H. R. 3448—90
under this subsection (and the information contained therein) from
unauthorized disclosure. Such protocols shall ensure that—
‘‘(A) each copy of such assessment, and all information
contained in or derived from the assessment, is kept in a
secure location;
‘‘(B) only individuals designated by the Administrator may
have access to the copies of the assessments; and
‘‘(C) no copy of an assessment, or part of an assessment,
or information contained in or derived from an assessment
shall be available to anyone other than an individual designated
by the Administrator.
At the earliest possible time prior to November 30, 2002, the
Administrator shall complete the development of such protocols
for the purpose of having them in place prior to receiving any
vulnerability assessments from community water systems under
this subsection.
‘‘(6)(A) Except as provided in subparagraph (B), any individual
referred to in paragraph (5)(B) who acquires the assessment sub-
mitted under paragraph (2), or any reproduction of such assessment,
or any information derived from such assessment, and who know-
ingly or recklessly reveals such assessment, reproduction, or
information other than—
‘‘(i) to an individual designated by the Administrator under
paragraph (5),
‘‘(ii) for purposes of section 1445 or for actions under section
1431, or
‘‘(iii) for use in any administrative or judicial proceeding
to impose a penalty for failure to comply with this section,
shall upon conviction be imprisoned for not more than one year
or fined in accordance with the provisions of chapter 227 of title
18, United States Code, applicable to class A misdemeanors, or
both, and shall be removed from Federal office or employment.
‘‘(B) Notwithstanding subparagraph (A), an individual referred
to in paragraph (5)(B) who is an officer or employee of the United
States may discuss the contents of a vulnerability assessment sub-
mitted under this section with a State or local official.
‘‘(7) Nothing in this section authorizes any person to withhold
any information from Congress or from any committee or sub-
committee of Congress.
‘‘(b) EMERGENCY RESPONSE PLAN.—Each community water
system serving a population greater than 3,300 shall prepare or
revise, where necessary, an emergency response plan that incor-
porates the results of vulnerability assessments that have been
completed. Each such community water system shall certify to
the Administrator, as soon as reasonably possible after the enact-
ment of this section, but not later than 6 months after the comple-
tion of the vulnerability assessment under subsection (a), that the
system has completed such plan. The emergency response plan
shall include, but not be limited to, plans, procedures, and identifica-
tion of equipment that can be implemented or utilized in the event
of a terrorist or other intentional attack on the public water system.
The emergency response plan shall also include actions, procedures,
and identification of equipment which can obviate or significantly
lessen the impact of terrorist attacks or other intentional actions
on the public health and the safety and supply of drinking water
provided to communities and individuals. Community water systems
H. R. 3448—91
shall, to the extent possible, coordinate with existing Local Emer-
gency Planning Committees established under the Emergency Plan-
ning and Community Right-to-Know Act (42 U.S.C. 11001 et seq.)
when preparing or revising an emergency response plan under
this subsection.
‘‘(c) RECORD MAINTENANCE.—Each community water system
shall maintain a copy of the emergency response plan completed
pursuant to subsection (b) for 5 years after such plan has been
certified to the Administrator under this section.
‘‘(d) GUIDANCE
TO
SMALL
PUBLIC
WATER
SYSTEMS.—The
Administrator shall provide guidance to community water systems
serving a population of less than 3,300 persons on how to conduct
vulnerability assessments, prepare emergency response plans, and
address threats from terrorist attacks or other intentional actions
designed to disrupt the provision of safe drinking water or signifi-
cantly affect the public health or significantly affect the safety
or supply of drinking water provided to communities and individ-
uals.
‘‘(e) FUNDING.—(1) There are authorized to be appropriated
to carry out this section not more than $160,000,000 for the fiscal
year 2002 and such sums as may be necessary for the fiscal years
2003 through 2005.
‘‘(2) The Administrator, in coordination with State and local
governments, may use funds made available under paragraph (1)
to provide financial assistance to community water systems for
purposes of compliance with the requirements of subsections (a)
and (b) and to community water systems for expenses and contracts
designed to address basic security enhancements of critical impor-
tance and significant threats to public health and the supply of
drinking water as determined by a vulnerability assessment con-
ducted under subsection (a). Such basic security enhancements
may include, but shall not be limited to the following:
‘‘(A) the purchase and installation of equipment for detec-
tion of intruders;
‘‘(B) the purchase and installation of fencing, gating,
lighting, or security cameras;
‘‘(C) the tamper-proofing of manhole covers, fire hydrants,
and valve boxes;
‘‘(D) the rekeying of doors and locks;
‘‘(E) improvements to electronic, computer, or other auto-
mated systems and remote security systems;
‘‘(F) participation in training programs, and the purchase
of training manuals and guidance materials, relating to security
against terrorist attacks;
‘‘(G) improvements in the use, storage, or handling of var-
ious chemicals; and
‘‘(H) security screening of employees or contractor support
services.
