Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug Applications for Combination Drug Medicated Feeds Containing an Arsenical Drug; Correction, 18990 [2014-07702]

Download as PDF 18990 Federal Register / Vol. 79, No. 66 / Monday, April 7, 2014 / Rules and Regulations (L) Fokker Drawing W69240, Sheet 004, Issue B, dated November 12, 2009. (M) Fokker Drawing W69335, Sheet 001, dated November 12, 2009. (N) Fokker Drawing W69405, Sheet 001, dated November 12, 2009. (O) Fokker Drawing W69710, Sheet 004, Issue B, dated November 12, 2008. (ii) Reserved. (3) For service information identified in this AD, contact Fokker Services B.V., Technical Services Dept., P.O. Box 1357, 2130 EL Hoofddorp, the Netherlands; telephone +31 (0)88–6280–350; fax +31 (0)88–6280–111; email technicalservices@fokker.com; Internet https://www.myfokkerfleet.com. (4) You may view this 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 view this 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/cfr/ibrlocations.html. Issued in Renton, Washington, on March 27, 2014. Jeffrey E. Duven, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. 2014–07326 Filed 4–4–14; 8:45 am] Medicine (HFV–6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–276–9019, George.haibel@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In FR Doc. 2014–02616, appearing on page 10974 in the Federal Register of February 27, 2014, the following corrections are made: On page 10974, in the third column, in the 2d line of the ‘‘SUMMARY’’ section remove ‘‘69’’ and add in its place ‘‘68’’. On page 10975, the first bulleted text ‘‘Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria has requested that FDA withdraw approval of the following 16 NADAs and 8 ANADAs’’ is corrected to read ‘‘Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria, has requested that FDA withdraw approval of the following 15 NADAs and 8 ANADAs’’; and on the same page in the table, the entry ‘‘013– 461 3–NITRO (roxarsone)/AMPROL Plus (amprolium and ethopabate).’’ is removed. Dated: April 2, 2014. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2014–07702 Filed 4–4–14; 8:45 am] BILLING CODE 4160–01–P BILLING CODE 4910–13–P DEPARTMENT OF THE TREASURY DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of Foreign Assets Control Food and Drug Administration 31 CFR Part 560 21 CFR Parts 556 and 558 Iranian Transactions and Sanctions Regulations [Docket No. FDA–2014–N–0002] Office of Foreign Assets Control, Treasury. ACTION: Final rule. AGENCY: Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug Applications for Combination Drug Medicated Feeds Containing an Arsenical Drug; Correction AGENCY: Food and Drug Administration, HHS. Notification of withdrawal of approval; correction. ACTION: The Food and Drug Administration (FDA) published a document in the Federal Register of February 27, 2014, concerning the voluntary withdrawal of approval of new animal drug applications (NADAs). The document contained an incorrect list of NADAs. DATES: This correction is effective April 7, 2014. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary ehiers on DSK2VPTVN1PROD with RULES SUMMARY: VerDate Mar<15>2010 14:32 Apr 04, 2014 Jkt 232001 The Department of the Treasury’s Office of Foreign Assets Control (‘‘OFAC’’) is adopting a final rule amending the Iranian Transactions and Sanctions Regulations (‘‘ITSR’’) by expanding an existing general license that authorizes the exportation or reexportation of food to individuals and entities in Iran to include the broader category of agricultural commodities. The rule also clarifies and adds certain definitions in OFAC regulations. Finally, the rule adds a new general license that authorizes the exportation or reexportation of certain replacement parts for certain medical devices. DATES: Effective: April 7, 2014. FOR FURTHER INFORMATION CONTACT: Assistant Director for Licensing, tel.: 202/622–2480, Assistant Director for SUMMARY: PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 Policy, tel.: 202/622–2746, Assistant Director for Regulatory Affairs, tel.: 202/ 622–4855, Assistant Director for Sanctions Compliance and Evaluation, tel.: 202/622–2490, Office of Foreign Assets Control, or Chief Counsel (Foreign Assets Control), tel.: 202/622– 2410, Office of the General Counsel, Department of the Treasury (not toll free numbers). SUPPLEMENTARY INFORMATION: OFAC is adopting a final rule amending the ITSR by expanding an existing general license that authorizes the exportation or reexportation of food to individuals and entities in Iran to include the broader category of agricultural commodities. Exports of certain specified items, as well as exports to certain persons, are excluded from the general license. Additionally, OFAC is clarifying, for purposes of the general licenses in ITSR § 560.530, that the definitions of the terms agricultural commodities, medicine, and medical device include, in the case of items subject to the Export Administration Regulations, 15 CFR Part 730 et seq. (‘‘EAR’’), items that are designated as EAR99 and, in the case of items that are not subject to the EAR, items that would be designated as EAR99 if they were located in the United States. Furthermore, this rule adds a definition of ‘‘covered person,’’ which, with respect to the exportation or reexportation of items subject to the EAR, is a U.S. person or a non-U.S. person, and for purposes of items not subject to the EAR, is a U.S. person, wherever located, or an entity owned or controlled by a U.S. person and established or maintained outside the United States (a ‘‘U.S.-owned or -controlled foreign entity’’). This amendment clarifies that, for purposes of the exportation or reexportation of items that are not subject to the EAR, and consistent with 31 CFR 560.556, the general licenses set forth in § 560.530 apply to any U.S. person, wherever located, or any U.S.-owned or -controlled foreign entity. Finally, OFAC is adding a new general license that authorizes the exportation or reexportation of replacement parts for certain medical devices to individuals and entities in Iran provided that the replacement parts are designated under the EAR as EAR99, or would be designated as EAR99 if they were located in the United States, and limited to a one-for-one export or reexport basis. This rule also updates the definition of ‘‘basic medical supplies’’ to exclude the word ‘‘basic’’ and make related conforming changes. Accordingly, the ‘‘List of Basic Medical E:\FR\FM\07APR1.SGM 07APR1

Agencies

[Federal Register Volume 79, Number 66 (Monday, April 7, 2014)]
[Rules and Regulations]
[Page 18990]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07702]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 556 and 558

[Docket No. FDA-2014-N-0002]


Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug 
Applications for Combination Drug Medicated Feeds Containing an 
Arsenical Drug; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal of approval; correction.

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

SUMMARY: The Food and Drug Administration (FDA) published a document in 
the Federal Register of February 27, 2014, concerning the voluntary 
withdrawal of approval of new animal drug applications (NADAs). The 
document contained an incorrect list of NADAs.

DATES: This correction is effective April 7, 2014.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9019, 
George.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In FR Doc. 2014-02616, appearing on page 
10974 in the Federal Register of February 27, 2014, the following 
corrections are made:
    On page 10974, in the third column, in the 2d line of the 
``SUMMARY'' section remove ``69'' and add in its place ``68''.
    On page 10975, the first bulleted text ``Huvepharma AD, 5th Floor, 
3A Nikolay Haitov Str., 1113 Sofia, Bulgaria has requested that FDA 
withdraw approval of the following 16 NADAs and 8 ANADAs'' is corrected 
to read ``Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, 
Bulgaria, has requested that FDA withdraw approval of the following 15 
NADAs and 8 ANADAs''; and on the same page in the table, the entry 
``013-461 3-NITRO (roxarsone)/AMPROL Plus (amprolium and ethopabate).'' 
is removed.

    Dated: April 2, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-07702 Filed 4-4-14; 8:45 am]
BILLING CODE 4160-01-P
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