53728 Federal Register / Vol. 70, No. 175 / Monday, September 12, 2005 / Rules and Regulations 

and Records Administration (NARA). For 

information on the availability of this 

material at NARA, call 202–741–6030, or go 

to: http://www.archives.gov/federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

Table 5 follows: 

TABLE 5.—INCORPORATION BY REFERENCE

Service Bulletin No. Page Revision Date 

RB.211–72–AD344 ............................................................. All ........................................ 7 .......................................... March 12, 2004. 

Total Pages: 11 

RB.211–72–AD344, Appendices 1 through 5 .................... All ........................................ 7 .......................................... March 12, 2004. 

Total Pages: 18 

RB.211–72–D672 ............................................................... All ........................................ Original ................................ February 1, 2002. 

Total Pages: 24 

Related Information 

(l) Civil Aviation Authority (CAA) 

airworthiness directive G–2004–0008, dated 

April 29, 2004, also addresses the subject of 

this AD. 

Issued in Burlington, Massachusetts, on 

September 6, 2005. 

Peter A. White, 

Acting Manager, Engine and Propeller 

Directorate, Aircraft Certification Service. 

[FR Doc. 05–17976 Filed 9–9–05; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 1 

[Docket No. 2005D–0356] 

Guidance for Industry: Questions and 

Answers Regarding the Final Rule on 

Establishment and Maintenance of 

Records; 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 for industry 

entitled ‘‘Questions and Answers 

Regarding Establishment and 

Maintenance of Records.’’ The guidance 

responds to various questions raised 

about the recordkeeping provisions 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. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance entitled 

‘‘Questions and Answers Regarding 

Establishment and Maintenance of 

Records’’ to Denise Beavers (see FOR

FURTHER INFORMATION CONTACT). Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Denise Beavers, Center for Food Safety 

and Applied Nutrition (HFS–24), 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 (21 U.S.C. 350c). 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. 

The guidance for industry entitled 

‘‘Questions and Answers Regarding 

Establishment and Maintenance of 

Records’’ responds to questions about 

the final rule on records. It is intended 

to help 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(g)(2)), 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 ensure 

complete implementation of the final 

rule. 

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 the 

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 this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

Federal Register / Vol. 70, No. 175 / Monday, September 12, 2005 / Rules and Regulations 53729 

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: September 1, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–18039 Filed 9–7–05; 3:12 pm] 

BILLING CODE 4160–01–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 228 

[FRL–7967–7] 

Ocean Dumping; LA–3 Ocean Dredged 

Material Disposal Site Designation 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) today designates LA–3 as 

a permanent ocean dredged material 

disposal site (ODMDS) located offshore 

of Newport Beach, California, managed 

at a maximum annual dredged material 

disposal quantity of 2,500,000 cubic 

yards (yd3) (1,911,000 cubic meters 

[m3]), and adjusts the management of 

the permanently-designated LA–2 

ODMDS at an increased maximum 

annual dredged material disposal 

quantity of 1,000,000 yd3 (765,000 m3) 

for the ocean disposal of clean dredged 

material from the Los Angeles County 

and Orange County regions. The 

availability of suitable ocean disposal 

sites to support ongoing maintenance 

and capital improvement projects is 

essential for the continued use and 

economic growth of the vital 

commercial and recreational areas in the 

region. Dredged material will not be 

allowed to be disposed of in the ocean 

unless the material meets strict 

environmental criteria established by 

the EPA and U.S. Army Corps of 

Engineers (USACE). 

The action would shift the center of 

the permanently-designated LA–3 site 

approximately 1.3 nautical miles (nmi) 

(2.4 kilometers [km]) to the southeast of 

the interim LA–3 site, and encompass a 

region that is already disturbed by 

dredged material. The permanent site 

also would be located on a flat, 

depositional plain, and away from the 

submarine canyons, that will be more 

amenable to surveillance and 

monitoring activities. The LA–2 site is 

a permanently designated ODMDS that 

has been historically managed at an 

average annual disposal quantity of 

200,000 yd3 (153,000 m3) for the 

disposal of material dredged primarily 

from the Los Angeles/Long Beach 

Harbor complex. The action will allow 

an increased volume of dredged 

material to be disposed annually at this 

site. The annual disposal quantity has 

occasionally exceeded the historical 

annual average due to capital projects 

from both the ports of Los Angeles and 

Long Beach. Thus, the new maximum 

volume designation would 

accommodate the projected average 

annual volume requirements as well as 

provide for substantial annual volume 

fluctuations. 

