Congressional Record, Volume 151 Issue 160 (Wednesday, December 14, 2005)

[Congressional Record Volume 151, Number 160 (Wednesday, December 14, 2005)]
[Senate]
[Pages S13572-S13591]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS

By Ms. MIKULSKI:
S. 2097. A bill to assist members of the Armed Forces in obtaining
United States citizenship, and for other purposes; to the Committee on
the Judiciary.
Ms. MIKULSKI. Mr. President, I am here today to talk about a bill I
will be introducing that rights a wrong and corrects a terrible
injustice. I am introducing legislation called the Kendell Frederick
Citizenship Assistance Act of 2005. This is legislation was inspired by
a young man from the State of Maryland, who was in the Army, had a
green card, was serving this country, though not a citizen, and was
killed while serving in Iraq. He was killed by a roadside bomb on his
way to be fingerprinted, on his way to become a U.S. citizen. He died
on his way to become a U.S. citizen because of the failed and flawed
information he was given by our immigration system.
He was a terrific young man, who came to this country when he was
fifteen from Trinidad. He joined his mother here in the U.S. and wanted
so much to be part of this country. He wanted to serve this country and
so he joined the ROTC when he was in high school. In fact, Randallstown
High School has one of the best high school ROTCs programs that
Maryland has. After graduation, he then joined the Army and off he went
to train to serve this country.
He was killed by the botched bureaucracy of the U.S. Government, by
their incompetence, by their indifference, by their ineptitude; and
this is absolutely inexcusable. Every military death in Iraq is a
tragedy, but this one did not need to happen. I am going to tell you a
little bit about him and then tell you what happened.
As I said, he graduated from high school and he decided to join the
Army with hopes that he would go back to school. In the Army he was a
generator mechanic assigned to a heavy combat battalion. His job was to
keep that battalion running. All he wanted was to do a good job, help
his buddies stay alive, stay alive himself, defend what we were doing
in Iraq and, along the way, become an American citizen and come back
home and resume his life. He had been trying to become an American
citizen for a while. He started working on it when he joined the Army.
Mr. President, because I know of your keen interest in national
security, I understand that you know when you join the Army you are
fingerprinted and a background check is run. We just don't let anybody
join the United States Army. You can't get in if you are a drug dealer,
if you have an extensive criminal record or if you would be a threat to
the security of the United States. You can't get in if there is even a
hint that you might be connected to a terrorist organization. So
Kendell Frederick was accepted into the Army after all these security
checks were run and his background was vetted. Then he sent in his
citizenship application but, guess what, he checked the wrong box. What
did that mean? Here he was, training for war, packing up to go to Iraq,
saying goodbye to his mom, his brother and two sisters and in the
middle of this he checked the wrong box saying that he was not in the
military. So his application was derailed, not once but three different
times.
The first time was after his mother checked the correct box saying
that Kendell was in the military. Immigration sent the application to
the wrong office, not the one that handles military applications that
is on a fast track but the general one where all the applications are
all stacked up. Second, Immigration rejected the fingerprints that were
sent from the military. There was no explanation. His mother did not
know why the fingerprints had been rejected. He had sent in the
paperwork from Iraq. As I said, Kendell had already been fingerprinted,
had already had his background vetted when he joined the military. So
here was a guy who had been fingerprinted and cleared to join the
military. The Army had said, you are OK, Kendell. He had an FBI
background check run. The FBI said you are OK, Kendell. The Army wants
somebody like you. But when he tried to get through Immigration, they
said no, the fingerprints he had taken when he joined the military and
even the fingerprints he sent into immigration were not enough.
Finally, when his mother called this 1-800 Immigration number--you
try to call that number--she got no help. It is like trying to make a
call from the Superdome in the middle of Katrina. You are not going to
get help going to get the right answer. His mother called that number.
They told his mother that he had to return from Baghdad and go to
Baltimore to get his fingerprints. His mother got on the phone again,
because he can't call from Baghdad--he is being shot at, he is trying
to defend himself and the troops of the United States of America--so he
was a little busy, couldn't afford to get a busy signal from
Immigration.
When his mother called and said, ``My boy is in Baghdad,''
Immigration at the 800 number told her, there was nothing they could
do. They didn't even know their own rules. They didn't know their own
system. They didn't know their own laws. Immigration was wrong. They
gave his mother the wrong information.
So here is Kendell, still keeping in touch, still trying to do his
job, trying to get his fingerprints taken to become a U.S. citizen.
Finally, there was an arrangement made. His staff sergeant came to his
rescue and made arrangements for him to be fingerprinted at a nearby
air base so he could complete this application. On October 19, with the
help of his staff sergeant, he was traveling in a convoy to get his
fingerprints. He didn't usually go in convoys, but that day he was on
that convoy to get his fingerprints to become an American citizen--to
compensate for the botched mistakes of Immigration--and on his way a
roadside bomb killed him.
They told his mother that immigration would give Kendell U.S.
citizenship. They granted his citizenship a week after he died. He was
buried at Arlington, as he should have been. He was trying to do the
right thing, yet he was given the wrong information.
As I said, his staff sergeant tried to help him, his mother tried to
help him, but the system, the immigration system, failed him time and
time again.
When I called his mother--and I try to call all the families of our
military from Maryland who die; some I reach, some I do not--I spoke to
his mother. She said to me that she did not want another mother to go
through what she went through, to go through what her son went through.
Service members and their moms and dads should not be worrying about
what box to check, where the fingerprints are, et cetera. She said
Immigration should know their own rules. When we explained to her the
rules of Immigration, that he should have been fast tracked, that these
fingerprints should have been OK, that he did not have to pay a $400
fee, she said, ``Nobody told me that.'' Every time I called, I got
different information.

I am introducing legislation today to prevent this from happening
again. His mother asked me to introduce legislation, and she asked me
to call it the

[[Page S13573]]

Kendell Frederick law. I am doing that today, and over in the House
Congressman Elijah Cummings is doing the same thing. We made this
promise when we stood in the church, a small, humble church in an
African-American community in Baltimore. We made this pledge to his
mother that we would do this for her and we are here today to do just
that.
The legislation I am introducing today makes it easier for military
servicemembers to become citizens. The provisions cut through the
redtape. It requires Immigration to use the fingerprints the military
takes when the person enlists in the military.
It requires the creation of a military citizen advocate to inform the
servicemembers about the citizenship process and help with the
application.
It also means they won't leave boot camp unless they are absolutely
apprised of all of the rules and all of the regulations about how to
apply to become a U.S. citizen.
The very process they have to go through to join the military,
fingerprinting and FBI background check, should be good enough. Because
you see, deep down inside, we believe that if you are good enough to
fight for this country, you are good enough to become a citizen of this
country.
There is a pileup of 3,000 people with green cards fighting in our
military today who have applied to become American citizens. You should
not have to be standing in that kind of line. We are not saying let
anyone become a U.S. citizen, but these are men and women who joined
the military and fighting for this country. They have a green card,
they have been fingerprinted, and they have passed an FBI check. Why do
they have to go through it all over again?
We are passing a law that would stop this needless bureaucracy, and
we are establishing a special 800 number for our military and their
families.
We talk a lot about standing up for our troops, and we certainly
should stand up for our troops. This means we should stand up for them
and enable them to follow their dreams. They are certainly standing up
for us.
Today, we introduced the Kendell Frederick bill to make sure that
anyone in the military who wants to be a U.S. citizen, who has a green
card, and who passed the fingerprint checks will be able to do so
quickly and easily. If they are willing to fight for America and die
for America, they should be able to become an American citizen.
I will be circulating a ``Dear Colleague'' to my colleagues to join
it. I hope we can pass this legislation on a bipartisan basis so that
as men and women such as Kendell Frederick fight for freedom, we ensure
that their memory is not in vain.
I thank the Chair.
______

By Ms. MURKOWSKI (for herself, Mr. Akaka, and Mr. Bingaman):
S. 2098. A bill to amend the Energy Employees Occupational Illness
Compensation Program Act of 2000 to clarify the eligibility of certain
employees of the Department of Energy under that Act; to the Committee
on Health, Education, Labor, and Pensions.
Ms. MURKOWSKI. Mr. President, I send to the desk for appropriate
reference legislation that will clarify that citizens of the former
Trust Territory of the Pacific Islands are eligible for coverage and
potential compensation under the Energy Employees Occupational Illness
Compensation Program Act, EEOICPA, for workers who developed radiogenic
cancers and other ailments after working at the Pacific Test Site in
the Marshall Islands.
An estimated up to 500 Republic of Marshall Islanders and other
Micronesian workers may have been employed by the Department of Energy,
or its predecessor agency, or Department subcontractors prior to 1986
when the Trusteeship was terminated for all areas except Palau. Both
Bikini and Enewetak Atolls were the sites for numerous nuclear and
thermonuclear tests. Other atolls, such as Rongelap and Utrik, were
affected by fallout from the Bravo hydrogen bomb test in March 1954.
Congress, in 2000, approved a compensation program to provide aid and
pay medical bills for those who suffered radiation-caused illnesses
because of working on the nuclear weapons program. Congress
specifically set up a ``Special Exposure Cohort'' to provide
compensation to certain workers with radiogenic cancer and other
illnesses because it was presumed that their illnesses resulted from
workplace exposure to radiation caused by their Government work.
Congress, in 2004, amended the act, first approved in the 2001 Military
Construction Authorization Act, to speed payments of compensation,
including funds for lost wages to workers or their heirs, to those who
worked for the Department of Energy and its predecessor agency on
nuclear weapons programs.
Earlier this year the Committee on Energy and Natural Resources held
an oversight hearing to review a number of issues raised by the
government of the Republic of the Marshall Islands related to the
effects of the nuclear testing program. One of the issues was coverage
for residents of the then-trust territory who were employed during the
testing and subsequent cleanup. During that period, the United States
was the administering authority over the area under a United Nations
Trusteeship Agreement and exercised all the powers of a sovereign. It
seems somewhat incongruous for the Congress to have established a
program that applied to U.S. citizens but not to those who lived and
worked under U.S. administration.
That also seems reasonable, since there is little other reason for
the specific inclusion of the Pacific Test Site if the workers were not
to be covered. During Senate debate, Senator Bingaman, a conferee on
the amendment, submitted a list of DOE facilities intended to be
covered by the act--a list which included the Marshall Islands, 146
Cong. Rec. S. 4754-7.
While most of the issues raised by the Minister of Foreign Affairs
for the Marshall Islands during our oversight hearing are now being
discussed with various Federal agencies under the auspices of Secretary
of the Interior Norton, this is an issue that will require
congressional action, given the interpretations from Federal agencies
that questioned whether Congress intended the Act to apply
extraterritorially. The act, of course, applies to individuals not
jurisdictions and the specific mention of the Pacific Test Site and
Enewetak would seem to indicate that Congress intended to include
workers at the site.
Subsequent to the hearing, I had the privilege to meet privately with
the President of the Marshall Islands when he visited Washington in
early September. We had a good meeting and at the time I offered my
assistance in ensuring that the proper agencies or groups would review
the issues they had raised. As I indicated, most of these issues are
properly now being discussed with representatives of the Marshalls
through a multi-agency dialogue headed by Secretary Norton. This issue,
however, may be one that is best handled directly through the
congressional process. Therefore, when I was asked by the Marshall's
Embassy here in Washington if I would introduce a bill to clarify
worker eligibility so that the proper congressional committees could
review it, I agreed.
Given the paperwork, record and radiation dosage requirements for
receipt of compensation, it is far from clear how many Marshallese and
Micronesian workers will actually qualify for the up to $150,000 in
compensation, plus medical benefits and lost wage compensation for
ailments caused by radiation stemming from the weapons tests. That is
an issue that I hope the congressional committees will consider
sympathetically. But it is only just that the program be opened equally
to all Department of Energy workers or subcontract workers who labored
to produce nuclear weapons to help this Nation's national defense at a
critical period of the Cold War. As an Alaskan from a State whose
workers have been compensated for injuries they gained resulting from
underground weapons testing at Amchitka Island in the Aleutian Chain
almost immediately after the ending of weapons testing in the
atmosphere over the Marshall Islands, it is impossible not to support
aid for the Marshallese.
While Congress and the administration continue to weigh additional
aid to the Republic of the Marshall Islands, passage of this measure
would be a sign of this Nation's continued commitment to aid the
islanders who in February 1946 followed the advice of Bikinian leader,
King Juda, and agreed to leave the Bikini Atoll so America could use

[[Page S13574]]

it for weapons testing saying, ``We will go believing that everything
is in the hands of God.''
I appreciate the understanding and the patience shown by the
Marshall's Government and their citizens as we proceed to review the
issues raised concerning the effects of the nuclear testing program,
and I hope the introduction of this legislation will be seen as an
example of our commitment to see that those issues receive a full and
fair review and discussion.
______

By Mr. REID (for himself, Mr. Ensign, Mr. Bennett, and Mr.
Hatch):
S. 2099. A bill to amend the Nuclear Waste Policy Act of 1982 to
require commercial nuclear utilities to transfer spent nuclear fuel
from spent nuclear fuel pools into spent nuclear fuel dry casks and
convey to the Secretary of Energy title to all spent nuclear fuel thus
safely stored; to the Committee on Environment and Public Works.
Mr. REID. Mr. President, I rise today for Senator Ensign, Senator
Bennett and myself to introduce a bill to increase the safety and
security of our Nation's nuclear power infrastructure, The Spent
Nuclear Fuel On-Site Storage Security Act of 2005.
I am convinced that the proposed Yucca Mountain nuclear waste dump
will never be built because of the myriad of scientific, safety and
technical problems in which it is mired. It simply is neither safe nor
secure, as illustrated by several significant scientific, legal, and
budgetary setbacks this past year.
Here are some of the highlights: On July 9, 2004, the DC Circuit
Court of Appeals sided with the people of Nevada in a lawsuit to stop
the proposed Yucca Mountain project. The court decided that U.S.
Environmental Protection Agency's radiation standard for the site was
not stringent enough to protect the public from the significant risks
associated with nuclear waste and failed to follow the recommendation
by the National Academy of Sciences.
On August 31, 2004, the Nuclear Regulatory Commission's Atomic Safety
and Licensing Board rejected Department of Energy's Yucca Mountain
document database, saying it had failed to make public many of the
documents that it had in its possession. The Board said, ``Given the 15
years that DOE had to gather, review, and produce its documents and the
fact that the date of production, and the incompleteness of its
privilege review, it is clear to us that DOE did not meet its
obligation, in good faith, to make all reasonable efforts to make all
documentary materials available.''
On October 4, 2004, the DOE Inspector General found that DOE has
given away more than $500,000 worth of Yucca Mountain construction
equipment in 2003. Half a million dollars is a tremendous amount of the
people's money to waste.
On November 22, 2004, the Nuclear Waste Technical Review Board said
DOE does not have a plan for safely transporting nuclear waste to the
proposed repository.
On February 7, 2005, Dr. Margaret Chu, most recently the Director of
the Office of Civilian Radioactive Waste Management, said the project
would be delayed until 2012 and that DOE's license application to the
Nuclear Regulatory Commission would not be filed until December 2005,
delayed a year. To date, the license application still has not been
filed.
On February 8, 2005, the Nuclear Waste Technical Review Board have
called for hearings to review concerns over the corrosion of the
titanium drip shields that are intended to keep water from leaking into
casks inside Yucca Mountain.
On February 28, 2005, a DOE official said the proposed Yucca Mountain
repository may not open until 2015.
On March 16, 2005, DOE revealed that documents and models about water
infiltration at Yucca Mountain, a key issue, had been falsified.
On July 18, 2005, DOE announced that it will use dedicated train
service for its rail transport of spent nuclear fuel and high-level
waste to Yucca Mountain, a shift from two decades of administration
policy that ignores the fact that about one-third of reactor sites are
not capable of shipping fuel by rail.
On August 22, 2005, EPA published its revised radiation standards for
the proposed Yucca Mountain high-level waste dump. These standards are
wholly inadequate, do not meet the law's requirements and do not
protect public health and safety.
On October 13, 2005, DOE began a series of actions to overhaul the
Yucca Mountain project. We are going back to the drawing board,
frequently revisiting proposals discarded decades ago as unsafe or
unworkable.
On October 25, 2005, DOE announced that it would be redesigning the
spent fuel storage process, both the containers and facilities.
On November 16, 2005, the DOE Inspector General announced that DOE
has ignored numerous admitted instances of falsification of technical
and scientific date on the project, showing that years of quality
assurance problems continue.
On November 17, 2005, DOE sent a detailed letter to its contractor
specifying some of the desired changes in the site proposal.
At the December 7, 2005, at the NRC-DOE quarterly meeting on Yucca
Mountain, DOE announced that it expects to re-baseline the project mid-
2006, requiring many of the technical and scientific analyses to be
redone.
On November 19, 2005, the Energy and Water Appropriations bill became
law, cutting the Yucca Mountain budget to $577 million, half of what
DOE said it would need to keep the project on track.
In numerous media reports, DOE has confirmed that it is preparing a
legislative package that addresses Yucca Mountain. Clearly, DOE cannot
meet the current public health, safety and technical requirements.
It should be clear to anyone that the proposed Yucca Mountain project
is scientifically unsound and that it cannot meet the requirements of
law. It is not going anywhere. Delay after delay costs the taxpayers
billions and billions of dollars for a project that the courts have
ruled does not meet sufficient safety or public health standards. I do
not believe that Yucca Mountain will ever open, and Nevada and the
country will be safer for our successful efforts to stop the project.
Yet, we must safely store spent nuclear fuel.
A 1979 study by the Sandia National Laboratory determined that, if
all the water were to drain from a spent fuel pool, dense-packed spent
fuel would likely heat up to the point where it would burst and then
catch fire, releasing massive quantities of volatile radioactive
fission products into the air. Both the short-term and the long-term
contamination impacts of such an event could be significantly worse
than those from Chernobyl. The consequences would be so severe and
would affect such a large area that all precautions must be taken to
preclude them. This is the type of serious, avoidable risk against
which all the Nation's nuclear sites can and should be protected to
counter terrorist threats.
It is time to look at other nuclear waste alternatives. Fortunately,
the technology to realize a viable, safe and secure alternative is
readily available and can be fully implemented within 6 years if we act
now. That technology is dry cask storage.
The technology for long-term storage of spent nuclear fuel in dry
storage casks has improved dramatically in the past 20 years. Seventeen
cask designs have. been licensed by the Nuclear Regulatory Commission,
which says that spent nuclear fuel can be safely stored using dry cask
storage on-site at the nuclear power plants for at least 100 years.
Already, dry casks safely store spent nuclear fuel at 34 sites
throughout the country, many of them near communities, water ways and
transportation routes. The Nuclear Energy Institute has projected 83 of
the 103 active reactors will have dry storage by 2050.
Compared to water-filled pools, dry storage casks are significantly
less vulnerable to natural and human-induced disasters, including
floods, tornadoes, temperature extremes, sabotage, and missile attacks.
In addition, dry storage casks are not subject to drainage risks,
whether intentional or accidental.
On March 28, 2005, the Washington Post revealed that a classified
National Academy of Sciences report concluded that the government does
not fully understand the risks a terrorist attack

[[Page S13575]]

could pose to spent nuclear fuel pools and that it ought to expedite
the removal of the fuel to dry storage casks that are more resilient to
attack.
Our bill requires commercial nuclear utilities to safely transfer
spent nuclear fuel from temporary storage in water-filled pools to
secure storage in licensed, on-site dry cask storage facilities. After
transferal, the Secretary of Energy will take title and full
responsibility for the possession, stewardship, maintenance, and
monitoring of all spent fuel thus safely stored. Finally, our bill
establishes a grant program to compensate utilities for expenses
associated with transferring the waste. The costs of transferring the
waste and providing the grants will be offset by withdrawals from the
utility-funded Nuclear Waste Fund.
Nuclear facilities currently provide 20 percent of our Nation's
electricity, but in light of the events of September 11, they also
present a security risk that we simply must address. There cannot be
any weak links in the chain of security of our Nation's nuclear power
infrastructure. There is absolutely no justification for endangering
the public by densely packing nuclear waste in vulnerable spent fuel
pools when it can be stored safely and securely in dry casks. This bill
guarantees all Americans that our Nation's nuclear waste will be stored
in the safest way possible.
I ask unanimous consent that the text of the bill printed in the
Record.
There being no objection, the bill was ordered to be printed in the
Record, as follows:

S. 2099

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 ``Spent Nuclear Fuel On-Site
Storage Security Act of 2005''.