Funding under this subsection for basic security enhancements
shall not include expenditures for personnel costs, or monitoring,
operation, or maintenance of facilities, equipment, or systems.
‘‘(3) The Administrator may use not more than $5,000,000
from the funds made available under paragraph (1) to make grants
to community water systems to assist in responding to and alle-
viating any vulnerability to a terrorist attack or other intentional
acts intended to substantially disrupt the ability of the system
to provide a safe and reliable supply of drinking water (including
H. R. 3448—92
sources of water for such systems) which the Administrator deter-
mines to present an immediate and urgent security need.
‘‘(4) The Administrator may use not more than $5,000,000
from the funds made available under paragraph (1) to make grants
to community water systems serving a population of less than
3,300 persons for activities and projects undertaken in accordance
with the guidance provided to such systems under subsection (d).
SEC. 402. OTHER SAFE DRINKING WATER ACT AMENDMENTS.
The Safe Drinking Water Act (title XIV of the Public Health
Service Act) is amended by inserting the following new sections
after section 1433 (as added by section 401 of this Act):
‘‘SEC. 1434. CONTAMINANT PREVENTION, DETECTION AND RESPONSE.
‘‘(a) IN GENERAL.—The Administrator, in consultation with the
Centers for Disease Control and, after consultation with appropriate
departments and agencies of the Federal Government and with
State and local governments, shall review (or enter into contracts
or cooperative agreements to provide for a review of) current and
future methods to prevent, detect and respond to the intentional
introduction of chemical, biological or radiological contaminants
into community water systems and source water for community
water systems, including each of the following:
‘‘(1) Methods, means and equipment, including real time
monitoring systems, designed to monitor and detect various
levels of chemical, biological, and radiological contaminants
or indicators of contaminants and reduce the likelihood that
such contaminants can be successfully introduced into public
water systems and source water intended to be used for
drinking water.
‘‘(2) Methods and means to provide sufficient notice to
operators of public water systems, and individuals served by
such systems, of the introduction of chemical, biological or
radiological contaminants and the possible effect of such
introduction on public health and the safety and supply of
drinking water.
‘‘(3) Methods and means for developing educational and
awareness programs for community water systems.
‘‘(4) Procedures and equipment necessary to prevent the
flow of contaminated drinking water to individuals served by
public water systems.
‘‘(5) Methods, means, and equipment which could negate
or mitigate deleterious effects on public health and the safety
and supply caused by the introduction of contaminants into
water intended to be used for drinking water, including an
examination of the effectiveness of various drinking water tech-
nologies in removing, inactivating, or neutralizing biological,
chemical, and radiological contaminants.
‘‘(6) Biomedical research into the short-term and long-term
impact on public health of various chemical, biological and
radiological contaminants that may be introduced into public
water systems through terrorist or other intentional acts.
‘‘(b) FUNDING.—For the authorization of appropriations to carry
out this section, see section 1435(e).
H. R. 3448—93
‘‘SEC. 1435. SUPPLY DISRUPTION PREVENTION, DETECTION AND
RESPONSE.
‘‘(a) DISRUPTION OF SUPPLY OR SAFETY.—The Administrator,
in coordination with the appropriate departments and agencies
of the Federal Government, shall review (or enter into contracts
or cooperative agreements to provide for a review of) methods
and means by which terrorists or other individuals or groups could
disrupt the supply of safe drinking water or take other actions
against water collection, pretreatment, treatment, storage and dis-
tribution facilities which could render such water significantly less
safe for human consumption, including each of the following:
‘‘(1) Methods and means by which pipes and other con-
structed conveyances utilized in public water systems could
be destroyed or otherwise prevented from providing adequate
supplies of drinking water meeting applicable public health
standards.
‘‘(2) Methods and means by which collection, pretreatment,
treatment, storage and distribution facilities utilized or used
in connection with public water systems and collection and
pretreatment storage facilities used in connection with public
water systems could be destroyed or otherwise prevented from
providing adequate supplies of drinking water meeting
applicable public health standards.
‘‘(3) Methods and means by which pipes, constructed
conveyances, collection, pretreatment, treatment, storage and
distribution systems that are utilized in connection with public
water systems could be altered or affected so as to be subject
to cross-contamination of drinking water supplies.
‘‘(4) Methods and means by which pipes, constructed
conveyances, collection, pretreatment, treatment, storage and
distribution systems that are utilized in connection with public
water systems could be reasonably protected from terrorist
attacks or other acts intended to disrupt the supply or affect
the safety of drinking water.
‘‘(5) Methods and means by which information systems,
including process controls and supervisory control and data
acquisition and cyber systems at community water systems
could be disrupted by terrorists or other groups.
