Hearing, Aging, and Direct-to-Consumer Television Advertisements

ICR 201601-0910-003

OMB: 0910-0818

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2016-06-21
Supporting Statement B
2016-01-11
Supporting Statement A
2016-01-11
ICR Details
0910-0818 201601-0910-003
Historical Active
HHS/FDA CDER
Hearing, Aging, and Direct-to-Consumer Television Advertisements
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 06/21/2016
Retrieve Notice of Action (NOA) 01/13/2016
  Inventory as of this Action Requested Previously Approved
06/30/2019 36 Months From Approved
5,193 0 0
1,560 0 0
0 0 0

Because older adults use a disproportionate number of prescription drugs and watch more television than other age groups, their understanding of DTC television advertising is important to investigate. Age-related changes in hearing are nearly universal and may influence the understanding of speech and therefore the understanding of DTC television ads. A large part of hearing and understanding speech involves both the physical structure of the ears as well as sufficient cognitive processes, meaning that cognitive factors specific to hearing and understanding speech are important to examine. This study will explore how hearing and cognitive declines in older adults affect comprehension of DTC television ads in general and of the major statement of risks in particular. In this study, approximately 1,000 individuals will visit a facility in-person to complete a hearing test, watch a direct-to-consumer television ad, and answer questions about what they saw. Outcomes of interest include risk and benefit recall, risk perceptions, and attitudes and behavioral intentions. The results of this study will inform the Office of Prescription Drug Promotion about the communication of DTC information to older adults.

None
None

Not associated with rulemaking

  80 FR 36545 06/25/2015
80 FR 79909 12/23/2015
Yes

6
IC Title Form No. Form Name
Cognitive Interviews
Pretest Screener
Cognitive Interview Screener
Pretest
Main Study 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 5,193 0 0 5,193 0 0
Annual Time Burden (Hours) 1,560 0 0 1,560 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new data collection.

$994,588
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.
01/13/2016


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