Notice2024-12338
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Animal Food
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Published
June 5, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements associated with current good manufacturing practice, hazard analysis, and risk-based preventive controls for human and animal food.
Full Text
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<title>Federal Register, Volume 89 Issue 109 (Wednesday, June 5, 2024)</title>
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[Federal Register Volume 89, Number 109 (Wednesday, June 5, 2024)]
[Notices]
[Pages 48172-48174]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-12338]
[[Page 48172]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2177]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Current Good Manufacturing Practice, Hazard Analysis,
and Risk-Based Preventive Controls for Human Food, and Current Good
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
Controls for Animal Food
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection requirements
associated with current good manufacturing practice, hazard analysis,
and risk-based preventive controls for human and animal food.
DATES: Either electronic or written comments on the collection of
information must be submitted by August 5, 2024.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 5, 2024. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2024-N-2177 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Current Good Manufacturing
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human
Food, and Current Good Manufacturing Practice, Hazard Analysis, and
Risk-Based Preventive Controls for Animal Food.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#fdadafbcae899c9b9bbd9b999cd395958ed39a928b"><span class="__cf_email__" data-cfemail="acfcfeedffd8cdcacaeccac8cd82c4c4df82cbc3da">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information
[[Page 48173]]
is necessary for the proper performance of FDA's functions, including
whether the information will have practical utility; (2) the accuracy
of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Current Good Manufacturing Practice and Hazard Analysis, and Risk-Based
Preventive Controls for Human Food--21 CFR Part 117; Current Good
Manufacturing Practice and Hazard Analysis, and Risk-Based Preventive
Controls for Animal Food--21 CFR Part 507
OMB Control Number 0910-0751--Extension
This information collection supports implementation of section 418
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
350g). Section 418(a) requires the owner, operator, or agent in charge
of a facility to evaluate hazards that could affect food manufactured,
processed, packed, or held by the facility; identify and implement
preventive controls; monitor the performance of those controls; and
maintain records demonstrating compliance. Section 418(b) through (i)
of the FD&C Act contains more specific requirements applicable to
facilities, including corrective actions (section 418(e)), verification
(section 418(f)), a written plan and documentation (section 418(h)),
and reanalysis of hazards (section 418(i)). Finally, section 301(uu) of
the FD&C Act (21 U.S.C. 331(uu)) prohibits ``[t]he operation of a
facility that manufactures, processes, packs, or holds food for sale in
the United States if the owner, operator, or agent in charge of such
facility is not in compliance with section 418 [of the FD&C Act].'' FDA
has promulgated regulations in part 117 (21 CFR part 117) governing
human food, while regulations governing food for animals are found in
part 507 (21 CFR part 507). The purpose of the regulations is to
prevent the introduction of adulterated and/or misbranded products into
the marketplace and ensure the safety of both human foods and animal
foods in accordance with sections 402 and 403 of the FD&C Act (21
U.S.C. 342 and 343). Generally, domestic and foreign food facilities
that are required to register in accordance with section 415 of the
FD&C Act (21 U.S.C. 350d) must comply with these requirements, unless
an exemption applies. It is important to note that applicability of the
current good manufacturing practice requirements for animal food is
dependent upon whether a facility is required to register, while the
applicability of the current good manufacturing practice requirements
for human food is not dependent upon whether a facility is required to
register. Respondents to the information collection are those who
manufacture, prepare, pack, or hold food intended for humans or
animals.
The regulations include recordkeeping necessary to demonstrate
compliance with the requirements; however, respondents that meet the
definition of a ``qualified facility,'' under (21 CFR 117.3 and 507.3),
are subject to reporting. To be subject to the modified requirements
set forth in part 117, subpart D and part 507, subpart D for human food
and animal food, respectively, respondents must attest to their status.
To assist respondents in this regard, we have developed Forms FDA 3942a
(Quality Facility Attestation: Human Food) and 3942b (Quality Facility
Attestation: Animal Food), available for downloading from our website
at <a href="https://www.fda.gov/food/registration-food-facilities-and-other-submissions/qualified-facility-attestation">https://www.fda.gov/food/registration-food-facilities-and-other-submissions/qualified-facility-attestation</a>.
Information collected will assist FDA in determining facility
compliance with current good manufacturing practice requirements and in
ensuring that food safety systems include hazard analysis and risk-
based preventive controls. Records will be examined during food
facility inspections and in the event of an outbreak or other food
safety incident involving the food manufactured at the facility.
