Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking, 70634-70637 [2020-24541]
Download as PDF
<![CDATA[
70634
Federal Register / Vol. 85, No. 215 / Thursday, November 5, 2020 / Notices
Dated: November 2, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2020–24611 Filed 11–4–20; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; OCSE Stafford Act
Flexibilities Request Form (New
Collection)
Office of Child Support
Enforcement, Administration for
Children and Families, HHS.
ACTION: Request for Public Comment.
AGENCY:
The Office of Child Support
Enforcement (OCSE), Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services (HHS), seeks approval of a
standardized request form to collect
information from state and tribal title
IV–D child support agencies requesting
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
administrative flexibilities under the
Robert T. Stafford Disaster Relief and
Emergency Assistance Act (the ‘‘Stafford
Act’’), due to the COVID–19 pandemic.
DATES: Comments due within 60 days of
publication. In compliance with the
requirements of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
ACF is soliciting public comment on the
specific aspects of the information
collection described above.
ADDRESSES: Copies of the proposed
collection of information can be
obtained and comments may be
forwarded by emailing infocollection@
acf.hhs.gov. Alternatively, copies can
also be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research,
and Evaluation (OPRE), 330 C Street
SW, Washington, DC 20201, Attn: ACF
Reports Clearance Officer. All requests,
emailed or written, should be identified
by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: Due to the exceptional
impact of the COVID–19 pandemic,
state and tribal agencies operating child
support programs under title IV–D of
the Social Security Act have faced
significant operational and other
challenges in providing critical child
support services to families. Section 301
of the Stafford Act, 42 U.S.C. 5141,
provides that ‘‘Any Federal agency
charged with the administration of a
Federal assistance program may, if so
requested by the applicant State [or
Indian tribal government] or local
authorities, modify or waive, for a major
disaster, such administrative conditions
for assistance as would otherwise
prevent the giving of assistance under
such programs if the inability to meet
such conditions is a result of the major
disaster.’’ To communicate that child
support agencies may request relief
under the Stafford Act, on May 28,
2020, OCSE published Dear Colleague
Letter 20–04: Flexibilities for State and
Tribal Child Support Agencies during
COVID–19 Pandemic. OCSE seeks
approval of a standardized request form
to collect information from state and
tribal IV–D agencies requesting Stafford
Act administrative flexibilities, due to
the COVID–19 pandemic and according
to OCSE Dear Colleague Letter 20–04.
Respondents: State and tribal agencies
administering a child support program
under title IV–D of the Social Security
Act.
Annual Burden Estimates
Instrument
Total Number
of respondents
Total Number
of responses
per
respondent
Average
burden hours
per response
Total burden
hours
Annual burden
hours
OCSE Stafford Act Flexibilities Request Form ....................
114
3
1
342
114
Estimated Total Annual Burden
Hours: 114
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: 42 U.S.C. 5141.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–24592 Filed 11–4–20; 8:45 am]
BILLING CODE 4184–41–P
VerDate Sep<11>2014
21:11 Nov 04, 2020
Jkt 253001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–5569]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices;
Device Tracking
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
SUMMARY:
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
response to the notice. This notice
solicits comments on information
collection requirements for the tracking
of medical devices.
DATES: Submit either electronic or
written comments on the collection of
information by January 4, 2021.
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 January 4,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 4, 2021. 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
E:\FR\FM\05NON1.SGM
05NON1
Federal Register / Vol. 85, No. 215 / Thursday, November 5, 2020 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
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–
2017–N–5569 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Medical
Devices; Device Tracking.’’ 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, 240–402–7500.
• 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
VerDate Sep<11>2014
20:36 Nov 04, 2020
Jkt 253001
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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), 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
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
70635
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.
Medical Devices; Device Tracking—21
CFR Part 821
OMB Control Number 0910–0442—
Extension
Section 519(e)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
360i(e)(1)), as amended by Food and
Drug Administration Modernization Act
(Pub. L. 105–115), provides that FDA
may require by order that a
manufacturer adopt a method for
tracking a class II or III medical device,
if the device meets one of the three
following criteria: (1) The failure of the
device would be reasonably likely to
have serious adverse health
consequences, (2) the device is intended
to be implanted in the human body for
more than 1 year (referred to as a
‘‘tracked implant’’), or (3) the device is
life-sustaining or life-supporting
(referred to as a ‘‘tracked l/s–l/s device’’)
and is used outside a device user
facility.
