Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices, 5888-5891 [2023-01849]
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Federal Register / Vol. 88, No. 19 / Monday, January 30, 2023 / Notices
if OMB receives it within 30 days of
publication.
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. You can also obtain
copies of the proposed collection of
information by emailing infocollection@
acf.hhs.gov. Identify all emailed
requests by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: ACF is primarily a grantmaking agency that promotes the
economic and social well-being of
families, children, individuals and
communities with partnerships,
funding, guidance, training and
technical assistance.
Prior to the use of this generic
program-specific PPR, a standard ACF
PPR (#0970–0406) was used for all ACF
discretionary grant and cooperative
agreement awards for post award
reporting. Historically, on the standard
ACF PPR form, ACF required grantees to
only respond to a common set of broad
questions, which often solicited
ADDRESSES:
A generic program-specific PPR that
can be tailored for program-specific
needs allows program offices to collect
useful data in a uniform and systematic
manner. The reporting format allows
program offices to gather uniform
program performance data from each
grantee, allowing aggregation at the
program level to calculate outputs and
outcomes, providing a snapshot and
allowing for longitudinal analysis.
Data from a tailored program-specific
PPR that demonstrates a program’s
successes and challenges have been
useful for accountability purposes, such
as required reports to Congress.
Moreover, it has been useful for program
management and oversight, such as
identifying grantees’ technical
assistance needs and ensuring
compliance with federal and
programmatic regulations and policies.
To review currently approved PPRs
under this generic, see: https://
www.reginfo.gov/public/do/
PRAICList?ref_nbr=202206-0970-004.
Respondents: ACF funding recipients.
Annual Burden Estimates: ACF is
requesting an increase in burden
account for the potential use by nondiscretionary programs and to reflect
use over the past 3 years and anticipated
use in the next 3 years.
Instrument
Total
number of
respondents
Total
number of
responses per
respondent
Average
burden
hours per
response
Total burden
hours
Program Specific PPRs ...................................................................................
900
3
6
16,200
John M. Sweet Jr.,
ACF/OPRE Certifying Officer.
[FR Doc. 2023–01762 Filed 1–27–23; 8:45 am]
BILLING CODE 4184–79–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0187]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Premarket
Approval of Medical Devices
AGENCY:
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qualitative or incomplete information.
This one-size-fits-all approach did not
adequately collect the specific data
needed for particular grant programs or
allow program offices to assess
continuous quality improvement.
Different grant programs vary in
purpose, target population, and
activities. Therefore, a need for program
offices to customize performance
measurements was identified and the
generic program-specific PPR was
developed. Non-discretionary funding
recipients have historically provided
performance and progress data through
program-specific information collection
requests. When subject to the Paperwork
Reduction Act, these collections have
been approved through full information
collection requests.
ACF program offices have provided
feedback that the ability to efficiently
customize performance measurements
would also be helpful for these funding
recipients and therefore, ACF would
like to expand this generic to cover
these non-discretionary funding
recipients as well.
ACF program offices have benefited
from the ability to create and use a
program-specific PPR that is more
effective and includes specific data
elements that reflects a specific
program’s indicators, demographics,
priorities and objectives.
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.
SUMMARY:
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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 premarket
approval of medical devices.
DATES: Submit either electronic or
written comments on the collection of
information by March 31, 2023.
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 March 31,
2023. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of March 31, 2023. Comments
received by mail/hand delivery/courier
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(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
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Federal Register / Vol. 88, No. 19 / Monday, January 30, 2023 / Notices
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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–
2023–N–0187 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Premarket Approval of Medical
Devices.’’ 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, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
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
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‘‘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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
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: Under the
PRA (44 U.S.C. 3501–3521), 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
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5889
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Premarket Approval of Medical Devices
OMB Control Number 0910–0231—
Revision
This information collection supports
implementation of statutory and
regulatory requirements that govern
premarket approval of medical devices.
