Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting, 19490-19494 [2025-08086]
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Federal Register / Vol. 90, No. 88 / Thursday, May 8, 2025 / Notices
proposed indication (use) is for the
treatment of adult patients with lowgrade intermediate-risk non-muscle
invasive bladder cancer (LG–IR–
NMIBC).
On the afternoon of May 21, 2025, the
Committee will discuss supplemental
new drug application (sNDA) 211651/S–
013, for TALZENNA (talazoparib)
capsules, submitted by Pfizer Inc. The
proposed indication (use) is in
combination with enzalutamide for the
treatment of adult patients with
metastatic castration-resistant prostate
cancer (mCRPC).
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Oncologic Drugs Advisory Committee
meeting due to technical issues. Because
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Dated: May 2, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2025–08060 Filed 5–7–25; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2025–N–0419]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Device
Reporting
AGENCY:
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.
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 revision 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
collections associated with
requirements for medical device
reporting for user facilities,
manufacturers, importers, and
distributors of medical devices.
DATES: Either electronic or written
comments on the collection of
information must be submitted by July
7, 2025.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
July 7, 2025. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
SUMMARY:
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
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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
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–
2025–N–0419 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Medical
Device Reporting.’’ 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
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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:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, 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 revision 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
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19491
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.
Medical Device Reporting—21 CFR Part
803
OMB Control Number 0910–0437—
Revision
This information collection supports
Food and Drug Administration (FDA)
regulations, programs, forms, and
guidance. Section 519 of the Federal
Food Drug and Cosmetic Act (the FD&C
Act) (21 U.S.C. 360i) (Records and
Reports on Devices) requires user
facilities, manufacturers, and importers
of medical devices to report adverse
events involving medical devices to
FDA and requires that medical device
manufacturers and importers submit
medical device reports (MDRs)
electronically. These provisions are
codified at part 803 (21 CFR part 803)—
Medical Device Reporting. The
regulations also provide for
recordkeeping requirements and certain
exemptions and alternative reporting.
Additionally, the regulations permit
user facilities to submit paper-based
annual reports, for which we have
provided form FDA 3419 entitled,
‘‘Medical Device Reporting Annual User
Facility Report.’’
Respondents are required to report
adverse events involving medical
devices to the FDA. The information
that is obtained from these reports will
be used to evaluate risks associated with
medical devices and enable FDA to take
appropriate regulatory measures to
protect the public health. Complete,
accurate, and timely adverse event
information is necessary for the
identification of emerging device
problems so the agency can protect the
public health under section 519 of the
FD&C Act. FDA makes the releasable
information available to the public for
downloading on its website (https://
www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfmaude/search.cfm).
In an effort at reducing burden, we
have developed the Voluntary
Malfunction Summary Reporting
(VMSR) Program for certain devices,
which allows for respondent reporting
of multiple malfunction events in a
single report on a quarterly basis. The
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VMSR Program was established under
section 519(a)(1)(B)(ii) of the FD&C Act.
The associated FDA notification and
order granting alternative entitled,
‘‘Medical Devices and Device-led
Combination Products; Voluntary
Malfunction Summary Reporting
Program for Manufacturers’’ (83 FR
40973; 8/17/2018; https://
www.federalregister.gov/documents/
2018/08/17/2018-17770/medicaldevices-and-device-led-combinationproducts-voluntary-malfunctionsummary-reporting-program) grants an
alternative under § 803.19 to permit
manufacturer reporting of certain device
malfunctions in summary form on a
quarterly basis. The associated FDA
guidance entitled ‘‘Voluntary
Malfunction Summary Reporting
(VMSR) Program for Manufacturers’’
(August 2024; https://www.fda.gov/
media/163692/download) is intended to
help manufacturers better understand
and use the VMSR Program.
