New Animal Drugs; Butorphanol; Doxapram; Triamcinolone; Tylosin, 60301-60302 [2012-24331]

Download as PDF 60301 Federal Register / Vol. 77, No. 192 / Wednesday, October 3, 2012 / Rules and Regulations (2) For Group 1 airplanes identified in Boeing Alert Service Bulletin 737–31A1332, Revision 1, dated June 24, 2010; except Groups 24, 25, and 27 through 33 airplanes identified in Boeing Alert Service Bulletin 737–31A1332, Revision 3, dated March 28, 2012: This paragraph provides credit for the corresponding actions required by paragraph (h) of this AD, if those actions were performed before the effective date of this AD, using Boeing Alert Service Bulletin 737– 31A1332, Revision 1, dated June 24, 2010, which is not incorporated by reference. (3) For airplanes identified in Boeing Alert Service Bulletin 737–31A1332, Revision 2, dated August 18, 2011; except airplanes identified in paragraph (i)(4) of this AD, and Groups 24, 25, and 27 through 33 airplanes identified in Boeing Alert Service Bulletin 737–31A1332, Revision 3, dated March 28, 2012: This paragraph provides credit for the corresponding actions required by paragraph (h) of this AD, if those actions were performed before the effective date of this AD using Boeing Alert Service Bulletin 737– 31A1332, Revision 2, dated August 18, 2011. (4) For Group 21, Configuration 2 airplanes identified in Boeing Alert Service Bulletin 737–31A1332, Revision 3, dated March 28, 2012: This paragraph provides credit for the corresponding actions required by paragraph (h) of this AD, if those actions were performed before the effective date of this AD using Boeing Alert Service Bulletin 737– 31A1332, Revision 2, dated August 18, 2011; and provided that those actions in Boeing Service Bulletin 737–21–1171, dated February 12, 2009, were accomplished prior to or concurrently with the actions in Boeing Alert Service Bulletin 737–31A1332, Revision 2, dated August 18, 2011. (j) Alternative Methods of Compliance (AMOCs) (1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the Seattle ACO, send it to the attention of the person identified in the Related Information section of this AD. Information may be emailed to: 9-ANMSeattle-ACO-AMOC-Requests@faa.gov. (2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/ certificate holding district office. (3) An AMOC that provides an acceptable level of safety may be used for any repair required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO, to make those findings. For a repair method to be approved, the repair must meet the certification basis of the airplane, and the approval must specifically refer to this AD. (k) Related Information For more information about this AD, contact Francis Smith, Aerospace Engineer, Cabin Safety and Environmental Systems Branch, ANM–150S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue SW., Renton, Washington 98057–3356; phone: (425) 917–6596; fax: (425) 917–6590; email: Francis.Smith@faa.gov. (l) Material Incorporated by Reference (1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51. (2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise. (i) Boeing Special Attention Service Bulletin 737–21–1164, Revision 1, dated May 17, 2012. (ii) Boeing Special Attention Service Bulletin 737–21–1165, Revision 1, dated July 16, 2010. (iii) Boeing Special Attention Service Bulletin 737–21–1165, Revision 2, dated April 30, 2012. (iv) Boeing Alert Service Bulletin 737– 31A1325, dated January 11, 2010. (v) Boeing Alert Service Bulletin 737– 31A1332, Revision 1, dated June 24, 2010. (vi) Boeing Alert Service Bulletin 737– 31A1332, Revision 2, dated August 18, 2011. (vii) Boeing Alert Service Bulletin 737– 31A1332, Revision 3, dated March 28, 2012. (3) For The Boeing Company service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H–65, Seattle, Washington 98124–2207; telephone 206–544–5000, extension 1; fax 206–766–5680; Internet https:// www.myboeingfleet.com. (4) You may review copies of the service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425–227–1221. (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 an NARA facility, 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 September 19, 2012. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. 2012–23800 Filed 10–2–12; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 522, 524, and 558 [Docket No. FDA–2012–N–0002] New Animal Drugs; Butorphanol; Doxapram; Triamcinolone; Tylosin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal approval of a new animal drug application (NADA) and three abbreviated new animal drug applications (ANADAs) at the sponsors’ request because the products are no longer manufactured or marketed. DATES: This rule is effective October 15, 2012. FOR FURTHER INFORMATION CONTACT: David Alterman, Center for Veterinary Medicine (HFV–212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–453–6843, email: david.alterman@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The sponsors of the NADA and ANADAs listed in table 1 have requested that FDA withdraw approval because the products are no longer manufactured or marketed: SUMMARY: TABLE 1—NADA AND ANADAS FOR WHICH WITHDRAWAL OF APPROVAL HAS BEEN REQUESTED NADA/ ANADA No. Trade name (drug) Applicant 100–556 ...... Vigorena Feeds Hy-Ty Premix (tylosin phosphate). RESPIRAM (doxapram hydrochloride) Injection. BUTORPHINE (butorphanol tartrate) Injection. VETAZINE (triamcinolone) Cream ... Springfield Milling Corp., Vigorena Feeds, Springfield, MN 56087 ............ 