New Animal Drugs for Use in Animal Feeds; Melengestrol, 66257-66258 [05-21808]

Download as PDF Federal Register / Vol. 70, No. 211 / Wednesday, November 2, 2005 / Rules and Regulations Issued in Washington, DC, on October 21, 2005. James J. Ballough, Director, Flight Standards Service. effective at 0901 UTC on the dates specified, as follows: PART 97—STANDARD INSTRUMENT APPROACH PROCEDURES Adoption of the Amendment Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal regulations, Part 97, 14 CFR part 97, is amended by amending Standard Instrument Approach Procedures, I 1. The authority citation for part 97 continues to read as follows: I Authority: 49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721–44722. 66257 2. Part 97 is amended to read as follows: By amending: § 97.23 VOR, VOR/ DME, VOR or TACAN, and VOR/DME or TACAN; § 97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; § 97.27 NDB, NDB/DME; § 97.29 ILS, ILS/DME, ISMLS, MLS/DME, MLS/ RNAV; § 97.31 RADAR SIAPs; § 97.33 RNAV SIAPs; and § 97.35 COPTER SIAPs, Identified as follows: I * * * Effective Upon Publication FDC date State City Airport 10/07/05 ....... NE ........ LINCOLN .......................... LINCOLN ................................................ 5/9286 10/07/05 ....... OK ........ NORMAN .......................... 5/9300 10/07/05 ....... OK ........ NORMAN .......................... 5/9302 GPS RWY 17, AMDT 1A. 10/09/05 ....... 10/09/05 ....... 10/11/05 ....... WA ....... WA ....... MO ....... TACOMA .......................... TACOMA .......................... SPRINGFIELD .................. UNIVERSITY OF OKLAHOMA WESTHEIMER. UNIVERSITY OF OKLAHOMA WESTHEIMER. TACOMA NARROWS ............................ TACOMA NARROWS ............................ SPRINGFIELD-BRANSON REGIONAL ILS OR LOC RWY 18, AMDT 6D. GPS RWY 3, ORIG–B. 5/9378 5/9379 5/9405 10/11/05 ....... MO ....... SPRINGFIELD .................. SPRINGFIELD-BRANSON REGIONAL 5/9406 10/11/05 ....... MO ....... SPRINGFIELD .................. SPRINGFIELD-BRANSON REGIONAL 5/9407 10/11/05 ....... IA .......... CEDAR RAPIDS .............. THE EASTERN IOWA ........................... 5/9439 GPS RWY 17, ORIG–A. GPS RWY 35, ORIG–A. VOR/DME OR TACAN RWY 2, ORIG–A. VOR OR TACAN RWY 20, AMDT 18B. ILS OR LOC RWY 2, AMDT 17A. RNAV (GPS) RWY 13, AMDT 1A. [FR Doc. 05–21578 Filed 11–1–05; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds; Melengestrol 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 abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The ANADA provides for use of a melengestrol acetate Type A medicated article with monensin and tylosin Type A medicated articles to make three-way combination Type C medicated feeds for heifers fed in confinement for slaughter. DATES: This rule is effective November 2, 2005. FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for Veterinary Medicine (HFV–104), Food and Drug Administration, 7500 Standish Pl., VerDate Aug<31>2005 16:38 Nov 01, 2005 Jkt 208001 FDC No. Rockville, MD 20855, 240–276–9808, email: john.harshman@fda.gov. SUPPLEMENTARY INFORMATION: Ivy Laboratories, Division of Ivy Animal Health, Inc., 8857 Bond St., Overland Park, KS 66214, filed ANADA 200–375 that provides for use of HEIFERMAX 500 Liquid Premix (melengestrol acetate), RUMENSIN (monensin sodium), and TYLAN (tylosin tartrate) Type A medicated articles to make dry and liquid three-way combination Type C medicated feeds used for increased rate of weight gain and improved feed efficiency, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii, for suppression of estrus (heat), and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes in heifers fed in confinement for slaughter. Ivy Laboratories’ ANADA 200–375 is approved as a generic copy of Pharmacia & Upjohn’s NADA 138–870. The ANADA is approved as of September 19, 2005, and the regulation in 21 CFR 558.342 is 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 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 Subject 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(a)(2) 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. I 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 1. The authority citation for 21 CFR part 558 continues to read as follows: I Authority: 21 U.S.C. 360b, 371. E:\FR\FM\02NOR1.SGM 02NOR1 66258 § 558.342 Federal Register / Vol. 70, No. 211 / Wednesday, November 2, 2005 / Rules and Regulations [Amended] due speed in order to return the bridge to normal operation as soon as possible. 2. Section 558.342 is amended in paragraph (e)(1)(vii) in the table in the ‘‘Sponsor’’ column by adding in numerical sequence ‘‘021641’’. I Dated: October 13, 2005. