Request for Information and Notice of Listening Session on Efforts To Advance Health Equity Among Native Hawaiian and Pacific Islander Populations, 59168-59169 [2021-23200]

Download as PDF 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 Federal Register / Vol. 86, No. 204 / Tuesday, October 26, 2021 / Notices no later than 11:59 p.m. EDT on November 19, 2021. ADDRESSES: All comments should be emailed to CAPT Samuel Wu at Samuel.Wu@hhs.gov. Please use the subject line ‘‘OMH RFI: CIIHE NHPI’’. Submitted comments received after the deadline will not be reviewed. Please respond concisely and in plain language. You may use any structure or layout that presents your information well. You may respond to some or all of our four questions below, and you can suggest other factors or relevant questions. You may also include links to online materials or interactive presentations. Proprietary information should be marked clearly and placed it in a separate section or file. Your response will become government property, and we may publish some of its non-proprietary content. FOR FURTHER INFORMATION CONTACT: CAPT Samuel Wu atSamuel.Wu@ hhs.gov. SUPPLEMENTARY INFORMATION: Authorized under Section 1707 of the Public Health Service Act, 42 U.S.C. 300u–6, as amended, the mission of OMH is to improve the health of racial and ethnic minority populations through the development of health policies and programs that help eliminate health disparities. OMH awards and other activities are intended to support the identification of effective policies, programs, and practices for improving health outcomes and to promote the sustainability and dissemination of these approaches. Under the authority of Public Law 116–260 (2021 Consolidated Appropriations Act), Congress directed OMH to create a Center to support education, service and policy development, and research advancing indigenous solutions that ultimately address health disparities among NHPI and AI/AN populations. I. Background Information NHPI communities experience persistent health disparities, including higher rates of diabetes, high blood pressure, and obesity, compared to nonHispanic white populations. Identification and awareness of health outcomes and health determinants are essential steps toward reducing health disparities in minority communities at greatest risk. Research has shown that culturally adapted and culturally grounded health and public health approaches and interventions that are aligned with indigenous communities’ cultural values and perspectives are effective in improving clinical outcomes within NHPI and AI/AN communities. VerDate Sep<11>2014 22:39 Oct 25, 2021 Jkt 256001 Program Information In September 2021, OMH announced awards to establish a Center for Indigenous Innovation and Health Equity, for which OMH will provide the organizational structure and operational framework. The Center will support efforts including education, service and policy development, and research related to advancing sustainable solutions to address health disparities and advance health equity in the AI/AN and NHPI populations. Two award recipients will function as a single initiative, coordinated by OMH. Each award recipient will focus on one of the two focus populations: AI/AN or NHPI populations. OMH expects the award recipients to implement the Center by: (1) Managing the Center advisory board; (2) partnering with academic institutions, indigenous leaders, and NHPI and AI/AN communities on Center activities; (3) identifying and disseminating culturally appropriate evidence-based and/or evidence-informed interventions, and lessons learned; and (4) designing and providing education and training to support community capacity-building. The Center’s activities are expected to result in: (1) Increased community capacity and knowledge of culturally appropriate, evidence-based and/or evidenceinformed interventions, and policies that address health disparities among NHPI and AI/AN populations; (2) increased utilization of effective strategies to reduce NHPI and AI/AN health disparities; and (3) improved NHPI and AI/AN health and reduction of health disparities. III. Questions • Are there priority health disparity issue(s) affecting NHPI communities that the Center should address? • How can the Center engage community partners to increase knowledge and adoption of culturally appropriate, evidence-based, and/or evidence-informed interventions, and policies that reduce health disparities among NHPI populations? • What should the Center consider when disseminating public health messages or promising practices Fmt 4703 Sfmt 4703 Dated: October 18, 2021. Samuel Wu, CAPT, Public Health Advisor. [FR Doc. 2021–23200 Filed 10–25–21; 8:45 am] BILLING CODE 4150–29–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Institute of Neurological Disorders and Stroke Special Emphasis Panel, November 1, 2021, 09:00 a.m. to November 2, 2021, 06:00 p.m., National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 which was published in the Federal Register on October 13, 2021, FR Doc 2021– 22196, 86 FR 56965. This notice is being amended to change the dates of this meeting from November 1–2, 2021 to November 15– 16, 2021. The meeting time remains the same. The meeting is closed to the public. Dated: October 21, 2021. Tyeshia M. Roberson-Curtis, Program Analyst, Office of Federal Advisory Committee Policy. BILLING CODE 4140–01–P Through this RFI and notice of a listening session, OMH is seeking information from NHPI communities, NHPI-serving organizations, and interested parties on the questions below. Frm 00058 designed to reduce health disparities to diverse NHPI communities? • What should the Center consider when addressing barriers to implementing culturally appropriate interventions and policies to advance indigenous health innovation and health equity? [FR Doc. 2021–23318 Filed 10–25–21; 8:45 am] II. Request for Information PO 00000 59169 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Patent License: Development and Commercialization of CRISPREngineered T Cell Therapies for the Treatment of Cancer AGENCY: National Institutes of Health, HHS. ACTION: Notice. The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to SUMMARY: E:\FR\FM\26OCN1.SGM 26OCN1

Agencies

[Federal Register Volume 86, Number 204 (Tuesday, October 26, 2021)]
[Notices]
[Pages 59168-59169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23200]


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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

AGENCY: 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.

