Medical Devices; Humanitarian Use Devices

ICR 202202-0910-005

OMB: 0910-0332

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2022-09-09
ICR Details
0910-0332 202202-0910-005
Received in OIRA 202101-0910-008
HHS/FDA CDRH
Medical Devices; Humanitarian Use Devices
Revision of a currently approved collection   No
Regular 09/19/2022
  Requested Previously Approved
36 Months From Approved 03/31/2024
382 213
22,902 22,542
0 0

This information collection supports implementation of statutory and regulatory requirements governing humanitarian use devices (HUDs) required by the Federal Food, Drug, and Cosmetic Act. Respondents to the information collection are manufacturers and/or sponsors of these devices.

US Code: 21 USC 360(d)
   US Code: 21 USC 360(e)
  
None

Not associated with rulemaking

  87 FR 20429 04/07/2022
87 FR 51993 08/24/2022
No

  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 382 213 0 0 169 0
Annual Time Burden (Hours) 22,902 22,542 0 0 360 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
Our estimated burden for the information collection reflects an increase of 360 total burden hours and a corresponding increase of 5 total annual responses. For efficiency of Agency operations, we are consolidating the related information activity and account for burden associated with HDE regulations currently approved in OMB control number 0910-0661. As a result, there is an increase in the total number of burden hours for this information collection.

$7,109,802
No
    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.
09/19/2022


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