A Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising

ICR 202311-0910-009

OMB: 0910-0929

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement B
2023-12-18
Supporting Statement A
2023-12-18
IC Document Collections
IC ID
Document
Title
Status
263599 New
ICR Details
202311-0910-009
Received in OIRA
HHS/FDA CDER
A Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising
New collection (Request for a new OMB Control Number)   No
Regular 12/21/2023
  Requested Previously Approved
36 Months From Approved
2,993 0
907 0
0 0

This survey collects insights on consumer understanding of quantitative claims in direct-to-consumer (DTC) prescription drug advertising. It will build on previous qualitative research by recruiting a wider range of respondents and weighting the data to make it nationally representative. We plan to use an address-based mixed-mode methodology that will direct one randomly chosen member of sampled households to complete a 20-minute online survey, with non-respondents receiving a paper questionnaire. We will also conduct a within-survey experiment to test whether a post-paid incentive increases survey response.

US Code: 21 USC 393(d)(2)(C) Name of Law: FFDCA
   US Code: 42 USC 300u(a)(4) Name of Law: PHS Act
  
None

Not associated with rulemaking

  88 FR 24997 04/25/2023
88 FR 87431 12/18/2023
No

1
IC Title Form No. Form Name
Pre-letter, invitation, reminder, survey

  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 2,993 0 0 2,993 0 0
Annual Time Burden (Hours) 907 0 0 907 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new data collection.

$520,000
No
    Yes
    No
No
No
No
No
Jonna Capezzuto 301 796-3794 [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.
12/21/2023


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