Notice To Announce Tribal Consultation for an All of Us Research Program Update and To Discuss the Program's Policies and Protections Around Data Access and Use Statement for Fiscal Year 2023, 41974-41975 [2023-13750]

Download as PDF 41974 Federal Register / Vol. 88, No. 123 / Wednesday, June 28, 2023 / Notices Date: June 27, 2023. Time: 10:00 a.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6710B Rockledge Drive, Room 2125C, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Magnus A. Azuine, Ph.D., Scientific Review Officer, Scientific Review Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 6710B Rockledge Drive, Room 2125C, Bethesda, MD 20892, (301) 480–4645, magnus.azuine@nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.865, Research for Mothers and Children, National Institutes of Health, HHS) Dated: June 22, 2023. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–13702 Filed 6–27–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Environmental Health Sciences; Notice of Closed Meetings ddrumheller on DSK120RN23PROD with NOTICES1 Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings of the National Institute of Environmental Health Sciences. 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 of Environmental Health Sciences Special Emphasis Panel; Career Development and Pathway to Independence in Biomedical/ Clinical Research Career Awards K99/R00. Date: July 11, 2023. Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Environmental Health Sciences, Keystone Building, 530 VerDate Sep<11>2014 18:48 Jun 27, 2023 Jkt 259001 Davis Drive, Durham, NC 27709 (Virtual Meeting). Contact Person: Beverly W. Duncan, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute of Environmental Health Sciences, Keystone Building, 530 Davis Drive, Room 3130, Durham, NC 27713, (240) 353–6598, beverly.duncan@nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel; Review of the Transition to Independent Environmental Health Research Career Award (K01/K23) Applications. Date: July 12, 2023. Time: 10:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Environmental Health Sciences, Keystone Building, 530 Davis Drive, Durham, NC 27709 (Virtual Meeting). Contact Person: Beverly W. Duncan, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute of Environmental Health Sciences, Keystone Building, 530 Davis Drive, Room 3130, Durham, NC 27713, (240) 353–6598, beverly.duncan@nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel; NIEHS Support for Conferences and Scientific Meetings. Date: July 18, 2023. Time: 10:30 a.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Environmental Health Sciences, Keystone Building, 530 Davis Drive, Durham, NC 27709 (Virtual Meeting). Contact Person: Alfonso R. Latoni, Ph.D., Chief and Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and Training, National Institute of Environmental Health Sciences, Research Triangle Park, NC 27709, 984–287– 3279, alfonso.latoni@nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel; Exploratory Grants for Climate Change and Health Research Center Development. Date: August 1–3, 2023. Time: 9:30 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Environmental Health Sciences, Keystone Building, 530 Davis Drive, Durham, NC 27709 (Virtual Meeting). Contact Person: Linda K. Bass, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and Training, Nat’l Institute of Environmental PO 00000 Frm 00101 Fmt 4703 Sfmt 4703 Health Sciences, P.O. Box 12233, MD EC–30, Research Triangle Park, NC 27709, (984) 287– 3236, bass@niehs.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.115, Biometry and Risk Estimation—Health Risks from Environmental Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety Training; 93.143, NIEHS Superfund Hazardous Substances—Basic Research and Education; 93.894, Resources and Manpower Development in the Environmental Health Sciences; 93.113, Biological Response to Environmental Health Hazards; 93.114, Applied Toxicological Research and Testing, National Institutes of Health, HHS) Dated: June 23, 2023. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–13722 Filed 6–27–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice To Announce Tribal Consultation for an All of Us Research Program Update and To Discuss the Program’s Policies and Protections Around Data Access and Use Statement for Fiscal Year 2023 AGENCY: National Institutes of Health, HHS. ACTION: Notice. The U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH) hereby gives notice that the All of Us Research Program will be hosting a virtual Tribal Consultation with American Indian and Alaska Native (AI/ AN) Federally Recognized Tribes. The consultation will include an update on our approach to Tribal engagement, discussion about integrating data from self-identified AI/AN participants in the program’s data platform, the All of Us Research Hub at https:// www.researchallofus.org, and program planning. SUMMARY: Thursday, September 28, 2023, from 1 to 3:00 p.m. ET. Written Tribal testimony is due by October 28, 2023. ADDRESSES: Registration links are available on our Tribal Engagement website at https://allofus.nih.gov/ tribalengagement. Elected Tribal Officials are encouraged to submit written testimony to AOUTribal@nih.gov. Please submit on Tribal letterhead by October 28, 2023, with the subject line ‘‘All of Us Tribal consultation written response.’’ DATES: E:\FR\FM\28JNN1.SGM 28JNN1 Federal Register / Vol. 88, No. 123 / Wednesday, June 28, 2023 / Notices Dr. Joshua Denny AOUTribal@nih.gov, 301– 827–9737. More information is available at https://allofus.nih.gov/ tribalengagement. The All of Us Tribal Engagement team may also be reached by email at AOUTribal@nih.gov, or by mail at All of Us Research Program, Division of Engagement and Outreach, Tribal Engagement, NIH, 6710–B Rockledge Drive, 4th Floor, Bethesda, MD 20817. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: I. Background Information The All of Us Research Program aims to accelerate health research and medical breakthroughs to enable an era of precision medicine for all. All of Us is committed to ensuring the program reflects the diversity of the United States. In the 21st Century Cures Act (Pub. L. 114–255), Congress authorized NIH to carry out the Precision Medicine Initiative, which includes the All of Us Research Program. The law provides NIH with critical tools and resources to advance biomedical research across the spectrum, from foundational basic research studies to advanced clinical trials of promising new therapies, in part through the establishment of a diverse cohort of individuals to support the goals of All of Us. II. Tribal Virtual Informational Presentations and Discussions With Tribal Communities In June 2023, All of Us held four information and discussion sessions virtually to continue to engage with Tribal Nations and rural and urban AI/ AN communities. Recorded sessions will be made available at https:// allofus.nih.gov/about/diversity-andinclusion/tribal-engagement. ddrumheller on DSK120RN23PROD with NOTICES1 III. Questions A. Management and Sharing of SelfIdentified AI/AN Data (Without Tribal Affiliation) 1. Integrating information from selfidentified AI/AN participants in our data platform, the All of Us Research Hub at https://www.researchallofus.org. (a) How can the program augment the current policies and protections for selfidentified AI/AN participant data so that it can be shared with researchers? (b) What additional policies or guidance would you like All of Us to consider around the use of data from self-identified AI/AN participants? 2. Honoring Tribal sovereignty when working with self-identified AI/AN individuals who consent to participate. (a) What kinds of protective practices and measures can be implemented to VerDate Sep<11>2014 20:02 Jun 27, 2023 Jkt 259001 avoid infringing upon Tribal sovereignty when collecting or working with individual participant data? (b) How should the program manage and share data from self-identified AI/ AN individuals who choose to participate in the program, including those who are living off Tribal lands and/or who are not affiliated with a federally recognized Tribe? B. Tribal Engagement and Outreach 1. Possible future marketing efforts in zip codes that overlap on Tribal land and areas bordering Tribal land. (a) How should the program guide engagement and outreach efforts where zip codes overlap with Tribal land? 2. Program activities for individual participants on Tribal land. (a) What protocol should be followed when individual participants request program materials to be mailed to them or request home visits on Tribal lands? C. Program Planning Activities 1. Future inclusion of children in the All of Us Research Program. (a) What unique considerations are there for the future inclusion of AI/AN infants, children, and adolescents as participants in the program, given that a child’s parent or legal guardian must be a current participant? (b) What unique considerations are there for family-based enrollment in the research program (e.g., parent or legal guardian participating with their child)? (c) What specific factors should be taken into account when enrolling families in the research program, considering the possibility of kinship caregivers or non-traditional child care arrangements for the child? 2. AI/AN traditional blessing ceremony for biosamples of participants who withdraw from the program. (a) How should the program proceed in conducting a traditional blessing ceremony for the participants who selfidentify as AI/AN and request a blessing ceremony prior to the biosample disposition? Dated: June 22, 2023. Tara A. Schwetz, Acting Principal Deputy Director, National Institutes of Health. [FR Doc. 2023–13750 Filed 6–27–23; 8:45 am] BILLING CODE 4140–01–P PO 00000 41975 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; NIH Support for Conferences and Scientific Meetings (Parent R13 Clinical Trial Not Allowed). Date: August 1–2, 2023. Time: 9:00 a.m. to 5:00 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 3G11, Rockville, MD 20892 (Virtual Meeting). Contact Person: Barry J. Margulies, 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 3G11, Rockville, MD 20852, (301) 761–7956, barry.margulies@ 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: June 23, 2023. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–13725 Filed 6–27–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings Pursuant to section 1009 of the Federal Advisory Committee Act, as Frm 00102 Fmt 4703 Sfmt 4703 E:\FR\FM\28JNN1.SGM 28JNN1

