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OMB Control No: 0925-0407	ICR Reference No: 201107-0925-004
Status: Historical Active	Previous ICR Reference No: 200808-0925-002
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Prostate, Lung, Colorectal and Overian Cancer Screening Trial (PLCO) (NCI)
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: 09/05/2011
Retrieve Notice of Action (NOA)	Date Received in OIRA: 07/15/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2014	36 Months From Approved	10/31/2011
Responses	191,600	0	135,741
Time Burden (Hours)	54,693	0	11,401
Cost Burden (Dollars)	0	0	0

Abstract: This trial is designed to determine if screening for prostate, lung, colorectal and ovarian cancer can reduce mortality from these cancers which currently cause an estimated 254,570 deaths annually in the U.S. The design is a two-armed randomized trial of men and women aged 55 to 74 at entry. OMB first approved this study in 1993 and has approved it every 3 years since then through 2011. During the first approval period a pilot study was conducted to evaluate recruitment methods and data collection procedures. Recruitment was completed in 2001 and data collection continues through 2014. When participants enrolled in the trial they agreed to be followed for at least 13 years from the time of enrollment. The current number of respondents in the study is 122,655; this is down from the initial total due to deaths. The primary endpoint of the trial is cancer specific mortality for each of the four cancer sites (prostate, lung, colorectal, and ovary). In addition, cancer incidence, stage shift, and case survival are to be monitored to help understand and explain results. Biologic prognostic characteristics of the cancers will be measured and correlated with mortality to determine the mortality predictive value of these intermediate endpoints. Basic demographic data, risk factor data for the four cancer sites and screening history data, as collected from all subjects at baseline, will be used to assure comparability between the screening and control groups and make appropriate adjustments in analysis. Further, demographic and risk factor information may be used to analyze the differential effectiveness of screening in high versus low risk individuals.

Authorizing Statute(s): None

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:
	76 FR 22108	04/20/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 41805	07/15/2011
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	191,600	135,741	55,859
Annual Time Burden (Hours)	54,693	11,401	43,292
Annual Cost Burden (Dollars)	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: This is a program change of the previously approved study due to OPDIV discretion; also considered a revision. Both the total number of respondents and the total burden hours have increased since the last submission due to the re-introduction of the Supplemental Questionnaire (SQX). The SQX substantially increases the average time per response. This questionnaire updates information on demographics, cancer risk factors, and history of cancer screening. The addition of a telephone script to contact respondents who do not return the ASU also contributed to the increase in respondents and burden hours. In addition to an increase in burden, another change from the 2008 application is that the Prostate Cancer Reoccurrence Questionnaire (PCR) project will be completed under the current approval period. The PCR Questionnaire will no longer be administered and has not been included in this submission. The PCRQ is no longer being used since that data collection effort will be completed by September 29, 2011.

Annual Cost to Federal Government: $6,476,382

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

Agency Contact: Saleda Perryman

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