Attachment 5_OHSR not needed

Horovitch-Kelley, Vivian (NIH/NCI) [E]
From:
Sent:
To:
Subject:

Pursley-Crotteau, Suzanne (NIH/OD) [E]
Monday, May 18, 2009 12:23 PM
Horovitch-Kelley, Vivian (NIH/NCI) [E]
Form 1572 - OHSR not needed

Good Afternoon Vivian,
Based on the information you have provided and our discussion over the collection of this data, OHSR would say this is
not research since this data is being collected to meet FDA requirements prior to the investigation of FDA regulated
products. In the event that you would want to analyze and publish all or part of the data you have collected then it would
be prudent for OHSR to review your project.
Please let me know if you have any questions.
Best regards,
Suzanne

Suzanne Pursley‐Crotteau, PhD, RN 
Senior Health Policy Analyst 
Office of Human Subjects Research 
Office of Intramural Research 
National Institutes of Health 
Bldg 10 Room 2C146 
Bethesda, MD 20892 
Direct line: 301‐402‐8630 
Office Telephone: 301‐402‐3444 
Office Fax: 301‐402‐3443 
From: Horovitch-Kelley, Vivian (NIH/NCI) [E]
Sent: Monday, May 18, 2009 10:40 AM
To: Pursley-Crotteau, Suzanne (NIH/OD) [E]
Subject: OHSR exemption?

Hi Suzanne.   I just left you a message.  I have an information collection that is more of an administrative, record‐keeping 
collection than it would be considered research.  The IC is collecting investigator’s names, etc. in accordance with FDA 
policy.  I have attached an overview along with the questionnaires that will be sent out to the investigators to complete. 
My question is – does this need OHSR review?  If not, can you send an email in that regard?  Thanks. 

Vivian Horovitch-Kelley
NCI PRA/OMB Project Clearance Liaison
Office of Management Analysis and Assessment (OMAA)
National Cancer Institute/NIH
6116 Executive Blvd., Suite 705
Rockville, MD 20892-0001
(T) 301-435-8526
(F) 301-402-2188
[email protected]
For more information about PRA/OMB clearance:
http://omaa.cancer.gov/policy/clearances/omb

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