‘‘(b) ALTERNATIVE SOURCES.—The review under this section
shall also include a review of the methods and means by which
alternative supplies of drinking water could be provided in the
event of the destruction, impairment or contamination of public
water systems.
‘‘(c) REQUIREMENTS AND CONSIDERATIONS.—In carrying out this
section and section 1434—
‘‘(1) the Administrator shall ensure that reviews carried
out under this section reflect the needs of community water
systems of various sizes and various geographic areas of the
United States; and
‘‘(2) the Administrator may consider the vulnerability of,
or potential for forced interruption of service for, a region
or service area, including community water systems that pro-
vide service to the National Capital area.
‘‘(d) INFORMATION
SHARING.—As soon as practicable after
reviews carried out under this section or section 1434 have been
evaluated, the Administrator shall disseminate, as appropriate as
determined by the Administrator, to community water systems
H. R. 3448—94
information on the results of the project through the Information
Sharing and Analysis Center, or other appropriate means.
‘‘(e) FUNDING.—There are authorized to be appropriated to carry
out this section and section 1434 not more than $15,000,000 for
the fiscal year 2002 and such sums as may be necessary for the
fiscal years 2003 through 2005.’’.
SEC. 403. MISCELLANEOUS AND TECHNICAL AMENDMENTS.
The Safe Drinking Water Act is amended as follows:
(1) Section 1414(i)(1) is amended by inserting ‘‘1433’’ after
‘‘1417’’.
(2) Section 1431 is amended by inserting in the first sen-
tence after ‘‘drinking water’’ the following: ‘‘, or that there
is a threatened or potential terrorist attack (or other intentional
act designed to disrupt the provision of safe drinking water
or to impact adversely the safety of drinking water supplied
to communities and individuals), which’’.
(3) Section 1432 is amended as follows:
(A) By striking ‘‘5 years’’ in subsection (a) and inserting
‘‘20 years’’.
(B) By striking ‘‘3 years’’ in subsection (b) and inserting
‘‘10 years’’.
(C) By striking ‘‘$50,000’’ in subsection (c) and inserting
‘‘$1,000,000’’.
(D) By striking ‘‘$20,000’’ in subsection (c) and
inserting ‘‘$100,000’’.
(4) Section 1442 is amended as follows:
(A) By striking ‘‘this subparagraph’’ in subsection (b)
and inserting ‘‘this subsection’’.
(B) By amending subsection (d) to read as follows:
‘‘(d) There are authorized to be appropriated to carry out sub-
section (b) not more than $35,000,000 for the fiscal year 2002
and such sums as may be necessary for each fiscal year thereafter.’’.
TITLE V—ADDITIONAL PROVISIONS
Subtitle A—Prescription Drug User Fees
SEC. 501. SHORT TITLE.
This subtitle may be cited as the ‘‘Prescription Drug User
Fee Amendments of 2002’’.
SEC. 502. FINDINGS.
The Congress finds that—
(1) prompt approval of safe and effective new drugs and
other therapies is critical to the improvement of the public
health so that patients may enjoy the benefits provided by
these therapies to treat and prevent illness and disease;
(2) the public health will be served by making additional
funds available for the purpose of augmenting the resources
of the Food and Drug Administration that are devoted to the
process for the review of human drug applications and the
assurance of drug safety;
(3) the provisions added by the Prescription Drug User
Fee Act of 1992, as amended by the Food and Drug Administra-
tion Modernization Act of 1997, have been successful in
H. R. 3448—95
substantially reducing review times for human drug applica-
tions and should be—
(A) reauthorized for an additional 5 years, with certain
technical improvements; and
(B) carried out by the Food and Drug Administration
with new commitments to implement more ambitious and
comprehensive improvements in regulatory processes of the
Food and Drug Administration, including—
(i) strengthening and improving the review and
monitoring of drug safety;
(ii) considering greater interaction between the
agency and sponsors during the review of drugs and
biologics intended to treat serious diseases and life-
threatening diseases; and
(iii) developing principles for improving first-cycle
reviews; and
(4) the fees authorized by amendments made in this subtitle
will be dedicated towards expediting the drug development
process and the process for the review of human drug applica-
tions as set forth in the goals identified for purposes of part
2 of subchapter C of chapter VII of the Federal Food, Drug,
and Cosmetic Act, in the letters from the Secretary of Health
and Human Services to the chairman of the Committee on
Energy and Commerce of the House of Representatives and
the chairman of the Committee on Health, Education, Labor
and Pensions of the Senate, as set forth in the Congressional
Record.
SEC. 503. DEFINITIONS.
