[Congressional Record Volume 153, Number 62 (Wednesday, April 18, 2007)]
[Senate]
[Pages S4678-S4699]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS
By Mr. LUGAR (for himself and Mr. Bayh):
S. 1138. A bill to enhance nuclear safeguards and to provide
assurances of nuclear fuel supply to countries that forgo certain fuel
cycle activities; to the Committee on Foreign Relations.
Mr. LUGAR. Mr. President, I rise today with my colleague from
Indiana, Senator Bayh, to introduce the Nuclear Safeguards and Supply
Act of 2007.
The future of the Nuclear Non-Proliferation Treaty and the larger
nonproliferation system it supports is in doubt. The existing
safeguards regime used by the International Atomic Energy Agency (IAEA)
has succeeded in forestalling nuclear weapons programs in the world's
advanced industrial states, several of which were weighing the nuclear
option 40 years ago. Unfortunately, this regime has failed to keep pace
with the increase in the global availability of nuclear weapons
technology, especially the technology and equipment for uranium
enrichment and spent nuclear reactor fuel reprocessing, which can
produce fissile material for weapons. Now the road to nuclear weapons
can be traveled by determined countries with only a minimal industrial
base. While the number of recognized nuclear weapon states has not
dramatically increased over the years, the dangers of proliferation
have become all too apparent as demonstrated by the A.Q. Khan network,
the Iranian, North Korean, and Libyan examples.
The construction of facilities for the enrichment of uranium and
reprocessing of spent nuclear fuel in new states, even for ostensibly
peaceful purposes, poses an unacceptable long-term risk to the national
security of the United States. The enrichment technology intended to
produce fuel for reactors can also be used to create highly-enriched
uranium for a nuclear weapon, and the plutonium that is produced from
reprocessing spent fuel is also suitable for nuclear weapons and
susceptible to diversion to terrorists. The spread of enrichment and
reprocessing capabilities will dangerously increase the chances that
new nations will develop nuclear weapons and that terrorists might
obtain fissile or radiological materials for crude devices. It is
therefore incumbent on the United States to lead an international
effort to halt the expansion of enrichment and reprocessing to new
countries.
We know President Bush shares our assessment of this situation. On
February 11, 2004, he stated, ``The world's leading nuclear exporters
should ensure that states have reliable access at reasonable cost to
fuel for civilian reactors, so long as those states renounce enrichment
and reprocessing. Enrichment and reprocessing are not necessary for
nations seeking to harness nuclear energy for peaceful purposes.''
The threats posed by new nuclear fuel cycle facilities in new states
are made worse by the fact that the use of nuclear power is likely to
increase, both in developed and developing countries. As energy costs
have soared in recent years, many states are reexamining nuclear power
as a potential source of electricity. Importantly, however, the
expansion of nuclear power does not require--either technically or
economically--the construction of enrichment or reprocessing facilities
in countries that do not currently have them.
Senator Bayh and I believe the United States should adopt as a basic
nonproliferation principle that countries who give up their own
enrichment and reprocessing programs have an assurance, either
bilateral or multilateral or both, of nuclear reactor fuel at
reasonable prices. Today, the market provides the basic framework for
commerce in and access to nuclear fuel, and should not be interrupted
by government action, but the exchange of nuclear fuel and fuel
services for enrichment and reprocessing capabilities is not currently
explicit. This would also require that states agreeing to accept fuel
services and leasing of fuel, in return for giving up joining the group
of states possessing reprocessing and enrichment capabilities, would
also consent to wide access and close monitoring of their nuclear
energy activities, exceeding the requirements of the IAEA Additional
Protocol. Related efforts in this area should also move forward in the
[Nuclear Suppliers Group, where various nations have advocated a
criteria-based approach to nuclear fuel supply.
Unfortunately, as the world looks to increase the number of civilian
nuclear power plants, the IAEA, charged with ensuring that energy
programs do not stray into weapons efforts through the verification of
safeguards agreements, operates on a shortsighted budget with old
equipment. This situation threatens the institution, and to some degree
the nuclear stability that the IAEA's safeguards verification mandate
supports. The IAEA is responsible for verifying that states do not
violate their obligations under the Nuclear Nonproliferation Treaty
(NPT). The IAEA monitors states' nuclear programs through safeguards
agreements and additional protocols to ensure that nuclear material,
equipment, and technology are used for declared, peaceful purposes.
Last November, I visited the IAEA and its Safeguards Analytical
Laboratory (SAL), located just outside Vienna, Austria. Samples
collected by IAEA inspectors during inspections are brought to the SAL
to verify that safeguards obligations are being met and that there are
no undeclared materials and activities. Unfortunately the laboratory's
aging equipment and dangerous working conditions will hamper the
important work done there, particularly as more samples arrive there
and as more states expand their nuclear power infrastructure. Such a
situation could, in the future, shut down a critical nonproliferation
facility. The IAEA's nuclear materials analysis capability is
vulnerable to a single point of failure given the situation at SAL.
Laboratory staff is also severely limited in the time they can spend
analyzing evidence in the ``hot'' or nuclear part of SAL because of the
dilapidated air purification system in one part of the laboratory.
Equally disturbing, SAL is still using equipment manufactured in the
1970's. If the IAEA is supposed to be the world's nuclear watchdog, the
least we can do is to provide the people who work there with
appropriate and effective tools to do their job.
Absent refurbishment of SAL, or the construction of a new IAEA
facility with modem equipment, President Ronald Reagan's charge ``trust
but verify'' will be abandoned because we have not taken action.
The SAL helped to discover the inconsistencies in Iran's cover-up of
its nuclear weapons program. The analysis and questioning by inspectors
prompted stonewalling by Tehran. The Iranian failure to provide
information and access led the IAEA Board of Governors to refer the
matter to the United Nations Security Council. While I wish this might
have happened more quickly, the fact is that SAL, the network of
laboratories in other Member States, and the IAEA's inspectors provided
the evidence necessary to build consensus on Iranian violations.
The Lugar-Bayh legislation works to create both bilateral and
multilateral assurances of nuclear fuel supply by specifically
authorizing the President to pursue such mechanisms. Importantly, our
legislation takes note of the fact that merely ensuring fuel supply is
not enough to truly deal with the potential proliferation that could
arise as a result of many more nuclear reactors being built around the
world. Proliferation of fuel cycle technologies may continue,
regardless of the ability of our Nation and others to craft layers of
assurance in fuel supply. Our bill makes an important point--that fuel
supply for new nuclear power is as important as the safeguards applied
to nuclear power.
The Lugar-Bayh legislation makes it the policy of the United States
to discourage the development of enrichment and reprocessing
capabilities in additional countries, and to encourage the creation of
bilateral and multilateral assurances of nuclear fuel supply,
[[Page S4679]]
and ensure that all supply mechanisms operate in strict accordance with
the IAEA safeguards system and do not result in any additional unmet
verification burdens for the system. To ensure that SAL does not cease
to function, we authorize an additional $10,000,000 for the
refurbishment or possible replacement of the IAEA Safeguards Analytical
Laboratory. We also authorize the Secretary of State, in cooperation
with the Secretary of Energy and the Directors of the National
Laboratories, and in consultation with the Secretary of Defense and the
Director of National Intelligence, to pursue a program that will
improve nuclear safeguards technology development.
With regard to fuel supply, our bill authorizes the President to
create, consistent with existing law, bilateral and multilateral
mechanisms to provide a reliable supply of nuclear fuel to those
countries and groups of countries that adhere to policies designed to
prevent the proliferation of nuclear weapons and that decide to forgo a
national uranium enrichment program and spent nuclear fuel reprocessing
facilities. Such mechanisms must confront the challenges of
international politics, thus the authority contained in the bill is
designed to provide a flexible framework, rather than a final set of
requirements, for such mechanisms. The bill embraces both bilateral and
multilateral fuel supply mechanisms, and calls for a report on the
establishment of an International Nuclear Fuel Authority.
The United States cannot fix the IAEA's problems alone, but we must
lead. An international diplomatic effort is required to raise the funds
necessary to ensure that the IAEA has the resources and leadership it
needs to continue its important mission. But the IAEA, its Member
States and Board of Governors must also act. The Board must review and
revise SAL staffing policies as they apply to professional staff
working at SAL to ensure that it attracts and retains key personnel.
Current policies are self-defeating and force experts out just as they
are accumulating the level of experience and expertise necessary to
succeed.
Not only is the existing IAEA infrastructure in desperate need of
modernization, but a global nuclear power expansion will require a
commensurate increase in IAEA capability. We must strengthen the
organization to ensure that multiplying nuclear power facilities are
not diverted to weapons work. This can and should be accompanied by
better support to our own efforts in verification activities and
technologies, such as through the Key Assets Verification Fund at the
Department of State and the U.S. Program of Technical Assistance to
IAEA Safeguards or POTAS.
If the world is at the dawn of a new nuclear power age, then there
will be more facilities and materials for the IAEA to inspect and
verify. The IAEA is not prepared for such a future, but there is still
time to put the necessary investments in place to ensure that it
continues its important role. The United States and other Member States
have the ability to plan and make decisions now that will ensure a
safer nuclear power option in the future. It is incumbent upon the
United States to assist in the construction of the best possible
safeguards system to provide for international peace and security.
Peaceful uses of nuclear energy are only as good as the means to verify
them.
The current budget of the IAEA cannot sustain further stress, nor can
the world afford to allow another state to develop nuclear weapons in
secret. The IAEA is underfunded to perform its current tasks and would
be required to do much more should nuclear energy become more
widespread. The Bush Administration must significantly increase funding
to the IAEA to improve its ability to exercise its rights and meet its
obligations. We hope this legislation will begin that process.
I look forward to working with my colleagues on the Committee on
Foreign Relations on these important matters. I thank Senator Bayh for
his partnership in this endeavor.
______
By Mr. BINGAMAN (for himself, Mr. Salazar, Ms. Cantwell, and Mr.
Sanders):
S. 1139. A bill to establish the National Landscape Conservation
System; to the Committee on Energy and Natural Resources.
Mr. BINGAMAN. Mr. President, together with Senators Salazar,
Cantwell, and Sanders, I am pleased today to introduce legislation to
codify the National Landscape Conservation System, the collection of
national monuments, national conservation areas, wilderness areas, wild
and scenic rivers and other remarkable landscapes on our public lands
administered by the Bureau of Land Management.
The National Landscape Conservation System was established
administratively by the Department of the Interior in 2000 and consists
of all areas the BLM administers for conservation purposes. The concept
behind grouping all of these areas into one system was to increase
public awareness of the importance of these lands and to highlight the
BLM's conservation of these areas and their cultural, historical,
scientific, and ecological significance to the Nation.
Within my own State of New Mexico, the National Landscape
Conservation System encompasses several nationally significant areas,
including the rugged lava flows of El Malpais National Conservation
Area, the unique cone-shaped rock formations of the Kasha-Katuwe Tent
Rocks National Monument, the Rio Grande Wild and Scenic River, the
Continental Divide National Scenic Trail and the El Camino Real de
Tierra Adentro and Old Spanish Trail National Historic Trails, as well
as over one million acres of wilderness and wilderness study areas.
However, because the NLCS was established administratively, it does
not have the permanence that it would have if enacted legislatively. In
addition, legislative enactment of the NLCS will help increase the
attention to these important, congressionally protected areas, and
hopefully will help ensure that the system remains a high priority
within the BLM and the Department of the Interior. The bill does not
create any new management authority and does not change the authorities
for any of the previously designated areas within the system.
Given the broad public support for these areas, I expect this bill to
be non-controversial and it is my hope that it will be able to move
quickly through the Congress and enactment into law.
I ask unanimous consent that the text of the bill be printed in the
Record.
There being no objection, the text of the bill was ordered to be
printed in the Record, as follows:
S. 1139
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``National Landscape
Conservation System Act''.
SEC. 2. DEFINITIONS.
In this Act:
(1) Secretary.--The term ``Secretary'' means the Secretary
of the Interior.
(2) System.--The term ``system'' means the National
Landscape Conservation System established by section 3(a).
SEC. 3. ESTABLISHMENT OF THE NATIONAL LANDSCAPE CONSERVATION
SYSTEM.
(a) Establishment.--In order to conserve, protect, and
restore nationally significant landscapes that have
outstanding cultural, ecological, and scientific values for
the benefit of current and future generations, there is
established in the Bureau of Land Management the National
Landscape Conservation System.
(b) Components.--The system shall include each of the
following areas administered by the Bureau of Land
Management:
(1) Each area that is designated as--
(A) a national monument;
(B) a national conservation area;
(C) an outstanding natural area;
(D) a wilderness study area;
(E) a component of the National Trails System;
(F) a component of the National Wild and Scenic Rivers
System; or
(G) a component of the National Wilderness Preservation
System.
(2) Any area designated by Congress to be administered for
conservation purposes, including--
(A) the Steens Mountain Cooperative Management and
Protection Area, as designated under section 101(a) of the
Steens Mountain Cooperative Management and Protection Act of
2000 (16 U.S.C. 460nnn-11(a));
(B) the Headwaters Forest Reserve; and
(C) any additional area designated by Congress for
inclusion in the system.
(c) Management.--The Secretary shall manage the system--
(1) in accordance with any applicable law (including
regulations) relating to any component of the system included
under subsection (b); and
(2) in a manner that protects the values for which the
components of the system were designated.
[[Page S4680]]
SEC. 4. AUTHORIZATION OF APPROPRIATIONS.
There are authorized to be appropriated such sums as are
necessary to carry out this Act.
Mr. Salazar. Mr. President, today Senator Bingaman and I are
introducing the National Landscape Conservation System Act, a bill that
will help protect some of our Nation's most treasured landscapes.
This bill, which we are introducing with Senators Cantwell and
Sanders, will make permanent a system of management for the 26 million
most spectacular acres of the 260 million acres that the Bureau of Land
Management oversees.
The National Landscape Conservation System was created
administratively in 2000 to guide the management of the national
monuments, national conservation areas, national wild and scenic
rivers, wilderness areas, wilderness study areas, and national historic
and scenic trails that are under the BLM's authority.
Many of these lands are on par with our national parks in their
beauty and value to the American people. Unfortunately, the National
Landscape Conservation System has taken a backseat in our country's
land conservation efforts. The NLCS has been shortchanged in funding in
the President's budget year in and year out. There are not enough
resources or staff to properly manage these lands, and we are hearing a
growing number of reports that natural, cultural, and archaeological
sites on NLCS lands are being overrun or destroyed. Last year, a report
by the National Trust for Historic Preservation painted a disappointing
portrait of how cultural resources are being managed on BLM lands.
At Colorado's Canyons of the Ancients National Monument, home to the
highest density of cultural sites in America, 47 ancestral Puebloan
sites were looted in the first half of 2006. With only one law
enforcement officer for the entire monument, it is almost impossible to
prevent this type of vandalism.
At McInnis Canyon National Conservation Area, also in Colorado, the
one law enforcement officer splits his time with other lands overseen
by the BLM field office. How is one officer to be expected to protect
1.3 million acres of BLM land?
This same unit of the NLCS shares an archaeologist with the Grand
Junction, CO, field office. There is no way that an individual can
oversee the archaeological surveys under way in the area's booming oil
and gas fields while still ensuring that the conservation area's
petroglyphs, fossils, and archaeological treasures are documented and
protected.
The Secretary of the Interior took a good step in 2000 when he
established the National Landscape Conservation System. The BLM should
have additional resources and tools for the management of lands that
the American people have determined to be of exceptional natural,
cultural, recreational, scenic, or historic value. Unfortunately, this
system has not come far in the last 7 years.
The administration provides no line item in the President's budget
for the system, NLCS units have endured repeated funding cuts, and
there are meager plans for where the system is going over the coming
decades.
The bill that Senator Bingaman and I are introducing today takes the
first step in improving the stewardship of these crown jewel BLM lands.
It is a straightforward bill: it simply writes the National Landscape
Conservation System into law, making it permanent for the enjoyment of
future generations.
The bill does not change how any of the units in the system are
managed. Grazing rights, water rights, and public access to the
national monuments, the wilderness areas, and the conservation areas
are unchanged.
The bill does, however, recognize that these landscapes are of great
interest to the American people and should be managed to protect their
values.
Over the coming decades, these lands will become more widely used and
known. Americans are already coming to see these landscapes--places
like canyons of the Ancients National Monument or Gunnison Gorge
National Conservation Area--as treasures that match our great national
parks and wildlife refuges.
This bill is a logical and needed step toward improving the
management of the units that comprise the National Landscape
Conservation. I thank Chairman Bingaman for his leadership on this
issue, and I hope we will have an opportunity to move this bill through
the Senate as quickly as possible.
______
By Mr. GREGG (for himself, Mr. Lautenberg, Mr. Cochran, Mr.
Warner, Mr. Wyden, Mr. Lieberman, Ms. Snowe, Mrs. Boxer, Mr.
Kerry, Mr. Menendez, Ms. Cantwell, Mrs. Feinstein, Mr. Reed,
Mrs. Murray, Ms. Collins, and Mr. Sununu):
S. 1142. A bill to authorize the acquisition of interests in
undeveloped coastal areas in order better to ensure their protection
from development; to the Committee on Commerce, Science, and
Transportation.
Mr. GREGG. Mr. President, I rise today along with Senator Lautenberg
to introduce the Coastal and Estuarine Land Protection Act. We are
introducing this much needed coastal protection act along with Senators
Cochran, Warner, Wyden, Kennedy, Lieberman, Snowe, Boxer, Kerry,
Menendez, Cantwell, Feinstein, Reed, Murray, Collins, and Sununu. In
addition, this legislation is supported by the Trust for Public Land,
The Nature Conservancy, Association of Fish and Wildlife Agencies, the
Land Trust Alliance, The Conservation Fund, Restore America's
Estuaries, The Ocean Conservancy, American Fly Fishing Trade
Association, Society for the Protection of New Hampshire Forests,
National Estuarine Research Reserve Association, Association of
National Estuary Programs, Coastal States Organization, New Jersey
Audubon Society, and the NY/NJ Baykeeper.
The Coastal and Estuarine Land Protection Act promotes coordinated
land acquisition and protection efforts in coastal and estuarine areas
by fostering partnerships between non-governmental organizations and
Federal, State, and local governments. As clearly outlined by the U.S.
Commission of Ocean Policy, these efforts are urgently needed. With
Americans rapidly moving to the coast, pressures to develop critical
coastal ecosystems are increasing. There are fewer and fewer
undeveloped and pristine areas left in the Nation's coastal and
estuarine watersheds. These areas provide important nursery habitat for
two-thirds of the Nation's commercial fish and shellfish, provide
nesting and foraging habitat for coastal birds, harbor significant
natural plant communities, and serve to facilitate coastal flood
control and pollutant filtration.
The Coastal and Estuarine Land Protection Act pairs willing sellers
through community-based initiatives with sources of federal funds to
enhance environmental protection. Lands can be acquired in full or
through easements, and none of the lands purchased through this program
would be held by the Federal Government. This bill puts land
conservation initiatives in the hands of State and local communities.
This new program, administered by the National Oceanic and Atmospheric
Administration, would provide Federal matching funds to states with
approved coastal management programs or to National Estuarine Research
Reserves through a competitive grant process. Federal matching funds
may not exceed 75 percent of the cost of a project under this program,
and non-Federal sources may count in-kind support toward their portion
of the cost share.
This coastal land protection program provides much needed support for
local coastal conservation initiatives throughout the country. In New
Hampshire, we have worked collaborative1y with local communities,
environmental groups, willing sellers, and the State to conserve lands
around Great Bay, Sagamore Creek, Massacre Marsh, Hurd Farm, Moose
Mountain, Winnicut Headwaters, Marden Woods, Sleeper Wetlands, and the
Piscassic River Greenway. These lands are home to a wide variety of
plants and animal species that are particularly threatened by
encroaching development and environmental pollutants. By working with
local communities to purchase lands or easements on these valuable
parcels of land, New Hampshire has been able to successfully conserve
the natural and scenic heritage of this vital estuary.
[[Page S4681]]
Programs like the Coastal and Estuarine Land Protection program will
further enable other states to participate in these community-based
conservation efforts in coastal areas. This program was modeled after
the U.S. Department of Agriculture's successful Forest Legacy Program,
which has conserved millions of acres of productive and ecologically
significant forest land around the country.
