Health and Diet Survey

Forms and Documents

Document Name	Status
0545 10-6-08 83-C.doc Justification for No Material/Nonsubstantive Change	2008-10-06
0545 Addendum to ss 10-6-08.doc Supporting Statement A	2008-10-06

IC Document Collections

IC ID	Document Title	Status
37678	Health and Diet Survey Other-survey	Modified
187039	Health and Diet Survey Other-survey	New
183125	Health and Diet Survey Other-survey	Modified
183124	Health and Diet Survey Other-survey	Modified
183123	Health and Diet Survey Other-survey	Modified
183122	Health and Diet Survey Other-guidelines	Modified

ICR Details

OMB Control No: 0910-0545	ICR Reference No: 200810-0910-005
Status: Historical Active	Previous ICR Reference No: 200806-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Health and Diet 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: 11/25/2008
	Date Received in OIRA: 10/29/2008
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2011	04/30/2011	04/30/2011
Responses	19,227	0	18,227
Time Burden (Hours)	1,334	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 Name of Law: FFDCA
  

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:
	72 FR 29332	05/25/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 70872	12/13/2007
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Health and Diet Survey
Health and Diet Survey
Health and Diet Survey
Health and Diet Survey
Health and Diet Survey
Health and Diet Survey

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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	19,227	18,227	0	1,000	0	0
Annual Time Burden (Hours)	1,334	1,301	0	33	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: FDA increased its estimate of the total burden hours from 1,083 hours to 1,300.75 hours, an increase of 217.75 hours. The increase in burden hours is due to an increase in the estimated number of respondents, which results from the addition of a pretest and screener to the Health and Diet survey (27 respondents for a 15 minute pretest, and 10,000 respondents for a 1.2-minute screener). The newly added pretest and screener add 206.75 hours and, thus, are primarily responsible for the 217.75 hour increase.

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Annual Cost to Federal Government: $343,000

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 10/29/2008

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