Section 735 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379g) is amended—
(1) in paragraph (1), in the matter after and below subpara-
graph (C), by striking ‘‘licensure, as described in subparagraph
(D)’’ and inserting ‘‘licensure, as described in subparagraph
(C)’’;
(2) in paragraph (3)—
(A) in subparagraph (A), by striking ‘‘and’’ at the end;
(B) in subparagraph (B), by striking the period and
inserting ‘‘, and’’;
(C) by inserting after subparagraph (B) the following
subparagraph:
‘‘(C) which is on the list of products described in section
505(j)(7)(A) or is on a list created and maintained by the
Secretary of products approved under human drug applica-
tions under section 351 of the Public Health Service Act.’’;
and
(D) in the matter after and below subparagraph (C)
(as added by subparagraph (C) of this paragraph), by
striking ‘‘Service Act,’’ and all that follows through
‘‘biological product’’ and inserting the following: ‘‘Service
Act. Such term does not include a biological product’’;
(3) in paragraph (6), by adding at the end the following
subparagraph:
‘‘(F) In the case of drugs approved after October 1,
2002, under human drug applications or supplements: col-
lecting, developing, and reviewing safety information on
the drugs, including adverse event reports, during a period
H. R. 3448—96
of time after approval of such applications or supplements,
not to exceed three years.’’; and
(4) in paragraph (8)—
(A) by striking the matter after and below subpara-
graph (B);
(B) by striking subparagraph (B);
(C) by striking ‘‘is the lower of’’ and all that follows
through ‘‘Consumer Price Index’’ and inserting ‘‘is the Con-
sumer Price Index’’; and
(D) by striking ‘‘1997, or’’ and inserting ‘‘1997.’’.
SEC. 504. AUTHORITY TO ASSESS AND USE DRUG FEES.
(a) TYPES OF FEES.—Section 736(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379h(a)) is amended—
(1) in the matter preceding paragraph (1), by striking ‘‘fiscal
year 1998’’ and inserting ‘‘fiscal year 2003’’;
(2) in paragraph (1)(A)—
(A) in each of clauses (i) and (ii), by striking ‘‘in sub-
section (b)’’ and inserting ‘‘under subsection (c)(4)’’; and
(B) in clause (ii), by adding at the end the following
sentence: ‘‘Such fee shall be half of the amount of the
fee established under clause (i).’’;
(3) in paragraph (2)(A), in the matter after and below
clause (ii)—
(A) by striking ‘‘in subsection (b)’’ and inserting ‘‘under
subsection (c)(4)’’; and
(B) by striking ‘‘payable on or before January 31’’ and
inserting ‘‘payable on or before October 1’’; and
(4) in paragraph (3)—
(A) by amending subparagraph (A) to read as follows:
‘‘(A) IN GENERAL.—Except as provided in subparagraph
(B), each person who is named as the applicant in a human
drug application, and 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 under subsection (c)(4).
Such fee shall be payable on or before October 1 of each
year. Such fee shall be paid only once for each product
for a fiscal year in which the fee is payable.’’; and
(B) in subparagraph (B), by striking ‘‘The listing’’ and
all that follows through ‘‘filed under section 505(b)(2)’’ and
inserting the following: ‘‘A prescription drug product shall
not be assessed a fee under subparagraph (A) if such
product is identified on the list compiled under section
505(j)(7)(A) with a potency described in terms of per 100
mL, or if such product is the same product as another
product approved under an application filed under section
505(b)’’.
(b) FEE AMOUNTS.—Section 736(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379h(b)) is amended to read as follows:
‘‘(b) FEE REVENUE AMOUNTS.—Except as provided in sub-
sections (c), (d), (f), and (g), fees under subsection (a) shall be
established to generate the following revenue amounts:
H. R. 3448—97
‘‘Type of Fee Rev-
enue
Fiscal Year
2003
Fiscal Year
2004
Fiscal Year
2005
Fiscal Year
2006
Fiscal Year
2007
Application/Sup-
plement ..............
$74,300,000
$77,000,000
$84,000,000
$86,434,000
$86,434,000
Establishment .......
$74,300,000
$77,000,000
$84,000,000
$86,433,000
$86,433,000
Product ..................
$74,300,000
$77,000,000
$84,000,000
$86,433,000
$86,433,000
Total Fee Revenue
$222,900,000
$231,000,000
$252,000,000
$259,300,000
$259,300,000
If, after the date of the enactment of the Prescription Drug User
Fee Amendments of 2002, legislation is enacted requiring the Sec-
retary to fund additional costs of the retirement of Federal per-
sonnel, fee revenue amounts shall be increased in each year by
the amount necessary to fully fund the portion of such additional
costs that are attributable to the process for the review of human
drug applications.’’.
