26288 Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Rules and Regulations 

SUPPLEMENTARY INFORMATION: A new 

Standard Instrument Approach 

Procedure (SIAP) to Front Royal-Warren 

County Airport, Front Royal, VA 

(KFFR), RNAV (GPS)–A, requires the 

establishment of Class E airspace 

extending upward from 700 feet above 

the surface in the vicinity of the airport. 

This action provides adequate 

controlled airspace to contain those 

aircraft executing the RNAV (GPS)–A 

approach. Class E airspace designations 

for airspace areas extending upward 

from 700 feet above the surface of the 

earth are published in paragraph 6005 of 

FAA Order 7400.9P, effective September 

16, 2006, which is incorporated by 

reference in 14 CFR 71.1. The Class E 

airspace designation listed in this 

document will be published 

subsequently in this Order. 

The Direct Final Rule Procedure 

The FAA anticipates that this 

regulation will not result in adverse or 

negative comment, and, therefore, issues 

it as a direct final rule. The FAA has 

determined that this regulation only 

involves an established body of 

technical regulations for which frequent 

and routine amendments are necessary 

to keep them operationally current. 

Unless a written adverse or negative 

comment or a written notice of intent to 

submit an adverse or negative comment 

is received within the comment period, 

the regulation will become effective on 

the date specified above. After the close 

of the comment period, the FAA will 

publish a document in the Federal 

Register indicating that no adverse or 

negative comments were received and 

confirming the date on which the final 

rule will become effective. If the FAA 

does receive, within the comment 

period, an adverse or negative comment, 

or written notice of intent to submit 

such a comment, a document 

withdrawing the direct final rule will be 

published in the Federal Register, and 

a notice of proposed rulemaking may be 

published with a new comment period. 

Comments Invited 

Although this action is in the form of 

a direct final rule, and was not preceded 

by a notice of proposed rulemaking, 

interested persons are invited to 

comment on this rule by submitting 

such written data, views, or arguments 

as they may desire. Communications 

should identify the Rules Docket 

number and be submitted in triplicate to 

the address specified under the caption 

ADDRESSES. All communications 

received on or before the closing date 

for comments will be considered, and 

this rule may be amended or withdrawn 

in light of the comments received. 

Factual information that supports the 

commenter’s ideas and suggestions is 

extremely helpful in evaluating the 

effectiveness of this action and 

determining whether additional 

rulemaking action would be needed. 

Comments are specifically invited on 

the overall regulatory, economic, 

environmental, and energy aspects of 

the rule that might suggest a need to 

modify the rule. All comments 

submitted will be available, both before 

and after the closing date for comments, 

in the Rules Docket for examination by 

interested persons. A report that 

summarizes each FAA-public contact 

concerned with the substance of this 

action will be filed in the Rules Docket. 

Commenters wishing the FAA to 

acknowledge receipt of their comments 

submitted in response to this rule must 

submit a self-addressed, stamped 

postcard on which the following 

statement is made: ‘‘Comments to 

Docket No. FAA 2007–27512; Airspace 

Docket No. 07–AEA–01.’’ The postcard 

will be date stamped and returned to the 

commenter. 

Agency Findings 

The regulations adopted herein 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. Therefore, in 

accordance with Executive Order 12612, 

it is determined that this final rule does 

not have sufficient federalism 

implications to warrant the preparation 

of a Federalism Assessment. 

The FAA has determined that this 

regulation is non-controversial and 

unlikely to result in adverse or negative 

comments. For the reasons discussed in 

the preamble, I certify that this 

regulation (1) is not a ‘‘significant 

regulatory action’’ under Executive 

Order 12866; (2) is not a ‘‘significant 

rule’’ under Department of 

Transportation (DOT) Regulatory 

Policies and Procedures (44 FR 11034, 

February 26, 1979); and (3) does not 

warrant preparation of a Regulatory 

Evaluation as these routine matters will 

only affect air traffic procedures and air 

navigation. It is certified that these 

proposed rules will not have significant 

economic impact on a substantial 

number of small entities under the 

criteria of the Regulatory Flexibility Act. 

List of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

Adoption of the Amendment 

■ Accordingly, pursuant to the authority 

delegated to me, the Federal Aviation 

Administration amends part 71 of the 

Federal Aviation Regulations (14 CFR 

part 71) as follows: 

PART 71—[Amended] 

■ 1. The authority citation for part 71 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40103, 40113, 

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389. 

■ 2. The incorporation by reference in 

14 CFR 71.1 of Federal Aviation 

Administration Order 7400.9P, Airspace 

Designations and Reporting Points, 

dated September 1, 2006 and effective 

September 15, 2006, is amended as 

follows: 

Paragraph 6005 Class E Airspace Areas 

Extending Upward from 700 Feet or More 

Above the Surface of the Earth. 

