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, 48172-48174 [2024-12338]
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48172
Federal Register / Vol. 89, No. 109 / Wednesday, June 5, 2024 / Notices
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.
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.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
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
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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
PO 00000
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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-201509-18/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, PRAStaff@
fda.hhs.gov.
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
E:\FR\FM\05JNN1.SGM
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Federal Register / Vol. 89, No. 109 / Wednesday, June 5, 2024 / Notices
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
48173
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-othersubmissions/qualified-facilityattestation.
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 RiskBased 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-fdaguidance-documents/guidanceindustry-determination-status-qualifiedfacility. 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
Number of
respondents
21 CFR section; reporting
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total
hours
117.201(c); qualified facility as reported on Form FDA 3942a ...........................
507.7(c); qualified facility as reported on Form FDA 3942b ...............................
37,134
1,120
2 0.5
0.5
18,567
560
0.5 (30 minutes) .........
0.5 (30 minutes) .........
9,284
280
Total ..............................................................................................................
....................
........................
....................
.....................................
9,564
1 There are
2 Reporting
no capital costs or operating and maintenance costs associated with this collection of information.
occurs biennially.
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TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section; activity
117.126(c) and 117.170(d); food safety plan and reanalysis ..............................
117.136; assurance records ................................................................................
117.145(c); monitoring records ............................................................................
117.150(d); corrective actions and corrections records ......................................
117.155(b); verification records ...........................................................................
117.160; validation records ..................................................................................
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46,685
16,285
8,143
16,285
8,143
3,677
Sfmt 4703
Number of
records per
recordkeeper
1
1
730
2
244
6
Total
annual
records
46,685
16,285
5,944,390
32,570
1,986,892
22,062
E:\FR\FM\05JNN1.SGM
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Average
burden per
recordkeeping
110 ..............................
0.25 (15 minutes) .......
0.05 (3 minutes) .........
1 ..................................
0.05 (3 minutes) .........
0.25 (15 minutes) .......
Total
hours 2
5,135,350
4,071
297,220
32,570
99,345
5,515
48174
Federal Register / Vol. 89, No. 109 / Wednesday, June 5, 2024 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
21 CFR section; activity
117.475(c)(7) through (c)(9); supplier records .....................................................
117.180(d); training records for preventive controls qualified individual .............
I
16,285
46,685
Number of
records per
recordkeeper
10
1
Total
annual
records
Total
hours 2
4 ..................................
0.25 (15 minutes) .......
651,400
11,671
5,579
0.05 (3 minutes) .........
279
519
3,876,411
0.1 (6 minutes) ...........
387,641
519
3,876,411
0.1 (6 minutes) ...........
387,641
I
I
162,850
46,685
Average
burden per
recordkeeping
I
Subpart A—General Provisions
507.4(d); documentation of animal food safety and hygiene training .................
7,469
0.75
Subpart C—Hazard Analysis and Risk-Based Preventive Controls
507.31 through 507.55; food safety plan—including hazard analysis, preventive controls, and procedures for monitoring, corrective actions, verification,
recall plan, validation, reanalysis, modifications, and implementation records.
7,469
Subpart E—Supply Chain Program
507.105 through 507.175; written supply-chain program—including records
documenting program.
7,469
Subpart F—Requirements Applying to Records That Must Be Established and Maintained
507.200 through 507.215; 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 ..............................................................................................................
7,469
519
3,876,411
0.1 (6 minutes) ...........
387,641
....................
........................
....................
.....................................
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
disclosures
per
respondent
Number of
respondents
21 CFR section; activity
Average
burden per
disclosure
Total
hours
117.201(e); disclosure of food manufacturing facility address ............................
507.27(b); labeling for the 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 products with labels .............................................
507.7(e)(2); change address on labeling (sales documents) for qualified facilities.
507.25(a)(2); animal food, including raw materials, other ingredients, and rework, is accurately identified.
507.28(b); holding and distribution of human food by-products for use as animal food.
37,134
330
1
10
37,134
3,300
0.25 (15 minutes) .......
0.25 (15 minutes) .......
9,284
825
1,120
974
4
1
4,480
974
1 ..................................
1 ..................................
4,480
974
373
312
116,376
0.01 (36 seconds) ......
1,163.76
40,798
2
81,596
0.25 (15 minutes) .......
20,399
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: May 31, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[Docket No. FDA–2024–N–2381]
[FR Doc. 2024–12338 Filed 6–4–24; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Device
Recall Authority
AGENCY:
Food and Drug Administration,
HHS.
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Total
annual
disclosures
ACTION:
Notice.
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
SUMMARY:
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16:50 Jun 04, 2024
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Sfmt 4703
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 provisions related to Medical
Device Recall Authority.
Either electronic or written
comments on the collection of
information must be submitted by
August 5, 2024.
DATES:
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
ADDRESSES:
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]]>Agencies
[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]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[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 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\
----------------------------------------------------------------------------------------------------------------
Number of Total
21 CFR section; reporting Number of responses per annual Average burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
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
[[Page 48174]]
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.
----------------------------------------------------------------------------------------------------------------
Subpart A--General Provisions
----------------------------------------------------------------------------------------------------------------
507.4(d); documentation of 7,469 0.75 5,579 0.05 (3 minutes)........ 279
animal food safety and
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 (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.
----------------------------------------------------------------------------------------------------------------
Subpart E--Supply Chain Program
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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 (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
----------------------------------------------------------------------------------------------------------------
\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 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
----------------------------------------------------------------------------------------------------------------
\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
