Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin and Betamethasone Spray, 5929-5930 [E7-2121]

Download as PDF 5929 Federal Register / Vol. 72, No. 26 / Thursday, February 8, 2007 / Rules and Regulations TABLE 2.—ALL MATERIAL INCORPORATED BY REFERENCE Service Bulletin Revision level Bombardier Alert Service Bulletin A601R–32–088, including Appendices A, B, and C. Bombardier Alert Service Bulletin A601R–32–088, including Appendices A, B, and C, dated February 20, 2003. Bombardier Service Bulletin 601R–32–093 ......................................................... Original .................................................. February 20, 2003. A ............................................................ June 16, 2005. B ............................................................ July 14, 2005. (1) The Director of the Federal Register approved the incorporation by reference of the documents in Table 3 of this AD, in Date accordance with 5 U.S.C. 552(a) and 1 CFR part 51. TABLE 3.—NEW MATERIAL INCORPORATED BY REFERENCE Service Bulletin Revision level Bombardier Alert Service Bulletin A601R–32–088, including Appendices A, B, and C, dated February 20, 2003. Bombardier Service Bulletin 601R–32–093 ......................................................... A ............................................................ June 16, 2005. B ............................................................ July 14, 2005. (2) On August 13, 2004 (69 FR 41421, July 9, 2004), the Director of the Federal Register approved the incorporation by reference of Bombardier Alert Service Bulletin A601R– 32–088, including Appendices A, B, and C, dated February 20, 2003. (3) Contact Bombardier, Inc., Canadair, Aerospace Group, P.O. Box 6087, Station Centre-ville, Montreal, Quebec H3C 3G9, Canada, for a copy of this service information. You may review copies at the Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street, SW., Room PL–401, Nassif Building, Washington, DC; on the Internet at https:// dms.dot.gov; or at the National Archives and Records Administration (NARA). For information on the availability of this material at the NARA, call (202) 741–6030, or go to https://www.archives.gov/ federal_register/code_of_federal_regulations/ ibr_locations.html. Issued in Renton, Washington, on January 29, 2007. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E7–1876 Filed 2–7–07; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 524 cprice-sewell on PROD1PC72 with RULES Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin and Betamethasone Spray AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the VerDate Aug<31>2005 13:42 Feb 07, 2007 Jkt 211001 animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by First Priority, Inc. The ANADA provides for topical use of a gentamicin sulfate and betamethasone valerate topical spray on dogs for the treatment of infected superficial lesions. DATES: This rule is effective February 8, 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: First Priority, Inc., 1585 Todd Farm Dr., Elgin, IL 60123, filed ANADA 200–415 for Gentamicin Sulfate Topical Spray (gentamicin sulfate, USP with betamethasone valerate, USP) for use on dogs for the treatment of infected superficial lesions caused by bacteria sensitive to gentamicin. First Priority’s Gentamicin Sulfate Topical Spray is approved as a generic copy of ScheringPlough Animal Health Corp.’s GENTOCIN Topical Spray, approved under NADA 132–338. The ANADA is approved as of January 12, 2006, and 21 CFR 524.1044f is amended 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 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 Date 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 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. In § 524.1044f, revise the section heading and paragraph (b) to read as follows: I § 524.1044f Gentamicin and betamethasone spray. * * * * * (b) See Nos. 000061, 054925, and 058829 in § 510.600(c) of this chapter. * * * * * E:\FR\FM\08FER1.SGM 08FER1 5930 Federal Register / Vol. 72, No. 26 / Thursday, February 8, 2007 / Rules and Regulations Dated: January 29, 2007. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. E7–2121 Filed 2–7–07; 8:45 am] Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. BILLING CODE 4160–01–S Background and Purpose The office of the United States Coast Guard Marine Safety Center will change their procedure for receiving private courier mail, resulting in the need for an address change in the Code of Federal Regulations. DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Parts 104 and 120 [USCG–2007–26953] RIN 1625–ZA12 Technical Amendments; Marine Safety Center Address Change Coast Guard, DHS. ACTION: Final rule. AGENCY: cprice-sewell on PROD1PC72 with RULES SUMMARY: By this final rule, the Coast Guard is making non-substantive changes to the address of delivery for all private mail to the United States Coast Guard Marine Safety Center as it appears in Coast Guard regulations. This rule will have no substantive effect on the regulated public. DATES: This rule is effective February 8, 2007. ADDRESSES: Any comments and material received from the public will be made part of docket, USCG–2006–26953, and will be available for inspection or copying at the Docket Management Facility, U.S. Department of Transportation, room PL–401, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. You may also find this docket on the Internet at https://dms.dot.gov. FOR FURTHER INFORMATION CONTACT: If you have questions on this amendment, call Commander Hung Nguyen, Executive Officer, United States Coast Guard Marine Safety Center, telephone 202–475–3406. If you have questions on viewing the docket, call Ms. Renee V. Wright, Program Manager, Docket Operations, telephone 202–493–0402. SUPPLEMENTARY INFORMATION: Regulatory History We did not publish a notice of proposed rulemaking (NPRM) for this amendment. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that this technical amendment is exempt from notice and comment rulemaking requirements because the amendment only makes non-substantive mailing address changes. These changes will have no substantive effect on the public; therefore, it is unnecessary to publish an NPRM. VerDate Aug<31>2005 13:42 Feb 07, 2007 Jkt 211001 Regulatory Evaluation This rule is not a ‘‘significant regulatory action’’ under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not ‘‘significant’’ under the regulatory policies and procedures of the Department of Homeland Security (DHS). Because this amendment makes only address changes, we expect the economic impact to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601–612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term ‘‘small entities’’ comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. It is not expected that this amendment will have a significant economic impact on any small entities. Therefore, the Coast Guard certifies under 5 U.S.C. 605(b) that this technical amendment will not have a significant economic impact on a substantial number of small entities. Collection of Information This amendment calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). Federalism A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 this amendment under that Order and have determined that it does not have implications for federalism. Unfunded Mandates Reform Act The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531–1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this amendment will not result in such an expenditure, we do discuss the effects of this amendment elsewhere in this preamble. Taking of Private Property This amendment will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. Civil Justice Reform This amendment meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. Protection of Children We have analyzed this amendment under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This amendment is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children. Indian Tribal Governments This amendment does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Energy Effects We have analyzed this amendment under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a ‘‘significant energy action’’ under that order because it is not a ‘‘significant regulatory action’’ E:\FR\FM\08FER1.SGM 08FER1

