Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry; Availability, 41364-41365 [2017-18464]
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Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Proposed Rules
List of Subjects in 18 CFR Part 11
Dams, Electric power, Indians-lands,
Public lands, Reporting and
recordkeeping requirements.
By direction of the Commission.
Issued: August 17, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
In consideration of the foregoing, the
Federal Energy Regulatory Commission
proposes to amend Part 11, Chapter I,
Title 18, Code of Federal Regulations, as
follows:
PART 11—ANNUAL CHARGES UNDER
PART I OF THE FEDERAL POWER ACT
1. The authority citation for part 11
continues to read as follows:
■
Authority: 16 U.S.C. 792–828c; 42 U.S.C.
7101–7352.
2. In § 11.2, add paragraph (c)(1)(iv) to
read as follows:
*
*
*
*
*
(c) * * *
(1) * * *
(iv) For all geographic areas in Alaska
except for the Aleutian Islands Area, the
Commission will calculate a statewide
average per-acre land value based on the
average per-acre land and building
values published in the NASS Census
for the Kenai Peninsula and the
Fairbanks Areas. This statewide average
per-acre value will be reduced by the
sum of the state-specific modifier and
seven percent. The resulting adjusted
statewide average per-acre value will be
applied to all projects located in Alaska,
except for those projects located in the
Aleutian Island Area.
*
*
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*
■
[FR Doc. 2017–17846 Filed 8–30–17; 8:45 am]
BILLING CODE 6717–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 117
[Docket No. FDA–2016–D–2343]
nlaroche on DSKBBV9HB2PROD with PROPOSALS
Hazard Analysis and Risk-Based
Preventive Controls for Human Food:
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of availability.
The Food and Drug
Administration (FDA, we, or Agency) is
announcing the availability of another
draft chapter of a multichapter guidance
for industry entitled ‘‘Hazard Analysis
SUMMARY:
VerDate Sep<11>2014
15:12 Aug 30, 2017
Jkt 241001
and Risk-Based Preventive Controls for
Human Food: Guidance for Industry.’’
This multichapter draft guidance is
intended to explain our current thinking
on how to comply with the
requirements for hazard analysis and
risk-based preventive controls under our
rule entitled ‘‘Current Good
Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive
Controls for Human Food.’’ The newly
available draft chapter is entitled
‘‘Chapter Six—Use of Heat Treatments
as a Process Control.’’
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that we consider
your comment on this draft guidance
before we issue the final version of the
guidance, submit either electronic or
written comments by February 27, 2018.
You may submit comments as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
PO 00000
Frm 00006
Fmt 4702
Sfmt 4702
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–D–2343 for ‘‘Hazard Analysis and
Risk-Based Preventive Controls for
Human Food: Guidance for Industry.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff office
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
Submit written requests for single
copies of the draft guidance to Office of
Food Safety, Center for Food Safety and
Applied Nutrition, Food and Drug
Administration (HFS–300), 5001
Campus Dr., College Park, MD 20740.
Send two self-addressed adhesive labels
E:\FR\FM\31AUP1.SGM
31AUP1
Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Proposed Rules
to assist that office in processing your
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance.
FOR FURTHER INFORMATION CONTACT:
Jenny Scott, Center for Food Safety and
Applied Nutrition (HFS–300), Food and
Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–2166.
SUPPLEMENTARY INFORMATION:
nlaroche on DSKBBV9HB2PROD with PROPOSALS
I. Background
The FDA Food Safety Modernization
Act (FSMA) (Pub. L. 111–353) enables
FDA to better protect public health by
helping to ensure the safety and security
of the food supply. It enables FDA to
focus more on preventing food safety
problems rather than relying primarily
on reacting to problems after they occur.
FSMA recognizes the important role
industry plays in ensuring the safety of
the food supply, including the adoption
of modern systems of preventive
controls in food production.
Section 103 of FSMA amended the
Federal Food, Drug, and Cosmetic Act
(FD&C Act), in section 418 of the FD&C
Act (21 U.S.C. 350g), by adding
requirements for hazard analysis and
risk-based preventive controls for
establishments that are required to
register as food facilities under our
regulations, in 21 CFR part 1, subpart H,
in accordance with section 415 of the
FD&C Act (21 U.S.C. 350d). We have
established regulations to implement
these requirements within part 117 (21
CFR part 117).
