Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 55051-55053 [2023-17287]
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Federal Register / Vol. 88, No. 155 / Monday, August 14, 2023 / Notices
subset of study participants to monitor
the quality of data collection interviews
and to validate that the interviewer
spoke with the participant; (4)
Implementation study interviews: using
topic guides, collect information from
program supervisors and frontline staff,
community providers, child welfare
staff, and parents enrolled in the
programs to assess the fidelity of
implementation, document program
services, and gather operational lessons;
and (5) Parent Interview Information
Form: demographic information to
support analysis of parent perspectives
by personal characteristics and history.
Future information collection requests
will be submitted to collect follow-up
data.
Respondents: Parents enrolled in the
R3-Impact Study, and program and
agency staff involved in implementing
the R3 interventions.
ANNUAL BURDEN ESTIMATES
Instrument
Baseline Parent Survey ....................
Contact Form ....................................
Validation Interviews .........................
Topic Guide–Child Welfare Lead
Staff.
Topic Guide–Child Welfare Frontline
Staff.
Topic Guide–Partners .......................
Topic Guide–Program Managers ......
Topic Guide–Mentor Supervisors .....
Topic Guide–Parent/Family Mentors
Topic Guide–Parents ........................
Parent Interview Information Form ...
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BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–2483]
Microbiology Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for Comments
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
ddrumheller on DSK120RN23PROD with NOTICES1
Annual burden
(in hours)
.75
.17
.08
1
[FR Doc. 2023–17364 Filed 8–11–23; 8:45 am]
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Microbiology Devices
Panel of the Medical Devices Advisory
Committee (the Committee). The general
function of the Committee as a medical
device panel is to provide advice and
SUMMARY:
17:38 Aug 11, 2023
Total burden
(in hours)
1
4
1
1
Mary B. Jones,
ACF/OPRE Certifying Officer.
VerDate Sep<11>2014
Avg. burden
per response
(in hours)
2,750 ................................................
1,843 ................................................
275 ...................................................
60 .....................................................
Estimated Total Annual Burden
Hours: 1,294.
Authority: The Substance UseDisorder Prevention that Promotes
Opioid Recovery and Treatment for
Patients and Communities Act
(SUPPORT for Patients and
Communities Act; Pub. L. 115–271)
AGENCY:
Number of
responses per
respondent
(total over
request
period)
Number of
respondents
(total over
request
period)
Jkt 259001
recommendations to FDA. In addition,
the Committee will meet to discuss and
provide advice to FDA on in vitro
diagnostic devices used in pandemic
preparedness and response to satisfy, in
part, a requirement under the Food and
Drug Omnibus Reform Act of 2022
(FDORA). The meeting will be open to
the public. FDA is establishing a docket
for public comment on this document.
DATES: The meeting will be held
virtually on September 7, 2023, from 9
a.m. to 5:15 p.m. Eastern Time and
September 8, 2023, from 9:30 a.m. to
3:45 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
about FDA advisory committee meetings
may be accessed at: https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2023–N–2483.
Please note that late, untimely filed
comments will not be considered. The
docket will close on October 10, 2023.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of October 10, 2023.
Comments received by mail/hand
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
delivery/courier (for written/paper
submissions) will be considered timely
if they are received on or before that
date.
Comments received on or before
August 30, 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
E:\FR\FM\14AUN1.SGM
14AUN1
55052
Federal Register / Vol. 88, No. 155 / Monday, August 14, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
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–2483 for ‘‘Microbiology Devices
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
VerDate Sep<11>2014
17:38 Aug 11, 2023
Jkt 259001
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, September18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
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, 301–636–0510,
Candace.Nalls@fda.hhs.gov, 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
FDA’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: All meeting presentations
will be heard, viewed, captioned, and
recorded through an online
teleconferencing and/or video
conferencing platform. FDA is seeking
the Committee’s preliminary input on
potential future reclassification of
certain microbiology devices to inform
FDA’s thinking regarding whether
reclassification from class III to class II
may be appropriate for such devices.
Specifically, on September 7, 2023,
during session I, the Committee will
discuss and make recommendations
regarding a potential future
reclassification from class III to class II
with special controls of nucleic acid and
serology-based in vitro diagnostic
devices indicated for use to aid in
diagnosis of hepatitis B virus (HBV)
infection and/or for use to aid in the
management of HBV infected patients.
The Committee, during session II, will
discuss and make recommendations
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
regarding a potential future
reclassification from class III to class II
with special controls of serology-based
in vitro diagnostic devices indicated for
use to aid in the detection of past,
recent, or current infection with human
parvovirus B19. The Committee, during
session III, will discuss and make
recommendations regarding a potential
future reclassification from class III to
class II with special controls of cellmediated immune reactivity in vitro
diagnostic devices indicated for use to
aid in identification of in vitro
responses to peptide antigens that are
associated with Mycobacterium
tuberculosis infection and/or for use as
detection of effector T cells that respond
to stimulation by M. tuberculosis agents.
