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. 

70490 Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 

1Copies of DoD issuances may be obtained at 

http://www.dtic.mil/whs/directives/. 2See footnote 1 to § 310.1. 

Public Law 96–511, ‘‘Paperwork 

Reduction Act’’ (44 U.S.C. Chapter 35) 

It has been determined that Privacy 

Act rules for the Department of Defense 

impose no information requirements 

beyond the Department of Defense and 

that the information collected within 

the Department of Defense is necessary 

and consistent with 5 U.S.C. 552a, 

known as the Privacy Act of 1974. 

Section 202, Public Law 104–4, 

‘‘Unfunded Mandates Reform Act’’

It has been determined that Privacy 

Act rulemaking for the Department of 

Defense does not involve a Federal 

mandate that may result in the 

expenditure by State, local and tribal 

governments, in the aggregate, or by the 

private sector, of $100 million or more 

and that such rulemaking will not 

significantly or uniquely affect small 

governments. 

Executive Order 13132, ‘‘Federalism’’

It has been determined that Privacy 

Act rules for the Department of Defense 

do not have federalism implications. 

The rules do 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. 

List of Subjects in 32 CFR Part 310 

Privacy. 

■ Accordingly, 32 CFR part 310, 

Subpart A—DoD Policy, is amended as 

follows: 

PART 310—DOD PRIVACY PROGRAM 

■ 1. The authority citation for 32 CFR 

part 310 continues to read as follows: 

Authority: Pub. L. 93–579, 88 Stat 1896 (5 

U.S.C. 552a). 

■ 2. Section 310.1 is revised to read as 

follows: 

§ 310.1 Reissuance. 

This part is reissued to consolidate 

into a single document (32 CFR part 

310) Department of Defense (DoD) 

policies and procedures for 

implementing the Privacy Act of 1974, 

as amended (5 U.S.C. 552a) by 

authorizing the development, 

publication and maintenance of the DoD 

Privacy Program set forth by DoD 

Directive 5400.11 1 and 5400.11–R, both 

entitled: ‘‘DoD Privacy Program.’’

■ 3. Section 310.3 is amended by 

revising paragraph (a) to read as follows: 

§ 310.3 Applicability and scope. 

* * * * * 

(a) Applies to the Office of the 

Secretary of Defense (OSD), the Military 

Departments, the Chairman of the Joint 

Chiefs of Staff, the Combatant 

Commands, the Office of the Inspector 

General of the Department of Defense 

(IG, DoD), the Defense Agencies, the 

DoD Field Activities, and all other 

organizational entities in the 

Department of Defense (hereinafter 

referred to collectively as ‘‘the DoD 

Components’’). This part is mandatory 

for use by all DoD Components. Heads 

of DoD Components may issue 

supplementary instructions only when 

necessary to provide for unique 

requirements within heir Components. 

Such instructions will not conflict with 

the provisions of this part. 

* * * * * 

■ 4. Section 310.4 amended by revising 

the definition of ‘‘Individual’’ to read as 

follows: 

§ 310.4 Definitions. 

* * * * * 

Individual. A living person who is a 

citizen of the United States or an alien 

lawfully admitted for permanent 

residence. The parent of a minor or the 

legal guardian of any individual also 

may act on behalf of an individual. 

Members of the United States Armed 

Forces are individuals. Corporations, 

partnerships, sole proprietorships, 

professional groups, businesses, 

whether incorporated or 

unincorporated, and other commercial 

entities are not individuals. 

* * * * * 

■ 5. Section 310.5 is amended as 

follows: 

■ a. Removing the introductory text; 

■ b. Revising paragraphs (a) and (g); 

■ c. Adding paragraph (j) to read as 

follows: 

§ 310.5 Policy. 

a. The privacy of an individual is a 

personal and fundamental right that 

shall be respected and protected. 

* * * * * 

(g) Disclosure of records pertaining to 

personnel of the National Security 

Agency, the Defense Intelligence 

Agency, the National Reconnaissance 

Office, and the National GeospatialIntelligence Agency shall be prohibited 

to the extent authorized by Public Law 

86–36 (1959) and 10 U.S.C. 424. 

