[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 666 Introduced in Senate (IS)]
1st Session
S. 666
To provide incentives to increase research by private sector entities
to develop antivirals, antibiotics and other drugs, vaccines,
microbicides, detection, and diagnostic technologies to prevent and
treat illnesses associated with a biological, chemical, or radiological
weapons attack.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 19, 2003
Mr. Lieberman (for himself and Mr. Hatch) introduced the following
bill; which was read twice and referred to the Committee on Finance
_______________________________________________________________________
A BILL
To provide incentives to increase research by private sector entities
to develop antivirals, antibiotics and other drugs, vaccines,
microbicides, detection, and diagnostic technologies to prevent and
treat illnesses associated with a biological, chemical, or radiological
weapons attack.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Biological,
Chemical, and Radiological Weapons Countermeasures Research Act''.
(b) In Honor.--This Act is enacted in honor of Robert Stevens,
Thomas Morris Jr., Joseph Curseen, Kathy Nguyen, Ottilie Lundgren, and
Lisa J. Raines, victims of terrorist attacks in the United States in
2001.
(c) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Amendment to Homeland Security Act of 2002.
``TITLE XVIII--BIOLOGICAL, CHEMICAL, AND RADIOLOGICAL COUNTERMEASURES
RESEARCH
``Sec. 1801. Short title.
``Sec. 1802. Definitions.
``Subtitle A--Strategy for the Development of Countermeasures
``Sec. 1811. Biological, chemical and radiological agent,
toxin, and material countermeasure research
priority list.
``Sec. 1812. Research registration requirements.
``Sec. 1813. Detectors incentives.
``Sec. 1814. Diagnostics incentives.
``Sec. 1815. Research tools incentives.
``Subtitle B--Incentives for the Development of Countermeasures
``Chapter 1--Primary Incentives
``Sec. 1821. Federal tax incentives.
``Sec. 1822. Terror Weapon Countermeasure Purchase Fund.
``Sec. 1823. Patent term protection and exclusive marketing.
``Sec. 1824. Liability and indemnification.
``Chapter 2--Other Incentives
``Sec. 1831. Accelerated approval of countermeasures.
``Sec. 1832. Biologics manufacturing capacity incentives.
``Sec. 1833. Biologics manufacturing efficiency incentives.
``Sec. 1834. Construction of biosafety level 3-4 research
facilities.
``Sec. 1835. National Institutes of Health countermeasures
partnership challenge grants.
``Subtitle C--Administrative Provisions
``Sec. 1841. Annual report.
``Sec. 1842. International conference on research to develop
countermeasures.
Sec. 4. Tax incentives.
Sec. 5. Patent term protection and exclusive marketing.
Sec. 6. Approvals of certain drugs based on animal trials.
Sec. 7. Limited antitrust exemption.
Sec. 8. Incentives for the construction of biologics manufacturing
facilities available for the production of
countermeasures.
Sec. 9. Human clinical trials and drugs for rare diseases and
conditions.
Sec. 10. Liability.
SEC. 2. FINDINGS.
Congress makes the following findings:
(1) The United States must be prepared with diagnostic and
medical countermeasures in the event of the use of biological,
chemical, and radiological weapons by terrorists and others
against military and intelligence personnel, government
officials, or civilians.
(2) The threat of biological and chemical weapons is real.
(A) Members of the cult Aum Shinrikyo were
responsible for chemical weapons attacks in Japan that
killed 12 people and injured over 5,000 on March 20,
1995. In this attack, terrorists placed plastic bags of
diluted sarin, a lethal nerve agent, on crowded subway
trains during the morning rush-hour. It was found that
sect members had legally stockpiled sodium cyanide and
hundreds of tons of chemicals used to make sarin,
including sodium fluoride, phosphorous trichloride,
isopropyl alcohol, and acetonitrile. Aum Shinrikyo
concealed its sarin manufacturing plant in a shrine to
a sect goddess. Investigators also found a biological
weapons research lab on the cult's compound. The
facility contained an incubator, an electron
microscope, a growth medium for fermenting or growing
cultures, and cultures of the deadly botulinum toxin.
Aum Shinrikyo members were apparently planning a more
devastating offensive. The cult also released anthrax
spores and botulinum in Tokyo nine times before it
carried out its nerve gas attack. Aum's attempted germ
attacks failed because the group's biologists cultured
the strain of anthrax used to make vaccine, which is
harmless. Had they used a potent culture, the outcome
might have been very different. No one knows why the
botulism attack failed. The horror is only magnified by
the thought that individuals and nations would consider
attacking others with such viruses. In October 1993,
Shoko Asahara, head of the Aum Shinrikyo cult, and 40
followers traveled to Zaire, ostensibly to help treat
Ebola victims. But the group's real intention,
according to an October 31, 1995, report by the
Permanent Subcommittee on Investigations of the Senate,
was probably to obtain virus samples, culture them and
use them in biological attacks.
(B) Before the 2001 anthrax attacks, the most
recent successful biological attack in the United
States, which was not recognized as such at the time,
was with salmonella. Followers of Bhagwan Shree
Rajneesh put the bacteria in salad bars in restaurants
in Dalles, Oregon, in 1984, sickening 750 people.
(C) There is a long and sordid history of chemical
and biological weapons, including use during the First
and Second World Wars, an accidental release of anthrax
spores in 1979 from a Soviet military microbiological
facility, use of mustard gas, tabun, and hydrogen
cyanide by Iraq in the Iran-Iraq War and against the
Kurds, and development by Iraq of an offensive
biological weapons capability including anthrax and
botulinum toxin. Before, during, and after the Second
World War, the Soviet Union produced many tens of
thousands of tons of chemical weapons (both nerve and
blister agents). During the later half of the Cold War,
Soviet scientists developed a series of new and more
lethal ``third generation'' nerve agents. Certain of
these new agents produced and tested in pilot and
experimental quantities in the late 1980s and early
1990s were up to 1O times more lethal than VX and soman. Additionally,
because these are binary agents, i.e., they consist of two relatively
non-toxic chemicals that are mixed together when the weapon is armed to
produce the lethal chemical agent, they can be manufactured at
commercial chemical plants that manufacture fertilizers and pesticides.
A new unitary agent was also developed that could be produced from
accessible raw materials that are used in civilian industry and which
cannot therefore be regulated by international experts. Although less
lethal per unit weight than traditional nerve agents, agricultural
organophosphate insecticides are available in enormous quantities and
can be used as nerve agents.
(D) The United States bioterror weapons program
focused on anthrax, botulinum toxin, brucellosis,
tularemia, psittacosis, plagua, Venezuelan equine
encephalitis, Q fever, cholera, dengue, shigellosis
dysentery, glanders, and Rocky Mountain spotted fever.
The United States Army concocted a botulinum toxin that
was so toxic that a pound, if expertly dispersed, could
kill 1,000,000,000 people. Botulinum toxin is 15,000
times more toxic than VX and 10,000 times more toxic
than Sarin. The Soviet bioterror program involved 47
laboratories and 65,000 people. It focused on 52
different pathogens, including smallpox, anthrax,
plague, Ebola and Marburg hemorrhagic fevers, yellow
fever, tularemia, brucellosis, Q fever, botulinum
toxin, and Venezuelan equine encephalitis. It created
2,000 strains of anthrax with 7,000 employees working
on nothing but anthrax. It produced 20 tons of smallpox
virus each year, created antibiotic resistant bacterial
strains with odd properties to confuse diagnosis,
plague bacteria that secreted diphtheria toxin and
resisted antibiotics. The Iraqi bioterror program
focused on anthrax, botulinum toxin, cholera, plague,
gas gangrene, Salmonella, ricin, staphylococcal
enterotoxin, camelpox, cancer-causing molds called
aflatoxins, rotavirus, and hemorrhagic conjunctivitis.
(E) A Central Intelligence Agency report concluded
that ``clandestine production of chemical and
biological weapons for multiple casualty attacks raises
no greater technical obstacles than does the
clandestine production of chemical narcotics or
heroin''. One of the aspects which makes chemical and
biological agents such an attractive weapon for a
terrorist is the high shock value of these weapons.
(F) The Office of Technology Assessment estimated
that 100 kilograms of anthrax released upwind in an
American city could cause between 130,000 and 3,000,000
deaths, depending on the weather and other variables.
This degree of carnage is in the same range as that
forecast for a hydrogen bomb.
(3) The threat of terrorism using radiological weapons is
real.
(A) In April 2000, customs officers from Uzbekistan
discovered 10 lead-lined containers at a remote border
crossing with Kazakhstan. These containers were filled
with enough radioactive material to make dozens of
crude weapons, each capable of contaminating a large
area for many years. The consignment was addressed to a
company in Quetta, Pakistan, called Ahmadjan Haji
Mohammed. Quetta, where border controls are virtually
non-existent, is the main Pakistani crossing into
southern Afghanistan and only a 6 hour drive from
Kandahar.
(B) In 1994 Czech police seized 3 kilograms of
highly enriched uranium. During the same year German
police seized 360 grams of plutonium. In 2001 Turkish
police seized two men with 1.16 kilograms of weapons
grade uranium. Russian general Alexander Ledbed claimed
that 40 suitcase nuclear weapons were unaccounted for.
(C) In 1995 Islamic Chechen rebels announced, and
Russians confirmed, that they had planted a 30 pound
shielded container holding the Cesium-137 core of a
cancer treatment device in a Moscow park.
(D) The International Atomic Energy Agency, a
Vienna-based division of the United Nations, has
documented almost 400 cases of trafficking in nuclear
or radiological materials since 1993. Many such
supplies are subject to few controls or are poorly
guarded, particularly in the former Soviet Union.
Reports also have cited weak protection of spent fuel
at nuclear facilities in the United States. Other
experts worry about the security of the nuclear
facilities in Pakistan, India, and other developing
countries. An estimated 1300 kilograms of highly
enriched uranium and 180,000 kilograms of plutonium,
the main fuels for a nuclear device, exists in civilian
nuclear facilities around the world. There are nearly
450 nuclear power plants, nearly 300 nuclear research
reactors, and 250 nuclear fuel cycle plants around the
world.
(E) In September 1987, scavengers broke into an
abandoned cancer clinic in Goiania, Brazil and stole a
medical device containing large amounts of radioactive
cesium-137. An estimated 250 people were exposed to the
source, eight developed radiation sickness, and four
died.
(F) A crude but deadly radiation dispersal device
(RDD) fashioned from stolen nuclear material (from a
nuclear waster processor, a nuclear power plant, a
university research facility, a medical radiotherapy
clinic, or an industrial complex) and a few sticks of
dynamite could spread radioactive material across an
area without a nuclear detonation. Such a weapon could
kill many, contaminate a square mile for 10 years or
more, and cause widespread panic. The Chernobyl nuclear reactor
meltdown in 1986 resulted in the uninhabitability of a 6 mile belt
around the reactor. That area is still uninhabitable today. It released
about 400 times as much radioactivity at the Hiroshima bomb. Half of
the atoms in a sample of cobalt-60 will disintegrate over a 5 year
period, but it takes 430 years for half of the atoms in a sample of
Americium-241 to decay.
(G) Even more threatening, during the Cold War the
United States and the Soviet Union fashioned a few
hundred portable nuclear weapons and some of the Soviet
weapons might fall into the hands of terrorists.
(H) The panic at dispersal or detonation of such a
device might well be much more damaging than the
morbidity and mortality. Radiation is invisible and
there is widespread fear of it. Few would understand
the difference between a dirty and a nuclear bomb.
(I) Such a device or bomb can cause exposure to a
variety of radioactive materials, including Plutonium,
enriched or depleted Uranium, Radium, Cesium,
Strontium, Cobalt, Iodine, Americium, etc.
(J) Such exposure can cause immediate death, as
well as adverse effects on radiosensitive tissues,
including suppression of white and red blood stem and
platelet cells production. Acute Radiation Syndrome
(ARS), Central Nervous System syndrome (CNS),
gastrointestinal syndrome, and bone marrow radiation
syndrome are early effects of substantial acute
exposure to ionizing radiation. Leukemia and other
forms of cancer can arise many years after exposure
even to lower doses. Other symptoms include nausea,
vomiting, hair loss, diarrhea, hemorrhages, and
internal bleeding. The United States has only one
hospital emergency room dedicated to treating patients
exposed to radiation hazards, at Oak Ridge, Tennessee.
