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:
201403-0938-003
Status:
Historical Active
Previous ICR Reference No:
201012-0938-013
Agency/Subagency:
HHS/CMS
Agency Tracking No:
21532
Title:
Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001
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:
08/26/2014
Retrieve Notice of Action (NOA)
Date Received in OIRA:
03/11/2014
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2017
36 Months From Approved
08/31/2014
Responses
34,200
0
31,520
Time Burden (Hours)
25,650
0
23,640
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):
PL:
Pub.L. 100 - 578 353
Name of Law: Clinical Laboratory Amendments of 1988
US Code:
42 USC 493
Name of Law: Laboratory Requirement
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:
78 FR 75925
12/13/2013
30-day Notice:
Federal Register Citation:
Citation Date:
79 FR 10160
02/24/2014
Did the Agency receive public comments on this ICR?
Yes
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
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
34,200
31,520
0
2,680
0
0
Annual Time Burden (Hours)
25,650
23,640
0
2,010
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 no program changes, however, the minor revisions to the form serve to shorten forms completion for the laboratory community and to enhance the data reporting of laboratory demographics and trends. The slight burden increase is due to new labs participating in the CLIA program.
Annual Cost to Federal Government:
$298,436
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
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
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:
03/11/2014
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