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:
202303-0910-022
Status:
Active
Previous ICR Reference No:
202206-0910-013
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CDRH
Title:
Testing Communications On Medical Devices and Radiation-Emitting Products
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
05/01/2023
Retrieve Notice of Action (NOA)
Date Received in OIRA:
03/30/2023
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
05/31/2026
36 Months From Approved
04/30/2023
Responses
9,124
0
8,848
Time Burden (Hours)
2,391
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.
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:
87 FR 66192
11/02/2022
30-day Notice:
Federal Register Citation:
Citation Date:
88 FR 18556
03/29/2023
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
6
IC Title
Form No.
Form Name
CDRH Rapid Message Testing with Consumers and Caregivers -- March 2023 Breast Implant Safety Communication
CDRH Rapid Message Testing with Consumers and Caregivers- February 2024 Smartwatch and Smart Ring Safety Communication
CDRH Rapid Message Testing with Consumers and Caregivers- Infusion Therapy - Getting the Most Out of Your Pump
CDRH Rapid Message Testing with Consumers and Caregivers- November 2022 Pulse Oximeter Safety Communication
CDRH Rapid Message Testing with Consumers and Caregivers- Products and Medical Procedures Page
CDRH Rapid Message Testing with Consumers and Caregivers-May 2023 Renuvion/J-Plasma Device Safety Communication
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
9,124
8,848
0
0
276
0
Annual Time Burden (Hours)
2,391
2,076
0
0
315
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:
Over the next 3-year approval period, we anticipate increasing our capability to conduct more communication surveys, which aligns with CDRH’s strategic priority of advancing health equity. We have adjusted our burden estimates accordingly. Additionally, we have added an estimated hour burden for “Healthcare professional individual in-depth interviews.” These changes reflect an increase of 315 burden hours and a corresponding increase of 276 responses annually.
Annual Cost to Federal Government:
$1,719,390
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:
03/30/2023
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