View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0152	ICR Reference No: 201707-0910-001
Status: Historical Active	Previous ICR Reference No: 201406-0910-016
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Current Good Manufacturing Practice Regulations for Medicated Feed, 21 CFR Part 225
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: 08/28/2017
	Date Received in OIRA: 07/27/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2020	36 Months From Approved	08/31/2017
Responses	15,757,633	0	15,689,545
Time Burden (Hours)	2,238,520	0	2,159,321
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	15,757,633	15,689,545	68,088
Annual Time Burden (Hours)	2,238,520	2,159,321	79,199
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: This information collection reflects a change due to the agency estimate. Specifically, the number of recordkeepers has increased from 840 to 877. This results in an increase in the number of annual responses of 68,088, with a corresponding increase in hours of 79,199.

Annual Cost to Federal Government: $23,160

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? Uncollected

Agency Contact: Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

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