Gluten-Free Labeling of Fermented or Hydrolyzed Foods

ICR 201605-0910-011

OMB: 0910-0817

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2016-05-16
Supporting Statement A
2016-05-16
ICR Details
0910-0817 201605-0910-011
Historical Inactive
HHS/FDA CFSAN
Gluten-Free Labeling of Fermented or Hydrolyzed Foods
New collection (Request for a new OMB Control Number)   No
Regular
Comment filed on proposed rule 06/17/2016
Retrieve Notice of Action (NOA) 05/16/2016
In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.
  Inventory as of this Action Requested Previously Approved
36 Months From Approved
0 0 0
0 0 0
0 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 Proposed rulemaking 80 FR 71990 11/18/2015

No

Yes
Changing Regulations
No
This is a new information collection associated with rulemaking.

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.
05/16/2016


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