Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Device Tracking, 84337-84339 [2023-26653]
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Federal Register / Vol. 88, No. 232 / Tuesday, December 5, 2023 / Notices
(DCBFD2) Regulatory Review
Branch 3 (DCBFD3)
Review Management Support Branch
(DCBFD4)
Division of Clinical and Toxicology
Review (DCBFE)
Clinical Review Branch 1 (DCBFE1)
Clinical Review Branch 2 (DCBFE2)
Clinical Review Branch 3 (DCBFE3)
Toxicology Staff (DCBFE4)
II. Delegations of Authority
Pending further delegation, directives,
or orders by the Commissioner of Food
and Drugs, all delegations and
redelegations of authority made to
officials and employees of affected
organizational components will
continue in them or their successors
pending further redelegations, provided
they are consistent with this
reorganization.
III. Electronic Access
After completion of the necessary
requirements for implementation, this
reorganization will be reflected in FDA’s
Staff Manual Guide (SMG) at: https://
www.fda.gov/AboutFDA/
ReportsManualsForms/
StaffManualGuides/default.htm.
Authority: 44 U.S.C. 3101.
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2023–26512 Filed 12–4–23; 8:45 am]
BILLING CODE 4164–01–P
FOR FURTHER INFORMATION CONTACT:
Cathryn Lee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–1394.
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), FDA will
award priority review vouchers to
sponsors of approved rare pediatric
disease product applications that meet
certain criteria. FDA has determined
that XENPOZYME (olipudase alfa-rpcp),
manufactured by Genzyme Corporation,
meets the criteria for a priority review
voucher. XENPOZYME (olipudase alfarpcp) is indicated for treatment of noncentral nervous system manifestations
of acid sphingomyelinase deficiency
(ASMD) in adult and pediatric patients.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDisease
PriorityVoucherProgram/default.htm.
For further information about
XENPOZYME (olipudase alfa-rpcp), go
to the ‘‘Drugs@FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: November 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2023–26652 Filed 12–4–23; 8:45 am]
Food and Drug Administration
BILLING CODE 4164–01–P
[Docket No. FDA–2020–N–0026]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act)
authorizes FDA to award priority review
vouchers to sponsors of approved rare
pediatric disease product applications
that meet certain criteria. FDA is
required to publish notice of the award
of priority review voucher. FDA has
determined that XENPOZYME
(olipudase alfa-rpcp), manufactured by
Genzyme Corporation, meets the criteria
for a priority review voucher.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
16:35 Dec 04, 2023
Food and Drug Administration
[Docket No. FDA–2017–N–5569]
Notice.
VerDate Sep<11>2014
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Jkt 262001
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices;
Device Tracking
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
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Fmt 4703
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84337
Submit written comments
(including recommendations) on the
collection of information by January 4,
2024.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0442. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10 a.m.–12 p.m., 11601
Landsdown St., North Bethesda, MD
20852, 301–796–3794, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Medical Devices; 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)) 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 lifesupporting (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.
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Federal Register / Vol. 88, No. 232 / Tuesday, December 5, 2023 / Notices
In addition, applicable regulations in
21 CFR part 821 (21 CFR 821.1 through
821.60) 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;
including hospitals. We currently
estimate 22,000 potential respondents.
In the Federal Register of August 8,
2023 (88 FR 53494), we published a 60day notice soliciting comment on the
proposed collection of information. No
comments were received.
We estimate the burden of this
collection of information as follows:
(5) confidentiality; and (6) record
retention requirements.
Respondents to the collection of
information are medical device
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,
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity; 21 CFR section
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 section
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
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
Activity; 21 CFR section
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 ..............................................................................
khammond on DSKJM1Z7X2PROD with NOTICES
1 There
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total
hours
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.
Upon evaluation of the information
collection, we have made no adjustment
to our currently approved burden
estimate of 615,380 hours annually,
based on 12 tracking orders. We
attribute the attendant burden to the
following activities:
Under § 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, we estimate it
VerDate Sep<11>2014
16:35 Dec 04, 2023
Jkt 262001
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,
we estimate no more than one notice
will be received in any year, and that it
would take 1 hour per incident.
Under § 821.30(c)(2), multiple
distributors must provide data on
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current users of tracked devices, current
device locations, and other information,
upon request from a manufacturer or
FDA. Assuming one multiple distributor
receives one request in a year from
either a manufacturer or FDA, and that
lists may be generated electronically, we
estimate 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. We assume
5 percent of tracked devices distributed
for estimating burden. Each audited
E:\FR\FM\05DEN1.SGM
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84339
Federal Register / Vol. 88, No. 232 / Tuesday, December 5, 2023 / Notices
database entry prompts one distributor
audit response. Because lists may be
generated electronically, we estimate a
burden of 1 hour to comply.
