View Information Collection Request (ICR) Package

Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.

View ICR - OIRA Conclusion

OMB Control No: 0910-0705	ICR Reference No: 201212-0910-007
Status: Historical Active	Previous ICR Reference No: 201105-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Draft Guidance FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/19/2012
	Date Received in OIRA: 12/13/2012
Terms of Clearance: Previous terms of clearance apply: In accordance with the terms of 5 CFR 1320, OMB approves this ICR for a period of three years. If FDA requests an extension of this approval,FDA should make significant progress in making an electronic submission available. If electronic submission is not available, the agency should submit a timeline for implementation and report on progress.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2015	03/31/2015	03/31/2015
Responses	114	0	114
Time Burden (Hours)	1,368	0	1,368
Cost Burden (Dollars)	0	0	0

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