OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

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

ICR 200610-0910-010 · OMB 0910-0597 · Historical Active

Forms and Documents
Document
Name
Status
Supplementary Document
2006-10-05
Supplementary Document
2006-10-05
Supporting Statement A
2006-10-05
IC Document Collections
IC ID
Document
Title
Status
45778
New
45777
New
45776
New
45775
New
ICR Details
0910-0597 200610-0910-010
Historical Active
HHS/FDA
Recordkeeping Requirements for Human Food and Cosmetics Manufactured from, Processed With, or Otherwise Containing, Material from Cattle
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 01/04/2007
Retrieve Notice of Action (NOA) 10/23/2006
  Inventory as of this Action Requested Previously Approved
01/31/2010 36 Months From Approved
37,707 0 0
43,039 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
0910-AF48 Final or interim final rulemaking 69 FR 42275 07/14/2004
No
  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 37,707 0 0 37,707 0 0
Annual Time Burden (Hours) 43,039 0 0 43,039 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Changing Regulations
No
In a final rule entitled Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle, published in the Federal Register of October 11, 2006, FDA is requiring 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. FDA is requiring recordkeeping because records are necessary to help FDA ensure compliance with the requirements of the interim final rule, and manufacturers and processors of human food and cosmetics need records to ensure their products do not contain prohibited cattle materials.
$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Saleda Perryman
  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.
10/10/2006