Implantation or Injectable Dosage Form New Animal Drugs; Butorphanol, 22524 [2010-9871]

Download as PDF 22524 Federal Register / Vol. 75, No. 82 / Thursday, April 29, 2010 / Rules and Regulations Related Information (k) Refer to MCAI Canadian Airworthiness Directive CF–2009–02, dated January 19, 2009; Bombardier Alert Service Bulletin A601R–11–077, Revision A, dated December 11, 2001; and Bombardier Service Bulletin 601R–11–088, Revision B, dated November 17, 2009; for related information. Material Incorporated by Reference (l) You must use Bombardier Service Bulletin 601R–11–088, Revision B, dated November 17, 2009; and Bombardier Alert Service Bulletin A601R–11–077, Revision A, dated December 11, 2001, excluding Service Bulletin Comment Sheet—Facsimile Reply Sheet and CRJ 100/200 Service Bulletin Facsimile Reply Sheet; as applicable; to do the actions required by this AD, unless the AD specifies otherwise. (1) The Director of the Federal Register approved the incorporation by reference of Bombardier Service Bulletin A601R–11–088, Revision B, dated November 17, 2009, under 5 U.S.C. 552(a) and 1 CFR part 51. (2) The Director of the Federal Register previously approved the incorporation by reference of Bombardier Alert Service Bulletin A601R–11–077, Revision A, dated December 11, 2001, excluding Service Bulletin Comment Sheet—Facsimile Reply Sheet and CRJ 100/200 Service Bulletin Compliance Facsimile Reply Sheet, on April 4, 2003 (68 FR 9509, February 28, 2003). (3) For service information identified in ˆ this AD, contact Bombardier, Inc., 400 Cote ´ Vertu Road West, Dorval, Quebec H4S 1Y9, Canada; telephone 514–855–5000; fax 514– 855–7401; e-mail thd.crj@aero.bombardier.com; Internet https:// www.bombardier.com. (4) You may review copies of the service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, Washington. For information on the availability of this material at the FAA, call 425–227–1221 or 425–227–1152. (5) You may also review copies of the service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: https://www.archives.gov/federal_register/ code_of_federal_regulations/ ibr_locations.html. mstockstill on DSKH9S0YB1PROD with RULES Issued in Renton, Washington on April 16, 2010. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. 2010–9594 Filed 4–28–10; 8:45 am] BILLING CODE 4910–13–P VerDate Mar<15>2010 16:14 Apr 28, 2010 Jkt 220001 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. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 [Docket No. FDA–2010–N–0002] Implantation or Injectable Dosage Form New Animal Drugs; Butorphanol 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 original abbreviated new animal drug application (ANADA) filed by Modern Veterinary Therapeutics, LLC. The ANADA provides for use of an injectable solution of butorphanol tartrate in cats for the relief of pain. DATES: This rule is effective April 29, 2010. FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for Veterinary Medicine (HFV–170), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–8197, email: john.harshman@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Modern Veterinary Therapeutics, LLC, 1550 Madruga Ave., suite 329, Coral Gables, FL 33146, filed ANADA 200–446 for the use of BUTORPHINE (butorphanol tartrate, USP) Veterinary Injection in cats for the relief of pain. Modern Veterinary Therapeutics’ BUTORPHINE Veterinary Injection is approved as a generic copy of TORBUGESIC–SA (butorphanol tartrate, USP) Veterinary Injection, approved under NADA 141– 047 held by Fort Dodge Animal Health, Division of Wyeth, a wholly owned subsidiary of Pfizer, Inc. The ANADA is approved as of March 26, 2010, and the regulations in 21 CFR 522.246 are amended 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. FDA has determined under 21 CFR 25.33 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 PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 List of Subjects in 21 CFR Part 522 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 522 is amended as follows: ■ PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 522 continues to read as follows: ■ Authority: 21 U.S.C. 360b. § 522.246 [Amended] 2. In paragraph (b)(2) of § 522.246, remove ‘‘No. 059130’’ and in its place add ‘‘Nos. 015914 and 059130’’. ■ Dated: April 23, 2010. William T. Flynn, Acting Director, Center for Veterinary Medicine. [FR Doc. 2010–9871 Filed 4–28–10; 8:45 am] BILLING CODE 4160–01–S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 228 [EPA–R10–OW–2010–0086; FRL–9143–2] Ocean Dumping; Designation of Ocean Dredged Material Disposal Sites Offshore of the Siuslaw River, Oregon AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This action finalizes the designation of the Siuslaw River ocean dredged material disposal sites pursuant to the Marine Protection, Research and Sanctuaries Act, as amended (MPRSA). The new sites are needed primarily to serve the long-term need for a location to dispose of material dredged from the Siuslaw River navigation channel, and to provide a location for the disposal of dredged material for persons who have received a permit for such disposal. The newly designated sites will be subject to ongoing monitoring and management to ensure continued protection of the marine environment. E:\FR\FM\29APR1.SGM 29APR1

Agencies

[Federal Register Volume 75, Number 82 (Thursday, April 29, 2010)]
[Rules and Regulations]
[Page 22524]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-9871]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2010-N-0002]


Implantation or Injectable Dosage Form New Animal Drugs; 
Butorphanol

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 original abbreviated new 
animal drug application (ANADA) filed by Modern Veterinary 
Therapeutics, LLC. The ANADA provides for use of an injectable solution 
of butorphanol tartrate in cats for the relief of pain.

DATES:  This rule is effective April 29, 2010.

FOR FURTHER INFORMATION CONTACT:  John K. Harshman, Center for 
Veterinary Medicine (HFV-170), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Modern Veterinary Therapeutics, LLC, 1550 
Madruga Ave., suite 329, Coral Gables, FL 33146, filed ANADA 200-446 
for the use of BUTORPHINE (butorphanol tartrate, USP) Veterinary 
Injection in cats for the relief of pain. Modern Veterinary 
Therapeutics' BUTORPHINE Veterinary Injection is approved as a generic 
copy of TORBUGESIC-SA (butorphanol tartrate, USP) Veterinary Injection, 
approved under NADA 141-047 held by Fort Dodge Animal Health, Division 
of Wyeth, a wholly owned subsidiary of Pfizer, Inc. The ANADA is 
approved as of March 26, 2010, and the regulations in 21 CFR 522.246 
are amended 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.
    FDA has determined under 21 CFR 25.33 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 522

    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 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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


Sec.  522.246  [Amended]

0
2. In paragraph (b)(2) of Sec.  522.246, remove ``No. 059130'' and in 
its place add ``Nos. 015914 and 059130''.

    Dated: April 23, 2010.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2010-9871 Filed 4-28-10; 8:45 am]
BILLING CODE 4160-01-S

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