Oral Dosage Form New Animal Drugs; Orbifloxacin, 14642-14643 [06-2791]

Download as PDF 14642 Federal Register / Vol. 71, No. 56 / Thursday, March 23, 2006 / Rules and Regulations Information Collection Statement 9. The Office of Management and Budget’s (OMB’s) regulations require that OMB approve certain information collection requirements imposed by agency rule. 5 CFR 1320.12 (2005). This Final Rule contains no additional information reporting requirements, and is not subject to OMB approval. Environmental Analysis 10. The Commission is required to prepare an Environmental Assessment or an Environmental Impact Statement for any action that may have a significant adverse effect on the human environment.7 The Commission has categorically excluded certain actions from this requirement as not having a significant effect on the human environment. Included in the exclusion are rules that are clarifying, corrective, or procedural that do not substantially change the effect of the regulations being amended. This rule is procedural in nature and, therefore, falls under this exception; consequently, no environmental consideration is necessary. Regulatory Flexibility Act Certification 11. The Regulatory Flexibility Act of 1980 (RFA) 8 generally requires a description and analysis of final rules that will have significant economic impact on a substantial number of small entities. The Commission is not required to make such analysis if a rule would not have such an effect. The Commission certifies that this rule will not have such an impact on small entities as it merely clarifies existing requirements. An analysis under the RFA, therefore, is not required. Document Availability rmajette on PROD1PC67 with RULES 12. In addition to publishing the full text of this document in the Federal Register, the Commission provides all interested persons an opportunity to view and/or print the contents of this document via the Internet through FERC’s Home Page (https://www.ferc.gov) under ‘‘What’s New’’ and in FERC’s Public Reference Room during normal business hours (8:30 a.m. to 5 p.m. Eastern time) at 888 First Street, NE., Room 2A, Washington, DC 20426. 13. From FERC’s Home Page on the Internet, this information is available in the Commission’s document management system, eLibrary. The full text of this document is available on 7 Regulations Implementing the National Environmental Policy Act, Order No. 486, 52 FR 47897 (December 17, 1987), FERC Stats. & Regs. Preambles 1986–1990 ¶ 30,783 (1987). 8 5 U.S.C. 601–612 (1994). VerDate Aug<31>2005 13:41 Mar 22, 2006 Jkt 208001 eLibrary in PDF and Microsoft Word format for viewing, printing, and/or downloading. To access this document in eLibrary, type the docket number excluding the last three digits of this document in the docket number field. 14. User assistance is available for eLibrary and the FERC’s Web site during normal business hours. For assistance, please contact the Commission’s Online Support at 1–866–208–3673 (toll free) or 202–502–6652 (e-mail at FERCOnlineSupport@ferc.gov) or the Public Reference Room at (202) 502– 8371, TTY (202) 502–8659. E-Mail the Public Reference Room at public.referenceroom@ferc.gov. Effective Date 15. These regulations are effective immediately upon publication in the Federal Register. In accordance with 5 U.S.C. 553(d)(3), the Commission finds that good cause exists to make this Final Rule effective immediately upon publication. It concerns only a matter of procedure eliminating a requirement affecting formatting of filings. 16. The provisions of 5 U.S.C. 801 regarding Congressional review of Final Rules does not apply to this Final Rule, because the rule concerns agency procedure and practice and will not substantially affect the rights of nonagency parties. 17. The Commission is issuing this as a final rule without a period for public comment. Under 5 U.S.C. 553(b), notice and comment procedures are unnecessary where a rulemaking concerns only agency procedure and practice, or where the agency finds that notice and comment is unnecessary. This rule concerns only a clarification of a matter of agency procedure and will not significantly affect regulated entities or the general public. List of Subjects in 18 CFR Part 385 Administrative practice and procedure, Electric utilities, Penalties, Pipelines, Reporting and recordkeeping requirements. By the Commission. Magalie R. Salas, Secretary. In consideration of the foregoing, the Commission amends part 385, Chapter I, Title 18, Code of Federal Regulations, as follows. I PART 385—RULES OF PRACTICE AND PROCEDURE 1. The authority citation for part 385 continues to read as follows: I Authority: 5 U.S.C. 551–557; 15 U.S.C. 717–717z; 3301–3432; 16 U.S.C. 791a–825r; PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 2601–2645; 28 U.S.C. 2461; 31 U.S.C. 3701, 9701; 42 U.S.C. 7101–7352; 49 U.S.C. 60502; 49 App. U.S.C. 1085 (1988). 2. Section 385.203 is amended by revising paragraph (a)(7) to read as follows: I § 385.203 Content of pleadings and tariff or rate filings (Rule 203). (a) * * * (7) The position taken by the participant filing any pleading, to the extent known when the pleading is filed, and the basis in fact and law for such position; * * * * * I 3. Section 385.713 is amended by revising paragraph (c)(2) to read as follows: § 385.713 713). Request for rehearing (Rule * * * * * (c) * * * (2) Conform to the requirements in Rule 203(a), which are applicable to pleadings, and, in addition, include a separate section entitled ‘‘Statement of Issues,’’ listing each issue in a separately enumerated paragraph that includes representative Commission and court precedent on which the party is relying; any issue not so listed will be deemed waived; and * * * * * [FR Doc. 06–2800 Filed 3–22–06; 8:45 