558.625 Modern Veterinary Therapeutics, LLC, 18001 Old Cutler Rd., suite 317, Miami, FL 33157. Modern Veterinary Therapeutics, LLC, 18001 Old Cutler Rd., suite 317, Miami, FL 33157. Modern Veterinary Therapeutics, LLC, 18001 Old Cutler Rd., suite 317, Miami, FL 33157. 522.775 erowe on DSK2VPTVN1PROD with 200–435 ...... 200–446 ...... 200–459 ...... VerDate Mar<15>2010 14:51 Oct 02, 2012 Jkt 229001 PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 E:\FR\FM\03OCR1.SGM Citation in 21 CFR 03OCR1 522.246 524.2483 60302 Federal Register / Vol. 77, No. 192 / Wednesday, October 3, 2012 / Rules and Regulations Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADA 100–556 and ANADAs 200– 435, 200–446, and 200–459, and all supplements and amendments thereto, is withdrawn, effective October 15, 2012. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these voluntary withdrawals of approval. Following these withdrawals of approval, Modern Veterinary Therapeutics, LLC, and Springfield Milling Corp. will no longer be the sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to remove the entries for these firms. 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 § 522.246 [Amended] 4. In § 522.246, in paragraph (b)(2), remove ‘‘Nos. 015914 and 059130’’ and in its place add ‘‘No. 059130’’. ■ § 522.775 [Amended] 5. In § 522.775, in paragraph (b), remove ‘‘Nos. 000010 and 015914’’ and in its place add ‘‘No. 000010’’. ■ PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 6. The authority citation for 21 CFR part 524 continues to read as follows: ■ Authority: 21 U.S.C. 360b. § 524.2483 [Amended] 7. In § 524.2483, in paragraph (b), remove ‘‘015914,’’. ■ PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 8. The authority citation for 21 CFR part 558 continues to read as follows: ■ 21 CFR Part 510 Authority: 21 U.S.C. 360b, 371. Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. § 558.625 [Amended] 9. In § 558.625, remove and reserve paragraph (b)(40). ■ 21 CFR Parts 522 and 524 Dated: September 27, 2012. Bernadette Dunham, Director, Center for Veterinary Medicine. Animal drugs. 21 CFR Parts 558 [FR Doc. 2012–24331 Filed 10–2–12; 8:45 am] Animal drugs, Animal feeds. Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 510, 522, 524, and 558 are amended as follows: BILLING CODE P DEPARTMENT OF HOMELAND SECURITY Coast Guard Table of Acronyms 33 CFR Part 100 PART 510—NEW ANIMAL DRUGS [Docket Number USCG–2012–0728] ■ 1. The authority citation for 21 CFR part 510 continues to read as follows: RIN 1625–AA08 Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. Special Local Regulations; Red Bull Flugtag Miami, Biscayne Bay; Miami, FL § 510.600 [Amended] erowe on DSK2VPTVN1PROD with PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 3. The authority citation for 21 CFR part 522 continues to read as follows: ■ Authority: 21 U.S.C. 360b. VerDate Mar<15>2010 14:51 Oct 02, 2012 Coast Guard, DHS. Temporary final rule. AGENCY: 2. In § 510.600, in the table in paragraph (c)(1), remove the entries for ‘‘Modern Veterinary Therapeutics, LLC’’ and ‘‘Springfield Milling Corp.’’; and in the table in paragraph (c)(2), remove the entries for ‘‘015914’’ and ‘‘035955’’. ■ Jkt 229001 ACTION: The Coast Guard is establishing a special local regulation on the waters of Biscayne Bay, east of Bayfront Park, in Miami, Florida during the Red Bull Flugtag. The Red Bull Flugtag is scheduled to take place on Saturday, November 3, 2012. The event consists of 30 participants launching self-propelled flying machines from a 30ft ramp to the water below. 150 spectator vessels are expected to attend the event. The special local regulation is SUMMARY: PO 00000 Frm 00018 Fmt 4700 necessary to provide for the safety of the participants, participant vessels, and general public on the navigable waters of the United States during the event. The special local regulation will encompass the following two areas: An event area, where non-participant vessels are prohibited from entering, transiting through, anchoring in, or remaining within; and a spectator area, where all vessels are permitted to anchor. DATES: This rule is effective and will be enforced from 11 a.m. to 4 p.m. on November 3, 2012. ADDRESSES: Documents mentioned in this preamble are part of docket [USCG– 2012–0728]. To view documents mentioned in this preamble as being available in the docket, go to https:// www.regulations.gov, type the docket number in the ‘‘SEARCH’’ box and click ‘‘SEARCH.’’ Click on Open Docket Folder on the line associated with this rulemaking. You may also visit the Docket Management Facility in Room W12–140 on the ground floor of the Department of Transportation West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: If you have questions on this rule, call or email Lieutenant Mike H. Wu, Sector Miami Prevention Department, Coast Guard; telephone 305–535–7576, email Mike.H.Wu@uscg.mil. If you have questions on viewing or submitting material to the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone (202) 366–9826. SUPPLEMENTARY INFORMATION: Sfmt 4700 DHS Department of Homeland Security FR Federal Register NPRM Notice of Proposed Rulemaking A. Regulatory History and Information The Coast Guard is issuing this final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are ‘‘impracticable, unnecessary, or contrary to the public interest.’’ Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the Coast Guard did not receive all event details until September 5, 2012. As a E:\FR\FM\03OCR1.SGM 03OCR1

