New Animal Drugs For Use in Animal Feeds; Tylosin, 74466-74467 [E6-21021]

Download as PDF 74466 Federal Register / Vol. 71, No. 238 / Tuesday, December 12, 2006 / Rules and Regulations part 51. Contact British Aerospace Regional Aircraft American Support, 13850 Mclearen Road, Herndon, Virginia 20171, 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. § 39.13 Issued in Renton, Washington, on December 1, 2006. Kevin M. Mullin, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E6–20952 Filed 12–11–06; 8:45 am] BILLING CODE 4910–13–P BILLING CODE 4910–13–P [Corrected] On page 682, in the first column, in the PART 39—AIRWORTHINESS DIRECTIVES Section, in the Applicability paragraph, in the second line, ‘‘UL29916’’ is corrected to read ‘‘UL26916’’. I Issued in Burlington, Massachusetts, on December 5, 2006. Diane M. Cook, Acting Manager, Engine and Propeller Directorate, Aircraft Certification Service. [FR Doc. E6–21122 Filed 12–11–06; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 DEPARTMENT OF TRANSPORTATION Federal Aviation Administration AGENCY: 14 CFR Part 39 RIN 2120–AA64 Airworthiness Directives; Rolls-Royce plc RB211–524 Series Turbofan Engines; Correction Federal Aviation Administration, DOT. ACTION: Final rule; correction. AGENCY: SUMMARY: This document makes a correction to airworthiness directive (AD) 2004–26–05 applicable to certain Rolls-Royce plc (RR) RB211–524 series turbofan engines that was published in the Federal Register on January 5, 2005. The part number UL29916 in the Applicability section is incorrect. This document corrects that part number. In all other respects, the original document remains the same. DATES: Effective Date: December 12, 2006. Ian Dargin, Aerospace Engineer, Engine Certification Office, FAA, Engine and Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803– 5299; telephone (781) 238–7178; fax (781) 238–7199. SUPPLEMENTARY INFORMATION: A final rule airworthiness directive FR Doc, 05– 85 applicable to RR RB211–524 series turbofan engines, was published in the Federal Register on January 5, 2005 (70 FR 681). The following correction is needed: jlentini on PROD1PC65 with RULES FOR FURTHER INFORMATION CONTACT: 17:58 Dec 11, 2006 Food and Drug Administration, HHS. [Docket No. 2004–NE–19–AD; Amendment 39–13197; AD 2004–26–05] VerDate Aug<31>2005 New Animal Drugs For Use in Animal Feeds; Tylosin Jkt 211001 ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health, A Division of Eli Lilly & Co. The supplemental NADA provides for an alternate feeding regimen for tylosin phosphate in Type C medicated swine feeds used for the control of swine proliferative enteropathies. DATES: This rule is effective December 12, 2006. FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for Veterinary Medicine (HFV–130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a supplement to NADA 12–491 that provides for use of TYLAN (tylosin phosphate) Type A medicated articles. The supplement provides for an alternate feeding regimen for the control of swine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis. In addition, Elanco Animal Health revised the names of other enteric pathogens of swine to reflect changes in the scientific nomenclature for these bacteria. The supplemental NADA is approved as of November 7, 2006, and the regulations PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 in 21 CFR 558.625 are amended to reflect the approval. 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. Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval qualifies for 3 years of marketing exclusivity beginning November 7, 2006. FDA 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 558 Animal drugs, Animal feeds. 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 558 is amended as follows: I PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 1. The authority citation for 21 CFR part 558 continues to read as follows: I Authority: 21 U.S.C. 360b, 371. 2. In § 558.625, revise paragraphs (f)(1)(i)(b), (f)(1)(vi)(b)(1), (f)(1)(vi)(c)(1), and (f)(1)(vi)(e)(1) to read as follows: I § 558.625 Tylosin. * * * * * (f) * * * (1) * * * (i) * * * (b) Indications for use. For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes. * * * * * (vi) * * * E:\FR\FM\12DER1.SGM 12DER1 Federal Register / Vol. 71, No. 238 / Tuesday, December 12, 2006 / Rules and Regulations (b) * * * (1) Indications for use. For control of swine dysentery associated with Brachyspira hyodysenteriae, and for control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis. * * * * * (c) * * * (1) Indications for use. For treatment and control of swine dysentery associated with B. hyodysenteriae. * * * * * (e) * * * (1) Indications for use. For control of porcine proliferative enteropathies (ileitis) associated with L. intracellularis. Dated: November 29, 2006. David R. Newkirk, Acting Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. E6–21021 Filed 12–11–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [TD 9301] RIN 1545–BF89 Reduction in Taxable Income for Housing Hurricane Katrina Displaced Individuals Internal Revenue Service (IRS), Treasury. ACTION: Temporary regulations. jlentini on PROD1PC65 with RULES AGENCY: SUMMARY: This document contains temporary regulations relating to the reduction in taxable income under