View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0886	ICR Reference No: 202210-0910-001
Status: Historical Active	Previous ICR Reference No: 202002-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Requests for Nonbinding Feedback After Certain FDA Inspections of Device Establishments
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/06/2022
	Date Received in OIRA: 10/04/2022
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2023	04/30/2023	04/30/2023
Responses	229	0	220
Time Burden (Hours)	110,135	0	110,000
Cost Burden (Dollars)	0	0	0

Annual Cost to Federal Government: $10,271,590

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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