[Federal Register Volume 84, Number 147 (Wednesday, July 31, 2019)]
[Notices]
[Pages 37324-37326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16289]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request Proposed 
Collection; 60-Day Comment Request; NIH Information Collection Forms To 
Support Genomic Data Sharing for Research Purposes (Office of Director)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: In compliance with 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.

DATES: Comments regarding this information collection are best assured 
of having their full effect if received within 30-days of the date of 
this publication.

ADDRESSES: 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: Desk 
Officer for NIH.

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: Dr. Lyric A. 
Jorgenson, Acting Director, Division of Scientific Data Sharing Policy, 
Office of Science Policy, NIH, 6705 Rockledge Dr., Suite 750, Bethesda, 
MD 20892, or call non-tollfree number (301) 496-9838 or email your 
request including your address to: [email protected].

SUPPLEMENTARY INFORMATION: This proposed information collection was 
previously published in the Federal Register on May 1, 2019, page 18555 
(84 FR 18555) and allowed 60 days for public comment. No public 
comments were 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.
    In compliance with 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.
    Proposed Collection: NIH Information Collection Forms to Support 
Genomic Data Sharing for Research Purposes--0925-0670--Expiration Date 
07/31/2019--Revision--Office of the Director (OD), National Institutes 
of Health (NIH).

[[Page 37325]]

    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 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 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 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. 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 5,850.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                    Type of         Number of        Number of      burden per     Total annual
          Form name               respondent       respondents     responses per   response (in     burden hour
                                                                    respondent        hours)
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                                     Study Registration and Data Submission
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dbGaP Registration and         Investigator      300............               1               1             300
 Submission.                    Submitting Data.
                               Institutional     300............               1           30/60             150
                                Official to
                                Certify
                                Submission.
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                                            Requesting Access to Data
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Data Access Request..........  Requester         1,500..........               2           45/60           2,250
                                Submitting
                                Request.
Data Access Request..........  Institutional     1,500..........               2           30/60           1,500
                                Signing
                                Official to
                                Certify Request.
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                                      Project Renewal or Project Close-out
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Project Renewal or Project     Requester         1,500 (same                   2           15/60             750
 Close-out form.                Submitting        individuals as
                                Request.          above).
Project Renewal or Project     Institutional     1,500 (same                   2           18/60             900
 Close-out form.                Signing           individuals as
                                Official to       above).
                                Certify Request.
                                                                 -----------------------------------------------
    Total....................  ................  ...............          12,600  ..............           5,850
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[[Page 37326]]

    Dated: July 24, 2019.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2019-16289 Filed 7-30-19; 8:45 am]
 BILLING CODE 4140-01-P