Small Entity Compliance Guide: What You Need To Know About Registration of Food Facilities; Availability, 74582-74583 [2012-30327]
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Federal Register / Vol. 77, No. 242 / Monday, December 17, 2012 / Rules and Regulations
(g) SPOST
Within 3 days after the effective date of
this AD, perform an SPOST of the FSECU, in
accordance with the applicable service
information identified in paragraph (h)(1) or
(h)(2) of this AD.
(1) For Model GIV–X (G350) airplanes: Use
Gulfstream G350 Alert Customer Bulletin 11,
dated December 4, 2012, excluding Service
Reply Card, dated December 4, 2012, and
excluding Revision 31, dated December 4,
2012, of the Gulfstream G350 Airplane Flight
Manual Document GAC–AC–G350–OPS–
0001.
(2) For Model GIV–X (G450) airplanes: Use
Gulfstream G450 Alert Customer Bulletin 11,
dated December 4, 2012, excluding Service
Reply Card, dated December 4, 2012, and
excluding Revision 33, dated December 4,
2012, of the Gulfstream G450 Airplane Flight
Manual Document GAC–AC–G450–OPS–
0001.
(h) Revision of Aircraft Flight Manual (AFM)
Before further flight after the FSECU passes
the SPOST required by paragraph (g) of this
AD, revise the Normal Procedures and
Limitations sections of the AFM to
incorporate the information identified in
paragraph (g)(1) or (g)(2) of this AD, as
applicable.
(1) For Model GIV–X (G350) airplanes:
Incorporate the information in Section 1–27–
40, ‘‘Flap/Stabilizer System Preflight Check,’’
and Section 2–03–20, ‘‘Before Starting
Engines,’’ of the Gulfstream G350 Airplane
Flight Manual Document GAC–AC–G350–
OPS–0001, Revision 31, dated December 4,
2012. This may be accomplished by inserting
into the AFM a copy of Gulfstream G350
Airplane Flight Manual Document GAC–AC–
G350–OPS–0001, Revision 31, dated
December 4, 2012.
(2) For Model GIV–X (G450) airplanes:
Section 1–27–40, ‘‘Flap/Stabilizer System
Preflight Check,’’ and Section 2–03–20,
‘‘Before Starting Engines,’’ of the Gulfstream
G450 Airplane Flight Manual Document
GAC–AC–G450–OPS–0001, Revision 33,
dated December 4, 2012. This may be
accomplished by inserting into the AFM a
copy of Gulfstream G450 Airplane Flight
Manual Document GAC–AC–G450–OPS–
0001, Revision 33, dated December 4, 2012.
pmangrum on DSK3VPTVN1PROD with
(i) Corrective Action for Failed SPOST
If the FSECU fails any SPOST required by
this AD or as specified in the applicable
AFM, repair before further flight in
accordance with a method approved by the
Manager, Atlanta Aircraft Certification Office
(ACO), FAA. For a repair method to be
approved by the Manager, Atlanta ACO, as
required by this paragraph, the Manager’s
approval letter must specifically refer to this
AD.
(j) Special Flight Permit
Special flight permits, as described in
Section 21.197 and Section 21.199 of the
Federal Aviation Regulations (14 CFR 21.197
and 21.199), are not allowed.
(k) Alternative Methods of Compliance
(AMOCs)
(1) The Manager, Atlanta ACO, FAA, has
the authority to approve AMOCs for this AD,
VerDate Mar<15>2010
14:24 Dec 14, 2012
Jkt 229001
if requested using the procedures found in 14
CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector
or local Flight Standards District Office, as
appropriate. If sending information directly
to the manager of the ACO, send it to the
attention of the person identified in the
Related Information section of this AD.
(2) Before using any approved AMOC,
notify your appropriate principal inspector,
or lacking a principal inspector, the manager
of the local flight standards district office/
certificate holding district office.
(l) Related Information
For more information about this AD,
contact Sanford Proveaux, Aerospace
Engineer, Continued Operational Safety and
Certificate Management Branch, ACE–102A,
FAA, Atlanta Aircraft Certification Office
(ACO), 1701 Columbia Avenue, College Park,
Georgia 30337; phone: 404–474–5566; fax:
404–474–5606; email:
sanford.proveaux@faa.gov.
