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View ICR - OIRA Conclusion

OMB Control No: 0910-0759	ICR Reference No: 201507-0910-006
Status: Historical Active	Previous ICR Reference No: 201312-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: 20991
Title: Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products; Final Rule
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: 09/30/2015
	Date Received in OIRA: 07/15/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2018	36 Months From Approved
Responses	225	0	0
Time Burden (Hours)	450	0	0
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	225	225
Annual Time Burden (Hours)	450	450
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: This is a new approval request. The total burden hours for the final rule is unchanged from the November 4, 2013, proposed rule.

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