The final order ‘‘Microbiology
Devices; Reclassification of Human
Immunodeficiency Virus Serological
Diagnostic and Supplemental Tests and
Human Immunodeficiency Virus
Nucleic Acid Diagnostic and
Supplemental Tests’’ (May 16, 2022; 87
FR 29661) established special controls
for certain Human Immunodeficiency
Virus (HIV) serological diagnostic and
supplemental tests (21 CFR 866.3956)
and for HIV nucleic acid tests (NATs)
diagnostic and supplemental tests (21
CFR 866.3957) to support their
classification into class II, including
Respondents are manufacturers and
importers of medical devices and device
user facilities. Device user facility
means a hospital, ambulatory surgical
facility, nursing home, outpatient
diagnostic facility, or outpatient
treatment facility as defined in § 803.3,
which is not a physician’s office (also
defined in § 803.3). Respondents are
also sponsors (manufacturers) of deviceled combination products (see part 4,
subpart B). Respondents also include
manufacturers of HIV diagnostic and
supplemental test devices.
Manufacturer and importer
respondents submit reports
electronically using FDA Form 3500A
(approved under OMB control number
0910–0291) via either ‘‘eSubmitter’’ for
low-volume reporters or Health Level
Seven (HL7) Individual Case Study
Report (ICSR) (HL7 ICSR) for highvolume reporters. User facilities
reporting under §§ 803.30 and 803.32
have the option of electronic or paperbased reporting. User facility annual
reporting under § 803.33 is paper based,
using form FDA 3419. Instructions for
submitting the information are available
in §§ 803.11, 803.12, and 803.20, and on
FDA’s public website at https://
www.fda.gov/medical-devices/
postmarket-requirements-devices/
mandatory-reporting-requirementsmanufacturers-importers-and-deviceuser-facilities (links to forms FDA
3500A and FDA 3419 are provided on
the web page).
FDA estimates the burden of this
collection of information as follows:
submission of a log of all complaints
annually for a period of 5 years
following FDA clearance of a traditional
premarket notification (510(k))
submission for these devices.
(Information collections associated with
premarket notification (510(k)) are
approved under OMB control number
0910–0120.)
Earlier notification through the
submission of the complaint log enables
us to more promptly determine whether
public health issues have been
adequately addressed. The agency
would not otherwise evaluate the kind
of complaint information that would be
included in the log until an FDA
inspection, which typically occurs less
frequently than annually. Implementing
these specific reporting measures as part
of the special controls for these devices
is necessary to provide a reasonable
assurance of safety and effectiveness for
HIV diagnostic and supplemental tests
subject to the reclassification order.
Provisions of part 4 subpart B (21 CFR
part 4, subpart B), provide that when
information regarding an event that
involves a death or serious injury, or an
adverse event, associated with the use of
a combination product is received by
the product sponsor, the information
must be provided to the other
constituent part applicant(s) no later
than 5 calendar days after receipt. Part
4 also explains how and where to
submit reports and provides for
associated recordkeeping. These
requirements are described in part 803.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Activity/CFR section
FDA
form Number
Number of
responses per
respondent
Number of
respondents
Total annual
responses
Average
burden per
response
Total hours 1
Total capital
costs
Total operating
and
maintenance
costs
ddrumheller on DSK120RN23PROD with NOTICES1
21 CFR Part 803 ‘‘Medical Device Reporting,’’ 21 CFR Part 4, subpart B ‘‘Postmarketing Safety Reporting for Combination Products,’’ and FDA notification; order granting alternative entitled, ‘‘Medical Devices and Device-led Combination Products; Voluntary Malfunction Summary Reporting Program
for Manufacturers’’
Exemptions—803.19 ......
User Facility Reporting—
803.30 and 803.32.
User Facility Annual Reporting—803.33.
Importer Reporting,
Death and Serious Injury—803.40 and
803.42.
Manufacturer Reporting—803.50 through
803.53.
Voluntary Malfunction
Summary Reporting
Program.
Supplemental Reports—
803.56.
VerDate Sep<11>2014
...........................
FDA 3500A .......
28
296
1
18.99
28
5,621
1
0.35
28
1,967
........................
........................
........................
........................
FDA 3419 .........
82
1
82
1
82
........................
........................
FDA 3500A .......
144
1,034.604
148,983
1
148,983
........................
........................
FDA 3500A .......
1,871
1,240.1887
2,320,393
0.10
232,039
........................
$18,710
FDA 3500A .......
44
56.88
2,503
0.10
250
........................
........................
FDA 3500A .......
1,501
684.604
1,027,591
0.10
102,759
........................
