Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Labeling Requirements; Unique Device Identification, 9524-9525 [2023-03071]
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9524
Federal Register / Vol. 88, No. 30 / Tuesday, February 14, 2023 / Notices
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: February 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–03070 Filed 2–13–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Medical Device Labeling Requirements;
Unique Device Identification
Food and Drug Administration
[Docket No. FDA–2014–N–1048]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device
Labeling Requirements; Unique Device
Identification
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0485. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
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.
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by March 16,
2023.
ADDRESSES: To ensure that comments on
the information collection are received,
SUMMARY:
OMB Control Number 0910–0485—
Revision
This information collection supports
implementation of section 519(f) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360i(f)), requiring
the establishment of a unique device
identification (UDI) system by FDA.
Medical device labeling requirements
governed by section 502 of the FD&C
Act (21 U.S.C. 352) provide that every
medical device and every device
package bear a unique device identifier.
Implementing regulations are found in
part 801, subpart B (21 CFR part 801,
subpart B) (Labeling Requirements for
UDI), including provisions for
exceptions from UDI requirements (21
CFR 801.30). Applicable regulations are
also found in part 821 (21 CFR part 821)
(Medical Device Tracking
Requirements); 21 CFR part 822
(Postmarket Surveillance); part 814 (21
CFR part 814) (Premarket Approval of
Medical Devices); and part 820 (21 CFR
part 820) (Quality System Regulations),
as well as regulations pertaining to in
vitro device labeling, biological device
product labeling, or any article subject
to the device labeling provisions in
section 502 of the FD&C Act. Products
not in compliance with requirements set
forth in the applicable statutory and
regulatory authorities may be subject to
enforcement action by FDA.
For operational efficiency, we are
revising the information collection to
include burden that may be attributable
to activities associated with provisions
found in part 830 (21 CFR part 830),
currently approved in OMB control
number 0910–0720 and established
through rulemaking on September 24,
2013 (0910–AG31). The regulations
define relevant terms, identify specific
data requirements, and incorporate
global standards applicable to the use
and discontinuation of a UDI. The
regulations also provide for FDA
accreditation of an issuing agency (21
CFR 830.110) and explain associated
information collection activities
including the establishment,
maintenance, and disclosure of records.
Finally, the regulations provide for
administration of the Global UDI
Database (GUDID) (part 830, subpart E),
which specifies data that must be
submitted to FDA to be made publicly
available. Users of the GUDID will be
able to use the device identifier portion
of the UDI to query descriptive data
about a specific device. The GUDID may
be accessed on our website at https://
www.fda.gov/medical-devices/uniquedevice-identification-system-udi-system/
global-unique-device-identificationdatabase-gudid.
In the Federal Register of August 24,
2022 (87 FR 51989), we published a 60day notice soliciting comment on the
proposed collection of information. No
comments were received. However,
upon further review and evaluation, we
have made adjustments to our estimated
burden for the collection of information,
as follows:
ddrumheller on DSK120RN23PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Part 801, subpart B: Labeling requirements for unique device identification
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Requirements for a unique device identifier under part 830 ................................
