Experimental Study of an Accelerated Approval Disclosure

ICR 201905-0910-001

OMB: 0910-0872

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
236002
New
236001
New
236000
New
235999
New
ICR Details
0910-0872 201905-0910-001
Historical Active
HHS/FDA CDER
Experimental Study of an Accelerated Approval Disclosure
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 06/11/2019
Retrieve Notice of Action (NOA) 05/09/2019
Approved consistent with the understanding that any changes made as a result of the pretest must be submitted for review and approval prior to fielding the main study.
  Inventory as of this Action Requested Previously Approved
06/30/2020 36 Months From Approved
3,441 0 0
530 0 0
0 0 0

This study will examine the effect of the presence, language, and prominence of a disclosure communicating information related to a prescription drug’s accelerated approval in direct-to-consumer promotional materials. We plan to conduct one pretest (N = 385) and one main study (N = 633) not longer than 20 minutes, administered via Internet panel. We will vary the presence and prominence of the disclosure (e.g., varying the presence, size, color, and location of the disclosure) on a website for a fictitious prescription drug. Participants will view the website and then answer questions about the drug information, including the disclosure.

None
None

Not associated with rulemaking
Other Documents for OIRA Review

  83 FR 52478 10/17/2018
84 FR 20148 05/08/2019
Yes

4
IC Title Form No. Form Name
Pretesting Screener
Study Screener
Pretest
Main 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 3,441 0 0 3,441 0 0
Annual Time Burden (Hours) 530 0 0 530 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new data collection.

$168,360
Yes Part B of Supporting Statement
    No
    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.
05/09/2019


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