Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices-Voluntary Improvement Program, 48854-48855 [2023-16079]
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48854
Federal Register / Vol. 88, No. 144 / Friday, July 28, 2023 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Responses per
respondent
Average
burden hours
per response
(minutes)
Total burden
hours
526
1
15
131.5
Dated: July 25, 2023.
Alison Barkoff,
Acting Administrator and Assistant Secretary
for Aging.
collection of information to OMB for
review and clearance.
[FR Doc. 2023–16015 Filed 7–27–23; 8:45 am]
OMB Control Number 0910–NEW
This information collection supports
FDA’s implementation of its Voluntary
Improvement Program (VIP). Included
among the strategic priorities of our
Center for Devices and Radiological
Health (CDRH) is promoting a culture of
quality and organizational excellence.
As communicated on our website at
https://www.fda.gov/medical-devices/
quality-and-compliance-medicaldevices/voluntary-medical-devicemanufacturing-and-product-qualitypilot-program, we conducted a pilot
project pertaining to voluntary medical
device manufacturing and product
quality and have incorporated some of
the successes and learnings into the VIP.
The VIP oversees third-party appraisers
who evaluate industry participants. The
VIP is facilitated by the Medical Device
Innovation Consortium, a public-private
partnership that evaluates the capability
and performance of a medical device
manufacturer’s practices using thirdparty appraisals and is intended to
guide improvement to enhance the
quality of devices. As part of the VIP
process, FDA receives information about
participating device manufacturers’
capability and performance for activities
covered in third-party appraisals.
The guidance document entitled
‘‘Fostering Medical Device
Improvement: FDA Activities and
Engagement with the Voluntary
Improvement Program’’ communicates
our policy regarding participation in the
VIP. Only eligible manufacturers of
medical devices regulated by CDRH
whose marketing applications are
reviewed under the applicable
provisions of the Federal Food, Drug,
and Cosmetic Act (including under
sections 510(k), 513, 515, and 520 (21
U.S.C. 360(k), 360c, 360e, and 360j))
may participate in the VIP. The
guidance document was developed and
issued consistent with our good
guidance practice regulations in 21 CFR
10.115, which provide for public
comment at any time. The guidance
document includes instruction to
respondents regarding eligibility, FDA
engagement with participants,
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–2757]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices—
Voluntary Improvement Program
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: Submit written comments
(including recommendations) on the
collection of information by August 28,
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 title
of this information collection is
‘‘Voluntary Improvement Program.’’
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
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:16 Jul 27, 2023
Jkt 259001
Voluntary Improvement Program
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
submission criteria, and withdrawal or
removal from the program.
Information included in VIP
applications is verified by FDA. This
helps the third-party appraiser to
determine the manufacturers’ eligibility
for participation in the VIP. We use
aggregate data to identify broad industry
trends and patterns to help inform riskbased inspection planning and improve
review efficiencies. We also consider
aggregate data to better allocate limited
Agency resources. Also included among
the goals of the program is to improve
the safety, quality, and access of
medical devices for patients by driving
quality and continuous improvement
within the device industry. The program
is intended to result in increased
production and access to higher quality
medical devices for patients, decreases
in safety issues, and lower production
costs, which will increase value to
industry, patients, providers, payors,
and FDA.
We published a 60-day notice
soliciting public comment on the
proposed collection of information in
the Federal Register of May 6, 2022 (87
FR 27165) and received several
comments. Most comments included
feedback on individual collection
elements and the operational logistics of
the program. We have considered these
comments. Although we intend to revise
the guidance to clarify what participants
must demonstrate to benefit from the
opportunities offered by VIP and add
further details regarding the role of FDA
in VIP in section V.B of the guidance,
we are making no adjustments to our
burden estimates. In addition, two
comments requested FDA clarify the
benefits and utility of VIP for patients
and consumers. FDA intends to address
these comments in the guidance
document, which guides improvement
to enhance the quality of devices.
Respondents: Respondents to the
information collection are
manufacturing sites who voluntary elect
to participate in the VIP. Based on our
device registration and listing data and
informal feedback from stakeholders, we
anticipate approximately 400 sites may
participate annually.
We estimate the burden of the
information collection as follows:
E:\FR\FM\28JYN1.SGM
28JYN1
Federal Register / Vol. 88, No. 144 / Friday, July 28, 2023 / Notices
48855
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Recommended information collection activity: Fostering
medical device improvement: FDA activities and engagement with the voluntary Improvement Program
Average
burden per
response
Total annual
responses
Total hours
Site manufacturer application ...........................................
Aggregate data reporting ..................................................
Summary of site appraisal ................................................
1
1
1
400
4
400
400
4
400
0.08 (5 minutes)
8 .......................
20 .....................
33
32
8,000
Total ...........................................................................
........................
........................
........................
...........................
8,065
1 There
are no capital or operating and maintenance costs associated with the information collection.
