The Secretary shall establish and maintain an information system to track the status and progress of each application or submission (including a petition, notification, or other similar form of request) submitted to the Food and Drug Administration requesting agency action.
21 U.S. Code § 379k - Information system
Pub. L. 105–115, title IV, § 407(b), Nov. 21, 1997, 111 Stat. 2370, provided that not later than 1 year after Nov. 21, 1997, Secretary of Health and Human Services was to submit report to Congress on status of system to be established under this section, including projected costs of system and concerns about confidentiality.