Ophthalmic and Topical Dosage Form New Animal Drugs; Mupirocin Ointment, 18118-18119 [E7-6828]

Download as PDF 18118 Federal Register / Vol. 72, No. 69 / Wednesday, April 11, 2007 / Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES 18 CFR Part 1310 rule to be a nonsubstantive rule relating to agency management and public property pursuant to 5 U.S.C. 553(a)(2). However, TVA provided a thirty day public comment period to hear from any interested parties. No comments were received. Since this rule relates to services provided by the agency, a regulatory flexibility analysis is not required. Administrative Cost Recovery List of Subjects in 18 CFR Part 1310 HHS. § 270.17 are paid on a prorated basis to the sector participants from whom those moneys were collected under § 270.20. [FR Doc. E7–6751 Filed 4–10–07; 8:45 am] BILLING CODE 3510–22–S TENNESSEE VALLEY AUTHORITY Tennessee Valley Authority (TVA). ACTION: Final rule. cprice-sewell on PROD1PC71 with RULES AGENCY: Government property, Hunting. SUMMARY: TVA is amending its administrative cost recovery regulations by eliminating cost recovery exemptions for the following: Conveyances of land pursuant to Section 4(k)(d) of the Tennessee Valley Authority Act of 1933, as amended (16 U.S.C. 831c(k)(d)); TVA phosphate land transactions; and permits and licenses for use of TVA land by distributors of TVA power. The implementation of this rule amendment will allow TVA to recover more of its administrative costs incurred in processing certain actions from those who directly benefit from the actions. EFFECTIVE DATE: April 11, 2007. FOR FURTHER INFORMATION CONTACT: Nancy Greer, Senior Manager, Process and Performance Management, (865) 632–3339. SUPPLEMENTARY INFORMATION: In order to help ensure that TVA land management and permitting activities are selfsustaining to the full extent possible, the agency is amending its administrative cost recovery regulations by eliminating certain mandatory cost recovery exemptions. This determination is consistent with the objectives of increasing efficiency and recovering the cost of government services from those who most directly benefit from the services. TVA is amending its administrative cost recovery regulation by eliminating the following exemptions: Conveyances of land pursuant to Section 4(k)(d) of the Tennessee Valley Authority Act of 1933, as amended (16 U.S.C. 831c(k)(d)); TVA phosphate land transactions; and permits and licenses for use of TVA land by distributors of TVA power. TVA is also amending the rule to reflect new organizational changes within the agency. The terms ‘‘Vice President of Land Management’’ or ‘‘Manager of Power Properties’’ are to be amended to read ‘‘Senior Manager of the TVA organization that manages the land.’’ TVA published a proposed rule on April 14, 2006. TVA considers this final VerDate Aug<31>2005 12:59 Apr 10, 2007 Jkt 211001 For the reasons set out in the preamble, TVA amends 18 CFR part 1310 as follows: PART 1310—ADMINISTRATIVE COST RECOVERY 1. The authority citation for part 1310 continues to read as follows: I Authority: 16 U.S.C. 831–831dd; 31 U.S.C. 9701. 2. Revise paragraphs (a) introductory text and (b) of § 1310.2 to read as follows: I § 1310.2 Application. (a) General. TVA will undertake the following actions only upon the condition that the applicant pay to TVA such administrative charges as the Senior Manager of the TVA organization that administers the land or permit being considered (hereinafter ‘‘responsible land manager’’), as appropriate, shall assess in accordance with § 1310.3; provided, however, that the responsible land manager may waive payment where he/she determines that there is a corresponding benefit to TVA or that such waiver is otherwise in the public interest. * * * * * (b) Exemption. An administrative charge shall not be made for the following actions: (1) Releases of unneeded mineral right options. (2) TVA mineral transactions. * * * * * Authority: 16 U.S.C. 831–831dd (2000 & Supp. III 2003). Dated: March 2, 2007. Kathryn J. Jackson, Executive Vice President, River System Operations & Environment and Environmental Executive, Tennessee Valley Authority. [FR Doc. 07–1702 Filed 4–10–07; 8:45 am] BILLING CODE 8120–08–M PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 Food and Drug Administration 21 CFR Part 524 Ophthalmic and Topical Dosage Form New Animal Drugs; Mupirocin Ointment AGENCY: ACTION: Food and Drug Administration, Final rule. 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 Altana, Inc. The ANADA provides for veterinary prescription use of mupirocin ointment for the treatment of bacterial skin infections in dogs. DATES: This rule is effective April 11, 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: Altana, Inc., 60 Baylis Rd., Melville, NY 11747, filed ANADA 200–418 that provides for veterinary prescription use of MURICIN (mupirocin) Ointment 2% for the treatment of bacterial skin infections in dogs. Altana, Inc.’s MURICIN Ointment 2% is approved as a generic copy of Pfizer, Inc.’s BACTODERM Ointment approved under new animal drug application (NADA) 140–839. The ANADA is approved as of March 8, 2007, and the regulations are amended in 21 CFR 524.1465 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 E:\FR\FM\11APR1.SGM 11APR1 18119 Federal Register / Vol. 72, No. 69 / Wednesday, April 11, 2007 / Rules and Regulations 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. 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: I PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 524 continues to read as follows: I Authority: 21 U.S.C. 360b. 2. Revise § 524.1465 to read as follows: I § 524.1465 Mupirocin. (a) Specifications. Each gram of ointment contains 20 milligrams mupirocin. (b) Sponsors. See Nos. 000069 and 025463 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Apply twice daily. Treatment should not exceed 30 days. (2) Indications for use. For the topical treatment of bacterial infections of the skin, including superficial pyoderma, caused by susceptible strains of Staphylococcus aureus and S. intermedius. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Dated: March 30, 2007. Bernadette A. Dunham, Acting Deputy Director, Center for Veterinary Medicine. [FR Doc. E7–6828 Filed 4–10–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF DEFENSE Department of the Navy 32 CFR Part 706 Certifications and Exemptions Under the International Regulations for Preventing Collisions at Sea, 1972 Department of the Navy, DOD. Final rule. AGENCY: ACTION: SUMMARY: The Department of the Navy is amending its certifications and exemptions under the International Regulations for Preventing Collisions at Sea, 1972 (72 COLREGS), to reflect that the Deputy Assistant Judge Advocate General (Admiralty and Maritime Law) has determined that USS SAMPSON (DDG 102) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with certain provisions of the 72 COLREGS without interfering with its special function as a naval ship. The intended effect of this rule is to warn mariners in waters where 72 COLREGS apply. DATES: Effective Date: April 11, 2007. FOR FURTHER INFORMATION CONTACT: Commander Gregg A. Cervi, JAGC, U.S. Navy, Deputy Assistant Judge Advocate General (Admiralty and Maritime Law), Office of the Judge Advocate General, Department of the Navy, 1322 Patterson Ave., SE., Suite 3000, Washington Navy Yard, DC 20374–5066, telephone 202– 685–5040. SUPPLEMENTARY INFORMATION: Pursuant to the authority granted in 33 U.S.C. 1605, the Department of the Navy amends 32 CFR Part 706. This amendment provides notice that the Deputy Assistant Judge Advocate General (Admiralty and Maritime Law), under authority delegated by the Secretary of the Navy, has certified that USS SAMPSON (DDG 102) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with the following specific provisions of 72 COLREGS without interfering with its special function as a naval ship: Annex I, paragraph 2(f)(i), pertaining to the placement of the masthead light or lights above and clear of all other lights and obstructions; Annex I, paragraph 2(f)(ii), pertaining to the vertical placement of task lights; Annex I, paragraph 3(a), pertaining to the location of the forward masthead light in the forward quarter of the ship, and the horizontal distance between the forward and after masthead lights; and Annex I, paragraph 3(c), pertaining to placement of task lights not less than two meters from the fore and aft centerline of the ship in the athwartship direction. The Deputy Assistant Judge Advocate General (Admiralty and Maritime Law) has also certified that the lights involved are located in closest possible compliance with the applicable 72 COLREGS requirements. Moreover, it has been determined, in accordance with 32 CFR Parts 296 and 701, that publication of this amendment for public comment prior to adoption is impracticable, unnecessary, and contrary to public interest since it is based on technical findings that the placement of lights on this vessel in a manner different from that prescribed herein will adversely affect the vessel’s ability to perform its military functions. List of Subjects in 32 CFR Part 706 Marine safety, Navigation (water), and Vessels. I For the reasons set forth in the preamble, amend part 706 of title 32 of the Code of Federal Regulations as follows: PART 706—CERTIFICATIONS AND EXEMPTIONS UNDER THE INTERNATIONAL REGULATIONS FOR PREVENTING COLLISIONS AT SEA, 1972 1. The authority citation for part 706 continues to read: I Authority: 33 U.S.C. 1605. 2. Table Four, Paragraph 15 of § 706.2 is amended by adding, in numerical order, the following entry for USS SAMPSON: I § 706.2 Certifications of the Secretary of the Navy under Executive Order 11964 and 33 U.S.C. 1605. * cprice-sewell on PROD1PC71 with RULES Vessel Number * * * * USS SAMPSON ...................................................................................................... * DDG 102 ................ * VerDate Aug<31>2005 * 12:59 Apr 10, 2007 * Jkt 211001 PO 00000 * Frm 00015 Fmt 4700 * * E:\FR\FM\11APR1.SGM * Horizontal distance from the fore and aft centerline of the vessel in the athwartship direction * 1.88 meters. * Sfmt 4700 * * 11APR1 * *

