Experimental Study of Patient Information Prototypes

Forms and Documents

Document Name	Status
201101-0910-009 Q&A.doc Supplementary Document	2011-08-10
Supporting Statement B - Experimental Study of Patient Information Prototypes.doc Supporting Statement B	2011-08-10
Stimuli 9 - Bubbles_W1wContext_110510.pdf Supplementary Document	2010-12-01
Stimuli 8 - Bubbles_W1NOcontext_110510.pdf Supplementary Document	2010-12-01
Stimuli 7 - Bubbles_D1wContext_110510.pdf Supplementary Document	2010-12-01
Stimuli 6 - Bubbles_D1NOcontext_110510.pdf Supplementary Document	2010-12-01
Stimuli 5 - OTC_W1wContext_110510.pdf Supplementary Document	2010-12-01
Stimuli 4 - OTC_W1NOcontext_110510.pdf Supplementary Document	2010-12-01
Stimuli 3 - OTC_D1wContext_110510.pdf Supplementary Document	2010-12-01
Stimuli 2 - OTC_D1NOcontext_110510.pdf Supplementary Document	2010-12-01
Stimuli 1 - MedGuide_Control110510.pdf Supplementary Document	2010-12-01
Supporting Statement A - Experimental Study of Patient Information Prototypes.doc Supporting Statement A	2011-08-10

IC Document Collections

IC ID	Document Title	Status
196074	Phase II - Questionnaire	New
196073	Phase II - Pretest	New
196072	Phase II - Screener	New
196071	Phase I - Interviews	New
196070	Phase I - Screener Other-Quantitative Questionnaire	New

ICR Details

OMB Control No: 0910-0691	ICR Reference No: 201101-0910-009
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Experimental Study of Patient Information Prototypes
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 with change	Conclusion Date: 08/11/2011
	Date Received in OIRA: 01/31/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2014	36 Months From Approved
Responses	4,420	0	0
Time Burden (Hours)	850	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this study is to investigate the usefulness of two possible prototypes for patient medication information (PMI). FDA has an interest in providing useful and accessible information to patients when they retrieve their prescriptions at the pharmacy. In order to ensure that a standard format of information is most useful, we propose approaching this issue both qualitatively and quantitatively. These approaches will allow us to provide information about the readability, usefulness, and understandability of the two formats in a variety of populations, including those with the medical condition in question, people with low literacy levels, and members of the general public. We will compare the two prototypes to each other and to the existing Medication Guide format in order to obtain empirically based information about the most comprehensible and preferred document. This study will inform future policy with regard to PMI.

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Authorizing Statute(s): US Code: 42 USC 300u(a)(4) Name of Law: Public Health Service Act
   PL: Pub.L. 110 - 104 601 Name of Law: Effective Medication Guides
  

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:
	75 FR 23775	05/04/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 78252	12/15/2010
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Phase I - Screener
Phase I - Interviews
Phase II - Screener
Phase II - Pretest
Phase II - Questionnaire

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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	4,420	0	0	4,420	0	0
Annual Time Burden (Hours)	850	0	0	850	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: This is a new data collection.

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Annual Cost to Federal Government: $1,613,294

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: 01/31/2011

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