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	Removed
Form 5 Attachment 11 Authorization to Release Medical Records Form and Instruction	New
Form 5 Attachment 5 ASU Telephone Script Form and Instruction	New
Form 4 Attachment 4 Medication Use Questionnaire (MUQ) Form and Instruction	New
Form 3 Attachment 2B HSQ Female Form and Instruction	New
Form 2 Attachment 2A HSQ Male Form and Instruction	New
Form 1 Attachment 1 Annual Study Update Form Form and Instruction	New
Form 5 Medication Use Questionnaire (MUQ) for PLCO Form and Instruction	Removed
Form 6 Script for Non-responders to ASU Form and Instruction	Removed
Form 3B Health Status Questionnaire (HSQ) for PLCO Form and Instruction	Removed
SSB_PLCO 6_22_2015.docx Supporting Statement B	2015-07-08
SSA_PLCO 6.22.2015.docx Supporting Statement A	2015-07-08
Attachment 14.List of Statistician Who Work on Study.docx Supplementary Document	2015-04-29
Attach_13_Sampling & Power.pdf Supplementary Document	2015-04-29
Attachment 12 PLCO Publications.pdf Supplementary Document	2015-04-29
Attach_10_Confidentiality Procedures.doc Supplementary Document	2015-04-29
Attach_9_NIH Privacy Act Memo.pdf Supplementary Document	2015-04-29
Attach_8_IRB Certifications.pdf Supplementary Document	2015-04-29
Attach_07_Literature Review.pdf Supplementary Document	2015-04-29
Attach_6_PIA.doc Supplementary Document	2015-04-29
Attach_3_Cover Letters.pdf Supplementary Document	2015-04-29

IC Document Collections

IC ID	Document Title	Status
7306	Annual Study Update (ASU) for PLCO Form and Instruction	Removed
216358	Attachment 11 Authorization to Release Medical Records Form and Instruction	New
216355	Attachment 5 ASU Telephone Script Form and Instruction	New
216354	Attachment 4 Medication Use Questionnaire (MUQ) Form and Instruction	New
216353	Attachment 2B HSQ Female Form and Instruction	New
216352	Attachment 2A HSQ Male Form and Instruction	New
216351	Attachment 1 Annual Study Update Form Form and Instruction	New
204674	Medication Use Questionnaire (MUQ) for PLCO Form and Instruction	Removed
198526	Script for Non-responders to ASU Form and Instruction	Removed
186212	Health Status Questionnaire (HSQ) for PLCO Form and Instruction	Removed

ICR Details

OMB Control No: 0925-0407	ICR Reference No: 201504-0925-008
Status: Historical Active	Previous ICR Reference No: 201210-0925-003
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: 11/13/2015
	Date Received in OIRA: 07/16/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2018	36 Months From Approved	12/31/2015
Responses	162,353	0	193,760
Time Burden (Hours)	26,320	0	31,813
Cost Burden (Dollars)	0	0	0

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Abstract: This is a request for a revision of the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO) for three years. This trial was designed to determine if cancer screening for prostate, lung, colorectal, and ovarian cancer can reduce mortality from these cancers which caused an estimated 253,320 deaths in the U.S in 2014. 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 77,281 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:
	80 FR 22211	04/21/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 41508	07/15/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

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 (Female-HSQ) ,   Health Status Questionnaire (Male-HSQ)
Script for Non-responders to ASU	6	Script for ASU Non-response
Attachment 2A HSQ Male	2	HSQ Male
Attachment 5 ASU Telephone Script	5	ASU Telephone Script
Attachment 11 Authorization to Release Medical Records	5	Authorization to Release Medical Records
Medication Use Questionnaire (MUQ) for PLCO	5	Medication Use Questionnaire (MUQ)
Attachment 1 Annual Study Update Form	1	Annual Study Update
Attachment 4 Medication Use Questionnaire (MUQ)	4	MUQ
Attachment 2B HSQ Female	3	HSQ Female

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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	162,353	193,760	0	-31,407	0	0
Annual Time Burden (Hours)	26,320	31,813	0	-5,493	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 continued follow up of an existing cohort as a result there will not be any new participants recruited into the study and thus no longer a need for a consent form. The total number of burden hours has decreased since the last submission primarily due to the number of deaths among the cohort and overestimate of the number of participants who consented to active follow-up from the ten screening centers.

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Annual Cost to Federal Government: $2,244,997

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: 07/16/2015

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