(m) Material Incorporated by Reference
(1) The Director of the Federal Register
approved the incorporation by reference
(IBR) of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR
part 51.
(2) You must use this service information
as applicable to do the actions required by
this AD, unless the AD specifies otherwise.
(i) Gulfstream G350 Alert Customer
Bulletin 11, dated December 4, 2012.
(ii) Gulfstream G450 Alert Customer
Bulletin 11, dated December 4, 2012.
(iii) Section 1–27–40, ‘‘Flap/Stabilizer
System Preflight Check,’’ of the Gulfstream
G350 Airplane Flight Manual Document
GAC–AC–G350–OPS–0001, Revision 31,
dated December 4, 2012. The document
number of this document is identified on the
revision transmittal page and the first page of
the Record of Revisions; no other page of this
document contains this information.
(iv) Section 1–27–40, ‘‘Flap/Stabilizer
System Preflight Check,’’ of the Gulfstream
G450 Airplane Flight Manual Document
GAC–AC–G450–OPS–0001, Revision 33,
dated December 4, 2012. The document
number of this document is identified on the
revision transmittal page and the first page of
the Record of Revisions; no other page of this
document contains this information.
(v) Section 2–03–20, ‘‘Before Starting
Engines,’’ of the Gulfstream G350 Airplane
Flight Manual Document GAC–AC–G350–
OPS–0001, Revision 31, dated December 4,
2012. The document number of this
document is identified on the revision
transmittal page and the first page of the
Record of Revisions; no other page of this
document contains this information.
(vi) Section 2–03–20, ‘‘Before Starting
Engines,’’ of the Gulfstream G450 Airplane
Flight Manual Document GAC–AC–G450–
OPS–0001, Revision 33, dated December 4,
2012. The document number of this
document is identified on the revision
transmittal page and the first page of the
Record of Revisions; no other page of this
document contains this information.
(3) For service information identified in
this AD, contact Gulfstream Aerospace
PO 00000
Frm 00028
Fmt 4700
Sfmt 4700
Corporation, Technical Publications Dept.,
P.O. Box 2206, Savannah, GA 31402–2206;
telephone 800–810–4853; fax 912–965–3520;
email pubs@gulfstream.com; Internet https://
www.gulfstream.com/product_support/
technical_pubs/pubs/index.htm.
(4) You may view this service information
at FAA, Transport Airplane Directorate,
Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, Washington. For
information on the availability of this
material at the FAA, call 425–227–1221.
(5) You may view this service information
that is incorporated by reference at the
National Archives 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/cfr/ibrlocations.html.
Issued in Renton, Washington, on
December 7, 2012.
Ali Bahrami,
Manager, Transport Airplane Directorate,
Aircraft Certification Service.
[FR Doc. 2012–30058 Filed 12–14–12; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1
[Docket No FDA–2012–D–1003]
Small Entity Compliance Guide: What
You Need To Know About Registration
of Food Facilities; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability of an updated guidance for
industry entitled ‘‘What You Need To
Know About Registration of Food
Facilities—Small Entity Compliance
Guide.’’ FDA has prepared this guidance
to restate the legal requirements
pertaining to registration of food
facilities in the Federal Food, Drug, and
Cosmetic Act (the FD&C Act), as
amended by the FDA Food Safety
Modernization Act (FSMA). Previously,
this guidance restated the legal
requirements of FDA’s food facility
registration regulation. This document
also served as FDA’s Small Entity
Compliance Guide for FDA’s food
facility registration regulation in
accordance with the Small Business
Regulatory Enforcement Fairness Act.
FDA is revising this document to
provide guidance intended to help any
entity comply with the requirements
pertaining to registration of food
SUMMARY:
E:\FR\FM\17DER1.SGM
17DER1
Federal Register / Vol. 77, No. 242 / Monday, December 17, 2012 / Rules and Regulations
pmangrum on DSK3VPTVN1PROD with
facilities in the FD&C Act, including the
amendments made by FSMA. This
document continues to serve as FDA’s
Small Entity Compliance Guide for
FDA’s food facility registration
regulation. Further, this guidance is
intended to set forth in plain language
the requirements for registration of food
facilities and help small businesses
understand the requirements.
DATES: December 17, 2012. Submit
either electronic or written comments
on Agency guidances at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Office of Compliance, Division of Field
Programs and Guidance (HFS–615),
Center for Food Safety and Applied
Nutrition, Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740. Send
one self-addressed adhesive label to
assist that office in processing your
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance.
