Infant Formula Recall Regulations

ICR 201410-0910-010

OMB: 0910-0188

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2014-10-20
ICR Details
0910-0188 201410-0910-010
Historical Active 201108-0910-013
HHS/FDA CFSAN
Infant Formula Recall Regulations
Extension without change of a currently approved collection   No
Regular
Approved without change 11/24/2014
Retrieve Notice of Action (NOA) 10/27/2014
  Inventory as of this Action Requested Previously Approved
11/30/2017 36 Months From Approved 11/30/2014
10 0 10
12,854 0 12,854
0 0 0

This collection request requires information from respondents that allow FDA to conduct effective recalls of infant forumula should recall be necessary. Respondents to the information collection are manufacturers of infant formula.

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

Not associated with rulemaking

  79 FR 46270 08/07/2014
79 FR 63127 10/22/2014
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

$296,748
No
No
No
No
No
Uncollected
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.
10/27/2014


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