SEC. 2. DRY CASK STORAGE OF SPENT NUCLEAR FUEL.

(a) In General.--Title I of the Nuclear Waste Policy Act of
1982 (42 U.S.C. 10121 et seq.) is amended by adding at the
end the following:

``Subtitle I--Dry Cask Storage of Spent Nuclear Fuel

``SEC. 185. DRY CASK STORAGE OF SPENT NUCLEAR FUEL.

``(a) Definitions.--In this section:
``(1) Contractor.--The term `contractor' means a person
that holds a contract under section 302(a).
``(2) Spent nuclear fuel pool.--The term `spent nuclear
fuel pool' means a water-filled container in which spent
nuclear fuel rods are stored.
``(3) Spent nuclear fuel dry cask.--The term `spent nuclear
fuel dry cask' means the container, and all the components
and systems associated with the container, in which spent
nuclear fuel is stored at a Commission-licensed independent
spent fuel storage facility located at the power reactor
site. The design of any such spent nuclear fuel dry cask
shall be approved by the Commission.
``(b) Transfer of Spent Nuclear Fuel.--
``(1) In general.--A contractor shall transfer spent
nuclear fuel from spent nuclear fuel pools to spent nuclear
fuel dry casks at a Commission-licensed independent spent
fuel storage facility located at the power reactor site.
``(2) Spent nuclear fuel stored as of date of enactment.--A
contractor shall complete the transfer of all spent nuclear
fuel that is stored in spent nuclear fuel pools as of the
date of enactment of this subsection not later than 6 years
after the date of enactment of this subsection.
``(3) Spent nuclear fuel stored after date of enactment.--A
contractor shall complete the transfer of any spent nuclear
fuel that is stored in a spent nuclear fuel pool after the
date of enactment of this subsection not later than 6 years
after the date on which the spent nuclear fuel is discharged
from the reactor.
``(4) Inadequate funds.--If funds are not available to
complete a transfer under paragraph (2) or (3), the
contractor may apply to the Commission to extend the deadline
for the transfer to be completed.
``(c) Funding.--The Secretary shall make grants to
compensate a contractor for expenses incurred in carrying out
subsection (b), including costs associated with--
``(1) licensing and construction of an independent spent
fuel storage facility located at the power reactor site;
``(2) construction and delivery of spent nuclear fuel dry
casks;
``(3) transfers of spent nuclear fuel;
``(4) documentation relating to the transfers;
``(5) security; and
``(6) hardening.
``(d) Conveyance of Title.--
``(1) Determination.--Not later than 30 days after the
transfer of spent nuclear fuel from a spent nuclear fuel pool
to a spent nuclear fuel dry cask, the Commission shall
determine whether the contractor carried out the transfer in
full compliance with regulations promulgated by the
Commission.
``(2) Noncompliance.--If the Commission determines that any
technical standard or compliance provision under the
regulations was not complied with, the Commission shall--
``(A) notify the contractor; and
``(B) take such actions as are necessary to obtain full
compliance.
``(3) Certification and conveyance of title.--When the
Commission determines that the contractor has fully complied
with the regulations--
``(A) the Commission shall certify that safe transfer has
been accomplished; and
``(B) the Secretary shall accept the conveyance of title to
the spent nuclear fuel dry cask (including the contents of
the cask) from the contractor.
``(4) Responsibility.--A conveyance of title under
paragraph (3)(B) shall confer on the Secretary full
responsibility (including financial responsibility) for the
possession, stewardship, maintenance, and monitoring of all
spent nuclear fuel transferred to the Secretary.''.
(b) Funding.--Section 302(d) of the Nuclear Waste Policy
Act of 1982 (42 U.S.C. 10222(d)) is amended--
(1) in paragraph (5), by striking ``and'' at the end;
(2) in paragraph (6), by striking the period at the end and
inserting ``; and''; and
(3) by adding at the end the following:
``(7) the provision of grants under section 185(d).''.

SEC. 3. IMMEDIATE CONVEYANCE OF TITLE TO SPENT NUCLEAR FUEL
PREVIOUSLY CERTIFIED TO BE IN COMPLIANCE.

Not later than 30 days after the date of enactment of this
Act, the Secretary of Energy shall accept the conveyance of
title to all spent nuclear fuel with respect to which, before
the date of enactment of this Act, the Nuclear Regulatory
Commission has certified that a contractor under section 302
of the Nuclear Waste Policy Act of 1982 (42 U.S.C. 10222) has
completed transfer to spent nuclear fuel dry casks in
compliance with applicable regulations in effect as of the
date of transfer.
______

By Mr. SMITH (for himself and Mr. Kerry):
S. 2100. A bill to amend the Internal Revenue Code of 1986 to improve
the deduction for depreciation; to the Committee on Finance.
Mr. SMITH. Mr. President, our economy has changed dramatically in
recent years as a result of the development of new technologies and
industries. However, we have not updated our tax depreciation system to
reflect these advancements. In fact, the recovery periods used to
calculate depreciation allowances have not been adjusted since 1986--
and in some cases not since 1962. For example, a personal computer has
a depreciable life of 5 years even though its economic life is only 2
to 3 years.
Today, I am introducing legislation that will respond to these
changes by modernizing and simplifying the tax depreciation rules.
Senator Kerry has joined me in introducing the Tax Depreciation,
Modernization and Simplification Act of 2005, which will encourage
capital investment and make it easier for companies to comply with the
tax law.
This legislation will allow the Treasury Department, in consultation
with Congress, to modify and create new class lives for capital assets.
Any new classification created by the Treasury Department must reflect
the anticipated useful life and decline in value over time of the
asset. In addition, it should take into account when the asset is
technologically or functionally obsolete for its original purpose. With
this new regulatory authority, Treasury will be able to develop class
lives that are more in line with assets' economic lives.
Another provision in this legislation deals with the mid-quarter
convention. The mid-quarter convention is one of the placed-in-service
conventions that directs when depreciation for an asset begins or ends.
The mid-quarter convention, however, creates significant complexity.
Taxpayers must wait until after the tax year ends to determine whether
to use the half-year or mid-quarter convention. Therefore, consistent
with a Joint Committee on Taxation recommendation, the bill eliminates
the mid-quarter convention for simplification purposes.
Small businesses are the heart of our economy. We, in Congress,
should do everything we can to ease the administrative burdens for
small businesses. That is why we should make small business expensing
permanent. These rules permit small businesses to expense immediately
up to $100,000 of the cost of property each year. This proposal will
maintain this important simplification which is set to expire at the
end of 2007.

[[Page S13576]]

Finally, this legislation will allow for mass asset accounting.
Currently, companies must generally calculate depreciation on an item-
by-item basis. For example, if a company has 200 desks or 200
computers, they must account for and depreciate each item separately.
This can be a challenge and an administrative burden for companies--
especially with small items, like chairs and telephones. Therefore, the
bill will permit all companies to elect to use mass asset accounting
for property that costs less than $10,000.
The bipartisan Tax Depreciation, Modernization and Simplification Act
of 2005 will make much needed changes to the tax depreciation system. I
look forward to working with my colleagues to enact these important
reforms and 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. 2100

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 ``Tax Depreciation,
Modernization, and Simplification Act of 2005''.

SEC. 2. AUTHORITY TO MODIFY CLASS LIVES.

(a) In General.--Paragraph (1) of section 168(i) of the
Internal Revenue Code of 1986 is amended to read as follows:
``(1) Class life.--
``(A) In general.--Except as provided in this section, the
term `class life' means the class life (if any) which would
be applicable with respect to any property as of January 1,
1986, under subsection (m) of section 167, as in effect on
the day before the date of the enactment of the Revenue
Reconciliation Act of 1990 (determined without regard to
paragraph (4) thereof and as if the taxpayer had made an
election under such subsection).
``(B) Secretarial authority.--
``(i) In general.--Except as provided in clause (ii), the
Secretary, after consultation with Congress, may prescribe by
regulation--

``(I) a new class life for any property, or
``(II) a class life for any property which does not have a
class life within the meaning of subparagraph (A).

``(ii) Exceptions.--Clause (i) shall not apply to--

``(I) residential rental property or nonresidential real
property, or
``(II) property for which a class life, classification, or
recovery period is assigned under subsection (e)(3) (other
than subparagraph (C)(v) thereof) or subparagraph (B), (C),
or (D) of subsection (g)(3).

``(iii) Standards.--Any class life prescribed or modified
under clause (i) shall reasonably reflect the anticipated
useful life and the anticipated decline in value over time of
the property to the industry or other group, and shall take
into account when the property is technologically or
functionally obsolete for the original purpose under which it
was acquired.
``(iv) Consultation.--Not later than 60 days before the
date on which the Secretary publishes any proposed regulation
under clause (i), the Secretary shall submit to Congress the
proposed regulation together with a report containing the
information considered by the Secretary in modifying or
prescribing any class life under the regulation.
``(v) Monitoring.--The Secretary, through an office
established in the Treasury, shall monitor and analyze actual
experience with respect to depreciable assets to which this
subparagraph applies.
``(C) Effect of modification.--Any class life with respect
to any property prescribed or modified under subparagraph (B)
shall be used in classifying such property under subsection
(e) and in applying subsection (g).''.
(b) Application of Congressional Review Act.--For purposes
of applying chapter 8 of title 5, United States Code, to any
regulation prescribed under section 168(i)(1)(B) of the
Internal Revenue Code of 1986, each class life prescribed
under such section shall be considered to be a separate rule.
(c) Effective Date.--The amendment made by this section
shall take effect on the date of the enactment of this Act.

SEC. 3. ELIMINATION OF MID-QUARTER CONVENTION.

(a) In General.--Subsection (d) of section 168 of the
Internal Revenue Code of 1986 is amended--
(1) by striking paragraph (3) and redesignating paragraph
(4) as paragraph (3), and
(2) in paragraph (3), as redesignated by paragraph (1), by
striking subparagraph (C).
(b) Effective Date.--The amendments made by this section
shall apply to property placed in service after the date of
the enactment of this Act.

SEC. 4. MASS ASSET ACCOUNTING.

(a) In General.--Section 168 of the Internal Revenue Code
of 1986 is amended by adding at the end the following new
subsection:
``(l) Mass Asset Accounting.--
``(1) Election.--
``(A) In general.--In lieu of the deduction otherwise
allowed under this section with respect to an item of
qualified property, the taxpayer may elect to add the
adjusted basis of such property to the mass asset account of
the taxpayer to which such qualified property is assigned and
to determine the deduction under this section using the
applicable depreciation method with respect to such mass
asset account.
``(B) Election to apply to all assets of the taxpayer with
same recovery period.--An election made under subparagraph
(A) shall be made in such manner as the Secretary may by
regulations prescribe and shall apply to all qualified
property of the taxpayer which has the same applicable
recovery period for such taxable year and all subsequent
taxable years.
``(C) Election irrevocable.--Any election made under this
paragraph shall be irrevocable except with the consent of the
Secretary. The Secretary shall prescribe rules for the proper
accounting of assets in a mass asset account in the case of
any such revocation.
``(2) Special rules.--
``(A) Modification of depreciation method.--In applying the
applicable depreciation method to any mass asset account,
subsection (b) shall be applied without regard to paragraph
(1)(B) thereof.
``(B) Adjustment to reflect half-year convention.--In
applying the deduction allowable under subsection (a) to any
mass asset account, the amount of the deduction under
subsection (a) shall be--
``(i) 100 percent of the deduction otherwise allowed under
this section in the case of qualified property placed in
service before the beginning of the taxable year, and
``(ii) 50 percent of the deduction otherwise allowed under
this section with respect to qualified property placed in
service during the taxable year.
``(C) Sale of qualified property.--
``(i) In general.--In the case of the sale of any property
the adjusted basis of which has been added to a mass asset
account, the balance of the mass asset account to which such
property was assigned shall be reduced (but not below zero)
by the amount of the proceeds from such sale.
``(ii) Recognition of gain.--If the proceeds from the sale
of any property the adjusted basis of which has been added to
a mass asset account exceed the balance of such mass asset
account, then the excess shall be treated as ordinary income.
``(3) Qualified property.--
``(A) In general.--For purposes of this subsection, the
term `qualified property' means any tangible property--
``(i) to which an applicable depreciation method under
paragraph (1) or (2) of subsection (b) applies, and
``(ii) the cost of which is not more than $10,000.
``(B) Inflation adjustment.--
``(i) In general.--In the case of any taxable year
beginning after 2006, the $10,000 amount under subparagraph
(A)(ii) shall be increased by an amount equal to--

``(I) such dollar amount, multiplied by
``(II) the cost-of-living adjustment determined under
section 1(f)(3) for the calendar year in which the taxable
year begins, determined by substituting `calendar year 2005'
for `calendar year 1992' in subparagraph (B) thereof.

``(ii) Rounding.--If any amount as adjusted under the
clause (i) is not a multiple of $1,000, such amount shall be
rounded to the next lowest multiple of $1,000.
``(4) Mass asset account.--The term `mass asset account'
means an account of the taxpayer which reflects the adjusted
basis of all qualified property to which the same applicable
depreciation method and applicable recovery period
applies.''.
(b) Effective Date.--The amendments made by this section
shall apply to property placed in service after the date of
the enactment of this Act.

SEC. 5. PERMANENT EXTENSION OF EXPENSING FOR SMALL
BUSINESSES.

(a) Dollar Limitation.--Paragraph (1) of section 179(b) of
the Internal Revenue Code of 1986 is amended by striking
``$25,000 ($100,000 in the case of taxable years beginning
after 2002 and before 2008)'' and inserting ``$100,000''.
(b) Reduction in Limitation.--Paragraph (2) of section
179(b) of such Code is amended by striking ``$200,000
($400,000 in the case of taxable years beginning after 2002
and before 2008)'' and inserting ``$400,000''.
(c) Inflation Adjustments.--Subparagraph (A) of section
179(b)(5) of such Code is amended by striking ``and before
2008''.
(d) Election.--Paragraph (2) of section 179(c) of such Code
is amended by striking ``and before 2008''.
(e) Computer Software.--Clause (ii) of section 179(d)(1)(A)
is amended by striking ``and before 2008''.
Mr. KERRY. Mr. President, today Senator Smith and I are introducing
the Tax Depreciation, Modernization, and Simplification Act of 2005.
Last July, the Senate Finance Subcommittee on Long-Term Growth and Debt
Reduction, on which Senator Smith is chairman and I am ranking member,
held a hearing on updating our depreciation system. During the hearing,
we heard that the current depreciation system is out of date and that
changes should be made.
Our tax system allows, as a current expense, a depreciation deduction
that represents a reasonable allowance for the exhaustion, wear and
tear of property used, or of property held for the production of
income. Since 1981, the

