Notice2022-18072
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice; Quality System Regulation
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 22, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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).
Full Text
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<title>Federal Register, Volume 87 Issue 161 (Monday, August 22, 2022)</title>
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[Federal Register Volume 87, Number 161 (Monday, August 22, 2022)]
[Notices]
[Pages 51433-51435]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-18072]
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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.
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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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#9acac8dbc9eefbfcfcdafcfefbb4f2f2e9b4fdf5ec"><span class="__cf_email__" data-cfemail="9ececcdfcdeafff8f8def8faffb0f6f6edb0f9f1e8">[email protected]</span></a>.
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\
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Number of Average burden
21 CFR part 820; required Number of records per Total annual per Total hours
records recordkeepers recordkeeper records recordkeeping
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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
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\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
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