Medical Device Labeling Regulations

ICR 202208-0910-007

OMB: 0910-0485

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2022-08-17
Supporting Statement A
2022-08-17
ICR Details
0910-0485 202208-0910-007
Received in OIRA 202108-0910-005
HHS/FDA CDRH
Medical Device Labeling Regulations
Revision of a currently approved collection   No
Regular 08/18/2022
  Requested Previously Approved
36 Months From Approved 11/30/2024
2,625 103,559,804
104,370 12,303,422
10,100,000 0

This information collection request supports rulemaking to establish an OTC category of hearing aid devices to enable these devices to become more accessible to American consumers.

PL: Pub.L. 115 - 52 709 Name of Law: FDA Reauthorization Act
  
None

0910-AI21 Final or interim final rulemaking 87 FR 50698 08/17/2022

Yes

  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 2,625 103,559,804 0 0 -103,557,179 0
Annual Time Burden (Hours) 104,370 12,303,422 0 0 -12,199,052 0
Annual Cost Burden (Dollars) 10,100,000 0 0 0 10,100,000 0
No
No
To reflect one-time burden respondents may incur adjusting to the new requirements, we have added 945 responses and 87,570 hours to our annualized estimate. To reflect recurring burden we attribute to maintaining compliance with the new requirements, we have added 1,680 responses and 16,800 hours annually. Cumulatively, these adjustments result in an increase of 2,625 responses and 104,370 hours annually to the information collection.

$2,633,260
No
    No
    No
No
No
No
No
Domini Bean 301 796-5733 [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.
08/18/2022


© 2022 OMB.report | Privacy Policy