National Children's Study (NCS) Vanguard Data and Sample Archive and Access System (NICHD)

Forms and Documents

Document Name	Status
Form 4 Research Materials Distribution Agreement Form and Instruction	New
Form 3 Vanguard Specimen and Data Request Form Form and Instruction	New
Form 2 Vanguard Request Form Form and Instruction	New
Form 1 Vanguard Downloadable Data Access Form Form and Instruction	New
Attachment A.8 NICHD Nat'l Children's Study Signed Privacy Officer Memo_02-02-2016.pdf Supplementary Document	2016-02-05
Attachment A.6 Data User Training_02-04-2016.pptx Supplementary Document	2016-02-05
Attachment A.5 Example Screenshot_02-04-2016_MARKED.docx Supplementary Document	2016-02-05
Attachment A.4 Research Materials Distribution Agreement (RMDA)_02-04-2016_MARKED.docx Supplementary Document	2016-02-05
Attachment A.3 Vanguard Specimen and Data Request Form_02-04-2016_MARKED.docx Supplementary Document	2016-02-05
Attachment A.2 Vanguard Data Request Form_02-04-2016_MARKED.docx Supplementary Document	2016-02-05
Attachment A.1 Vanguard Data User Agreement Form_02-04-2016_MARKED.docx Supplementary Document	2016-02-05
Attachment A.5 Example Screenshot.docx Supplementary Document	2015-08-27
Attachment A.4 Research Materials Distribution Agreement (RMDA).docx Supplementary Document	2015-08-27
Attachment A.3 Vanguard Specimen and Data Request Form.docx Supplementary Document	2015-08-27
Attachment A.2 Vanguard Data Request Form.docx Supplementary Document	2015-08-27
Attachment A.1 Vanguard Downloadable Data Access Form.docx Supplementary Document	2015-08-27
Attachment A.8 NICHD Nat'l Children's Study August 2015 Signed Privacy Officer Memo.pdf Supplementary Document	2015-08-26
Attachment A.6 Data User Training.pptx Supplementary Document	2015-08-26
Final Supporting Statement A NCS Data Archive_02-04-2016_MARKED.doc Supporting Statement A	2016-02-05

IC Document Collections

IC ID	Document Title	Status
220005	Research Materials Distribution Agreement Form and Instruction	New
220004	Vanguard Specimen and Data Request Form Form and Instruction	New
220003	Vanguard Request Form Form and Instruction	New
220002	Vanguard Downloadable Data Access Form Form and Instruction	New

ICR Details

OMB Control No: 0925-0730	ICR Reference No: 201508-0925-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: National Children's Study (NCS) Vanguard Data and Sample Archive and Access System (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: 02/08/2016
	Date Received in OIRA: 09/04/2015
Terms of Clearance: Approved consistent with the understanding that all Gen IC nstruements submitted under this generic will display appropriate OMB control numbers and SORNs.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2019	36 Months From Approved
Responses	1,500	0	0
Time Burden (Hours)	327	0	0
Cost Burden (Dollars)	9,919	0	0

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Abstract: At this time, the NCS seeks OMB approval to collect information from researchers who seek access to NCS Vanguard data. Data will be housed securely in the NCS Vanguard Data and Sample Archive and Access System, and will allow researchers access to the data through a secure data enclave. There is significant potential public benefit to sharing NCS Vanguard Study data with a broader audience.

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Authorizing Statute(s): PL: Pub.L. 106 - 310 1004 Name of Law: Childrens Health Act of 2000
  

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 77	04/22/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 53546	09/04/2015
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Vanguard Downloadable Data Access Form	1	Vanguard Data user Agreement Form
Vanguard Specimen and Data Request Form	3	Vanguard Specimen and Data Request Form
Research Materials Distribution Agreement	4	Research Materials Distribution Agreement
Vanguard Request Form	2	Vanguard Data Request Form

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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	1,500	0	0	1,500	0	0
Annual Time Burden (Hours)	327	0	0	327	0	0
Annual Cost Burden (Dollars)	9,919	0	0	9,919	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 generic submission

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Annual Cost to Federal Government: $32,064

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: 09/04/2015

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