Disclosure of records pertaining to 

personnel of overseas, sensitive, or 

routinely deployable units shall be 

prohibited to the extent authorized by 

10 U.S.C. 130b. Disclosure of medical 

records is prohibited except as 

authorized by DoD 6025.18–R. 2

* * * * * 

(j) DoD Field Activities shall receive 

Privacy Program support from the 

Director, Washington Headquarters 

Services. 

■ 6. Section 310.6 is amended by 

revising paragraphs (a)(4), (b), (c) 

introductory text, (c)(3), (d) introductory 

text and (d)(5); and adding paragraph 

(a)(5) to read as follows: 

§ 310.6 Responsibilities. 

(a) * * * 

(4) Serve as the Chair to the Defense 

Privacy Board and Defense Data 

Integrity Board (§ 310.9). 

(5) Supervise and oversee the 

activities of the Defense Privacy Office 

(§ 310.9). 

(b) The Director, Washington 

Headquarters Services, under the 

DA&M, OSD, shall provide Privacy 

Program support for DoD Field 

Activities. 

(c) The General Counsel of the 

Department of Defense (GC, DoD) shall: 

* * * * * 

(3) Serve as a member of the Defense 

Privacy Board, the Defense Data 

Integrity Board, the Defense Privacy 

Board Legal Committee (§ 310.9). 

(d) The Secretaries of the Military 

Departments and the Heads of the Other 

DoD Components, except as noted in 

Sec. 310.5(j), shall: 

* * * * * 

(5) Submit reports, consistent with the 

requirements of DoD 5400.11–R, as 

mandated by 5 U.S.C. 552a and OMB 

Circular A–130, and as otherwise 

directed by the Defense Privacy Office. 

* * * * * 

■ 7. Section 310.9 is amended as 

follows: 

■ a. Revise paragraphs (a)(1), (b)(1), 

(c)(1); 

■ b. Redesignate the second paragraph 

(c) as a new paragraph (d); 

■ c. Revise newly redesignated (d)(2)(vi) 

and (d)(2)(x) to read as follows: 

§ 310.9 Privacy boards and office 

composition and responsibilities. 

(a) * * * 

(1) Membership. The Board shall 

consist of the DA&M, OSD, who shall 

serve as the Chair; the Director of the 

Defense Privacy Office, DA&M, who 

shall serve as the Executive Secretary 

and as a member; The representatives 

designated by the Secretaries of the 

Military Departments; and the following 

officials or their designees: The Deputy 

Under Secretary of Defense for Program 

Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 70491 

Integration (DUSD (PI)); the Assistant 

Secretary of Defense for Health Affairs; 

the Assistant Secretary of Defense for 

Networks and Information Integration 

(ASD(NII))/Chief Information Officer 

(CIO); the Director, Executive Services 

and Communications Directorate, 

Washington Headquarters Services 

(WHS); the GC, DoD; and the Director 

for Information Technology 

Management Directorate (ITMD), WHS. 

The designees also may be the principal 

point of contact for the DoD Component 

for privacy matters. 

* * * * * 

(b) * * * 

(1) Membership. The Board shall 

consist of the DA&M, OSD, who shall 

serve as the Chair; the Director of the 

Defense Privacy Office, DA&M, who 

shall serve as the Executive Secretary; 

and the following officials or their 

designees: The representatives 

designated by the Secretaries of the 

Military Departments; the DUSD (PI); 

the ASD (NII)/CIO; the GC, DoD; the 

Inspector General, DoD; the ITMD, 

WHS; and the Director, Defense 

Manpower Data Center. The designees 

also may be the principal points of 

contact for the DoD Component for 

privacy matters. 

* * * * * 

(c) * * * 

(1) The Committee shall consist of the 

Director, Defense Privacy Office, DA&M, 

who shall serve as the Chair and the 

Executive Secretary; the GC, DoD, or 

designee; and civilian and/or military 

counsel from each of the DoD 

Components. The General Counsels 

(GCs) and The Judge Advocates General 

of the Military Departments shall 

determine who shall provide 

representation for their respective 

Department to the Committee. This does 

not preclude representation from each 

office. The GCs of the other DoD 

Components shall provide legal 

representation to the Committee. Other 

DoD civilian or military counsel may be 

appointed by the Executive Secretary, 

after coordination with the DoD 

Component concerned, to serve on the 

Committee on those occasions when 

specialized knowledge or expertise shall 

be required. 

