National Health and Nutrition Examination Survey

Forms and Documents

Document Name	Status
NHANES Questionnaire Form and Instruction	Modified
NHANES 2013-2014 Supporting Statement B 24-Hour Urine 10282013.doc Supporting Statement B	2013-11-01
Attachment 15b-Federal Register Notice Responses - 24-Hour Urine Rev 093013.docx Supplementary Document	2013-11-01
Attachment 13-NHANES Results of 24-Hour Urine Pilot Study_FINAL_20130620.docx Supplementary Document	2013-11-01
NHANES 2013-2014 Supporting Statement A 24-Hour Urine Revision rev 10282013.docx Supporting Statement A	2013-11-06

IC Document Collections

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

ICR Details

OMB Control No: 0920-0950	ICR Reference No: 201311-0920-004
Status: Historical Active	Previous ICR Reference No: 201308-0920-005
Agency/Subagency: HHS/CDC	Agency Tracking No: 20834
Title: National Health and Nutrition Examination Survey
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/09/2013
	Date Received in OIRA: 11/07/2013
Terms of Clearance: The prior approval included the protocol for the 2013-2014 collection. This revision adds the 24 hour urine collection module into the full NHANES for the duration of the 2013-2014 collection, contingent upon meeting the following criteria: 70% response rate for both the first and second urine collections and no more than 5% reduction in response rate for other follow up for other post exam components (as compared to those participants who do not agree to participate in the 24 hour urine collection). On a quarterly basis, CDC should let OMB know if the response rates fall below these values, and set up a discussion of the implications for drawing conclusions and/or the other follow up modules. The protocol 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	24 Months From Approved	11/30/2015
Responses	17,911	0	18,286
Time Burden (Hours)	46,028	0	46,591
Cost Burden (Dollars)	0	0	0

---

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 request seeks a revised approval for data collection for the 2013-2014 survey to include the 24-Hour Urine Collection Project.

---

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

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 43883	07/22/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 65652	11/01/2013
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
NHANES Questionnaire	none	NHANES Questionnaire
Special Studies and Pretests
National Health and Nutrition Examination Survey (NHANES) 24-Hour Urine Pilot Study

---

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	17,911	18,286	0	-375	0	0
Annual Time Burden (Hours)	46,028	46,591	0	-563	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This is a correction designed to bring the burden hours back to what was approved for at the prior revision. [i.e, during an recent nonsubstantive change, the hours were inadvertently increased; this change corrects that error.]

---

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

---

Common Form ICR:  No

---

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: 11/07/2013

---