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

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
7304	Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial	Migrated

ICR Details

OMB Control No: 0925-0407	ICR Reference No: 199908-0925-002
Status: Historical Active	Previous ICR Reference No: 199608-0925-002
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial
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: 10/26/1999
	Date Received in OIRA: 08/13/1999
Terms of Clearance: This collection is approved, subject to the following change: The PLCO Cancer Screening Trial will alter the race/ethnicity categories used so that race/ethnicity data is collected in accordance with the 1997 OMB standards, cited in the Oct 30, 1997 copy of the Federal Register. This includes changes to the racial categories listed in Question 3 of the Eligibility Screenings and Question 2 of the Male and Female Baseline Questionnaires. In addition, the study should be altered so that it is in compliance with the OMB mandate that a participant be allowed to select more than one racial category. The new race/ ethnicity categories should be adopted for the remainder of the recuitment phase of this study.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2002	10/31/2002	10/31/1999
Responses	1	0	192,737
Time Burden (Hours)	94,809	0	114,537
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. Persons aged 55-74 will be randomized into two cohorts. One cohort will receive annual screening and the other usual care. Baseline and annual health status information will be obtained from all subjects.

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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:

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial

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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	1	192,737	0	-192,736	0	0
Annual Time Burden (Hours)	94,809	114,537	0	-19,728	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $0

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: 08/13/1999

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