View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0938-0544	ICR Reference No: 201805-0938-007
Status: Historical Active	Previous ICR Reference No: 201503-0938-006
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Survey Report Form Clinical Laboratory Improvement Amendments (CLIA) and supporting regulations (CMS-1557)
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: 12/03/2018
	Date Received in OIRA: 05/15/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2021	36 Months From Approved	11/30/2018
Responses	9,593	0	9,526
Time Burden (Hours)	4,796	0	4,763
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	9,593	9,526	-3	70
Annual Time Burden (Hours)	4,796	4,763	-2	35
Annual Cost Burden (Dollars)	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Changes in burden are the result of an increase in the numbers of respondents in the CLIA program (i.e., 132 additional laboratory facilities that have a CLIA certificate of compliance). The respondents increased from 19,051 to 19,183. The burden hours increased from 4,763 to 4796. There are no program changes.

Annual Cost to Federal Government: $3,000

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? Uncollected

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

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