Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 59167-59168 [2021-23334]
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59167
Federal Register / Vol. 86, No. 204 / Tuesday, October 26, 2021 / Notices
Household Water Assistance Program
(LIHWAP) program. The information
collection is essential to the mission of
the agency for this emergency assistance
effort and the use of normal clearance
procedures is reasonably likely to
disrupt and prevent the collection of
information.
Comments due within 60 days of
publication. In compliance with the
requirements of the Paperwork
Reduction Act of 1995, ACF is soliciting
public comment on the specific aspects
of the information collection described
in this notice.
ADDRESSES: Copies of the proposed
collection of information can be
obtained and comments may be
submitted by emailing infocollection@
acf.hhs.gov. All requests should identify
the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: ACF is requesting that
OMB grant a 180-day approval for this
request under procedures for expedited
processing. A request for review under
normal procedures will be submitted
DATES:
within 180 days of the approval for this
request. The LIHWAP effort was
authorized under two separate
appropriations as part of an emergency
effort to prevent and respond to COVID–
19: The Consolidated Appropriations
Act, 2021 (Pub. L. 116–260) and the
American Rescue Plan Act of 2021 (Pub.
L. 117–2). As a result of the emergency
nature, the timeline to implement the
program was very short and the time to
develop and submit related performance
measures is similarly short. The
proposed LIHWAP Quarterly
Performance and Management Report
and the LIHWAP Annual Report are
conducted in accordance with the
LIHWAP statute (Pub. L. 116–260) and
will provide ACF and Congress
information necessary for oversight of
recipients’ performance in
administering the LIHWAP program.
The completeness, accuracy,
consistency, and timeliness of responses
to data collections are needed for the
agency to do the following:
• Ensure that LIHWAP, an emergency
and temporary program, is implemented
effectively and efficiently;
• Provide reliable and complete fiscal
and household data for OCS analysis
and reporting to Congress and the
public; and
• Respond to questions from the
Congress, Department, OMB, White
House, and other interested parties in a
timely and accurate manner.
This information collection package
also includes a burden estimate related
to the information collected from
households. While grant recipients will
collect necessary information from
households using a variety of intake
systems and local forms, OCS is
providing technical assistance in this
area and has included a sample
application template in supplementary
materials. This is a sample template;
there will be no mandated household
application format and OCS will not
receive or analyze copies of individual
household application materials.
Respondents: LIHWAP grant
recipients.
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
Quarterly Report ..................................................................
Annual Report ......................................................................
Household Application .........................................................
Total
number of
responses per
respondent
157
157
1,200,000
Average
burden
hours per
response
4
2
1
13
211
.5
Total burden
hours
8,164
66,254
600,000
Annual
burden hours
8,164
33,127
200,000
Estimated Total Annual Burden Hours: 241,291 (for first year with Quarterly reports), 233,127 (for subsequent years without Quarterly reports).
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Comments will be considered and any
necessary updates to materials made
prior to, and responses provided in, the
submission to OMB that will follow this
public comment period.
Authority: Public Law 116–260 and
LIHWAP Terms and Conditions Section
10 (https://www.acf.hhs.gov/sites/
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22:39 Oct 25, 2021
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default/files/documents/LIHWAP%20
Terms%20and%20Conditions%20for
%20States.pdf).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2021–23271 Filed 10–25–21; 8:45 am]
BILLING CODE 4184–86–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0008]
Neurological Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Neurological Devices
SUMMARY:
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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 December 10, 2021, from 9
a.m. to 6 p.m. Eastern Time.
ADDRESSES: Please note that due to the
impact of this COVID–19 pandemic, all
meeting participants will be joining this
advisory committee meeting via an
online teleconferencing 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-advisorycommittees/common-questions-andanswers-about-fda-advisory-committeemeetings.
FOR FURTHER INFORMATION CONTACT:
James Swink, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5214, Silver Spring,
E:\FR\FM\26OCN1.SGM
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59168
Federal Register / Vol. 86, No. 204 / Tuesday, October 26, 2021 / Notices
MD 20993–0002, James.Swink@
fda.hhs.gov, 301–796–6313, 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 December
10, 2021, the committee will discuss,
make recommendations, and vote on
information regarding the premarket
approval application (PMA) for the
BrainsGate Ischemic Stroke System
(ISS500) by BrainsGate Ltd. The
proposed indications for use, submitted
by the sponsor, as stated in the PMA,
are as follows: The ISS500 is indicated
to increase cerebral blood flow and
reduce disability in adult patients with
acute ischemic stroke with confirmed
cortical involvement in the anterior
circulation who are ineligible or have no
access to IV-tPA and endovascular
thrombectomy. Treatment is to be
initiated between 8 and 24 hours from
stroke onset (last known well).
