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 Request Form 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
NCS Archive Privacy Impact Assessment 20181119.docx Supplementary Document	2019-04-12
0925-New Supporting Statement A_NCS Data Archive_3-11-2019 (1).docx Supporting Statement A	2019-03-21
30-day FRN2019-05101.pdf Supplementary Document	2019-03-19
0925-0730 Attachment A.7 NICHD Nat'l Children's Study Signed Privacy Officer Memo_02-02-2016.pdf Supplementary Document	2019-03-19
0925-0730 Attach-ment A.6 NCS Archive Data User Training.pdf Supplementary Document	2019-03-19

IC Document Collections

IC ID	Document Title	Status
235419	Research Materials Distribution Agreement Form and Instruction	New
235418	NCS Vanguard Specimen and Data Request Form Form and Instruction	New
235417	NCS Vanguard Data Request Form Form and Instruction	New
235416	NCS Vanguard Downloadable Data Access Form Form and Instruction	New

ICR Details

OMB Control No: 0925-0760	ICR Reference No: 201903-0925-001
Status: 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 without change	Conclusion Date: 04/22/2019
	Date Received in OIRA: 03/21/2019
Terms of Clearance: OMB is approving this information collection request for a period of three years during which time NIH will request approval to extend or revise the collection if the agency seeks to continue the information collection activity beyond the period approved under this action.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2022	36 Months From Approved
Responses	300	0	0
Time Burden (Hours)	68	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This document contains information supporting a request for the Office of Management and Budget (OMB) to approve a new regular clearance to replace an existing generic clearance (OMB clearance #0925-0730, expiration date 2/28/2019) for registration procedures associated with the National Children’s Study (NCS) Data and Sample Archive and Access System (“NCS Archive”) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health.

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Authorizing Statute(s): US Code: 42 USC 203, 241, 289l-1 Name of Law: Public Health Service Act
   US Code: 44 USC 3101 Name of Law: Public Health Service Act
  

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 10103	03/19/2019
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
NCS Vanguard Specimen and Data Request Form	3	NCS Vanguard Data and Sample Request Form
Research Materials Distribution Agreement	4	Research Materials Distribution Agreement
NCS Vanguard Downloadable Data Access Form	1	NCS Vanguard Data User Agreement Form
NCS Vanguard Data Request Form	2	NCS 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	300	0	0	300	0	0
Annual Time Burden (Hours)	68	0	0	68	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: $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: 03/21/2019

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