Risk and Benefit Perception Scale Development

ICR 201510-0910-008

OMB: 0910-0784

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2015-10-16
Justification for No Material/Nonsubstantive Change
2015-06-09
Supporting Statement B
2015-04-15
Supporting Statement A
2015-04-15
IC Document Collections
ICR Details
0910-0784 201510-0910-008
Historical Active 201506-0910-010
HHS/FDA CDER
Risk and Benefit Perception Scale Development
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 11/04/2015
Retrieve Notice of Action (NOA) 10/19/2015
  Inventory as of this Action Requested Previously Approved
05/31/2018 05/31/2018 05/31/2018
35,348 0 33,300
6,873 0 6,310
0 0 0

The goal of this project is to develop and validate risk and benefit perception scales and to explore various methods for measuring perceptions, attitudes, and intentions about prescription drug advertising that can be used for research moving forward. We plan to conduct 1,000 online 30-minute pretests with individuals who self-identify as having been diagnosed with either chronic pain or high blood pressure, 5,000 online 30-minute surveys with adults who self-identify as having been diagnosed with either chronic pain or high blood pressure, and 5,000 online 30-minute surveys with adults from a general population sample who do not have the target medical conditions. In the pretests and self-identified medical condition samples, participants will view an ad that matches their medical condition (chronic pain or hypertension). In the final sample, half of the general population sample will be exposed to the DTC ad for chronic pain, and half will be exposed to the DTC ad for high blood pressure. We are also varying the level of risk (high, low) and benefit (high, low) in the ad. After viewing the fictitious DTC ad, participants will complete a questionnaire that will include measures of perceptions, attitudes, and intentions.

US Code: 42 USC 300u(a)(4) Name of Law: Public Health Service Act
   US Code: 21 USC 393(b)(2)(c) Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  79 FR 22143 04/21/2014
79 FR 69121 11/20/2014
Yes

4
IC Title Form No. Form Name
Main Study Screener
Pretest
Pretest Screener
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 35,348 33,300 0 0 2,048 0
Annual Time Burden (Hours) 6,873 6,310 0 0 563 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$1,669,260
Yes Part B of Supporting Statement
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.
10/19/2015


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