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S.2536
Agriculture, Rural Development, Food and Drug Administration, and
Related Agencies Appropriations Act, 2001 (Placed on the Calendar in the
Senate)
CHAPTER 8
GENERAL PROVISIONS--THIS TITLE
SEC. 2801. For purposes of Section 201 of the Drug Price Competition and
Patent Term Restoration Act, commonly known as the Hatch -Waxman Act (35 U.S.C. 156), a patent
which claims an elemental biologic used in manufacturing a product shall be
eligible for an extension of its term on the same terms and conditions as
other patents eligible under such Section, except that: (1) under 35 U.S.C.
156(a)(4), the product manufactured using such elemental biologic, rather than
such elemental biologic, shall have been subject to a regulatory review period
before its commercial marketing or use; and (2) an application for extension
of term may be submitted within the sixty-day period beginning on the date of
enactment of this section or within the sixty-day period beginning on the date
the patent becomes eligible for extension under this section. For purposes of
this section, the term `elemental biologic' means a genetically engineered
cell, or method of making thereof, used in manufacturing five or more new
drugs, antibiotic drugs, or human biological products, each subject to a
regulatory review period before commercial marketing or use and each receiving
permission under the provision of law under which the applicable regulatory
review period occurred for commercial marketing or use. To be eligible to
apply for a term extension under this section, the owner of record of a patent
claiming an elemental biologic must: (1) be a non-profit organization as
defined by section 201 of title 35; (2) not itself commercially sell the
product, and have made reasonable efforts to promote utilization of the
patented invention in commercial markets by licensing, on a non-exclusive,
royalty free or reasonable royalty basis, rights to make, use, offer to sell,
or sell the invention; and (3) share any royalties with the inventor, and
after payment of expenses (including payments to inventors) incidental to
administration of inventions, invest the balance of any royalties or income
earned from the invention in scientific research or education. This section
shall apply to any patent not yet expired at the time of enactment of this
section and to any patent issued thereafter. A timely applicant shall be
entitled to a decision by the Commissioner of Patents and Trademarks granting
or denying the application prior to such expiration of the patent, or if the
Commissioner cannot render such decision prior to such expiration, an
extension under section 156(e)(2), Title 35 United States Code, prior to
expiration of the patent.
SEC. 2802. At the end of the first paragraph under the heading `National
Oceanic and Atmospheric Administration, Operations, Research, and Facilities'
in title II of H.R. 3421 of the 106th Congress as enacted by section
1000(a)(1) of Public Law 106-113, add the following: `: Provided
further, That the vessel RAINIER shall use Ketchikan, Alaska as its home
port'.
SEC. 2803. Notwithstanding any other provision of law Section 109 of the
Commerce, Justice, and State, the Judiciary and Related Agencies
Appropriations Act 1995, Public Law 103-317 (28 U.S.C. 509 note) is
repealed.
SEC. 2804. Notwithstanding any other provision of law, not later than 15
days after the date of enactment of this Act the Department of Justice shall
transfer back to any Department or Agency all funds provided to the Department
of Justice as reimbursement for the costs of tobacco litigation:
Provided, That the Department of Justice shall report to the
Committees on Appropriations on the amounts reimbursed, by Department and
Agency, and the date when the reimbursements are completed.
SEC. 2805. Under the heading `Federal Communications Commission, Salaries
and Expenses' in title V of H.R. 3421 of the 106th Congress, as enacted by
section 1000(a)(1) of Public Law 106-113, delete `$210,000,000' and insert
`$215,800,000'; in the first and third provisos delete `$185,754,000' and
insert `$191,554,000' in each such proviso.
SEC. 2806. Under the heading `Telecommunications carrier compliance fund'
in title I of H.R. 3421 of the 106th Congress, as enacted by section
1000(a)(1) of Public Law 106-113, strike `$15,000,000' and insert
`$115,000,000'.
SEC. 2807. At the end of the paragraph under the heading `Justice prisoner
and alien transportation system fund, United States Marshals Service' in title
I of H.R. 3421 of the 106th Congress, as enacted by section 1000(a)(1) of
Public Law 106-113, add the following: `In addition, $13,500,000, to remain
available until expended, shall be available only for the purchase of two
Sabreliner-class aircraft.'.
