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 

Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 70489 

and additional information on the 

rulemaking process, see the 

‘‘Comments’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.fda.gov/ohrms/dockets/ 

default.htm and insert the docket 

number(s), found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Denise Beavers, Office of Regulations 

and Policy (HFS–24), Center for Food 

Safety and Applied Nutrition, Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 301–

436–1721. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of December 9, 

2004 (69 FR 71562), FDA issued a final 

rule to implement section 306 of the 

Bioterrorism Act. The regulation 

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 subject to the regulation 

are required to be in compliance by 

December 9, 2005, June 9, 2006, or 

December 11, 2006, depending on the 

size of the business. On September 12, 

2005, FDA issued the first edition of a 

guidance entitled ‘‘Questions and 

Answers Regarding Establishment and 

Maintenance of Records.’’ This guidance 

entitled ‘‘Questions and Answers 

Regarding Establishment and 

Maintenance of Records (Edition 2)’’

responds to questions about the final 

rule on records. It is intended to help 

the industry better understand and 

comply with the regulation in 21 CFR 

part 1, subpart J. FDA is issuing this 

guidance as a Level 1 guidance. The 

guidance represents the agency’s current 

thinking on the topic. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. Consistent with FDA’s good 

guidance practices regulation 

§ 10.115(g)(2) (21 CFR 10.115), the 

agency will accept comments, but it is 

implementing the guidance document 

immediately, in accordance with 

§ 10.115(g)(2), because the agency has 

determined that prior public 

participation is not feasible or 

appropriate. As noted, the final rule 

requires that covered persons begin to 

establish and maintain records 

identifying the immediate previous 

sources and immediate subsequent 

recipients of food by December 9, 2005, 

June 9, 2006, or December 11, 2006, 

depending on the size of the business. 

Clarifying the provisions of the final 

rule will facilitate prompt compliance 

with these requirements and complete 

the rule’s implementation. 

FDA continues to receive large 

numbers of questions regarding the 

records final rule, and is responding to 

these questions under § 10.115 as 

promptly as possible, using a questionand-answer format. The agency believes 

that it is reasonable to maintain all 

responses to questions concerning 

establishment and maintenance of 

records in a single document that is 

periodically updated as the agency 

receives and responds to additional 

questions. The following four indicators 

will be employed to help users of this 

guidance identify revisions: (1) The 

guidance will be identified as a revision 

of a previously issued document, (2) the 

revision date of the guidance will 

appear on its cover, (3) the edition 

number of the guidance will be 

included in its title, and (4) questions 

and answers that have been added to the 

original guidance will be identified as 

such in the body of the guidance. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding the guidance at any 

time. Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments and the guidance may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at http:// 

www.cfsan.fda.gov/guidance.html. 

Dated: November 15, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–23062 Filed 11–21–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

32 CFR Part 310 

Department of Defense Privacy 

Program 

AGENCY: Department of Defense. 

ACTION: Final rule. 

SUMMARY: The Department of Defense 

updates policies and responsibilities for 

the Defense Privacy Program which 

implements the Privacy Act of 1974 by 

showing organizational changes and 

realignments and by revising referenced 

statutory and regulatory authority. 

DATES: Effective Date: November 7, 

2005. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Vahan Moushegian, Jr., at (703) 607–

2943. 

SUPPLEMENTARY INFORMATION: The 

proposed rule was published September 

7, 2005 at 70 FR 53135. No comments 

were received. The Office of the 

Secretary is therefore adopting the rule 

as published. 

Executive Order 12866, ‘‘Regulatory 

Planning and Review’’

It has been determined that Privacy 

Act rules for the Department of Defense 

are not significant rules. The rules do 

not (1) have an annual effect on the 

economy of $100 million or more or 

adversely affect in a material way the 

economy; a sector of the economy; 

productivity; competition; jobs; the 

environment; public health or safety; or 

State, local, or tribal governments or 

communities; (2) Create a serious 

inconsistency or otherwise interfere 

with an action taken or planned by 

another Agency; (3) Materially alter the 

budgetary impact of entitlements, 

grants, user fees, or loan programs, or 

the rights and obligations of recipients 

thereof; or (4) Raise novel legal or policy 

issues arising out of legal mandates, the 

President’s priorities, or the principles 

set forth in this Executive order. 

Public Law 96–354, ‘‘Regulatory 

Flexibility Act’’ (5 U.S.C. Chapter 6) 

It has been determined that Privacy 

Act rules for the Department of Defense 

do not have significant economic impact 

on a substantial number of small entities 

because they are concerned only with 

the administration of Privacy Act 

systems of records within the 

Department of Defense.