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 Food for Animals, 49543-49546 [2021-19116]
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Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices
Administration Amendments Act of
2007), authorizes FDA to collect user
fees for certain medical device
applications. Under this authority,
companies pay a fee for certain new
medical device applications or
supplements submitted to the Agency
for review. Because the submission of
user fees concurrently with applications
and supplements is required, the review
of an application cannot begin until the
fee is submitted. Form FDA 3601, the
‘‘Medical Device User Fee Cover Sheet,’’
is designed to provide the minimum
necessary information to determine
whether a fee is required for review of
an application, to determine the amount
of the fee required, and to account for
and track user fees. The form provides
a cross-reference between the fees
submitted for an application with the
actual submitted application by using a
unique number tracking system. The
information collected is used by FDA’s
Center for Devices and Radiological
Health and FDA’s Center for Biologics
Evaluation and Research to initiate the
administrative screening of new medical
device applications and supplemental
applications.
We are revising the information
collection to add Form FDA 3601a, the
‘‘Device Facility User Fee Cover Sheet.’’
Owners or operators of places of
business (also called establishments or
facilities) that are involved in the
production and distribution of medical
devices intended for use in the United
States are required to register annually
with FDA, a process known as
establishment registration (21 CFR part
807, subparts A through D). (The
information collection for medical
device establishment registration and
listing is approved under OMB control
number 0910–0625.) All establishments
required to register must pay a user fee.
Form FDA 3601a, the ‘‘Device Facility
User Fee Cover Sheet,’’ is designed to
collect payments for the annual
establishment registration fee for
medical device establishments.
The total number of annual responses
for Form FDA 3601 is based on the
average number of cover sheet
submissions received by FDA in recent
years. The number of received annual
responses includes cover sheets for
applications that were qualified for
small businesses and fee waivers or
49543
reductions. The estimated hours per
response are based on past FDA
experience with the various cover sheet
submissions and range from 5 to 30
minutes. For this analysis, we estimate
18 minutes per coversheet.
The total number of annual responses
for Form FDA 3601a is based on the
average number of cover sheet
submissions received by FDA in recent
years. Based on past FDA experience
with various cover sheet submissions,
we estimate 10 minutes per response.
In the Federal Register of June 12,
2020 (85 FR 35939), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Although two comments
were received, only one was responsive
to the four collection of information
topics solicited.
FDA’s response to the comment is
that the establishment registration fee is
not eligible for a reduced small business
fee. This can be found on our website
at: https://www.fda.gov/medicaldevices/how-study-and-market-yourdevice/device-registration-and-listing.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2
Number of
responses
per
respondent
Number of
respondents
FDA Form No.
Total annual
responses
Average burden
per response
Total hours
3601 .........................................................................
3601a .......................................................................
6,182
24,086
1
1
6,182
24,086
0.30 (18 minutes) ......
0.17 (10 minutes) ......
1,855
4,095
Total ..................................................................
........................
........................
30,268
....................................
5,950
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
have been rounded.
2 Numbers
Our estimated burden for the
information collection reflects an
overall increase of 4,036 hours and a
corresponding increase of 23,889
responses/records. We attribute these
increases to two factors: We have
revised the burden estimate to include
Form FDA 3601a and we have adjusted
the number of respondents for Form
FDA 3601 to reflect our current data.
Dated: August 31, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
lotter on DSK11XQN23PROD with NOTICES1
[FR Doc. 2021–19113 Filed 9–2–21; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
[Docket No. FDA–2018–N–1857]
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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 Food for Animals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing that a proposed collection
SUMMARY:
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PO 00000
Frm 00040
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Sfmt 4703
Submit written comments
(including recommendations) on the
collection of information by October 4,
2021.
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
control number for this information
collection is 0910–0751. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
E:\FR\FM\03SEN1.SGM
03SEN1
49544
Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices
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 Food for Animals—21 CFR
Part 507
OMB Control Number 0910–0751—
Revision
This information collection supports
FDA regulations setting forth criteria
and definitions applicable to human
food and to animal food, as established
under the FDA Food Safety and
Modernization Act (FSMA) (Pub. L.
