Guidance for Industry on What You Need To Know About Establishment, Maintenance, and Availability of Records-Small Entity Compliance Guide; Availability, 18867-18868 [2014-07548]
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Federal Register / Vol. 79, No. 65 / Friday, April 4, 2014 / Proposed Rules
conclude that these information
collection provisions are exempt from
OMB review under 44 U.S.C.
3518(c)(1)(B)(ii) and 5 CFR 1320.4(a)(2)
as collections of information obtained
during the conduct of a civil action to
which the United States or any official
or Agency thereof is a party, or during
the conduct of an administrative action,
investigation, or audit involving an
Agency against specific individuals or
entities. The regulations in 5 CFR
1320.3(c) provide that the exception in
5 CFR 1320.4(a)(2) applies during the
entire course of the investigation, audit
or action, but only after a case file or
equivalent is opened with respect to a
particular party. Such a case file would
be opened as part of the request to
access records.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). 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 guidance at either
https://www.fda.gov/FoodGuidances or
https://www.regulations.gov. Use the
FDA Web site listed in the previous
sentence to find the most current
version of the guidance.
Dated: April 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–07551 Filed 4–3–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
emcdonald on DSK67QTVN1PROD with PROPOSALS
21 CFR Part 1
[Docket No. FDA–2013–N–1421]
Guidance for Industry on What You
Need To Know About Establishment,
Maintenance, and Availability of
Records—Small Entity Compliance
Guide; Availability
AGENCY:
Food and Drug Administration,
HHS.
VerDate Mar<15>2010
16:47 Apr 03, 2014
Jkt 232001
ACTION:
Notification.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘What You Need To Know
About Establishment, Maintenance, and
Availability of Records—Small Entity
Compliance Guide’’ (SECG), which
updates an earlier guidance of the same
title. Previously, this guidance restated
the legal requirements of FDA’s
maintenance and establishment of
records regulation and served as that
regulation’s SECG. Because the FDA
Food Safety Modernization Act (FSMA)
amended FDA’s maintenance and
establishment of records regulation,
FDA issued an interim final rule (IFR)
amending certain regulations to be
consistent with the changes.
Accordingly, FDA is revising this
guidance to help any entity comply with
FDA’s maintenance and establishment
of records requirements, including the
amendments to these requirements
made by the IFR as finalized. This
guidance continues to serve as FDA’s
SECG.
DATES: Submit either electronic or
written comments on FDA guidances at
any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Outreach and Information Center,
Center for Food Safety and Applied
Nutrition, Food and Drug
Administration (HFS–009), 5100 Paint
Branch Pkwy., College Park, MD 20740.
Send two self-addressed adhesive labels
to assist that office in processing your
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
William A. Correll, Jr., Office of
Compliance, Center for Food Safety and
Applied Nutrition (HFS–009), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
402–1611.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
We are announcing the availability of
a guidance for industry entitled ‘‘What
You Need To Know About
Establishment, Maintenance, and
Availability of Records—Small Entity
Compliance Guide (SECG).’’ This
guidance is being issued consistent with
PO 00000
Frm 00022
Fmt 4702
Sfmt 4702
18867
our good guidance practices regulation
(21 CFR 10.115(c)(2)). The guidance
represents our current thinking on the
establishment, maintenance, and
availability of records. 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.
FSMA (Pub. L. 111–353), among other
things, amended FDA’s records access
under section 414(a) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act). In the Federal Register of February
23, 2012 (77 FR 10658), FDA issued an
IFR that amended certain requirements
on the availability of records in the
regulation on the establishment and
maintenance of records in 21 CFR Part
1, Subpart J to be consistent with
amendments to the FD&C Act made by
FSMA. This interim final rule was
effective March 1, 2012.
Previously, this guidance restated the
legal requirements of FDA’s
establishment and maintenance of
records regulation at 21 CFR part 1,
Subpart J, implementing section 414 of
the FD&C Act, as added by the Public
Health Security and Bioterrorism
Preparedness and Response Act of 2002
(Pub. L. 107–188). This guidance also
served as FDA’s SECG for 21 CFR Part
1, Subpart J in accordance with section
212 of the Small Business Regulatory
Enforcement Fairness Act (Pub. L. 104–
121). Because section 101 of FSMA
amended section 414(a) of the FD&C
Act, FDA issued an IFR amending
certain requirements on the availability
of records in 21 CFR Part 1, Subpart J.
