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: 0938-0612	ICR Reference No: 202008-0938-009
Status: Historical Active	Previous ICR Reference No: 201702-0938-020
Agency/Subagency: HHS/CMS	Agency Tracking No: 21125
Title: (CMS-R-26) Clinical Laboratory Improvement Amendments (CLIA) and Supporting Regulations
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/19/2021
	Date Received in OIRA: 08/14/2020
Terms of Clearance: In CMS's next revision, extension, or reinstatement request for this collection, CMS shall upload a copy of any public guidance (if any) in effect that provides instructions on the information collections included in this submission.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2024	36 Months From Approved	01/31/2021
Responses	74,476,376	0	79,172,009
Time Burden (Hours)	14,514,802	0	14,975,521
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	74,476,376	79,172,009	-4,695,633
Annual Time Burden (Hours)	14,514,802	14,975,521	-460,719
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 reduction of 460,719 hours from the previous collection is a direct result from the slight decrease in enrollment of laboratories into the CLIA program. It is not related to any statute or regulatory change.

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: Denise King 410 786-1013 Denise.King@cms.hhs.gov

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