View Information Collection Request (ICR) Package
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Certification
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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:
202309-0938-015
Status:
Active
Previous ICR Reference No:
202203-0938-007
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:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
03/04/2024
Retrieve Notice of Action (NOA)
Date Received in OIRA:
09/27/2023
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
03/31/2027
36 Months From Approved
03/31/2024
Responses
64,598
0
52,140
Time Burden (Hours)
64,598
0
52,140
Cost Burden (Dollars)
0
0
0
Abstract:
Clincal Laboratory Certification - The application must be completed by entities performing laboratory's testing specimens for diagnostic or treatment purposes. This information is vital to the certification process.
Authorizing Statute(s):
US Code:
42 USC 493
Name of Law: Laboratory Requirement
PL:
Pub.L. 100 - 578 353
Name of Law: Clinical Laboratory Amendments of 1988
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
88 FR 45218
07/14/2023
30-day Notice:
Federal Register Citation:
Citation Date:
88 FR 65689
09/25/2023
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001 (CMS-116)
CMS-116
CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) - Application for Certification
ICR Summary of Burden
Total Approved
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
64,598
52,140
0
12,458
0
0
Annual Time Burden (Hours)
64,598
52,140
0
12,458
0
0
Annual Cost Burden (Dollars)
0
0
0
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:
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 17,050 to 24,400) and an increase in the number of laboratories reporting changes (from 26,340 to 31,575). The number of laboratories using the form has increased from 52,140 to 64,598. The burden hours have increased from 52,140 to 64,598.
Annual Cost to Federal Government:
$696,864
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
Common Form ICR:
No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Certification Date:
09/27/2023
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