Document ID: FDA-2013-N-0557-0010
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarket Surveillance of Medical Devices
Posted Date: 2022-11-07T05:00Z

[Federal Register Volume 87, Number 214 (Monday, November 7, 2022)]
[Notices]
[Pages 67045-67046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24232]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0557]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) 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 December 7, 2022.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. 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 0910-0449. Also include the FDA docket 
number found in brackets in the heading of this document.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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.
    In the Federal Register of May 27, 2022 (87 FR 32169), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
      21 CFR part/activity           Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       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
                                 -------------------------------------------------------------------------------
    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

[[Page 67046]]

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)).

                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                     Number of                        Average
      21 CFR part/activity           Number of      records per    Total annual     burden 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........................
                                 -------------------------------------------------------------------------------
    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 145 responses. We believe these adjustments 
more accurately reflect the current number of requests associated with 
postmarket surveillance of medical devices.

    Dated: November 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24232 Filed 11-4-22; 8:45 am]
BILLING CODE 4164-01-P