Implantation or Injectable Dosage Form New Animal Drugs; Phenylbutazone Injection, 48272-48273 [05-16240]

Download as PDF 48272 Federal Register / Vol. 70, No. 158 / Wednesday, August 17, 2005 / Rules and Regulations (purchases only); other trade-related services; performing arts, sports, and other live performances, presentations, and events; primary insurance premiums (payments only); primary insurance losses recovered; sale or purchase of rights to natural resources, and lease bonus payments; use or lease of rights to natural resources, excluding lease bonus payments; waste treatment and depollution services; and other private services (language translation services; salvage services; security services; account collection services; satellite photography and remote sensing/satellite imagery services; space transport (includes satellite launches, transport of goods and people for scientific experiments, and space passenger transport); and transcription services). * * * * * [FR Doc. 05–16305 Filed 8–16–05; 8:45 am] BILLING CODE 3510–06–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 510 New Animal Drugs; Change of Sponsor’s Address 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’s address for Peptech Animal Health Pty, Ltd. DATES: This rule is effective August 17, 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: Peptech Animal Health Pty, Ltd., 35–41 Waterloo Rd., North Ryde, New South Wales 2113, Australia has informed FDA of a change of address to 19–25 Khartoum Rd., Macquarie Park, New South Wales 2113, Australia. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c) to reflect the change. 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. VerDate jul<14>2003 11:00 Aug 16, 2005 Jkt 205001 List of Subjects in 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. 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 510 is amended as follows: I PART 510—NEW ANIMAL DRUGS DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Phenylbutazone Injection 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 Authority: 21 U.S.C. 321, 331, 351, 352, drug application (ANADA) filed by 353, 360b, 371, 379e. Sparhawk Laboratories, Inc. The ANADA provides for the veterinary I 2. Section 510.600 is amended in the prescription use of phenylbutazone table in paragraph (c)(1) by revising the injectable solution in horses for relief of entry for ‘‘Peptech Animal Health Pty, Ltd.’’; and in the table in paragraph (c)(2) inflammatory conditions associated with the musculoskeletal system. by revising the entry for ‘‘064288’’ to read as follows: DATES: This rule is effective August 17, 2005. § 510.600 Names, addresses, and drug FOR FURTHER INFORMATION CONTACT: John labeler codes of sponsors of approved K. Harshman, Center for Veterinary applications. Medicine (HFV 104), Food and Drug * * * * * Administration, 7500 Standish Pl., (c) * * * Rockville, MD 20855, 240–276–9808, email: john.harshman@fda.gov. (1) * * * SUPPLEMENTARY INFORMATION: Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Drug labeler Firm name and address code Dr., Lenexa , KS 66215–3591, filed ANADA 200–371 for the use of Phenylbutazone 20% Injection by * * * * * veterinary prescription for relief of Peptech Animal Health Pty, 064288 inflammatory conditions associated Ltd., 19–25 Khartoum with the musculoskeletal system in Rd., Macquarie Park, horses. Sparhawk Laboratories, Inc.’s, New South Wales 2113, Phenylbutazone 20% Injection is Australia. approved as a generic copy of Schering* * * * * Plough Animal Health Corp.’s, BUTAZOLIDIN Injectable 20%, (2) * * * approved under NADA 11–575. The ANADA is approved as of July 8, 2005, Drug labeler Firm name and adand the regulations in 21 CFR 522.1720 code dress are amended to reflect the approval. The basis of approval is discussed in the * * * * * freedom of information(FOI) summary. 064288 .................... Peptech Animal In accordance with the FOI provisions Health Pty, Ltd., of 21 CFR part 20 and 21 CFR 19–25 Khartoum 514.11(e)(2)(ii), a summary of safety and Rd., Macquarie effectiveness data and information Park, New South submitted to support approval of this Wales 2113, Ausapplication may be seen in the Division tralia of Dockets Management (HFA–305), * * * * * Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD July 28, 2005. 20852, between 9 a.m. and 4 p.m., Bernadette A. Dunham, Monday through Friday. Deputy Director, Office of New Animal Drug The agency has determined under 21 Evaluation, Center for Veterinary Medicine. CFR 25.33(a)(1) that this action is of a [FR Doc. 05–16280 Filed 8–16–05; 8:45 am] type that does not individually or cumulatively have a significant effect on BILLING CODE 4160–01–S the human environment. Therefore, 1. The authority citation for 21 CFR part 510 continues to read as follows: I PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 E:\FR\FM\17AUR1.SGM 17AUR1 Federal Register / Vol. 70, No. 158 / Wednesday, August 17, 2005 / Rules and Regulations 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 522 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 522 is amended as follows: I PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS Documents referred to in this rule are available for inspection or copying at the office of the Eighth Coast Guard District, Bridge Administration Branch, 500 Poydras Street, New Orleans, Louisiana 70130–3310, between 7 a.m. and 3 p.m., Monday through Friday, except Federal holidays. The telephone number is (504) 589– 2965. The Eighth District Bridge Administration Branch maintains the public docket for this rulemaking. ADDRESSES: FOR FURTHER INFORMATION CONTACT: David Frank, Bridge Administration Branch, (504) 589–2965. SUPPLEMENTARY INFORMATION: Good Cause for Not Publishing an NPRM We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the I 1. The authority citation for 21 CFR Coast Guard finds that good cause exists part 522 continues to read as follows: for not publishing an NPRM. Thousands Authority: 21 U.S.C. 360b. of pedestrians will cross the bridge during the event and this temporary rule § 522.1720 [Amended] is necessary to ensure their safety as I 2. Section 522.1720 is amended in they cross the bridge. Additionally, the paragraph (b)(2) by removing ‘‘No. event will only impact the waterway 000010’’ and by adding in its place ‘‘Nos. users for one hour and will open for 000010 and 058005’’. vessels in distress. Dated: July 26, 2005. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 05–16240 Filed 8–16–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [CGD08–05–040] RIN 1625–AA09 Drawbridge Operation Regulation; Massalina Bayou, Panama City, FL Coast Guard, DHS. Temporary rule. AGENCY: ACTION: SUMMARY: The Commander, Eighth Coast Guard District, has temporarily changed the regulation governing the operation of the Tarpon Dock bascule span drawbridge across Massalina Bayou, mile 0.0, at Panama City, Bay County, Florida. The regulation will allow the draw of the bridge to remain closed to navigation for one hour to facilitate the American Heart Walk. DATES: This temporary rule is effective from 9 a.m. to 10 a.m. on October 15, 2005. VerDate jul<14>2003 11:00 Aug 16, 2005 Jkt 205001 Background and Purpose The American Heart Association, on behalf of the City of Panama City, has requested a temporary rule changing the operation of the Tarpon Dock bascule span drawbridge across Massalina Bayou, mile 0.0, in Panama City, Bay County, Florida. This temporary rule is needed to accommodate approximately 2,000 pedestrians that are expected to participate in a 3.5-mile walk. The bridge is near the beginning of the walk and allowing the bridge to open for navigation during this short time period would disrupt the event and could result in injury. The bridge has a vertical clearance of 7 feet above mean high water in the closed-to-navigation position and unlimited in the open-tonavigation position. Navigation on the waterway consists primarily of commercial fishing vessels, sailing vessels and other recreational craft. Presently, Title 33, Code of Federal Regulations (CFR), Part 117.301 states: The draw of the Tarpon Dock bascule span bridge, Massalina Bayou, mile 0.0, shall open on signal; except that from 9 p.m. until 11 p.m. on July 4, each year, the draw need not open for the passage of vessels. The draw will open at any time for a vessel in distress. This temporary rule will allow the bridge to be maintained in the closed-tonavigation position from 9 a.m. to 10 PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 48273 a.m. on October 15, 2005 to facilitate the American Heart Walk. 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). This temporary rule will be effective for only one hour and is therefore expected to have only a minor affect on the local economy. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601–612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term ‘‘small entities’’ comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this temporary rule will not have a significant economic impact on a substantial number of small entities. This rule may affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit through the Tarpon dock bridge across Massalina Bayou during the closure. There is not expected to be a significant impact due to the short duration of the closure and the publicity given to the event. Assistance for Small Entities Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104– 121), we want to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking process. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency’s responsiveness to small business. If you wish to comment on actions by E:\FR\FM\17AUR1.SGM 17AUR1

