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, 84895-84898 [2024-24771]
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lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 206 / Thursday, October 24, 2024 / Notices
Ave., Bldg. 71, Silver Spring, MD
20993–0002, 202–657–8533,
CBERVRBPAC@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last-minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
FDA’s website at https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations
will be heard, viewed, captioned, and
recorded through an online
teleconferencing and/or video
conferencing platform. On December 12,
2024, under Topic I, the Committee will
meet in open session to discuss
Considerations for RSV Vaccine Safety
in Pediatric Populations. Under Topic
II, the Committee will meet in open
session to hear overviews of the LI and
LR research programs in the Division of
Viral Products, Office of Vaccines
Research and Review, and Center for
Biologics Evaluation and Research.
After the open session ends for Topic II,
the meeting will be closed to the public
for Committee deliberations.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available on FDA’s
website at the time of the advisory
committee meeting. Background
material and the link to the online
teleconference and/or video conference
meeting will be available at: https://
www.fda.gov/AdvisoryCommittees/
Calendar/default.htm. Scroll down to
the appropriate advisory committee
meeting link. The meeting will include
slide presentations with audio and
video components to allow the
presentation of materials in a manner
that most closely resembles an in-person
advisory committee meeting.
Procedure: On December 12, 2024,
from 8:30 a.m. to 3 p.m. Eastern Time
for Topic I and from 3:10 p.m. to 4:40
p.m. Eastern Time for Topic II, the
meeting is open to the public. Interested
persons may present data, information,
or views, orally or in writing, on issues
pending before the Committee. All
electronic and written submissions
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submitted to the Docket (see ADDRESSES)
on or before December 4, 2024, will be
provided to the Committee. Comments
received on or after December 4, 2024,
and by December 11, 2024, will be taken
into consideration by FDA. Oral
presentations from the public will be
scheduled between approximately 12:15
p.m. to 1 p.m. Eastern Time for Topic
I, and between 4:25 p.m. to 4:40 p.m.
Eastern Time for Topic II. Those
individuals interested in making formal
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, along with their names, email
addresses, and direct contact phone
numbers of proposed participants, and
an indication of the approximate time
requested to make their presentation on
or before 12 p.m. Eastern Time on
November 25, 2024. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by November 27, 2024.
Closed Committee Deliberations: On
December 12, 2024, the meeting will be
closed from 4:40 p.m. to 5:30 p.m. to
permit discussion where disclosure
would constitute a clearly unwarranted
invasion of personal privacy (5 U.S.C.
552b(c)(6)). The recommendations of the
advisory committee regarding the
progress of the individual investigators’
research programs, along with other
information, will be discussed during
this session. We believe that public
discussion of these recommendations on
individual scientists would constitute
an unwarranted invasion of personal
privacy.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Sussan Paydar
or Kathleen Hayes (see FOR FURTHER
INFORMATION CONTACT) at least 7 days in
advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm111462.htm for
procedures on public conduct during
advisory committee meetings.
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84895
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. 1001 et seq.). This meeting notice
also serves as notice that, pursuant to 21
CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the
location of advisory committee meetings
are hereby waived to allow for this
meeting to take place using an online
meeting platform. This waiver is in the
interest of allowing greater transparency
and opportunities for public
participation, in addition to
convenience for advisory committee
members, speakers, and guest speakers.
No participant will be prejudiced by
this waiver, and that the ends of justice
will be served by allowing for this
modification to FDA’s advisory
committee meeting procedures.
Dated: October 18, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024–24713 Filed 10–23–24; 8:45 am]
BILLING CODE 4164–01–P
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.
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
SUMMARY:
E:\FR\FM\24OCN1.SGM
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84896
Federal Register / Vol. 89, No. 206 / Thursday, October 24, 2024 / Notices
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, PRAStaff@
fda.hhs.gov.
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 §§ 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-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.
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 60day 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
respondents
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21 CFR section; reporting activity
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Human Foods: 117.201(c); qualified facility as reported
on Form FDA 3942a ....................................................
37,134
2 0.5
18,567
0.5 (30
minutes)
9,284
Animal Foods: 507.7(c); qualified facility as reported on
Form FDA 3942b ..........................................................
1,120
0.5
560
0.5 (30
minutes)
280
Total ..........................................................................
........................
............................
........................
........................
9,564
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
occurs biennially.
2 Reporting
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Federal Register / Vol. 89, No. 206 / Thursday, October 24, 2024 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section; recordkeeping activity
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total
hours 2
Human Foods: Subparts A—Required Records and B—General Provisions
117.126(c) and 117.170(d); food safety plan and reanalysis ...........................................................................
