View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0834	ICR Reference No: 202008-0910-012
Status: Historical Active	Previous ICR Reference No: 201706-0910-021
Agency/Subagency: HHS/FDA	Agency Tracking No: CROSS CENTER
Title: Postmarketing Safety Reporting for Combination Products
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: 10/02/2020
	Date Received in OIRA: 08/31/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2023	36 Months From Approved	10/31/2020
Responses	594	0	16,668
Time Burden (Hours)	267	0	12,885
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	594	16,668	-16,074
Annual Time Burden (Hours)	267	12,885	-12,618
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The burden for this extension request has decreased (an adjustment) because the burden for drug, devices and biological products has been omitted from this ICR and consolidated into the appropriate center ICRs referred to in section 1 of this document.

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? No

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

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