Document ID: FDA-2016-N-2544-0012
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice; Quality System Regulation
Posted Date: 2022-08-22T04:00Z

[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]

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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 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\
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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