Gluten-Free Labeling of Fermented or Hydrolyzed Foods

Forms and Documents

Document Name	Status
0817 Gluten SSA Final Rule August 2020.pdf Supporting Statement A	2020-08-13
FDA Gluten RIA.pdf Supplementary Document	2020-08-12

IC Document Collections

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

ICR Details

OMB Control No: 0910-0817	ICR Reference No: 202008-0910-016
Status: Active	Previous ICR Reference No: 201605-0910-011
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: Approved without change	Conclusion Date: 08/18/2020
	Date Received in OIRA: 08/13/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2023	36 Months From Approved
Responses	370,000	0	0
Time Burden (Hours)	165,661	0	0
Cost Burden (Dollars)	1,500,000	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	Final or interim final rulemaking	85 FR 49240	08/13/2020

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 71990	11/18/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 49240	08/13/2020
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

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

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ICR Summary of Burden

	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

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement: 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.

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Annual Cost to Federal Government: $2,257,884

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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? No

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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: 08/13/2020

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