(K) Medical responses currently available with
respect to exposure to radioactive materials are rather
limited and can include use of chelation agents to
speed secretion of radioactive metals from the body if
radioactive material was swallowed or inhaled,
preventive blocking of thyroid uptake of radioactive
iodine by use of potassium iodine tablets, and use of
Investigational New Drugs like Prussian Blue.
(L) The United States needs to develop additional
medical responses, including antiemetics, hematological
colony-stimulating factors, and chelating agents. The
United States also needs to develop better means of
assessing radiation exposure using new molecular,
biological, physical and other technologies.
(M) The ill-defined and uncontrolled nature of
radiation exposure and nuclear accidents usually causes
a non-uniform exposure with the variable dose
distribution complicating dosimetry, which is important
for medical management of exposed patient with a need
to determine the degree to which bone marrow or
gastrointestinal stem cells have survived.
(4) The United States must take steps to prevent access to
the biological and chemical agents and toxins and radiological
materials by terrorists and others, but attacks may nonetheless
occur. The United States needs to respond to attacks with well-
coordinated public health measures. We also need a broad array
of effective diagnostics and medicines to rapidly identify and
treat those who are exposed to, or infected by, the agents,
toxins, or materials.
(5) The United States faces a public health crisis with the
spread of antibiotic resistant bacteria. This alone should lead
us to take urgent action to develop new vaccines and medicines.
The antibiotic vancomycin, our last line of defense against the
often deadly bacterium, Staphylococcus aureus, is losing its
effectiveness. Worldwide, many strains of S. aureus are already
resistant to all antibiotics except vancomycin. Emergence of
strains lacking sensitivity to vancomycin signifies that
variants untreatable by every known antibiotic are on their
way. S. aureus, a major cause of hospital-acquired infections,
has thus moved one step closer to becoming an unstoppable
killer. What is more, strains of at least three bacterial
species capable of causing life-threatening illnesses
(Enterococcus faecalis, Mycobacleriumn tuberculosis and
Pseudomonas aeruginosa) already evade every antibiotic in the
clinician's armamentarium, a stockpile of more than 100 drugs.
In part because of the rise in resistance to antibiotics, the
death rates for some communicable diseases (such as
tuberculosis) have started to rise again, after having declined
in the industrial nations.
(6) The possibility exists that terrorists or others will
use biotechnology techniques to enhance the lethality of a
biological agent. According to the Defense Science Board,
``Motivated researchers using advanced genetics techniques can
engineer pathogens with unnatural characteristics that enhance
their offensive properties by altering such characteristics as
stability, dissemination properties, host range,
contagiousness, resistance to drugs and vaccines, and
persistence in the environment, among others''.
(7) Vaccines exist for some of the biological agents that
might be used by terrorists and others, but these vaccines need
substantial additional development. The development of new
vaccines is a difficult, costly, and time-consuming endeavor
with no assurance of success. In the last 25 years, the Federal
Government though its efforts to protect the public health and
the military against disease has successfully developed very
few new vaccines. The development of vaccines against highly
lethal bioterror agents may face far greater difficulties. For
such vaccines often there may be no animal model or the animal
will be of questionable value. The development of vaccines
against many such disease agents will require clinical trials
in countries where the disease agent in endemic and the
prevalence of infection is sufficiently high to prove efficacy.
The current United States vaccine against anthrax was
formulated in the 1960s and licensed in 1970. Before and
subsequent to the licensing of this vaccine in the United
States, additional preclinical and clinical studies have been
conducted to confirm its safety and efficacy. The current Food
and Drug Administration-licensed immunization schedule for the
anthrax vaccine involves 6 doses over 18 months followed by
yearly boosters. Since this is a cumbersome schedule for
immunizing both military personnel and civilian laboratory
workers and first responders at occupational risk of exposure
to the biothreat from an anthrax attack, the Centers for
Disease Control and Prevention has initiated multi-center
studies to develop the next generation of the anthrax vaccine
by reducing the number of doses and changing its route of
administration. Additional early development phase studies of
experimental recombinant and live attenuated anthrax vaccines
are underway to determine their suitability, safety and
efficacy.
(8) Treatments for those who are not protected by vaccines
are often not effective. Inhalation anthrax (woolsorters'
disease) results from inhaling anthrax spores disseminated from
either a natural source or a biological attack and, if
untreated, it is considered to be 99 percent fatal. Antibiotics
and standard interventions provided after symptoms have
developed rarely prevent a fatal outcome.
(9) The United States does not currently have available the
diagnostics, drugs, and vaccines needed in the event of a
bioterror attack. It has been estimated by the Defense Science
Board that the United States is adequately protected with
respect to only 13 of the top 50 pathogens that might be
weaponized. For example, while the United States has a vaccine
for smallpox, that vaccine has side effects and is one that
cannot be well tolerated by many, and for those who are
infected, the United States has no effective treatment. The
United States has a treatment for early stage inhalation
anthrax, but those treatments are ineffective when there are
delays in diagnosis. The United States has very few products
that are effective against viruses. The United States is not
well protected with broad-spectrum antibiotics that are needed
to deal with pathogens that have been modified or selected for
antibiotic resistance. It takes more than 24 hours to diagnose
many of the most dangerous pathogens.
(10) A ring vaccination strategy may well be impossible to
implement given the mobility of Americans. Twenty-three million
international airline passengers embarked or disembarked at
United States airports in the fourth quarter of 2001. Nearly
500,000,000 people crossed the United States-Canada and United
States-Mexico boarders by land in 2000. Tens of millions of
people each day cross from one metropolitan area to another.
For the same reasons, it may not be possible to enforce a
quarantine. If, however, the United States has safe and
effective treatments to deploy, there will be less need to
attempt to implement a ring vaccination strategy or quarantine.
(11) Vaccines and treatments for exposure to nerve toxins
and radiological materials do not exist or are ineffective.
(12) The United States Government is directly funding
biomedical research on vaccines and treatments for biological
and chemical agents and radiological materials. These funding
efforts could be matched many-fold if the 1,500 biotechnology
companies, 100 pharmaceutical companies, medical device and
research tool companies, and research institutions were able to
secure the funding from private investors, or justify the
investment of retained earnings, to conduct this research.
(13) The enactment of tax, procurement, patent, liability,
and other incentives will enable the biotechnology,
pharmaceutical, device, and research tool industries to raise
equity and other capital from investors to fund research on
countermeasures for biological, chemical, and radiological
attacks. This will supplement direct Federal funding for this
research and speed development of life saving technologies. The
existence of these technologies will reassure the public that
if attacks occur, effective medical treatments are available
and there is no reason for panic.
(14) Past efforts by agencies of the Federal Government to
contract for the development and manufacture of countermeasures
have been, and likely will continue to be, ineffective. These
efforts have been under-funded, too complex, financially
restrictive, and unreliable and therefore have failed to
attract the commitment of capital and research-intensive
biotechnology, pharmaceutical, medical device, and research
tool companies. These shortcomings are likely to be even more
apparent and severe with respect to proposals to use Federal
taxpayer dollars for Federal Government construction,
ownership, and operation of research and development and
manufacturing facilities for the production of vaccines for
military and civilian use (GOGOs and GOCOs) or for the
establishment of a National Vaccine Authority for the research
and development and production of vaccines for the protection
of civilians against bioterrorist attacks. These federalized
proposals will result in significantly higher costs for
taxpayers, add significant additional layers of Federal
bureaucracy, and delay the availability of needed
countermeasures.
(15) Efforts by the Department of Defense to acquire drugs
and vaccines for bioterror agents have been ineffective. The
Defense Science Board has found that ``DOD has failed to
implement a proactive strategy for engagement of the private
sector in gaining access to new technologies relevant to
biodefense . . . (There are) significant obstacles to
engagement of the private sector. Neither the DOD nor the
nation can achieve a robust biodefense without engagement of
private sector R&D and leading scientists in academia and
closer ties to industry . . . A program of longer-term
investment in new R&D initiatives to address major gaps in drug
and vaccine coverage is crucial but it will take 10 to 15 years
to bring such investments to fruition.''
(16) The Defense Science Board has noted the ``private
sector's declared lack of interest in seeking Government R&D
contracts.'' It has found that the ``medical-related industry
differs from traditional defense industries. The financial
disincentives inherent in producing products for limited
markets (i.e. DOD only) with no commitment to longterm supply
in the face of massive capitalization needs and the long,
multi-year lead times to build new manufacturing facilities for
drugs, biologics, and vaccines are considerable. Nonetheless,
it is difficult to see how DOD or the nation can pursue a
successful biodefense strategy if they do not engage leading
companies and top scientists from outside the physics/
engineering circles of traditional defense contractors.''
(17) This Act is premised on the belief that the most
effective strategy is to capitalize on the experience and
entrepreneurship of America's world preeminent biotechnology,
pharmaceutical, medical device, research tool companies, and
research institutions engaged in this research, development,
and manufacturing at their own risk, their own expense, for
their own good business reasons.
SEC. 3. AMENDMENT TO HOMELAND SECURITY ACT OF 2002.
The Homeland Security Act of 2002 (Public Law 107-296) is amended
by adding at the end thereof the following:
``TITLE XVIII--BIOLOGICAL, CHEMICAL, AND RADIOLOGICAL COUNTERMEASURES
RESEARCH
``SEC. 1801. SHORT TITLE.
``This title may be cited as the `Biological, Chemical, and
Radiological Weapons Countermeasures Research Act of 2003'.
``SEC. 1802. DEFINITIONS.
``In this title:
``(1) Biological or chemical agent; toxin; nuclear or
radiological material; terror weapon.--The term--
``(A) `biological agent', `biological toxin',
`chemical agent', or `chemical toxin', or any variation
of any such term, means any microorganism, virus,
infectious substance, biological product, toxic or
poisonous chemical, or precursor of a toxic or
poisonous chemical, that may be used in a manner that
is intended to cause widespread death or serious bodily
injury, including biological agents and toxins
described in paragraphs (1) and (2) of section 178 of
title 18, United States Code;
``(B) `nuclear or radiological material' means any
radioactive material that may be used in a manner that
is intended to cause widespread death or serious bodily
injury; and
``(C) `terror weapon' and `weapon of mass
destruction' mean any matter described in subparagraph
(A) or (B) that may be used in a manner that is
intended to cause widespread death or serious bodily
injury.
``(2) Countermeasures.--The term `countermeasures' means--
``(A) a vaccine and related delivery system,
antiviral, microbicide, diagnostic technology, drug, or
other technology that can be used to diagnose, treat,
or prevent infection with or bodily harm from, or the
spread of, a biological or chemical agent or toxin on
the list described in section 1811, and that is subject
to applicable provisions of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.), the Public Health
Service Act (42 U.S.C. 201 et seq.), or the Virus-
Serum-Toxin Act (21 U.S.C. 151 et seq.); and
``(B) a therapy, diagnostic, or piece of equipment
that may be used to detect, treat, or prevent bodily
harm that may be caused by the use of nuclear or
radiological material as a terror weapon.
``(3) Department.--The term `Department' means the
Department of Homeland Security.
``(4) Detection equipment.--The term `detection equipment'
means a device for the detection of the presence,
concentration, or characteristics of a biological, chemical, or
radiological agent in evironmental or field samples.
``(5) Development.--The term `development' or `to develop'
includes research leading to the identification and isolation
of suitable compounds or biological materials, engineering/
modification, production, and formulation of such compounds or
materials, the conduct of preclinical and clinical studies, the
preparation of an application for marketing approval, and other
actions related to preparation of a countermeasure.
``(6) Diagnostics.--The term `diagnostics' includes
products, devices, and technologies to detect, identify, or
analyze, the potential presence or absence of 1 or more
biological or chemical agents or toxins in patient samples to
enable effective medical intervention through the
administration of appropriate countermeasures.
``(7) Manufacturer.--The term `manufacturer' means an
entity responsible for research, development, and production of
a terror weapons countermeasure and, except for countermeasures
that are not subject to review and approval by the Food and
Drug Administration prior to marketing (such as research
tools), the potential or actual holder of the approved new drug
application, biologic license application, or product license
application or equivalent for such countermeasure. Such term
does not require that a manufacturer conduct the actual
research, development, or production in its own facilities, but
may enter into arrangements with third parties including
contracts and cooperative agreements for research, development,
or production of the countermeasure.
