Oral Dosage Form New Animal Drugs; Chlortetracycline Powder, 62490-62491 [E9-28468]

Download as PDF 62490 Federal Register / Vol. 74, No. 228 / Monday, November 30, 2009 / Rules and Regulations Examining the AD Docket You may examine the AD docket on the Internet at https:// www.regulations.gov; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647–5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. Adoption of the Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows: ■ PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: ■ Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The FAA amends § 39.13 by adding the following new AD: ■ 2009–24–14 Empresa Brasileira de ´ Aeronautica S.A. (EMBRAER): Amendment 39–16108; Docket No. FAA–2009–0870; Directorate Identifier 2009–CE–049–AD. Effective Date (a) This airworthiness directive (AD) becomes effective January 4, 2010. Affected ADs (b) None. Applicability (c) This AD applies to EMB–500 airplanes, serial numbers 50000005, 50000006, 50000008 through 50000036, 50000038 through 50000041, 50000043 through 50000046, 50000048, and 50000053, certificated in any category. WReier-Aviles on DSKGBLS3C1PROD with RULES Subject (d) Air Transport Association of America (ATA) Code 27: Flight Controls. Reason (e) The mandatory continuing airworthiness information (MCAI) states: It has been found the possibility of elevator mass balance fasteners becoming slack under certain conditions. The loose of at least two fasteners may lead to an unbalance condition, which may induce flutter on airplane elevators. VerDate Nov<24>2008 14:56 Nov 27, 2009 Jkt 220001 The MCAI requires replacement of the nuts of the right and left elevators mass balance fasteners. Actions and Compliance (f) Unless already done, do the following actions: (1) Within the next 30 days after January 4, 2010 (the effective date of this AD), replace the nuts of the right-hand (RH) and left-hand (LH) elevators’ mass balance fasteners with new ones of self-locking type bearing part number (P/N) MS21043–4. Do the replacements following Phenom by Embraer Service Bulletin No. 500–55–0001, dated July 24, 2009. (2) As of 30 days after January 4, 2010 (the effective date of this AD), only install selflocking type nuts, P/N MS21043–4, on the RH and LH elevators’ mass balance fasteners. FAA AD Differences Note: This AD differs from the MCAI and/ or service information as follows: No differences. Other FAA AD Provisions (g) The following provisions also apply to this AD: (1) Alternative Methods of Compliance (AMOCs): The Manager, Standards Office, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to Attn: Karl Schletzbaum, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329–4146; fax: (816) 329– 4090. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector (PI) in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO. (2) Airworthy Product: For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service. (3) Reporting Requirements: For any reporting requirement in this AD, under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has approved the information collection requirements and has assigned OMB Control Number 2120–0056. Related Information ˆ (h) Refer to MCAI Agencia Nacional de Aviacao Civil (ANAC) Brazilian ¸˜ Airworthiness Directive AD No.: 2009–09– 01, dated September 3, 2009, and Phenom by Embraer Service Bulletin No. 500–55–0001, dated July 24, 2009, for related information. Material Incorporated by Reference (i) You must use Phenom by Embraer Service Bulletin No. 500–55–0001, dated July 24, 2009, to do the actions required by this AD, unless the AD specifies otherwise. (1) The Director of the Federal Register approved the incorporation by reference of PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 this service information under 5 U.S.C. 552(a) and 1 CFR part 51. (2) For service information identified in this AD, contact EMBRAER Empresa ´ Brasileira de Aeronautica S.A., Phenom Maintenance Support, Av. Brig. Farina Lima, 2170, Sao Jose dos Campos—SP, CEP: 12227– 901—PO Box: 38/2, BRASIL, telephone: ++55 12 3927–5383; fax: ++55 12 3927–2610; Email: reliability.executive@embraer.com.br; Internet: https://www.embraer.com.br. (3) You may review copies of the service information incorporated by reference for this AD at the FAA, Central Region, Office of the Regional Counsel, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the Central Region, call (816) 329–3768. (4) You may also review copies of the service information incorporated by reference for this AD 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/ code_of_federal_regulations/ibr_ locations.html. Issued in Kansas City, Missouri, on November 19, 2009. Patrick R. Mullen, Acting Manager, Small Airplane Directorate, Aircraft Certification Service. [FR Doc. E9–28306 Filed 11–27–09; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA–2009–N–0665] Oral Dosage Form New Animal Drugs; Chlortetracycline Powder 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 Alpharma Inc. The ANADA provides for use of generic chlortetracycline soluble powder to make medicated drinking water for cattle, swine, chickens, and turkeys for the treatment of several bacterial diseases. DATES: This rule is effective November 30, 2009. FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for Veterinary Medicine (HFV–104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–8197, email: john.harshman@fda.hhs.gov. E:\FR\FM\30NOR1.SGM 30NOR1 Federal Register / Vol. 74, No. 228 / Monday, November 30, 2009 / Rules and Regulations Alpharma Inc., 440 Route 22, Bridgewater, NJ 08807, filed ANADA 200–441 that provides for the use of A–MYCIN (chlortetracycline) Soluble Powder to make medicated drinking water for cattle, swine, chickens, and turkeys for the treatment of several bacterial diseases. Alpharma Inc.’s A–MYCIN Soluble Powder is approved as a generic copy of Fort Dodge Animal Health, A Division of Wyeth Holdings Corp.’s AUREOMYCIN (chlortetracycline) Soluble Powder, approved under NADA 65–440. The ANADA is approved as of October 9, 2009, and the regulations are amended in 21 CFR 520.445b to reflect the approval. 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 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. SUPPLEMENTARY INFORMATION: List of Subjects in 21 CFR Part 520 Animal drugs. ■ 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 520 is amended as follows: PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: ■ WReier-Aviles on DSKGBLS3C1PROD with RULES Authority: 21 U.S.C. 360b. 2. In § 520.445b, revise paragraph (b)(2) to read as follows: ■ § 520.445b Chlortetracycline powder. * * * * * (b) * * * (2) Nos. 046573 and 053501 for use as in paragraph (d) of this section. * * * * * VerDate Nov<24>2008 14:56 Nov 27, 2009 Jkt 220001 Dated: November 23, 2009. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. E9–28468 Filed 11–27–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG–2009–0985] RIN 1625–AA00 Safety Zone; Atlantic Intracoastal Waterway, Sunset Beach, NC Coast Guard, DHS. Temporary final rule. AGENCY: ACTION: SUMMARY: The Coast Guard is establishing a temporary safety zone on the waters of the Atlantic Intracoastal Waterway at Sunset Beach, North Carolina. The safety zone is necessary to provide for the safety of mariners on navigable waters during the installation of bridge girders at the new high-level fixed highway bridge at Sunset Beach, North Carolina. DATES: This rule will be in effect from 6 a.m. on December 1, 2009 through 6 p.m. on January 31, 2010. ADDRESSES: Documents indicated in this preamble as being available in the docket are part of docket USCG–2009– 0985 and are available online by going to https://www.regulations.gov, inserting USCG–2009–0985 in the ‘‘Keyword’’ box, and then clicking ‘‘Search.’’ They are also available for inspection or copying at the Docket Management Facility (M–30), U.S. Department of Transportation, West Building Ground Floor, Room W12–140, 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 temporary rule, call or e-mail CWO4 Stephen Lyons, Waterways Management Division Chief, Coast Guard Sector North Carolina; telephone (252) 247– 4525, e-mail Stephen.W.Lyons2@uscg.mil. If you have questions on viewing the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone 202–366– 9826. SUPPLEMENTARY INFORMATION: Regulatory Information The Coast Guard is issuing this temporary final rule without prior PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 62491 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 it is in the public interest to have this regulation in place during the girder installation due to the hazards associated with potential falling debris and the use of heavy equipment and machinery in the waterway. Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date would be contrary to public interest, since immediate action is needed to ensure the public’s safety from the hazards noted above. Background and Purpose The State of North Carolina Department of Transportation awarded a contract to English Construction Company Inc. of Lynchburg, Virginia to perform bridge girder installation at the new high-level fixed highway bridge at Sunset Beach, North Carolina. The contract provides for the installation of bridge girders. The center bridge girder installation is scheduled daily from 6 a.m. on December 1, 2009 through 6 p.m. on January 31, 2010. The contractor will be utilizing a deck barge with a 50′ beam, a ringer crane on a stationary barge with an 85′ beam, and an assist tug to conduct the girder installation. This operation presents a potential hazard to mariners from falling debris and the use of heavy equipment and machinery. To provide for the safety of the public, the Coast Guard will temporarily restrict access to this section of the Atlantic Intracoastal Waterway during girder installation, scheduled daily from 6 a.m. until 6 p.m. Discussion of Rule The Coast Guard is establishing a temporary safety zone to encompass the waters of the Atlantic Intracoastal Waterway extending 250 yards in all directions from the main construction site. All vessels are prohibited from transiting this section of the waterway while the safety zone is in effect. Entry into the zone will not be permitted except as specifically authorized by the Captain of the Port or a designated E:\FR\FM\30NOR1.SGM 30NOR1

