Health and Diet Survey

Forms and Documents

Document Name	Status
0545 Supporting Statement Part B 2014.pdf Supporting Statement B	2014-09-29
0545 Supporting Statement Part A 2014 2.doc Supporting Statement A	2014-11-18
0545 Health and Diet Survey 83 C Request.doc Justification for No Material/Nonsubstantive Change	2014-03-26

IC Document Collections

IC ID	Document Title	Status
37678	Pretest Other-Questionnaire	Modified
213284	Cognitive Interview Other-Core questions	New
183125	Survey screener Other-Core questions	Modified
183124	Cognitive interview screener Other-Core questions	Modified
183123	Survey Other-Core questions	Modified
183122	Pretest screener Other-Questionnaire	Modified

ICR Details

OMB Control No: 0910-0545	ICR Reference No: 201409-0910-003
Status: Historical Active	Previous ICR Reference No: 201403-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Health and Diet Survey
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 12/05/2014
	Date Received in OIRA: 09/29/2014
Terms of Clearance: This generic clearance for the Health and Diet Survey is approved for 3-years under the following conditions: (1) For individual collections, FDA shall submit a generic IC in ROCIS along with: (a) an abbreviated supporting statement in the template agreed to by OMB and FDA (including a statement of need, intended use of information, description of respondents, date(s) and location(s), collection procedures, number of surveys or interviews, justification for any proposed incentive, and estimated burden); (b) the participant screener, and (c) any moderator guides. (2) OMB will respond with clearance or questions within 10 working days.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2017	36 Months From Approved	12/31/2014
Responses	35,318	0	18,227
Time Burden (Hours)	1,882	0	1,301
Cost Burden (Dollars)	0	0	0

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Abstract: The Health and Diet Survey is a voluntary consumer survey intended to gauge and track consumer attitudes, awareness, knowledge, and behavior regarding various topics related to health, nutrition and physical activity. The authority for FDA to collect the information derives from the FDA Commissioner's authority provided in section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)). FDA and other Federal agencies will use the information from the Health and Diet Survey to evaluate and develop strategies and programs to encourage and help consumers adopt healthy lifestyles. The information will also help the FDA and other Federal agencies evaluate and track consumer awareness and behavior as outcome measures of their achievement in improving public health.

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Authorizing Statute(s): US Code: 21 USC 393 (d)(2) Name of Law: null
  

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 40760	07/14/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 53711	09/10/2014
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
Pretest
Pretest screener
Survey
Cognitive interview screener
Survey screener
Cognitive Interview

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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	35,318	18,227	0	17,091	0	0
Annual Time Burden (Hours)	1,882	1,301	0	581	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This collection is being revised as a generic collection. The inventory for both burden hours and annual responses has increased. This is explained more fully in Q15 of the agency's supporting statement part A.

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Annual Cost to Federal Government: $460,000

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: 09/29/2014

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