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part 51. Contact British Aerospace Regional § 39.13 [Corrected] in 21 CFR 558.625 are amended to
Aircraft American Support, 13850 Mclearen reflect the approval. The basis of
■ On page 682, in the first column, in
Road, Herndon, Virginia 20171, for a copy of approval is discussed in the freedom of
this service information. You may review the PART 39—AIRWORTHINESS
DIRECTIVES Section, in the information summary.
copies at the Docket Management Facility,
U.S. Department of Transportation, 400 Applicability paragraph, in the second In accordance with the freedom of
Seventh Street, SW., Room PL–401, Nassif line, ‘‘UL29916’’ is corrected to read information provisions of 21 CFR part
Building, Washington, DC; on the Internet at ‘‘UL26916’’. 20 and 21 CFR 514.11(e)(2)(ii), a
http://dms.dot.gov; or at the National summary of safety and effectiveness
Issued in Burlington, Massachusetts, on
Archives and Records Administration December 5, 2006.
data and information submitted to
(NARA). For information on the availability support approval of this application
of this material at the NARA, call (202) 741– Diane M. Cook,
may be seen in the Division of Dockets
6030, or go to http://www.archives.gov/ Acting Manager, Engine and Propeller
Management (HFA–305), Food and Drug
federal_register/code_of_federal_regulations/ Directorate, Aircraft Certification Service.
Administration, 5630 Fishers Lane, rm.
ibr_locations.html. [FR Doc. E6–21122 Filed 12–11–06; 8:45 am]
1061, Rockville, MD 20852, between 9
Issued in Renton, Washington, on BILLING CODE 4910–13–P
a.m. and 4 p.m., Monday through
December 1, 2006. Friday.
Kevin M. Mullin, Under section 512(c)(2)(F)(iii) of the
Acting Manager, Transport Airplane DEPARTMENT OF HEALTH AND Federal Food, Drug, and Cosmetic Act
Directorate, Aircraft Certification Service. HUMAN SERVICES (21 U.S.C. 360b(c)(2)(F)(iii)), this
[FR Doc. E6–20952 Filed 12–11–06; 8:45 am] approval qualifies for 3 years of
Food and Drug Administration marketing exclusivity beginning
BILLING CODE 4910–13–P
November 7, 2006.
21 CFR Part 558 FDA has determined under 21 CFR
DEPARTMENT OF TRANSPORTATION 25.33(a)(1) that this action is of a type
New Animal Drugs For Use in Animal
Feeds; Tylosin that does not individually or
Federal Aviation Administration cumulatively have a significant effect on
AGENCY: Food and Drug Administration, the human environment. Therefore,
14 CFR Part 39 HHS. neither an environmental assessment
[Docket No. 2004–NE–19–AD; Amendment
ACTION: Final rule. nor an environmental impact statement
39–13197; AD 2004–26–05] is required.
SUMMARY: The Food and Drug This rule does not meet the definition
RIN 2120–AA64
Administration (FDA) is amending the of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
animal drug regulations to reflect it is a rule of ‘‘particular applicability.’’
Airworthiness Directives; Rolls-Royce approval of a supplemental new animal Therefore, it is not subject to the
plc RB211–524 Series Turbofan drug application (NADA) filed by congressional review requirements in 5
Engines; Correction Elanco Animal Health, A Division of Eli U.S.C. 801–808.
Lilly & Co. The supplemental NADA
AGENCY: Federal Aviation provides for an alternate feeding List of Subjects in 21 CFR Part 558
Administration, DOT. regimen for tylosin phosphate in Type Animal drugs, Animal feeds.
ACTION: Final rule; correction. C medicated swine feeds used for the
■ Therefore, under the Federal Food,
control of swine proliferative
SUMMARY: This document makes a Drug, and Cosmetic Act and under
enteropathies.
correction to airworthiness directive authority delegated to the Commissioner
DATES: This rule is effective December of Food and Drugs and redelegated to
(AD) 2004–26–05 applicable to certain
Rolls-Royce plc (RR) RB211–524 series 12, 2006. the Center for Veterinary Medicine, 21
turbofan engines that was published in FOR FURTHER INFORMATION CONTACT: Joan CFR part 558 is amended as follows:
the Federal Register on January 5, 2005. C. Gotthardt, Center for Veterinary
Medicine (HFV–130), Food and Drug PART 558—NEW ANIMAL DRUGS FOR
The part number UL29916 in the
Administration, 7500 Standish Pl., USE IN ANIMAL FEEDS
Applicability section is incorrect. This
document corrects that part number. In Rockville, MD 20855, 301–827–7571, e-
mail: joan.gotthardt@fda.hhs.gov. ■ 1. The authority citation for 21 CFR
all other respects, the original document part 558 continues to read as follows:
remains the same. SUPPLEMENTARY INFORMATION: Elanco
Animal Health, A Division of Eli Lilly Authority: 21 U.S.C. 360b, 371.
DATES: Effective Date: December 12,
2006. & Co., Lilly Corporate Center, ■ 2. In § 558.625, revise paragraphs
Indianapolis, IN 46285, filed a (f)(1)(i)(b), (f)(1)(vi)(b)(1), (f)(1)(vi)(c)(1),
FOR FURTHER INFORMATION CONTACT: Ian supplement to NADA 12–491 that and (f)(1)(vi)(e)(1) to read as follows:
Dargin, Aerospace Engineer, Engine provides for use of TYLAN (tylosin
Certification Office, FAA, Engine and phosphate) Type A medicated articles. § 558.625 Tylosin.
Propeller Directorate, 12 New England The supplement provides for an * * * * *
Executive Park, Burlington, MA 01803– alternate feeding regimen for the control (f) * * *
5299; telephone (781) 238–7178; fax of swine proliferative enteropathies (1) * * *
(781) 238–7199. (ileitis) associated with Lawsonia (i) * * *
SUPPLEMENTARY INFORMATION: A final intracellularis. In addition, Elanco (b) Indications for use. For reduction
rule airworthiness directive FR Doc, 05– Animal Health revised the names of of incidence of liver abscesses caused by
85 applicable to RR RB211–524 series other enteric pathogens of swine to Fusobacterium necrophorum and
jlentini on PROD1PC65 with RULES
turbofan engines, was published in the reflect changes in the scientific Arcanobacterium (Actinomyces)
Federal Register on January 5, 2005 (70 nomenclature for these bacteria. The pyogenes.
FR 681). The following correction is supplemental NADA is approved as of * * * * *
needed: November 7, 2006, and the regulations (vi) * * *
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Federal Register / Vol. 71, No. 238 / Tuesday, December 12, 2006 / Rules and Regulations 74467
SUPPLEMENTARY INFORMATION:
2005–73 (2005–42 I.R.B. 723) (Oct. 17, regulatory assessment is not required. It
Background 2005) (listing parishes and counties also has been determined that section
This document contains amendments designated for assistance under the 553(b) of the Administrative Procedure
to the Income Tax Regulations (26 CFR Stafford Act). Act (5 U.S.C. chapter 5) does not apply
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