Image-Assisted Cytology Workload Assessment and Measure

Forms and Documents

Document Name	Status
Image-Assisted Cytology Workload Assessment Survey--Cytotechnologists Form	New
Image-Assisted Cytology Workload Practices Survey--Laboratory Form	New
OMB Supporting Statement B Cytology Workload Assessment and Measure_ttp2.docx Supporting Statement B	2013-09-17
Attachment H Cytology Workload Human subjects.pdf Supplementary Document	2013-09-17
Attachment F Consultants.docx Supplementary Document	2013-09-17
Attachment A Authorizing Legislation.docx Supplementary Document	2013-09-17
Attachement E Comments and Responses to 60 day FRN.docx Supplementary Document	2013-09-17
OMB Supporting Statement A Cytology Workload Assessment and Measure (3)_ttp2.docx Supporting Statement A	2013-09-17

IC Document Collections

IC ID	Document Title	Status
208767	Image-Assisted Cytology Workload Assessment Survey--Cytotechnologists Form	New
208766	Image-Assisted Cytology Workload Practices Survey--Laboratory Form	New

ICR Details

OMB Control No: 0920-1000	ICR Reference No: 201309-0920-008
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 20551
Title: Image-Assisted Cytology Workload Assessment and Measure
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/02/2013
	Date Received in OIRA: 09/23/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2014	12 Months From Approved
Responses	5,577	0	0
Time Burden (Hours)	2,789	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: CDC is tasked with providing technical guidance to HHS for implementing the Clinical Laboratory Improvement Amendments (CLIA). The major impetus for CLIA was overworked cytotechnologists screening too many Pap Slides. A workload maximum is included in the regulations to limit the number of slides that might be screened in an 8 hour day. When semi-automated screening devices were introduced in cytology laboratories the workload maximum number was doubled. The cytology community feels this number is too high. Data is needed to support the current number or impose a change in the regulations.

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Authorizing Statute(s): PL: Pub.L. 42 - 493 1274 Name of Law: Clinical Laboratory Improvement Amendments of 1988
  

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:
	78 FR 18983	03/28/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 55258	09/10/2013
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Image-Assisted Cytology Workload Practices Survey--Laboratory	None	Image-Assisted Cytology Workload Practices Survey--Laboratory
Image-Assisted Cytology Workload Assessment Survey--Cytotechnologists	None	Image-Assisted Cytology Workload Assessment Survey--Cytotechnologists

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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	5,577	0	0	5,577	0	0
Annual Time Burden (Hours)	2,789	0	0	2,789	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: This is a new Information Collection Request.

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Annual Cost to Federal Government: $189,658

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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: 09/23/2013

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