Agency Information Collection Activities; Proposed Collection; Comment Request; Unique Device Identification System, 37315-37317 [2019-16269]
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Federal Register / Vol. 84, No. 147 / Wednesday, July 31, 2019 / Notices
FDA is requesting the extension of
OMB approval for the collection of
information required under the statutory
mandate of sections 515A (21 U.S.C.
360e–1) and 520(m) of the FD&C Act.
In the Federal Register of March 12,
2019 (84 FR 8874), FDA published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity/section of FD&C Act, as amended by the
Food and Drug Administration
Safety and Innovation Act
(FDASIA) and the Cures Act
Pediatric Subpopulation and Patient Information—
515A(a)(2) of the FD&C Act .............................................
Exemption
from
Profit
Prohibition
Information—
520(m)(6)(A)(i) and (ii) of the FD&C Act ..........................
Request for Determination of Eligibility Criteria—613(b) of
FDASIA .............................................................................
ADN Notification—520(m)(6)(A)(iii) of the FD&C Act ..........
ADN Modification—520(m)(6)(C) of the FD&C Act .............
Total ..............................................................................
1 There
Dated: July 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–16244 Filed 7–30–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–4319]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Unique Device
Identification System
Food and Drug Administration,
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:
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Total hours
1
1
1
100
100
1
1
1
50
50
1
1
1
1
1
1
1
1
1
10
100
100
10
100
100
........................
........................
........................
........................
360
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response to the notice. This notice
solicits comments on information
collection associated with the Unique
Device Identification System.
DATES: Submit either electronic or
written comments on the collection of
information by September 30, 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 September 30,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of September 30, 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
HHS.
ACTION:
Average
burden per
response
Total annual
responses
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects a
decrease in the number of responses and
corresponding decrease of 1,010 hours
in the total burden since our last OMB
approval. We attribute this adjustment
to a decrease in the number of
submissions we received over the last
few years.
AGENCY:
Number of
responses per
respondent
Number of
respondents
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
PO 00000
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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–
2016–N–4319 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Unique
Device Identification System.’’ 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
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Federal Register / Vol. 84, No. 147 / Wednesday, July 31, 2019 / Notices
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
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Jkt 247001
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.
Unique Device Identification System—
21 CFR Parts 16, 801, 803, 806, 810,
814, 820, 821, 822, and 830
OMB Control Number 0910–0720—
Extension
In accordance with the Unique Device
Identification (UDI) system (see 21 CFR
part 801, subpart B), medical device
labelers, unless excepted, are required
to design and use medical device labels
and device packages that bear a UDI,
present dates on labels in a particular
format, and submit data concerning
each version or model of a device to the
Global Unique Device Identification
Database (GUDID) no later than the date
the label of the device must bear a UDI.
Once a device becomes subject to UDI
requirements, respondents will be
required to update the information
reported whenever the information
changes.
The recordkeeping, reporting, and
third-party disclosure requirements
referenced in this document are
imposed on any person who causes a
label to be applied to a device, or who
causes the label to be modified, with the
intent that the device will be
commercially distributed without any
subsequent replacement or modification
of the label. In most instances, the
labeler would be the device
manufacturer, but other types of labelers
include a specification developer, a
single-use device reprocessor, a
convenience kit assembler, a private
label distributor, a repackager, or a
relabeler. Respondents may also include
any private organization that applies for
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accreditation by FDA as an issuing
agency.
FDA has identified the following
requirements as having burdens that
must be accounted for under the PRA;
the burdens associated with these
requirements are summarized in the
table that follows:
Section 801.18 requires that whenever
a labeler of a medical device includes an
expiration date, a date of manufacture,
or any other date intended to be brought
to the attention of the user of the device,
the labeler must present the date on the
label in a format that meets the
requirements of this section.
Section 801.20 requires every medical
device label and package to bear a UDI.
Under § 801.35, any labeler of a
device that is not required to bear a UDI
on its label may include a UDI on the
label of that device and utilize the
GUDID.
Under § 801.45, any device that has to
be labeled with a UDI also has to bear
a permanent marking providing the UDI
on the device itself if the device is
intended for more than one use and
intended to be reprocessed before each
use.
Section 801.50 requires stand-alone
software to comply with specific
labeling requirements that identify the
software.
Section 801.55 authorizes additional,
case-by-case, labeling exceptions and
alternatives to standard UDI labeling
requirements.
If a labeler relabels or modifies a label
of a device that is required to bear a
UDI, under § 830.60 it has to keep a
record showing the relationship of the
original device identifier to the new
device identifier.
