Post Cinical Laboratory Survey Questionnaire and Supporting Regulations in 42 CFR 493.1771, 483.1773, and 493.1777 (CMS-668B)

Forms and Documents

Document Name	Status
Form CMS-668B Private Sector - Post Cinical Laboratory Survey Questionnaire and Supporting Regulations in 42 CFR 493.1771, 483.1773, and 493.1777 Form and Instruction	Modified
Form CMS-668B State, Local, or Tribal Governments - Post Cinical Laboratory Survey Questionnaire and Supporting Regulations in 42 CFR 493.1771, 483.1773, and 493.1777 Form and Instruction	Modified
Form CMS-668B Federal Government - Post Cinical Laboratory Survey Questionnaire and Supporting Regulations in 42 CFR 493.1771, 483.1773, and 493.1777 Form and Instruction	Modified
CMS-668B - Supporting Statement 2015 .doc Supporting Statement A	2015-08-11

IC Document Collections

IC ID	Document Title	Status
43661	Private Sector - Post Cinical Laboratory Survey Questionnaire and Supporting Regulations in 42 CFR 493.1771, 483.1773, and 493.1777 Form and Instruction	Modified
202097	State, Local, or Tribal Governments - Post Cinical Laboratory Survey Questionnaire and Supporting Regulations in 42 CFR 493.1771, 483.1773, and 493.1777 Form and Instruction	Modified
202096	Federal Government - Post Cinical Laboratory Survey Questionnaire and Supporting Regulations in 42 CFR 493.1771, 483.1773, and 493.1777 Form and Instruction	Modified

ICR Details

OMB Control No: 0938-0653	ICR Reference No: 201508-0938-008
Status: Historical Active	Previous ICR Reference No: 201204-0938-006
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Post Cinical Laboratory Survey Questionnaire and Supporting Regulations in 42 CFR 493.1771, 483.1773, and 493.1777 (CMS-668B)
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: 06/17/2016
	Date Received in OIRA: 08/12/2015
Terms of Clearance: The agency is required to display the OMB Control Number and inform respondents of its legal significance in accordance with 5 CFR 1320.5(b).

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	36 Months From Approved	06/30/2016
Responses	9,526	0	10,244
Time Burden (Hours)	2,382	0	2,561
Cost Burden (Dollars)	0	0	0

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Abstract: To provide an opportunity and a mechanism for CLIA laboratories surveyed by CMS or CMS' agent to express their satisfaction and concerns about the CLIA survey process.

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Authorizing Statute(s): PL: Pub.L. 100 - 578 42.493 Name of Law: CLIA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 29713	05/22/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 45978	08/03/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Federal Government - Post Cinical Laboratory Survey Questionnaire and Supporting Regulations in 42 CFR 493.1771, 483.1773, and 493.1777	CMS-668B	Post Clinical Laboratory Survey Questionnaire
Private Sector - Post Cinical Laboratory Survey Questionnaire and Supporting Regulations in 42 CFR 493.1771, 483.1773, and 493.1777	CMS-668B	Post Clinical Laboratory Survey Questionnaire
State, Local, or Tribal Governments - Post Cinical Laboratory Survey Questionnaire and Supporting Regulations in 42 CFR 493.1771, 483.1773, and 493.1777	CMS-668B	Post Clinical Laboratory Survey Questionnaire

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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	9,526	10,244	0	-718	0	0
Annual Time Burden (Hours)	2,382	2,561	0	-179	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The burden has been adjusted to account for the smaller number of respondents (20,486 in the 2012 estimate and 19,051 in this submission).

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Annual Cost to Federal Government: $50,300

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

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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: 08/12/2015

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