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View ICR - OIRA Conclusion

OMB Control No: 0910-0616	ICR Reference No: 202011-0910-004
Status: Historical Active	Previous ICR Reference No: 201801-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CROSS CENTER
Title: Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
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: 04/14/2021
	Date Received in OIRA: 03/03/2021
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2024	36 Months From Approved	04/30/2021
Responses	17,409	0	21,427
Time Burden (Hours)	5,976	0	7,175
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	17,409	21,427	-19,377	15,359
Annual Time Burden (Hours)	5,976	7,175	-6,663	5,464
Annual Cost Burden (Dollars)	0	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The adjustment (decrease) in burden is due to a decrease in the overall number of research and marketing applications/submissions received by FDA since the previous submission. Additionally, we decreased the number of ICs in ROCIS from seven to one.

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? No

Agency Contact: Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@fda.hhs.gov

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