[Federal Register Volume 81, Number 51 (Wednesday, March 16, 2016)]
[Notices]
[Pages 14118-14119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05910]


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

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 (OD)

    Summary: Under the provisions of 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. This proposed information collection was previously published in 
the Federal Register on December 1, 2015, page 75120 and allowed 60 
days for public comment. A public comment was 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 October 1, 1995, unless it displays a currently 
valid OMB control number.
    Direct Comments to OMB: Written comments and/or suggestions 
regarding the item(s) contained in this notice, especially regarding 
the estimated public burden and associated response time, should be 
directed to the: Office of Management and Budget, Office of Regulatory 
Affairs, [email protected] or by fax to 202-395-6974, 
Attention: NIH Desk Officer.
    Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 30 days 
of the date of this publication.
    For Further Information Contact: To obtain a copy of the data 
collection plans and instruments, or request more information on the 
proposed project, contact: Dina Paltoo, Office of Science Policy, 6705 
Rockledge Drive 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.
    Proposed Collection: Forms to Support Genomic Data Sharing for 
Research Purposes, 0925-0670, Expiration Date 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

[[Page 14119]]

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 (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 the 
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
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                    Type of         Number of        Number of      burden per     Total annual
          Form name               respondent       respondents     responses per   response (in     burden hour
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Study Registration and Data    Investigator      150............               1               1             150
 Submission.                    Submitting Data.
                               Institutional     150............               1           30/60              75
                                Official to
                                Certify
                                Submission.
Requesting Access to Data....  Investigator      633............               2           45/60             950
                                Requesting Data.
                               Signing Official  633............               2           30/60             633
                                to Certify
                                Request.
Renewal/project Close-out      Investigator      633 (same                     2           15/60             317
 Process.                       Requesting Data.  individuals as
                                                  listed above).
                               Signing Official  633 (same                     2           18/60             380
                                to Certify        individuals as
                                Request.          listed above).
                                                ----------------------------------------------------------------
    Grand Total..............  ................  1,566..........           5,064  ..............           2,505
----------------------------------------------------------------------------------------------------------------


    Dated: March 10, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016-05910 Filed 3-15-16; 8:45 am]
BILLING CODE 4140-01-P