Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Reports of Corrections and Removals, 51451-51453 [2020-18269]
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Federal Register / Vol. 85, No. 162 / Thursday, August 20, 2020 / Notices
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.
SUMMARY:
Submit written comments
(including recommendations) on the
collection of information by September
21, 2020.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0497. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10:00 a.m.–12:00 p.m.,
11601 Landsdown St., North Bethesda,
MD 20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Focus Groups as Used by the Food and
Drug Administration (All FDARegulated Products)
OMB Control Number 0910–0497—
Extension
FDA conducts focus group interviews
on a variety of topics involving FDAregulated products, including drugs,
biologics, devices, food, tobacco, and
veterinary medicine.
Focus groups provide an important
role in gathering information because
they allow for a more indepth
understanding of consumers’ attitudes,
beliefs, motivations, and feelings than
do quantitative studies. Focus groups
serve the narrowly defined need for
direct and informal opinion on a
specific topic and as a qualitative
research tool have three major purposes:
• To obtain consumer information
that is useful for developing variables
and measures for quantitative studies,
• to better understand consumers’
attitudes and emotions in response to
topics and concepts, and
• to further explore findings obtained
from quantitative studies.
51451
FDA will use focus group findings to
test and refine their ideas but will
generally conduct further research
before making important decisions such
as adopting new policies and allocating
or redirecting significant resources to
support these policies.
Respondents to this collection of
information will include members of the
general public, healthcare professionals,
the industry, and other stakeholders
who are related to a product under
FDA’s jurisdiction. Inclusion and
exclusion criteria will vary depending
on the research topic.
In the Federal Register of January 8,
2020 (85 FR 916), we published a 60day notice requesting public comment
on the proposed collection of
information. FDA received three
comments. FDA thanks the commenters
for their comments and provides our
response below. The first and second
comments strongly support the
proposed information collection related
to focus groups used by the FDA. The
third comment was not responsive to
the four collection of information topics
solicited and therefore will not be
discussed in this document.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Focus Group Interviews .......................................................
8,800
1
8,800
1.75
15,400
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: August 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–18243 Filed 8–19–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices;
Reports of Corrections and Removals
Food and Drug Administration,
HHS.
jbell on DSKJLSW7X2PROD with NOTICES
ACTION:
Notice.
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.
SUMMARY:
VerDate Sep<11>2014
18:01 Aug 19, 2020
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Frm 00049
Fmt 4703
Sfmt 4703
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0359. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
[Docket No. FDA–2016–N–4620]
AGENCY:
Submit written comments
(including recommendations) on the
collection of information by September
21, 2020.
DATES:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
E:\FR\FM\20AUN1.SGM
20AUN1
51452
Federal Register / Vol. 85, No. 162 / Thursday, August 20, 2020 / Notices
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Medical Devices; Reports of Corrections
and Removals—21 CFR part 806
OMB Control Number 0910–0359—
Extension
FDA is requesting approval for the
collection of information pertaining to
reports of corrections and removals
required under part 806 (21 CFR part
806), which implements section 519(g)
of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 360i(g)), as
amended by the Food and Drug
Administration Modernization Act of
1997 (Pub. L. 105–115).
Under § 806.10 (21 CFR 806.10),
within 10 working days of initiating any
action to correct or remove a device to
reduce a risk to health posed by the
device or to remedy a violation of the
FD&C Act caused by the device that may
present a risk to health, device
manufacturers or importers must submit
a written report to FDA of the correction
or removal.
Under § 806.20(a) (21 CFR 806.20(a)),
device manufacturers or importers that
initiate a correction or removal that is
not required to be reported to FDA must
keep a record of the correction or
removal.
In the Federal Register of December
20, 2016 (81 FR 92603), FDA published
a final rule titled ‘‘Postmarketing Safety
Reporting for Combination Products.’’
This final rule describes the
postmarketing safety reporting
requirements that apply when two or
more different types of regulated
medical products (drugs, devices, and/
or biological products, which are
referred to as ‘‘constituent parts’’ of a
combination product) comprise a
combination product and the
combination product or its constituent
parts have received FDA marketing
authorization. PMSR is approved under
OMB control number 0910–0834.
