Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification of Devices, 38063-38065 [2023-12489]
Download as PDF
<![CDATA[
Federal Register / Vol. 88, No. 112 / Monday, June 12, 2023 / Notices
Adverse Event Program for Medical
Devices (Medical Product Safety
Network (MedSun))
OMB Control Number 0910–0471—
Extension
Section 519 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
360i) authorizes FDA to require: (1)
manufacturers to report medical devicerelated deaths, serious injuries, and
malfunctions and (2) user facilities to
report device-related deaths directly to
manufacturers and FDA and serious
injuries to the manufacturer. Section
213 of the Food and Drug
Administration Modernization Act of
1997 (Pub. L. 105–115) amended section
519(b) of the FD&C Act relating to
mandatory reporting by user facilities of
deaths, serious injuries, and serious
illnesses associated with the use of
medical devices. This amendment
legislated the replacement of universal
user facility reporting by a system that
is limited to a ‘‘. . . subset of user
facilities that constitutes a
representative profile of user reports’’
for device-related deaths and serious
injuries. This amendment is reflected in
section 519(b)(5)(A) of the FD&C Act (21
U.S.C. 360i(b)(5)(A)). This legislation
provides FDA with the opportunity to
design and implement a national
surveillance network, composed of welltrained clinical facilities, to provide
high-quality data on medical devices in
clinical use. This system is called
MedSun. FDA is seeking OMB clearance
to continue to use electronic data
collection to obtain information related
to medical devices and tissue products
from the user facilities participating in
MedSun, to obtain a demographic
profile of the facilities, and for
additional questions, which will permit
FDA to better understand the cause of
reported adverse events. Participation in
the program is voluntary and includes
approximately 300 facilities. In addition
to collecting data on the electronic
adverse event report form, MedSun
38063
collects additional information from
participating sites about reported
problems emerging from the MedSun
hospitals. This data collection is also
voluntary and is collected on the same
website as the report information. The
burden estimate is based on the number
of facilities participating in MedSun
(300). FDA estimates an average of 18
reports per site annually. This estimate
is based on MedSun working to promote
reporting in general from the sites, as
well as promoting reporting from
specific parts of the hospitals, such as
the pediatric intensive care units, the
electrophysiology laboratories, and the
hospital laboratories.
In the Federal Register of January 19,
2023 (88 FR 3417), FDA published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Adverse event reporting ................................................
1 There
Dated: June 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–12483 Filed 6–9–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–1889]
ddrumheller on DSK120RN23PROD with NOTICES1
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Premarket
Notification of Devices
Food and Drug Administration,
HHS.
ACTION:
300
Total annual
responses
18
Average burden
per response
5,400
Total hours
0.5 (30 minutes) ...
2,700
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
AGENCY:
Number of
responses per
respondent
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
SUMMARY:
VerDate Sep<11>2014
17:39 Jun 09, 2023
Jkt 259001
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(PRA).
DATES: Submit written comments
(including recommendations) on the
collection of information by July 12,
2023.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0120. 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
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
collection of information to OMB for
review and clearance.
Premarket Notification of Devices
OMB Control Number 0910–0120—
Revision
This information collection helps
support implementation of statutory
provisions that govern premarket
clearance of devices. Section 510(k) of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 360(k)) and
implementing regulations in part 807,
subpart E (21 CFR part 807, subpart E),
establish premarket notification
procedures. Persons who intend to
market a medical device, for which a
premarket approval application (PMA)
is not required, must submit a
premarket notification to FDA, unless
the device is exempt from 510(k)
requirements and does not exceed the
limitations of exemptions of the device
classification regulations, at least 90
days before proposing to begin the
introduction, or delivery for
introduction into interstate commerce,
for commercial distribution of a device
intended for human use. Based on the
information provided in the
notification, FDA must determine
whether the new device is substantially
E:\FR\FM\12JNN1.SGM
12JNN1
38064
Federal Register / Vol. 88, No. 112 / Monday, June 12, 2023 / Notices
equivalent to a legally marketed device.
If a device is determined to be not
substantially equivalent to a legally
marketed device, it must have an
approved PMA, product development
protocol, humanitarian device
exemption (HDE), request for an
evaluation of automatic class III
designation (De Novo request), or be
reclassified into class I or class II before
being marketed. The information
collection also helps support section
510(l) of the FD&C Act, which provides
for exemption from premarket
notification.
