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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:
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
Retrieve Notice of Action (NOA)
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
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.
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:
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
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)
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.
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
Agency Contact:
Mikia Currie 3014350941
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:
08/22/2008
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