Under § 4.102(c)(1)(iii) (21 CFR
4.102(c)(1)(iii)), combination product
applicants whose combination products
received marketing authorization under
a BLA, NDA, or ANDA and include a
device constituent part must also submit
correction or removal reports as
described in § 806.10 and comply with
recordkeeping requirements as
described in § 806.20.
Under § 4.105(b) (21 CFR 4.105(b)),
combination product applicants must
maintain records relating to their
postmarketing safety reports for
whichever is the longest required
recordkeeping period under the PMSR
requirements applicable to the
combination product applicant under
§ 4.102.
The information collected in the
reports of corrections and removals will
be used by FDA to identify marketed
devices that have serious problems and
to ensure that defective devices are
removed from the market. This will
assure that FDA has current and
complete information regarding these
corrections and removals to determine
whether recall action is adequate.
Failure to collect this information
would prevent FDA from receiving
timely information about devices that
may have a serious effect on the health
of users of the devices.
Reports of corrections and removals
may be submitted to FDA via mail or
using FDA’s Electronic Submission
Gateway (ESG). We estimate that
approximately 50 percent of submitters
will use the ESG. Our estimate of the
reporting and recordkeeping burden is
based on Agency records and our
experience with this program, as well as
similar programs that utilize FDA’s ESG.
For respondents who submit
corrections and removals using the
electronic process, the operating and
maintenance costs associated with this
information collection are
approximately $50 per year to purchase
a digital verification certificate
(certificate must be valid for 1 to 3
years). This burden may be minimized
if the respondent has already purchased
a verification certificate for other
electronic submissions to FDA.
However, FDA is assuming that all
respondents who submit corrections
and removals using the electronic
process will be establishing a new
WebTrader account and purchasing a
digital verification certificate. We
therefore estimate the total operating
and maintenance costs to be $25,850
annually (517 respondents × $50).
In the Federal Register of February
21, 2020 (85 FR 10168), we published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received. We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
(21 CFR part)
Number of
respondents
Electronic process setup 3 .......................
Submission of corrections and removals
(part 806) ..............................................
4.102(c)(1)(iii) Submitting correction or
removal reports ....................................
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours 2
Total operating
and
maintenance
costs
517
1
517
3.08
1,592
$25,850
1,033
1
1,033
10
10,330
........................
20
1
20
10
200
........................
1 There
are no capital costs associated with this collection of information.
may not sum due to rounding.
estimate that approximately 50 percent of respondents will submit corrections and removals using the electronic process. The actual burden hours for setup of the electronic process listed in the reporting burden table are divided by 3 to avoid double counting in the Office of Information and Regulatory Affairs Consolidated Information System. However, the one-time Average Burden per Response is 9.25 hours, resulting in
a total one-time burden of 4,782 hours for the setup of the electronic process.
2 Totals
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3 We
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity
(21 CFR Part)
Number of
recordkeepers
Records of corrections and removals (part 806) .................
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Number of
records per
recordkeeper
93
Fmt 4703
Sfmt 4703
Total annual
records
1
E:\FR\FM\20AUN1.SGM
93
20AUN1
Average
burden per
recordkeeping
10
Total hours 2
930
51453
Federal Register / Vol. 85, No. 162 / Thursday, August 20, 2020 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Activity
(21 CFR Part)
Number of
recordkeepers
4.105(b) additional recordkeeping by device-led combination products .....................................................................
Number of
records per
recordkeeper
279
Total annual
records
0.45
126
Average
burden per
recordkeeping
0.5
Total hours 2
63
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Totals may not sum due to rounding.
New information technology
applications have allowed us to more
accurately calculate the number of
registrants of medical device facilities
that submit information electronically.
Therefore, there is a 50 percent
reduction in the number of respondents
who will submit corrections and
removals using the electronic process.
In addition, under OMB control
number 0910–0834 (‘‘Postmarketing
Safety Reporting for Combination
Products’’), an additional 200 hours
have been added to the annual reporting
burden and an additional 63 hours have
been added to the annual recordkeeping
burden to comply with the PMSR
requirements.
We have therefore revised the number
of respondents to the information
collection. This adjustment has resulted
in a 1,293-hour decrease of the
estimated burden.
Dated: August 14, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–18269 Filed 8–19–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0008]
Circulatory System Devices Panel of
the Medical Devices Advisory
Committee; Notice of Meeting
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Circulatory System
Devices Panel of the Medical Devices
Advisory Committee. The general
function of the committee is to provide
advice and recommendations to the
Agency on FDA’s regulatory issues. The
meeting will be open to the public.