6,199
51
316,149
1
316,149
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our figures are based on economic
analysis from previous Agency
rulemaking. We assume most burden
associated with activities applicable to
satisfying UDI requirements as
prescribed by part 830 is accounted for
VerDate Sep<11>2014
20:12 Feb 13, 2023
Jkt 259001
in currently approved information
collections. For example, information
collection associated with medical
device tracking provisions in part 821 is
currently approved in OMB control
number 0910–0442; information
PO 00000
Frm 00099
Fmt 4703
Sfmt 4703
collection associated with premarket
approval of medical devices (part 814)
is currently approved in OMB control
number 0910–0231. Similarly,
information collection associated with
our quality system regulation (part 820)
E:\FR\FM\14FEN1.SGM
14FEN1
9525
Federal Register / Vol. 88, No. 30 / Tuesday, February 14, 2023 / Notices
and information collection associated
with our medical device recall authority
(21 CFR part 810) is approved in OMB
control numbers 0910–0073 and 0910–
0432, respectively. We assume burden
respondents may have incurred as the
result of any product relabeling, as well
as one-time burden that respondents
may have incurred resulting from
integrating requirements into current
tracking and labeling activities, has
since been realized and is now
accounted for among our currently
approved inventory. Here, we are
accounting for burden associated with
UDI requirements prescribed by part
830 not otherwise included in currently
approved collections and subject to
general medical device labeling
requirements established in part 801,
subpart B. Because the PRA defines a
recordkeeping requirement to include
retained records, third-party
notifications and disclosures, and
reporting to the Federal government as
well as the public, we have accounted
for these activities cumulatively,
characterizing them as recordkeeping
activities.
Dated: February 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–03071 Filed 2–13–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection; Public
Comment Request; Application and
Other Forms Used by the National
Health Service Corps Scholarship
Program, the NHSC Students to
Service Loan Repayment Program, and
the Native Hawaiian Health
Scholarship Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than April 17, 2023.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Samantha Miller, the acting
HRSA Information Collection Clearance
Officer, at 301–594–4394.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Application and Other Forms Used by
the National Health Service Corps
(NHSC) Scholarship Program (SP), the
NHSC Students to Service Loan
Repayment Program (S2S LRP), and the
Native Hawaiian Health Scholarship
Program (NHHSP), OMB No. 0915–
0146–Revision.
Abstract: Administered by HRSA’s
Bureau of Health Workforce, the NHSC
SP, NHSC S2S LRP, and the NHHSP
provide scholarships or loan repayment
to qualified students who are pursuing
primary care health professions
education and training. In return,
students agree to provide primary health
care services in underserved
communities located in federally
designated Health Professional Shortage
Areas once they are fully trained and
licensed health professionals. Awards
are made to applicants who demonstrate
the greatest potential for successful
completion of their education and
training as well as commitment to
provide primary health care services to
communities of greatest need. The
SUMMARY:
information from program applications,
forms, and supporting documentation is
used to select the best qualified
candidates for these competitive
awards, and to monitor program
participants’ enrollment in school,
postgraduate training, and compliance
with program requirements.
Although some program forms vary
from program to program (see programspecific burden charts below), required
forms generally include: a program
application, academic and nonacademic letters of recommendation, the
authorization to release information,
and the acceptance/verification of good
academic standing report. The NHHSP
is not seeking to change or add any
forms or documentation.
Need and Proposed Use of the
Information: The NHSC SP, S2S LRP,
and NHHSP applications, forms, and
supporting documentation are used to
collect necessary information from
applicants and schools that enable
HRSA to make selection determinations
for the competitive awards and monitor
compliance (via training programs and
sites) with program requirements.
Likely Respondents: Qualified
students who are pursuing education
and training in primary care health
professions and are interested in
working in health professional shortage
areas and schools at which such
students are enrolled.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
ddrumheller on DSK120RN23PROD with NOTICES
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Number of
responses
per
respondent
Total
responses
Average
burden
per response
(in hours)
Total burden
hours
NHSC Scholarship Program Application
NHSC Scholarship Program Application .............................
Letters of Recommendation .................................................
Authorization to Release Information ..................................
