Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice; Quality System Regulation, 51433-51435 [2022-18072]
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51433
Federal Register / Vol. 87, No. 161 / Monday, August 22, 2022 / Notices
Industry and Food and Drug
Administration Staff; Center for Devices
and Radiological Health (CDRH)
Appeals Processes’’ (July 2019), there
are various processes by which appeals
requests regarding review of decisions
or actions by CDRH may be submitted
to the Agency. The guidance is available
for download from our website at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/center-devices-andradiological-health-cdrh-appealsprocesses. The guidance document
provides general format and content
recommendations in this regard,
discusses applicable regulations with
regard to the timing of such
submissions, and describes the
collection of information not expressly
specified under existing regulations
such as the submission of the request for
review, minor clarifications as part of
the request, and supporting information.
While CDRH already possesses in the
administrative file the information that
would form the basis of a decision on
a matter under appeal, the submission
of information as recommended in the
guidance regarding the appeal request
itself, as well as data and information
relied on by the requestor in the appeal,
will help facilitate timely resolution of
the decision under review. We are
accounting for burden respondents may
incur as a result of these Agency
recommendations in this collection
request. Additional information about
the CDRH appeals process is described
in the companion guidance entitled
‘‘Center for Devices and Radiological
Health (CDRH) Appeals Processes:
Questions and Answers About 517A—
Guidance for Industry and Food and
Drug Administration Staff’’ (March
2020), also available for download from
our website at https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/center-devicesand-radiological-health-cdrh-appealsprocesses-questions-and-answers-about517a.
In the Federal Register of February
18, 2022 (87 FR 9365) 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
CDRH Appeals Processes: Guidance for Industry and
FDA Staff
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Recommended format and content elements .....................
35
1
35
8
280
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We estimate 35 requests will be
submitted annually to review decisions
and actions by CDRH employees, we
attribute one respondent per
submission, and we assume each
request will take 8 hours to prepare.
Based on our evaluation of the
information collection since last OMB
approval, we have made no adjustments
to the currently approved burden
estimate.
Dated: August 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–18065 Filed 8–19–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–2544]
jspears on DSK121TN23PROD with NOTICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Current Good
Manufacturing Practice; Quality
System Regulation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
SUMMARY:
VerDate Sep<11>2014
18:17 Aug 19, 2022
Jkt 256001
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 recordkeeping
requirements related to the medical
devices current good manufacturing
practice (CGMP) quality system (QS)
regulation (CGMP/QS regulation).
DATES: Either electronic or written
comments on the collection of
information must be submitted by
October 21, 2022.
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
October 21, 2022. 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.
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Fmt 4703
Sfmt 4703
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
E:\FR\FM\22AUN1.SGM
22AUN1
jspears on DSK121TN23PROD with NOTICES
51434
Federal Register / Vol. 87, No. 161 / Monday, August 22, 2022 / Notices
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–N–2544 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Current
Good Manufacturing Practice; Quality
System Regulation.’’ 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-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
VerDate Sep<11>2014
18:17 Aug 19, 2022
Jkt 256001
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, 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
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.
Medical Devices: Current Good
Manufacturing Practice Quality System
Regulation—21 CFR Part 820
OMB Control Number 0910–0073—
Extension
As authorized under section 520(f) of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 360j(f)), the
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Fmt 4703
Sfmt 4703
Secretary of the Department of Health
and Human Services has issued
regulations requiring that the methods
used in, and the facilities and controls
used for, the manufacture,
preproduction design validation
(including a process to assess the
performance of a device, but not
including an evaluation of the safety
and effectiveness of a device), packing,
storage, and installation of a device
conform to CGMP, and assure that the
device will be safe and effective and
otherwise in compliance with the FD&C
Act.
The QSR under part 820 (21 CFR part
820) sets forth CGMP requirements
governing the design, manufacture,
packing, labeling, storage, installation,
and servicing of all finished medical
devices intended for human use. The
requirements cover purchasing and
service controls, clarify recordkeeping
for device failure and complaint
investigations, clarify requirements for
verifying/validating production
processes and process or product
changes, and clarify requirements for
product acceptance activities, quality
data evaluations, and corrections of
nonconforming product/quality
problems. In the Federal Register of
February 23, 2022 (87 FR 10119), we
proposed to incorporate by reference
International Organization for
Standardization 13485 (ISO 13485):
Medical devices—Quality Management
Systems—Requirements for Regulatory
Purposes, the 2016 edition, to the QSR
(RIN 0910–AH99), to align
implementation of requirements.
