Done in Washington, DC, this 29th day of June 2006. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E6–10555 Filed 7–5–06; 8:45 am] Executive Order 12988 HHS. This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule. Paperwork Reduction Act This rule contains no information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). List of Subjects in 9 CFR Part 94 Animal diseases, Imports, Livestock, Meat and meat products, Milk, Poultry and poultry products, Reporting and recordkeeping requirements. I Accordingly, we are amending 9 CFR part 94 as follows: PART 94—RINDERPEST, FOOT-ANDMOUTH DISEASE, FOWL PEST (FOWL PLAGUE), EXOTIC NEWCASTLE DISEASE, AFRICAN SWINE FEVER, CLASSICAL SWINE FEVER, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED AND RESTRICTED IMPORTATIONS 1. The authority citation for part 94 continues to read as follows: I wwhite on PROD1PC61 with RULES Authority: 7 U.S.C. 450, 7701–7772, 7781– 7786, and 8301–8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4. § 94.6 [Amended] 2. In § 94.6, paragraph (a)(2) is amended by adding the word ‘‘Denmark,’’ before the word ‘‘Fiji.’’ I VerDate Aug<31>2005 19:48 Jul 05, 2006 Jkt 208001 BILLING CODE 3410–34–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 524 Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin Sulfate, Betamethasone Valerate, Clotrimazole Ointment AGENCY: ACTION: Food and Drug Administration, Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Altana Inc. The ANADA provides for veterinary prescription use of gentamicin sulfate, betamethasone valerate, clotrimazole ointment for the treatment of canine otitis externa. DATES: This rule is effective July 6, 2006. 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. The agency 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 524 Animal drugs. 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 524 is amended as follows: PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 524 continues to read as follows: I FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary Medicine (HFV–104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–0223, email: daniel.benz@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Altana Inc., 60 Baylis Rd., Melville, NY 11747, filed ANADA 200–283 that provides for veterinary prescription use of VETRO– MAX (gentamicin sulfate, USP; betamethasone valerate, USP; and clotrimazole, USP, ointment) for the treatment of canine otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin. Altana Inc.’s VETRO–MAX Otic Ointment is approved as a generic copy of Schering-Plough Animal Health Corp.’s OTOMAX Ointment approved under NADA 140–896. The ANADA is approved as of June 1, 2006, and the regulations are amended in 21 CFR 524.1044g 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 PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 38261 Authority: 21 U.S.C. 360b. 2. In § 524.1044g, add paragraph (b)(4) to read as follows: I § 524.1044g Gentamicin sulfate, betamethasone valerate, clotrimazole ointment. * * * * * (b) * * * (4) No. 025463 for use of 7.5- or 15g tubes, or 215-g bottles. * * * * * Dated: June 22, 2006. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. E6–10496 Filed 7–5–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 Corporate Distributions and Adjustments CFR Correction In Title 26 of the Code of Federal Regulations, part 1 (§§ 1.301 to 1.400), E:\FR\FM\06JYR1.SGM 06JYR1

Agencies

[Federal Register Volume 71, Number 129 (Thursday, July 6, 2006)]
[Rules and Regulations]
[Page 38261]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-10496]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524


Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin 
Sulfate, Betamethasone Valerate, Clotrimazole Ointment

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 an abbreviated new animal drug 
application (ANADA) filed by Altana Inc. The ANADA provides for 
veterinary prescription use of gentamicin sulfate, betamethasone 
valerate, clotrimazole ointment for the treatment of canine otitis 
externa.

DATES: This rule is effective July 6, 2006.

FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary 
Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0223, e-mail: daniel.benz@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Altana Inc., 60 Baylis Rd., Melville, NY 
11747, filed ANADA 200-283 that provides for veterinary prescription 
use of VETRO-MAX (gentamicin sulfate, USP; betamethasone valerate, USP; 
and clotrimazole, USP, ointment) for the treatment of canine otitis 
externa associated with yeast (Malassezia pachydermatis, formerly 
Pityrosporum canis) and/or bacteria susceptible to gentamicin. Altana 
Inc.'s VETRO-MAX Otic Ointment is approved as a generic copy of 
Schering-Plough Animal Health Corp.'s OTOMAX Ointment approved under 
NADA 140-896. The ANADA is approved as of June 1, 2006, and the 
regulations are amended in 21 CFR 524.1044g 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.
    The agency 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 524

    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 524 is 
amended as follows:

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 524 continues to read as 
follows:

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

0
2. In Sec.  524.1044g, add paragraph (b)(4) to read as follows:


Sec.  524.1044g  Gentamicin sulfate, betamethasone valerate, 
clotrimazole ointment.

* * * * *
    (b) * * *
    (4) No. 025463 for use of 7.5- or 15-g tubes, or 215-g bottles.
* * * * *

    Dated: June 22, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6-10496 Filed 7-5-06; 8:45 am]
BILLING CODE 4160-01-S
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