[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]


-----------------------------------------------------------------------

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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of     Average  time
                  Type of form                       Number of     responses per   per  response   Total annual
                                                    respondents     respondent      (in hours)      burden hour
----------------------------------------------------------------------------------------------------------------
                                     Study Registration and Data Submission
----------------------------------------------------------------------------------------------------------------
Investigator Submitting Data....................             150               1               1             150
Institutional Official to Certify...............             150               1           30/60              75
----------------------------------------------------------------------------------------------------------------
                                           Initial Data Access Request
----------------------------------------------------------------------------------------------------------------
Investigator Requesting Data....................             633               2           45/60             950
Signing Official to Certify.....................             633               2           30/60             633
----------------------------------------------------------------------------------------------------------------
                                      Renewal and Close-out of Data Access
----------------------------------------------------------------------------------------------------------------
Investigator Requesting Data....................             633               2           15/60             317
Signing Official to Certify.....................             633               2           18/60             380
----------------------------------------------------------------------------------------------------------------



[[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