Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Unique Device Identification System, 72368-72369 [2019-28246]
Download as PDF
<![CDATA[
72368
Federal Register / Vol. 84, No. 250 / Tuesday, December 31, 2019 / Notices
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB—Continued
OMB control
No.
Title of collection
Abbreviated New Animal Drug Applications ............................................................................................................
Medical Devices: Use of Certain Symbols in Labeling—Glossary to Support the Use of Symbols in Labeling ....
Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act ....................................
Investigational Device Exemptions Reports and Records ......................................................................................
510(k) Third-Party Review Program ........................................................................................................................
Guidance for Industry With the Center for Veterinary Medicine’s Electronic Submission System ........................
Dated: December 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
has submitted the following proposed
collection of information to OMB for
review and clearance.
[FR Doc. 2019–28249 Filed 12–30–19; 8:45 am]
Unique Device Identification System—
21 CFR Parts 16, 801, 803, 806, 810,
814, 820, 821, 822, and 830
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; Submission for Office of
Management and Budget Review;
Comment Request; Unique Device
Identification System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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: Fax written comments on the
collection of information by January 30,
2020.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0720. Also
include the FDA docket number found
in brackets in the heading of this
document.
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: In
compliance with 44 U.S.C. 3507, FDA
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:30 Dec 30, 2019
Jkt 250001
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,
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
0910–0669
0910–0740
0910–0768
0910–0078
0910–0375
0910–0454
Date
approval
expires
10/31/2022
10/31/2022
10/31/2022
11/30/2022
11/30/2022
11/30/2022
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 to furnish FDA an
application containing certain
information, materials, and supporting
documentation.
Under § 830.120, an FDA-accredited
issuing 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.
E:\FR\FM\31DEN1.SGM
31DEN1
72369
Federal Register / Vol. 84, No. 250 / Tuesday, December 31, 2019 / Notices
Section 830.360 requires each labeler
to retain records showing all UDIs used
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).
In the Federal Register of July 31,
2019 (84 FR 37315), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Although one comment
was received, it was not responsive to
the four collection of information topics.
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
51
51
51
Total annual
responses 3
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: December 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–28246 Filed 12–30–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–3586]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Focus Groups
About Drug Products as Used by the
Food and Drug Administration
AGENCY:
Food and Drug Administration,
khammond on DSKJM1Z7X2PROD with NOTICES
The Food and Drug
Administration (FDA or Agency) 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
(PRA).
SUMMARY:
18:32 Dec 30, 2019
Focus Groups About Drug Products as
Used by the Food and Drug
Administration
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0677. Also
include the FDA docket number found
in brackets in the heading of this
document.
OMB Control Number 0910–0677—
Extension
Focus groups provide an important
role in gathering information because
they allow for a more indepth
understanding of individuals’ 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 information that is useful
for developing variables and measures
for quantitative studies;
• to better understand people’s
attitudes and emotions in response to
topics and concepts; and
• to further explore findings obtained
from quantitative studies.
We use information gathered from
focus group findings to test and refine
ideas and to help develop messages and
other communications, 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.
Our Center for Drug Evaluation and
Research, as well as other Agency
components, engage focus groups about
ADDRESSES:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, 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:
Notice.
VerDate Sep<11>2014
Fax written comments on the
collection of information by January 30,
2020.
FOR FURTHER INFORMATION CONTACT:
HHS.
ACTION:
DATES:
Jkt 250001
PO 00000
Frm 00078
Fmt 4703
Sfmt 4703
E:\FR\FM\31DEN1.SGM
31DEN1
]]>Agencies
[Federal Register Volume 84, Number 250 (Tuesday, December 31, 2019)]
[Notices]
[Pages 72368-72369]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28246]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-4319]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Unique Device
Identification System
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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: Fax written comments on the collection of information by January
30, 2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0720.
Also include the FDA docket number found in brackets in the heading of
this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 to furnish FDA an application containing
certain information, materials, and supporting documentation.
Under Sec. 830.120, an FDA-accredited issuing 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.
[[Page 72369]]
Section 830.360 requires each labeler to retain records showing all
UDIs used 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).
In the Federal Register of July 31, 2019 (84 FR 37315), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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: December 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-28246 Filed 12-30-19; 8:45 am]
BILLING CODE 4164-01-P
