Assessment of Terms and Phrases Commonly Used in Prescription Drug Promotion

ICR 202009-0910-009

OMB: 0910-0895

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2020-09-21
Supporting Statement B
2020-09-21
ICR Details
202009-0910-009
Received in OIRA
HHS/FDA CDER
Assessment of Terms and Phrases Commonly Used in Prescription Drug Promotion
New collection (Request for a new OMB Control Number)   No
Regular 09/22/2020
  Requested Previously Approved
36 Months From Approved
4,956 0
1,052 0
0 0

The proposed research involves assessment of how consumers and primary care physicians (PCPs) interpret terms and phrases commonly used in prescription drug promotion. This includes both what these terms and phrases mean to each population (e.g., definitions) and what these terms and phrases imply (e.g., about efficacy and safety). Understanding the most prevalent interpretations of these terms and phrases can help OPDP determine the impact of specific language in prescription drug promotion. For example, certain terms and phrases might overstate the efficacy or minimize the risk of a product. Additionally, from a health literacy perspective, it is helpful to ascertain general understanding of such terms and phrases as this may aid in the development of best practices around communicating these concepts. We plan to conduct this research in two phases. First, we will conduct formative semi-structured interviews with 30 members of each population (general population consumers and PCPs). Second, we will conduct nationally representative, probability-based surveys of more than 1,000 members of each population.

None
None

Not associated with rulemaking

  84 FR 59833 11/06/2019
85 FR 58362 09/18/2020
Yes

  Total Request 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 4,956 0 0 4,956 0 0
Annual Time Burden (Hours) 1,052 0 0 1,052 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new data collection.

$658,901
Yes Part B of Supporting Statement
    No
    No
No
No
No
No
Ila Mizrachi 301 796-7726 [email protected]

  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.
09/22/2020


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