Food Allergen Labeling and Reporting

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
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	Unchanged
215823	Notification under 403(w)(7) Other-Agency Guidance	Unchanged
215822	Petition for exemption under 403(w)(6) Other-Agency Guidance	Unchanged

ICR Details

OMB Control No: 0910-0792	ICR Reference No: 202104-0910-009
Status: Received in OIRA	Previous ICR Reference No: 201804-0910-012
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Food Allergen Labeling and Reporting
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 04/14/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	05/31/2021
Responses	77,511	81,385
Time Burden (Hours)	78,356	140,340
Cost Burden (Dollars)	0	0

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Abstract: This information collection supports an agency guidance document entitled, "Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications." The guidance is intended to help industry prepare petitions and notifications seeking exemptions from the labeling requirements for 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
  

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
	Other Documents for OIRA Review

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 68333	10/28/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 17843	04/06/2021
Did the Agency receive public comments on this ICR? Yes

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

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

	Total Request	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	77,511	81,385	0	0	-3,874	0
Annual Time Burden (Hours)	78,356	140,340	0	0	-61,984	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 are decreasing the estimated number of respondents redesigning their label and the number of hours to do so, resulting in a decrease of 3874 responses and 61,984 hours annually.

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Annual Cost to Federal Government: $3,784,603

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: 04/14/2021

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