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Federal forms, ICRs, and supporting documents

Information Collection Request

Experimental Study of Direct-to-Consumer Promotion Directed at Adolescents

ICR 201509-0910-012 · OMB 0910-0778 · Historical Active

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2015-09-30
Supporting Statement B
2014-08-28
Supporting Statement A
2014-08-28
Supplementary Document
2014-08-28
Supplementary Document
2014-08-28
IC Document Collections
IC ID
Document
Title
Status
212884 Unchanged
212883 Unchanged
212882 Unchanged
212881 Unchanged
212880 Unchanged
212879 Unchanged
212878 Unchanged
212877 Unchanged
212876 Unchanged
212875 Unchanged
212872 Unchanged
ICR Details
0910-0778 201509-0910-012
Historical Active 201408-0910-005
HHS/FDA CDER
Experimental Study of Direct-to-Consumer Promotion Directed at Adolescents
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 10/06/2015
Retrieve Notice of Action (NOA) 10/01/2015
  Inventory as of this Action Requested Previously Approved
10/31/2017 10/31/2017 10/31/2017
67,218 0 67,218
8,065 0 8,065
0 0 0
Sponsors for several prescription drug classes market their products directly to adolescents, but research regarding how adolescents use risk and benefit information for health-related decisions is limited. Despite the lack of previous research specific to DTC drug marketing to adolescents, existing theoretical and empirical data make a strong case for treating adolescence as a unique life stage during which vulnerabilities that can affect informed decision-making must be taken into account. We plan to conduct a randomized, controlled study in two different medical conditions that assesses adolescents' perceptions following exposure to DTC prescription drug advertising that varies in benefit and risk onset and risk severity. We plan to compare adolescents' perceptions to those of young adult counterparts. Each participant will view a web-based promotional campaign for either a fictitious Attention Deficit Hyperactivity Disorder (ADHD) medication or a fictitious acne medication. Because adolescents typically depend on their parents for prescription drug purchases, we also will include a sample of parents matched to their adolescent children to explore similarities and differences in perceptions for these matched pairs. The study will enroll three specific age groups (13–15, 16–17, and 25–30). We propose to explore differences in effects of the ad manipulations across these three age groups on a variety of outcomes, including benefit and risk recall, benefit and risk perceptions, and behavioral intentions. The study findings will inform FDA of relevant issues related to DTC promotion directed at adolescent populations.
US Code: 21 USC 393 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 42 USC 300u(a)(4) Name of Law: Public Health Service Act
  
None
Not associated with rulemaking
  78 FR 65326 10/31/2013
79 FR 42333 07/21/2014
Yes
  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 67,218 67,218 0 0 0 0
Annual Time Burden (Hours) 8,065 8,065 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
This is a new data collection.
$1,082,664
No
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.
10/01/2015