Information collection under the QSR
is intended to assist FDA in assuring the
safety of medical devices. Requirements
include documenting the establishment
of procedures and identifying required
records that assist FDA in determining
whether firms are in compliance with
CGMP. In particular, for example,
compliance with CGMP design control
requirements should decrease the
number of design-related device failures
that have resulted in deaths and serious
injuries. Records must be made
available for review or copying during
FDA inspection. The regulations in part
820 apply to approximately 29,424
respondents, based on current data
within our device registration and
listing database.
We estimate the burden of this
collection of information as follows:
E:\FR\FM\22AUN1.SGM
22AUN1
51435
Federal Register / Vol. 87, No. 161 / Monday, August 22, 2022 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR part 820; required records
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
QUALITY SYSTEM REQUIREMENTS—Subpart B ............
DESIGN CONTROLS—Subpart C ......................................
DOCUMENT CONTROLS—Subpart D ...............................
PURCHASING CONTROLS—Subpart E ............................
IDENTIFICATION & TRACEABILITY—Subpart F ...............
PRODUCTION & PROCESS CONTROLS—Subpart G .....
ACCEPTANCE ACTIVITIES—Subpart H ............................
NONCONFORMING PRODUCT; CORRECTIVE & PREVENTATIVE ACTION—Subparts I and J ........................
LABELING & PACKAGING CONTROLS—Subpart K ........
HANDLING, STORAGE, DISTRUBTION, & INSTALLATION—Subpart L ..............................................................
RECORDS—Subpart M .......................................................
SERVICING—Subpart N .....................................................
STATISTICAL TECHNIQUES—820.250—Subpart O .........
29,424
29,424
29,424
29,424
29,424
29,424
29,424
1
1
1
1
1
1
1
29,424
29,424
29,424
29,424
29,424
29,424
29,424
83
132
11
28
2
31
6
2,442,192
3,883,968
323,664
823,872
58,848
912,144
176,544
29,424
29,424
1
1
29,424
29,424
23
3
676,752
88,272
29,424
29,424
29,424
29,424
1
1
1
1
29,424
29,424
29,424
29,424
15
10
3
1
441,360
294,240
88,272
29,424
Totals ............................................................................
........................
........................
........................
........................
10,239,552
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
overall increase of 1,217,800 hours. We
made this adjustment to correspond
with an observed increase in
submissions relating to medical devices
and an increase in respondents in the
medical device industry since last OMB
review and approval of the information
collection.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: August 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
[FR Doc. 2022–18072 Filed 8–19–22; 8:45 am]
AGENCY:
BILLING CODE 4164–01–P
HHS.
Food and Drug Administration
[Docket Nos. FDA–2021–N–1222; FDA–
2015–N–3662; FDA–2013–N–1425; FDA–
2008–D–0530; FDA–2019–N–0482; FDA–
2021–N–1192; FDA–2018–N–4042; FDA–
2015–N–3815; FDA–2019–N–0721; and
FDA–2013–N–0013]
ACTION:
Food and Drug Administration,
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
jspears on DSK121TN23PROD with NOTICES
Title of collection
Food Labeling: Notification Procedures for Statements on Dietary Supplements ..................................................
Guidance for Reagents for Detection of Specific Novel Influenza A Viruses .........................................................
Mitigation Strategies to Protect Food Against Intentional Adulteration ...................................................................
Tropical Disease Priority Review Vouchers ............................................................................................................
Reporting Associated with New Animal Drug Applications and Veterinary Master Files .......................................
Substances Generally Recognized as Safe: Notification Procedure ......................................................................
Establishing and Maintaining Lists of U.S. Product Manufacturers/Processors With Interest in Exporting
CFSAN-Regulated Products ................................................................................................................................
Electronic Submission of Medical Device Registration and Listing ........................................................................
Accreditation of Third Party Certification Bodies to Conduct Food Safety Audits and Issue Certifications ...........
Sanitary Transportation of Human and Animal Food ..............................................................................................
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18:17 Aug 19, 2022
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E:\FR\FM\22AUN1.SGM
22AUN1
Date approval
expires
0910–0331
0910–0584
0910–0812
0910–0822
0910–0032
0910–0342
7/31/2025
7/31/2025
7/31/2025
7/31/2025
8/31/2025
8/31/2025
0910–0509
0910–0625
0910–0750
0910–0773
8/31/2025
8/31/2025
8/31/2025
8/31/2025
]]>Agencies
[Federal Register Volume 87, Number 161 (Monday, August 22, 2022)]
[Notices]
[Pages 51433-51435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18072]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-2544]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Current Good Manufacturing Practice; Quality System
Regulation
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 recordkeeping requirements
related to the medical devices current good manufacturing practice
(CGMP) quality system (QS) regulation (CGMP/QS regulation).