I welcome the opportunity to offer this important legislation, with
my good friend from New Jersey, Senator Lautenberg. I am thankful for
his leadership on this issue, and look forward to working with him to
make the vision for this legislation a reality, and to successfully
conserve our coastal lands for their ecological, historical,
recreational, and aesthetic values.
Mr. LAUTENBERG. Mr. President, I rise today to join Senator Gregg in
our introduction of legislation that would help protect and preserve
the valuable coastal and estuarine lands of our Nation.
Development of the Nation's coastal and estuarine areas poses an
increasing threat to water quality, wildlife habitat, flood protection,
and recreational opportunities. The U.S. Commission on Ocean Policy
emphasized that intact coastal lands are vital to ensuring the
ecological and economic health of coastal communities. However, as
these areas are fragmented and disappear, so do the benefits they
provide. The Coastal and Estuarine Land Protection Act (CELP) would
authorize the National Oceanic and Atmospheric Administration (NOAA) as
the lead Federal agency supporting State, local or private acquisition
of land or conservation easements in undeveloped coastal areas in order
to ensure their protection from development. The Joint Ocean Commission
Initiative has identified enactment of the Coastal and Estuarine Land
Protection Act as a high priority for improving our coastal resource
management. This legislation builds upon the existing Coastal and
Estuarine Land Conservation Program (CELCP) within NOAA. The Program
allows States to compete for matching funds to acquire land or
easements for the protection of sensitive coastal ecosystems. The
Federal funds provided through this program help leverage additional
State, local and private funding.
The CELCP complements private, Federal and State conservation
programs. This program is based on the highly successful Forest Legacy
program which is a Federal-State partnership program that supports
efforts to protect environmentally sensitive forest lands. Permanent
protection of lands in the coastal zone is also necessary to maintain
and enhance coastal and estuarine areas for the benefit of the Nation,
including protecting water quality, keeping public beachfront
accessible, conserving wildlife habitat, and sustaining sport and
commercial fisheries.
Coastal and estuarine areas are some of the most productive
ecosystems on earth. They are home to countless plants, animals, birds,
and fish. These are complex ecosystems that provide a foundation for
marine life as well as protection of inland areas from storm damage.
Over the last 150 years the national system of estuaries has decreased
in size because of our growing coastal populations and short-sighted
land-use planning. Today our coastal areas are home to over 150 million
Americans, about 53 percent of the U.S. population, and over 180
million people visit the coasts each year. Due to the increasing
pressures from development in low-lying areas, NOAA has estimated 80
percent of our Nations' coastal waters are impaired for human use and
marine life.
The National Estuarine Research Reserve System (NERRS) established
under the Coastal Zone Management Act is a network of 27 protected
estuaries throughout the United States, including the Jacques Cousteau
NERRS site in New Jersey. These are pristine areas that provide public
education and conservation awareness, and serve as living laboratories
for scientific research. The funds provided through the CELP program
established by our legislation would promote the expansion of these
estuarine areas and assist in keeping coastal ecosystems healthy and
productive.
Federal funds help make New Jersey conservation possible. New
Jersey's treasured natural resources--from the Meadowlands to the
marshlands of Barnegat Bay--have substantially benefited from Federal
support. The existing CELCP has aided in securing protection for over a
thousand acres in New Jersey including lands for Gunning Island,
Tuckerton Creek, and the Harbor Herons project. This week there will be
a formal dedication of a 115-acre property, acquired with the aid of
CELCP, on Potter Creek in Berkeley Township for public use and
recreation. Lands have been protected in the Manahawkin Marsh, for
wildlife habitat, including migratory birds along the Atlantic Flyway.
In Ocean County, the CELCP helped secure the acquisition of 800 acres
on Tuckerton Creek in Little Egg Harbor which is vital to protecting
Atlantic white cedar stands and improving the water quality of the
Barnegat Bay. These projects have successfully protected our coasts
while sustaining human activity.
The coastal zone is essential to our country's prosperity and well-
being. The coastal and estuarine lands are areas of national importance
and they are vulnerable to human activities. From 2002 through 2006
twenty-five States have benefited from the CELCP. Now is the time for
Congress to authorize this program to conserve lands that are vital to
our Nation.
The bill Senator Gregg and I are introducing today, the Coastal and
Estuarine Land Protection Act, will ensure an ongoing partnership
between Federal, State, and local governments to support the economic
and natural resource base of communities through the acquisition of
coastal and estuarine lands. This legislation offers the opportunity
for States to protect coastal and estuarine areas that have significant
conservation, recreation, ecological, historical, or aesthetic values
and are threatened by conversion to other uses.
The organizations supporting this legislation include The Trust for
Public Land, The American Littoral Society, NY/NJ Baykeeper,
Association of Fish and Wildlife Agencies, Land Trust Alliance, Restore
America's Estuaries, American Fly Fishing Trade Association, Society
for the Protection of New Hampshire's Forests, National Estuarine
Research Reserve Association, Association of National Estuary Programs,
The Ocean Conservancy, Coastal States Organization, The Conservation
Fund, The Nature Conservancy, and the New Jersey Audubon Society. I ask
unanimous consent that a letter of support from these groups be printed
in the Record.
I would like to thank Senator Gregg for his long-time leadership on
this issue. I would also like to thank Senator Mikulski for her many
years of support for this legislation. I look forward to continuing to
work with Senator Gregg and my colleagues in the Senate to ensure its
passage so that we can fill this vital need for coastal and estuarine
protection.
There being no objection, the letter was ordered to be printed in the
Record, as follows:
April 16, 2007.
Hon. Judd Gregg,
Russell Senate Office Building,
Washington, DC.
Hon. Frank Lautenberg,
Hart Senate Office Building,
Washington, DC.
Dear Senators Gregg and Lautenberg: On behalf of the
organizations listed below, we would like to thank you for
your longstanding support of coastal zone management and
coastal land conservation. We are writing today in support of
the Coastal and Estuarine Land Protection Act (CELP), which
would formally codify the Coastal and Estuarine Land
Conservation Program. This program was created by Congress in
FY 2002 in order to ``protect those coastal and estuarine
areas with significant conservation, recreation, ecological,
historical or aesthetic values, or that are threatened by
conversion from their natural or recreational states to other
uses.'' Thus far, this program has invested over $177 million
towards 119 conservation projects in 25 of the nation's 35
coastal states. This federal investment has leveraged more
than an equal amount of state, local and private funding,
demonstrating the importance of coastal protection throughout
the nation and the critical role of federal funding to its
success.
Our nation's coastal zone is under significant pressures
from unplanned development. In fact, it is estimated that by
2025, nearly 75 percent of the nation's population will live
within 50 miles of the coast, in addition to millions more
who enjoy America's storied coastlines. Across the nation,
beaches and waterfronts have always been the destination of
choice for Americans. Fully one-half of the nation's gross
domestic product, $4.5
[[Page S4682]]
trillion annually, is generated in coastal watershed
counties, inexorably linking our coastal zone with the
economic health of the nation.
As a result of this economic boom, rapid, unplanned
development has marred the once-pristine viewshed and
substantially reduced public access to the coast. The
resulting increase in impervious surfaces has correspondingly
increased non-point source pollution and seriously degraded
coastal and estuarine waters. The loss of coastal wetlands
has drastically impaired estuaries, some of the most
productive habitat on earth, and has exacerbated damage from
coastal storms. The U.S. Commission on Ocean Policy has also
stressed the importance of land conservation as part of its
broader recommendations to Congress and the nation.
From our first-hand experience at the local level, we know
that CELP will significantly leverage ongoing community-based
conservation, and will provide a much needed boost to local
efforts. Given the importance of healthy, productive and
accessible coastal areas, a federal commitment to state and
local coastal protection is a sound investment. The new
legislation codifies the existing investment that Congress
has already made to coastal protection and authorizes the
program formally. We believe this is an important and
necessary step to enhance efforts to ensure safe and
accessible coastal waters.
We thank you for introducing this legislation, and look
forward to working with you towards its enactment.
Sincerely,
Gary J. Taylor, Legislative Director, Association of Fish
and Wildlife Agencies; Russell Shay, Director of Public
Policy, Land Trust Alliance; Alan Front, Senior Vice
President, The Trust for Public Land; Steven Bosak,
Vice President for External Affairs, Restore America's
Estuaries; Robert Ramsay, President, American Fly
Fishing Trade Association; Jane A. Difley, President-
Forester, Society for the Protection of New Hampshire's
Forests; Angela Corridore, Executive Director, National
Estuarine Research Reserve Association; Rich Innes,
Executive Director, Association of National Estuary
Programs; David Hoskins, Vice President for Government
Affairs and General Counsel, The Ocean Conservancy;
Kacky Andrews, Executive Director, Coastal States
Organization; Lawrence A. Selzer, President, The
Conservation Fund; Jimmie Powell, Director of
Government Relations, The Nature Conservancy; Eric
Stiles, Vice President for Conservation and
Stewardship, New Jersey Audubon Society; Tim
Dillingham, Executive Director, American Littoral
Society (NJ).
______
By Mr. NELSON of Florida:
S. 1143. A bill to designate the Jupiter Inlet Lighthouse and the
surrounding Federal land in the State of Florida as an Outstanding
Natural Area and as a unit of the National Landscape System, and for
other purposes; to the Committee on Energy and Natural Resources.
Mr. NELSON of Florida. Mr. President, today I am introducing a bill
designating the Jupiter Inlet Lighthouse and the 126 surrounding acres
in Jupiter, Florida, as an ``Outstanding Natural Area.'' The Jupiter
Lighthouse is a local and regional icon, full of rich history and home
to many endangered plant and animal species. Designating the lighthouse
as an ``Outstanding Natural Area'' will preserve the rich cultural
heritage and important ecological value of the site. This designation
would give the Jupiter Inlet the distinction of being the sole East
Coast representative of the National Landscape Conservation System--the
eastern counterpart to the Yaquina Head Lighthouse in Oregon.
This bill is the product of the hard work and cooperation of many
people in Florida, including the Town of Jupiter Island, the Town of
Jupiter, the Board of County Commissioners of Palm Beach County, the
Loxahatchee River Historical Society, and numerous others. I am also
pleased that Representative Tim Mahoney is introducing similar
legislation in the House of Representatives.
I ask unanimous consent that the text of the bill be printed in the
Record.
There being no objection, the text of the bill was ordered to be
printed in the Record, as follows:
S. 1143
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Jupiter Inlet Lighthouse
Outstanding Natural Area Act of 2007''.
SEC. 2. FINDINGS.
Congress finds that--
(1) the area surrounding the Jupiter Inlet Lighthouse in
the State of Florida--
(A) is at the confluence of the Loxahatchee River and the
Indian River Lagoon; and
(B) supports significant ecological values, including--
(i) endangered species of flora and fauna; and
(ii) imperiled natural communities rapidly vanishing in
south Florida;
(2) the area surrounding the Lighthouse was first used by
Native Americans over 4,000 years ago;
(3) Europeans made contact with the area surrounding the
Lighthouse in the 17th century;
(4) the Lighthouse and the associated Oil House, which was
constructed in 1860, are nationally recognized historical
structures that should be preserved for present and future
generations of people in the United States;
(5) the Lighthouse tells an important story about--
(A) the maritime history of southeast Florida;
(B) the prehistory and history of southeast Florida; and
(C) the role of southeast Florida in the Civil War, World
War II, and the creation of the National Weather Service;
(6) the Lighthouse is listed on the National Register of
Historic Places;
(7) the Lighthouse has been, and continues to be, a
physical manifestation of the commitment of the Federal
Government to maritime safety and security;
(8) the current operations and activities of the Coast
Guard at Jupiter Inlet perpetuate the commitment described in
paragraph (7);
(9) the Jupiter Inlet Lighthouse Outstanding Natural Area--
(A) would make a significant addition to the National
Landscape Conservation System administered by the Bureau of
Land Management; and
(B) would be the only unit of the National Landscape
Conservation System located east of the Mississippi River;
(10) statutory protection is needed for the Lighthouse and
the Federal land surrounding the Lighthouse to ensure that
the natural and cultural resources continue to be--
(A) a part of the historic, cultural, and natural heritage
of the United States; and
(B) a source of inspiration for the people of the United
States;
(11) the actions of the Federal Government to protect and
conserve the land and historic structures associated with the
Outstanding Natural Area should not be construed,
interpreted, or allowed to diminish or control ongoing or
future Coast Guard operations or activities; and
(12) the Lighthouse and the Federal land surrounding the
Lighthouse represent a true partnership of the highest order
in which collaboration is, and would continue to be, an
everyday reality leading to successful management and land
stewardship by the Bureau of Land Management, Palm Beach
County, Florida, the Town of Jupiter, Florida, the Village of
Tequesta, Florida, the Loxahatchee River Historical Society,
and the Coast Guard (collectively known as the ``Jupiter
Working Group'') and other partners.
SEC. 3. DEFINITIONS.
In this Act:
(1) Commandant.--The term ``Commandant'' means the
Commandant of the Coast Guard.
(2) Lighthouse.--The term ``Lighthouse'' means the Jupiter
Inlet Lighthouse located in Palm Beach County, Florida.
(3) Local partners.--The term ``Local Partners'' includes--
(A) Palm Beach County, Florida;
(B) the Town of Jupiter, Florida;
(C) the Village of Tequesta, Florida; and
(D) the Loxahatchee River Historical Society.
(4) Management plan.--The term ``management plan'' means
the management plan developed under section 5(a).
(5) Map.--The term ``map'' means the map entitled ``Jupiter
Inlet Lighthouse: Outstanding Natural Area'' and dated
February 2007.
(6) Outstanding natural area.--The term ``Outstanding
Natural Area'' means the Jupiter Inlet Lighthouse Outstanding
Natural Area established by section 4(a).
(7) Public land.--The term ``public land'' has the meaning
given the term ``public lands'' in section 103(e) of the
Federal Land Policy and Management Act of 1976 (43 U.S.C.
1702(e)).
(8) Secretary.--The term ``Secretary'' means the Secretary
of the Interior.
(9) State.--The term ``State'' means the State of Florida.
SEC. 4. ESTABLISHMENT OF THE JUPITER INLET LIGHT HOUSE
OUTSTANDING NATURAL AREA.
(a) Establishment.--Subject to valid existing rights, there
is established for the purposes described in subsection (b)
the Jupiter Inlet Lighthouse Outstanding Natural Area, the
boundaries of which are depicted on the map.
(b) Purposes.--The purposes of the Outstanding Natural Area
are to protect, conserve, and enhance the unique and
nationally important historic, natural, cultural, scientific,
educational, scenic, and recreational values of the Federal
land surrounding the Lighthouse for the benefit of present
generations and future generations of people in the United
States, while--
(1) allowing certain recreational and research activities
to continue in the Outstanding Natural Area; and
[[Page S4683]]
(2) ensuring that Coast Guard operations and activities are
unimpeded within the boundaries of the Outstanding Natural
Area.
(c) Availability of Map.--The map shall be on file and
available for public inspection in--
(1) the Office of the Director of the Bureau of Land
Management; and
(2) the Eastern States Office of the Bureau of Land
Management in the State of Virginia.
(d) Withdrawal.--
(1) In general.--Subject to valid existing rights, section
7, and any existing withdrawals under the Executive orders
and public land order described in paragraph (2), the Federal
land and any interests in the Federal land included in the
Outstanding Natural Area are withdrawn from--
(A) all forms of entry, appropriation, or disposal under
the public land laws;
(B) location, entry, and patent under the public land
mining laws; and
(C) operation of the mineral leasing and geothermal leasing
laws and the mineral materials laws.
(2) Description of executive orders.--The Executive orders
and public land order described in paragraph (1) are--
(A) the Executive Order dated October 22, 1854;
(B) Executive Order No. 4254 (June 12, 1925); and
(C) Public Land Order No. 7202 (61 Fed. Reg. 29758).
SEC. 5. MANAGEMENT PLAN.
(a) In General.--Not later than 3 years after the date of
enactment of this Act, the Secretary, in consultation with
the Commandant, shall develop a comprehensive management plan
in accordance with section 202 of the Federal Land Policy and
Management Act of 1976 (43 U.S.C. 1712) to--
(1) provide long-term management guidance for the public
land in the Outstanding Natural Area; and
(2) ensure that the Outstanding Natural Area fulfills the
purposes for which the Outstanding Natural Area is
established.
(b) Consultation; Public Participation.--The management
plan shall be developed--
(1) in consultation with appropriate Federal, State,
county, and local government agencies, the Commandant, the
Local Partners, the Loxahatchee River Historical Society, and
other partners; and
(2) in a manner that ensures full public participation.
(c) Existing Plans.--The management plan shall, to the
maximum extent practicable, be consistent with existing
resource plans, policies, and programs.
(d) Inclusions.--The management plan shall include--
(1) objectives and provisions to ensure--
(A) the protection and conservation of the resource values
of the Outstanding Natural Area; and
(B) the restoration of native plant communities and
estuaries in the Outstanding Natural Area, with an emphasis
on the conservation and enhancement of healthy, functioning
ecological systems in perpetuity;
(2) objectives and provisions to maintain or recreate
historic structures;
(3) an implementation plan for a program of interpretation
and public education about the natural and cultural resources
of the Lighthouse, the public land surrounding the
Lighthouse, and associated structures;
(4) a proposal for administrative and public facilities to
be developed or improved that--
(A) are compatible with achieving the resource objectives
for the Outstanding Natural Area described in section
6(a)(1)(B); and
(B) would accommodate visitors to the Outstanding Natural
Area;
(5) natural and cultural resource management strategies for
the Outstanding Natural Area, to be developed in consultation
with appropriate departments of the State, the Local
Partners, and the Commandant, with an emphasis on resource
conservation in the Outstanding Natural Area and the
interpretive, educational, and long-term scientific uses of
the resources; and
(6) recreational use strategies for the Outstanding Natural
Area, to be prepared in consultation with the Local Partners,
appropriate departments of the State, and the Coast Guard,
with an emphasis on passive recreation.
(e) Interim Plan.--Until a management plan is adopted for
the Outstanding Natural Area, the Jupiter Inlet Coordinated
Resource Management Plan (including any updates or amendments
to the Jupiter Inlet Coordinated Resource Management Plan)
shall be in effect.
SEC. 6. MANAGEMENT OF THE JUPITER INLET LIGHTHOUSE
OUTSTANDING NATURAL AREA.
(a) Management.--
(1) In general.--The Secretary, in consultation with the
Local Partners and the Commandant, shall manage the
Outstanding Natural Area--
(A) as part of the National Landscape Conservation System;
and
(B) in a manner that conserves, protects, and enhances the
unique and nationally important historical, natural,
cultural, scientific, educational, scenic, and recreational
values of the Outstanding Natural Area, including an emphasis
on the restoration of native ecological systems.
(2) Limitation.--In managing the Outstanding Natural Area,
the Secretary shall not take any action that precludes,
prohibits, or otherwise affects the conduct of ongoing or
future Coast Guard operations or activities on lots 16 and
18, as depicted on the map.
(b) Uses.--Subject to valid existing rights and section 7,
the Secretary shall only allow uses of the Outstanding
Natural Area that the Secretary, in consultation with the
Commandant and Local Partners, determines would likely
further--
(1) the purposes for which the Outstanding Natural Area is
established;
(2) the Federal Land Policy and Management Act of 1976 (43
U.S.C. 1701 et seq.); and
(3) other applicable laws.
(c) Cooperative Agreements.--To facilitate implementation
of the management plan and to continue the successful
partnerships with local communities and other partners, the
Secretary shall, in accordance with section 307(b) of the
Federal Land Management Policy and Management Act of 1976 (43
U.S.C. 1737(b)), enter into cooperative agreements with the
appropriate Federal, State, county, other local government
agencies, and other partners (including the Loxahatchee River
Historical Society) for the long-term management of the
Outstanding Natural Area
(d) Research Activities.--To continue successful research
partnerships, pursue future research partnerships, and assist
in the development and implementation of the management plan,
the Secretary may, in accordance with section 307(a) of the
Federal Land Policy and Management Act of 1976 (43 U.S.C.
