Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Multi-Cancer Detection Devices, 77591-77593 [2023-24896]
Download as PDF
<![CDATA[
77591
Federal Register / Vol. 88, No. 217 / Monday, November 13, 2023 / Notices
Estimated Total Annual Burden
Hours: 3,090.53.
Authority: 42 U.S.C. 652(a)(9), 42
U.S.C. 653(a)(1) and 42 U.S.C. 652(m).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2023–24857 Filed 11–9–23; 8:45 am]
BILLING CODE 4184–41–P
Management and Budget (OMB) to
extend approval of the Multistate
Financial Institution (MSFIDM) Data
Match with Federally Assisted State
Transmitted (FAST) Levy, without
changes, for an additional three years.
The current OMB approval expires
January 31, 2024.
Comments due within 30 days of
publication. OMB must make a decision
about the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Multistate Financial Institution Data
Match With Federally Assisted State
Transmitted Levy (OMB No.: 0970–
0169)
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
ADDRESSES:
Office of Child Support
Services Office, Administration for
Children and Families, Department of
Health and Human Services.
ACTION: Request for public comments.
AGENCY:
The Office of Child Support
Services (OCSE), Administration for
Children and Families (ACF), is
requesting the federal Office of
SUMMARY:
requests by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: State child support
agencies are statutorily required to enter
into data matching agreements with
financial institutions doing business in
their state to locate obligors’ accounts.
OCSE operates the MSFIDM program
through the Federal Parent Locator
Service (FPLS) and facilitates the
required data match between state child
support agencies and multistate
financial institutions (MSFIs). State
child support agencies use the data
match outcomes to fulfill a statutory
requirement to seize an obligor’s assets
to satisfy past due child support
payments.
OCSE also operates FAST Levy,
which is an automated application
within the FPLS to exchange electronic
lien/levy information securely and
efficiently. State child support agencies
and MSFIs use FAST Levy to seize
financial assets more quickly and
efficiently.
Respondents: Multistate Financial
Institutions and State Child Support
Agencies.
ANNUAL BURDEN ESTIMATES
Financial Data Match Record Specifications Match File Upload/Download:
Portal Users .................................................................................................
Election Form ...................................................................................................
FAST-Levy Response Withhold Record Specifications: Financial Institutions
FAST-Levy Request Withhold Record Specifications: State Child Support
Agencies .......................................................................................................
Estimated Total Annual Burden
Hours: 5,029.8.
Authority: 42 U.S.C. 652(l); 42 U.S.C.
666(a)(2) and (c)(1)(G)(ii); 42 U.S.C.
666(a)(17)(A); 42 U.S.C. 652(a)(7); and,
45 CFR 303.7(a)(5).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2023–24855 Filed 11–9–23; 8:45 am]
BILLING CODE 4184–41–P
Average
annual burden
hours per
response
263
13
1
4
1
1
0.083
0.5
1,716
87.3
6.5
1,716.0
2
1
1,610
3,220.0
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–4720]
Molecular and Clinical Genetics Panel
of the Medical Devices Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments—Multi-Cancer
Detection Devices
AGENCY:
khammond on DSKJM1Z7X2PROD with NOTICES
Total annual
number of
responses per
respondent
Total annual
number of
respondents
Information collection instrument
Food and Drug Administration,
HHS.
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 Molecular and Clinical
Genetics Panel of the Medical Devices
SUMMARY:
VerDate Sep<11>2014
17:12 Nov 09, 2023
Jkt 262001
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Total annual
burden hours
Advisory Committee (the Committee).
The general function of the Committee
is to provide advice and
recommendations to FDA on regulatory
issues. The meeting will be open to the
public. FDA is establishing a docket for
public comment on this document.
DATES: The meeting will take place
virtually on November 29, 2023, from 9
a.m. to 5 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.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
E:\FR\FM\13NON1.SGM
13NON1
77592
Federal Register / Vol. 88, No. 217 / Monday, November 13, 2023 / Notices
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2023–N–4720.
Please note that late, untimely filed
comments will not be considered. The
docket will close on December 29, 2023.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 29, 2023.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are received on or before that
date.
Comments received on or before
November 15, 2023, will be provided to
the committee. Comments received after
that date 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:
Electronic Submissions
khammond on DSKJM1Z7X2PROD with NOTICES
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
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.
VerDate Sep<11>2014
17:12 Nov 09, 2023
Jkt 262001
• 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–4720 for ‘‘Molecular and
Clinical Genetics Panel of the Medical
Devices Advisory Committee; Notice of
Meeting; Establishment of a Public
Docket; Request for Comments.’’