Section 830.110 requires an applicant
seeking initial FDA accreditation as a
UDI-issuing agency to furnish FDA an
application containing certain
information, materials, and supporting
documentation.
Under § 830.120, an FDA-accredited
issuing agency is required to disclose
information concerning its system for
the assignment of UDIs; maintain a list
of labelers that use its system for the
assignment of UDIs and provide FDA a
copy of such list; and upon request,
provide FDA with information
concerning a labeler that is employing
the issuing agency’s system for
assignment of UDIs.
Sections 830.310 and 830.320 require
the labeler to provide certain
information to the GUDID concerning
the labeler and each version or model of
a device required to be labeled with a
UDI, unless the labeler obtains a waiver.
Section 830.360 requires each labeler
to retain records showing all UDIs used
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Federal Register / Vol. 84, No. 147 / Wednesday, July 31, 2019 / Notices
to identify devices that must be labeled
with a UDI and the particular version or
model associated with each device
identifier, until 3 years after it ceases to
market a version or model of a device.
Respondents who are required to
submit data to the Agency under certain
other approved information collections
(listed below) are required to include
UDI data elements for the device that is
the subject of such information
collection. Addition of the UDI data
elements is included in this burden
estimate for the conforming
amendments in the following 21 CFR
parts:
Part 803—Medical Device Reporting
(OMB control number 0910–0437),
Part 806—Medical Devices; Reports of
Corrections and Removals (OMB control
number 0910–0359),
Part 814—Premarket Approval of
Medical Devices (OMB control number
0910–0231),
Part 820—Quality System Regulation
(OMB control number 0910–0073),
Part 821—Medical Device Tracking
Requirements (OMB control number
0910–0442), and
Part 822—Postmarket Surveillance
(OMB control number 0910–0449).
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL BURDEN
Number of
respondents 1
Reporting ......................................
Recordkeeping .............................
Third-Party Disclosure .................
Number of
responses per
respondent 2
6,199
5,987
5,987
Total annual
responses 3
51
51
51
316,149
305,337
305,337
Average burden
per response 4
0.023 (1 minute) ........
0.989 (59 minutes) ....
0.885 (53 minutes) ....
Total
hours 5
7,289
302,121
270,143
Total capital
costs and
operating and
maintenance
costs
$425,000
14,733,333
13,033,333
1 Maximum number of respondents for any regulatory requirement within each category. Individual regulatory requirements within the category
may involve fewer respondents.
2 Maximum number of responses for any regulatory requirement within each category. Individual regulatory requirements within the category
may involve fewer responses.
3 Maximum total annual responses for any regulatory requirement within each category. Individual regulatory requirements within the category
may involve fewer total annual responses.
4 Rounded to three decimals. Total hours reflects a more precise, non-rounded average burden per response. An approximate (non-rounded)
conversion to minutes is shown in parentheses.
5 Total hours is based on a more precise burden per response than the rounded value show in this table.
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: July 24, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–16269 Filed 7–30–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–2544]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices;
Current Good Manufacturing Practice
Quality System Regulation
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
jbell on DSK3GLQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
20:09 Jul 30, 2019
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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 recordkeeping
requirements related to the medical
devices current good manufacturing
practice (CGMP) quality system (QS)
regulation (CGMP/QS regulation).
DATES: Submit either electronic or
written comments on the collection of
information by September 30, 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 September 30,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of September 30, 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,
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
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
E:\FR\FM\31JYN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 147 (Wednesday, July 31, 2019)]
[Notices]
[Pages 37315-37317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16269]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-4319]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Unique Device Identification System
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 associated with the
Unique Device Identification System.
DATES: Submit either electronic or written comments on the collection
of information by September 30, 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 September 30, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 30, 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-2016-N-4319 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Unique Device Identification
System.'' 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
[[Page 37316]]
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 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.
Unique Device Identification System--21 CFR Parts 16, 801, 803, 806,
810, 814, 820, 821, 822, and 830
OMB Control Number 0910-0720--Extension
In accordance with the Unique Device Identification (UDI) system
(see 21 CFR part 801, subpart B), medical device labelers, unless
excepted, are required to design and use medical device labels and
device packages that bear a UDI, present dates on labels in a
particular format, and submit data concerning each version or model of
a device to the Global Unique Device Identification Database (GUDID) no
later than the date the label of the device must bear a UDI. Once a
device becomes subject to UDI requirements, respondents will be
required to update the information reported whenever the information
changes.
