[Federal Register Volume 84, Number 118 (Wednesday, June 19, 2019)]
[Notices]
[Pages 28554-28555]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13004]


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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 or Agency) 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 of 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 August 19, 2019.

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 August 19, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of August 19, 2019. 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be 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 https://www.regulations.gov. 
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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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.

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: Under the PRA (44 U.S.C. 3501-3520), 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

[[Page 28555]]

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 Sec.  822.38 (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
     Activity/21 CFR section         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per 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
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    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
     Activity/21 CFR section         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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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: June 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13004 Filed 6-18-19; 8:45 am]
BILLING CODE 4164-01-P


