[Federal Register Volume 89, Number 218 (Tuesday, November 12, 2024)]
[Notices]
[Pages 89019-89020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-26138]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request; Data Use 
Certification for the NIH Brain Development Cohorts (NBDC), (National 
Institute on Drug Abuse)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The purpose of this revision is to clarify inclusion of the 
HBCD Study, to update data use terms and conditions, and to request a 
progress report statement at the time of renewal. Burden levels remain 
unchanged.
    In compliance with the requirement of the Paperwork Reduction Act 
of 1995 to provide opportunity for public comment on proposed data 
collection projects, the National Institute on Drug Abuse (NIDA) will 
publish periodic summaries of proposed projects to be submitted to the 
Office of Management and Budget (OMB) for review and approval.

DATES: Comments regarding this information collection are best assured 
of having their full effect if received within 60 days of the date of 
this publication.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments, submit comments in writing, or 
request more information on the proposed project, contact: Dr. 
Elizabeth A. Hoffman, Associate Director, Division of Extramural 
Research, National Institute on Drug Abuse, 3WFN Room 09C75 MSC 6021, 
Gaithersburg, MD 20877, or call non-toll-free number (301) 594-2265 or 
Email your request, including your address to: 
<a href="/cdn-cgi/l/email-protection#82e7eeebf8e3e0e7f6eaaceaede4e4efe3ecc2ecebeaace5edf4"><span class="__cf_email__" data-cfemail="e3868f8a99828186978bcd8b8c85858e828da38d8a8bcd848c95">[email protected]</span></a>. Formal requests for additional plans and 
instruments must be requested in writing.

SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995 requires: written comments and/or suggestions 
from the public and affected agencies are invited to address one or 
more of the following points: (1) Whether the proposed collection of 
information is necessary for the proper performance of the function of 
the agency, including whether the information will have practical 
utility; (2) The accuracy of the agency's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) Ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) Ways 
to minimizes the burden of the collection of information on those who 
are to respond, including the use of appropriate automated, electronic, 
mechanical, or other technological collection techniques or other forms 
of information technology.
    Proposed Collection Title: Data Use Certification for the NIH BRAIN 
Development Cohorts (NBDC), (NIDA) 0925-0780, exp., date 10/31/2026 
REVISION, National Institute on Drug Abuse (NIDA), National Institutes 
of Health (NIH).
    Need and Use of Information Collection: The purpose of this 
proposal is to inform data requestors about terms and conditions for 
using data generated by the Adolescent Brain Cognitive Development 
\(SM)\ (ABCD) Study and the Healthy Brain and Child Development (HBCD) 
Study, collectively known as the NIH Brain Development Cohorts (NBDC), 
and to obtain signed agreements from requestors and their institutional 
officials attesting to their commitment to abide by the data use terms 
and conditions. These include using data for research purposes; 
adhering to human subjects research requirements; not distributing the 
data to non-authorized users; minimizing risk of participant 
identifiability; using data ethically and responsibly; and keeping the 
data secure. Recipients must include a brief description of their 
research project and submit their signed data use agreements to the 
data repository to gain access to NBDC Study data. Recipients who plan 
to conduct research studies specifically on American Indian/Alaska 
Native (AI/AN) populations must submit an additional signed data use 
certification.
    OMB approval is requested for 3 years. There are no costs to 
respondents

[[Page 89020]]

other than their time. The total estimated annualized burden hours are 
2,000.

                                        Estimated Annualized Burden Hours
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                                                                    Number of      Average time
                Type of respondent                   Number of    responses per    per response    Total annual
                                                    respondents     respondent      (in hours)      burden hour
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Individuals (standard DUC form)..................         1,800                1               1           1,800
Individuals (additional AI/AN DUC form when                 200                1               1             200
 needed).........................................
                                                  --------------------------------------------------------------
    Total........................................  ............            2,000  ..............           2,000
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Lanette A. Palmquist,
Project Clearance Liaison, National Institute on Drug Abuse, National 
Institutes of Health.
[FR Doc. 2024-26138 Filed 11-8-24; 8:45 am]
BILLING CODE 4140-01-P


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