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View ICR - OIRA Conclusion

OMB Control No: 0910-0705	ICR Reference No: 201501-0910-006
Status: Historical Active	Previous ICR Reference No: 201212-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Guidance FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act
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: 05/27/2015
	Date Received in OIRA: 03/12/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2018	36 Months From Approved	05/31/2015
Responses	118	0	114
Time Burden (Hours)	1,416	0	1,368
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	118	114	4
Annual Time Burden (Hours)	1,416	1,368	48
Annual Cost Burden (Dollars)	0	0	0

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

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: The total burden hours have increased by 48 hours. This adjustment is due to a slight increase in the number of respondents.

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