The following instruments are
included in the information collection:
• Form FDA 3514, ‘‘CDRH Premarket
Review Submission Cover Sheet’’
• Form FDA 3881, ‘‘Indications for
Use’’
• Voluntary eSTAR Program Interactive
PDF Form and instructional web page
• Form FDA 4062, ‘‘Electronic
Submission Template and Resource
(eSTAR)’’ (for non-In Vitro Diagnostic
(IVD) 510(k) submissions)
• Form FDA 4078, ‘‘Electronic
Submission Template and Resource
(eSTAR)’’ (for In Vitro Diagnostic
(IVD) 510(k) submissions)
We are revising the information
collection to include Form FDA 3674,
‘‘Certification of Compliance, Under 42
U.S.C., 282(j)(5)(B), with Requirements
of ClinicalTrials.gov.’’ Under applicable
authorities, 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 Public Health Service
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.
The information collection also
includes an ‘‘Acceptance Checklist.’’ As
discussed in the guidance document
‘‘Refuse to Accept Policy for 510(k)s’’
(April 2022), available at https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/refuseaccept-policy-510ks, we believe the
checklist can be a helpful resource for
510(k) submitters and may simplify
preparation of the 510(k). Similarly, the
guidance document ‘‘Recognition and
Withdrawal of Voluntary Consensus
Standards’’ (September 2020), available
at https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/recognition-and-withdrawalvoluntary-consensus-standards,
communicates procedures followed by
the Center for Devices and Radiological
Health (CDRH) when requests for
recognition of a voluntary consensus
standard for medical products are
received. The guidance document
outlines principles for recognizing a
standard wholly, partly, or not at all, as
well as reasons and rationales for
withdrawing a standard. Section 514 of
the FD&C Act (21 U.S.C. 360d) allows
FDA to recognize consensus standards
developed by international and national
organizations for use in satisfying
portions of device premarket review
submissions, including premarket
notifications or other requirements. We
publish and update the list of
recognized standards regularly at
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards/ucm123792.htm. As
instructed in the guidance document,
any interested party may submit a
request for recognition of a standard by
mail directed to the CDRH Standards
Program (i.e., paper copy) or
electronically via email.
For efficiency of Agency operations,
we are also revising the information to
include activities associated with
section 520(b) of the FD&C Act,
governing custom devices. Regulations
in 21 CFR 812.3 define a custom device
and implementing regulations in 21 CFR
807.85 provide for exemption from
premarket notification. Section 520(b) of
the FD&C Act also provides for the
issuance of guidance. The guidance
document entitled, ‘‘Custom Device
Exemption’’ (September 2014), and
available for download at https://
www.fda.gov/media/89897/download,
explains how FDA interprets provisions
in section 520(b)(2)(B) of the FD&C Act,
describes what information should be
submitted in a Custom Device Annual
Report (‘‘annual report’’), and provides
recommendations on how to submit an
annual report for devices distributed
under the custom device exemption.
Finally, we discuss the guidance
document entitled, ‘‘Transition Plan for
Medical Devices That Fall Within
Enforcement Policies Issued During the
Coronavirus Disease 2019 (COVID–19)
Public Health Emergency,’’ announced
in the Federal Register of March 27,
2023 (88 FR 18153), which describes a
phased approach intended to help avoid
disruption in device supply and help
facilitate compliance with applicable
legal requirements. The
recommendations discussed in the
guidance document result in the onetime collection of information intended
to ensure an orderly and transparent
transition from temporary policies
established during the COVID–19 public
health emergency to normal operations.
Because the information collection
recommendations apply to specific
medical devices already in distribution,
we believe the information discussed is
appropriately characterized as
nonstandardized followup designed to
clarify responses to approved
collections of information (i.e., plans for
compliance with applicable
requirements unique to that distributed
device). We therefore believe the
activity constitutes the collection of
non-identical and/or followup
information, as defined under 5 CFR
1320.3. At the same time, we expect
some degree of fluctuation in future
submissions under part 807, subpart E,
as a result of implementation of the
medical device transition plan.
In the Federal Register of February
21, 2023 (88 FR 10517), we published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received. However, since publication of
our 60-day notice, we have adjusted our
previous estimate to include burden
associated with Form FDA 3674
(submission certification), as well as
custom device reporting currently
included in OMB control number 0910–
0767 and discussed in the Federal
Register of March 13, 2023 (88 FR
15410).
We estimate the burden of the
information collection as follows:
ddrumheller on DSK120RN23PROD with NOTICES1
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity and 21 CFR part/section
Form FDA No.
