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 NCS Vanguard Specimen and Data Form and Instruction	New
Form 2 NCS Vanguard Data Request Form Form and Instruction	New
Form 1 NCS Vanguard Downloadable Data Access Form Form and Instruction	New
0925-0730_NCS Data Archive_SSA 2018_Final.docx Supporting Statement A	2019-02-05
0925-0730 Attachment A.8 NCS Archive Mini Supporting Statement_2-1-2019.docx Supplementary Document	2019-02-05
0925-0730 Attachment A.7 NICHD Nat'l Children's Study Signed Privacy Officer Memo_02-02-2016.pdf Supplementary Document	2019-01-31
0925-0730 Attach-ment A.6 NCS Archive Data User Training.pdf Supplementary Document	2019-01-31
0925-0730 Attach-ment A.5 Example Screenshot to Show NCS Branding on Data Forms.pdf Supplementary Document	2019-01-31
0925-0730 Attach-ment A.4 Research Materials Distribution Agreement 2018.pdf Supplementary Document	2019-01-31
0925-0730 Attach-ment A.3 NCS Vanguard Data and Sample Request Form 2018.pdf Supplementary Document	2019-01-31
0925-0730 Attach-ment A.2 NCS Vanguard Data Request Form 2018.pdf Supplementary Document	2019-01-31
0925-0730 Attach-ment A.1 NCS Vanguard Data User Agreement Form 2018.pdf Supplementary Document	2019-01-31
30day FRN 2019-00437.pdf Supplementary Document	2019-01-31

IC Document Collections

IC ID	Document Title	Status
235147	Research Materials Distribution Agreement Form and Instruction	New
235146	NCS Vanguard Specimen and Data Form and Instruction	New
235144	NCS Vanguard Data Request Form Form and Instruction	New
235141	NCS Vanguard Downloadable Data Access Form Form and Instruction	New

ICR Details

OMB Control No: 0925-0730	ICR Reference No: 201901-0925-001
Status: Historical Inactive	Previous ICR Reference No: 201508-0925-002
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: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Withdrawn and continue	Conclusion Date: 04/22/2019
	Date Received in OIRA: 02/06/2019
Terms of Clearance: Withdrawn at request of agency.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2019	36 Months From Approved	04/30/2019
Responses	1,500	0	1,500
Time Burden (Hours)	327	0	327
Cost Burden (Dollars)	9,919	0	9,919

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Abstract: At this time, the NCS seeks OMB approval to extend 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:
	83 FR 55905	11/08/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 782	01/31/2019
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
NCS Vanguard Data Request Form	2	NCS Vanguard Data Request Form
NCS Vanguard Specimen and Data	3	NCS Vanguard Data and Sample Request Form
NCS Vanguard Downloadable Data Access Form	1	NCS Vanguard Data User Agreement Form
Research Materials Distribution Agreement	4	Reseach Materials Distribution Agrement

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Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $104,609

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? 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: 02/06/2019

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