In the Federal Register of August 24,
2016 (81 FR 57816), we announced the
availability of several chapters of a
multichapter draft guidance for industry
entitled ‘‘Hazard Analysis and RiskBased Preventive Controls for Human
Food.’’ We now are announcing the
availability of an additional draft
chapter of this multichapter guidance
for industry. We are issuing the draft
guidance consistent with our good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the current
thinking of FDA on this topic. It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternate approach if it
satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
The multichapter draft guidance for
industry is intended to explain our
current thinking on how to comply with
the requirements for hazard analysis
and risk-based preventive controls
under part 117, principally in subparts
C and G. The chapter that we are
VerDate Sep<11>2014
15:12 Aug 30, 2017
Jkt 241001
announcing in this document is entitled
‘‘Chapter Six—Use of Heat Treatments
as a Process Control.’’
We intend to announce the
availability for public comment of
additional chapters of the draft guidance
as we complete them.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information 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). The collections
of information in part 117 have been
approved under OMB control number
0910–0751.
III. Electronic Access
Persons with access to the Internet
may obtain the draft 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: August 22, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–18464 Filed 8–30–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF LABOR
Employee Benefits Security
Administration
29 CFR Part 2550
[Application Number D–11712; D–11713;
D–11850]
ZRIN 1210–ZA27
Extension of Transition Period and
Delay of Applicability Dates; Best
Interest Contract Exemption (PTE
2016–01); Class Exemption for
Principal Transactions in Certain
Assets Between Investment Advice
Fiduciaries and Employee Benefit
Plans and IRAs (PTE 2016–02);
Prohibited Transaction Exemption 84–
24 for Certain Transactions Involving
Insurance Agents and Brokers,
Pension Consultants, Insurance
Companies, and Investment Company
Principal Underwriters (PTE 84–24)
Employee Benefits Security
Administration, Labor.
ACTION: Notice of proposed amendments
to PTE 2016–01, PTE 2016–02, and PTE
84–24.
AGENCY:
PO 00000
Frm 00007
Fmt 4702
Sfmt 4702
41365
This document proposes to
extend the special transition period
under sections II and IX of the Best
Interest Contract Exemption and section
VII of the Class Exemption for Principal
Transactions in Certain Assets Between
Investment Advice Fiduciaries and
Employee Benefit Plans and IRAs. This
document also proposes to delay the
applicability of certain amendments to
Prohibited Transaction Exemption 84–
24 for the same period. The primary
purpose of the proposed amendments is
to give the Department of Labor the time
necessary to consider possible changes
and alternatives to these exemptions.
The Department is particularly
concerned that, without a delay in the
applicability dates, regulated parties
may incur undue expense to comply
with conditions or requirements that it
ultimately determines to revise or
repeal. The present transition period is
from June 9, 2017, to January 1, 2018.
The new transition period would end on
July 1, 2019. The proposed amendments
to these exemptions would affect
participants and beneficiaries of plans,
IRA owners and fiduciaries with respect
to such plans and IRAs.
DATES: Comments must be submitted on
or before September 15, 2017.
ADDRESSES: All written comments
should be sent to the Office of
Exemption Determinations by any of the
following methods, identified by RIN
1210–AB82:
Federal eRulemaking Portal: https://
www.regulations.gov at Docket ID
number: EBSA–2017–0004. Follow the
instructions for submitting comments.
Email to:
EBSA.FiduciaryRuleExamination@
dol.gov.
Mail: Office of Exemption
Determinations, EBSA, (Attention: D–
11712, 11713, 11850), U.S. Department
of Labor, 200 Constitution Avenue NW.,
Suite 400, Washington, DC 20210.
Hand Delivery/Courier: OED, EBSA
(Attention: D–11712, 11713, 11850),
U.S. Department of Labor, 122 C St.
NW., Suite 400, Washington, DC 20001.
