[Federal Register Volume 87, Number 227 (Monday, November 28, 2022)]
[Notices]
[Pages 73009-73010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25840]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request;

    NIH Information Collection Forms To Support Genomic Data Sharing 
for Research Purposes (Office of Director)
AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the 
National Institutes of Health (NIH) has submitted to the Office of 
Management and Budget (OMB) a request for review and approval of the 
information collection listed below.

DATES: Comments regarding this information collection are best assured 
of having their full effect if received within 30-days of the date of 
this publication.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact: Julia Slutsman, Ph.D. Director, Genomic Data 
Sharing Policy Implementation, OER, OD, NIH, Natcher Building, Room 
3AN-44D, 6705 Rockledge Dr., Suite 750, Bethesda, MD 20892, or call 
non-toll-free number (301) 594-7783 or email your request, including 
your address to: [email protected].

SUPPLEMENTARY INFORMATION: This proposed information collection was 
previously published in the Federal Register on September 21, 2022, 
pages 57705-57707 (87 FR 57705) and allowed 60 days for public comment. 
No public comments were received. The purpose of this notice is to 
allow an additional 30 days for public comment. The Office of the 
Director (OD), National Institutes of Health, may not conduct or 
sponsor, and the respondent is not required to respond to, an 
information collection that has been extended, revised, or implemented 
on or after November 30, 2022, unless it displays a currently valid OMB 
control number.
    In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction 
Act of 1995, the National Institutes of Health (NIH) has submitted to 
the Office of Management and Budget (OMB) a request for review and 
approval of the information collection listed below.
    Proposed Collection: NIH Information Collection Forms to Support 
Genomic Data Sharing for Research Purposes--0925--REVISION--expiration 
date 11/30/2022, Office of the Director (OD), National Institutes of 
Health (NIH).
    Need and Use of Information Collection: Sharing research data 
supports the National Institutes of Health (NIH) mission and is 
essential to facilitate the translation of research results into 
knowledge, products, and procedures that improve human health. NIH has 
longstanding policies to make a broad range of research data, including 
genomic data, publicly available in a timely manner from the research 
activities that it funds. Genomic research data sharing is an integral 
element of the NIH mission as it facilitates advances in our 
understanding of factors that influence health and disease, while also 
providing opportunities to accelerate research through the power of 
combining large and information-rich datasets. To promote robust 
sharing of human and non-human data from a wide range of large-scale 
genomic research and provide appropriate protections for research 
involving human data, the NIH issued the NIH Genomic Data Sharing 
Policy (NIH GDS Policy). Human genomic data submissions and controlled 
access are managed through a central data repository, the database of 
Genotypes and Phenotypes (dbGaP) which is administered by the National 
Center for Biotechnology Information (NCBI), part of the National 
Library of Medicine at NIH. Under the NIH GDS Policy, all investigators 
who receive NIH funding to conduct large-scale genomic research are 
expected to register studies with human genomic data in dbGaP, no 
matter which NIH-designated data repository will maintain the data. As 
part of the registration process, investigators must provide basic 
study information such as the type of data that will be submitted to 
dbGaP, a description of the study, and an institutional assurance (i.e. 
Institutional Certification) of the data submission which delineates 
any limitations on the secondary use of the data (e.g., data cannot be 
shared with for-profit companies, data can be used only for research of 
particular diseases). Investigators interested in using controlled-
access data for secondary research must apply through dbGaP and be 
granted permission from the relevant NIH Data Access Committee(s). As 
part of the application process, investigators and their institutions 
must provide information such as a description of the proposed research 
use of controlled access datasets that conforms to any data use 
limitations, agree to the Genomic Data User Code of Conduct, and agree 
to the terms of access through a Data Use Certification agreement. 
Requests to renew data access and reports to close out data use are 
similar to the initial data access request, requiring sign-off by both 
the requestor and the institution, but also ask for information about 
how the data have been used, and about publications, presentations, or 
intellectual property based on the research conducted with the accessed 
data as well as any data security issues or other data management 
incidents. NIH has developed online forms, available through dbGaP, in 
an effort to reduce the burden for researchers and their

[[Page 73010]]

institutional officials to complete the study registration, data 
submission, data access, and renewal and closeout processes.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 158,776.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
           Form name                 Type of         Number of     responses per   per response    Total annual
                                   respondent       respondents     respondent      (in hours)      burden hour
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dbGaP Registration and          Investigator               1,050               1               1            1050
 Submission.                     Submitting Data.
Institutional Certification...  Investigator               1,050               1           45/60             788
                                 filling out
                                 Institutional
                                 Certification.
Institutional Certification...  Institutional              1,050               1           45/60             788
                                 Official to
                                 Certify
                                 Submission.
Provisional Institutional       Investigator                 100               1           45/60              75
 Certification.                  filling out
                                 Provisional
                                 Institutional
                                 Certification.
Provisional Institutional       Institutional                100               1           45/60              75
 Certification.                  Official to
                                 Certify
                                 Provisional
                                 Submission.
Data Access Request...........  Requester                  3,900              10               1          39,000
                                 Submitting
                                 Request.
Data Access Request...........  Institutional              3,900              10               1          39,000
                                 Signing
                                 Official to
                                 Certify Request.
Project Renewal or Project      Requester                  3,900              10               1          39,000
 Close-out form.                 Submitting
                                 Request.
Project Renewal or Project      Institutional              3,900              10               1          39,000
 Close-out form.                 Signing
                                 Official to
                                 Certify Request.
                                                 ---------------------------------------------------------------
    Total.....................  ................          18,950         159,350  ..............         158,776
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    Dated: November 21, 2022.
Tara A. Schwetz,
Acting Principal Deputy Director, National Institutes of Health.
[FR Doc. 2022-25840 Filed 11-25-22; 8:45 am]
BILLING CODE 4140-01-P