Oral Dosage Form New Animal Drugs; Ivermectin Paste, 40010 [E6-11073]

Download as PDF 40010 Federal Register / Vol. 71, No. 135 / Friday, July 14, 2006 / Rules and Regulations approved by the FAA in accordance with § 21.305(d) or Technical Standard Order C–100b, or a later version. (D) Except as provided in § 125.211(b)(2)(C)(3) and § 125.211(b)(2)(C)(4), booster-type child restraint systems (as defined in Federal Motor Vehicle Safety Standard No. 213 (49 CFR 571.213)), vest- and harnesstype child restraint systems, and lap held child restraints are not approved for use in aircraft; and (c) * * * (1) Except as provided in § 125.211(b)(2)(ii)(C)(3) and § 125.211(b)(2)(ii)(C)(4), no certificate holder may permit a child, in an aircraft, to occupy a booster-type child restraint system, a vest-type child restraint system, a harness-type child restraint system, or a lap held child restraint system during take off, landing, and movement on the surface. * * * * * PART 135—OPERATING REQUIREMENTS: COMMUTER AND ON-DEMAND OPERATIONS Authority: 49 U.S.C. 106(g), 44113, 44701– 44702, 44705, 44709, 44711–44713, 44715– 44717, 44722. 8. Amend § 135.128 by revising paragraphs (a)(2)(ii)(C)(3), (a)(2)(ii)(D), and (b)(1), and adding pargraph (a)(2)(ii)(C)(4) to read as follows: I cprice-sewell on PROD1PC66 with RULES § 135.128 Use of safety belts and child restraint systems. (a) * * * (2) * * * (ii) * * * (C) * * * (3) That the seat or child restraint device furnished by the certificate holder was approved by the FAA through Type Certificate or Supplemental Type Certificate. (4) That the seat or child restraint device furnished by the certificate holder, or one of the persons described in paragraph (b)(2)(i) of this section, was approved by the FAA in accordance with § 21.305(d) or Technical Standard Order C–100b, or a later version. (D) Except as provided in § 135.128(a)(2)(C)(3) and § 135.128(a)(2)(C)(4), booster-type child restraint systems (as defined in Federal Motor Vehicle Safety Standard No. 213 (49 CFR 571.213)), vest- and harnesstype child restraint systems, and lap held child restraints are not approved for use in aircraft; and (b) * * * (1) Except as provided in § 135.128 (a)(2)(ii)(C)(3) and § 135.128 Jkt 208001 BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Ivermectin Paste 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 520 Food and Drug Administration, Animal drugs. HHS. 7. The authority citation for part 135 continues to read as follows: 15:14 Jul 13, 2006 Issued in Washington, DC, on July 7, 2006. Marion C. Blakey, Administrator. [FR Doc. E6–11112 Filed 7–13–06; 8:45 am] AGENCY: I VerDate Aug<31>2005 (a)(2)(ii)(C)(4), no certificate holder may permit a child, in an aircraft, to occupy a booster-type child restraint system, a vest-type child restraint system, a harness-type child restraint system, or a lap held child restraint system during take off, landing, and movement on the surface. * * * * * ACTION: 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 Med-Pharmex, Inc. The ANADA provides for oral use of ivermectin paste in horses for treatment and control of various internal parasites or parasitic conditions. DATES: PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: I This rule is effective July 14, Authority: 21 U.S.C. 360b. 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: MedPharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767–1861, filed ANADA 200–390 for oral use of Ivermectin Paste 1.87% in horses for the treatment and control of various species of internal parasites or parasitic conditions. Med-Pharmex’s Ivermectin Paste 1.87% is approved as a generic copy of Merial Ltd.’s EQVALAN Paste, approved under NADA 134–314. ANADA 200–390 is approved as of June 20, 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 PO 00000 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 Final rule. Frm 00008 Fmt 4700 Sfmt 4700 2. In § 520.1192, add paragraph (b)(4) to read as follows: I § 520.1192 Ivermectin paste. * * * * * (b) * * * (4) No. 054925 for use of a 1.87 percent paste as in paragraphs (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this section. * * * * * Dated: June 30, 2006. Catherine P. Beck, Acting Director, Center for Veterinary Medicine. [FR Doc. E6–11073 Filed 7–13–06; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\14JYR1.SGM 14JYR1

Agencies

[Federal Register Volume 71, Number 135 (Friday, July 14, 2006)]
[Rules and Regulations]
[Page 40010]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-11073]


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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 an abbreviated new animal drug 
application (ANADA) filed by Med-Pharmex, Inc. The ANADA provides for 
oral use of ivermectin paste in horses for treatment and control of 
various internal parasites or parasitic conditions.

DATES:  This rule is effective July 14, 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: Med-Pharmex, Inc., 2727 Thompson Creek Rd., 
Pomona, CA 91767-1861, filed ANADA 200-390 for oral use of Ivermectin 
Paste 1.87% in horses for the treatment and control of various species 
of internal parasites or parasitic conditions. Med-Pharmex's Ivermectin 
Paste 1.87% is approved as a generic copy of Merial Ltd.'s EQVALAN 
Paste, approved under NADA 134-314. ANADA 200-390 is approved as of 
June 20, 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.
    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 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.

0
2. In Sec.  520.1192, add paragraph (b)(4) to read as follows:


Sec.  520.1192   Ivermectin paste.

* * * * *
    (b) * * *
    (4) No. 054925 for use of a 1.87 percent paste as in paragraphs 
(e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this section.
* * * * *

    Dated: June 30, 2006.
Catherine P. Beck,
Acting Director, Center for Veterinary Medicine.
[FR Doc. E6-11073 Filed 7-13-06; 8:45 am]
BILLING CODE 4160-01-S

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