Agencies

[Federal Register Volume 70, Number 158 (Wednesday, August 17, 2005)]
[Rules and Regulations]
[Pages 48272-48273]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-16240]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Phenylbutazone Injection

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 Sparhawk Laboratories, Inc. The ANADA 
provides for the veterinary prescription use of phenylbutazone 
injectable solution in horses for relief of inflammatory conditions 
associated with the musculoskeletal system.

DATES: This rule is effective August 17, 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: Sparhawk Laboratories, Inc., 12340 Santa Fe 
Trail Dr., Lenexa , KS 66215-3591, filed ANADA 200-371 for the use of 
Phenylbutazone 20% Injection by veterinary prescription for relief of 
inflammatory conditions associated with the musculoskeletal system in 
horses. Sparhawk Laboratories, Inc.'s, Phenylbutazone 20% Injection is 
approved as a generic copy of Schering-Plough Animal Health Corp.'s, 
BUTAZOLIDIN Injectable 20%, approved under NADA 11-575. The ANADA is 
approved as of July 8, 2005, and the regulations in 21 CFR 522.1720 are 
amended to reflect the approval. The basis of approval is discussed in 
the freedom of information(FOI) summary.
    In accordance with the FOI 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.
    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,

[[Page 48273]]

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 522

    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 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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


Sec.  522.1720  [Amended]

0
2. Section 522.1720 is amended in paragraph (b)(2) by removing ``No. 
000010'' and by adding in its place ``Nos. 000010 and 058005''.

    Dated: July 26, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-16240 Filed 8-16-05; 8:45 am]
BILLING CODE 4160-01-S
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