Pub. L. 112-144, tit. VII, sec. 704 (as amended)
ELECTRONIC SYSTEM FOR REGISTRATION AND LISTING.
SEC. 704. ELECTRONIC SYSTEM FOR REGISTRATION AND LISTING.
Section 510(p) (21 U.S.C. 360(p)) is amended—
(1) by striking “(p) Registrations and listings” and inserting the following:
“(p) Electronic Registration and Listing.
“(1) In general. Registrations and listings”
; and
(2) by adding at the end the following:
“(2) Electronic database. Not later than 2 years after the Secretary specifies a unique facility identifier system under subsections (b) and (i), the Secretary shall maintain an electronic database, which shall not be subject to inspection under subsection (f), populated with the information submitted as described under paragraph (1) that—
“(A) enables personnel of the Food and Drug Administration to search the database by any field of information submitted in a registration described under paragraph (1), or combination of such fields; and
“(B) uses the unique facility identifier system to link with other relevant databases within the Food and Drug Administration, including the database for submission of information under section 801(r).
“(3) Risk-based information and coordination. The Secretary shall ensure the accuracy and coordination of relevant Food and Drug Administration databases in order to identify and inform risk-based inspections under section 510(h).”
.