Submit electronic comments on this
guidance to https://www.regulations.gov.
Submit written comments on this
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Amy Barringer, Office of Compliance,
Center for Food Safety and Applied
Nutrition, Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
402–1988.
SUPPLEMENTARY INFORMATION:
I. Background
The FDA Food Safety Modernization
Act (FSMA), enacted on January 4,
2011, amended section 415 of the FD&C
Act, in relevant part, to require that
facilities engaged in manufacturing,
processing, packing, or holding food for
consumption in the United States
submit additional registration
information to FDA, including an
assurance that FDA will be permitted to
inspect the facility at the times and in
the manner permitted by the FD&C Act.
Section 415 of the FD&C Act, as
amended by FSMA, also requires food
facilities required to register with FDA
to renew such registrations every other
year and provides FDA with authority to
suspend the registration of a food
facility in certain circumstances.
FDA has prepared this guidance to
restate the legal requirements in section
415 of the FD&C Act. Previously, this
guidance restated the legal requirements
of FDA’s food facility registration
regulation at 21 CFR part 1, Subpart H
VerDate Mar<15>2010
14:24 Dec 14, 2012
Jkt 229001
(§§ 1.225 through 1.243), implementing
section 415 of the FD&C Act, as added
by the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002. This guidance
also served as FDA’s Small Entity
Compliance Guide for 21 CFR part 1,
Subpart H in accordance with section
212 of the Small Business Regulatory
Enforcement Fairness Act (Pub. L. 104–
121). Because section 415 of the FD&C
Act was amended by section 102 of
FSMA in 2011, FDA is revising this
document to provide guidance on
section 415 of the FD&C Act, as
amended by FSMA. This updated
guidance is intended to help any entity
comply with the requirements of section
415 of the FD&C Act, including the
amendments made by section 102 of
FSMA. This document continues to
serve as FDA’s Small Entity Compliance
Guide for 21 CFR Part 1, Subpart H.
FDA is issuing this guidance
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115) as
level 1 guidance. Consistent with FDA’s
good guidance practices regulation, the
Agency will accept comments, but it is
implementing this guidance document
immediately, in accordance with 21
CFR 10.115(g)(2), because the Agency
has determined that prior public
participation is not feasible or
appropriate because the updated
guidance document is merely specifying
the new requirements of section 102 of
FSMA, many of which are already in
effect. This guidance represents the
Agency’s current thinking on the
registration of food facilities. It does not
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
II. The Paperwork Reduction Act of
1995
This guidance refers to previously
approved collections of information
found in FDA regulations and section
415 of the FD&C Act. These collections
of information are subject to review by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in §§ 1.230
through 1.235 and section 415 of the
FD&C Act have been approved under
OMB control number 0910–0502.
III. Comments
Interested persons may submit either
written comments regarding this
document to the Division of Dockets
Management (see ADDRESSES) or
electronic comments to https://
PO 00000
Frm 00029
Fmt 4700
Sfmt 4700
74583
www.regulations.gov. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov. Always access an
FDA guidance document by using
FDA’s Web site listed previously to find
the most current version of the
guidance.
Dated: December 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–30327 Filed 12–14–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 9564]
RIN 1545–BJ93
Guidance Regarding Deduction and
Capitalization of Expenditures Related
to Tangible Property
Internal Revenue Service (IRS),
Treasury.
ACTION: Technical amendments.
AGENCY:
This document contains
amendments to temporary regulations
relating to guidance regarding deduction
and capitalization of expenditures
related to tangible property. These
amendments change the applicability
dates of the temporary regulations to
taxable years beginning on or after
January 1, 2014, while permitting
taxpayers to choose to apply the
temporary regulations for taxable years
beginning on or after January 1, 2012.
The amendments to the temporary
regulations will affect all taxpayers that
acquire, produce, or improve tangible
property.
SUMMARY:
These amendments are effective
December 17, 2012.
FOR FURTHER INFORMATION CONTACT:
Concerning §§ 1.162–3T, 1.162–4T,
1.162–11T, 1.263(a)–1T, 1.263(a)–2T,
1.263(a)–3T, and 1.263(a)–6T, Merrill D.