-----------------------------------------------------------------------

SUMMARY: 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, NHPI-serving 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-6qpj4tGrQwQx2vdmoUfMZmRWXZNDs. Written comments also may be submitted 
and must be received at the address provided below,

[[Page 59169]]

no later than 11:59 p.m. EDT on November 19, 2021.

ADDRESSES: All comments should be emailed to CAPT Samuel Wu [email protected]">at[email protected]. Please use the subject line ``OMH RFI: CIIHE NHPI''.
    Submitted comments received after the deadline will not be 
reviewed. Please respond concisely and in plain language. You may use 
any structure or layout that presents your information well. You may 
respond to some or all of our four questions below, and you can suggest 
other factors or relevant questions. You may also include links to 
online materials or interactive presentations. Proprietary information 
should be marked clearly and placed it in a separate section or file. 
Your response will become government property, and we may publish some 
of its non-proprietary content.

FOR FURTHER INFORMATION CONTACT: CAPT Samuel Wu [email protected]">at[email protected].

SUPPLEMENTARY INFORMATION: Authorized under Section 1707 of the Public 
Health Service Act, 42 U.S.C. 300u-6, as amended, the mission of OMH is 
to improve the health of racial and ethnic minority populations through 
the development of health policies and programs that help eliminate 
health disparities. OMH awards and other activities are intended to 
support the identification of effective policies, programs, and 
practices for improving health outcomes and to promote the 
sustainability and dissemination of these approaches.
    Under the authority of Public Law 116-260 (2021 Consolidated 
Appropriations Act), Congress directed OMH to create a Center to 
support education, service and policy development, and research 
advancing indigenous solutions that ultimately address health 
disparities among NHPI and AI/AN populations.

I. Background Information

    NHPI communities experience persistent health disparities, 
including higher rates of diabetes, high blood pressure, and obesity, 
compared to non-Hispanic white populations. Identification and 
awareness of health outcomes and health determinants are essential 
steps toward reducing health disparities in minority communities at 
greatest risk. Research has shown that culturally adapted and 
culturally grounded health and public health approaches and 
interventions that are aligned with indigenous communities' cultural 
values and perspectives are effective in improving clinical outcomes 
within NHPI and AI/AN communities.

Program Information

    In September 2021, OMH announced awards to establish a Center for 
Indigenous Innovation and Health Equity, for which OMH will provide the 
organizational structure and operational framework. The Center will 
support efforts including education, service and policy development, 
and research related to advancing sustainable solutions to address 
health disparities and advance health equity in the AI/AN and NHPI 
populations. Two award recipients will function as a single initiative, 
coordinated by OMH. Each award recipient will focus on one of the two 
focus populations: AI/AN or NHPI populations. OMH expects the award 
recipients to implement the Center by:
    (1) Managing the Center advisory board;
    (2) partnering with academic institutions, indigenous leaders, and 
NHPI and AI/AN communities on Center activities;
    (3) identifying and disseminating culturally appropriate evidence-
based and/or evidence-informed interventions, and lessons learned; and
    (4) designing and providing education and training to support 
community capacity-building.
    The Center's activities are expected to result in:
    (1) Increased community capacity and knowledge of culturally 
appropriate, evidence-based and/or evidence-informed interventions, and 
policies that address health disparities among NHPI and AI/AN 
populations;
    (2) increased utilization of effective strategies to reduce NHPI 
and AI/AN health disparities; and
    (3) improved NHPI and AI/AN health and reduction of health 
disparities.

II. Request for Information

    Through this RFI and notice of a listening session, OMH is seeking 
information from NHPI communities, NHPI-serving organizations, and 
interested parties on the questions below.

III. Questions

     Are there priority health disparity issue(s) affecting 
NHPI communities that the Center should address?
     How can the Center engage community partners to increase 
knowledge and adoption of culturally appropriate, evidence-based, and/
or evidence-informed interventions, and policies that reduce health 
disparities among NHPI populations?
     What should the Center consider when disseminating public 
health messages or promising practices designed to reduce health 
disparities to diverse NHPI communities?
     What should the Center consider when addressing barriers 
to implementing culturally appropriate interventions and policies to 
advance indigenous health innovation and health equity?

    Dated: October 18, 2021.
Samuel Wu, CAPT,
Public Health Advisor.
[FR Doc. 2021-23200 Filed 10-25-21; 8:45 am]
BILLING CODE 4150-29-P