View Information Collection Request (ICR) Package

Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.

View ICR - OIRA Conclusion

OMB Control No: 0910-0381	ICR Reference No: 202001-0910-005
Status: Historical Active	Previous ICR Reference No: 201711-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Food Labeling Regulations
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: 08/17/2020
	Date Received in OIRA: 07/13/2020
Terms of Clearance: Approved consistent with the understanding that FDA plans to discontinue 0910-0813 upon approval.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2023	36 Months From Approved	08/31/2020
Responses	2,612,905	0	2,424,463
Time Burden (Hours)	1,974,605	0	1,786,323
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	2,612,905	2,424,463	188,442
Annual Time Burden (Hours)	1,974,605	1,786,323	188,282
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: The information collection reflects adjustment. As a result of consolidating burden applicable to provisions associated with the Nutrition Facts and Supplemental Facts labels (previously included under OMB control no. 0910-0813), we have increased the number of annual responses by 188,442 and associated burden hours by 188,942.

Annual Cost to Federal Government: $5,900,498

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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