SEC. 2808. Title IV of the Departments of Commerce, Justice, and State,
the Judiciary, and Related Agencies Appropriations Act, 2000 (as contained in
Public Law 106-113) is amended in the paragraph entitled `Diplomatic and
consular programs' by inserting after the fourth proviso: `Provided
further, That of the amount made available under this heading,
$5,000,000, less any costs already paid, shall be used to reimburse the City
of Seattle and other Washington state jurisdictions for security costs
incurred in hosting the Third World Trade Organization Ministerial
Conference:'.
SEC. 2809. Of the discretionary funds appropriated to the Edward Byrne
Memorial State and Local Law Enforcement Assistance Program in fiscal year
2000, $1,000,000 shall be transferred to the Violent Offender Incarceration
and Truth In Sentencing Incentive Grants Program to be used for the
construction costs of the Hoonah Spirit Camp, as authorized under section
20109(a) of subtitle A of title II of the 1994 Act.
SEC. 2810. Title I of the Departments of Commerce, Justice, and State, the
Judiciary, and Related Agencies Appropriations Act, 2000 (as contained in
Public Law 106-113) is amended in the paragraph entitled `Federal Bureau of
Investigation, Salaries and Expenses' by inserting after the third proviso the
following new proviso: `: Provided further, That in addition to
amounts made available under this heading, $3,000,000 shall be available for
the creation of a new site for the National Domestic Preparedness Office
outside of FBI Headquarters and the implementation of the `Blueprint' with
regard to the National Domestic Preparedness Office'.
SEC. 2811. Of the funds made available in fiscal year 2000 for the
Department of Commerce, $1,000,000 shall be derived from the account entitled
`General Administration' and $500,000 from the account entitled `Office of the
Inspector General' and made available for the Commission on Online Child
Protection as established under Title XIII of Public Law 105-825, and extended
by subsequent law.
TITLE III
GENERAL PROVISIONS--THIS DIVISION
SEC. 3101. No part of any appropriation contained in this Act shall remain
available for obligation beyond the current fiscal year unless expressly so
provided herein.
SEC. 3102. Notwithstanding the provisions of 10 U.S.C. 125(a), 3013, 3014,
3015, and 3016, none of the funds made available in this or any other Act may
be used to restructure, reorganize, abolish, transfer, consolidate, or
otherwise alter or modify, the organizational or management oversight
structure; existing delegations; or functions or activities, applicable to the
Army Corps of Engineers.
SEC. 3103. Notwithstanding any other provision of law, no funds provided
in this or any other Act may be used to further reallocate Central Arizona
Project water or to prepare an Environmental Assessment, Environmental Impact
Statement, or Record of Decision providing for a reallocation of Central
Arizona Project water until further act of Congress authorizing and directing
the Secretary of the Interior to make allocations and enter into contracts for
delivery of Central Arizona Project water.
SEC. 3104. Funds appropriated in this or any other Act and hereafter may
not be used to pay on behalf of the United States or a contractor or
subcontractor of the United States for posting a bond or fulfilling any other
financial responsibility requirement relating to closure or post-closure care
and monitoring of the Waste Isolation Pilot Plant. The State of New Mexico or
any other entity may not enforce against the United States or a contractor or
subcontractor of the United States, in this or any subsequent fiscal year, a
requirement to post bond or any other financial responsibility requirement
relating to closure or post-closure care and monitoring of the Waste Isolation
Pilot Plant. Any financial responsibility requirement in a permit or license
for the Waste Isolation Pilot Plant on the date of enactment of this section
may not be enforced against the United States or its contractors or
subcontractors at the Plant.
SEC. 3105. None of the funds made available under this Act or any other
Act shall be used by the Secretary of the Interior, in this or the succeeding
fiscal year, to promulgate final rules to revise or amend 43 C.F.R. Subpart
3809, except that the Secretary may finalize amendments to that Subpart that
are limited to only the specific regulatory gaps identified at pages 7 through
9 of the National Research Council report entitled `Hardrock Mining on Federal
Lands' and that are consistent with existing statutory authorities. Nothing in
this section shall be construed to expand the existing statutory authority of
the Secretary.
