Infant Formula Recall Regulations

ICR 200505-0910-007

OMB: 0910-0188

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
5796
Migrated
ICR Details
0910-0188 200505-0910-007
Historical Active 200206-0910-001
HHS/FDA
Infant Formula Recall Regulations
Extension without change of a currently approved collection   No
Regular
Approved without change 07/29/2005
Retrieve Notice of Action (NOA) 05/27/2005
  Inventory as of this Action Requested Previously Approved
07/31/2008 07/31/2008 07/31/2005
1 0 3
12,854 0 18,956
0 0 0

21 CFR Part 107 implements the Infant Formula Act of 1980. The subject regulations establish certain reporting procedures, mandatory recordkeeping requirements, and operating protocol necessary to perform an effective recall for manufacturers of infant formula products.

None
None


No

1
IC Title Form No. Form Name
Infant Formula Recall Regulations

  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 1 3 0 0 -2 0
Annual Time Burden (Hours) 12,854 18,956 0 0 -6,102 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
05/27/2005


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