[Federal Register Volume 89, Number 206 (Thursday, October 24, 2024)]
[Notices]
[Pages 84895-84898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24771]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-2177]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by November 25, 2024.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB

[[Page 84896]]

control number for this information collection is 0910-0751. Also 
include the FDA docket number found in brackets in the heading of this 
document.

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#623230233116030404220406034c0a0a114c050d14"><span class="__cf_email__" data-cfemail="94c4c6d5c7e0f5f2f2d4f2f0f5bafcfce7baf3fbe2">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 issued 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 Sec. Sec.  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.
    In the Federal Register of June 5, 2024 (89 FR 48172) we published 
a 60-day notice requesting public comment on the proposed collection of 
information. Although no comments were received, on our own initiative 
we have modified estimates since publication of our 60-day notice. 
Specifically, we have modified estimates for certain recordkeeping 
elements associated with animal foods in tables 2 and 3.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of
   21 CFR section; reporting       Number of      responses per    Total annual   Average burden    Total hours
           activity               respondents      respondent        responses     per response
----------------------------------------------------------------------------------------------------------------
Human Foods: 117.201(c);                37,134           \2\ 0.5          18,567         0.5 (30           9,284
 qualified facility as                                                                  minutes)
 reported on Form FDA 3942a...
Animal Foods: 507.7(c);                  1,120               0.5             560         0.5 (30             280
 qualified facility as                                                                  minutes)
 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.


[[Page 84897]]


                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of                         Average
 21 CFR section; recordkeeping     Number of       records per     Total  annual    burden per     Total  hours
           activity              recordkeepers    recordkeeper        records      recordkeeping        \2\
----------------------------------------------------------------------------------------------------------------
                       Human Foods: Subparts A--Required Records and B--General Provisions
----------------------------------------------------------------------------------------------------------------
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           4,071
                                                                                    (15 minutes)
117.145(c); monitoring records           8,143               730       5,944,390            0.05         297,220
                                                                                     (3 minutes)
117.150(d); corrective actions          16,285                 2          32,570               1          32,570
 and corrections records......
117.155(b); verification                 8,143               244       1,986,892            0.05          99,345
 records......................                                                       (3 minutes)
117.160; validation records...           3,677                 6          22,062            0.25           5,515
                                                                                    (15 minutes)
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          11,671
 for preventive controls                                                            (15 minutes)
 qualified individual.........
----------------------------------------------------------------------------------------------------------------
                                          Subpart A--General Provisions
----------------------------------------------------------------------------------------------------------------
507.4(d); documentation of               7,469              0.75           5,579            0.05             279
 animal food safety and                                                              (3 minutes)
 hygiene training.............
----------------------------------------------------------------------------------------------------------------
                          Subpart C--Hazard Analysis and Risk-Based Preventive Controls
----------------------------------------------------------------------------------------------------------------
507.31 through 507.55; food              7,469               519       3,876,411             0.1         387,641
 safety plan--including hazard                                                       (6 minutes)
 analysis, preventive
 controls, and procedures for
 monitoring, corrective
 actions, verification, recall
 plan, validation, reanalysis,
 modifications, and
 implementation records.......
----------------------------------------------------------------------------------------------------------------
                                         Subpart E--Supply Chain Program
----------------------------------------------------------------------------------------------------------------
507.105 through 507.175;                 7,469               519       3,876,411             0.1         387,641
 written supply-chain program--                                                      (6 minutes)
 including records documenting
 program......................
----------------------------------------------------------------------------------------------------------------
               Subpart F--Requirements Applying to Records That Must Be Established and Maintained
----------------------------------------------------------------------------------------------------------------
507.200 through 507.215;                 7,469               519       3,876,411             0.1         387,641
 general requirements,                                                               (6 minutes)
 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
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
                                                    Number of                         Average
   21 CFR section; activity        Number of    disclosures  per   Total  annual    burden per     Total  hours
                                  respondents      respondent       disclosures     disclosure
----------------------------------------------------------------------------------------------------------------
117.201(e); disclosure of food          37,134                 1          37,134            0.25           9,284
 manufacturing facility                                                             (15 minutes)
 address......................
507.27(b); labeling for the                330                10           3,300            0.25             825
 animal food product contains                                                       (15 minutes)
 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.....

[[Page 84898]]

 
507.25(a)(2); animal food,                 373               312         116,376            0.01        1,163.76
 including raw materials,                                                           (36 seconds)
 other ingredients, and
 rework, is accurately
 identified...................
507.28(b); holding and                  40,798                 2          81,596            0.25          20,399
 distribution of human food by-                                                     (15 minutes)
 products for use as animal
 food.........................
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ................  ..............  ..............       37,125.76
----------------------------------------------------------------------------------------------------------------
\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: October 21, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024-24771 Filed 10-23-24; 8:45 am]
BILLING CODE 4164-01-P


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