Experimental Study of Risk Information Amount and Location in Direct-to-Consumer Print Ads

ICR 201907-0910-021

OMB: 0910-0861

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2019-07-24
Supporting Statement B
2018-08-10
Supporting Statement A
2018-09-17
IC Document Collections
IC ID
Document
Title
Status
232120 Unchanged
232119 Unchanged
232118 Unchanged
232117 Modified
232115 Modified
232113 Unchanged
ICR Details
0910-0861 201907-0910-021
Historical Active 201807-0910-005
HHS/FDA CDER
Experimental Study of Risk Information Amount and Location in Direct-to-Consumer Print Ads
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved with change 07/24/2019
Retrieve Notice of Action (NOA) 07/24/2019
  Inventory as of this Action Requested Previously Approved
09/30/2020 09/30/2020 09/30/2020
1,760 0 1,760
486 0 480
0 0 0

This information collection request collects information from an adult sample of individuals who self-identify as having rheumatoid arthritis or overactive bladder regarding their perceptions of the important safety information and brief summary in direct-to-consumer prescription drug print advertising. Additionally, we will collect eye-tracking data to observe participants’ gaze maps while reading the information. Using an in-person interview methodology, we plan to conduct two 60-minute pilots with a total of 40 adults and two 60-minute studies with a total of 400 adults.

None
None

Not associated with rulemaking

  82 FR 27842 06/19/2017
83 FR 40295 08/14/2018
Yes

6
IC Title Form No. Form Name
Study 1 Screener
Study 2 Screener
Pilot Screener
Completes, Pilot
Completes, Study 1
Completes, Study 2

  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 1,760 1,760 0 0 0 0
Annual Time Burden (Hours) 486 480 0 6 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
This is a new data collection.

$798,027
Yes Part B of Supporting Statement
    Yes
    No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 [email protected]

  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.
07/24/2019


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