[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.

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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