the taxes imposed by section 5701 of such Code
shall, insofar as applicable and not inconsistent with
the provisions of this subsection, apply to the floor
stocks taxes imposed by paragraph (1), to the same
extent as if such taxes were imposed by such section
5701. The Secretary may treat any person who bore
the ultimate burden of the tax imposed by para-
graph (1) as the person to whom a credit or refund
under such provisions may be allowed or made.
SEC. 522. MODIFICATION OF DEPOSIT REQUIREMENT.
(a) IN GENERAL.—Paragraph (1) of section 6302(f)
of the Internal Revenue Code of 1986 is amended by add-
ing at the end the following new sentence: ‘‘This para-
graph shall not apply to 1999 with respect to taxes im-
posed by chapters 51 and 52.’’
(b) EFFECTIVE DATE.—The amendment made by
this section shall take effect on the date of the enactment
of this Act.
PART III—CUSTOMS ACCESS FEE
SEC. 531. CUSTOMS ACCESS FEE.
(a) CUSTOMS ACCESS FEE.—Section 13031 of the
Consolidated Omnibus Budget Reconciliation Act of 1985
(19 U.S.C. 58c) is amended as follows:
(1) Subsection (a) is amended by adding at the
end the following new paragraph:
‘‘(11)(A) For the use of any automated system
of the Customs Service for processing commercial
operations, the Secretary of the Treasury shall as-
sess a fee based on the volume of usage of the sys-
tem.
‘‘(B) The Secretary shall publish in the Federal
Register a notice establishing the fee under this
paragraph to ensure collection in each fiscal year of
the amount appropriated for that fiscal year for the
cost of modernizing automated commercial oper-
ations of the Customs Service and of deploying the
International Trade Data System.’’.
(2) Subsection (b) is amended by adding at the
end the following new paragraph:
‘‘(12) No fee may be charged to a Federal agency
under subsection (a)(11).’’.
(3) Subsection (d) is amended by adding at the
end the following new paragraph:
‘‘(5) The Customs Service shall issue bills on a
monthly basis for the fee charged under subsection
(a)(11).’’.
(4) Subsection (f)(1) is amended by adding at
the end the following:
‘‘The fees authorized under subsection (a)(11) shall be
available for obligation only to the extent and in the
amount provided in advance in appropriations Acts for the
costs of modernizing the automated commercial operations
of the Customs Service and of deploying the International
Trade Data System. The fees authorized under subsection
(a)(11) shall be adjusted accordingly and are authorized
to remain available until expended.’’.
(b) EFFECTIVE DATE.—The amendments made by
this section take effect on October 1, 1999.
PART IV—CUSTOMS AIR AND SEA PASSENGER
PROCESSING FEE AMENDMENTS
SEC. 541. CUSTOMS PASSENGER AND CARGO FEE.
Section 13031 of the Consolidated Omnibus Budget
Reconciliation Act of 1985 (19 U.S.C.58c) is amended as
follows:
(1) Subsection (a)(5) is amended to read as fol-
lows:
‘‘(5)(A) For the arrival of each passenger
aboard a commercial vessel from a place referred to
in subsection (b)(1)(A)(i), $1.75.
‘‘(B) Subject to subsection (f)(5), for the ar-
rival of each passenger aboard a commercial vessel
or commercial aircraft from a place outside the
United States, $6.40, except that—
‘‘(i) the exemptions under clauses (i) and
(iv) of subsection (b)(1)(A) shall not apply; and
‘‘(ii) the exemption under clause (iii) of
subsection (b)(1)(A) shall not apply, except to
the arrival of a ferry which began operating on
or before January 1, 1999.’’.
(2) Subsection (b)(1) is amended—
(A) in subparagraph (A), in the matter
preceding clause (i), by striking ‘‘(a)(5)(B)’’
and inserting ‘‘(a)(5)’’; and
(B) by striking subparagraph (C).
(3) Subsection (f) is amended—
(A) in paragraph (3)—
(i) by redesignating subparagraphs
(B), (C), and (D) as subparagraphs (C),
(D), and (E), respectively;
(ii) by inserting after subparagraph
(A) the following:
‘‘(B) Notwithstanding subparagraph (A) and subject
to paragraph (5), the Secretary of the Treasury is author-
ized to reimburse directly from the fees collected under
paragraph (5)(B) of subsection (a), the Customs ‘Salaries
and Expenses’ appropriation for the costs incurred by the
Secretary for inspectional services, to the following extent:
‘‘(i) Each fee ($6.40) collected pursuant to
paragraph (5)(B) of subsection (a) for services in
connection with the arrival of each passenger ex-
empt, before the enactment of the Discretionary
Spending Offsets Act for Fiscal Year 2000, from
paying a fee under clause (i), (iii), or (iv) of sub-
section (b)(1)(A), except for the arrival of any pas-
senger on a ferry which began operating on or be-
fore January 1, 1999.
‘‘(ii) $1.40 of each fee collected pursuant to
paragraph (5)(B) of subsection (a) for services in
connection with the arrival of all other passengers.’’;
and
(iii) by striking the last sentence of
subparagraph (A); and
(B) by amending paragraph (5) to read as
follows:
‘‘(5) Of the fees charged under paragraph (5)(B) of
subsection (a), the amount specified under paragraph
(3)(B) of this subsection for reimbursement shall be avail-
able for obligation only to the extent and in the amount
provided in advance in appropriations Acts. Such fees
shall apply to documents or tickets issued on or after the
30th day following the enactment of the applicable appro-
priations Act. Such fees are authorized to remain available
until expended.’’.
PART V—HARBOR SERVICES USER FEE
SEC. 551. HARBOR SERVICES FEE.
(a) IN GENERAL.—The Secretary of the Army, acting
through the Chief of Engineers, shall impose a fee on the
owners or operators of commercial vessels for services pro-
vided for the use of ports.
(b) AMOUNT OF FEE.—
(1) INDIVIDUAL FEES.—The amount of the fee
imposed under subsection (a) shall be based on ves-
sel category and vessel capacity unit in accordance
with the following:
(A) Bulkers, $0.12 per vessel capacity
unit.
(B) Tankers, $0.28 per vessel capacity
unit.
(C) General cargo vessels, $2.74 per vessel
capacity unit.
(D) Cruise vessels, $0.12 per vessel capac-
ity unit.
(2) TOTAL
FEES.—The aggregate amount of
fees imposed under subsection (a) in any fiscal year
shall be sufficient to pay the projected total expendi-
tures of the Department of the Army, subject to ap-
propriations, for harbor development, operation, and
maintenance for a fiscal year. If amounts appro-
priated in any fiscal year are less than the amount
collected in fees for the prior fiscal year, then the
rate of the fee for each vessel category shall be re-
duced in the year of the appropriation so as to result
in collections not exceeding the total amount appro-
priated from the Harbor Services Fund for that fis-
cal year.
(c) IMPOSITION OF FEES.—Fees imposed under sub-
section (a) shall be imposed on a voyage basis for commer-
cial vessels and shall be payable by the operator of a com-
mercial vessel upon the first port use by a vessel entering
a United States port from a foreign port or at the origi-
nating port for domestic voyages.
(d) AVAILABILITY OF FEES.—Fees imposed under
subsection (a) in any fiscal year shall be available for obli-
gation in the following fiscal year only to the extent and
in the amount provided in advance in the appropriations
Act for such fiscal year. Such fees are authorized to be
appropriated to remain available until expended.
(e) EXEMPTIONS.—No fee shall be imposed under
subsection (a) for port use—
(1) by the United States or any agency or in-
strumentality of the United States;
(2) in connection with intraport movements;
(3) in connection with transporting commercial
cargo from the United States mainland to Alaska,
Hawaii, or any possession of the United States;
(4) in connection with transporting commercial
cargo from Alaska, Hawaii, or any possession of the
United States to the United States mainland, Alas-
ka, Hawaii, or such possession for ultimate use or
consumption in the United States mainland, Alaska,
Hawaii, or such a possession;
(5) in connection with transporting commercial
cargo within Alaska, Hawaii, or a possession of the
United States; or
(6) in connection with transporting passengers
on vessels, documented under the laws of the United
States, operating solely within the States of Alaska
or Hawaii and adjacent international waters.
(f) REGULATIONS
OF
THE SECRETARY
OF
THE
TREASURY.—The Secretary of the Treasury shall be re-
sponsible for prescribing regulations—
(1) providing for the manner and method of
payment and collection of the fees imposed under
this section;
(2) providing for the posting of bonds to secure
payment of such fees; and
(3) exempting any transaction or class of trans-
actions from such fees where the collection of such
fees is not administratively practical.
(g) REGULATIONS
OF
THE SECRETARY
OF
THE
ARMY.—The Secretary of the Army shall be responsible
for prescribing regulations—
(1) providing for the remittance or mitigation
of penalties and the settlement or compromise of
claims with respect to fees imposed under this sec-
tion;
(2) providing for a period review of amounts
collected under this section to ensure that the fees
charged fairly approximate the cost of services pro-
vided to commercial vessels for port use;
(3) providing for the prospective adjustment of
the rate of the fees imposed under this section for
any one or more of the bulker, tanker, or cruise ves-
sel categories by up to $0.05, or, in the case of the
general cargo vessel category, by up to $0.25, as
necessary to fairly approximate the cost of services
provided to commercial vessels in each vessel cat-
egory; and
(4) such other regulations as may be necessary
to carry out the purposes of this part.
SEC. 552. HARBOR SERVICES FUND.
(a) ESTABLISHMENT.—There is hereby established in
the Treasury of the United States a Harbor Services Fund
(hereinafter in this section referred to as ‘‘the Fund’’) into
which shall be deposited as offsetting receipts all fees col-
lected under section 551 and to which shall be transferred
balances in the Harbor Maintenance Trust Fund estab-
lished under section 9505 of the Internal Revenue Code
of 1986 (26 U.S.C. 9505).