Premarket approval (PMA) is the FDA
process of scientific and regulatory
review to evaluate the safety and
effectiveness of Class III medical
devices. Class III devices are those that
support or sustain human life, are of
substantial importance in preventing
impairment of human health, or which
present a potential, unreasonable risk of
illness or injury. Due to the level of risk
associated with Class III devices, FDA
has determined that general and special
controls alone are insufficient to assure
the safety and effectiveness of Class III
devices. Therefore, these devices require
a premarket approval (PMA) application
under section 515 of the FD&C Act (21
U.S.C. 360e) in order to obtain
marketing approval. Please note that
PMA requirements apply differently to
preamendments devices,
postamendments devices, and
transitional class III devices and some
Class III preamendment devices may
require a Class III 510(k). See the PMA
Historical Background web page at
https://www.fda.gov/medical-devices/
premarket-approval-pma/pmahistorical-background for additional
information. Section 515A of the FD&C
Act (21 U.S.C. 360e–1) governs pediatric
uses of devices.
The PMA is the most stringent type of
device marketing application required
by FDA. Applicants must receive FDA
approval of a PMA application prior to
marketing the device. PMA approval is
based on a determination that the PMA
contains sufficient valid scientific
evidence to assure that the device is safe
and effective for its intended use(s).
Respondents to the information
collection are PMA applicants, or
persons who own the rights, or
otherwise have authorized access, to the
data and other information to be
submitted in support of FDA approval.
This person may be an individual,
partnership, corporation, association,
scientific or academic establishment,
government agency or organizational
unit, or other legal entity. The applicant
is often the inventor/developer and
ultimately the manufacturer. A Class III
device that fails to meet PMA
requirements is considered to be
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Federal Register / Vol. 88, No. 19 / Monday, January 30, 2023 / Notices
adulterated under section 501(f) of the
FD&C Act (21 U.S.C. 351(f)) and may
not be marketed.
FDA regulations in part 814 (21 CFR
part 814) implement section 515 and
515A of the FD&C Act and establish
procedures for the premarket approval
of medical devices intended for human
use, including the submission of
information concerning use in pediatric
patients. Regulations in part 814,
subpart A (§§ 814.1 to 814.19) set forth
general provisions pertaining to the
confidentiality of data and information
submitted to FDA in a PMA, research
conducted outside the United States,
service of orders, and product
development protocols. Provisions in
part 814, subparts B and C (§§ 814.20 to
814.47) establish format and content
elements that must be included in an
application, explain submission and
review schedules, and address the
withdrawal and temporary suspension
of a PMA. Postapproval requirements,
including reports required under 21
CFR part 803 (medical device reporting),
are covered in regulations in part 814,
subpart E (§§ 814.80 to 814.84). Burden
attributable to information collection
associated with regulations in part 814,
subpart H (§§ 814.100 to 814.126)
pertaining to Humanitarian Use Devices
is currently approved in OMB control
number 0910–0332.
For operational efficiency, we are
revising the information collection to
include burden that may be associated
with recommendations found in the
Agency guidance document entitled,
‘‘Providing Information about Pediatric
Uses of Medical Devices’’ (May 2014),
currently approved in OMB control
number 0910–0748. The guidance
document describes how to compile and
submit the readily available pediatric
use information required under section
515A of the FD&C Act. The guidance
document is available for download
from our website at https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
providing-information-about-pediatricuses-medical-devices.
Relatedly, we are revising the
information collection to include
burden that may be associated with the
submission of information on pediatric
use of medical devices under section
515A of the FD&C Act, also currently
approved in OMB control number 0910–
0748. Section 515A(a) of the FD&C Act
requires applicants who submit
information to include readily available
information providing a description of
any pediatric subpopulations that suffer
from the disease or condition that the
device is intended to treat, diagnose, or
cure, and the number of affected
pediatric patients. This information
allows FDA to track the number of
approved devices for which there is a
pediatric subpopulation that suffers
from the disease or condition that the
device is intended to treat, diagnose, or
cure and the review time for each such
device application.
We are also revising the information
collection to include burden applicable
to implementing requirements under
section 402(j)(5)(B) of the Public Health
Service (PHS) Act (42 U.S.C.
282(j)(5)(b)), and set forth in regulations
at 42 CFR part 11 (see 81 FR 64981,
September 21, 2016). Specifically,
applications under sections 505, 515, or
520(m) of the FD&C Act (21 U.S.C. 355,
360e, or 360j(m)), or under section 351
of the PHS Act (42 U.S.C. 262), or
submission of a report under section
510(k) of the FD&C Act, must be
accompanied by a certification. Where
available, such certification must
include the appropriate National
Clinical Trial numbers. We have
developed Form FDA 3674
(‘‘Certifications to Accompany Drug,
Biological Product, and Medical Device
Applications/Submissions’’), available
at https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/form-fda-3674-certificationsaccompany-drug-biological-productand-device-applicationssubmissions, for
respondents to submit the requisite
information.
