PUBLIC LAW 102-571—OCT. 29, 1992

106 STAT. 4495

"(A) owns a prescription drug establishment, at which
is manufactured at least 1 prescription drug product which
is not the, or not the same as a, product approved under
an application filed under section 505(b)(2) or 505(j), and
"(B) after September 1, 1992, had pending before the
Secretary a human drug application or supplement,
shall be subject to the annual fee established in subsection
(b) for each such establishment, payable on or before January
31 of each year.

"(3) PRESCRIPTION DRUG PRODUCT FEE.—

"(A) IN GENERAL.—Except as provided in subparagraph
(B), each person—

"(i) who is named as the applicant in a human
drug application for a prescription drug product which
is listed under section 510, and

"(ii) who, after September 1, 1992, had pending
before the Secretary a human drug application or
supplement,

shall pay for each such prescription drug product the
annual fee established in subsection (b). Such fee shall
be payable at the time of the first such listing of such
product in each calendar year. Such fee shall be paid only
once each year for each listed prescription drug product
irrespective of the number of times such product is listed
under section 510.

"(B) EXCEPTION.—The listing of a prescription drug
product under section 510 shall not require the person
who listed such product to pay the fee prescribed by
subparagraph (A) if such product is the same product as
a product approved under an application filed under section
505(b)(2)or505(j).
"(b) FEE AMOUNTS.—

"(1) SCHEDULE.—Except as provided in paragraph (2) and
subsections (c), (d), (f), and (g), the fees required under sub-
section (a) shall be paid in accordance with the following
schedule:

Fiscal Year 1993
Fiscal Year 1994
Fiscal Year 1995
Fiscal Year 1996
Fiscal Year 1997

Drug application fee: Subsection (aXIXAXi) fee ...... Subsection (aXIXAXii) fee ..... Pee revenue ...... . .....
$100,000
$50,000 $12,000,000
$150,000
$75,000 $18,000,000
$208,000
$104,000 $25,000,000
$217,000
$108,000 $26,000,000
$233,000
$116,000 $28,000,000

Annual establishment fee: Fee per eetab-
$60,000
$88,000
$126,000
$131,000
$138,000

Fee revenue ., ..........
$12,000 000
$18 000,000
$25,000,000
$26,000,000
$28,000,000

Annual product fee: Fee per product ...... Fee revenue .........
$6,000 $12000000
$9,000 $18 000,000
$12,500 $25,000,000
$13,000 $26,000,000
$14,000 $28,000,000

Total fee revenues .........
$36,000,000
$54,000,000
$75,000,000
$78,000,000
$84,000,000

"(2) SMALL BUSINESS EXCEPTION.—Any business which has
fewer than 500 employees, including employees of affiliates,
and which does not have a prescription drug product introduced