``(8) Research tool.--The term `research tool' includes the
full range of tools that scientists may use in the laboratory,
including cell lines, monoclonal antibodies, reagents, drug
delivery technologies, vaccine adjuvants, laboratory animals-
large animals including nonhuman primates, growth factors,
combinatorial chemistry and DNA libraries, clones and cloning
tools (such as PCR), methods, laboratory equipment and
machines, databases, and other technologies that enable the
rapid and effective development of countermeasures, including
diagnostics, vaccines, and drugs.
``(9) Secretary.--The term `Secretary' means the Secretary
of the Department of Homeland Security.
``Subtitle A--Strategy for the Development of Countermeasures
``SEC. 1811. BIOLOGICAL, CHEMICAL AND RADIOLOGICAL AGENT, TOXIN, AND
MATERIAL COUNTERMEASURE RESEARCH PRIORITY LIST.
``(a) Development.--
``(1) In general.--Not later than 180 days after the date
of enactment of this title, the Secretary, in consultation with
the Secretary of Defense and the Secretary of Health and Human
Services, shall develop and make available to potential
manufacturers of terror weapons countermeasures and, except as
provided in paragraph (5) publish, a list of biological and chemical
agents and toxins and nuclear and radiological materials that may be
used as weapons of mass destruction with respect to which the Secretary
finds that research to develop new and improved countermeasures is in
the national security interest of the United States.
``(2) Requirements.--
``(A) In general.--The Secretary shall only include
on the list developed under paragraph (1) agents,
toxins, and materials--
``(i) that pose a significant security or
medical threat to the United States military
and intelligence personnel, government
officials, or civilians;
``(ii) that are more likely to be subject
to a countermeasure that is developed as a
result of the availability of the tax,
procurement, intellectual property, liability,
and other provisions of this title (and the
amendment made by the Biological, Chemical, and
Radiological Weapons Countermeasures Research
Act); and
``(iii) with respect to which safe and
effective countermeasures are not available or
with respect to which the development of safer
and more effective countermeasures, or
countermeasures that may be deployed more
safely or effectively, is in the public
interest.
``(B) Certain determinations.--For purposes of
subparagraph (A)(ii), in determining whether the
agents, toxins, and materials are more likely to be
subject to a countermeasure, the Secretary shall
consider--
``(i) the status of existing public and
private sector research to develop such
countermeasure;
``(ii) the status of public and private
sector research that could be adapted or
redirected to develop such countermeasure;
``(iii) the availability of products that
could be utilized as countermeasures;
``(iv) the extent to which such
countermeasures may be utilized for purposes
other than as a countermeasure for a biological
agent or toxin or radiological material on the
list developed under this section;
``(v) the extent to which market-based
reimbursement is available for uses of the
countermeasure other than as a countermeasure
for a biological agent or toxin or radiological
material on the list developed under this
section; and
``(vi) the most effective strategy for
expediting development of such countermeasure,
including reliance on Government contracts,
grants and cooperative research agreements and
utilization of the incentives provided for in
this title (and the amendments made by the
Biological, Chemical, and Radiological Weapons
Countermeasures Research Act).
``(3) Use of existing lists and data.--The list developed
under paragraph (1) may, at the discretion of the Secretary,
make reference to or incorporate elements of the list of
biological agents and toxins established and maintained by the
Secretary of Health and Human Services under section 351A of
the Public Health Service Act (as added by section 201 of the
Public Health Security and Bioterrorism Preparedness and
Response Act of 2002) and under section 178 of title 18, United
States Code.
``(4) Information and determinations relating to potential
manufacturers.--With respect to the list developed under
paragraph (1), the Secretary shall--
``(A) provide such information regarding such
weapons of mass destruction as the Secretary determines
to be necessary to enable such potential manufacturers
to structure and manage their research and development
programs for the development of terror weapons
countermeasures; and
``(B) determine when such a manufacturer has
successfully developed a countermeasure and therefore
becomes entitled to the procurement, intellectual
property, market exclusivity, and liability provisions
of this title (or an amendment made by the Biological,
Chemical, and Radiological Weapons Countermeasures
Research Act), except that in the absence of such a
determination, the approval of the Food and Drug
Administration of the manufacturer's new drug
application, biologic license application, or product
license application for a countermeasure to an agent or
toxin listed by the Secretary shall be deemed to be a
determination of successful development of a safe and
effective countermeasure and entitle the manufacturer
to the same benefits as though the determination was
made by the Secretary.
``(5) Exemption.--
``(A) In general.--The Secretary may exempt certain
information concerning weapons of mass destruction from
publication if the Secretary determines that such
publication would (or could) be detrimental to the
security of the United States. In providing an
exemption under the preceding sentence, the Secretary
shall develop procedures for making such list or
information available on a confidential basis to
potential manufacturers of countermeasures.
``(B) Sufficiency of information.--In developing
the procedures described in subparagraph (A), the
Secretary shall ensure that the information provided to
potential manufacturers of countermeasures is
sufficient to enable the Federal Government and the
manufacturer to determine when such a manufacturer has
successfully developed a countermeasure and therefore
becomes entitled to the procurement, intellectual
property, and liability provisions of this title (or an
amendment made by the Biological, Chemical, and Radiological Weapons
Countermeasures Research Act).
``(b) Initial List.--The initial list developed under subsection
(a) may, at the discretion of the Secretary, contain the following
biological agents and diseases caused by biological agents, chemical
toxins, and nuclear and radiological materials:
``(1) Variola major (confluent, flat, and hemorrhagic
smallpox).
``(2) Bacillus anthracis (anthrax).
``(3) Clostridium botulinum (botulism).
``(4) Francisella tularensis (tularemia).
``(5) Yersina pestis (Black Death: bubonic plague,
pneumonic plague).
``(6) Filoviridae (Ebola hemorrhagic fever).
``(7) Filoviridae (Marbug hemorrhagic fever).
``(8) Arenaviridae (Lassa fever).
``(9) Arenaviridae Junin (Argentine hemmorrhagic fever).
``(10) Filoviridae (Crimean-Congo Hemmorrhagic Fever).
``(11) Coxiella burnetti (Q fever).
``(12) Coccidioidomycosis (San Joaquin Valley or desert
fever).
``(13) Clostridium perfringens (gas gangrene, necrotizing
enteritis).
``(14) Chlamydia psittaci (parrot fever).
``(15) Bunyaviridae (Rift Valley Fever).
``(16) Rickettsia rickettsii (Rocky Mountain Spotted
Fever).
``(17) Brucella species (brucellosis).
``(18) Burkholderia mallei (glanders).
``(19) Arboviridae (Venezuelan encephalomyelitis).
``(20) Arboviridae (Eastern and Western equine
encephalomyelitis).
``(21) Ricin toxin from ricinus communis (castor beans).
``(22) Trichothcene Mycotoxins (Yellow Rain).
``(23) Dinoflagellate neurotoxin (Paralytic Shellfish
Toxin).
``(24) Aflatoxins.
``(25) Epsilon toxin of clostridium perfringens (CNS
effects, lethal).
``(26) Staphylococcus enterotoxin B (Staphylococcus
entertoxin B intoxication).
``(27) Salmonella species (gastrointestinal upset, enteric
fever).
``(28) Salmonella Typhi (typhoid fever).
``(29) Shigella dysenteriae (dysentery, hemolytic-uremic
syndrome).
``(30) Escherichia coli 0157:H7 (severe diarrhea,
hemolytic-uremic syndrome).
``(31) Vibrio cholerae (cholera).
``(32) Cryptosporidium parvum.
``(33) Nipah virus.
``(34) Bunyaviridae (Hantaviruses).
``(35) Tickborne homorrhagic fever viruses.
``(36) Tickborne encephalitis virus.
``(37) Flaviviridae (Yellow fever).
``(38) Plasmodium falciparum, P. ovale, P. vivax, P.
malariae (Malaria).
``(39) Rickettsia typhi (typhus).
``(40) Antibiotic resistant tuberculosis.
``(41) Entamoeba histolytica (amebiasis).
``(42) Shigella sp. (bacillary dysentery, Shigellosis).
``(43) Giardia lamblia (giardiasis).
``(44) Trichomonas vaginalis (trichomoniasis).
``(45) Trypanosoma brucei gambiense or rhodesiense
(trypanosomiasis, sleeping sickness).
``(46) Leishmania donovane (visceral leishmaniasis, black
fever, Kala Azar).
``(47) Nerve agents (including Tabun, Sarin, Soman, GF, VX,
V-gas, third generation nerve agents and organophosphate
pesticides).
``(48) Blood agents (including hydrogen cyanide and
cyanogen chloride).
``(49) Blister agents (including Lewisite, nitrogen and
sulfur mustards).
``(50) Heavy metals (including arsenic, lead, and mercury).
``(51) Volatile toxins (including benzene, chloroform, and
trihalomethanes).
``(52) Pulmonary agents (including phosgene and chlorine
vinyl chloride).
``(53) Incapacitating agents (including BZ).
``(54) Nuclear and radiological materials.
``(55) Exotic agents including hybrid organisms,
genetically modified organisms, antibiotic-induced toxins,
autoimmune peptides, immune mimicry agents, binary bioweapons,
stealth viruses, and bioregulators and biomodulators.
``(c) Revisions.--The Secretary shall revise the list developed
under subsection (a) on at least an annual basis, and make such list
available, under the terms and limitations described in this section,
to potential manufacturers of terror weapons countermeasures or to
holders of approved certifications. Such terms and conditions shall be
consistent with the security interests of the United States.
``(d) No Judicial Review.--Notwithstanding any other provision of
law, there shall be no judicial review of the Secretary's
determinations regarding which agents, toxins, or materials to include
on the list, or revised list, developed under this section or of a
determination to exempt information from public distribution under this
section.
``(e) Procurement.--
``(1) Purpose.--It is the purpose of this subsection to
provide potential manufacturers of countermeasures that are
registered with the Department under section 1812 with
sufficient information to enable that manufacturer to structure
and manage its research and development of a terror weapons
countermeasure and to determine when the manufacturer has
successfully developed such a countermeasure and therefore
becomes entitled to the procurement, intellectual property, and
liability incentives provided for under this title (or an
amendment made by the Biological, Chemical, and Radiological
Weapons Countermeasures Research Act).
``(2) Federal government success and market
determination.--Not later than 180 days after the development
of the list, or revised list, under subsection (a), the Secretary, in
consultation with the Food and Drug Administration, shall, with respect
to each agent, toxin, or material on the list, determine--
``(A) the type of countermeasure to be developed,
including whether such countermeasure is a diagnostic,
vaccine, biological, drug, or other countermeasure;
``(B) the testing and clinical trial standards that
will be required with respect to the countermeasure, in
order for the manufacturer to become entitled to
procurement, intellectual property, and liability
provisions of this title (or an amendment made by the
Biological, Chemical, and Radiological Weapons
Countermeasures Research Act), including the terms of
review of the countermeasure by the Food and Drug
Administration and whether the approval of such
Administration is required;
``(C) the safety and efficacy profile of the
countermeasure;
``(D) the projected utilization of such
countermeasure in combination;
``(E) the Federal procurement market that will be
available to the manufacturer of such countermeasure,
including the minimum number of dosages or units that
will be purchased, the minimum price per dose or unit,
and the timing and minimum number of years projected
for such purchases;
``(F) the advance, partial, progress, milestone or
other payments that may be available to the
manufacturer under section 1822, and the terms and
conditions for the adjustment of any such payments for
uncontrollable factors; and
``(G) such other information as the manufacturer
may reasonably request to enable the manufacturer to
structure and manage research and development
activities and determine when a countermeasure has been
successfully developed therefore entitling the
manufacturer to the procurement, intellectual property,
and liability provisions of this title (or an amendment
made by the Biological, Chemical, and Radiological
Weapons Countermeasures Research Act).
``(3) Determinations.--
``(A) In general.--The Secretary shall make
determinations with respect to the successful
development of countermeasures under section
1812(d)(3).