(b) PURPOSES.—
(1) IN GENERAL.— Subject to subsection (c),
amounts in the Fund may be made available for
each fiscal year to pay—
(A) 100 percent of the eligible harbor de-
velopment costs;
(B) 100 percent of the eligible operations
and maintenance costs assigned to commercial
navigation of all ports within the United States;
and
(C) 100 percent of the eligible costs of
maintaining the Federal dredging capability for
the Nation.
(2) ADDITIONAL PURPOSES.—In addition to the
purposes set forth in paragraph (1) of this sub-
section, an amount of up to $100,000,000 per fiscal
year is authorized to be appropriated from the Fund
for dredging of berthing areas and construction and
maintenance of bulkheads associated with a federally
authorized project and for all or a portion of the
non-Federal share of project costs of an eligible non-
Federal interest participating in the construction,
operating, or maintenance of a federally authorized
project.
(c) 
EXPENDITURES
FROM
HARBOR
SERVICES
FUND.—
(1) IN GENERAL.— Except as provided in para-
graph (2), amounts in the Fund shall be available,
as provided in advance in appropriation Acts, to
carry out subsection (b) and for the payment of ex-
penses incurred in administering the fee imposed by
section 551. Such amounts are authorized to be ap-
propriated to remain available until expended.
(2) ST. LAWRENCE
SEAWAY
DEVELOPMENT
CORPORATION.—From the balances transferred to
the Harbor Services Fund pursuant to subsection
(a), such sums as may be necessary are hereby re-
served to implement legislation to be enacted to es-
tablish the Saint Lawrence Seaway Development
Corporation as a Performance Based Organization.
SEC. 553. CONFORMING AMENDMENTS.
(a) WATER RESOURCES DEVELOPMENT ACT
OF
1986.—Upon enactment of an appropriation Act for fiscal
year 2000 authorizing the collection of fees pursuant to
section 551(d), section 210 of the Water Resources Devel-
opment Act of 1986 (33 U.S.C. 2238) shall no longer have
effect.
(b) INTERNAL REVENUE CODE OF 1986.—Upon en-
actment of an appropriation Act for fiscal year 2000 au-
thorizing the collection of fees pursuant to section 551(d),
sections 4461 and 4462 of the Internal Revenue Code of
1986 (26 U.S.C. 4461, 4462) shall no longer have effect.
SEC. 554. DEFINITIONS.
In this part:
(1) The term ‘‘bulker’’ means a waterborne ves-
sel designed to transport dry bulk cargo, including
self-propelled vessels and nonself-propelled vessels.
(2) The term ‘‘commercial cargo’’ means any
cargo transported on a commercial vessel, except
that the term does not include bunker fuel, ship’s
stores, sea stores, or equipment necessary to the op-
eration of a vessel, or fish or other aquatic animal
life caught and not previously landed on shore, and
for purposes of paragraphs (3), (4), and (5) of sec-
tion 551(d), such term shall not include crude oil
with respect to Alaska.
(3) The term ‘‘commercial vessel’’ means any
vessel in excess of 3,000 gross registered tons used
in transporting cargo or passengers by water for
compensation or hire, or in transporting cargo by
water in the business of the owner, lessee, or oper-
ator of the vessel, exceppt that such term shall not
include any ferry engaged primarily in the ferrying
of passengers (including their vehicles) between
points within the United States, or between the
United States and contiguous countries.
(4) The term ‘‘eligible harbor development
costs’’ means the Federal share of the costs associ-
ated with construction of the general navigation fea-
tures at a harbor or inland harbor within the United
States.
(5) The term ‘‘eligible non-Federal interest’’
means a non-Federal interest for a federally author-
ized navigation project at a port where the average
amount of the harbor service fee collected over 3
consecutive fiscal years exceeds the average Federal
expenditures from the Harbor Services Fund at that
port during the same consecutive fiscal years by
$10,000,000.
(6) The term ‘‘ferry’’ means any vessel which
arrives in United States on a regular schedule dur-
(11) The term ‘‘United States mainland’’
means the contiguous 48 States.
(12) The term ‘vessel capacity unit’’ means the
unit measure of vessel capacity represented by net
tonnage, or, in the case of containerships or cruise
vessels, gross tonnage.
SEC. 555. EFFECTIVE DATE.
The fees imposed under section 551(a) shall take ef-
fect on October 1, 1999.
Subtitle F—Human Services
PART I—SOCIAL SECURITY ADMINISTRATION
CLAIMANT REPRESENTATIVE FEES
SEC. 611. ASSESSMENT ON ATTORNEYS WHO RECEIVE
THEIR FEES VIA THE SOCIAL SECURITY AD-
MINISTRATION.
(a) IN GENERAL.—Section 206 of the Social Security
Act (42 U.S.C. 406) is amended by adding at the end the
following new subsection:
‘‘(d) ASSESSMENT ON ATTORNEYS.—
‘‘(1) IN GENERAL.—Whenever a fee for services
is required to be certified for payment to an attorney
from a claimant’s past-due benefits pursuant to sub-
section (a)(4)(A) or (b)(1)(A), the Commissioner
shall impose on the attorney an assessment cal-
culated in accordance with paragraph (2).
‘‘(2) AMOUNT.—
‘‘(A) The amount of an assessment under
paragraph (1) shall be equal to the product ob-
tained by multiplying the amount of the rep-
resentative’s fee that would be required to be so
certified by subsection (a)(4)(A) or (b)(1)(A)
before the application of this subsection, by the
percentage specified in subparagraph (B).
‘‘(B) The percentage specified in this sub-
paragraph is—
‘‘(i) for calendar years before 2001,
6.3 percent, and
‘‘(ii) for calendar years after 2000,
6.3 percent or such different percentage
rate as the Commissioner determines is
necessary in order to achieve full recovery
of the costs of certifying fees to attorneys
from the past-due benefits of claimants.
‘‘(3) COLLECTION.—The Commissioner is au-
thorized to collect the assessment imposed on an at-
torney under paragraph (1) by offset from the
amount of the fee otherwise required by subsection
(a)(4)(A) or (b)(1)(A) to be certified for payment to
the attorney from a claimant’s past-due benefits.
‘‘(4) PROHIBITION ON CLAIMANT REIMBURSE-
MENT.—An attorney subject to an assessment under
paragraph (1) may not, directly or indirectly, re-
quest or otherwise obtain reimbursement for such
assessment from the claimant whose claim gave rise
to the assessment.
‘‘(5) DISPOSITION OF ASSESSMENTS.—Assess-
ments on attorneys collected under this subsection
shall be credited to the Federal Old-Age and Sur-
vivors Insurance Trust Fund and Federal Disability
Insurance Trust Fund, as appropriate.
‘‘(6) AUTHORIZATION
OF
APPROPRIATIONS.—
The assessments authorized under this section shall
be available for obligation only to the extent and in
the amount provided in advance by appropriation
Acts. These amounts are authorized to be appro-
priated to remain available until expended, for ad-
ministrative expenses in carrying out this title and
related laws.’’.
(b) CONFORMING AMENDMENTS.—
(1) Section 206(a)(4)(A) of such Act is amend-
ed by inserting ‘‘and subsection (d)’’ after ‘‘subpara-
graph (B)’’.
(2) Section 206(b)(1)(A) of such Act is amend-
ed by inserting ‘‘, but subject to the provisions of
subsection (d)’’ after ‘‘section 205(i)’’.
(c) EFFECTIVE DATE.—The amendments made by
this section shall apply in the case of any attorney with
respect to whom a fee for services is required to be cer-
tified for payment from a claimant’s past-due benefits
pursuant to subsection (a)(4)(A) or (b)(1)(A) of section
206 of the Social Security Act after the later of—
(1) December 31, 1999, or
(2) the last day of the first month beginning
after the month in which this Act is enacted.
PART II—TEMPORARY ASSISTANCE FOR NEEDY
FAMILIES AMENDMENTS
SEC. 621. FY 2000 STATE TANF SUPPLEMENTAL GRANT LIM-
ITED TO AMOUNT OF GRANT FOR FY 1999.
(a) IN GENERAL.—Section 403(a)(3) of the Social
Security Act (42 U.S.C. 603(a)(3)) is amended—
(1) in subparagraph (A)—
(A) in clause (i), by striking ‘‘and’’ at the
end;
(B) in clause (ii)—
(i) by striking ‘‘each of fiscal years
1999, 2000, 2001’’ and inserting ‘‘fiscal
year 1999’’; and
(ii) by striking the period and insert-
ing a semicolon; and
(C) by adding at the end the following:
‘‘(iii) for fiscal year 2000, a grant in
an amount equal to the amount of the
grant to the State under clause (ii) for fis-
cal year 1999; and
‘‘(iv) for fiscal year 2001, a grant in
the amount that would be determined pur-
suant to clause (ii) if the grant for fiscal
year 2000 had been determined pursuant
to former clause (ii) (as in effect during
fiscal year 1999).’’; and
(2) in subparagraph (B), by striking ‘‘subpara-
graph (A)(ii)’’ and inserting ‘‘clause (ii), (iii), or (iv)
of subparagraph (A)’’.
PART III—TEMPORARY ASSISTANCE FOR NEEDY
FAMILIES CONTINGENCY FUND
SEC. 631. DEPOSITS INTO FUND.
Section 403(b)(2) of the Social Security Act (42
U.S.C. 603(b)(2)) is amended by striking ‘‘in a total
amount not to exceed $2,000,000,000’’.
(c) STATE
WITH
SUBSTANTIAL
UNOBLIGATED
GRANTS REQUIRED
TO RETURN ALL CONTINGENCY
FUND GRANTS.—Section 403(b)(6) of such Act (42
U.S.C. 603(b)(6)) is amended—
(1) in subparagraph (A), in the matter pre-
ceding clause (i), by inserting ‘‘the amount specified
in subparagraph (D), if applicable, and otherwise’’
after ‘‘is not a needy State’’; and
(2) by adding at the end the following:
‘‘(D) FULL
REPAYMENT
REQUIRED
IF
STATE
HAS
SUBSTANTIAL
FUNDS
UNOBLI-
GATED.—A State shall remit to the Secretary,
as provided in subparagraph (A), the entire
payment made under this subsection for a fiscal
year if the State fails to obligate, on or before
the last day of the fiscal year—
‘‘(i) 90 percent of all grants under
subsection (a)(1) to which the State is en-
titled for the fiscal year; and
‘‘(ii) all grants received under sub-
section (a) for prior fiscal years.’’.
