National Health and Nutrition Examination Survey

Forms and Documents

Document Name	Status
NHANES Special Studies Form	Modified
Form 2 NHANES Questionnaire Form	Unchanged
NHANES 2015 Feasibility study_HPV 05JAN2015.docx Justification for No Material/Nonsubstantive Change	2015-01-05
NHANES_15-16_Sup_Stat_A_102114.docx Supporting Statement A	2014-10-28
Att 6 ERB Approval 101614.rtf Supplementary Document	2014-10-22
Att_11_PM_flyer_15-16 100114.doc Supplementary Document	2014-10-22
Att_9_ROF_15-16 100114.docx Supplementary Document	2014-10-22
Att_7_labs_15-16 100114.docx Supplementary Document	2014-10-22
Att_5b_Child_Assent_15-16 100114.docx Supplementary Document	2014-10-22
Att_5a_MEC_Consent_15-16 100114.pdf Supplementary Document	2014-10-22
Att_5_Consents_15-16 100114.docx Supplementary Document	2014-10-22
Att_4 _Letters_scripts 15-16 100114.doc Supplementary Document	2014-10-22
Att_3_Agencies_15-16 100114.docx Supplementary Document	2014-10-22
Att_2b_60_day responses 100114.docx Supplementary Document	2014-10-22
Att_2a_60-day_15-16 100114.pdf Supplementary Document	2014-10-22
Att_1_15-16_Laws 100114.docx Supplementary Document	2014-10-22
NHANES_15-16_Sup_Stat_B_100114.docx Supporting Statement B	2014-10-22

IC Document Collections

IC ID	Document Title	Status
213575	NHANES Special Studies Form	Modified
213574	NHANES Questionnaire Form	Unchanged

ICR Details

OMB Control No: 0920-0950	ICR Reference No: 201412-0920-015
Status: Historical Active	Previous ICR Reference No: 201410-0920-025
Agency/Subagency: HHS/CDC	Agency Tracking No: 21617
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: 01/06/2015
	Date Received in OIRA: 01/05/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2016	11/30/2016	11/30/2016
Responses	16,910	0	16,910
Time Burden (Hours)	43,525	0	43,525
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 is a request for a nonsubstantive change to the National Health and Nutrition Examination Survey (NHANES) (OMB No. 0920-0950, exp. November 30, 2016) to conduct an Oral HPV Self-collection Follow-up Feasibility Study.

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Authorizing Statute(s): 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
   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
  

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:
	79 FR 20204	04/11/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 64196	10/28/2014
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
NHANES Questionnaire	2	NHANES Questionaire -revised
NHANES Special Studies	none, None	Special Studies ,   NHANES oral HPV Follow-Up Feasibility Study Questioinnaire

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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	16,910	16,910	0	0	0	0
Annual Time Burden (Hours)	43,525	43,525	0	0	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: No

Burden Reduction Due to:

Short Statement:

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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: 01/05/2015

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