Data and Specimen Hub (DASH) (NICHD)

Forms and Documents

Document Name	Status
Form 9 Data Collection Catalog Submission Form and Instruction	New
Form 8 Study Catalog Submission Form and Instruction	New
Form 3 Institutional Certification Template Form and Instruction	Modified
Form 7 Biospecimen Use Annual Progress Report Form and Instruction	Modified
Form 6 Data Use Annual Progress Report Form and Instruction	Modified
Form 5 Biospecimen Request Form and Instruction	Modified
Form 4 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
pub 30day correction 2021-07754.pdf Supplementary Document	2021-04-19
pub 30 day FRN 2021-07313.pdf Supplementary Document	2021-04-09
NICHD_DASH_PrivacyActMemo.pdf Supplementary Document	2021-04-09
0925-0744-Rev_DASH_SSA_final.docx Supporting Statement A	2021-04-09
NICHD_DASH_PIA_20181220.pdf Supplementary Document	2021-04-09

IC Document Collections

IC ID	Document Title	Status
246754	Data Collection Catalog Submission Form and Instruction	New
246753	Study Catalog Submission Form and Instruction	New
234076	Institutional Certification Template Form and Instruction	Modified
233992	Biospecimen Use Annual Progress Report Form and Instruction	Modified
233989	Data Use Annual Progress Report Form and Instruction	Modified
233987	Biospecimen Request Form and Instruction	Modified
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: 202104-0925-002
Status: Received in OIRA	Previous ICR Reference No: 201811-0925-002
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	Date Submitted to OIRA: 04/20/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	01/31/2022
Responses	480	464
Time Burden (Hours)	211	204
Cost Burden (Dollars)	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:
	86 FR 3160	01/14/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 18548	04/09/2021
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
Biospecimen Request	5	Biospecimen Request Form
Biospecimen Use Annual Progress Report	7	Biospecimen Use Annual Progress Report
Data Collection Catalog Submission	9	Attachment 2.9 Data Collection Catalog Submission
Data Request	4	Data Request
Data Use Annual Progress Report	6	Data Use Annual Progress Report
Data and Biospecimen Inventory Submission	2	Data Submission
Institutional Certification Template	3	Institutional Certification Template
Study Catalog Submission	8	Attachment 2.8 Study Catalog Submission
User Registration	1	User Registration

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ICR Summary of Burden

	Total Request	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	480	464	0	16	0	0
Annual Time Burden (Hours)	211	204	0	7	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: NICHD DASH is expanding its functionality to facilitate the findability of NICHD-funded studies and data collections shared through other publicly accessible archives. The new functionality will enable investigators to discover studies and data collections available through other publicly accessible archives for the purposes of secondary research. Establishing a central resource to showcase all NICHD-funded studies and data collections, including those housed in DASH and in other archives, in a standardized format also helps address the objectives of various NIH and federal data sharing and data science initiatives. Enabling these new functionalities, however, will necessitate additional information gathering, as described in section A.2, Purpose and Use of the Information Collection. Accordingly, there will be two new data collections forms implemented for users to submit information about their research study (New information collection form; Attachment A.2-8 Study Catalog Submission) or data collection (New information collection form; Attachment A.2-9 Data Collection Catalog Submission) stored in another publicly accessible archive – a process referred to as ‘cataloging’ in DASH.

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Annual Cost to Federal Government: $15,022

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.     Yes

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.     Yes

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? No

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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: 04/20/2021

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