1737(a)), authorize the conduct of appropriate research
activities in the Outstanding Natural Area for the purposes
described in section 4(b).
(e) Acquisition of Land.--
(1) In general.--Subject to paragraph (2), the Secretary
may acquire for inclusion in the Outstanding Natural Area any
State or private land or any interest in State or private
land that is--
(A) adjacent to the Outstanding Natural Area; and
(B) identified in the management plan as appropriate for
acquisition.
(2) Means of acquisition.--Land or an interest in land may
be acquired under paragraph (1) only by--
(A) donation;
(B) exchange with a willing party; or
(C) purchase from a willing seller.
(3) Additions to the outstanding natural area.--Any land or
interest in land adjacent to the Outstanding Natural Area
acquired by the United States after the date of enactment of
this Act under paragraph (1) shall be added to, and
administered as part of, the Outstanding Natural Area.
(f) Law Enforcement Activities.--Nothing in this Act, the
management plan, or the Jupiter Inlet Coordinated Resource
Management Plan (including any updates or amendments to the
Jupiter Inlet Coordinated Resource Management Plan)
precludes, prohibits, or otherwise affects--
(1) any maritime security, maritime safety, or
environmental protection mission or activity of the Coast
Guard;
(2) any border security operation or law enforcement
activity by the Department of Homeland Security or the
Department of Justice; or
(3) any law enforcement activity of any Federal, State, or
local law enforcement agency in the Outstanding Natural Area.
(g) Future Disposition of Coast Guard Facilities.--If the
Commandant determines, after the date of enactment of this
Act, that Coast Guard facilities within the Outstanding
Natural Area exceed the needs of the Coast Guard, the
Commandant may relinquish the facilities to the Secretary
without removal, subject only to any environmental
remediation that may be required by law.
SEC. 7. EFFECT ON ONGOING AND FUTURE COAST GUARD OPERATIONS.
Nothing in this Act, the management plan, or the Jupiter
Inlet Coordinated Resource Management Plan (including updates
or amendments to the Jupiter Inlet Coordinated Resource
Management Plan) precludes, prohibits, or otherwise affects
ongoing or future Coast Guard operations or activities in the
Outstanding Natural Area, including--
(1) the continued and future operation of, access to,
maintenance of, and, as may be necessitated for Coast Guard
missions, the expansion, enhancement, or replacement of, the
Coast Guard High Frequency antenna site on lot 16;
(2) the continued and future operation of, access to,
maintenance of, and, as may be necessitated for Coast Guard
missions, the expansion, enhancement, or replacement of, the
military family housing area on lot 18;
(3) the continued and future use of, access to, maintenance
of, and, as may be necessitated for Coast Guad missions, the
expansion, enhancement, or replacement of, the pier on lot
18;
(4) the existing lease of the Jupiter Inlet Lighthouse on
lot 18 from the Coast Guard to the Loxahatchee River
Historical Society; or
(5) any easements or other less-than-fee interests in
property appurtenant to existing Coast Guard facilities on
lots 16 and 18.
SEC. 8. AUTHORIZATION OF APPROPRIATIONS.
There are authorized to be appropriated such sums as are
necessary to carry out this Act.
______
By Ms. SNOWE:
S. 1144. A bill to provide for an assessment of the achievements by
the Government of Iraq of benchmarks for
[[Page S4684]]
political settlement and national reconciliation in Iraq; to the
Committee on Foreign Relations.
Ms. SNOWE. Mr. President, I rise to speak to the monumental and
consequential matter regarding the future course of the United States
and our courageous men and women in uniform in Iraq.
Today, we are at a profoundly challenging moment in time, and at a
critical crossroads with respect to our direction in this war. I know
that none of us arrive at this question lightly. In my 28-year tenure
in Congress, I have witnessed and participated in debates on such vital
matters as Lebanon, Panama, the Persian Gulf, Somalia, Bosnia, and
Kosovo. And indisputably, myriad, deeply-held beliefs and arguments
were expressed on those pivotal matters--some in concert, some
complementary, some in conflict. Yet, without question, all were rooted
in mutual concern for--and love of--our great Nation. And there was--
and should not be today--no question about our support for our brave
and extraordinary troops.
It is therefore with the utmost respect for our troops that I today
introduce a bill which allows them the ability to complete the mission
they have selflessly undertaken, while assuring them that their valor
shall not be unconditionally expended upon an Iraqi government which
fails to respond in kind. This amendment requires that government to
actually achieve previously agreed political and security benchmarks
while the Baghdad Security Plan--commonly referred to as the
``surge''--is in effect, or face the redeployment of those U.S. troops
dedicated to that plan.
Specifically, this legislation would require that, 120 days after
enactment--a point in time at which our military commanders have stated
that they should know whether the surge will succeed--the Commander of
Multi-National Forces, Iraq would report to Congress as to whether the
Iraqi government has met each of six political and security-related
benchmarks which it has already agreed to meet by that time. These six
benchmarks are:
Iraqi assumption of control of its military . . .
Enactment of a Militia Law to disarm and demobilize militias and to
ensure that such security forces are accountable only to the central
government and loyal to the constitution of Iraq . . .
Completion of the constitutional review and a referendum held on
special amendments to the Iraqi Constitution that ensure equitable
participation in the government of Iraq without regard to religious
sect or ethnicity . . .
Completion of provincial election law and preparation for the conduct
of provincial elections that ensures equitable constitution of
provincial representative bodies without regard to religious sect or
ethnicity . . .
Enactment and implementation of legislation to ensure that the energy
resources of Iraq benefit Sunni Arabs, Shia Arabs, Kurds, and other
Iraqi citizens in an equitable manner; and
Enactment and implementation of legislation that equitably reforms
the de-Ba'athification process in Iraq.
The Iraqi Government must know that any opportunity gained from our
increased troop levels in Baghdad is a window that we will soon close
if it fails to take urgent action and show tangible results in tandem.
If, at the end of 120 days, the Commander of Multi-National Forces,
Iraq reports the Iraqi Government has not met the benchmarks, then the
Commander should plan for the phased redeployment of the troops we
provided for the Baghdad Security Plan, period.
That is why, under this amendment, after 120 days, should the
Commander report that the Iraqi Government has failed to meet the
benchmarks listed, he will then be required to present a plan for the
phased redeployment of those combat troops sent to Iraq in support of
the Baghdad Security Plan and to provide plans detailing the transition
of the mission of the U.S. forces remaining in Iraq to one of
logistical support, training, force protection, and targeted counter-
terrorism operations--i.e., those functions set forth in the Iraq Study
Group Report. As General Petraeus stated in March, ``I have an
obligation to the young men and women in uniform out here, that if I
think it's not going to happen, to tell them that it's not going to
happen, and there needs to be a change.''
The message must be loud and clear--the Iraqi government must
understand in no uncertain terms that our presence is neither open-
ended nor unconditional, and I support setting conditions for a phased
withdrawal. My concern with the supplemental appropriations bill stems
from the fact that it mandates a specific date for troop withdrawal by
requiring it to occur within 120 days of passage. This arbitrary
timeline would telegraph a precise and immediate departure date to our
enemies that I believe would jeopardize the security of our men and
women remaining on the ground.
Moreover, this mandated, 120-day timetable does not place the
necessary pressure and conditions on the Iraqi government to implement
national reconciliation and solidify their own security. Rather, we
should require that the Iraqi government complete work within 120 days
on the specific, concrete benchmarks they have already agreed to that
would lead to national reconciliation. If the Iraqis cannot meet these
benchmarks within this 120-day period, our commanders should begin
planning for the phased redeployment of the troops we deployed for the
Baghdad Security Plan.
My colleagues may recall that I opposed the surge because I did not--
and still do not--believe that additional troops are a substitute for
political will and capacity. General Petraeus said last month that a
political resolution is crucial because that is what will determine in
the long run the success of this effort. I could not agree more. The
fact is, America and the world require more than Iraq's commitment
to accomplishing the benchmarks that will lead to a true national
reconciliation--we must see actual results. The Iraqi Government must
find the will to ensure that it represents and protects the rights of
every Iraqi.
After our four-year commitment, Iraq's Government should not doubt
that we must observe more than incremental steps toward political
reconciliation we require demonstrable changes. While limited progress
has been made on necessary legislative initiatives such as the
Hydrocarbon Law, it is in fact a sheaf of laws and not just a single
measure that must pass to ensure that all Iraqis have a share and stake
in their government. Chief among these are constitutional amendments
which will permit Iraqis of all ethnicities and confessions to be
represented at the local level of government. Yet, so far, the review
committee has yet to even finish drafts of these critical amendments.
I believe we were all encouraged by the recent Ambassadorial meetings
in Baghdad and the follow-on ministerial conference called at the Iraqi
government's request. These talks are vital to securing Iraq's border,
reversing the flow of refugees, and stemming the foreign interference
which exacerbates sectarian divisions. But we also look for the Iraqi
government's leadership in dismantling the militias and strengthening
the National Army so that it is truly a national institution that can
provide the security so desperately desired by all Iraqis in every
province.
We are now three months into the surge, and our troops have made
gains in reducing the still horrific levels of violence on Baghdad
through their heroic efforts. Yet it is deeply concerning to me that--
mirroring the slowness with which the Iraqi government has moved on
political reforms--their sacrifice remains by and largely unmatched by
their Iraqi counterparts.
Two weeks ago, Leon Panetta, a member of the Iraq Study Group, wrote
the following in a New York Times Op-Ed, ``. . . every military
commander we talked to felt that the absence of national reconciliation
was the fundamental cause of violence in Iraq. As one American general
told us, `if the Iraqi government does not make political progress on
reforms, all the troops in the world will not provide security.' `` He
went on to enumerate the progress or, more to the point, the lack of
progress toward the agreed upon benchmarks and concluded that `unless
the United States finds new ways to bring strong pressure on the
Iraqis, things are not likely to pick up any time soon.'''
In fact, over the past few months, many have come to the realization
that political action by the Iraqi government is a paramount precursor
to
[[Page S4685]]
national reconciliation and stability and, without it, the Baghdad
Security Plan is only a temporary, tactical fix for one specific
location. And while we are hearing about incremental successes, I agree
with Thomas Friedman who said recently in an interview, ``there's only
one metric for the surge working, and that is whether we're seeing a
negotiation among Iraqis to share power, to stabilize the political
situation in Iraq, which only they can do . . . telling me that the
violence is down 10 percent or 8 percent here or 12 percent there, I
don't really think that's the metric at all.''
To this day, the public looks to the United States Senate to temper
the passions of politics and to bridge divides. And if ever there were
a moment when Americans are imploring us to live up to the moniker of
``world's greatest deliberative body,'' that moment is upon us.
If I had a son or daughter or other family member serving in Iraq, I
would want at least the assurance that someone was speaking up to tell
the Iraqi government--and frankly our government as well--that my
family's sacrifice must be matched by action and sacrifice on the part
of the Iraqi government. I would want to know that the most profound of
all issues was fully debated by those who are elected to provide
leadership. For those of us who seek success in Iraq, and believe that
a strategy predicated on political and diplomatic solutions--not merely
increased troop levels--presents the strongest opportunity to reach
that goal, let us coalesce around this bill, which will allow us to
speak as one voice strong . . . together . . . and united in service to
a purpose we believe to be right.
______
By Mr. LEAHY (for himself, Mr. Hatch, Mr. Schumer, Mr. Cornyn,
and Mr. Whitehouse):
S. 1145. A bill to amend title 35, United States Code, to provide for
patent reform; to the Committee on the Judiciary.
Mr. LEAHY. Mr. President, our patent system is grounded in the
Constitution. Among the specifically enumerated powers of Congress in
Article I, Section 8, stands the command to ``promote the progress of
science and the useful arts, by securing for limited times to authors
and inventors the exclusive right to their respective discoveries.''
Those discoveries have, since the founding of our Nation, made us the
envy of the world. Our inventors, our research institutions, and the
many companies that commercialize those discoveries have brought a
wealth of new products and processes to our society; we have all been
the beneficiaries of that creativity and hard work.
Vermont has long played an important role in bringing such inventions
to the public, combining `Yankee ingenuity' with lots of sweat equity.
In fact, the very first U.S. patent was granted to Samuel Hopkins, a
farmer in Pittsford, VT, who discovered a process for making potash.
That ethic continues to the present day; just last year, inventors in
IBM's Essex Junction plant received 360 patents 10 percent of IBM's
total U.S. patents.
Vermont is special, of course, but not unique in this regard.
American inventors are in every community, every company and school.
They are individuals tinkering on the weekends in their garages. They
are teams of PhDs in our largest corporations. They are scientists
training students in laboratories at our colleges and universities. Our
patent laws should support and reward all American innovators--
independent inventors, small businesses, venture capitalists, academic
researchers, and large corporations. To do so, we must update our
patent laws. Crafted for an earlier time, when smokestacks rather than
microchips were the emblems of industry, those laws have served well
but need some refinements.
Senator Hatch and I introduced an earlier version of this bill, S.
3818, last August. At that time, I said we had taken the first step
down a road to real, constructive patent reform, which could reduce the
unnecessary burdens of litigation in the patent system and enhance the
quality of patents granted by the Patent and Trademark Office. Senator
Hatch wisely noted that we would have to have continuing conversations
about issues that remained unresolved. We have spent the time since
then hearing from all manner of interested parties, and indeed we have
learned as much since we introduced S. 3818 as we had in the two years
prior to its introduction.
In this Congress, the partnership is not only bipartisan but
bicameral. We have reached not only across the aisle but across the
Hill to work out a bill that joins the Senate and the House, Democrats
and Republicans, so that today we are introducing a Leahy-Hatch bill in
the Senate that mirrors a Berman-Smith bill in the House. The message
is both strong and clear: We have a unified and resolute approach to
improving the nation's patent system. We will all have time to focus on
the bill's many provisions in the weeks to come, but I would highlight
three significant changes we have made since last summer, aided by the
many stakeholders in this process.
First, the Patent Reform Act of 2007 now includes a pure ``first-to-
file'' system, which will inject needed clarity and certainty into the
system. The United States stands alone among nations that grant patents
in giving priority for a patent to the first inventor, as opposed to
the first to file a patent application for a claimed invention. The
result is a lack of international consistency, and a complex and costly
system in the United States to determine inventors' rights. At the same
time, our legislation provides important protections for inventors at
universities, by permitting them to discuss publicly their work without
losing priority for their inventions.
Second, poor patent quality has been identified as a key element of
the law that needs attention. After a patent is issued, a party seeking
to challenge the validity and enforceability of the patent has two
avenues under current law: by reexamination proceeding at the USPTO or
by litigation in federal district court. The former is used sparingly
and some see it as ineffective; the latter, district court litigation,
can be unwieldy and expensive. S. 3818 had created a new, post-grant
review to provide an effective and efficient system for considering
challenges to the validity of patents. The Patent Reform Act of 2007
has improved that system, and in particular, we have addressed concerns
about misuse of the procedure. Post-grant review will include
protections to avoid the possibility of misuse of the post-grant
process. The Director is instructed to prescribe rules to prevent
harassment or abuse, successive petitions are prohibited, and
petitioners are barred from raising the same arguments in court.
Third, we are keenly aware that a sound patent system needs fair and
equitable remedies. As products have become more complex, often
involving hundreds or even thousands of patented aspects, litigation
has not reliably produced damages awards in infringement cases that
correspond to the value of the infringed patent. Our bill last summer
was our first effort to ensure that damages awards accurately reflected
the harm caused by infringement. Subsequent conversations with many
affected parties have led us to language that, we believe, better
serves that purpose and avoids potential pitfalls.
The Patent Reform Act of 2007 is also significant for what is not
included. S. 3818 would have made three considerable changes to the
patent laws that, upon further consideration and after listening to the
affected parties, we have decided not to make in this year's
legislation. First is the requirement that patent applicants not
intentionally misrepresent a material fact or fail to disclose material
information to the PTO. Candor and truthfulness are the backbone of the
patent application system, and are protected by the inequitable conduct
doctrine. S. 3818 would have weakened that doctrine, but it is
preserved this year. Second, we maintain the traditional rule on
attorneys' fees, instead of shifting fees and other expenses to the
non-prevailing party as was proposed in S. 3818. Finally, we do not
inject Congress into the ongoing litigation over the extra-territorial
provision, section 271(f). S. 3818 would have repealed the provision in
its entirety; the Patent Reform Act of 2007 does not, while the
interpretation of the provision is currently pending before the Supreme
Court. If the Court does not resolve that issue, we will revisit it in
the legislative process.
If we are to maintain our position at the forefront of the world's
economy, if
[[Page S4686]]
we are to continue to lead the globe in innovation and production, if
we are to continue to enjoy the fruits of the most creative citizens,
then we must have a patent system that produces high quality patents,
that limits counterproductive litigation over those patents, and that
makes the entire system more streamlined and efficient. This bill is an
important step towards that goal. I look forward to immediate and
intense debate that will inform both the Members of Congress and the
public about these improvements, that will allow us to further refine
our legislation, and that will lead us to consideration on the Senate
floor.
I ask unanimous consent that the text of the bill be printed in the
Record.
There being no objection, the bill was ordered to be printed in the
Record, as follows:
S. 1145
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Patent
Reform Act of 2007''.
(b) Table of Contents.--The table of contents of this Act
is as follows:
Sec. 1. Short title; table of contents.
Sec. 2. Reference to title 35, United States Code.
Sec. 3. Right of the first inventor to file.
Sec. 4. Inventor's oath or declaration.
Sec. 5. Right of the inventor to obtain damages.
Sec. 6. Post-grant procedures and other quality enhancements.
Sec. 7. Definitions; patent trial and appeal board.
Sec. 8. Study and report on reexamination proceedings.
Sec. 9. Submissions by third parties and other quality enhancements.
Sec. 10. Venue and jurisdiction.
Sec. 11. Regulatory authority.
Sec. 12. Technical amendments.
Sec. 13. Effective date; rule of construction.
SEC. 2. REFERENCE TO TITLE 35, UNITED STATES CODE.
Whenever in this Act a section or other provision is
amended or repealed, that amendment or repeal shall be
considered to be made to that section or other provision of
title 35, United States Code.
SEC. 3. RIGHT OF THE FIRST INVENTOR TO FILE.
(a) Definitions.--Section 100 is amended by adding at the
end the following:
``(f) The term `inventor' means the individual or, if a
joint invention, the individuals collectively who invented or
discovered the subject matter of the invention.
``(g) The terms `joint inventor' and `coinventor' mean any
1 of the individuals who invented or discovered the subject
matter of a joint invention.
``(h) The `effective filing date of a claimed invention'
is--
``(1) the filing date of the patent or the application for
patent containing the claim to the invention; or
``(2) if the patent or application for patent is entitled
to a right of priority of any other application under section
119, 365(a), or 365(b) or to the benefit of an earlier filing
date in the United States under section 120, 121, or 365(c),
the filing date of the earliest such application in which the
claimed invention is disclosed in the manner provided by the
first paragraph of section 112.
``(i) The term `claimed invention' means the subject matter
defined by a claim in a patent or an application for a
patent.
``(j) The term `joint invention' means an invention
resulting from the collaboration of inventive endeavors of 2
or more persons working toward the same end and producing an
invention by their collective efforts.''.
(b) Conditions for Patentability.--
(1) In general.--Section 102 is amended to read as follows:
``Sec. 102. Conditions for patentability; novelty
``(a) Novelty; Prior Art.--A patent for a claimed invention
may not be obtained if--
``(1) the claimed invention was patented, described in a
printed publication, or in public use or on sale--
``(A) more than one year before the effective filing date
of the claimed invention; or
``(B) one year or less before the effective filing date of
the claimed invention, other than through disclosures made by
the inventor or a joint inventor or by others who obtained
the subject matter disclosed directly or indirectly from the
inventor or a joint inventor; or
``(2) the claimed invention was described in a patent
issued under section 151, or in an application for patent
published or deemed published under section 122(b), in which
the patent or application, as the case may be, names another
inventor and was effectively filed before the effective
filing date of the claimed invention.