Site Manufacturer Application
In section IV.A of the guidance, we
explain that manufacturers wishing to
apply for an appraisal may do so at the
third-party appraiser’s application
portal. As part of the VIP process (see
section IV.D, Process Flow, of the
guidance), the site manufacturers’
application information is provided to
FDA by the third-party appraiser. We
assume it will take the third-party
appraiser approximately 5 minutes to
notify FDA of the availability of each
application. Such notification is
provided via email and FDA may then
access the information via the thirdparty appraiser’s online portal.
Aggregate Data Reporting
As discussed in sections III and IV of
the guidance, the third-party appraiser
provides FDA with aggregated data
across all participating manufacturer
sites quarterly. We assume that it will
take approximately 8 hours to prepare
and submit the aggregate data.
Summary of Site Appraisal
lotter on DSK11XQN23PROD with NOTICES1
Number of
responses
per
respondent
Number of
respondents
In section IV.D of the guidance, we
communicate that the third-party
appraiser will provide FDA a summary
of the appraisal result for each
participating site. We assume an average
of 20 hours is necessary to prepare and
submit the summary.
This is a new information collection.
Specifically, we are accounting for
third-party appraiser burden to provide
the site manufacturer’s information to
FDA under the VIP process. We believe
associated recordkeeping by
participating manufactures to be usual
and customary business practice and
have therefore not included estimates
for VIP application activities by
manufacturers. The estimated average
burden per response is largely based on
our experience with the program pilot
and informal communications with
participants.
VerDate Sep<11>2014
17:16 Jul 27, 2023
Jkt 259001
Dated: July 25, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–16079 Filed 7–27–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–2966]
Biosimilar User Fee Rates for Fiscal
Year 2024
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the rates for
biosimilar user fees for fiscal year (FY)
2024. The Federal Food, Drug, and
Cosmetic Act (FD&C Act), as amended
by the Biosimilar User Fee Amendments
of 2022 (BsUFA III), authorizes FDA to
assess and collect user fees for certain
activities in connection with biosimilar
biological product development; review
of certain applications for approval of
biosimilar biological products; and each
biosimilar biological product approved
in a biosimilar biological product
application. BsUFA III directs FDA to
establish, before the beginning of each
fiscal year, the amount of initial and
annual biosimilar biological product
development (BPD) fees, the
reactivation fee, and the biosimilar
biological product application and
program fees for such year. These fees
apply to the period from October 1,
2023, through September 30, 2024.
FOR FURTHER INFORMATION CONTACT:
Olufunmilayo (Funmi) Ariyo, Office of
Financial Management, Food and Drug
Administration, 4041 Powder Mill Rd.,
6th Floor, Beltsville, MD 20705–4304,
240–402–4989, and the User Fees
Support Staff at OO-OFBAP-OFM-UFSSGovernment@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
I. Background
Sections 744G, 744H, and 744I of the
FD&C Act (21 U.S.C. 379j–51, 379j–52,
and 379j–53), as amended by BsUFA III,
authorize the collection of fees for
biosimilar biological products. Under
section 744H(a)(1)(A) of the FD&C Act,
the initial BPD fee for a product is due
when the sponsor submits an
investigational new drug (IND)
application that FDA determines is
intended to support a biosimilar
biological product application or within
7 calendar days after FDA grants the
first BPD meeting, whichever occurs
first. A sponsor who has paid the initial
BPD fee is considered to be participating
in FDA’s BPD program for that product.
Under section 744H(a)(1)(B) of the
FD&C Act, once a sponsor has paid the
initial BPD fee for a product, the annual
BPD fee is assessed beginning with the
next fiscal year. The annual BPD fee is
assessed for the product each fiscal year
until the sponsor submits a marketing
application for the product that is
accepted for filing, the sponsor
discontinues participation in FDA’s
BPD program for the product, or the
sponsor has been administratively
removed from the BPD program for the
product.
Under section 744H(a)(1)(D) of the
FD&C Act, if a sponsor has discontinued
participation in FDA’s BPD program or
has been administratively removed from
the BPD program for a product and
wants to reengage with FDA on
development of the product, the sponsor
must pay all annual BPD fees previously
assessed for such product and still
owed, and a reactivation fee to resume
participation in the program. The
sponsor must pay the reactivation fee by
the earlier of the following dates: (1) no
later than 7 calendar days after FDA
grants the sponsor’s request for a BPD
meeting for that product or (2) upon the
date of submission by the sponsor of an
IND describing an investigation that
FDA determines is intended to support
a biosimilar biological product
application for that product. The
sponsor will be assessed an annual BPD
E:\FR\FM\28JYN1.SGM
28JYN1
]]>Agencies
[Federal Register Volume 88, Number 144 (Friday, July 28, 2023)]
[Notices]
[Pages 48854-48855]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16079]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2757]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Devices--
Voluntary Improvement Program
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: Submit written comments (including recommendations) on the
collection of information by August 28, 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 title of this
information collection is ``Voluntary Improvement Program.'' 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.
