Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 70487 

ANM WA E Eagle, CO [Removed] 

* * * * * 

Issued in Seattle, Washington, on 

November 4, 2005. 

Raul C. Trevin ̃ o, 

Area Director, Western En Route and Oceanic 

Operations. 

[FR Doc. 05–23017 Filed 11–21–05; 8:45am] 

BILLING CODE 4910–13–M 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 71 

[Docket No. FAA–2005–22998; Airspace 

Docket No. 2005–ASW–19] 

Establishment to Class E Airspace; 

Hillsboro, TX 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Direct final rule; request for 

comments. 

SUMMARY: This action establishes the 

Class E airspace area at Hillsboro 

Municipal Airport, Hillsboro, TX (INJ), 

to provide adequate controlled airspace 

for the area navigation (RNAV) global 

positioning system (GPS) standard 

instrument approach procedure (SIAP). 

DATES: Effective 0901 UTC, February 16, 

2006. 

Comments for inclusion in the Rules 

Docket must be received on or before 

January 16, 2006. 

ADDRESSES: Send comments on the rule 

to the Docket Management System, U.S. 

Department of Transportation, Room 

Plaza 401, 400 Seventh Street, SW., 

Washington, DC 20590–0001. You must 

identify the docket number, FAA–2005–

22998/Airspace Docket No. 2005–ASW–

20, at the beginning of your comments. 

You may also submit comments on the 

Internet at http://dms.dot.gov. Anyone 

can find and read the comments 

received in this docket, including the 

name, address and any other personal 

information placed in the docket by a 

commenter. You may review the public 

docket containing any comments 

received and this direct final rule in 

person at the Dockets Office between 9 

a.m. and 5 p.m., Monday through 

Friday, except Federal holidays. The 

Docket Office (telephone 1–800–647–

5527) is located on the plaza level of the 

Department of Transportation NASSIF 

Building at the street address stated 

previously. 

An informal docket may also be 

examined during normal business hours 

at the office of the Air Traffic Division, 

Airspace Branch, Federal Aviation 

Administration, Southwest Region, 2601 

Meacham Boulevard, Forth Worth, TX. 

Call the manager, Airspace Branch, 

ASW–520, telephone (817) 222–5520; 

fax (817) 222–5981, to make 

arrangements for your visit. 

FOR FURTHER INFORMATION CONTACT: 

Joseph R. Yadouga, Air Traffic Division, 

Airspace Branch, Federal Aviation 

Administration, Southwest Region, Fort 

Worth, TX 76193–0520; telephone (817) 

222–5597. 

SUPPLEMENTARY INFORMATION: This 

amendment to 14 CFR part 71 

establishes a Class D airspace 

designation for an airspace area from the 

surface up to but not including, 3,900 

feet MSL at Rogers Municipal/Carter 

Field, Rogers, AR, and will be published 

in paragraph 5000 of FAA Order 

7400.9N, dated September 1, 2004, and 

effective September 16, 2005, which is 

incorporated by reference in 14 CFR 

71.1. 

This amendment to 14 CFR part 71 

also modifies the Class E airspace area 

extending upward from the surface at 

Rogers Municipal/Carter Field, Rogers, 

AR, and will be published in paragraph 

6000 of FAA Order 7400.9N, dated 

September 1, 2005, and effective 

September 16, 2005, which is 

incorporated by reference in 14 CFR 

71.1. 

The Direct Final Rule Procedure 

The FAA anticipates that this 

regulation will not result in an 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. 

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 

must identify both docket numbers. 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. 

Agency Findings 

This rule does not have federalism 

implications, as defined in Executive 

Order No. 13132, because it does not 

have a substantial direct effect 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. Accordingly, the 

FAA has not consulted with state 

authorities prior to publication of this 

rule. 

The FAA has determined that this 

regulation is noncontroversial and 

unlikely to result in adverse or negative 

comments. For the reasons discussed, 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. I certify that this rule will 

not have a significant economic impact 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

Authority for This Rulemaking 

The FAA authority to issue rules 

regarding aviation safety is found in 

70488 Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 

Title 49 of the United States Code. 

Subtitle I, section 106 describes the 

authority of the FAA Administrator. 

Subtitle VII, Aviation Programs, 

describes in more detail the scope of the 

agency’s authority. 

This rulemaking is promulgated 

under the authority described in subtitle 

VII, part A, subpart I, section 40103, 

‘‘Sovereignty and use of airspace.’’

Under that section, the FAA is charged 

with developing plans and policy for 

the use of the navigable airspace and 

assigning by regulation or order the 

airspace necessary to ensure the safety 

of aircraft and the efficient use of 

airspace. The FAA may modify or 

revoke an assignment when required in 

the public interest. This regulation is 

within the scope of that authority 

because it is in the public interest to 

provide greater control of the airspace 

for the safety of aircraft operating in the 

vicinity of the newly established airport 

traffic control tower. 