Tracked device information is
collected to facilitate identifying the
current location of medical devices and
patients possessing those devices, to the
extent that patients permit the
collection of identifying information.
Manufacturers and FDA (where
necessary) use the data to: (1) Expedite
the recall of distributed medical devices
that are dangerous or defective and (2)
facilitate the timely notification of
patients or licensed practitioners of the
risks associated with the medical
device.
In addition, the regulations include
provisions for: (1) Exemptions and
variances; (2) system and content
requirements for tracking; (3)
obligations of persons other than device
manufacturers, e.g., distributors; (4)
records and inspection requirements; (5)
confidentiality; and (6) record retention
requirements.
Respondents for this collection of
information are medical device
E:\FR\FM\05NON1.SGM
05NON1
70636
Federal Register / Vol. 85, No. 215 / Thursday, November 5, 2020 / Notices
manufacturers, importers, and
distributors of tracked implants or
tracked l/s–l/s devices used outside a
device user facility. Distributors include
multiple and final distributors,
including hospitals.
The annual hourly burden for
respondents involved with medical
device tracking is estimated to be
615,380 hours per year. The burden
estimates cited in tables 1 through 3 are
based on the approximate number of
device tracking orders, 12 annually.
FDA estimates that approximately
22,000 respondents may be subject to
tracking reporting requirements.
Under § 821.25(a) (21 CFR 821.25(a)),
device manufacturers subject to FDA
tracking orders must adopt a tracking
method that can provide certain device,
patient, and distributor information to
FDA within 3 to 10 working days.
Assuming one occurrence per year, FDA
estimates it would take a firm 20 hours
to provide FDA with location data for
all tracked devices and 56 hours to
identify all patients and/or multiple
distributors possessing tracked devices.
Under § 821.25(d) manufacturers must
notify FDA of distributor
noncompliance with reporting
requirements. Based on the number of
audits manufacturers conduct annually,
FDA estimates it would receive no more
than one notice in any year, and that it
would take 1 hour per incident.
Under § 821.30(c)(2) (21 CFR
821.30(c)(2)), multiple distributors must
provide data on current users of tracked
devices, current device locations, and
other information, upon request from a
manufacturer or FDA. FDA has not
made such a request and is not aware of
any manufacturer making a request.
Assuming one multiple distributor
receives one request in a year from
either a manufacturer or FDA, and that
lists may be generated electronically,
the Agency estimates a burden of 1 hour
to comply.
Under § 821.30(d) distributors must
verify data or make required records
available for auditing, if a manufacturer
provides a written request. FDA’s
estimate of the burden for distributor
audit responses assumes that
manufacturers audit database entries for
5 percent of tracked devices distributed.
Each audited database entry prompts
one distributor audit response. Because
lists may be generated electronically,
FDA estimates a burden of 1 hour to
comply.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity; 21 CFR part
Total
annual
responses
Average
burden per
response
Total hours
Discontinuation of business—821.1(d) ........................
Exemption or variance—821.2 and 821.30(e) .............
Notification of failure to comply—821.25(d) ................
Multiple distributor data—821.30(c)(2) ........................
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
Total ......................................................................
..........................
............................
........................
..........................
4
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity; 21 CFR part
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total hours
Tracking information—821.25(a) .................................
Record of tracking data—821.25(b) ............................
Standard operating procedures—821.25(c) 2 ..............
Manufacturer data audit—821.25(c)(3) ........................
Multiple distributor data and distributor tracking
records—821.30(c)(2) and (d) ..................................
12
12
12
12
1
46,260
1
1,124
12
555,120
12
13,488
76
1
63
1
912
555,120
756
13,488
22,000
1
22,000
1
22,000
Total ......................................................................
..........................
............................
........................
..........................
592,276
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
burden.
2 One-time
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
khammond on DSKJM1Z7X2PROD with NOTICES
Activity; 21 CFR part
Acquisition of tracked devices and final distributor
data—821.30(a) and (b) ...........................................
Multiple distributor data and distributor tracking
records—821.30(c)(2) and (d) ..................................
