[Federal Register Volume 80, Number 230 (Tuesday, December 1, 2015)]
[Notices]
[Pages 75120-75122]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30465]
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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)
SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the Office of the Director, the
National Institutes of Health (NIH) will publish periodic summaries of
proposed projects to be submitted to the Office of Management and
Budget (OMB) for review and approval.
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
[[Page 75121]]
methodology and assumptions used; (3) The quality, utility, and clarity
of the information to be collected; and (4) Minimization of 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.
To Submit Comments and For Further Information: To obtain a copy of
the data collection plans and instruments, submit comments in writing,
or request more information on the proposed project, contact: Dina N.
Paltoo, Ph.D., MPH, Director, Genetics, Health, and Society Program,
Office of Clinical Research and Bioethics Policy, Office of Science
Policy, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892 or call
non-toll-free number 301-496-9838 or Email your request, including your
address to: [email protected]. Formal requests for additional plans and
instruments must be requested in writing.
DATES: Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Proposed Collection: National Institutes of Health Information
Collection Forms to Support Genomic Data Sharing for Research
Purposes--0925-0670--Expiration Data 03/31/2016--Revision--Office of
the Director (OD), National Institutes of Health (NIH).
Need and Use of Information Collection: Sharing research data
supports the NIH mission and is essential to facilitate the translation
of research results into knowledge, products, and procedures that
improve human health. The 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 National Institutes
of Health (NIH) issued the NIH Genomic Data Sharing Policy (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 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.
The NIH has developed online forms, available through dbGaP, in an
effort to reduce the burden for researchers and their 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 2,505.
Estimated Annualized Burden Hours
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Number of Average time
Type of form Number of responses per per response Total annual
respondents respondent (in hours) burden hour
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Study Registration and Data Submission
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Investigator Submitting Data.................... 150 1 1 150
Institutional Official to Certify............... 150 1 30/60 75
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Initial Data Access Request
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Investigator Requesting Data.................... 633 2 45/60 950
Signing Official to Certify..................... 633 2 30/60 633
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Renewal and Close-out of Data Access
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Investigator Requesting Data.................... 633 2 15/60 317
Signing Official to Certify..................... 633 2 18/60 380
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[[Page 75122]]
Dated: November 23, 2015.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2015-30465 Filed 11-30-15; 8:45 am]
BILLING CODE 4140-01-P