[Federal Register Volume 84, Number 84 (Wednesday, May 1, 2019)]
[Notices]
[Pages 18555-18557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08855]


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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 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: 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-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.

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 minimize 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

[[Page 18556]]

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 07/31/2019--EXTENSION--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 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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                                                                     Number of    Average burden
          Form name                 Type of         Number of      responses per   per response    Total annual
                                  respondent       respondents      respondent      (in hours)      burden hour
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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.          listed above).
Project Renewal or Project     Institutional     1,500 (same                   2           18/60             900
 Close-out form.                Signing           individuals as
                                Official to       listed above).
                                Certify Request.
                                                ----------------------------------------------------------------
    Grand Total..............  ................  6,600..........          12,600  ..............           5,850
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[[Page 18557]]

    Dated: April 23, 2019.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2019-08855 Filed 4-30-19; 8:45 am]
 BILLING CODE 4140-01-P