National Health and Nutrition Examination Survey

Forms and Documents

Document Name	Status
Telephone Dietary Recall and Dietary Supplements Form	Unchanged
Mobile Exam Center Interview and Exam Form	Unchanged
Screener Form	Unchanged
Flexible Consumer Behavior Survey Phone Follow-up Form	Unchanged
Household Interview Form	Unchanged
Att 1e Blood Infants - Additional Information 021220.docx Supplementary Document	2020-02-25
Att 1d 011420.docx Supplementary Document	2020-02-25
Att 1c Blood - Infants Measurements List 010920.docx Supplementary Document	2020-02-25
Att 1a Blood - Infants 011420.docx Supplementary Document	2020-02-25
0920-0950 Developmental Projects Infant Blood 022020.docx Justification for No Material/Nonsubstantive Change	2020-02-25
Att_20a DXA Crossover Study Description 103018.docx Supplementary Document	2018-11-19
Att_19b Incentive Pilot Details 111618.docx Supplementary Document	2018-11-19
Att_19a Incentive Pilot Summary 103018.docx Supplementary Document	2018-11-19
Att_9p 284418-A_2017-18_MEC_Adult_ParentalConsentBrochure_English print.pdf Supplementary Document	2018-09-20
Att_7_ NHANES History 072718.docx Supplementary Document	2018-09-20
Att_18b Make A Plan tracker.pdf Supplementary Document	2018-09-13
Att_18a Make A Plan - multi color.pdf Supplementary Document	2018-09-13
Att_17b_Background 082818.pdf Supplementary Document	2018-09-13
Att_17a_ Background 082818 word.docx Supplementary Document	2018-09-13
Att_16_ROF 19-20 OMB 072718.docx Supplementary Document	2018-09-13
Att_15 3-5 Yr Urine Fact Sheet 072518.pdf Supplementary Document	2018-09-13
Att_14b Sample Design 2015-2018 072718.docx Supplementary Document	2018-09-13
Att_14a Sample Design Tables 2019-20 072518.docx Supplementary Document	2018-09-13
Att_11_HPV Informational_flyer 072418.docx Supplementary Document	2018-09-13
Att_10 ERB Approval 072718.docx Supplementary Document	2018-09-13
Att_9o NHANES_Child_Assent_Brochure.pdf Supplementary Document	2018-09-13
Att_9n 2019 NHANES Health Measurements 082018.docx Supplementary Document	2018-09-13
Att_9m 2018 Home Intv Consent English_Final 072718.doc Supplementary Document	2018-09-13
Att_9l 2018 Future Research non DNA English 082018.doc Supplementary Document	2018-09-13
Att_9k Confidentiality Brochure_2018_English 082018 word.docx Supplementary Document	2018-09-13
Att_9j 2018 Auth for Transport_English 072718.doc Supplementary Document	2018-09-13
Att_9i 2017-18 NHANES Health Measurements.pdf Supplementary Document	2018-09-13
Att_9h Rev Transport Auth HC 17-18 072718.doc Supplementary Document	2018-09-13
Att_9g e-consent Adult 17-18 082018.docx Supplementary Document	2018-09-13
Att_9f assent 12-17 072718.docx Supplementary Document	2018-09-13
Att 9e_Assent 7-11 072718.docx Supplementary Document	2018-09-13
Att_9c_Child_Assent Brochure 072718.docx Supplementary Document	2018-09-13
ATT_9b_Adult Consent Brochure 082118.pdf Supplementary Document	2018-09-13
Att_9a_Consents 081718_2019 OMB changes 082118.docx Supplementary Document	2018-09-13
Att_8b 2018 Advance Letter 08208.docx Supplementary Document	2018-09-13
Att_8a _Letters_scripts 082918.docx Supplementary Document	2018-09-13
Att_6_Agencies_19-20 072718.docx Supplementary Document	2018-09-13
Att_5b_Lab_17-18 072718.docx Supplementary Document	2018-09-13
Att_5a_Lab_19-20_FINAL 072718.pdf Supplementary Document	2018-09-13
Att_4_Developmental Project Reports.docx Supplementary Document	2018-09-13
Att_3l_Questionnaires & Hand Cards 17-18.docx Supplementary Document	2018-09-13
Att_3a_Question Changes19-20 rev 102318.docx Supplementary Document	2018-11-19
Att_2a Federal Register Notice.pdf Supplementary Document	2018-09-13
Att_1_17-18_Laws 12152017.docx Supplementary Document	2018-09-13
Sup_Stat_A 111618.docx Supporting Statement A	2018-11-19
Sup_Stat_B 111618.docx Supporting Statement B	2018-11-19

IC Document Collections

IC ID	Document Title	Status
233004	24 Hour Blood Pressure Pilot Instruction	Unchanged
233002	Telephone Dietary Recall and Dietary Supplements Form	Unchanged
233001	Mobile Exam Center Interview and Exam Form	Unchanged
233000	Screener Form	Unchanged
219202	Developmental Projects and Special Studies Instruction	Modified
218879	Flexible Consumer Behavior Survey Phone Follow-up Form	Unchanged
213574	Household Interview Form	Unchanged

ICR Details

OMB Control No: 0920-0950	ICR Reference No: 202002-0920-011
Status: Active	Previous ICR Reference No: 201809-0920-002
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0950-20KM
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 without change	Conclusion Date: 02/27/2020
	Date Received in OIRA: 02/25/2020
Terms of Clearance: Please provide OMB with an update on this project every four months.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2021	11/30/2021	11/30/2021
Responses	39,500	0	39,500
Time Burden (Hours)	68,417	0	68,417
Cost Burden (Dollars)	1,632,030	0	1,632,030

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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 nonsubstantive change request seeks approval to pilot test blood collection, via venipuncture, from 100 study participants less than 12 months of age. The burden hours for this project have already been accounted for within the Developmental Projects & Special Projects line in the most recently approved revision.

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Authorizing Statute(s): US Code: 42 USC 306 Name of Law: PHSA
   PL: Pub.L. 104 - 170 301 Name of Law: Food Quality Protection Act
   PL: Pub.L. 110 - 234 4403 Name of Law: Food, Conservation, and Energy Act of 2008
   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
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 22069	05/11/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 50934	10/10/2018
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Developmental Projects and Special Studies	0920-0950	Blood - Infants Questionnaire
Household Interview	none	Household Interview
Flexible Consumer Behavior Survey Phone Follow-up	none	Flexible Consumer Behavior Survey
Screener	none	Screener and Non-response Bias Module
Mobile Exam Center Interview and Exam	none	MEC Questionnaire and Exam
Telephone Dietary Recall and Dietary Supplements	none	Telephone Dietary Recall
24 Hour Blood Pressure Pilot

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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	39,500	39,500	0	0	0	0
Annual Time Burden (Hours)	68,417	68,417	0	0	0	0
Annual Cost Burden (Dollars)	1,632,030	1,632,030	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: No

Burden Reduction Due to:

Short Statement: The revision requests a reduction in burden. The burden table has be reformatted to show each level of possible participation (screener, interview, exam, post exam etc.) in NHANES as a separate line item. Past clearance documents used an average participant burden across all the possible levels of participation. The reduction in the burden estimates for the main parts of NHANES (screener through post MEC interviews) is due to streamlining the questionnaire instruments. The 24-hour blood pressure pilot represents a new burden request.

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Annual Cost to Federal Government: $46,200,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     Yes

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: 02/25/2020

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