am] BILLING CODE 6717–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Orbifloxacin 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 Schering-Plough Animal Health Corp. The supplemental NADA provides for revised animal safety labeling for orbifloxacin tablets used in dogs and cats for the management of diseases associated with susceptible bacteria. DATES: This rule is effective March 23, 2006. FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for Veterinary Medicine (HFV–110), Food and Drug E:\FR\FM\23MRR1.SGM 23MRR1 Federal Register / Vol. 71, No. 56 / Thursday, March 23, 2006 / Rules and Regulations Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–7543, email: melanie.berson@fda.hhs.gov. ScheringPlough Animal Health Corp., 556 Morris Ave., Summit, NJ 07901, filed a supplement to NADA 141–081 for the veterinary prescription use of ORBAX (orbifloxacin) Tablets for management of diseases in dogs and cats associated with bacteria susceptible to orbifloxacin. The supplemental NADA provides for revised animal safety labeling, specifically, the addition of postapproval adverse drug experience information and fluoroquinolone class statements regarding retinal toxicity in cats. The supplemental NADA is approved as of March 3, 2006, and the regulations are amended in 21 CFR 520.1616 to reflect 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(d)(5) 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 ‘‘articular applicability.’’ Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801–808. SUPPLEMENTARY INFORMATION: List of Subjects in 21 CFR Part 520 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 rmajette on PROD1PC67 with RULES 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. Revise § 520.1616 to read as follows: I VerDate Aug<31>2005 13:41 Mar 22, 2006 Jkt 208001 § 520.1616 Orbifloxacin. (a) Specifications. Each tablet contains 5.7, 22.7, or 68 milligrams (mg) orbifloxacin. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats—(1) Amount. 2.5 to 7.5 mg per kilogram body weight once daily. (2) Indications for use. For management of diseases associated with bacteria susceptible to orbifloxacin. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food producing animals. Dated: March 14, 2006. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 06–2791 Filed 3–22–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 950 [WY–033–FOR] Wyoming Abandoned Mine Land Reclamation Plan Office of Surface Mining Reclamation and Enforcement, Interior. ACTION: Final rule; approval of amendment. AGENCY: SUMMARY: We are approving an amendment to the Wyoming abandoned mine land reclamation (AMLR) plan (hereinafter referred to as the ‘‘Wyoming Plan’’ or ‘‘Plan’’) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Wyoming proposed revisions and additions to its abandoned mine land (AML) Plan by removing phrases concerning liens for reclamation on private lands and by removing and adding words concerning contract eligibility. Wyoming intended to revise its Plan in accordance with the amendments required by OSM to make it consistent with SMCRA. DATES: Effective Date: March 23, 2006. FOR FURTHER INFORMATION CONTACT: Richard W. Buckley, Acting Field Office Director, Telephone: 307/261–6550; Email address: RBuckley@osmre.gov. SUPPLEMENTARY INFORMATION: I. Background on the Wyoming Plan II. Submission of the Proposed Amendment III. Office of Surface Mining Reclamation and Enforcement’s (OSM) Findings PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 14643 IV. Summary and Disposition of Comments V. OSM’s Decision VI. Procedural Determinations I. Background on the Wyoming Plan The Abandoned Mine Land Reclamation Program was established by Title IV of the Act (30 U.S.C. 1201 et seq.) in response to concerns over extensive environmental damage caused by past coal mining activities. The program is funded by a reclamation fee collected on each ton of coal that is produced. The money collected is used to finance the reclamation of abandoned coal mines and for other authorized activities. Section 405 of the Act allows States and Indian tribes to assume exclusive responsibility for reclamation activity within the State or on Indian lands if they develop and submit to the Secretary of the Interior for approval, a program (often referred to as a plan) for the reclamation of abandoned coal mines. On February 14, 1983, the Secretary of the Interior approved the Wyoming Plan. You can find general background information on the Wyoming Plan, including the Secretary’s findings and the disposition of comments, in the February 14, 1983, Federal Register (48 FR 6536). You can also find later actions concerning Wyoming’s Plan and plan amendments at 30 CFR 950.35 and outstanding required amendments at 30 CFR 950.36. II. Submission of the Proposed Amendment By letter dated September 1, 2005, Wyoming sent us an amendment to its Plan (Administrative Record No. WY– 038–01) under SMCRA (30 U.S.C. 1201 et seq.). Wyoming sent the amendment in response to the required plan amendments at 30 CFR 950.36(a) and (b) to make its Plan consistent with SMCRA. The provisions of the Wyoming Plan that it proposed to add to or revise were: Wyoming Statute (W.S.) 35–11–1206(a) and (b), liens for reclamation on private lands; and W.S. 35–11–1209, contract eligibility. We announced receipt of the proposed amendment in the November 29, 2005, Federal Register (70 FR 71444). In the same document, we opened the public comment period and provided an opportunity for a public hearing or meeting on the amendment’s adequacy (Administrative Record No. WY–038–4). We did not hold a public hearing or meeting because no one requested one. The public comment period ended on December 29, 2005. We did not receive any comments. E:\FR\FM\23MRR1.SGM 23MRR1

