Gluten-Free Labeling of Fermented or Hydrolyzed Foods

ICR 202008-0910-016

OMB: 0910-0817

Federal Form Document

Forms and Documents
Supporting Statement A
Supplementary Document
ICR Details
0910-0817 202008-0910-016
Active 201605-0910-011
Gluten-Free Labeling of Fermented or Hydrolyzed Foods
New collection (Request for a new OMB Control Number)   No
Approved without change 08/18/2020
Retrieve Notice of Action (NOA) 08/13/2020
  Inventory as of this Action Requested Previously Approved
08/31/2023 36 Months From Approved
370,000 0 0
165,661 0 0
1,500,000 0 0

Respondents to the information collection are manufacturers of foods that are fermented, hydrolyzed, or contain fermented or hydrolyzed ingredients and bear the claim “gluten-free,” “no gluten,” “free of gluten,” or “without gluten.” It imposes recordkeeping that FDA believes will provide a reasonable assurance that food so labeled is gluten-free before fermentation or hydrolysis; that the manufacturer has evaluated the potential for cross-contact with gluten during the manufacturing process; and that measures have been taken to prevent the introduction of gluten into the food during the manufacturing process.

US Code: 21 USC 343(a)(1), 321(n), and 371(a) Name of Law: Federal Food Drug & Cosmetic Act
PL: Pub.L. 108 - 286 206 Name of Law: Food Allergen Labeling and Consumer Protection Act

0910-AH00 Final or interim final rulemaking 85 FR 49240 08/13/2020

  80 FR 71990 11/18/2015
85 FR 49240 08/13/2020

  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 370,000 0 0 0 370,000 0
Annual Time Burden (Hours) 165,661 0 0 0 165,661 0
Annual Cost Burden (Dollars) 1,500,000 0 0 0 1,500,000 0
This is a new information collection. We have not adjusted estimates from our proposed rulemaking. As discussed at Question 8, we have addressed comments (no. 13) regarding potential concers pertaining to electronic records.

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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