[Federal Register Volume 84, Number 194 (Monday, October 7, 2019)]
[Proposed Rules]
[Pages 53347-53348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21643]
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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Food; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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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.'' This multichapter draft guidance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 14--Recall Plan.''
DATES: Submit either electronic or written comments on the draft
guidance by February 4, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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
[[Page 53348]]
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.
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.
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 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 one self-addressed adhesive label 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: 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. 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 (21 CFR part 117).
In the Federal Register of August 24, 2016 (81 FR 57816), we
announced the availability of several chapters (Chapters 1-5) of a
multichapter draft guidance for industry entitled ``Hazard Analysis and
Risk-Based Preventive Controls for Human Food.'' In the Federal
Register of August 31, 2017 (82 FR 41364), and January 25, 2018 (83 FR
3449), we announced the availability of additional chapters (Chapter 6
and Chapter 15, respectively). We now are announcing the availability
of an additional draft chapter of this multichapter guidance for
industry.
II. Significance of Guidance
This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the current thinking of FDA on ``Current
Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
Controls for Human Food.'' 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. 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 14--Recall Plan.'' We intend to announce
the availability for public comment of additional chapters of the draft
guidance as we complete them.
III. 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.
IV. 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 website listed in the previous
sentence to find the most current version of the guidance.
Dated: September 27, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21643 Filed 10-4-19; 8:45 am]
BILLING CODE 4164-01-P