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

ICR 202104-0910-001

OMB: 0910-0885

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2021-04-01
Justification for No Material/Nonsubstantive Change
2020-08-11
Justification for No Material/Nonsubstantive Change
2020-07-22
Justification for No Material/Nonsubstantive Change
2020-07-07
Supporting Statement B
2020-01-27
Supporting Statement A
2020-01-27
ICR Details
0910-0885 202104-0910-001
Received in OIRA 202007-0910-004
HHS/FDA CDER
Study of Oncology Indications in Direct-to-Consumer Television Advertising
No material or nonsubstantive change to a currently approved collection   No
Regular 04/05/2021
  Requested Previously Approved
02/28/2023 02/28/2023
4,704 3,622
657 641
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 Request 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 4,704 3,622 0 1,082 0 0
Annual Time Burden (Hours) 657 641 0 16 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
Based on cognitive interviews and pretesting, we made several revisions to the study materials and updated the burden chart to reflect the actual pretest burden and the revised estimated burden for the main studies.

$652,824
Yes Part B of Supporting Statement
    No
    No
No
No
No
No
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.
04/05/2021


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