``(b) Exceptions.--
``(1) Prior inventor disclosure exception.--Subject matter
that would otherwise qualify as prior art under subparagraph
(B) of subsection (a)(1) shall not be prior art to a claimed
invention under that subparagraph if the subject matter had,
before the applicable date under such subparagraph (B), been
publicly disclosed by the inventor or a joint inventor or
others who obtained the subject matter disclosed directly or
indirectly from the inventor, joint inventor, or applicant.
``(2) Derivation and common assignment exceptions.--Subject
matter that would otherwise qualify as prior art only under
subsection (a)(2), after taking into account the exception
under paragraph (1), shall not be prior art to a claimed
invention if--
``(A) the subject matter was obtained directly or
indirectly from the inventor or a joint inventor; or
``(B) the subject matter and the claimed invention, not
later than the effective filing date of the claimed
invention, were owned by the same person or subject to an
obligation of assignment to the same person.
``(3) Joint research agreement exception.--
``(A) In general.--Subject matter and a claimed invention
shall be deemed to have been owned by the same person or
subject to an obligation of assignment to the same person in
applying the provisions of paragraph (2) if--
``(i) the claimed invention was made by or on behalf of
parties to a joint research agreement that was in effect on
or before the effective filing date of the claimed invention;
``(ii) the claimed invention was made as a result of
activities undertaken within the scope of the joint research
agreement; and
``(iii) the application for patent for the claimed
invention discloses or is amended to disclose the names of
the parties to the joint research agreement.
``(B) For purposes of subparagraph (A), the term `joint
research agreement' means a written contract, grant, or
cooperative agreement entered into by two or more persons or
entities for the performance of experimental, developmental,
or research work in the field of the claimed invention.
``(4) Patents and published applications effectively
filed.--A patent or application for patent is effectively
filed under subsection (a)(2) with respect to any subject
matter described in the patent or application--
``(A) as of the filing date of the patent or the
application for patent; or
``(B) if the patent or application for patent is entitled
to claim a right of priority under section 119, 365(a), or
365(b) or to claim the benefit of an earlier filing date
under section 120, 121, or 365(c), based upon one or more
prior filed applications for patent, as of the filing date of
the earliest such application that describes the subject
matter.''.
(2) Conforming amendment.--The item relating to section 102
in the table of sections for chapter 10 is amended to read as
follows:
``102. Conditions for patentability; novelty.''.
(c) Conditions for Patentability; Non-Obvious Subject
Matter.--Section 103 is amended to read as follows:
``Sec. 103. Conditions for patentability; nonobvious subject
matter
``A patent for a claimed invention may not be obtained
though the claimed invention is not identically disclosed as
set forth in section 102, if the differences between the
claimed invention and the prior art are such that the claimed
invention as a whole would have been obvious before the
effective filing date of the claimed invention to a person
having ordinary skill in the art to which the claimed
invention pertains. Patentability shall not be negated by the
manner in which the invention was made.''.
(d) Repeal of Requirements for Inventions Made Abroad.--
Section 104, and the item relating to that section in the
table of sections for chapter 10, are repealed.
(e) Repeal of Statutory Invention Registration.--
(1) In general.--Section 157, and the item relating to that
section in the table of sections for chapter 14, are
repealed.
(2) Removal of cross references.--Section 111(b)(8) is
amended by striking ``sections 115, 131, 135, and 157'' and
inserting ``sections 131 and 135''.
(f) Earlier Filing Date for Inventor and Joint Inventor.--
Section 120 is amended by striking ``which is filed by an
inventor or inventors named'' and inserting ``which names an
inventor or joint inventor''.
(g) Conforming Amendments.--
(1) Right of priority.--Section 172 is amended by striking
``and the time specified in section 102(d)''.
(2) Limitation on remedies.--Section 287(c)(4) is amended
by striking ``the earliest effective filing date of which is
prior to'' and inserting ``which has an effective filing date
before''.
(3) International application designating the united
states: effect.--Section 363 is amended by striking ``except
as otherwise provided in section 102(e) of this title''.
(4) Publication of international application: effect.--
Section 374 is amended by striking ``sections 102(e) and
154(d)'' and inserting ``section 154(d)''.
(5) Patent issued on international application: effect.--
The second sentence of section 375(a) is amended by striking
``Subject to section 102(e) of this title, such'' and
inserting ``Such''.
(6) Limit on right of priority.--Section 119(a) is amended
by striking ``; but no patent shall be granted'' and all that
follows through ``one year prior to such filing''.
(7) Inventions made with federal assistance.--Section
202(c) is amended--
(A) in paragraph (2)--
(i) by striking ``publication, on sale, or public use,''
and all that follows through ``obtained in the United
States'' and inserting ``the 1-year period referred to in
section 102(a) would end before the end of that 2-year
period''; and
[[Page S4687]]
(ii) by striking ``the statutory'' and inserting ``that 1-
year''; and
(B) in paragraph (3), by striking ``any statutory bar date
that may occur under this title due to publication, on sale,
or public use'' and inserting ``the expiration of the 1-year
period referred to in section 102(a)''.
(h) Repeal of Interfering Patent Remedies.--Section 291,
and the item relating to that section in the table of
sections for chapter 29, are repealed.
(i) Action for Claim to Patent on Derived Invention.--
Section 135(a) is amended to read as follows:
``(a) Dispute Over Right to Patent.--
``(1) Institution of derivation proceeding.--An applicant
may request initiation of a derivation proceeding to
determine the right of the applicant to a patent by filing a
request which sets forth with particularity the basis for
finding that an earlier applicant derived the claimed
invention from the applicant requesting the proceeding and,
without authorization, filed an application claiming such
invention. Any such request may only be made within 12 months
after the date of first publication of an application
containing a claim that is the same or is substantially the
same as the claimed invention, must be made under oath, and
must be supported by substantial evidence. Whenever the
Director determines that patents or applications for patent
naming different individuals as the inventor interfere with
one another because of a dispute over the right to patent
under section 101, the Director shall institute a derivation
proceeding for the purpose of determining which applicant is
entitled to a patent.
``(2) Requirements.--A proceeding under this subsection may
not be commenced unless the party requesting the proceeding
has filed an application that was filed not later than 18
months after the effective filing date of the application or
patent deemed to interfere with the subsequent application or
patent.
``(3) Determination by patent trial and appeal board.--In
any proceeding under this subsection, the Patent Trial and
Appeal Board--
``(A) shall determine the question of the right to patent;
``(B) in appropriate circumstances, may correct the naming
of the inventor in any application or patent at issue; and
``(C) shall issue a final decision on the right to patent.
``(4) Derivation proceeding.--The Board may defer action on
a request to initiate a derivation proceeding until 3 months
after the date on which the Director issues a patent to the
applicant that filed the earlier application.
``(5) Effect of final decision.--The final decision of the
Patent Trial and Appeal Board, if adverse to the claim of an
applicant, shall constitute the final refusal by the Patent
and Trademark Office on the claims involved. The Director may
issue a patent to an applicant who is determined by the
Patent Trial and Appeal Board to have the right to patent.
The final decision of the Board, if adverse to a patentee,
shall, if no appeal or other review of the decision has been
or can be taken or had, constitute cancellation of the claims
involved in the patent, and notice of such cancellation shall
be endorsed on copies of the patent distributed after such
cancellation by the Patent and Trademark Office.''.
(j) Elimination of References to Interferences.--(1)
Sections 6, 41, 134, 141, 145, 146, 154, 305, and 314 are
each amended by striking ``Board of Patent Appeals and
Interferences'' each place it appears and inserting ``Patent
Trial and Appeal Board''.
(2) Sections 141, 146, and 154 are each amended--
(A) by striking ``an interference'' each place it appears
and inserting ``a derivation proceeding''; and
(B) by striking ``interference'' each additional place it
appears and inserting ``derivation proceeding''.
(3) The section heading for section 134 is amended to read
as follows:
``Sec. 134. Appeal to the Patent Trial and Appeal Board''.
(4) The section heading for section 135 is amended to read
as follows:
``Sec. 135. Derivation proceedings''.
(5) The section heading for section 146 is amended to read
as follows:
``Sec. 146. Civil action in case of derivation proceeding''.
(6) Section 154(b)(1)(C) is amended by striking
``interferences'' and inserting ``derivation proceedings''.
(7) The item relating to section 6 in the table of sections
for chapter 1 is amended to read as follows:
``6. Patent Trial and Appeal Board.''.
(8) The items relating to sections 134 and 135 in the table
of sections for chapter 12 are amended to read as follows:
``134. Appeal to the Patent Trial and Appeal Board.
``135. Derivation proceedings.''.
(9) The item relating to section 146 in the table of
sections for chapter 13 is amended to read as follows:
``146. Civil action in case of derivation proceeding.''.
(10) Certain Appeals.--Subsection 1295(a)(4)(A) of title
28, United States Code, is amended to read as follows:
``(A) the Patent Trial and Appeal Board of the United
States Patent and Trademark Office with respect to patent
applications, derivation proceedings, and post-grant review
proceedings, at the instance of an applicant for a patent or
any party to a patent interference (commenced before the
effective date of the Patent Reform Act of 2007), derivation
proceeding, or post-grant review proceeding, and any such
appeal shall waive any right of such applicant or party to
proceed under section 145 or 146 of title 35;''.
SEC. 4. INVENTOR'S OATH OR DECLARATION.
(a) Inventor's Oath or Declaration.--
(1) In general.--Section 115 is amended to read as follows:
``Sec. 115. Inventor's oath or declaration
``(a) Naming the Inventor; Inventor's Oath or
Declaration.--An application for patent that is filed under
section 111(a), that commences the national stage under
section 363, or that is filed by an inventor for an invention
for which an application has previously been filed under this
title by that inventor shall include, or be amended to
include, the name of the inventor of any claimed invention in
the application. Except as otherwise provided in this
section, an individual who is the inventor or a joint
inventor of a claimed invention in an application for patent
shall execute an oath or declaration in connection with the
application.
``(b) Required Statements.--An oath or declaration under
subsection (a) shall contain statements that--
``(1) the application was made or was authorized to be made
by the affiant or declarant; and
``(2) such individual believes himself or herself to be the
original inventor or an original joint inventor of a claimed
invention in the application.
``(c) Additional Requirements.--The Director may specify
additional information relating to the inventor and the
invention that is required to be included in an oath or
declaration under subsection (a).
``(d) Substitute Statement.--
``(1) In general.--In lieu of executing an oath or
declaration under subsection (a), the applicant for patent
may provide a substitute statement under the circumstances
described in paragraph (2) and such additional circumstances
that the Director may specify by regulation.
``(2) Permitted circumstances.--A substitute statement
under paragraph (1) is permitted with respect to any
individual who--
``(A) is unable to file the oath or declaration under
subsection (a) because the individual--
``(i) is deceased;
``(ii) is under legal incapacity; or
``(iii) cannot be found or reached after diligent effort;
or
``(B) is under an obligation to assign the invention but
has refused to make the oath or declaration required under
subsection (a).
``(3) Contents.--A substitute statement under this
subsection shall--
``(A) identify the individual with respect to whom the
statement applies;
``(B) set forth the circumstances representing the
permitted basis for the filing of the substitute statement in
lieu of the oath or declaration under subsection (a); and
``(C) contain any additional information, including any
showing, required by the Director.
``(e) Making Required Statements in Assignment of Record.--
An individual who is under an obligation of assignment of an
application for patent may include the required statements
under subsections (b) and (c) in the assignment executed by
the individual, in lieu of filing such statements separately.
``(f) Time for Filing.--A notice of allowance under section
151 may be provided to an applicant for patent only if the
applicant for patent has filed each required oath or
declaration under subsection (a) or has filed a substitute
statement under subsection (d) or recorded an assignment
meeting the requirements of subsection (e).
``(g) Earlier-Filed Application Containing Required
Statements or Substitute Statement.--The requirements under
this section shall not apply to an individual with respect to
an application for patent in which the individual is named as
the inventor or a joint inventor and that claims the benefit
under section 120 or 365(c) of the filing of an earlier-filed
application, if--
``(1) an oath or declaration meeting the requirements of
subsection (a) was executed by the individual and was filed
in connection with the earlier-filed application;
``(2) a substitute statement meeting the requirements of
subsection (d) was filed in the earlier filed application
with respect to the individual; or
``(3) an assignment meeting the requirements of subsection
(e) was executed with respect to the earlier-filed
application by the individual and was recorded in connection
with the earlier-filed application.
``(h) Supplemental and Corrected Statements; Filing
Additional Statements.--
``(1) In general.--Any person making a statement required
under this section may withdraw, replace, or otherwise
correct the statement at any time. If a change is made in the
naming of the inventor requiring the filing of 1 or more
additional statements under this section, the Director shall
establish regulations under which such additional statements
may be filed.
``(2) Supplemental statements not required.--If an
individual has executed an oath or declaration under
subsection (a) or an assignment meeting the requirements of
subsection (e) with respect to an application
[[Page S4688]]
for patent, the Director may not thereafter require that
individual to make any additional oath, declaration, or other
statement equivalent to those required by this section in
connection with the application for patent or any patent
issuing thereon.
``(3) Savings clause.--No patent shall be invalid or
unenforceable based upon the failure to comply with a
requirement under this section if the failure is remedied as
provided under paragraph (1).''.
(2) Relationship to divisional applications.--Section 121
is amended by striking ``If a divisional application'' and
all that follows through ``inventor.''.
(3) Requirements for nonprovisional applications.--Section
111(a) is amended--
(A) in paragraph (2)(C), by striking ``by the applicant''
and inserting ``or declaration'';
(B) in the heading for paragraph (3), by striking ``and
oath''; and
(C) by striking ``and oath'' each place it appears.
(4) Conforming amendment.--The item relating to section 115
in the table of sections for chapter 10 is amended to read as
follows:
``115. Inventor's oath or declaration.''.
(b) Filing by Other Than Inventor.--Section 118 is amended
to read as follows:
``Sec. 118. Filing by other than inventor
``A person to whom the inventor has assigned or is under an
obligation to assign the invention may make an application
for patent. A person who otherwise shows sufficient
proprietary interest in the matter may make an application
for patent on behalf of and as agent for the inventor on
proof of the pertinent facts and a showing that such action
is appropriate to preserve the rights of the parties. If the
Director grants a patent on an application filed under this
section by a person other than the inventor, the patent shall
be granted to the real party in interest and upon such notice
to the inventor as the Director considers to be
sufficient.''.
(c) Specification.--Section 112 is amended--
(1) in the first paragraph----
(A) by striking ``The specification'' and inserting ``(a)
In General.--The specification'';
(B) by striking ``of carrying out his invention'' and
inserting ``or joint inventor of carrying out the
invention''; and
(2) in the second paragraph--
(A) by striking ``The specifications'' and inserting ``(b)
Conclusion.--The specifications''; and
(B) by striking ``applicant regards as his invention'' and
inserting ``inventor or a joint inventor regards as the
invention'';
(3) in the third paragraph, by striking ``A claim'' and
inserting ``(c) Form.--A claim'';
(4) in the fourth paragraph, by striking ``Subject to the
following paragraph,'' and inserting ``(d) Reference in
Dependent Forms.--Subject to subsection (e),'';
(5) in the fifth paragraph, by striking ``A claim'' and
inserting ``(e) Reference in Multiple Dependent Form.--A
claim''; and
(6) in the last paragraph, by striking ``An element'' and
inserting ``(f) Element in Claim for a Combination.--An
element''.
SEC. 5. RIGHT OF THE INVENTOR TO OBTAIN DAMAGES.
(a) Damages.--Section 284 is amended--
(1) in the first paragraph--
(A) by striking ``Upon'' and inserting ``(a) Award of
Damages.--
``(1) In general.--Upon'';
(B) by aligning the remaining text accordingly; and
(C) by adding at the end the following:
``(2) Relationship of damages to contributions over prior
art.--The court shall conduct an analysis to ensure that a
reasonable royalty under paragraph (1) is applied only to
that economic value properly attributable to the patent's
specific contribution over the prior art. In a reasonable
royalty analysis, the court shall identify all factors
relevant to the determination of a reasonable royalty under
this subsection, and the court or the jury, as the case may
be, shall consider only those factors in making the
determination. The court shall exclude from the analysis the
economic value properly attributable to the prior art, and
other features or improvements, whether or not themselves
patented, that contribute economic value to the infringing
product or process.
``(3) Entire market value.--Unless the claimant shows that
the patent's specific contribution over the prior art is the
predominant basis for market demand for an infringing product
or process, damages may not be based upon the entire market
value of that infringing product or process.
``(4) Other factors.--In determining damages, the court may
also consider, or direct the jury to consider, the terms of
any nonexclusive marketplace licensing of the invention,
where appropriate, as well as any other relevant factors
under applicable law.'';
(2) by amending the second undesignated paragraph to read
as follows:
``(b) Willful Infringement .--
``(1) Increased damages.--A court that has determined that
the infringer has willfully infringed a patent or patents may
increase the damages up to three times the amount of damages
found or assessed under subsection (a), except that increased
damages under this paragraph shall not apply to provisional
rights under section 154(d).
``(2) Permitted grounds for willfulness.--A court may find
that an infringer has willfully infringed a patent only if
the patent owner presents clear and convincing evidence
that--
``(A) after receiving written notice from the patentee--
``(i) alleging acts of infringement in a manner sufficient
to give the infringer an objectively reasonable apprehension
of suit on such patent, and
``(ii) identifying with particularity each claim of the
patent, each product or process that the patent owner alleges
infringes the patent, and the relationship of such product or
process to such claim,
the infringer, after a reasonable opportunity to investigate,
thereafter performed one or more of the alleged acts of
infringement;
``(B) the infringer intentionally copied the patented
invention with knowledge that it was patented; or
``(C) after having been found by a court to have infringed
that patent, the infringer engaged in conduct that was not
colorably different from the conduct previously found to have
infringed the patent, and which resulted in a separate
finding of infringement of the same patent.
``(3) Limitations on willfulness.--(A) A court may not find
that an infringer has willfully infringed a patent under
paragraph (2) for any period of time during which the
infringer had an informed good faith belief that the patent
was invalid or unenforceable, or would not be infringed by
the conduct later shown to constitute infringement of the
patent.
``(B) An informed good faith belief within the meaning of
subparagraph (A) may be established by--
``(i) reasonable reliance on advice of counsel;
``(ii) evidence that the infringer sought to modify its
conduct to avoid infringement once it had discovered the
patent; or
``(iii) other evidence a court may find sufficient to
establish such good faith belief.
``(C) The decision of the infringer not to present evidence
of advice of counsel is not relevant to a determination of
willful infringement under paragraph (2).
``(4) Limitation on pleading.--Before the date on which a
court determines that the patent in suit is not invalid, is
enforceable, and has been infringed by the infringer, a
patentee may not plead and a court may not determine that an
infringer has willfully infringed a patent. The court's
determination of an infringer's willfulness shall be made
without a jury.''; and
(3) in the third undesignated paragraph, by striking ``The
court'' and inserting ``(c) Expert Testimony.--The court''.
(b) Defense to Infringement Based on Earlier Inventor.--
Section 273 of title 35, United States Code, is amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) by striking ``of a method''; and
(ii) by striking ``review period;'' and inserting ``review
period; and'';
(B) in paragraph (2)(B), by striking the semicolon at the
end and inserting a period; and
(C) by striking paragraphs (3) and (4);
(2) in subsection (b)--
(A) in paragraph (1)--
(i) by striking ``for a method''; and
(ii) by striking ``at least 1 year before the effective
filing date of such patent, and'' and all that follows
through the period and inserting ``and commercially used, or
made substantial preparations for commercial use of, the
subject matter before the effective filing date of the
claimed invention.'';
(B) in paragraph (2)--
(i) by striking ``The sale or other disposition of a useful
end result produced by a patented method'' and inserting
``The sale or other disposition of subject matter that
qualifies for the defense set forth in this section''; and
(ii) by striking ``a defense under this section with
respect to that useful end result'' and inserting ``such
defense''; and
(C) in paragraph (3)--
(i) by striking subparagraph (A); and
(ii) by redesignating subparagraphs (B) and (C) as
subparagraphs (A) and (B), respectively;
(3) in paragraph (7), by striking ``of the patent'' and
inserting ``of the claimed invention''; and
(4) by amending the heading to read as follows:
``Sec. 273. Special defenses to and exemptions from
infringement''.
