Data and Specimen Hub (DASH) (NICHD)

Forms and Documents

Document Name	Status
Form 3 Data Request Form and Instruction	New
Form 2 Data Submission Form and Instruction	New
Form 1 User Registration Form and Instruction	New
0925-New_DASH_PIA.docx Supplementary Document	2016-06-10
0925-New_DASH_30dayFRN_published2016-04178.pdf Supplementary Document	2016-02-29
0925-New_DASH_SSA_final_20160211.doc Supporting Statement A	2016-02-24

IC Document Collections

IC ID	Document Title	Status
220216	Data Request Form and Instruction	New
220215	Data Submission Form and Instruction	New
220214	User Registration Form and Instruction	New

ICR Details

OMB Control No: 0925-0744	ICR Reference No: 201602-0925-014
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Data and Specimen Hub (DASH) (NICHD)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 06/10/2016
	Date Received in OIRA: 03/01/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	36 Months From Approved
Responses	216	0	0
Time Burden (Hours)	142	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: NICHD DASH is being established by NICHD as a data sharing mechanism for biomedical research investigators. It will serve as a centralized resource for investigators to store and access de-identified data from studies funded by NICHD. The potential for public benefit to be achieved through sharing research study data for secondary analysis is significant. Data sharing and reuse will promote testing of new hypotheses from data already collected, facilitate collaboration, accelerate scientific findings and enable NICHD to maximize the return on its investments in research. Anyone can access NICHD DASH to browse and view descriptive information about the studies and data archived in NICHD DASH without creating an account. Users who wish to submit or request research study data must register for an account.

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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

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 66913	10/30/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 9865	02/26/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Data Submission	2	Attachment 2-2 Data Submission
User Registration	1	Attachment 2-1 User Registration
Data Request	3	Attachment 2-3 Data Request

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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	216	0	0	216	0	0
Annual Time Burden (Hours)	142	0	0	142	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: new submission

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Annual Cost to Federal Government: $14,496

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

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Common Form ICR:  No

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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: 03/01/2016

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