Food Allergen Labeling and Reporting

Forms and Documents

Document Name	Status
Final FALCPA Petition Notification Guidance Redlined-OCC-2-25-15.doc Supplementary Document	2015-05-22
FALCPA supporting statement 2015 ver2.pdf Supporting Statement A	2015-05-22

IC Document Collections

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

ICR Details

OMB Control No: 0910-0792	ICR Reference No: 201503-0910-010
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Food Allergen Labeling and Reporting
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 with change	Conclusion Date: 05/29/2015
	Date Received in OIRA: 03/30/2015
Terms of Clearance: Approved consistent with content of the final guidance document.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2018	36 Months From Approved
Responses	81,385	0	0
Time Burden (Hours)	140,340	0	0
Cost Burden (Dollars)	7,071,875	0	0

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Abstract: This information collection request supports an agency guidance document entitled, "Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications." The draft guidance is intended to help industry prepare petitions and notifications seeking exemptions from the labeling requirements for ingredients derived from major food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. Respondents to the reporting elements are manufacturers and packers of packaged foods sold in the United States that 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: null
  

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:
	79 FR 47145	08/12/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 71107	12/01/2014
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Petition for exemption under 403(w)(6)
Notification under 403(w)(7)
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 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	81,385	0	0	81,385	0	0
Annual Time Burden (Hours)	140,340	0	0	140,340	0	0
Annual Cost Burden (Dollars)	7,071,875	0	0	7,071,875	0	0

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 request.

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Annual Cost to Federal Government: $3,282,134

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: 03/30/2015

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