The recordkeeping, reporting, and third-party disclosure
requirements referenced in this document are imposed on any person who
causes a label to be applied to a device, or who causes the label to be
modified, with the intent that the device will be commercially
distributed without any subsequent replacement or modification of the
label. In most instances, the labeler would be the device manufacturer,
but other types of labelers include a specification developer, a
single-use device reprocessor, a convenience kit assembler, a private
label distributor, a repackager, or a relabeler. Respondents may also
include any private organization that applies for accreditation by FDA
as an issuing agency.
FDA has identified the following requirements as having burdens
that must be accounted for under the PRA; the burdens associated with
these requirements are summarized in the table that follows:
Section 801.18 requires that whenever a labeler of a medical device
includes an expiration date, a date of manufacture, or any other date
intended to be brought to the attention of the user of the device, the
labeler must present the date on the label in a format that meets the
requirements of this section.
Section 801.20 requires every medical device label and package to
bear a UDI.
Under Sec. 801.35, any labeler of a device that is not required to
bear a UDI on its label may include a UDI on the label of that device
and utilize the GUDID.
Under Sec. 801.45, any device that has to be labeled with a UDI
also has to bear a permanent marking providing the UDI on the device
itself if the device is intended for more than one use and intended to
be reprocessed before each use.
Section 801.50 requires stand-alone software to comply with
specific labeling requirements that identify the software.
Section 801.55 authorizes additional, case-by-case, labeling
exceptions and alternatives to standard UDI labeling requirements.
If a labeler relabels or modifies a label of a device that is
required to bear a UDI, under Sec. 830.60 it has to keep a record
showing the relationship of the original device identifier to the new
device identifier.
Section 830.110 requires an applicant seeking initial FDA
accreditation as a UDI-issuing agency to furnish FDA an application
containing certain information, materials, and supporting
documentation.
Under Sec. 830.120, an FDA-accredited issuing agency is required
to disclose information concerning its system for the assignment of
UDIs; maintain a list of labelers that use its system for the
assignment of UDIs and provide FDA a copy of such list; and upon
request, provide FDA with information concerning a labeler that is
employing the issuing agency's system for assignment of UDIs.
Sections 830.310 and 830.320 require the labeler to provide certain
information to the GUDID concerning the labeler and each version or
model of a device required to be labeled with a UDI, unless the labeler
obtains a waiver.
Section 830.360 requires each labeler to retain records showing all
UDIs used
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to identify devices that must be labeled with a UDI and the particular
version or model associated with each device identifier, until 3 years
after it ceases to market a version or model of a device.
Respondents who are required to submit data to the Agency under
certain other approved information collections (listed below) are
required to include UDI data elements for the device that is the
subject of such information collection. Addition of the UDI data
elements is included in this burden estimate for the conforming
amendments in the following 21 CFR parts:
Part 803--Medical Device Reporting (OMB control number 0910-0437),
Part 806--Medical Devices; Reports of Corrections and Removals (OMB
control number 0910-0359),
Part 814--Premarket Approval of Medical Devices (OMB control number
0910-0231),
Part 820--Quality System Regulation (OMB control number 0910-0073),
Part 821--Medical Device Tracking Requirements (OMB control number
0910-0442), and
Part 822--Postmarket Surveillance (OMB control number 0910-0449).
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Burden
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Total capital
Number of Number of costs and
respondents responses per Total annual Average burden per response \4\ Total hours operating and
\1\ respondent \2\ responses \3\ \5\ maintenance
costs
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Reporting........................... 6,199 51 316,149 0.023 (1 minute).................. 7,289 $425,000
Recordkeeping....................... 5,987 51 305,337 0.989 (59 minutes)................ 302,121 14,733,333
Third-Party Disclosure.............. 5,987 51 305,337 0.885 (53 minutes)................ 270,143 13,033,333
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Maximum number of respondents for any regulatory requirement within each category. Individual regulatory requirements within the category may
involve fewer respondents.
\2\ Maximum number of responses for any regulatory requirement within each category. Individual regulatory requirements within the category may involve
fewer responses.
\3\ Maximum total annual responses for any regulatory requirement within each category. Individual regulatory requirements within the category may
involve fewer total annual responses.
\4\ Rounded to three decimals. Total hours reflects a more precise, non-rounded average burden per response. An approximate (non-rounded) conversion to
minutes is shown in parentheses.
\5\ Total hours is based on a more precise burden per response than the rounded value show in this table.
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: July 24, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16269 Filed 7-30-19; 8:45 am]
BILLING CODE 4164-01-P