(c) ADJUSTMENTS.—Section 736(c) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379h(c)) is amended—
(1) in paragraph (1)—
(A) in the matter preceding subparagraph (A), by
striking ‘‘fees and total fee revenues’’ and inserting ‘‘reve-
nues’’;
(B) in subparagraph (A)—
(i) by striking ‘‘during the preceding fiscal year’’;
and
(ii) by striking ‘‘, or’’ and inserting the following:
‘‘for the 12 month period ending June 30 preceding
the fiscal year for which fees are being established,
or’’;
(C) in subparagraph (B), by striking ‘‘for such fiscal
year’’ and inserting ‘‘for the previous fiscal year’’; and
(D) in the matter after and below subparagraph (B),
by striking ‘‘fiscal year 1997’’; and inserting ‘‘fiscal year
2003’’;
(2) by redesignating paragraphs (2) and (3) as paragraphs
(4) and (5), respectively;
(3) by inserting after paragraph (1) the following para-
graphs:
‘‘(2) WORKLOAD ADJUSTMENT.—Beginning with fiscal year
2004, after the fee revenues established in subsection (b) are
adjusted for a fiscal year for inflation in accordance with para-
graph (1), the fee revenues shall be adjusted further for such
fiscal year to reflect changes in the workload of the Secretary
for the process for the review of human drug applications.
With respect to such adjustment:
‘‘(A) The adjustment shall be determined by the Sec-
retary based on a weighted average of the change in the
total number of human drug applications, commercial
investigational new drug applications, efficacy supple-
ments, and manufacturing supplements submitted to the
Secretary. The Secretary shall publish in the Federal Reg-
ister the fee revenues and fees resulting from the adjust-
ment and the supporting methodologies.
‘‘(B) Under no circumstances shall the adjustment
result in fee revenues for a fiscal year that are less than
the fee revenues for the fiscal year established in subsection
(b), as adjusted for inflation under paragraph (1).
H. R. 3448—98
‘‘(3) FINAL YEAR ADJUSTMENT.—For fiscal year 2007, the
Secretary may, in addition to adjustments under paragraphs
(1) and (2), further increase the fee revenues and fees estab-
lished in subsection (b) if such an adjustment is necessary
to provide for not more than three months of operating reserves
of carryover user fees for the process for the review of human
drug applications for the first three months of fiscal year 2008.
If such an adjustment is necessary, the rationale for the amount
of the increase shall be contained in the annual notice estab-
lishing fee revenues and fees for fiscal year 2007. If the Sec-
retary has carryover balances for such process in excess of
three months of such operating reserves, the adjustment under
this paragraph shall not be made.’’; and
(4) in paragraph (4) (as redesignated by paragraph (2)
of this subsection), by amending such paragraph to read as
follows:
‘‘(4) ANNUAL FEE SETTING.—The Secretary shall, 60 days
before the start of each fiscal year that begins after September
30, 2002, establish, for the next fiscal year, application, product,
and establishment fees under subsection (a), based on the rev-
enue amounts established under subsection (b) and the adjust-
ments provided under this subsection.’’.
(d) FEE WAIVER OR REDUCTION.—Section 736(d)) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379h(d)) is amended—
(1) in paragraph (1)—
(A) in subparagraph (C), by inserting ‘‘or’’ after the
comma at the end;
(B) by striking subparagraph (D); and
(C) by redesignating subparagraph (E) as subpara-
graph (D); and
(2) in paragraph (3), in each of subparagraphs (A) and
(B), by striking ‘‘paragraph (1)(E)’’ each place such term appears
and inserting ‘‘paragraph (1)(D)’’.
(e) ASSESSMENT OF FEES.—Section 736(f) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379h(f)) is amended—
(1) in the heading for the subsection, by striking ‘‘ASSESS-
MENT OF FEES.—’’ and inserting ‘‘LIMITATIONS.—’’; and
(2) in paragraph (1), by striking the heading for the para-
graph and all that follows through ‘‘fiscal year beginning’’ and
inserting the following: ‘‘IN GENERAL.—Fees under subsection
(a) shall be refunded for a fiscal year beginning’’.
(f) CREDITING AND AVAILABILITY OF FEES.—
(1) IN GENERAL.—Section 736(g)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379h(g)(1)) is amended
by striking ‘‘Fees collected for a fiscal year’’ and all that follows
through ‘‘fiscal year limitation.’’ and inserting the following:
‘‘Fees authorized under subsection (a) shall be collected and
available for obligation only to the extent and in the amount
provided in advance in appropriations Acts. Such fees are
authorized to remain available until expended.’’.