DATES: The meeting will take place
virtually on October 7, 2020, from 9 a.m.
Eastern Time to 6 p.m. Eastern Time.
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:01 Aug 19, 2020
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Please note that due to the
impact of the COVID–19 pandemic, all
meeting participants will be joining this
advisory committee meeting via an
online teleconferencing platform.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FOR FURTHER INFORMATION CONTACT:
Aden Asefa, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5214, Silver Spring,
MD 20993–0002, aden.asefa@
fda.hhs.gov, 301–796–0400, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before the meeting.
SUPPLEMENTARY INFORMATION: Agenda:
The meeting presentations will be
heard, viewed, captioned, and recorded
through an online teleconferencing
platform. On October 7, 2020, the
committee will discuss, make
recommendations, and vote on
information regarding the premarket
approval application (PMA) for the
TransMedics Organ Care System
(OCS)—Heart, by TransMedics, Inc. The
proposed Indication for Use for the
TransMedics OCS—Heart, as stated in
the PMA, is as follows:
The TransMedics OCS Heart System
is a portable ex-vivo organ perfusion and
monitoring system indicated for the
resuscitation, preservation, and
assessment of donor hearts with one or
more of the following characteristics for
transplantation into a potential recipient
ADDRESSES:
PO 00000
Frm 00051
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in a near-physiologic, normothermic,
and beating state:
• Expected cross-clamp or ischemic
time ≥4 hours due to donor or
recipient characteristics (e.g., donorrecipient geographical distance,
expected recipient surgical time)
• Donor Age ≥55 years
• Donors with history cardiac arrest and
downtime ≥20 minutes
• Donor history of alcohol use
• Donor LV Ejection Fraction ≤50
percent but ≥40 percent
• Donor history of Left Ventricular
Hypertrophy (septal or posterior wall
thickness of >12 and ≤16 millimeters)
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available on FDA’s
website at the time of the advisory
committee meeting, and the background
material will be posted on FDA’s
website after the meeting. Background
material and the link to the online
teleconference meeting room will be
available at https://www.fda.gov/
advisory-committees/circulatory-systemdevices-panel/2020-meeting-materialscirculatory-system-devices-panel. Select
the link for the 2020 Meeting Materials.
The meeting will include slide
presentations with audio components to
allow the presentation of materials in a
manner that most closely resembles an
in-person advisory committee meeting.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before October 1, 2020.
Oral presentations from the public will
be scheduled on October 7, 2020,
between approximately 1 p.m. Eastern
Time and 2 p.m. Eastern Time. Those
individuals interested in making formal
oral presentations should notify the
contact person (see FOR FURTHER
INFORMATION CONTACT). The notification
should include a brief statement of the
general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
E:\FR\FM\20AUN1.SGM
20AUN1
]]>Agencies
[Federal Register Volume 85, Number 162 (Thursday, August 20, 2020)]
[Notices]
[Pages 51451-51453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18269]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-4620]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Devices;
Reports of Corrections and Removals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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: Submit written comments (including recommendations) on the
collection of information by September 21, 2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0359. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD
[[Page 51452]]
20852, 301-796-5733, [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.
Medical Devices; Reports of Corrections and Removals--21 CFR part 806
OMB Control Number 0910-0359--Extension
FDA is requesting approval for the collection of information
pertaining to reports of corrections and removals required under part
806 (21 CFR part 806), which implements section 519(g) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360i(g)), as amended
by the Food and Drug Administration Modernization Act of 1997 (Pub. L.
105-115).
Under Sec. 806.10 (21 CFR 806.10), within 10 working days of
initiating any action to correct or remove a device to reduce a risk to
health posed by the device or to remedy a violation of the FD&C Act
caused by the device that may present a risk to health, device
manufacturers or importers must submit a written report to FDA of the
correction or removal.
Under Sec. 806.20(a) (21 CFR 806.20(a)), device manufacturers or
importers that initiate a correction or removal that is not required to
be reported to FDA must keep a record of the correction or removal.