Agencies

[Federal Register Volume 77, Number 192 (Wednesday, October 3, 2012)]
[Rules and Regulations]
[Pages 60301-60302]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24331]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 522, 524, and 558

[Docket No. FDA-2012-N-0002]


New Animal Drugs; Butorphanol; Doxapram; Triamcinolone; Tylosin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect the withdrawal approval of a new animal 
drug application (NADA) and three abbreviated new animal drug 
applications (ANADAs) at the sponsors' request because the products are 
no longer manufactured or marketed.

DATES: This rule is effective October 15, 2012.

FOR FURTHER INFORMATION CONTACT: David Alterman, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-453-6843, email: david.alterman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The sponsors of the NADA and ANADAs listed 
in table 1 have requested that FDA withdraw approval because the 
products are no longer manufactured or marketed:

   Table 1--NADA and ANADAs for Which Withdrawal of Approval Has Been
                                Requested
------------------------------------------------------------------------
                      Trade name                          Citation in 21
  NADA/ANADA No.        (drug)            Applicant             CFR
------------------------------------------------------------------------
100-556..........  Vigorena Feeds   Springfield Milling          558.625
                    Hy-Ty Premix     Corp., Vigorena
                    (tylosin         Feeds, Springfield,
                    phosphate).      MN 56087.
200-435..........  RESPIRAM         Modern Veterinary            522.775
                    (doxapram        Therapeutics, LLC,
                    hydrochloride)   18001 Old Cutler
                    Injection.       Rd., suite 317,
                                     Miami, FL 33157.
200-446..........  BUTORPHINE       Modern Veterinary            522.246
                    (butorphanol     Therapeutics, LLC,
                    tartrate)        18001 Old Cutler
                    Injection.       Rd., suite 317,
                                     Miami, FL 33157.
200-459..........  VETAZINE         Modern Veterinary           524.2483
                    (triamcinolone   Therapeutics, LLC,
                    ) Cream.         18001 Old Cutler
                                     Rd., suite 317,
                                     Miami, FL 33157.
------------------------------------------------------------------------


[[Page 60302]]

    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of NADA 100-556 and ANADAs 200-435, 200-446, and 200-459, 
and all supplements and amendments thereto, is withdrawn, effective 
October 15, 2012. As provided in the regulatory text of this document, 
the animal drug regulations are amended to reflect these voluntary 
withdrawals of approval.
    Following these withdrawals of approval, Modern Veterinary 
Therapeutics, LLC, and Springfield Milling Corp. will no longer be the 
sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is 
being amended to remove the entries for these firms.
    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

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Parts 522 and 524

    Animal drugs.

21 CFR Parts 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510, 
522, 524, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.


Sec.  510.600  [Amended]

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the 
entries for ``Modern Veterinary Therapeutics, LLC'' and ``Springfield 
Milling Corp.''; and in the table in paragraph (c)(2), remove the 
entries for ``015914'' and ``035955''.

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

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

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


Sec.  522.246  [Amended]

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


Sec.  522.775  [Amended]

0
5. In Sec.  522.775, in paragraph (b), remove ``Nos. 000010 and 
015914'' and in its place add ``No. 000010''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
6. The authority citation for 21 CFR part 524 continues to read as 
follows:

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


Sec.  524.2483  [Amended]

0
7. In Sec.  524.2483, in paragraph (b), remove ``015914,''.

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

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

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


Sec.  558.625  [Amended]

0
9. In Sec.  558.625, remove and reserve paragraph (b)(40).

    Dated: September 27, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-24331 Filed 10-2-12; 8:45 am]
BILLING CODE P
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