Respondents can make single
submissions in an electronic format that
includes eCopies, submissions
submitted on CD, DVD, or flash drive
and mailed to FDA and eSubmissions,
submissions created using an electronic
submission template (e.g., ‘‘electronic
Submission Template and Resource’’
(eSTAR)). Consistent with our authority
in section 745A(b) of the FD&C Act (21
U.S.C. 379k–1(b)), and performance
goals found in our current Medical
Device User Fee Amendments
Commitment Letter, we developed
eSTAR for use through the Center for
Devices and Radiological Health
Customer Collaboration Portal. We use
eSTAR as a tool to facilitate the
preparation of submissions in electronic
format (available on FDA’s website at
https://www.fda.gov/medical-devices/
how-study-and-market-your-device/
voluntary-estar-program and identified
as Form FDA 4062 ‘‘Electronic
Submission Template and Resource
(eSTAR)’’ (for Non-In Vitro Diagnostic
submissions) and form FDA 4078
‘‘Electronic Submission Template and
Resource (eSTAR)’’ (for In Vitro
Diagnostic submissions)). We believe
respondents’ use of eSTAR will
significantly reduce burden attendant to
application submissions by providing a
uniform format for requisite elements
and by enhancing user interface through
the use of modernized technology.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity/21 CFR or FD&C Act section
Average
burden per
response (hours)
Total annual
responses
Total hours
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Premarket Approval Submissions (‘‘traditional’’ preparation; eCopy submission)
21 CFR Part 814, Premarket Approval of Medical Devices
Subpart A—General:
Research conducted outside the United States (814.15(b)) ........
Subpart B—Premarket Approval Application (PMA):
PMA application (814.20) .............................................................
Information on clinical investigations conducted outside the
United States (814.20(b)(6)(ii)(C)).
PMA amendments and resubmitted PMAs (814.37(a)–(c) and
(e)).
PMA supplements (814.39(a)) ......................................................
Special PMA supplement—changes being affected (814.39(d))
30-day notice (814.39(f)) ..............................................................
Subtotal Parts A and B ..........................................................
Subpart C—FDA Action on a PMA:
Panel of experts request (814.42 and 515(c)(3) of the FD&C
Act).
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20
1
20
2 ......................................
40
40
10
1
1
40
10
654.6 ...............................
0.5 (30 minutes) .............
26,184
5
1,356
1
1,356
167 ..................................
226,452
762
75
1,181
........................
1
1
1
........................
762
75
1,181
........................
0.983 (59.11 minutes) ....
6 ......................................
16 ....................................
.........................................
45,048
450
18,896
317,075
1
1
1
30 ....................................
30
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
Activity/21 CFR or FD&C Act section
Number of
responses per
respondent
Average
burden per
response (hours)
Total annual
responses
Total hours
Subpart E—Postapproval Requirements:
Postapproval requirements (814.82(a)(9)) ...................................
Periodic reports (814.84(b)) ..........................................................
121
764
1
1
121
764
135 ..................................
10 ....................................
16,335
7,640
Total Subpart E .....................................................................
........................
........................
........................
.........................................
24,005
42 CFR part 11, Clinical Trials Registration and Results Information Submission, subparts D and E; and FDA Guidance ‘‘Form FDA 3674—Certifications To
Accompany Drug, Biological Product, and Device Applications/Submissions’’
Certification to accompany PMA submissions (Form FDA 3674) .......
40
1
40
0.75 (45 minutes) ...........
30
FD&C Act section 515A Pediatric Uses of Devices:
Pediatric information in a PMA, PDP, or PMA supplement ................
Pediatric use information outside approved indication ........................
944
800
1
1
944
800
2.10 .................................
0.5 (30 minutes) .............
1984
400
Subtotal ..................................................................................
1,744
1
1,744
.........................................
2,384
Premarket Approval Submissions (eSTAR preparation; eCopy submission):
eSTAR setup ........................................................................................
30
1
30
0.08 (5 minutes) .............
2
Total ................................................................................
........................
........................
........................
.........................................
