[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,
[email protected].
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\
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Number of
21 CFR section; reporting Number of responses per Total annual Average burden Total hours
activity respondents respondent responses per response
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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...
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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.
[[Page 84897]]
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average
21 CFR section; recordkeeping Number of records per Total annual burden per Total hours
activity recordkeepers recordkeeper records recordkeeping \2\
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Human Foods: Subparts A--Required Records and B--General Provisions
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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 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.........
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Subpart A--General Provisions
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507.4(d); documentation of 7,469 0.75 5,579 0.05 279
animal food safety and (3 minutes)
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 0.1 387,641
safety plan--including hazard (6 minutes)
analysis, preventive
controls, and procedures for
monitoring, corrective
actions, verification, recall
plan, validation, reanalysis,
modifications, and
implementation records.......
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Subpart E--Supply Chain Program
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507.105 through 507.175; 7,469 519 3,876,411 0.1 387,641
written supply-chain program-- (6 minutes)
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 0.1 387,641
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............
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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 Average
21 CFR section; activity Number of disclosures per Total annual burden per Total hours
respondents respondent disclosures disclosure
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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.....
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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.........................
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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: 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