FDA Recall Regulations

ICR 202102-0910-006

OMB: 0910-0249

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2021-04-13
ICR Details
0910-0249 202102-0910-006
Received in OIRA 201802-0910-013
HHS/FDA ORA
FDA Recall Regulations
Extension without change of a currently approved collection   No
Regular 04/14/2021
  Requested Previously Approved
36 Months From Approved 04/30/2021
1,277,656 1,523,502
513,528 584,477
0 0

This information collection supports FDA regulations governing recalls. The information collection provisions apply to all regulated products (i.e., food, including animal feed; drugs, including animal drugs; medical devices, including in vitro diagnostic products; cosmetics; biological products intended for human use; and tobacco). Respondents to the collection are those who introduce FDA-regulated products into interstate commerce or who are otherwise subject to the applicable regulations.

US Code: 21 USC 301 et seq. Name of Law: FFDCA
  
None

Not associated with rulemaking

  86 FR 1508 01/08/2021
86 FR 18543 04/09/2021
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 1,277,656 1,523,502 0 0 -245,846 0
Annual Time Burden (Hours) 513,528 584,477 0 0 -70,949 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
We have adjusted our estimate to reflect an overall decrease in the average number of annual responses by 245,846 and a decrease in the average number of annual burden hours by 70,949.25 since our last review of the information collection. The adjustment reflects a decrease in FDA-product recalls over the most recent calendar years.

$27,313,886
No
    No
    No
No
No
No
No
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

  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.
04/14/2021


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