SEC. 3106. No funds may be expended in fiscal year 2000 by the Federal
Communications Commission to conduct competitive bidding procedures that
involve mutually exclusive applications where one or more of the applicants in
a station, including an auxiliary radio booster or translator station or
television translator station, licensed under section 397(6) of the
Communications Act, whether broadcasting on reserved or non-reserved
spectrum.
SEC. 3107. Using previously appropriated and available funds, the
Secretary shall develop and implement a process which pays interim
compensation by June 15, 2000, to all persons and entities eligible for
compensation under section 123 of title I, section 101(e) of Public Law
105-277, as amended.
SEC. 3108. OREGON INLET, NORTH CAROLINA, FLOOD CONTROL IMPROVEMENTS. (a)
IN GENERAL-
(1) JOINT DESIGNATION- Not later than 60 days after the date of
enactment of this Act--
(A) the Secretary of the Interior and the Secretary of the Army,
acting through the Chief of Engineers, shall jointly designate tracts of
land for the jetty and sand transfer system for the Oregon Inlet on the
Coast of North Carolina, approximately 85 miles south of Cape Henry and 45
miles north of Cape Hatteras (as described on page 12 of the Report of the
House of Representatives numbered 91-1665), authorized under the River and
Harbor Act of 1970 and the Flood Control Act of 1970 (Public Law 91-611;
84 Stat. 1818); and
(B) the Secretary of the Interior shall transfer administrative
jurisdiction over the tracts of land referred to in subparagraph (A) to
the Secretary of the Army.
(2) FAILURE TO JOINTLY DESIGNATE- If the Secretary of the Interior and
the Secretary of the Army fail to jointly designate the tracts of land
referred to in paragraph (1)(A) by the date that is 60 days after the date
of enactment of this Act, the Secretary of the Army shall designate the
tracts of land pursuant to a description prepared by the Secretary of the
Army, in consultation with the Chief of Engineers, and shall provide notice
to the Secretary of the Interior of the designation. Upon receipt of the
notice, the Secretary of the Interior shall transfer administrative
jurisdiction over the tracts of land to the Secretary of the Army.
(1) LIMITS- Except as provided in paragraph (2), the quantity of acreage
in the tracts of land referred to in subsection (a) shall not exceed--
(A) with respect to the tract in the Cape Hatteras National Seashore
Recreational Area, 93 acres; and
(B) with respect to the tract in the Pea Island National Wildlife
Refuge, 33 acres.
(2) EXCEPTION- If the Secretary of the Army and the Secretary of the
Interior jointly designate the tracts of land pursuant to subsection
(a)(1)(A), the area of each tract may exceed the acreage specified for the
tract in paragraph (1).
(c) MODIFICATION OF SIZE IN EVENT OF FAILURE TO JOINTLY DESIGNATE-
Notwithstanding subsection (b)(1), if, after designating the tracts of land
pursuant to subsection (a)(2), the Secretary of the Army determines that any
tract is inadequate for the construction, operation, and maintenance of a
jetty and sand transfer system for the Oregon Inlet, the Secretary of the Army
may designate, not earlier than 60 days after providing notice of a
designation to the Secretary of the Interior under subsection (a)(2), an
additional tract of land adjacent to the inadequate tract.
SEC. 3109. Notwithstanding any other provision of law, the Indian Health
Service is authorized to improve municipal, private or tribal lands with
respect to the new construction of the clinic for the community of King Cove,
Alaska authorized under section 353 of Public Law 105-277 (112 Stat.
2681-303).
SEC. 3110. Section 306 of H.R. 3425 of the 106th Congress, as enacted into
law by section 1000(a)(5) of Public Law 106-113, is hereby repealed.
TITLE IV--FOOD AND MEDICINE FOR THE WORLD ACT
SEC. 4001. SHORT TITLE.
This title may be cited as the `Food and Medicine for the World Act'.
SEC. 4002. DEFINITIONS.
(1) AGRICULTURAL COMMODITY- The term `agricultural commodity' has the
meaning given the term in section 102 of the Agricultural Trade Act of 1978
(7 U.S.C. 5602).