[[Page S13577]]

depreciation deduction for most tangible property has been under rules
specified in section 168 of the Internal Revenue Code. The Modified
Accelerated Cost Recovery System, or MACRS, specified under section 168
applies to most new investment in tangible property. MACRS depreciation
allowances are computed by determining a recovery period called a class
life and an applicable recovery method for each asset.
The current depreciation system has not kept pace with technological
advances. Several industries were not even contemplated when class
lives were assigned in 1981, and some class lives even date back to
1962.
In the 1980s it would have been difficult to imagine what our
reliance on computer and wireless technology would be today. At that
time, for example, the wireless industry was in its infancy, and there
was no specifically assigned life for wireless equipment. As a result,
today's depreciation system is like playing ``audit roulette.'' There
is no certainty in how these assets should be depreciated.
All this matters because it impacts investment, innovation,
competitiveness, and ultimately the quality and quantity of jobs in
America. My home State of Massachusetts is a leader in the high tech
industry. Massachusetts employs hundreds of thousands of skilled
workers in key technology sectors, including computer hardware, life
sciences, software, medical products, semiconductor, defense technology
and telecommunications. We have learned in Massachusetts that a
strategic tax policy can have a positive effect on economic
competitiveness.
For these reasons, we are introducing the Tax Depreciation,
Modernization, and Simplification Act of 2005. This legislation makes
four important changes to the current depreciation system.
First, the legislation creates a process that provides the Department
of Treasury with the authority to modernize class lives. The Secretary
of the Treasury will prescribe regulations to provide a new class life
for certain eligible property. Eligible property does not include
residential rental property, nonresidential real property, or property
for which Congress has specifically legislated the recovery period.
The purpose of this provision is to provide Treasury with a mechanism
to modify class lives that reasonably reflect the anticipated useful
life and the anticipated decline in value over time of the property to
the industry and take into account when the property becomes
technologically or functionally obsolete to perform its original
purpose. Treasury will also have the authority to modify class lives in
order to more accurately reflect economic depreciation. For example, a
personal computer has a depreciable life of 5 years, but it has an
economic life of only 2 to 3 years. Even though a computer can be used
for 5 years, it becomes economically obsolete after a couple of years
because of the newer, faster, and more advanced computers on the
market.
Our depreciation system has not been adequately updated since
Congress revoked Treasury's rule making authority in 1988. When the
MACRS system was enacted in 1986, Congress directed Treasury to
establish an office to monitor and analyze the actual experience with
class lives and to modify class lives if the new class life reasonably
reflected the anticipated useful life and the anticipated decline in
value over time of the property to the industry. The authority was then
revoked because Congress did not agree with all of the decisions made
by Treasury.
The authority provided in this legislation addresses this previous
problem by requiring Treasury to consult with Congress 60 days prior to
publishing any proposed regulations. In addition, the Congressional
Review Act would apply to any regulation proposed by Treasury and each
class life prescribed by Treasury would be considered a separate rule.
Providing Treasury with the authority to modify class lives would
allow the process to move more efficiently than allowing Congress to
make piecemeal changes to the current depreciation system. Congress
would provide guidelines, and Treasury would have the role of
administering the guidelines. Under the legislation, Treasury would
monitor and analyze the actual experience of depreciable assets and
report their findings to Congress. We expect Treasury to establish
guidelines that will take into consideration the fact that some assets
lose a significant percentage of their original value in the early part
of their lives. This legislation specifically provides consultation
with Congress in order for Congress to continue to have a role in this
important tax policy issue.
We do not expect Treasury within the first year or two to review all
classes of assets. Rather, we expect Treasury to begin with new assets
that do not fit into the system, assets that have underdone
technological advances, and existing assets that do not really fit into
the current system. For example, the current system creates an
irrational result for fiber optic lines. The class life of a fiber
optic line depends upon whether if it is used for one-way or two-way
communications.
Second, the legislation would eliminate the mid quarter convention.
The placed-in-service conventions determine the point in time during
the year that the property is considered ``placed in service'' and this
determines when depreciation for an asset begins or ends. Under current
law, there are the half-year, mid month, and mid quarter conventions.
The mid quarter convention is a source of complexity because it
requires an analysis of the depreciable basis of property placed in
service during the last 3 months of any taxable year. The Joint
Committee on Taxation recommended the elimination of the mid-quarter
convention in its 2001 recommendations on simplifying the Federal tax
system. The calculation of the mid-quarter convention is burdensome,
and it requires taxpayers to wait until after the end of the taxable
year to determine whether the proper placed-in-service convention was
used to calculate depreciation for assets during the taxable year.
Third, the legislation would allow taxpayers to elect to use mass
asset accounting for assets with a cost of less than $10,000.
Generally, taxpayers calculate depreciation on an item-by-item basis.
The bill would allow taxpayers to elect to use mass asset accounting
for all assets with the same recovery period. This provision will help
simplify the recordkeeping associated with depreciation.
Fourth, the legislation would permanently extend increased expensing
for small businesses. In lieu of depreciation, a taxpayer with a small
amount of annual investment may elect to deduct such costs. The Jobs
and Growth Tax Relief Reconciliation Act of 2003 increased the amount a
taxpayer may deduct from $25,000 to $100,000 and increased the total
amount of investment a business can make in a year and still qualify
for expensing from $200,000 to $400,000. In addition, the Act allows
off-the-shelf computer software to be eligible for the provision. These
changes originally were effective for 3 years. The American Jobs
Creation Act of 2004 provided an additional 2 year extension of this
provision through 2007.
The Tax Depreciation, Modernization, and Simplification Act of 2005
would make the $100,000 and $400,000 amounts permanent and index them
for inflation. Off-the-shelf computer software would be eligible for
the provision. Increased expensing for small businesses helps lower the
cost of capital for small businesses and eliminates complicated
recordkeeping. In addition, it should reduce administrative costs for
small businesses.
The provisions in this legislation will not be the only
recommendations made on how to improve our current depreciation system,
but the four components of this legislation will result in updating and
simplifying the current depreciation system. The Tax Depreciation,
Modernization, and Simplification Act of 2005 will provide certainty
for taxpayers and put an end to ``audit roulette.''
______

By Mr. REID (for Mr. Lieberman (for himself, Mr. Cochran, Mr.
Carper, and Mrs. Hutchison)):
S. 2104. A bill to amend the Public Health Service Act to establish
the American Center for Cures to accelerate the development of public
and private research efforts towards tools and therapies for human
diseases with the goal of early disease detection, prevention, and
cure, and for other purposes; to the Committee on Health, Education,
Labor, and Pensions.

[[Page S13578]]

(At the request of Mr. Reid, the following statement was ordered to
be printed in the Record.)
Mr. LIEBERMAN. Mr. President, today, Senator Cochran, Senator Carper,
Senator Hutchison, and I are introducing the American Center for CURES
Act of 2005, which would establish the American Center for Cures,
within the National Institutes of Health (NIH). The purpose of the
Center would be to bring promising and novel diagnostics, therapies,
drugs, and tools to treat disease faster to the public.
We continue to face significant health challenges. In the US today,
chronic diseases account for 7 out of 10 deaths, with the major killers
being heart attack, cancer and stroke. Seventy percent of the $1.7
trillion dollars we spend on healthcare each year goes to chronic
disease care. Around the world, HIV, tuberculosis, and malaria kill 4,
3, and 2 million people a year. On the horizon are emerging manmade and
natural threats such as SARS, flu and bioterrorism. There are other
diseases that we need better treatments and cures for, but that we do
not devote enough attention to. Diseases of social stigma, such as
depression, which is the most frequent reason people visit their
physician, and seizure disorder, which is the primary neurological
disorder in children, are often neglected. We have bacteria growing and
spreading in our hospitals that do not respond to our antibiotic
supply. These are the health challenges facing us in the 21st century.
Fortunately, the United States has no equal in the biomedical
sciences. This is due in large part to our nation's premier biomedical
research investment the--NIH, which receives $28 billion per year after
a doubling of their budget of $14 billion from 1998 to 2003. The NIH is
comprised of 27 major institutes and centers, leading the way for the
world in cancer, cardiovascular, infectious disease and allergy
advancements for health promotion and relief from the burdens of
disease. US biomedical advances are also due to our dynamic
biotechnology and pharmaceutical sectors.
In our search for answers to our pressing health problems, the NIH
has grown in the number of Institutes and Centers and in funding. At
the same time, Congress and others have wanted to ensure that we are
building on NIH's strengths to respond to complex health problems
requiring interdisciplinary and collaborative work. Therefore, Congress
commissioned the 2003 National Academy of Sciences report, ``Enhancing
the Vitality of the National Institutes of Health: Organizational
Change to Meet New Challenges'', that examined whether and how we could
optimize the NIH's organizational structure to meet our next set of
health challenges.
The report stated that ``no organization as important as NIH should
remain frozen in organization space''. At the same time, the report
cautioned that any changes in organizational structure to achieve
greater progress in chronic and emerging diseases were not without some
difficulty and risk. The NAS report made a number of recommendations
and our CURES legislation addresses the six major points.
First, CURES seeks to strengthen the clinical research process by
streamlining the clinical trials process by creating Centralized
Internal Review Boards (CIRB). CIRB's would focus on simplifying the
human subjects review processes for multi-institutional clinical
trials. CURES also significantly augments current NIH investments to
train the clinical research workforce of the future, and provides
additional funding for multidisciplinary teams of researchers examining
issues of quality and design of clinical trials. We need to continue to
bring safe and effective diagnostics and therapeutics, but more
efficiently.
Secondly, our proposal enhances and increases trans-NIH strategic
planning and funding. Currently, the NIH's 27 Centers and Institutes
each have their own directors and budgets and thus, operate
independently. The resulting structural and organizational stovepipes
are limited in their ability to capitalize on the NIH's collective
research capacity to address complex problems using the expertise of
multiple fields. For example, the problem of diabetic retinopathy could
be tackled by researchers in the Institutes of the Eye, Diabetes,
Digestive and Kidney disease, Biomedical Imaging and Bioengineering,
and Allergy Immunology and Infectious disease. However, there are few
mechanisms for such trans-Institute initiatives that could lead to a
cure or treatment. To address this problem, CURES has created multiple
funding mechanisms for trans-Institute research and cross-fertilization
of ideas. Strategic planning and prioritizing disease research is also
integral to achieving progress more quickly. Therefore, the American
Center for CURES Act would establish a CURES council, comprised of key
health stakeholders to produce a translational research agenda for the
Center based on research breakthroughs and areas of health need.
Thirdly, the American Center for CURES Act of 2005 strengthens the
Office of the NIH Director. Our legislation emphasizes the need for
greater budgetary support and flexibility in the area of translational
research. This follows much of the NIH Director's current efforts with
the NIH Roadmap. Our legislation further supports the spirit of the NIH
Roadmap with organizational and funding commitments that bring
translational research investment to a necessary and appropriate scale,
which has not been the case to date. The NIH Director, with the CURES
Advisory Council, would play a key role in these efforts by
recommending appointees for the Director of the American Center for
CURES to the President. The NIH Director will also be a co-chair of the
Center's Council and have a leading role in setting the research and
funding priorities for translational research projects at the NIH. The
NIH Director will also head other initiatives outlined in the
legislation, such as launching a publicly accessible electronic
database for all published NIH funded research.
Fourth, our legislation creates a Director's Special Projects
Program, called the Health Advanced Research Projects Agency (HARPA).
The NAS committee recommended the creation of a program to support
high-risk, high-potential payoff research. The Department of Defense
has had significant success with its Defense Advanced Research Program
Agency (DARPA), where a group of expert portfolio managers invest in
and oversee innovative, multidisciplinary, collaborative projects to
advance specific fields or to develop needed technologies. DARPA has
lead to the creation of stealth technology, satellite surveillance,
lasers, internet, and e-mail. Based on this model, HARPA would be
housed within the Center and would help lead breakthrough advances
using a translational ``challenge model'' in biomedical research.
Breakthroughs could include a vaccine or other treatment against HIV or
genetic probes pivotal to the elucidation of disease producing genes.
HARPA would also be the key funding mechanism for trans-Institute
research to prioritize and foster collaborative and trans-Institute
research initiatives.

Fifth, the NAS report recommended that the NIH intramural research
program be more unique, innovative, and risk-taking. In response, CURES
creates an Office of Intramural Risk Mapping, within the Office of
Technology Transfer, which will oversee NIH's intramural research
programs to help assure they are complementary to extramural and
private sector research. The Office will also ensure that intramural
research is also innovative and risk-taking to produce more novel and
promising biomedical breakthroughs. The office will also make funds
available to trans-Institute and center initiatives that focus on
health risk analysis and corresponding scientific risk opportunity.
Sixth, our legislation addresses the NAS report recommendation to
standardize data and information management systems. The report was
clear that the NIH must increase its capacity for data gathering and
reporting to meet its obligations ``. . . for effective management,
accountability, and transparency.'' Cures seek to improve the sharing
of information by providing funding to the National Library of Medicine
to create and maintain a publicly accessible database of all
publications resulting from NIH-funded research and by establishing a
national electronic registry and results database to increase
enrollment in public and private clinical trials and to share

[[Page S13579]]

efficacy and safety outcomes emanating from NIH-funded clinical
research endeavors. Cures focuses on the need to expand the NLM
facilities according to the demands of new scientific discoveries and
fields, especially within the areas of genomics and proteinomics.
In addition to the NAS report recommendations, other changes in the
biomedical research landscape demand more targeted investments in
promising and novel treatments. Our current response to research on
important health problems is arguably dichotomous. We invest public
money into the NIH or we hope the private market will produce essential
drugs and tools. However, there needs to be greater collaboration
between the private and public sectors. Private sector investment in
biomedical research has grown to approximately $46 billion per year--
far more than our public sector investment in NIH. For new and
effective therapies to become available, we need to build better public
and private partnerships. Cures includes key provisions to accomplish
this. Cures promotes the innovative efforts of small to medium sized
biotechnology and bioengineering firms who require additional support
in key traditionally under-funded stages of product development--the so
called R&D ``Valley of Death.'' It expands the NIH's current small
business support and rapid access to interventional development
programs to move basic science through the product development pipeline
faster. These programs would facilitate NIH partnerships with private
industry in the preclinical stage of the R&D process so as to formulate
a plan for health research translation and commercialization from the
outset. Additionally, our legislation would move the NIH's Office of
Technology Transfer into the American Center for Cures, where it would
survey research being conducted in the private and public sectors to
avoid duplication, target promising research investments, and broker
more flexible and productive agreements for licensing and patents
between the public and private sectors. The HARPA entity within the
center is also designed to promote public-private joint R&D efforts.
Today, we are proposing the establishment of the American Center for
Cures, whose mission would be to promote more rapid translation of
public and private research into therapies, diagnostics and tools,
which can effectively treat and possibly cure diseases of critical
importance to domestic and global health. With more targeted investment
in translating our basic science research into diagnostics and
therapeutics, we hope to bring more tangible health benefits to
Americans and people all over the world.
I ask unanimous consent that explanatory materials on the legislation
including, ``Short Summary of the American Center for CURES Act of
2005,'' ``Explanation of How the American Center for CURES Act of 2005
Addresses the Findings of the 2003 National Academy of Sciences Report:
`Enhancing the Vitality of the National Institutes of Health:
Organizational Change to Meet New Challenges','' ``Section by Section
Summary of the American Center for CURES Act of 2005,'' the full text
of the legislation, and ``Quotes in Support of the American Center for
CURES Act of 2005'' be printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:

A Short Summary of the American Center for CURES Act of 2005

A bill to facilitate more rapid development of novel
diagnostics, therapies, and cures
From 1998-2003, Congress doubled funding to the world's
leader in biomedical research, the National Institutes of
Health (NIH), to $28 billion per year. In order to meet 21st
century health challenges and optimize the use of this public
investment, Senators Lieberman and Cochran have introduced
legislation to increase the capacity of the NIH to produce
effective treatments, diagnostics and cures for our nation's
most burdensome diseases using a novel approach to publicly
funded research.
Cures will do the following:
Create an American Center for Cures (ACC) in the NIH to
orchestrate focused research and development of solutions to
pressing ailments. The ACC, led by a Center Director, will
identify and promote translational research, which involves
developing basic science research for application purposes,
in the public and private sectors. The ACC will fund
innovative and collaborative research, breakdown bottlenecks
in clinical research, and facilitate information exchange.
Establish an advisory council comprised of key health
experts and stakeholders to advise the ACC on national
medical needs and novel developments in all sectors. To use
public funds effectively, a centralized mechanism to track
research on health threats is necessary. A Council will
inform the ACC on biomedical needs, technical feasibility
issues, and current research breakthroughs.
Create a Health Advanced Projects Agency for research
promotion. A research projects agency will promote strategic
risk-taking and follow a ``challenge model'' to support
innovative multidisciplinary research between NIH Institutes,
other federal agencies, grantees and business partners, for
projects with the potential for significant health impact.
Funding for projects will be flexible and outcomes based.
Promote the innovative efforts of small to medium sized
biotechnology and bioengineering firms. The ACC will support
firms requiring assistance in key traditionally underfunded
stages of research and development, the R&D ``Valley of
Death''. Funding will be available to assist companies with
promising and novel therapeutics and diagnostics in both
preclinical and clinical stages.
Strengthen the clinical research process. Clinical trials
are essential to ensuring the safety and efficacy of new
products. The ACC will streamline clinical trial protocols to
supply the public with new treatments in a timelier, more
efficient, and more economical way. It will augment NIH
training funds to create a clinical research workforce of the
future. It will establish a clinical trial registry and
results database to promote information sharing and to avoid
duplicative efforts.
Facilitate complete and efficient transfer of intellectual
property from development at the molecular level to clinical
trials and into production. Active participation of the
commercial sector in development is critical. An Office of
Technology Transfer in the ACC will catalog and disseminate
the NIH translational research portfolio and oversee NIH
intellectual property licensing.
____

Explanation of How the American Center for CURES Act of 2005 Addresses
the Findings of the 2003 National Academy of Sciences Report:
``Enhancing the Vitality of the National Institutes of Health:
Organizational Change to Meet New Challenges''

Background

The health challenges facing the U.S. and the world today
are a mix of infectious diseases, such as HIV, tuberculosis
and malaria, long-standing chronic such as diabetes and
cancer, and new emerging threats, such as SARS and avian
influenza. In the context of these growing concerns, Congress
commissioned the National Academy of Sciences (NAS) in 2001
to report on ``whether the current structure and organization
of NIH are optimally configured for the scientific needs of
the 21st century.'' Indeed, NIH is America's premier public
research investment and between 1998 and 2003, the NIH budget
of $14 billion dollars doubled to $28 billion. By
commissioning the NAS report, Congress asked how it might
optimize its burgeoning research investment. Congress
solidified its support for the NIH but simultaneously posed
questions of NIH can best address domestic and global health
needs:
Are the 27 NIH Institutes and Centers able to coordinate
their research goals and priorities to reflect the
multidisciplinary nature of today's health problems?
How is the NIH producing and sharing biomedical knowledge
from multiple disciplines to spur the development of clinical
tools, drugs, and other therapies to battle longstanding and
emerging diseases?
Can the NIH respond effectively to acute health threats,
such as to burgeoning HIV infection rates and the threat of a
bioterrorism attack?
Is the NIH cultivating the next generation of researchers
to build upon the great works of NIH past?
The end result was the 2003 NAS and Institute of Medicine
(IOM) report, ``Enhancing the Vitality of the National
Institutes of Health: Organizational Change to Meet New
Challenges''. The report reinforced NIH successes over the
last 50 years as the national and global leader in biomedical
research. NIH accomplished this by developing a cutting edge
internal research infrastructure and a democratic extramural
grant program that almost single-handedly supports
University-based research in the biological sciences.
However, the report also cautioned that ``no organization as
important as NIH should remain frozen in organizational
space'' and any changes in organizational structure to
achieve greater progress in chronic and emerging diseases,
however essential, would face difficulty and risk.

NAS Report Findings

The NAS report made a total of 14 recommendations. In the
final analysis, the NAS report recommended maintaining the
general structure of NIH to ensure NIH's strengths would be
protected: conducting essential basic science, and disease,
behavioral, organ, and system based research in its
intramural program and funding peer-reviewed grants to
University researches in its extramural program. However, the
report also recognized the need for organizational changes
which could help institutes work across their respective
stovepipes, foster a culture of risk-taking and innovation,
and

[[Page S13580]]

give the NIH director, other leadership, and the public the
power to prioritize NIH research to solve the Nation's most
burdensome health problems. Collectively, these changes would
enhance the capacity of the NIH to not only pursue
fundamental knowledge about the nature and behavior of living
systems, but to apply that knowledge to extend healthy life
and reduce the burdens of illness and disability. This is
NIH's mission.