All devices to be discussed by the
Committee on September 7, 2023, are
postamendments devices that currently
are classified into class III under section
513(f)(1) of the Federal Food, Drug, and
Cosmetic (FD&C) Act (21 U.S.C.
360c(f)(1)). For these devices, the
Committee will discuss: (1) if there is
sufficient information for FDA to
consider reclassifying them from class
III to class II and (2) what special
controls, in addition to general controls,
may be appropriate and necessary to
provide reasonable assurance of safety
and effectiveness for these devices, if
FDA were to take action to reclassify
them into class II devices. FDA intends
to follow the procedures outlined in
section 513 of the FD&C Act related to
the reclassification of postamendments
devices after considering the
Committee’s input.
On September 8, 2023, the Committee
will discuss and provide
recommendations to FDA regarding
topics related to in vitro diagnostic
devices used in pandemic preparedness
and response, consistent with the
requirements under section 3302 of
FDORA.
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. Background
material and the link to the online
teleconference and/or video conference
meeting will be available at https://
www.fda.gov/AdvisoryCommittees/
Calendar/default.htm. Scroll down to
the appropriate advisory committee
meeting link.
The meeting will include slide
presentations with audio and video
components to allow the presentation of
materials in a manner that most closely
E:\FR\FM\14AUN1.SGM
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ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 155 / Monday, August 14, 2023 / Notices
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
written submissions to the Docket (see
ADDRESSES) on or before August 18,
2023, will be provided to the
Committee. Oral presentations from the
public will be scheduled on September
7, 2023, between approximately 10:05
a.m. and 10:35 a.m., 1:15 p.m. and 1:45
p.m., and 3:30 p.m. and 4 p.m. Eastern
Time; and on September 8, 2023,
between approximately 10:30 a.m. and
11:30 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 August 10, 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 August 11, 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
VerDate Sep<11>2014
17:38 Aug 11, 2023
Jkt 259001
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 that the ends of justice
will be served by allowing for this
modification to FDA’s advisory
committee meeting procedures.
Dated: August 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–17287 Filed 8–11–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Statement of Organization, Functions,
and Delegations of Authority
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA), Center for
Devices and Radiological Health
(CDRH), Office of Strategic Partnerships
and Technology Innovation (OST) has
modified its organizational structure.
DATES: These new organizations’
structures were approved by the
Secretary of Health and Human Services
on June 27, 2023, and effective on
August 8, 2023.
FOR FURTHER INFORMATION CONTACT:
Denise Huttenlocker, Associate Director
for Management, Office of Management,
Center for Devices and Radiological
Health, Food and Drug Administration,
Bldg. 66, 10903 New Hampshire Ave.,
Silver Spring, MD 20993, 240–743–
1760.
SUMMARY:
SUPPLEMENTARY INFORMATION:
I. Introduction
Part D, Chapter D–B, (Food and Drug
Administration), the Statement of
Organization, Functions and
Delegations of Authority for the
Department of Health and Human
Services (35 FR 3685, February 25,
1970, 60 FR 56606, November 9, 1995,
64 FR 36361, July 6, 1999, 72 FR 50112,
August 30, 2007, 74 FR 41713, August
18, 2009, 76 FR 45270, July 28, 2011,
and 84 FR 22854, May 20, 2019) is
amended to reflect Food and Drug
Administration’s reorganization of
CDRH, OST.
This reorganization changed the OST
organizational structure from an office
with three divisions to an office with
five suboffices each with their own
PO 00000
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Fmt 4703
Sfmt 4703
55053
divisions. The previous divisions were:
the Division of All Hazards Response,
Science and Strategic Partnerships, the
Division of Digital Health, and the
Division of Technology and Data
Services. The OST will elevate the
programs performed by these former
divisions to a super office structure
whereby these divisions are abolished,
and their functions and resources are
realigned across five new OST
suboffices. DCCC. ORGANIZATION.
The Office of Office of Strategic
Partnerships and Technology
Innovation is headed by the Director of
Strategic Partnerships and Technology
Innovation and includes the following
organizational units:
Office of Readiness and Response
Division of All Hazards Preparedness
and Response
Division of Standards and Conformity
Assessment
Division of Medical Device
Cybersecurity
Office of Equity and Innovative
Development
Division of Patient-Centered
Development
Division of Heath Equity
Division of Partnerships and Innovation
Digital Health Center of Excellence
Division of Digital Health Policy
Division of Digital Health Technology
Assessment
Division of Digital Health Outreach
Office of Technology and Data Services
Division of Business Transformation
Delivery
Division of Technology Services
Division of Data Services
Office of Supply Chain Resilience
Division of Prevention, Innovation, and
Resilience
Division of Shortage Assessment and
Product Authentication
II. Delegations of Authority
Pending further delegation, directives,
or orders by the Commissioner of Food
and Drugs, all delegations and
redelegations of authority made to
officials and employees of affected
organizational components will
continue in them or their successors
pending further redelegations, provided
they are consistent with this
reorganization.
