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U.S. Department of Health and Human Services

About FDA

Population Assessment of Tobacco and Health (PATH) Study

Description: The Population Assessment of Tobacco and Health (PATH) Study is a nationally representative, longitudinal cohort study of approximately 59,000 non-users and users of tobacco products and those at risk for tobacco use across the United States. The sample will include approximately 42,000 adults 18 and up and 16,900 youth age 12-17. Survey data on tobacco use, attitudes, and health will be collected from adults, youth, and parents of youth and biospecimens (buccal cell, urine, and blood) will be collected from adults. PATH Study data will provide an evidence base for assessing and monitoring FDA’s current and future regulatory actions in meeting its mandate under the Family Smoking Prevention and Tobacco Control Act. Regulatory domains include product standards, new and modified risk products, health warnings, and health education campaigns. The PATH Study is conducted through an Interagency Agreement with the National Institute for Drug Abuse (NIDA) and the National Institutes for Health (NIH).

Briefing Status: ON TRACK

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Request for Proposal (RFP) awarded by NIDA-NIH to contractor

9/1/2011

Completed 9/1/2011

2. Develop draft survey instruments

7/1/2012

Completed 7/1/2012

3. Prepare and submit Office of Management and Budget (OMB) package for field test and main study

Summer 2012

Completed 8/1/2012

4. Obtain OMB Approval for Field Test

Fall 2012

Completed 11/1/2012

5. Launch Field Test

Fall 2012/Winter 2013

Completed 12/5/2012

6. Complete Field Test analysis

Winter/Spring 2013

Completed 4/1/2013

7. Submit OMB materials for main study

Summer 2013

Completed 7/1/2013

8. Obtain OMB approval

Summer 2013

Completed 8/23/2013

9. Launch baseline data collection

Fall 2013/Winter 2014

Completed 9/12/2013

10. Complete data collection for baseline

Fall 2014/Winter 2015

On Track

11. Launch first phase of follow up data collection

Fall 2014/Winter 2015

Not Yet Started

12. Complete first manuscript of baseline results

Fall 2015

Not Yet Started

13. Finalize restricted Use Data Set for baseline data

Fall 2015

Not Yet Started

14. Complete first phase of follow up data collection

Fall 2015/Winter 2016

Not Yet Started

15. Launch second phase of follow up data collection

Fall 2015/Winter 2016

Not Yet Started

16. Publish First manuscript with first phase of follow up data

Fall 2016

Not Yet Started

17. Finalize restricted Use Data Set from first phase of follow up data

Fall 2016

Not Yet Started

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.