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: 0910-0797	ICR Reference No: 201808-0910-003
Status: Historical Inactive	Previous ICR Reference No: 201507-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: GFI: Controlled Correspondence Related to Generic Drug Development
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Improperly submitted and continue	Conclusion Date: 08/22/2018
	Date Received in OIRA: 08/21/2018
Terms of Clearance: According to the supporting statement, the information collection reflects an increase in the number of annual responses based on submissions received, a revision of the companion guidance to align with GDUFA II commitments regarding timeframes and agency goals, AND the establishment of an electronic submission portal to replace submissions by e-mail. As such, this should be submitted as a revision request and not an extension without change. The portal must also be included as an IC in the revision request.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2018	36 Months From Approved	10/31/2018
Responses	1,020	0	1,020
Time Burden (Hours)	5,100	0	5,100
Cost Burden (Dollars)	0	0	0

Annual Cost to Federal Government: $0

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: Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

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