Food Allergen Labeling and Reporting

ICR 202104-0910-009

OMB: 0910-0792

Federal Form Document

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ICR Details
0910-0792 202104-0910-009
Received in OIRA 201804-0910-012
Food Allergen Labeling and Reporting
Extension without change of a currently approved collection   No
Regular 04/14/2021
  Requested Previously Approved
36 Months From Approved 05/31/2021
77,511 81,385
78,356 140,340
0 0

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: Misbranded Foods; ingredients containing food allergens

Not associated with rulemaking
Other Documents for OIRA Review

  85 FR 68333 10/28/2020
86 FR 17843 04/06/2021

  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 77,511 81,385 0 0 -3,874 0
Annual Time Burden (Hours) 78,356 140,340 0 0 -61,984 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
We are decreasing the estimated number of respondents redesigning their label and the number of hours to do so, resulting in a decrease of 3874 responses and 61,984 hours annually.

Domini Bean 301 796-5733 [email protected]


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.

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