Infant Formula Recall Regulations

ICR 202010-0910-012

OMB: 0910-0188

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2020-11-27
ICR Details
0910-0188 202010-0910-012
Active 201710-0910-010
HHS/FDA CFSAN
Infant Formula Recall Regulations
Extension without change of a currently approved collection   No
Regular
Approved without change 12/30/2020
Retrieve Notice of Action (NOA) 11/27/2020
  Inventory as of this Action Requested Previously Approved
12/31/2023 36 Months From Approved 12/31/2020
10 0 10
12,854 0 12,854
0 0 0

This collection request supports agency regulations requiring information from manufacturers of infant formula that allows FDA to conduct effective recalls of infant formula should it become necessary.

US Code: 21 USC 350a(e) Name of Law: FFDCA
  
None

Not associated with rulemaking

  85 FR 23367 04/27/2020
85 FR 48705 08/12/2020
No

  Total Approved 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 10 10 0 0 0 0
Annual Time Burden (Hours) 12,854 12,854 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$338,790
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.
11/27/2020


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