View Information Collection Request (ICR) Package

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: 0910-0598	ICR Reference No: 201908-0910-008
Status: Historical Active	Previous ICR Reference No: 201606-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: CLIA Waiver Applications
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: 09/10/2019
	Date Received in OIRA: 08/16/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2022	36 Months From Approved	09/30/2019
Responses	13	0	40
Time Burden (Hours)	52,000	0	160,000
Cost Burden (Dollars)	113,750	0	350,000

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	13	40	-27
Annual Time Burden (Hours)	52,000	160,000	-108,000
Annual Cost Burden (Dollars)	113,750	350,000	-236,250

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: Our estimated burden for the information collection reflects a decrease of 27 responses and 27 records, and a corresponding overall decrease of 108,000 hours. We attribute this adjustment to a decrease in the average number of submissions we received over the last few years.

Annual Cost to Federal Government: $1,621,830

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? Uncollected

Agency Contact: Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

Something went wrong when downloading this file. If you have any questions, please send an email to risc@gsa.gov.