PUBLIC LAW 102-571—OCT. 29,1992 106 STAT. 4497

"(e) EFFECT OF FAILURE To PAY FEES.—A human drug applica-
tion or supplement submitted by a person subject to fees under
subsection (a) shall be considered incomplete and shall not be
accepted for filing by the Secretary until all fees owed by such
person have been paid.

"(f) ASSESSMENT OF FEES.—

a(l) LIMITATION.—Fees may not be assessed under sub-
section (a) for a fiscal year beginning after fiscal year 1993
unless appropriations for salaries and expenses of the Food
and Drug Administration for such fiscal year (excluding the
amount of fees appropriated for such fiscal year) are equal
to or greater than the amount of appropriations for the salaries
and expenses of the Food and Drug Administration for the
fiscal year 1992 multiplied by the adjustment factor applicable
to the fiscal year involved.

"(2) AUTHORITY.—If the Secretary does not assess fees
under subsection (a) during any portion of a fiscal year because
of paragraph (1) and if at a later date in such fiscal year
the Secretary may assess such fees, the Secretary may assess
and collect such fees, without any modification in the rate,
for human drug applications and supplements, prescription
drug establishments, and prescription drug products at any
time in such fiscal year notwithstanding the provisions of sub-
section (a) relating to the date fees are to be paid,
"(g) CREDITING AND AVAILABILITY OF FEES.—

"(1) IN GENERAL.—Fees collected for a fiscal year pursuant
to subsection (a) shall be credited to the appropriation account
for salaries and expenses of the Food and Drug Administration
and shall be available in accordance with appropriation Acts
until expended without fiscal year limitation.

"(2) COLLECTIONS AND APPROPRIATION ACTS.—The fees
authorized by this section—

"(A) shall be collected in each fiscal year in an amount
equal to the amount specified in appropriation Acts for
such fiscal year, and

"(B) shall only be collected and available to defray
increases in the costs of the resources allocated for the
process for the review of human drug applications (includ-
ing increases in such costs for an additional number of
full-time equivalent positions in the Department of Health
and Human Services to be engaged in such process) over
such costs for fiscal year 1992 multiplied by the adjustment
factor.

"(3) AUTHORIZATION OF APPROPRIATIONS.—There are
authorized to be appropriated for fees under this section—
"(A) $36,000,000 for fiscal year 1993,
"(B) $54,000,000 for fiscal year 1994,
a(C)! 175,000,000 for fiscal year 1995,
"(D) $78,000,000 for fiscal year 1996, and
"(E) $84,000,000 for fiscal year 1997,

as adjusted to reflect increases in the total fee revenues made
under subsection (cXl).

"(h) COLLECTION OF UNPAID FEES.—In any case where the
Secretary does not receive payment of a fee assessed under sub-
section (a) within 30 days after it is due, such fee shall be treated
as a claim of the United States Government subject to subchapter
II of chapter 37 of title 31, United States Code.