Oral Dosage Form New Animal Drugs; Dichlorophene and Toluene Capsules, 19261 [05-7337]

Download as PDF 19261 Federal Register / Vol. 70, No. 70 / Wednesday, April 13, 2005 / Rules and Regulations TABLE 1.—ROTATING PARTS REQUIRING CYCLIC LIFE CORRECTION—Continued Required cycle correction P/N SN Part name 9061M26P20 ...................... PMOA0508 ......................... Shaft, LPT Rear .............................................................. (3) After correcting the cycles and hours, remove from service any rotating parts listed in Table 1 of this AD that exceed their LCF life limit, within 100 cycles-in-service after the effective date of this AD. (g) After the effective date of this AD, do not install any part listed in Table 1 of this AD into any engine, unless the cycles and hours have been corrected as specified in paragraph (f) of this AD. (h) After the effective date of this AD, do not install any engine unless the records check specified in paragraph (f) of this AD has been performed. Alternative Methods of Compliance (i) The Manager, Engine Certification Office, has the authority to approve alternative methods of compliance for this AD if requested using the procedures found in 14 CFR 39.19. Related Information (j) General Electric Company Alert Service Bulletin No. CF6–50 S/B 72–A1275, dated March 24, 2005, pertains to the subject of this AD. Material Incorporated by Reference (k) None. Issued in Burlington, Massachusetts, on April 7, 2005. Jay J. Pardee, Manager, Engine and Propeller Directorate, Aircraft Certification Service. [FR Doc. 05–7387 Filed 4–12–05; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Dichlorophene and Toluene Capsules AGENCY: Food and Drug Administration, HHS. ACTION: The Food and Drug Administration (FDA) is amending the animal drug regulations that reflect approval of a new animal drug application (NADA) for dichlorophene and toluene capsules used in dogs and cats for removal of certain intestinal parasites. In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of the NADA. SUMMARY: 16:30 Apr 12, 2005 This rule is effective April 25, 2005. Jkt 205001 +2,429 +15,936 DEPARTMENT OF HEALTH AND HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for Veterinary Medicine (HFV–212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301–827– 7818; e-mail: pesposit@cvm.fda.gov. Food and Drug Administration Natchez Animal Supply Co., 201 John R. Junkin Dr., Natchez, MS 39120, has requested that FDA withdraw approval of NADA 121–557 for THR Worm (dichlorophene and toluene) Capsules used in dogs and cats for removal of certain intestinal parasites. This action is requested because the product is no longer manufactured or marketed. The animal drug regulations are amended to reflect the withdrawal of approval. 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. AGENCY: SUPPLEMENTARY INFORMATION: 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Ivermectin Meal; Change of Sponsor Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) from Merial Ltd. to Farnam Companies, Inc. DATES: This rule is effective April 13, 2005. 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, email: david.newkirk@fda.gov. SUPPLEMENTARY INFORMATION: Merial List of Subjects in 21 CFR Part 520 Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096–4640, has informed Animal drugs. FDA that it has transferred ownership I Therefore, under the Federal Food, of, and all rights and interest in, NADA Drug, and Cosmetic Act and under 141–241 for ZIMECTERIN–EZ authority delegated to the Commissioner (ivermectin) 0.6% w/w for Horses to of Food and Drugs and redelegated to the Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013–3928. Center for Veterinary Medicine, 21 CFR This rule does not meet the definition part 520 is amended as follows: of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because PART 520—ORAL DOSAGE FORM it is a rule of ‘‘particular applicability.’’ NEW ANIMAL DRUGS Therefore, it is not subject to the congressional review requirements in 5 I 1. The authority citation for 21 CFR U.S.C. 801–808. part 520 continues to read as follows: List of Subjects in 21 CFR Part 520 Authority: 21 U.S.C. 360b. § 520.580 Final rule. VerDate jul<14>2003 DATES: Required hour correction [Amended] 2. Section 520.580 is amended in paragraph (b)(1) by removing ‘‘049968,’’. I Dated: March 31, 2005. Catherine P. Beck, Acting Director, Center for Veterinary Medicine. [FR Doc. 05–7337 Filed 4–12–05; 8:45 am] BILLING CODE 4160–01–S PO 00000 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: I PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: I Authority: 21 U.S.C. 360b. Frm 00009 Fmt 4700 Sfmt 4700 E:\FR\FM\13APR1.SGM 13APR1

Agencies

[Federal Register Volume 70, Number 70 (Wednesday, April 13, 2005)]
[Rules and Regulations]
[Page 19261]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-7337]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Dichlorophene and Toluene 
Capsules

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule.

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

SUMMARY:  The Food and Drug Administration (FDA) is amending the animal 
drug regulations that reflect approval of a new animal drug application 
(NADA) for dichlorophene and toluene capsules used in dogs and cats for 
removal of certain intestinal parasites. In a notice published 
elsewhere in this issue of the Federal Register, FDA is withdrawing 
approval of the NADA.

DATES:  This rule is effective April 25, 2005.

FOR FURTHER INFORMATION CONTACT:  Pamela K. Esposito, Center for 
Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-7818; e-mail: 
pesposit@cvm.fda.gov.

SUPPLEMENTARY INFORMATION: Natchez Animal Supply Co., 201 John R. 
Junkin Dr., Natchez, MS 39120, has requested that FDA withdraw approval 
of NADA 121-557 for THR Worm (dichlorophene and toluene) Capsules used 
in dogs and cats for removal of certain intestinal parasites. This 
action is requested because the product is no longer manufactured or 
marketed. The animal drug regulations are amended to reflect the 
withdrawal of approval.
    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.


Sec.  520.580  [Amended]

0
2. Section 520.580 is amended in paragraph (b)(1) by removing 
``049968,''.

    Dated: March 31, 2005.
Catherine P. Beck,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 05-7337 Filed 4-12-05; 8:45 am]
BILLING CODE 4160-01-S
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