Food Allergen Labeling and Reporting

ICR 201804-0910-012

OMB: 0910-0792

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0792 201804-0910-012
Active 201503-0910-010
HHS/FDA CFSAN
Food Allergen Labeling and Reporting
Extension without change of a currently approved collection   No
Regular
Approved without change 05/16/2018
Retrieve Notice of Action (NOA) 04/18/2018
  Inventory as of this Action Requested Previously Approved
05/31/2021 36 Months From Approved 05/31/2018
81,385 0 81,385
140,340 0 140,340
0 0 7,071,875

This information collection supports an agency guidance document entitled, "Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications." The guidance is intended to help industry prepare petitions and notifications seeking exemptions from the labeling requirements for ingredients derived from major food allergens. The respondents to this collection are manufacturers and packers of packaged foods sold in the United States that declare the presence of a major food allergen on the product label and seek an exemption from the labeling requirements of section 403(w)(1) of the FD&C Act.

PL: Pub.L. 108 - 282 203 Name of Law: Food Allergen Labeling and Consumer Protection Act of 2004
   US Code: 21 USC 343(w)(1) Name of Law: null
  
None

Not associated with rulemaking
Other Documents for OIRA Review

  82 FR 58407 12/12/2017
83 FR 15848 04/12/2018
Yes

  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 81,385 81,385 0 0 0 0
Annual Time Burden (Hours) 140,340 140,340 0 0 0 0
Annual Cost Burden (Dollars) 0 7,071,875 0 0 -7,071,875 0
No
No

$3,539,348
No
    No
    No
No
No
No
Uncollected
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.
04/18/2018


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