* * * * * 

AEA VA E5 FRONT ROYAL, VA [New] 

Front Royal-Warren County Airport, VA 

(Lat. 38°55′03.11′′ N., long. 78°15′12.65′′ 

W.) 

That airspace extending upward from 700 

feet above the surface within a 11.3-mile 

radius of Front Royal-Warren County Airport, 

VA. 

* * * * * 

Issued in College Park, GA, on April 18, 

2007. 

Lynda Otting, 

Acting Group Manager, System Support, 

AJ02–E2, Eastern Service Center. 

[FR Doc. 07–2210 Filed 5–8–07; 8:45am] 

BILLING CODE 4910–13–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 510 

New Animal Drugs; Change of 

Sponsor’s Name and 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 name from 

American Pharmaceutical Partners, Inc., 

to Abraxis Pharmaceuticals Products 

and to change the sponsor’s mailing 

address. 

DATES: This rule is effective May 9, 

2007. 


rmajette on PROD1PC67 with RULES
Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Rules and Regulations 26289 

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.hhs.gov. 

SUPPLEMENTARY INFORMATION: American 

Pharmaceuticals Partners, Inc., 2045 

North Cornell Ave., Melrose Park, IL 

60160, has informed FDA of a change of 

name and mailing address to Abraxis 

Pharmaceutical Products, a Div. of 

Abraxis Bioscience, 6133 River Rd., 

suite 500, Rosemont, Il 60018. 

Accordingly, the agency is amending 

the regulations in 21 CFR 510.600(c) to 

reflect these changes. 

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 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: 

PART 510—NEW ANIMAL DRUGS 

■ 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. 

■ 2. Section 510.600 is amended in the 

table in paragraph (c)(1) by removing 

the entry for ‘‘American 

Pharmaceuticals Partners, Inc.’’ and 

alphabetically adding a new entry for 

‘‘Abraxis Pharmaceutical Products’’; and 

in the table in paragraph (c)(2) by 

revising the entry for ‘‘063323’’ to read 

as follows: 

§ 510.600 Names, addresses, and drug 

labeler codes of sponsors of approved 

applications. 

* * * * * 

(c) * * * 

(1) * * * 

Firm name and address Drug labeler 

code 

* * * * * 

Abraxis Pharmaceutical Products, a Div. of Abraxis Bioscience, 6133 River Rd., 

suite 500, Rosemont, IL 

60018.

063323 

* * * * * 

(2) * * * 

Drug labeler 

code Firm name and address 

* * * * * 

063323 ....... Abraxis Pharmaceutical Products, a Div. of Abraxis Bioscience, 6133 River Rd., 

suite 500, Rosemont, IL 

60018 

* * * * * 

Dated: May 1, 2007. 

Bernadette Dunham, 

Deputy Director, Center for Veterinary 

Medicine. 

[FR Doc. E7–8870 Filed 5–8–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 529 

Certain Other Dosage Form New 

Animal Drugs; Oxytetracycline 

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 

Cross Vetpharm Group Ltd. The 

ANADA provides for use of 

oxytetracycline hydrochloride soluble 

powder for skeletal marking of finfish 

fry and fingerlings by immersion. 

DATES: This rule is effective May 9, 

2007. 

FOR FURTHER INFORMATION CONTACT: John 

K. Harshman, Center for Veterinary 

Medicine (HFV–104), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–0169, email: john.harshman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Cross 

Vetpharm Group Ltd., Broomhill Rd., 

Tallaght, Dublin 24, Ireland, filed 

ANADA 200–460 that provides for use 

of TETROXY Aquatic (oxytetracycline 

hydrochloride) Soluble Powder for 

skeletal marking of finfish fry and 

fingerlings by immersion. The 

application is approved as of April 20, 

2007, and the regulations are amended 

in 21 CFR 529.1660 to reflect the 

approval. 

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 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. 

FDA 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. 

List of Subjects in 21 CFR Part 529 

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 529 is amended as follows: 

PART 529—CERTAIN OTHER DOSAGE 

FORM NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 529 continues to read as follows: 

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

■ 2. In § 529.1660, revise paragraph 

(b)(1) to read as follows: 

§ 529.1660 Oxytetracycline. 

* * * * * 

(b) * * * 

(1) Nos. 046573 and 061623 for use of 

product in paragraph (a)(1) of this 

section. 

* * * * * 

Dated: May 1, 2007. 

Bernadette Dunham, 

Deputy Director, Center for Veterinary 

Medicine. 

[FR Doc. E7–8869 Filed 5–8–07; 8:45 am] 

BILLING CODE 4160–01–S 


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