........................
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Federal Register / Vol. 90, No. 88 / Thursday, May 8, 2025 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN—Continued
Activity/CFR section
FDA
form Number
Number of
responses per
respondent
Number of
respondents
Total annual
responses
Average
burden per
response
Total hours 1
Total capital
costs
Total operating
and
maintenance
costs
21 CFR 866.3956 ‘‘Human immunodeficiency virus (HIV) serological diagnostic and/or supplemental test’’ and 866.3957 ‘‘Human immunodeficiency virus
(HIV) nucleic acid (NAT) diagnostic and/or supplemental test’’
Special controls: submission of complaint log;
866.3956(b)(1)(iii) and
866.3957(b)(1)(iii).
...........................
10
1
10
3
30
........................
........................
Total ........................
...........................
........................
........................
3,505,201
........................
486,138
........................
18,710
1 Numbers
are rounded.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity/21 CFR section
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours 2
MDR Procedures—803.17 ...................................................
MDR Files—803.18 ..............................................................
1,871
1,871
1
1
1,871
1,871
3.3
1.5
6,174
2,807
Total ..............................................................................
........................
........................
3,742
........................
8,981
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
are rounded.
2 Numbers
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Importer Reporting, Death and Serious Injury—803.40
and 803.42 ...................................................................
1 There
Number of
disclosures
per respondent
Number of
respondents
Activity/21 CFR section
144
I
1,034.60
Average
burden per
disclosure
Total annual
disclosures
148,983
I
I
0.35
Total hours 2
52,144
are no capital costs or operating and maintenance costs associated with this collection of information.
are rounded.
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2 Numbers
Upon review of this information
collection, we updated the burden
estimates based on internal data
regarding MDRs received by FDA for
fiscal year (FY) 2024. Device-led
combination product reporting and
disclosure under part 4, subpart B, are
included in the burden estimates. Based
on FY2024 data for ‘‘Manufacturer
Reporting 803.50 through 803.53,’’ we
estimate 1,871 respondents and
2,320,393 total annual responses.
The FDA notification and order
granting alternative entitled, ‘‘Medical
Devices and Device-led Combination
Products; Voluntary Malfunction
Summary Reporting Program for
Manufacturers’’ grants an alternative
under § 803.19 to permit manufacturer
reporting of certain device malfunctions
in summary form on a quarterly basis.
The associated FDA guidance entitled
‘‘Voluntary Malfunction Summary
Reporting (VMSR) Program for
Manufacturers’’ (August 2024) is
intended to help manufacturers better
understand and use the VMSR Program.
The Voluntary Malfunction Summary
Reporting (VMSR) Program does not
apply to reportable death or serious
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injury events, which are required to be
reported to FDA within the mandatory
30-calendar day timeframe, under
§§ 803.50 and 803.52, or within the 5work day timeframe under § 803.53.
Thus, if a manufacturer participating in
the program becomes aware of
information reasonably suggesting that a
device it markets may have caused or
contributed to a death or serious injury,
then the manufacturer must submit an
individual MDR for that event because
it involves a reportable death or serious
injury. We expect that a summary report
will take approximately the same
amount of time to prepare as an
individual report.
Unlike manufacturers, device user
facilities are not required to submit
malfunction reports under part 803.
User facilities, such as hospitals or
nursing homes, are required to submit
MDRs to FDA and/or the manufacturer
only for reportable death or serious
injury events. (See section 519(b) of the
FD&C Act; 21 CFR 803.30(a).) We
believe that by permitting alternative
reporting for certain devices, the VMSR
Program may reduce burden on
respondents who elect to participate
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and are otherwise subject to mandatory
requirements.
Special controls established in the
final order ‘‘Microbiology Devices;
Reclassification of Human
Immunodeficiency Virus Serological
Diagnostic and Supplemental Tests and
Human Immunodeficiency Virus
Nucleic Acid Diagnostic and
Supplemental Tests’’ to support the
class II classification of certain HIV
serological diagnostic and supplemental
tests (21 CFR 866.3956) and for HIV
NATs diagnostic and supplemental tests
(21 CFR 866.3957) require the
submission of a log of all complaints
annually for a period of 5 years
following FDA clearance of a traditional
premarket notification (510(k))
submission for these devices.
