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OMB Control No: 0910-0342	ICR Reference No: 202608-0910-006
Status: Received in OIRA	Previous ICR Reference No: 202501-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: HFP
Title: Generally Recognized as Safe (GRAS) Notices
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 08/11/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	09/30/2028
Responses	3,388	1,936
Time Burden (Hours)	152,242	31,712
Cost Burden (Dollars)	0	0

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	3,388	1,936	1,452
Annual Time Burden (Hours)	152,242	31,712	120,530
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: Rulemaking will revise OMB control no. 0910-0342. As a result, we have revised our estimate adding 101,490 hours and 2,736 responses annually to reflect the information collection associated with new regulatory requirements.

Annual Cost to Federal Government: $24,796,380

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: Christopher Colburn 301-415-6157 cxc7@nrc.gov

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