Notice Number: NOT-OD-17-034

Key Dates
Release Date: January 11, 2017

Issued by
National Institutes of Health (NIH)
U.S. Food and Drug Administration, Center for Tobacco Products (CTP)

Purpose

The purpose of this Notice is to announce a major data consensus effort from the NIH Tobacco Regulatory Science Program (TRSP) and the Food and Drug Administration (FDA) Center for Tobacco Products (CTP).

TRSP and CTP are dedicated to advancing science by improving the yield and impact of its research portfolio. One way to accomplish this is to provide investigators with a common set of tools and resources to facilitate sharing, comparing, replication of findings, and integration of data from multiple sources. Toward this end, TRSP and CTP, in conjunction with the National Human Genome Research Institute and the broader scientific community, have identified a series of measures that will promote comparable data collection across tobacco regulatory research studies.

The following Tobacco Regulatory Research Collections have been added to the PhenX Toolkit (www.phenxtoolkit.org) to augment this already-rich measurement resource:

• The Core Collections: two-tiered set of measures with broad applicability across tobacco regulatory research
  • Core Tier 1 measures require little time to collect and have been deemed relevant and essential to all areas of tobacco regulatory research. CTP grantees/applicants conducting human-subject studies are encouraged to use the Core Tier 1 measures.
  • Core Tier 2 measures are more specialized than the Core Tier 1 measures. CTP grantees and applicants conducting human-subject studies are encouraged to incorporate the Core Tier 2 measures whenever possible and appropriate.
• The Specialty Collections: five sets of measures related to the Host (Social/Cognitive and Biobehavioral), Agent, Vector, and Environment. TRSP grantees/applicants conducting human-subject studies in the specified areas of science are encouraged to consider incorporation of the Specialty measures.

TRSP recognizes that researchers may have longstanding data collection protocols that do not incorporate the recommended measures. In such situations, it may be necessary to collect data using more than one measure to ensure compatibility with legacy data as well as to allow data from multiple studies to be easily aggregated and/or compared as the field moves forward. Researchers may also want to include additional measures of a construct to best address their hypotheses. This Notice does not preclude the use of measures in addition to the common data elements that have been established. By advocating the use of these common measures, TRSP and its partners in science aim to optimize the value of this research and further accelerate and enhance tobacco regulatory research, while advancing a culture of scientific collaboration.

Inquiries

Please direct all inquiries to:

Kay Wanke, PhD, MPH
Office of Disease Prevention
Telephone: 301-451-1856
Email: wankek@nih.gov
http://prevention.nih.gov/tobacco/