Stress and Cortisol Measurement for the National Childrens Study (NICHD)

Forms and Documents

Document Name	Status
Form 3.1 Clinic Visit 2 Form and Instruction	Modified
Form 1.1 Clinic Visit 1 Form and Instruction	Modified
Stress and Cortisol Supporting Statement B FINAL 20121205.docx Supporting Statement B	2012-12-06
Itemized Burden Table.docx Supplementary Document	2012-12-06
Attach 11. Postpartum Abstraction Form.doc Supplementary Document	2012-12-06
Attach 5. Enrollment Medical Record Abstraction Form.doc Supplementary Document	2012-12-06
Attach 12. Protocol Summary Excerpt.pdf Supplementary Document	2012-12-06
Attach 13. IRB Approval Letters.pdf Supplementary Document	2012-12-06
Attach 3. Exemplar Consent Form.docx Supplementary Document	2012-12-06
Attach 1. Exemplar Recruitment Flyer.doc Supplementary Document	2012-12-06
Attach 18. Visit 2 Blood Processing Protocol.docx Supplementary Document	2012-12-06
Attach 16. Study Visit 2 Blood Requisition Form.docx Supplementary Document	2012-12-06
Attach 14. Study Hair Collection Protocol.docx Supplementary Document	2012-12-06
Attach 17. Visit 1 Blood Processing Protocol.doc Supplementary Document	2012-12-06
Attach 15. Study Visit 1 Blood Requisition Form.docx Supplementary Document	2012-12-06
Stress and Cortisol Supporting Statement A FINAL 20130307.docx Supporting Statement A	2013-03-07

IC Document Collections

IC ID	Document Title	Status
205264	Follow Up Studies Other-Note to File	New
203352	Clinic Visit 2 Form and Instruction	Modified
203351	Ambulatory Assessment Period Instruction	Modified
203350	Clinic Visit 1 Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0671	ICR Reference No: 201301-0925-001
Status: Historical Active	Previous ICR Reference No: 201207-0925-002
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Stress and Cortisol Measurement for the National Childrens 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: Approved without change	Conclusion Date: 03/25/2013
	Date Received in OIRA: 01/04/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2016	36 Months From Approved
Responses	1,399	0	0
Time Burden (Hours)	3,147	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: With this submission, the NCS seeks OIRA clearance to perform a multi-center substudy, called the Stress and Cortisol Measurement Substudy, aimed at developing a validated questionnaire that will reflect specific physiological measures of stress. This substudy will develop a common, core protocol for determining the most reliable, acceptable, and cost-efficient approach for assessing maternal stress in the form of a brief questionnaire that correlates with more invasive and burdensome approaches to the measurement of biological and physiological measures of stress. Birth outcomes have been selected for this substudy because they represent priority outcomes for the NCS, and they will be available and can be collected within the study timeframe. Identification of a standardized, validated approach to evaluate exposure to psychosocial stress during pregnancy will facilitate the measurement of stress as a variable of interest in the NCS by providing an efficient, low-burden approach to stress measurement.

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Authorizing Statute(s): None

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 9666	02/17/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 30294	05/22/2012
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
Clinic Visit 1	1.1, 1.2, 1.4, 1.5, 1.3	Survey ,   Form ,   Survey ,   Survey ,   Attach 6. Demographic and Health Survey
Ambulatory Assessment Period	2.1	Attach 8. Take Home Packet
Clinic Visit 2	3.1	Survey
Follow Up Studies

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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	1,399	0	0	1,399	0	0
Annual Time Burden (Hours)	3,147	0	0	3,147	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: This request proposes a new data collection.

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Annual Cost to Federal Government: $605,887

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: 01/04/2013

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