In accordance
with the terms of 5 CFR 1320, this ICR has been withdrawn so that
the agency can reconsider it's burden estimates.
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 371 Name of Law: Federal Food, Drug, and Cosmetic Act
US Code: 21
USC 342 Name of Law: Federal Food, Drug, and Cosmetic Act
There were no program changes.
Please refer to item # 15 of the supporting statement for the
adjustment explanation.
$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.
SS-0910-0597 #2 -Rev. 04-14-2011..doc
Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material from Cattle