(Information collections associated with
premarket notification (510(k)) are
approved under OMB control number
0910–0120.) Although manufacturers of
HIV serological diagnostic and
supplemental tests and HIV NAT
diagnostic and supplemental tests are
already required to maintain complaint
files and to review and evaluate
complaints for these devices under 21
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Federal Register / Vol. 90, No. 88 / Thursday, May 8, 2025 / Notices
CFR 820.198, special controls are
necessary to provide a reasonable
assurance of safety and effectiveness of
these devices. (Information collections
associated with Quality System
requirements under 21 CFR part 820 are
approved under OMB control number
0910–0073.) We estimate it will take a
manufacturer approximately 3 hours
annually to review their existing
records, prepare the complaint log, and
submit to FDA.
We assume a cost of $10 associated
with the payment of an annual fee to
maintain e-certification will apply to
each respondent. We estimate a total
operating and maintenance cost of
$18,710 ($10 × 1,871 respondents).
Since the last OMB approval, we have
adjusted the respondent and response
estimates based on FY 2024 data. We
also adjusted the Average Burden per
Response for ‘‘Exemptions—803.19’’
and ‘‘Importer Reporting, Death and
Serious Injury—803.40 and 803.42’’
from 0.1 hour to 1 hour to correct an
error introduced in a previous request
for extension of this information
collection. These adjustments have
resulted in an overall increase of
1,374,708 total responses, and a
corresponding increase of 262,681 total
burden hours.
We are revising this information
collection to add the FDA guidance
entitled ‘‘Voluntary Malfunction
Summary Reporting (VMSR) Program
for Manufacturers’’ (August 2024;
https://www.fda.gov/media/163692/
download), which is intended to help
manufacturers better understand and
use the VMSR Program. The guidance
does not affect the estimated burden
estimates.
Dated: May 5, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2025–08086 Filed 5–7–25; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
ddrumheller on DSK120RN23PROD with NOTICES1
[Docket No. FDA–2025–N–1146]
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting; Establishment of a Public
Docket; Request for Comments—
2025–2026 Formula for COVID–19
Vaccines for Use in the United States
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
18:48 May 07, 2025
Jkt 265001
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Vaccines and Related
Biological Products Advisory
Committee. The general function of the
committee is to provide advice and
recommendations to FDA on regulatory
issues. The committee will meet in an
open session to discuss and make
recommendations on the selection of the
2025–2026 Formula for COVID–19
vaccines for use in the United States.
FDA is establishing a docket for public
comment on this document.
DATES: The meeting will be held
virtually on May 22, 2025, from 8:30
a.m. to 4:30 p.m. Eastern Time.
ADDRESSES: All meeting participants
will be heard, viewed, captioned, and
recorded for this advisory committee
meeting via an online teleconferencing
and/or video conferencing platform. The
online web conference meeting will be
available on the day of the meeting by
visiting https://www.fda.gov/advisorycommittees.
Answers to commonly asked
questions about FDA advisory
committee meetings may be accessed at:
https://www.fda.gov/advisorycommittees/about-advisory-committees/
common-questions-and-answers-aboutfda-advisory-committee-meetings.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2025–N–1146.
The docket will close on May 23, 2025.
Please note that late, untimely filed
comments will not be considered. The
https://www.regulations.gov electronic
filing system will accept comments
until 11:59 p.m. Eastern Time at the end
of May 23, 2025. 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.
Comments received on or before noon
by May 14, 2025, will be provided to the
committee. Comments received after
May 14 and by May 23, 2025 will be
taken into consideration by FDA. In the
event that the meeting is cancelled, FDA
will continue to evaluate any relevant
applications or information, and
consider any comments submitted to the
docket, as appropriate.
You may submit comments as
follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
• 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
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–
2025–N–1146 for ‘‘Vaccines and Related
Biological Products Advisory
Committee’’; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments—2025–2026
formula for COVID–19 vaccines for use
in the United States.’’
