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View ICR - OIRA Conclusion

OMB Control No: 0938-0612	ICR Reference No: 202401-0938-001
Status: Active	Previous ICR Reference No: 202008-0938-009
Agency/Subagency: HHS/CMS	Agency Tracking No: 21125
Title: Clinical Laboratory Improvement Amendments (CLIA) and Supporting Regulations (CMS-R-26)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 06/07/2024
	Date Received in OIRA: 01/12/2024
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2027	36 Months From Approved	06/30/2024
Responses	84,959,102	0	74,476,376
Time Burden (Hours)	15,839,779	0	14,514,802
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	84,959,102	74,476,376	10,482,726
Annual Time Burden (Hours)	15,839,779	14,514,802	1,324,977
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: This increase of 1,324,977 hours from the previous collection is a direct result from the significant increase in enrollment of laboratories into the CLIA program during the COVID-19 Public Health Emergency (PHE), due to the increased need for testing. Apart from the one-time it is not related to any statute or regulatory change.

Annual Cost to Federal Government: $35,000

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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