View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View Generic ICR - OIRA Conclusion
OMB Control No:
0910-0678
ICR Reference No:
202206-0910-013
Status:
Historical Active
Previous ICR Reference No:
202003-0910-001
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CDRH
Title:
Testing Communications On Medical Devices and Radiation-Emitting Products
Type of Information Collection:
No material or nonsubstantive change to a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
07/05/2022
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/30/2022
Terms of Clearance:
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
Expiration Date
04/30/2023
04/30/2023
04/30/2023
Responses
8,848
0
8,848
Time Burden (Hours)
2,076
0
2,076
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Authorizing Statute(s):
US Code:
21 USC 393
Name of Law: FFDCA
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
84 FR 62541
11/15/2019
30-day Notice:
Federal Register Citation:
Citation Date:
85 FR 7566
02/10/2020
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
3
IC Title
Form No.
Form Name
CDRH Rapid Message Testing with Consumers and Caregivers- Information About At-Home COVID-19 Diagnostic Tests
CDRH Rapid Message Testing with Consumers and Caregivers- Philips CPAP Machine, BiPAP Machine, and Ventilator Recall Communications
CDRH Rapid Message Testing with Consumers and Caregivers-Web Content About Recently-Approved Medical Devices
ICR Summary of Burden
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
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Annual Cost to Federal Government:
$1,712,514
Does this IC contain surveys, censuses, or employ statistical methods?
Yes
Part B of Supporting Statement
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
Yes
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
No
Agency Contact:
Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@fda.hhs.gov
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
06/30/2022
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