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: 0938-0581	ICR Reference No: 202203-0938-007
Status: Historical Active	Previous ICR Reference No: 202010-0938-010
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001 (CMS-116)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/18/2022
Retrieve Notice of Action (NOA)	Date Received in OIRA: 03/18/2022
Terms of Clearance: In CMS's next revision, reinstatement, or extension request, CMS shall have analyzed the necessity and practical utility of the need to submit copies of diplomas in addition to transcripts. If CMS cannot articulate a clear need for diplomas separate and apart from transcripts, CMS should be prepared to no longer collect copies of them. In considering the necessity and practical utility, CMS should consider differing practices among US and international institutions of higher education.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2024	03/31/2024	03/31/2024
Responses	52,140	0	52,140
Time Burden (Hours)	52,140	0	52,140
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved
Annual Number of Responses	52,140	52,140
Annual Time Burden (Hours)	52,140	52,140
Annual Cost Burden (Dollars)	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: There are minor revisions to the form that enhance the completion for the laboratory community and enhance the data reporting of laboratory demographics and trends. The burden increase is due to an increase in the number of new laboratories participating in the CLIA program (from 16,000 to 17,050), an increase in the number of laboratories reporting changes (from 25,350 to 26,340), and the addition of 100% fringe to the hourly wage of laboratory staff completing the CMS-116 form. The number of laboratories using the form has increased from 51,000 to 52,140. The burden hours have increased from 51,000 to 52,140.

Annual Cost to Federal Government: $516,530

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