Medical Conference Attendees’ Observations about Prescription Drug Promotion

ICR 202106-0910-015

OMB:

Federal Form Document

Forms and Documents
IC Document Collections
IC ID
Document
Title
Status
248053 New
248052 New
248051 New
ICR Details
202106-0910-015
Received in OIRA
HHS/FDA CDER
Medical Conference Attendees’ Observations about Prescription Drug Promotion
New collection (Request for a new OMB Control Number)   No
Regular 07/14/2021
  Requested Previously Approved
36 Months From Approved
1,326 0
204 0
0 0

The current study focuses on the landscape of healthcare provider (HCP)-directed promotion of prescription drugs at medical conferences in general and, more specifically, at pharmaceutical promotional booths. We will ask attendees who are prescribers within different disciplines (primary care physicians, specialists, nurse practitioners, and physician assistants) general questions about their attendance at medical conferences, including questions about their motivations for attending, activities they participate in (e.g., symposia, poster sessions, social events, exhibit halls), and their opinions about the prescription drug treatments promoted at medical conferences. We will also embed an experimental manipulation into the survey, whereby participants watch a video that mimics a pharmaceutical representative/HCP interaction, and varies in the professional expertise of the pharmaceutical representative (medical vs. business) and whether or not the discussion includes a disclosure of important limitations. Approximately 350 HCPs will be recruited from 12 medical conferences over the course of one year. The entire online survey, including the experiment, will take approximately 20 minutes.

None
None

Not associated with rulemaking

  85 FR 58366 09/18/2020
86 FR 37160 07/14/2021
Yes

3
IC Title Form No. Form Name
Main Test
Pretest
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 1,326 0 0 1,326 0 0
Annual Time Burden (Hours) 204 0 0 204 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new data collection.

$499,832
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.
07/14/2021


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