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
U:\08MYN1.SGM
08MYN1
]]>Agencies
[Federal Register Volume 90, Number 88 (Thursday, May 8, 2025)]
[Notices]
[Pages 19490-19494]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-08086]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0419]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Reporting
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 revision 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 collections associated with
requirements for medical device reporting for user facilities,
manufacturers, importers, and distributors of medical devices.
DATES: Either electronic or written comments on the collection of
information must be submitted by July 7, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 7, 2025. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received 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
[[Page 19491]]
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 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-2025-N-0419 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Device Reporting.''
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: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[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 revision 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.
Medical Device Reporting--21 CFR Part 803
OMB Control Number 0910-0437--Revision
This information collection supports Food and Drug Administration
(FDA) regulations, programs, forms, and guidance. Section 519 of the
Federal Food Drug and Cosmetic Act (the FD&C Act) (21 U.S.C. 360i)
(Records and Reports on Devices) requires user facilities,
manufacturers, and importers of medical devices to report adverse
events involving medical devices to FDA and requires that medical
device manufacturers and importers submit medical device reports (MDRs)
electronically. These provisions are codified at part 803 (21 CFR part
803)--Medical Device Reporting. The regulations also provide for
recordkeeping requirements and certain exemptions and alternative
reporting. Additionally, the regulations permit user facilities to
submit paper-based annual reports, for which we have provided form FDA
3419 entitled, ``Medical Device Reporting Annual User Facility
Report.''
Respondents are required to report adverse events involving medical
devices to the FDA. The information that is obtained from these reports
will be used to evaluate risks associated with medical devices and
enable FDA to take appropriate regulatory measures to protect the
public health. Complete, accurate, and timely adverse event information
is necessary for the identification of emerging device problems so the
agency can protect the public health under section 519 of the FD&C Act.
FDA makes the releasable information available to the public for
downloading on its website (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm).
In an effort at reducing burden, we have developed the Voluntary
Malfunction Summary Reporting (VMSR) Program for certain devices, which
allows for respondent reporting of multiple malfunction events in a
single report on a quarterly basis. The
[[Page 19492]]
VMSR Program was established under section 519(a)(1)(B)(ii) of the FD&C
Act. The associated FDA notification and order granting alternative
entitled, ``Medical Devices and Device-led Combination Products;
Voluntary Malfunction Summary Reporting Program for Manufacturers'' (83
FR 40973; 8/17/2018; https://www.federalregister.gov/documents/2018/08/17/2018-17770/medical-devices-and-device-led-combination-products-voluntary-malfunction-summary-reporting-program) grants an alternative
under Sec. 803.19 to permit manufacturer reporting of certain device
malfunctions in summary form on a quarterly basis. The associated FDA
guidance entitled ``Voluntary Malfunction Summary Reporting (VMSR)
Program for Manufacturers'' (August 2024; https://www.fda.gov/media/163692/download) is intended to help manufacturers better understand
and use the VMSR Program.
The final order ``Microbiology Devices; Reclassification of Human
Immunodeficiency Virus Serological Diagnostic and Supplemental Tests
and Human Immunodeficiency Virus Nucleic Acid Diagnostic and
Supplemental Tests'' (May 16, 2022; 87 FR 29661) established special
controls for certain Human Immunodeficiency Virus (HIV) serological
diagnostic and supplemental tests (21 CFR 866.3956) and for HIV nucleic
acid tests (NATs) diagnostic and supplemental tests (21 CFR 866.3957)
to support their classification into class II, including submission of
a log of all complaints annually for a period of 5 years following FDA
clearance of a traditional premarket notification (510(k)) submission
for these devices. (Information collections associated with premarket
notification (510(k)) are approved under OMB control number 0910-0120.)
Earlier notification through the submission of the complaint log
enables us to more promptly determine whether public health issues have
been adequately addressed. The agency would not otherwise evaluate the
kind of complaint information that would be included in the log until
an FDA inspection, which typically occurs less frequently than
annually. Implementing these specific reporting measures as part of the
special controls for these devices is necessary to provide a reasonable
assurance of safety and effectiveness for HIV diagnostic and
supplemental tests subject to the reclassification order.
