FDA Recall Regulations

ICR 200109-0910-002

OMB: 0910-0249

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
5831
Migrated
ICR Details
0910-0249 200109-0910-002
Historical Active 199809-0910-002
HHS/FDA
FDA Recall Regulations
Extension without change of a currently approved collection   No
Regular
Approved without change 10/17/2001
Retrieve Notice of Action (NOA) 09/06/2001
  Inventory as of this Action Requested Previously Approved
10/31/2004 10/31/2004 10/31/2001
12,985 0 1,712
157,675 0 74,986
0 0 0

FDA's recall regulations provide guidance to manufacturers on recall responsibilities. The guidelines apply to all regulated products (i.e., food, including animal feed; drugs, including animal drugs; medical devices, including in vitro diagnostic products; cosmetics; and biological products intended for human use).

None
None


No

1
IC Title Form No. Form Name
FDA 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 12,985 1,712 0 0 11,273 0
Annual Time Burden (Hours) 157,675 74,986 0 0 82,689 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.
09/06/2001


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