Elsewhere in this issue of the Federal
Register, we are issuing a final rule
adopting the IFR without changes. The
final rule is effective upon publication.
Accordingly, FDA is updating this SECG
to help any entity comply with the
requirements in 21 CFR part 1, Subpart
J, including the amendments to 21 CFR
Part 1, Subpart J made by the IFR and
adopted as final. This guidance
continues to serve as FDA’s SECG for 21
CFR part 1, Subpart J.
The Regulatory Flexibility Act (5
U.S.C. 601–612) requires Agencies to
determine whether a final rule will have
a significant impact on small entities
when an Agency issues a final rule
‘‘after being required . . . to publish a
general notice of proposed rulemaking.’’
Although FDA is not required to
perform a regulatory flexibility analysis
because, in accordance with 5 U.S.C.
553(b)(3)(B) and 21 CFR 10.40(e)(1), the
Agency found for good cause that use of
prior notice and comment procedures
were contrary to the public interest;
E:\FR\FM\04APP1.SGM
04APP1
18868
Federal Register / Vol. 79, No. 65 / Friday, April 4, 2014 / Proposed Rules
FDA has nonetheless examined the
economic implications of the final rule
in accordance with the Regulatory
Flexibility Act and determined that the
final rule will not have a significant
economic impact on a substantial
number of small entities. Similarly,
because FDA is not required to perform
a final regulatory flexibility analysis
under 5 U.S.C 605(b) for the final rule,
FDA is not required to issue an SECG to
comply with section 212 of the Small
Business Regulatory Enforcement
Fairness Act (Pub. L. 104–121);
nevertheless, FDA has updated this
SECG to state in plain language the
requirements of 21 CFR part 1, Subpart
J, as amended by the final rule.
emcdonald on DSK67QTVN1PROD with PROPOSALS
II. Paperwork Reduction Act of 1995
This guidance refers to information
collection provisions found in FDA
regulations. 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).
Except for the provision regarding
access to records, the collections of
information in 21 CFR part 1, Subpart
J, have been approved under OMB
control number 0910–0560. With regard
to access to records, we conclude that
these information collection provisions
are exempt from OMB review under 44
U.S.C. 3518(c)(1)(B)(ii) and 5 CFR
1320.4(a)(2) as collections of
information obtained during the
conduct of a civil action to which the
United States or any official or Agency
thereof is a party, or during the conduct
of an administrative action,
investigation, or audit involving an
Agency against specific individuals or
entities. The regulations in 5 CFR
1320.3(c) provide that the exception in
5 CFR 1320.4(a)(2) applies during the
entire course of the investigation, audit
or action, but only after a case file or
equivalent is opened with respect to a
particular party. Such a case file would
be opened as part of the request to
access records.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). 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://
regulations.gov.
VerDate Mar<15>2010
16:47 Apr 03, 2014
Jkt 232001
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance at either
https://www.fda.gov/
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: April 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–07548 Filed 4–3–14; 8:45 am]
BILLING CODE 4160–01–P
during the Regional Office normal hours
of operation, and special arrangements
should be made for deliveries of boxed
information. The Regional Office official
hours of business are Monday through
Friday, 8:30 a.m. to 4:30 p.m., excluding
Federal holidays.
Please see the direct final rule which
is located in the Rules section of this
Federal Register for detailed
instructions on how to submit
comments.
FOR FURTHER INFORMATION CONTACT:
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R05–OAR–2013–0646; FRL–9908–71–
Region 5]
Approval and Promulgation of Air
Quality Implementation Plans;
Michigan; PSD Rules for PM2.5
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
The Environmental Protection
Agency (EPA) is proposing to approve
revisions to Michigan’s Prevention of
Significant Deterioration Program rules
and definitions, including revisions to
Parts 1 and 18 of Michigan’s Air
Pollution Control Rules into Michigan’s
State Implementation Plan (SIP). The
revised rules address the Federal
requirements for significant emission
levels, and definitions for fine
particulate matter. The Michigan
Department of Environmental Quality
submitted these revisions to EPA on
August 9, 2013, and September 19,
2013.
