View Information Collection Request (ICR) Package
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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:
0925-0744
ICR Reference No:
201811-0925-002
Status:
Historical Active
Previous ICR Reference No:
201602-0925-014
Agency/Subagency:
HHS/NIH
Agency Tracking No:
Title:
Data and Specimen Hub (DASH) (NICHD)
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:
01/30/2019
Retrieve Notice of Action (NOA)
Date Received in OIRA:
11/27/2018
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
01/31/2022
36 Months From Approved
06/30/2019
Responses
464
0
216
Time Burden (Hours)
204
0
142
Cost Burden (Dollars)
0
0
0
Abstract:
This is a request to revise the previously approved submission (OMB number: 0925-0744) to add the collection of additional information from Users who will request biospecimens, submit the Institutional Certification for data/biospecimen inventory, and submit DASH data/biospecimen Annual Progress Report for the NICHD Data and Specimen Hub (DASH).
Authorizing Statute(s):
US Code:
42 USC 285g
Name of Law: Establishment of Institute of Child Health and Human Development
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:
83 FR 18575
04/27/2018
30-day Notice:
Federal Register Citation:
Citation Date:
83 FR 55729
11/07/2018
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
7
IC Title
Form No.
Form Name
Biospecimen Request
4
Biospecimen Request Form
Biospecimen Use Annual Progress Report
6
Biospecimen Use Annual Progress Report
Data Request
3
Data Request
Data Use Annual Progress Report
5
Data Use Annual Progress Report
Data and Biospecimen Inventory Submission
2
Data Submission
Institutional Certification Template
7
Institutional Certification Template
User Registration
1
User Registration
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
464
216
0
248
0
0
Annual Time Burden (Hours)
204
142
0
62
0
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 NICHD DASH is expanding its functionality to facilitate biospecimen sharing. The new functionality will enable investigators to access biospecimens, available from the NICHD Biorepository, for purposes of secondary research. Establishing a central biospecimen inventory sharing resource through NICHD DASH also helps address the objectives of various NIH and federal data sharing initiatives. Enabling these new functionalities, however, will necessitate additional information gathering, as described in section A.2, Purpose and Use of the Information Collection. An Annual Progress Report is necessary to keep track of progress of study data and biospecimen use from NICHD DASH to ensure that research conducted with DASH data and NICHD biospecimens conforms to the Data Use Agreement and the Material Transfer Agreement, respectively
Annual Cost to Federal Government:
$14,781
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
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:
11/27/2018
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