Oral Dosage Form New Animal Drugs; Ivermectin Paste, 67298 [E6-19616]

Download as PDF 67298 Federal Register / Vol. 71, No. 224 / Tuesday, November 21, 2006 / Rules and Regulations airspace on users of airspace in the vicinity of Cedar Springs, GA, notice and public procedure under 5 U.S.C. 553(b) are not necessary. Designations for Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in paragraph 6005 of FAA Order 7400.9P, dated September 16, 2006, and effective September 16, 2006, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order. September 16, 2006, is amended as follows: Paragraph 6005 Class E Airspace Areas Extending Upward from 700 feet or More Above the Surface on the Earth. * * * * * ASO GA E 5 Cedar Springs, GA [Remove] Cedar Springs, Georgia-Pacific Airport, GA (Lat. 31°08′26″ N, long. 85°02′48″ W) That airspace extending upward from 700 feet or more above the surface of the earth within a 6.4-mile radius of Georgia-Pacific Airport. The Rule * This amendment to part 71 of the Federal Aviation Regulations (14 CFR part 71) removes Class E5 airspace at Cedar Springs, GA. The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally currently. If, therefore, (1) Is not a ‘‘significant regulatory action’’ under Executive Order 12866; (2) is not a ‘‘significant rule’’ under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule will not have a significant economic impact on a substantial number of small entities under the criteria of the regulatory Flexibility Act. Issued in College Park, Georgia, on October 26, 2006. Mark D. Ward, Group Manager, System Support, Eastern Service Center. [FR Doc. 06–9231 Filed 11–21–06; 8:45 am] List of Subjects in 14 CFR Part 71 Airspace, Incorporation by reference, Navigation (air). Adoption of the Amendment In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows: I PART 71—DESIGNATION OF CLASS A, CLASS B, CLASS C, CLASS D AND CLASS E AIRSPACE AREAS; AIRWAYS; AND REPORTING POINTS 1. The authority citation for 14 CFR part 71 continues to read as follows: I cprice-sewell on PROD1PC66 with RULES Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; EO 10854, 24 FR 9565, 3 CFR, 1959– 1963 Comp., p. 389; 14 CFR 11.69. § 71.1 [Amended] 2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation Administration Order 7400.9P, Airspace Designations and Reporting Points, dated September 16, 2006, and effective I VerDate Aug<31>2005 14:15 Nov 20, 2006 Jkt 211001 * * * * BILLING CODE 4910–13–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 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. 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 520 Oral Dosage Form New Animal Drugs; Ivermectin Paste 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 abbreviated new animal drug application (ANADA) filed by Virbac AH, Inc. The supplemental ANADA provides revised labeling for oral use of generic ivermectin paste in horses that conforms to the pioneer product label. DATES: This rule is effective November 21, 2006. FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for Veterinary Medicine (HFV–104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–0169, email: john.harshman@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137, filed a supplement to ANADA 200–320 for EQUELL (ivermectin) Paste 1.87% that provides revised labeling for oral use of generic ivermectin paste in horses that conforms to the pioneer product label. The supplemental application is approved as of October 24, 2006, and 21 CFR 520.1192 is amended to reflect the approval. The basis of approval is PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 Animal drugs. 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 520 is amended as follows: I PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: I Authority: 21 U.S.C. 360b. § 520.1192 [Amended] 2. In § 520.1192, in paragraph (b)(2) remove ‘‘Nos. 051311 and’’ and add in its place ‘‘No.’’; and in paragraph (b)(4) remove ‘‘No.’’ and add in its place ‘‘Nos. 051311 and’’. I Dated: November 3, 2006. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. E6–19616 Filed 11–20–06; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\21NOR1.SGM 21NOR1

Agencies

[Federal Register Volume 71, Number 224 (Tuesday, November 21, 2006)]
[Rules and Regulations]
[Page 67298]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-19616]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Ivermectin Paste

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a supplemental abbreviated new 
animal drug application (ANADA) filed by Virbac AH, Inc. The 
supplemental ANADA provides revised labeling for oral use of generic 
ivermectin paste in horses that conforms to the pioneer product label.

DATES: This rule is effective November 21, 2006.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Virbac AH, Inc., 3200 Meacham Blvd., Ft. 
Worth, TX 76137, filed a supplement to ANADA 200-320 for EQUELL 
(ivermectin) Paste 1.87% that provides revised labeling for oral use of 
generic ivermectin paste in horses that conforms to the pioneer product 
label. The supplemental application is approved as of October 24, 2006, 
and 21 CFR 520.1192 is amended 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.
    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 520

    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 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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


Sec.  520.1192  [Amended]

0
2. In Sec.  520.1192, in paragraph (b)(2) remove ``Nos. 051311 and'' 
and add in its place ``No.''; and in paragraph (b)(4) remove ``No.'' 
and add in its place ``Nos. 051311 and''.

    Dated: November 3, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E6-19616 Filed 11-20-06; 8:45 am]
BILLING CODE 4160-01-S

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