SEC. 634. EFFECTIVE DATE.
The amendments made by this part shall be effective
with respect to fiscal year 2000 and succeeding fiscal
years.
Subtitle G—Health Care
PART I—MEDICARE SAVERS
SEC. 711. REFERENCES IN PART.
Except as otherwise provided in this part, references
to a section or other provision of law are references to
the Social Security Act, and amendments made by this
part to a section or other provision of law are amendments
to such section or other provision of that Act.
SEC. 712. REDUCTION OF CLINICAL DIAGNOSTIC LABORA-
TORY TEST CAP FROM 74 PERCENT TO 72
PERCENT.
Section 1833(h)(4)(B) (42 U.S.C. 13951(h)(4)(B)) is
amended—
(1) by striking ‘‘and’’ at the end of clause (vii);
(2) in clause (viii)—
(A) by inserting ‘‘and before January 1,
2000,’’ after ‘‘December 31, 1997,’’; and
(B) by striking the period and inserting ‘‘,
and’’; and
(3) by adding at the end the following new
clause:
‘‘(ix) after December 31, 1999, is equal to 72
percent of such median.’’.
SEC. 713. ESTABLISHMENT OF NATIONAL LIMIT ON PAY-
MENTS FOR PROSTHETICS AND ORTHOTICS.
Section 1834(h) (42 U.S.C. 1395m(h)) is amended—
(1) in paragraph (1)—
(A) in subparagraph (B)(ii), by inserting
‘‘or (3), as applicable,’’ after ‘‘paragraph (2)’’;
and
(B) in subparagraph (E)—
(i) in the heading, by inserting before
the period ‘‘FOR
ITEMS
FURNISHED
BE-
FORE 2000’’; and
(ii) by striking ‘‘Payment for’’ and in-
serting ‘‘For items furnished before 2000,
payment for’’;
(2) in paragraph (2)—
(A) in the heading, by inserting before the
period ‘‘FOR ITEMS FURNISHED BEFORE 2000’’;
(B) in the matter preceding subparagraph
(A), by striking ‘‘For purposes of’’ and insert-
ing ‘‘For items furnished before 2000, for pur-
poses of’’;
(C) in subparagraph (B)(ii), by striking
‘‘for each subsequent year’’ and inserting ‘‘for
each of 1993 through 1999’’;
(D) in subparagraph (C)—
(i) in the heading, by inserting before
the period ‘‘FOR
ITEMS
FURNISHED
BE-
FORE 2000’’;
(ii) in the matter preceding clause (i),
by striking ‘‘For purposes of’’ and insert-
ing ‘‘For items furnished before 2000, for
purposes of’’; and
(iii) in clause (iv), by striking ‘‘1994
or a subsequent year’’ and inserting ‘‘each
of 1994 through 1999’’; and
(E) in subparagraph (D)(ii), by striking
‘‘in a subsequent year’’ and inserting ‘‘in each
of 1993 through 1999’’;
(3) by redesignating paragraphs (3) and (4) as
paragraphs (4) and (5), respectively;
(4) by inserting after paragraph (2) the fol-
lowing new paragraph:
‘‘(3) PURCHASE PRICE RECOGNIZED FOR 2000
AND SUBSEQUENT YEARS.—For 2000 and each sub-
sequent year, for purposes of paragraph (1), the
amount recognized under this paragraph as the pur-
chase price for prosthetic devices, orthotics, and
prosthetics is the national limited payment amount
for purchase of the item for that year determined in
accordance with subparagraphs (B) and (C) of sec-
tion 1834(a)(2).’’; and
(5) in paragraph (5)(A), as so redesignated—
(A) by adding ‘‘and’’ at the end of clause
(iv);
(B) by amending clause (v) to read as fol-
lows:
‘‘(v) for 1998 and 1999, 1 percent.’’;
and
(C) by striking clause (vi).
SEC. 714. REDUCTION IN PAYMENT FOR BAD DEBTS.
(a) REDUCTION IN PAYMENT FOR HOSPITAL BAD
DEBTS.—Section 
1861(v)(1)(T)(iii) 
(42 
U.S.C.
1395x(v)(1)(T)(iii)) is amended by striking ‘‘45 percent’’
and inserting ‘‘55 percent’’.
(b) EXTENSION OF BAD DEBT PAYMENT LIMITA-
TION TO OTHER RELEVANT FACILITIES AND PROVIDERS
OF
SERVICES.—Section 
1861(v)(1)(T) 
(42 
U.S.C.
1395x(v)(1)(T)), as amended by subsection (a), is further
amended—
(1) by redesignating clauses (i) through (iii) as
subclauses (I) through (III), respectively;
(2) by inserting ‘‘(i)’’ after ‘‘(T)’’; and
(3) by adding at the end the following new
clause:
‘‘(ii) In determining such reasonable or allowable
costs for all facilities or other providers of services entitled
to claim bad debt reimbursement, the amount of bad debts
treated as allowable costs which are attributable to the
deductibles and coinsurance amounts under this title shall
be reduced for cost reporting periods beginning on or after
October 1, 1999, by 55 percent of such amount otherwise
allowable.’’.
(c) REPEAL OF MORATORIUM ON BAD DEBT POL-
ICY.—Section 4008(c) of the Omnibus Budget Reconcili-
ation Act of 1987 (42 U.S.C. 1395f note) is repealed.
SEC. 715. PPS HOSPITAL PAYMENT UPDATE FOR FISCAL
YEAR 2000.
Section 
1886(b)(3)(B)(i)(XV) 
(42 
U.S.C.
1395ww(b)(3)(B)(i)(XV)) is amended by striking ‘‘the
market basket percentage increase minus 1.8 percentage
points for hospitals in all areas’’ and inserting ‘‘0 per-
cent’’.
SEC. 716. NO MARKUP FOR COVERED DRUGS; ELIMINATION
OF OVERPAYMENTS FOR EPOGEN.
(a) NO MARKUP
FOR COVERED DRUGS.—Section
1842(o)(1) (42 U.S.C. 1395u(o)(1)) is amended by strik-
ing ‘‘is equal to 95 percent of the average wholesale price.’’
and inserting ‘‘is equal to—
‘‘(A) for 1998 and 1999, 95 percent of the
average wholesale price, and
‘‘(B) for 2000 and each subsequent year,
83 percent of the average wholesale price.’’.
(b) 
ELIMINATION
OF
OVERPAYMENTS
FOR
EPOGEN.—Section 
1881(b)(11)(B)(ii) 
(42 
U.S.C.
1395rr(b)(11)(B)(ii)) is amended—
(1) in subclause (I)—
(A) by striking ‘‘provided during 1994’’
and inserting ‘‘provided before 2000’’; and
(B) by striking ‘‘and’’ at the end;
(2) by redesignating subclause (II) as subclause
(III); and
(3) by inserting after subclause (I) the fol-
lowing new subclause:
‘‘(II) for erythropoietin provided during
2000, in an amount equal to $9 per thousand
units (rounded to the nearest 100 units), and’’.
SEC. 717. PARTIAL HOSPITALIZATION SERVICES.
(a) SERVICES NOT TO BE FURNISHED IN RESIDEN-
TIAL
SETTINGS.—Section 1861(ff)(3)(A) (42 U.S.C.
1395x(ff)(3)(A)) is amended by inserting ‘‘other than in
an individual’s home or in an inpatient or residential set-
ting’’ before the period.
100
(b) ADDITIONAL REQUIREMENTS FOR COMMUNITY
MENTAL HEALTH CENTERS.—Section 1861(ff)(3)(B) (42
U.S.C. 1395x(ff)(3)(B)) is amended by striking ‘‘entity—
’’ and all that follows and inserting the following: ‘‘entity
that—
‘‘(i) provides the services specified in section
1913(c)(1) of the Public Health Service Act;
‘‘(ii) meets applicable certification or licensing
requirements for community mental health centers
in the State in which it is located; and
‘‘(iii) meets such additional standards or re-
quirements as the Secretary may specify in the in-
terest of the health and safety of individuals fur-
nished services, or for the effective or efficient fur-
nishing of services.’’.
(c) EFFECTIVE DATE.—The amendments made by
subsections (a) and (b) apply to services furnished after
the date that is 60 days after the date of enactment of
this part.
SEC. 718. INFORMATION REQUIREMENTS.
(a) INFORMATION FROM GROUP HEALTH PLANS.—
Section 1862(b) (42 U.S.C. 1395y(b)) is amended by add-
ing at the end the following new paragraph:
‘‘(7) INFORMATION
FROM
GROUP
HEALTH
PLANS.—
101
‘‘(A) PROVISION
OF
INFORMATION
BY
GROUP HEALTH PLANS.—The administrator of
a group health plan subject to the requirements
of paragraph (1) shall provide to the Secretary
any or all of the information elements listed in
subparagraph (C), and in such manner and at
such times (but not more frequently than four
times per year), as the Secretary may specify,
with respect to each individual covered under
the plan and entitled to benefits under this
title.
‘‘(B) PROVISION
OF
INFORMATION
BY
DEPLOYERS
WIND
EMPLOYEE
ORGANIZA-
TIONS.—An employer (or employee organiza-
tion) that maintains or participates in a group
health plan subject to the requirements of para-
graph (1) shall provide to the administrator of
the plan any or all of the information elements
listed in subparagraph (C), and in such manner
and at such times (but not more frequently
than four times per year), as the Secretary may
specify, with respect to each individual covered
under the plan and entitled to benefits under
this title.
102
‘‘(C) INFORMATION ELEMENTS TO BE PRO-
VIDED.—The information elements to be pro-
vided under subparagraph (A) or (B) are the
following:
‘‘(i) ELEMENTS CONCERNING THE IN-
DIVIDUAL.—
‘‘(I) The individual’s name.
‘‘(II) The individual’s date of
birth.
