Information Collection Request

Testing Communications On Medical Devices and Radiation-Emitting Products

ICR 202507-0910-006 · OMB 0910-0678 · Received in OIRA

Forms and Documents
DocumentTypeStatusAvailability
0678 CDRH Testing Comunications Individual Request Summaries 2026 EXT.docx Supplementary Document Uploaded 2026-05-29 Available
0678 CDRH Testing Communications GENERIC SSA 2026.docx Supporting Statement A Uploaded 2026-05-29 Available
0678_Supporting Statement B_2026.docx Supporting Statement B Uploaded 2026-05-28 Available
0678 OMB Memo Template 3-30-2023.docx Supplementary Document Uploaded 2023-03-30 Available
IC Document Collections
IC IDCollectionTypeStatusForm
ICR Details
0910-0678 202507-0910-006
Received in OIRA 202303-0910-022
HHS/FDA CDRH
Testing Communications On Medical Devices and Radiation-Emitting Products
Extension without change of a currently approved collection   No
Regular 05/29/2026
  Requested Previously Approved
36 Months From Approved 06/30/2026
9,124 9,124
2,391 2,391
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.

US Code: 21 USC 393 Name of Law: FFDCA
  
None

Not associated with rulemaking

  90 FR 38155 08/07/2025
91 FR 25582 05/11/2026
No

0

  Total Request 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 9,124 0 0 0 0
Annual Time Burden (Hours) 2,391 2,391 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$1,736,781
Yes Part B of Supporting Statement
    Yes
    No
No
No
No
No
Amber Sanford 301 796-8867 [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.
05/29/2026