Accelerated Approval Disclosures on Direct-to-Consumer Prescription Drug Websites

ICR 202204-0910-010

OMB: 0910-0872

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement B
2022-04-07
Supporting Statement A
2022-04-07
ICR Details
0910-0872 202204-0910-010
Received in OIRA 201908-0910-019
HHS/FDA CDER/OPDP
Accelerated Approval Disclosures on Direct-to-Consumer Prescription Drug Websites
Reinstatement with change of a previously approved collection   No
Regular 04/08/2022
  Requested Previously Approved
36 Months From Approved
25,410 0
2,335 0
0 0

The study will examine the effect of a disclosure communicating information related to a prescription drug’s accelerated approval in direct-to-consumer promotional materials. Participants will view a website for a fictitious oncology prescription drug and answer questions about it.

US Code: 21 USC 393(d)(2)(C) Name of Law: FDA; General Powers; Research relating to food and drugs.
  
None

Not associated with rulemaking

  86 FR 31323 06/11/2021
87 FR 16743 03/24/2022
Yes

1
IC Title Form No. Form Name
Main Study
Pretesting Screener
Study Instruments: Consent; Pre- and Main Test; Questionnaire; Recruitment e-mail
Study Screener

  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 25,410 0 0 0 22,354 3,056
Annual Time Burden (Hours) 2,335 0 0 0 1,932 403
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
Although the proposed study does not duplicate, it builds upon previous research conducted under this control number and we are therefore submitting our request as a reinstatement with change. We explain this more fully in our justification at Question 1 of our Supporting Statement Part A.

$270,000
Yes Part B of Supporting Statement
    No
    No
No
No
No
No
Domini Bean 301 796-5733 [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.
04/08/2022


© 2024 OMB.report | Privacy Policy