Dated: November 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–26653 Filed 12–4–23; 8:45 am]
BILLING CODE 4161–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Home Visiting
Assessment of Implementation Quality
Study: Exploring Family Voice and
Leadership in Home Visiting
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 February 5, 2024.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
SUMMARY:
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Joella Roland, the HRSA
Information Collection Clearance
Officer, at (301) 443–3983.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
Information Collection Request Title:
Home Visiting Assessment of
Implementation Quality Study:
Exploring Family Voice and Leadership
in Home Visiting, OMB No. 0915–
xxxx—[NEW]
Abstract: The Maternal, Infant, and
Early Childhood Home Visiting
(MIECHV) Program, authorized by
Social Security Act, title V, section 511
(42 U.S.C. 711) and administered by
HRSA in partnership with the
Administration for Children and
Families, supports voluntary, evidencebased home visiting services during
pregnancy and for parents with young
children up to kindergarten entry.
States, tribal entities, and certain
nonprofit organizations are eligible to
receive funding from the MIECHV
Program and have the flexibility to tailor
the program to serve the specific needs
of their communities. Funding
recipients may subaward grant funds to
local implementing agencies (LIAs) to
provide home visiting services to
eligible families in at-risk communities.
Through the Home Visiting
Assessment of Implementation Quality
Study, HRSA aims to examine specific
components of the Home Visiting
Implementation Quality Conceptual
Framework to inform strategies for
implementing high quality home
visiting programs. One of the three
quality components the study will focus
on is family voice and leadership (FVL),
which involves including families in
decisions related to program
implementation. The requested
information collection will provide a
better understanding of how MIECHVfunded home visiting programs
currently engage families and will
provide preliminary information on
how FVL may influence home visiting
implementation and program quality.
Data collection activities include an
online survey, focus groups, and
interviews.
Need and Proposed Use of the
Information: HRSA is seeking additional
information about how the MIECHV
Program engages and supports families
in leadership opportunities to inform
and improve programs. HRSA intends to
use this information to identify
actionable strategies that MIECHV
awardees and LIAs could take to engage
families meaningfully and effectively in
program decisions and to ensure that
families’ unique strengths, needs,
cultures, and preferences drive service
delivery.
Likely Respondents: MIECHV Program
awardees that are states, nonprofit
organizations, and Tribes, LIA staff
(program directors, coordinators,
supervisors, and home visitors); and
families who have been engaged in FVL
activities by MIECHV-funded home
visiting programs.
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.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
khammond on DSKJM1Z7X2PROD with NOTICES
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
MIECHV Program FVL Online Survey ................................
Family Focus Group Protocol ..............................................
Tribal and State MIECHV Administrators Interview Guide ..
LIA Program Staff Focus Group Protocol ............................
1,000
48
12
48
1
1
1
1
1,000
48
12
48
0.33
1.00
1.00
1.00
330
48
12
48
Total ..............................................................................
1,108
........................
1,108
........................
438
HRSA specifically requests comments
on (1) the necessity and utility of the
VerDate Sep<11>2014
16:35 Dec 04, 2023
Jkt 262001
proposed information collection for the
proper performance of the agency’s
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functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
E:\FR\FM\05DEN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 232 (Tuesday, December 5, 2023)]
[Notices]
[Pages 84337-84339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26653]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-5569]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Devices;
Device Tracking
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 January 4, 2024.
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 0910-0442. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10
a.m.-12 p.m., 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
3794, [email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Medical Devices; 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)) 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.
[[Page 84338]]
In addition, applicable regulations in 21 CFR part 821 (21 CFR
821.1 through 821.60) 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 to the collection of information are medical device
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. We currently estimate 22,000 potential respondents.
In the Federal Register of August 8, 2023 (88 FR 53494), we
published a 60-day notice soliciting comment on the proposed collection
of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity; 21 CFR section 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 and 1 1 1 1 1
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 section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Tracking information--821.25(a). 12 1 12 76 912
Record of tracking data-- 12 46,260 555,120 1 555,120
821.25(b)......................
Standard operating procedures-- 12 1 12 63 756
821.25(c) \2\..................
Manufacturer data audit-- 12 1,124 13,488 1 13,488
821.25(c)(3)...................
Multiple distributor data and 22,000 1 22,000 1 22,000
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
Number of disclosures Total annual Average burden
Activity; 21 CFR section respondents per disclosures per disclosure Total hours
respondent
----------------------------------------------------------------------------------------------------------------
Acquisition of tracked devices 22,000 1 22,000 1 22,000
and final distributor data--
821.30(a) and (b)..............
Multiple distributor data and 1,100 1 1,100 1 1,100
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.
Upon evaluation of the information collection, we have made no
adjustment to our currently approved burden estimate of 615,380 hours
annually, based on 12 tracking orders. We attribute the attendant
burden to the following activities:
Under Sec. 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, we estimate 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, we estimate no more than one
notice will be received in any year, and that it would take 1 hour per
incident.
Under Sec. 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. Assuming
one multiple distributor receives one request in a year from either a
manufacturer or FDA, and that lists may be generated electronically, we
estimate 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. We assume 5 percent of tracked devices distributed for
estimating burden. Each audited
[[Page 84339]]
database entry prompts one distributor audit response. Because lists
may be generated electronically, we estimate a burden of 1 hour to
comply.
Dated: November 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26653 Filed 12-4-23; 8:45 am]
BILLING CODE 4161-01-P
