OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

Disclosures in Professional and Consumer Prescription Drug Promotion

ICR 201808-0910-002 · OMB 0910-0860 · Historical Active

Forms and Documents
Document
Name
Status
Supporting Statement B
2018-08-08
Supporting Statement A
2018-09-17
IC Document Collections
IC ID
Document
Title
Status
232573 New
232572 New
232571 New
232570 New
232569 New
232568 New
232567 New
232566 New
232565 New
232564 New
232563 New
232562 New
ICR Details
0910-0860 201808-0910-002
Historical Active
HHS/FDA CDER
Disclosures in Professional and Consumer Prescription Drug Promotion
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 09/17/2018
Retrieve Notice of Action (NOA) 08/10/2018
  Inventory as of this Action Requested Previously Approved
09/30/2020 36 Months From Approved
10,474 0 0
1,562 0 0
0 0 0
When promoting their products, pharmaceutical sponsors (sponsors) may present a variety of information including the indication, details about the administration of the product, efficacy information, and clinical trial data. In an effort to present often complicated information concisely, sponsors may not include relevant information in the body of the text or visual display of the claim. In these cases, sponsors typically include disclosures of information somewhere in the promotional piece. The purpose of our study is to determine how useful disclosures regarding prescription drug information are when presented prominently and adjacent to claims. Specifically, are Healthcare Professionals (HCP's) and consumers able to use disclosures to effectively frame information in efficacy claims in prescription drug promotion? To address this research question, we have designed a set of studies that cover both consumers and HCPs, as well as three presentations addressing different types of information: scope of treatment, ease of use, and statistical significance. Each participant will view three different professionally developed mock promotional print pieces for different prescription drug products that mimic currently available promotion. For each of the three promotional pieces, they will be randomized to see an ad with a weak disclosure, a strong disclosure, or no disclosure. Outcomes of interest include attention, recall, comprehension, and behavioral intention. The results of this study will inform the Office of Prescription Drug Promotion about how consumers and HCPs process information presented in disclosure form.
None
None
Not associated with rulemaking
  82 FR 27268 06/14/2017
83 FR 39441 08/09/2018
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 10,474 0 0 10,474 0 0
Annual Time Burden (Hours) 1,562 0 0 1,562 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new data collection.
$669,354
Yes Part B of Supporting Statement
    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.
08/10/2018