PUBLIC LAW 102-571—OCT. 29,1992 106 STAT. 4493

"(6) The term 'process for the review of human drug applica-
tions' means the following activities of the Secretary with
respect to the review of human drug applications and supple-
ments:

"(A) The activities necessary for the review of human
drug applications and supplements.

"(B) The issuance of action letters which approve
human drug applications or which set forth in detail the
specific deficiencies in such applications and, where appro-
priate, the actions necessary to place such applications
in condition for approval.

"(C) The inspection of prescription drug establishments
and other facilities undertaken as part of the Secretary's
review of pending human drug applications and supple-
ments.

"(D) Activities necessary for the review of applications
for licensure of establishments subject to section 351 of
the Public Health Service Act and for the release of lots
of biologies under such section.

"(E) Monitoring of research conducted in connection
with the review of human drug applications.
"(7) The term 'costs of resources allocated for the process
for the review of human drug applications' means the expenses
incurred in connection with the process for the review of human
drug applications for—

"(A) officers and employees of the Food and Drug
Administration, employees under contract with the Food
and Drug Administration who work in facilities owned
or leased for the Food and Drug Administration, advisory
committees, and costs related to such officers, employees,
and committees,

"(B) management of information, and the acquisition,
maintenance, and repair of computer resources,

"(C) leasing, maintenance, renovation, and repair of
facilities and acquisition, maintenance, and repair of fix-
tures, furniture, scientific equipment, and other necessary
materials and supplies, and

"(D) collecting fees under section 736 and accounting
for resources allocated for the review of human drug
applications and supplements.

"(8) The term 'adjustment factor* applicable to a fiscal
year is the lower of—

"(A) the Consumer Price Index for all urban consumers
(all items; United States city average) for August of the
preceding fiscal year divided by such Index for August
1992, or

"(B) the total of discretionary budget authority pro-
vided for programs in the domestic category for the imme-
diately preceding fiscal year (as reported in the Office
of Management and Budget sequestration preview report,
if available, required under section 254(d) of the Balanced
Budget and Emergency Deficit Control Act of 1985) divided
by such budget authority for fiscal year 1992 (as reported
in the Office of Management and Budget final sequestration
report submitted after the end of the 102d Congress, 2d
Session).