(c) Table of Sections.--The item relating to section 273 in
the table of sections for chapter 28 is amended to read as
follows:
``273. Special defenses to and exemptions from infringement.''.
(d) Effective Date.--The amendments made by this section
shall apply to any civil action commenced on or after the
date of enactment of this Act.
SEC. 6. POST-GRANT PROCEDURES AND OTHER QUALITY ENHANCEMENTS.
(a) Reexamination.--Section 303(a) is amended to read as
follows:
``(a) Within 3 months after the owner of a patent files a
request for reexamination under section 302, the Director
shall determine whether a substantial new question of
patentability affecting any claim of the patent concerned is
raised by the request, with or without consideration of other
patents or printed publications. On the Director's own
initiative, and at any time, the Director may determine
whether a substantial new question of patentability is raised
by patents and publications discovered by the Director, is
cited under section 301, or is cited by any person other than
the owner of the patent
[[Page S4689]]
under section 302 or section 311. The existence of a
substantial new question of patentability is not precluded by
the fact that a patent or printed publication was previously
cited by or to the Office or considered by the Office.''.
(b) Reexamination.--Section 315(c) is amended by striking
``or could have raised''.
(c) Reexamination Prohibited After District Court
Decision.--Section 317(b) is amended--
(1) in the subsection heading, by striking ``Final
Decision'' and inserting ``District Court Decision''; and
(2) by striking ``Once a final decision has been entered''
and inserting ``Once the judgment of the district court has
been entered''.
(d) Effective Dates.--Notwithstanding any other provision
of law, sections 311 through 318 of title 35, United States
Code, as amended by this Act, shall apply to any patent that
issues before, on, or after the date of enactment of this Act
from an original application filed on any date.
(e) Post-Grant Opposition Procedures.--
(1) In general.--Part III is amended by adding at the end
the following new chapter:
``CHAPTER 32--POST-GRANT REVIEW PROCEDURES
``Sec.
``321. Petition for post-grant review.
``322. Timing and bases of petition.
``323. Requirements of petition.
``324. Prohibited filings.
``325. Submission of additional information; showing of sufficient
grounds.
``326. Conduct of post-grant review proceedings.
``327. Patent owner response.
``328. Proof and evidentiary standards.
``329. Amendment of the patent.
``330. Decision of the Board.
``331. Effect of decision.
``332. Relationship to other pending proceedings.
``333. Effect of decisions rendered in civil action on future post-
grant review proceedings.
``334. Effect of final decision on future proceedings.
``335. Appeal.
``Sec. 321. Petition for post-grant review
``Subject to sections 322, 324, 332, and 333, a person who
is not the patent owner may file with the Office a petition
for cancellation seeking to institute a post-grant review
proceeding to cancel as unpatentable any claim of a patent on
any ground that could be raised under paragraph (2) or (3) of
section 282(b) (relating to invalidity of the patent or any
claim). The Director shall establish, by regulation, fees to
be paid by the person requesting the proceeding, in such
amounts as the Director determines to be reasonable.
``Sec. 322. Timing and bases of petition
``A post-grant proceeding may be instituted under this
chapter pursuant to a cancellation petition filed under
section 321 only if--
``(1) the petition is filed not later than 12 months after
the grant of the patent or issuance of a reissue patent, as
the case may be;
``(2)(A) the petitioner establishes a substantial reason to
believe that the continued existence of the challenged claim
in the petition causes or is likely to cause the petitioner
significant economic harm; or
``(B) the petitioner has received notice from the patent
holder alleging infringement by the petitioner of the patent;
or
``(3) the patent owner consents in writing to the
proceeding.
``Sec. 323. Requirements of petition
``A cancellation petition filed under section 321 may be
considered only if--
``(1) the petition is accompanied by payment of the fee
established by the Director under section 321;
``(2) the petition identifies the cancellation petitioner;
and
``(3) the petition sets forth in writing the basis for the
cancellation, identifying each claim challenged and providing
such information as the Director may require by regulation,
and includes copies of patents and printed publications that
the cancellation petitioner relies upon in support of the
petition; and
``(4) the petitioner provides copies of those documents to
the patent owner or, if applicable, the designated
representative of the patent owner.
``Sec. 324. Prohibited filings
``A post-grant review proceeding may not be instituted
under paragraph (1), (2), or (3) of section 322 if the
petition for cancellation requesting the proceeding
identifies the same cancellation petitioner and the same
patent as a previous petition for cancellation filed under
the same paragraph of section 322.
``Sec. 325. Submission of additional information; showing of
sufficient grounds
``The cancellation petitioner shall file such additional
information with respect to the petition as the Director may
require. The Director may not authorize a post-grant review
proceeding to commence unless the Director determines that
the information presented provides sufficient grounds to
proceed.
``Sec. 326. Conduct of post-grant review proceedings
``(a) In General.--The Director shall--
``(1) prescribe regulations, in accordance with section
2(b)(2), establishing and governing post-grant review
proceedings under this chapter and their relationship to
other proceedings under this title;
``(2) prescribe regulations setting forth the standards for
showings of substantial reason to believe and significant
economic harm under section 322(2) and sufficient grounds
under section 325;
``(3) prescribe regulations establishing procedures for the
submission of supplemental information after the petition for
cancellation is filed; and
``(4) prescribe regulations setting forth procedures for
discovery of relevant evidence, including that such discovery
shall be limited to evidence directly related to factual
assertions advanced by either party in the proceeding, and
the procedures for obtaining such evidence shall be
consistent with the purpose and nature of the proceeding.
``(b) Post-Grant Regulations.--Regulations under subsection
(a)(1)--
``(1) shall require that the final determination in a post-
grant proceeding issue not later than one year after the date
on which the post-grant review proceeding is instituted under
this chapter, except that, for good cause shown, the Director
may extend the 1-year period by not more than six months;
``(2) shall provide for discovery upon order of the
Director;
``(3) shall prescribe sanctions for abuse of discovery,
abuse of process, or any other improper use of the
proceeding, such as to harass or to cause unnecessary delay
or unnecessary increase in the cost of the proceeding;
``(4) may provide for protective orders governing the
exchange and submission of confidential information; and
``(5) shall ensure that any information submitted by the
patent owner in support of any amendment entered under
section 328 is made available to the public as part of the
prosecution history of the patent.
``(c) Considerations.--In prescribing regulations under
this section, the Director shall consider the effect on the
economy, the integrity of the patent system, and the
efficient administration of the Office.
``(d) Conduct of Proceeding.--The Patent Trial and Appeal
Board shall, in accordance with section 6(b), conduct each
post-grant review proceeding authorized by the Director.
``Sec. 327. Patent owner response
``After a post-grant proceeding under this chapter has been
instituted with respect to a patent, the patent owner shall
have the right to file, within a time period set by the
Director, a response to the cancellation petition. The patent
owner shall file with the response, through affidavits or
declarations, any additional factual evidence and expert
opinions on which the patent owner relies in support of the
response.
``Sec. 328. Proof and evidentiary standards
``(a) In General.--The presumption of validity set forth in
section 282 shall not apply in a challenge to any patent
claim under this chapter.
``(b) Burden of Proof.--The party advancing a proposition
under this chapter shall have the burden of proving that
proposition by a preponderance of the evidence.
``Sec. 329. Amendment of the patent
``(a) In General.--In response to a challenge in a petition
for cancellation, the patent owner may file 1 motion to amend
the patent in 1 or more of the following ways:
``(1) Cancel any challenged patent claim.
``(2) For each challenged claim, propose a substitute
claim.
``(3) Amend the patent drawings or otherwise amend the
patent other than the claims.
``(b) Additional Motions.--Additional motions to amend may
be permitted only for good cause shown.
``(c) Scope of Claims.--An amendment under this section may
not enlarge the scope of the claims of the patent or
introduce new matter.
``Sec. 330. Decision of the Board
``If the post-grant review proceeding is instituted and not
dismissed under this chapter, the Patent Trial and Appeal
Board shall issue a final written decision with respect to
the patentability of any patent claim challenged and any new
claim added under section 329.
``Sec. 331. Effect of decision
``(a) In General.--If the Patent Trial and Appeal Board
issues a final decision under section 330 and the time for
appeal has expired or any appeal proceeding has terminated,
the Director shall issue and publish a certificate canceling
any claim of the patent finally determined to be unpatentable
and incorporating in the patent by operation of the
certificate any new claim determined to be patentable.
``(b) New Claims.--Any new claim held to be patentable and
incorporated into a patent in a post-grant review proceeding
shall have the same effect as that specified in section 252
for reissued patents on the right of any person who made,
purchased, offered to sell, or used within the United States,
or imported into the United States, anything patented by such
new claim, or who made substantial preparations therefore,
prior to issuance of a certificate under subsection (a) of
this section.
``Sec. 332. Relationship to other pending proceedings
``Notwithstanding subsection 135(a), sections 251 and 252,
and chapter 30, the Director may determine the manner in
which any reexamination proceeding, reissue proceeding,
interference proceeding (commenced before the effective date
of the Patent Reform Act of 2007), derivation proceeding, or
post-grant
[[Page S4690]]
review proceeding, that is pending during a post-grant review
proceeding, may proceed, including providing for stay,
transfer, consolidation, or termination of any such
proceeding.
``Sec. 333. Effect of decisions rendered in civil action on
future post-grant review proceedings
``If a final decision has been entered against a party in a
civil action arising in whole or in part under section 1338
of title 28 establishing that the party has not sustained its
burden of proving the invalidity of any patent claim--
``(1) that party to the civil action and the privies of
that party may not thereafter request a post-grant review
proceeding on that patent claim on the basis of any grounds,
under the provisions of section 311, which that party or the
privies of that party raised or had actual knowledge of; and
``(2) the Director may not thereafter maintain a post-grant
review proceeding previously requested by that party or the
privies of that party on the basis of such grounds.
``Sec. 334. Effect of final decision on future proceedings
``(a) In General.--If a final decision under section 330 is
favorable to the patentability of any original or new claim
of the patent challenged by the cancellation petitioner, the
cancellation petitioner may not thereafter, based on any
ground which the cancellation petitioner raised during the
post-grant review proceeding--
``(1) request or pursue a reexamination of such claim under
chapter 31;
``(2) request or pursue a derivation proceeding with
respect to such claim;
``(3) request or pursue a post-grant review proceeding
under this chapter with respect to such claim; or
``(4) assert the invalidity of any such claim, in any civil
action arising in whole or in part under section 1338 of
title 28.
``(b) Extension of Prohibition.--If the final decision is
the result of a petition for cancellation filed on the basis
of paragraph (2) of section 322, the prohibition under this
section shall extend to any ground which the cancellation
petitioner raised during the post-grant review proceeding.
``Sec. 335. Appeal
``A party dissatisfied with the final determination of the
Patent Trial and Appeal Board in a post-grant proceeding
under this chapter may appeal the determination under
sections 141 through 144. Any party to the post-grant
proceeding shall have the right to be a party to the
appeal.''.
(f) Conforming Amendment.--The table of chapters for part
III is amended by adding at the end the following:
``32. Post-Grant Review Proceedings..........................321''.....
(g) Regulations and Effective Date.--
(1) Regulations.--The Under Secretary of Commerce for
Intellectual Property and Director of the United States
Patent and Trademark Office (in this subsection referred to
as the ``Director'') shall, not later than the date that is 1
year after the date of the enactment of this Act, issue
regulations to carry out chapter 32 of title 35, United
States Code, as added by subsection (e) of this section
(2) Applicability.--The amendments made by subsection (e)
shall take effect on the date that is 1 year after the date
of the enactment of this Act and shall apply to patents
issued before, on, or after that date, except that, in the
case of a patent issued before that date, a petition for
cancellation under section 321 of title 35, United States
Code, may be filed only if a circumstance described in
paragraph (2), (3), or (4) of section 322 of title 35, United
States Code, applies to the petition.
(3) Pending interferences.--The Director shall determine
the procedures under which interferences commenced before the
effective date under paragraph (2) are to proceed, including
whether any such interference is to be dismissed without
prejudice to the filing of a cancellation petition for a
post-grant opposition proceeding under chapter 32 of title
35, United States Code, or is to proceed as if this Act had
not been enacted. The Director shall include such procedures
in regulations issued under paragraph (1).
SEC. 7. DEFINITIONS; PATENT TRIAL AND APPEAL BOARD.
(a) Definitions.--Section 100 (as amended by this Act) is
further amended--
(1) in subsection (e), by striking ``or inter partes
reexamination under section 311'';
(2) by adding at the end the following:
``(k) The term `cancellation petitioner' means the real
party in interest requesting cancellation of any claim of a
patent under chapter 31 of this title and the privies of the
real party in interest.''.
(b) Patent Trial and Appeal Board.--Section 6 is amended to
read as follows:
``Sec. 6. Patent Trial and Appeal Board
``(a) Establishment and Composition.--There shall be in the
Office a Patent Trial and Appeal Board. The Director, the
Deputy Director, the Commissioner for Patents, the
Commissioner for Trademarks, and the administrative patent
judges shall constitute the Patent Trial and Appeal Board.
The administrative patent judges shall be persons of
competent legal knowledge and scientific ability who are
appointed by the Director. Any reference in any Federal law,
Executive order, rule, regulation, or delegation of
authority, or any document of or pertaining to the Board of
Patent Appeals and Interferences is deemed to refer to the
Patent Trial and Appeal Board.
``(b) Duties.--The Patent Trial and Appeal Board shall--
``(1) on written appeal of an applicant, review adverse
decisions of examiners upon application for patents;
``(2) on written appeal of a patent owner, review adverse
decisions of examiners upon patents in reexamination
proceedings under chapter 30; and
``(3) determine priority and patentability of invention in
derivation proceedings under subsection 135(a); and
``(4) conduct post-grant opposition proceedings under
chapter 32.
Each appeal and derivation proceeding shall be heard by at
least 3 members of the Patent Trial and Appeal Board, who
shall be designated by the Director. Only the Patent Trial
and Appeal Board may grant rehearings. The Director shall
assign each post-grant review proceeding to a panel of 3
administrative patent judges. Once assigned, each such panel
of administrative patent judges shall have the
responsibilities under chapter 32 in connection with post-
grant review proceedings.''.
SEC. 8. STUDY AND REPORT ON REEXAMINATION PROCEEDINGS.
The Under Secretary of Commerce for Intellectual Property
and Director of the Patent and Trademark Office shall, not
later than 3 years after the date of the enactment of this
Act--
(1) conduct a study of the effectiveness and efficiency of
the different forms of proceedings available under title 35,
United States Code, for the reexamination of patents; and
(2) submit to the Committees on the Judiciary of the House
of Representatives and the Senate a report on the results of
the study, including any of the Director's suggestions for
amending the law, and any other recommendations the Director
has with respect to patent reexamination proceedings.
SEC. 9. SUBMISSIONS BY THIRD PARTIES AND OTHER QUALITY
ENHANCEMENTS.
(a) Publication.--Section 122(b)(2) is amended--
(1) by striking subparagraph (B); and
(2) in subparagraph (A)--
(A) by striking ``(A) An application'' and inserting ``An
application''; and
(B) by redesignating clauses (i) through (iv) as
subparagraphs (A) through (D), respectively.
(b) Preissuance Submissions by Third Parties.--Section 122
is amended by adding at the end the following:
``(e) Preissuance Submissions by Third Parties.--
``(1) In general.--Any person may submit for consideration
and inclusion in the record of a patent application, any
patent, published patent application or other publication of
potential relevance to the examination of the application, if
such submission is made in writing before the earlier of--
``(A) the date a notice of allowance under section 151 is
mailed in the application for patent; or
``(B) either--
``(i) 6 months after the date on which the application for
patent is published under section 122, or
``(ii) the date of the first rejection under section 132 of
any claim by the examiner during the examination of the
application for patent,
whichever occurs later.
``(2) Other requirements.--Any submission under paragraph
(1) shall--
``(A) set forth a concise description of the asserted
relevance of each submitted document;
``(B) be accompanied by such fee as the Director may
prescribe; and
``(C) include a statement by the submitter affirming that
the submission was made in compliance with this section.''.
SEC. 10. VENUE AND JURISDICTION.
(a) Venue for Patent Cases.--Section 1400 of title 28,
United States Code, is amended by striking subsection (b) and
inserting the following:
``(b) Any civil action arising under any Act of Congress
relating to patents, other than an action for declaratory
judgment or an action seeking review of a decision of the
Patent Trial and Appeal Board under chapter 13 of title 35,
may be brought only--
``(1) in the judicial district where either party resides;
or
``(2) in the judicial district where the defendant has
committed acts of infringement and has a regular and
established place of business.
``(c) Notwithstanding section 1391(c) of this title, for
purposes of venue under subsection (b), a corporation shall
be deemed to reside in the judicial district in which the
corporation has its principal place of business or in the
State in which the corporation is incorporated.''.
(b) Interlocutory Appeals.--Subsection (c)(2) of section
1292 of title 28, United States Code, is amended by adding at
the end the following:
``(3) of an appeal from an interlocutory order or decree
determining construction of claims in a civil action for
patent infringement under section 271 of title 35.
Application for an appeal under paragraph (3) shall be made
to the court within 10 days after entry of the order or
decree, and proceedings in the district court under such
paragraph shall be stayed during pendency of the appeal.''.
SEC. 11. REGULATORY AUTHORITY.
Section 3(a) is amended by adding at the end the following:
[[Page S4691]]
``(5) Regulatory authority.--In addition to the authority
conferred by other provisions of this title, the Director may
promulgate such rules, regulations, and orders that the
Director determines appropriate to carry out the provisions
of this title or any other law applicable to the United
States Patent and Trademark Office or that the Director
determines necessary to govern the operation and organization
of the Office.''.
SEC. 12. TECHNICAL AMENDMENTS.
(a) Joint Inventions.--Section 116 is amended--
(1) in the first paragraph, by striking ``When'' and
inserting ``(a) Joint Inventions.--When'';
(2) in the second paragraph, by striking ``If a joint
inventor'' and inserting ``(b) Omitted Inventor.--If a joint
inventor''; and
(3) in the third paragraph, by striking ``Whenever'' and
inserting ``(c) Correction of Errors in Application.--
Whenever''.
(b) Filing of Application in Foreign Country.--Section 184
is amended--
(1) in the first paragraph, by striking ``Except when'' and
inserting ``(a) Filing in Foreign Country.--Except when'';
(2) in the second paragraph, by striking ``The term'' and
inserting ``(b) Application.--The term''; and
(3) in the third paragraph, by striking ``The scope'' and
inserting ``(c) Subsequent Modifications, Amendments, and
Supplements.--The scope''.
(c) Reissue of Defective Patents.--Section 251 is amended--
(1) in the first paragraph, by striking ``Whenever'' and
inserting ``(a) In General.--Whenever'';
(2) in the second paragraph, by striking ``The Director''
and inserting ``(b) Multiple Reissued Patents.--The
Director'';
(3) in the third paragraph, by striking ``The provision''
and inserting ``(c) Applicability of This Title.--The
provisions''; and
(4) in the last paragraph, by striking ``No reissued
patent'' and inserting ``(d) Reissue Patent Enlarging Scope
of Claims.--No reissued patent''.
(d) Effect of Reissue.--Section 253 is amended--
(1) in the first paragraph, by striking ``Whenever'' and
inserting ``(a) In General.--Whenever''; and
(2) in the second paragraph, by striking ``in like manner''
and inserting ``(b) Additional Disclaimer or Dedication.--In
the manner set forth in subsection (a),''.
(e) Correction of Named Inventor.--Section 256 is amended--
(1) in the first paragraph, by striking ``Whenever'' and
inserting ``(a) Correction.--Whenever''; and
(2) in the second paragraph, by striking ``The error'' and
inserting ``(b) Patent Valid if Error Corrected.--The
error''.
(f) Presumption of Validity.--Section 282 is amended--
(1) in the first undesignated paragraph, by striking ``A
patent'' and inserting ``(a) In General.--A patent'';
(2) in the second undesignated paragraph, by striking ``The
following'' and inserting ``(b) Defenses.--The following'';
and
(3) in the third undesignated paragraph, by striking ``In
actions'' and inserting ``(c) Notice of Actions; Actions
During Extension of Patent Term.--In actions''.