DATES:
E:\FR\FM\17DER1.SGM
17DER1
]]>Agencies
[Federal Register Volume 77, Number 242 (Monday, December 17, 2012)]
[Rules and Regulations]
[Pages 74582-74583]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30327]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1
[Docket No FDA-2012-D-1003]
Small Entity Compliance Guide: What You Need To Know About
Registration of Food Facilities; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of an updated guidance for industry entitled ``What You
Need To Know About Registration of Food Facilities--Small Entity
Compliance Guide.'' FDA has prepared this guidance to restate the legal
requirements pertaining to registration of food facilities in the
Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the
FDA Food Safety Modernization Act (FSMA). Previously, this guidance
restated the legal requirements of FDA's food facility registration
regulation. This document also served as FDA's Small Entity Compliance
Guide for FDA's food facility registration regulation in accordance
with the Small Business Regulatory Enforcement Fairness Act. FDA is
revising this document to provide guidance intended to help any entity
comply with the requirements pertaining to registration of food
[[Page 74583]]
facilities in the FD&C Act, including the amendments made by FSMA. This
document continues to serve as FDA's Small Entity Compliance Guide for
FDA's food facility registration regulation. Further, this guidance is
intended to set forth in plain language the requirements for
registration of food facilities and help small businesses understand
the requirements.
DATES: December 17, 2012. Submit either electronic or written comments
on Agency guidances at any time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Office of Compliance, Division of Field Programs and Guidance
(HFS-615), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send
one self-addressed adhesive label to assist that office in processing
your request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance.
Submit electronic comments on this guidance to https://www.regulations.gov. Submit written comments on this guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Amy Barringer, Office of Compliance,
Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1988.
SUPPLEMENTARY INFORMATION:
I. Background
The FDA Food Safety Modernization Act (FSMA), enacted on January 4,
2011, amended section 415 of the FD&C Act, in relevant part, to require
that facilities engaged in manufacturing, processing, packing, or
holding food for consumption in the United States submit additional
registration information to FDA, including an assurance that FDA will
be permitted to inspect the facility at the times and in the manner
permitted by the FD&C Act. Section 415 of the FD&C Act, as amended by
FSMA, also requires food facilities required to register with FDA to
renew such registrations every other year and provides FDA with
authority to suspend the registration of a food facility in certain
circumstances.
FDA has prepared this guidance to restate the legal requirements in
section 415 of the FD&C Act. Previously, this guidance restated the
legal requirements of FDA's food facility registration regulation at 21
CFR part 1, Subpart H (Sec. Sec. 1.225 through 1.243), implementing
section 415 of the FD&C Act, as added by the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002. This guidance also
served as FDA's Small Entity Compliance Guide for 21 CFR part 1,
Subpart H in accordance with section 212 of the Small Business
Regulatory Enforcement Fairness Act (Pub. L. 104-121). Because section
415 of the FD&C Act was amended by section 102 of FSMA in 2011, FDA is
revising this document to provide guidance on section 415 of the FD&C
Act, as amended by FSMA. This updated guidance is intended to help any
entity comply with the requirements of section 415 of the FD&C Act,
including the amendments made by section 102 of FSMA. This document
continues to serve as FDA's Small Entity Compliance Guide for 21 CFR
Part 1, Subpart H.
FDA is issuing this guidance consistent with FDA's good guidance
practices regulation (21 CFR 10.115) as level 1 guidance. Consistent
with FDA's good guidance practices regulation, the Agency will accept
comments, but it is implementing this guidance document immediately, in
accordance with 21 CFR 10.115(g)(2), because the Agency has determined
that prior public participation is not feasible or appropriate because
the updated guidance document is merely specifying the new requirements
of section 102 of FSMA, many of which are already in effect. This
guidance represents the Agency's current thinking on the registration
of food facilities. It does not create or confer any rights for or on
any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.
II. The Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations and section 415 of the FD&C Act.
These collections of information are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The collections of information in Sec. Sec.
1.230 through 1.235 and section 415 of the FD&C Act have been approved
under OMB control number 0910-0502.
III. Comments
Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to https://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/RegulatoryInformation/Guidances/default.htm
or https://www.regulations.gov. Always access an FDA guidance document
by using FDA's Web site listed previously to find the most current
version of the guidance.
Dated: December 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30327 Filed 12-14-12; 8:45 am]
BILLING CODE 4160-01-P