343,496
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimate is based on the annual
rate of receipt of PMA submissions,
including PDPs and PMA supplements,
for fiscal years 2019 through 2021 and
our expectation of submissions to come
in the next few years. We also account
for referrals of PMAs to a panel for
review, as provided for under
§ 814.44(a). FDA may refer the PMA to
a panel on its own initiative, and will
do so upon request of an applicant,
unless FDA determines that the
application substantially duplicates
information previously reviewed by a
panel. We have adjusted our figures to
reflect an overall decrease, which we
attribute to respondents’ use of
modernized submission technologies
including eSTAR. At the same time, we
include in our estimate an initial burden
attributable to respondents who need to
set up an eSTAR account for the first
time.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity/21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Maintenance of records (814.82(a)(5) and (a)(6)) ...............
552
1
552
17
9,384
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The regulations require the
maintenance of records, which are used
to trace patients, and the organization
and indexing of records into identifiable
files to ensure a device’s continued
safety and effectiveness. These records
are required of all applicants who have
an approved PMA. Currently there are
815 active PMAs that could be subject
to these requirements, based on FDA
data, and approximately 33 new PMAs
are approved each year. We estimate our
annual recordkeeping burden based on
an average of 552 PMA holders. The
applicant determines which records
should be maintained during product
development to document and/or
substantiate the device’s safety and
effectiveness. Records required under 21
CFR part 820 may be relevant to a PMA
review and may be submitted as part of
an application. In individual instances,
records may be required as conditions of
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approval to ensure the device’s
continuing safety and effectiveness.
Cumulatively, our adjustments reflect
only a slight increase to the estimated
burden for the information collection.
Dated: January 25, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–01849 Filed 1–27–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–2658]
Acromegaly: Developing Drugs for
Treatment; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Acromegaly: Developing Drugs for
Treatment.’’ The purpose of this
guidance is to provide
recommendations to sponsors regarding
clinical development of drugs for the
treatment of patients with acromegaly.
This draft guidance is intended to serve
as a focus for continued discussions
among the FDA Division of General
Endocrinology, pharmaceutical
sponsors, the academic community, and
the public.
DATES: Submit either electronic or
written comments on the draft guidance
by March 31, 2023 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
SUMMARY:
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]]>Agencies
[Federal Register Volume 88, Number 19 (Monday, January 30, 2023)]
[Notices]
[Pages 5888-5891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01849]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0187]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Premarket Approval of Medical Devices
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
premarket approval of medical devices.
DATES: Submit either electronic or written comments on the collection
of information by March 31, 2023.
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 March 31, 2023. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 31, 2023. 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
[[Page 5889]]
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-2023-N-0187 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Premarket Approval of Medical
Devices.'' 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, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your 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.govinfo.gov/content/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, 240-402-7500.
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: Under the PRA (44 U.S.C. 3501-3521), 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.
Premarket Approval of Medical Devices
OMB Control Number 0910-0231--Revision
This information collection supports implementation of statutory
and regulatory requirements that govern premarket approval of medical
devices. Premarket approval (PMA) is the FDA process of scientific and
regulatory review to evaluate the safety and effectiveness of Class III
medical devices. Class III devices are those that support or sustain
human life, are of substantial importance in preventing impairment of
human health, or which present a potential, unreasonable risk of
illness or injury. Due to the level of risk associated with Class III
devices, FDA has determined that general and special controls alone are
insufficient to assure the safety and effectiveness of Class III
devices. Therefore, these devices require a premarket approval (PMA)
application under section 515 of the FD&C Act (21 U.S.C. 360e) in order
to obtain marketing approval. Please note that PMA requirements apply
differently to preamendments devices, postamendments devices, and
transitional class III devices and some Class III preamendment devices
may require a Class III 510(k). See the PMA Historical Background web
page at https://www.fda.gov/medical-devices/premarket-approval-pma/pma-historical-background for additional information. Section 515A of the
FD&C Act (21 U.S.C. 360e-1) governs pediatric uses of devices.
The PMA is the most stringent type of device marketing application
required by FDA. Applicants must receive FDA approval of a PMA
application prior to marketing the device. PMA approval is based on a
determination that the PMA contains sufficient valid scientific
evidence to assure that the device is safe and effective for its
intended use(s). Respondents to the information collection are PMA
applicants, or persons who own the rights, or otherwise have authorized
access, to the data and other information to be submitted in support of
FDA approval. This person may be an individual, partnership,
corporation, association, scientific or academic establishment,
government agency or organizational unit, or other legal entity. The
applicant is often the inventor/developer and ultimately the
manufacturer. A Class III device that fails to meet PMA requirements is
considered to be
[[Page 5890]]
adulterated under section 501(f) of the FD&C Act (21 U.S.C. 351(f)) and
may not be marketed.
