New Animal Drugs; Change of Sponsor; Soluble Bacitracin Methylene Disalicylate and Streptomycin Sulfate Oral Powder, 17701-17702 [06-3353]

Download as PDF 17701 Federal Register / Vol. 71, No. 67 / Friday, April 7, 2006 / Rules and Regulations § 39.13 Compliance (e) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done. [Amended] 2. The Federal Aviation Administration (FAA) amends § 39.13 by adding the following new airworthiness directive (AD): I 2006–07–19 Aerospatiale: Amendment 39– 14546. Docket No. FAA–2006–23635; Directorate Identifier 2005–NM–245–AD. Effective Date (a) This AD becomes effective May 12, 2006. Affected ADs (b) None. Applicability (c) This AD applies to Aerospatiale Model ATR42–200, –300, –320, and –500 airplanes, and Model ATR72–101, –201, –102, –202, –211, –212, and –212A airplanes, certificated in any category; except those on which ATR Modification 05450 has been incorporated in production. Unsafe Condition (d) This AD results from a finding that the protective guard of the standby pitch trim switch, which is installed on the center pedestal, could be damaged or missing. We are issuing this AD to prevent inadvertent activation of the standby pitch trim, which could result in pitch trim runaway and consequent reduced controllability of the airplane. Installation, Inspection, and Corrective Action If Necessary (f) Within 4 months after the effective date of this AD: Install protective ramps on trim panel 110VU; and do a general visual inspection of the protective guard of the standby pitch trim switch (18CG) to determine if it is missing, damaged, or ineffective, and do the corrective action if applicable; by accomplishing all the applicable actions specified in the Accomplishment Instructions of Avions de Transport Regional Service Bulletin ATR42– 92–0010, Revision 1, dated March 11, 2003 (for Model ATR42–200, –300, –320, and –500 airplanes); or Avions de Transport Regional Service Bulletin ATR72–92–1010, Revision 1, dated March 11, 2003 (for Model ATR72– 101, –201, –102, –202, –211, –212, and –212A airplanes), as applicable. The corrective action, if required, must be done before further flight after the inspection. Note 1: For the purposes of this AD, a general visual inspection is: ‘‘A visual examination of an interior or exterior area, installation, or assembly to detect obvious damage, failure, or irregularity. This level of inspection is made from within touching distance unless otherwise specified. A mirror may be necessary to ensure visual access to all surfaces in the inspection area. This level of inspection is made under normally available lighting conditions such as daylight, hangar lighting, flashlight, or droplight and may require removal or opening of access panels or doors. Stands, ladders, or platforms may be required to gain proximity to the area being checked.’’ Alternative Methods of Compliance (AMOCs) (g)(1) The Manager, International Branch, ANM–116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19. (2) Before using any AMOC approved in accordance with § 39.19 on any airplane to which the AMOC applies, notify the appropriate principal inspector in the FAA Flight Standards Certificate Holding District Office. Related Information (h) French airworthiness directive 2003– 106(B) R1, dated April 16, 2003, also addresses the subject of this AD. Material Incorporated by Reference (i) You must use Avions de Transport Regional Service Bulletin ATR42–92–0010, Revision 1, dated March 11, 2003; or Avions de Transport Regional Service Bulletin ATR72–92–1010, Revision 1, dated March 11, 2003; as applicable, to perform the actions that are required by this AD, unless the AD specifies otherwise. Avions de Transport Regional Service Bulletin ATR42– 92–0010, Revision 1, dated March 11, 2003, includes the following effective pages: Page Nos. Revision level shown on page 1, 4, 5, 9, 13 ............................................................................................................................................... 2, 3, 6–8, 10–12 ......................................................................................................................................... 1 ....................... Original ............. Avions de Transport Regional Service Bulletin ATR72–92–1010, Revision 1, dated 1–3, 7, 11 ................................................................................................................................................... 4–6, 8–10 .................................................................................................................................................... wwhite on PROD1PC65 with RULES Revision level shown on page 1 ....................... Original ............. The Director of the Federal Register approved the incorporation by reference of these documents in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Contact Aerospatiale, 316 Route de Bayonne, 31060 Toulouse, Cedex 03, France, 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. 16:05 Apr 06, 2006 Jkt 208001 March 11, 2003. February 20, 2003. March 11, 2003, includes the following effective pages: Page Nos. VerDate Aug<31>2005 Date shown on page Date shown on page March 11, 2003. February 20, 2003. Issued in Renton, Washington, on March 24, 2006. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. 06–3199 Filed 4–6–06; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4910–13–P New Animal Drugs; Change of Sponsor; Soluble Bacitracin Methylene Disalicylate and Streptomycin Sulfate Oral Powder PO 00000 Food and Drug Administration 21 CFR Parts 510 and 520 AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the Frm 00011 Fmt 4700 Sfmt 4700 E:\FR\FM\07APR1.SGM 07APR1 17702 Federal Register / Vol. 71, No. 67 / Friday, April 7, 2006 / Rules and Regulations animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) for bacitracin methylene disalicylate and streptomycin sulfate oral powder from Veterinary Specialties, Inc., to Alpharma Inc. DATES: This rule is effective April 7, 2006. ‘‘Veterinary Specialties, Inc.’’; and in the table in paragraph (c)(2) remove the entry for ‘‘062925’’. FOR FURTHER INFORMATION CONTACT: I David R. Newkirk, Center for Veterinary Medicine (HFV–100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Veterinary Specialties, Inc., 387 North Valley Ct., Barrington, IL 60010, has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 65–107 for ENTROMYCIN (bacitracin methylene disalicylate and streptomycin sulfate) Powder to Alpharma Inc., One Executive Dr., Fort Lee, NJ 07024. Accordingly, the regulations are amended in 21 CFR 520.154b to reflect this change of sponsorship and a current format. Following these changes of sponsorship, Veterinary Specialties, Inc., is no longer the sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to remove the entries for Veterinary Specialties, Inc. 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. PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 3. The authority citation for 21 CFR part 520 continues to read as follows: I Authority: 21 U.S.C. 360b. 4. Revise § 520.154b to read as follows: § 520.154b Bacitracin methylene disalicylate and streptomycin sulfate powder. (a) Specifications. Each gram of powder contains 200 units bacitracin methylene disalicylate and streptomycin sulfate equivalent to 20 milligrams of streptomycin. (b) Sponsor. See No. 046573 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer 1 level teaspoonful per 10 pounds of body weight three times daily, mixed in a small quantity of liquid or feed. (2) Indications for use. For the treatment of bacterial enteritis caused by pathogens susceptible to bacitracin and streptomycin such as Escherichia coli, Proteus spp., Staphylococcus spp., and Streptococcus spp., and for the symptomatic treatment of associated diarrhea. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. List of Subjects Dated: March 30, 2006. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 06–3353 Filed 4–6–06; 8:45 am] 21 CFR Part 510 BILLING CODE 4160–01–S Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. DEPARTMENT OF HEALTH AND HUMAN SERVICES 21 CFR Part 520 Food and Drug Administration 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 parts 510 and 520 are amended as follows: 21 CFR Part 558 I PART 510—NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 510 continues to read as follows: wwhite on PROD1PC65 with RULES I Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. 2. In § 510.600, in the table in paragraph (c)(1) remove the entry for I VerDate Aug<31>2005 16:05 Apr 06, 2006 Jkt 208001 New Animal Drugs for Use in Animal Feeds; Chlortetracycline 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 Pennfield Oil Co. that provides for a 0day preslaughter withdrawal time following use of chlortetracycline in cattle feed. PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 DATES: This rule is effective April 7, 2006. 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.gov. SUPPLEMENTARY INFORMATION: Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144, filed a supplement to NADA 138–935 for PENNCHLOR (chlortetracycline) Type A medicated articles used for making medicated feeds for the treatment of various bacterial diseases of livestock. The supplemental NADA provides for a 0day withdrawal time before slaughter when Type C medicated feeds containing chlortetracycline are fed to cattle. The application is approved as of February 28, 2006, and the regulations are amended in 21 CFR 558.128 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 these applications 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. The agency 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. FOR FURTHER INFORMATION CONTACT: 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\07APR1.SGM 07APR1