111–353). Congress enacted FSMA in
response to dramatic changes in the
global food system and in our
understanding of foodborne illness and
its consequences, including the
realization that preventable foodborne
illness is both a significant public health
problem and a threat to the economic
well-being of the food system. 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 food in
accordance with sections 402 and 403 of
the Federal Food, Drug, and Cosmetic
Act (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, however, 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.
Regulations governing human food are
set forth in part 117 (21 CFR part 117),
while regulations governing animal food
are found in part 507 (21 CFR part 507).
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 A
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.
Section 418(l)(2)(B)(ii) of the FD&C
Act (21 U.S.C. 350g(l)(2)(B)(ii)) 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/regulatoryinformation/search-fda-guidancedocuments/guidance-industrydetermination-status-qualified-facility.
The guidance discusses the content,
format, frequency, and timing of
submissions. For efficiency of Agency
operations, we are now accounting for
burden we attribute to reporting
associated with Forms FDA 3942a and
3942b, currently approved under OMB
control number 0910–0854, with this
information collection.
In the Federal Register of March 16,
2021 (86 FR 14436), we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section; reporting
Number of
respondents
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
2 0.5
18,567
0.5 (30 minutes) ......................
9,284
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
lotter on DSK11XQN23PROD with NOTICES1
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN: HUMAN FOODS 1
21 CFR section; activity
Number of
recordkeepers
117.126(c) and 117.170(d);
food safety plan and reanalysis.
117.136; assurance records ....
117.145(c); monitoring records
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16:55 Sep 02, 2021
Jkt 253001
Number of
records per
recordkeeper
Total annual
records
Average burden per
recordkeeping
Total hours
46,685
1
46,685
110 ..........................................
5,135,350
16,285
8,143
1
730
16,285
5,944,390
0.25 (15 minutes) ....................
0.05 (3 minutes) ......................
4,071
297,220
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Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices
49545
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN: HUMAN FOODS 1—Continued
Number of
recordkeepers
21 CFR section; activity
Number of
records per
recordkeeper
Total annual
records
Average burden per
recordkeeping
Total hours
117.150(d); corrective actions
and corrections records.
117.155(b); verification records
117.160; validation records ......
117.475(c)(7)–(9); supplier
records.
117.180(d); training records for
preventive controls qualified
individual.
16,285
2
32,570
1 ..............................................
32,570
8,143
3,677
16,285
244
6
10
1,986,892
22,062
162,850
0.05 (3 minutes) ......................
0.25 (15 minutes) ....................
4 ..............................................
99,345
5,515
651,400
46,685
1
46,685
0.25 (15 minutes) ....................
11,671
Total ..................................
..............................
..............................
..............................
..................................................
6,237,142
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN: ANIMAL FOOD 1
21 CFR section; activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average burden per
recordkeeping
Total hours 2
Subpart A—General Provisions
507.4(d); documentation of animal food safety and hygiene
training.
7,469
0.75
5,579
0.05 (3 minutes) ......................
279
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
3,876,411
0.1 (6 minutes) ........................
387,641
0.1 (6 minutes) ........................
387,641
Subpart E—Supply Chain Program
507.105 through 507.175; written supply-chain program—
including records documenting program.
7,469
519
3,876,411
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 ..................................
..............................
..............................
11,635,372
..................................................
1,163,258
1 There
lotter on DSK11XQN23PROD with NOTICES1
2 Total
are no capital costs or operating and maintenance costs associated with this collection of information.
hours have been rounded.
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16:55 Sep 02, 2021
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E:\FR\FM\03SEN1.SGM
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49546
Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices
TABLE 4—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN: HUMAN FOODS 1
21 CFR section; activity
Number of
respondents
Number of
disclosures per
respondent
Total annual
disclosures
Average burden
per disclosure
Total hours
37,134
1
37,134
0.25 (15 minutes) ....................