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
21 CFR Part 807, Subpart E, Premarket Notification Procedures
510(k) submission (807 subpart E) ...
Summary cover sheet (807.87) .........
Status request (807.90(a)(3)) ............
VerDate Sep<11>2014
17:39 Jun 09, 2023
3881
3514
........................
Jkt 259001
PO 00000
Frm 00050
3,800
1,906
1
Fmt 4703
1
1
1
Sfmt 4703
3,800
1,906
1
E:\FR\FM\12JNN1.SGM
79.25 ....................
0.5 (30 minutes) ...
0.25 (15 minutes)
12JNN1
301,150
953
1
38065
Federal Register / Vol. 88, No. 112 / Monday, June 12, 2023 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Activity and 21 CFR part/section
Form FDA No.
510(k) summary (807.92) ..................
510(k) statement (807.93) .................
510(k) submission (807 subpart E)—
using eSTAR format.
........................
........................
4062, 4078
Number of
responses per
respondent
Number of
respondents
2,725
215
100
Average
burden per
response
Total annual
responses
1
1
1
Total hours
2,725
215
100
4 ...........................
10 .........................
40 .........................
10,900
2,150
4,000
Guidance Document Recommendations
Submitting information associated
with requests for recognition of a
voluntary consensus standard.
Annual reporting for custom devices
under 520(b) of the FD&C Act.
........................
9
1
9
1 ...........................
9
........................
34
1
34
40 .........................
1,360
‘‘Form FDA 3674—Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions’’
Certification to accompany 510(k)
submissions.
3674
3,800
1
3,800
0.75 (45 minutes)
2,850
Electronic Submission Template and Resource (eSTAR)
eSTAR setup—one-time burden .......
........................
80
1
80
0.08 (5 minutes) ...
6
Total ...........................................
........................
........................
........................
12,670
..............................
323,379
ddrumheller on DSK120RN23PROD with NOTICES1
1 There
are no capital costs, or operating and maintenance costs, associated with the information collection.
Both the regulations in part 807,
subpart E and the associated guidance
documents prescribe specific format and
content elements necessary for FDA
action on submissions. Based on recent
trends, an estimated 3,800 submissions
are expected each year. Our
administrative and technical staff, who
are familiar with the requirements for
submission of premarket notifications,
estimate that it takes an average of 79.25
hours to prepare a submission. Because
the PRA defines a recordkeeping
requirement to include a requirement to
report those records to the Federal
government, we account for burden
associated with preparing, transmitting,
and responding to followup requests
from FDA for supplemental information
in our estimate. We expect to receive
approximately 100 510(k) submissions
via eSTAR per year and estimate that
eSTAR submissions will each require 40
hours to complete. In addition, based on
a recent review of submissions, we
estimate 1,906 summary cover sheets
will be received annually. We assume
30 minutes are needed to complete the
summary cover sheet. We further
estimate that 9 respondents will submit
information pertaining to a request for
recognition of a voluntary standard and
that the activity requires an average of
1 hour. We also account for a one-time
setup burden of 5 minutes for an
estimated 80 new eSTAR users
annually.
As a result of adding burden
previously included under OMB control
VerDate Sep<11>2014
17:39 Jun 09, 2023
Jkt 259001
numbers 0910–0616 (submission
certification element) and 0910–0767
(custom device exemptions), we have
adjusted our burden upward. We have
also made nominal adjustments on
individual provisions to reflect expected
fluctuations in submissions.
Cumulatively, these actions result in an
overall increase of 3,671 hours and a
corresponding increase of 4,210
responses annually.
Dated: June 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–12489 Filed 6–9–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
PO 00000
Frm 00051
Fmt 4703
Sfmt 9990
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
General Medical Sciences Special Emphasis
Panel; Centers of Biomedical Research
Excellence (COBRE Phase 1).
Date: July 20, 2023.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute of General Medical
Sciences, Natcher Building, 45 Center Drive,
Bethesda, Maryland 20892 (Virtual Meeting).
Contact Person: Jason M. Chan, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Institute of General Medical
Sciences, 45 Center Drive, MSC 6200,
Bethesda, Maryland 20892, 301–594–3663,
jason.chan2@nih.gov.
Information is also available on the
Institute’s/Center’s home page:
www.nigms.nih.gov/, where an agenda and
any additional information for the meeting
will be posted when available.
