[Federal Register Volume 89, Number 109 (Wednesday, June 5, 2024)]
[Notices]
[Pages 48172-48174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     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-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 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.

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, 
[email protected].

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

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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 https://www.fda.gov/food/registration-food-facilities-and-other-submissions/qualified-facility-attestation.
    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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-determination-status-qualified-facility. 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.
                               ---------------------------------------------------------------------------------
    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\
----------------------------------------------------------------------------------------------------------------
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.
                              ----------------------------------------------------------------------------------
    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
----------------------------------------------------------------------------------------------------------------
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.
                               ---------------------------------------------------------------------------------
    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