OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

Utilization of Adequate Provision Among Low to Non-Internet Users

ICR 201803-0910-005 · OMB 0910-0853 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Supporting Statement Part A Adequate Provisions.docx Supporting Statement A Uploaded 2018-03-15 Available
Supporting Statement Part B Adequate Provision.docx Supporting Statement B Uploaded 2018-03-13 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
230677 Main Study Survey Other-Survey New
230676 Main Study Screener Other-Screener New
230675 Pretest Survey Other-Survey New
230668 Pretest Screener Other-Screener New
ICR Details
0910-0853 201803-0910-005
Historical Active
HHS/FDA CDER
Utilization of Adequate Provision Among Low to Non-Internet Users
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 06/25/2018
Retrieve Notice of Action (NOA) 03/16/2018
  Inventory as of this Action Requested Previously Approved
06/30/2021 36 Months From Approved
7,074 0 0
758 0 0
0 0 0
This ICR collects information from a low to non-internet user sample regarding their utilization of the components of adequate provision in direct-to-consumer prescription drug broadcast advertising. Additionally, we will examine the impact of statements that could be used to frame risk information in the same context. Using a telephone survey methodology, we plan to conduct one 15-minute pretest with 25 adults followed by a 15-minute main study including 1996 adults.
US Code: 21 USC 393(d)(2)(C) Name of Law: Federal Food, Drug, and Cosmetic Act
  
None
Not associated with rulemaking
  82 FR 26934 06/12/2017
83 FR 10855 03/13/2018
Yes
4
IC Title Form No. Form Name
Pretest Screener
Pretest Survey
Main Study Screener
Main Study Survey
  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 7,074 0 0 7,074 0 0
Annual Time Burden (Hours) 758 0 0 758 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new data collection.
$400,899
Yes Part B of Supporting Statement
    No
    No
No
No
No
Uncollected
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.
03/16/2018