INFANT FORMULA RECALL REGULATIONS -- 21 CFR PART 107

ICR 199509-0910-017

OMB: 0910-0188

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
37613
Migrated
ICR Details
0910-0188 199509-0910-017
Historical Active 199212-0910-004
HHS/FDA
INFANT FORMULA RECALL REGULATIONS -- 21 CFR PART 107
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 09/30/1995
Retrieve Notice of Action (NOA) 09/30/1995
  Inventory as of this Action Requested Previously Approved
05/31/1996 05/31/1996 02/28/1996
3 0 3
5,901 0 5,901
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 -- 21 CFR PART 107

  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 3 3 0 0 0 0
Annual Time Burden (Hours) 5,901 5,901 0 0 0 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.
09/30/1995


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