Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability, 66457-66458 [2023-20738]
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Federal Register / Vol. 88, No. 186 / Wednesday, September 27, 2023 / Notices
currently funded to carry out The Link
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Dated: September 21, 2023.
Alison Barkoff,
Senior Official Performing the Duties of the
Administrator and the Assistant Secretary for
Aging.
[FR Doc. 2023–21046 Filed 9–26–23; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–2343]
Hazard Analysis and Risk-Based
Preventive Controls for Human Food;
Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of availability.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the availability of
two additional draft chapters of a
multichapter draft guidance for industry
entitled ‘‘Hazard Analysis and RiskBased Preventive Controls for Human
Food.’’ This multichapter draft
guidance, when finalized, will explain
FDA’s current thinking on how to
comply with the requirements for
hazard analysis and risk-based
preventive controls under FDA’s
regulation entitled ‘‘Current Good
Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive
Controls for Human Food.’’ The newly
available draft chapters are entitled
‘‘Chapter 11—Food Allergen Program’’
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:44 Sep 26, 2023
Jkt 259001
and ‘‘Chapter 16—Acidified Foods.’’
This draft guidance is not final nor is it
in effect at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by March 25, 2024 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time 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.’’ 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
PO 00000
Frm 00097
Fmt 4703
Sfmt 4703
66457
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the Office
of Food Safety (HFS–300), Center for
Food Safety and Applied Nutrition,
Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740.
Send two self-addressed adhesive labels
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Linda Kahl, Center for Food Safety and
Applied Nutrition (HFS–300), Food and
Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–2784.
E:\FR\FM\27SEN1.SGM
27SEN1
66458
Federal Register / Vol. 88, No. 186 / Wednesday, September 27, 2023 / Notices
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of
two draft chapters entitled ‘‘Chapter
11—Food Allergen Program’’ and
‘‘Chapter 16—Acidified Foods’’ of a
multichapter draft guidance for industry
entitled ‘‘Hazard Analysis and Risk-
Based Preventive Controls for Human
Food.’’ We previously announced the
availability of several chapters of that
draft guidance as shown in table 1.
TABLE 1—AVAILABLE DRAFT CHAPTERS IN HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN
FOOD
Chapter No.
Chapter title
N/A ..................
1 ......................
2 ......................
3 ......................
Introduction ............................................................................................................................
The Food Safety Plan ...........................................................................................................
Conducting a Hazard Analysis ..............................................................................................
Potential Hazards Associated with the Manufacturing, Processing, Packing, and Holding
of Human Food.
Preventive Controls ...............................................................................................................
Application of Preventive Controls and Preventive Control Management Components ......
Use of Heat Treatments as a Process Control ....................................................................
Recall plan ............................................................................................................................
Supply-Chain Program for Human Food Products ...............................................................
Potential Hazards for Foods and Processes ........................................................................
Food Safety Plan Forms .......................................................................................................
Bacterial Pathogen Growth and Inactivation ........................................................................
ddrumheller on DSK120RN23PROD with NOTICES1
4 ......................
5 ......................
6 ......................
14 ....................
15 ....................
Appendix 1 .....
Appendix 2 .....
Appendix 3 .....
We also are announcing changes to
the expected table of contents for the
complete multichapter guidance.
We are issuing these chapters of 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 how to comply with
the requirements for hazard analysis
and risk-based preventive controls
under part 117 (21 CFR part 117),
principally in subparts C and G. It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
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. FSMA 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) by adding section 418 (21
U.S.C. 350g) with 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.
VerDate Sep<11>2014
18:44 Sep 26, 2023
Jkt 259001
Publication
We intend to announce the
availability for public comment of
additional chapters of the draft guidance
as we complete them. The titles of the
additional chapters that we expect to
make available for public comment are
included in the table of contents for the
complete multichapter guidance.
III. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in part 117 have been
approved under OMB control number
0910–0751.
IV. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/FoodGuidances, https://
www.fda.govregulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov. Use the
FDA website listed in the previous
sentence to find the most current
version of the guidance.
Dated: September 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–20738 Filed 9–26–23; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00098
Fmt 4703
Sfmt 4703
81
81
81
81
FR
FR
FR
FR
57816,
57816,
57816,
57816,
August
August
August
August
24,
24,
24,
24,
2016.
2016.
2016.
2016.
81
81
82
84
83
81
81
81
FR
FR
FR
FR
FR
FR
FR
FR
57816, August 24, 2016.
57816, August 24, 2016.
41364, August 31, 2017.
53347, October 7, 2019.
3449, January 25, 2018.
57816, August 24, 2016.
57816, August 24, 2016.
