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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
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
Retrieve Notice of Action (NOA)
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
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
Authorizing Statute(s):
None
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
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
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)
Attachment 1 Annual Study Update Form
1
Annual Study Update
Attachment 11 Authorization to Release Medical Records
5
Authorization to Release Medical Records
Attachment 2A HSQ Male
2
HSQ Male
Attachment 2B HSQ Female
3
HSQ Female
Attachment 4 Medication Use Questionnaire (MUQ)
4
MUQ
Attachment 5 ASU Telephone Script
5
ASU Telephone Script
Health Status Questionnaire (HSQ) for PLCO
3A, 3B
Health Status Questionnaire (Male-HSQ)
,
Health Status Questionnaire (Female-HSQ)
Medication Use Questionnaire (MUQ) for PLCO
5
Medication Use Questionnaire (MUQ)
Script for Non-responders to ASU
6
Script for ASU Non-response
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.
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
Agency Contact:
Saleda Perryman
Common Form ICR:
No
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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