``(B) Testing and clinical trials.--The
determination by the Secretary under paragraph (2)(B)
with respect to the testing and clinical trial
standards that will be required shall apply only to the
entitlement of the manufacturer to the procurement,
intellectual property, and liability provisions of this
title (or an amendment made by the Biological,
Chemical, and Radiological Weapons Countermeasures
Research Act). Nothing in this title shall be construed
otherwise to alter or affect the authority of the Food
and Drug Administration with respect to the testing,
clinical trial, or other regulatory standards
applicable to the countermeasure involved.
``(C) No judicial review.--Notwithstanding any
other provision of law, there shall be no judicial
review of determinations made by the Secretary under
this subsection.
``(4) Revisions.--The Secretary is authorized to--
``(A) revise upward determinations under
subparagraphs (E) and (G) of paragraph (2) with respect
to minimum number of dosages that will be purchased and
minimum price per dose and the advance, partial,
progress, milestone or other payments that may be
available to the manufacturer upon a determination that
such revision is necessary to protect the national
security interests of the United States and provide an
effective incentive to entities developing
countermeasures; and
``(B) revise determinations under paragraph (2)(C)
to reduce the requirements of safety and efficacy
profiles for purposes of the successful development
determination pursuant to paragraph (3) upon a
determination that such a revision is in the best
interests of the United States.
``SEC. 1812. RESEARCH REGISTRATION REQUIREMENTS.
``(a) In General.--On or before December 31 of each year each
entity that operates any private sector establishment in any State that
seeks to be eligible for the tax, procurement, intellectual property,
and liability provisions in subtitle B (and the amendments made by
sections 4 through 9 of the Biological, Chemical, and Radiological
Weapons Countermeasures Research Act), and that is engaged in the
conduct of research to develop countermeasures, detections equipment
(as provided for in section 1813), diagnostics (as provided for in
section 1814), or research tools (as provided for in section 1815)
shall register with the Department. Such registration shall contain--
``(1) the name and address of the entity;
``(2) the name and address of the establishment at which
the research is being conducted;
``(3) the name of the agent, toxin, or material with
respect to which the entity seeks to develop countermeasures,
detection equipment, diagnostics or research tools;
``(4) a description of the research that is being, or that
will be, conducted to develop countermeasures to, or detection
equipment, diagnostic or research tools with respect to, such
agent, toxin, or material;
``(5) a description of the capability of the entity,
including its technology and personnel, to develop
countermeasures to such agents, toxins, or material that meet
the safety and efficacy profiles specified by the Secretary;
``(6) the name of each individual who is conducting the
research involved;
``(7) the procedures that the entity will follow to ensure
that the security interests of the United States are met; and
``(8) any other information required under regulations
promulgated by the Secretary, including additions and
corrections to the information required under this subsection
as may be required by the Secretary through regulation.
``(b) Availability of Information.--
``(1) In general.--Not later than 90 days after the date of
enactment of this title, the Secretary shall promulgate
regulations with respect to the availability of information
under this subsection.
``(2) Inspections.--Subject to regulations promulgated
under paragraph (1), the Department shall make available for
inspection, to any person so requesting, any registration filed
pursuant to subsection (a), except as provided in paragraph
(3).
``(3) Certain information not available.--The Secretary
shall promulgate regulations to exempt certain information from
disclosure under paragraph (2). Such regulations shall exempt
from publication and disclosure trade secret and commercial or
financial information which is exempt from disclosure to the
public under section 552(b)(4) of title 5, United States Code,
national security information, and information affecting the
security of research and other facilities.
``(4) No judicial review.--Notwithstanding any other
provision of law, there shall be no judicial review of
determinations made by the Secretary to exempt information
under paragraph (3), except that this paragraph shall not apply
to judicial review of the failure to exempt from publication
and disclosure trade secret and commercial or financial
information, national security information, and information
affecting the security of research and other facilities.
``(c) Reports.--
``(1) In general.--The Secretary shall promulgate
regulations that prescribe the reports that each establishment
that is registered with the Department under this section shall
be required to file with the Secretary. Such regulations shall
limit such reports to those necessary to enable the Secretary
to--
``(A) ensure that the capital derived by the
utilization of the tax incentives provided for in
subtitle B (and the amendments made by section 4 and 5
of the Biological, Chemical, and Radiological Weapons
Countermeasures Research Act) is used to fund the
research that is the subject of the registration and
certification under this section;
``(B) determine the status of the research
involved; and
``(C) determine the outlook for United States
preparedness for a biological, chemical, or
radiological attack.
``(2) No public disclosure.--Notwithstanding any other
provision of law, reports under this subsection, and the
contents of such reports, shall be exempt from disclosure to
the public. The submission of the reports required under this
subsection to the Federal Government shall not constitute
public disclosure or public use of the reports, or the
information contained therein, and shall not vest any
intellectual property rights relating to discoveries or
inventions derived from such information, or any intellectual
property rights in such information, in the United States or
any person or entity.
``(d) Certification.--
``(1) In general.--With respect to each entity that
registers with the Department under this section, the
Secretary, in consultation with the Secretary of Health and
Human Services, shall determine--
``(A) whether the research to be conducted under
such registration is directed to lead to the
development of a--
``(i) countermeasure with respect to a
biological or chemical agent or radiological
material on the list under section 1811;
``(ii) detections equipment with respect to
the list developed under section 1813;
``(iii) diagnostic with respect to the list
developed under section 1814; or
``(iv) research tool with respect to the
list developed under section 1815;
``(B) whether the entity is qualified to conduct
research to develop the countermeasure with respect to
which the entity seeks certification, and, with respect
to such determination, the Secretary shall not presume
that the entity is unqualified because the entity has
not previously secured approval of the Food and Drug
Administration of a device, drug, or biologic, nor
shall the Secretary presume that the entity is
unqualified because the entity itself lacks research
laboratories, testing facilities, or manufacturing
facilities as research, testing, and manufacturing
services are reasonably available through contracts
with third parties and collaborative agreements; and
``(C) whether the procedures of the entity will
ensure compliance with section 351A of the Public
Health Service Act (as added by section 201 of the
Public Health Security and Bioterrorism Preparedness
and Response Act of 2002.
``(2) Inspection.--The Department shall be authorized to
require the inspection of an entity seeking certification as a
precondition to such certification to the extent necessary to
enable the Secretary to make the determinations required under
subparagraphs (A) through (C) of paragraph (1) pursuant to
regulations promulgated by the Secretary.
``(3) Determination.--If the Secretary makes an affirmative
determination under paragraph (1) with respect to an entity--
``(A) the Secretary shall certify the entity as
being entitled to utilize the tax incentive provisions
described in section 1821 (and the amendments made by
section 4 of the Biological, Chemical, and Radiological
Weapons Countermeasures Research Act); and
``(B) the Secretary shall enter into a written
agreement with the entity setting forth the agreement
of the parties to the contract with respect to the
issues raised as a result of the determinations made
under section 1811(e)(2) and the terms and conditions
to be offered by the Secretary pursuant to subsection
(e)(2) upon the Secretary's determination pursuant to
such subsection (e) that the entity successfully has
developed the countermeasure, detection equipment,
diagnostic, or research tool, including the Secretary's
agreement regarding the availability of the liability
protections provided for under section 1824.
The execution by the parties of the agreement described in
subparagraph (B) shall create vested contractual rights in the
certified entity, including with respect to procurement by the
government upon successful development of the relevant
countermeasure, detection equipment, diagnostic, or research
tool.
``(e) Successful Development.--Not later than 90 days after the
date on which a certified entity submits to the Secretary an
application for a determination that the entity has successfully
developed a terror weapons countermeasure in accordance with section
1811(e)(2), detections equipment in accordance with section 1813,
diagnostic in accordance with section 1814, or research tool in
accordance with section 1815, and the terms of the agreement of the
parties pursuant to subsection (d)(3)(B), the Secretary shall notify
the entity--
``(1) of such determination; and
``(2) in the case of an affirmative determination by the
Secretary with respect to the countermeasure, detection
equipment, diagnostic, or research tool involved, that the
entity shall be entitled to--
``(A) procurement of the countermeasure, detection
equipment, diagnostic, or research tool under the terms
and conditions of the parties agreement pursuant to
subsection (d)(3)(B), upon the Secretary's execution of
a contract consistent with such agreement, or based on
such other terms more favorable to the entity as shall
be deemed by the Secretary to be in the interests of
national security and agreed to by the entity;
``(B) the patent restoration and extension
protection under section 156a or 158 of title 35,
United States Code, as added by section 5 of the
Biological, Chemical, and Radiological Weapons
Countermeasures Research Act;
``(C) the market exclusivity provisions of sections
505(c)(3)(D) and 505(j)(4)(D) of the Federal Food,
Drug, and Cosmetic Act (as amended by section 505B);
and
``(D) the liability protections provided for under
section 1824 to the extent that the Secretary agreed to
such protections in the parties agreement pursuant to
subsection (d)(3)(B) or determines that the provision
of such protections is in the national interests.
``(f) Required Affirmative Determination.--The Secretary shall make
an affirmative determination that an entity has successfully developed
a terror weapons countermeasure, detection equipment, diagnostic, or
research tool under this section if, with respect to the testing and
clinical trial standards and the safety and efficacy profile of the
countermeasure referred to in subparagraphs (B) and (C) of section
1811(e)(2) and set forth in the parties' agreement pursuant to
subsection (d)(3)(B), such countermeasure, detection equipment,
diagnostic, or research tool--
``(1) has been authorized under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.) and the Public Health
Service Act (42 U.S.C. 201 et seq.) for introduction or
distribution into commerce;
``(2) has not been authorized for such introduction or
distribution into commerce under subparagraph (A) but has been
authorized for investigation or compassionate use as a terror
weapons countermeasure, detection equipment, diagnostic, or
research tool under such Acts and the Secretary determines that
significant quantities of the countermeasure, detection
equipment, diagnostic, or research tool have been manufactured
by or on behalf of the entity and are available for such
investigational or compassionate use; or
``(3) is not required by the parties' agreement to be
authorized for introduction or distribution in commerce or
investigational use under such Acts, but otherwise complies
with the requirements set forth in the agreement of the
parties.
``(g) Discretionary Affirmative Determination.--The Secretary is
authorized to make an affirmative determination that an entity has
successfully developed a terror weapons countermeasure, detection
equipment, diagnostic, or research tool within the meaning of
subsection (e) upon a determination that such a finding is in the
national interest.
``(h) Judicial Review.--An adverse determination by the Secretary
under subsection (f) with respect to the development by a manufacturer
of a terror weapons countermeasure, detection equipment, diagnostic, or
research tool within the meaning of this title, or the refusal or
failure of the Secretary to enter into a contract with the manufacturer
pursuant to subsection (e)(2)(A), shall be considered a final decision
of the agency with the meaning of section 702 of title 5, United States
Code, and shall be subject to appropriate judicial review. A plaintiff
who is successful in challenging an adverse determination by the
Secretary under subsection (f) may be awarded reasonable and ordinary
attorneys fees.
``(i) Eligibility of Entities With More Than $750,000,000 in
Aggregate Gross Assets, etc.--
``(1) Authority of secretary to waive aggregate gross
assets limitation.--Within 60 days of the request of an entity
for a certification under subsection (d)(1) or a determination
under subsection (d)(3), and upon a finding by the Secretary that it is
in the public interest, the Secretary may extend the entitlement to
utilize the tax incentives described in section 1821 (and the
amendments made by section 4 of the Biological, Chemical, and
Radiological Weapons Countermeasures Research Act) and the patent
restoration and extension protection described in section 1823 (and the
amendments made by section 5 of the Biological, Chemical, and
Radiological Weapons Countermeasures Research Act), to such an entity
with aggregate gross assets exceeding $750,000,000 (as defined in
section 1202(d)(2) of the Internal Revenue Code of 1986).
``(2) Waiver with regard to entities with net operating
losses.--Any entity obtaining a certification or determination
described in paragraph (1) shall be entitled to utilize the tax
incentives described in paragraphs (1), (2), and (3) of section
1821(b) and the patent restoration and extension protection
described in section 158 of title 35, United States Code, as
added by section 5 of the Biological, Chemical, and
Radiological Weapons Countermeasures Research Act, if such
entity's tax status in no fewer than 3 of the 5 taxable years
preceding such certification or determination is that of an
entity with net operating losses (as defined in section 172(c)
of the Internal Revenue Code of 1986).
