Character-Space-Limited Online Prescription Drug Communications

ICR 201707-0910-014

OMB: 0910-0846

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2017-08-16
Supporting Statement B
2017-08-01
IC Document Collections
IC ID
Document
Title
Status
227665 New
ICR Details
0910-0846 201707-0910-014
Historical Active
HHS/FDA CDER
Character-Space-Limited Online Prescription Drug Communications
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 10/25/2017
Retrieve Notice of Action (NOA) 08/16/2017
  Inventory as of this Action Requested Previously Approved
10/31/2020 36 Months From Approved
6,502 0 0
1,128 0 0
0 0 0

The studies will examine whether substantive risk information in direct-to-consumer character-space-limited prescription drug communications is effective in communicating risks when benefit claims are made, or whether a link to the risk information is sufficient. We plan to conduct two pretests and four main studies, each 20 minutes long, with 277 participants in each pretest (total = 554) and 469 participants in each main study (total = 1,876). We will manipulate whether (1) the communication includes substantive risk information, (2) whether the landing page includes benefit information, and (3) whether participants are instructed to browse or search for information. After viewing the study materials, participants will complete a questionnaire that assesses their retention of the risk information and their perceptions of the drug’s risks and benefits.

None
None

Not associated with rulemaking

  81 FR 78163 11/07/2016
82 FR 32842 07/18/2017
Yes

1
IC Title Form No. Form Name
Character Spaced Study

  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 6,502 0 0 6,502 0 0
Annual Time Burden (Hours) 1,128 0 0 1,128 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new data collection.

$273,819
Yes Part B of Supporting Statement
    No
    No
Yes
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.
08/16/2017


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