Cover Letter_2011_10-6-2011

Date: October 6, 2011

To: Office of Management and Budget (OMB)

Through: Mary Forbes, Report Clearance Officer, HHS

Seleda Perryman, Project Clearance Officer, OPERA, NIH

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

From: Richard P. Moser, Ph.D.,

Science of Research and Technology Branch, Behavioral Research Program

Division of Cancer Control and Population Sciences (DCCPS)

National Cancer Institute/NIH

Subject: A Generic Submission for Theory Development and Validation (NCI)

A Generic Clearance is requested from OMB for formative research related to behavioral science theory development and validation to be carried out in 2012-2015 by the Division of Cancer Control and Population Sciences (DCCPS), National Cancer Institute, NIH. These activities are to be overseen by staff of the Behavioral Research Program (BRP/DCCPS) and involve using standard focus group and questionnaire methodology to develop and validate health behavior theories in the context of cancer prevention and control, using a methodology which has been employed effectively by Federal Agencies within DHHS and elsewhere.

The following types of activities would be carried out under this generic clearance:

1) Research to identify psychological, biobehavioral, demographic, and individual difference predictors of cancer prevention and control behaviors and outcomes, involving questionnaires, focus groups, and message testing;

2) Research to develop (focus groups) and refine (questionnaires, message testing) integrative theories;

3) Specialized questionnaire research involving experts that would identify and observe theoretical and innovative trends in cancer prevention and control research;

4) Focus group and questionnaire research to determine feasibility and usefulness of collaborative and multidisciplinary approaches to cancer prevention and control.

OMB Approval of Individual Collections

NCI will submit individual collections under this generic clearance to OMB that will include details that highlight the purpose, methodology, participants and burden of each project.