* * * * * 

(d) The Defense Privacy Office. 

* * * * * 

(2) * * * 

(vi) Review proposed DoD Component 

privacy rulemaking, to include 

submission of the rule to the Office of 

the Federal Register for publication and 

providing OMB and the Congress 

reports, consistent with 5 U.S.C. 552a, 

OMB Circular A–130, and DoD 5400.11–

R. 

* * * * * 

(x) Compile and submit the ‘‘Biennial 

Matching Activity Report’’ to the OMB 

as required by OMB Circular A–130 and 

DoD 5400.11–R, and such other reports 

as required. 

* * * * * 

Dated: November 16, 2005. 

L.M. Bynum, 

OSD Federal Register Liaison Officer, 

Department of Defense. 

[FR Doc. 05–23070 Filed 11–21–05; 8:45 am] 

BILLING CODE 5001–06–M 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[CGD05–05–129] 

RIN 1625–AA–09 

Drawbridge Operation Regulations; 

Elizabeth River, Eastern Branch, VA 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of temporary deviation 

from regulations. 

SUMMARY: The Commander, Fifth Coast 

Guard District, has approved a 

temporary deviation from the 

regulations governing the operation of 

the Berkley Bridge, at mile 0.4, across 

the Eastern Branch of the Elizabeth 

River in Norfolk, Virginia. To facilitate 

electrical and mechanical repairs, this 

deviation allows the drawbridge to 

remain closed-to-navigation each day, 

from 7 a.m. to 7 p.m., on four two-day 

closure periods: November 29 & 30, 

2005; December 28 & 29, 2005; January 

24 & 25, 2006; and February 21 & 22, 

2006. 

DATES: This deviation is effective from 

7 a.m. on November 29, 2005, to 7 p.m. 

on February 22, 2006. 

FOR FURTHER INFORMATION CONTACT: Gary 

Heyer, Bridge Management Specialist, 

Fifth Coast Guard District, at (757) 398–

6629. 

SUPPLEMENTARY INFORMATION: The 

Berkley Bridge, a lift-type drawbridge, 

has a vertical clearance in the closed 

position to vessels of 48 feet, at mean 

high water. 

The bridge owner, the Virginia 

Department of Transportation, has 

requested a temporary deviation from 

the current operating regulation set out 

in 33 CFR 117.1007, to effect electrical 

and mechanical repairs of the draw 

span. 

To facilitate the repairs, the 

drawbridge will be closed to navigation 

each day, from 7 a.m. to 7 p.m., on four 

two-day closure periods: November 29 & 

30, 2005; December 28 & 29, 2005; 

January 24 & 25, 2006; and February 21 

& 22, 2006. During these periods, the 

repairs require immobilizing the 

operation of the lift span in the closedto-navigation position. At all other 

times, the drawbridge will operate in 

accordance with the current operating 

regulations outlined in 33 CFR 

117.1007. 

The Coast Guard has informed the 

known users of the waterway so that 

they can arrange their transits to 

minimize any impact caused by the 

temporary deviation. 

In accordance with 33 CFR 117.35(c), 

this work will be performed with all due 

speed in order to return the bridge to 

normal operation as soon as possible. 

This deviation from the operating 

regulations is authorized under 33 CFR 

117.35. 

Dated: November 10, 2005. 

Waverly W. Gregory, Jr., 

Chief, Bridge Administration Branch, Fifth 

Coast Guard District. 

[FR Doc. 05–23029 Filed 11–21–05; 8:45 am] 

BILLING CODE 4910–15–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[COTP Jacksonville 05–153] 

RIN 1625–AA87 

Security Zone; Sea Buoy at the 

Entrance of St. Mary’s River to Kings 

Bay, GA 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary moving 

security zone around foreign naval 

submarines in transit within the area 

between 12 nautical miles offshore from 

the baseline, also known as the 

shoreline, at the mouth of the St. Mary’s 

River to the Kings Bay Naval Submarine 

Base, Kings Bay, GA. The security zone 

includes all waters within 500 yards in 

any direction of the submarine. The rule 

prohibits entry into the security zone 

without the permission of the Captain of 

the Port (COTP) Jacksonville or his 

designated representative. Persons or 

vessels that receive permission to enter 

the security zone must proceed at a 

minimum safe speed, must comply with