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	Modified
Form 4 Prostate Cancer Recurrence Questionnaire (PCRQ) for PLCO Form	New
Form 2 Health Status Questionnaire (HSQ) for PLCO Form	New
Supporting Statement B_PLCO_05-29-08.doc Supporting Statement B	2008-07-29
Attachment 13 (Sampling & Power).pdf Supplementary Document	2008-07-29
Attachment 12 (Cover Letters).doc Supplementary Document	2008-07-29
Attachment 11 (PLCO Publications).doc Supplementary Document	2008-07-29
Attachment 10 (Privacy Act Memo).pdf Supplementary Document	2008-07-29
Attachment 9 (IRB Approvals).pdf Supplementary Document	2008-07-29
Attachment 8 (Confidentiality Procedures).doc Supplementary Document	2008-07-29
Attachment 7 (Consent & Authorization).doc Supplementary Document	2008-07-29
Attachment 6 (List of Contractors).doc Supplementary Document	2008-07-29
Attachment 2 (Users of Scientific Findings).pdf Supplementary Document	2008-07-29
Attachment 1 (Literature Review).pdf Supplementary Document	2008-07-29
Cover memo_PLCO.doc Supplementary Document	2008-07-29
Supporting Statement A_PLCO_7-28-08.doc Supporting Statement A	2008-07-29

IC Document Collections

IC ID	Document Title	Status
7306	Annual Study Update (ASU) for PLCO Form	Modified
186213	Prostate Cancer Recurrence Questionnaire (PCRQ) for PLCO Form	New
186212	Health Status Questionnaire (HSQ) for PLCO Form	New

ICR Details

OMB Control No: 0925-0407	ICR Reference No: 200808-0925-002
Status: Historical Active	Previous ICR Reference No: 200506-0925-003
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: 10/21/2008
	Date Received in OIRA: 08/22/2008
Terms of Clearance: Prior terms of clearance continue

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2011	36 Months From Approved	10/31/2008
Responses	135,741	0	1
Time Burden (Hours)	11,401	0	23,086
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of the PLCO Trial is to determine if screening for prostate, lung colorectal, and ovarian cancers aids in reducing mortality from these diseases. Men and women 55-74 years old were recruited into the study at 10 sites nationwide. Recruitment was completed in 2001 with 154,938 participants recruited into the study. Each participant will be followed for at least 13 years from randomization. During this next approval period PLCO participants will be followed for cancer and vital status ascertainment. Participants will complete an Annual Study Update (ASU) questionnaire, Health Screening Questionnaire (HSQ), and a Prostate Cancer Recurrence Questionnaire (PCRQ). If cancer is reported, diagnosis and treatment information is collected through abstracting medical records. Deaths are ascertained through the annual follow-up 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:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 32338	06/06/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 48214	08/18/2008
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
Annual Study Update (ASU) for PLCO	1	Annual Study Update (ASU)
Health Status Questionnaire (HSQ) for PLCO	2, 3	Health Status Questionnaire (HSQ) for Males ,   Health Status Questionnaire (HSQ) for Females
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	135,741	1	0	135,740	0	0
Annual Time Burden (Hours)	11,401	23,086	0	-11,685	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: Annualized burden is estimated at 11,401 hours per year for the proposed 3 years of data collection (Years 16, 17, and 18) of the PLCO trial. The annualized burden hours for the previous cycle (Years 13-15) was 23,086 hours. Estimated burden hours for this OMB cycle have dropped considerably this year because we are experiencing more deaths with study participants as they age. Additionally, a new instrument has been added, the Prostate Cancer Recurrence Questions (PCRQ) to complete information on prostate cancer in selected PLCO trial participants. The PCRQ will be administered twice: once at 5-years post-diagnosis and again at 10-years post-diagnosis.

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Annual Cost to Federal Government: $12,599,193

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]? 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: 08/22/2008

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