OMB is approving this information collection request for a period of three years during which time the agency will request approval to extend or revise the collection if the agency seeks to continue the information collection activity beyond the period approved under this action.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
11/30/2022
36 Months From Approved
11/30/2019
12,600
0
5,364
5,850
0
2,505
0
0
0
Sharing of research data is an integral element of the mission of the National Institutes of Health (NIH), as it advances 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 genomic data from a wide range of large-scale genomic research, and to provide appropriate protections for research involving human data, the NIH issued the NIH Genomic Data Sharing Policy (GDS Policy). The GDS Policy, an extension of the 2008 NIH Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (the GWAS Policy), applies to all NIH-funded research that generates large-scale human or non-human genomic data as well as the use of these data for subsequent research.
This application is for a revision to an existing Office of Management and Budget (OMB) approved collection of information, 0925-0670. Changes in Attachments 1 and 2 are described below and noted in red boxes in the attachments. Some changes focus on reducing redundancy among data submissions and access requests and increasing awareness of the ethical responsibilities associated with the responsible use of genomic information. In the dbGaP registration and submission forms (Attachment 1): additional questions on publication embargo deleted because this is no longer applicable (slide 4), added ability for investigator to add additional investigators that are notified when a submitted dataset is used (slide 4), added ability to review previously entered submission information for accuracy (slide 4), added ability to auto-create the DUC from existing information in the submission package (slide 5), added ability to auto-create the DUC from existing information in the submission package (slide 6), added a column for âCollaborating Siteâ that automatically adds additional rows to form when information is entered for all rows and columns (slide 7), and created new ability for investigators and Institutional Officials to digitally sign form (slide 8). In the dbGaP data access, renewal, and close-out forms (Attachment 2): information on the login page have been reorganized and consolidated to make the application information more apparent and prominent (slide 3), a pop-up reminder has been added to the âcreate decryption passwordâ field to alert requester additional information is needed (slide 7), the âResearch Plans with Approved Dataset(s)â field has been removed as it is redundant with information provided in the âResearch Progressâ and âResearch Plans with Approved Datasetsâ sections (slide 22)
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Project Renewal or Project Close-out Official to Certify Request