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.’’ FDA
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 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 the 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-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
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Candace Nalls, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5216, Silver Spring,
MD 20993–0002, Candace.Nalls@
fda.hhs.gov, 301–636–0510, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572) in the
Washington, DC area). A notice in the
Federal Register about last-minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations
will be heard, viewed, captioned, and
recorded through an online
teleconferencing platform. On
November 29, 2023, the committee will
discuss and make recommendations on
the design of multi-cancer detection
(MCD) in vitro diagnostic devices (tests)
as well as potential study designs and
study outcomes of interest that could
inform the assessment of the probable
benefits and risks of MCD screening
tests. The committee’s discussion and
recommendations from this meeting
will help inform future Agency
regulatory efforts for these novel tests.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available on FDA’s
website at the time of the advisory
committee meeting, and the background
material will be posted on FDA’s
website after the meeting. Background
material and the link to the online
teleconference meeting room will be
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down and select the
appropriate advisory committee meeting
link. The meeting will include slide
presentations with audio components to
allow the presentation of materials in a
manner that most closely resembles an
in-person advisory committee meeting.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the Committee. All electronic and
E:\FR\FM\13NON1.SGM
13NON1
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 217 / Monday, November 13, 2023 / Notices
written submissions may be made to the
contact person on or before November
15, 2023 will be provided to the
Committee. Oral presentations from the
public will be scheduled between
approximately 9:45 a.m. and 10:45 a.m.
Eastern Time. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before
November 16, 2023. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by November 17, 2023.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Artair Mallett
at Artair.Mallett@fda.hhs.gov or 301–
796–9638 at least 7 days in advance of
the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. 1001 et seq.). This meeting notice
also serves as notice that, pursuant to 21
CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the
location of advisory committee meetings
are hereby waived to allow for this
meeting to take place using an online
meeting platform. This waiver is in the
interest of allowing greater transparency
and opportunities for public
participation, in addition to
convenience for advisory committee
members, speakers, and guest speakers.
No participant will be prejudiced by
this waiver, and the ends of justice will
be served by allowing for this
modification to FDA’s advisory
committee meeting procedures.
VerDate Sep<11>2014
17:12 Nov 09, 2023
Jkt 262001
Dated: November 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–24896 Filed 11–9–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–P–2055]
Determination That COGENTIN
(Benztropine Mesylate) Injection, 1
Milligram per 1 Milliliter, Was Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined that COGENTIN
(benztropine mesylate) Injection, 1
milligram (mg)/1 milliliter (mL), was
not withdrawn from sale for reasons of
safety or effectiveness. This
determination means that FDA will not
begin procedures to withdraw approval
of abbreviated new drug applications
(ANDAs) that refer to this drug product,
and it will allow FDA to continue to
approve ANDAs that refer to the
product as long as they meet relevant
legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT:
Nisha Shah, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6222, Silver Spring,
MD 20993–0002, 301–796–4455,
Nisha.Shah@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section
505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)) allows the submission of an
ANDA to market a generic version of a
previously approved drug product. To
obtain approval, the ANDA applicant
must show, among other things, that the
generic drug product: (1) has the same
active ingredient(s), dosage form, route
of administration, strength, conditions
of use, and (with certain exceptions)
labeling as the listed drug, which is a
version of the drug that was previously
approved and (2) is bioequivalent to the
listed drug. ANDA applicants do not
have to repeat the extensive clinical
testing otherwise necessary to gain
approval of a new drug application
(NDA).
Section 505(j)(7) of the FD&C Act
requires FDA to publish a list of all
approved drugs. FDA publishes this list
SUMMARY:
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
77593
as part of the ‘‘Approved Drug Products
With Therapeutic Equivalence
Evaluations,’’ which is known generally
as the ‘‘Orange Book.’’ Under FDA
regulations, drugs are removed from the
list if the Agency withdraws or
suspends approval of the drug’s NDA or
ANDA for reasons of safety or
effectiveness or if FDA determines that
the listed drug was withdrawn from sale
for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
FDA’s approval of an ANDA that refers
to the listed drug (§ 314.161 (21 CFR
314.161)). FDA may not approve an
ANDA that does not refer to a listed
drug.
