View Information Collection Request (ICR) Package
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Burden
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Common Form Info.
Certification
View Information Collection (IC) List
View Supporting Statement and Other Documents
Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0925-0670
ICR Reference No:
201602-0925-015
Status:
Historical Active
Previous ICR Reference No:
201301-0925-003
Agency/Subagency:
HHS/NIH
Agency Tracking No:
18667
Title:
NIH Information Collection Forms to Support Genomic Data Sharing for Research Purposes (OD)
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
07/06/2016
Retrieve Notice of Action (NOA)
Date Received in OIRA:
03/16/2016
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
07/31/2019
36 Months From Approved
07/31/2016
Responses
5,364
0
1,366
Time Burden (Hours)
2,505
0
1,646
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Authorizing Statute(s):
US Code:
42 USC 241 sect. 301
Name of Law: Public Health Service Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
80 FR 75120
12/01/2015
30-day Notice:
Federal Register Citation:
Citation Date:
81 FR 14118
03/16/2016
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
6
IC Title
Form No.
Form Name
Data Access Request (DAR)
2
Screen Shots of Online Forms form Data Access Request, Renewal, and Close-out
Renewal/Project Close-out process Investigator Requesting Data
2
Attachment 2 Documentation of the dbGaP access system
Renewal/project Close-out process Signing Official to Certify Request
2
Attachment 2 Documentation of the dbGaP access system
Requesting Access to Data Investigator Requesting Data
2
Attachment 2 Documentation of the dbGaP access system
Requesting Access to Data Signing Official to Certify Request
2
Attachment 2 Documentation of the dbGaP access system
Study Registration and Data Submission
1
Attachment 1 Documentation of the dbGaP Registration system
Study Registration and Data Submission Institutional Official to Certify Submission
1
Attachment 1 Documentation of the dbGaP registration system
ICR Summary of Burden
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
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Revision
Annual Cost to Federal Government:
$5,100,000
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Tawanda Abdelmouti 240 276-5530 ta401@nih.gov
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
03/16/2016
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