Guidance for Industry: Questions and Answers Regarding the Final Rule on Establishment and Maintenance of Records; Availability, 53728-53729 [05-18039]
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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: https://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
RB.211–72–AD344 .............................................................
Total Pages: 11
RB.211–72–AD344, Appendices 1 through 5 ....................
Total Pages: 18
RB.211–72–D672 ...............................................................
Total Pages: 24
All ........................................
7 ..........................................
March 12, 2004.
All ........................................
7 ..........................................
March 12, 2004.
All ........................................
Original ................................
February 1, 2002.
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.
Notice of availability of
guidance.
ACTION:
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.
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14:58 Sep 09, 2005
Jkt 205001
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:
DATES:
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
PO 00000
Frm 00006
Fmt 4700
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Date
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
E:\FR\FM\12SER1.SGM
12SER1
Federal Register / Vol. 70, No. 175 / Monday, September 12, 2005 / Rules and Regulations
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 https://
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
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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.
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.
DATES:
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.
SUPPLEMENTARY INFORMATION:
53729
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: https://
www.epa.gov/region9.
13. U.S. Army Corps of Engineers’
Web site: https://
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.
Governments owning and/or responsible for ports, harbors, and/or berths.
Government agencies requiring disposal of dredged material associated with public works
projects.
U.S. Army Corps of Engineers Civil Works and O & M projects.
State, local and tribal governments ....................
Federal Government ...........................................
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]]>Agencies
[Federal Register Volume 70, Number 175 (Monday, September 12, 2005)]
[Rules and Regulations]
[Pages 53728-53729]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-18039]
=======================================================================
-----------------------------------------------------------------------
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 Sec. 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 Sec. 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 Sec.
10.115 as promptly as possible, using a question-and-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
[[Page 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
https://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
