Implantation or Injectable Dosage Form New Animal Drugs; Ivermectin, 62771 [E7-21839]

Download as PDF Federal Register / Vol. 72, No. 215 / Wednesday, November 7, 2007 / Rules and Regulations Dated: October 23, 2007. Christopher A. Padilla, Assistant Secretary for Export Administration. [FR Doc. E7–21840 Filed 11–6–07; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Ivermectin pwalker on PROD1PC71 with RULES DEPARTMENT OF THE TREASURY SUMMARY: This document contains temporary Income Tax Regulations relating to a United States taxpayer’s obligation under section 905(c) of the Internal Revenue Code (Code) to notify the IRS of a foreign tax redetermination, which is a change in the taxpayer’s foreign tax liability that may affect the taxpayer’s foreign tax credit. This document also contains temporary Procedure and Administration Regulations under section 6689 relating to the civil penalty for failure to notify the IRS of a foreign tax redetermination as required under section 905(c). These temporary regulations affect taxpayers that have paid foreign taxes which have been redetermined and provide guidance needed to comply with statutory changes made to the applicable law by the Taxpayer Relief Act of 1997 and the American Jobs Creation Act of 2004. The text of the temporary regulations also serves as the text of the proposed regulations (REG– 209020–86) set forth in the notice of proposed rulemaking on this subject published elsewhere in this issue of the Federal Register. DATES: Effective Date: These regulations are effective on November 7, 2007. Applicability Dates: For dates of applicability, see §§ 1.905–3T(a), 1.905– 4T(f), and 301.6689–1T(e). These regulations generally apply to foreign tax redeterminations occurring in taxable years of United States taxpayers beginning on or after November 7, 2007, where the foreign tax redetermination affects the amount of foreign taxes paid or accrued by a United States taxpayer. Where the redetermination of foreign tax paid or accrued by a foreign corporation affects the amount of foreign taxes deemed paid under section 902 or 960, this section applies to foreign tax redeterminations occurring in a taxable year of a foreign corporation which ends with or within the taxable year of the domestic corporate shareholder beginning on or after November 7, 2007. Section 1.905–3T(b) generally applies to taxes paid or Animal drugs. Food and Drug Administration, 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 522 is amended as follows: I HHS. ACTION: 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 522 BILLING CODE 3510–33–P AGENCY: 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 Norbrook Laboratories, Ltd. The supplemental ANADA adds claims for persistent effectiveness against various species of external and internal parasites when cattle are treated with a one percent ivermectin solution by subcutaneous injection. DATES: This rule is effective November 7, 2007. 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: Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, Northern Ireland, filed a supplement to ANADA 200–437 that provides for use of NOROMECTIN (ivermectin) Injection for Cattle and Swine. The supplemental ANADA adds claims for persistent effectiveness against various species of external and internal parasites of cattle. The supplemental ANADA is approved as of October 5, 2007, and the regulations are amended in 21 CFR 522.1192 to reflect the approval. 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. VerDate Aug<31>2005 15:56 Nov 06, 2007 Jkt 214001 62771 PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 522 continues to read as follows: I Authority: 21 U.S.C. 360b. 2. In § 522.1192, revise paragraph (b)(2) and add paragraph (b)(3) to read as follows: I § 522.1192 Ivermectin. * * * * * (b) * * * (2) No. 055529 for use of the product described in paragraph (a)(2) of this section as in paragraphs (e)(2)(i), (e)(2)(ii)(A), (e)(2)(ii)(C), (e)(2)(iii), (e)(3), (e)(4) and (e)(5) of this section. (3) No. 059130 for use of the product described in paragraph (a)(2) of this section as in paragraphs (e)(2)(i), (e)(2)(ii)(A), (e)(2)(ii)(B), (e)(2)(iii), (e)(3), (e)(4), and (e)(5) of this section. * * * * * Dated: October 26, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7–21839 Filed 11–6–07; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 Internal Revenue Service 26 CFR Parts 1 and 301 [TD 9362] RIN 1545–BG23 Foreign Tax Credit: Notification of Foreign Tax Redeterminations Internal Revenue Service (IRS), Treasury. ACTION: Temporary regulations. AGENCY: E:\FR\FM\07NOR1.SGM 07NOR1

Agencies

[Federal Register Volume 72, Number 215 (Wednesday, November 7, 2007)]
[Rules and Regulations]
[Page 62771]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-21839]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Ivermectin

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 Norbrook Laboratories, Ltd. 
The supplemental ANADA adds claims for persistent effectiveness against 
various species of external and internal parasites when cattle are 
treated with a one percent ivermectin solution by subcutaneous 
injection.

DATES: This rule is effective November 7, 2007.

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: Norbrook Laboratories, Ltd., Station Works, 
Newry BT35 6JP, Northern Ireland, filed a supplement to ANADA 200-437 
that provides for use of NOROMECTIN (ivermectin) Injection for Cattle 
and Swine. The supplemental ANADA adds claims for persistent 
effectiveness against various species of external and internal 
parasites of cattle. The supplemental ANADA is approved as of October 
5, 2007, and the regulations are amended in 21 CFR 522.1192 to reflect 
the approval.
    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 522

    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 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
2. In Sec.  522.1192, revise paragraph (b)(2) and add paragraph (b)(3) 
to read as follows:


Sec.  522.1192  Ivermectin.

* * * * *
    (b) * * *
    (2) No. 055529 for use of the product described in paragraph (a)(2) 
of this section as in paragraphs (e)(2)(i), (e)(2)(ii)(A), 
(e)(2)(ii)(C), (e)(2)(iii), (e)(3), (e)(4) and (e)(5) of this section.
    (3) No. 059130 for use of the product described in paragraph (a)(2) 
of this section as in paragraphs (e)(2)(i), (e)(2)(ii)(A), 
(e)(2)(ii)(B), (e)(2)(iii), (e)(3), (e)(4), and (e)(5) of this section.
* * * * *

    Dated: October 26, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-21839 Filed 11-6-07; 8:45 am]
BILLING CODE 4160-01-S

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