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—DESIGNATION OF CLASS A, 

CLASS B, CLASS C, CLASS D, AND 

CLASS E AIRSPACE AREAS; 

AIRWAYS; ROUTES; AND REPORTING 

POINTS 

■ 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. 

§ 71.1 [Amended] 

■ 2. The incorporation by reference in 

14 CFR 71.1 of Federal Aviation 

Administration Order 7400.9N, 

Airspace Designations and Reporting 

Points, dated September 1, 2005, and 

effective September 16, 2005, is 

amended as follows: 

Paragraph 5000 Class D airspace areas 

extending upward from the surface of the 

earth. 

* * * * * 

ASW AR D Rogers, AR [New] 

Rogers Municipal/Carter Field, Rogers, AR 

Lat. 36°22′20′′ N, long. 94°06′25′′ W 

Razorback VOR 

Lat. 36°14′47′′ N, long. 94°07′17′′ W 

That airspace extending upward from the 

surface up to but not including 3,900 feet 

MSL within a 4-mile radius of Rogers 

Municipal/Carter Field and within 2.2 miles 

each side of the 005° radial of the Razorback 

VOR extending from the 4-mile radius to 6.0 

miles south of the airport excluding that 

airspace west of a line (lat. 36°24′10′′ N., 

long. 94°10′49′′ W and lat. 36°16′24′′ N., long. 

94°7′55′′ W) and excluding the Class C 

airspace associated with the Northwest 

Arkansas Regional Airport (XNA). This Class 

D airspace area is effective during the 

specific dates and times established in 

advance by a Notice to Airmen. The effective 

date and time will thereafter be continuously 

published in the Airport/Facility Directory. 

Paragraph 6000 Class E airspace areas 

extending upward from the surface of the 

earth. 

* * * * * 

ASW AR E2 Rogers, AR [Revised] 

Rogers Municipal/Carter Field, Rogers, AR 

Lat. 36°22′20′′ N, long. 94°06′25′′ W 

Razorback VOR 

Lat. 36°14′47′′ N, long. 94°07′17′′ W 

Within a 4-mile radius of Rogers 

Municipal/Carter Field and within 2.2 miles 

each side of the 005° radial of the Razorback 

VOR extending from the 4-mile radius to 6.0 

miles south of the airport excluding that 

airspace west of a line (lat. 36°24′10′′ N., 

long. 94°10′49′′ W and lat. 36°16′24′′ N., long. 

94°7′55′′ W) and excluding the Class C 

airspace associated with the Northwest 

Arkansas Regional Airport (XNA). This Class 

E airspace area is effective during the specific 

dates and times established in advance by a 

Notice to Airmen. The effective date and time 

will thereafter be continuously published in 

the Airport/Facility Directory. 

* * * * * 

Issued in Fort Worth, TX, on November 15, 

2005. 

William C. Yuknewicz, 

Acting Area Director, Central En Route and 

Oceanic Operations. 

[FR Doc. 05–23021 Filed 11–21–05; 8:45 am] 

BILLING CODE 4910–13–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 1 and 11 

[Docket No. 2005D–0356] 

Guidance for Industry: Questions and 

Answers Regarding the Final Rule on 

Establishment and Maintenance of 

Records (Edition 2); Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability of 

guidance. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled 

‘‘Questions and Answers Regarding 

Establishment and Maintenance of 

Records (Edition 2).’’ The guidance 

responds to various questions raised 

about section 306 of the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002 (the 

Bioterrorism Act) and the agency’s 

implementing regulation, which 

requires the establishment and 

maintenance of records by persons who 

manufacture, process, pack, transport, 

distribute, receive, hold, or import food 

in the United States. Such records are to 

allow for the identification of the 

immediate previous sources and the 

immediate subsequent recipients of 

food. Persons covered by the regulation 

must be in compliance by December 9, 

2005, June 9, 2006, or December 11, 

2006, depending on the size of the 

business. 

DATES: Submit written or electronic 

comments on the agency guidance at 

any time. 

ADDRESSES: You may submit comments, 

identified by Docket No. 2005D–0356, 

by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following ways: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Agency Web site: http:// 

www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting 

comments on the agency Web site. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier [For 

paper, disk, or CD–ROM submissions]: 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal or the 

agency Web site, as described in the 

Electronic Submissions portion of this 

paragraph. 

Instructions: All submissions received 

must include the agency name and 

Docket No(s). and Regulatory 

Information Number (RIN) (if a RIN 

number has been assigned) for this 

rulemaking. All comments received may 

be posted without change to http:// 

www.fda.gov/ohrms/dockets/ 

default.htm, including any personal 

information provided. For detailed 

instructions on submitting comments