STUDY OF FOOD LABEL FORMATS: PHASE II

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
109975	STUDY OF FOOD LABEL FORMATS: PHASE II	Migrated

ICR Details

OMB Control No: 0910-0271	ICR Reference No: 199107-0910-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: STUDY OF FOOD LABEL FORMATS: PHASE II
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/27/1991
	Date Received in OIRA: 07/15/1991
Terms of Clearance: This information collection request is approved based on the following understanding between FDA and OMB: 1) The preceding study had some basic sampling methodology flaws that disguise selection bias and nonresponse problems, 2) this follow-up experiment, while an improvement over the previous effort,also presents some significant limitations that may not solve t bias problems, particularly the uncertainty of the non-response follow up effort and the non-generalizeable sample, and 3) any discussion of the results of this study and its predecessor wil contain a full disclosure and discussion of bias factors. Such bias constitutes a major concern for FDA policy makers, OMB and Congress. In its report on Paperwork Reduction of September 1989, GAO singled out low response and potential for bias as serious problems in Federal data collections, particularly when "motivation not to report respond might be strongest for exactly that group whose responses are most critical" or when the data collection did not provide for "ways o estimating the size and direction of bias." In the context of this study the views likely to be excluded are those of people who place a high premium on their time and in turn might provide FDA with the clearest understanding of which format is most quickly understood. We strongly encourage FDA to vigorously pursue wa to characterize the bias of this study.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/1992	03/31/1992
Responses	1,720	0	0
Time Burden (Hours)	643	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: A SAMPLE OF HOUSEHOLD FOOD SHOPPERS WILL BE INTERVIEWED IN AN EXPERIMENTAL SETTING TO DETERMINE ABILITY TO ACCOMPLISH COMMON LABEL USE TASKS UNDER ALTERNATIVE NUTRITION LABEL FORMATS. THE DATA WILL PROVIDE INPUT TO PROPOSED RULEMAKING TO ESTABLISH A NEW STANDARDIZED FORMAT.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
STUDY OF FOOD LABEL FORMATS: PHASE II

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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	1,720	0	0	1,720	0	0
Annual Time Burden (Hours)	643	0	0	643	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:

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: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

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: 07/15/1991

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