III. Electronic Access
This reorganization is reflected in
FDA’s Staff Manual Guide (SMG).
Persons interested in seeing the
E:\FR\FM\14AUN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 155 (Monday, August 14, 2023)]
[Notices]
[Pages 55051-55053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17287]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2483]
Microbiology Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting; Establishment of a Public Docket; Request
for Comments
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 Microbiology Devices Panel of
the Medical Devices Advisory Committee (the Committee). The general
function of the Committee as a medical device panel is to provide
advice and recommendations to FDA. In addition, the Committee will meet
to discuss and provide advice to FDA on in vitro diagnostic devices
used in pandemic preparedness and response to satisfy, in part, a
requirement under the Food and Drug Omnibus Reform Act of 2022 (FDORA).
The meeting will be open to the public. FDA is establishing a docket
for public comment on this document.
DATES: The meeting will be held virtually on September 7, 2023, from 9
a.m. to 5:15 p.m. Eastern Time and September 8, 2023, from 9:30 a.m. to
3:45 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 about FDA advisory committee meetings may be
accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2023-N-2483. Please note that late, untimely
filed comments will not be considered. The docket will close on October
10, 2023. The https://www.regulations.gov electronic filing system will
accept comments until 11:59 p.m. Eastern Time at the end of October 10,
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 August 30, 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
[[Page 55052]]
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-2483 for ``Microbiology Devices 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, September18, 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, 301-636-0510,
[email protected], 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 FDA'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: All meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing and/or video
conferencing platform. FDA is seeking the Committee's preliminary input
on potential future reclassification of certain microbiology devices to
inform FDA's thinking regarding whether reclassification from class III
to class II may be appropriate for such devices. Specifically, on
September 7, 2023, during session I, the Committee will discuss and
make recommendations regarding a potential future reclassification from
class III to class II with special controls of nucleic acid and
serology-based in vitro diagnostic devices indicated for use to aid in
diagnosis of hepatitis B virus (HBV) infection and/or for use to aid in
the management of HBV infected patients. The Committee, during session
II, will discuss and make recommendations regarding a potential future
reclassification from class III to class II with special controls of
serology-based in vitro diagnostic devices indicated for use to aid in
the detection of past, recent, or current infection with human
parvovirus B19. The Committee, during session III, will discuss and
make recommendations regarding a potential future reclassification from
class III to class II with special controls of cell-mediated immune
reactivity in vitro diagnostic devices indicated for use to aid in
identification of in vitro responses to peptide antigens that are
associated with Mycobacterium tuberculosis infection and/or for use as
detection of effector T cells that respond to stimulation by M.
tuberculosis agents.
All devices to be discussed by the Committee on September 7, 2023,
are postamendments devices that currently are classified into class III
under section 513(f)(1) of the Federal Food, Drug, and Cosmetic (FD&C)
Act (21 U.S.C. 360c(f)(1)). For these devices, the Committee will
discuss: (1) if there is sufficient information for FDA to consider
reclassifying them from class III to class II and (2) what special
controls, in addition to general controls, may be appropriate and
necessary to provide reasonable assurance of safety and effectiveness
for these devices, if FDA were to take action to reclassify them into
class II devices. FDA intends to follow the procedures outlined in
section 513 of the FD&C Act related to the reclassification of
postamendments devices after considering the Committee's input.
On September 8, 2023, the Committee will discuss and provide
recommendations to FDA regarding topics related to in vitro diagnostic
devices used in pandemic preparedness and response, consistent with the
requirements under section 3302 of FDORA.
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. Background material and the
link to the online teleconference and/or video conference meeting will
be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
The meeting will include slide presentations with audio and video
components to allow the presentation of materials in a manner that most
closely
[[Page 55053]]
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 written submissions to the Docket (see ADDRESSES) on
or before August 18, 2023, will be provided to the Committee. Oral
presentations from the public will be scheduled on September 7, 2023,
between approximately 10:05 a.m. and 10:35 a.m., 1:15 p.m. and 1:45
p.m., and 3:30 p.m. and 4 p.m. Eastern Time; and on September 8, 2023,
between approximately 10:30 a.m. and 11:30 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
August 10, 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 August 11, 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 that the ends of justice will be served
by allowing for this modification to FDA's advisory committee meeting
procedures.
Dated: August 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17287 Filed 8-11-23; 8:45 am]
BILLING CODE 4164-01-P
