[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

[[Page S4694]]

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

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     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.

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