Agencies

[Federal Register Volume 72, Number 26 (Thursday, February 8, 2007)]
[Rules and Regulations]
[Pages 5929-5930]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-2121]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524


Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin 
and Betamethasone Spray

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 First Priority, Inc. The ANADA provides 
for topical use of a gentamicin sulfate and betamethasone valerate 
topical spray on dogs for the treatment of infected superficial 
lesions.

DATES:  This rule is effective February 8, 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: First Priority, Inc., 1585 Todd Farm Dr., 
Elgin, IL 60123, filed ANADA 200-415 for Gentamicin Sulfate Topical 
Spray (gentamicin sulfate, USP with betamethasone valerate, USP) for 
use on dogs for the treatment of infected superficial lesions caused by 
bacteria sensitive to gentamicin. First Priority's Gentamicin Sulfate 
Topical Spray is approved as a generic copy of Schering-Plough Animal 
Health Corp.'s GENTOCIN Topical Spray, approved under NADA 132-338. The 
ANADA is approved as of January 12, 2006, and 21 CFR 524.1044f is 
amended 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 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. In Sec.  524.1044f, revise the section heading and paragraph (b) to 
read as follows:


Sec.  524.1044f  Gentamicin and betamethasone spray.

* * * * *
    (b) See Nos. 000061, 054925, and 058829 in Sec.  510.600(c) of this 
chapter.
* * * * *


[[Page 5930]]


    Dated: January 29, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7-2121 Filed 2-7-07; 8:45 am]
BILLING CODE 4160-01-S
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.