CURES Addresses the Six Key Recommendations of the NAS Report

1. Strengthen Clinical Research: The NAS report recommended
that the NIH ``pursue a new organizational strategy to better
integrate leadership, funding, and management of its clinical
research enterprise''. Senators Lieberman, Cochran, Carper,
and Hutchison are introducing a proposal that creates the
American Center for Cures (ACC), headed by a Cures Director.
One of the new Director's key charges will be to promote and
simplify the clinical research endeavor. The Director will
establish a national electronic registry and results database
for clinical trials in order to increase enrollment of
research subjects and improve sharing efficacy and safety
outcomes emanating from the clinical research endeavor. The
Director will fund multidisciplinary clinical research teams
in the academic and private sector, create Centralized
Internal Review Boards (CIRB) to simplify the human subjects
review processes for multi-institutional clinical trials, and
augment NIH investments in training the clinical research
workforce of the future.
2. Enhance and Increase Trans-NIH Strategic Planning and
Funding: The 27 NIH Centers and Institutes with their own
directors and budgets generally operate independently. The
resulting structural and organizational stovepipes are
limited in their ability to capitalize on the NIH's
collective research capacity to address complex problems from
different fields. For example, the problem of diabetic
retinopathy could be tackled by researchers in the Institutes
of the Eye, Diabetes, Digestive and Kidney disease,
Biomedical Imaging and Bioengineering, and Allergy Immunology
and Infectious disease. To address this problem, Cures funds
innovative multidisciplinary collaborative research across
NIH institutes and centers. NIH Institute and Center
Directors on the Cures Council will be entrusted to
coordinate the intramural research agenda with that of the
ACC.
3. Strengthen the Office of the NIH Director: The NAS
report emphasizes the need for the NIH Director to have more
budgetary support and flexibility. Dr. Zerhouni's office has
taken these steps with the NIH Roadmap. The Cures legislation
further supports the spirit of the NIH Roadmap with
organizational and funding commitments that bring the
translational research investment to necessary and
appropriate scale. The NIH Director and the Cures Advisory
Council will recommend appointees for the Cures Director to
the President. The NIH Director will be a co-chair of the ACC
Council that will set the research and funding priorities for
translational research projects at the NIH. The NIH Director
will head efforts to establish a publicly accessible
electronic database for all published NIH funded research,
among other initiatives.
4. Create a Director's Special Projects Program: The NAS
committee recommended the creation of a program to support
high-risk, high-potential payoff research. The Department of
Defense has had significant success with its Defense Advanced
Research Program Agency (DARPA), where a group of expert
portfolio managers invest in and oversee innovative,
multidisciplinary, collaborative projects to advance specific
fields or to develop needed technologies. DARPA has lead to
the creation of the stealth technology, satellite
surveillance, lasers, internet, and email. A Health Advanced
Research Program Agency (HARPA) will be established within
the ACC to help lead breakthrough advances, using a
translational ``challenge'' model in biomedical research,
such as a vaccine against HIV or genetic probes pivotal to
the elucidation of disease producing genes.
5. Promote Innovation and Risk-Taking in Intramural
Research: The NAS report recommended that the NIH intramural
research portfolio be distinct from that of the extramural
program and private sector. Cures creates an Office of
Intramural Risk Mapping which will oversee the intramural
research programs of the NIH to be certain they are
complementary to extramural and private programs. The office
will make funds available to groups of institutes and centers
to promote engagement in multi-institute projects that focus
on health risk analysis and corresponding scientific risk
opportunity.
6. Standardize Data and Information Management Systems: The
NAS committee recommended that the NIH must increase its
capacity for data gathering and reporting to meet its
obligations ``. . . for effective management, accountability,
and transparency''. Cures seeks to improve the sharing of
information by providing funding to the National Library of
Medicine to create and maintain a publicly accessible
database of all publications resulting from NIH-funded
research and by establishing a national electronic registry
and results database to increase enrollment in public and
private clinical trials and to share efficacy and safety
outcomes emanating from the clinical research endeavor. Cures
focuses on the need to grow the NLM facilities according to
the demands of new scientific discoveries and fields,
especially within the areas of genomics and proteinomics.

CURES Build on the NIH Roadmap

In response to the NAS report, NIH Director Dr. Elias
Zerhouni launched the NIH Roadmap in FY 2004 with $128
million in funding from existing NIH budget allocations.
Funding increases every year until FY 2009 and tops out at
$507 million. The NIH Roadmap consists of:
New Pathways to Discovery to obtain a deeper understanding
of biological systems based on new models.
Research Teams of the Future to facilitate collaboration
across institutes by awarding grants to support institutional
partnerships and cutting-edge research.
Re-engineering the Clinical Research Enterprise reforms the
clinical trial process to allow for broader participation
from community-level patients and providers.
While the NIH roadmap addresses some of the concerns of the
NAS report, it does not address key provisions including
increasing the power of the NIH Director, establishing an
advanced research projects agency, and establishing a new
leadership that can facilitate the research essential to
moving products faster from bench to bedside. Unlike CURES,
the roadmap relies on traditional academic-government
relationships. CURES builds on the Roadmap to cultivate new
relationships between NIH researchers and innovative
industrial partners. Unlike the roadmap, which asks the NIH
to focus on new priorities with old tools and funds, Cures
provides much higher levels of funding for a Center uniquely
devoted to translating research to produce new therapies and
even cures to the most important diseases.
____

Section by Section Summary of the American Center for CURES Act of 2005

A bill to facilitate more rapid development of novel diagnostics,
therapies and cures critical to national and global health

Background
When it comes to investments and advancements in biomedical
research, the United States has no equal. Its National
Institutes of Health (NIH) is the world's largest public
source of biomedical research funding with an annual budget
of over $28 billion. The NIH is comprised of 27 major
institutes and centers, leading the way in cancer,
cardiovascular, infectious disease and allergy advancements
for health promotion and relief from the burdens of disease.
The private sector is also investing substantial resources
in increasing both longevity and quality of life. These
companies now invest more than the federal government in
biomedical research and development (R&D). Potent
pharmaceuticals and cutting edge medical devices provide
health care professionals with a therapeutic arsenal that has
increased lifespan seven years since 1960 and dropped
neonatal mortality four fold. Partnerships between NIH and
private industry are not often recognized for their key roles
in bringing new treatments to the public, but are of great
importance as they have led to life-changing therapies from
to Taxol to Claritin to HIV anti-retrovirals.
But how can biomedical R&D proceed even faster? How can
partnerships between NIH's Institutes and Centers, disease-
based NGO's, biotech companies and small and large
pharmaceuticals occur even more frequently? Towards which
diseases should our resources be prioritized in the first
place? How can NIH and the private sector be more responsive
to emerging public health threats such as bioterrorism, an
avian flu pandemic, antibiotic resistance, and a waning
vaccine supply?
Center for Cures
In response to these pressing questions and the capacity of
the NIH to address our health needs, Senators Lieberman,
Cochran, Carper and Hutchison are proposing a $5 billion
dollar annual investment to create the American Center for
Cures (ACC). The mission of this new NIH Center will be to
promote more rapid translation of public and private research
into therapies, diagnostics and tools, which can effectively
treat and possibly cure diseases of critical importance to
domestic and global health. The ACC will enhance NIH's
ability to not only pursue fundamental knowledge about the
nature and behavior of living systems, but to apply that
knowledge to extend healthy life and reduce the burdens of
illness and disability. This is NIH's mission.
Specifically, the American Center for Cures will:
(1) Direct new resources towards the world's most
burdensome diseases and towards biomedical, bioengineering,
and biotechnological research with the greatest therapeutic
impact and promise.
(2) Create an ACC national advisory board consisting of key
health experts and stakeholders, who will help identify the
critical diseases and health threats requiring greater public
and private investment.
(3) Create a special Health Advanced Research Projects
Agency (HARPA) to support innovative multidisciplinary
collaborate research between NIH Institutes, between NIH and
other federal agencies and between NIH grantees and business
partners, for projects with the potential for significant
health impact.
(4) Create health-centered Federally Funded Research and
Development Centers (FFRDC) which will bring together
interdisciplinary teams of experts including scientists,
clinicians, epidemiologists, and

[[Page S13581]]

pharmacists for a time limited period to focus on developing
therapeutic breakthroughs for important disease entities.
(5) Invest further in the development of an expert
workforce which will augment the nation's translational
research capacity. Such an effort will include training new
clinical researchers and bioinformatics professionals.
(6) Promote risk-taking and collaboration between NIH
Institutes and Centers.
(7) Streamline the clinical research process essential to
determining if new treatments are effective and safe.
(8) Promote the innovative efforts of small to medium sized
biotechnology and bioengineering firms who require additional
support in key traditionally under-funded stages of product
development--the so called R&D ``Valley of Death''.
(9) Facilitate NIH partnerships with private industry in
the preclinical stage of the R&D process so as to formulate a
plan for health research translation and commercialization
from the outset.
(10) Standardize NIH information management systems and
reporting requirements of publicly funded research to improve
information sharing between the applied science,
translational research and business communities.
A section by section summary of the legislation is included
below.
Section 1: Short title.
Section 2: Table of contents.
Section 3: Findings.
Section 4: Amends Title IV of the Public Health Services
Act to establish a new Center at the National Institutes of
Health (NIH) called the American Center for Cures (ACC).

Part J--American Center for Cures

Section 499A: Definitions.
Section 499B(a): States the mission of the proposed
American Center for Cures (ACC), which is to increase the
capacity of the NIH to promote translational research between
its Institutes and Centers, between the NIH and other Federal
agencies and between NIH grantees and business partners so as
to speed the development of effective diagnostics, therapies
and cures essential to human health and well being.
The ACC shall formulate and implement a strategy for the
nation's translational research investment based on (1) a
prioritization of biomedical research based on disease burden
and research promise, and (2) funding for innovative, multi-
disciplinary, and collaborative research.
The ACC will be guided in part by a series of ``Grand
Challenges'' or strategic challenges that direct the health
research community towards multi-staged projects with the
potential to transform the healthcare landscape. Examples
include: the creation of laboratory diagnostics that enable
the country to detect quickly and accurately to acute health
threats, such as an avian flu pandemic or a bioterrorism
attack; a commitment by researchers and manufacturers from
public and private sectors to develop vaccines for the
world's most deadly infectious diseases including HIV,
tuberculosis, and malaria. Other examples are provided in
this section.
Section 499B(b): Establishes a Director of Cures (to be
called in this document the ``Director'') who will administer
the ACC. The President of the United States will appoint the
Director. The NIH Director in consultation with the Cures
Advisory Council (Section 499B(c)) will recommend candidates
for the Director to the President. The NIH Director will work
with the Director to promote the nation's translational
research efforts.
The Director will have at his disposal an annual
acceleration fund of $5 billion dollars to provide support
for research and development of breakthrough biomedical
discoveries and to carry out the purposes of the ACC. No less
than one half of the acceleration fund will be allocated to a
Health Advanced Research Projects Agency described in Subpart
II.
Section 499B(c): Establishes a Cures Council to advise and
direct the translational research efforts of the ACC. The
Council will be co-chaired by the Director of Cures and the
Director of NIH. Membership will include NIH Institute and
Center Directors; leaders from at least 9 federal agencies
including the Director of the Agency for Healthcare Research
and Quality (AHRQ), the Director of the Defense Advanced
Research Projects Agency (DARPA), and the President of the
Institute of Medicine (IOM); no fewer than three leaders from
the small business community; three leaders from large
pharmaceutical or biotechnology companies; and three leaders
from academia. All Council members will be appointed by the
President.
The Council shall establish subcommittees including one of
NIH Institute and Center Directors to coordinate research
priorities in, and ensure sharing of research agendas among,
the Institutes and Centers. The subcommittee shall also
coordinate the ACC research agenda with that of the NIH
Institutes and Centers.
The Council will make recommendations that help the
Director set research priorities for the ACC. The Council
shall consider risk and burden of disease as well as lines of
research uniquely poised to deliver effective diagnostics and
therapies.
The Council shall be aided by the Office of Intramural Risk
Opportunity and Mapping of the Office of Technology Transfer
established in subpart V.
The Council shall conduct an annual assessment of ACC
priorities and progress and make this available to the public
in written and electronic forms.
Section 499B(d): The Director of Cures shall prepare and
submit, directly to the President for review and transmittal
to Congress, an annual budget estimate for the Center.
The Director will receive directly all funds appropriated
by Congress for obligation and expenditure by the Center.

Subpart 1--Federally Funded Research and Development Centers

Section 499C: Federally Funded Research and Development
Centers (FFRDC's) will serve as sites for multidisciplinary
and cross-scientific research within particular areas of
health. The Director may establish one or more FFRDC's to
carry out activities related to the mission of the ACC. These
Centers will establish, as appropriate, technology test beds
and incubators, utilize cooperative agreements with the
private sector, and conduct large-scale multi-disciplinary
translational research projects in health or disease areas
which are essential to medical advancement, but lack adequate
private sector funding.
The FFRDC's shall consult widely with representatives from
private industry, institutions of higher education, nonprofit
institutions, other federal governmental agencies, and other
federally funded research and development centers.
The Director shall ensure that competitive mechanisms are
used to select and to promote the ongoing quality and
performance of the FFRDC's.
Contracts between the ACC and FFRDC's shall be for no
longer than 7 years, after which time refunding shall be
contingent upon approval by the Director and the Cures
Council.
Each FFRDC shall biannually submit a report on the
activities carried out by the Centers under this section to
the Director and the appropriate committees of Congress.
For any fiscal year, the Director may use not more than 25
percent of the funds available in the Director's Acceleration
Fund for FFRDC's.

Subpart 2--Health Advanced Research Projects Agency

Section 499d. Technological and scientific innovations
often require strategic risk taking and significant funding
streams that are rapid and are outcomes based. Funds must
also encourage expert multidisciplinary collaboration. This
section establishes at the ACC a Health Advanced Research
Projects Agency (HARPA) for these purposes.
HARPA will be headed by a Director of the Research Projects
Agency who will be appointed by the Director of Cures.
HARPA shall be composed of not more than 100 expert
portfolio managers in key health areas, as determined by the
Director of HARPA in conjunction with the Director and Cures
Council.
HARPA shall undertake the grand challenges formulated by
the Center and encourage innovative, multidisciplinary, and
collaborative research between NIH Institutes and Centers,
between the NIH and other Federal agencies, and between NIH
grantees and business partners.
Management and organizing principles include an agency
which is small, flexible, entrepreneurial, and non-
hierarchical; which empowers portfolio managers to foster
research opportunities free from bureaucratic impediments;
which seeks to employ the strongest scientific and technical
talent in the Nation; which rotates a significant portion of
the staff every 3-5 years, which leverages comparable
matching investment from other NIH institutes and centers,
federal agencies, and from the private and non profit
sectors; which creates a translational research model that
supports fundamental research breakthroughs, early and late
stage applied development, prototyping, knowledge diffusion,
and technology deployment; which establishes metrics to
evaluate research success; which ensures that revolutionary
research dominates HARPA's agenda and portfolio. Other
management and organizing principles are provided.
HARPA activities will include supporting basic and applied
research to promote revolutionary technology changes which
address health needs. It will advance the development,
testing, evaluation, prototyping and deployment of critical
health products. Multiple other activities are provided.
HARPA will have flexible hiring practices as described in
the Strom Thurmond National Defense Authorization Act, 1999.
HARPA will have the authority to flexibly fund projects,
including the prompt awarding, releasing, enhancing and
withdrawal of monies.
HARPA will be funded through the Director's acceleration
fund at a minimum of $2.5 billion dollars annually.

Subpart 3--Clinical Trials

Clinical trials are an essential part of the research and
development process. This is where the effectiveness and
safety of products are scientifically and systematically
investigated. However, clinical trials are complex,
expensive, and time-consuming, making it difficult for
individuals to perform all the functions necessary to
successfully organize and implement clinical trials. This
subpart improves how clinical trials are conducted and how
their results are disseminated. It also promotes the
development of a future clinical research workforce.
Section 499E. Increasing Research Study Participation: The
Director of NIH shall create a national electronic clinical
trial registry with the National Library of Medicine

[[Page S13582]]

(NLM) as specified in Subpart 6, Section 499H (b). The ACC
shall publicize the registry with special attention given to
minority groups, who are frequently underrepresented in
clinical trials.
Section 499E-1. Grants for Quality Clinical Trial and
Execution: The Director shall provide grants for clinical
trial design and execution to academic centers or to private
firms with highly promising therapeutic entities to fund
multidisciplinary clinical research teams, whose members may
include project managers, clinicians, epidemiologists, and
nursing staff.
Section 499E-2. Streamlining the Regulatory Process
Governing Clinical Research: This section streamlines the
regulatory process governing clinical research, which has
become increasingly unwieldy due to necessary but complex
patient privacy and safety rules. The ACC shall establish a
series of Centralized Institutional Review Boards (CIRB) to
ensure human subject safety and well-being for multi-
institutional clinical trials. CIRB's shall be established in
accordance with professional best practices and Good Clinical
Practice (GCP) guidelines.
A CIRB shall be housed at the Institute or Center with
expertise on the subject of the clinical trial or outside of
the NIH in a public or private institution with comparable
expertise and organizational capacity.
CIRB's will be available at the request of public or
private institutions and funded through user fees or Center
funds.
The CIRB shall act on behalf, in whole or in part, of the
bodies ordinarily responsible for the safety of research
subjects in a locality, on a contractual basis.
The CIRB will review and package research applications for
facilitated electronic review by local IRB's participating in
multi-center clinical trials. Local IRB review can be
performed by a subcommittee that is empowered to make
decisions in a timely manner. Local IRB's can either accept
or reject the CIRB review.
Local IRB's which are part of the CIRB network shall be
responsible for taking into consideration local
characteristics such as educational level of research
subjects to assure sound selection of research subjects and
to minimize risks to vulnerable populations.
Each CIRB shall regularly communicate important information
electronically to the local institutional review boards.
Section 499E-3. Training Clinical Researchers of the
Future: The ACC will augment NIH's investment into programs
developing the nation's clinical research workforce. These
programs include: the NIH's Mentored Patient-oriented
Research Career Development Award, NIH grants to help
institutions develop curricula for clinical researchers, and
NIH grants to fund participants in clinical science programs,
which shall include but not be limited to clinical science
certificates or clinical science Masters' Degrees.
Section 499E-4. Clinical Research Study and Clinical Trial:
The Director shall commission the Institute of Medicine (IOM)
to study the regulations protecting patient safety and
anonymity so that in a contemporary clinical research
context, a more realistic balance can be achieved between
clinical research promotion and regulatory requirements
governing research subject safety and privacy. The IOM will
issue a written report within eighteen months of the passage
of the Cures act which shall consider changes to the current
Health Insurance Portability and Accountability Act (HIPAA)
to further promote the clinical research endeavor.
Section 499E-5. Authorization of Appropriations from the
Directors Acceleration Fund. $100 million dollars for
Sections 499E-1(1), $50 million dollars for Section 499E-2,
$200 million dollars for Section 499E-3, $2.5 million dollars
for Section 499E-4.