Provisions of part 4 subpart B (21 CFR part 4, subpart B), provide
that when information regarding an event that involves a death or
serious injury, or an adverse event, associated with the use of a
combination product is received by the product sponsor, the information
must be provided to the other constituent part applicant(s) no later
than 5 calendar days after receipt. Part 4 also explains how and where
to submit reports and provides for associated recordkeeping. These
requirements are described in part 803.
Respondents are manufacturers and importers of medical devices and
device user facilities. Device user facility means a hospital,
ambulatory surgical facility, nursing home, outpatient diagnostic
facility, or outpatient treatment facility as defined in Sec. 803.3,
which is not a physician's office (also defined in Sec. 803.3).
Respondents are also sponsors (manufacturers) of device-led combination
products (see part 4, subpart B). Respondents also include
manufacturers of HIV diagnostic and supplemental test devices.
Manufacturer and importer respondents submit reports electronically
using FDA Form 3500A (approved under OMB control number 0910-0291) via
either ``eSubmitter'' for low-volume reporters or Health Level Seven
(HL7) Individual Case Study Report (ICSR) (HL7 ICSR) for high-volume
reporters. User facilities reporting under Sec. Sec. 803.30 and 803.32
have the option of electronic or paper-based reporting. User facility
annual reporting under Sec. 803.33 is paper based, using form FDA
3419. Instructions for submitting the information are available in
Sec. Sec. 803.11, 803.12, and 803.20, and on FDA's public website at
https://www.fda.gov/medical-devices/postmarket-requirements-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities (links to forms FDA 3500A and FDA 3419 are provided on
the web page).
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Number of Total annual Average burden Total hours Total capital operating and
Activity/CFR section FDA form Number respondents responses per responses per response \1\ costs maintenance
respondent costs
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR Part 803 ``Medical Device Reporting,'' 21 CFR Part 4, subpart B ``Postmarketing Safety Reporting for Combination Products,'' and FDA notification; order granting alternative entitled,
``Medical Devices and Device-led Combination Products; Voluntary Malfunction Summary Reporting Program for Manufacturers''
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Exemptions--803.19............................ ................................ 28 1 28 1 28 .............. ..............
User Facility Reporting--803.30 and 803.32.... FDA 3500A....................... 296 18.99 5,621 0.35 1,967 .............. ..............
User Facility Annual Reporting--803.33........ FDA 3419........................ 82 1 82 1 82 .............. ..............
Importer Reporting, Death and Serious Injury-- FDA 3500A....................... 144 1,034.604 148,983 1 148,983 .............. ..............
803.40 and 803.42.
Manufacturer Reporting--803.50 through 803.53. FDA 3500A....................... 1,871 1,240.1887 2,320,393 0.10 232,039 .............. $18,710
Voluntary Malfunction Summary Reporting FDA 3500A....................... 44 56.88 2,503 0.10 250 .............. ..............
Program.
Supplemental Reports--803.56.................. FDA 3500A....................... 1,501 684.604 1,027,591 0.10 102,759 .............. ..............
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[[Page 19493]]
21 CFR 866.3956 ``Human immunodeficiency virus (HIV) serological diagnostic and/or supplemental test'' and 866.3957 ``Human immunodeficiency virus (HIV) nucleic acid (NAT) diagnostic and/or
supplemental test''
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Special controls: submission of complaint log; ................................ 10 1 10 3 30 .............. ..............
866.3956(b)(1)(iii) and 866.3957(b)(1)(iii).
-------------------------------------------------------------------------------------------------------------------------------------------------
Total..................................... ................................ .............. .............. 3,505,201 .............. 486,138 .............. 18,710
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\1\ Numbers are rounded.
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 \2\
----------------------------------------------------------------------------------------------------------------
MDR Procedures--803.17.......... 1,871 1 1,871 3.3 6,174
MDR Files--803.18............... 1,871 1 1,871 1.5 2,807
-------------------------------------------------------------------------------
Total....................... .............. .............. 3,742 .............. 8,981
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Numbers are rounded.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR section Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure \2\
----------------------------------------------------------------------------------------------------------------
Importer Reporting, Death and 144 1,034.60 148,983 0.35 52,144
Serious Injury--803.40 and
803.42.......................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Numbers are rounded.
