View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0540	ICR Reference No: 202006-0910-009
Status: Historical Active	Previous ICR Reference No: 201707-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Animal Drug User Fee Program
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 with the understanding that the agency will discontinue 0910-0539 and 0910-0632 upon approval.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2023	36 Months From Approved	08/31/2020
Responses	223	0	161
Time Burden (Hours)	303	0	277
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	223	161	62
Annual Time Burden (Hours)	303	277	26
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 changes and adjustments. By revising the information collection to include related elements associated with animal drug user fees (approved under OMB control nos. 0539 – Animal Drug User Fee Cover Sheet and 0910-0632 – Animal Generic Drug User Fee Cover Sheet) there is an increase of 62 annual responses and 26 annual burden hours.

Annual Cost to Federal Government: $59,887

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. Yes

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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