Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting-TriClip G4 System, 3930-3931 [2024-01082]
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3930
Federal Register / Vol. 89, No. 14 / Monday, January 22, 2024 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
21 CFR section activity
Number of
records per
recordkeeper
Total annual
records
Average burden
per recordkeeping
Total hours
Subpart D: Samples
§§ 203.30 to 203.39; documentation regarding
sample distribution.
140
46,716.67
6,540,334
0.08 (5 minutes) ...........
523,227
Total ...............................................................
........................
........................
6,857,094
.......................................
575,492
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of Agency data,
since our last request for OMB approval,
we have adjusted our estimate of 1
burden to reflect an increase of
6,492,354 responses and 516,028 hours
annually. The estimates in table 1 (a
decrease of 19,700 responses and 4,928
hours since the last OMB approval)
reflect an assessment of the volume of
loss/theft/falsification reports received
by the Agency under § 203.37 over the
past 18 months. While the requirements
have not changed, we believe this more
accurately reflects the number of reports
estimated to be submitted to FDA under
this section. Our adjustments to table 2
are attributable to a more accurate
reflection of the number of drug sample
requests received by manufacturers and
authorized distributors of record. The
PDMA does not require manufacturers
and distributors to report the number of
drug sample requests they receive to
FDA. However, section 6004 of the
Patient Protection and Affordable Care
Act (Pub. L. 111–148) requires that
manufacturers and authorized
distributors submit to FDA annually the
identity and quantity of drug samples
requested, among other information.
Dated: January 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–01079 Filed 1–19–24; 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–2023–N–0008]
Circulatory System Devices Panel of
the Medical Devices Advisory
Committee; Notice of Meeting—TriClip
G4 System
AGENCY:
Food and Drug Administration,
announces a forthcoming public
advisory committee meeting of the
Circulatory System Devices 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 February 13, 2024, from 9
a.m. to 6 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/advisory-committees/
about-advisory-committees/commonquestions-and-answers-about-fdaadvisory-committee-meetings.
FOR FURTHER INFORMATION CONTACT:
Akinola Awojope, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg., 66, Rm. 5214, Silver Spring,
MD 20993–0002, Akinola.Awojope@
fda.hhs.gov, 301–636–0512, 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:
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency)
SUMMARY:
VerDate Sep<11>2014
18:02 Jan 19, 2024
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Agenda: The meeting presentations
will be heard, viewed, captioned, and
recorded through an online
teleconferencing platform. On February
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13, 2024, the committee will discuss,
make recommendations, and vote on
information regarding the premarket
approval application (PMA) for the
TriClip G4 System by Abbott Medical.
The proposed Indication for Use
statement is as follows: The TriClip G4
System is indicated for the
improvement of health status in patients
with symptomatic severe tricuspid
regurgitation despite being treated
optimally with medical therapy, who
are at intermediate or greater risk for
surgery and in whom tricuspid valve
edge-to-edge repair is appropriate as
determined by a heart team.
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. Written
submissions may be made to the contact
person on or before February 2, 2024.
Oral presentations from the public will
be scheduled on February 13, 2024,
between approximately 1 p.m. and 2
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
E:\FR\FM\22JAN1.SGM
22JAN1
Federal Register / Vol. 89, No. 14 / Monday, January 22, 2024 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
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 January 25, 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
January 29, 2024.
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 AnnMarie
Williams at AnnMarie.Williams@
fda.hhs.gov or 240–507–6496 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. app. 2). 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: January 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–01082 Filed 1–19–24; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
18:02 Jan 19, 2024
Jkt 262001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
Notice of Closed Meetings
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel;
Translating Research to Practice to End the
Overdose Crisis.
Date: February 14–15, 2024.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Health,
National Institute on Drug Abuse, 301 North
Stonestreet Avenue, Bethesda, MD 20892.
Contact Person: Sheila Pirooznia, Ph.D.,
Scientific Review Officer, Division of
Extramural Review, Scientific Review
Branch, National Institute on Drug Abuse,
NIH, 301 North Stonestreet Avenue, MSC
6021, Bethesda, MD 20892, (301) 496–9350,
sheila.pirooznia@nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; NIDA–
K Alternate SEP.
Date: February 21, 2024.
Time: 12:00 p.m. to 1:15 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Health,
National Institute on Drug Abuse, 301 North
Stonestreet Avenue, Bethesda, MD 20892.
Contact Person: Marisa Srivareerat, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Office of Extramural Policy, National
Institute on Drug Abuse, NIH, 301 North
Stonestreet Avenue, MSC 6021, Bethesda,
MD 20892, (301) 435–1258,
marisa.srivareerat@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.277, Drug Abuse Scientist
Development Award for Clinicians, Scientist
Development Awards, and Research Scientist
Awards; 93.278, Drug Abuse National
Research Service Awards for Research
Training; 93.279, Drug Abuse and Addiction
Research Programs, National Institutes of
Health, HHS)
PO 00000
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3931
Dated: January 16, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–01048 Filed 1–19–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Development of Software for
Data Science in Infectious and ImmuneMediated Diseases Research (U01 Clinical
Trial Not Allowed).
Date: March 6–7, 2024.
Time: 10:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G42,
Rockville, MD 20892 (Video Assisted
Meeting).
Contact Person: Sandip Bhattacharyya,
Ph.D., Scientific Review Officer, Scientific
Review Program, Division of Extramural
Activities, National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G42,
Rockville, MD 20852, sandip.bhattacharyya@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: January 17, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–01131 Filed 1–19–24; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\22JAN1.SGM
22JAN1
]]>Agencies
[Federal Register Volume 89, Number 14 (Monday, January 22, 2024)]
[Notices]
[Pages 3930-3931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01082]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0008]
Circulatory System Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting--TriClip G4 System
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) announces a
forthcoming public advisory committee meeting of the Circulatory System
Devices 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 February 13, 2024, from
9 a.m. to 6 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/advisory-committees/about-advisory-committees/common-questions-and-answers-about-fda-advisory-committee-meetings.
FOR FURTHER INFORMATION CONTACT: Akinola Awojope, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg., 66, Rm. 5214, Silver Spring, MD 20993-0002,
[email protected], 301-636-0512, 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 February
13, 2024, the committee will discuss, make recommendations, and vote on
information regarding the premarket approval application (PMA) for the
TriClip G4 System by Abbott Medical. The proposed Indication for Use
statement is as follows: The TriClip G4 System is indicated for the
improvement of health status in patients with symptomatic severe
tricuspid regurgitation despite being treated optimally with medical
therapy, who are at intermediate or greater risk for surgery and in
whom tricuspid valve edge-to-edge repair is appropriate as determined
by a heart team.
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.
Written submissions may be made to the contact person on or before
February 2, 2024. Oral presentations from the public will be scheduled
on February 13, 2024, between approximately 1 p.m. and 2 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
[[Page 3931]]
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 January 25, 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 January 29, 2024.
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 AnnMarie Williams at [email protected] or 240-507-
6496 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. app. 2). 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: January 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-01082 Filed 1-19-24; 8:45 am]
BILLING CODE 4164-01-P
