FDA is extending the proposal period for the Quality Metrics Site Visit Program. The program was announced in the Federal Register on June 29, 2018. Interested stakeholders were originally given until August 28, 2018 to submit a proposal. Due to the interest in the program, the proposal period is being extended to December 17, 2018.
The Quality Metrics Site Visit Program is designed to offer experiential and firsthand learning opportunities to FDA staff involved in development of FDA’s Quality Metrics Program. Staff will gain exposure to robust quality metrics programs through on-site visits, tours of operations, and discussions with establishments to assist staff in further developing FDA’s Quality Metrics Program. FDA staff will also observe how quality metrics data are gathered, collected, and reported to management. The intended timeframe of the on-location Quality Metrics site visits is from October 1, 2018 to September 30, 2019. The end date may be change based on interest and resources.