Subpart 4--Valley of Death

Small businesses are major drivers of innovation. Facile,
motivated, numerous, and creative, these small businesses can
extend the limits of R&D in a way large companies with secure
product lines are unable to do. However, small businesses
often encounter difficulty securing capital in the so called,
``Valley of Death''--the period between a research idea with
possible application to the time the safety and efficacy of a
product is demonstrated in human clinical trials. Common end-
pathways within the Valley of Death include development of
pharmacological assays, scale-up of production from lab-scale
to clinical-trials scale, development of suitable
formulations, evaluation of chemical stability, evaluation of
materials testing for durability or reactivity, undertaking
initial toxicology studies, and planning and implementation
of clinical trials.
Section 499F. Small Business Partnerships: The Small
Business Innovation Research (SBIR) and Small Business
Technology Transfer (STTR) programs are effective major
investments in promoting the R&D portfolios of small
businesses. SBIR and STTR receive 2.5% and 0.3% of the
budgets, respectively, of federal agencies with R&D budgets
greater than $100 million dollars. SBIR/STTR grants and
contracts consist of three phases. Phase I plans for product
development and procurement. Phase II addresses
implementation of the plan. Phase III involves
commercialization yet by law is ineligible for SBIR/STTR
funding. Management and orientation of SBIR/STTR programs at
the NIH can be improved.
This section moves the NIH's SBIR and STTR programs from
the Extramural Research Office to the new Office of
Bioscientific Enterprise Development (OBED) in the ACC Office
of Technology Transfer (OTT).
The NIH currently awards its SBIR and STTR grants and
contracts through a peer review process. Now, not less than
35% of SBIR and STTR grants and contracts shall be rewarded
on a competitive basis by an OBED program manager with
significant managerial, technical, and translational research
experience to expertly assess the quality of a SBIR or STTR
proposal.
Program managers will place special emphasis on partnering
grantees with potential purchasers or investors of technology
from the start of the research and development process with
potential purchasers or investors including federal agencies
such as the NIH.
ACC shall reduce the time between Phase I and Phase II
funding to 6 months or less. Currently, grantees can wait up
to 5 years to learn whether or not they are a recipient of a
phase II grant.
An SBIR/STTR project manager may petition the OTT for Phase
III funding from the Director's acceleration fund for
projects requiring a supplementary funds to finalize product
commercialization. The maximum funding for Phase III funding
of a project shall be $2,000,000 for a maximum of 2 years.
All recipients of SBIR/STTR funding are required to report
to the OTT whether there was eventual commercial success of
the product. OTT shall keep a publicly accessible electronic
record of all SBIR/STTR investments in research and
development. The record shall include at minimum the
following information: the grantee, a description of the
funded research, the amount of money awarded in each phase of
SBIR/STTR research, and if applicable, the nature of the
products developed.
For each fiscal year, the two grants program managers who
have had the greatest success in helping to commercialize
products may be awarded a bonus up to $10,000.
Section 499F-1. Rapid Access to Intervention Development:
The National Cancer Institute of the NIH has a successful
translational research program called RAID (Rapid Access to
Interventional Development). RAID lends essential expertise
and resources including access to laboratories and facilities
to researchers outside of the NIH. OTT shall expand upon this
program and establish other RAID programs, designed to
accelerate the process of bringing promising and novel
discoveries from the laboratory to the pre-clinical trial
stage.
RAID awardees have traditionally been selected to receive
access to laboratories, facilities and other NIH supports for
the pre-clinical development of drugs, biologics, diagnostics
and devices, using the peer review process. Now, not less
than 35% of RAID awards shall be awarded on a competitive
basis by a program manager with significant managerial,
technical, and translational research experience to
adequately assess the quality of a project proposal.
Eligible awardees include university researchers, non-
profit research organizations, and firms of less than 100
employees in collaboration with one or more university or
non-profit organizations.
The Office may discontinue support at any point when the
entity fails to meet commercialization success criteria
established by the Office.
Examples of RAID support are given. These include advice
regarding the investigational new drug or investigational new
device filing with the Food and Drug Administration.
The Office shall not support products past proof-of-
principle clinical trials.
Section 499F-2. Toxicity Studies: Toxicity studies are
essential to the development of any drug therapy, but are
difficult to stage. The Center for Cures shall support
ongoing research into the most efficient methods of screening
for human toxicity, including using cell-based and animal
model technologies.
OTT may offer support for toxicity studies to private
companies licensing NIH intellectual property.
Section 499F-3. Additional funding sources and models: The
Director of the Center for Cures may provide acceleration
funds for flexible contracts for translational research
development to entities that license intellectual property
from NIH where such contracts support innovation and
commercialization.
Section 499F-4. Authorization of Appropriations from the
Directors Acceleration Fund. $400 million dollars for
Sections 499F for $100 million dollars for 499F-1.

Subpart 5--Office of Technology Transfer

The Office of Technology Transfer (OTT) should be one of
the NIH's most active entities. It is within the process of
technology transfer where basic science research informs
applications to health and where ideas are brought from bench
to bedside and back to the bench. The OTT should be a library
of innovation administered by experts who have experience in
linking the translational research community with industry.
This subpart improves upon the current research translation
authorities of NIH's OTT.
Section 499G. Restructuring: The NIH Office of Technology
Transfer in the NIH Director's Office shall be transferred to
a new OTT Office in the American Center for Cures.
Section 499G-1. Marketing Function: The OTT office shall
create a program for transfer management & support that
cultivates industry interest in NIH funded research, reaches
out to potential industry partners, coordinates patents from
different NIH Institutes and Centers, and manages Cooperative
Research and Development Agreements (CRADA's), biological
licensing agreements,

[[Page S13583]]

material transfer agreements, and intellectual property
licensing.
To promote government-industry partnerships, the OTT shall
create an electronic database within the National Library of
Medicine that tabulates translational research efforts
occurring at the NIH. The OTT shall hold an annual
translational research conference the bring together public
and private stakeholders.
The OTT shall develop a program for transfer management &
support which will be familiar with the NIH's intramural and
extramural research portfolio as well as with the interests
of small and large biotech and pharmaceutical industries. For
those Institutes or Centers with their own OTT offices, the
new OTT program for transfer management & support will work
closely with those offices to coordinate industry outreach
efforts.
As appropriate, OTT shall register CRADA's within a
publicly accessible electronic database maintained by NLM.
Section 499G-2. Office of Intramural Risk Opportunity and
Mapping: An Office of Intramural Risk Mapping within OTT
shall oversee the intramural research programs of the NIH to
be certain they are complementary, non-duplicative, and
distinct from extramural and private programs.
The Office shall identify and map health risks and
scientific opportunities and update the data on these topics
as necessary to ensure they are current. This information is
to be provided to the Cures Council on a biannual basis to
help them prioritize the nation's translational research
investment.
The Office shall make funds available to groups of NIH
Institutes and Centers to promote multidisciplinary projects
that focus on health risk analysis and corresponding
scientific risk opportunity. Preference will go to projects
that demonstrate a high degree of collaboration and which
address diseases with the great burden or research promise,
and that are most likely to result in the development of a
diagnostic or therapeutic prototype.
$150 million dollars is authorized to be appropriated from
the Director's Acceleration Fund to fund the Office.
Section 499G-3. Patenting and Licensing Incentives: The OTT
shall make every effort to increase licensing to stimulate
the availability of products for clinical use. The OTT shall
recommend to the Director incentives that create private
sector, financial, commercial, and academic interest in the
NIH's IP portfolio. These incentives may include extensions
of NIH health patents, restoration of NIH health patents, and
partnering options to pursue exclusive and nonexclusive
licensing to one or multiple partners in the government,
industrial, and/or academic sectors.
The Director shall encourage OTT to develop flexible models
for contracts that fulfill the needs of industry and the
public.
Section 499G-4. Translational Researcher Development: The
Director shall oversee development of a curriculum for
internships in translational research encompassing rotations
through multiple NIH Institutes and Centers, the clinical
trial design process, the NLM, and other related disciplines
with an emphasis on practical experience.
Tuition grants for extramural translational research
programs shall be administered under the supervision of the
Director.
The ACC shall train interdisciplinary scientists in the
science of risk analysis & mapping through a program of
internships and fellowships.
Section 499G-6. Translational Research Training Program:
The NIH Director shall ensure that each NIH Institute or
Center establishes a translational research training program.

Subpart 6--Developing Information Systems

The NIH's National Center for Biotechnology Information
(NCBI) at the NLM provides essential information resources to
scientists worldwide and is the underpinning of much of NIH
conducted biomedical research. The NCBI's databases and
computational and linkage tools nurture information sharing
and are critical to identifying interconnections, developing
insights, and accelerating biomedical breakthroughs.
Section 499H. Advancing National Health Information
Infrastructure.
The NLM shall develop new computational methods to assist
in the processing of genomic data. There is authorized to be
appropriated $2.5 million dollars to support the
computational infrastructure and $5.5 million dollars to hire
expert biologists and computer scientists trained in
bioinformatics.
Secretary of Health and Human Services acting through the
Director of NIH will work with the NLM to construct a
clinical trial registry and clinical results database
tracking all phase III clinical trials taking place in the
United States. This registry and database will expand upon
the NLM's current information system and database.
The registry of clinical trials shall include at least the
following: clinical trial title, description of the product
under study, the hypothesis to be tested, brief description
of the intervention, the study design, methodology, duration
and location, participation criteria, contact information and
sponsoring organization.
The databank of clinical trial results shall consist of at
least the following: trial start date and completion date,
summary of the results of the trial, summary data tables with
respect to the primary and secondary outcome measures,
information on the statistical significance of the results,
links to publications in peer reviewed journals relating to
the trial, a description of the process used to review the
results of the trial, and safety data concerning the trial.
Public or private entities shall register a phase III
clinical trial not later than 3 months after submitting the
Food and Drug Administration (FDA) approves the clinical
trial protocol and report phase III clinical trial results
not later than 3 months after completing the trial.
Information provided to the NLM must be accurate and updated.
Penalties for not registering clinical trials or reporting
clinical trial results can be loss of future public funding
or in cases where an entity does not receive public funding,
a fine of up to $2,000,000 dollars.
The Secretary may waive clinical trial submission
requirements upon a written request from the responsible
person if the Secretary determines that providing the waiver
is in the public's interest or consistent with protection of
the public's health.
Section 499H-1. Publication Requirement for Research: The
Director of the NIH shall require that for any research
funded by the NIH, Centers for Disease Control and Prevention
(CDC), and the Agency for Healthcare Research and Quality
(AHRQ), there will be a standardized report of this research
for public viewing. Department of Health and Human Services
(DHHS) grantees shall provide the NLM an electronic copy of
the final version of all peer-reviewed manuscripts accepted
for publication for display on their digital library archive,
PubMed Central, within 6 months from the date of its
publication.
Failure to submit required information to the NLM within 6
months from the date of publication may result in loss of
public funding for investigators.
Section 499H-2. Informatics Training and Workforce
Development. 21st Century technologies for analyzing DNA,
RNA, proteins, and other biologically important molecules are
generating a ``tsunami of data'' which are far beyond the
understanding of unaided human cognition, but hold the key to
improved understanding of human health and disease. Training
of individuals in ``clinical bioinformatics''--translational
research that applies computerized analytic methods of
molecules, cells, tissues, and body systems to the
prevention, diagnosis and treatment of human disease--will be
pivotal to fostering this emerging and important data-
intensive field.
The NIH shall develop a multi-faceted approach to
increasing the number of persons trained in clinical
bioinformatics. This shall include but not be limited to
augmenting secondary school science programs, undergraduate
degree programs in Bioinformatics, NIH bioinformatics
graduate training programs, and Centers of Excellence in
Clinical Bioinformatics.
Authorization of Appropriations from the Cures Acceleration
Fund is $50 million dollars for this section.
Section 499H-3. NLM Expansion of Facilities. In 2002,
Congress authorized an expansion of the NLM. These facilities
may be essential to the NLM's capacity to fill its numerous
informatics functions. The Director will commission the IOM
to report to Congress on the impact of not funding the
expansion of facilities.

Subpart 7--Research Tools

Innovation requires proper tools for discovery. These
include animal models that can be surrogates for human
systems and markers that illuminate otherwise invisible
cells, DNA, proteins and viruses. Arguably, the development
of research tools is subject to the same market forces as
more common end products--drugs, medical devices, and
vaccines.
Section 499I. NIH Research Tool Inventory: The Director of
NIH shall direct the head of each NIH Institute and Center to
perform an annual review of its research tool inventory for
the specific purpose of enabling each Institute and Center to
understand processes for research tool distribution,
frequency of use, IP status, and utility. Each NIH Institute
and Center shall also describe in its review the type and
quantity of research tools it desires to obtain in order to
better fulfill its R&D goals.
The ACC shall enter this inventory into an electronic
research tool database and use this database to oversee the
prioritization and funding of new projects to fulfill
pressing needs and to encourage promising technologies.
Section 499I-1. Exceptions to Tool Guidelines: The Director
of NIH may advise the OTT to provide exceptions to
prohibition against patenting and licensing research tools
under some appropriate circumstances when exclusive or non-
exclusive licensing provides the swiftest, and most
efficacious final development of an important health care
technology.
____

S. 2104

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 ``American Center for Cures
Act of 2005''.

SEC. 2. TABLE OF CONTENTS.

The table of contents for this Act is as follows:

[[Page S13584]]

Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Findings.
Sec. 4. American Center for Cures.

``Part J--American Center for Cures

``Sec. 499A. Definitions.
``Sec. 499B. Establishment of American Center for Cures.

``Subpart 1--Federally Funded Research and Development Centers

``Sec. 499C. Federally Funded Research and Development Centers.

``Subpart 2--Health Advanced Research Projects

``Sec. 499D. Health Advanced Research Projects Agency.

``Subpart 3--Clinical Trials

``Sec. 499E. Increasing research study participation.
``Sec. 499E-1. Grants for quality clinical trial design and execution.
``Sec. 499E-2. Streamlining the regulatory process governing clinical
research.
``Sec. 499E-3. Training clinical researchers of the future.
``Sec. 499E-4. Clinical research study and clinical trial.
``Sec. 499E-5. Authorization of appropriations.

``Subpart 4--Valley of Death

``Sec. 499F. Small business partnerships.
``Sec. 499F-1. Rapid access to intervention development.
``Sec. 499F-2. Toxicity studies.
``Sec. 499F-3. Additional funding sources and models.
``Sec. 499F-4. Authorization of appropriations.

``Subpart 5--Office of Technology Transfer

``Sec. 499G. Restructuring.
``Sec. 499G-1. Marketing function.
``Sec. 499G-2. Office of Intramural Risk Opportunity and Mapping.
``Sec. 499G-3. Patenting and licensing incentives.
``Sec. 499G-4. Translational researcher development.
``Sec. 499G-5. Translational research training program.

``Subpart 6--Developing Information Systems

``Sec. 499H. Advancing national health information infrastructure.
``Sec. 499H-1. Public access requirement for research.
``Sec. 499H-2. Informatics training and workforce development.
``Sec. 499H-3. National Library of Medicine expansion of facilities.

``Subpart 7--Research Tools

``Sec. 499I. NIH research tool inventory.
``Sec. 499I-1. Exceptions to tool guidelines.

SEC. 3. FINDINGS.

Congress finds the following:
(1) The National Institutes of Health (referred to in this
section as the ``NIH'') is the United States premier
biomedical research investment with annual appropriations
exceeding $28,000,000,000.
(2) The mission of the NIH is science in pursuit of
fundamental knowledge about the nature and behavior of living
systems and the application of that knowledge to extend
healthy life and reduce the burdens of illness and
disability.
(3) The pace of knowledge application to promote health and
reduce disease can be influenced through strategic funding
and reorganization of some aspects of the traditional
research endeavor. This process is known as translational
research investment.
(4) The United States translational research investment
will be key to the Nation responding effectively--
(A) to acute man-made or natural health threats;
(B) to the complexity and multi-disciplinary nature of
chronic diseases, which are responsible for 7 out of every 10
deaths in the United States and for more than 70 percent of
the $1,700,000,000,000 spent in the United States on health
care each year; and
(C) to research and development vacuums in the private for-
profit market, such as in the fields of vaccine and
antibiotic production, drugs for Third World diseases, and
medical tools for pediatric populations.
(5) Key components of the translational research process
include research prioritization, an expert workforce, multi-
disciplinary collaborative work, facilitated information
exchange, strategic risk taking, support of small innovative
businesses caught along common pathways in the research and
development Valley of Death, simplification and promotion of
the clinical research endeavor, and involvement of private
entities early on in the translational research endeavor that
are skilled in the manufacturing and marketing process.

SEC. 4. AMERICAN CENTER FOR CURES.

(a) American Center for Cures.--Title IV of the Public
Health Service Act (42 U.S.C. 281 et seq.) is amended by
adding at the end the following:

``PART J--AMERICAN CENTER FOR CURES

``SEC. 499A. DEFINITIONS.

``In this part:
``(1) Center.--The term `Center' means the American Center
for Cures established under section 499B.
``(2) Council.--The term `Council' means the Cures Council
established under section 499B.
``(3) Director.--The term `Director' means the Director of
the American Center for Cures.
``(4) Incubator.--The term `incubator' means an economic
development organization designed to accelerate the growth
and success of entrepreneurial individuals, concepts, and
companies.
``(5) Research tool.--The term `research tool' means a
resource that scientists use in their laboratories that has
no immediate therapeutic or diagnostic value, including cell
lines, monoclonal antibodies, reagents, laboratory equipment
and machines, databases, and computer software.
``(6) Test bed.--The term `test bed' means the pilot
environment to prototype innovation.
``(7) Translational research.--The term `translational
research' means investigation in which knowledge obtained
from fundamental research such as with genes, cells, or
animals, is transformed through early and late stage
development prototyping and testing into diagnostic or
therapeutic interventions that can be applied to the
treatment or prevention of disease or frailty.

``SEC. 499B. ESTABLISHMENT OF AMERICAN CENTER FOR CURES.

