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

Forms and Documents

Document Name	Status
Form 3.1 Biospecimen Collection Form and Instruction	New
Form 2.1 Questionnaires, Time Diary, Heart Monitoring Form and Instruction	New
Form 1.1 Screening Form and Instruction	New
Stress & Cortisol Request Part B 20120416.docx Supporting Statement B	2012-07-17
Itemized Burden Table.docx Supplementary Document	2012-07-17
Attach 12. Protocol Summary Excerpt.pdf Supplementary Document	2012-07-17
Attach 13. IRB Approval Letters.pdf Supplementary Document	2012-07-17
Attach 3. Exemplar Consent Form.docx Supplementary Document	2012-07-17
Attach 1. Exemplar Recruitment Flyer.doc Supplementary Document	2012-07-17
Attach 20. Saliva Processing Protocol.docx Supplementary Document	2012-07-17
Attach 18. Visit 2 Blood Processing Protocol.docx Supplementary Document	2012-07-17
Attach 17. Visit 1 Blood Processing Protocol.doc Supplementary Document	2012-07-17
Attach 16. Study Visit 2 Blood Requisition Form.docx Supplementary Document	2012-07-17
Attach 15. Study Visit 1 Blood Requisition Form.docx Supplementary Document	2012-07-17
Attach 14. Study Hair Collection Protocol.docx Supplementary Document	2012-07-17
Note-to-File - Burden for IC #3.docx Supplementary Document	2012-07-17
Note-to-File - Burden for IC #2.docx Supplementary Document	2012-07-17
Attach 11. Postpartum Abstraction Form.doc Supplementary Document	2012-07-17
Attach 5. Enrollment Medical Record Abstraction Form.doc Supplementary Document	2012-07-17
Stress & Cortisol Request Part A 20120417_REVISED.docx Supporting Statement A	2012-07-17

IC Document Collections

IC ID	Document Title	Status
203352	Biospecimen Collection Form and Instruction	New
203351	Questionnaires, Time Diary, Heart Monitoring Form and Instruction	New
203350	Screening Form and Instruction	New

ICR Details

OMB Control No: 0925-0671	ICR Reference No: 201207-0925-002
Status: Historical Inactive	Previous ICR Reference No:
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OIRA Conclusion Action: Withdrawn	Conclusion Date: 10/26/2012
	Date Received in OIRA: 07/18/2012
Terms of Clearance: Please resubmit with updated ICs, incentives, and characterization of additional work that might need to be done. No additonal public notice is required.

	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 NCS has requested and received approval for topic-based generic clearances. Formative research substudies submitted through these mechanisms are designed to assist the NCS in developing best practice protocols and to answer specific research questions related to recruitment, retention, biospecimen collection, and physical measurement gathering. Some formative research projects related to the overall goals of the NCS Vanguard (Pilot) and Main Study have a larger scope and may provide more information on exposures and outcomes, in addition to informing the protocols and processes used in the Vanguard (Pilot) and Main Study. 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. This substudy will begin building a base of information regarding stress and pregnancy and will provide further opportunities for researchers to evaluate the exposure/outcome relationships between stress and birth outcomes. 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: 3

IC Title	Form No.	Form Name
Screening	1.1	Screening Tool
Questionnaires, Time Diary, Heart Monitoring	2.1, 2.2, 2.3, 2.4, 2.5, 2.6	Participant Contact Information Sheet ,   Demographic and Health Survey ,   Visit 1 Stress Questionnaire ,   Take Home Packet ,   Visit 2 Stress Questionnaire ,   SLES Checklist
Biospecimen Collection	3.1	Saliva Specimen Log

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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 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: 07/18/2012

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