NIH Information Collection Forms to Support Genomic Data Sharing for Research Purposes (OD)

ICR 201602-0925-015

OMB: 0925-0670

Federal Form Document

ICR Details
0925-0670 201602-0925-015
Historical Active 201301-0925-003
HHS/NIH 18667
NIH Information Collection Forms to Support Genomic Data Sharing for Research Purposes (OD)
Revision of a currently approved collection   No
Regular
Approved with change 07/06/2016
Retrieve Notice of Action (NOA) 03/16/2016
  Inventory as of this Action Requested Previously Approved
07/31/2019 36 Months From Approved 07/31/2016
5,364 0 1,366
2,505 0 1,646
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.

US Code: 42 USC 241 sect. 301 Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  80 FR 75120 12/01/2015
81 FR 14118 03/16/2016
Yes

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 5,364 1,366 0 5,264 -1,266 0
Annual Time Burden (Hours) 2,505 1,646 0 2,442 -1,583 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
Revision

$5,100,000
No
No
No
No
No
Uncollected
Tawanda Abdelmouti 240 276-5530 ta401@nih.gov

  No

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.
03/16/2016


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