(2) 
COLLECTIONS
AND
APPROPRIATION
ACTS.—Section
736(g)(2) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379h(g)(2)) is amended—
(A) by redesignating subparagraphs (A) and (B) as
clauses (i) and (ii), respectively;
H. R. 3448—99
(B) by striking ‘‘(2) COLLECTIONS’’ and all that follows
through ‘‘the amount specified’’ in clause (i) (as so redesig-
nated) and inserting the following:
‘‘(2) COLLECTIONS AND APPROPRIATION ACTS.—
‘‘(A) IN
GENERAL.—The fees authorized by this
section—
‘‘(i) shall be retained in each fiscal year in an
amount not to exceed the amount specified’’;
(C) by moving clause (ii) (as so redesignated) two ems
to the right; and
(D) by adding at the end the following subparagraph:
‘‘(B) COMPLIANCE.—The Secretary shall be considered
to have met the requirements of subparagraph (A)(ii) in
any fiscal year if the costs funded by appropriations and
allocated for the process for the review of human drug
applications—
‘‘(i) are not more than 3 percent below the level
specified in subparagraph (A)(ii); or
‘‘(ii)(I) are more than 3 percent below the level
specified in subparagraph (A)(ii), and fees assessed
for the fiscal year following the subsequent fiscal year
are decreased by the amount in excess of 3 percent
by which such costs fell below the level specified in
such subparagraph; and
‘‘(II) such costs are not more than 5 percent below
the level specified in such subparagraph.’’.
(3) AUTHORIZATION OF APPROPRIATIONS.—Section 736(g)(3)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379h(g)(3)) is amended by striking subparagraphs (A) through
(E) and inserting the following:
‘‘(A) $222,900,000 for fiscal year 2003;
‘‘(B) $231,000,000 for fiscal year 2004;
‘‘(C) $252,000,000 for fiscal year 2005;
‘‘(D) $259,300,000 for fiscal year 2006; and
‘‘(E) $259,300,000 for fiscal year 2007;’’.
SEC. 505. ACCOUNTABILITY AND REPORTS.
(a) PUBLIC ACCOUNTABILITY.—
(1) CONSULTATION.—In developing recommendations to the
Congress for the goals and plans for meeting the goals for
the process for the review of human drug applications for
the fiscal years after fiscal year 2007, and for the reauthoriza-
tion of sections 735 and 736 of the Federal Food, Drug, and
Cosmetic Act, the Secretary of Health and Human Services
(referred to in this section as the ‘‘Secretary’’) shall consult
with the Committee on Energy and Commerce of the House
of Representatives, the Committee on Health, Education, Labor,
and Pensions of the Senate, appropriate scientific and academic
experts, health care professionals, representatives of patient
and consumer advocacy groups, and the regulated industry.
(2) RECOMMENDATIONS.—The Secretary shall publish in the
Federal Register recommendations under paragraph (1), after
negotiations with the regulated industry; shall present such
recommendations to the congressional committees specified in
such paragraph; shall hold a meeting at which the public may
present its views on such recommendations; and shall provide
H. R. 3448—100
for a period of 30 days for the public to provide written com-
ments on such recommendations.
(b) PERFORMANCE REPORT.—Beginning with fiscal year 2003,
not later than 60 days after the end of each fiscal year during
which fees are collected under part 2 of subchapter C of chapter
VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g
et seq.), the Secretary of Health and Human Services shall prepare
and submit to the President, the Committee on Energy and Com-
merce of the House of Representatives, and the Committee on
Health, Education, Labor, and Pensions of the Senate a report
concerning the progress of the Food and Drug Administration in
achieving the goals identified in the letters described in section
502(4) during such fiscal year and the future plans of the Food
and Drug Administration for meeting the goals.
(c) FISCAL REPORT.—Beginning with fiscal year 2003, not later
than 120 days after the end of each fiscal year during which
fees are collected under the part described in subsection (b), the
Secretary of Health and Human Services shall prepare and submit
to the Committee on Energy and Commerce of the House of Rep-
resentatives, and the Committee on Health, Education, Labor, and
Pensions of the Senate, a report on the implementation of the
authority for such fees during such fiscal year and the use, by
the Food and Drug Administration, of the fees collected during
such fiscal year for which the report is made.
SEC. 506. REPORTS OF POSTMARKETING STUDIES.
Section 506B of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 356b) is amended by adding at the end the following
subsections:
‘‘(d) DISCLOSURE.—If a sponsor fails to complete an agreed
upon study required by this section by its original or otherwise
negotiated deadline, the Secretary shall publish a statement on
the Internet site of the Food and Drug Administration stating
that the study was not completed and, if the reasons for such
failure to complete the study were not satisfactory to the Secretary,
a statement that such reasons were not satisfactory to the Sec-
retary.