(Catalogue of Federal Domestic Assistance
Program No. 93.859, Biomedical Research
and Research Training, National Institutes of
Health, HHS)
Dated: June 7, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–12457 Filed 6–9–23; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\12JNN1.SGM
12JNN1
]]>Agencies
[Federal Register Volume 88, Number 112 (Monday, June 12, 2023)]
[Notices]
[Pages 38063-38065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12489]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-1889]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Premarket
Notification of Devices
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 (PRA).
DATES: Submit written comments (including recommendations) on the
collection of information by July 12, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0120. 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.
Premarket Notification of Devices
OMB Control Number 0910-0120--Revision
This information collection helps support implementation of
statutory provisions that govern premarket clearance of devices.
Section 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 360(k)) and implementing regulations in part 807, subpart E
(21 CFR part 807, subpart E), establish premarket notification
procedures. Persons who intend to market a medical device, for which a
premarket approval application (PMA) is not required, must submit a
premarket notification to FDA, unless the device is exempt from 510(k)
requirements and does not exceed the limitations of exemptions of the
device classification regulations, at least 90 days before proposing to
begin the introduction, or delivery for introduction into interstate
commerce, for commercial distribution of a device intended for human
use. Based on the information provided in the notification, FDA must
determine whether the new device is substantially
[[Page 38064]]
equivalent to a legally marketed device. If a device is determined to
be not substantially equivalent to a legally marketed device, it must
have an approved PMA, product development protocol, humanitarian device
exemption (HDE), request for an evaluation of automatic class III
designation (De Novo request), or be reclassified into class I or class
II before being marketed. The information collection also helps support
section 510(l) of the FD&C Act, which provides for exemption from
premarket notification.
The following instruments are included in the information
collection:
Form FDA 3514, ``CDRH Premarket Review Submission Cover
Sheet''
Form FDA 3881, ``Indications for Use''
Voluntary eSTAR Program Interactive PDF Form and instructional
web page
Form FDA 4062, ``Electronic Submission Template and Resource
(eSTAR)'' (for non-In Vitro Diagnostic (IVD) 510(k) submissions)
Form FDA 4078, ``Electronic Submission Template and Resource
(eSTAR)'' (for In Vitro Diagnostic (IVD) 510(k) submissions)
We are revising the information collection to include Form FDA
3674, ``Certification of Compliance, Under 42 U.S.C., 282(j)(5)(B),
with Requirements of ClinicalTrials.gov.'' Under applicable
authorities, 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
Public Health Service 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.
The information collection also includes an ``Acceptance
Checklist.'' As discussed in the guidance document ``Refuse to Accept
Policy for 510(k)s'' (April 2022), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks, we believe the checklist can be a helpful resource for
510(k) submitters and may simplify preparation of the 510(k).
Similarly, the guidance document ``Recognition and Withdrawal of
Voluntary Consensus Standards'' (September 2020), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recognition-and-withdrawal-voluntary-consensus-standards, communicates
procedures followed by the Center for Devices and Radiological Health
(CDRH) when requests for recognition of a voluntary consensus standard
for medical products are received. The guidance document outlines
principles for recognizing a standard wholly, partly, or not at all, as
well as reasons and rationales for withdrawing a standard. Section 514
of the FD&C Act (21 U.S.C. 360d) allows FDA to recognize consensus
standards developed by international and national organizations for use
in satisfying portions of device premarket review submissions,
including premarket notifications or other requirements. We publish and
update the list of recognized standards regularly at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. As instructed in the guidance document, any interested
party may submit a request for recognition of a standard by mail
directed to the CDRH Standards Program (i.e., paper copy) or
electronically via email.
For efficiency of Agency operations, we are also revising the
information to include activities associated with section 520(b) of the
FD&C Act, governing custom devices. Regulations in 21 CFR 812.3 define
a custom device and implementing regulations in 21 CFR 807.85 provide
for exemption from premarket notification. Section 520(b) of the FD&C
Act also provides for the issuance of guidance. The guidance document
entitled, ``Custom Device Exemption'' (September 2014), and available
for download at https://www.fda.gov/media/89897/download, explains how
FDA interprets provisions in section 520(b)(2)(B) of the FD&C Act,
describes what information should be submitted in a Custom Device
Annual Report (``annual report''), and provides recommendations on how
to submit an annual report for devices distributed under the custom
device exemption.