Agencies

[Federal Register Volume 71, Number 67 (Friday, April 7, 2006)]
[Unknown Section]
[Pages 17701-17702]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-3353]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520


New Animal Drugs; Change of Sponsor; Soluble Bacitracin Methylene 
Disalicylate and Streptomycin Sulfate Oral Powder

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the

[[Page 17702]]

animal drug regulations to reflect a change of sponsor for a new animal 
drug application (NADA) for bacitracin methylene disalicylate and 
streptomycin sulfate oral powder from Veterinary Specialties, Inc., to 
Alpharma Inc.

DATES: This rule is effective April 7, 2006.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: 
david.newkirk@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Veterinary Specialties, Inc., 387 North 
Valley Ct., Barrington, IL 60010, has informed FDA that it has 
transferred ownership of, and all rights and interest in, NADA 65-107 
for ENTROMYCIN (bacitracin methylene disalicylate and streptomycin 
sulfate) Powder to Alpharma Inc., One Executive Dr., Fort Lee, NJ 
07024. Accordingly, the regulations are amended in 21 CFR 520.154b to 
reflect this change of sponsorship and a current format.
    Following these changes of sponsorship, Veterinary Specialties, 
Inc., is no longer the sponsor of an approved application. Accordingly, 
21 CFR 510.600(c) is being amended to remove the entries for Veterinary 
Specialties, Inc.
    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

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

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 parts 510 and 
520 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. In Sec.  510.600, in the table in paragraph (c)(1) remove the entry 
for ``Veterinary Specialties, Inc.''; and in the table in paragraph 
(c)(2) remove the entry for ``062925''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
4. Revise Sec.  520.154b to read as follows:


Sec.  520.154b  Bacitracin methylene disalicylate and streptomycin 
sulfate powder.

    (a) Specifications. Each gram of powder contains 200 units 
bacitracin methylene disalicylate and streptomycin sulfate equivalent 
to 20 milligrams of streptomycin.
    (b) Sponsor. See No. 046573 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 1 level 
teaspoonful per 10 pounds of body weight three times daily, mixed in a 
small quantity of liquid or feed.
    (2) Indications for use. For the treatment of bacterial enteritis 
caused by pathogens susceptible to bacitracin and streptomycin such as 
Escherichia coli, Proteus spp., Staphylococcus spp., and Streptococcus 
spp., and for the symptomatic treatment of associated diarrhea.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: March 30, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 06-3353 Filed 4-6-06; 8:45 am]
BILLING CODE 4160-01-S

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