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.
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.
0678 Supporting Statement Part A - Testing Communications on Medical Devices 2020.docx