The U.S. Department of Health and Human Services and Food and Drug Administration (FDA) has announced the Data Standards for Tobacco Research and Scientific Review Program (U24) to provide a public benefit to a wide range of external stakeholders, including industry as well as health institutions that make use of such data, e.g. clinical research organizations, health service providers, and medical and academic institutions.

These benefits include enabling efficiencies in data management and analysis, facilitating traceability of data and combining of data from different sources. Enabling more consistent data collection in studies could lead to more efficient studies with better quality data which ultimately leads to improved knowledge about risks of a tobacco product.

Goals

The CTP Data Standards Program strategic goals include:

• Support open, consensus-based, data standards development
• Maintain and promote a well-defined data standards governance function,
• Promote electronic submission of regulatory data using established standards
• Optimize the CTP’s regulatory review process to fully leverage data conformed to standards

Objectives

The Food and Drug Administration is announcing the availability of a cooperative agreement for the development of data standards and terminology standards to support tobacco product development and evaluation. The primary objective is to support the development of non-proprietary, consensus-based data standards for use in studies, scientific review, and post-market surveillance of tobacco products. Projects may focus on solutions to general data standards development and implementation challenges or on specific concepts or domains where standardization is needed. This cooperative agreement program involves an expectation that appropriate research and testing is conducted to ensure applicability and usability of the standards.

Priorities

The applicant is responsible for developing data standards and terminologies standards to support tobacco product development and evaluation. FDA will be involved in the cooperative agreement by providing advice and guidance on key aspects. A Data Standards for Tobacco Research and Scientific Review program should include the following:

• An overall program plan describing the approach, process to be used in developing the selected area for standardization, any specific technologies to be utilized and experience with those technologies and deliverables
• Definition of scope to be addressed (e.g. use case) during the project period
• Description of the standard (concept, terminology, domain, target area) to be addressed in the application
• Description of the research, coordination, and collaboration among stakeholders (to achieve consensus) that is needed to address the area of standardization including but not limited to: engagement of subject matter experts, organizations, standards development organizations, affected stakeholders
• How the standard being addressed aligns with currently available standards and approach to making the standard publicly available
• A method (e.g. Gantt Chart) to plan and track progress toward specific deliverables under this award for the purpose of reporting the status to FDA and its stakeholders. At a minimum, information reported should include a listing of interim steps necessary to complete a given deliverable, the timeline for completing those tasks, and a report of any issues in meeting those established deadlines.
• Description of the result (concept, terminology, domain) to be developed in the application (e.g., completed implementation guide)
• Description of the coordination/collaboration (to achieve consensus) needed to address the area of standardization including but not limited to: engagement of subject matter experts, organizations, standards development organizations, affected stakeholders.
• How the standard being addressed aligns with currently available standards and approach to   making the standard publicly available
• A description of the experience of the principal investigators (PI), who is/are the Program Director (PD), should be described, together with his/her/their involvement in the projects. It is expected that PI(s) should have experience with data standards development as the PI(s) have the ultimate responsibility for the successful outcomes of the projects.

Funding Information

• FDA /Center for Tobacco Products intends to commit up to $750,000 in FY 2022 to fund 2-3 awards.
• Award Project Period: The scope of the proposed project should determine the project period. The maximum project period is two (2) years.

Eligibility Criteria

• Higher Education Institutions
  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education
• The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:
  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
• Nonprofits Other Than Institutions of Higher Education
  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• For-Profit Organizations
  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)
• Governments
  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • U.S. Territory or Possession
• Other
  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
  • Non-domestic (non-U.S.) Entities (Foreign Institutions)

For more information, visit Grants.gov.