``(a) In General.--There is established within the National
Institutes of Health an American Center for Cures--
``(1) whose mission shall be to increase the capacity of
the National Institutes of Health to promote translational
research, including between the institutes and centers of the
National Institutes of Health, between the National
Institutes of Health and other Federal agencies, and between
grantees and business partners of the National Institutes of
Health, so as to speed the development of effective
therapies, diagnostics, and cures essential to human health
and well being;
``(2) that shall formulate and implement a strategy for the
Nation's translational research investment, which strategy
shall include--
``(A) a prioritization of biomedical research on diseases
based on disease burden and research promise; and
``(B) funding for innovative, multidisciplinary, and
collaborative research across the institutes and centers of
the National Institutes of Health, across Federal agencies,
and between public and private partners of the National
Institutes of Health;
``(3) that shall be guided, in part, by a series of `Grand
Challenges' formulated through collaboration between the
Director of Cures and the Council, that shall be strategic
challenges that direct the public and private health research
community towards collaborative multi-staged projects that
have the potential to transform the healthcare environment,
such as--
``(A) the creation of laboratory diagnostics that enable
the Nation to detect quickly and accurately acute health
threats such as an avian flu pandemic or a bioterrorism
attack;
``(B) a focus on therapeutic delivery systems targeting
individual viruses or hard to reach cells in the body, such
as the brain, using advances in nanotechnology;
``(C) accelerated research into the potential of stem cells
to replace the form and function of tissues lost to patients
suffering from diseases such as spinal cord injury,
Parkinson's disease, and insulin-dependent diabetes;
``(D) creation of a biomedical informatics infrastructure
that can organize the human genome and the proteins for which
the genome codes in ways that scientists can better
understand the genetic contribution to phenotypic disease;
``(E) the elaboration of adjuvant technology that can
bolster the effectiveness of vaccines;
``(F) development of antigen sparing vaccines such as those
based on triggering the innate immune response;
``(G) development of rapid vaccine manufacturing capacity
from new production methods such as viral cell culture or
bioengineering technology;
``(H) creation of a fast track clinical trial
infrastructure that incorporates a national doctor and
patient registry, centralized investigational review boards,
electronic medical records, and other health information
technologies;
``(I) a focus on addressing less profitable conditions for
which research and development efforts are insufficient, such
as--
``(i) orphan, small population, and third world diseases;
``(ii) antibiotic resistance;
``(iii) a threat of a flu epidemic or pandemic;
``(iv) diseases associated with social stigma such as
depression and seizure disorders; or
``(v) other comparable problems;
``(J) a commitment by researchers and manufacturers from
all sectors to develop vaccines for the world's most deadly
infectious diseases, including HIV, tuberculosis, and
malaria; and
``(K) other appropriate challenges; and
``(4) that shall have other appropriate purposes.
``(b) Director of the Center and the Director of NIH.--
``(1) In general.--The Center shall be administered by a
Director of Cures who shall be appointed by the President
with the advice and consent of the Senate. The Director of
the NIH, in consultation with the Council, shall recommend
candidates for the Director of Cures to the President.
``(2) Activities.--
``(A) Director of nih.--The Director of NIH shall--
``(i) work with the Director of Cures to promote
translational research efforts; and
``(ii) serve as a co-chair of the Council.

[[Page S13585]]

``(B) Director of cures.--
``(i) Acceleration fund.--

``(I) In general.--The Director of Cures shall have at the
Director's disposal an annual acceleration fund to provide
support for research and development of breakthrough
biomedical discoveries and to carry out the purpose of the
Center. Amounts in the fund may be available through grants,
contracts, and cooperative agreements to public sector
entities, private sector entities, and non-governmental
organizations. The Director of Cures shall allocate not less
than \1/2\ of the acceleration funds to the Health Advanced
Research Projects Agency described in subpart 2. The
remainder of such funds shall be available to the Federally
Funded Research and Development Centers described in subpart
1 and other activities of the Center.
``(II) Authorization of appropriations.--There are
authorized to be appropriated to fund the acceleration fund
under subclause (I) $5,000,000,000 for fiscal year 2007 and
each succeeding fiscal year.

``(ii) Direct other offices.--The Director of Cures shall
direct other offices within the Center that are established
under this part.
``(c) Council.--
``(1) Establishment.--There is established within the
Center a Cures Council that shall convene not less frequently
than twice a year to help advise and direct the translational
research efforts of the Center.
``(2) Membership.--
``(A) In general.--The Council shall be composed of the
following members:
``(i) The Director of NIH and the Director of Cures who
shall be Council co-chairs.
``(ii) The heads of the institutes and centers of the
National Institutes of Health.
``(iii) Heads from not less than 9 Federal agencies,
including--

``(I) the Administrator for the Substance Abuse and Mental
Health Services Administration;
``(II) the Under Secretary for Science and Technology of
the Department of Homeland Security;
``(III) the Commanding General for the United States Army
Medical Research and Materiel Command;
``(IV) the Director of the Centers for Disease Control and
Prevention;
``(V) the Commissioner of Food and Drugs;
``(VI) the Director of the Office of Science of the
Department of Energy;
``(VII) the President of the Institute of Medicine;
``(VIII) the Director of the Agency for Healthcare Research
and Quality; and
``(IX) the Director of the Defense Advanced Research
Projects Agency.

``(B) Other members.--Membership of the Council shall also
include not fewer than 3 leaders from the small business
community, 3 leaders from large pharmaceutical or
biotechnology companies, and 3 leaders from academia, all of
whom shall be appointed by the President.
``(3) Subcommittees.--The Council or the Council co-chairs
may form subcommittees of the Council as needed.
``(4) Recommendations; coordination.--The Council shall
make recommendations that help the Director of Cures set
research priorities for the Center. In making
recommendations, the Council shall consider risk and burden
of disease as well as lines of research uniquely poised to
deliver effective diagnostics and therapies. The Council
shall also coordinate research priorities in, and ensure
sharing of research agendas among, the institutes and centers
of the National Institutes of Health.
``(5) Office of intramural risk opportunity and mapping.--
The Council shall be aided by the Office of Intramural Risk
Opportunity and Mapping of the Office of Technology Transfer
of the Center established in subpart 5.
``(6) Annual assessment.--The Council shall make an annual
assessment of the priorities and progress of the Center and
shall make the assessment available to the public in written
and electronic form.
``(d) Budget and Funds.--The Director of Cures shall--
``(1) prepare and submit, directly to the President for
review and transmittal to Congress, an annual budget estimate
for the Center, after reasonable opportunity for comment (but
without change) by the Secretary, the Director of NIH, and
the Council; and
``(2) receive from the President and the Office of
Management and Budget directly all funds appropriated by
Congress for obligation and expenditure by the Center.

``Subpart 1--Federally Funded Research and Development Centers

``SEC. 499C. FEDERALLY FUNDED RESEARCH AND DEVELOPMENT
CENTERS.

``(a) In General.--The Director of Cures is authorized to
establish 1 or more Federally Funded Research and Development
Centers that shall carry out activities related to the
mission of the Center, as described in section 499B(a)(1).
``(b) Duties.--
``(1) In general.--The Federally Funded Research and
Development Centers shall serve as sites for the performance
of multidisciplinary and cross-disciplinary research and
shall--
``(A) establish, as appropriate, technology test beds and
incubators;
``(B) utilize cooperative agreements with the private
sector; and
``(C) conduct large-scale multidisciplinary translational
research projects in health or disease areas that are
essential to medical advancement but lack adequate private
sector funding.
``(2) Consultation.--In carrying out the duties described
in paragraph (1), the Federally Funded Research and
Development Centers shall consult widely with representatives
from private industry, institutions of higher education,
nonprofit institutions, other Federal governmental agencies,
and other federally funded research and development centers.
``(c) Competition.--The Director of Cures shall ensure that
competitive mechanisms are used to select and to promote the
ongoing quality and performance of the Federally Funded
Research and Development Centers.
``(d) Term of Funding.--Federally Funded Research and
Development Centers shall be funded for not more than 7
years, after which time the Federally Funded Research and
Development Centers' re-funding shall be contingent upon
approval by the Director of Cures and the Council.
``(e) Reports.--Each Federally Funded Research and
Development Center receiving funding under this section shall
submit a biannual report to the Director and the appropriate
committees of Congress on the activities carried out by the
Federally Funded Research and Development Center under this
section.
``(f) Funding for Support.--For any fiscal year, the
Director of Cures may use not more than 25 percent of the
funds available to the Director under the acceleration fund
under section 499B(b)(2)(B)(i)(II) to establish Federally
Funded Research and Development Centers under this section.

``Subpart 2--Health Advanced Research Projects

``SEC. 499D. HEALTH ADVANCED RESEARCH PROJECTS AGENCY.

``(a) Establishment.--There is established within the
Center a Health Advanced Research Projects Agency (referred
to in this section as the `Research Projects Agency') that
shall--
``(1) carry out activities related to the mission of the
Center, as described in section 499B(a)(1); and
``(2) be headed by a Director of the Research Projects
Agency who is appointed by the Director of Cures.
``(b) Composition.--The Research Projects Agency shall be
composed of not more than 100 portfolio managers in key
health areas, which areas are determined by the Director of
the Research Projects Agency in conjunction with the Director
of Cures and the Council.
``(c) Guidance.--The Research Projects Agency shall be
guided by and shall undertake grand challenges formulated by
the Center that encourage innovative, multi-disciplinary, and
collaborative research across institutes and centers of the
National Institutes of Health, across Federal agencies, and
between public and private partners of the National
Institutes of Health.
``(d) Management Guidance.--The Research Projects Agency
shall be guided by the following management and organizing
principles in directing the Research Projects Agency:
``(1) Keep the Research Projects Agency small, flexible,
entrepreneurial, and non-hierarchical, and empower portfolio
managers with substantial autonomy to foster research
opportunities with freedom from bureaucratic impediments in
administering the manager's portfolios.
``(2) Seek to employ the strongest scientific and technical
talent in the Nation in research fields in which the Research
Projects Agency is working.
``(3) Rotate a significant portion of the staff after 3 to
5 years of experience to ensure continuous entry of new
talent into the Research Projects Agency.
``(4) Use whenever possible research and development
investments by the Research Projects Agency to leverage
comparable matching investment and coordinated research from
other institutes and centers of the National Institutes of
Health, from other Federal agencies, and from the private and
non-profit research sectors.
``(5) Utilize supporting technical, contracting, and
administrative personnel from other institutes and centers of
the National Institutes of Health in administering and
implementing research effort to encourage participation,
collaboration, and cross-fertilization of ideas across the
National Institutes of Health.
``(6) Utilize a challenge model in Research Projects Agency
research efforts, creating a translational research model
that supports fundamental research breakthroughs, early and
late stage applied development, prototyping, knowledge
diffusion, and technology deployment.
``(7) Establish metrics to evaluate research success and
periodically revisit ongoing research efforts to carefully
weigh new research opportunities against ongoing research.
``(8) Tolerate risk-taking in research pursuits.
``(9) Ensure that revolutionary and breakthrough technology
research dominates the Research Projects Agency's research
agenda and portfolio.
``(e) Activities.--Using the funds and authorities provided
to the Director of Cures, and the authorities provided to the
Director of NIH, the Research Projects Agency shall carry out
the following activities:
``(1) The Research Projects Agency shall support basic and
applied health research to promote revolutionary technology
changes that promote health needs.

[[Page S13586]]

``(2) The Research Projects Agency shall advance the
development, testing, evaluation, prototyping, and deployment
of critical health products.
``(3) The Research Projects Agency, consistent with
recommendations of the Council, with the priorities of the
Director of Cures, and with the need to discuss challenges
described in section 499B(a)(3), shall emphasize--
``(A) translational research efforts, including efforts
conducted through collaboration with the private sector, that
pursue--
``(i) innovative health products that could significantly
and promptly address acute health threats such as a flu
pandemic, spread of antibiotic resistant hospital acquired
infections, or other comparable problems;
``(ii) remedies for diseases afflicting lesser developed
countries;
``(iii) remedies for orphan and small population diseases;
``(iv) alternative technologies with significant health
promise that are not well-supported in the system of health
research, such as adjuvant technology or technologies for
vaccines based on the innate immunological response; and
``(v) fast track development, including development through
accelerated completion of animal and human clinical trials,
for emerging remedies for significant public health problems;
and
``(B) other appropriate translational research efforts for
critical health issues.
``(4) The Research Projects Agency shall utilize funds to
provide support to outstanding research performers in all
sectors and encourage cross-disciplinary research
collaborations that will allow scientists from fields such as
information and computer sciences, nanotechnology, chemistry,
physics, and engineering to work alongside top researchers
with more traditional biomedical backgrounds.
``(5) The Research Projects Agency shall provide selected
research projects with single-year or multi-year funding and
require researchers for such projects to provide interim
progress reports to the Research Projects Agency on not less
frequently than a biannual basis.
``(6) The Research Projects Agency shall award competitive,
merit-reviewed grants, cooperative agreements, or contracts
to public or private entities, including businesses,
federally-funded research and development centers, and
universities.
``(7) The Research Projects Agency shall provide advice to
the Director of Cures concerning funding priorities.
``(8) The Research Projects Agency may solicit proposals
for competitions to address specific health vulnerabilities
identified by the Director and award prizes for successful
outcomes.
``(9) The Research Projects Agency shall periodically hold
health research and technology demonstrations to improve
contact among researchers, technology developers, vendors,
and acquisition personnel.
``(10) The Research Projects Agency shall carry out other
activities determined appropriate by the Director of Cures.
``(f) Employees.--
``(1) Hiring.--The Research Projects Agency, in hiring
employees for positions with the Research Projects Agency,
shall have the same hiring and management authorities as
described in section 1101 of the Strom Thurmond National
Defense Authorization Act for Fiscal Year 1999 (5 U.S.C. 3104
note).
``(2) Term.--
``(A) In general.--Except as provided in subparagraph (B),
the term of such appointments for employees of the Research
Projects Agency may not exceed 5 years.
``(B) Extension.--The Director of the Research Projects
Agency may, in the case of a particular employee of the
Research Projects Agency, extend the term to which employment
is limited under subparagraph (A) by up to 2 years if the
Director of the Research Projects Agency determines that such
action is necessary to promote the efficiency of the Research
Projects Agency.
``(g) Flexibility.--The Research Projects Agency shall have
the authority to flexibly fund projects, including the prompt
awarding, releasing, enhancing, or withdrawal of monies in
accordance with the assessment of the Research Projects
Agency and project manager.
``(h) Funding.--The Research Projects Agency shall utilize
funds received from the acceleration fund, described in
section 499B(b)(2)(B)(i), for the Agency's research and
development activities. There is authorized to be
appropriated from such fund $2,500,000,000 to carry out the
activities of the Research Projects Agency.

``Subpart 3--Clinical Trials

``SEC. 499E. INCREASING RESEARCH STUDY PARTICIPATION.

``The Director of NIH shall establish a national clinical
study registry within the National Library of Medicine of the
National Institutes of Health in accordance with section
499H. The Center shall publicize the registry, with attention
given to minority groups that are frequently underrepresented
in clinical trials.

``SEC. 499E-1. GRANTS FOR QUALITY CLINICAL TRIAL DESIGN AND
EXECUTION.

``The Director of Cures--
``(1) shall award grants for clinical trial design and
execution to academic centers to fund multi-disciplinary
clinical research teams, which clinical research teams may be
composed of members who include project managers, clinicians,
epidemiologists, social scientists, and nursing staff; and
``(2) may award grants for clinical trial design and
execution to researchers from small firms with highly
promising novel therapeutic entities.

``SEC. 499E-2. STREAMLINING THE REGULATORY PROCESS GOVERNING
CLINICAL RESEARCH.

``(a) Establishment of Centralized Institutional Review
Boards.--
``(1) In general.--The Director of Cures shall establish a
series of Centralized institutional Review Boards (referred
to in this section as `CIRBs') to serve as human subject
safety and well being custodians for multi-institutional
clinical trials that are funded partially or in full by
public research dollars.
``(2) Existing guidelines and best practices.--CIRBs shall
be established in accordance with professional best practices
and Good Clinical Practice (GCP) guidelines so that
institutions involved in multi-institutional studies may--
``(A) use joint review;
``(B) rely upon the review of another qualified
institutional review board; or
``(C) use similar arrangements aimed to avoid duplication
of effort and to assure a high quality of expert oversight.
``(b) Housed.--Each CIRB shall be housed--
``(1) at the institute or center of the National Institutes
of Health with expertise on the subject of the clinical
trial; or
``(2) at a public or private institution with comparable
organizational capacity, such as the Department of Veterans
Affairs.
``(c) Service.--The use of CIRBs shall be available, as
appropriate, at the request of public or private institutions
and shall be funded through user fees of the CIRBs or the
Center's funds.
``(d) Review Process.--
``(1) In general.--Each CIRB shall review research
protocols and informed consent to ensure the protection and
safety of research participants enrolled in multi-
institutional clinical trials.
``(2) Process.--The CIRB review process shall consist of
contractual agreements between the CIRB and the study sites
of multi-institutional clinical trials. The CIRB shall act on
behalf, in whole or in part, of the bodies ordinarily
responsible for the safety of research subjects in a
locality. In the case in which a locality does not have such
a body, the locality shall depend solely on the CIRB to
oversee the protection of human subjects and the CIRB shall
assume responsibility for ensuring adequate assessment of the
local research context.
``(e) Research Applications.--
``(1) In general.--Each CIRB shall review and package
research applications for facilitated electronic review by
local institutional review boards participating in a multi-
institutional clinical trial.
``(2) Local review.--Local institutional review board
review may be performed by a subcommittee of the local
institutional review board that is empowered to make
decisions in a timely manner.
``(3) CIRB review.--A local institutional review board may
accept or reject a CIRB review. In the case in which a local
institutional review board accepts a CIRB review, the CIRB
shall assume responsibility for annual, amendment, and
adverse event reviews.
``(f) Work in Concert.--In the case in which a local
institutional review board works in concert with a CIRB, the
local institutional review board shall be responsible for
taking into consideration local characteristics (including
ethnicity, educational level, and other demographic
characteristics) of the population from which research
subjects will be drawn, which influence, among other things,
whether there is sound selection of research subjects or
whether adequate provision is made to minimize risks to
vulnerable populations.
``(g) Communication of Important Information.--Each CIRB
shall regularly communicate important information in
electronic form to the local institutional review boards or,
in cases where a local institutional review board does not
exist, to the principal investigator, including regular
safety updates or changes in research protocol to improve
safety.
``(h) Coordination.--Each CIRB shall fully coordinate with
the institute or center of the National Institutes of Health
that has specialized knowledge of the research area of the
clinical trial. Other Federal agencies and private entities
undertaking clinical trials may contract with the Center to
use a CIRB.

``SEC. 499E-3. TRAINING CLINICAL RESEARCHERS OF THE FUTURE.

