Gluten-Free Labeling of Fermented or Hydrolyzed Foods

Forms and Documents

Document Name	Status
Gluten Free Labeling PRIA.pdf Supplementary Document	2016-05-16
Gluten Free Labeling of Fermented or Hydrolyzed Foods SS.pdf Supporting Statement A	2016-05-16

IC Document Collections

IC ID	Document Title	Status
221531	Maintenance of outside lab testing results	New
221530	Collecting samples for testing by outside lab	New
221529	Maintenance of test kit test results	New
221528	Collecting samples for test kit testing	New
221527	Maintenance of SOP records for gluten control	New
221526	SOP for gluten control	New
221525	ONE TIME Recordkeeping for rule implementation	New

ICR Details

OMB Control No: 0910-0817	ICR Reference No: 201605-0910-011
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Gluten-Free Labeling of Fermented or Hydrolyzed Foods
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule	Conclusion Date: 06/17/2016
	Date Received in OIRA: 05/16/2016
Terms of Clearance: 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
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): US Code: 21 USC 343(a)(1), 321(n), and 371(a) Name of Law: Federal Food Drug & Cosmetic Act
  

Citations for New Statutory Requirements: PL: Pub.L. 108 - 286 206 Name of Law: Food Allergen Labeling and Consumer Protection Act

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AH00	Proposed rulemaking	80 FR 71990	11/18/2015

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
ONE TIME Recordkeeping for rule implementation
SOP for gluten control
Maintenance of SOP records for gluten control
Collecting samples for test kit testing
Maintenance of test kit test results
Collecting samples for testing by outside lab
Maintenance of outside lab testing results

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Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection associated with rulemaking.

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Annual Cost to Federal Government:

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 05/16/2016

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