New Animal Drugs For Use in Animal Feeds; Change of Sponsor, 60551-60552 [E7-21059]

Download as PDF Federal Register / Vol. 72, No. 206 / Thursday, October 25, 2007 / Rules and Regulations 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. 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 change of sponsor for five approved new animal drug applications (NADAs) from Merial Ltd., to Huvepharma AD. DATES: This rule is effective October 25, 2007. FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for Veterinary Medicine (HFV–100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Merial Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096–4640 has informed FDA that it has transferred ownership of, and all rights and interest in, the following five approved NADAs to Huvepharma AD, 33 James Boucher Blvd., Sophia 1407, Bulgaria: 1. The authority citation for 21 CFR part 520 continues to read as follows: Application No. Authority: 21 U.S.C. 360b. 2. Add § 520.2130 to read as follows: § 520.2130 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. § 520.100 [Amended] 2. In paragraph (b)(1) of § 520.100, remove ‘‘050604’’ and in its place add ‘‘016592’’. I PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 3. The authority citation for 21 CFR part 558 continues to read as follows: I Authority: 21 U.S.C. 360b, 371. § 558.55 [Amended] 4. In paragraph (a) of § 558.55, remove ‘‘050604’’ and in its place add ‘‘No. 016592’’. I 5. In § 558.58, in the table in paragraph (e)(1)(i), in the first entry, in the ‘‘Sponsor’’ column, add ‘‘050604’’ and ‘‘016592’’; add paragraph (a)(3); and revise paragraph (b) to read as follows: I I I 60551 012–350 Spinosad. (a) Specifications. Each chewable tablet contains 140, 270, 560, 810, or 1620 milligrams (mg) spinosad. (b) Sponsor. See No. 000986 in § 510.600 of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer tablets once a month at a recommended minimum dosage of 13.5 mg per pound (30 mg per kilogram) of body weight. (2) Indications for use. To kill fleas and for the prevention and treatment of flea infestations (Ctenocephalides felis) on dogs for 1 month. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Dated: October 17, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7–21058 Filed 10–24–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Trade name(s) AMPROVINE (amprolium) 25% Type A Medicated Article; CORID (amprolium) 25% Type A Medicated Article 013–149 AMPROVINE (amprolium) 9.6% Solution 013–461 Broiler PMX No. 1620 (amprolium/ethopabate) 033–165 AMPROVINE (amprolium) 20% Soluble Powder; CORID (amprolium) 20% Soluble Powder 034–393 COYDEN 25 (clopidol); Lerbek 25 Accordingly, the agency is amending the regulations in 21 CFR 520.100, 558.55, 558.58, and 558.175 to reflect the transfer of ownership. 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. § 558.58 Amprolium and ethopabate. (a) * * * (3) 25 percent amprolium and 0.8 percent ethopabate. (b) Approvals. See § 510.600(c) of this chapter. (1) No. 050604 for products described in paragraph (a) of this section. (2) No. 016592 for product described in paragraph (a)(3) of this section. § 558.175 [Amended] 6. In § 558.175, in paragraph (b) and in the table in paragraph (d)(1) in the ‘‘Sponsor’’ column, remove ‘‘050604’’ and in its place add ‘‘016592’’. I Dated: October 17, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7–21057 Filed 10–24–07; 8:45 am] BILLING CODE 4160–01–S List of Subjects 21 CFR Part 520 Food and Drug Administration DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Animal drugs. 21 CFR Parts 520 and 558 21 CFR Part 558 New Animal Drugs; Change of Sponsor rwilkins on PROD1PC63 with RULES AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a SUMMARY: VerDate Aug<31>2005 18:00 Oct 24, 2007 Jkt 214001 21 CFR Part 558 Animal drugs, Animal feeds. 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 parts 520 and 558 are amended as follows: New Animal Drugs For Use in Animal Feeds; Change of Sponsor I PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the E:\FR\FM\25OCR1.SGM 25OCR1 60552 Federal Register / Vol. 72, No. 206 / Thursday, October 25, 2007 / Rules and Regulations animal drug regulations to reflect a change of sponsor for seven approved new animal drug applications (NADAs) from Schering-Plough Animal Health Corp. to Huvepharma AD. DATES: This rule is effective October 25, 2007. FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for Veterinary Medicine (HFV–100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.hhs.gov. SUPPLEMENTARY INFORMATION: ScheringPlough Animal Health Corp., 556 Morris Application No. Ave., Summit NJ 07901, has informed FDA that it has transferred ownership of, and all rights and interest in, the following seven approved NADAs to Huvepharma AD, 33 James Boucher Blvd., Sophia 1407, Bulgaria: Trade name(s) 140–951 CLINICOX (diclazuril) Type A Medicated Article 141–090 CLINICOX / STAFAC 141–153 CLINICOX / BMD 141–158 CLINICOX / FLAVOMYCIN 141–190 CLINICOX / BMD / 3–NITRO 141–194 CLINICOX / BMD 141–195 CLINICOX / FLAVOMYCIN Accordingly, the agency is amending the regulations in 21 CFR 558.198 to reflect the transfer of ownership. 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 558 Animal drugs, Animal feeds. PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 1. The authority citation for 21 CFR part 558 continues to read as follows: I Authority: 21 U.S.C. 360b, 371. [Amended] 2. In § 558.198, in paragraph (b), remove ‘‘000061’’ and in its place add ‘‘016592’’; and in the tables in paragraphs (d)(1) and (d)(2), in the ‘‘Sponsor’’ column, remove ‘‘000061’’ wherever it occurs and in its place add ‘‘016592’’. rwilkins on PROD1PC63 with RULES I Dated: October 17, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7–21059 Filed 10–24–07; 8:45 am] BILLING CODE 4160–01–S VerDate Aug<31>2005 18:00 Oct 24, 2007 Jkt 214001 Internal Revenue Service 26 CFR Part 1 [TD 9361] RIN 1545–BD56 Corporate Reorganizations; Transfers of Assets or Stock Following a Reorganization Internal Revenue Service (IRS), Treasury. ACTION: Final regulations. AGENCY: 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 558 is amended as follows: I § 558.198 DEPARTMENT OF THE TREASURY SUMMARY: This document contains final regulations that provide guidance regarding the effect of certain transfers of assets or stock on the continuing qualification of transactions as reorganizations under section 368(a). This document also contains final regulations that provide guidance on the continuity of business enterprise requirement and the definitions of ‘‘qualified group’’ and ‘‘party to a reorganization.’’ These regulations affect corporations and their shareholders. DATES: Effective Date: These regulations are effective October 25, 2007. Applicability Date: For dates of applicability, see §§ 1.368–1(d)(4)(iv), 1.368–1(d)(5), 1.368–2(f), 1.368– 2(j)(3)(iv), and 1.368–2(k)(3). FOR FURTHER INFORMATION CONTACT: Mary W. Lyons, at (202) 622–7930 (not a toll free number). SUPPLEMENTARY INFORMATION: Background On August 18, 2004, the IRS and Treasury Department published a notice PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 of proposed rulemaking (REG–130863– 04) in the Federal Register (69 FR 51209) proposing regulations that would provide guidance regarding the effect of certain transfers of assets or stock on the qualification of a transaction as a reorganization under section 368(a) (the proposed regulations). The proposed regulations also included amendments to the continuity of business enterprise (COBE) regulations under § 1.368–1(d) and the definition of a ‘‘party to a reorganization’’ under § 1.368–2(f). The proposed regulations replaced an earlier proposal, dated March 2, 2004 (REG– 165579–02) and published in the Federal Register (69 FR 9771), which was withdrawn. No public hearing regarding the proposed regulations was requested or held. However, a number of comments were received, the most significant of which are discussed in this preamble. The theory underlying the tax-free treatment afforded reorganizations described in section 368 is that such transactions ‘‘effect only a readjustment of continuing interest in property under modified corporate forms.’’ See § 1.368– 1(b). The continuity of interest and continuity of business enterprise requirements are expressions of this principle. Earlier cases also implemented this principle through a concept that later became known as the prohibition of ‘‘remote’’ continuity of interest. Commonly viewed as arising out of the Supreme Court decisions in Groman v. Commissioner, 302 U.S. 82 (1937), and Helvering v. Bashford, 302 U.S. 454 (1938), remote continuity of interest focuses on the link between the former target corporation (T) E:\FR\FM\25OCR1.SGM 25OCR1

