‘‘SEC. 505B. INCENTIVES FOR DEVELOPMENT OF QUALIFY-
ING ANTIADDICTION DRUGS.
‘‘(a) IN GENERAL.—If (on or after the effective date
of this section) an application under section 505(b)(1) is
submitted and the drug involved is approved as a qualify-
ing antiaddiction drug (as defined in subsection (e)), then
the person who submitted the application may in accord-
ance with subsection (b) select one qualifying on-market
drug (as so defined) for purposes of providing for the ex-
tension under subsection (c) of the period of market exclu-
sivity for such on-market drug.
‘‘(b) NOTIFICATION OF SECRETARY.—
‘‘(1) IN GENERAL.—For purposes of subsection
(a), a selection by a person of a qualifying on-mar-
ket drug is made in accordance with this subsection
if the following conditions are met:
‘‘(A) The person submits to the Secretary
a written notification stating that the selection
has been made.
‘‘(B) The notification demonstrates that
the person is both—
‘‘(i) the holder of the approved appli-
cation for the qualifying on-market drug;
and
‘‘(ii) the holder of the approved appli-
cation for the qualifying antiaddiction drug
with respect to which the selection is made.
‘‘(C) The notification is submitted not
later than 30 days after the date of the ap-
proval under section 505(c) of such qualifying
antiaddiction drug.
‘‘(D) The notification is submitted not
later than 90 days before the expiration of the
period that would but for this section apply to
the qualifying on-market drug as the period
during which an application may not be ap-
proved under section 505(c)(3) or section
505(j)(5)(B).
‘‘(2) PUBLICATION BY SECRETARY.—After de-
termining that a notification received by the Sec-
retary pursuant to subsection (a) meets the condi-
tions described in paragraph (1), the Secretary shall
publish in the Federal Register a statement for the
purpose of informing the public of the fact that the
drug involved has been selected as a qualifying on-
market drug and of the legal effect of such selection
on the approval of applications under section
505(b)(2) and applications under section 505(j).
‘‘(c) EXTENSION OF PERIOD.—Subject to subsection
(d), with respect to a qualifying on-market drug selected
under subsection (a)—
‘‘(1)(A)(i) the period referred to in subsection
(c)(3)(D)(ii) of section 505, and in subsection
(j)(5)(D)(ii) of such section, is deemed to be five
years and six months rather than five years, and the
references 
in 
subsections 
(c)(3)(D)(ii) 
and
(j)(5)(D)(ii) of such section to four years, to forty-
eight months, and to seven and one-half years are
deemed to be four and one-half years, fifty-four
months, and eight years, respectively; or
‘‘(ii) the period referred to in clauses (iii) and
(iv) of subsection (c)(3)(D) of such section, and in
clauses (iii) and (iv) of subsection (j)(5)(D) of such
section, is deemed to be three years and six months
rather than three years; and
‘‘(B) if the drug is designated under section
526 for a rare disease or condition, the period re-
ferred to in section 527(a) is deemed to be seven
years and six months rather than seven years; and
‘‘(2)(A) if the drug is the subject of—
‘‘(i) a listed patent for which a certification
has 
been 
submitted 
under 
subsection
(b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of section 505
and for which the application under section
505(b)(1) is approved prior to the expiration of
the patent (including any patent extensions); or
‘‘(ii) a listed patent for which a certifi-
cation has been submitted under subsections
(b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of section
505;
the period during which an application may not be
approved 
under 
section 
505(c)(3) 
or 
section
505(j)(5)(B) shall be extended by a period of six
months after the date the patent expires (including
any patent extensions); or
‘‘(B) if the drug is the subject of a listed patent
for which a certification has been submitted under
subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of sec-
tion 505, and in the patent infringement litigation
resulting from the certification the court determines
that the patent is valid and would be infringed, the
period during which an application may not be ap-
proved 
under 
section 
505(c)(3) 
or 
section
505(j)(5)(B) shall be extended by a period of six
months after the date the patent expires (including
any patent extensions).
‘‘(d) RELATIONSHIP TO MARKET EXCLUSIVITY RE-
GARDING PEDIATRIC STUDIES.—The extension under this
section of the period of market exclusivity for a drug is
in addition to any extension of the period of market exclu-
sivity that may apply for the drug under section 505A.
