Physician Interpretation of Information About Prescription Drugs in Scientific Publications vs. Promotional Pieces

ICR 202006-0910-002

OMB: 0910-0875

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2020-06-01
Supporting Statement B
2019-07-03
Supporting Statement A
2019-07-03
ICR Details
0910-0875 202006-0910-002
Active 201907-0910-005
HHS/FDA CDER
Physician Interpretation of Information About Prescription Drugs in Scientific Publications vs. Promotional Pieces
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 06/02/2020
Retrieve Notice of Action (NOA) 06/02/2020
Previous terms continue: Any changes made as a result of the pre-test will need to be submitted and approved prior to fielding the main study.
  Inventory as of this Action Requested Previously Approved
09/30/2021 09/30/2021 09/30/2021
3,469 0 1,621
398 0 267
0 0 0

This study will examine how physician perception of professional prescription drug communications is influenced by variations in information context, methodologic rigor of the underlying clinical study, and time pressure. We plan to conduct one pretest (N = 158) and one main study (N = 566) not longer than 20 minutes, administered via Internet panel. Using a description of a trial for a fictitious prescription drug, we will vary the context of the information, the methodologic rigor of the information, and the amount of time available to read the information. Participants will view the information and then answer questions about the drug information.

None
None

Not associated with rulemaking

  83 FR 52490 10/17/2018
84 FR 34897 07/19/2019
Yes

6
IC Title Form No. Form Name
Completes, Pretest 1
Pretest 1 Screener
Pretest 2 Screener
Completes Pretest 2
Main Study Screener
Completes, 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 3,469 1,621 0 1,848 0 0
Annual Time Burden (Hours) 398 267 0 131 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new data collection.

$179,670
Yes Part B of Supporting Statement
    No
    No
No
No
No
No
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.
06/02/2020


© 2024 OMB.report | Privacy Policy