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

ICR 202011-0910-013

OMB: 0910-0623

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2021-01-12
IC Document Collections
ICR Details
0910-0623 202011-0910-013
Received in OIRA 201711-0910-005
HHS/FDA CFSAN
Reporting and Recordkeeping Requirements for Human Food and Cosmetics Manufactured from, Processed With, or Otherwise Containing, Material from Cattle
Extension without change of a currently approved collection   No
Regular 01/12/2021
  Requested Previously Approved
36 Months From Approved 01/31/2021
138,703 138,703
22,884 22,884
0 0

This information collection supports FDA regulations regarding food and cosmetics containing material from cattle. The regulations are intended to protect against the transmission of bovine spongiform encephalopathy (BSE). Respondents to the collection are manufacturers and/or distributors of food and cosmetic products who must comply with applicable reporting and recordkeeping.requirements.

US Code: 21 USC 301 et. seq. Name of Law: FFDCA
  
None

Not associated with rulemaking

  85 FR 49657 08/14/2020
85 FR 75330 11/25/2020
Yes

  Total Request 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 138,703 138,703 0 0 0 0
Annual Time Burden (Hours) 22,884 22,884 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$9,300
No
    No
    No
No
No
No
No
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

  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.
01/12/2021


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