According to whether this section or section 505A first
applies for the drug, the beginning date for the extension
under this section, or the beginning date for the extension
under section 505A, is deemed to be the date necessary
to achieve the effect described in the preceding sentence.
‘‘(e) DEFINITIONS.—
‘‘(1) QUALIFYING ANTIADDICTION DRUG.—
‘‘(A) IN GENERAL.—For purposes of this
section, the term ‘qualifying antiaddiction drug’
means a new drug approved under section
505(c) as a treatment for dependence on a con-
trolled substance that—
‘‘(i) is included in schedule I or II of
the schedules of controlled substances
under section 202(c) of the Controlled
Substances Act; and
‘‘(ii) is designated by the Secretary as
a controlled substance to which this section
applies.
‘‘(B) 
CERTAIN
CONTROLLED
SUB-
STANCES.—Controlled substances designated
under subparagraph (A)(ii) by the Secretary
shall include the following:
‘‘(i) Cocaine, and the other substances
included in schedule II in the provision in
which cocaine is included.
‘‘(ii) Injectable liquids included in
schedule II in the provision concerning
methamphetamine.
‘‘(2) QUALIFYING ON-MARKET DRUG.—For pur-
poses of this section, the term ‘qualifying on-market
drug’ means a new drug for which an application
was submitted under section 505(b)(1) and approved
under section 505(c) before the approval under such
section of the qualifying antiaddiction drug in-
volved.’’.
Subtitle B—Commission on Role of
Medication Education in Reduc-
ing Substance Abuse
SEC. 211. NATIONAL COMMISSION ON THE ROLE OF MEDI-
CAL EDUCATION IN REDUCING SUBSTANCE
ABUSE.
(a) IN GENERAL.—The Secretary of Health and
Human Services shall establish an advisory commission to
be known as the National Commission on the Role of Med-
ical Education in Reducing Substance Abuse.
(b) DUTIES.—
(1) IN GENERAL.—The Commission shall con-
duct a study for the purpose of determining the
manner in which programs of initial and continuing
medical education can be modified to improve the ef-
forts of health professionals in preventing, diagnos-
ing, and treating cases of substance abuse.
(2) DATE
CERTAIN
FOR
COMPLETION.—Not
later than one year after the date of the enactment
of this Act, the Commission shall complete the study
required in paragraph (1).
(3) REPORT.—Upon completing the study re-
quired in paragraph (1), the Commission shall pre-
pare a report describing the findings made as a re-
sult of the study. The report shall be submitted to
the President, to the appropriate departments and
Federal agencies, and to the appropriate committees
of the Congress. The Commission may include in the
report any recommendations of the Commission re-
garding administrative or legislative actions. The
Secretary shall disseminate the report to the public
health officers of the States with the request that
the States disseminate the report to public and pri-
vate programs within the State that provide edu-
cation in the health professions.
(c) MEMBERSHIP.—
(1) IN
GENERAL.—The Commission shall be
composed of 10 voting members appointed in accord-
ance with paragraph (2) and the nonvoting, ex offi-
cio members designated under paragraph (3).
(2) APPOINTMENT OF NON-FEDERAL INDIVID-
UALS.—Subject to paragraph (3), the voting mem-
bers of the Commission under paragraph (1) shall be
appointed by the Secretary, and shall be appointed
from among individuals who on the day before being
appointed were not officers or employees of the Fed-
eral Government. Of such members—
(A) one shall be a representative of the
American College of Physicians;
(B) one shall be a representative of the
American Medical Association;
(C) one shall be a representative of the As-
sociation of Professors of Medicine;
(D) one shall be a representative of the
American Academy of Pediatrics;
(E) one shall be a representative of the As-
sociation of American Medical Colleges;
(F) one shall be a representative of the As-
sociation for Substance Abuse Medicine;
(G) one shall be a representative of the
American Society of Addiction Medicine;
(H) one shall be a representative of the
American Academy of Family Physicians;
(I) one shall be a representative of the
American Academy of Neurology; and
(J) one shall be a representative of the
American College of Preventive Medicine.
(3) EX OFFICIO MEMBERS.—Each of the follow-
ing officials (or the designees of the officials) shall
serve as the ex officio members of the Commission
under paragraph (1):
(A) The Director of the National Institutes
of Health.
(B) The Director of National Drug Control
Policy.
(C) The Director of the Center on Sub-
stance Abuse Prevention.
(D) The Director of the Center on Sub-
stance Abuse Treatment.
