Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarket Surveillance of Medical Devices, 28554-28555 [2019-13004]
Download as PDF
<![CDATA[
28554
Federal Register / Vol. 84, No. 118 / Wednesday, June 19, 2019 / Notices
available to the FTC information or
subsequent compliance reports, as
requested.
Part VI is a provision ‘‘sun-setting’’
the order after twenty (20) years, with
certain exceptions.
The purpose of this analysis is to aid
public comment on the proposed order.
It is not intended to constitute an
official interpretation of the complaint
or proposed order, or to modify in any
way the proposed order’s terms.
By direction of the Commission.
April J. Tabor,
Acting Secretary.
[FR Doc. 2019–13003 Filed 6–18–19; 8:45 am]
BILLING CODE 6750–01–P
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.
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
jbell on DSK3GLQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:06 Jun 18, 2019
Jkt 247001
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
PO 00000
Frm 00096
Fmt 4703
Sfmt 4703
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/201523389.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
E:\FR\FM\19JNN1.SGM
19JNN1
28555
Federal Register / Vol. 84, No. 118 / Wednesday, June 19, 2019 / Notices
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
§ 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
Number of
respondents
Activity/21 CFR section
Number of
responses per
respondent
Total annual
responses
Average
burden
per response
Total hours
PS submission (822.9 and 822.10) .....................................
Changes to PS plan after approval (822.21) .......................
Changes to PS plan for a device that is no longer marketed (822.28) ..................................................................
Waiver (822.29) ...................................................................
Exemption request (822.30) ................................................
Periodic reports (822.38) .....................................................
25
9
1
1
25
9
120
40
3,000
360
6
1
16
25
1
1
1
3
6
1
16
75
8
40
40
40
48
40
640
3,000
Total ..............................................................................
........................
........................
........................
........................
7,088
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
Number of
respondents
Activity/21 CFR section
Total annual
responses
Average
burden
per response
Total hours
Manufacturer records (822.31) ............................................
Investigator records (822.32) ...............................................
25
75
1
1
25
75
20
5
500
375
Total ..............................................................................
........................
........................
........................
........................
875
1 There
jbell on DSK3GLQ082PROD with NOTICES
Number of
responses per
respondent
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
VerDate Sep<11>2014
19:06 Jun 18, 2019
Jkt 247001
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
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0823]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Format and
Content Requirements for Over-theCounter Drug Product Labeling
AGENCY:
Food and Drug Administration,
HHS.
Frm 00097
Fmt 4703
Sfmt 4703
E:\FR\FM\19JNN1.SGM
19JNN1
]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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,
[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
[[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
----------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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
----------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Manufacturer records (822.31)... 25 1 25 20 500
Investigator records (822.32)... 75 1 75 5 375
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 875
----------------------------------------------------------------------------------------------------------------
\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