Total ......................................................................
1 There
Number of
disclosures
per respondent
Total
annual
disclosures
Average
burden per
disclosure
22,000
1
22,000
1
22,000
1,100
1
1,100
1
1,100
..........................
............................
........................
..........................
23,100
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Sep<11>2014
20:36 Nov 04, 2020
Jkt 253001
PO 00000
Total hours
Frm 00061
Fmt 4703
Sfmt 4703
E:\FR\FM\05NON1.SGM
05NON1
Federal Register / Vol. 85, No. 215 / Thursday, November 5, 2020 / Notices
The burden estimate for this
information collection has not changed
since the last OMB approval.
Dated: October 30, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–24541 Filed 11–4–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1561]
Evaluating the Effect of the Opioid
Analgesics Risk Evaluation and
Mitigation Strategy Education Program
on Prescribing Behaviors and Patient
Outcomes—Exploring the Path
Forward for Assessment; Public
Workshop; Issues Paper; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
As part of the work by the
Federal Government to address the
opioid crisis, the Food and Drug
Administration (FDA or the Agency) is
announcing the following public
workshop entitled ‘‘Evaluating the
Effect of the Opioid Analgesics Risk
Evaluation and Mitigation Strategy
Education Program on Prescribing
Behaviors and Patient Outcomes—
Exploring the Path Forward for
Assessment.’’ The purpose of the public
workshop is to obtain scientific input on
methods to evaluate the Opioid
Analgesics Risk Evaluation and
Mitigation Strategy (OA REMS)
education program. To assist in the
workshop discussion, FDA is making
available an issues paper that provides
a brief overview of the REMS
background and challenges with
evaluating the REMS education
intervention.
DATES: The public workshop will be
held virtually and broadcast via webcast
only on December 11, 2020, from 9 a.m.
to 5 p.m., Eastern Time. Submit either
electronic or written comments on this
public workshop by February 11, 2021.
See the SUPPLEMENTARY INFORMATION
section for registration date and
information.
ADDRESSES: Please note that due to the
impact of the COVID–19 pandemic, all
meeting participants will be joining this
public workshop via an online
teleconferencing platform.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
20:36 Nov 04, 2020
Jkt 253001
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 February 11, 2021. The
https://www.regulations.gov electronic
filing system will accept comments
until 11:59 p.m. Eastern Time at the end
of February 11, 2021. 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–
2020–N–1561 for ‘‘Evaluating the Effect
of the Opioid Analgesics Risk
Evaluation and Mitigation Strategy
Education Program on Prescribing
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
70637
Behaviors and Patient Outcomes—
Exploring the Path Forward for
Assessment; Public Workshop; Issues
Paper; Request for Comments.’’
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, 240–402–7500.
• 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
FOR FURTHER INFORMATION CONTACT: Paul
Tran, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 4462, Silver Spring,
MD 20993–0002, 301–796–9029,
OAREMS@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\05NON1.SGM
05NON1
]]>Agencies
[Federal Register Volume 85, Number 215 (Thursday, November 5, 2020)]
[Notices]
[Pages 70634-70637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24541]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-5569]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices; Device Tracking
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 the
tracking of medical devices.
DATES: Submit either electronic or written comments on the collection
of information by January 4, 2021.
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 January 4, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 4, 2021. 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
[[Page 70635]]
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-2017-N-5569 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Devices; Device
Tracking.'' 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, 240-402-7500.
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.govinfo.gov/content/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, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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.
Medical Devices; Device Tracking--21 CFR Part 821
OMB Control Number 0910-0442--Extension
Section 519(e)(1) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360i(e)(1)), as amended by Food and Drug Administration
Modernization Act (Pub. L. 105-115), provides that FDA may require by
order that a manufacturer adopt a method for tracking a class II or III
medical device, if the device meets one of the three following
criteria: (1) The failure of the device would be reasonably likely to
have serious adverse health consequences, (2) the device is intended to
be implanted in the human body for more than 1 year (referred to as a
``tracked implant''), or (3) the device is life-sustaining or life-
supporting (referred to as a ``tracked l/s-l/s device'') and is used
outside a device user facility.
