[Federal Register Volume 87, Number 182 (Wednesday, September 21, 2022)]
[Pages 57705-57707]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20467]



National Institutes of Health

Proposed Collection; 60-Day Comment Request; NIH Information 
Collection Forms To Support Genomic Data Sharing for Research Purposes 

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.


SUMMARY: In compliance with the requirement of the Paperwork Reduction 
Act of 1995, for opportunity for public comment on proposed data 
collection projects, the National Institutes of Health Office of the 
Director (OD) 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

[[Page 57706]]

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: Julia 
Slutsman, Ph.D., Director, Genomic Data Sharing Policy Implementation 
Team, Office of Extramural Research, NIH, Office of Extramural 
Research, OD, NIH 6705 Rockledge Dr. (RKL1), Room 800-C, Bethesda, MD 
20892, or call non-toll-free number (301)-594-7783 or email your 
request including your address to: [email protected]. Formal 
requests for additional plans and instruments must be requested in 

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 from 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: NIH Information Collection Forms to 
Support Genomic Data Sharing for Research Purposes--0925-0670--
Expiration Date 11/31/2022--REVISION--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 genomic and related phenotypic data are managed through 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 Database of Genotypes and Phenotypes 
(dbGaP), no matter which NIH-designated data repository will ultimately 
maintain the data. As part of the study 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., provided through submission of an 
Institutional Certification form) of the data submission which 
delineates any necessary 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 the Database of 
Genotypes and Phenotypes (dbGaP), in an effort to minimize burden for 
researchers and their institutional officials completing the study 
registration, data submission, data access, and renewal and closeout 
    OMB approval is requested for three years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 72,301 hours.

                                        Estimated Annualized Burden Hours
                                     Type of         Number of       Number of      burden per     Total annual
           Form name               respondents      respondents    responses per   response  (in   burden hours
                                                                    respondent        hours)
                                     Study Registration and Data Submission
dbGaP Registration and          Investigator               1,050               1           45/60             788
 Submission.                     Submitting Data.
Institutional Certification...  Investigator               1,050               1           45/60             788
                                 filling out
Institutional Certification...  Institutional              1,050               1           30/60             525
                                 Official to
                                            Requesting Access to Data
Data Access Request...........  Requester                  3,900              10           45/60          29,250

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Data Access Request...........  Institutional              3,900              10           30/60          19,500
                                 Official to
                                 Certify Request.
                                      Project Renewal or Project Close-out
Project Renewal or Project      Requester                  3,900              10           15/60           9,750
 Close-out form.                 Submitting
Project Renewal or Project      Institutional              3,900              10           18/60          11,700
 Close-out form.                 Signing
                                 Official to
                                 Certify Request.
    Total.....................  ................          18,750         159,150  ..............          72,301

    Dated: September 15, 2022.
Tara A. Schwetz,
Acting Principal Deputy Director, National Institutes of Health.
[FR Doc. 2022-20467 Filed 9-20-22; 8:45 am]