[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)]
[Notices]
[Pages 62142-62143]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21554]


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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

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 October 
11, 2016.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written

[[Page 62143]]

comments be faxed to the Office of Information and Regulatory Affairs, 
OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to 
[email protected]. 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.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, [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--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 part 822 
(21 CFR part 822) in 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 who require postmarket surveillance of their products.
    In the Federal Register of April 28, 2016 (81 FR 25409), 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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Postmarket surveillance                      131               1             131             120          15,720
 submission (Sec.  Sec.   822.9
 and 822.10)....................
Changes to PS plan after                      15               1              15              40             600
 approval (Sec.   822.21).......
Changes to PS plan for a device               80               1              80               8             640
 that is no longer marketed
 (Sec.   822.28)................
Waiver (Sec.   822.29)..........               1               1               1              40              40
Exemption request (Sec.                       16               1              16              40             640
 822.30)........................
Periodic reports (Sec.   822.38)             131               3             393              40          15,720
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          33,360
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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 of this document 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 respondents 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 (Sec.                   131               1             131              20           2,620
 822.31)........................
Investigator records (Sec.                   393               1             393               5           1,965
 822.32)........................
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    Total.......................  ..............  ..............  ..............  ..............           4,585
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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 postmarket surveillance.

    Dated: September 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21554 Filed 9-7-16; 8:45 am]
 BILLING CODE 4160-01-P