FDA regulations in part 814 (21 CFR part 814) implement section 515
and 515A of the FD&C Act and establish procedures for the premarket
approval of medical devices intended for human use, including the
submission of information concerning use in pediatric patients.
Regulations in part 814, subpart A (Sec. Sec. 814.1 to 814.19) set
forth general provisions pertaining to the confidentiality of data and
information submitted to FDA in a PMA, research conducted outside the
United States, service of orders, and product development protocols.
Provisions in part 814, subparts B and C (Sec. Sec. 814.20 to 814.47)
establish format and content elements that must be included in an
application, explain submission and review schedules, and address the
withdrawal and temporary suspension of a PMA. Postapproval
requirements, including reports required under 21 CFR part 803 (medical
device reporting), are covered in regulations in part 814, subpart E
(Sec. Sec. 814.80 to 814.84). Burden attributable to information
collection associated with regulations in part 814, subpart H
(Sec. Sec. 814.100 to 814.126) pertaining to Humanitarian Use Devices
is currently approved in OMB control number 0910-0332.
For operational efficiency, we are revising the information
collection to include burden that may be associated with
recommendations found in the Agency guidance document entitled,
``Providing Information about Pediatric Uses of Medical Devices'' (May
2014), currently approved in OMB control number 0910-0748. The guidance
document describes how to compile and submit the readily available
pediatric use information required under section 515A of the FD&C Act.
The guidance document is available for download from our website at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-information-about-pediatric-uses-medical-devices.
Relatedly, we are revising the information collection to include
burden that may be associated with the submission of information on
pediatric use of medical devices under section 515A of the FD&C Act,
also currently approved in OMB control number 0910-0748. Section
515A(a) of the FD&C Act requires applicants who submit information to
include readily available information providing a description of any
pediatric subpopulations that suffer from the disease or condition that
the device is intended to treat, diagnose, or cure, and the number of
affected pediatric patients. This information allows FDA to track the
number of approved devices for which there is a pediatric subpopulation
that suffers from the disease or condition that the device is intended
to treat, diagnose, or cure and the review time for each such device
application.
We are also revising the information collection to include burden
applicable to implementing requirements under section 402(j)(5)(B) of
the Public Health Service (PHS) Act (42 U.S.C. 282(j)(5)(b)), and set
forth in regulations at 42 CFR part 11 (see 81 FR 64981, September 21,
2016). Specifically, applications under sections 505, 515, or 520(m) of
the FD&C Act (21 U.S.C. 355, 360e, or 360j(m)), or under section 351 of
the PHS Act (42 U.S.C. 262), or submission of a report under section
510(k) of the FD&C Act, must be accompanied by a certification. Where
available, such certification must include the appropriate National
Clinical Trial numbers. We have developed Form FDA 3674
(``Certifications to Accompany Drug, Biological Product, and Medical
Device Applications/Submissions''), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/form-fda-3674-certifications-accompany-drug-biological-product-and-device-applicationssubmissions, for respondents to submit the requisite
information.
Respondents can make single submissions in an electronic format
that includes eCopies, submissions submitted on CD, DVD, or flash drive
and mailed to FDA and eSubmissions, submissions created using an
electronic submission template (e.g., ``electronic Submission Template
and Resource'' (eSTAR)). Consistent with our authority in section
745A(b) of the FD&C Act (21 U.S.C. 379k-1(b)), and performance goals
found in our current Medical Device User Fee Amendments Commitment
Letter, we developed eSTAR for use through the Center for Devices and
Radiological Health Customer Collaboration Portal. We use eSTAR as a
tool to facilitate the preparation of submissions in electronic format
(available on FDA's website at https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program and identified as
Form FDA 4062 ``Electronic Submission Template and Resource (eSTAR)''
(for Non-In Vitro Diagnostic submissions) and form FDA 4078
``Electronic Submission Template and Resource (eSTAR)'' (for In Vitro
Diagnostic submissions)). We believe respondents' use of eSTAR will
significantly reduce burden attendant to application submissions by
providing a uniform format for requisite elements and by enhancing user
interface through the use of modernized technology.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR or FD&C Act section Number of responses per Total annual Average burden per response (hours) Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Approval Submissions (``traditional'' preparation; eCopy submission)
21 CFR Part 814, Premarket Approval of Medical Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Subpart A--General:
Research conducted outside the United 20 1 20 2......................................... 40
States (814.15(b)).
