; and (B) require the Commissioner of Food and Drugs to submit to the Secretary prior to final approval of the vaccine being reviewed, a report, with appropriate provisions for commercial confidentiality, detailing the safety of the vaccine and contrasting its safety profile based on its mechanisms of action to safety concerns expressed to the Food and Drug Administration regarding the human vaccine withdrawn from the market in 2002 and how those concerns with the withdrawn vaccine have been addressed or why they are not relevant. (4) Monitoring and understanding human cases of Lyme disease and other tick-borne diseases (A) In general The Secretary shall— (i) establish and maintain a statistically sound, scientifically credible surveillance system to be known as the National Tick-Borne Disease Surveillance System; (ii) enhance and expand infrastructure and activities to track the epidemiology of Lyme disease and other tick-borne diseases and disorders; and (iii) incorporate information obtained through such activities into the National Tick-Borne Disease Surveillance System. (B) Research The Secretary shall ensure that the National Tick-Borne Disease Surveillance System is designed in a manner that facilitates further research on Lyme disease and other tick-borne diseases and disorders. (C) Content In carrying out subparagraph (A), the Secretary— (i) shall provide for the collection and storage of information on the incidence and prevalence of tick-borne disease in the United States— (I) while continuing to support activities in the 14 States with the highest number of reported cases of Lyme disease, and intensifying efforts in other States where Lyme disease has been reported and where all reported cases cannot be affirmatively associated with out-of-State travel in order to better determine where the disease is emerging