section 302 of the Katrina Emergency Tax Relief Act of 2005. The regulations affect taxpayers who provide housing in their principal residences to individuals displaced by Hurricane Katrina. The text of the temporary regulations also serves as the text of the proposed regulations set forth in the notice of proposed rulemaking on this subject in the Proposed Rules section in this issue of the Federal Register. DATES: Effective Date: These regulations are effective December 11, 2006. Applicability Date: For date of applicability, see § 1.9300–1T(g). FOR FURTHER INFORMATION CONTACT: Marnette M. Myers, 202–622–4920 (not a toll-free number). SUPPLEMENTARY INFORMATION: Background This document contains amendments to the Income Tax Regulations (26 CFR VerDate Aug<31>2005 17:58 Dec 11, 2006 Jkt 211001 part 1) relating to the reduction in taxable income for housing provided to displaced individuals under section 302 of the Katrina Emergency Tax Relief Act of 2005 (Pub. L. No. 109–73, 119 Stat. 2016) (KETRA). For taxable years beginning in 2005 and 2006, a taxpayer may reduce taxable income by $500 for each Hurricane Katrina displaced individual to whom the taxpayer provides free housing in the taxpayer’s principal residence for a period of 60 consecutive days that ends in the taxable year. No reduction is allowed if the taxpayer receives rent or other compensation from any source for providing the housing. A taxpayer may not claim a reduction in taxable income with respect to the same Hurricane Katrina displaced individual in more than one taxable year and must include the Hurricane Katrina displaced individual’s tax identification number on the taxpayer’s return. Generally, the total reduction for all taxable years is $2,000. A Hurricane Katrina displaced individual is defined as a natural person who was displaced from a principal place of abode that, on August 28, 2005, was in the Hurricane Katrina core disaster area. A Hurricane Katrina displaced individual also is defined as an individual whose principal place of abode was located in the Hurricane Katrina disaster area, but outside the core disaster area, if the abode was damaged by Hurricane Katrina or the individual was evacuated from the abode because of Hurricane Katrina. A Hurricane Katrina displaced individual may not be the taxpayer’s spouse or dependent. Under section 2(1) of KETRA, the Hurricane Katrina disaster area is the area with respect to which a major disaster by reason of Hurricane Katrina has been declared by the President before September 14, 2005, under section 401 of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5170) (Stafford Act). For purposes of relief provided under KETRA, this area comprises the states of Louisiana, Mississippi, Alabama, and Florida. Under section 2(2) of KETRA, the Hurricane Katrina core disaster area is the portion of the Hurricane Katrina disaster area determined by the President to warrant individual or individual and public assistance from the Federal government under the Stafford Act. See Appendix to Notice 2005–73 (2005–42 I.R.B. 723) (Oct. 17, 2005) (listing parishes and counties designated for assistance under the Stafford Act). PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 74467 Explanation of Provisions Provision of Housing The temporary regulations provide that a taxpayer is considered to provide housing if the housing is provided either in, or on the site of, the taxpayer’s principal residence. In addition, the taxpayer must be an owner or lessee of the residence to be treated as providing housing to a Hurricane Katrina displaced individual. The term principal residence has the same meaning as in section 121 and the regulations thereunder. Amounts in connection with the provision of housing (for which the taxpayer may not be reimbursed or compensated) include rent and utilities. Amounts for telephone calls, food, clothing and transportation are not amounts in connection with the provision of housing for this purpose. Limitations on Amount of Reduction The temporary regulations provide that the $2,000 aggregate limit on the reduction in taxable income applies to unmarried individuals and married taxpayers filing a joint tax return. Married taxpayers who file separate returns may reduce taxable income by $1,000 each for all taxable years. The temporary regulations clarify that a taxpayer may reduce taxable income with respect to a specific Hurricane Katrina displaced individual in 2005 or 2006, but not both years. Additionally, the temporary regulations provide that a Hurricane Katrina displaced individual may be taken into account by only one taxpayer occupying the same principal residence. Effective Date The temporary regulations apply to taxable years beginning after December 31, 2004, and before January 1, 2007, and ending on or after December 11, 2006, which is the date the temporary regulations were filed with the Federal Register. Taxpayers may rely on the temporary regulations with respect to taxable years ending before the filing date, but may not rely on the absence of regulations for taxable years ending before the filing date for a result contrary to that under the temporary regulations. Special Analyses It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply E:\FR\FM\12DER1.SGM 12DER1

