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View ICR - OIRA Conclusion

OMB Control No: 0910-0813	ICR Reference No: 201907-0910-001
Status: Historical Active	Previous ICR Reference No: 201605-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Food Labeling: Nutrition Facts and Supplement Facts labels
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/22/2019
	Date Received in OIRA: 07/22/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2022	36 Months From Approved	08/31/2019
Responses	188,442	0	1,338,100
Time Burden (Hours)	188,942	0	2,488,258
Cost Burden (Dollars)	22,434,973	0	3,480,000,000

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	188,442	1,338,100	-1,149,658
Annual Time Burden (Hours)	188,942	2,488,258	-2,299,316
Annual Cost Burden (Dollars)	22,434,973	3,480,000,000	-3,457,565,027

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 information collection reflects adjustments resulting from regulations that have become effective since last OMB review (RIN 0910-AF22). Accordingly, we have lowered our third-party disclosure estimate to reflect that burden associated with changes in labeling resulting from the new requirements has since been realized by respondents. This results in a decrease of 1,149,158 annual disclosures and 2,299,816 burden hours attributable to those labeling changes. We have also made corresponding cost adjustments.

Annual Cost to Federal Government: $199,000

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? Uncollected

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

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