View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0495	ICR Reference No: 202512-0910-012
Status: Active	Previous ICR Reference No: 202403-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: HFP
Title: Food Additives; Food Contact Substances Notification System
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/16/2026
	Date Received in OIRA: 12/31/2025
Terms of Clearance: Upon approval of this change, FDA will discontinue 0910-0298.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2027	04/30/2027	04/30/2027
Responses	472	0	465
Time Burden (Hours)	33,171	0	32,835
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	472	465	7
Annual Time Burden (Hours)	33,171	32,835	336
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: For efficiency of agency operations, we are requesting to incorporate related information collection activity currently approved in OMB control no. 0910-0298 and applicable to regulatory requirements found in 21 CFR 170.39 (threshold of regulation for substances used in food-contact articles) into this ICR. We have therefore added a new IC element corresponding with the regulation into our summary table to reflect 7 responses and 336 hours annually, burden we attribute to information collection activity under 21 CFR 170.39. Upon OMB approval, we intend to discontinue control no. 0910-0298.

Annual Cost to Federal Government: $1,332,030

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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