117.136; assurance records ............................................
46,685
16,285
1
1
46,685
16,285
117.145(c); monitoring records ........................................
8,143
730
5,944,390
(15
(3
117.150(d); corrective actions and corrections records ..
117.155(b); verification records .......................................
16,285
8,143
2
244
32,570
1,986,892
117.160; validation records ..............................................
3,677
6
22,062
(3
(15
117.475(c)(7) through (c)(9); supplier records ................
117.180(d); training records for preventive controls
qualified individual ........................................................
110
0.25
minutes)
0.05
minutes)
1
0.05
minutes)
0.25
minutes)
4
5,135,350
4,071
297,220
32,570
99,345
5,515
16,285
10
162,850
651,400
46,685
1
46,685
0.25
(15 minutes)
11,671
0.75
5,579
0.05
(3 minutes)
279
3,876,411
0.1
(6 minutes)
387,641
3,876,411
0.1
(6 minutes)
387,641
Subpart A—General Provisions
507.4(d); documentation of animal food safety and hygiene training ................................................................
7,469
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
519
Subpart E—Supply Chain Program
507.105 through 507.175; written supply-chain program—including records documenting program ..........
7,469
519
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 ...............................................................
7,469
519
3,876,411
0.1
(6 minutes)
387,641
Total ..........................................................................
........................
............................
........................
........................
7,400,400
1 There
2 Total
are no capital costs or operating and maintenance costs associated with this collection of information.
hours have been rounded.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
lotter on DSK11XQN23PROD with NOTICES1
21 CFR section; activity
Number of
disclosures
per respondent
Total
annual
disclosures
Average
burden per
disclosure
Total
hours
117.201(e); disclosure of food manufacturing facility address .............................................................................
37,134
1
37,134
0.25
(15 minutes)
9,284
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 .........................................................................
330
10
3,300
825
1,120
4
4,480
0.25
(15 minutes)
1
4,480
974
1
974
1
974
507.7(e)(1); change labels on products with labels ........
507.7(e)(2); change address on labeling (sales documents) for qualified facilities .........................................
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84898
Federal Register / Vol. 89, No. 206 / Thursday, October 24, 2024 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of
respondents
21 CFR section; activity
Total
annual
disclosures
Average
burden per
disclosure
Total
hours
507.25(a)(2); animal food, including raw materials, other
ingredients, and rework, is accurately identified ..........
373
312
116,376
0.01
(36 seconds)
1,163.76
507.28(b); holding and distribution of human food byproducts for use as animal food ..................................
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.
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title:
Environmental Information and
Documentation
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate
below or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than December 23,
2024.
SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1
Number of
disclosures
per respondent
VerDate Sep<11>2014
17:56 Oct 23, 2024
Jkt 265001
Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14NWH04, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Joella Roland, the HRSA
Information Collection Clearance
Officer, at (301) 443–3983.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
Information Collection Request Title:
HRSA Environmental Information and
Documentation, OMB No. 0915–0324—
Extension.
Abstract: HRSA proposes an
extension of the Paperwork Reduction
Act approval for the Environmental
Information and Documentation (EID)
checklist, which consists of information
the agency is required to obtain to
comply with the National
Environmental Policy Act (NEPA) of
1969 as amended by the Fiscal
Responsibility Act of 2023. NEPA
establishes the federal government’s
national policy for protection of the
environment. The EID checklist must be
completed and submitted by applicants
for HRSA funds that plan to engage in
construction or other projects that will
potentially impact the environment.
HRSA uses the checklist to ensure that
decision-making processes are
consistent with NEPA and other related
environmental and historic preservation
laws. The extension will support
HRSA’s implementation of programs
ADDRESSES:
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Fmt 4703
Sfmt 4703
with capital improvements that have the
potential to significantly affect the
human environment, such as
construction/expansion and alteration/
renovation activities, as defined in the
associated HRSA program guidance, or
installation of fixed equipment.
Need and Proposed Use of the
Information: Applicants for HRSA funds
must provide information and assurance
of compliance with NEPA on the EID
checklist. This information is reviewed
during the Pre-Award stage (and/or
prior to the implementation of the
project). The information is reviewed in
the Post-Award stage for project changes
and the information is reviewed before
the implementation of the project
changes.
Likely Respondents: HRSA applicants
applying for federal loan guarantees,
federal construction grants, and
cooperative agreements.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
E:\FR\FM\24OCN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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............
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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.........................
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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
