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

ICR 201807-0910-005

OMB: 0910-0861

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement B
2018-08-10
Supporting Statement A
2018-09-17
ICR Details
0910-0861 201807-0910-005
Historical Active
HHS/FDA CDER
Experimental Study of Risk Information Amount and Location in Direct-to-Consumer Print Ads
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 09/17/2018
Retrieve Notice of Action (NOA) 08/15/2018
  Inventory as of this Action Requested Previously Approved
09/30/2020 36 Months From Approved
1,760 0 0
480 0 0
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
Pilot Screener
Completes, Pilot
Completes, Study 1
Completes, Study 2
Study 1 Screener
Study 2 Screener

  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 0 0 1,760 0 0
Annual Time Burden (Hours) 480 0 0 480 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
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 ila.mizrachi@fda.hhs.gov

  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.
08/15/2018


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