Comments will be available for public
inspection in the Public Disclosure
Room, EBSA, U.S. Department of Labor,
Room N–1513, 200 Constitution Avenue
NW., Washington, DC 20210. Comments
will also be available online at
www.regulations.gov, at Docket ID
number: EBSA–2017–0004 and
www.dol.gov/ebsa, at no charge. Do not
include personally identifiable
information or confidential business
information that you do not want
publicly disclosed. Comments online
can be retrieved by most Internet search
engines.
SUMMARY:
E:\FR\FM\31AUP1.SGM
31AUP1
Agencies
[Federal Register Volume 82, Number 168 (Thursday, August 31, 2017)]
[Proposed Rules]
[Pages 41364-41365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18464]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 117
[Docket No. FDA-2016-D-2343]
Hazard Analysis and Risk-Based Preventive Controls for Human
Food: Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is
announcing the availability of another draft chapter of a multichapter
guidance for industry entitled ``Hazard Analysis and Risk-Based
Preventive Controls for Human Food: Guidance for Industry.'' This
multichapter draft guidance is intended to explain our current thinking
on how to comply with the requirements for hazard analysis and risk-
based preventive controls under our rule entitled ``Current Good
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
Controls for Human Food.'' The newly available draft chapter is
entitled ``Chapter Six--Use of Heat Treatments as a Process Control.''
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that we consider your comment on this draft
guidance before we issue the final version of the guidance, submit
either electronic or written comments by February 27, 2018.
You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-D-2343 for ``Hazard Analysis and Risk-Based Preventive
Controls for Human Food: Guidance for Industry.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff office between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the draft guidance to
Office of Food Safety, Center for Food Safety and Applied Nutrition,
Food and Drug Administration (HFS-300), 5001 Campus Dr., College Park,
MD 20740. Send two self-addressed adhesive labels
[[Page 41365]]
to assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance.
FOR FURTHER INFORMATION CONTACT: Jenny Scott, Center for Food Safety
and Applied Nutrition (HFS-300), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, 240-402-2166.
SUPPLEMENTARY INFORMATION:
I. Background
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353)
enables FDA to better protect public health by helping to ensure the
safety and security of the food supply. It enables FDA to focus more on
preventing food safety problems rather than relying primarily on
reacting to problems after they occur. FSMA recognizes the important
role industry plays in ensuring the safety of the food supply,
including the adoption of modern systems of preventive controls in food
production.
Section 103 of FSMA amended the Federal Food, Drug, and Cosmetic
Act (FD&C Act), in section 418 of the FD&C Act (21 U.S.C. 350g), by
adding requirements for hazard analysis and risk-based preventive
controls for establishments that are required to register as food
facilities under our regulations, in 21 CFR part 1, subpart H, in
accordance with section 415 of the FD&C Act (21 U.S.C. 350d). We have
established regulations to implement these requirements within part 117
(21 CFR part 117).
In the Federal Register of August 24, 2016 (81 FR 57816), we
announced the availability of several chapters of a multichapter draft
guidance for industry entitled ``Hazard Analysis and Risk-Based
Preventive Controls for Human Food.'' We now are announcing the
availability of an additional draft chapter of this multichapter
guidance for industry. We are issuing the draft guidance consistent
with our good guidance practices regulation (21 CFR 10.115). The draft
guidance, when finalized, will represent the current thinking of FDA on
this topic. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternate approach if it
satisfies the requirements of the applicable statutes and regulations.
This guidance is not subject to Executive Order 12866.
The multichapter draft guidance for industry is intended to explain
our current thinking on how to comply with the requirements for hazard
analysis and risk-based preventive controls under part 117, principally
in subparts C and G. The chapter that we are announcing in this
document is entitled ``Chapter Six--Use of Heat Treatments as a Process
Control.''
We intend to announce the availability for public comment of
additional chapters of the draft guidance as we complete them.
II. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information 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). The
collections of information in part 117 have been approved under OMB
control number 0910-0751.
III. Electronic Access
Persons with access to the Internet may obtain the draft 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: August 22, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18464 Filed 8-30-17; 8:45 am]
BILLING CODE 4164-01-P