CLINICAL LABORATORY IMPROVEMENT AMENDEMENTS (CLIA) APPLICATION FORMS

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
114025	CLINICAL LABORATORY IMPROVEMENT AMENDEMENTS (CLIA) APPLICATION FORMS Form	Migrated

ICR Details

OMB Control No: 0938-0581	ICR Reference No: 199206-0938-001
Status: Historical Active	Previous ICR Reference No: 199104-0938-006
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: CLINICAL LABORATORY IMPROVEMENT AMENDEMENTS (CLIA) APPLICATION FORMS
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: 08/03/1992
	Date Received in OIRA: 06/12/1992
Terms of Clearance: Approved for use through 9/93 under the following conditions: 1) HCFA adopts the revised HCFA-114 and 116, glossary, and cover letter included in this package; 2) HCFA adopts the sampling frame agreed upon with OMB that would apply to currently regulated labs, waived labs, and all other labs subject to CLIA. This sampling approach determines which labs solely will receive the HCFA-114 and 116 materials with these standard forms; 3) HCFA completes the addendu providing baseline data for the evaluation of CLIA and a cover letter explaining the need for the addendum no later than 8/7/92; and 4) no later than 9/92, HCFA submits for OMB review a plan and instrument for collecting data from laboratories that may have closed due to the regulatory costs of CLIA. This approval applies to the HCFA 114 and 116 and the agreed upon addendum. Due to the likely substantial impact of CLIA on laboratory operations and costs, HHS has developed the addendum to collect baseli information regarding current operations that will assist in the measurement of such impacts.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/1993	09/30/1993	04/30/1994
Responses	320,000	0	320,000
Time Burden (Hours)	826,667	0	826,667
Cost Burden (Dollars)	0	0	0

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Abstract: THESE FORMS MUST BE COMPLETED ENTITIES PERFORMING LABORATORY TESTING ON HUMAN SPECIMENS FOR HEALTH PURPOSES. THE INFORMATION ON THESE FORMS INITIATES THE CERTIFICATION PROCESS.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
CLINICAL LABORATORY IMPROVEMENT AMENDEMENTS (CLIA) APPLICATION FORMS	HCFA-108, 109

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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	320,000	320,000	0	0	0	0
Annual Time Burden (Hours)	826,667	826,667	0	0	0	0
Annual Cost Burden (Dollars)	0	0	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: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $0

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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: 06/12/1992

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