Upon review of this information collection, we updated the burden
estimates based on internal data regarding MDRs received by FDA for
fiscal year (FY) 2024. Device-led combination product reporting and
disclosure under part 4, subpart B, are included in the burden
estimates. Based on FY2024 data for ``Manufacturer Reporting 803.50
through 803.53,'' we estimate 1,871 respondents and 2,320,393 total
annual responses.
The FDA notification and order granting alternative entitled,
``Medical Devices and Device-led Combination Products; Voluntary
Malfunction Summary Reporting Program for Manufacturers'' grants an
alternative under Sec. 803.19 to permit manufacturer reporting of
certain device malfunctions in summary form on a quarterly basis. The
associated FDA guidance entitled ``Voluntary Malfunction Summary
Reporting (VMSR) Program for Manufacturers'' (August 2024) is intended
to help manufacturers better understand and use the VMSR Program. The
Voluntary Malfunction Summary Reporting (VMSR) Program does not apply
to reportable death or serious injury events, which are required to be
reported to FDA within the mandatory 30-calendar day timeframe, under
Sec. Sec. 803.50 and 803.52, or within the 5-work day timeframe under
Sec. 803.53. Thus, if a manufacturer participating in the program
becomes aware of information reasonably suggesting that a device it
markets may have caused or contributed to a death or serious injury,
then the manufacturer must submit an individual MDR for that event
because it involves a reportable death or serious injury. We expect
that a summary report will take approximately the same amount of time
to prepare as an individual report.
Unlike manufacturers, device user facilities are not required to
submit malfunction reports under part 803. User facilities, such as
hospitals or nursing homes, are required to submit MDRs to FDA and/or
the manufacturer only for reportable death or serious injury events.
(See section 519(b) of the FD&C Act; 21 CFR 803.30(a).) We believe that
by permitting alternative reporting for certain devices, the VMSR
Program may reduce burden on respondents who elect to participate and
are otherwise subject to mandatory requirements.
Special controls established in the final order ``Microbiology
Devices; Reclassification of Human Immunodeficiency Virus Serological
Diagnostic and Supplemental Tests and Human Immunodeficiency Virus
Nucleic Acid Diagnostic and Supplemental Tests'' to support the class
II classification of certain HIV serological diagnostic and
supplemental tests (21 CFR 866.3956) and for HIV NATs diagnostic and
supplemental tests (21 CFR 866.3957) require the submission of a log of
all complaints annually for a period of 5 years following FDA clearance
of a traditional premarket notification (510(k)) submission for these
devices. (Information collections associated with premarket
notification (510(k)) are approved under OMB control number 0910-0120.)
Although manufacturers of HIV serological diagnostic and supplemental
tests and HIV NAT diagnostic and supplemental tests are already
required to maintain complaint files and to review and evaluate
complaints for these devices under 21
[[Page 19494]]
CFR 820.198, special controls are necessary to provide a reasonable
assurance of safety and effectiveness of these devices. (Information
collections associated with Quality System requirements under 21 CFR
part 820 are approved under OMB control number 0910-0073.) We estimate
it will take a manufacturer approximately 3 hours annually to review
their existing records, prepare the complaint log, and submit to FDA.
We assume a cost of $10 associated with the payment of an annual
fee to maintain e-certification will apply to each respondent. We
estimate a total operating and maintenance cost of $18,710 ($10 x 1,871
respondents).
Since the last OMB approval, we have adjusted the respondent and
response estimates based on FY 2024 data. We also adjusted the Average
Burden per Response for ``Exemptions--803.19'' and ``Importer
Reporting, Death and Serious Injury--803.40 and 803.42'' from 0.1 hour
to 1 hour to correct an error introduced in a previous request for
extension of this information collection. These adjustments have
resulted in an overall increase of 1,374,708 total responses, and a
corresponding increase of 262,681 total burden hours.
We are revising this information collection to add the FDA guidance
entitled ``Voluntary Malfunction Summary Reporting (VMSR) Program for
Manufacturers'' (August 2024; https://www.fda.gov/media/163692/download), which is intended to help manufacturers better understand
and use the VMSR Program. The guidance does not affect the estimated
burden estimates.
Dated: May 5, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-08086 Filed 5-7-25; 8:45 am]
BILLING CODE 4164-01-P
