Recordkeeping Requirements for Human Food and Cosmetics Manufactured from, Processed With, or Otherwise Containing, Material from Cattle

ICR 201111-0910-005

OMB: 0910-0597

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2011-11-10
ICR Details
0910-0597 201111-0910-005
Historical Inactive 200610-0910-010
HHS/FDA
Recordkeeping Requirements for Human Food and Cosmetics Manufactured from, Processed With, or Otherwise Containing, Material from Cattle
Reinstatement without change of a previously approved collection   No
Regular
Withdrawn 03/21/2012
Retrieve Notice of Action (NOA) 11/14/2011
In accordance with 5 CFR 1320, this ICR has been withdrawn at the request of the agency.
  Inventory as of this Action Requested Previously Approved
36 Months From Approved
0 0 0
0 0 0
0 0 0

To address the potential risk of bovine spongiform encephalopathy (BSE), in human food, including dietary supplements, and cosmetics, the BSE Recordkeeping final rule requires that manufacturers and processors of human food and cosmetics that are manufactured from, processed with, or otherwise contain, material from cattle establish and maintain records that document the absence of prohibited cattle materials in such products and require that such records be made available to FDA for inspection and copying.

US Code: 21 USC 342 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 371 Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  74 FR 54827 10/23/2009
75 FR 4077 01/26/2010
No

No
Yes
Miscellaneous Actions
There were no program changes. Please refer to Item #15 of the supporting statement for the adjustment explanation. Also this ICR was inadvertantly withdrawn by OMB and is being resubmitted for reinstatement again. As per discussion with the OMB Desk Officer, Drew Perraut, republication of another 30 day notice is waived.

$297,340
No
No
No
No
No
Uncollected
Denver Presley 3018271462

  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.
11/14/2011


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