Agencies

[Federal Register Volume 71, Number 238 (Tuesday, December 12, 2006)]
[Rules and Regulations]
[Pages 74466-74467]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-21021]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs For Use in Animal Feeds; 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 approval of a supplemental new animal drug 
application (NADA) filed by Elanco Animal Health, A Division of Eli 
Lilly & Co. The supplemental NADA provides for an alternate feeding 
regimen for tylosin phosphate in Type C medicated swine feeds used for 
the control of swine proliferative enteropathies.

DATES: This rule is effective December 12, 2006.

FOR FURTHER INFORMATION CONTACT:  Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: 
joan.gotthardt@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a 
supplement to NADA 12-491 that provides for use of TYLAN (tylosin 
phosphate) Type A medicated articles. The supplement provides for an 
alternate feeding regimen for the control of swine proliferative 
enteropathies (ileitis) associated with Lawsonia intracellularis. In 
addition, Elanco Animal Health revised the names of other enteric 
pathogens of swine to reflect changes in the scientific nomenclature 
for these bacteria. The supplemental NADA is approved as of November 7, 
2006, and the regulations in 21 CFR 558.625 are amended to reflect the 
approval. 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.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval qualifies 
for 3 years of marketing exclusivity beginning November 7, 2006.
    FDA 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 558

    Animal drugs, Animal feeds.

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 558 is 
amended as follows:

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

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

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

0
2. In Sec.  558.625, revise paragraphs (f)(1)(i)(b), (f)(1)(vi)(b)(1), 
(f)(1)(vi)(c)(1), and (f)(1)(vi)(e)(1) to read as follows:


Sec.  558.625  Tylosin.

* * * * *
    (f) * * *
    (1) * * *
    (i) * * *
    (b) Indications for use. For reduction of incidence of liver 
abscesses caused by Fusobacterium necrophorum and Arcanobacterium 
(Actinomyces) pyogenes.
* * * * *
    (vi) * * *

[[Page 74467]]

    (b) * * *
    (1) Indications for use. For control of swine dysentery associated 
with Brachyspira hyodysenteriae, and for control of porcine 
proliferative enteropathies (ileitis) associated with Lawsonia 
intracellularis.
* * * * *
    (c) * * *
    (1) Indications for use. For treatment and control of swine 
dysentery associated with B. hyodysenteriae.
* * * * *
    (e) * * *
    (1) Indications for use. For control of porcine proliferative 
enteropathies (ileitis) associated with L. intracellularis.

    Dated: November 29, 2006.
David R. Newkirk,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. E6-21021 Filed 12-11-06; 8:45 am]
BILLING CODE 4160-01-S
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