Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 59167-59168 [2021-23334]

Download as PDF 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/ VerDate Sep<11>2014 22:39 Oct 25, 2021 Jkt 256001 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: PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 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 26OCN1 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] BILLING CODE 4164–01–P PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 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: E:\FR\FM\26OCN1.SGM 26OCN1

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]


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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