Subpart B--Premarket Approval Application
(PMA):
PMA application (814.20)................ 40 1 40 654.6..................................... 26,184
Information on clinical investigations 10 1 10 0.5 (30 minutes).......................... 5
conducted outside the United States
(814.20(b)(6)(ii)(C)).
PMA amendments and resubmitted PMAs 1,356 1 1,356 167....................................... 226,452
(814.37(a)-(c) and (e)).
PMA supplements (814.39(a))............. 762 1 762 0.983 (59.11 minutes)..................... 45,048
Special PMA supplement--changes being 75 1 75 6......................................... 450
affected (814.39(d)).
30-day notice (814.39(f))............... 1,181 1 1,181 16........................................ 18,896
Subtotal Parts A and B.............. .............. .............. .............. .......................................... 317,075
Subpart C--FDA Action on a PMA:
Panel of experts request (814.42 and 1 1 1 30........................................ 30
515(c)(3) of the FD&C Act).
[[Page 5891]]
Subpart E--Postapproval Requirements:
Postapproval requirements (814.82(a)(9)) 121 1 121 135....................................... 16,335
Periodic reports (814.84(b))............ 764 1 764 10........................................ 7,640
-----------------------------------------------------------------------------------------------------------
Total Subpart E..................... .............. .............. .............. .......................................... 24,005
--------------------------------------------------------------------------------------------------------------------------------------------------------
42 CFR part 11, Clinical Trials Registration and Results Information Submission, subparts D and E; and FDA Guidance ``Form FDA 3674--Certifications To
Accompany Drug, Biological Product, and Device Applications/Submissions''
--------------------------------------------------------------------------------------------------------------------------------------------------------
Certification to accompany PMA submissions 40 1 40 0.75 (45 minutes)......................... 30
(Form FDA 3674).
--------------------------------------------------------------------------------------------------------------------------------------------------------
FD&C Act section 515A Pediatric Uses of Devices:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pediatric information in a PMA, PDP, or PMA 944 1 944 2.10...................................... 1984
supplement.
Pediatric use information outside approved 800 1 800 0.5 (30 minutes).......................... 400
indication.
-----------------------------------------------------------------------------------------------------------
Subtotal............................ 1,744 1 1,744 .......................................... 2,384
--------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Approval Submissions (eSTAR preparation; eCopy submission):
--------------------------------------------------------------------------------------------------------------------------------------------------------
eSTAR setup................................. 30 1 30 0.08 (5 minutes).......................... 2
-----------------------------------------------------------------------------------------------------------
Total........................... .............. .............. .............. .......................................... 343,496
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimate is based on the annual rate of receipt of PMA
submissions, including PDPs and PMA supplements, for fiscal years 2019
through 2021 and our expectation of submissions to come in the next few
years. We also account for referrals of PMAs to a panel for review, as
provided for under Sec. 814.44(a). FDA may refer the PMA to a panel on
its own initiative, and will do so upon request of an applicant, unless
FDA determines that the application substantially duplicates
information previously reviewed by a panel. We have adjusted our
figures to reflect an overall decrease, which we attribute to
respondents' use of modernized submission technologies including eSTAR.
At the same time, we include in our estimate an initial burden
attributable to respondents who need to set up an eSTAR account for the
first time.
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maintenance of records (814.82(a)(5) and (a)(6))................... 552 1 552 17 9,384
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The regulations require the maintenance of records, which are used
to trace patients, and the organization and indexing of records into
identifiable files to ensure a device's continued safety and
effectiveness. These records are required of all applicants who have an
approved PMA. Currently there are 815 active PMAs that could be subject
to these requirements, based on FDA data, and approximately 33 new PMAs
are approved each year. We estimate our annual recordkeeping burden
based on an average of 552 PMA holders. The applicant determines which
records should be maintained during product development to document
and/or substantiate the device's safety and effectiveness. Records
required under 21 CFR part 820 may be relevant to a PMA review and may
be submitted as part of an application. In individual instances,
records may be required as conditions of approval to ensure the
device's continuing safety and effectiveness.
Cumulatively, our adjustments reflect only a slight increase to the
estimated burden for the information collection.
Dated: January 25, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01849 Filed 1-27-23; 8:45 am]
BILLING CODE 4164-01-P
