National Health and Nutrition Examination Survey

Forms and Documents

Document Name	Status
NHANES Questionnaire Form and Instruction	Modified
NHANES_24-Hour_Urine_Pilot_Supporting_Statement_02282013.docx Justification for No Material/Nonsubstantive Change	2013-03-11

IC Document Collections

IC ID	Document Title	Status
205696	National Health and Nutrition Examination Survey (NHANES) 24-Hour Urine Pilot Study Instruction	New
204607	Special Studies and Pretests Instruction	Modified
204606	NHANES Questionnaire Form and Instruction	Modified

ICR Details

OMB Control No: 0920-0950	ICR Reference No: 201302-0920-004
Status: Historical Active	Previous ICR Reference No: 201210-0920-011
Agency/Subagency: HHS/CDC	Agency Tracking No: 18670
Title: National Health and Nutrition Examination Survey
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/11/2013
	Date Received in OIRA: 02/05/2013
Terms of Clearance: Criteria for moving the 24 hour urine collection module into the full NHANES are included in the supporting statement. In addition, The protocol for NHANES 2013-2014 are approved. The protocols for additional calendar years must be submitted to OMB as full revisions. CDC may submit protocols/requests to conduct small methodological tests as well as field test of items being considered for subsequent calendar years as nonsubtantive changes. However, special studies, large methodological tests, and pilot tests on separate samples must be submitted as full revisions.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2015	11/30/2015	11/30/2015
Responses	18,286	0	17,911
Time Burden (Hours)	46,591	0	46,028
Cost Burden (Dollars)	0	0	0

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Abstract: The National Health and Nutrition Examination Survey (NHANES) is a continuous nationally representative sample of the civilian, non-institutionalized U.S. population. The survey is unique in that it contains interview, laboratory and physical examination segments. The examination component is conducted in mobile examination centers that travel to fifteen survey locations each year. NHANES data have been the cornerstone for numerous national health and nutrition policy and surveillance activities. . This requests seeks approval to test changes for a 24-hr urine component

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Authorizing Statute(s): US Code: 42 USC 306 Name of Law: PHSA
   PL: Pub.L. 101 - 445 103 Name of Law: National Nutrition Monitoring and Related Research Act of 1990
   PL: Pub.L. 104 - 170 301 Name of Law: Food Quality Protection Act
   US Code: 21 USC 393 Name of Law: Federal Food, Drug and Cosmetic 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

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
Special Studies and Pretests
National Health and Nutrition Examination Survey (NHANES) 24-Hour Urine Pilot Study
NHANES Questionnaire	none	NHANES Questionnaire

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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	18,286	17,911	0	375	0	0
Annual Time Burden (Hours)	46,591	46,028	0	563	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: addition of pilot test to determine if 24 hour urine should be added to the full NHANES in 2014

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Annual Cost to Federal Government: $41,200,000

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: 02/05/2013

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