Experimental Study of Patient Information Prototypes

ICR 201101-0910-009

OMB: 0910-0691

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2011-08-10
Supporting Statement B
2011-08-10
Supplementary Document
2010-12-01
Supplementary Document
2010-12-01
Supplementary Document
2010-12-01
Supplementary Document
2010-12-01
Supplementary Document
2010-12-01
Supplementary Document
2010-12-01
Supplementary Document
2010-12-01
Supplementary Document
2010-12-01
Supplementary Document
2010-12-01
Supporting Statement A
2011-08-10
IC Document Collections
ICR Details
0910-0691 201101-0910-009
Historical Active
HHS/FDA
Experimental Study of Patient Information Prototypes
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 08/11/2011
Retrieve Notice of Action (NOA) 01/31/2011
  Inventory as of this Action Requested Previously Approved
08/31/2014 36 Months From Approved
4,420 0 0
850 0 0
0 0 0

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.

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
  
None

Not associated with rulemaking

  75 FR 23775 05/04/2010
75 FR 78252 12/15/2010
Yes

5
IC Title Form No. Form Name
Phase I - Screener
Phase I - Interviews
Phase II - Screener
Phase II - Pretest
Phase II - Questionnaire

  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
Yes
Miscellaneous Actions
No
This is a new data collection.

$1,613,294
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Eliazabeth Berbakos 3018271482

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
01/31/2011


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