eral employees stationed in the District of Co-
lumbia that exceeds 3.5 percent.
The Secretary shall, by notice published in the Fed-
eral Register, make an adjustment under this para-
graph within the first 60 days of a fiscal year.
‘‘(2) LIMIT.—The total amount of fees charged,
as adjusted under paragraph (1), for a fiscal year
may not exceed the total costs for such fiscal year
for the resources allocated for the process for the re-
view of device applications and related activities.
‘‘(d) FEE WAIVER OR REDUCTION.—The Secretary
shall grant a waiver from or a reduction of a fee for a
person under subsection (a) if the person has submitted
an application under section 515(c) or section 351 of the
Public Health Service Act and if the Secretary finds—
‘‘(1) that such application is a device applica-
tion for a device which has a humanitarian device
exemption under section 520(m), or
‘‘(2)(A) such waiver or reduction is necessary to
protect the public health, and
‘‘(B) the assessment of the fee would present a
significant barrier to innovation because of limited
resources available to such person or other cir-
cumstances.
‘‘(e) EFFECT OF FAILURE TO PAY FEES.—A device
application or supplement submitted by a person subject
to fees under subsection (a) shall be considered incomplete
and shall not be accepted for review by the Secretary until
all fees owed by such person under subsection (a) have
been paid. The Secretary may discontinue review of any
device application submitted by a person if such person
has not paid all fees owed by such person under subsection
(a).
‘‘(f) ASSESSMENT OF FEES.—
‘‘(1) LIMITATION.—Fees may not be assessed
under subsection (a) for a fiscal year beginning after
fiscal year 1995 unless appropriations for salaries
and expenses of the Food and Drug Administration
for such fiscal year (excluding the amount of fees
appropriated under chapter 7, chapter 97 of title 31,
United States Code, or other authority for such fis-
cal 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
1994 (excluding the amount of fees appropriated
under chapter 7, chapter 97 of title 31, United
States Code, or other authority for such fiscal year)
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 is au-
thorized to assess such fees, the Secretary may as-
sess and collect such fees, without any modification
in the rate to account for the time in which the Sec-
retary could not collect such fees.
‘‘(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) AVAILABILITY.—Not more than 5 percent
of the projected fee receipts in any fiscal year may
be used for activities described in subparagraphs (L)
and (N) of section 741(3), except that up to 15 per-
cent of the projected fee receipts in any fiscal year
may be used for such activities after the Commis-
sioner of the Food and Drug Administration issues
a public notice that the Food and Drug Administra-
tion has met the applicable goals referenced in sec-
tion 2(3) of the Medical Device User Fee Act of
1994. If subsequent to such public notice the Food
and Drug Administration is not meeting such
goals—
‘‘(A) the Commissioner shall issue a public
notice of the Food and Drug Administration’s
actual performance level, and
‘‘(B) not more than 5 percent of projected
fee receipts may be used for such activities until
the Commissioner issues a subsequent notice
that the Food and Drug Administration is
again meeting such goals.
‘‘(3) 
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 device
applications and related activities (including in-
creases in such costs for an additional number
of full-time equivalent employees in the Depart-
ment of Health and Human Services to be en-
gaged in such process) over such costs for fiscal
year 1994 multiplied by the adjustment factor.
‘‘(4) AUTHORIZATION
OF
APPROPRIATIONS.—
There are authorized to be appropriated for fees
under this section—
‘‘(A) $23,000,000 for fiscal year 1995,
‘‘(B) $21,300,000 for fiscal year 1996,
‘‘(C) $23,000,000 for fiscal year 1997,
‘‘(D) $24,000,000 for fiscal year 1998,
and
‘‘(E) $24,000,000 for fiscal year 1999,
as adjusted to reflect the percentage adjustment of
fees authorized under subsection (c)(1).
‘‘(h) COLLECTION OF UNPAID FEES.—In any case
where the Secretary does not receive payment of a fee for
a pending application assessed under subsection (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.
‘‘(i) POSITIONS.—
‘‘(1) GENERAL RULE.—The number of full-time
equivalent employees in the Department of Health
and Human Services not engaged in the process of
the review of device applications and related activi-
ties, may not be reduced by the Secretary to offset
the number of officers, employees, and advisory com-
mittees so engaged.
‘‘(2) EXECUTIVE ORDER AND OTHER LIMITS.—
The number of full-time equivalent employees en-
gaged in the process of the review of device applica-
tions and related activities are not subject to count-
ing or inclusion in the limits on hiring Civilian Per-
sonnel set out in Executive Order 12839 of Feb-
ruary 10, 1993, any other current limit, or any limit
that may be implemented through September 30,
1999. The full-time equivalent employees not so en-
gaged may not be reduced by the Secretary to offset
the number of full-time equivalent employees exempt
from such limit.’’.
SEC. 4. ANNUAL REPORTS.
(a) FIRST REPORT.—Within 90 days after the end
of each fiscal year during which fees are collected under
part 3 of subchapter C of chapter VII of the Federal Food,
Drug, and Cosmetic Act, the Secretary of Health and
Human Services shall submit a report stating the Food
and Drug Administration’s progress in achieving the goals
identified in section 2(3) of this Act during such fiscal
year and that agency’s future plans for meeting such
goals. There shall be included in such report—
(1) a specific statement from the Secretary con-
cerning the Food and Drug Administration’s actions
to reduce the backlog in the review of device applica-