Experimental Study: Disease Information in Branded Promotional Material

ICR 201206-0910-009

OMB: 0910-0724

Federal Form Document

Forms and Documents
Supporting Statement B
Supplementary Document
Supplementary Document
Supporting Statement A
ICR Details
0910-0724 201206-0910-009
Historical Active
Experimental Study: Disease Information in Branded Promotional Material
New collection (Request for a new OMB Control Number)   No
Approved with change 11/26/2012
Retrieve Notice of Action (NOA) 06/22/2012
In accordance with 5 CFR 1320, the information collection is approved. However, the agency must submit a final version of the instrument (as it will be fielded) prior to beginning the study.
  Inventory as of this Action Requested Previously Approved
11/30/2015 36 Months From Approved
14,338 0 0
1,873 0 0
0 0 0

This project will investigate the effects of adding disease information to branded prescription drug promotional materials on consumer perceptions and understanding. Part of FDA's public health mission is to ensure the safe use of prescription drugs; therefore it is important to communicate the risks and benefits of prescription drugs to consumers in a way that is clear, useful and non-misleading. The results from this project will be used by FDA to inform its understanding of DTC advertising, inform regulatory policy, and may also help to identify areas for further research.

US Code: 42 USC 300u(a)(4) Name of Law: Section 1701(a)(4) - Public Health Service Act
   US Code: 21 USC 393(d)(2)(c)) Name of Law: Federal Food, Drug, and Cosmetic Act (the FD&C Act)

Not associated with rulemaking

  76 FR 50737 08/16/2011
77 FR 37051 06/20/2012

IC Title Form No. Form Name
Number of Completes - Screener
Number of Completes - Pretests
Number of Completes - 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 14,338 0 0 0 14,338 0
Annual Time Burden (Hours) 1,873 0 0 0 1,873 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0

Yes Part B of Supporting Statement
Johnny Vilela 301 796-3792 [email protected]


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.

© 2023 OMB.report | Privacy Policy