Voluntary Improvement Program
OMB Control Number 0910-NEW
This information collection supports FDA's implementation of its
Voluntary Improvement Program (VIP). Included among the strategic
priorities of our Center for Devices and Radiological Health (CDRH) is
promoting a culture of quality and organizational excellence. As
communicated on our website at https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/voluntary-medical-device-manufacturing-and-product-quality-pilot-program, we conducted a pilot
project pertaining to voluntary medical device manufacturing and
product quality and have incorporated some of the successes and
learnings into the VIP. The VIP oversees third-party appraisers who
evaluate industry participants. The VIP is facilitated by the Medical
Device Innovation Consortium, a public-private partnership that
evaluates the capability and performance of a medical device
manufacturer's practices using third-party appraisals and is intended
to guide improvement to enhance the quality of devices. As part of the
VIP process, FDA receives information about participating device
manufacturers' capability and performance for activities covered in
third-party appraisals.
The guidance document entitled ``Fostering Medical Device
Improvement: FDA Activities and Engagement with the Voluntary
Improvement Program'' communicates our policy regarding participation
in the VIP. Only eligible manufacturers of medical devices regulated by
CDRH whose marketing applications are reviewed under the applicable
provisions of the Federal Food, Drug, and Cosmetic Act (including under
sections 510(k), 513, 515, and 520 (21 U.S.C. 360(k), 360c, 360e, and
360j)) may participate in the VIP. The guidance document was developed
and issued consistent with our good guidance practice regulations in 21
CFR 10.115, which provide for public comment at any time. The guidance
document includes instruction to respondents regarding eligibility, FDA
engagement with participants, submission criteria, and withdrawal or
removal from the program.
Information included in VIP applications is verified by FDA. This
helps the third-party appraiser to determine the manufacturers'
eligibility for participation in the VIP. We use aggregate data to
identify broad industry trends and patterns to help inform risk-based
inspection planning and improve review efficiencies. We also consider
aggregate data to better allocate limited Agency resources. Also
included among the goals of the program is to improve the safety,
quality, and access of medical devices for patients by driving quality
and continuous improvement within the device industry. The program is
intended to result in increased production and access to higher quality
medical devices for patients, decreases in safety issues, and lower
production costs, which will increase value to industry, patients,
providers, payors, and FDA.
We published a 60-day notice soliciting public comment on the
proposed collection of information in the Federal Register of May 6,
2022 (87 FR 27165) and received several comments. Most comments
included feedback on individual collection elements and the operational
logistics of the program. We have considered these comments. Although
we intend to revise the guidance to clarify what participants must
demonstrate to benefit from the opportunities offered by VIP and add
further details regarding the role of FDA in VIP in section V.B of the
guidance, we are making no adjustments to our burden estimates. In
addition, two comments requested FDA clarify the benefits and utility
of VIP for patients and consumers. FDA intends to address these
comments in the guidance document, which guides improvement to enhance
the quality of devices.
Respondents: Respondents to the information collection are
manufacturing sites who voluntary elect to participate in the VIP.
Based on our device registration and listing data and informal feedback
from stakeholders, we anticipate approximately 400 sites may
participate annually.
We estimate the burden of the information collection as follows:
[[Page 48855]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommended information collection activity:
Fostering medical device improvement: FDA Number of Number of Total annual
activities and engagement with the voluntary respondents responses per responses Average burden per response Total hours
Improvement Program respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
Site manufacturer application.................. 1 400 400 0.08 (5 minutes)....................... 33
Aggregate data reporting....................... 1 4 4 8...................................... 32
Summary of site appraisal...................... 1 400 400 20..................................... 8,000
--------------------------------------------------------------------------------------------------------
Total...................................... .............. .............. .............. ....................................... 8,065
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with the information collection.
Site Manufacturer Application
In section IV.A of the guidance, we explain that manufacturers
wishing to apply for an appraisal may do so at the third-party
appraiser's application portal. As part of the VIP process (see section
IV.D, Process Flow, of the guidance), the site manufacturers'
application information is provided to FDA by the third-party
appraiser. We assume it will take the third-party appraiser
approximately 5 minutes to notify FDA of the availability of each
application. Such notification is provided via email and FDA may then
access the information via the third-party appraiser's online portal.
Aggregate Data Reporting
As discussed in sections III and IV of the guidance, the third-
party appraiser provides FDA with aggregated data across all
participating manufacturer sites quarterly. We assume that it will take
approximately 8 hours to prepare and submit the aggregate data.
Summary of Site Appraisal
In section IV.D of the guidance, we communicate that the third-
party appraiser will provide FDA a summary of the appraisal result for
each participating site. We assume an average of 20 hours is necessary
to prepare and submit the summary.
This is a new information collection. Specifically, we are
accounting for third-party appraiser burden to provide the site
manufacturer's information to FDA under the VIP process. We believe
associated recordkeeping by participating manufactures to be usual and
customary business practice and have therefore not included estimates
for VIP application activities by manufacturers. The estimated average
burden per response is largely based on our experience with the program
pilot and informal communications with participants.
Dated: July 25, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16079 Filed 7-27-23; 8:45 am]
BILLING CODE 4164-01-P