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 05–21808 Filed 11–1–05; 8:45 am] Dated: October 25, 2005. Gary Kassof, Bridge Program Manager, First Coast Guard District. [FR Doc. 05–21850 Filed 11–1–05; 8:45 am] BILLING CODE 4910–15–P BILLING CODE 4160–01–S DEPARTMENT OF HOMELAND SECURITY DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 Coast Guard [CGD08–05–041] 33 CFR Part 117 RIN 1625–AA09 [CGD01–05–098] Drawbridge Operation Regulation; Tennessee River, Chattanooga, TN Drawbridge Operation Regulations: Newtown Creek, Dutch Kills, English Kills, and Their Tributaries, NY ACTION: Coast Guard, DHS. Notice of temporary deviation from regulations. AGENCY: ACTION: SUMMARY: The Commander, First Coast Guard District, has issued a temporary deviation from the drawbridge operation regulations for the Metropolitan Avenue Bridge, mile 3.4, across English Kills at New York City, New York. Under this temporary deviation the bridge may remain in the closed position from November 14, 2005 through November 20, 2005. This temporary deviation is necessary to facilitate scheduled bridge maintenance. DATES: This deviation is effective from November 14, 2005 through November 20, 2005. FOR FURTHER INFORMATION CONTACT: Judy Leung-Yee, Project Officer, First Coast Guard District, at (212) 668–7195. SUPPLEMENTARY INFORMATION: The Metropolitan Avenue Bridge has a vertical clearance in the closed position of 10 feet at mean high water and 15 feet at mean low water. The existing drawbridge operation regulations are listed at 33 CFR 117.801(e). The owner of the bridge, New York City Department of Transportation (NYCDOT), requested a temporary deviation from the drawbridge operation regulations to facilitate scheduled bridge repairs. Under this temporary deviation the NYCDOT Metropolitan Avenue Bridge may remain in the closed position from November 14, 2005 through November 20, 2005. This deviation from the operating regulations is authorized under 33 CFR 117.35, and will be performed with all VerDate Aug<31>2005 16:38 Nov 01, 2005 Jkt 208001 Coast Guard, DHS. Temporary Final rule. AGENCY: SUMMARY: The Coast Guard is changing the regulation governing the Chief John Ross Drawbridge, mile 464.1, across the Tennessee River at Chattanooga, Tennessee. Under the temporary change, the drawbridge need not open for river traffic and may remain in the closed-to-navigation position from 8 a.m., December 1, 2005 until 8 a.m., July 1, 2006. This temporary change will allow the drawbridge to be maintained in the closed-to-navigation position to allow major repair work to be performed on the bridge. DATES: This rule is effective from 8 a.m., December 1, 2005 through 8 a.m., July 1, 2006. ADDRESSES: Comments and material received from the public, as well as documents indicated in this preamble as being available in the docket, are part of docket [CGD08–05–041] and are available for inspection or copying at room 2.107f in the Robert A. Young Federal Building, Eighth Coast Guard District, 1222 Spruce Street, St. Louis, MO 63103–2831 between 8 a.m. and 4 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: Mr. Roger K. Wiebusch, Bridge Administrator, (314) 539–3900, extension 2378. SUPPLEMENTARY INFORMATION: Regulatory Information On August 25, 2005, we published a notice of proposed rulemaking (NPRM) entitled Drawbridge Operation Regulation; Tennessee River, Chattanooga, TN in the Federal Register (70 FR 49900). We received no letters PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 commenting on the proposed rule. No public meeting was requested, and none was held. Background and Purpose On February 11, 2005, the State of Tennessee Department of Transportation requested a temporary change to the operation of the Chief John Ross Drawbridge, across the Tennessee River, mile 464.1, at Chattanooga, Tennessee to allow the drawbridge to remain in the closed-tonavigation position for seven months to perform major repairs to the bridge. The drawbridge has a vertical clearance of 58.7 feet above normal pool in the closed-to-navigation position. Navigation on the waterway consists primarily of commercial tows and recreational watercraft that will be minimally impacted by the closure period. Presently, the draw opens on signal for the passage of river traffic when the vertical clearance beneath the draw is 50 feet or less. When the vertical clearance beneath the draw is more than 50 feet, at least eight hours notice is required. The Tennessee Department of Transportation requested the drawbridge be permitted to remain in the closed-to-navigation position from 8 a.m., December 1, 2005, until 8 a.m., July 1, 2006. This temporary change to the drawbridge’s schedule has been coordinated with the commercial waterway operators. Discussion of Comments and Changes We received no comments on the NPRM, and have made no changes from the proposed rule. Regulatory Evaluation This rule is not a ‘‘significant regulatory action’’ under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not ‘‘significant’’ under the regulatory policies and procedures of the Department of Homeland Security (DHS). The Coast Guard expects this temporary change will have minimal economic impact on commercial traffic operating on the Tennessee River. There is sufficient height, when the drawbridge is closed, to allow for the vast majority of commercial users to pass. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601–612), we have considered E:\FR\FM\02NOR1.SGM 02NOR1

