Notice2022-27023
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 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
December 13, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 238 (Tuesday, December 13, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 238 (Tuesday, December 13, 2022)]
[Notices]
[Pages 76199-76200]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-27023]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-2544]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Quality System
Regulation
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by January 12, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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 0910-0073. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#e5b5b7a4b691848383a5838184cb8d8d96cb828a93"><span class="__cf_email__" data-cfemail="7a2a283b290e1b1c1c3a1c1e1b54121209541d150c">[email protected]</span></a>.
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.
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 current good
manufacturing practice (CGMP) and assure that the device will be safe
and effective and otherwise in compliance with the FD&C Act.
The quality system regulation (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.
In the Federal Register of August 22, 2022 (87 FR 51433), we
published a 60-day notice soliciting 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 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 and 29,424 1 29,424 2 58,848
Traceability--Subpart F......
Production and Process 29,424 1 29,424 31 912,144
Controls--Subpart G..........
Acceptance Activities--Subpart 29,424 1 29,424 6 176,544
H............................
Nonconforming Product; 29,424 1 29,424 23 676,752
Corrective and Preventative
Action--Subparts I And J.....
Labeling and Packaging 29,424 1 29,424 3 88,272
Controls--Subpart K..........
Handling, Storage, 29,424 1 29,424 15 441,360
Distribution, and
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-- 29,424 1 29,424 1 29,424
section 820.250--Subpart O...
---------------------------------------------------------------------------------
Total..................... ............... ............... .............. .............. 10,239,552
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 76200]]
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: December 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27023 Filed 12-12-22; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on December 13, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.