``(3) Implementing rules.--The Secretary shall publish
appropriate rules to implement this subsection taking into
account the need to encourage participation by entities which
have not yet become profitable on a sustainable basis.
``(4) No judicial review.--Notwithstanding any other
provision of law, there shall be no judicial review of
determinations made by the Secretary with respect to waivers
under this subsection.
``(j) Rule of Construction.--Nothing in this section shall be
construed to prohibit--
``(1) a private sector establishment from filing more than
1 registration concerning research and from obtaining more than
1 certification of eligibility under this section;
``(2) a consortium, partnership, or joint venture of more
than one private sector establishment from filing one or more
registrations concerning research and obtaining one or more
certification of eligibility under this section; and
``(3) a private sector establishment from receiving Federal
grants, contracts, or cooperative agreements for research,
investigations, experiments, demonstrations, and studies in
addition to the incentives provided for under this title (and
the amendments made by the Biological, Chemical, and
Radiological Weapons Countermeasures Research Act).
``(k) Priority Access to Certain Research Results.--An entity that
is certified under this section shall be given priority access to the
results of research related to the epidemiology and pathogenesis of
agents, the genomes and other DNA analysis, or other comparative
analysis of agents, and other relevant research conducted under
subparagraphs (A), (B), and (C) of section 391F(h)(1) of the Public
Health Service Act (as added by section 125 of the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002.
``(l) Accelerated Approval.--An entity that is certified under this
section shall be eligible for accelerated approval of a countermeasure
as described in section 1831 and as provided for in section 122 of the
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002.
``(m) Priority for Technical and Other Assistance.--An entity that
is certified under this section shall be given priority for receiving
technical and other assistance to provide security for their personnel
and facilities that conduct development, production, distribution, or
storage of countermeasures under section 319K of the Public Health
Service Act (as added by section 124 of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002).
``SEC. 1813. DETECTORS INCENTIVES.
``(a) Findings.--Congress finds that--
``(1) early detection of a terrorist attack using a terror
weapon is critical in maximizing the ability of governments and
first responders to limit and manage the consequences;
``(2) with early detection, first responders can be quickly
deployed, containment areas can be established, and evacuation
plans can be implemented;
``(3) medical treatment is often more effective immediately
after an attack than it is at later stages of a disease;
``(4) detector systems must be integrated into
comprehensive response plans, including medical diagnostics and
other countermeasures;
``(5) such technology facilitates the determination of when
and where an attack has occurred, the identification of what
type of terror weapon has been utilized, and the extent and
dispersal of the agent, and must do so with a minimum of false
negative or false positive reports;
``(6) early detection is also critical in apprehending the
terrorists who have unleashed the terror weapon; and
``(7) a suite of detection devices, with different
sensitivities, is best capable of providing the timeliness,
range, and depth of information needed to detect and respond to
an attack.
``(b) Identification.--
``(1) In general.--Not later than 180 days after the date
of enactment of this title, the Secretary shall develop and
make available to potential manufacturers, a list of agents to
be detected as well as the standards and regulations under
which detection equipment will be evaluated and approved. The
detection targets shall include chemical or biological agents
or toxins or nuclear or radiological materials.
``(2) Availability of information.--The Secretary shall
provide such information as the Secretary determines to be
necessary to enable the potential manufacturers of terror
weapons detection equipment to structure and focus their
research and development programs for the development of such
equipment.
``(3) Revisions.--The Secretary shall revise the list
developed under paragraph (1) on at least an annual basis, and
make such list available to potential manufacturers of terror
weapons detections equipment under terms and conditions
consistent with the security interests of the United States.
``(4) No Judicial Review.--Notwithstanding any other
provision of law, there shall be no judicial review of the
Secretary's determinations regarding which agents, toxins, or
materials to include on the list, or revised list, developed
under this subsection.
``SEC. 1814. DIAGNOSTICS INCENTIVES.
``(a) Findings.--Congress finds that--
``(1) in the case of a bioterrorist attack, the United
States public health authorities need the capacity to quickly
and accurately diagnose the agent, toxin, or material involved
so that appropriate medical intervention can be implemented;
``(2) public health authorities need information on which
vaccines and drugs will be effective in preventing infection,
or in treating those who are infected, as a result of a
terrorist attack, and whether there are any existing vaccines
or drugs that are effective;
``(3) there is a lack of information on the complications
involved in administering vaccines and drugs via the use of
diagnostic devices to portions of society that are known or
unknown to carry contraindication diseases or conditions;
``(4) few diagnostics for agents, toxins, or materials that
could be used in a terror attack are currently available;
``(5) the current structure and management of patients in
both the emergency room and outpatient clinical settings is not
conducive to rapid recognition of infectious disease agents,
which may in fact be biothreat agents or chemical agents, which
may require immediate appropriate treatment to prevent
permanent injury and loss of life;
``(6) financial inducements to conduct screening tests for
infectious diseases are nonexistent or require substantial
justification before a health care provider will order a
specific test to diagnose an infectious disease;
``(7) cultures, the gold standard currently for infectious
disease agents, can require 48 hours to many days or weeks to
provide a definitive diagnosis while new molecular level tests
can reduce that time to hours;
``(8) the clinical presentation of many conditions,
including biothreat agents, is a very common and nonspecific
pattern of symptoms and doctors, in general, will not order a
test unless they happen to think of a particular disease in
their presumptive differential diagnosis;
``(9) it is often easier to prescribe an antibiotic rather
than to determine the underlying causative organism;
``(10) both screening and more specific tests to diagnose
infectious diseases need to be available to physicians; and
``(11) screening particularly needs to be part of the
routine way physicians practice medicine, and this means the
ready availability of tests in emergency room settings, the
ability to rapidly provide a definitive diagnosis, and the
ability to report out electronically to local public health
agencies and hospital infection control monitors results of
these tests.
``(b) Identification.--Not later than 180 days after the date of
enactment of this title, the Secretary shall develop and make available
to potential manufacturers, a list of the diagnostics and diagnostics
for contraindicators to vaccines or drugs that need to be developed to
prepare the United States for a terrorist attack with a biological or
chemical agent or toxin or nuclear or radiological materials. The
Secretary shall provide such information as the Secretary determines to
be necessary to enable such potential manufacturers to structure and
focus their research and development programs for the development of
such research tools.
``(c) Revisions.--The Secretary shall revise the list developed
under subsection (b) on at least an annual basis, and make such list
available to potential manufacturers of diagnostics under terms and
conditions consistent with the security interests of the United States.
``(d) Development of Certain Diagnostics.--
``(1) In general.--The Secretary shall develop and
implement a strategy for the development of infectious disease
multiplexed molecular level technologies and the building of an
integrated information system linking the local, State, and
Federal public health systems for reporting automated
laboratory results for all infectious diseases.
``(2) Strategy.--The strategy developed and implemented
pursuant to paragraph (1) shall--
``(A) include the development of confirmatory
laboratory tests to back up presumptive results
available from initial screening;
``(B) recognize the importance and the need for
advancement in the field of bioinformatics which will
accelerate the discovery of countermeasures, using
advanced mathematical, computing, and image processing
technologies to solve complex problems including
pattern recognition methods, lossless digital data
compression for storage and transmission of biomedical
images, and the ability to analyze massive amounts of
data; and
``(C) promote the advancement of bioinformatics
through the use of incentives, the procurement and
rapid development of new devices, and the development
of a robust information infrastructure for carrying out
medical surveillance tasks.
``(3) Technology.--The specific screening and diagnostics
technology used to implement the strategy described in
paragraph (1) may consist of multiplexed devices that screen
for routinely encountered common infectious diseases and have
biothreat agent detection algorithms embedded in the devices
with automatic reporting features such that the results can be
rapidly added and saved into the public health system databases
and put into the public health system quickly.
``(e) Utilization of Diagnostics by Health Care Providers.--
``(1) In general.--The Secretary shall develop and
implement a strategy that recognizes the need to provide the
right incentives to the health care industry to allow them to
utilize the new diagnostic tools that will be made available
through research and allow for routine screening for infectious
diseases.
``(2) Reimbursement.--The strategy shall include
appropriate incentives to allow for reimbursement to hospitals,
clinics, and other providers who perform routine laboratory
screening utilizing newer molecular level tests that rapidly
detect infectious diseases.
``(3) Guidelines.--The Secretary shall establish similar
guidelines for States to utilize to promote infectious disease
screening, including testing for the rapid identification of
potential biothreat agents.
``(f) No Judicial Review.--Notwithstanding any other provision of
law, there shall be no judicial review of the list, or revised list,
developed by the Secretary under this section.
``SEC. 1815. RESEARCH TOOLS INCENTIVES.
``(a) Findings.--Congress finds that--
``(1) it may not be possible for the United States to
anticipate the biological or chemical agent or toxin or nuclear
or radiological material that might be utilized in a terrorist
attack against the United States;
``(2) terrorists may develop a biological or chemical agent
or toxin or nuclear or radiological material that the United
States has not anticipated would be weaponized;
``(3) terrorists may be able to genetically modify an
organism or manufacture a novel biological or chemical agent or
toxin or nuclear or radiological material so that available
diagnostics, vaccines, and drugs are not effective;
``(4) in such cases, the United States needs the capacity
to develop and deploy, in the middle of an epidemic or attack,
effective diagnostics, vaccines, drugs, and research tools;
``(5) the ability of terrorists to deploy novel weapons of
mass destruction far exceeds the power of existing research
tools;
``(6) to be prepared, the United States needs to provide
incentives for the development of new and more powerful
research tools; and
``(7) the Defense Science Board has found `Effective
biodefense measures for treatment or proactive vaccination
against engineered agents introduces an additional element of
technical complexity that would demand just-in-time R&D
initiatives on a case-by-case basis to address the specific
technical manipulation used in producing the engineered agent'.
``(b) Identification.--Not later than 180 days after the date of
enactment of this title, the Secretary shall develop and make available
to potential manufacturers, a list of the research tools that need to
be developed to prepare the United States for a terrorist attack with a
biological or chemical agent or toxin or nuclear or radiological
materials. The list developed by the Secretary shall include research
tools for which there is a need for development in order to understand
why certain countermeasures may cause adverse events, how to minimize
such adverse events, and how to treat such adverse events. The
Secretary shall provide such information as the Secretary determines to
be necessary to enable such potential manufacturers to structure and
focus their research and development programs for the development of
such diagnostics.
``(c) Revisions.--The Secretary shall revise the list developed
under subsection (b) on at least an annual basis, and make such list
available to potential manufacturers of research tools under terms and
conditions consistent with the security interests of the United States.
``(d) No Judicial Review.--Notwithstanding any other provision of
law, there shall be no judicial review of the list, or revised list,
developed by the Secretary under this section.
``(e) Utilization and Availability.--
``(1) In general.--Entities with respect to which an
affirmative determination is made under subsection (f) or (g)
of section 1812 shall maximize the utilization of the research
tools involved for the development of countermeasures,
including making such tools available on commercially
reasonable terms to other entities certified under section 1812
to develop countermeasures.
``(2) Rule of construction.--Nothing in this title or
chapter 18 of title 35, United States Code, shall be construed
to restrict the right of an entity described in paragraph (1)
to--
``(A) secure and enforce patents with regard to
research tools;
``(B) enter into exclusive, revocable, and
nontransferable licenses of such research tools; or
``(C) impose limits on royalty-reach-through
agreements, option rights, or product reach-through
rights concerning such research tools.
``Subtitle B--Incentives for the Development of Countermeasures
``CHAPTER 1--PRIMARY INCENTIVES
``SEC. 1821. FEDERAL TAX INCENTIVES.
``(a) Findings and Purpose.--
``(1) Findings.--Congress makes the following findings:
``(A) Most biotechnology companies, and many device
and research tool companies, are early stage research
ventures with no revenue from product sales to finance
their medical research. Most biotechnology companies
must rely on repeated and large infusions of investor
capital to fund this research. To conduct research on
countermeasures to biological agents and other toxins
or any other type of research, these companies must
persuade venture capitalists and other investors that funding this
research may lead to a rate of return commensurate with the risk and
comparable to the rate of return available to other, comparable
investment opportunities.