Agencies

[Federal Register Volume 88, Number 123 (Wednesday, June 28, 2023)]
[Notices]
[Pages 41974-41975]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13750]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Notice To Announce Tribal Consultation for an All of Us Research 
Program Update and To Discuss the Program's Policies and Protections 
Around Data Access and Use Statement for Fiscal Year 2023

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The U.S. Department of Health and Human Services (HHS), 
National Institutes of Health (NIH) hereby gives notice that the All of 
Us Research Program will be hosting a virtual Tribal Consultation with 
American Indian and Alaska Native (AI/AN) Federally Recognized Tribes. 
The consultation will include an update on our approach to Tribal 
engagement, discussion about integrating data from self-identified AI/
AN participants in the program's data platform, the All of Us Research 
Hub at https://www.researchallofus.org, and program planning.

DATES: Thursday, September 28, 2023, from 1 to 3:00 p.m. ET. Written 
Tribal testimony is due by October 28, 2023.

ADDRESSES: Registration links are available on our Tribal Engagement 
website at https://allofus.nih.gov/tribalengagement.
    Elected Tribal Officials are encouraged to submit written testimony 
to [email protected]. Please submit on Tribal letterhead by October 28, 
2023, with the subject line ``All of Us Tribal consultation written 
response.''

[[Page 41975]]


FOR FURTHER INFORMATION CONTACT: Dr. Joshua Denny [email protected], 
301-827-9737. More information is available at https://allofus.nih.gov/tribalengagement. The All of Us Tribal Engagement team may also be 
reached by email at [email protected], or by mail at All of Us Research 
Program, Division of Engagement and Outreach, Tribal Engagement, NIH, 
6710-B Rockledge Drive, 4th Floor, Bethesda, MD 20817.

SUPPLEMENTARY INFORMATION: 

I. Background Information

    The All of Us Research Program aims to accelerate health research 
and medical breakthroughs to enable an era of precision medicine for 
all. All of Us is committed to ensuring the program reflects the 
diversity of the United States.
    In the 21st Century Cures Act (Pub. L. 114-255), Congress 
authorized NIH to carry out the Precision Medicine Initiative, which 
includes the All of Us Research Program. The law provides NIH with 
critical tools and resources to advance biomedical research across the 
spectrum, from foundational basic research studies to advanced clinical 
trials of promising new therapies, in part through the establishment of 
a diverse cohort of individuals to support the goals of All of Us.

II. Tribal Virtual Informational Presentations and Discussions With 
Tribal Communities

    In June 2023, All of Us held four information and discussion 
sessions virtually to continue to engage with Tribal Nations and rural 
and urban AI/AN communities. Recorded sessions will be made available 
at https://allofus.nih.gov/about/diversity-and-inclusion/tribal-engagement.

III. Questions

A. Management and Sharing of Self-Identified AI/AN Data (Without Tribal 
Affiliation)

    1. Integrating information from self-identified AI/AN participants 
in our data platform, the All of Us Research Hub at https://www.researchallofus.org.
    (a) How can the program augment the current policies and 
protections for self-identified AI/AN participant data so that it can 
be shared with researchers?
    (b) What additional policies or guidance would you like All of Us 
to consider around the use of data from self-identified AI/AN 
participants?
    2. Honoring Tribal sovereignty when working with self-identified 
AI/AN individuals who consent to participate.
    (a) What kinds of protective practices and measures can be 
implemented to avoid infringing upon Tribal sovereignty when collecting 
or working with individual participant data?
    (b) How should the program manage and share data from self-
identified AI/AN individuals who choose to participate in the program, 
including those who are living off Tribal lands and/or who are not 
affiliated with a federally recognized Tribe?

B. Tribal Engagement and Outreach

    1. Possible future marketing efforts in zip codes that overlap on 
Tribal land and areas bordering Tribal land.
    (a) How should the program guide engagement and outreach efforts 
where zip codes overlap with Tribal land?
    2. Program activities for individual participants on Tribal land.
    (a) What protocol should be followed when individual participants 
request program materials to be mailed to them or request home visits 
on Tribal lands?

C. Program Planning Activities

    1. Future inclusion of children in the All of Us Research Program.
    (a) What unique considerations are there for the future inclusion 
of AI/AN infants, children, and adolescents as participants in the 
program, given that a child's parent or legal guardian must be a 
current participant?
    (b) What unique considerations are there for family-based 
enrollment in the research program (e.g., parent or legal guardian 
participating with their child)?
    (c) What specific factors should be taken into account when 
enrolling families in the research program, considering the possibility 
of kinship caregivers or non-traditional child care arrangements for 
the child?
    2. AI/AN traditional blessing ceremony for biosamples of 
participants who withdraw from the program.
    (a) How should the program proceed in conducting a traditional 
blessing ceremony for the participants who self-identify as AI/AN and 
request a blessing ceremony prior to the biosample disposition?

    Dated: June 22, 2023.
Tara A. Schwetz,
Acting Principal Deputy Director, National Institutes of Health.
[FR Doc. 2023-13750 Filed 6-27-23; 8:45 am]
BILLING CODE 4140-01-P
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