Agencies

[Federal Register Volume 72, Number 69 (Wednesday, April 11, 2007)]
[Rules and Regulations]
[Pages 18118-18119]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-6828]


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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; Mupirocin 
Ointment

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 an abbreviated new animal drug 
application (ANADA) filed by Altana, Inc. The ANADA provides for 
veterinary prescription use of mupirocin ointment for the treatment of 
bacterial skin infections in dogs.

DATES: This rule is effective April 11, 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: Altana, Inc., 60 Baylis Rd., Melville, NY 
11747, filed ANADA 200-418 that provides for veterinary prescription 
use of MURICIN (mupirocin) Ointment 2% for the treatment of bacterial 
skin infections in dogs. Altana, Inc.'s MURICIN Ointment 2% is approved 
as a generic copy of Pfizer, Inc.'s BACTODERM Ointment approved under 
new animal drug application (NADA) 140-839. The ANADA is approved as of 
March 8, 2007, and the regulations are amended in 21 CFR 524.1465 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

[[Page 18119]]

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.

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. Revise Sec.  524.1465 to read as follows:


Sec.  524.1465  Mupirocin.

    (a) Specifications. Each gram of ointment contains 20 milligrams 
mupirocin.
    (b) Sponsors. See Nos. 000069 and 025463 in Sec.  510.600(c) of 
this chapter.
    (c) Conditions of use in dogs--(1) Amount. Apply twice daily. 
Treatment should not exceed 30 days.
    (2) Indications for use. For the topical treatment of bacterial 
infections of the skin, including superficial pyoderma, caused by 
susceptible strains of Staphylococcus aureus and S. intermedius.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: March 30, 2007.
Bernadette A. Dunham,
Acting Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-6828 Filed 4-10-07; 8:45 am]
BILLING CODE 4160-01-S

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