View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0889	ICR Reference No: 202002-0910-010
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Accreditation Scheme for Conformity Assessment Pilot Program
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 06/19/2020
	Date Received in OIRA: 05/01/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2023	36 Months From Approved
Responses	1,945	0	0
Time Burden (Hours)	13,491	0	0
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	1,945	1,795	150
Annual Time Burden (Hours)	13,491	12,103	1,388
Annual Cost Burden (Dollars)	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: No

Burden Reduction Due to:

Short Statement: This is a new information collection.

Annual Cost to Federal Government: $1,791,525

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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