Memo to OMB_Key to #7 and #8

Date: December 14, 2010

To: Office of Management and Budget (OMB)

Through: Seleda Perryman, DHHS Report Clearance Officer

Mikia Currie, Program Analyst, NIH Project Clearance Branch, OPERA

From: Vivian Horovitch-Kelley, NCI OMB Project Clearance Liaison, OMAA

National Cancer Institute (NCI)/NIH

Subject: Bundled Generic Sub-Study Packages for 0925-0046-07 and -08

The “Combined Generic Sub-study (GS) Form” for sub-study #7 and #8 highlight the abstracts for each project and is included in this submission.

The key to understanding the attachments and files in ICRAS/ROCIS is as listed below.

Sub-study #7:

Full title: “Prostate-Specific Antigen (PSA) Decision-Making Focus Groups”

Attachments are labeled “#7” and include:

• Justification Memo and Attachments 7C (Advertisements) and 7D (Consent)

• Attachments 7A (Screener), 7B (Moderator Guide) and 7E (Questionnaire)

Sub-study #8:

Full title: “Protocol and Information Office (PIO) External Customer Satisfaction

Survey”

Attachments are labeled “#8” and include:

• Justification Memo and Attachment 8B (Email Letter)

• Attachment 8A (PIO Survey)

Notes to OMB: The total requested responses and burden was calculated by taking the sum for the two sub-studies to account for the total in the electronic system.

Estimates of Hour Burden for Sub-studies #7 and #8
Type of Respondents	Instruments	Number of Respondents	Frequency of Response	Average Response Time (minutes/hour)	Hour Burden
Males between the ages of 55-74 (Sub-study #7)	Screener (Attach 7A)	80	1	5/60 (0.08)	7
	Focus Group (Attach 7B)	45	1	90/60 (1.5)	68
	Questionnaire (Attach 7E)	45	1	5/60 (0.08)	4
Project Investigators and Clinical Staff (Sub-study #8)	PIO Customer Satisfaction Survey (Attach 8A)	240	1	10/60 (0.167)	40
Total		410			119

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