Oral Dosage Form New Animal Drugs; Ivermectin Meal; Change of Sponsor, 19261-19262 [05-7344]

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 19262 § 520.1194 Federal Register / Vol. 70, No. 70 / Wednesday, April 13, 2005 / Rules and Regulations [Amended] The Parole Commission’s hearing examiners travel I 2. Section 520.1194 is amended in paragraph (b) by removing ‘‘050604’’ and to more than 60 locations of Federal correctional facilities to conduct parole by adding in its place ‘‘017135’’. release and revocation hearings. In order Dated: March 31, 2005. to reduce travel costs and to conserve Bernadette A. Dunham, the time and effort of its hearing Deputy Director, Office of New Animal Drug examiners, in 2004 the Commission Evaluation, Center for Veterinary Medicine. initiated a pilot project in which [FR Doc. 05–7344 Filed 4–12–05; 8:45 am] examiners conducted some parole BILLING CODE 4160–01–S release hearings by videoconference between the Commission’s office in Maryland and the prisoner’s Federal institution. The Commission published DEPARTMENT OF JUSTICE an interim rule that provided notice that the Commission would be using the Parole Commission videoconference procedure. 69 FR 5273 (Feb. 4, 2004). 28 CFR Part 2 By the end of 2004, the Commission conducted 102 hearings via Paroling, Recommitting, and videoconference at 11 institutions. The Supervising Federal Prisoners: videoconference technology has worked Prisoners Serving Sentences Under well. Video and audio transmissions are the United States and District of clear and the hearings are seldom Columbia Codes interrupted by technical difficulties. AGENCY: United States Parole The Commission’s experience is that the Commission, Justice. prisoner’s ability to effectively participate in the hearing has not been ACTION: Interim rule with request for diminished by the use of the comments. videoconference procedure. SUMMARY: During 2004 the Parole The Commission’s pilot project only Commission carried out a pilot project included parole release hearings. Now to study the feasibility of conducting the Commission is extending the use of parole release hearings through the videoconference procedure to videoconferences between an examiner institutional revocation hearings. A at the Commission’s office and prisoners revocation hearing is held at a Federal at selected institutions of the Federal institution when the releasee admits to Bureau of Prisons. In order to give the violation charge, is convicted of a notice of this project, the Commission new crime, or waives a local revocation promulgated an interim rule that hearing, i.e., a hearing at the place of the provided that a parole release hearing alleged violation or arrest. Adverse may be conducted through a witnesses are not produced at videoconference with the prisoner. The institutional revocation hearings for pilot project has been a success and the confrontation and cross-examination. Commission is now amending the On rare occasions, the releasee has a interim rule to include institutional witness testify on his behalf at the revocation hearings as hearings that may hearing. Because the violation charge is either not contested by the releasee or be conducted by videoconference. The is conclusively established by the new Commission is taking this action to conviction, an institutional revocation further conserve personnel resources hearing primarily focuses on the and reduce the costs associated with decisions regarding the appropriate travel by the agency’s hearing prison term for the releasee’s violation examiners. and whether the releasee should be DATES: Effective Date: May 13, 2005. returned to the community on Comments must be received by June 13, supervision. Therefore, an institutional 2005. revocation hearing bears considerable ADDRESSES: Send comments to Office of similarity to a parole determination General Counsel, U.S. Parole proceeding. Given this similarity and Commission, 5550 Friendship Blvd., the additional cost savings and Chevy Chase, Maryland 20815. conservation of resources that may be FOR FURTHER INFORMATION CONTACT: gained from use of the videoconference Office of General Counsel, U.S. Parole procedure, the Commission is adding Commission, 5550 Friendship Blvd., institutional revocation hearings to Chevy Chase, Maryland 20815, those hearings an examiner may telephone (301) 492–5959. Questions conduct by videoconference. Extending the videoconference about this publication are welcome, but procedure to institutional revocation inquiries concerning individual cases cannot be answered over the telephone. hearings will provide additional VerDate jul<14>2003 16:30 Apr 12, 2005 SUPPLEMENTARY INFORMATION: Jkt 205001 PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 flexibility for both the Commission and the Bureau of Prisons in the disposition of accused release violators and the use of personnel. For example, if the releasee is serving a new prison term at an institution where the Commission conducts parole hearings via videoconference, the Bureau will be able to designate that same institution as the site of the releasee’s institutional revocation hearing. This saves either the cost of transporting the releasee to FTC Oklahoma or FDC Philadelphia, the institutions where the Commission conducts the majority of institutional revocation hearings, or the cost of sending a hearing examiner to travel to the institution to conduct one institutional revocation hearing when all other hearings at that same institution are conducted via videoconference. Moreover, conducting institutional revocation hearings by videoconference may avoid some violations of the 90-day time period for holding such hearings in situations where transportation difficulties or other problems have delayed the scheduling of the hearing. The Commission is promulgating this rule as an interim rule in order to promptly take full advantage of the cost savings and other benefits in the deployment of examiner personnel that result from the extension of the videoconference procedure to institutional revocation hearings. The Commission is providing a 60-day period for the public to comment on the use of the videoconference procedure for such revocation hearings. Implementation The amended rule will take effect May 13, 2005, and will apply to institutional revocation hearings for Federal parolees and District of Columbia parolees and supervised releasees held on or after the effective date. Executive Order 12866 The U.S. Parole Commission has determined that this interim rule does not constitute a significant rule within the meaning of Executive Order 12866. Executive Order 13132 This regulation will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Under Executive Order 13132, this rule does not have sufficient federalism implications requiring a federalism Assessment. E:\FR\FM\13APR1.SGM 13APR1

Agencies

[Federal Register Volume 70, Number 70 (Wednesday, April 13, 2005)]
[Rules and Regulations]
[Pages 19261-19262]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-7344]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Ivermectin Meal; Change of 
Sponsor

AGENCY:  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, e-mail: 
david.newkirk@fda.gov.

SUPPLEMENTARY INFORMATION: Merial Ltd., 3239 Satellite Blvd., Bldg. 
500, Duluth, GA 30096-4640, has informed FDA that it has transferred 
ownership of, and all rights and interest in, NADA 141-241 for 
ZIMECTERIN-EZ (ivermectin) 0.6% w/w for Horses to Farnam Companies, 
Inc., 301 West Osborn, Phoenix, AZ 85013-3928.
    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.

[[Page 19262]]

Sec.  520.1194  [Amended]

0
2. Section 520.1194 is amended in paragraph (b) by removing ``050604'' 
and by adding in its place ``017135''.

    Dated: March 31, 2005.
Bernadette A. Dunham,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 05-7344 Filed 4-12-05; 8:45 am]
BILLING CODE 4160-01-S
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