FDA/CTP/OCE Contract and Technical Assistance Case Study

Services: Project Management; Technical assistance and recommendations to jurisdictions to assist in meeting contract requirements regarding review of inspections of tobacco retail establishments.

Opportunity: The FDA Center for Tobacco Products (CTP) is responsible for carrying out the Family Smoking Prevention and Tobacco Control Act, which Congress passed in 2009. This law—commonly called the Tobacco Control Act—gives CTP broad authority to regulate the manufacturing, distribution, and marketing of tobacco products.

The Food and Drug Administration (FDA) Center for Tobacco Products (CTP), Office of Compliance and Enforcement (OCE) contracted Laisar to identify barriers which precluded a state or territory agency from effectively and efficiently performing their contractual requirements and assist them in creating and implementing solutions to such barriers; Assist in identifying practices States and Territories can utilize to meet the contractual requirements of the program; and perform duties to assist States and Territories in fulfilling their contractual requirements, when necessary.

Laisar was tasked to collaborate with Program Coordinators (PCs), program staff, and Commissioned Officers in contracted jurisdictions–to examine financial records, personnel files, program files, subcontracts, insurance documents, evidence handling and storage, and any other pertinent records in order to facilitate technical assistance.

Challenges: There were several potential challenges to providing technical assistance to the contracted jurisdictions, including distinct administrative guidelines, organizational structures, jurisdictional regulations, and differences in the methods of meeting contract requirements within each jurisdiction.

Solutions: Laisar applied its knowledge in compliance related policies and regulations, experience in project planning and reporting, management oversight utilizing technology applications to streamline processes.

Based on the technical assistance plan and project timeline, Laisar’s Technical Advisors conducted a variety of tasks which included, but were not limited to:

  • Reviewing records and documentation required by the jurisdiction’s tobacco retail compliance inspection contract;
  • Assisting the jurisdiction’s contracted agency with compiling required records and documents;
  • Assisting the jurisdiction’s contracted agency with entering data into one or more systems that may include CTP’s Tobacco Inspection Management System (TIMS);
  • Assisting the jurisdiction’s contracted agency with reviewing evidence and data entered in TIMS;
  • Conducting other similar administrative and auditing tasks agreed upon by Laisar, OCE, and the jurisdiction’s PC.

Following each technical assistance project, Laisar submitted a final progress report to OCE staff The Assistance Project Report detailed Laisar’s findings, including recommendations for follow-up actions with the jurisdiction.