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View ICR - OIRA Conclusion

OMB Control No: 0910-0541	ICR Reference No: 201611-0910-009
Status: Historical Active	Previous ICR Reference No: 201312-0910-012
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition
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: 01/12/2017
	Date Received in OIRA: 12/08/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2020	36 Months From Approved	02/28/2017
Responses	108	0	45
Time Burden (Hours)	10,668	0	45
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	108	45	63
Annual Time Burden (Hours)	10,668	45	10,623
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 an overall increase. The number of respondents has changed from 45 to 108, reflecting an increase of 63. This results in a corresponding increase to burden hours from 45 to 10,668, an increase of 10,623. While we attribute the increase in submissions to an increase in respondents to the collection, we attribute a larger part of the increased burden hours to a reassessment of the time necessary to prepare submissions. Where previously we estimated one hour for the preparation of a submission, we have revised the estimate to eight hours.

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