DATES: Either electronic or written comments on the collection of
information must be submitted by October 21, 2022.
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 October 21, 2022. 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
[[Page 51434]]
information submitted, marked and identified, as confidential, if
submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-N-2544 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Current Good Manufacturing
Practice; Quality System Regulation.'' 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: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[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 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.
Medical Devices: Current Good Manufacturing Practice Quality System
Regulation--21 CFR Part 820
OMB Control Number 0910-0073--Extension
As authorized under section 520(f) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 360j(f)), the Secretary of the
Department of Health and Human Services has issued regulations
requiring that the methods used in, and the facilities and controls
used for, the manufacture, preproduction design validation (including a
process to assess the performance of a device, but not including an
evaluation of the safety and effectiveness of a device), packing,
storage, and installation of a device conform to CGMP, and assure that
the device will be safe and effective and otherwise in compliance with
the FD&C Act.
The QSR under part 820 (21 CFR part 820) sets forth CGMP
requirements governing the design, manufacture, packing, labeling,
storage, installation, and servicing of all finished medical devices
intended for human use. The requirements cover purchasing and service
controls, clarify recordkeeping for device failure and complaint
investigations, clarify requirements for verifying/validating
production processes and process or product changes, and clarify
requirements for product acceptance activities, quality data
evaluations, and corrections of nonconforming product/quality problems.
In the Federal Register of February 23, 2022 (87 FR 10119), we proposed
to incorporate by reference International Organization for
Standardization 13485 (ISO 13485): Medical devices--Quality Management
Systems--Requirements for Regulatory Purposes, the 2016 edition, to the
QSR (RIN 0910-AH99), to align implementation of requirements.
Information collection under the QSR is intended to assist FDA in
assuring the safety of medical devices. Requirements include
documenting the establishment of procedures and identifying required
records that assist FDA in determining whether firms are in compliance
with CGMP. In particular, for example, compliance with CGMP design
control requirements should decrease the number of design-related
device failures that have resulted in deaths and serious injuries.
Records must be made available for review or copying during FDA
inspection. The regulations in part 820 apply to approximately 29,424
respondents, based on current data within our device registration and
listing database.
We estimate the burden of this collection of information as
follows:
[[Page 51435]]
Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR part 820; required Number of records per Total annual per Total hours
records recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
QUALITY SYSTEM REQUIREMENTS-- 29,424 1 29,424 83 2,442,192
Subpart B......................
DESIGN CONTROLS--Subpart C...... 29,424 1 29,424 132 3,883,968
DOCUMENT CONTROLS--Subpart D.... 29,424 1 29,424 11 323,664
PURCHASING CONTROLS--Subpart E.. 29,424 1 29,424 28 823,872
IDENTIFICATION & TRACEABILITY-- 29,424 1 29,424 2 58,848
Subpart F......................
PRODUCTION & PROCESS CONTROLS-- 29,424 1 29,424 31 912,144
Subpart G......................
ACCEPTANCE ACTIVITIES--Subpart H 29,424 1 29,424 6 176,544
NONCONFORMING PRODUCT; 29,424 1 29,424 23 676,752
CORRECTIVE & PREVENTATIVE
ACTION--Subparts I and J.......
LABELING & PACKAGING CONTROLS-- 29,424 1 29,424 3 88,272
Subpart K......................
HANDLING, STORAGE, DISTRUBTION, 29,424 1 29,424 15 441,360
& INSTALLATION--Subpart L......
RECORDS--Subpart M.............. 29,424 1 29,424 10 294,240
SERVICING--Subpart N............ 29,424 1 29,424 3 88,272
STATISTICAL TECHNIQUES--820.250-- 29,424 1 29,424 1 29,424
Subpart O......................
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Totals...................... .............. .............. .............. .............. 10,239,552
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Our estimated burden for the information collection reflects an
overall increase of 1,217,800 hours. We made this adjustment to
correspond with an observed increase in submissions relating to medical
devices and an increase in respondents in the medical device industry
since last OMB review and approval of the information collection.
Dated: August 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18072 Filed 8-19-22; 8:45 am]
BILLING CODE 4164-01-P
