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: 0910-0458	ICR Reference No: 201911-0910-003
Status: Historical Active	Previous ICR Reference No: 201701-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/29/2020
Retrieve Notice of Action (NOA)	Date Received in OIRA: 01/10/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2023	36 Months From Approved	02/29/2020
Responses	49,328	0	48,930
Time Burden (Hours)	94,592	0	93,854
Cost Burden (Dollars)	4,256,663	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	49,328	48,930	398
Annual Time Burden (Hours)	94,592	93,854	738
Annual Cost Burden (Dollars)	4,256,663	0	4,256,663

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 estimated burden for the information collection reflects an overall increase of 738 hours and a corresponding increase of 398 responses. We attribute this adjustment to an increase in the number of submissions we received over the last few years.

Annual Cost to Federal Government: $879,025

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