Section 418(l)(2)(B)(ii) of the FD&C Act directs us to issue
guidance on documentation required to determine status as a qualified
facility. Accordingly, we issued a guidance for industry entitled
``Determination of Status as a Qualified Facility Under Part 117:
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based
Preventive Controls for Human Food and Part 507: Current Good
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
Controls for Food for Animals,'' also available for downloading from
our website at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-determination-status-qualified-facility">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-determination-status-qualified-facility</a>. The guidance discusses the content, format, frequency, and
timing of submissions.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Total
21 CFR section; reporting Number of responses per annual Average burden per Total hours
respondents respondent responses response
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117.201(c); qualified facility 37,134 \2\ 0.5 18,567 0.5 (30 minutes)......... 9,284
as reported on Form FDA 3942a.
507.7(c); qualified facility 1,120 0.5 560 0.5 (30 minutes)......... 280
as reported on Form FDA 3942b.
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Total..................... ........... .............. ........... ......................... 9,564
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Reporting occurs biennially.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Total
21 CFR section; activity Number of records per annual Average burden per Total hours
recordkeepers recordkeeper records recordkeeping \2\
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117.126(c) and 117.170(d); 46,685 1 46,685 110..................... 5,135,350
food safety plan and
reanalysis.
117.136; assurance records... 16,285 1 16,285 0.25 (15 minutes)....... 4,071
117.145(c); monitoring 8,143 730 5,944,390 0.05 (3 minutes)........ 297,220
records.
117.150(d); corrective 16,285 2 32,570 1....................... 32,570
actions and corrections
records.
117.155(b); verification 8,143 244 1,986,892 0.05 (3 minutes)........ 99,345
records.
117.160; validation records.. 3,677 6 22,062 0.25 (15 minutes)....... 5,515
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117.475(c)(7) through (c)(9); 16,285 10 162,850 4....................... 651,400
supplier records.
117.180(d); training records 46,685 1 46,685 0.25 (15 minutes)....... 11,671
for preventive controls
qualified individual.
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Subpart A--General Provisions
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507.4(d); documentation of 7,469 0.75 5,579 0.05 (3 minutes)........ 279
animal food safety and
hygiene training.
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Subpart C--Hazard Analysis and Risk-Based Preventive Controls
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507.31 through 507.55; food 7,469 519 3,876,411 0.1 (6 minutes)......... 387,641
safety plan--including
hazard analysis, preventive
controls, and procedures for
monitoring, corrective
actions, verification,
recall plan, validation,
reanalysis, modifications,
and implementation records.
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Subpart E--Supply Chain Program
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507.105 through 507.175; 7,469 519 3,876,411 0.1 (6 minutes)......... 387,641
written supply-chain
program--including records
documenting program.
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Subpart F--Requirements Applying to Records That Must Be Established and Maintained
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507.200 through 507.215; 7,469 519 3,876,411 0.1 (6 minutes)......... 387,641
general requirements,
additional requirements
applying to food safety
plan, requirements for
record retention, use of
existing records, and
special requirements
applicable to written
assurance.
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Total.................... ............. .............. ........... ........................ 7,400,400
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Total hours have been rounded.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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Number of Total
21 CFR section; activity Number of disclosures annual Average burden per Total hours
respondents per respondent disclosures disclosure
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117.201(e); disclosure of food 37,134 1 37,134 0.25 (15 minutes)........ 9,284
manufacturing facility
address.
507.27(b); labeling for the 330 10 3,300 0.25 (15 minutes)........ 825
animal food product contains
the specific information and
instructions needed so the
food can be safely used for
the intended animal species.
507.7(e)(1); change labels on 1,120 4 4,480 1........................ 4,480
products with labels.
507.7(e)(2); change address on 974 1 974 1........................ 974
labeling (sales documents)
for qualified facilities.
507.25(a)(2); animal food, 373 312 116,376 0.01 (36 seconds)........ 1,163.76
including raw materials,
other ingredients, and
rework, is accurately
identified.
507.28(b); holding and 40,798 2 81,596 0.25 (15 minutes)........ 20,399
distribution of human food by-
products for use as animal
food.
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Total..................... ........... .............. ........... ......................... 37,125.76
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: May 31, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-12338 Filed 6-4-24; 8:45 am]
BILLING CODE 4164-01-P
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