57816, August 24, 2016.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–D–1158]
Cybersecurity in Medical Devices:
Quality System Considerations and
Content of Premarket Submissions;
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Cybersecurity in
Medical Devices: Quality System
Considerations and Content of
Premarket Submissions.’’ As more
medical devices are becoming
interconnected, cybersecurity threats
have become more numerous, more
frequent, more severe, and more
clinically impactful. As a result,
ensuring medical device safety and
effectiveness includes adequate medical
device cybersecurity, as well as its
security as part of the larger system.
This final guidance supersedes the final
guidance ‘‘Content of Premarket
Submissions for Management of
Cybersecurity in Medical Devices,’’
issued October 2, 2014.
DATES: The announcement of the
guidance is published in the Federal
Register on September 27, 2023.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
E:\FR\FM\27SEN1.SGM
27SEN1
]]>Agencies
[Federal Register Volume 88, Number 186 (Wednesday, September 27, 2023)]
[Notices]
[Pages 66457-66458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20738]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-2343]
Hazard Analysis and Risk-Based Preventive Controls for Human
Food; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of two additional draft chapters of a
multichapter draft guidance for industry entitled ``Hazard Analysis and
Risk-Based Preventive Controls for Human Food.'' This multichapter
draft guidance, when finalized, will explain FDA's current thinking on
how to comply with the requirements for hazard analysis and risk-based
preventive controls under FDA's regulation entitled ``Current Good
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
Controls for Human Food.'' The newly available draft chapters are
entitled ``Chapter 11--Food Allergen Program'' and ``Chapter 16--
Acidified Foods.'' This draft guidance is not final nor is it in effect
at this time.
DATES: Submit either electronic or written comments on the draft
guidance by March 25, 2024 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time 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.'' 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 between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
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.govinfo.gov/content/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, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft guidance to
the Office of Food Safety (HFS-300), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740. Send two self-addressed adhesive labels to assist that office
in processing your requests. See the SUPPLEMENTARY INFORMATION section
for electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Linda Kahl, Center for Food Safety and
Applied Nutrition (HFS-300), Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240-402-2784.
[[Page 66458]]
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of two draft chapters entitled
``Chapter 11--Food Allergen Program'' and ``Chapter 16--Acidified
Foods'' of a multichapter draft guidance for industry entitled ``Hazard
Analysis and Risk-Based Preventive Controls for Human Food.'' We
previously announced the availability of several chapters of that draft
guidance as shown in table 1.
Table 1--Available Draft Chapters in Hazard Analysis and Risk-Based
Preventive Controls for Human Food
------------------------------------------------------------------------
Chapter No. Chapter title Publication
------------------------------------------------------------------------
N/A.................... Introduction............. 81 FR 57816, August
24, 2016.
1...................... The Food Safety Plan..... 81 FR 57816, August
24, 2016.
2...................... Conducting a Hazard 81 FR 57816, August
Analysis. 24, 2016.
3...................... Potential Hazards 81 FR 57816, August
Associated with the 24, 2016.
Manufacturing,
Processing, Packing, and
Holding of Human Food.
4...................... Preventive Controls...... 81 FR 57816, August
24, 2016.
5...................... Application of Preventive 81 FR 57816, August
Controls and Preventive 24, 2016.
Control Management
Components.
6...................... Use of Heat Treatments as 82 FR 41364, August
a Process Control. 31, 2017.
14..................... Recall plan.............. 84 FR 53347, October
7, 2019.
15..................... Supply-Chain Program for 83 FR 3449, January
Human Food Products. 25, 2018.
Appendix 1............. Potential Hazards for 81 FR 57816, August
Foods and Processes. 24, 2016.
Appendix 2............. Food Safety Plan Forms... 81 FR 57816, August
24, 2016.
Appendix 3............. Bacterial Pathogen Growth 81 FR 57816, August
and Inactivation. 24, 2016.
------------------------------------------------------------------------
We also are announcing changes to the expected table of contents
for the complete multichapter guidance.
We are issuing these chapters of 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
how to comply with the requirements for hazard analysis and risk-based
preventive controls under part 117 (21 CFR part 117), principally in
subparts C and G. It does not establish any rights for any person and
is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.
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. FSMA 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) by adding section 418 (21 U.S.C. 350g) with 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.
We intend to announce the availability for public comment of
additional chapters of the draft guidance as we complete them. The
titles of the additional chapters that we expect to make available for
public comment are included in the table of contents for the complete
multichapter guidance.
III. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in part 117 have been approved under OMB control number 0910-0751.
IV. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/FoodGuidances, https://www.fda.govregulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA website listed in the previous
sentence to find the most current version of the guidance.
Dated: September 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20738 Filed 9-26-23; 8:45 am]
BILLING CODE 4164-01-P