‘‘(e) NOTIFICATION.—With respect to studies of the type required
under section 506(b)(2)(A) or under section 314.510 or 601.41 of
title 21, Code of Federal Regulations, as each of such sections
was in effect on the day before the effective date of this subsection,
the Secretary may require that a sponsor who, for reasons not
satisfactory to the Secretary, fails to complete by its deadline a
study under any of such sections of such type for a drug or biological
product (including such a study conducted after such effective date)
notify practitioners who prescribe such drug or biological product
of the failure to complete such study and the questions of clinical
benefit, and, where appropriate, questions of safety, that remain
unanswered as a result of the failure to complete such study.
Nothing in this subsection shall be construed as altering the
requirements of the types of studies required under section
506(b)(2)(A) or under section 314.510 or 601.41 of title 21, Code
of Federal Regulations, as so in effect, or as prohibiting the Sec-
retary from modifying such sections of title 21 of such Code to
provide for studies in addition to those of such type.’’.
H. R. 3448—101
SEC. 507. SAVINGS CLAUSE.
Notwithstanding section 107 of the Food and Drug Administra-
tion Modernization Act of 1997, and notwithstanding the amend-
ments made by this subtitle, part 2 of subchapter C of chapter
VII of the Federal Food, Drug, and Cosmetic Act, as in effect
on the day before the date of the enactment of this Act, continues
to be in effect with respect to human drug applications and supple-
ments (as defined in such part as of such day) that, on or after
October 1, 1997, but before October 1, 2002, were accepted by
the Food and Drug Administration for filing and with respect to
assessing and collecting any fee required by such Act for a fiscal
year prior to fiscal year 2003.
SEC. 508. EFFECTIVE DATE.
The amendments made by this subtitle shall take effect October
1, 2002.
SEC. 509. SUNSET CLAUSE.
The amendments made by sections 503 and 504 cease to be
effective October 1, 2007, and section 505 ceases to be effective
120 days after such date.
Subtitle B—Funding Provisions Regarding
Food and Drug Administration
SEC. 521. OFFICE OF DRUG SAFETY.
Of the amounts appropriated for the Food and Drug Adminis-
tration for a fiscal year, the Secretary of Health and Human Serv-
ices shall reserve for the Office of Drug Safety (within such Adminis-
tration), the following amounts:
(1) For fiscal year 2003, an amount equal to the sum
of $5,000,000 and the amount made available under appropria-
tions Acts for such Office for fiscal year 2002.
(2) For fiscal year 2004, an amount equal to the sum
of $10,000,000 and the amount made available under appropria-
tions Acts for such Office for fiscal year 2002.
(3) For each subsequent fiscal year, an amount equal to
the sum of the amount made available under appropriations
Acts for such Office for fiscal year 2004 and an amount suffi-
cient to offset the effects of inflation occurring after the begin-
ning of fiscal year 2004.
SEC. 522. DIVISION OF DRUG MARKETING, ADVERTISING, AND COMMU-
NICATIONS.
For the Division of Drug Marketing, Advertising, and Commu-
nications (within the Office of Medical Policy, Food and Drug
Administration), there are authorized to be appropriated the fol-
lowing amounts, stated as increases above the amount made avail-
able under appropriations Acts for such Division for fiscal year
2002:
(1) For fiscal year 2003, an increase of $2,500,000.
(2) For fiscal year 2004, an increase of $4,000,000.
(3) For fiscal year 2005, an increase of $5,500,000.
(4) For fiscal year 2006, an increase of $7,500,000.
(5) For fiscal year 2007, an increase of $7,500,000.
H. R. 3448—102
SEC. 523. OFFICE OF GENERIC DRUGS.
For the Office of Generic Drugs (within the Food and Drug
Administration), there are authorized to be appropriated the fol-
lowing amounts, stated as increases above the amount made avail-
able under appropriations Acts for such Office for fiscal year 2002:
(1) For fiscal year 2003, an increase of $3,000,000.
(2) For fiscal year 2004, an increase of $6,000,000.
(3) For fiscal year 2005, an increase of $9,000,000.
(4) For fiscal year 2006, an increase of $12,000,000.
(5) For fiscal year 2007, an increase of $15,000,000.
Subtitle C—Additional Provisions
SEC. 531. TRANSITION TO DIGITAL TELEVISION.
(a) PAIR ASSIGNMENT REQUIRED.—In order to further promote
the orderly transition to digital television, and to promote the
equitable allocation and use of digital channels by television broad-
cast permittees and licensees, the Federal Communications
Commission, at the request of an eligible licensee or permittee,
shall, within 90 days after the date of enactment of this Act,
allot, if necessary, and assign a paired digital television channel
to that licensee or permittee, provided that—
(1) such channel can be allotted and assigned without
further modification of the tables of allotments as set forth
in sections 73.606 and 73.622 of the Commission’s regulations
(47 CFR 73.606, 73.622); and
(2) such allotment and assignment is otherwise consistent
with the Commission’s rules (47 CFR part 73).
