Food Allergen Labeling and Reporting

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0792 Food allergens SSA 2024 REV.docx	Supporting Statement A	Uploaded 2024-04-12	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
215825	Redesign labels to comply with food allergen labeling requirements	Other-Agency Guidance	Modified
215824	Review of labels for compliance with food allergen labeling requirements	Other-Agency Guidance	Modified
215823	Notification under 403(w)(7)	Other-Agency Guidance	Modified
215822	Petition for exemption under 403(w)(6)	Other-Agency Guidance	Modified

ICR Details

OMB Control No: 0910-0792	ICR Reference No: 202404-0910-002
Status: Historical Active	Previous ICR Reference No: 202104-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Food Allergen Labeling and Reporting
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/04/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 04/12/2024
Terms of Clearance: FDA should update this collection each time a relevant guidance document is posted.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2027	36 Months From Approved	06/30/2024
Responses	78,287	0	77,511
Time Burden (Hours)	90,908	0	78,356
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection helps support implementation of statutory requirements pertaining to 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.

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Authorizing Statute(s): 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
   PL: Pub.L. 117 - 11 2 Name of Law: FASTER Act of 2021
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 85640	12/08/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 25635	04/11/2024
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

table that charts list of burden

IC Title	Form No.	Form Name
Notification under 403(w)(7)
Petition for exemption under 403(w)(6)
Redesign labels to comply with food allergen labeling requirements
Review of labels for compliance with food allergen labeling requirements

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ICR Summary of Burden

table that charts list 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	78,287	77,511	0	0	776	0
Annual Time Burden (Hours)	90,908	78,356	0	0	12,552	0
Annual Cost Burden (Dollars)	0	0	0	0	0	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: We believe firms have already redesigned their labels to comply with requirements under the Food Allergen Labeling and Consumer Protection Act of 2004. However, in this revision we account for firms that will redesign their label to comply with requirements more recently enacted under the FASTER Act. We have increased our cumulative estimate by 12,552 hours and 776 responses to reflect the inclusion of sesame as a major food allergen.

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Annual Cost to Federal Government: $4,305,550

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: 04/12/2024

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