VerDate Sep<11>2014
20:12 Feb 13, 2023
Jkt 259001
PO 00000
Frm 00100
2,575
2,575
2,575
Fmt 4703
Sfmt 4703
1
2
1
E:\FR\FM\14FEN1.SGM
2,575
5,150
2,575
14FEN1
2.00
1.00
.10
5150.00
5150.00
257.50
]]>Agencies
[Federal Register Volume 88, Number 30 (Tuesday, February 14, 2023)]
[Notices]
[Pages 9524-9525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03071]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1048]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Device
Labeling Requirements; Unique Device Identification
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by March 16, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0485. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Medical Device Labeling Requirements; Unique Device Identification
OMB Control Number 0910-0485--Revision
This information collection supports implementation of section
519(f) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360i(f)), requiring the establishment of a unique device
identification (UDI) system by FDA. Medical device labeling
requirements governed by section 502 of the FD&C Act (21 U.S.C. 352)
provide that every medical device and every device package bear a
unique device identifier. Implementing regulations are found in part
801, subpart B (21 CFR part 801, subpart B) (Labeling Requirements for
UDI), including provisions for exceptions from UDI requirements (21 CFR
801.30). Applicable regulations are also found in part 821 (21 CFR part
821) (Medical Device Tracking Requirements); 21 CFR part 822
(Postmarket Surveillance); part 814 (21 CFR part 814) (Premarket
Approval of Medical Devices); and part 820 (21 CFR part 820) (Quality
System Regulations), as well as regulations pertaining to in vitro
device labeling, biological device product labeling, or any article
subject to the device labeling provisions in section 502 of the FD&C
Act. Products not in compliance with requirements set forth in the
applicable statutory and regulatory authorities may be subject to
enforcement action by FDA.
For operational efficiency, we are revising the information
collection to include burden that may be attributable to activities
associated with provisions found in part 830 (21 CFR part 830),
currently approved in OMB control number 0910-0720 and established
through rulemaking on September 24, 2013 (0910-AG31). The regulations
define relevant terms, identify specific data requirements, and
incorporate global standards applicable to the use and discontinuation
of a UDI. The regulations also provide for FDA accreditation of an
issuing agency (21 CFR 830.110) and explain associated information
collection activities including the establishment, maintenance, and
disclosure of records. Finally, the regulations provide for
administration of the Global UDI Database (GUDID) (part 830, subpart
E), which specifies data that must be submitted to FDA to be made
publicly available. Users of the GUDID will be able to use the device
identifier portion of the UDI to query descriptive data about a
specific device. The GUDID may be accessed on our website at https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/global-unique-device-identification-database-gudid.
In the Federal Register of August 24, 2022 (87 FR 51989), we
published a 60-day notice soliciting comment on the proposed collection
of information. No comments were received. However, upon further review
and evaluation, we have made adjustments to our estimated burden for
the collection of information, as follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Part 801, subpart B: Labeling requirements for unique device Number of records per Total annual per Total hours
identification recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Requirements for a unique device identifier under part 830......... 6,199 51 316,149 1 316,149
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Our figures are based on economic analysis from previous Agency
rulemaking. We assume most burden associated with activities applicable
to satisfying UDI requirements as prescribed by part 830 is accounted
for in currently approved information collections. For example,
information collection associated with medical device tracking
provisions in part 821 is currently approved in OMB control number
0910-0442; information collection associated with premarket approval of
medical devices (part 814) is currently approved in OMB control number
0910-0231. Similarly, information collection associated with our
quality system regulation (part 820)
[[Page 9525]]
and information collection associated with our medical device recall
authority (21 CFR part 810) is approved in OMB control numbers 0910-
0073 and 0910-0432, respectively. We assume burden respondents may have
incurred as the result of any product relabeling, as well as one-time
burden that respondents may have incurred resulting from integrating
requirements into current tracking and labeling activities, has since
been realized and is now accounted for among our currently approved
inventory. Here, we are accounting for burden associated with UDI
requirements prescribed by part 830 not otherwise included in currently
approved collections and subject to general medical device labeling
requirements established in part 801, subpart B. Because the PRA
defines a recordkeeping requirement to include retained records, third-
party notifications and disclosures, and reporting to the Federal
government as well as the public, we have accounted for these
activities cumulatively, characterizing them as recordkeeping
activities.
Dated: February 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03071 Filed 2-13-23; 8:45 am]
BILLING CODE 4164-01-P