In the Federal Register of December 20, 2016 (81 FR 92603), FDA
published a final rule titled ``Postmarketing Safety Reporting for
Combination Products.'' This final rule describes the postmarketing
safety reporting requirements that apply when two or more different
types of regulated medical products (drugs, devices, and/or biological
products, which are referred to as ``constituent parts'' of a
combination product) comprise a combination product and the combination
product or its constituent parts have received FDA marketing
authorization. PMSR is approved under OMB control number 0910-0834.
Under Sec. 4.102(c)(1)(iii) (21 CFR 4.102(c)(1)(iii)), combination
product applicants whose combination products received marketing
authorization under a BLA, NDA, or ANDA and include a device
constituent part must also submit correction or removal reports as
described in Sec. 806.10 and comply with recordkeeping requirements as
described in Sec. 806.20.
Under Sec. 4.105(b) (21 CFR 4.105(b)), combination product
applicants must maintain records relating to their postmarketing safety
reports for whichever is the longest required recordkeeping period
under the PMSR requirements applicable to the combination product
applicant under Sec. 4.102.
The information collected in the reports of corrections and
removals will be used by FDA to identify marketed devices that have
serious problems and to ensure that defective devices are removed from
the market. This will assure that FDA has current and complete
information regarding these corrections and removals to determine
whether recall action is adequate. Failure to collect this information
would prevent FDA from receiving timely information about devices that
may have a serious effect on the health of users of the devices.
Reports of corrections and removals may be submitted to FDA via
mail or using FDA's Electronic Submission Gateway (ESG). We estimate
that approximately 50 percent of submitters will use the ESG. Our
estimate of the reporting and recordkeeping burden is based on Agency
records and our experience with this program, as well as similar
programs that utilize FDA's ESG.
For respondents who submit corrections and removals using the
electronic process, the operating and maintenance costs associated with
this information collection are approximately $50 per year to purchase
a digital verification certificate (certificate must be valid for 1 to
3 years). This burden may be minimized if the respondent has already
purchased a verification certificate for other electronic submissions
to FDA. However, FDA is assuming that all respondents who submit
corrections and removals using the electronic process will be
establishing a new WebTrader account and purchasing a digital
verification certificate. We therefore estimate the total operating and
maintenance costs to be $25,850 annually (517 respondents x $50).
In the Federal Register of February 21, 2020 (85 FR 10168), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received. We estimate the
burden of this collection of information as follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Number of Total annual Average Total hours operating and
Activity (21 CFR part) respondents responses per responses burden per \2\ maintenance
respondent response costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Electronic process setup \3\............................ 517 1 517 3.08 1,592 $25,850
Submission of corrections and removals (part 806)....... 1,033 1 1,033 10 10,330 ..............
4.102(c)(1)(iii) Submitting correction or removal 20 1 20 10 200 ..............
reports................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.
\2\ Totals may not sum due to rounding.
\3\ We estimate that approximately 50 percent of respondents will submit corrections and removals using the electronic process. The actual burden hours
for setup of the electronic process listed in the reporting burden table are divided by 3 to avoid double counting in the Office of Information and
Regulatory Affairs Consolidated Information System. However, the one-time Average Burden per Response is 9.25 hours, resulting in a total one-time
burden of 4,782 hours for the setup of the electronic process.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity (21 CFR Part) Number of records per Total annual burden per Total hours
recordkeepers recordkeeper records recordkeeping \2\
----------------------------------------------------------------------------------------------------------------
Records of corrections and 93 1 93 10 930
removals (part 806)............
[[Page 51453]]
4.105(b) additional 279 0.45 126 0.5 63
recordkeeping by device-led
combination products...........
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Totals may not sum due to rounding.
New information technology applications have allowed us to more
accurately calculate the number of registrants of medical device
facilities that submit information electronically. Therefore, there is
a 50 percent reduction in the number of respondents who will submit
corrections and removals using the electronic process.
In addition, under OMB control number 0910-0834 (``Postmarketing
Safety Reporting for Combination Products''), an additional 200 hours
have been added to the annual reporting burden and an additional 63
hours have been added to the annual recordkeeping burden to comply with
the PMSR requirements.
We have therefore revised the number of respondents to the
information collection. This adjustment has resulted in a 1,293-hour
decrease of the estimated burden.
Dated: August 14, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-18269 Filed 8-19-20; 8:45 am]
BILLING CODE 4164-01-P
