Neuropsychosocial Measures Formative Research Methodology Studies for the National Children's Study (NICHD)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
2011 Neuropsychosocial Generic Clearance Request Part B 20110912.docx	Supporting Statement B	Uploaded 2011-10-31	Repair queued
Example Neuropsychosocial Generic Clearance Project.docx	Supplementary Document	Uploaded 2011-11-02	Repair queued
LOI2-QUEX-5 Exemplar Telephone Screener.docx	Supplementary Document	Uploaded 2011-11-02	Repair queued
LOI2-QUEX-5 Exemplar Assessment Description Bayley-3 Short Form.docx	Supplementary Document	Uploaded 2011-11-02	Repair queued
LOI2-QUEX-5 Exemplar Consent.docx	Supplementary Document	Uploaded 2011-11-02	Repair queued
LOI2-QUEX-05 Exemplar IRB Approval Letters.pdf	Supplementary Document	Uploaded 2011-11-02	Repair queued
LOI2-QUEX-05 Exemplar Protocol Summary.docx	Supplementary Document	Uploaded 2011-11-02	Repair queued
LOI2-QUEX-5 Exemplar Recruitment Flyer.docx	Supplementary Document	Uploaded 2011-11-02	Repair queued
2011 Neuropsychosocial Generic Clearance Request Part A 20110912 Lee Added.docx	Supporting Statement A	Uploaded 2011-10-31	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form

ICR Details

OMB Control No:	ICR Reference No: 201111-0925-006
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Neuropsychosocial Measures Formative Research Methodology Studies for the National Children's Study (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OIRA Conclusion Action: Withdrawn	Conclusion Date: 11/18/2011
	Date Received in OIRA: 11/14/2011
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: In conjunction with the Vanguard Study and its Recruitment Substudy component, the NCS has conducted preliminary and proof-of-concept assessments of study recruitment, retention, and questionnaire items through smaller-scale formative research projects approved through OMB Generic Clearance (#0925-0590; Expiration Date: 9/30/2014). This clearance mechanism allowed preliminary, proof-of-concept evaluation of innovative recruitment and retention materials and approaches, as well as questionnaire items, needed to address the complexity of the NCS design in an efficient manner prior to further testing with a larger group of participants in the Vanguard Study, if warranted. Moreover, this clearance mechanism allows the NCS to receive crucial feedback regarding questionnaire items and recruitment and retention materials from providers, community representatives, and other stakeholders before these materials or approaches are presented to potential or actual NCS Vanguard participants. The NCS would continue to benefit from the burden and cost efficiencies generated by additional types of formative research projects that could be reviewed through the generic clearance mechanism. With this submission, the NCS seeks approval from OMB to conduct formative research featuring neuro-developmental and psychosocial measures. The results of formative research related to the collection of neuro-developmental and psycho-social measures will inform the feasibility, acceptability, and cost of NCS Vanguard and Main Study collection procedures and tools used to assess language, behavior, and neurodevelopment, psychosocial stress, and health literacy in a manner that minimizes public information collection burden compared to burden anticipated if these projects were incorporated directly into either the NCS Vanguard or Main Study.

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Authorizing Statute(s): PL: Pub.L. 106 - 310 1004 Name of Law: Children's 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:
	76 FR 24497	05/02/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 66724	10/27/2011
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 0

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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: This is a new ICR.

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Annual Cost to Federal Government: $540,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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: 11/14/2011

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