SEC. 13. EFFECTIVE DATE; RULE OF CONSTRUCTION.
(a) Effective Date.--Except as otherwise provided in this
Act, the provisions of this Act shall take effect 12 months
after the date of the enactment of this Act and shall apply
to any patent issued on or after that effective date.
(b) Continuity of Intent Under the Create Act.--The
enactment of section 102(b)(3) of title 35, United States
Code, under section (3)(b) of this Act is done with the same
intent to promote joint research activities that was
expressed, including in the legislative history, through the
enactment of the Cooperative Research and Technology
Enhancement Act of 2004 (Public Law 108-453; the ``CREATE
Act''), the amendments of which are stricken by section 3(c)
of this Act. The United States Patent and Trademark Office
shall administer section 102(b)(3) of title 35, United States
Code, in a manner consistent with the legislative history of
the CREATE Act that was relevant to its administration by the
Patent and Trademark Office.
Mr. HATCH. Mr. President, I rise today to introduce with Senate
Judiciary Committee Chairman Patrick Leahy the Patent Reform Act of
2007, S. 1145. S. 1145 represents years of careful negotiation and
input from a wide-spectrum of stake holders. In fact, the 2006 Hatch-
Leahy bill has served as a blueprint for this year's legislation and
contains substantially similar language. Chairman Leahy's desire to
have a piece of legislation that is both bipartisan and bicameral is a
great undertaking and represents a tremendous commitment by Congress to
move forward in streamlining and strengthening our patent system.
The patent system is the bedrock of innovation, especially in today's
global economy. Last year, more than 440,000 patent applications were
filed at the United States Patent and Trademark Office (USPTO). The
sheer volume of patent applications reflects the vibrant, innovative
spirit that has made America a world-wide leader in science,
engineering, and technology. Because America's ingenuity continues to
fund our economy, we must protect new ideas and investments in
innovation and creativity. Patents encourage technological advancement
by providing incentives to invent, invest in, and disclose new
technology. Now, more than ever, it is important to ensure efficiency
and increased quality in the issuance of patents. This in turn creates
an environment that fosters entrepreneurship and the creation of jobs:
two significant pillars in our economy. In my home State of Utah alone,
there are over 3,200 technology and 500 life science companies, and
eight percent year-over-year growth. Utah leads the western States
region in creating and sustaining these companies.
Additionally, the concentration of college graduates in Utah is
contributing to the State's technological friendliness, attracting
growth companies to Utah and creating new ones. There is a large, young
adult population in Utah attending not only the two world-class
research universities of the University of Utah and Utah State
University, but also Brigham Young University, Utah Valley State
College and Weber State University. These universities and colleges are
strong economic drivers that encourage technology industry growth in my
State.
For years, Chairman Leahy and I have been working together to craft
meaningful patent reform to address problems that have been identified
through a series of hearings and discussions with stake holders. This
bill addresses many of the problems with the substantive, procedural,
and administrative aspects of the patent system, which governs how
entities here in the United States apply for, receive, and eventually
make use of patents.
The Patent Reform Act of 2007 includes provisions to improve patent
quality. Many complaints about the current patent system deal with the
number of suspect and over-broad patents that are issued. Because bad
patents are generally of little value to productive companies, in many
cases their value is maximized by using them as a basis for
infringement suits against deep-pocket defendants. This bill institutes
a robust post-grant review process so that third parties can challenge
suspect patents in an administrative process, rather than through
costly litigation. In the bill we introduced today, Section 6 has been
tightened by including an anti-harassment provision to discourage
companies from colluding and perpetually harassing one company. I am
hopeful this will serve as a deterrent to those who seek to abuse post-
grant review process.
In addition, S. 1145 is designed to harmonize U.S. law with the law
of other countries by instituting a first-to-file system. The United
States is the only significant country following the first-to-invent
system, in which the right of the patent lies with the first inventor,
rather than the first inventor to file for a patent. The Patent Reform
Act of 2007 provides greater certainty because the filing date of an
application can very rarely be challenged.
S. 1145 also seeks to provide fair and equitable remedies. Some claim
that courts have allowed damages for infringement to be based on the
market for an entire product when all that was infringed is a minor
component of the product. The bill's language preserves the current
rule that mandates that a damages award shall not be less than a
reasonable royalty for the infringed patent, and further requires the
court to conduct an analysis to ensure that when a reasonable royalty
is the award, it reflects only the economic value of the patent's
specific contribution over the prior art.
There are a few provisions I believe need further discussion. I was
disappointed that the inequitable conduct provision from last year's
bill was removed. Attorneys well know that the inequitable conduct
defense has been overpleaded and has become a drag on the litigation
process. I think last year's language struck the correct balance by
focusing on the patentability of the claims in dispute and properly
prevented parties from asserting the defense frivolously. Let me hasten
to add that I do believe there should be consequences for misconduct. I
believe that reforms to the inequitable conduct defense should focus on
the nature
[[Page S4692]]
of the misconduct and not permit the unenforceability of a perfectly
valid patent on a meritorious invention. And, sanctions should be
commensurate with the misconduct.
Moreover, establishing inequitable conduct is supposed to require
independent proof that: (1) the information at issue was material; and
(2) the person who failed to disclose it or made the misrepresentation
had the specific intention of misleading the USPTO. The two elements
have become linked, and courts often discount the intent requirement by
finding that the information is ``highly material.'' In fact, the
materiality standard has become so inclusive that virtually anything
now is portrayed as material. Information should only be considered
material when it causes the USPTO to improperly grant patent claims.
Using a standard of whether USPTO examiners would reject the claims is
a good approximation of materiality because of the prima facie standard
they use to determine whether the claims meet the requirements for
patentability. Unfortunately, this bill preserves the status quo.
A provision that would provide attorneys' fees and costs to a
prevailing party was also left out of this bill. I included this
provision in last year's bill to discourage weak cases from clogging
the already-burdened judicial system. This is not a new concept in the
realm of intellectual property. In fact, I note, Section 505 of the
Copyright Act clearly provides courts the discretion to award
attorneys' fees and costs. It seems logical that we would provide the
same discretion in S. 1145 and I look forward to discussing this issue
with Chairman Leahy.
We opted this year not to include a provision that would repeal
Section 271(f) of Title 35, pending a Supreme Court decision that is
expected soon. Section 271(f) creates a cause of action for
infringement due to foreign sales when a component of a patented
invention is supplied from this country, knowing that a component will
be combined in an infringing manner outside the United States. In the
event of an unfavorable ruling, Chairman Leahy and I are committed to
addressing this issue using the legislative process.
Patent law is vital to our Nation's ability to compete in the global
economy. S. 1145 is designed to ensure that the United States remains
at the forefront of developing and translating new ideas into tangible
goods and services through an effective patent review and protection
system
This bill represents a commitment from Congress to move forward in
streamlining and strengthening our patent system. I am hopeful that
further refinements will be made to this bill during the legislative
process. I am committed to moving this legislation forward and hope
that we can join efforts to refine and enact this important bill.
______
By Mr. SALAZAR (for himself, Mr. Thune, Mr. Tester, Mr. Burr,
Mrs. Murray, Mr. Grassley, Mr. Wyden, Ms. Collins, Mr. Pryor,
Mr. Enzi, Mrs. Lincoln, Ms. Snowe, Mr. Kerry, Mr. Bingaman, Mr.
Smith, Mr. Baucus, and Mr. Dorgan):
S. 1146. A bill to amend title 38, United States Code, to improve
health care for veterans who live in rural areas, and for other
purposes; to the Committee on Veterans' Affairs.
Mr. SALAZAR. Mr. President, today I am introducing the Rural Veterans
Healthcare Improvement Act of 2007, with my colleague from South
Dakota, Senator Thune, and my colleague from Montana, Senator Tester.
We are pleased to be joined by Senators Burr, Murray, Grassley, Wyden,
Collins, Pryor, Enzi, Lincoln, Snowe, Kerry, Bingaman, Smith, Baucus,
and Dorgan.
Over the last two years my colleagues have heard me speak repeatedly
about the challenges that are facing rural America. In the America
where I grew up--the America of farmers, ranchers, small business
owners, and generations of close-knit families--it is getting more
difficult to make a living, to access affordable healthcare, and to
provide opportunities for kids to learn and grow.
The challenges facing veterans in rural communities are particularly
grave. For generations, men and women from rural America have devoted
themselves to the cause of freedom without hesitation and in numbers
greatly beyond their proportion of the U.S. population. Yet we
consistently overlook the unique challenges these men and women face
after they return home to their families and friends in the heartland
of America. When it comes to the VA healthcare system, we fail our
Nation's rural veterans by not doing more to ensure they can access the
high-quality health care they have earned. We owe them much better.
Over and over, I hear from veterans in my state about obstacles to
care. In northwest Colorado, veterans must brave three and four hour
drives on winding mountain roads to reach the VA hospital in Grand
Junction.
In northeast Colorado I have heard from a veteran who must travel 500
miles round trip just to get a simple blood test at a VA hospital. I
think most of my colleagues would agree with me that this is ludicrous.
I wish I could say these are isolated circumstances. Unfortunately,
they are not. Because of gaps in the network of VA hospitals and
clinics, we hear stories like this all the time.
Every day, veterans from rural communities throughout the country are
forced to put off crucial treatment because they live too far from VA
facilities and can't get the care they need. As a result, rural
veterans die younger and suffer from more debilitating illnesses--all
because our system is not equipped to address their needs and provide
care accordingly. A 2004 study of over 750,000 veterans conducted by
Dr. Jonathan Perlin, the Under Secretary for Health at the VA,
consistently found that veterans living in rural areas are in poorer
health than their urban counterparts.
Last year, we took an important first step in improving care for
rural veterans. Thanks to the bipartisan efforts of my colleagues on
the Veterans' Affairs Committee, we were able to create the Office of
Rural Health within the VA. The Office of Rural Health is charged with
working to reduce the wide disparities between care for rural and non-
rural veterans by developing and refining policies and programs to
improve care and services for rural veterans. Because nearly one in
every four veterans is from a rural area, the creation of this Office
of Rural Health is crucial if we are to live up to our promise to
provide all of our Nation's veterans with high-quality services.
The bill we are introducing today, the Rural Veterans Healthcare and
Improvement Act of 2007, builds on last year's work by giving direction
and resources to the Office of Rural Health and by making healthcare
more accessible to veterans in rural areas.
The bill tasks the Office of Rural Health with developing
demonstration projects that would expand care in rural areas through
partnerships between the VA, Centers for Medicare and Medicaid
Services, and the Department of Health and Human Services at critical
access hospitals and community health centers. The bill also instructs
the Director of the Office of Rural Health to carry out demonstration
projects in partnership with the Indian Health Service to improve
healthcare for Native American veterans.
In addition, the Rural Veterans Healthcare Improvement Act of 2007
establishes centers of excellence to research ways to improve care for
rural veterans. The centers would be based at VA medical centers with
strong academic connections. The Office of Rural Health would establish
between one and five centers across the country with the advice of an
advisory panel.
The Rural Veterans Healthcare Improvement Act includes two key
provisions that will help veterans in rural areas reach healthcare
facilities.
First, the bill establishes the VetsRide grant program to provide
innovative transportation options to veterans in remote rural areas.
The bill tasks the Director of the Office of Rural Health to create a
program that would provide grants of up to $50,000 to veterans' service
organizations and State veterans' service officers to assist veterans
with travel to VA medical
[[Page S4693]]
centers and to improve healthcare access in remote rural areas. The
bill authorizes $3 million per year for the grant program through 2012.
Secondly, the bill increases the reimbursement rates for veterans for
their travel expenses related to VA medical care so that they are
compensated at the same rate paid to federal employees.
Finally, our bill requires the VA to report to Congress on the
assessment it is conducting of its fee-based healthcare policies. We
need to improve the VA's fee-based healthcare policies to be more
equitable and efficient in helping veterans in rural areas get the care
they deserve.
With almost one-quarter of our Nation's veterans living in rural
communities, and with the obstacles they face in accessing high-quality
care, it is evident that we need to do a better job of making sure they
receive the care they deserve. The creation of the Office of Rural
Veterans Healthcare was a first step, and this legislation will move us
further down the path toward improved care.
I want to again thank my colleague from South Dakota, Senator Thune,
and my colleague from Montana, Senator Tester, for their efforts on
this bill. We have a strong group of 17 Senators from both sides of the
aisle behind this bill so far.
I know that each and every one of my colleagues deals with veterans'
issues and feels a deep sense of gratitude towards the brave men and
women who have fought for our freedom. I hope we can join together to
move this legislation through Congress and send it to the President for
his signature.
Mr. President, I yield the floor.
______
By Mrs. MURRAY:
S. 1147. A bill to amend title 38, United States Code, To terminate
the administrative freeze on the enrollment into the health care system
of the Department of Veterans Affairs of veterans in the lowest
priority category for enrollment (referred to as ``Priority 8''); to
the Committee on Veterans' Affairs.
Mrs. MURRAY. Mr. President, I rise today to introduce the Honor Our
Commitment to Veterans Act.
More than four years ago, the Bush Administration cut off enrollment
of Priority 8 veterans in the VA healthcare system. Priority 8 veterans
are those veterans without service-connected disabilities whose income
is above a means tested level that varies across the country. Many of
these so-called ``high-income veterans'' have annual incomes as low as
$26,902.
When the Administration announced its intention to suspend healthcare
enrollment for new Priority 8 veterans, they said that they were doing
so in order to reduce the backlog and alleviate a longstanding funding
crisis within the VA.
There is no doubt that the VA has problems. Nearly five years into
this war, our veterans are facing lengthy waits just to get in the door
to see a primary care physician. They are having trouble accessing
critical mental health services, and some are waiting up to two years
for benefits claims to be processed. These are real problems facing
real people, and they deserve real solutions.
But instead of cutting off enrollment to veterans of modest means
four years ago, the Bush Administration should have asked Congress for
the resources necessary to address its shortcomings and increase access
to this high quality health care system.
It is absolutely unacceptable that veterans in need of care are being
prohibited from enrolling in the system that is supposed to serve them.
Veterans who have fought hard to secure our freedoms shouldn't have to
fight for access to health care at home. Our veterans deserve better.
That is why I am introducing the Honor Our Commitment to Veterans Act
today, which would permit new Priority 8 veterans to enroll in the VA
healthcare system.
According to a recent Congressional Research Service report, the VA
estimates that if the enrollment freeze was lifted, approximately
273,000 Priority 8 veterans would have been eligible to receive medical
care from VA in FY2006, and 242,000 Priority 8 veterans would be
eligible in FY2007.
This legislation, which has been introduced in the House by
Congressman Steve Rothman of New Jersey, would correct the injustice
perpetrated in 2003 by allowing all new Priority 8 veterans to enroll
in the VA healthcare system.
______
By Mr. KOHL (for himself, Mr. Baucus, and Mr. Conrad):
S. 1149. A bill to amend the Federal Meat Inspection Act and the
Poultry Products Inspection Act to authorize the interstate
distribution of State-inspected meat and poultry if the Secretary of
Agriculture determines that the State inspection requirements are at
least equal to Federal inspection requirements and to require the
Secretary to reimburse State agencies for part of the costs of the
inspections; to the Committee on Agriculture, Nutrition, and Forestry.
Mr. KOHL. Mr. President, I am today introducing with Senators Baucus
and Conrad a bill that will eliminate the prohibition on interstate
commerce in State-inspected meat and poultry products. Senator Hatch is
also introducing a State meat inspection measure and I congratulate him
on his bill. We are working together and in collaboration with the
National Association of State Departments of Agriculture and a
coalition of national, State, and local agricultural organizations on
this effort. I expect our coalition to grow over time. Together, we
intend to push for changes that will protect public health and safety
and at the same time help state-inspected meat and poultry processors
compete in new markets.
Removing the current prohibition will help level the playing field
for small businesses and spur additional competition in the
marketplace. It will help main street businesses--who often specialize
in local, organic, grass-fed or artisinal products--meet emerging
markets. And it will help livestock producers who want more options for
marketing their livestock.
For too long, processors with State-inspected facilities have been
unfairly constrained to selling only within their home States.
Meanwhile, foreign-processed meat can be shipped anywhere in the United
States so long as the originating Nation's inspection program is deemed
equivalent to U.S. Federal standards. We want our State-inspected
processors to be treated at least as well. This is an effort to give
main street businesses the same opportunity our Government confers on
foreign processors.
I look forward to working with Senators Hatch, Baucus and Conrad and
a number of our House colleagues on this topic in the months to come.
______
By Ms. SNOWE (for herself and Mr. Coleman):
S. 1153. A bill to require assessment of the impact on small business
concerns of rules relating to internal controls, and for other
purposes; to the Committee on Banking, Housing, and Urban Affairs.
Ms. SNOWE. Mr. President, I rise today with my colleague Senator
Coleman, to introduce the ``Small Business Regulatory Review Act.''
This is a targeted, non-controversial measure. It would ensure that the
Securities and Exchange Commission (SEC) and the Public Company
Accounting Oversight Board (PCAOB) fully consider the impacts of their
final rules mandating how small public companies must comply with the
internal control requirements of the Sarbanes-Oxley Act.
Our Nation's small stock companies are the cornerstone of our
entrepreneurial economy, and it is essential that we carefully address
the regulatory barriers that impede their growth.
The Sarbanes-Oxley Act was essential in restoring investor confidence
after accounting fraud and massive company deceptions shook the
public's trust in U.S. markets. The horrendous debacle of corporate
greed from companies like Enron and Worldcom forced not only thousands
of employees to lose their jobs, but also wiped out the life savings of
many retirees. Now, as we refine Sarbanes-Oxley's regulations, we must
carefully preserve investor protections and ensure company transparency
and accountability.
In my home State of Maine, small publicly-traded companies are
indispensable to the strength and renewal of our economy. However, the
fact is that many of these small stock companies are struggling
mightily with the cost and regulatory burden imposed by Sarbanes-Oxley
compliance, regardless of
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their industry. Whether it's a utility company, a dairy pharmaceutical
company that makes large animal vaccines, or a community bank that
fears being smothered by the combined weight of Sarbanes-Oxley and
banking regulations, it is crucial that Maine's home grown companies
focus their energies on developing new products, entering new markets,
and creating jobs--not on compliance.
This is why I rise today, with Senator Coleman, to introduce the
``Small Business Regulatory Review Act of 2007.'' Our bill would
require the SEC to conduct a small business analysis, consistent with
the Regulatory Flexibility Act (RFA), before the SEC publishes its
final rules on small business internal controls compliance. This non-
controversial provision simply restates existing law, ensuring that the
SEC conducts a final RFA analysis. As the SEC should already be
conducting this analysis as part of its final rulemaking process, this
bill will impose no additional delay.
Our bill would also require the SEC to publish a small business
compliance guide, consistent with the Small Business Regulatory
Enforcement Fairness Act (SBREFA). This compliance guide would explain,
in plain language, the small business requirements under the rule. The
SEC should publish this small businesses compliance guide when it
publishes its final rule, so that small business understand the new
requirements. As this non-controversial provision also restates
existing law, this measure would impose no additional delay on the
SEC's rulemaking process.
Regulations disproportionately affect small businesses and
significantly hinder their competitiveness. In 2004, Senator Enzi and I
jointly requested that the Government Accountability Office (GAO) study
the effects of the Sarbanes-Oxley Act on small public companies' access
to capital. The study found that the costs for complying with Sarbanes-
Oxley were nine times greater for smaller companies than for large
stock companies. We must reduce the burden imposed by Sarbanes-Oxley so
that our small stocks in Maine, Minnesota, and across the country can
continue to be some of the world's fastest growing and most innovative
companies.
Finally, to address this disproportionate regulatory burden on small
businesses, our bill would require that the GAO re-analyze the impact
of these rules on small public companies two years after final rules
are published. The GAO's report would include an assessment of the
costs and time commitments the SEC and PCAOB requirements impose on
small businesses and whether these costs are expected to decrease or
increase in the future. Additionally, the final report would include
recommendations, and regulatory alternatives, on how to simplify or
improve the process of complying with SEC and PCAOB small company stock
requirements. This provision simply ensures that the rules do not
impose unintended, undue burdens on small businesses.