(b) ELIGIBLE TRANSITION LICENSEE OR PERMITTEE.—For pur-
poses of subsection (a), the term ‘‘eligible licensee or permittee’’
means only a full power television broadcast licensee or permittee
(or its successor in interest) that—
(1) had an application pending for an analog television
station construction permit as of October 24, 1991, which
application was granted after April 3, 1997; and
(2) as of the date of enactment of this Act, is the permittee
or licensee of that station.
(c) REQUIREMENTS ON LICENSEE OR PERMITTEE.—
(1) CONSTRUCTION DEADLINE.—Any licensee or permittee
receiving a paired digital channel pursuant to this section—
(A) shall be required to construct the digital television
broadcast facility within 18 months of the date on which
the Federal Communications Commission issues a construc-
tion permit therefore, and
(B) shall be prohibited from obtaining or receiving
an extension of time from the Commission beyond the
construction deadline established by paragraph (1).
(2) PROHIBITION
OF
ANALOG
OPERATION
USING
DIGITAL
PAIR.—Any licensee or permittee receiving a paired digital
channel pursuant to this section shall be prohibited from giving
up its current paired analog assignment and becoming a single-
channel broadcaster and operating in analog on such paired
digital channel.
(d) RELIEF RESTRICTED.—Any paired digital allotment and
assignment made under this section shall not be available to any
H. R. 3448—103
other applicant unless such applicant is an eligible licensee or
permittee within the meaning of subsection (b).
SEC. 
532. 
3-YEAR 
DELAY 
IN 
LOCK 
IN 
PROCEDURES 
FOR
MEDICARE+CHOICE 
PLANS; 
CHANGE 
IN 
CERTAIN
MEDICARE+CHOICE DEADLINES AND ANNUAL, COORDI-
NATED ELECTION PERIOD FOR 2003, 2004, AND 2005.
(a) LOCK-IN DELAY.—Section 1851(e) of the Social Security Act
(42 U.S.C. 1395w–21(e)) is amended—
(1) in paragraph (2)(A), by striking ‘‘THROUGH 2001’’ and
‘‘during 1998, 1999, 2000, and 2001’’ and inserting ‘‘THROUGH
2004’’ and ‘‘during the period beginning January 1, 1998, and
ending on December 31, 2004’’, respectively;
(2) in the heading to paragraph (2)(B), by striking ‘‘DURING
2002’’ and inserting ‘‘DURING 2005’’;
(3) in paragraphs (2)(B)(i) and (2)(C)(i), by striking ‘‘2002’’
and inserting ‘‘2005’’ each place it appears;
(4) in paragraph (2)(D), by striking ‘‘2001’’ and inserting
‘‘2004’’; and
(5) in paragraph (4), by striking ‘‘2002’’ and inserting ‘‘2005’’
each place it appears.
(b) CHANGE IN REPORTING DEADLINE.—
(1) IN GENERAL.—Section 1854(a)(1) of such Act (42 U.S.C.
1395w–24(a)(1)) is amended by striking ‘‘Not later than July
1 of each year’’ and inserting ‘‘Not later than the second Monday
in September of 2002, 2003, and 2004 (or July 1 of each other
year)’’.
(2) EFFECTIVE DATE.—The amendment made by paragraph
(1) shall apply to information submitted for years beginning
with 2003.
(c) DELAY IN ANNUAL, COORDINATED ELECTION PERIOD.—
(1) IN GENERAL.—Section 1851(e) of such Act (42 U.S.C.
1395w–21(e)) is amended—
(A) in paragraph (3)(B), by striking ‘‘means’’ and all
that follows and inserting the following: ‘‘means, with
respect to a year before 2003 and after 2005, the month
of November before such year and with respect to 2003,
2004, and 2005, the period beginning on November 15
and ending on December 31 of the year before such year.’’;
and
(B) in paragraph (6)(A), by striking ‘‘each subsequent
year (as provided in paragraph (3))’’ and inserting ‘‘during
the annual, coordinated election period under paragraph
(3) for each subsequent year’’.
(2) EFFECTIVE DATE.—The amendment made by paragraph
(1) shall apply to the annual, coordinated election period for
years beginning with 2003.
(d) CHANGE TO ANNUAL ANNOUNCEMENT OF PAYMENT RATES.—
(1) IN GENERAL.—Section 1853(b)(1) of such Act (42 U.S.C.
1395w–23(b)(1)) is amended by striking ‘‘not later than March
1 before the calendar year concerned’’ and inserting ‘‘for years
before 2004 and after 2005 not later than March 1 before
the calendar year concerned and for 2004 and 2005 not later
than the second Monday in May before the respective calendar
year’’.
H. R. 3448—104
(2) EFFECTIVE DATE.—The amendment made by paragraph
(1) shall first apply to announcements for years after 2003.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.