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/
advisory-committees/medical-devicesadvisory-committee/neurologicaldevices-panel. Select the link for the
2021 Meeting Materials. 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
VerDate Sep<11>2014
22:39 Oct 25, 2021
Jkt 256001
submissions may be made to the contact
person on or before November 29, 2021.
Oral presentations from the public will
be scheduled on December 10, 2021,
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
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 18, 2021. 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 19, 2021.
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/about-advisory-committees/
public-conduct-during-fda-advisorycommittee-meetings 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).
Dated: October 19, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–23334 Filed 10–25–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Request for Information and Notice of
Listening Session on Efforts To
Advance Health Equity Among Native
Hawaiian and Pacific Islander
Populations
Office of Minority Health,
Office of the Secretary, Department of
Health and Human Services.
ACTION: Request for information (RFI)
and notice of a listening session on
efforts to advance health equity among
Native Hawaiian and Pacific Islander
populations.
AGENCY:
The U.S. Department of
Health and Human Services (HHS)
Office of Minority Health (OMH) seeks
input from Native Hawaiian and Pacific
Islander (NHPI) communities, NHPIserving organizations, and other
interested parties regarding efforts of the
new Center for Indigenous Innovation
and Health Equity (Center). The Center
is tasked with supporting education,
service and policy development, and
research related to advancing
sustainable solutions, to address health
disparities and advance health equity
among NHPI and American Indian/
Alaska Native (AI/AN) populations.
This is NOT a solicitation for proposals
or proposal abstracts.
Please Note: This RFI and notice of a
listening session is for planning
purposes only. It is not a notice for a
proposal and does not commit the
federal government to issue a
solicitation, make an award, or pay any
costs associated with responding to this
announcement. All submitted
information shall remain with the
federal government and will not be
returned. All responses will become
part of the public record and will not be
held confidential. The federal
government reserves the right to use the
information provided by respondents
for purposes deemed necessary and
legally appropriate. Respondents are
advised that the federal government is
under no obligation to acknowledge
receipt of the information received or
provide feedback to respondents
concerning any information submitted.
Responses will not be accepted after the
due date.
DATES: The virtual listening session will
be held on Tuesday, November 2, 2021,
from 3:30 p.m.–4:30 p.m. EDT. To
register for the listening session,
visithttps://www.zoomgov.com/meeting/
register/vJIsc-6qpj4tGrQwQx2vdmo
UfMZmRWXZNDs. Written comments
also may be submitted and must be
received at the address provided below,
SUMMARY:
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]]>Agencies
[Federal Register Volume 86, Number 204 (Tuesday, October 26, 2021)]
[Notices]
[Pages 59167-59168]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23334]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0008]
Neurological Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Neurological 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 December 10, 2021, from
9 a.m. to 6 p.m. Eastern Time.
ADDRESSES: Please note that due to the impact of this COVID-19
pandemic, all meeting participants will be joining this advisory
committee meeting via an online teleconferencing 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: James Swink, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5214, Silver Spring,
[[Page 59168]]
MD 20993-0002, [email protected], 301-796-6313, 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 December
10, 2021, the committee will discuss, make recommendations, and vote on
information regarding the premarket approval application (PMA) for the
BrainsGate Ischemic Stroke System (ISS500) by BrainsGate Ltd. The
proposed indications for use, submitted by the sponsor, as stated in
the PMA, are as follows: The ISS500 is indicated to increase cerebral
blood flow and reduce disability in adult patients with acute ischemic
stroke with confirmed cortical involvement in the anterior circulation
who are ineligible or have no access to IV-tPA and endovascular
thrombectomy. Treatment is to be initiated between 8 and 24 hours from
stroke onset (last known well).
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/advisory-committees/medical-devices-advisory-committee/neurological-devices-panel. Select the link for the
2021 Meeting Materials. 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
November 29, 2021. Oral presentations from the public will be scheduled
on December 10, 2021, 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 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 18, 2021. 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 19,
2021.
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/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-meetings 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).
Dated: October 19, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23334 Filed 10-25-21; 8:45 am]
BILLING CODE 4164-01-P