The ``Small Business Regulatory Review Act of 2007'' will help to
ensure that small stock companies do not suffer from additional
unintended consequences which harm their ability to compete, innovate,
and grow--and, most importantly, create jobs.
______
By Mr. DORGAN (for himself, Mr. Brownback, Ms. Landrieu, Mr.
Allard, Mr. Harkin, Mrs. Murray, Mr. Roberts, Mr. Nelson of
Nebraska, Mr. Salazar, Mr. Hagel, Mr. Thune, and Mr. Levin):
S. 1155. A bill to treat payments under the Conservation Reserve
Program as rentals from real estate; to the Committee on Finance.
Mr. DORGAN. Mr. President, today I am joined by Senator Brownback and
ten of our colleagues in introducing the Conservation Reserve Program
Tax Fairness Act of 2007. This legislation clarifies once and for all
that Conservation Reserve Program (CRP) payments received by active or
retired farmers, or other landowners for that matter will be treated
for Federal tax purposes as rental payments that are not subject to
self-employment taxes.
Let me take a moment to describe this problem. For many years now,
the Internal Revenue Service (IRS) has been taking the erroneous
position that CRP payments received by farmers are self-employment
income derived from a trade or business and therefore are subject to
Self-Employment Contributions Act (SECA) taxes. Regrettably, the IRS
and the Treasury Department proposed a new ruling late last year that
not only requires active farmers to pay SECA taxes on CRP payments but
expands similar tax treatment to CRP payments received by retired
farmers and other landowners.
This latest ruling proposed by the IRS would impose a significant
financial hardship on family farmers and others who have voluntarily
agreed to take environmentally-sensitive lands out of farm production
and place them in the Conservation Reserve Program in return for an
annual rental payment from the Commodity Credit Corporation of the U.S.
Department of Agriculture.
Today, North Dakota has some 3.4 million acres with about $112
million in rental payments in the CRP program. Left intact, the IRS's
ruling would mean that farmers in North Dakota may owe an additional
$16 million in Federal taxes this coming year. A typical North Dakota
farmer with 160 acres of CRP would owe nearly $750 in new self-
employment taxes because of the agency's ill-advised position.
If the IRS decides to pursue back taxes on returns filed by farmers
in past years, the amount of taxes owed by individual farmers for CRP
payments could amount to thousands of dollars. That would be
devastating to many farmers and others who depend on CRP rental
payments to make ends meet. As a result, the proposed change in our
bill applies to CRP payments made in open tax years before, on, or
after the date of its enactment.
We believe the IRS's position on the tax treatment of CRP payments is
dead wrong. In our judgment, forcing CRP recipients to pay self-
employment taxes on CRP payments is not what Congress intended, nor is
it supportable in law. The U.S. Tax Court, the Federal court with the
most expertise on tax issues, shares our view that the IRS position is
improper. In fact, the U.S. Tax Court ruled in the late 1990's that CRP
payments are properly treated by farmers as rental payments and, thus,
not subject to self-employment taxes. Unfortunately, the IRS challenged
the Tax Court decision and the Tax Court was later reversed by a
Federal appellate court.
In February, IRS Commissioner Mark Everson sent a letter to me and a
number of our colleagues who are concerned about this issue. In his
letter, Commissioner Everson made clear that the IRS would not change
its position that CRP payments are subject to self-employment tax as
income derived from a trade or business--absent new statutory language
passed by the Congress and enacted into law.
With the legislation we are introducing today, Congress will send a
clear message to the IRS that its misguided effort to subject CRP
payments to self-employment taxes is inappropriate and will not be
allowed to stand. Our bill also makes sure that Federal trust funds
that would have received SECA revenues but for the enactment of our
bill are held harmless through the use of revenue transfers from the
Treasury general fund.
Senator Brownback and I ask our colleagues to support this much-
needed tax relief for family farmers and other CRP recipients by
cosponsoring the Conservation Reserve Program Tax Fairness Act. And we
hope you will work with us to get this legislation enacted into law
without delay.
______
By Mr. DODD (for himself, Mr. Kennedy, Mr. Harkin, Mr. Bingaman,
Mrs. Murray, Mrs. Clinton, and Mr. Brown):
S. 1156. A bill to amend the Federal Food, Drug, and Cosmetic Act to
reauthorize the Best Pharmaceuticals for Children program; to the
Committee on Health, Education, Labor, and Pensions.
Mr. DODD. Mr. President, I rise today to introduce the Best
Pharmaceuticals for Children Amendments of 2007, which is a bill to
reauthorize the Best Pharmaceuticals for Children Act--BPCA. If
Congress doesn't act, this successful program will expire on October I,
2007. I thank my colleagues Senators Kennedy, Harkin, Bingaman, Murray,
Clinton and Brown who are joining me as original cosponsors of this
important legislation.
[[Page S4695]]
I am pleased that Senators Kennedy and Enzi, the distinguished
chairman and ranking member of the Health Education Labor, and
Pensions--HELP--Committee, have included this bill in the chairman's
mark for S. 1082, which is expected to be voted on today in the HELP
Committee.
I would also like to recognize the contributions and leadership of
former Senator Mike De Wine, a friend and colleague, who always fought
to ensure children would not be treated as second-class citizens when
it came to drug and device development. He was a champion of BPCA along
with me even when it wasn't popular to hold that view.
The story of the Best Pharmaceuticals for Children Act is one of huge
success for children and their families. Children with a wide range of
diseases such as HIV/AIDS, cancer, allergies, asthma, neurological and
psychiatric disorders, and obesity can now lead healthier, more
productive lives as a result of new information about the safety and
efficacy of drugs they use to treat and manage their diseases where
previously there was none.
Children are not simply little adults and results of the drug studies
conducted under the BPCA have shown us that they should not be treated
as such. Pediatric drug studies conducted. under the BPCA showed that
children may have been exposed to ineffective drugs, ineffective
dosing, overdosing, or side effects that were previously unknown.
Since the BPCA's passage in 1997 and its reauthorization in 2002, FDA
has requested nearly 800 studies involving more than 45,000 children in
clinical trials. Useful new pediatric information is now part of
product labeling for 119 drugs. By comparison, in the 7 years prior to
the BPCA's passage, only 11 studies of marketed drugs were completed.
In the past 10 years, there has been a twentyfold increase in the
number of drugs studied in infants, children, and adolescents since
BPCA was enacted.
Labeling changes resulting from clinical studies under the BPCA have
informed physicians of the proper dosing in the examples of Viracept, a
protease inhibitor used in a combination therapy for the treatment of
HIV, and Neurontin, a pain relief medication used to treat children
with chronic pain. For children with epilepsy, the BPCA studies
informed physicians that the drugs Keppra and Trileptal could be used
safely and effectively at an even earlier age than previously known.
Studies of Imitrex as a result of the BPCA showed no better results
than placebo for the treatment of migraine headaches in adolescents.
These same studies also showed serious adverse events due to Imitrex in
pediatric populations and therefore the drug is not recommended to
treat migraines in anyone less than 18 years of age.
Recent studies of the BPCA by the Government Accountability Office--
GAO--and by several authors from Duke University in an article which
appeared in the Journal of the American Medical Association--JAMA--have
demonstrated that the program is a success and have identified
opportunities to strengthen the program. Authors of the recent JAMA
article found that outside of the BPCA, the FDA is limited in the
number and scope of studies for which it can require pediatric data for
existing products on the market.
Data from this article showed that only a minority of drugs studied
under the BPC, about 20 percent, had more than $1 billion in annual
sales. In fact, the median drug granted exclusivity was a small-market
drug with annual sales of $180 million and 30 percent of drugs studied
had sales less than $200 million. This article went on to say that a
universal reduction in the length of pediatric exclusivity from 6 to 3
months would mean that products with small profit margins may not be
submitted for pediatric testing.
The BPCA has always tried to strike the right balance between cost to
consumers and benefits to children. I believe there is an ongoing need
to evaluate the cost of the incentive as it relates to reaching the
goal of having medications properly studied and labeled for children.
In fact, that is why I strongly support a 5-year sunset of the BPCA.
After 10 years, experience and data has shown us that for a small
number of drugs, pediatric exclusivity has far exceeded the ``carrot''
it was intended to provide for manufacturers. As the authors of the
recent JAMA article noted, ``our study shows that the Pediatric
Exclusivity Program overcompensates blockbuster products for performing
clinical trials in children, while other products have more modest
returns on investment under this program.''
The bill I am introducing today contains a reasonable, workable
proposal to address cost concerns without jeopardizing the
extraordinary success of BPCA. I have worked closely with the chairman
and ranking member of the HELP Committee to craft this proposal into
the form it appears in this legislation and in the bipartisan
chairman's mark which is expected to be voted on in the HELP Committee
today.
On March 27, the HELP Committee held a hearing, which I chaired,
entitled ``Ensuring Safe Medicines and Medical Devices for Children.''
We learned from pediatricians and a parent of five children, four of
whom are HIV-positive, Mrs. Susan Belfiore, about the tremendous impact
BPCA has had on the quality of life for countless numbers of children
and their families. We received testimony with many suggestions for
improvements to BPCA which I believe are reflected in this bill. I
would also add that in the month since I circulated this bill as a
draft, I received comments from several pharmaceutical companies. Some
have been strongly supportive of this effort and many of their ideas
and suggestions are incorporated in this bill.
The success of the BPCA has transformed the drug development process
for children. It is my hope that we will achieve similar success with
another piece of legislation I recently introduced called the Pediatric
Medical Device Safety and Improvement Act. It is also contained within
the chairman's mark to S. 1082 and I thank Chairman Kennedy and Ranking
Member Enzi for working with me to ensure that medical devices used in
children are safe and are designed specifically for their use.
The BPCA has had a long history of bipartisan support and it has been
my longstanding hope that this initiative will continue to be
bipartisan as the chairman's mark to S. 1082 moves to the Senate floor.
The safety of our Nation's children is not a partisan issue.
As the parent of two young children, I know that it is essential that
products used in children's growing bodies, whether they be drugs or
devices, are appropriately tested and designed specifically for their
use. We must continue the tremendous success of BPCA and its
complementary program, the Pediatric Research Improvement Act, of which
I am an original cosponsor, by strengthening both programs through the
reauthorization process this year. It is essential that we use the past
experience of both programs to ensure they will continue to thrive in
the future.
I urge my colleagues to support this legislation.
I ask unanimous consent that the text of the bill be printed in the
Record.
There being no objection, the text of the bill was ordered to be
printed in the Record, as follows:
S. 1156
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Best Pharmaceuticals for
Children Amendments of 2007''.
SEC. 2. PEDIATRIC STUDIES OF DRUGS.
(a) In General.--Section 505A of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355a) is amended--
(1) in subsection (a), by inserting before the period at
the end the following: ``, and, at the discretion of the
Secretary, may include preclinical studies'';
(2) in subsection (b)--
(A) in paragraph (1)(A)(i), by striking ``(D)'' both places
it appears and inserting ``(E)'';
(B) in paragraph (1)(A)(ii), by striking ``(D)'' and
inserting ``(E)'';
(C) by striking ``(1)(A)(i)'' and inserting ``(A)(i)(I)'';
(D) by striking ``(ii) the'' and inserting ``(II) the'';
(E) by striking ``(B) if the drug is designated'' and
inserting ``(ii) if the drug is designated'';
(F) by striking ``(2)(A)'' and inserting ``(B)(i)'';
(G) by striking ``(i) a listed patent'' and inserting ``(I)
a listed patent'';
(H) by striking ``(ii) a listed patent'' and inserting
``(II) a listed patent'';
[[Page S4696]]
(I) by striking ``(B) if the drug is the subject'' and
inserting ``(ii) if the drug is the subject'';
(J) by striking ``If'' and all that follows through
``subsection (d)(3)'' and inserting the following:
``(1) In general.--Except as provided in paragraph (2), if,
prior to approval of an application that is submitted under
section 505(b)(1), the Secretary determines that information
relating to the use of a new drug in the pediatric population
may produce health benefits in that population, the Secretary
makes a written request for pediatric studies (which shall
include a timeframe for completing such studies), the
applicant agrees to the request, such studies are completed
using appropriate formulations for each age group for which
the study is requested within any such timeframe and the
reports thereof are submitted and accepted in accordance with
subsection (d)(3), and if the Secretary determines that
labeling changes are appropriate, such changes are made
within the timeframe requested by the Secretary--''; and
(K) by adding at the end the following:
``(2) Exception.--The Secretary shall not extend the period
referred to in paragraph (1)(A) or in paragraph (1)(B) later
than 9 months prior to the expiration of such period.'';
(3) in subsection (c)--
(A) in paragraph (1)(A)(i), by striking ``(D)'' both places
it appears and inserting ``(E)'';
(B) in paragraph (1)(A)(ii), by striking ``(D)'' and
inserting ``(E)'';
(C) by striking ``(1)(A)(i)'' and inserting ``(A)(i)(I)'';
(D) by striking ``(ii) the'' and inserting ``(II) the'';
(E) by striking ``(B) if the drug is designated'' and
inserting ``(ii) if the drug is designated'';
(F) by striking ``(2)(A)'' and inserting ``(B)(i)'';
(G) by striking ``(i) a listed patent'' and inserting ``(I)
a listed patent'';
(H) by striking ``(ii) a listed patent'' and inserting
``(II) a listed patent'';
(I) by striking ``(B) if the drug is the subject'' and
inserting ``(ii) if the drug is the subject'';
(J) by striking ``If'' and all that follows through
``subsection (d)(3)'' and inserting the following:
``(1) In general.--Except as provided in paragraph (2), if
the Secretary determines that information relating to the use
of an approved drug in the pediatric population may produce
health benefits in that population and makes a written
request to the holder of an approved application under
section 505(b)(1) for pediatric studies (which shall include
a timeframe for completing such studies), the holder agrees
to the request, such studies are completed using appropriate
formulations for each age group for which the study is
requested within any such timeframe and the reports thereof
are submitted and accepted in accordance with subsection
(d)(3), and if the Secretary determines that labeling changes
are appropriate, such changes are made within the timeframe
requested by the Secretary--''; and
(K) by adding at the end the following:
``(2) Exception.--The Secretary shall not extend the period
referred to in paragraph (1)(A) or in paragraph (1)(B) later
than 9 months prior to the expiration of such period.'';
(4) by striking subsection (d) and inserting the following:
``(d) Conduct of Pediatric Studies.--
``(1) Request for studies.--
``(A) In general.--The Secretary may, after consultation
with the sponsor of an application for an investigational new
drug under section 505(i), the sponsor of an application for
a new drug under section 505(b)(1), or the holder of an
approved application for a drug under section 505(b)(1),
issue to the sponsor or holder a written request for the
conduct of pediatric studies for such drug. In issuing such
request, the Secretary shall take into account adequate
representation of children of ethnic and racial minorities.
Such request to conduct pediatric studies shall be in writing
and shall include a timeframe for such studies and a request
to the sponsor or holder to propose pediatric labeling
resulting from such studies.
``(B) Single written request.--A single written request--
``(i) may relate to more than 1 use of a drug; and
``(ii) may include uses that are both approved and
unapproved.
``(2) Written request for pediatric studies.--
``(A) Request and response.--
``(i) In general.--If the Secretary makes a written request
for pediatric studies (including neonates, as appropriate)
under subsection (b) or (c), the applicant or holder, not
later than 180 days after receiving the written request,
shall respond to the Secretary as to the intention of the
applicant or holder to act on the request by--
``(I) indicating when the pediatric studies will be
initiated, if the applicant or holder agrees to the request;
or
``(II) indicating that the applicant or holder does not
agree to the request and the reasons for declining the
request.
``(ii) Disagree with request.--If, on or after the date of
enactment of the Best Pharmaceuticals for Children Amendments
of 2007, the applicant or holder does not agree to the
request on the grounds that it is not possible to develop the
appropriate pediatric formulation, the applicant or holder
shall submit to the Secretary the reasons such pediatric
formulation cannot be developed.
``(B) Adverse event reports.--An applicant or holder that,
on or after the date of enactment of the Best Pharmaceuticals
for Children Amendments of 2007, agrees to the request for
such studies shall provide the Secretary, at the same time as
submission of the reports of such studies, with all
postmarket adverse event reports regarding the drug that is
the subject of such studies and are available prior to
submission of such reports.
``(3) Meeting the studies requirement.--Not later than 180
days after the submission of the reports of the studies, the
Secretary shall accept or reject such reports and so notify
the sponsor or holder. The Secretary's only responsibility in
accepting or rejecting the reports shall be to determine,
within the 180 days, whether the studies fairly respond to
the written request, have been conducted in accordance with
commonly accepted scientific principles and protocols, and
have been reported in accordance with the requirements of the
Secretary for filing.
``(4) Effect of subsection.--Nothing in this subsection
alters or amends section 301(j) of this Act or section 552 of
title 5 or section 1905 of title 18, United States Code.'';
(5) by striking subsections (e) and (f) and inserting the
following:
``(e) Notice of Determinations on Studies Requirement.--
``(1) In general.--The Secretary shall publish a notice of
any determination, made on or after the date of enactment of
the Best Pharmaceuticals for Children Amendments of 2007,
that the requirements of subsection (d) have been met and
that submissions and approvals under subsection (b)(2) or (j)
of section 505 for a drug will be subject to the provisions
of this section. Such notice shall be published not later
than 30 days after the date of the Secretary's determination
regarding market exclusivity and shall include a copy of the
written request made under subsection (b) or (c).
``(2) Identification of certain drugs.--The Secretary shall
publish a notice identifying any drug for which, on or after
the date of enactment of the Best Pharmaceuticals for
Children Amendments of 2007, a pediatric formulation was
developed, studied, and found to be safe and effective in the
pediatric population (or specified subpopulation) if the
pediatric formulation for such drug is not introduced onto
the market within 1 year of the date that the Secretary
publishes the notice described in paragraph (1). Such notice
identifying such drug shall be published not later than 30
days after the date of the expiration of such 1 year period.
``(f) Internal Review of Written Requests and Pediatric
Studies.--
``(1) Internal review.--
``(A) In general.--The Secretary shall create an internal
review committee to review all written requests issued and
all reports submitted on or after the date of enactment of
the Best Pharmaceuticals for Children Amendments of 2007, in
accordance with paragraphs (2) and (3).
``(B) Members.--The committee under subparagraph (A) shall
include individuals, each of whom is an employee of the Food
and Drug Administration, with the following expertise:
``(i) Pediatrics.
``(ii) Biopharmacology.
``(iii) Statistics.
``(iv) Drugs and drug formulations.
``(v) Legal issues.
``(vi) Appropriate expertise pertaining to the pediatric
product under review.
``(vii) One or more experts from the Office of Pediatric
Therapeutics, including an expert in pediatric ethics.
``(viii) Other individuals as designated by the Secretary.
``(2) Review of written requests.--All written requests
under this section shall be reviewed and approved by the
committee established under paragraph (1) prior to being
issued.
``(3) Review of pediatric studies.--The committee
established under paragraph (1) shall review all studies
conducted pursuant to this section to determine whether to
accept or reject such reports under subsection (d)(3).