‘‘(III) The individual’s sex.
‘‘(IV) The individual’s social se-
curity number.
‘‘(V) The number assigned by the
Secretary to the individual for claims
under this title.
‘‘(VI) The family relationship of
the individual to the person who has
or had current or former employment
status with the employer.
‘‘(ii) ELEMENTS
CONCERNING
THE
FAMILY
MEMBER
WITH
CURRENT
OR
FORMER EMPLOYMENT STATUS.—
‘‘(I) The name of the person in
the individual’s family who has cur-
103
rent or former employment status
with the employer.
‘‘(II) That person’s social secu-
rity number.
‘‘(III) The number or other iden-
tifier assigned by the plan to that per-
son.
‘‘(IV) The periods of coverage for
that person under the plan.
‘‘(V) The employment status of
that person (current or former) dur-
ing those periods of coverage.
‘‘(VI) The classes of that per-
son’s family members covered under
the plan.
‘‘(iii) PLAN ELEMENTS.—
‘‘(I) The nature of the items and
services covered under the plan.
‘‘(II) The name and address to
which claims under the plan are to be
sent.
‘‘(III) The name, address, and
tax identification number of the plan
sponsor.
104
‘‘(iv) ELEMENTS
CONCERNING
THE
EMPLOYER.—
‘‘(I) The employer’s name.
‘‘(II) The employer’s address.
‘‘(III) The employer identifica-
tion number of the employer.
‘‘(IV) The employer tax identi-
fication number of the employer (if
different from the number under sub-
clause (III)).
‘‘(D) USE OF IDENTIFIERS.—The adminis-
trator of a group health plan shall utilize an
identifier for the plan (that the Secretary may
furnish) in providing information under sub-
paragraph (A) and in other transactions, as
may be specified by the Secretary, related to
the provisions of this subsection.
‘‘(E) PENALTY
FOR
NONCOMPLIANCE.—
Any entity that knowingly and willfully fails to
comply with a requirement imposed by the pre-
vious subparagraphs shall be subject to a civil
money penalty not to exceed $1,000 for each in-
cident of such failure. The provisions of section
1128A (other than subsections (a) and (b))
shall apply to a civil money penalty under the
105
previous sentence in the same manner as those
provisions apply to a penalty or proceeding
under section 1128A(a).’’.
(b) EFFECTIVE DATE.—The amendment made by
subsection (a) is effective 180 days after the date of enact-
ment of this part.
SEC. 719. CENTERS OF EXCELLENCE.
(a) IN GENERAL.—Title XVIII (42 U.S.C. 1395 et
seq.) is amended by inserting after section 1888 the fol-
lowing new section:
‘‘CENTERS OF EXCELLENCE
‘‘SEC. 1889. (a) IN GENERAL.—The Secretary shall
use a competitive process to contract with specific hos-
pitals or other entities for furnishing services related to
surgical procedures, and for furnished services (unrelated
to surgical procedures) to hospital inpatients that the Sec-
retary determines to be appropriate. Such services may in-
clude any services covered under this title that the Sec-
retary determines to be appropriate, including post-hos-
pital services.
‘‘(b) QUALITY STANDARDS.—Only entities that meet
quality standards established by the Secretary shall be eli-
gible to contract under this section. Entities shall imple-
ment a quality improvement plan approved by the Sec-
retary.
106
‘‘(c) PAYMENT.—Payment under this section shall be
made on the basis of negotiated all-inclusive rates. The
amount of payment made by the Secretary to an entity
under this title for services covered under a contract shall
be less than the aggregate amount of the payments that
the Secretary would have otherwise made for the services.
‘‘(d) CONTRACT PERIOD.—A contract period shall be
3 years (subject to renewal), as long as the entity con-
tinues to meet quality and other contractual standards.
‘‘(e) INCENTIVES FOR USE OF CENTERS.—The Sec-
retary may permit entities under a contract under this sec-
tion to furnish additional services or waive beneficiary
cost-sharing, subject to the approval of the Secretary.
‘‘(f) LIMIT ON NUMBER OF CENTERS.—The Sec-
retary shall limit the number of centers in a geographic
area to the number needed to meet projected demand for
contracted services.’’.
(b) EFFECTIVE DATES.—
(1) The amendment made by subsection (a) ap-
plies to services furnished on or after October 1,
2000.
(2) Not later than October 1, 2000, the Sec-
retary shall enter into contracts under the amend-
ment made by subsection (a) for coronary artery by-
pass surgery and other heart procedures, knee re-
107
placement surgery, and hip replacement surgery, in
geographic areas nationwide such that at least 20
percent of the projected number of those procedures
can be provided.
SEC. 719A. EFFECT OF ENACTMENT.
Not more than $1,100,000,000 of the savings for fis-
cal year 2000 resulting from the enactment of this part
may be treated as negative discretionary budget authority
and outlays for such fiscal year.
PART II—FOOD AND DRUG ADMINISTRATION
USER FEES
SEC. 720. REFERENCES IN PART.
Except as otherwise provided in this part, references
to a section or other provision of law are references to
the Federal Food, Drug, and Cosmetic Act, and amend-
ments made by this part to a section or other provision
of law are amendments to such section or other provision
of that Act.
Subpart A—Medical Device Fees
SEC. 721. SHORT TITLE.
This subpart may be cited as the ‘‘Medical Device
Fee Act of 1999’’.
SEC. 722. FEES RELATING TO DEVICES.
Chapter VII (21 U.S.C. 371 et seq.) is amended—
108
(1) by redesignating sections 741, 742, 746,
751, 752, and 756, respectively; and
(2) by adding at the end of subchapter C the
following new part:
‘‘PART 3—FEES RELATING TO DEVICES
‘‘SEC. 741. DEFINITIONS.
‘‘For the purposes of this part, the terms listed in
this section have the following meanings:
‘‘(1) DEVICE APPLICATIONS.—The term ‘device
application’ means—
‘‘(A) an application for approval of a de-
vice submitted under section 515(c) or section
351 of the Public Health Service Act;
‘‘(B) a supplement to an application de-
scribed in subparagraph (A); or
‘‘(C) a product development protocol de-
scribed in section 515(f).
‘‘(2) SUPPLEMENT.—The term ‘supplement’
means a request to the Secretary to approve a
change in a device for which a notice of completion
has become effective under section 515(f) or for
which an application has been approved under sec-
tion 515(d) or under section 351 of the Public
Health Service Act.
109
‘‘(3) ESTABLISHMENT.—The term ‘establish-
ment’ means an establishment engaged in the manu-
facture, preparation, propagation, compounding, or
processing of a device or devices, with respect to
which the person owning or operating such establish-
ment is subject to the annual registration require-
ment under section 510. For purposes of the fees
under this part, a place of business that is owned or
operated by a single person, and which is at 1 gen-
eral physical location consisting of 1 or more build-
ings all of which are within 5 miles of each other,
shall be considered a single establishment.
‘‘(4) PERIODIC PMA REPORT.—The term ‘peri-
odic PMA report’ means any of such periodic reports
as the Secretary may be regulation require of the
holder of an approved premarket application or
product development protocol pursuant to section
515.
‘‘(5) PROCESS FOR THE REVIEW OF DEVICE AP-
PLICATIONS.—The term ‘process for the review of
device applications’ means the following activities of
the Secretary with respect to the review of device ap-
plications and related activities:
110
‘‘(A) The activities necessary for the re-
view of device applications and related activi-
ties.
‘‘(B) The issuance of action letters which
allow marketing of devices or which set forth in
detail the specific deficiencies in such applica-
tions and, where appropriate, the actions nec-
essary to place such applications in approvable
form.
‘‘(C) The inspection of device establish-
ments and other facilities undertaken as part of
the Secretary’s review of pending device appli-
cations.
‘‘(D) Any activity necessary for the review
of applications—
‘‘(i) for licensure of devices subject to
section 351 of the Public Health Service
Act; and
‘‘(ii) for the release of lots of such de-
vices.
‘‘(E) Review of device applications for an
investigational new drug exemption under sec-
tion 505(i) or for an investigational device ex-
emption under section 520(g) and activities
111
conducted in anticipation of the submission of
an application under section 505(i) or 520(g).
‘‘(F) The development of guidance, policy
documents, or regulations to improve the proc-
ess for the review of device applications.
‘‘(G) The development of test methods or
standards in connection with the review of de-
vice applications and related activities.
‘‘(H) The provision of technical assistance
to device manufacturers in connection with the
submission of a device application.
‘‘(I) Any activity undertaken under section
513 or 515(i) in connection with the initial clas-
sification or reclassification of a device or under
section 515(b) in connection with any require-
ment for approval of a device.
‘‘(J) Monitoring of research on devices.
‘‘(K) Any activity undertaken under sec-
tion 519(a) or 519(b).
‘‘(L) Evaluation of postmarket studies re-
quired as a condition of an approval of a device
application under section 515(d) or section 351
of the Public Health Service Act.
‘‘(M) Evaluation of postmarket surveil-
lance required under section 522.
112
‘‘(6) COSTS
OF
RESOURCES
ALLOCATED
FOR
THE PROCESS FOR THE REVIEW OF DEVICE APPLI-
CATIONS.—The term ‘costs of resources allocated for
the process for the review of device applications’
means the expenses incurred in connection with the
process for the review of device applications and re-
lated activities for—
‘‘(A) officers and employees of the Food
and Drug Administration, employees under con-
tract with 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 com-
puter resources;
‘‘(C) leasing, maintenance, renovation, and
repair of facilities and acquisition, maintenance,
and repair of fixtures, furniture, scientific
equipment, and other necessary materials, serv-
ices, and supplies; and
‘‘(D) collecting fees under section 742 and
accounting for resources allocated for the re-
view of device applications, including activities
related to the review of applications for fee ex-
ceptions, waivers, and reductions.
113
‘‘(7) ADJUSTMENT FACTOR.—The term ‘adjust-
ment factor’ has the meaning given that term in sec-
tion 735(8), except that references therein—
‘‘(A) to ‘1997’ shall be read to mean
‘1999’; and
‘‘(B) to ‘the 105th Congress’ shall be read
to mean ‘the 106th Congress’.