``The Center shall augment the National Institutes of
Health's investment into programs dedicated to developing the
clinical research workforce for tomorrow. The programs shall
include:
``(1) The National Institutes of Health's Mentored Patient-
Oriented Research Career Development Award to support the
career development of investigators who have made a
commitment to focus their research endeavors on patient-
oriented research.
``(2) The National Institutes of Health's award to
encourage mentorship among particularly talented early- and
mid-career investigators doing clinical research who want to
train new investigators.
``(3) The National Institutes of Health grants to help
institutions develop curricula for clinical researchers
leading to a clinical science certificate or master's degree.
``(4) The National Institutes of Health grants to fund
participants in clinical science programs, including clinical
science certificates or clinical science masters' degrees.

[[Page S13587]]

``SEC. 499E-4. CLINICAL RESEARCH STUDY AND CLINICAL TRIAL.

``The Director of NIH shall--
``(1) commission the Institute of Medicine of the National
Academies to study the rules that protect patient safety and
anonymity so that in a contemporary clinical research
context, a better balance can be achieved between clinical
research promotion and regulatory requirement governing
research subject safety and privacy; and
``(2) request that the Institute of Medicine issue a
written report not later than 18 months after the date of
enactment of this part that shall--
``(A) consider changes to the Health Insurance Portability
and Accountability Act of 1996 (Public Law 104-191) and the
amendments made by such Act that further promote the clinical
research endeavor; and
``(B) include recommendations for changes that shall not be
limited to legislation but shall include changes to health
care systems and to researcher practice that facilitate the
clinical research endeavor.

``SEC. 499E-5. AUTHORIZATION OF APPROPRIATIONS.

``There are authorized to be appropriated from the
acceleration fund of the Director of Cures described in
section 499B(b)(2)(B)(i)--
``(1) $100,000,000 to carry out section 499E-1(1) for
fiscal year 2007 and each succeeding fiscal year;
``(2) $50,000,000 to carry out section 499E-2 for fiscal
year 2007 and each succeeding fiscal year;
``(3) $200,000,000 to carry out section 499E-3 for fiscal
year 2007 and each succeeding fiscal year; and
``(4) $2,500,000 to carry out section 499E-4.

``Subpart 4--Valley of Death

``SEC. 499F. SMALL BUSINESS PARTNERSHIPS.

``(a) Establishment of the Office of Bioscientific
Enterprise Development.--
``(1) Establishment.--There is established within the
Office of Technology Transfer of the Center (as established
in subpart 5) an Office of Bioscientific Enterprise
Development (referred to in the subpart as the `OBED').
``(2) Transfers.--
``(A) In general.--The OBED shall include the functions
(including related personnel and resources) of the following
programs of the Office of Extramural Research in the Office
of the Director of the National Institutes of Health:
``(i) The Small Business Innovation Research program
(referred to in this subpart as the `SBIR').
``(ii) The Small Business Technology Transfer program
(referred to in this subpart as the `STTR').
``(B) Time for transfers.--The Secretary shall ensure that
the programs described in subparagraph (A) are transferred to
the OBED not later than 6 months after the date of enactment
of this part.
``(b) SBIR and STTR Grants and Contracts.--
``(1) In general.--Not less than 35 percent of the grants
and contracts awarded by the SBIR and STTR shall be awarded
on a competitive basis by an OBED program manager with
sufficient managerial, technical, and translational research
expertise to expertly assess the quality of a SBIR or STTR
proposal. The OBED, through such project manager, shall place
special emphasis on SBIR and STTR grant and contract
applications that identify from the onset products with
commercial potential that influence human health.
``(2) Potential purchasers or investors.--The OBED shall
administer non-peer reviewed grants and contracts under this
subsection through program managers who shall place special
emphasis on partnering grantees and entities awarded
contracts from the very beginning of the research and
development process with potential purchasers or investors of
the products, including large pharmaceutical or biotechnology
companies, venture capital firms, and Federal agencies
(including the National Institutes of Health).
``(3) Phase i and ii.--The OBED shall reduce the time
period between Phase I and Phase II funding of grants and
contracts under the SBIR and STTR to--
``(A) 6 months; or
``(B) less than 6 months if the grantee or entity awarded a
contract demonstrates that the grantee or entity awarded a
contract has interest from third parties to buy or fund the
product developed with the grant or contract.
``(4) Phase iii.--
``(A) Funding.--A program manager under this subsection may
petition the Director of Cures for Phase III funding of the
grant or contract for a project that requires a boost to
finalize procurement of a product. The maximum funding for
Phase III funding of a project shall be $2,000,000 for a
maximum of 2 years. Such Phase III funding shall come from
the acceleration fund, as described in section
499B(b)(2)(B)(i), of the Director of Cures.
``(B) Report success.--Each recipient of a SBIR or STTR
grant or contract, as a condition of receiving such grant or
contract, shall report to the OBED whether there was eventual
commercial success of the product developed with the
assistance of the grant or contract.
``(5) Record.--
``(A) In general.--The OBED shall keep a publicly
accessible electronic record of all SBIR or STTR investments
in research and development.
``(B) Contents.--The record described in subparagraph (A)
shall include, at minimum, the following information:
``(i) The grantee or entity awarded a contract.
``(ii) A description of the research being funded.
``(iii) The amount of money awarded in each phase of SBIR
or STTR funding.
``(iv) If applicable, the purchaser of the product, current
use of the product, and estimated annual revenue resulting
from the procurement.
``(6) Bonus.--For each fiscal year, for the non-peer
reviewed SBIR and STTR grants or contracts, the 2 program
managers who are most successful in terms of the number of
grantees or entities awarded a contract who complete Phase
III shall each be awarded a $10,000 bonus.

``SEC. 499F-1. RAPID ACCESS TO INTERVENTION DEVELOPMENT.

``(a) Establishment of Office.--The Office of Technology
Transfer of the Center shall establish an Office of Rapid
Access to Intervention Development (referred to in this
subpart as the `RAID') that--
``(1) is designed to assist translating promising, novel,
and scientifically meritorious therapeutic interventions to
clinical use by providing support to help investigators
navigate the product development pipeline;
``(2) shall aim to remove barriers between laboratory
discoveries and clinical trials of new molecular therapies,
technologies, and other clinical interventions;
``(3) shall aim to progress, augment, and complement the
innovation and research conducted in private entities to
reduce duplicative and redundant work using public funds; and
``(4) shall coordinate with the offices of the National
Institutes of Health that promote translational research in
the pre-clinical phase across the National Institutes of
Health.
``(b) Projects.--
``(1) In general.--The RAID, in collaboration with the
Director of Cures, shall carry out a program that shall
select, in accordance with paragraph (2), projects of
eligible entities that shall receive access to laboratories,
facilities, and other support resources of the National
Institutes of Health for the pre-clinical development of
drugs, biologics, diagnostics, and devices.
``(2) Selection.--Not less than 35 percent of the projects
selected under paragraph (1) shall be selected on a
competitive basis by a program manager with sufficient
managerial, technical, and translational research expertise
to adequately assess the quality of a project proposal.
Projects under paragraph (1) may also be selected from a peer
review process.
``(3) Eligible entities.--In this subsection, the term
`eligible entity' means--
``(A) a university researcher;
``(B) a nonprofit research organization; or
``(C) a firm of less than 100 employees in collaboration
with 1 or more universities or nonprofit organizations.
``(4) Discontinue support.--The RAID may discontinue
support of a project if the project fails to meet
commercialization success criteria established by the RAID.
``(c) Discoveries From Lab to Clinic.--The program under
subsection (b) shall accelerate the process of bringing
discoveries from the laboratory to the clinic through--
``(1) the development of pharmacological assays;
``(2) the scale-up of production from lab scale to
clinical-trials scale;
``(3) the development of suitable formulations;
``(4) the evaluation of chemical stability;
``(5) the evaluation of materials testing for durability or
reactivity;
``(6) undertaking initial toxicology studies;
``(7) planning clinical trials; and
``(8) advice regarding the investigational new drug or
investigational new device filing with the Food and Drug
Administration.
``(d) Ongoing Review.--The RAID shall review, on an ongoing
basis, potential products and may not support products past
the proof-of-principle stage.

``SEC. 499F-2. TOXICITY STUDIES.

``(a) Ongoing Research.--The Center shall support ongoing
research into the most efficient methods of screening for in
vivo toxicity, including using cell-based and animal model
technologies.
``(b) Offer of Studies.--The Director of Cures shall direct
the Office of Technology Transfer of the Center to offer
toxicity studies as an available feature to precede
completion of licensing agreement contracts because toxicity
studies are expensive and rate-limiting barriers to the
licensing of intellectual property from the National
Institutes of Health.

``SEC. 499F-3. ADDITIONAL FUNDING SOURCES AND MODELS.

``The Director of Cures may provide acceleration funds,
described in section 499B(b)(2)(B)(i), for innovative custom
contracts for translational research development to entities
that license intellectual property from the National
Institutes of Health where such contracts support innovation
and new models of cooperation and commercialization.

``SEC. 499F-4. AUTHORIZATION OF APPROPRIATIONS.

``There are authorized to be appropriated from the
acceleration fund of the Director of Cures described in
section 499B(b)(2)(B)(i)--
``(1) $400,000,000 to carry out section 499F for fiscal
year 2007 and each succeeding fiscal year; and

[[Page S13588]]

``(2) $100,000,000 to carry out section 499F-1 for fiscal
year 2007 and each succeeding fiscal year.

``Subpart 5--Office of Technology Transfer

``SEC. 499G. RESTRUCTURING.

``(a) Establishment.--There is established within the
Center an Office of Technology Transfer (referred to in this
subpart as the `OTT').
``(b) Transfers.--The OTT shall include the functions (and
related personnel and resources) of the Office of Technology
Transfer in the Office of the Director of the National
Institutes of Health.

``SEC. 499G-1. MARKETING FUNCTION.

``(a) In General.--The OTT shall establish a program that--
``(1) cultivates industry interest in funded research of
the National Institutes of Health;
``(2) reaches out to potential industry partners;
``(3) coordinates patents from the other institutes and
centers of the National Institutes of Health; and
``(4) manages Cooperative Research and Development
Agreements, biological licensing agreements, material
transfer agreements, and intellectual property licensing.
``(b) Promotion.--The program under subsection (a) shall
assist in promoting the success of government and industry
partnerships for the development of new technologies by
soliciting involvement of the private sector from the
beginning of the translational research process, including by
creating an electronic database within the National Library
of Medicine, which shall be updated regularly, that tabulates
translational research efforts occurring at the National
Institutes of Health. The OTT shall hold an annual national
translational research conference that brings together
researchers and industry representatives from across fields
from both the private and public sectors.
``(c) Transfer Management and Support.--The OTT shall
develop a program for transfer management and support that is
familiar with the National Institutes of Health's intramural
and extramural research portfolio, which program's mission is
to reach out to potential industry partners to cultivate
interest in collaboration with public researchers with the
goal of product development and procurement. For those
Institutes or Centers with their own Office of Technology
Transfer Offices, the OTT shall work closely with those
offices to coordinate industry outreach efforts. Those
offices, on a biannual basis, shall meet with the OTT and
shall submit a report to the OTT describing the translational
research efforts of the Center or Institute and corresponding
efforts to attract commercial interest in their research
portfolio.
``(d) Management.--
``(1) In general.--The OTT shall manage the Cooperative
Research and Development Agreements between industry and
public research partners.
``(2) Registration.--The OTT shall--
``(A) as appropriate, register the agreements within a
publicly accessible electronic database maintained by the
National Library of Medicine of the National Institutes of
Health; and
``(B) oversee the collaborative process in terms of pre-
determined outputs, negotiating problems that may occur
between collaborating entities, and assuring intellectual
property protections necessary for successful product
development.

``SEC. 499G-2. OFFICE OF INTRAMURAL RISK OPPORTUNITY AND
MAPPING.

``(a) Establishment.--There is established in the Office of
Technology Transfer of the Center, an Office of Intramural
Risk Opportunity and Mapping that shall oversee the
intramural research programs of the National Institutes of
Health to be certain they are complementary and distinct from
extramural and private programs.
``(b) Reviews and Reports.--The Office of Intramural Risk
Opportunity and Mapping shall--
``(1) conduct regular reviews of the intramural research
programs of the National Institutes of Health; and
``(2) report every 2 years on such reviews.
``(c) Health Risks and Opportunities.--The Office of
Intramural Risk Opportunity and Mapping shall--
``(1) identify and map public health risks and scientific
opportunities and keep data on such topics current and
updated; and
``(2) provide the information described in paragraph (1) to
the Council on a biannual basis to help the Council
prioritize the Nation's translation research investment.
``(d) Trans-NIH Collaborative Research.--
``(1) In general.--The Office of Intramural Risk
Opportunity and Mapping shall make, in coordination with the
Director of Cures and the Director of NIH, funds available to
groups of institutes and centers of the National Institutes
of Health to promote engagement in multi-institute projects
that focus on translational research endeavors.
``(2) Funding.--Funding levels and periods of funding under
paragraph (1) shall be flexible as necessary to achieve
trans-institute project objectives. Preference for funding
shall be given to projects that promote high levels of cross-
disciplinary collaboration, that address diseases with the
greatest burden or research promise, and that are most likely
to result in the development of a diagnostic or therapeutic
prototype.
``(3) Authorization of appropriations.--There is authorized
to be appropriated, from the acceleration fund of the
Director of Cures described in section 499B(b)(2)(B)(i), to
carry out this subsection $150,000,000.

``SEC. 499G-3. PATENTING AND LICENSING INCENTIVES.

``(a) In General.--The OTT shall make every effort to
increase licensing throughput in order to stimulate the
availability of useful products for patients.
``(b) Incentives.--The OTT shall develop incentives that
create private sector, financial, commercial, and academic
interest in the National Institutes of Health's intellectual
property portfolio, which incentives may include the
following:
``(1) The patent extension of National Institutes of
Health's health patents, in which there is an extension of
the time during which the licensee has exclusive right to the
intellectual property.
``(2) The patent restoration of National Institutes of
Health's health patents, in which there is restoration of the
full patent life, or another agreed upon term, of a
technology to the licensee from the time of Food and Drug
Administration passage or other agreed upon milestone.
``(3) Partnering options, which are options to pursue
exclusive and nonexclusive licensing to 1 or more partners in
the government, industrial, or academic sectors.
``(c) Customized Models.--The Director of Cures shall
encourage the OTT to cultivate customized models for
contracts that fulfill the needs of industry and the public.

``SEC. 499G-4. TRANSLATIONAL RESEARCHER DEVELOPMENT.

``(a) In General.--The Director of Cures shall oversee the
development of a curriculum for internships in
interdisciplinary research that will encompass rotations
through multiple institutes and centers of the National
Institutes of Health (including the National Library of
Medicine), the clinical trial design process, and other
related disciplines with an emphasis on practical experience.
``(b) Tuition Grants.--The Director of Cures shall award
tuition grants for extramural interdisciplinary research
programs.
``(c) Training.--The Center shall train interdisciplinary
scientists in the science and art of risk analysis and
mapping through a program of internships and fellowships.

``SEC. 499G-5. TRANSLATIONAL RESEARCH TRAINING PROGRAM.

``The Director of NIH shall ensure that each institute and
center of the National Institutes of Health has established,
or contracted for the establishment of, a translational
research training program at the institute or center.

``Subpart 6--Developing Information Systems

``SEC. 499H. ADVANCING NATIONAL HEALTH INFORMATION
INFRASTRUCTURE.

``(a) Genomic Data.--
``(1) In general.--The National Center for Biotechnology
Information of the National Library of Medicine of the
National Institutes of Health shall develop new computational
methods to aid in the processing of genomic data by novice
and experienced researchers.
``(2) Authorization of appropriations.--There is authorized
to be appropriated, from the acceleration fund of the
Director of Cures described in section 499B(b)(2)(B)(i), to
carry out paragraph (1) $8,000,000, of which--
``(A) $2,500,000 is authorized to be appropriated to
support the program's computational infrastructure; and
``(B) $5,500,000 is authorized to be appropriated for
hiring biologists and computer scientists who are trained in
bioinformatics.
``(b) Database.--The Secretary, acting through the Director
of NIH, shall undertake, in collaboration with the National
Library of Medicine of the National Institutes of Health,
construction of a clinical study registry and results
database that may expand upon the National Library of
Medicine's information system and database.
``(c) Clinical Trial Information.--
``(1) In general.--
``(A) In general.--The clinical study registry and results
database, described in subsection (b), shall consist of a
registry of phase III clinical trials taking place in the
United States and a database of their results.
``(B) Clinical study registry.--Participation in the
clinical study registry shall be mandatory for both public
and private entities.
``(C) Results database.--Participation in the clinical
trial results database shall be mandatory for both public and
private entities. The clinical trial results database shall
include even negative studies, which demonstrate no
therapeutic effect.
``(2) Registry of clinical trials.--The registry of
clinical trials shall include not less than the following:
``(A) The clinical trial title.
``(B) A description of the product under study.
``(C) The hypothesis to be tested.
``(D) The intervention.
``(E) The study design, methodology, duration, and
location.
``(F) Participation criteria.
``(G) Contact information.
``(H) Sponsoring organization.
``(3) Clinical trial results.--The database of clinical
trial results shall consist of not less than the following:
``(A) The trial start date and completion date.
``(B) A summary of the results of the trial in a standard,
non-promotional summary format.

[[Page S13589]]

``(C) Summary data tables with respect to the primary and
secondary outcome measures.
``(D) Information on the statistical significance of the
results and publications in peer reviewed journals relating
to the trial, with, when available, an electronic link to the
journal article.
``(E) A description of the process used to review the
results of the trial, including a statement about whether the
results have been peer reviewed by reviewers independent of
the trial sponsor.
``(F) Safety data concerning the trial, including a summary
of all adverse events specifying the number and type of
events.
``(G) Reference information to the clinical trial in the
clinical registry.
``(d) Registration of Trials and Reporting of Results.--
``(1) Website publication.--Each principal investigator of
a public clinical trial or responsible person for a private
clinical trial shall register phase III clinical trials in
accordance with paragraph (2) and report phase III clinical
trial results in accordance with paragraph (2) with the
National Library of Medicine of the National Institutes of
Health. The National Library of Medicine shall make the
information available for viewing on the Library's Website,
www.clinicaltrials.gov. The National Library of Medicine
shall electronically link each registered clinical trial with
its database of results and link each database of results
with its registered clinical trial.
``(2) Timeline of registration.--
``(A) In general.--An entity described in paragraph (1)
shall register a clinical trial not later than 3 months after
the Food and Drug Administration has approved the entity's
clinical trial protocol and report clinical trial results not
later than 3 months after completing the clinical trial,
which shall be defined as the point where the specified trial
duration has been surpassed and the analysis of the data is
complete or the trial is stopped because of vital positive or
negative findings, or as the point determined by the judgment
of the Secretary. All information submitted to the National
Library of Medicine shall be accurate and updated
``(B) Loss of funding.--In the case in which an entity
described in paragraph (1) does not register a clinical trial
or report on clinical trial results in accordance with
subparagraph (A), the Secretary may--
``(i) not award a grant, contract, cooperative agreements,
or any other award to the principal investigators of such
entity until the principal investigators comply with the
requirements under subparagraph (A); and
``(ii) in the case of an entity that does not receive
Federal funding for the clinical trial, fine the entity
$10,000 a day for a sum not to exceed $2,000,000 until the
responsible person for the clinical trial complies with the
requirements under subparagraph (A).
``(C) Waiver.--The Secretary may waive the requirements of
subparagraph (A) upon a written request from the responsible
person if the Secretary determines that extraordinary
circumstances justify the waiver and that providing the
waiver is in the public's interest or consistent with the
protection of public health.

