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

ICR 201409-0910-006

OMB: 0910-0623

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2014-09-29
ICR Details
0910-0623 201409-0910-006
Historical Active 201106-0910-008
HHS/FDA CFSAN
Reporting and Recordkeeping Requirements for Human Food and Cosmetics Manufactured from, Processed With, or Otherwise Containing, Material from Cattle
Revision of a currently approved collection   No
Regular
Approved without change 11/26/2014
Retrieve Notice of Action (NOA) 09/30/2014
  Inventory as of this Action Requested Previously Approved
11/30/2017 36 Months From Approved 11/30/2014
138,703 0 2
22,884 0 106
0 0 0

Section 801(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 381(a)) provides requirements with regard to imported food and cosmetics and provides for refusal of admission into the United States of human food and cosmetics that appear to be adulterated. Section 701(b) of the FD&C Act (21 U.S.C. 371(b)) authorizes the Secretaries of Treasury and Health and Human Services to jointly prescribe regulations for the efficient enforcement of section 801 of the FD&C Act. To address the potential risk of bovine spongiform encephalopathy (BSE) in human food and cosmetics, FDA regulations in 189.5 and 700.27 (21 CFR 189.5 and 700.27) designate certain materials from cattle as "prohibited cattle materials," including specified risk materials, the small intestine of cattle not otherwise excluded from being a prohibited cattle material, material from nonambulatory disabled cattle, and mechanically separated (MS) (Beef). Under the regulations no human food or cosmetic may be manufactured from, processed with, or otherwise contain prohibited cattle materials. However, the Agency may designate a country from which cattle materials inspected and passed for human consumption are not considered prohibited cattle materials and their use does not render a human food or cosmetic adulterated. Sections 189.5(e) and 700.27(e) provide that a country seeking to be so designated must send a written request to the Director, Center for Food Safety and Applied Nutrition (CFSAN). Sections 189.5 and 700.27 further state that countries that have been designated under 189.5(e) and 700.27(e) will be subject to future review by FDA to determine whether designation remains appropriate.

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

Not associated with rulemaking

  79 FR 44785 08/01/2014
79 FR 57937 09/26/2014
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 138,703 2 0 138,701 0 0
Annual Time Burden (Hours) 22,884 106 0 22,778 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
Burden increase reflects incorporation of collection elements previously included under 0910-0597. This is explained more fully at Q.15 of the supporting statement.

$300,337
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733 [email protected]

  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.
09/30/2014


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