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

Forms and Documents

Document Name	Status
Form 1 Annual Study Update (ASU) for PLCO Form and Instruction	Modified
Form 5 Medication Use Questionnaire (MUQ) for PLCO Form and Instruction	New
Form 6 Script for Non-responders to ASU Form and Instruction	Modified
Form 3 Supplemental Questionnaire (SQX) for PLCO Form	Removed
Form 3A Health Status Questionnaire (HSQ) for PLCO Form and Instruction	Modified
SSB_PLCO_100512.doc Supporting Statement B	2012-10-05
Cover_Memo_PLCO_092412.doc Supplementary Document	2012-10-05
Attach_14_Sampling & Power.pdf Supplementary Document	2012-10-05
Attach_13_PLCO Publications_2011.doc Supplementary Document	2012-10-05
Attach_12_Confidentiality Procedures.doc Supplementary Document	2012-10-05
Attach_11_NIH Privacy Act Memo.pdf Supplementary Document	2012-10-05
Attach_10_IRB.pdf Supplementary Document	2012-10-05
Attach_9_Consent_&_Authorization_9_27.pdf Supplementary Document	2012-10-05
Attach_08_Literature Review.pdf Supplementary Document	2012-10-05
Attach_7_PIA.doc Supplementary Document	2012-10-05
Attach_4_Cover Letters.pdf Supplementary Document	2012-10-05
Attach_01_Users of Science.doc Supplementary Document	2012-10-05
SSA_PLCO_100512.doc Supporting Statement A	2012-10-05

IC Document Collections

IC ID	Document Title	Status
7306	Annual Study Update (ASU) for PLCO Form and Instruction	Modified
204674	Medication Use Questionnaire (MUQ) for PLCO Form and Instruction	New
198526	Script for Non-responders to ASU Form and Instruction	Modified
198525	Supplemental Questionnaire (SQX) for PLCO Form	Removed
186212	Health Status Questionnaire (HSQ) for PLCO Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0407	ICR Reference No: 201210-0925-003
Status: Historical Active	Previous ICR Reference No: 201107-0925-004
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Prostate, Lung, Colorectal and Ovarian 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: 12/21/2012
	Date Received in OIRA: 10/31/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2015	36 Months From Approved	09/30/2014
Responses	193,760	0	191,600
Time Burden (Hours)	31,813	0	54,693
Cost Burden (Dollars)	0	0	0

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Abstract: This is a request for a revision due to the replacement of the Supplemental Questionnaire with the Medication Use Questionnaire (MUQ). The previous submission was approved in September, 2011. This trial was designed to determine if cancer screening for prostate, lung, colorectal, and ovarian cancer can reduce mortality from these cancers which currently cause an estimated 255,700 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. Recruitment was completed in 2001, baseline cancer screening was completed in 2006, and data collection continues on the current cohort of 94,000 participants who are actively being followed. The additional follow-up will provide data that will clarify further the long term effects of the screening on cancer incidence and mortality for the four targeted cancers. Further, demographic and risk factor information may be used to analyze the differential effectiveness of cancer 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:
	77 FR 41791	07/16/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 62518	10/15/2012
Did the Agency receive public comments on this ICR? Yes

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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	Annual Study Update (ASU)
Health Status Questionnaire (HSQ) for PLCO	3A, 3B	Health Status Questionnaire (Male-HSQ) ,   Health Status Questionnaire (Female-HSQ)
Script for Non-responders to ASU	6	Script for ASU Non-response
Medication Use Questionnaire (MUQ) for PLCO	5	Medication Use Questionnaire (MUQ)
Supplemental Questionnaire (SQX) for PLCO	3	Supplemental Questionnaire (SQX).

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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	193,760	191,600	0	2,160	0	0
Annual Time Burden (Hours)	31,813	54,693	0	-22,880	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: Changing Forms

Short Statement: This is a program change of the previously approved study due to OPDIV discretion; also considered a revision. Number of responses to the follow up forms in the PLCO is consistently declining because more deaths are occurring as the study participant's age. In the 2008, the estimated number of responses was 131,341, however due to death rates it was only 122,655 responses. In 2011, the estimated number of annual responses was 191,600; a substantial increase from the previous submission because a new questionnaire, the Supplemental Questionnaire (SQX), was introduced (30 minutes to 93,000 respondents). The current number of annual responses estimated for this submission is 193,760; a slight increase from the previous submission due to an underestimate of the number of participants who consented to active follow-up from the first eight screening centers. However, the total number of burden hours has decreased since the last submission primarily due to the replacement of the Supplemental Questionnaire with the Medication Use Questionnaire. The decrease in burden hours is not as large as expected due to the increase in number of respondents.

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Annual Cost to Federal Government: $5,402,128

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: 10/31/2012

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