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48272 Federal Register / Vol. 70, No.

158 / Wednesday, August 17, 2005 / Rules and Regulations

(purchases only); other trade-related List of Subjects in 21 CFR Part 510 DEPARTMENT OF HEALTH AND
services; performing arts, sports, and HUMAN SERVICES
other live performances, presentations, Administrative practice and
and events; primary insurance procedure, Animal drugs, Labeling, Food and Drug Administration
premiums (payments only); primary Reporting and recordkeeping
insurance losses recovered; sale or requirements. 21 CFR Part 522
purchase of rights to natural resources, ■ Therefore, under the Federal Food,
and lease bonus payments; use or lease Implantation or Injectable Dosage
Drug, and Cosmetic Act and under
of rights to natural resources, excluding Form New Animal Drugs;
authority delegated to the Commissioner
lease bonus payments; waste treatment Phenylbutazone Injection
of Food and Drugs and redelegated to the
and depollution services; and other Center for Veterinary Medicine, 21 CFR AGENCY: Food and Drug Administration,
private services (language translation part 510 is amended as follows: HHS.
services; salvage services; security
ACTION: Final rule.
services; account collection services; PART 510—NEW ANIMAL DRUGS
satellite photography and remote SUMMARY: The Food and Drug
sensing/satellite imagery services; space ■ 1. The authority citation for 21 CFR Administration (FDA) is amending the
transport (includes satellite launches, part 510 continues to read as follows: animal drug regulations to reflect
transport of goods and people for approval of an abbreviated new animal
scientific experiments, and space Authority: 21 U.S.C. 321, 331, 351, 352, drug application (ANADA) filed by
passenger transport); and transcription 353, 360b, 371, 379e.
Sparhawk Laboratories, Inc. The
services). ■ 2. Section 510.600 is amended in the ANADA provides for the veterinary
* * * * * table in paragraph (c)(1) by revising the prescription use of phenylbutazone
[FR Doc. 05–16305 Filed 8–16–05; 8:45 am] entry for ‘‘Peptech Animal Health Pty, injectable solution in horses for relief of
BILLING CODE 3510–06–P Ltd.’’; and in the table in paragraph (c)(2) inflammatory conditions associated
by revising the entry for ‘‘064288’’ to with the musculoskeletal system.
read as follows: DATES: This rule is effective August 17,
DEPARTMENT OF HEALTH AND 2005.
§ 510.600 Names, addresses, and drug
HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: John
labeler codes of sponsors of approved
applications. K. Harshman, Center for Veterinary
Food and Drug Administration Medicine (HFV 104), Food and Drug
* * * * * Administration, 7500 Standish Pl.,
21 CFR Part 510 (c) * * * Rockville, MD 20855, 240–276–9808, e-
(1) * * * mail: john.harshman@fda.gov.
New Animal Drugs; Change of
SUPPLEMENTARY INFORMATION: Sparhawk
Sponsor’s Address
Drug labeler Laboratories, Inc., 12340 Santa Fe Trail
AGENCY: Food and Drug Administration, Firm name and address code Dr., Lenexa , KS 66215–3591, filed
HHS. ANADA 200–371 for the use of
ACTION: Final rule. Phenylbutazone 20% Injection by
* * * * *
veterinary prescription for relief of
SUMMARY: The Food and Drug Peptech Animal Health Pty, 064288
Ltd., 19–25 Khartoum inflammatory conditions associated
Administration (FDA) is amending the with the musculoskeletal system in
animal drug regulations to reflect a Rd., Macquarie Park,
New South Wales 2113, horses. Sparhawk Laboratories, Inc.’s,
change of sponsor’s address for Peptech Australia. Phenylbutazone 20% Injection is
Animal Health Pty, Ltd. * * * * * approved as a generic copy of Schering-
DATES: This rule is effective August 17, Plough Animal Health Corp.’s,
2005. BUTAZOLIDIN Injectable 20%,
(2) * * *
FOR FURTHER INFORMATION CONTACT: approved under NADA 11–575. The
David R. Newkirk, Center for Veterinary Drug labeler ANADA is approved as of July 8, 2005,
Medicine (HFV–100), Food and Drug Firm name and ad- and the regulations in 21 CFR 522.1720
code
Administration, 7500 Standish Pl., dress
are amended to reflect the approval. The
Rockville, MD 20855, 301–827–6967, e- basis of approval is discussed in the
mail: david.newkirk@fda.gov. * * * * * freedom of information(FOI) summary.
SUPPLEMENTARY INFORMATION: Peptech 064288 .................... Peptech Animal In accordance with the FOI provisions
Animal Health Pty, Ltd., 35–41 Health Pty, Ltd., of 21 CFR part 20 and 21 CFR
19–25 Khartoum
Waterloo Rd., North Ryde, New South 514.11(e)(2)(ii), a summary of safety and
Rd., Macquarie
Wales 2113, Australia has informed Park, New South effectiveness data and information
FDA of a change of address to 19–25 Wales 2113, Aus- submitted to support approval of this
Khartoum Rd., Macquarie Park, New tralia application may be seen in the Division
South Wales 2113, Australia. * * * * * of Dockets Management (HFA–305),
Accordingly, the agency is amending Food and Drug Administration, 5630
the regulations in 21 CFR 510.600(c) to Fishers Lane, rm. 1061, Rockville, MD
July 28, 2005.
reflect the change. 20852, between 9 a.m. and 4 p.m.,
This rule does not meet the definition Bernadette A. Dunham, Monday through Friday.
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because Deputy Director, Office of New Animal Drug The agency has determined under 21
it is a rule of ‘‘particular applicability.’’ Evaluation, Center for Veterinary Medicine. CFR 25.33(a)(1) that this action is of a
Therefore, it is not subject to the [FR Doc. 05–16280 Filed 8–16–05; 8:45 am] type that does not individually or
congressional review requirements in 5 BILLING CODE 4160–01–S cumulatively have a significant effect on
U.S.C. 801–808. the human environment. Therefore,

