Reporting Associated with Food Additive Petitions, Investigational Food Additive Files Exemptions, and Declaration of Color Additives on Animal Food Labels

ICR 202308-0910-022

OMB: 0910-0546

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2023-09-06
Supporting Statement A
2022-02-04
ICR Details
0910-0546 202308-0910-022
Received in OIRA 202201-0910-005
HHS/FDA CVM
Reporting Associated with Food Additive Petitions, Investigational Food Additive Files Exemptions, and Declaration of Color Additives on Animal Food Labels
No material or nonsubstantive change to a currently approved collection   No
Regular 09/06/2023
  Requested Previously Approved
03/31/2025 03/31/2025
2,616 2,616
119,147 119,147
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. In addition, section 403(i) of the FD&C Act (21 U.S.C. 343(i)) requires that certified color additives used in or on a food must be declared by their common or usual names and not be designated by the collective term “colorings.” Our regulations in part 501 (21 CFR part 501) set forth the requirements for animal food labeling. Under § 501.22(k) (21 CFR 501.22(k)), animal food manufacturers must declare on the animal food label the presence of certified and noncertified color additives in their animal food products. Our animal food labeling regulation at § 501.22(k) is consistent with the regulations requiring the declaration of color additives on human food labels.

US Code: 21 USC 409(a) and (b) Name of Law: Federal Food, Drug and Cosmetic Act
   US Code: 21 USC 343(i) Name of Law: Federal Food, Drug and Cosmetic Act
  
None

Not associated with rulemaking

  86 FR 56277 10/08/2021
87 FR 4614 01/28/2022
No

  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 2,616 2,616 0 0 0 0
Annual Time Burden (Hours) 119,147 119,147 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$54,253
No
    Yes
    No
No
No
No
No
Rachel Showalter 202 693-2146 Showalter.Rachel@dol.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.
09/06/2023


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