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: 0910-0429	ICR Reference No: 202002-0910-002
Status: Historical Active	Previous ICR Reference No: 201510-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Formal Meetings with Sponsors and Applicants for PDUFA Products
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 05/04/2020
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/13/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2023	36 Months From Approved
Responses	6,153	0	0
Time Burden (Hours)	83,386	0	0
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	6,153	6,153
Annual Time Burden (Hours)	83,386	83,386
Annual Cost Burden (Dollars)	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement: The information collection is being reinstated with change. We have revised the guidance document to include relevant discussion of updated performance goals under the FDARA of 2017. Although it currently remains a draft, we ultimately intend to finalize the guidance. We have also made adjustments to the annual burden hours and responses, which reflect an increase of 83,386 and 6,153 respectively. We attribute the adjustment to an increase in meeting requests and packages associated with our PDUFA program.

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. Yes

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