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Federal Register / Vol. 70, No. 158 / Wednesday, August 17, 2005 / Rules and Regulations 48273

neither an environmental assessment ADDRESSES: Documents referred to in a.m. on October 15, 2005 to facilitate the
nor an environmental impact statement this rule are available for inspection or American Heart Walk.
is required. copying at the office of the Eighth Coast
Regulatory Evaluation
This rule does not meet the definition Guard District, Bridge Administration
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because Branch, 500 Poydras Street, New This rule is not a ‘‘significant
it is a rule of ‘‘particular applicability.’’ Orleans, Louisiana 70130–3310, regulatory action’’ under section 3(f) of
Therefore, it is not subject to the between 7 a.m. and 3 p.m., Monday Executive Order 12866, Regulatory
congressional review requirements in 5 through Friday, except Federal holidays. Planning and Review, and does not
U.S.C. 801–808. The telephone number is (504) 589– require an assessment of potential costs
2965. The Eighth District Bridge and benefits under section 6(a)(3) of that
List of Subjects in 21 CFR Part 522
Administration Branch maintains the Order. The Office of Management and
Animal drugs. public docket for this rulemaking. Budget has not reviewed it under that
■ Therefore, under the Federal Food, Order. It is not ‘‘significant’’ under the
FOR FURTHER INFORMATION CONTACT:
Drug, and Cosmetic Act and under regulatory policies and procedures of
David Frank, Bridge Administration
authority delegated to the Commissioner the Department of Homeland Security
Branch, (504) 589–2965.
of Food and Drugs and redelegated to the (DHS). This temporary rule will be
Center for Veterinary Medicine, 21 CFR SUPPLEMENTARY INFORMATION: effective for only one hour and is
part 522 is amended as follows: Good Cause for Not Publishing an therefore expected to have only a minor
NPRM affect on the local economy.
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW Small Entities
We did not publish a notice of
ANIMAL DRUGS proposed rulemaking (NPRM) for this Under the Regulatory Flexibility Act
regulation. Under 5 U.S.C. 553(b)(B), the (5 U.S.C. 601–612), we have considered
■ 1. The authority citation for 21 CFR Coast Guard finds that good cause exists whether this rule would have a
part 522 continues to read as follows: for not publishing an NPRM. Thousands significant economic impact on a
Authority: 21 U.S.C. 360b. of pedestrians will cross the bridge substantial number of small entities.
during the event and this temporary rule The term ‘‘small entities’’ comprises
§ 522.1720 [Amended] small businesses, not-for-profit
is necessary to ensure their safety as
■ 2. Section 522.1720 is amended in they cross the bridge. Additionally, the organizations that are independently
paragraph (b)(2) by removing ‘‘No. event will only impact the waterway owned and operated and are not
000010’’ and by adding in its place ‘‘Nos. users for one hour and will open for dominant in their fields, and
000010 and 058005’’. vessels in distress. governmental jurisdictions with
Dated: July 26, 2005. populations of less than 50,000.
Background and Purpose
Stephen F. Sundlof, The Coast Guard certifies under 5
