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View ICR - OIRA Conclusion

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
	Date Received in OIRA: 04/12/2024
Terms of Clearance: FDA should update this collection each time a relevant guidance document is posted.

	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

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	78,287	77,511	776
Annual Time Burden (Hours)	90,908	78,356	12,552
Annual Cost Burden (Dollars)	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.

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

Agency Contact: Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

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