National Health and Nutrition Examination Survey

Forms and Documents

Document Name	Status
HPV PRC Providers Form	Unchanged
HPV PRC Participants Form	Unchanged
Liver Ultrasound Pilot Form	Unchanged
NHANES Questionnaire Form	Modified
Att_6_ERB Approval 120415.rtf Supplementary Document	2015-12-07
Sup_Stat_B_112315.docx Supporting Statement B	2015-12-07
NHANES_15-16_Sup_Stat_A_011416.docx Supporting Statement A	2016-01-14
Att_11_PM_flyer_15-16 100114.doc Supplementary Document	2015-12-03
Att_9_ROF_15-16 100114.docx Supplementary Document	2015-12-03
Att_7_labs_15-16 112315.docx Supplementary Document	2015-12-03
Att_5b_Child_Assent_15-16 100114.docx Supplementary Document	2015-12-03
Att_5a_MEC_Consent_15-16 100114 (1).pdf Supplementary Document	2015-12-03
Att_5_Consents_15-16 100114.docx Supplementary Document	2015-12-03
Att_4 _Letters_scripts 15-16 100114.doc Supplementary Document	2015-12-03
Att_3_Agencies_15-16 100114.docx Supplementary Document	2015-12-03
Att_2b_60_day response 102015.docx Supplementary Document	2015-12-03
Att_2a_60-day_15-16 100114.pdf Supplementary Document	2015-12-03
Att_1_15-16_Laws 100114.docx Supplementary Document	2015-12-03
Combined nonsubs 11_23.docx Supplementary Document	2015-11-23

IC Document Collections

IC ID	Document Title	Status
219202	NHANES Waist Circumference Study Instruction	New
218880	HPV PRC Providers Form	Unchanged
218879	HPV PRC Participants Form	Unchanged
218863	Liver Ultrasound Pilot Form	Unchanged
213575	NHANES Special Studies Other-Other	Modified
213574	NHANES Questionnaire Form	Modified

ICR Details

OMB Control No: 0920-0950	ICR Reference No: 201512-0920-003
Status: Historical Active	Previous ICR Reference No: 201511-0920-004
Agency/Subagency: HHS/CDC	Agency Tracking No:
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: 01/15/2016
	Date Received in OIRA: 12/16/2015
Terms of Clearance: CDC may submit non-substantive changes to describe in more detail the protocol for the special studies foreshadowed in Supporting Statement Part A.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2017	36 Months From Approved	11/30/2016
Responses	22,310	0	18,310
Time Burden (Hours)	46,925	0	43,525
Cost Burden (Dollars)	0	0	0

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Abstract: This revision request is to a) add the collection of waist circumference data on 3000 people who are participating in NHANES during 2016, b) extend the expiration date to the end of 2017 in order to allow completion of the 2015-2016 data collection and continue conducting special studies that allow refinement in NHANES methods, add additional hours for these special studies.

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Authorizing Statute(s): US Code: 21 USC 393 Name of Law: Federal Food, Drug and Cosmetic Act
   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
  

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:
	80 FR 53799	09/08/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 76992	12/11/2015
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
NHANES Waist Circumference Study
Liver Ultrasound Pilot	none	Liver Ultrasound
NHANES Questionnaire	none	NHAMES Questionnaire
NHANES Special Studies
HPV PRC Participants	none	HPV Participants
HPV PRC Providers	none	HPV PRC Providers

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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	22,310	18,310	0	4,000	0	0
Annual Time Burden (Hours)	46,925	43,525	0	3,400	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: The increase in burden is due to a newly added Waist Circumference Study and additional hours added to the Special Studies.

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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: 12/16/2015

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