Request for Designation as Country not Subject to the Restrictions Applicable to Human Food and Cosmetics Manufactured from, Processed With, or Otherwise Containing, Material from Cattle

ICR 200804-0910-003

OMB: 0910-0623

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2008-04-21
ICR Details
0910-0623 200804-0910-003
Historical Active
HHS/FDA
Request for Designation as Country not Subject to the Restrictions Applicable to 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 06/12/2008
Retrieve Notice of Action (NOA) 04/23/2008
  Inventory as of this Action Requested Previously Approved
06/30/2011 36 Months From Approved
20 0 0
531 0 0
0 0 0

FDA is amending its regulations at §§ 189.5 and 700.27 to provide that FDA may designate a country as not subject to the restrictions applicable to human food and cosmetics manufactured from, processed with, or that otherwise contain specified risk materials, the small intestine of cattle, material from nonambulatory disabled cattle, and mechanically separated (MS) (Beef). The IFR, as amended, provides that these materials, when from cattle from a designated country, are not considered prohibited cattle materials and their use does not render a human food or cosmetic adulterated.

US Code: 21 USC 801(a) Name of Law: FFDCA
  
None

0910-AF47 Final or interim final rulemaking 73 FR 20785 04/17/2008

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 20 0 0 20 0 0
Annual Time Burden (Hours) 531 0 0 531 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Changing Regulations
No
FDA is amending its regulations at §§ 189.5 and 700.27 to provide that FDA may designate a country as not subject to the restrictions applicable to human food and cosmetics manufactured from, processed with, or that otherwise contain specified risk materials, the small intestine of cattle, material from nonambulatory disabled cattle, and mechanically separated (MS) (Beef). The IFR, as amended, provides that these materials, when from cattle from a designated country, are not considered prohibited cattle materials and their use does not render a human food or cosmetic adulterated.

$49,000
No
No
Uncollected
Uncollected
Uncollected
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.
04/23/2008


© 2024 OMB.report | Privacy Policy