(E) The Surgeon General of the Public
Health Service.
(d) CHAIR.—The Commission shall, from among the
members appointed under subsection (c)(2), designate an
individual to serve as the chair of the Commission.
(e) TERMS.—The term of a member of the Commis-
sion appointed under subsection (c)(2) is for the duration
of the Commission.
(f) VACANCIES.—
(1) AUTHORITY OF COMMISSION.—A vacancy in
the membership of the Commission does not affect
the power of the remaining members to carry out
the duties under subsection (b).
(2) APPOINTMENT OF SUCCESSORS.—A vacancy
in the membership of the Commission shall be filled
in the manner in which the original appointment was
made.
(3) INCOMPLETE TERM.—If a member of the
Commission does not serve the full term applicable
to the member, the individual appointed to fill the
resulting vacancy shall be appointed for the remain-
der of the term of the predecessor of the individual.
(g) MEETINGS.—
(1) IN GENERAL.—The Commission shall meet
at the call of the Chair or a majority of the mem-
bers. The Commission shall meet no fewer than four
times.
(2) QUORUM.—A quorum for meetings of the
Commission is constituted by the presence of ll
members.
(h) COMPENSATION; REIMBURSEMENT
OF
EX-
PENSES.—
(1) APPOINTED
MEMBERS.—Members of the
Commission appointed under subsection (c)(2) shall
receive compensation for each day (including travel-
time) engaged in carrying out the duties of the Com-
mittee. Such compensation may not be in an amount
in excess of the daily equivalent of the annual maxi-
mum rate of basic pay payable under the General
Schedule (under title 5, United States Code) for po-
sitions above GS–15.
(2) EX
OFFICIO
MEMBERS.—Members of the
Commission who are designated under subsection
(a)(4) may not receive compensation for service on
the Commission in addition to the compensation oth-
erwise received for duties carried out as Federal offi-
cers or employees.
(3) REIMBURSEMENT.—Members of the Com-
mission may, in accordance with chapter 57 of title
5, United States Code, be reimbursed for travel,
subsistence, and other necessary expenses incurred
in carrying out the duties of the Commission.
(i) STAFF AND CONSULTANTS.—
(1) STAFF.—
(A) IN GENERAL.—The Commission may
appoint and determine the compensation of
such staff as may be necessary to carry out the
duties of the Commission, including an execu-
tive director. Such appointments and compensa-
tion may be made without regard to the provi-
sions of title 5, United States Code, that govern
appointments in the competitive services, and
the provisions of chapter 51 and subchapter III
of chapter 53 of such title that relate to classi-
fications and the General Schedule pay rates.
(B) 
LIMITATION.—Staff 
members 
ap-
pointed under paragraph (1) may not be com-
pensated in excess of the maximum rate of
basic pay payable for GS–15, except that the
executive director may not be compensated in
an amount exceeding the maximum rate of
basic pay payable under the General Schedule
for positions above GS–15.
(2) CONSULTANTS.—The Commission may pro-
cure such temporary and intermittent services of
consultants under section 3109(b) of title 5, United
States Code, as the Commission may determine to
be appropriate in carrying out the duties under sub-
section (b). The Commission may not procure serv-
ices under this subsection at any rate in excess of
the daily equivalent of the maximum annual rate of
basic pay payable under the General Schedule for
positions above GS–15. Consultants under this sub-
section may, in accordance with chapter 57 of title
5, United States Code, be reimbursed for travel,
subsistence, and other necessary expenses incurred
for activities carried out on behalf of the Commis-
sion pursuant to subsection (b).
(j) ADMINISTRATIVE SUPPORT.—The Administrator
of General Services shall, on a reimbursable basis, provide
for the Commission such quarters and administrative sup-
port as may be necessary for the Commission to carry out
the duties under subsection (b).
(k) DURATION OF COMMISSION.—The Commission
terminates 45 days after the date on which the report
under subsection (b)(3) is submitted under such sub-
section.
(l) DEFINITIONS.—For purposes of this section:
(1) The term ‘‘Commission’’ means the Na-
tional Commission on the Role of Medical Education
in Reducing Substance Abuse.
(2) The term ‘‘Secretary’’ means the Secretary
of Health and Human Services
(m) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out this section, there is authorized
to be appropriated $1,000,000 for fiscal year 1999, to re-
main available until the termination of the Commission
under subsection (k).
