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Federal forms, ICRs, and supporting documents

Information Collection Request

Testing Communications On Medical Devices and Radiation-Emitting Products

ICR 202003-0910-001 · OMB 0910-0678 · Active

Forms and Documents
Document
Name
Status
Supporting Statement A
2020-04-17
Supporting Statement B
2020-03-09
IC Document Collections
IC ID
Document
Title
Status
ICR Details
0910-0678 202003-0910-001
Active 201703-0910-004
HHS/FDA CDRH
Testing Communications On Medical Devices and Radiation-Emitting Products
Extension without change of a currently approved collection   No
Regular
Approved with change 04/17/2020
Retrieve Notice of Action (NOA) 03/09/2020
Prior terms remain in effect: OMB approves this generic ICR, with the understanding that FDA will submit each individual IC into ROCIS for approval. Justification must be provided for the collection of any personally identifiable information.
  Inventory as of this Action Requested Previously Approved
04/30/2023 36 Months From Approved 05/31/2020
8,848 0 8,848
2,076 0 2,076
0 0 0
This generic ICR collects information through a variety of research methods for developing and testing communications involving medical devices and radiation-emitting products that are regulated by FDA. The information will be used to assess the need for communications on specific topics and to assist in the development and modification of communication messages to promote public health and compliance with regulations. FDA creates and uses a variety of media, including print, broadcast, and electronic formats to communicate with the public and health professionals about the risks and benefits of regulated products. To ensure that such health communication messages have the highest potential to be received, understood, and accepted by those for whom they are intended, FDA will conduct research and studies relating to the control and prevention of disease. This type of research involves (1) assessing audience knowledge, attitudes, behaviors and other characteristics for the planning/development of health messages, communication strategies, and public information programs; (2) testing these health messages, strategies, and program components while they are in developmental form to assess audience comprehension, reactions, and perceptions; and (3) evaluating the final communication products to determine the effectiveness of the messages and distribution methods.
US Code: 21 USC 393 Name of Law: FFDCA
  
None
Not associated with rulemaking
  84 FR 62541 11/15/2019
85 FR 7566 02/10/2020
No
0
  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 8,848 8,848 0 0 0 0
Annual Time Burden (Hours) 2,076 2,076 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
$1,712,514
Yes Part B of Supporting Statement
    Yes
    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.
03/09/2020