Agencies

[Federal Register Volume 72, Number 206 (Thursday, October 25, 2007)]
[Rules and Regulations]
[Pages 60551-60552]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-21059]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs For Use in Animal Feeds; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the

[[Page 60552]]

animal drug regulations to reflect a change of sponsor for seven 
approved new animal drug applications (NADAs) from Schering-Plough 
Animal Health Corp. to Huvepharma AD.

DATES: This rule is effective October 25, 2007.

FOR FURTHER INFORMATION CONTACT:  David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: 
david.newkirk@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 556 
Morris Ave., Summit NJ 07901, has informed FDA that it has transferred 
ownership of, and all rights and interest in, the following seven 
approved NADAs to Huvepharma AD, 33 James Boucher Blvd., Sophia 1407, 
Bulgaria:

------------------------------------------------------------------------
        Application No.                       Trade name(s)
------------------------------------------------------------------------
140-951                         CLINICOX (diclazuril) Type A Medicated
                                 Article
------------------------------------------------------------------------
141-090                         CLINICOX / STAFAC
------------------------------------------------------------------------
141-153                         CLINICOX / BMD
------------------------------------------------------------------------
141-158                         CLINICOX / FLAVOMYCIN
------------------------------------------------------------------------
141-190                         CLINICOX / BMD / 3-NITRO
------------------------------------------------------------------------
141-194                         CLINICOX / BMD
------------------------------------------------------------------------
141-195                         CLINICOX / FLAVOMYCIN
------------------------------------------------------------------------

    Accordingly, the agency is amending the regulations in 21 CFR 
558.198 to reflect the transfer of ownership.
    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 558

    Animal drugs, Animal feeds.

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 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority:  21 U.S.C. 360b, 371.


Sec.  558.198  [Amended]

0
2. In Sec.  558.198, in paragraph (b), remove ``000061'' and in its 
place add ``016592''; and in the tables in paragraphs (d)(1) and 
(d)(2), in the ``Sponsor'' column, remove ``000061'' wherever it occurs 
and in its place add ``016592''.

    Dated: October 17, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-21059 Filed 10-24-07; 8:45 am]
BILLING CODE 4160-01-S

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