9,284
117.201(e); disclosure of food
manufacturing facility address.
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 5—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN: ANIMAL FOOD 1
Number of
respondents
21 CFR section; activity
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 byproducts for use as animal food.
Total ..................................
1 There
Average burden
per disclosure
Total hours
10
3,300
0.25 (15 minutes) ....................
825
1,120
4
4,480
1 ..............................................
4,480
974
1
974
1 ..............................................
974
373
312
116,376
0.01 (36 seconds) ...................
1,163.76
40,798
2
81,596
0.25 (15 minutes) ....................
20,399
..............................
..............................
..............................
..................................................
27,841.76
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: August 31, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–19116 Filed 9–2–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
lotter on DSK11XQN23PROD with NOTICES1
Total annual
disclosures
330
Based on a review of the information
collection since our last request for
OMB approval, we have made slight
adjustments to reflect a decrease in
third-party disclosure burden associated
with animal food. In this submission we
provide a cumulative estimate for
related disclosure activities that we had
previously accounted for separately.
[Docket No. FDA–2021–N–0897]
Oncologic Drugs Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for Comments
AGENCY:
Number of
disclosures per
respondent
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
16:55 Sep 02, 2021
Jkt 253001
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Oncologic Drugs
Advisory Committee. The general
function of the committee is to provide
advice and recommendations to FDA on
regulatory issues. The meeting will be
open to the public. FDA is establishing
a docket for public comment on this
document.
DATES: The meeting will be held on
October 28, 2021, from 10:30 a.m. to 3
p.m. Eastern Time.
ADDRESSES: Please note that due to the
impact of this COVID–19 pandemic, all
meeting participants will be joining this
advisory committee meeting via an
online teleconferencing platform.
Answers to commonly asked questions
about FDA advisory committee meetings
may be accessed at: https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2021–N–0897.
SUMMARY:
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
The docket will close on October 27,
2021. Submit either electronic or
written comments on this public
meeting by October 27, 2021. Please
note that late, untimely filed comments
will not be considered. Electronic
comments must be submitted on or
before October 27, 2021. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
October 27, 2021. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Comments received on or before
October 14, 2021, will be provided to
the committee. Comments received after
that date will be taken into
consideration by FDA. In the event that
the meeting is cancelled, FDA will
continue to evaluate any relevant
applications or information, and
consider any comments submitted to the
docket, as appropriate.
You may submit comments as
follows:
E:\FR\FM\03SEN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 169 (Friday, September 3, 2021)]
[Notices]
[Pages 49543-49546]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19116]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1857]
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 Food for
Animals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 October 4, 2021.
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 control number for
this information collection is 0910-0751. Also include the FDA docket
number found in brackets in the heading of this document.
[[Page 49544]]
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 Food for Animals--21 CFR Part 507
OMB Control Number 0910-0751--Revision
This information collection supports FDA regulations setting forth
criteria and definitions applicable to human food and to animal food,
as established under the FDA Food Safety and Modernization Act (FSMA)
(Pub. L. 111-353). Congress enacted FSMA in response to dramatic
changes in the global food system and in our understanding of foodborne
illness and its consequences, including the realization that
preventable foodborne illness is both a significant public health
problem and a threat to the economic well-being of the food system. 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 food in accordance with
sections 402 and 403 of the Federal Food, Drug, and Cosmetic Act (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, however, 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. Regulations governing human food are
set forth in part 117 (21 CFR part 117), while regulations governing
animal food are found in part 507 (21 CFR part 507). 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 A 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.
Section 418(l)(2)(B)(ii) of the FD&C Act (21 U.S.C.
350g(l)(2)(B)(ii)) 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. For efficiency
of Agency operations, we are now accounting for burden we attribute to
reporting associated with Forms FDA 3942a and 3942b, currently approved
under OMB control number 0910-0854, with this information collection.
In the Federal Register of March 16, 2021 (86 FR 14436), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
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 per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
117.201(c); qualified facility as reported on 37,134 \2\ 0.5 18,567 0.5 (30 minutes)................ 9,284
Form FDA 3942a.
