81 FR 25409 - Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarket Surveillance

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 82 (April 28, 2016)

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the 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.

[Federal Register Volume 81, Number 82 (Thursday, April 28, 2016)]
[Notices]
[Pages 25409-25411]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-09940]


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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 June 27, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential

[[Page 25410]]

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 http://www.regulations.gov. Submit both copies to the 
Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

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 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--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.
    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
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    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)).

[[Page 25411]]



                               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)........................
                                 -------------------------------------------------------------------------------
    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: April 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09940 Filed 4-27-16; 8:45 am]
BILLING CODE 4164-01-P