Ophthalmic and Topical Dosage Form New Animal Drugs; Copper Naphthenate Solution, 38073-38074 [E6-10407]

Download as PDF Federal Register / Vol. 71, No. 128 / Wednesday, July 5, 2006 / Rules and Regulations jlentini on PROD1PC65 with RULES SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (ANADA) filed by IVX Animal Health, Inc. The ANADA provides for veterinary prescription use of griseofulvin powder orally as a systemic antifungal agent in horses. DATES: This rule is effective July 5, 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: IVX Animal Health, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503, filed ANADA 200–391 that provides for veterinary prescription use of Griseofulvin Powder Microsize, orally as a systemic antifungal agent in horses. IVX Animal Health’s Griseofulvin Powder Microsize, is approved as a generic copy of Schering-Plough Animal Health Corp.’s FULVICIN–U/F (griseofulvin) Powder approved under NADA 39–792. The ANADA is approved as of June 1, 2006, and the regulations are amended in 21 CFR 520.1100 to reflect the approval and a current format. 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. I Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner VerDate Aug<31>2005 19:23 Jul 03, 2006 Jkt 208001 of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is amended as follows: 38073 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 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. 2. Amend § 520.1100 as follows: a. Revise paragraphs (a), (b), (c), and (d)(1); I b. Remove paragraphs (d)(2) and (d)(3)(iii); and I c. Redesignate paragraphs (d)(3) introductory text, (d)(3)(i), (d)(3)(i)(a), (d)(3)(i)(b), and (d)(3)(ii) as paragraphs (d)(2) introductory text, (d)(2)(i), (d)(2)(i)(A), (d)(2)(i)(B), and (d)(2)(ii). The revisions read as follows: I I § 520.1100 Griseofulvin. (a) Specifications—(1) The powder complies with U.S.P. for griseofulvin, microsize. (2) Each bolus contains 2.5 grams griseofulvin. (3) Each tablet contains 125 or 500 milligrams griseofulvin. (b) Sponsors. See sponsors in § 510.600(c) of this chapter. (1) No. 000061 for use of products described in paragraph (a) for use as in paragraph (d) of this section. (2) No. 059130 for use of the powder described in paragraph (a)(1) for use as in paragraphs (d)(1)(i)(A) and (d)(1)(ii) of this section. (c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (d) Conditions of use—(1) Horses—(i) Amount and indications for use—(A) For equine ringworm infection caused by Trichophyton equinum or Microsporum gypseum, administer soluble powder described in paragraph (a)(1) of this section daily as a drench or as a top dressing on feed for not less than 10 days as follows: adults, 2.5 grams; yearlings, 1.25 to 2.5 grams; and foals, 1.25 grams. (B) For treating ringworm infection caused by T. equinum, administer boluses described in paragraph (a)(2) of this section daily for not less than 10 days as follows: adults, 1 bolus; yearlings, one-half to 1 bolus; and foals, one-half bolus. (ii) Limitations. Not for use in horses intended for food. * * * * * Dated: June 23, 2006. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. E6–10406 Filed 7–3–06; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 21 CFR Part 524 Ophthalmic and Topical Dosage Form New Animal Drugs; Copper Naphthenate Solution 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 new animal drug application (NADA) filed by Farnam Companies, Inc. The supplemental NADA provides for a revised food safety warning on labeling for copper naphthenate topical solution for horse and pony hooves. DATES: This rule is effective July 5, 2006. FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for Veterinary Medicine (HFV–110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–7540, e-mail: melanie.berson@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013–3928, filed a supplement to NADA 100–616 for THRUSH-XX (copper naphthenate), a solution approved for topical use on horse and pony hooves as an aid in treating thrush. The supplemental NADA provides for a revised food safety warning on the labeling. The supplemental NADA is approved as of May 30, 2006, and the regulations are amended in 21 CFR 524.463 to reflect the approval and a current format. Approval of this supplemental NADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required. The agency has determined under 21 CFR 25.33(d)(3) 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. E:\FR\FM\05JYR1.SGM 05JYR1 38074 Federal Register / Vol. 71, No. 128 / Wednesday, July 5, 2006 / Rules and Regulations 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: jlentini on PROD1PC65 with RULES I FOR FURTHER INFORMATION CONTACT: Daniel F. Heins, at (202) 622–7930 (not a toll-free number). SUPPLEMENTARY INFORMATION: Background The IRS published temporary PART 524—OPHTHALMIC AND regulations (TD 9071) in the Federal TOPICAL DOSAGE FORM NEW Register on July 9, 2003 (68 FR 40766) ANIMAL DRUGS (the temporary regulations), along with a notice of proposed rulemaking by I 1. The authority citation for 21 CFR cross-reference to the temporary part 524 continues to read as follows: regulations (REG–143679–02) (the Authority: 21 U.S.C. 360b. proposed regulations). These temporary regulations provide, notwithstanding I 2. In § 524.463, revise the section and anything to the contrary in § 1.338– paragraph (c) headings, and paragraphs 3(c)(1)(i), a section 338(h)(10) election (a) and (c)(3) to read as follows: may be made for T where P’s acquisition § 524.463 Copper naphthenate. of T stock, viewed independently, (a) Amount. The drug is a 37.5 percent constitutes a qualified stock purchase solution of copper naphthenate. and, after the stock acquisition, T merges or liquidates into P (or another * * * * * (c) Conditions of use in horses—* * * member of the affiliated group that includes P), whether or not, under * * * * * relevant provisions of law, including the (3) Limitations. Use on horses and ponies only. Avoid contact around eyes. step transaction doctrine, the acquisition of the T stock and the Do not contaminate feed. Do not use in merger or liquidation of T qualify as a horses intended for human reorganization described in section consumption. 368(a). If a section 338(h)(10) election is Dated: June 22, 2006. made in a case where the acquisition of Steven D. Vaughn, T stock followed by a merger or Director, Office of New Animal Drug liquidation of T into P qualifies as a Evaluation, Center for Veterinary Medicine. reorganization described in section [FR Doc. E6–10407 Filed 7–3–06; 8:45 am] 368(a), for all Federal tax purposes, P’s BILLING CODE 4160–01–S acquisition of T stock is treated as a qualified stock purchase and is not treated as part of a reorganization described in section 368(a). For rules DEPARTMENT OF THE TREASURY about the operation of the step Internal Revenue Service transaction doctrine and the relationship between section 338 and 26 CFR Part 1 the reorganization provisions when a section 338 election is not made, see [TD 9271] § 1.338–3(d). See also Rev. Rul. 90–95 RIN 1545–BB68 (1990–2 CB 67). See § 601.601(d)(2). No public hearing regarding the Effect of Elections in Certain Multiproposed regulations was requested or Step Transactions held. The IRS received written and electronic comments regarding the AGENCY: Internal Revenue Service (IRS), proposed regulations. After Treasury. consideration of the comments, the ACTION: Final regulations. proposed regulations are adopted by this Treasury decision. The most SUMMARY: This document contains final significant comments received with regulations that give effect to section respect to the proposed regulations are 338(h)(10) elections in certain multidiscussed in this preamble. step transactions. These final regulations are necessary in order to Explanation of Provisions provide taxpayers with guidance A. Section 338(g) Elections regarding the validity of certain elections made under section Some commentators recommend that 338(h)(10). These final regulations affect the final regulations allow section corporations and their shareholders. 338(g) elections, as well as section 338(h)(10) elections, to turn off the step DATES: Effective Date: These regulations transaction doctrine in a multi-step are effective July 5, 2006. transaction that constitutes a Applicability Date: For dates of reorganization under section 368(a). applicability, see § 1.338(h)(10)–1(h) of Although a section 338(g) election is these regulations. VerDate Aug<31>2005 19:23 Jul 03, 2006 Jkt 208001 PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 made by the purchasing corporation and the shareholders of the target corporation (target) do not consent to the election, one commentator states that the IRS will not be subject to whipsaw if the IRS provides regulations requiring the shareholders of the acquired corporation to treat the transaction consistently with the acquiring corporation’s election, rather than as a reorganization under section 368(a). The final regulations do not adopt the commentators’ recommendation, and continue to turn off the step transaction doctrine only in the case of section 338(h)(10) elections. Extending the final regulations to section 338(g) elections would allow the acquiring corporation to unilaterally elect to treat the transaction, for all parties, as other than a reorganization under section 368(a). In light of potential whipsaw and other concerns, the final regulations continue to apply only to section 338(h)(10) elections, not section 338(g) elections. B. Corporate Purchaser Requirement One commentator suggests that § 1.338–3(b) be amended to clarify under what circumstances a corporation will be considered, for tax purposes, to have purchased the stock of target pursuant to section 338(d)(3). Under § 1.338–3(b), an individual cannot make a qualified stock purchase of target. If an individual forms a corporation (new P) to acquire target stock, new P can make a qualified stock purchase of target if new P is considered, for tax purposes, to purchase the target stock. Facts that may indicate that new P does not purchase the target stock include new P’s merging downstream into target, liquidating, or otherwise disposing of the target stock following the purported qualified stock purchase. The IRS and Treasury Department are continuing to study whether any amendments to the portion of the regulations under section 338 related to the corporate purchaser requirement are appropriate. Special Analyses It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It is hereby certified that these regulations do not have a significant economic impact on a substantial amount of small entities. The number of corporations affected is limited because section 338(h)(10) elections are made only in extraordinary circumstances, the sale of a business. Furthermore, these E:\FR\FM\05JYR1.SGM 05JYR1