507.7(c); qualified facility as reported on 1,120 0.5 560 0.5 (30 minutes)................ 280
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: Human Foods \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Number of records Total annual
21 CFR section; activity recordkeepers per recordkeeper records Average burden per recordkeeping Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
117.126(c) and 117.170(d); food safety plan 46,685 1 46,685 110............................. 5,135,350
and reanalysis.
117.136; assurance records................... 16,285 1 16,285 0.25 (15 minutes)............... 4,071
117.145(c); monitoring records............... 8,143 730 5,944,390 0.05 (3 minutes)................ 297,220
[[Page 49545]]
117.150(d); corrective actions and 16,285 2 32,570 1............................... 32,570
corrections records.
117.155(b); verification records............. 8,143 244 1,986,892 0.05 (3 minutes)................ 99,345
117.160; validation records.................. 3,677 6 22,062 0.25 (15 minutes)............... 5,515
117.475(c)(7)-(9); supplier records.......... 16,285 10 162,850 4............................... 651,400
117.180(d); training records for preventive 46,685 1 46,685 0.25 (15 minutes)............... 11,671
controls qualified individual.
----------------------------------------------------------------------------------------------------------
Total.................................... ................. ................. ................. ................................ 6,237,142
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 3--Estimated Annual Recordkeeping Burden: Animal Food \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Number of records Total annual Total hours
21 CFR section; activity recordkeepers per recordkeeper records Average burden per recordkeeping \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Subpart A--General Provisions
--------------------------------------------------------------------------------------------------------------------------------------------------------
507.4(d); documentation of animal food safety 7,469 0.75 5,579 0.05 (3 minutes)................ 279
and hygiene training.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Subpart C--Hazard Analysis and Risk-Based Preventive Controls
--------------------------------------------------------------------------------------------------------------------------------------------------------
507.31 through 507.55; food safety plan-- 7,469 519 3,876,411 0.1 (6 minutes)................. 387,641
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; written supply-chain 7,469 519 3,876,411 0.1 (6 minutes)................. 387,641
program--including records documenting
program.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Subpart F--Requirements Applying to Records That Must Be Established and Maintained
--------------------------------------------------------------------------------------------------------------------------------------------------------
507.200 through 507.215; general 7,469 519 3,876,411 0.1 (6 minutes)................. 387,641
requirements, 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.................................... ................. ................. 11,635,372 ................................ 1,163,258
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Total hours have been rounded.
[[Page 49546]]
Table 4--Estimated Annual Third-Party Disclosure Burden: Human Foods \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of disclosures per Total annual Average burden per disclosure Total hours
respondents respondent disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
117.201(e); disclosure of food 37,134 1 37,134 0.25 (15 minutes)............. 9,284
manufacturing facility address.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 5--Estimated Annual Third-Party Disclosure Burden: Animal Food \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of disclosures per Total annual Average burden per disclosure Total hours
respondents respondent disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
507.27(b); labeling for the animal food 330 10 3,300 0.25 (15 minutes)............... 825
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 1,120 4 4,480 1............................... 4,480
labels.
507.7(e)(2); change address on labeling 974 1 974 1............................... 974
(sales documents) for qualified facilities.
507.25(a)(2); animal food, including raw 373 312 116,376 0.01 (36 seconds)............... 1,163.76
materials, other ingredients, and rework, is
accurately identified.
507.28(b); holding and distribution of human 40,798 2 81,596 0.25 (15 minutes)............... 20,399
food byproducts for use as animal food.
----------------------------------------------------------------------------------------------------------
Total.................................... ................. ................. ................. ................................ 27,841.76
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 slight adjustments to reflect a
decrease in third-party disclosure burden associated with animal food.
In this submission we provide a cumulative estimate for related
disclosure activities that we had previously accounted for separately.
Dated: August 31, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19116 Filed 9-2-21; 8:45 am]
BILLING CODE 4164-01-P
