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: 0910-0495	ICR Reference No: 202201-0910-011
Status: Historical Active	Previous ICR Reference No: 201902-0910-013
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Food Additives; Food Contact Substances Notification System
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: 03/18/2022
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/14/2022
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2025	36 Months From Approved	03/31/2022
Responses	458	0	463
Time Burden (Hours)	32,675	0	31,330
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	458	463	-5
Annual Time Burden (Hours)	32,675	31,330	1,345
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: Our estimated burden for the information collection reflects an overall increase of 1,345 hours and a corresponding decrease of 5 responses. We attribute this adjustment to a decrease in Pre-Notification Consultations or Master Files by 40 responses, a subsequent decrease of amendments to Pre-Notification Consultations or Master Files by 20 responses, and an increase of 55 respondents using the recommendations in the guidance document entitled, “Use of Recycled Plastics in Food Packaging: Chemistry Considerations.” As the average burden for preparing recycling submissions is higher than for Pre-notification Consultations or Master Files, this results in an overall increase in total burden even with an overall decrease in responses.

Annual Cost to Federal Government: $6,360,000

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? No

Agency Contact: Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov