[Federal Register Volume 87, Number 182 (Wednesday, September 21, 2022)]
[Notices]
[Pages 57705-57707]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20467]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; NIH Information
Collection Forms To Support Genomic Data Sharing for Research Purposes
(OD)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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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
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 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
processes.
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
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Average
Type of Number of Number of burden per Total annual
Form name respondents respondents responses per response (in burden hours
respondent hours)
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Study Registration and Data Submission
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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 Certification... Institutional 1,050 1 30/60 525
Official to
Certify
Institutional
Certification.
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Requesting Access to Data
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Data Access Request........... Requester 3,900 10 45/60 29,250
Submitting
Request.
[[Page 57707]]
Data Access Request........... Institutional 3,900 10 30/60 19,500
Signing
Official to
Certify Request.
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Project Renewal or Project Close-out
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Project Renewal or Project Requester 3,900 10 15/60 9,750
Close-out form. Submitting
Request.
Project Renewal or Project Institutional 3,900 10 18/60 11,700
Close-out form. Signing
Official to
Certify Request.
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Total..................... ................ 18,750 159,150 .............. 72,301
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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]
BILLING CODE 4140-01-P