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View ICR - OIRA Conclusion

OMB Control No: 0910-0623	ICR Reference No: 200804-0910-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Request for Designation as Country not Subject to the Restrictions Applicable to Human Food and Cosmetics Manufactured from, Processed With, or Otherwise Containing, Material from Cattle
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/12/2008
	Date Received in OIRA: 04/23/2008
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2011	36 Months From Approved
Responses	20	0	0
Time Burden (Hours)	531	0	0
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	20	20
Annual Time Burden (Hours)	531	531
Annual Cost Burden (Dollars)	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: FDA is amending its regulations at §§ 189.5 and 700.27 to provide that FDA may designate a country as not subject to the restrictions applicable to human food and cosmetics manufactured from, processed with, or that otherwise contain specified risk materials, the small intestine of cattle, material from nonambulatory disabled cattle, and mechanically separated (MS) (Beef). The IFR, as amended, provides that these materials, when from cattle from a designated country, are not considered prohibited cattle materials and their use does not render a human food or cosmetic adulterated.

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