Agencies

[Federal Register Volume 74, Number 228 (Monday, November 30, 2009)]
[Rules and Regulations]
[Pages 62490-62491]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-28468]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2009-N-0665]


Oral Dosage Form New Animal Drugs; Chlortetracycline Powder

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 Alpharma Inc. The ANADA provides for use 
of generic chlortetracycline soluble powder to make medicated drinking 
water for cattle, swine, chickens, and turkeys for the treatment of 
several bacterial diseases.

DATES: This rule is effective November 30, 2009.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: 
john.harshman@fda.hhs.gov.

[[Page 62491]]


SUPPLEMENTARY INFORMATION: Alpharma Inc., 440 Route 22, Bridgewater, NJ 
08807, filed ANADA 200-441 that provides for the use of A-MYCIN 
(chlortetracycline) Soluble Powder to make medicated drinking water for 
cattle, swine, chickens, and turkeys for the treatment of several 
bacterial diseases. Alpharma Inc.'s A-MYCIN Soluble Powder is approved 
as a generic copy of Fort Dodge Animal Health, A Division of Wyeth 
Holdings Corp.'s AUREOMYCIN (chlortetracycline) Soluble Powder, 
approved under NADA 65-440. The ANADA is approved as of October 9, 
2009, and the regulations are amended in 21 CFR 520.445b to reflect the 
approval.
    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 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 520

    Animal drugs.

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 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

0
2. In Sec.  520.445b, revise paragraph (b)(2) to read as follows:


Sec.  520.445b  Chlortetracycline powder.

* * * * *
    (b) * * *
    (2) Nos. 046573 and 053501 for use as in paragraph (d) of this 
section.
* * * * *

    Dated: November 23, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-28468 Filed 11-27-09; 8:45 am]
BILLING CODE 4160-01-S

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