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Federal forms, ICRs, and supporting documents

Information Collection Request

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

ICR 202411-0910-006 · OMB 0910-0929 · Received in OIRA

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2024-11-29
Supplementary Document
2024-11-29
Supporting Statement B
2024-05-14
Supporting Statement A
2024-05-14
IC Document Collections
IC ID
Document
Title
Status
263599 Modified
ICR Details
0910-0929 202411-0910-006
Received in OIRA 202311-0910-009
HHS/FDA CDER
A Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising
No material or nonsubstantive change to a currently approved collection   No
Regular 12/02/2024
  Requested Previously Approved
06/30/2027 06/30/2027
4,493 2,993
1,250 1,094
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 4,493 2,993 0 0 1,500 0
Annual Time Burden (Hours) 1,250 1,094 0 0 156 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
We anticipated 1,100 participants would respond to the survey from our initial recruitment of 2,993 individuals. However, the response rate was lower than expected due to declining survey response rates seen across Federal surveys, resulting in 480 survey responses. The purpose of this change is to increase the number of respondents to get closer to the previously estimated survey response and therefore increase the power to detect differences among subgroups. We request an additional recruitment of 1,500 individuals, with the intent to yield an additional 214 completed surveys and allow us to detect differences of 14.4 percentage points. Based on the initial recruitment, we are assuming a 15 percent response rate and a 5 percent postage non-deliverable rate for the additional sample.
$520,000
No
    Yes
    No
No
No
No
No
Amber Sanford 301 796-8867 amber.sanford@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.
12/02/2024