``SEC. 499H-1. PUBLIC ACCESS REQUIREMENT FOR RESEARCH.

``(a) In General.--The Secretary shall require all funded
investigators, whether direct employees of the Department of
Health and Human Services or recipients of grants, contracts,
or other support of the National Institutes of Health, the
Centers for Disease Control and Prevention, or the Agency for
Healthcare Research and Quality, to submit to the National
Library of Medicine of the National Institutes of Health
(referred to in this section as the `National Library of
Medicine'), upon acceptance for publication in a journal or
other publication included in the PubMed directory, final
manuscripts resulting from research in which direct costs are
supported in whole or in part by the National Institutes of
Health, the Centers for Disease Control and Prevention, or
the Agency for Healthcare Research and Quality.
``(b) Public Availability.--
``(1) In general.--The National Library of Medicine shall
include all such manuscripts described in subsection (a),
after peer review, for display in the National Library of
Medicine's digital library archive, PubMed Central. The
copyright holder of a manuscript described in subsection (a)
may request the author's manuscript be replaced with final
published text.
``(2) Timeline.--A manuscript described in subsection (a)
shall become publicly available on the Internet through
PubMed Central not later than 6 months after the date of
publication of the manuscript.
``(3) Loss of funding for failure to submit on time.--
Failure to submit required information under this section to
the National Library of Medicine within 6 months of the date
of publication of the manuscript involved shall be considered
by the Secretary in the context of grant compliance review
and may result in the loss of public funding for the
investigators involved as determined appropriate by the
agency involved.

``SEC. 499H-2. INFORMATICS TRAINING AND WORKFORCE
DEVELOPMENT.

``(a) In General.--The Director of NIH shall develop a
multi-faceted approach to increasing the number of persons
trained in clinical bioinformatics by implementing
appropriate programs, including the programs described in
subsection (b).
``(b) Programs.--The programs under this subsection are the
following:
``(1) K-12 science program.--The National Library of
Medicine of the National Institutes of Health shall develop
with the National Science Foundation a kindergarten through
grade 12 clinical informatics education curriculum that shall
include an assessment component. The National Library of
Medicine shall award not more than 500 schools each $30,000
to implement the curriculum.
``(2) Undergraduate degree programs in bioinformatics.--The
National Library of Medicine of the National Institutes of
Health shall--
``(A) award grants to academic health centers and graduate
training programs to collaborate with an undergraduate
institution of higher education's department of biology,
chemistry, or computer science to develop curricula leading
to a bachelor's degree in bioinformatics; and
``(B) encourage grantees to form an inter-institutional
consortium.
``(3) Increasing the number of nih bioinformatics graduate
training programs.--The National Library of Medicine of the
National Institutes of Health shall increase the number of
bioinformatics graduate training programs through funding
existing graduate training programs of the National
Institutes of Health to meet the expanding needs for training
and outreach to the biomedical community. The programs shall
focus on the skills needed to apply bioinformatics methods
specifically to problems of human health and disease. The
Director of NIH shall hire 12 individuals with a doctorate in
molecular biology and expertise in training and developing
educational programs to assist in carrying out the programs
under this paragraph.
``(4) Centers of excellence in clinical bioinformatics.--
The National Library of Medicine of the National Institutes
of Health, through the Center, shall establish Centers of
Excellence in Clinical Bioinformatics that shall have state-
of-the-art computational methods and tools applicable to
human disease prevention, diagnosis, and treatment. The
Centers of Excellence in Clinical Bioinformatics shall
provide graduate student and postdoctoral support, through
distinguished faculty, in order to contribute to the highest
level of training in the bioinformatics workforce pipeline.
``(c) Authorization of Appropriations.--There is authorized
to be appropriated, from the acceleration fund of the
Director of Cures described in section 499B(b)(2)(B)(i), to
carry out this section $50,000,000 for fiscal year 2007 and
each succeeding fiscal year of which--
``(1) $15,000,000 is authorized to be appropriated for
fiscal year 2007 and each succeeding fiscal year to carry out
subsection (b)(1); and
``(2) $2,000,000 is authorized to be appropriated to carry
out subsection (b)(3).

``SEC. 499H-3. NATIONAL LIBRARY OF MEDICINE EXPANSION OF
FACILITIES.

``(a) Sense of Congress.--It is the sense of Congress that
Congress should make special effort to fund the expansion of
facilities of the National Library of Medicine of the
National Institutes of Health. These facilities are essential
to the National Library of Medicine being able to fulfill its
many informatics functions, which include providing essential
informational resources to scientists worldwide and advancing
the underpinning of much of the National Institutes of Health
conducted biomedical research.
``(b) Report.--The Director shall request that the
Institute of Medicine of the National Academies report to
Congress on the impact of not providing funding for the
expansion of facilities described in subsection (a).

``Subpart 7--Research Tools

``SEC. 499I. NIH RESEARCH TOOL INVENTORY.

``(a) Annual Review.--The Director of NIH shall direct the
head of each institute and center of the National Institutes
of Health to perform an annual review of the institute or
center's research tool inventory for the specific purpose of
enabling each institute or center to understand the research
tool distribution, frequency of use, intellectual property
status, and utility. Each institute and center of the
National Institutes of Health shall describe in the institute
or center's annual review the type and quantity of research
tools the institute or center desires to obtain to better
fulfill the institute or center's research and development
goals.
``(b) Database.--The Director of Cures shall--
``(1) enter the information obtained from the annual review
under subsection (a) into an electronic research tool
database; and
``(2) use such database to oversee the prioritization and
funding of new projects to fulfill pressing needs and
promising technologies.

``SEC. 499I-1. EXCEPTIONS TO TOOL GUIDELINES.

``The Director of Cures may advise the Office of Technology
Transfer of the Center to provide exceptions to prohibitions
against patenting and licensing research tools under some
circumstances of customized contracts when exclusive or non-
exclusive licensing provides the swiftest and most
efficacious final development of an important health care
technology.''.
(b) Conforming Amendment.--Section 401(b)(1) of the Public
Health Service Act (42 U.S.C. 281(b)(1)) is amended by adding
at the end the following:
``(S) The American Center for Cures.''.

[[Page S13590]]

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Quotes in Support of the American Center for CURES Act of 2005

``The American Center for Cures will be a tremendous
addition to our nation's valuable tradition of biomedical
research. By emphasizing translational and applications
research as well as discovery of diagnostic markers, the ACC
will bring the hope of basic science discovery to the reality
of patient care. The mandate and goal will be to prevent,
early diagnose, or cure the diseases that cause such
suffering to humanity. This effort will promote health
diplomacy that will bring the genius and resources of our
nation to better the health of all Americans.''--Secretary
Tommy Thompson, Former Secretary, Department of Health and
Human Services, Former Governor, State of Wisconsin.
``The need for a federal focus on finding cures has long
been a top priority for all of us who seek the rapid
translation of scientific advances into personal health
benefits. With their landmark legislative proposal, Senators
Cochran and Lieberman have taken a critical step along our
path to cures.''--S. Robert Levine MD, Chairman of the Health
Priorities Project of the Progressive Policy Institute.
``As Governors around the country look to transform our
complex health care system, we must seek new cost-effective
solutions that continue to improve our overall health and
productivity,'' said Michigan Governor Jennifer M. Granholm.
``The American Center for Cures represents a bi-partisan
effort to devote significant and lasting resources toward an
innovative approach to disease treatment and management,
offering Americans grappling with chronic and debilitating
diseases the lasting gift of hope.''--Governor Jennifer
Granholm, Michigan.
``Finding cures will improve the health of mankind. As an
example, by simply delaying the onset of Alzheimer's disease
by five years, the health and productivity of older Americans
will be enhanced. Developing cures will provide American
families with a better quality of health care that can be
sustained over a longer period of time. That is why I urge
the establishment of the American Center for Cures.''--
Governor Tom Vilsack, Iowa.
The American Center for Cures is a timely and creative
proposal for tackling an urgent national challenge: the
skyrocketing costs of treating and preventing chronic
diseases. The confluence of such diseases and a graying
population not only threatens to make health care
unaffordable, but also jeopardizes prospects for healthy and
successful aging. The Center would focus the prodigious
talents of our scientific community on specific strategies to
cure disease, saving lives and money over the long run.--Will
Marshall, President, Progressive Policy Institute.
``The American Center for Cures is a simple, bold,
breakthrough idea: A can-do country ought to have the
capacity to solve chronic problems, not just treat them.''--
Bruce Reed, President, Democratic Leadership Council.
``I think this goes a long way toward improving NIH's
ability to do large projects across institutes and to
facilitate translational research. I am happy to support this
concept . . . there are already a lot of good ideas here.''--
Leland Hartwell, Ph.D., Nobel Laureate, Medicine and
Physiology, President, Fred Hutchinson Cancer Research
Center.
``I believe the American Center for Cures (ACC) is a
wonderful effort that focuses physicians and scientists on
bringing the discoveries of the laboratory to the patient.
The lives of many Americans will be improved by having the
ACC bring to bear new resources in the fight against chronic
neurological diseases such as Alzheimer's, Parkinson's,
multiple sclerosis, and other neurodegenerative disorders. I
enthusiastically support the American Center for Cures and
hope that my colleagues in biomedical research will join
me.''--Stanley Prusiner, M.D., Nobel Laureate, Medicine and
Physiology, University of California, San Francisco.
``The proposed ACC offers a blend of existing federal
activities in health research with several new initiatives,
all aimed at speeding the move from discovery to products
that help human health. The proposal has multiple components
including strengthening existing NIH authorities in support
of small business. When enacted and in operation the results
of this new focused activity should be very visible with
improvements to the public health that would not be possible
without this new money with mandates on how it is spent.''--
Robert Day, M.D., Ph.D., M.P.H., Emeritus Professor and Dean,
University of Washington School of Public Health and
Community Medicine, Emeritus Professor and Director, Fred
Hutchinson Cancer Research Center, Member, Public Health
Sciences, Member, National Cancer Advisory Board, National
Cancer Policy Board.
``The establishment of an American Center for Cures with
its emphasis, prominence and integration into the rest of the
United States organization of health care related ventures
would represent an enormous step forward. The focus of the
Center on translation of basic science initiatives to the
clinical arena will benefit those whose support has taken us
to the present date. I applaud the initiative.''--Fritz H
Bach, M.D., Lewis Thomas Distinguished Professor, Harvard
Medical School.
``Medical discoveries over the past century have greatly
increased the quality and quantity of human life. New
insights into biology will make even more advances possible.
The American Center for Cures will make the translation of
biological discoveries to the patient occur not only faster
but much more likely to happen. It is hard to imagine another
investment that would extend the quality and quantity of life
than fully funding the American Center for Cures.''--James O.
Armitage, M.D., Joe Shapiro Professor of Medicine, University
of Nebraska College of Medicine, Member, National Cancer
Advisory Board.
``I am pleased to support the American Center for Cures
(ACC) proposed legislation that you introduced to the United
Sates Senate on Wednesday, December 7. This legislation is
critical and in the translation of advances in fundamental
biomedical science to improvements in the care of people.
Please let me know if I can help make this dream a
reality.''--Lee Goldman, M.D., MPH, Julius R. Krevans
Distinguished Professor and Chair, Associate Dean for
Clinical Affairs, University of California San Francisco
School of Medicine, President, Association of Professors of
Medicine.
``I enthusiastically support The American Center for Cures
(ACC) Senate legislation. The ACC will focus our nation's
scientists and doctors on applying basic scientific
discoveries to help the patient. This critical approach to
research will not only help our friends and loved ones with
their health, it will be the 21st Century American approach
to solving the health care financial crisis. By eliminating
or reducing certain diseases for all Americans, the looming
federal and state Medicare and Medicaid financial tsunami
will be markedly reduced. There is no time to lose. I urge
the immediate passage of the ACC legislation.'' --Stephen
Gleason, D.O., Ph.D., Former CEO Mercy Clinics, Former VP
Medical Operations for Catholic Health Initiatives, Former
White House advisor, Former chief of staff, Governor Tom
Vilsack, Former Presidential Representative to the World
Health Organization, Assistant Professor, Mayo Graduate
School of Medicine.
``The American Center for Cures will be the engine that
brings basic science discoveries and apply them to the
patient. It has been said that women and minorities are not
dying from the lack of research, they are dying from the lack
of research being applied to them. The ACC will focus the
talent of the greatest scientists and clinicians for one
singular purpose: to cure, prevent, or diagnose earlier
diseases that afflict so many in the world. As a mother,
nurse, researcher, and educator, I believe that the ACC will
bring better health to all of us. The time is now . . . let
us not waste another moment.''-- Sandra Underwood, RN, PhD,
University of Wisconsin School of Nursing.
``The American Center for Cures is a remarkable idea that
will be the bridge between the promise of scientific
opportunities and the reality of our nation's health needs--
to deliver cures. Americans deserve a center that is totally
dedicated to finding cures for our most devastating and
debilitating chronic diseases. The ACC is the natural
extension of the doubling of the NIH budget. Now we must have
as a top national priority an accountable, mission-driven
Center for Cures to rapidly identify ``cure opportunities''
already created by federal, academic and private research
laboratories and proactively accelerate and rapidly translate
these opportunities into real cures.
In an era of expanding needs, exploding knowledge of the
biomedical sciences, and demands of the public to have the
knowledge applied to their loved ones' ailments, the American
Center for Cures offers new hope and dynamic reality to
Americans. The American Center for Cures is the opportunity
to commit the American genius, resources, and ethic to a
greater cause in a ``moonshot'' approach to diseases.''--
Richard J. Boxer, M.D., Clinical Professor, Health Policy,
Medical College of Wisconsin, Clinical Professor, Family and
Community Medicine, Medical College of Wisconsin, Clinical
Professor, Surgery/Urology, University of Wisconsin-Madison.
``Having reviewed the material you so kindly sent me, I
want to applaud this pioneering, entrepreneurial approach
which will undoubtedly accelerate the process by which we
discover and implement cures for diseases and improve and
enrich the quality of life of tens of millions of Americans.
I hope that this bold solutions-oriented approach will have
overwhelmingly bi-partisan support in Congress and that it
will be signed into law by the President at the earliest
possible moment.''--Steve Grossman, Former Chair, Democratic
National Committee, C.E.O. Massachusetts Envelope Company.
``The American Center for Cures is the best new idea in
Washington DC in a generation. It is timely, creative and
compelling.''--Joe Andrew, Former Chair, Democratic National
Committee, Sonnenschein, Nath and Rosenthal, LLP.
``The combination of NIH and industry-supported research,
combined with venture capital, has been very successful in
bringing new drugs based on fundamental biological
discoveries into commercial reality. In areas that combine
fundamental biology and physical science and engineering--
biomedical devices, analytical, genomic, and diagnostic
tools, bioinformation systems, tissue engineering--the
current system works substantially less well.''--George
Whitesides, Ph.D., Professor of Chemistry, Harvard Medical
School, (given in 2004).
``The concept of the new institute is exciting.''--Arthur
W. Nienhuis, M.D., Director,

[[Page S13591]]

St. Jude Children's Research Hospital, (given in 2004).
``The concept and its underlying philosophy are right on
target. We need to open cancer research in prevention, early
diagnosis, and cure to scientists in diverse fields that
include physicists, chemists, computer scientists and
mathematicians.''--Frederick P. Li, M.D., Director, Division
of Cancer Epidemiology and Control, Dana-Farber Cancer
Institute, (given in 2004).
``The 20th Century saw a 100-percent increase in worldwide
life expectancy--one of the greatest achievements in history.
Today's children face different challenges, including a
higher risk of dying from cancer and other diseases of aging
than their grandparents did. In the 21st Century, our
challenge is to use incredible advancements in information
technology and biology to defeat such diseases as cancer,
Alzheimer's, diabetes, Parkinson's and many other afflictions
that take years of quality life from our loved ones. The
most-important benefit will be reduced human suffering. And
the value to our economy will be measured in trillions of
dollars. The American Center for Cures (ACC) legislation
recognizes and responds to the imperative of defeating these
deadly diseases in our lifetimes. I believe we can do that if
we summon the will to change the way we pursue new medical
solutions. FasterCures supports passage of the ACC
legislation and urges its rapid implementation. There is not
a moment to lose.''--M. Millken, Chairman, FasterCures/The
Center for Accelerating Medical Solutions.
``The American Center for Cures will be extraordinarily
important for all Americans, and indeed all humanity. The new
Center will combine scientific disciplines that have
previously not been brought to bear upon biomedical problems.
This is a unique and desperately needed approach will break
through the impasse and finally bring the formidable power of
all science to focus and solve the diseases that plague the
world. The American Center for Cures has been designed to
bring accountability and responsibility for ultimate cures.
Its success will be measured by cures and cures alone. As a
father, husband, entrepreneur, and one who has seen too much
suffering, I believe it is incumbent upon us to take a bold
approach to biomedical research that will make our children
and future generations free of the diseases that have
afflicted us and our ancestors. Let our descendents look back
at our generation and say, `They reached for the stars, and
found they were capable of conquering old paradigms, fears,
and diseases.' ''--Lou Weisbach, C.E.O. Stadium Capital
Associates, Founder, HA-LO Industries, Inc.
``Oscar Wilde once wrote, ``Morality, like art, begins with
a line being drawn someplace.'' With tremendous suffering and
disease so prevalent in our country, the American Center for
Cures' (ACC) proposed legislation being introduced by
Senators Lieberman and Cochran draws a line in the sand for
health and extending the lifetime of every individual. From a
religious point of view, this certainly responds to the
notion that we are identified with life affirmation. I
heartily endorse this legislation.''--Rabbi Steven B. Jacobs,
Temple Kol Tikvah, Woodland Hills, CA--Rabbi Michael Lerner,
Editor, Tikkun Magazine, Rabbi, Beyt Tikkun Synagogue, San
Francisco, California.

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