Memo_Request_Limited_Ethnic_Category_3-2-2012

Date: March 1, 2012

TO: Office of Management and Budget (OMB)

Through: Keith Tucker, Reports Clearance Officer, HHS

Seleda Perryman, Program Clearance Officer, NIH

Vivian Horovitch-Kelley, PRA OMB Project Clearance Liaison, OMAA, NCI

FROM: Nathaniel Rothman, M.D., M.P.H., M.H.S, NCI Project Officer

Senior Investigator and Head, Molecular Epidemiology Studies

Occupational and Environmental Epidemiology Branch

Division of Cancer Epidemiology and Statistics

National Cancer Institute (NCI)/NIH

SUBJECT: Justification for Limited Ethnic/Racial categories for “A multi-center

international hospital-based case-control study of lymphoma in Asia (AsiaLymph) (NCI)”

NCI requests authorization from OMB to approve the use of modified race and ethnicity categories for this epidemiology study based on the 2011 HHS guidance that states, “The specified race and ethnicity categories provide a minimum set of categories except when the collection …focuses on a specific racial or ethnic group.”

This study proposes to collect information from patients with lymphoma or patients undergoing surgery or other treatment for non-cancer related medical issues who live in Hong Kong, Taiwan, and Chengdu and Tianjin, China will be enrolled at treating hospitals. This study population involves only Chinese, including Han, who constitute the vast majority of Chinese living in these geographic regions, and Chinese minority groups living in these regions. The “Other” category is listed for both study subjects and their parents since some study subjects will come from mixed Chinese and other ethnic group parentage. There are a relatively small numbers of individuals from dozens of additional ethnic groups living in these regions and it is not possible to list them all. The purpose of identifying “Other” is to use this information in statistical sensitivity analyses where risk factors including genetic susceptibility for lymphoma will be analyzed for all study subjects, and then only for those subjects without a mixed ethnic background.