Agencies

[Federal Register Volume 71, Number 128 (Wednesday, July 5, 2006)]
[Rules and Regulations]
[Pages 38073-38074]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-10407]


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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; Copper 
Naphthenate Solution

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 new animal drug 
application (NADA) filed by Farnam Companies, Inc. The supplemental 
NADA provides for a revised food safety warning on labeling for copper 
naphthenate topical solution for horse and pony hooves.

DATES: This rule is effective July 5, 2006.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Farnam Companies, Inc., 301 West Osborn, 
Phoenix, AZ 85013-3928, filed a supplement to NADA 100-616 for THRUSH-
XX (copper naphthenate), a solution approved for topical use on horse 
and pony hooves as an aid in treating thrush. The supplemental NADA 
provides for a revised food safety warning on the labeling. The 
supplemental NADA is approved as of May 30, 2006, and the regulations 
are amended in 21 CFR 524.463 to reflect the approval and a current 
format.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    The agency has determined under 21 CFR 25.33(d)(3) 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.

[[Page 38074]]


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.  524.463, revise the section and paragraph (c) headings, and 
paragraphs (a) and (c)(3) to read as follows:


Sec.  524.463  Copper naphthenate.

    (a) Amount. The drug is a 37.5 percent solution of copper 
naphthenate.
* * * * *
    (c) Conditions of use in horses--* * *
* * * * *
    (3) Limitations. Use on horses and ponies only. Avoid contact 
around eyes. Do not contaminate feed. Do not use in horses intended for 
human consumption.

    Dated: June 22, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E6-10407 Filed 7-3-06; 8:45 am]
BILLING CODE 4160-01-S

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