Population Assessment of Tobacco and Health (PATH) Study Biospecimen Access (X01)

The Population Assessment of Tobacco and Health (PATH) Study Biospecimen Access (X01) is a funding opportunity offered through the National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health (NIH), within the U.S. Department of Health and Human Services. This initiative is part of a broader effort to support research that informs regulatory activities of the U.S. Food and Drug Administration (FDA) under the Family Smoking Prevention and Tobacco Control Act. The PATH Study is a longitudinal cohort study that began in 2011 to assess tobacco use behaviors and health outcomes among adults and youth in the United States. The goal of this opportunity is to grant research investigators access to valuable biospecimens—such as urine, plasma, serum, and genomic DNA—collected during multiple waves of the PATH Study. These samples are paired with detailed questionnaire data covering tobacco usage, beliefs, attitudes, exposures, and health statuses. The biospecimens are available for use in studies that align with tobacco regulatory science objectives or broader tobacco-related health inquiries. High-priority access will be given to projects that directly support regulatory research aims, particularly those that involve exploratory or pilot studies. No direct funding is awarded under the X01 mechanism. Instead, investigators are granted access to biospecimens if their research proposal meets scientific merit criteria and if sufficient specimens are available. Interested applicants must confirm biospecimen availability with the PATH Study team at least five months before the application deadline and must include a confirmation letter in their submission. Applications must be submitted through one of the NIH’s approved portals—NIH ASSIST, Grants.gov Workspace, or an institutional S2S system—and must follow strict formatting and submission guidelines outlined in the SF424 (R&R) Application Guide and this NOFO. Applications will be evaluated on multiple criteria including the significance of the proposed study, the investigators’ qualifications, innovation, the robustness of the approach, and the feasibility of the proposed timeline. Applicants must also provide a detailed biospecimen usage plan, assay methodology, statistical analysis strategy, and power calculations when applicable. Data management and human subjects protections must also be addressed, even though the use of de-identified PATH biospecimens typically does not constitute human subjects research under NIH definitions. Submissions are accepted semiannually with due dates on April 30 and October 31 each year through October 31, 2026. The earliest possible start date for successful applications varies by cycle, ranging from December to April depending on the review and advisory timeline. Although there is no financial award, selected applicants receive detailed instructions for accessing and using the biospecimens. Recipients must comply with PATH Study data sharing policies and provide progress updates as specified in the program's reporting requirements.

Strong justification for biospecimen need and validation of assay methodology will enhance application competitiveness. Ensure early contact with PATH team to confirm biospecimen availability.