FDA CTP Regulatory Submission Receipt and Analysis
Investment ID: 009-000276359
Overview
Program Title
FDA CTP Regulatory Submission Receipt and Analysis
Description
This investment supports development, implementation, and operations and maintenance of CTP s electronic submissions as well as CTP s current and future business process automation needs.
Type of Program
Major IT Investments
Multi-Agency Category
Not Applicable
Associated Websites
https://ctpportal.fda.gov/
Investment Detail
The Regulatory Submission Receipt and Analysis Investment significantly reduces the manual burden on both Industry submitters and government FTE's by automating the full range of CTP regulatory data management needs. This investment provides efficient and accurate management of data and enables CTP scientists to perform research and analysis toward the production of better informed regulatory decisions. These outcomes allow CTP to meet the needs of the Family Smoking and Prevention and Tobacco Control Act (TCA) by reducing morbidity and mortality due to the use of tobacco products. Through this investment CTP is able to meet its business needs, including statutory, regulatory, and administrative obligations required by the Government Performance and Results Act. By streamlining practices CTP is able to improve Industry participation and overall stakeholder satisfaction. In addition, the Regulatory Submission Receipt and Analysis Investment complies with the Paper Reduction Act of 1995 by reducing the burden of paper submissions and shrinking costs associated with a manual process.