Study of Oncology Indications in Direct-to-Consumer Television Advertising

ICR 202001-0910-013

OMB: 0910-0885

Federal Form Document

Forms and Documents
ICR Details
0910-0885 202001-0910-013
Historical Active
HHS/FDA CDER
Study of Oncology Indications in Direct-to-Consumer Television Advertising
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 02/28/2020
Retrieve Notice of Action (NOA) 01/29/2020
Approved with the understanding that if changes are made to the collection as a result of the pretests, the updates will be submitted for review and approval prior to fielding the main studies. All instruments must be updated to display the OMB control number, expiration date, and burden statement.
  Inventory as of this Action Requested Previously Approved
02/28/2023 36 Months From Approved
3,622 0 0
641 0 0
0 0 0

This study will examine how oncology prescription drug indications are communicated to consumers in direct-to-consumer (DTC) promotional materials. We plan to conduct two rounds of in-person one-hour cognitive interviews (N = 9 in each), two pretests (N = 60 in each), and two main studies (N = 700 in Study 1; N = 520 in Study 2) not longer than 20 minutes, administered via Internet panel. In the first cognitive interview, pretest, and main study, we will vary the indication (hematology or solid tumor), the clinical endpoint (overall survival, overall response rate, or progression-free survival), and the presence of a disclosure in a television ad for a fictitious oncology prescription drug. In the second cognitive interview, pretest, and main study, we will vary the indication (hematology or solid tumor) and the presentation of material information in audio and superimposed text in a television ad for a fictitious oncology prescription drug. In each study, participants will view the television ad and then answer questions about the drug information.

None
None

Not associated with rulemaking

  84 FR 29213 06/21/2019
85 FR 5213 01/29/2020
Yes

  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 3,622 0 0 3,622 0 0
Annual Time Burden (Hours) 641 0 0 641 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new data collection.

$652,824
Yes Part B of Supporting Statement
    No
    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.
01/29/2020


© 2024 OMB.report | Privacy Policy