(2) AGRICULTURAL PROGRAM- The term `agricultural program' means--
(A) any program administered under the Agricultural Trade Development
and Assistance Act of 1954 (7 U.S.C. 1691 et seq.);
(B) any program administered under section 416 of the Agricultural Act
of 1949 (7 U.S.C. 1431);
(C) any program administered under the Agricultural Trade Act of 1978
(7 U.S.C. 5601 et seq.);
(D) the dairy export incentive program administered under section 153
of the Food Security Act of 1985 (15 U.S.C. 713a-14);
(E) any commercial export sale of agricultural commodities;
or
(F) any export financing (including credits or credit guarantees)
provided by the United States Government for agricultural
commodities.
(3) JOINT RESOLUTION- The term `joint resolution' means--
(A) in the case of section 4003(a)(1), only a joint resolution
introduced within 10 session days of Congress after the date on which the
report of the President under section 4003(a)(1) is received by Congress,
the matter after the resolving clause of which is as follows: `That
Congress approves the report of the President pursuant to section
4003(a)(1) of the Food and Medicine for the World Act, transmitted on
XXXXXXX.', with the blank completed with the appropriate date;
and
(B) in the case of section 4006(1), only a joint resolution introduced
within 10 session days of Congress after the date on which the report of
the President under section 4006(2) is received by Congress, the matter
after the resolving clause of which is as follows: `That Congress approves
the report of the President pursuant to section 4006(1) of the Food and
Medicine for the World Act, transmitted on XXXXXXX.', with the
blank completed with the appropriate date.
(4) MEDICAL DEVICE- The term `medical device' has the meaning given the
term `device' in section 201 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321).
(5) MEDICINE- The term `medicine' has the meaning given the term `drug'
in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321).
(6) UNILATERAL AGRICULTURAL SANCTION- The term `unilateral agricultural
sanction' means any prohibition, restriction, or condition on carrying out
an agricultural program with respect to a foreign country or foreign entity
that is imposed by the United States for reasons of foreign policy or
national security, except in a case in which the United States imposes the
measure pursuant to a multilateral regime and the other member countries of
that regime have agreed to impose substantially equivalent measures.
(7) UNILATERAL MEDICAL SANCTION- The term `unilateral medical sanction'
means any prohibition, restriction, or condition on exports of, or the
provision of assistance consisting of, medicine or a medical device with
respect to a foreign country or foreign entity that is imposed by the United
States for reasons of foreign policy or national security, except in a case
in which the United States imposes the measure pursuant to a multilateral
regime and the other member countries of that regime have agreed to impose
substantially equivalent measures.
SEC. 4003. RESTRICTION.
(a) NEW SANCTIONS- Except as provided in sections 4004 and 4005 and
notwithstanding any other provision of law, the President may not impose a
unilateral agricultural sanction or unilateral medical sanction against a
foreign country or foreign entity, unless--
(1) not later than 60 days before the sanction is proposed to be
imposed, the President submits a report to Congress that--
(A) describes the activity proposed to be prohibited, restricted, or
conditioned; and
(B) describes the actions by the foreign country or foreign entity
that justify the sanction; and
(2) there is enacted into law a joint resolution stating the approval of
Congress for the report submitted under paragraph (1).
(1) IN GENERAL- Except as provided in paragraph (2), the President shall
terminate any unilateral agricultural sanction or unilateral medical
sanction that is in effect as of the date of enactment of this Act.
(2) EXEMPTIONS- Paragraph (1) shall not apply to a unilateral
agricultural sanction or unilateral medical sanction imposed--
(A) with respect to any program administered under section 416 of the
Agricultural Act of 1949 (7 U.S.C. 1431);
(B) with respect to the Export Credit Guarantee Program (GSM-102) or
the Intermediate Export Credit Guarantee Program (GSM-103) established
under section 202 of the Agricultural Trade Act of 1978 (7 U.S.C. 5622);
or
(C) with respect to the dairy export incentive program administered
under section 153 of the Food Security Act of 1985 (15 U.S.C.
713a-14).
SEC. 4004. EXCEPTIONS.
Section 4003 shall not affect any authority or requirement to impose (or
continue to impose) a sanction referred to in section 4003--
(1) against a foreign country or foreign entity--
(A) pursuant to a declaration of war against the country or
entity;
(B) pursuant to specific statutory authorization for the use of the
Armed Forces of the United States against the country or entity;
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