``(B) Biotechnology companies are justifiably
reluctant to modify their ongoing research priorities
and devote scarce management and scientific talent to
new and risky projects. Their first priority and
obligation is and must be to secure approval to market
a product that will generate revenue sufficient to
reduce the dependence of the company on continued
infusions of investor capital and to provide a long-
awaited return to patient investors.
``(C) Biotechnology companies tend to focus on
breakthrough research to develop medical treatments for
diseases where no effective treatments are currently
available. They often specialize in research and
development on rare diseases and they are parties in
the vast majority of the collaborations in the United
States between private industry and academic medical
centers and the National Institutes of Health. Many
biotechnology companies do not have approval to market
products with respect to which they might develop minor
improvements to maintain a market advantage.
``(D) No type of industrial research is as costly
as biotechnology research. Successful research and
development of countermeasures will necessitate
breakthroughs in virology, immunology, biochemistry,
antibiotics, genetic engineering, and many other
disciplines in biology.
``(E) Many biotechnology companies have no tax
liability with respect to which to claim a tax credit.
Many of the tax incentives in the income tax system of
the United States have no value to a company with no
current revenue or tax liability. Large pharmaceutical
companies can utilize tax credits as an incentive for
research.
``(F) The provision of tax incentives will help in
enabling biotechnology companies to form the capital
needed to conduct research to develop countermeasures.
Such incentives lower the cost of capital, induce
investors to fund research, and enable biotechnology
companies to justify the investment of retained
earnings. Without such capital, research on
countermeasures is not likely to go forward. Tax
incentives are less costly than direct Federal
Government funding of the research and tend to shift
some of the risk of failure to the companies.
``(2) Purpose.--It is the purpose of this section to
provide tax incentives to enable biotechnology, pharmaceutical,
diagnostics, and research tool companies to form capital to
conduct research to develop countermeasures.
``(b) In General.--Any entity certified as entitled to the
provisions described in this section for any taxable year under section
1812(d) may irrevocably elect 1 of the following Federal tax incentives
to fund research with respect to each certification to develop
countermeasures, detection equipment, diagnostics, or medical research
tools:
``(1) Research and development limited partnerships to fund
countermeasure research.--The entity may establish a limited
partnership for the certified countermeasures, detection
equipment, diagnostics, or research tools research, but only if
such entity is a qualified small business as determined under
section 1202(d) of the Internal Revenue Code of 1986, by
substituting `$750,000,000' for `$50,000,000' each place it
appears. For purposes of the Internal Revenue Code of 1986,
section 469 of such Code shall not apply with respect to a
limited partnership established under this paragraph.
``(2) Capital gains exclusion for investors to fund
countermeasure research.--The entity may issue a class of stock
for the certified countermeasures, detection equipment,
diagnostics, or research tools research under section 1202 of
the Internal Revenue Code of 1986 with the following
modifications:
``(A) Increased exclusion for noncorporate
taxpayers.--Subsection (a) of section 1202 of such Code
shall be applied by substituting `100 percent' for `50
percent'.
``(B) Application to corporate taxpayers.--
Subsection (a) of section 1202 of such Code shall be
applied without regard to the phrase `other than a
corporation'.
``(C) Stock of larger businesses eligible for
exclusion.--Paragraph (1) of section 1202(d) of such
Code (defining qualified small business) shall be
applied by substituting `$750,000,000' for
`$50,000,000' each place it appears.
``(D) Reduction in holding period.--Subsection (a)
of section 1202 of such Code shall be applied by
substituting `3 years'' for `5 years''.
``(E) Nonapplication of per-issuer limitation.--
Section 1202 of such Code shall be applied without
regard to subsection (b) (relating to per-issuer
limitations on taxpayer's eligible gain).
``(F) Modification of working capital limitation.--
Section 1202(e)(6) of such Code shall be applied--
``(i) in subparagraph (B), by substituting
`5 years' for `2 years', and
``(ii) without regard to the last sentence.
``(G) Nonapplication of minimum tax preference.--
Section 57(a) of such Code shall be applied without
regard to paragraph (7).
``(3) Tax credit to fund countermeasure research.--The
entity may be eligible for the tax credits provided for in the
amendments made by section 4 of the Biological, Chemical, and
Radiological Weapons Countermeasures Research Act.
``(c) Reporting; Recapture.--
``(1) Reporting.--Each certified entity under subsection
(b) shall submit to the Secretary and the Secretary of the
Treasury such information regarding its election of any tax
incentive under this section for the purpose certified under
section 1812(d) as the Director and the Secretary determine
necessary to carry out the enforcement provisions prescribed
under paragraph (2).
``(2) Recapture.--The Secretary of the Treasury, in
consultation with the Secretary, shall provide for the
recapture of any tax benefits resulting from any elected tax
incentive under this section if the resulting research is for a
purpose other than that certified under section 1811(e).
``(d) Effective Date.--The provisions of this section shall apply
to taxable years beginning after December 31, 2002.
``SEC. 1822. TERROR WEAPON COUNTERMEASURE PURCHASE FUND.
``(a) Findings and Purpose.--
``(1) Findings.--Congress finds that--
``(A) the market for countermeasures is uncertain
at best and it is not possible for private, for-profit
entities to determine the prospects for a reasonable
rate of return on their research and development
investments relating to such countermeasures;
``(B) such entities and their investors have
reasonable concerns that they will not realize a
reasonable rate of return in a market where the Federal
Government has monopoly or oligopoly purchasing power;
``(C) such entities need to know in advance, prior
to undertaking the research necessary to develop a
countermeasure, the nature, size, duration, and terms
of the market that is available if it is successful in
such development; and
``(D) the market and rate of return that the
Federal Government guarantees for a countermeasure must
be comparable to a market and rate of return that would
be available to the entity and investors for non-
countermeasure research.
``(2) Purpose.--It is the purpose of this section to--
``(A) establish the guaranteed market and a long-
term commitment for private sector research that leads
to the successful development of countermeasures to
respond to an attack with biological and chemical
agents or toxins or nuclear and radiological materials,
or detection equipment, diagnostics or research tools
with respect to such agents, toxins or materials; and
``(B) provide advance, partial, progress or other
payments to manufacturers of countermeasures, detection
equipment, diagnostics, or research tools described in
subparagraph (A).
``(3) Limitation.--Private sector entities are entitled to
the procurement incentives provided for in this title (and the
amendments made by the Biological, Chemical, and Radiological
Weapons Countermeasures Research Act) only when such entities
successfully develop a countermeasure that meets the
specifications prescribed by the Secretary.
``(b) Definitions.--In this section:
``(1) Eligible countermeasure, detection equipment,
diagnostic, or research tool.--The term `eligible
countermeasure, detection equipment, diagnostic, or research
tool' means a countermeasure (as defined in section 1802(1)),
detection equipment (developed under section 1813), diagnostic
(developed under section 1814), or research tool (developed
under section 1815)--
``(A) that is developed by an entity that has been
certified under section 1812(d);
``(B) in the case of a countermeasure, that the
Secretary has determined is successful pursuant to
subsection (f) or (g) of section 1812; and
``(C) with respect to which an affirmative notice
has been provided under section 1812(d).
``(2) Fund.--The term `Fund' means the Terror Weapon
Countermeasure Purchase Fund established under subsection (c).
``(c) Establishment of Fund.--There is established in the Treasury
of the United States a fund to be known as the `Terror Weapon
Countermeasure Purchase Fund' consisting of amounts appropriated under
subsection (f).
``(d) Investment of Fund.--Amounts in the Fund shall be invested in
accordance with section 9702 of title 31, United States Code, and any
interest on, and proceeds from any such investment shall be credited to
and become part of the Fund.
``(e) Use of Fund.--
``(1) In general.--The Secretary of the Treasury shall
expend amounts in the Fund--
``(A) for the purchase of eligible countermeasures,
detection equipment, diagnostics, or research tools
with respect to which the Secretary has made an
affirmative determination as provided for in subsection
(f) or (g) of section 1812 which shall be made
available to the Secretary and distributed as the
Secretary, in consultation with the Secretary of Health
and Human Services and the Secretary of Defense,
determines appropriate; and
``(B) to provide advance, partial, progress or
other payments, in accordance with paragraph (4), to an
entity pursuant to an agreement reached under section
1812(d)(3)(B), or pursuant to a contract under section
1812(e), to manufacturers of eligible countermeasures,
detection equipment, diagnostics, or research tools
with respect to which the Secretary has made an
affirmative determination as provided for in such
section 1812.
``(2) Purchase.--Countermeasures, detection equipment,
diagnostics, or research tools shall be purchased by the Fund--
``(A) in the case of a countermeasure, in the
amount and at the per dosage price as described in the
notice received by the entity under section 1812(d)(3)
unless superceded by the contract between the parties
pursuant to section 1812(e); or
``(B) in the case of detection equipment,
diagnostics, or research tools, at the price and under
the terms negotiated by the Secretary and the
manufacturer.
``(3) Conditions for purchase.--Payments made for purchases
under paragraph (1)(A) shall be made under such terms and
conditions as are set forth in the contract between the parties
pursuant to section 1812(e), including the provision by the
manufacturer of adequate security for such payments if
applicable. If such security is in the form of a lien on
property or equipment in favor of the United States, such lien
shall be paramount to all other liens on such property or
equipment and shall be effective immediately upon the first
payment, without filing, notice, or other action by the United
States.
``(4) Advance, partial, progress or other payments.--
``(A) In general.--The Secretary of the Treasury
may make payments under paragraph (1)(B) to
manufacturers of eligible countermeasures, detection
equipment, diagnostics, or research tools prior to the
final purchase of such countermeasure, equipment,
diagnostic, or research tool.
``(B) Basis for payments.--Payments under this
paragraph shall be based on--
``(i) the performance of the manufacturer
involved as measured by the Secretary of the
Treasury using objective, quantifiable methods
(such as delivery of acceptable items, work
measurement, or statistical process controls)
established by the Secretary of the Treasury in
consultation with the Secretary;
``(ii) the accomplishment of events as
defined in a program management plan that is
developed by the manufacturer and submitted to
the Secretary of the Treasury; or
``(iii) other quantifiable measures of
results determined appropriate by the Secretary
of the Treasury, in consultation with the
Secretary.
``(C) Number, time, and amount of payments.--
``(i) In general.--The Secretary of the
Treasury, in consultation with the Secretary,
shall, with respect to a manufacturer of an
eligible countermeasure, detection equipment,
diagnostic, or research tool, determine the
number payments to be made, the timing of such
payments, and subject to clause (ii), the
amount of each such payment.
``(ii) Limitation.--The amount of any
payment made to a manufacturer under this
paragraph shall not exceed the amount of the
final purchase price (described in paragraph
(2)(A)) for the countermeasure, detection
equipment, diagnostic, or research tool
involved that remains unpaid as of the date of
the payment involved.
``(D) Conditions for payment.--The Secretary of the
Treasury, in consultation with the Secretary, shall
ensure that any payment to which this paragraph applies
is commensurate with the actions taken by the
manufacturer and the progress made in achieving the
performance measures under subparagraph (B)(i) through
the time of such payment. The manufacturer shall
provide such information and evidence as the Secretary
of the Treasury and the Secretary determine is
necessary to determine compliance with the preceding
sentence.
``(E) Security.--The provisions of paragraph (3)
relating to security shall apply to payments made under
this paragraph.
``(5) Distribution.--Eligible countermeasures, detection
equipment, diagnostics, or research tools purchased by the Fund
shall be distributed as provided for by the Secretary, in
consultation with the Secretary of Health and Human Services,
determines appropriate after--
``(A) consideration of--
``(i) in the case of countermeasures, the
prevalence of the infection or exposure to an
agent, toxin, or material to be treated by the
eligible countermeasure; or
``(ii) in the case of detection equipment,
diagnostics, or research tools, the predicted
demand for the use of such equipment,
diagnostics, or research tools; and
``(B) consideration of the ability of the recipient
to effectively and safely deliver the countermeasures,
detection equipment, diagnostics, or research tools.
