Disease Awareness and Prescription Drug Promotion on Television

ICR 201906-0910-011

OMB: 0910-0874

Federal Form Document

Forms and Documents
ICR Details
0910-0874 201906-0910-011
Historical Active
HHS/FDA CDER
Disease Awareness and Prescription Drug Promotion on Television
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 08/06/2019
Retrieve Notice of Action (NOA) 06/28/2019
Any changes made as a result of the pretest will need to be submitted for review prior to initiation of the full study.
  Inventory as of this Action Requested Previously Approved
08/31/2021 36 Months From Approved
10,166 0 0
4,425 0 0
0 0 0

This research concerns disease awareness and prescription drug promotion communications on television. When pharmaceutical companies market a new drug, they often also release disease awareness communications about the medical condition the new drug is intended to treat. FDA is interested in whether and to what extent this practice may result in consumers confusing or otherwise misinterpreting the different information and claims presented in disease awareness communications and prescription drug promotion. We propose two studies designed to provide insights on this topic.

None
None

Not associated with rulemaking

  83 FR 52472 10/17/2018
84 FR 30724 06/27/2019
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 10,166 0 0 10,166 0 0
Annual Time Burden (Hours) 4,425 0 0 4,425 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new data collection.

$568,507
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.
06/28/2019


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