Child Health Disparities Substudy for the National Children's Study (NICHD)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 9 Primary Data Collection Interview-First Time Mom	Form and Instruction	New	Repair queued
Form 8 Primary Data Collection Interview-Current Mom	Form and Instruction	New	Repair queued
Form 4 Cognitive Interview	Form and Instruction	New	Repair queued
Form 2 Eligibility Screening	Form and Instruction	New	Repair queued
Child Health Disparities Clearance Request Part B 20120613.docx	Supporting Statement B	Uploaded 2012-06-25	Repair queued
Attach 3 Consent for Cognitive Interview.doc	Supplementary Document	Uploaded 2012-06-25	Repair queued
NCS Certificate of Confidentiality.pdf	Supplementary Document	Uploaded 2012-06-25	Repair queued
Attach 7 Consent Current Moms.doc	Supplementary Document	Uploaded 2012-06-25	Repair queued
Attach 6 Consent First Time Moms.doc	Supplementary Document	Uploaded 2012-06-25	Repair queued
Attach 1 Exemplar Recruitment Flyer.docx	Supplementary Document	Uploaded 2012-06-25	Repair queued
Child Health Disparities Clearance Request Part A 20120709.docx	Supporting Statement A	Uploaded 2012-07-09	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
203256	Primary Data Collection Interview-First Time Mom	Form and Instruction	New
203255	Saliva Collection	Instruction	New
203254	Primary Data Collection Interview-Current Mom	Form and Instruction	New
203253	Cognitive Interview	Form and Instruction	New
203252	Eligibility Screening	Form and Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 201207-0925-001
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Child Health Disparities Substudy 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OIRA Conclusion Action: Withdrawn	Conclusion Date: 10/26/2012
	Date Received in OIRA: 07/13/2012
Terms of Clearance: Please resubmit in two phases - First cog testing; second full study. Since the details of the full study have yet to be fleshed out, at minimum an additonal 30 day notice will be required upon submission of the full study design.

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: The primary goal of this substudy will be to validate measures, including questionnaire items and appropriate saliva analytes, needed for studying health disparities and selected biomarkers. Some definitions of health disparities include inequitable and potentially avoidable differences in health and health care. Developing optimum measures needed for studying health disparities is of particular interest to the NCS because studies have shown that health literacy, discrimination, parenting self-efficacy, health care accessibility (access, utilization, and quality) contribute to health disparities. The NCS perceives a need to collect critical data related to health disparities in mothers and children. Knowledge of factors that contribute to health disparities is needed to investigate and understand mechanisms involved in disparities not only in pregnancy outcomes but also for contributing to disparate health and development outcomes in children. It is also critical to have valid measures that are appropriate for families who may not speak English, have low health literacy, and are from diverse backgrounds.

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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:
	77 FR 15780	03/16/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 38840	06/29/2012
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

table that charts list of burden

IC Title	Form No.	Form Name
Eligibility Screening	2, 5	Cognitive Interview Phone Screen Script ,   Combined Screeners
Cognitive Interview	4	Cognitive Interviewing Guide
Primary Data Collection Interview-Current Mom	8	Primary Data Collection Interview-Current Mom
Saliva Collection
Primary Data Collection Interview-First Time Mom	9, 10	Primary Data Collection Interview-Prenatal First Time Mom ,   Primary Data Collection Interview-Postnatal First Time Mom

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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 request proposes a new collection.

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Annual Cost to Federal Government: $488,864

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: 07/13/2012

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