Agencies

[Federal Register Volume 70, Number 211 (Wednesday, November 2, 2005)]
[Rules and Regulations]
[Pages 66257-66258]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-21808]


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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; Melengestrol

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 abbreviated new animal drug 
application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal 
Health, Inc. The ANADA provides for use of a melengestrol acetate Type 
A medicated article with monensin and tylosin Type A medicated articles 
to make three-way combination Type C medicated feeds for heifers fed in 
confinement for slaughter.

DATES: This rule is effective November 2, 2005.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-9808, e-mail: 
john.harshman@fda.gov.

SUPPLEMENTARY INFORMATION: Ivy Laboratories, Division of Ivy Animal 
Health, Inc., 8857 Bond St., Overland Park, KS 66214, filed ANADA 200-
375 that provides for use of HEIFERMAX 500 Liquid Premix (melengestrol 
acetate), RUMENSIN (monensin sodium), and TYLAN (tylosin tartrate) Type 
A medicated articles to make dry and liquid three-way combination Type 
C medicated feeds used for increased rate of weight gain and improved 
feed efficiency, prevention and control of coccidiosis due to Eimeria 
bovis and E. zuernii, for suppression of estrus (heat), and reduction 
of incidence of liver abscesses caused by Fusobacterium necrophorum and 
Actinomyces (Corynebacterium) pyogenes in heifers fed in confinement 
for slaughter. Ivy Laboratories' ANADA 200-375 is approved as a generic 
copy of Pharmacia & Upjohn's NADA 138-870. The ANADA is approved as of 
September 19, 2005, and the regulation in 21 CFR 558.342 is 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.
    FDA has determined under 21 CFR 25.33(a)(2) 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.

[[Page 66258]]

Sec.  558.342  [Amended]

0
2. Section 558.342 is amended in paragraph (e)(1)(vii) in the table in 
the ``Sponsor'' column by adding in numerical sequence ``021641''.

    Dated: October 13, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-21808 Filed 11-1-05; 8:45 am]
BILLING CODE 4160-01-S

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