Director, Center for Veterinary Medicine. The American Heart Association, on U.S.C. 605(b) that this temporary rule
behalf of the City of Panama City, has will not have a significant economic
[FR Doc. 05–16240 Filed 8–16–05; 8:45 am]
requested a temporary rule changing the impact on a substantial number of small
BILLING CODE 4160–01–S
operation of the Tarpon Dock bascule entities.
span drawbridge across Massalina This rule may affect the following
Bayou, mile 0.0, in Panama City, Bay entities, some of which may be small
DEPARTMENT OF HOMELAND County, Florida. This temporary rule is entities: the owners or operators of
SECURITY needed to accommodate approximately vessels intending to transit through the
2,000 pedestrians that are expected to Tarpon dock bridge across Massalina
Coast Guard
participate in a 3.5-mile walk. The Bayou during the closure. There is not
bridge is near the beginning of the walk expected to be a significant impact due
33 CFR Part 117
and allowing the bridge to open for to the short duration of the closure and
[CGD08–05–040] navigation during this short time period the publicity given to the event.
would disrupt the event and could Assistance for Small Entities
RIN 1625–AA09
result in injury. The bridge has a
Drawbridge Operation Regulation; vertical clearance of 7 feet above mean Under section 213(a) of the Small
Massalina Bayou, Panama City, FL high water in the closed-to-navigation Business Regulatory Enforcement
position and unlimited in the open-to- Fairness Act of 1996 (Public Law 104–
AGENCY: Coast Guard, DHS. navigation position. Navigation on the 121), we want to assist small entities in
ACTION: Temporary rule. waterway consists primarily of understanding this rule so that they can
commercial fishing vessels, sailing better evaluate its effects on them and
SUMMARY: The Commander, Eighth vessels and other recreational craft. participate in the rulemaking process.
Coast Guard District, has temporarily Presently, Title 33, Code of Federal Small businesses may send comments
changed the regulation governing the Regulations (CFR), Part 117.301 states: on the actions of Federal employees
operation of the Tarpon Dock bascule The draw of the Tarpon Dock bascule who enforce, or otherwise determine
span drawbridge across Massalina span bridge, Massalina Bayou, mile 0.0, compliance with, Federal regulations to
Bayou, mile 0.0, at Panama City, Bay shall open on signal; except that from 9 the Small Business and Agriculture
County, Florida. The regulation will p.m. until 11 p.m. on July 4, each year, Regulatory Enforcement Ombudsman
allow the draw of the bridge to remain the draw need not open for the passage and the Regional Small Business
closed to navigation for one hour to of vessels. The draw will open at any Regulatory Fairness Boards. The
facilitate the American Heart Walk. time for a vessel in distress. This Ombudsman evaluates these actions
DATES: This temporary rule is effective temporary rule will allow the bridge to annually and rates each agency’s
from 9 a.m. to 10 a.m. on October 15, be maintained in the closed-to- responsiveness to small business. If you
2005. navigation position from 9 a.m. to 10 wish to comment on actions by

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