‘‘SEC. 742. AUTHORITY TO ASSESS AND USE DEVICE FEES.
‘‘(a) TYPES
OF FEES.—Beginning in fiscal year
2000, the Secretary shall assess and collect fees in accord-
ance with this section as follows:
‘‘(1) DEVICE APPLICATION FEE.—
‘‘(A) IN GENERAL.—Subject to the remain-
ing provisions of this section, except as provided
in subparagraph (B), each person that submits
a device application on or after October 1,
1999, shall be subject to the fee prescribed by
subsection (b). Before April 30, 2000, the Sec-
retary shall establish guidelines for the com-
bination of multiple device applications in those
situations where it is appropriate to combine
the applications and assess a single fee. A sin-
gle fee shall be assessed upon an application
which is such a combination.
‘‘(B) EXCEPTIONS.—
114
‘‘(i) 
FURTHER
MANUFACTURING
USE.—No fee shall be required for the sub-
mission of a device application under sec-
tion 351 of the Public Health Service Act
for a product licensed for further manufac-
turing use only.
‘‘(ii) PREVIOUSLY FILED APPLICATION
OR SUPPLEMENT.—If a device application
was—
‘‘(I) submitted by a person that
paid the fee for such application;
‘‘(II) accepted for filing; and
‘‘(III) not approved or was with-
drawn,
the submission of a device application for
the identical device by the same person (or
the person’s licensee, assignee, or suc-
cessor) shall not be subject to a fee under
subparagraph (A).
‘‘(iii) SPECIAL
LABELING
IMPROVE-
MENTS.—No fee shall be required for the
submission of a device application for a
change in approved labeling that enhances
the safety of the device or the safety in the
use of the device.
115
‘‘(2) ESTABLISHMENT
REGISTRATION
FEE.—
Each person that is subject to the annual registra-
tion requirement under section 510 with respect to
1 or more establishments shall be assessed an an-
nual fee established in subsection (b) for each such
establishment.
‘‘(3) PERIODIC PMA REPORT FEE.—Each per-
son that is required to make a periodic PMA report
on or after October 1, 1999, shall be assessed and
annual fee established in subsection (b) for each de-
vice with respect to which such report is required.
‘‘(b) FEE AMOUNTS.—Except as otherwise provided
in this section, the fees required under subsection (a) shall
be determined and assessed as follows:
‘‘(1) FOR FISCAL YEAR 2000.—
‘‘(A) 
APPLICATION
AND
SUPPLEMENT
FEES.—The application fee under subsection
(a)(1) shall be—
‘‘(i) $40,000 for a device application
described in subparagraph (A) or (C) of
section 741(1); and
‘‘(ii) $4,590 for a device application
described in subparagraph (B) of section
741(1).
116
‘‘(B) 
ESTABLISHMENT
REGISTRATION
FEE.—The annual establishment registration
fee under subsection (a)(2) shall be $200.
‘‘(C) PERIODIC
PMA
REPORT
FEE.—The
periodic PMA report fee under subsection
(a)(3) shall be $1,000.
‘‘(2) INFLATION
ADJUSTMENT
FOR
SUBSE-
QUENT YEARS.—The fees established in subsection
(b) shall be adjusted by the Secretary by notice,
published in the Federal Register, for fiscal year
2001 and each succeeding fiscal year to reflect an
inflation adjustment determined as described in sec-
tion 736(c)(1), except that the reference therein to
‘fiscal year 1997’ shall be considered to mean ‘fiscal
year 2000’.
‘‘(c) SPECIAL CIRCUMSTANCES FOR FEE WAIVER OR
REDUCTION; SMALL BUSINESS EXCEPTION.—
‘‘(1) WAIVERS.—The Secretary shall grant a
waiver from or a reduction of a fee for a person
under this subsection if the person has submitted an
application under section 515(c) or 515(f), or under
section 351 of the Public Heath Service Act and if
the Secretary finds—
117
‘‘(A) that such application is a device ap-
plication for a device which has a humanitarian
device exemption under section 520(m); or
‘‘(B)(i) such waiver or reduction is nec-
essary to protect the public health; or
‘‘(ii) the assessment of the fee would
present a significant barrier to innovation be-
cause of limited resources available to such per-
son or other circumstances.
‘‘(2) SMALL BUSINESS EXCEPTION.—
‘‘(A) APPLICATIONS AND SUBMISSIONS.—
The Secretary may waive the fee for any person
employing fewer than 20 employees, including
employees of affiliates (as defined in section
735(9)), that does not have, and whose affili-
ates do not have, an approved application sub-
mitted under section 515(c) or under section
351 of the Public Health Service Act or a
cleared premarket notification under section
510(k).
‘‘(B) 
CERTIFICATION.—The 
Secretary
shall require any person who seeks a waiver in
accordance with subparagraph (A) to certify
such person’s qualification under such subpara-
graph. The Secretary shall periodically publish
118
in the Federal Register a list of persons making
such certification.
‘‘(d) PAYMENT DEADLINE; EFFECT OF FAILURE TO
PAY FEES.—
‘‘(1) DEVICE APPLICATION FEE.—A device ap-
plication fee required under this section shall be due
at the time the application is submitted to the Sec-
retary. A device application or supplement submitted
by a person subject to fees under this section shall
be considered incomplete and shall not be accepted
for review by the Secretary until all such fees owed
by such person have been paid.
‘‘(2) ESTABLISHMENT REGISTRATION FEE.—An
establishment registration fee required under this
section shall be due not later than December 31 of
each year. A device establishment for which a fee
due under this section has not been paid by such
date shall not be considered a registered establish-
ment for purposes of section 510.
‘‘(3) PERIODIC PMA REPORT FEE.—A periodic
PMA report fee shall be due not later than the due
date of the periodic PMA report, as set forth in the
notice approving the PMA application (or, in the
case of a PMA for which reports are required to be
submitted more often than annually, on the due date
119
of the first such report in such fiscal year). A peri-
odic PMA report with respect to which such annual
fee has not been paid by such due date shall not be
considered to have been filed as required in the no-
tice of approval of the PMA.
‘‘(4) ADDITIONAL SANCTIONS.—In addition to
the sanctions described above, the Secretary may—
‘‘(A) discontinue review of any device ap-
plication submitted by a person if such person
has not paid all fees owed under this section;
and
‘‘(B) assess a penalty of 25 percent of the
fee due, in the case of any fee overdue by more
than 3 months.
‘‘(e) REFUND OF FEES.—
‘‘(1) IF DEVICE APPLICATION REFUSED.—The
Secretary shall refund 75 percent of the fee paid
under subsection (d)(1) for any device application
which the Secretary refuses to accept for review.
‘‘(2) IF DEVICE APPLICATION WITHDRAWN.—If
a device application is withdrawn after the Secretary
has accepted it for review, the Secretary may refund
all or a portion of the fee if no substantial work was
performed on the application after acceptance for re-
view. The determination whether to refund all or any
120
portion of the fee shall be in the Secretary’s sole dis-
cretion and shall not be reviewable.
‘‘(f) GENERAL CONDITIONS APPLICABLE TO FEE AS-
SESSMENT AUTHORITY.—
‘‘(1) LIMITATION.—Fees may not be assessed
under this section for a fiscal year beginning after
fiscal year 2000 unless appropriations for such fiscal
year for salaries and expenses of the Food and Drug
Administration (excluding amounts appropriated for
fees under this subchapter), and for that portion of
such appropriation designated for the Center for De-
vices and Radiological Health, equal or exceed such
appropriations for fiscal year 1999 multiplied by the
adjustment factor.
‘‘(2) DELAYED ASSESSMENT.—If the Secretary
does not assess fees under this section 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 modification in the rate, at
any time in such fiscal year notwithstanding the pro-
visions of subsection (d) relating to the date fees are
to be paid.
‘‘(g) CREDITING AND AVAILABILITY OF FEES.—
122
creases in such costs for an additional number of
full-time equivalent employees in the Department of
Health and Human Services to be engaged in such
process) over such costs for fiscal year 1999 multi-
plied by the adjustment factor.
‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—
‘‘(1) DEVICE
APPLICATION
FEES.—There are
authorized to be appropriated for device application
fees under this section—
‘‘(A) $3,645,000 for fiscal year 2000;
‘‘(B) $3,745,000 for fiscal year 2001;
‘‘(C) $3,845,000 for fiscal year 2002;
‘‘(D) $3,945,000 for fiscal year 2003; and
‘‘(E) $4,000,000 for fiscal year 2004.
‘‘(2) ESTABLISHMENT REGISTRATION FEES.—
There are authorized to be appropriated for estab-
lishment registration fees under this section—
‘‘(A) $2,880,000 for fiscal year 2000;
‘‘(B) $2,955,000 for fiscal year 2001;
‘‘(C) $3,030,000 for fiscal year 2002;
‘‘(D) $3,100,000 for fiscal year 2003; and
‘‘(E) $3,200,000 for fiscal year 2004.
‘‘(3) PERIODIC PMA REPORT FEES.—There are
authorized to be appropriated for periodic PMA re-
port fees under this section—
123
‘‘(A) $475,000 for fiscal year 2000;
‘‘(B) $500,000 for fiscal year 2001;
‘‘(C) $525,000 for fiscal year 2002;
‘‘(D) $550,000 for fiscal year 2003; and
‘‘(E) $570,000 for fiscal year 2004.
‘‘(i) COLLECTION OF UNPAID FEES.—In any case
where the Secretary does not receive payment of a fee as-
sessed under this section 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.
‘‘(j) ANNUAL REPORT.—Beginning with fiscal year
2000, not later than 120 days after the end of each fiscal
year during which fees are collected under this part the
Secretary shall prepare and submit to the Committee on
Commerce of the House of Representatives and the Com-
mittee on Health, Education, Labor, and Pensions of the
Senate a report concerning—
‘‘(1) the reduction in the backlog for the review
of device applications and the reduction in the
amount of time to complete review of such applica-
tions after submission;
‘‘(2) the implementation of the authority for
such fees during such fiscal year; and
124
‘‘(3) the use, by the Food and Drug Adminis-
tration, of the fees collected during such fiscal
year.’’.