Agencies

[Federal Register Volume 71, Number 56 (Thursday, March 23, 2006)]
[Rules and Regulations]
[Pages 14642-14643]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-2791]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Orbifloxacin

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 Schering-Plough Animal Health Corp. The 
supplemental NADA provides for revised animal safety labeling for 
orbifloxacin tablets used in dogs and cats for the management of 
diseases associated with susceptible bacteria.

DATES: This rule is effective March 23, 2006.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug

[[Page 14643]]

Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7543, 
e-mail: melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 556 
Morris Ave., Summit, NJ 07901, filed a supplement to NADA 141-081 for 
the veterinary prescription use of ORBAX (orbifloxacin) Tablets for 
management of diseases in dogs and cats associated with bacteria 
susceptible to orbifloxacin. The supplemental NADA provides for revised 
animal safety labeling, specifically, the addition of postapproval 
adverse drug experience information and fluoroquinolone class 
statements regarding retinal toxicity in cats. The supplemental NADA is 
approved as of March 3, 2006, and the regulations are amended in 21 CFR 
520.1616 to reflect 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(d)(5) 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 ``articular 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

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. Revise Sec.  520.1616 to read as follows:


Sec.  520.1616  Orbifloxacin.

    (a) Specifications. Each tablet contains 5.7, 22.7, or 68 
milligrams (mg) orbifloxacin.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. 2.5 to 7.5 mg 
per kilogram body weight once daily.
    (2) Indications for use. For management of diseases associated with 
bacteria susceptible to orbifloxacin.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. Federal law prohibits the 
extralabel use of this drug in food producing animals.

    Dated: March 14, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 06-2791 Filed 3-22-06; 8:45 am]
BILLING CODE 4160-01-S
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