Notice2024-08656
Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting-Guardant Shield Blood Collection Kit
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 23, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Full Text
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<title>Federal Register, Volume 89 Issue 79 (Tuesday, April 23, 2024)</title>
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[Federal Register Volume 89, Number 79 (Tuesday, April 23, 2024)]
[Notices]
[Pages 30383-30384]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-08656]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0008]
Molecular and Clinical Genetics Panel of the Medical Devices
Advisory Committee; Notice of Meeting--Guardant Shield Blood Collection
Kit
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) announces
a forthcoming public advisory committee meeting of the Molecular and
Clinical Genetics Panel of the Medical Devices Advisory Committee. The
general function of the committee is to provide advice and
recommendations to the Agency on FDA's regulatory issues. The meeting
will be open to the public.
DATES: The meeting will take place virtually on May 23, 2024, from 9:30
a.m. to 5:30 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. Answers to
commonly asked questions about FDA advisory committee meetings,
including information regarding special accommodations due to a
disability may be accessed at: <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm</a>.
FOR FURTHER INFORMATION CONTACT: Jarrod Collier, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993-0002,
<a href="/cdn-cgi/l/email-protection#1a507b6868757e3459757676737f685a7c7e7b34727269347d756c"><span class="__cf_email__" data-cfemail="642e0516160b004a270b08080d0116240200054a0c0c174a030b12">[email protected]</span></a>, 240-672-5763, 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 <a href="https://www.fda.gov/AdvisoryCommittees/default">https://www.fda.gov/AdvisoryCommittees/default</a>.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 May 23,
2024, the committee will discuss, make recommendations, and vote on
information regarding the premarket approval application for the Shield
test by Guardant Health, Inc. The proposed indication for use statement
is as follows: The Shield test is a qualitative in vitro diagnostic
test intended to detect colorectal cancer derived alterations in cell-
free DNA from blood collected in the Guardant Blood Collection Kit.
Shield is intended for colorectal cancer screening in individuals at
average risk of the disease, age 45 years or older. Patients with an
``Abnormal Signal Detected'' may have colorectal cancer or advanced
adenomas and should be referred for colonoscopy evaluation. Shield is
not a replacement for diagnostic colonoscopy or for surveillance
colonoscopy in high-risk individuals. The test is performed at Guardant
Health, Inc.
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
[[Page 30384]]
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 <a href="https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm">https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm</a>. 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.
Written submissions may be made to the contact person on or before May
10, 2024. Oral presentations from the public will be scheduled on May
23, 2024, between approximately 1:45 p.m. and 2:45 p.m. Eastern Time.
Those individuals interested in making formal oral presentations should
notify the contact person (see FOR FURTHER INFORMATION CONTACT). The
notification should include 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 May 7, 2024. 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 May 8, 2024.
For press inquiries, please contact the Office of Media Affairs at
<a href="/cdn-cgi/l/email-protection#4b2d2f2a24262a0b2d2f2a65232338652c243d"><span class="__cf_email__" data-cfemail="b6d0d2d7d9dbd7f6d0d2d798dedec598d1d9c0">[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#9ddcefe9fcf4efb3d0fcf1f1f8e9e9ddfbf9fcb3f5f5eeb3faf2eb"><span class="__cf_email__" data-cfemail="beffcccadfd7cc90f3dfd2d2dbcacafed8dadf90d6d6cd90d9d1c8">[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. The conditions for issuance of a
waiver under 21 CFR 10.19 are met.
Dated: April 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-08656 Filed 4-22-24; 8:45 am]
BILLING CODE 4164-01-P
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