SEC. 723. SUNSET.
The amendments made by this subpart shall not be
in effect after September 30, 2005.
Subpart B—Fees To Support Costs of Review of Food
and Color Additive Petitions
SEC. 725. SHORT TITLE.
This subpart may be cited as the ‘‘Food and Color
Additive Petition Fee Act of 1999’’.
SEC. 726. FEES TO SUPPORT COSTS OF FOOD AND COLOR
ADDITIVE PETITIONS.
Chapter VII (21 U.S.C. 371 et seq.) is further
amended by adding at the end of subchapter C the fol-
lowing new part:
‘‘PART 4—FEES RELATING TO FOOD AND COLOR
ADDITIVE PETITIONS
‘‘SEC. 750. AUTHORITY TO ASSESS AND USE FEES.
‘‘(a) DEFINITIONS.—For purposes of this part, the
terms listed in this subsection have the following mean-
ings:
‘‘(1) FOOD
ADDITIVE
PETITION.—The term
‘food additive petition’ means a petition submitted
pursuant to section 409(b).
125
‘‘(2) COLOR
ADDITIVE
PETITION.—The term
‘color additive petition’ means a petition submitted
pursuant to section 721(d).
‘‘(3) PETITION REVIEW ACTIVITIES.—The term
‘petition review activities’ means the following activi-
ties of the Secretary with respect to the review of
food additive and color additive petitions:
‘‘(A) The activities necessary for the re-
view of food additive and color additive peti-
tions and related activities.
‘‘(B) The issuance of regulations which
allow marketing of an additive or written cor-
respondence or other documentation which sets
forth the deficiencies in such an additive peti-
tion and, where appropriate, the actions nec-
essary to resolve such deficiencies.
‘‘(C) The evaluation of the regulatory sta-
tus and issuance of correspondence or other
written documentation concerning the sub-
stances described in paragraphs (1) through (4)
of section 908(a).
‘‘(D) The inspection of testing facilities
undertaken as part of the Secretary’s review of
a pending additive petition.
126
‘‘(E) The development of guidance and pol-
icy documents regarding the review of additive
petitions.
‘‘(F) The development of test methods and
standards in connection with the review of addi-
tive petitions and related activities.
‘‘(G) The provision of technical assistance
to prospective petitioners in connection with the
submission of an additive petition.
‘‘(H) Monitoring of studies and data per-
taining to the safety of substances described in
paragraphs (1) through (4) of section 908(a).
‘‘(I) The activities necessary for registra-
tion under section 908.
‘‘(4) COSTS
OF
RESOURCES
ALLOCATED
FOR
PETITION REVIEW ACTIVITIES.—The term ‘costs of
resources allocated for petition review activities’
means the expenses incurred in connection with the
process for the review of food and color additive pe-
titions and related activities for—
‘‘(A) officers and employees of the Food
and Drug Administration, employees under con-
tract with the Food and Drug Administration,
advisory committees, and costs related to such
officers, employees, and committees;
127
‘‘(B) management of information, and the
acquisition, maintenance, and repair of com-
puter resources;
‘‘(C) leasing, maintenance, renovation, and
repair of facilities and acquisition, maintenance,
and repair of fixtures, furniture, scientific
equipment, and other necessary materials, serv-
ices, and supplies; and
‘‘(D) collecting fees under this section and
accounting for resources allocated for petition
review activities, including activities related to
the review of applications for fee exceptions,
waivers, and reductions.
‘‘(5) TIER I, TIER II, TIER III PETITIONS; REGU-
LATORY MODIFICATION.—
‘‘(A) The term ‘tier I petition’ means a pe-
tition for approval of an additional use or uses
of an additive for which a use is already ap-
proved, except as otherwise provided in sub-
paragraph (B).
‘‘(B) The term ‘tier II petition’ means—
‘‘(i) a petition for first-time approval
of any use of an additive (other than a pe-
tition described in subparagraph (C)); or
128
‘‘(ii) a petition for approval of an ad-
ditional use or uses of an already approved
additive, where the proposed additional use
would—
‘‘(I) result in a significant in-
crease in dietary exposure to such
substance; or
‘‘(II) raise novel safety issues.
‘‘(C) The term ‘tier III petition’ means a
petition for first-time approval of any use of an
additive that would—
‘‘(i) result in a significant dietary ex-
posure to such substance; or
‘‘(ii) raise novel safety issues.
‘‘(D) REGULATORY
MODIFICATION.—The
Secretary may by regulation revise the defini-
tions in subparagraphs (A) through (C).
‘‘(6) ADJUSTMENT FACTOR.—The term ‘adjust-
ment factor’ has the meaning given that term in sec-
tion 735(8), except that references therein—
‘‘(A) to ‘1997’ shall be read to mean
‘1999’; and
‘‘(B) to ‘the 105th Congress’ shall be read
to mean ‘the 106th Congress’.
129
‘‘(b) ASSESSMENT OF FEES.—Subject to the remain-
ing provisions of this section, except to the extent other-
wise provided in subsection (d), each person that, on or
after October 1, 1999—
‘‘(1) submits a food or color additive petition;
or
‘‘(2) is required to register under section 908
(other than a person that manufactures, processes,
or packages a substance that is subject to certifi-
cation under section 721(c)(1)), shall be subject to
fees under this part.
‘‘(c) FEE AMOUNTS.—
‘‘(1) FOR INITIAL FISCAL YEARS.—
‘‘(A) FOR FOOD OR COLOR ADDITIVE PETI-
TION.—The fee under this part for a food or
color additive petition shall be—
‘‘(i) FOR FISCAL YEAR 2000.—
‘‘(I) $15,000 for a tier I petition;
‘‘(II) $60,000 for a tier II peti-
tion; and
‘‘(III) $260,000 for a tier III pe-
tition.
‘‘(ii) FOR FISCAL YEAR 2001.—
‘‘(I) $20,000 for a tier I petition;
130
‘‘(II) $88,500 for a tier II peti-
tion; and
‘‘(III) $275,000 for a tier III pe-
tition.
‘‘(iii) FOR FISCAL YEAR 2002.—
‘‘(I) $27,000 for a tier I petition;
‘‘(II) $120,000 for a tier II peti-
tion; and
‘‘(III) $290,000 for a tier III pe-
tition.
‘‘(iv) FOR FISCAL YEAR 2003.—
‘‘(I) $37,000 for a tier I petition;
‘‘(II) $155,000 for a tier II peti-
tion; and
‘‘(III) $345,000 for a tier III pe-
tition.
‘‘(v) FOR FISCAL YEAR 2004.—
‘‘(I) $43,000 for a tier I petition;
‘‘(II) $175,000 for a tier II peti-
tion; and
‘‘(III) $400,000 for a tier III pe-
tition.
‘‘(B) FOR REGISTRATION OF FOOD ADDI-
TIVE AND COLOR ADDITIVE PRODUCERS.—The
131
fee under this part for registration under sec-
tion 908 shall be—
‘‘(i) $4,500 for fiscal year 2000;
‘‘(ii) $7,380 for fiscal year 2001;
‘‘(iii) $9,927 for fiscal year 2002;
‘‘(iv) $12,390 for fiscal year 2003;
and
‘‘(v) $14,853 for fiscal year 2004,
for each place of business listed in the registra-
tion of such person under section 908.
‘‘(2) INFLATION
ADJUSTMENT.—The fees es-
tablished in paragraph (1) shall be adjusted by the
Secretary by notice, published in the Federal Reg-
ister, for fiscal year 2001 and each succeeding fiscal
year to reflect an inflation adjustment determined as
described in section 736(c)(1), except that the ref-
erence therein to ‘fiscal year 1997’ shall be consid-
ered to mean ‘fiscal year 2000’.
‘‘(d) WAIVERS
AND EXCEPTIONS
FOR PETITION
FEES: EXTRAORDINARY CIRCUMSTANCES; SMALL BUSI-
NESS.—
‘‘(1) EXTRAORDINARY
CIRCUMSTANCES.—The
Secretary may waive or reduce food or color additive
petition fees based on extraordinary circumstances
as determined by the Secretary, including the cir-
132
cumstance of a food additive petition for a proposed
use of a substance that is intended to reduce signifi-
cantly human pathogens or their toxins in or on
food, where the petitioner demonstrates that assess-
ment of a fee would present a significant barrier to
innovation because the petitioner has limited re-
sources available.
‘‘(2) SMALL BUSINESSES.—
‘‘(A) IN GENERAL.—Any business that—
‘‘(i) has fewer that 20 employees, in-
cluding employees of affiliates; and
‘‘(ii) has not previously submitted a
petition under section 409 or under section
721,
shall pay 1⁄2 the amount of the petition fee
under this part for the first submission
under such section 409 or section 721.
‘‘(B) AFFILIATE.—For purposes of this
paragraph, the term ‘affiliate’ has the meaning
given that term in section 735(9).
‘‘(e) PAYMENT DEADLINE; EFFECT OF FAILURE TO
PAY FEES.—
‘‘(1) FOOD
AND
COLOR
ADDITIVE
PETITION
FEES.—Fees assessed under this section with re-
spect to a petition shall be due and payable at the
134
determination whether to refund any portion of the
fee shall be in the Secretary’s sole discretion, and
shall not be reviewable.
‘‘(g) GENERAL CONDITIONS APPLICABLE TO FEE
ASSESSMENT AUTHORITY.—
‘‘(1) LIMITATION.—Fees may not be assessed
under this section for a fiscal year beginning after
fiscal year 2000 unless appropriations for such fiscal
year for salaries and expenses of the Food and Drug
Administration (excluding amounts appropriated for
fees under this subchapter), and for that portion of
such appropriation designated for the Center for
Food Safety and Applied Nutrition, equal or exceed
such appropriations for fiscal year 1999 multiplied
by the adjustment factor.