``(4) Tracking pediatric studies and labeling changes.--The
committee established under paragraph (1) shall be
responsible for tracking and making available to the public,
in an easily accessible manner, including through posting on
the website of the Food and Drug Administration--
``(A) the number of studies conducted under this section;
``(B) the specific drugs and drug uses, including labeled
and off-labeled indications, studied under this section;
``(C) the types of studies conducted under this section,
including trial design, the number of pediatric patients
studied, and the number of centers and countries involved;
``(D) the number of pediatric formulations developed and
the number of pediatric formulations not developed and the
reasons such formulations were not developed;
``(E) the labeling changes made as a result of studies
conducted under this section;
``(F) an annual summary of labeling changes made as a
result of studies conducted under this section for
distribution pursuant to subsection (k)(2); and
``(G) information regarding reports submitted on or after
the date of enactment of the Best Pharmaceuticals for
Children Amendments of 2007.'';
(6) in subsection (g)--
[[Page S4697]]
(A) in paragraph (1)--
(i) by striking ``(c)(1)(A)(ii)'' and inserting
``(c)(1)(A)(i)(II)''; and
(ii) by striking ``(c)(2)'' and inserting ``(c)(1)(B)'';
(B) in paragraph (2), by striking ``(c)(1)(B)'' and
inserting ``(c)(1)(A)(ii)'';
(C) by redesignating paragraphs (1) and (2) as
subparagraphs (A) and (B), respectively;
(D) by striking ``Limitations.--A drug'' and inserting
``Limitations.--
``(1) In general.--Notwithstanding subsection (c)(2), a
drug''; and
(E) by adding at the end the following:
``(2) Exclusivity adjustment.--
``(A) Adjustment.--
``(i) In general.--With respect to any drug, if the
organization designated under subparagraph (B) notifies the
Secretary that the combined annual gross sales for all drugs
with the same active moiety exceeded $1,000,000,000 in any
calendar year prior to the time the sponsor or holder agrees
to the initial written request pursuant to subsection (d)(2),
then each period of market exclusivity deemed or extended
under subsection (b) or (c) shall be reduced by 3 months for
such drug.
``(ii) Determination.--The determination under clause (i)
of the combined annual gross sales shall be determined--
``(I) taking into account only those sales within the
United States; and
``(II) taking into account only the sales of all drugs with
the same active moiety of the sponsor or holder and its
affiliates.
``(B) Designation.--The Secretary shall designate an
organization other than the Food and Drug Administration to
evaluate whether the combined annual gross sales for all
drugs with the same active moiety exceeded $1,000,000,000 in
a calendar year as described in subparagraph (A). Prior to
designating such organization, the Secretary shall determine
that such organization is independent and is qualified to
evaluate the sales of pharmaceutical products. The Secretary
shall re-evaluate the designation of such organization once
every 3 years.
``(C) Notification.--Once a year at a time designated by
the Secretary, the organization designated under subparagraph
(B) shall notify the Food and Drug Administration of all
drugs with the same active moiety with combined annual gross
sales that exceed $1,000,000,000 during the previous calendar
year.''.
(7) in subsection (i)--
(A) in the heading, by striking ``Supplements'' and
inserting ``Changes'';
(B) in paragraph (1)--
(i) in the heading, by inserting ``applications and'' after
``pediatric'';
(ii) by inserting ``application or'' after ``Any'';
(iii) by striking ``change pursuant to a report on a
pediatric study under'' and inserting ``change as a result of
any pediatric study conducted pursuant to''; and
(iv) by inserting ``application or'' after ``to be a
priority''; and
(C) in paragraph (2)(A), by--
(i) striking ``If the Commissioner'' and inserting ``If, on
or after the date of enactment of the Best Pharmaceuticals
for Children Amendments of 2007, the Commissioner''; and
(ii) striking ``an application with'' and all that follows
through ``on appropriate'' and inserting ``the sponsor and
the Commissioner have been unable to reach agreement on
appropriate'';
(8) by striking subsection (m);
(9) by redesignating subsections (j), (k), (l), and (n), as
subsections (k), (m), (o), and (p), respectively;
(10) by inserting after subsection (i) the following:
``(j) Other Labeling Changes.--If, on or after the date of
enactment of the Best Pharmaceuticals for Children Amendments
of 2007, the Secretary determines that a pediatric study
conducted under this section does or does not demonstrate
that the drug that is the subject of the study is safe and
effective, including whether such study results are
inconclusive, in pediatric populations or subpopulations, the
Secretary shall order the labeling of such product to include
information about the results of the study and a statement of
the Secretary's determination.'';
(11) in subsection (k), as redesignated by paragraph (9)--
(A) in paragraph (1)--
(i) by striking ``a summary of the medical and'' and
inserting ``the medical, statistical, and''; and
(ii) by striking ``for the supplement'' and all that
follows through the period and inserting ``under subsection
(b) or (c).'';
(B) by redesignating paragraph (2) as paragraph (3); and
(C) by inserting after paragraph (1) the following:
``(2) Dissemination of information regarding labeling
changes.--Beginning on the date of enactment of the Best
Pharmaceuticals for Children Amendments of 2007, the
Secretary shall require that the sponsors of the studies that
result in labeling changes that are reflected in the annual
summary developed pursuant to subsection (f)(4)(F)
distribute, at least annually (or more frequently if the
Secretary determines that it would be beneficial to the
public health), such information to physicians and other
health care providers.'';
(12) by inserting after subsection (k), as redesignated by
paragraph (9), the following:
``(l) Adverse Event Reporting.--
``(1) Reporting in year one.--Beginning on the date of
enactment of the Best Pharmaceuticals for Children Amendments
of 2007, during the 1-year period beginning on the date a
labeling change is made pursuant to subsection (i), the
Secretary shall ensure that all adverse event reports that
have been received for such drug (regardless of when such
report was received) are referred to the Office of Pediatric
Therapeutics established under section 6 of the Best
Pharmaceuticals for Children Act (Public Law 107-109). In
considering such reports, the Director of such Office shall
provide for the review of the report by the Pediatric
Advisory Committee, including obtaining any recommendations
of such Committee regarding whether the Secretary should take
action under this section in response to such reports.
``(2) Reporting in subsequent years.--Following the 1-year
period described in paragraph (1), the Secretary shall, as
appropriate, refer to the Office of Pediatric Therapeutics
all pediatric adverse event reports for a drug for which a
pediatric study was conducted under this section. In
considering such reports, the Director of such Office may
provide for the review of such reports by the Pediatric
Advisory Committee, including obtaining any recommendation of
such Committee regarding whether the Secretary should take
action in response to such reports.
``(3) Effect.--The requirements of this subsection shall
supplement, not supplant, other review of such adverse event
reports by the Secretary.'';
(13) by inserting after subsection (m), as redesignated by
paragraph (9), the following:
``(n) Referral if Pediatric Studies Not Completed.--
``(1) In general.--Beginning on the date of enactment of
the Best Pharmaceuticals for Children Amendments of 2007, if
pediatric studies of a drug have not been completed under
subsection (d) and if the Secretary, through the committee
established under subsection (f), determines that there is a
continuing need for information relating to the use of the
drug in the pediatric population (including neonates, as
appropriate), the Secretary shall carry out the following:
``(A) For a drug for which a listed patent has not expired,
make a determination regarding whether an assessment shall be
required to be submitted under section 505B. Prior to making
such determination, the Secretary may take not more than 60
days to certify whether the Foundation for the National
Institutes of Health has sufficient funding at the time of
such certification to initiate 1 or more of the pediatric
studies of such drug referred to in the sentence preceding
this paragraph and fund 1 or more of such studies in their
entirety. Only if the Secretary makes such certification in
the affirmative, the Secretary shall refer such pediatric
study or studies to the Foundation for the National
Institutes of Health for the conduct of such study or
studies.
``(B) For a drug that has no listed patents or has 1 or
more listed patents that have expired, determine whether
there are funds available under section 736 to award a grant
to conduct the requested studies pursuant to paragraph (2).
``(2) Funding of studies.--If, pursuant to paragraph (1),
the Secretary determines that there are funds available under
section 736 to award a grant to conduct the requested
pediatric studies, then the Secretary shall issue a proposal
to award a grant to conduct the requested studies. If the
Secretary determines that funds are not available under
section 736, the Secretary shall refer the drug for inclusion
on the list established under section 409I of the Public
Health Service Act for the conduct of studies.
``(3) Public notice.--The Secretary shall give the public
notice of--
``(A) a decision under paragraph (1)(A) not to require an
assessment under section 505B and the basis for such
decision;
``(B) the name of any drug, its manufacturer, and the
indications to be studied pursuant to a grant made under
paragraph (2); and
``(C) any decision under paragraph (2) to refer a drug for
inclusion on the list established under section 409I of the
Public Health Service Act.
``(4) Effect of subsection.--Nothing in this subsection
alters or amends section 301(j) of this Act or section 552 of
title 5 or section 1905 of Title 18, United States Code.'';
(14) in subsection (p), as redesignated by paragraph (9)--
(A) striking ``6-month period'' and inserting ``3-month or
6-month period'';
(B) by striking ``subsection (a)'' and inserting
``subsection (b)''; and
(C) by striking ``2007'' both places it appears and
inserting ``2012''.
(b) Effective Date.--Except as otherwise provided in the
amendments made by subsection (a), such amendments shall
apply to written requests under section 505A of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355a) made after the
date of enactment of this Act.
SEC. 3. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.
Section 409I of the Public Health Service Act (42 U.S.C.
284m) is amended--
(1) by striking subsections (a) and (b) and inserting the
following:
``(a) List of Priority Issues in Pediatric Therapeutics.--
``(1) In general.--Not later than 1 year after the date of
enactment of the Best Pharmaceuticals for Children Amendments
of 2007, the Secretary, acting through the Director of the
National Institutes of Health
[[Page S4698]]
and in consultation with the Commissioner of Food and Drugs
and experts in pediatric research, shall develop and publish
a priority list of needs in pediatric therapeutics, including
drugs or indications that require study. The list shall be
revised every 3 years.
``(2) Consideration of available information.--In
developing and prioritizing the list under paragraph (1), the
Secretary shall consider--
``(A) therapeutic gaps in pediatrics that may include
developmental pharmacology, pharmacogenetic determinants of
drug response, metabolism of drugs and biologics in children,
and pediatric clinical trials;
``(B) particular pediatric diseases, disorders or
conditions where more complete knowledge and testing of
therapeutics, including drugs and biologics, may be
beneficial in pediatric populations; and
``(C) the adequacy of necessary infrastructure to conduct
pediatric pharmacological research, including research
networks and trained pediatric investigators.
``(b) Pediatric Studies and Research.--The Secretary,
acting through the National Institutes of Health, shall award
funds to entities that have the expertise to conduct
pediatric clinical trials or other research (including
qualified universities, hospitals, laboratories, contract
research organizations, practice groups, federally funded
programs such as pediatric pharmacology research units, other
public or private institutions, or individuals) to enable the
entities to conduct the drug studies or other research on the
issues described in subsection (a). The Secretary may use
contracts, grants, or other appropriate funding mechanisms to
award funds under this subsection.'';
(2) in subsection (c)--
(A) in the heading, by striking ``Contracts'' and inserting
``Proposed Pediatric Study Requests'';
(B) by striking paragraphs (4) and (12);
(C) by redesignating paragraphs (1), (2), and (3), as
paragraphs (2), (3), and (4);
(D) by inserting before paragraph (2), as redesignated by
subparagraph (C), the following:
``(1) Submission of proposed pediatric study request.--The
Director of the National Institutes of Health shall, as
appropriate, submit proposed pediatric study requests for
consideration by the Commissioner of Food and Drugs for
pediatric studies of a specific pediatric indication
identified under subsection (a). Such a proposed pediatric
study request shall be made in a manner equivalent to a
written request made under subsection (b) or (c) of section
505A of the Federal Food, Drug, and Cosmetic Act, including
with respect to the information provided on the pediatric
studies to be conducted pursuant to the request. The Director
of the National Institutes of Health may submit a proposed
pediatric study request for a drug for which--
``(A)(i) there is an approved application under section
505(j) of the Federal Food, Drug, and Cosmetic Act; or
``(ii) there is a submitted application that could be
approved under the criteria of section 505(j) of the Federal
Food, Drug, and Cosmetic Act; and
``(B) there is no patent protection or market exclusivity
protection for at least 1 form of the drug under the Federal
Food, Drug, and Cosmetic Act; and
``(C) additional studies are needed to assess the safety
and effectiveness of the use of the drug in the pediatric
population.'';
(E) in paragraph (2), as redesignated by subparagraph (C)--
(i) by inserting ``based on the proposed pediatric study
request for the indication or indications submitted pursuant
to paragraph (1)'' after ``issue a written request'';
(ii) by striking ``in the list described in subsection
(a)(1)(A) (except clause (iv))'' and inserting ``under
subsection (a)''; and
(iii) by inserting ``and using appropriate formulations for
each age group for which the study is requested'' before the
period at the end;
(F) in paragraph (3), as redesignated by subparagraph (C)--
(i) in the heading, by striking ``contracts'';
(ii) by striking ``paragraph (1)'' and inserting
``paragraph (2)'';
(iii) by striking ``or if a referral described in
subsection (a)(1)(A)(iv) is made,'';
(iv) by striking ``for contract proposals'' and inserting
``for proposals''; and
(v) by inserting ``in accordance with subsection (b)''
before the period at the end;
(G) in paragraph (4), as redesignated by subparagraph (C)--
(i) by striking ``contract''; and
(ii) by striking ``paragraph (2)'' and inserting
``paragraph (3)'';
(H) in paragraph (5)--
(i) by striking the heading and inserting ``Contracts,
grants, or other funding mechanisms''; and
(ii) by striking ``A contract'' and all that follows
through ``is submitted'' and inserting ``A contract, grant,
or other funding may be awarded under this section only if a
proposal is submitted'';
(I) in paragraph (6)(A)--
(i) by striking ``a contract awarded'' and inserting ``an
award''; and
(ii) by inserting ``, including a written request if
issued'' after ``with the study''; and
(3) by inserting after subsection (c) the following:
``(d) Dissemination of Pediatric Information.--Not later
than 1 year after the date of enactment of the Best
Pharmaceuticals for Children Amendments of 2007, the
Secretary, acting through the Director of the National
Institutes of Health, shall study the feasibility of
establishing a compilation of information on pediatric drug
use and report the findings to Congress.''
``(e) Authorization of Appropriations.--
``(1) In general.--There are authorized to be appropriated
to carry out this section--
``(A) $200,000,000 for fiscal year 2008; and
``(B) such sums as are necessary for each of the 4
succeeding fiscal years.
``(2) Availability.--Any amount appropriated under
paragraph (1) shall remain available to carry out this
section until expended.''.
SEC. 4. REPORTS AND STUDIES.
(a) GAO Report.--Not later than January 31, 2011, the
Comptroller General of the United States, in consultation
with the Secretary of Health and Human Services, shall submit
to Congress a report that addresses the effectiveness of
section 505A of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355a) in ensuring that medicines used by children are
tested and properly labeled, including--
(1) the number and importance of drugs for children that
are being tested as a result of the amendments made by this
Act and the importance for children, health care providers,
parents, and others of labeling changes made as a result of
such testing;
(2) the number and importance of drugs for children that
are not being tested for their use notwithstanding the
provisions of this Act and the amendments made by this Act,
and possible reasons for the lack of testing, including
whether the number of written requests declined by sponsors
or holders of drugs subject to section 505A(g)(2) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(g)(2)),
has increased or decreased as a result of the amendments made
by this Act;
(3) the number of drugs for which testing is being done and
labeling changes required, including the date labeling
changes are made and which labeling changes required the use
of the dispute resolution process established pursuant to the
amendments made by this Act, together with a description of
the outcomes of such process, including a description of the
disputes and the recommendations of the Pediatric Advisory
Committee;
(4) any recommendations for modifications to the programs
established under section 505A of the Federal Food, Drug and
Cosmetic Act (21 U.S.C. 355a) and section 409I of the Public
Health Service Act that the Secretary determines to be
appropriate, including a detailed rationale for each
recommendation; and
(5)(A) the efforts made by the Secretary to increase the
number of studies conducted in the neonate population; and
(B) the results of those efforts, including efforts made to
encourage the conduct of appropriate studies in neonates by
companies with products that have sufficient safety and other
information to make the conduct of the studies ethical and
safe.
(b) IOM Study.--Not later than 3 years after the date of
enactment of this Act, the Secretary of Health and Human
Services shall enter into a contract with the Institute of
Medicine to conduct a study and report to Congress regarding
the written requests made and the studies conducted pursuant
to section 505A of the Federal Food, Drug, and Cosmetic Act.
The Institute of Medicine may devise an appropriate mechanism
to review a representative sample of requests made and
studies conducted pursuant to such section in order to
conduct such study. Such study shall--
(1) review such representative written requests issued by
the Secretary since 1997 under subsections (b) and (c) of
such section 505A;
(2) review and assess such representative pediatric studies
conducted under such subsections (b) and (c) since 1997 and
labeling changes made as a result of such studies; and
(3) review the use of extrapolation for pediatric
subpopulations, the use of alternative endpoints for
pediatric populations, neonatal assessment tools, and ethical
issues in pediatric clinical trials.
SEC. 5. TRAINING OF PEDIATRIC PHARMACOLOGISTS.
(a) Investment in Tomorrow's Pediatric Researchers.--
Section 452G(2) of the Public Health Service Act (42 U.S.C.
285g-10(2)) is amended by adding before the period at the end
the following: ``, including pediatric pharmacological
research''.
(b) Pediatric Research Loan Repayment Program.--Section
487F(a)(1) of the Public Health Service Act (42 U.S.C. 288-
6(a)(1)) is amended by inserting ``including pediatric
pharmacological research,'' after ``pediatric research,''.
SEC. 6. FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH.
Section 499(c)(1)(C) of the Public Health Service Act (42
U.S.C. 290b(c)(1)(C)) is amended by striking ``and studies
listed by the Secretary pursuant to section 409I(a)(1)(A) of
the is Act and referred under section 505A(d)(4)(C) of the
Federal Food, Drug and Cosmetic Act (21 U.S.C.
355(a)(d)(4)(C)'' and inserting ``and studies for which the
Secretary issues a certification under section 505A(n)(1)(A)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355a(n)(1)(A))''.
SEC. 7. CONTINUATION OF OPERATION OF COMMITTEE.
Section 14 of the Best Pharmaceuticals for Children Act (42
U.S.C. 284m note) is amended by adding at the end the
following:
``(d) Continuation of Operation of Committee.--
Notwithstanding section 14 of the
[[Page S4699]]
Federal Advisory Committee Act (5 U.S.C. App.), the advisory
committee shall continue to operate during the 5-year period
beginning on the date of enactment of the Best
Pharmaceuticals for Children Amendments of 2007.''.
SEC. 8. PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC DRUGS
ADVISORY COMMITTEE.
Section 15 of the Best Pharmaceuticals for Children Act (42
U.S.C. 284m note) is amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) in subparagraph (B), by striking ``and'' after the
semicolon;
(ii) in subparagraph (C), by striking the period at the end
and inserting ``; and''; and
(iii) by adding at the end the following:
``(D) provide recommendations to the internal review
committee created under section 505A(f) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355a(f)) regarding the
implementation of amendments to sections 505A and 505B of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a and
355c) with respect to the treatment of pediatric cancers.'';
and
(B) by adding at the end the following:
``(3) Continuation of operation of subcommittee.--
Notwithstanding section 14 of the Federal Advisory Committee
Act (5 U.S.C. App.), the Subcommittee shall continue to
operate during the 5-year period beginning on the date of
enactment of the Best Pharmaceuticals for Children Amendments
of 2007.''; and
(2) in subsection (d), by striking ``2003'' and inserting
``2009''.
SEC. 9. EFFECTIVE DATE AND LIMITATION FOR RULE RELATING TO
TOLL-FREE NUMBER FOR ADVERSE EVENTS ON LABELING
FOR HUMAN DRUG PRODUCTS.
(a) In General.--Notwithstanding subchapter II of chapter
5, and chapter 7, of title 5, United States Code (commonly
known as the ``Administrative Procedure Act'') and any other
provision of law, the proposed rule issued by the
Commissioner of Food and Drugs entitled ``Toll-Free Number
for Reporting Adverse Events on Labeling for Human Drug
Products'', 69 Fed. Reg. 21778, (April 22, 2004) shall take
effect on January 1, 2008, unless such Commissioner issues
the final rule before such date.
(b) Limitation.--The proposed rule that takes effect under
subsection (a), or the final rule described under subsection
(a), shall, notwithstanding section 17(a) of the Best
Pharmaceuticals for Children Act (21 U.S.C. 355b(a)), not
apply to a drug--
(1) for which an application is approved under section 505
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355);
(2) that is not described under section 503(b)(1) of such
Act (21 U.S.C. 353(b)(1)); and
(3) the packaging of which includes a toll-free number
through which consumers can report complaints to the
manufacturer or distributor of the drug.
____________________