``(6) PUSH packs.--The Secretary of the Treasury may use
amounts in the Fund for the purchase of countermeasures to be
included in Federal or State government maintained PUSH Packs
to be used in the case of a terror attack using chemical,
biological, or radiologic toxins, agents or materials.
``(7) Rule of construction.--Nothing in this subsection
shall be construed to require that the Fund purchase a
countermeasure, detection equipment, diagnostic, or research
tool for each agent, toxin, or material contained on the
Biological and Chemical Agent Priority List developed under
section 1811 from an entity that the Secretary has not
certified for development of that countermeasure, detection
equipment, diagnostic, or research tool under section 1812(d).
``(8) Regulations.--The Secretary shall promulgate such
regulations as are necessary to carry out the provisions of
this subsection.
``(f) Appropriations.--
``(1) In general.--Subject to paragraph (2), there are
appropriated out of any funds in the Treasury not otherwise
appropriated such sums as may be necessary to carry out the
purposes of the Fund for each of 10 fiscal years beginning with
the first fiscal year after the date that the Secretary of the
Treasury determines that any eligible countermeasure, detection
equipment diagnostic, or research tool is available for
purchase by the Fund.
``(2) Transfer to fund.--The Secretary of the Treasury
shall transfer the amount appropriated under paragraph (1) for
a fiscal year to the Fund.
``(3) Availability.--Amounts appropriated under this
section shall remain available until expended.
``(g) Authority to Contracts.--
``(1) In general.--Notwithstanding any other provision of
law, including section 1341 of title 31, United States Code, a
multi-year contract may be entered into by the Secretary under
subsection (d)(3) or (e) of section 1812, except that any such
contract shall be for a period of not to exceed 10 years.
``(2) Federal acquisition.--Notwithstanding any other
provision of law, a contract described in paragraph (1) shall
not be subject to the requirements of title III of the Federal
Property and Administrative Services Act of 1949 (41 U.S.C. 251
et seq.) or Federal regulations relating to acquisitions.
``(h) Rule of Construction.--Nothing in this section shall be
construed to limit in any manner, the sale or terms of sale of an
eligible countermeasure, detection equipment, diagnostic, or research
tool to any other entity or individual in any public or private sector
market.
``SEC. 1823. PATENT TERM PROTECTION AND EXCLUSIVE MARKETING.
``(a) Findings.--Congress makes the following findings:
``(1) Patents are necessary to protect the inventions of
entrepreneurial firms. Without patents, the inventions of these
companies can be expropriated by competitors and investors'
expectations of a reasonable rate of return on their investment
are frustrated. In return for a limited term of protection from
competitors, inventors are required to publish a detailed
description of the invention for which the patent has been
granted.
``(2) The 20 year term of a patent is measured from the
date of the patent application. The effective term of a patent,
however, is the term remaining after an invention has been
approved for sale by Government regulators. Erosion of the term
of patents for biotechnology and pharmaceutical firms, which
cannot market a product until it has been approved, is common
and increasing. Protection against such erosion, due to delays
caused by Government regulatory review, will ensure that the
full term of the patent granted by the Patent and Trademark
Office is available to the inventor to recoup their investment.
Such protections maintain the full term of the patent.
``(3) As an incentive for capital formation to fund
research to develop countermeasures, companies and investors
will respond to the prospect of being able to extend other
patents in their portfolio.
``(4) Biotechnology and pharmaceutical companies and their
investors are sensitive to any possibility that successful
completion of breakthrough research leading to the approval for
the sale of a product, including a countermeasure, will lead to
challenges to their patents.
``(b) Reference to Other Law.--For provisions relating to patent
term protection and exclusive marketing incentives, see section 5 of
the Biological, Chemical, and Radiological Weapons Countermeasures
Research Act.
``SEC. 1824. LIABILITY AND INDEMNIFICATION.
``(a) Findings and Purpose.--
``(1) Findings.--Congress makes the following findings:
``(A) Many countermeasures to terror agents,
toxins, and materials will be deployed with a minimum
of human clinical trials, which are either impractical
or unethical. In other cases, when countermeasures are
deployed in an emergency, no human clinical trials may
have been conducted.
``(B) Companies are justifiably reluctant to permit
deployment of a countermeasure where so little clinical
testing is possible. They need reassurance that they
will not be held liable for claims that may arise
related to the safety and efficacy of countermeasures,
especially from vaccines as well as prophylactically
administered countermeasures that they develop.
``(C) The United States faces dire public health
consequences if agents, toxins, and materials are used
in an attack for which no countermeasures are
available. The United States has enemies who will not
hesitate to use these agents in an attack. Our national
security requires that we ensure that these
countermeasures are developed and the most effective
available research and development expertise lies with
biotechnology and pharmaceutical companies.
``(2) Purpose.--It is the purpose of this section to
provide liability protections to encourage companies to conduct
research to develop and produce countermeasures.
``(b) Reference to Other Provision.--For provisions relating to
liability provisions for manufacturers, disributors, and other entities
involved with countermeasures developed under this title see section
224(p) of the Public Health Service Act.
``CHAPTER 2--OTHER INCENTIVES
``SEC. 1831. ACCELERATED APPROVAL OF COUNTERMEASURES.
``(a) In General.--The Secretary of Health and Human Services may
designate a countermeasure as a fast-track product pursuant to section
506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) or as a
device granted priority review pursuant to section 515(d)(5) of such
Act (21 U.S.C. 366e(d)(5)). Such a designation may be made prior to the
submission of--
``(1) a request for designation by the sponsor or
applicant; or
``(2) an application for the investigation of the drug
under section 505(i) of such Act or section 351(a)(3) of the
Public Health Service Act.
Nothing in this subsection shall be construed to prohibit a sponsor or
applicant from declining such a designation.
``(b) Use of Animal Trials.--A drug for which approval is sought
under section 505(d) of the Federal Food, Drug, and Cosmetic Act or
section 351 of the Public Health Service Act on the basis of evidence
of effectiveness that is derived from animal studies under section 1832
may be designated as a fast track product for purposes of this section.
``(c) Priority Review.--
``(1) In general.--A countermeasure that is a drug or
biological product shall be subject to the performance goals
established by the Commissioner of Food and Drugs for priority
drugs or biological products.
``(2) Definition.--In this subsection the term `priority
drugs or biological products' means a drug or biological
product that is the subject of a drug application referred to
in section 101(4) of the Food and Drug Administration
Modernization Act of 1997.
``SEC. 1832. BIOLOGICS MANUFACTURING CAPACITY INCENTIVES.
``(a) Findings.--Congress makes the following findings:
``(1) When the United States develops new biologically
derived materials, including vaccines, monoclonal antibodies,
and recombinant proteins, plant compounds, and blood products
to prevent infection by bioterrorist agents or toxins or to
treat those infected in bioterrorist attacks or to protect or
treat those exposed to chemical agents, a shortage of
manufacturing facilities for biologics may delay or prevent the
production and stockpiling of such materials.
``(2) There is a severe shortage of manufacturing capacity
to produce such materials. There are nearly 100 biologics in
clinical trials, and current manufacturing capacity is 475,000
liters, virtually all of which is utilized. An additional
1,100,000 liters of capacity will come online by the end of
2006, but civilian demand will continue to outstrip capacity.
There is little or no available capacity to produce such
biologically derived materials to treat those who might be
infected by bioterror agents.
``(3) The Defense Science Board has found `Any bioterrorism
attack that created the need to treat more than 50,000 people
with an extended course of antibiotic therapy . . . or to
immunize more than 1 to 3 million people with a vaccine would
completely overwhelm the total production capacity of the
industry.' The Federal Government `must establish a proactive
long-term plan to address these inventory and production
shortfalls'.
``(4) A typical manufacturing facility costs between
$200,000,000 and $400,000,000 to build, and there is no
incentive for companies to build these facilities until a
product has been developed and approved. On average, a plant
takes 4 years to build, considering the intricacies of the
process and the necessary Food and Drug Administration
procedures.
``(5) Biotechnology and pharmaceutical companies have no
reason to fund the construction of biologics manufacturing
facilities unless and until there is a market demand for the
facilities.
``(6) The incentives provided under this title, and the
tax, procurement, intellectual property, and liability
provisions in subtitle B (and the amendments made by the
Biological, Chemical, and Radiological Weapons Countermeasures
Research Act), should lead to the development of new
biologically derived materials to prevent and treat
bioterrorist attacks and decisions to purchase, stockpile and
perhaps deploy such materials.
``(7) It is in the national interest for the United States
to provide incentives for the construction of sufficient
biologics manufacturing facilities so that there will be no
delay in the production of biologically active materials once
such materials are developed.
``(b) Survey and Plan.--Not later than 90 days after the date of
enactment of this title, the Secretary shall--
``(1) conduct a survey of the biologics manufacturing
facilities, including those for the production of monoclonal
antibodies, recombinant proteins, and plant compounds using
cell culture methods as wall as those for the production of
antibodies and other blood products from human blood, operating
in the United States and determine whether additional
manufacturing facilities that will be needed (and if so the
number of such facilities) to manufacture and stockpile
biologically active materials for bioterrorist attacks; and
``(2) develop a plan to ensure that sufficient biologics
manufacturing facilities are available in the United States
when they are needed, including an analysis of the feasibility
of the Federal Government contracting for the construction of
such facilities or of providing tax and other incentives for
the construction of such facilities by private sector entities.
``(c) Submission to Congress.--The Secretary shall submit the plan
developed under subsection (b)(2) to Congress together with
recommendations concerning the manner in which to ensure that the
needed biologics manufacturing facilities available for the production
of countermeasures under this title are constructed and available,
including the siting, design and certification costs, costs of training
and recruitment of expert staff, and other costs associated with such
facilities.
``(d) Incentives for the Construction of Biologics Manufacturing
Facilities Available for the Production of Countermeasures.--The
Secretary shall issue regulations regarding the selection of an entity
that agrees to operate as a biologics manufacturing facility available
for the production of countermeasures under this title in accordance
with the plan developed under subsection (b)(2) for the investment tax
credit provided under section 8 of the Biological, Chemical, and
Radiological Weapons Countermeasures Research Act. Such regulations
shall state when such an entity shall be available and the terms for
the use for the production of such countermeasures. If an entity is
constructed to produce such countermeasures, such entity shall provide
notice that such entity is available to produce such countermeasures.
``SEC. 1833. BIOLOGICS MANUFACTURING EFFICIENCY INCENTIVES.
``(a) Findings.--Congress finds that--
``(1) the manufacturing of biologics, which are derived
from living organisms, is an art as well as a science;
``(2) the efficiency of the biologics manufacturing process
determines the output capacity, purity, and manufacturing cost
of vaccines, recombinant proteins, plant compounds, and blood
products;
``(3) technical advances in manufacturing sciences for
biologics can increase the capacity of the Federal Government
to ensure that vaccines, recombinant proteins, plant compounds,
and blood products are available as part of a bioterror plan
and to reduce the cost of manufacturing and stockpiling these
vaccines, recombinant proteins, plant compounds, and blood
products; and
``(4) the subjects of research relating to the
manufacturing of biologics may include the development of--
``(A) additional well characterized cell lines for
vaccine, recombinant proteins, plant compounds, and
monoclonal antibody production;
``(B) new biologic and chemical standards for use
in product testing, including testing of potency and
purity;
``(C) improved preservatives for vaccines or other
biologics to prolong shelf-life;
``(D) adjuvants that enhance the immune response to
a vaccine or antigen;
``(E) tests to determine contamination with human
or animal viruses or prions;
``(F) improved tests of potency and purity during
the manufacturing process, not just for the final
product;
``(G) improved characterization of biologics at the
macro-molecular level;
``(H) processes that enhance the yield and quality
of biologics;
``(I) improved methods that enhance disinfection
and sterilization of material and facilities;
``(J) new methods to improve output, manufacturing
costs, and product quality with a particular emphasis
on downstream processing (separation and purification)
where particular bottlenecks occur with much lost
product, complexity and very high costs; and
``(K) improved methods for decontamination of
production of facilities to enable switching from one
product to another.
``(b) Survey and Plan.--Not later than 90 days after the date of
enactment of this title, the Secretary shall--
``(1) conduct a survey of existing biologics manufacturing
sciences and determine whether technical advances in such
sciences might increase the biologics output capacity and
purity, and lower the manufacturing cost of vaccines,
recombinant proteins, plant compounds, and blood products; and
``(2) develop a plan to provide incentives to enhance
scientific research to develop new technologies identified
under the survey conducted under paragraph (1), including a
list of the possible technologies that may be developed and the
possible incentives that may lead to their development.