‘‘(2) DELAYED ASSESSMENT.—If the Secretary
does not assess fees under this part during any por-
tion of a fiscal year due to paragraph (1) and if at
a later date in such fiscal year the Secretary may as-
sess such fees, the Secretary may assess and collect
such fees, without modification in the rate, any time
in such fiscal year notwithstanding the provisions of
subsection (e) relating to the date fees are to be
paid.
‘‘(h) CREDITING AND AVAILABILITY OF FEES.—
135
‘‘(1) IN GENERAL.—Fees authorized under this
section shall be available for obligation only to the
extent and in the amounts provided in advance in
appropriations Acts. Such fees are authorized to be
appropriated to remain available until expended sole-
ly for the petition review activities set forth in sub-
section (a)(4). Such fees shall be credited to the ap-
propriation account for salaries and expenses of the
Food and Drug Administration. Any amount of fees
collected for a fiscal year under this subsection that
exceeds the amount of fees made available in appro-
priations Acts for such fiscal year may be credited
to the appropriation account for salaries and ex-
penses of the Food and Drug Administration. Ex-
cess fees may be retained but are not available for
obligation until appropriated. Such sums as may be
necessary may be transferred from the Food and
Drug Administration salaries and expenses appro-
priation account without fiscal year limitation to
such appropriation account for salaries and expenses
with such fiscal year limitation.
‘‘(2) LIMITATION.—The fees authorized by this
section shall only be available to defray increases in
the costs of the resources allocated for petition re-
view activities (including increases in such costs for
136
an additional number of full-time equivalent employ-
ees in the Department of Health and Human Serv-
ices to be engaged in such process) over such costs
for fiscal year 1999, multiplied by the adjustment
factor.
‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—There
are authorized to be appropriated for fees under this
section—
‘‘(1) for food and color additive petitions—
‘‘(A) $1,300,000 for fiscal year 2000;
‘‘(B) $1,675,000 for fiscal year 2001;
‘‘(C) $2,250,000 for fiscal year 2002;
‘‘(D) $2,875,000 for fiscal year 2003; and
‘‘(E) $3,500,000 for fiscal year 2004 and
each succeeding fiscal year; and
‘‘(2) for food ingredient and color additive
producers—
‘‘(A) $2,700,000 for fiscal year 2000;
‘‘(B) $4,428,000 for fiscal year 2001;
‘‘(C) $5,956,000 for fiscal year 2002;
‘‘(D) $7,434,000 for fiscal year 2003; and
‘‘(E) $8,912,000 for fiscal year 2004 and
each succeeding fiscal year,
adjusted to reflect the percentage adjustment of fees au-
thorized under subsection (c).
137
‘‘(j) COLLECTION OF UNPAID FEES.—In any case
where the Secretary does not receive payment of a fee as-
sessed under this section 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.
‘‘(k) PERFORMANCE GOALS.—Upon enactment of
this section, the Secretary shall send to the Congress a
letter which shall declare goals and timetables for review
by the Food and Drug Administration of food additive and
color additive petitions.
‘‘(l) ANNUAL REPORT.—Beginning with fiscal year
2000, not later than 120 days after the end of each fiscal
year during which fees are collected under this part, the
Secretary shall submit to the Committee on Commerce of
the House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the Senate a
report concerning—
‘‘(1) the progress of the Food and Drug Admin-
istration in achieving the goals declared pursuant to
subsection (k);
‘‘(2) the implementation of the authority for
such fees during such fiscal year; and
‘‘(3) the use by the Food and Drug Administra-
tion of the fees collected during such fiscal year.’’.
138
SEC. 727. REGISTRATION OF FOOD INGREDIENT AND
COLOR ADDITIVE PRODUCERS.
(a) 
REGISTRATION
REQUIREMENT
FOR
PRO-
DUCERS.—Chapter IX (21 U.S.C. 391 et seq.) is amended
by adding at the end the following new section:
‘‘SEC. 907. REGISTRATION OF FOOD INGREDIENT AND
COLOR ADDITIVE PRODUCERS.
‘‘(a) REGISTRATION REQUIREMENT.—On or before
October 1, 1999 (or, if later, the date 3 months after the
date of enactment of this section), and on or before Octo-
ber 1 of each succeeding year, a person in any State en-
gaged in the manufacture, processing, or packaging of any
of the following substances shall register with the Sec-
retary the person’s name and all places of business of such
person engaged in such manufacture, processing, or pack-
aging:
‘‘(1) A substance that is subject to regulation
under section 409 of this Act except a substance
that is distributed in interstate commerce on the
basis of section 409(a)(3)(B).
‘‘(2) A substance that is distributed in inter-
state commerce on the basis that it is generally rec-
ognized as safe within the meaning of section 201(s)
of this Act, including any substance listed as gen-
erally recognized as safe in the Code of Federal Reg-
ulations, and any substance asserted to be generally
139
recognized as safe where the Food and Drug Admin-
istration has been notified of such assertion as part
of a notification program of the Food and Drug Ad-
ministration.
‘‘(3) A substance that is distributed in inter-
state commerce on the basis of section 201(s)(4).
‘‘(4) A substance that is subject to regulation
under section 721.
‘‘(b) DELINEATION
OF SINGLE PLACE
OF BUSI-
NESS.—For purposes of this section and part 4 of sub-
chapter C of chapter VII, a place of business that is owned
or operated by a single person, and which is at 1 general
physical location consisting of 1 or more buildings all of
which are within 5 miles of each other, shall be considered
a single place of business.’’.
(b) ARTICLES PRODUCED
BY
AN UNREGISTERED
PERSON.—Section 403 (21 U.S.C. 343) is amended by
adding at the end the following new subsection:
‘‘(t) If it was manufactured, processed, or packaged
in any State by a person not duly registered under section
908.’’.
SEC. 728. AMENDMENTS RELATING TO FOOD ADDITIVE PE-
TITION REVIEW PROCESS.
(a) ACTION
ON
PETITION.—Section 409(c) (21
U.S.C. 348(c)) is amended—
140
(1) in paragraph (1)(A)—
(A) by striking ‘‘(A) by order establish’’
and inserting ‘‘(A) establish’’; and
(B) by striking ‘‘petitioner of such order’’
and inserting ‘‘petitioner of such regulation’’;
(2) in paragraph (1)(B)—
(A) by striking ‘‘(B) by order deny’’ and
inserting ‘‘(B) deny’’; and
(B) by striking ‘‘such order’’ and inserting
‘‘such denial’’;
(3) in paragraph (2)—
(A) by striking ‘‘The order required’’ and
inserting ‘‘The Secretary shall take the action
required’’; and
(B) by striking ‘‘shall be issued’’; and
(4) in paragraph (3) by striking ‘‘No such regu-
lation shall issue if’’ and inserting ‘‘No regulation
shall issue under paragraph (1) if’’.
(b) REGULATION ISSUED ON SECRETARY’S INITIA-
TIVE.—Section 409(d) (21 U.S.C. 348(d)) is amended in
the second sentence by striking ‘‘by order’’.
(c) PUBLICATION AND EFFECTIVE DATE OF OR-
DERS.—Section 409 (21 U.S.C. 348) is amended in sub-
section (e) to read as follows:
141
‘‘(e) Any regulation issued under subsection (c) or (d)
shall be published and shall be effective upon publica-
tion.’’.
(d) JUDICIAL REVIEW.—Section 409(f) (21 U.S.C.
348(f)) is amended read as follows:
‘‘(f)(1) Any person adversely affected by an action
by the Secretary under subsection (c) or (d), including any
amendment or repeal of a regulation issued under this sec-
tion, may obtain judicial review of such action by filing
in the United States Court of Appeals for the circuit in
which such person resides or has his principal place of
business, or in the United States Court of Appeals for the
District of Columbia, within 60 days of such action, a peti-
tion requesting that the regulation be set aside in whole
or in part.
‘‘(2) The court, on such judicial review, shall not sus-
tain the Secretary’s action if such action was not based
upon a fair evaluation of the entire record before the Sec-
retary.’’.
(e) FINALITY OF COURT ORDER.—Section 409(g)
(21 U.S.C. 348(g)) is amended by striking paragraphs (1)
through (4) and by striking the paragraph designation
‘‘(5)’’.
142
(f) ACCESS TO OUTSIDE EXPERTS DURING REVIEW
PROCESS.—Section 409 (21 U.S.C. 348) is amended by
adding at the end the following new subsection:
‘‘(k) ACCESS TO OUTSIDE EXPERTS DURING REVIEW
PROCESS.—Notwithstanding the Federal Advisory Com-
mittee Act (5 U.S.C. App.), the Secretary may consult
with, or seek advice from, a person who is not a full-time
officer or employee of the Federal Government, either as
an individual or as part of a group of such individuals,
for the purpose of obtaining expert scientific review of
data or other information submitted to the Secretary
under this section, if the Secretary determines that the
expertise provided by such individual or group of individ-
uals would contribute to the quality of the scientific review
of such submission or to the timeliness of such review and
such expertise is not otherwise available within the Food
and Drug Administration. The reviews, opinions, and con-
clusions of individuals obtained under the authority of this
subsection shall be reduced to written form and place in
the relevant administrative file.’’.
SEC. 728A. AMENDMENTS RELATING TO COLOR ADDITIVE
PETITION REVIEW PROCESS.
(a) DETERMINATION OF SAFETY OF COLOR ADDI-
TIVES.—Section 721(b)(5) (21 U.S.C. 379e(b)(5)) is
amended by striking subparagraphs (C) and (D).
143
(b) PROCEDURE FOR ISSUANCE, AMENDMENT, OR
REPEAL
OF REGULATIONS.—Subsection (d) of section
721 (21 U.S.C. 379e(d)) is amended to read as follows:
‘‘Procedure for Issuance, Amendment, or Repeal of
Regulations
‘‘(d)(1) The issuance, amendment, or repeal of regu-
lations under subsection (b) may be commenced by a pro-
posal made (A) by the Secretary on the Secretary’s own
initiative, or (B) by petition of any interested person,
showing reasonable grounds therefor, submitted to the
Secretary. Where an action is commenced by the submis-
sion of a petition, the Secretary shall, within 30 days of
its filing by the Secretary, publish notice of such petition,
describing in general terms the action proposed by the pe-
tition. The Secretary shall act upon such petition within
the time period set out in section 409(c)(2) by establishing
a regulation under subsection (b) or by denying such peti-
tion. The Secretary shall notify the petitioner of the action
taken on the petition and the reasons for such action.
