Medical Device Labeling Regulations

ICR 202203-0910-001

OMB: 0910-0485

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2022-03-10
Supplementary Document
2022-03-10
ICR Details
0910-0485 202203-0910-001
Received in OIRA 202108-0910-005
HHS/FDA CDRH
Medical Device Labeling Regulations
Revision of a currently approved collection   No
Regular 03/10/2022
  Requested Previously Approved
36 Months From Approved 11/30/2024
103,569,307 103,559,804
12,390,401 12,303,422
0 0

This ICR supports agency rulemaking RIN 0910-AI21.

US Code: 21 USC 352 Name of Law: FD&C Act
  
None

0910-AI21 Proposed rulemaking 86 FR 58150 10/20/2021

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 103,569,307 103,559,804 0 0 9,503 0
Annual Time Burden (Hours) 12,390,401 12,303,422 0 0 86,979 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
We are requesting changes and revisions consistent with our proposed rule. If finalized, we believe there will be an initial burden increase associated with product labeling adjustments and understanding provisions of the new regulations. However, we believe that implementation over time will result in lower burden associated with product labeling for OTC hearing aids, as the regulations are intended to more clearly define these products.

$0
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.
03/10/2022


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