Prostate, Lung, Colorectal and Overian Cancer Screening Trial (PLCO) (NCI)

Forms and Documents

Document Name	Status
Form 1 Annual Study Update (ASU) for PLCO Form and Instruction	Modified
Form 4 Script for Non-responders to ASU Form and Instruction	New
Form 3 Supplemental Questionnaire (SQX) for PLCO Form	New
Form 4 Prostate Cancer Recurrence Questionnaire (PCRQ) for PLCO Form	Removed
Form 2a Health Status Questionnaire (HSQ) for PLCO Form	Modified
Supporting Statement B_PLCO_7-8-2011.docx Supporting Statement B	2011-07-08
Attach_15_PIA.doc Supplementary Document	2011-07-08
Attach_13_Sampling & Power.pdf Supplementary Document	2011-07-08
Attach_12_Cover Letters.doc Supplementary Document	2011-07-08
Attach_11_PLCO Publications_2011.doc Supplementary Document	2011-07-08
Attach_10_Memo from NIH Privacy Act Officer.pdf Supplementary Document	2011-07-08
Attach_08_Confidentiality Procedures.doc Supplementary Document	2011-07-08
Attach_07_Consent & Authorization.doc Supplementary Document	2011-07-08
Attach_09_Assurances of Compliance.pdf Supplementary Document	2011-07-08
Attach_06_Steering Committee and DSMD.doc Supplementary Document	2011-07-08
Attach_02_Users of Scientific Findings.doc Supplementary Document	2011-07-08
Attach_01_Literature Review.pdf Supplementary Document	2011-07-08
Cover Memo_PLCO.doc Supplementary Document	2011-07-08
Supporting Statement A_PLCO_7-11-2011.docx Supporting Statement A	2011-07-11

IC Document Collections

IC ID	Document Title	Status
7306	Annual Study Update (ASU) for PLCO Form and Instruction	Modified
198526	Script for Non-responders to ASU Form and Instruction	New
198525	Supplemental Questionnaire (SQX) for PLCO Form	New
186213	Prostate Cancer Recurrence Questionnaire (PCRQ) for PLCO Form	Removed
186212	Health Status Questionnaire (HSQ) for PLCO Form	Modified

ICR Details

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
	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

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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.

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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:
	Not associated with rulemaking

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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

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Annual Study Update (ASU) for PLCO	1	ASU
Health Status Questionnaire (HSQ) for PLCO	2a, 2b	Health Status Questionnaire (HSQ) for Males ,   Health Status Questionnaire (HSQ) for Females
Supplemental Questionnaire (SQX) for PLCO	3	Supplemental Questionnaire (SQX).
Script for Non-responders to ASU	4	Script for ASU Nonresponders
Prostate Cancer Recurrence Questionnaire (PCRQ) for PLCO	4	Prostate Cancer Recurrence Questionnaire (PCRQ)

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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	191,600	135,741	0	55,859	0	0
Annual Time Burden (Hours)	54,693	11,401	0	43,292	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: 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.

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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

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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: 07/15/2011

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