Notice2023-17287
Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
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Published
August 14, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 155 (Monday, August 14, 2023)</title>
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[Federal Register Volume 88, Number 155 (Monday, August 14, 2023)]
[Notices]
[Pages 55051-55053]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-17287]
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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.
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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: <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm</a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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
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identifies you in the body of your comments, that information will be
posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#b9fad8d7ddd8dadc97f7d8d5d5caf9dfddd897d1d1ca97ded6cf"><span class="__cf_email__" data-cfemail="a5e6c4cbc1c4c6c08bebc4c9c9d6e5c3c1c48bcdcdd68bc2cad3">[email protected]</span></a>, 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 <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a> 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 <a href="https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm">https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm</a>. 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
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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
<a href="/cdn-cgi/l/email-protection#5f393b3e30323e1f393b3e7137372c71383029"><span class="__cf_email__" data-cfemail="94f2f0f5fbf9f5d4f2f0f5bafcfce7baf3fbe2">[email protected]</span></a> 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 <a href="/cdn-cgi/l/email-protection#cc8dbeb8ada5bee281ada0a0a9b8b88caaa8ade2a4a4bfe2aba3ba"><span class="__cf_email__" data-cfemail="bffecdcbded6cd91f2ded3d3dacbcbffd9dbde91d7d7cc91d8d0c9">[email protected]</span></a> 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 <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm</a> 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
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