CONSUMER COMPREHENSION OF OTC DRUG LABELING

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
109605	CONSUMER COMPREHENSION OF OTC DRUG LABELING	Migrated

ICR Details

OMB Control No: 0910-0105	ICR Reference No: 198011-0910-003
Status: Historical Inactive	Previous ICR Reference No: 197909-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: CONSUMER COMPREHENSION OF OTC DRUG LABELING
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Disapproved	Conclusion Date: 01/12/1981
	Date Received in OIRA: 11/12/1980
Terms of Clearance: THIS PROJECT IS NOT APPROVED FOR THE FOLLOWING REASONS: 1) OMB IS NOT CONVINCED THAT THE USE OF A CONVENIENCE SAMPLE WILL PROVIDE GENERALIZABLE RESULTS. 2) THE SURVEY INSTRUMENT IS TOO LENGTHY, COMPLEX AND REDUNDANT, PARTICULARLY FOR USE IN A NON-HOUSEHOLD SETTING, AND 3) THE PROPOSED RESEARCH DESIGN CONFUSES ISSUES OF "UNDERSTANDABILITY" AND "SIMILARITY" OF TERMS. RESULTS OF THIS SURVEY, IF APPROVED, WOULD NOT BE ACCEPTED BY INDUSTRY AND WOULD PERPETUATE DISAGREEMENT ON THE ISSUE OF OTC LABELING. FDA IS ENCOURAGED TO SUBMIT AN IMPROVED RESEARCH DESIGN TO OMB FOR RECONSIDERATION.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		01/12/1981
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: THE DATA COLLECTION AND ANALYSIS ARE INTENDED TO ASSIST FDA IN THE PREPARATION OF TRUTHFUL, NONMISLEADING, MEDICALLY ACCURATE AND UNDER STANDABLE TERMS FOR USE IN WRITING LABELING FOR OTC DRUG PRODUCTS.

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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
CONSUMER COMPREHENSION OF OTC DRUG LABELING

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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: $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: 11/12/1980

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