‘‘(2) Any regulation issued under this subsection shall
be published and shall be effective upon publication.
‘‘(3)(A) Any person adversely affected by an action
by the Secretary under this subsection, including any
amendment or repeal of a regulation issued under this sec-
tion, may obtain judicial review of such action by filing
144
in the United States Court of Appeals for the circuit in
which such person resides or has his or her principal place
of business, or in the United States Court of Appeals for
the District of Columbia, within 60 days of such action,
a petition requesting that the regulation be set aside in
whole or in part.
‘‘(B) The court, on such judicial review, shall not sus-
tain the Secretary’s action if such action was not based
upon a fair evaluation of the entire record before the Sec-
retary.
‘‘(4) The judgment of the court affirming or setting
aside, in whole or in part, any order under paragraph (3)
shall be final, subject to review by the Supreme Court of
the United States upon certiorari or certification as pro-
vided in section 1254 of title 28 of the United States Code.
The commencement of proceedings under this section shall
not, unless specifically ordered by the court to the con-
trary, operate as a stay of an order.’’.
(c) FEES.—Section 721(e) (21 U.S.C. 379e(e)) is
amended by striking ‘‘admitting to listing and’’.
(d) ACCESS TO OUTSIDE EXPERTS DURING REVIEW
PROCESS.—Section 721 (21 U.S.C. 379e) is amended by
adding at the end the following new subsection:
145
‘‘Access to Outside Experts During Review Process
‘‘(g) Notwithstanding the Federal Advisory Com-
mittee Act (5 U.S.C. App.), the Secretary may consult
with, or seek advice from, a person who is not a full-time
officer or employee of the Federal Government, either as
an individual or as part of a group of such individuals,
for the purpose of obtaining expert scientific review of
data or other information submitted to the Secretary
under this section, if the Secretary determines that the
expertise provided by such individual or group of individ-
uals would contribute to the quality of the scientific review
of such submission or to the timeliness of such review and
such expertise is not otherwise available within the Food
and Drug Administration. The reviews, opinions, and con-
clusions of individuals obtained under the authority of this
subsection shall be reduced to written form and placed in
the relevant administrative file.’’.
Subpart C—Food Contact Substance Notification
Fees
SEC. 729. SHORT TITLE.
This subpart may be cited as the ‘‘Food Contact Sub-
stance Notification Fee Act of 1999’’.
149
‘‘(B) TIER
II
NOTIFICATION.—The term
‘tier II notification’ means a notification for a
use or uses—
‘‘(i) that results in an incremental in-
crease in estimated dietary exposure to the
food contact substances of less than or
equal to 50 parts per billion, but greater
than 0.5 parts per billion in the diet; or
‘‘(ii) that does not require review of
more than 1 animal toxicity study with a
duration of 90 days or more.
‘‘(C) TIER III NOTIFICATION.—The term
‘tier III notification’ means a notification—
‘‘(i) not described in subparagraph
(A) or (B); or
‘‘(ii) for a food contact substance that
is a new food contact material.
‘‘(D) REGULATORY
MODIFICATION.—The
Secretary may by regulation revise the defini-
tions in subparagraphs (A) through (C).
‘‘(6) ADJUSTMENT FACTOR.—The term ‘adjust-
ment factor’ has the meaning given that term in sec-
tion 735(8), except that references therein—
‘‘(A) to ‘1997’ shall be read to mean
‘1999’; and
151
‘‘(d) PAYMENT DEADLINE; EFFECT OF FAILURE TO
PAY FEES.—Fees assessed under this section shall be due
and payable at the time the notification is submitted to
the Secretary. A notification submitted by a person sub-
ject to fees assessed under this section shall be considered
incomplete, shall not be accepted by the Secretary, and
shall 
not 
be 
considered 
effective 
under 
section
409(a)(3)(B) until 120 days after all fees owed by such
persons have been paid.
‘‘(e) GENERAL CONDITIONS APPLICABLE TO FEE AS-
SESSMENT AUTHORITY.—
‘‘(1) LIMITATION.—Fees may not be assessed
under this section for a fiscal year beginning after
fiscal year 2000 unless appropriations for such fiscal
year for salaries and expenses of the Food and Drug
Administration (excluding amounts appropriated for
fees under this subchapter), and for that portion of
such appropriation designated for the Center for
Food Safety and Applied Nutrition, equal or exceed
such appropriations for fiscal year 1999 multiplied
by the adjustment factor.
‘‘(2) DELAYED ASSESSMENT.—If the Secretary
does not assess fees under this part during any por-
tion of a fiscal year because of paragraph (1) and
if at a later date in such fiscal year the Secretary
152
may assess such fees, the Secretary may assess and
collect such fees, without modification in the rate,
for activities related to the regulatory purpose for
which they were collected any time in such fiscal
year notwithstanding the provisions of subsection (d)
relating to the date fees are to be paid.
‘‘(f) CREDITING AND AVAILABILITY OF FEES.—Fees
authorized under this section shall be available for obliga-
tion only to the extent and in the amounts provided in
advance in appropriations Acts. Such fees are authorized
to be appropriated to remain available until expended sole-
ly to support the notification review activities set forth in
subsection (a)(3). Such fees shall be credited to the appro-
priation account for salaries and expenses of the Food and
Drug Administration. Any amount of fees collected for a
fiscal year under this subsection that exceeds the amount
of fees made available in appropriations Acts for such fis-
cal year may be credited to the appropriation account for
salaries and expenses of the Food and Drug Administra-
tion. Excess fees may be retained but are not available
for obligation until appropriated. Such sums as may be
necessary may be transferred from the Food and Drug
Administration salaries and expenses appropriation ac-
count without fiscal year limitation to such appropriation
153
account for salaries and expenses with such fiscal year
limitation.
‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There
are authorized to be appropriated for fees under this sec-
tion $6,000,000 for fiscal year 2000 and each succeeding
fiscal year, as adjusted to reflect the percentage adjust-
ment of fees authorized under subsection (b).
‘‘(h) COLLECTION OF UNPAID FEES.—In any case
where the Secretary does not receive payment of a fee as-
sessed under this section 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.’’.
SEC. 729B. AMENDMENT RELATING TO FOOD CONTACT
SUBSTANCE NOTIFICATION PROCESS.
Section 
409(h)(5)(A)(iv) 
(21 
U.S.C.
348(h)(5)(A)(iv)) is amended to read as follows:
‘‘(iv) For fiscal year 2000 and subse-
quent fiscal years, the applicable amount
under this clause is the amount specified
in section 754(g).’’.
154
PART III—HEALTH CARE FINANCING
ADMINISTRATION USER FEES
SEC. 731. REFERENCES IN PART.
Except as otherwise provided in this part, references
to a section or other provision of law are references to
the Social Security Act, and amendments made by this
part to a section or other provision of law are amendments
to such section or other provision of that Act.
SEC. 732. INCREASE IN MEDICARE+CHOICE FEE FOR EN-
ROLLMENT-RELATED COSTS.
Section 
1857(e)(2)(D)(ii) 
(42 
U.S.C. 
1395w–
27(e)(2)(D)(ii)) is amended—
(1) by adding ‘‘and’’ at the end of subclause
(I);
(2) in subclause (II)—
(A) by inserting ‘‘and each subsequent fis-
cal year’’ after ‘‘in fiscal year 1999’’; and
(B) by striking ‘‘; and’’ and inserting a pe-
riod; and
(3) by striking subclause (III).
SEC. 733. COLLECTION OF FEES FROM MEDICARE+CHOICE
ORGANIZATIONS FOR CONTRACT INITIATION
AND RENEWAL.
Section 1857 (42 U.S.C. 1395w–27) is amended by
adding at the end the following new subsection:
155
‘‘(i) FEES FOR CONTRACT ISSUANCE AND RENEWAL
AND ONGOING MONITORING.—
‘‘(1) AUTHORITY TO IMPOSE FEES.—The Sec-
retary shall impose—
‘‘(A) fees for initial Medicare+Choice con-
tracts under this part; and
‘‘(B) annual fees for renewal of such con-
tracts and monitoring of the ongoing operations
of Medicare+Choice organizations.
‘‘(2) ASSESSMENT OF FEES.—
‘‘(A) TYPES OF FEES.—
‘‘(i) INITIATION FEES.—Fee amounts
assessed against a member of a class of or-
ganizations pursuant to paragraph (1)(A)
shall not exceed the Secretary’s reasonable
estimate of the average cost of initiating a
Medicare+Choice contract for an organiza-
tion in such class.
‘‘(ii) RENEWAL
AND
MONITORING
FEES.—Fee amounts assessed pursuant to
paragraph (1)(B) against members of a
class of organizations shall not exceed the
amount which the Secretary reasonably es-
timates will generate total revenues suffi-
cient to cover total annual costs for renew-
156
ing contracts and performing ongoing mon-
itoring with respect to such class.
‘‘(B) REDUCTION OR WAIVER OF FEES.—
The Secretary may reduce or waive the fees
under this subsection in exceptional cir-
cumstances which the Secretary determines to
be in the public interest.
‘‘(3) COLLECTION AND CREDITING OF FEES.—
‘‘(A) 
INITIAL
FEES.—Fees 
assessed
against an organization pursuant to paragraph
(1)(A) shall be payable upon submission of the
application to participate in the program under
this title as a Medicare+Choice organization
(and shall apply whether or not the Secretary
approves such application) and shall be credited
to the Health Care Financing Administration
Program Management Account.
‘‘(B) RENEWAL AND MONITORING FEES.—
Fees assessed against an organization pursuant
to paragraph (1)(B) shall be payable annually
and may be deducted from amounts otherwise
payable from a Trust Fund under this title to
such organization. Such fees shall be credited to
the Health Care Financing Administration Pro-
gram Management Account.