SUMMARY:
Comments must be received on
or before May 5, 2014.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–R05–
OAR–2013–0646, by one of the
following methods:
1. www.regulations.gov: Follow the
on-line instructions for submitting
comments.
2. Email: damico.genevieve@epa.gov.
3. Fax: (312) 886–0968.
4. Mail: Genevieve Damico, Chief, Air
Permits Section, Air Programs Branch
(AR–18J), U.S. Environmental
Protection Agency, 77 West Jackson
Boulevard, Chicago, Illinois 60604.
5. Hand Delivery: Genevieve Damico,
Chief, Air Permits Section, Air Programs
Branch (AR–18J), U.S. Environmental
Protection Agency, 77 West Jackson
Boulevard, Chicago, Illinois 60604.
Such deliveries are only accepted
DATES:
PO 00000
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Fmt 4702
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Constantine Blathras, Environmental
Engineer, Air Permits Sections, Air
Programs Branch (AR–18J),
Environmental Protection Agency,
Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604, (312) 886–0671,
Blathras.constantine@epa.gov.
In the
Rules section of this Federal Register,
EPA is approving the State’s SIP
submittal as a direct final rule without
prior proposal because the Agency
views this as a noncontroversial
submittal and anticipates no adverse
comments. A detailed rationale for the
approval is set forth in the direct final
rule. If no adverse comments are
received in response to this rule, no
further activity is contemplated. If EPA
receives adverse comments, we will
withdraw the direct final rule and will
address all public comments in a
subsequent final rule based on this
proposed action. EPA will not institute
a second comment period. Any parties
interested in commenting on this action
should do so at this time. Please note
that if EPA receives adverse comment
on an amendment, paragraph, or section
of this rule which may be severed from
the remainder of the rule, EPA may
adopt as final those provisions of the
rule that are not the subject of an
adverse comment. For additional
information, see the direct final rule
which is located in the Rules section of
this Federal Register.
SUPPLEMENTARY INFORMATION:
Dated: March 17, 2014.
Susan Hedman,
Regional Administrator, Region 5.
[FR Doc. 2014–06827 Filed 4–3–14; 8:45 am]
BILLING CODE 6560–50–P
E:\FR\FM\04APP1.SGM
04APP1
Agencies
[Federal Register Volume 79, Number 65 (Friday, April 4, 2014)]
[Proposed Rules]
[Pages 18867-18868]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07548]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1
[Docket No. FDA-2013-N-1421]
Guidance for Industry on What You Need To Know About
Establishment, Maintenance, and Availability of Records--Small Entity
Compliance Guide; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``What You Need To
Know About Establishment, Maintenance, and Availability of Records--
Small Entity Compliance Guide'' (SECG), which updates an earlier
guidance of the same title. Previously, this guidance restated the
legal requirements of FDA's maintenance and establishment of records
regulation and served as that regulation's SECG. Because the FDA Food
Safety Modernization Act (FSMA) amended FDA's maintenance and
establishment of records regulation, FDA issued an interim final rule
(IFR) amending certain regulations to be consistent with the changes.
Accordingly, FDA is revising this guidance to help any entity comply
with FDA's maintenance and establishment of records requirements,
including the amendments to these requirements made by the IFR as
finalized. This guidance continues to serve as FDA's SECG.
DATES: Submit either electronic or written comments on FDA guidances at
any time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Outreach and Information Center, Center for Food Safety and
Applied Nutrition, Food and Drug Administration (HFS-009), 5100 Paint
Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive
labels to assist that office in processing your request. See the
SUPPLEMENTARY INFORMATION section for electronic access to the
guidance.
Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: William A. Correll, Jr., Office of
Compliance, Center for Food Safety and Applied Nutrition (HFS-009),
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740, 240-402-1611.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a guidance for industry
entitled ``What You Need To Know About Establishment, Maintenance, and
Availability of Records--Small Entity Compliance Guide (SECG).'' This
guidance is being issued consistent with our good guidance practices
regulation (21 CFR 10.115(c)(2)). The guidance represents our current
thinking on the establishment, maintenance, and availability of
records. 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.
FSMA (Pub. L. 111-353), among other things, amended FDA's records
access under section 414(a) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act). In the Federal Register of February 23, 2012 (77 FR 10658),
FDA issued an IFR that amended certain requirements on the availability
of records in the regulation on the establishment and maintenance of
records in 21 CFR Part 1, Subpart J to be consistent with amendments to
the FD&C Act made by FSMA. This interim final rule was effective March
1, 2012.
Previously, this guidance restated the legal requirements of FDA's
establishment and maintenance of records regulation at 21 CFR part 1,
Subpart J, implementing section 414 of the FD&C Act, as added by the
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002 (Pub. L. 107-188). This guidance also served as FDA's SECG for
21 CFR Part 1, Subpart J in accordance with section 212 of the Small
Business Regulatory Enforcement Fairness Act (Pub. L. 104-121). Because
section 101 of FSMA amended section 414(a) of the FD&C Act, FDA issued
an IFR amending certain requirements on the availability of records in
21 CFR Part 1, Subpart J. Elsewhere in this issue of the Federal
Register, we are issuing a final rule adopting the IFR without changes.
The final rule is effective upon publication. Accordingly, FDA is
updating this SECG to help any entity comply with the requirements in
21 CFR part 1, Subpart J, including the amendments to 21 CFR Part 1,
Subpart J made by the IFR and adopted as final. This guidance continues
to serve as FDA's SECG for 21 CFR part 1, Subpart J.
The Regulatory Flexibility Act (5 U.S.C. 601-612) requires Agencies
to determine whether a final rule will have a significant impact on
small entities when an Agency issues a final rule ``after being
required . . . to publish a general notice of proposed rulemaking.''
Although FDA is not required to perform a regulatory flexibility
analysis because, in accordance with 5 U.S.C. 553(b)(3)(B) and 21 CFR
10.40(e)(1), the Agency found for good cause that use of prior notice
and comment procedures were contrary to the public interest;
[[Page 18868]]
FDA has nonetheless examined the economic implications of the final
rule in accordance with the Regulatory Flexibility Act and determined
that the final rule will not have a significant economic impact on a
substantial number of small entities. Similarly, because FDA is not
required to perform a final regulatory flexibility analysis under 5
U.S.C 605(b) for the final rule, FDA is not required to issue an SECG
to comply with section 212 of the Small Business Regulatory Enforcement
Fairness Act (Pub. L. 104-121); nevertheless, FDA has updated this SECG
to state in plain language the requirements of 21 CFR part 1, Subpart
J, as amended by the final rule.
II. Paperwork Reduction Act of 1995
This guidance refers to information collection provisions found in
FDA regulations. 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). Except for the provision
regarding access to records, the collections of information in 21 CFR
part 1, Subpart J, have been approved under OMB control number 0910-
0560. With regard to access to records, we conclude that these
information collection provisions are exempt from OMB review under 44
U.S.C. 3518(c)(1)(B)(ii) and 5 CFR 1320.4(a)(2) as collections of
information obtained during the conduct of a civil action to which the
United States or any official or Agency thereof is a party, or during
the conduct of an administrative action, investigation, or audit
involving an Agency against specific individuals or entities. The
regulations in 5 CFR 1320.3(c) provide that the exception in 5 CFR
1320.4(a)(2) applies during the entire course of the investigation,
audit or action, but only after a case file or equivalent is opened
with respect to a particular party. Such a case file would be opened as
part of the request to access records.
III. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). 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://regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the guidance at
either https://www.fda.gov/RegulatoryInformation/Guidances/default.htm
or https://www.regulations.gov.
Dated: April 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07548 Filed 4-3-14; 8:45 am]
BILLING CODE 4160-01-P