Notice2022-11412
Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarket Surveillance of Medical Devices
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
May 27, 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 an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements for postmarket surveillance of medical devices.
Full Text
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<title>Federal Register, Volume 87 Issue 103 (Friday, May 27, 2022)</title>
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[Federal Register Volume 87, Number 103 (Friday, May 27, 2022)]
[Notices]
[Pages 32169-32171]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-11412]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0557]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Postmarket Surveillance of Medical Devices
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 an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
requirements for postmarket surveillance of medical devices.
DATES: Submit either electronic or written comments on the collection
of information by July 26, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before July 26, 2022. 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 July 26, 2022. 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.
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 information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2013-N-0557 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Postmarket Surveillance of
Medical Devices.'' 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
[[Page 32170]]
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#cb9b998a98bfaaadad8badafaae5a3a3b8e5aca4bd"><span class="__cf_email__" data-cfemail="3d6d6f7c6e495c5b5b7d5b595c1355554e135a524b">[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.
Postmarket Surveillance of Medical Devices--21 CFR Part 822
OMB Control Number 0910-0449--Extension
Section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360l) authorizes FDA to require a manufacturer to conduct postmarket
surveillance (PS) of any device that meets the criteria set forth in
the statute. The PS regulation establishes procedures that FDA uses to
approve and disapprove PS plans. The regulation provides instructions
to manufacturers, so they know what information is required in a PS
plan submission. FDA reviews PS plan submissions in accordance with 21
CFR 822.15 through 822.19 of the regulation, which describe the grounds
for approving or disapproving a PS plan. In addition, the PS regulation
provides instructions to manufacturers to submit interim and final
reports in accordance with 21 CFR 822.38. Respondents to this
collection of information are those manufacturers that require PS of
their products.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR part/activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Sec. Sec. 822.9 and 822.10; 5 1 5 120 600
PS submission..................
Sec. 822.21; Changes to PS 9 1 9 40 360
plan after approval............
Sec. 822.28; Changes to PS 1 1 1 8 8
plan for a device that is no
longer marketed................
Sec. 822.29; Waiver........... 0 0 0 40 0
Sec. 822.30; Exemption request 0 0 0 40 0
Sec. 822.38; Periodic reports. 17 3 51 40 2,040
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Total....................... .............. .............. .............. .............. 3,008
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Explanation of Reporting Burden Estimate: The burden captured in
table 1 is based on the data from FDA's internal tracking system. 21
CFR 822.26, 822.27, and 822.34 do not constitute information collection
subject to review under the PRA because it entails no burden other than
that necessary to identify the respondent, the date, the respondent's
address, and the nature of the instrument (see 5 CFR 1320.3(h)(1)).
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Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
21 CFR part/activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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Sec. 822.31; Manufacturer 5 1 5 20 100
records........................
Sec. 822.32; Investigator 15 1 15 5 75
records........................
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Total....................... .............. .............. .............. .............. 175
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Explanation of Recordkeeping Burden Estimate: FDA expects that at
least some of the manufacturers will be able to satisfy the PS
requirement using information or data they already have. For purposes
of calculating burden, however, FDA has assumed that each PS order can
only be satisfied by a 3-year clinically based surveillance plan, using
three investigators. These estimates are based on FDA's knowledge and
experience with PS.
We have adjusted our burden estimate, which has resulted in a
decrease to the currently approved burden. Our estimated burden for the
information collection reflects an overall decrease of 4,780 hours and
a corresponding decrease of 13 responses. We believe these adjustments
more accurately reflect the current number of requests associated with
postmarket surveillance of medical devices.
Dated: May 23, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-11412 Filed 5-26-22; 8:45 am]
BILLING CODE 4164-01-P
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