This collection
has been improperly submitted under the terms of 5 CFR 1320. The
collection is listed as an extension but contains discretionary
changes that impact the burden. Please resumbit this collection as
a revision.
Inventory as of this Action
Requested
Previously Approved
01/31/2010
36 Months From Approved
03/31/2010
37,707
0
37,707
43,039
0
43,039
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
The recordkeeping burden hours
have decreased primaily because the one-time record design burden
hours associated with the new rule in 2006 are no longer included
in the burden estimate. In addition the reporting burden hours have
increased from zero hours to 1809 hours because the reporting hours
were erroneously included in the recodkeeping burden table in the
2006 estimate.
$297,340
No
No
Uncollected
Uncollected
No
Uncollected
Jonnalynn Capezzuto
3018274659
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.