Memo to OMB_Key to #9 and #10

Date: March 7, 2011

To: Office of Management and Budget (OMB)

Through: Seleda Perryman, Report Clearance Officer, HHS

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

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

National Cancer Institute (NCI)/NIH

Subject: Bundled Generic Sub-Study Packages for 0925-0046-09 and -10

Both submissions come from the same division at NCI, the Division of Cancer Treatment and Diagnosis (DCTD), and are short web-based surveys initiated by an email invitation. The topics are very different and the “Gen IC Forms” for sub-study #9 and #10 highlight the abstract for each project.

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

Sub-study #9:

Full title: “Survey to Determine IRB Policy Regarding NCI Action Letters”

Files and attachments are labeled “#9” and include:

• Justification Memo and Attachments 9A (Email to Respondents)

• Attachment 9B (Survey)

Sub-study #10:

Full title: “NCI Cancer Research Imaging Camp”

Attachments are labeled “#10” and include:

• Justification Memo and Attachments 10A (Invitation Letter) and 10B (Consent Form)

• Attachment 10C (NCI Cancer Research Imaging Camp 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 #9 and #10
Type of Respondents	Instruments	Number of Respondents	Frequency of Response	Average Response Time (minutes/hour)	Hour Burden
IRB Chairs and Directors (Sub-study #9)	Survey (Attach 9B)	600	1	5/60 (0.083)	50
Former and New Camp Students (Sub-study #10)	(Attach 10C)	110	1	10/60 (0.167)	17
Total		710			67

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