COGENTIN (benztropine mesylate)
Injection, 1 mg/1 mL, is the subject of
NDA 012015, held by Akorn Operating
Company LLC, and initially approved
on December 21, 1959. COGENTIN is
indicated for use as an adjunct in the
therapy of all forms of parkinsonism
and for the control of extrapyramidal
disorders (except tardive dyskinesia)
due to neuroleptic drugs (e.g.,
phenothiazines).
In a letter dated March 18, 2022,
Akorn Operating Company LLC notified
FDA that COGENTIN (benztropine
mesylate) Injection, 1 mg/1 mL, was
being discontinued, and FDA moved the
drug product to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
Nexus Pharmaceuticals submitted a
citizen petition dated May 19, 2023
(Docket No. FDA–2023–P–2055), under
21 CFR 10.30, requesting that the
Agency determine whether COGENTIN
(benztropine mesylate) Injection, 1 mg/
1 mL, was withdrawn from sale for
reasons of safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that COGENTIN (benztropine
mesylate) Injection, 1 mg/1 mL, was not
withdrawn from sale for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that this drug
product was withdrawn for reasons of
safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of
COGENTIN (benztropine mesylate)
Injection, 1 mg/1 mL, from sale. We
have also independently evaluated
E:\FR\FM\13NON1.SGM
13NON1
]]>Agencies
[Federal Register Volume 88, Number 217 (Monday, November 13, 2023)]
[Notices]
[Pages 77591-77593]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24896]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-4720]
Molecular and Clinical Genetics Panel of the Medical Devices
Advisory Committee; Notice of Meeting; Establishment of a Public
Docket; Request for Comments--Multi-Cancer Detection Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Molecular and Clinical
Genetics Panel of the Medical Devices Advisory Committee (the
Committee). The general function of the Committee is to provide advice
and recommendations to FDA on regulatory issues. The meeting will be
open to the public. FDA is establishing a docket for public comment on
this document.
DATES: The meeting will take place virtually on November 29, 2023, from
9 a.m. to 5 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. Answers to
commonly asked questions including information regarding special
accommodations due to a disability may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
[[Page 77592]]
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2023-N-4720. Please note that late, untimely
filed comments will not be considered. The docket will close on
December 29, 2023. The https://www.regulations.gov electronic filing
system will accept comments until 11:59 p.m. Eastern Time at the end of
December 29, 2023. Comments received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
received on or before that date.
Comments received on or before November 15, 2023, will be provided
to the committee. Comments received after that date 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:
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 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-4720 for ``Molecular and Clinical Genetics Panel of the
Medical Devices Advisory Committee; Notice of Meeting; Establishment of
a Public Docket; Request for Comments.'' 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.'' FDA 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 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 the 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: Candace Nalls, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 20993-0002,
[email protected], 301-636-0510, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572) in the Washington, DC
area). A notice in the Federal Register about last-minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before the
meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. On November
29, 2023, the committee will discuss and make recommendations on the
design of multi-cancer detection (MCD) in vitro diagnostic devices
(tests) as well as potential study designs and study outcomes of
interest that could inform the assessment of the probable benefits and
risks of MCD screening tests. The committee's discussion and
recommendations from this meeting will help inform future Agency
regulatory efforts for these novel tests.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting, and the background material
will be posted on FDA's website after the meeting. Background material
and the link to the online teleconference meeting room will be
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down and select the appropriate advisory committee
meeting link. The meeting will include slide presentations with audio
components to allow the presentation of materials in a manner that most
closely resembles an in-person advisory committee meeting.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the Committee.
All electronic and
[[Page 77593]]
written submissions may be made to the contact person on or before
November 15, 2023 will be provided to the Committee. Oral presentations
from the public will be scheduled between approximately 9:45 a.m. and
10:45 a.m. Eastern Time. Those individuals interested in making formal
oral presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before November 16, 2023. Time allotted for each presentation may
be limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by November
17, 2023.
For press inquiries, please contact the Office of Media Affairs at
[email protected] or 301-796-4540.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Artair Mallett at [email protected] or 301-796-9638 at
least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. 1001 et seq.). This meeting notice also serves
as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the location of advisory committee
meetings are hereby waived to allow for this meeting to take place
using an online meeting platform. This waiver is in the interest of
allowing greater transparency and opportunities for public
participation, in addition to convenience for advisory committee
members, speakers, and guest speakers. No participant will be
prejudiced by this waiver, and the ends of justice will be served by
allowing for this modification to FDA's advisory committee meeting
procedures.
Dated: November 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-24896 Filed 11-9-23; 8:45 am]
BILLING CODE 4164-01-P
