Data and Specimen Hub (DASH) (NICHD)

Forms and Documents

Document Name	Status
Form 7 Institutional Certification Template Form and Instruction	New
Form 6 Biospecimen Use Annual Progress Report Form and Instruction	New
Form 5 Data Use Annual Progress Report Form and Instruction	New
Form 4 Biospecimen Request Form and Instruction	New
Form 3 Data Request Form and Instruction	Modified
Form 2 Data and Biospecimen Inventory Submission Form and Instruction	Modified
Form 1 User Registration Form and Instruction	Modified
NICHD_DASH_PIA_20181220.pdf Supplementary Document	2019-01-08
30-day correction 2018-25784.pdf Supplementary Document	2018-11-27
30 day FRN2018-24313.pdf Supplementary Document	2018-11-21
0925-0744_Rev_DASH_Attachement A3.1_PIA.docx Supplementary Document	2018-11-21
0925-0744_Rev_DASH_OMB Supporting Statement A_Final Revision.docx Supporting Statement A	2019-01-08

IC Document Collections

IC ID	Document Title	Status
234076	Institutional Certification Template Form and Instruction	New
233992	Biospecimen Use Annual Progress Report Form and Instruction	New
233989	Data Use Annual Progress Report Form and Instruction	New
233987	Biospecimen Request Form and Instruction	New
220216	Data Request Form and Instruction	Modified
220215	Data and Biospecimen Inventory Submission Form and Instruction	Modified
220214	User Registration Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0744	ICR Reference No: 201811-0925-002
Status: 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
	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

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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).

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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:
	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

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Data and Biospecimen Inventory Submission	2	Data Submission
User Registration	1	User Registration
Data Request	3	Data Request
Biospecimen Request	4	Biospecimen Request Form
Data Use Annual Progress Report	5	Data Use Annual Progress Report
Biospecimen Use Annual Progress Report	6	Biospecimen Use Annual Progress Report
Institutional Certification Template	7	Institutional Certification Template

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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	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

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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

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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: 11/27/2018

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