TITLE III—STATEMENT OF
NATIONAL ANTIDRUG POLICY
Subtitle A—Congressional Leader-
ship in Community Coalitions
SEC. 301. SENSE OF CONGRESS.
(a) FINDINGS.—The Congress finds the following:
(1) Illegal drug use is dangerous to the physical
well-being of the Nation’s youth.
(2) Illegal drug use can destroy the lives of the
Nation’s youth by diminishing their sense of moral-
ity and with it everything in life that is important
and worthwhile.
(3) According to recently released national sur-
veys, drug use among the Nation’s youth remains at
alarmingly high levels.
(4) National leadership is critical to conveying
to the Nation’s youth the message that drug use is
dangerous and wrong.
(5) National leadership can help mobilize every
sector of the community to support the implementa-
tion of comprehensive, sustainable, and effective pro-
grams to reduce drug abuse.
(6) As of September 1, 1998, 76 Members of
the House of Representatives were establishing com-
munity-based anti-drug coalitions in their congres-
sional districts or were actively supporting such coa-
litions that already existed.
(7) The individual Members of the House of
Representatives can best help their constituents pre-
vent drug use among the Nation’s youth by estab-
lishing community-based anti-drug coalitions in their
congressional districts or by actively supporting such
coalitions that already exist.
(b) SENSE OF CONGRESS.—It is the sense of Con-
gress that the individual Members of the House of Rep-
resentatives, including the Delegates and the Resident
Commissioner, should establish community-based anti-
drug coalitions in their congressional districts or should
actively support such coalitions that already exist.
Subtitle B—Rejection of
Legalization of Drugs
SEC. 311. SENSE OF CONGRESS.
(a) FINDINGS.—The Congress finds the following:
(1) Illegal drug use is harmful and wrong.
a Federal law or treaty is preempted by such law or
treaty.
(8) The Controlled Substances Act (title II of
Public Law 91–513; 21 U.S.C. 801 et seq.) strictly
regulates the use and possession of drugs.
(9) The United Nations Convention Against Il-
licit Traffic in Narcotic Drugs and Psychotrophic
Substances Treaty similarly regulates the use and
possession of drugs.
(10) Any attempt to authorize under State law
an activity prohibited under such Treaty or the Con-
trolled Substances Act would conflict with that Trea-
ty or Act.
(b) SENSE OF CONGRESS.—It is the sense of Con-
gress that—
(1) the several States, and the citizens of such
States, should reject the legalization of drugs
through legislation, ballot proposition, constitutional
amendment, or any other means; and
(2) every State should make efforts to be a
drug-free State.
Subtitle C—Report on Streamlining
Federal Prevention and Treat-
ment Efforts
SEC. 321. REPORT ON STREAMLINING FEDERAL PREVEN-
TION AND TREATMENT EFFORTS.
(a) SENSE OF CONGRESS.—It is the sense of Con-
gress that—
(1) the efforts of the Federal Government to re-
duce the demand for illegal drugs in the United
States are frustrated by the fragmentation of those
efforts across multiple departments and agencies;
and
(2) improvement of those efforts can best be
achieved through consolidation and coordination.
(b) REPORT REQUIREMENT.—
(1) IN GENERAL.—Not later than 18 months
after the date of enactment of this Act, the Director
of National Drug Control Policy shall prepare and
submit to the appropriate committee a report evalu-
ating options for increasing the efficacy of drug pre-
vention and treatment programs and activities by
the Federal Government. Such option shall include
the merits of a consolidation of programs into a sin-
gle agency, transferring programs from one agency
to another, and improving coordinating mechanisms
and authorities.
(2) RECOMMENDATION
AND
EXPLANATORY
STATEMENT.—The study submitted under para-
graph (1) shall identify options the Director deems
have merit, and an explanation which options should
be implemented.
(3) AUTHORIZATION OF APPROPRIATIONS.—For
purposes of carrying out this section, there are au-
thorized to be appropriated to the Director of Na-
tional Drug Control Policy $1,000,000 for contract-
ing, policy research, and related costs.
(c) APPROPRIATE COMMITTEE DEFINED.—In this
section, the term ‘‘appropriate committees’’ means the
Committee on Appropriations, the Committee on Com-
merce, and the Committee on Education and the Work-
force of the House of Representatives, and the Committee
on Appropriations, and Committee on Labor and Human
Resources of the Senate.
Æ