Finally, we discuss the guidance document entitled, ``Transition
Plan for Medical Devices That Fall Within Enforcement Policies Issued
During the Coronavirus Disease 2019 (COVID-19) Public Health
Emergency,'' announced in the Federal Register of March 27, 2023 (88 FR
18153), which describes a phased approach intended to help avoid
disruption in device supply and help facilitate compliance with
applicable legal requirements. The recommendations discussed in the
guidance document result in the one-time collection of information
intended to ensure an orderly and transparent transition from temporary
policies established during the COVID-19 public health emergency to
normal operations. Because the information collection recommendations
apply to specific medical devices already in distribution, we believe
the information discussed is appropriately characterized as
nonstandardized followup designed to clarify responses to approved
collections of information (i.e., plans for compliance with applicable
requirements unique to that distributed device). We therefore believe
the activity constitutes the collection of non-identical and/or
followup information, as defined under 5 CFR 1320.3. At the same time,
we expect some degree of fluctuation in future submissions under part
807, subpart E, as a result of implementation of the medical device
transition plan.
In the Federal Register of February 21, 2023 (88 FR 10517), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received. However, since
publication of our 60-day notice, we have adjusted our previous
estimate to include burden associated with Form FDA 3674 (submission
certification), as well as custom device reporting currently included
in OMB control number 0910-0767 and discussed in the Federal Register
of March 13, 2023 (88 FR 15410).
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity and 21 CFR part/section Form FDA No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR Part 807, Subpart E, Premarket Notification Procedures
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) submission (807 subpart E)..... 3881 3,800 1 3,800 79.25........................... 301,150
Summary cover sheet (807.87).......... 3514 1,906 1 1,906 0.5 (30 minutes)................ 953
Status request (807.90(a)(3))......... .............. 1 1 1 0.25 (15 minutes)............... 1
[[Page 38065]]
510(k) summary (807.92)............... .............. 2,725 1 2,725 4............................... 10,900
510(k) statement (807.93)............. .............. 215 1 215 10.............................. 2,150
510(k) submission (807 subpart E)-- 4062, 4078 100 1 100 40.............................. 4,000
using eSTAR format.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document Recommendations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submitting information associated with .............. 9 1 9 1............................... 9
requests for recognition of a
voluntary consensus standard.
Annual reporting for custom devices .............. 34 1 34 40.............................. 1,360
under 520(b) of the FD&C Act.
--------------------------------------------------------------------------------------------------------------------------------------------------------
``Form FDA 3674--Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions''
--------------------------------------------------------------------------------------------------------------------------------------------------------
Certification to accompany 510(k) 3674 3,800 1 3,800 0.75 (45 minutes)............... 2,850
submissions.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Electronic Submission Template and Resource (eSTAR)
--------------------------------------------------------------------------------------------------------------------------------------------------------
eSTAR setup--one-time burden.......... .............. 80 1 80 0.08 (5 minutes)................ 6
-----------------------------------------------------------------------------------------------------------------
Total............................. .............. .............. .............. 12,670 ................................ 323,379
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs, or operating and maintenance costs, associated with the information collection.
Both the regulations in part 807, subpart E and the associated
guidance documents prescribe specific format and content elements
necessary for FDA action on submissions. Based on recent trends, an
estimated 3,800 submissions are expected each year. Our administrative
and technical staff, who are familiar with the requirements for
submission of premarket notifications, estimate that it takes an
average of 79.25 hours to prepare a submission. Because the PRA defines
a recordkeeping requirement to include a requirement to report those
records to the Federal government, we account for burden associated
with preparing, transmitting, and responding to followup requests from
FDA for supplemental information in our estimate. We expect to receive
approximately 100 510(k) submissions via eSTAR per year and estimate
that eSTAR submissions will each require 40 hours to complete. In
addition, based on a recent review of submissions, we estimate 1,906
summary cover sheets will be received annually. We assume 30 minutes
are needed to complete the summary cover sheet. We further estimate
that 9 respondents will submit information pertaining to a request for
recognition of a voluntary standard and that the activity requires an
average of 1 hour. We also account for a one-time setup burden of 5
minutes for an estimated 80 new eSTAR users annually.
As a result of adding burden previously included under OMB control
numbers 0910-0616 (submission certification element) and 0910-0767
(custom device exemptions), we have adjusted our burden upward. We have
also made nominal adjustments on individual provisions to reflect
expected fluctuations in submissions. Cumulatively, these actions
result in an overall increase of 3,671 hours and a corresponding
increase of 4,210 responses annually.
Dated: June 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-12489 Filed 6-9-23; 8:45 am]
BILLING CODE 4164-01-P
