Food Additive Petitions, 21 CFR Part 571, Center for Veterinary Medicine

ICR 201902-0910-010

OMB: 0910-0546

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2019-03-01
ICR Details
0910-0546 201902-0910-010
Active 201602-0910-010
HHS/FDA CVM
Food Additive Petitions, 21 CFR Part 571, Center for Veterinary Medicine
Extension without change of a currently approved collection   No
Regular
Approved without change 04/02/2019
Retrieve Notice of Action (NOA) 03/04/2019
  Inventory as of this Action Requested Previously Approved
04/30/2022 36 Months From Approved 04/30/2019
35 0 35
189,600 0 189,600
0 0 0

This collection specifies the information that must be submitted by a petition in order to establish the safety of a food additive and to secure the issuance of a regulation permitting its use in animal food. Section 409(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 348(a)) provides that a food additive shall be deemed to be unsafe unless its use is permitted by a regulation which prescribes the condition(s) under which it may safely be used, or unless it is exempted by regulation for investigational use. Section 409(b) of the FD&C Act (21 U.S.C. 348(b)) specifies the information that must be submitted by a petitioner to establish the safety of a food additive and to secure the issuance of a regulation permitting its use. To implement the provisions of § 409 of the FD&C Act, we issued procedural regulations under 21 CFR part 571. These procedural regulations are designed to specify more thoroughly the information that must be submitted to meet the requirement set down in broader terms by the FD&C Act. The regulations add no substantive requirements to those indicated in the FD&C Act, but attempt to explain these requirements and provide a standard format for submission to speed processing of the petition. Labeling requirements for food additives intended for animal consumption are also set forth in various regulations contained in 21 CFR parts 501, 573, and 579. The labeling regulations are considered by FDA to be cross-referenced to § 571.1, which is the subject of this same OMB clearance for food additive petitions.

US Code: 21 USC 409(a) Name of Law: Federal Food, Drug and Cosmetic Act
  
None

Not associated with rulemaking

  83 FR 38149 08/03/2018
84 FR 4828 02/19/2019
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 35 35 0 0 0 0
Annual Time Burden (Hours) 189,600 189,600 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$49,560
No
    Yes
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 amber.sanford@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.
03/04/2019


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