Tracked device information is collected to facilitate identifying
the current location of medical devices and patients possessing those
devices, to the extent that patients permit the collection of
identifying information. Manufacturers and FDA (where necessary) use
the data to: (1) Expedite the recall of distributed medical devices
that are dangerous or defective and (2) facilitate the timely
notification of patients or licensed practitioners of the risks
associated with the medical device.
In addition, the regulations include provisions for: (1) Exemptions
and variances; (2) system and content requirements for tracking; (3)
obligations of persons other than device manufacturers, e.g.,
distributors; (4) records and inspection requirements; (5)
confidentiality; and (6) record retention requirements.
Respondents for this collection of information are medical device
[[Page 70636]]
manufacturers, importers, and distributors of tracked implants or
tracked l/s-l/s devices used outside a device user facility.
Distributors include multiple and final distributors, including
hospitals.
The annual hourly burden for respondents involved with medical
device tracking is estimated to be 615,380 hours per year. The burden
estimates cited in tables 1 through 3 are based on the approximate
number of device tracking orders, 12 annually. FDA estimates that
approximately 22,000 respondents may be subject to tracking reporting
requirements.
Under Sec. 821.25(a) (21 CFR 821.25(a)), device manufacturers
subject to FDA tracking orders must adopt a tracking method that can
provide certain device, patient, and distributor information to FDA
within 3 to 10 working days. Assuming one occurrence per year, FDA
estimates it would take a firm 20 hours to provide FDA with location
data for all tracked devices and 56 hours to identify all patients and/
or multiple distributors possessing tracked devices.
Under Sec. 821.25(d) manufacturers must notify FDA of distributor
noncompliance with reporting requirements. Based on the number of
audits manufacturers conduct annually, FDA estimates it would receive
no more than one notice in any year, and that it would take 1 hour per
incident.
Under Sec. 821.30(c)(2) (21 CFR 821.30(c)(2)), multiple
distributors must provide data on current users of tracked devices,
current device locations, and other information, upon request from a
manufacturer or FDA. FDA has not made such a request and is not aware
of any manufacturer making a request. Assuming one multiple distributor
receives one request in a year from either a manufacturer or FDA, and
that lists may be generated electronically, the Agency estimates a
burden of 1 hour to comply.
Under Sec. 821.30(d) distributors must verify data or make
required records available for auditing, if a manufacturer provides a
written request. FDA's estimate of the burden for distributor audit
responses assumes that manufacturers audit database entries for 5
percent of tracked devices distributed. Each audited database entry
prompts one distributor audit response. Because lists may be generated
electronically, FDA estimates a burden of 1 hour to comply.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity; 21 CFR part Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Discontinuation of business-- 1 1 1 1 1
821.1(d)...................
Exemption or variance--821.2 1 1 1 1 1
and 821.30(e)..............
Notification of failure to 1 1 1 1 1
comply--821.25(d)..........
Multiple distributor data-- 1 1 1 1 1
821.30(c)(2)...............
-----------------------------------------------------------------------------------
Total................... ............... ................ .............. ............... 4
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity; 21 CFR part Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Tracking information-- 12 1 12 76 912
821.25(a)..................
Record of tracking data-- 12 46,260 555,120 1 555,120
821.25(b)..................
Standard operating 12 1 12 63 756
procedures--821.25(c) \2\..
Manufacturer data audit-- 12 1,124 13,488 1 13,488
821.25(c)(3)...............
Multiple distributor data 22,000 1 22,000 1 22,000
and distributor tracking
records--821.30(c)(2) and
(d)........................
-----------------------------------------------------------------------------------
Total................... ............... ................ .............. ............... 592,276
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ One-time burden.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity; 21 CFR part Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
----------------------------------------------------------------------------------------------------------------
Acquisition of tracked 22,000 1 22,000 1 22,000
devices and final
distributor data--821.30(a)
and (b)....................
Multiple distributor data 1,100 1 1,100 1 1,100
and distributor tracking
records--821.30(c)(2) and
(d)........................
-----------------------------------------------------------------------------------
Total................... ............... ................ .............. ............... 23,100
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 70637]]
The burden estimate for this information collection has not changed
since the last OMB approval.
Dated: October 30, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-24541 Filed 11-4-20; 8:45 am]
BILLING CODE 4164-01-P