DATES: This final regulation is effective 

on October 12, 2005. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Allan Ota, Dredging and Sediment 

Management Team, U.S. Environmental 

Protection Agency, Region IX (WTR–8), 

75 Hawthorne Street, San Francisco, CA 

94105, telephone (415) 972–3476 or 

FAX: (415) 947–3537 or e-mail: 

ota.allan@epa.gov. 

SUPPLEMENTARY INFORMATION: The 

supporting document for this site 

designation is the Final Environmental 

Impact Statement for the Site 

Designation of the LA–3 Ocean Dredged 

Material Disposal Site off Newport Bay, 

Orange County, California. This 

document is available for public 

inspection at the following locations: 

1. EPA Region IX, Library, 75 

Hawthorne Street, 13th Floor, San 

Francisco, California 94105. 

2. EPA Public Information Reference 

Unit, Room 2904, 401 M Street, SW., 

Washington, DC 20460. 

3. U.S. EPA, Southern California Field 

Office, 600 Wilshire Boulevard, Suite 

1460, Los Angeles, CA 90017. 

4. Lloyd Taber-Marina del Rey 

Library, 4533 Admiralty Way, Marina 

del Rey, CA 90292. 

5. Long Beach Public Library, 101 

Pacific Avenue, Long Beach, CA 90822. 

6. Los Angeles Public Library, Central 

Library, 630 West 5th Street, Los 

Angeles, CA 90071. 

7. Los Angeles Public Library, San 

Pedro Regional Branch Library, 931 

South Gaffey Street, San Pedro, CA 

90731. 

8. Newport Beach Public Library, 

Balboa Branch, 100 East Balboa 

Boulevard, Balboa, CA 92661. 

9. Newport Beach Public Library, 

Central Library, 1000 Avocado Avenue, 

Newport Beach, CA 92660. 

10. Newport Beach Public Library, 

Corona del Mar Branch, 420 Marigold 

Avenue, Corona del Mar, CA 92625. 

11. Newport Beach Public Library, 

Mariners Branch, 2005 Dover Drive, 

Newport Beach, CA 92660. 

12. U.S. EPA Web site: http:// 

www.epa.gov/region9. 

13. U.S. Army Corps of Engineers’

Web site: http:// 

www.spl.usace.army.mil. 

A. Potentially Affected Entities 

Entities potentially affected by this 

action are persons, organizations, or 

government bodies seeking to dispose of 

dredged material in ocean waters at the 

LA–3 and LA–2 ODMDS, under the 

Marine Protection Research and 

Sanctuaries Act, 33 U.S.C. 1401 et seq. 

The Rule would be primarily of 

relevance to parties in the Los Angeles 

and Orange County areas seeking 

permits from the USACE to transport 

dredged material for the purpose of 

disposal into ocean waters at the LA–3 

and LA–2 ODMDS, as well as the 

USACE itself (when proposing to 

dispose of dredged material at the LA–

3 and LA–2 ODMDS). Potentially 

affected categories and entities seeking 

to use the LA–3 and LA–2 ODMDS and 

thus subject to this Rule include: 

Category Examples of potentially affected entities 

Industry and General Public ............................... Ports. 

Marinas and Harbors. 

Shipyards and Marine Repair Facilities. 

Berth owners. 

State, local and tribal governments .................... Governments owning and/or responsible for ports, harbors, and/or berths.

Government agencies requiring disposal of dredged material associated with public works 

projects. 

Federal Government ........................................... U.S. Army Corps of Engineers Civil Works and O & M projects.