Document ID: FDA-2013-N-0557-0007
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: 2019-10-24T04:00Z

[Federal Register Volume 84, Number 206 (Thursday, October 24, 2019)]
[Notices]
[Pages 57029-57030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23205]

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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: Fax written comments on the collection of information by 
November 25, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0449. 
Also include the FDA docket number found in brackets in the heading of 
this document.

[[Page 57030]]

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, 
PRAStaff@fda.hhs.gov.

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 
Sec. Sec.  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 Sec.  822.38. Respondents to this 
collection of information are those manufacturers that require PS of 
their products.
    In the Federal Register of June 19, 2019 (84 FR 28554), 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
     Activity/21 CFR section         Number of    responses  per   Total annual     burden per      Total hours
                                    respondents      respondent      responses       response
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PS submission (822.9 and 822.10)              25               1              25             120           3,000
Changes to PS plan after                       9               1               9              40             360
 approval (822.21)..............
Changes to PS plan for a device                6               1               6               8              48
 that is no longer marketed
 (822.28).......................
Waiver (822.29).................               1               1               1              40              40
Exemption request (822.30)......              16               1              16              40             640
Periodic reports (822.38).......              25               3              75              40           3,000
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           7,088
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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. 
Sections 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)).

                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                     Number of                        Average
     Activity/21 CFR section         Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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Manufacturer records (822.31)...              25               1              25              20             500
Investigator records (822.32)...              75               1              75               5             375
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    Total.......................  ..............  ..............  ..............  ..............             875
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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.
    Our estimated burden for the information collection reflects a 
decrease of 29,982 hours. We attribute this adjustment to a decrease in 
the number of submissions we received over the last few years.

    Dated: October 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23205 Filed 10-23-19; 8:45 am]
 BILLING CODE 4164-01-P