``(c) Submission to Congress.--The Secretary shall submit the plan
developed under subsection (b)(2) to Congress together with
recommendations concerning the provision of funding or incentives for
the conduct of scientific research to develop new technologies relating
to biologics manufacturing sciences.
``(d) Incentives.--The Secretary shall establish a program under
which entities that agree to develop new technologies in accordance
with the plan developed under subsection (b)(2) are eligible for the
tax incentives provided for under the amendments made by section 4 of
the Biological, Chemical, and Radiological Weapons Countermeasures
Research Act.
``SEC. 1834. CONSTRUCTION OF BIOSAFETY LEVEL 3-4 RESEARCH FACILITIES.
``(a) Findings.--Congress finds that--
``(1) research to develop countermeasures requires the use
of special facilities where biological agents and chemical
agents can be handled safely both for laboratory research as
well as research and efficacy tests in animals;
``(2) very few companies can capitalize the construction of
these special facilities; and
``(3) the Federal Government can facilitate research and
development of countermeasures by financing the construction of
these special facilities.
``(b) Grants Authorized.--
``(1) In general.--The Secretary is authorized to award
grants and contracts to grantees to construct, maintain, and
manage (including funding for staff and staff training)
biosafety level 3-4 facilities.
``(2) Requirements.--To be eligible for a grant under
paragraph (1) an entity shall--
``(A) allow use of the facility involved by only
those researchers who meet qualifications set by the
Secretary;
``(B) give priority for the use of the facility
involved to those entities that have been registered
and certified by the Secretary to develop
countermeasures; and
``(C) allow the National Institutes of Health to
inspect the facility involved at any time.
``(3) Number of grants.--The Secretary of the Department of
Homeland Security shall determine the number of facilities that
need to be constructed under this section, not to exceed 10
such facilities nationwide, and the Secretary shall award
grants based on such determination.
``(c) Application.--
``(1) In general.--To be eligible to receive a grant under
this section an entity shall submit to the Secretary an
application at such time, in such form and containing such
information, as the Secretary may require.
``(2) Contents.--Each application submitted pursuant to
paragraph (1) shall--
``(A) provide detailed information on the technical
specifications of proposed facilities;
``(B) propose a design that includes offices for
personnel, visiting researchers, and facilities for
research and laboratory materials;
``(C) provide assurances that the facilities shall
be available on a fee-for-service or other basis to
companies and academic researchers; and
``(D) provide assurances that the facilities will
be constructed as secure facilities.
``(d) Definitions.--For the purposes of this section--
``(1) unless otherwise specifically identified, the term
`Director' means the Director of the National Institutes of
Health; and
``(2) a `biosafety level 3-4 facility' means a facility for
research on indigenous, exotic, or dangerous agents with the
potential for aerosol transmission of disease that may have
serious or lethal consequences or that pose a high risk of
life-threatening disease, aerosol-transmitted laboratory
infections, or related agents with unknown risk of
transmission.
``(e) Authorization of Appropriations.--There are authorized to be
appropriated such sums as may be necessary to carry out this section.
``SEC. 1835. NATIONAL INSTITUTES OF HEALTH COUNTERMEASURES PARTNERSHIP
CHALLENGE GRANTS.
``(a) Grants Authorized.--The Director of the National Institutes
of Health (in this section referred to as the `Director') is authorized
to award partnership challenge grants to promote joint ventures between
the National Institutes of Health, its grantees, and for-profit
biotechnology, pharmaceutical, and medical device industries for the
development of countermeasures and research tools.
``(b) Regulations.--The Director shall issue regulations within 90
days of the date of enactment of this section to implement the awarding
of grants under subsection (a).
``(c) Rule of Construction.--Nothing in this section shall be
construed to preclude an entity that receives a partnership challenge
grant under this section from also being certified as being eligible
for incentives under this title (and the amendments made by tax,
procurement, intellectual property, and liability provisions in
subtitle B (and the amendments made by the Biological, Chemical, and
Radiological Weapons Countermeasures Research Act).
``(d) Authorization of Appropriations.--There are authorized to be
appropriated $200,000,000 for each of fiscal years 2004, 2005, 2006,
2007, and 2008 for the purpose of carrying out this section.
``Subtitle C--Administrative Provisions
``SEC. 1841. ANNUAL REPORT.
``(a) In General.--Not later than January 1, 2005, and each January
1 thereafter, the Secretary shall prepare and submit to the appropriate
committees of Congress and make available to the public, a report
concerning the implementation of this title (and the amendment made by
the Biological, Chemical, and Radiological Weapons Countermeasures
Research Act). Such reports shall include--
``(1) an assessment of whether the incentives provided for
in this title are sufficient, as determined by the Secretary,
to induce the biotechnology, pharmaceutical, device, and
research tools industries to modify their ongoing research
priorities and devote scarce management and scientific talent
to research to develop terror weapons countermeasures;
``(2) an assessment of whether such incentives are
sufficient, as determined by the Secretary, to address the
sensitivity of such industries to the possibility of challenges
to their prices and patents and the terms of sales that may
arise when the Federal Government is an oligopoly or monopoly
purchaser;
``(3) an assessment of whether such incentives are likely
to lead to the development of countermeasures to prepare the
United States in the event of the use of biological, chemical,
and radiological weapons by terrorists and others against both
military or intelligence, government, and civilian personnel;
``(4) an assessment of whether such incentives will lead to
the development of research tools;
``(5) an assessment of whether sections 1831, 1832, 1833,
1834, 1835 and 1836, and the amendments made by sections 6
through 9 of the Biological, Chemical, and Radiological Weapons
Countermeasures Research Act are being carried out and having
the intended effect on industry activity;
``(6) a description of how such incentives for private
sector research relate to the provision of public funding for
the development of countermeasures; and
``(7) recommendations for the modification of such
incentives to increase their effectiveness.
``(b) Limitation on Publication.--In making the report under
subsection (a) available to the public, the Secretary may exempt
certain information from disclosure if the Secretary determines that
such publication would (or could) be detrimental to the security of the
United States. Such determinations by the Secretary shall not be
subject to judicial review.
``SEC. 1842. INTERNATIONAL CONFERENCE ON RESEARCH TO DEVELOP
COUNTERMEASURES.
``(a) In General.--The Director of the Centers for Disease Control
and Prevention shall annually convene an International Conference on
Research to Develop Countermeasures to biological, chemical and nuclear
terror attacks.
``(b) Focus of Conference.--Each conference convened under
subsection (a) shall focus on one or more of the following:
``(1) An assessment of the biological, chemical, or
radiological threats that may arise and the countermeasures
that may be needed.
``(2) The status of research to develop countermeasures,
including research tools.
``(3) The need for and effectiveness of incentives for such
research by private sector entities, including tax,
procurement, intellectual property, and liability incentives.
``(4) Mechanisms that will improve coordination among
public and private sector entities conducting such research and
development.
``(5) The potential benefits and applications of such
research for the prevention and treatment of tropical and other
diseases.
``(c) Authorization of Appropriations.--There are authorized to be
appropriated, such sums as be necessary in each fiscal year to carry
out this section.''.
SEC. 4. TAX INCENTIVES.
(a) Amendments to the Internal Revenue Code.--
(1) Tax credit to fund countermeasure research.--
(A) In general.--Subpart D of part IV of subchapter
A of chapter 1 of the Internal Revenue Code of 1986
(relating to business related credits) is amended by
adding at the end the following new section:
``SEC. 45G. CREDIT FOR MEDICAL RESEARCH RELATED TO DEVELOPING
COUNTERMEASURES.
``(a) General Rule.--For purposes of section 38, in the case of any
certified entity under section 1812(d) of the Biological, Chemical, and
Radiological Weapons Countermeasures Research Act of 2003 which makes
an election under section 1821(b) of such Act to apply this section,
the countermeasures research credit determined under this section for
the taxable year is an amount equal to 35 percent of the qualified
countermeasures research expenses for the taxable year.
``(b) Qualified Countermeasures Research Expenses.--For purposes of
this section--
``(1) Qualified countermeasures research expenses.--
``(A) In general.--Except as otherwise provided in
this paragraph, the term `qualified countermeasures
research expenses' means the amounts which are paid or
incurred by the taxpayer during the taxable year which
would be described in subsection (b) of section 41 if
such subsection were applied with the modifications set
forth in subparagraph (B).
``(B) Modifications; increased incentive for
contract research payments.--For purposes of
subparagraph (A), subsection (b) of section 41 shall be
applied--
``(i) by substituting `qualified
countermeasures research' for `qualified
research' each place it appears in paragraphs
(2) and (3) of such subsection, and
``(ii) by substituting `100 percent' for
`65 percent' in paragraph (3)(A) of such
subsection.
``(C) Exclusion for amounts funded by grants,
etc.--The term `qualified countermeasures research
expenses' shall not include any amount to the extent
such amount is funded by any grant, contract, or
otherwise by another person (or any governmental
entity).
``(2) Countermeasures research.--The term `countermeasures
research' means certified countermeasures research for any
biological or chemical agent or toxin or nuclear or
radiological material on the list described in section 1811 of
the Biological, Chemical, and Radiological Weapons
Countermeasures Research Act of 2003.
``(c) Coordination With Credit for Increasing Research
Expenditures.--
``(1) In general.--Except as provided in paragraph (2), any
qualified countermeasures research expenses for a taxable year
to which an election under this section applies shall not be
taken into account for purposes of determining the credit
allowable under section 41 for such taxable year.
``(2) Expenses included in determining base period research
expenses.--Any qualified countermeasures research expenses for
any taxable year which are qualified research expenses (within
the meaning of section 41(b)) shall be taken into account in
determining base period research expenses for purposes of
applying section 41 to subsequent taxable years.
``(d) Special Rules.--
``(1) Pre-clinical research.--No credit shall be allowed
under this section for pre-clinical research unless such
research is pursuant to a research plan an abstract of which
has been filed with the Director of the Office of Homeland
Security before the beginning of such year. This paragraph
shall be waived for any research that is pursuant to a research
plan or abstract that has been filed with the Secretary of
Homeland Security not later than 270 days after the date of
enactment of this section. The Director of the Office of
Homeland Security, in consultation with the Secretary of Health
and Human Services, shall prescribe regulations specifying the
requirements for such plans and procedures for filing under
this paragraph.
``(2) Certain rules made applicable.--Rules similar to the
rules of paragraphs (1) and (2) of section 41(f) shall apply
for purposes of this section.
``(3) Coordination with credit for clinical testing
expenses for certain drugs for rare diseases.--Any qualified
countermeasures research expense for a taxable year shall not
be taken into account for purposes of determining the credit
allowable under section 45C for such taxable year.''.
(B) Inclusion in general business credit.--
(i) In general.--Section 38(b) of such Code
is amended by striking ``plus'' at the end of
paragraph (14), by striking the period at the
end of paragraph (15) and inserting ``, plus'',
and by adding at the end the following new
paragraph:
``(16) the countermeasures research credit determined under
section 45G.''.
(ii) Transition rule.--Section 39(d) of
such Code is amended by adding at the end the
following new paragraph:
``(11) No carryback of section 45g credit before
enactment.--No portion of the unused business credit for any
taxable year which is attributable to the countermeasures
research credit determined under section 45G may be carried
back to a taxable year beginning before January 1, 2003.''.
(C) Denial of double benefit.--Section 280C of such
Code is amended by adding at the end the following new
subsection:
``(d) Credit for Qualified Countermeasures Research Expenses.--
``(1) In general.--No deduction shall be allowed for that
portion of the qualified countermeasures research expenses (as
defined in section 45G(b)) otherwise allowable as a deduction
for the taxable year which is equal to the amount of the credit
determined for such taxable year under section 45G(a).
``(2) Certain rules to apply.--Rules similar to the rules
of paragraphs (2), (3), and (4) of subsection (c) shall apply
for purposes of this subsection.''.
(D) Deduction for unused portion of credit.--
Section 196(c) of such Code (defining qualified
business credits) is amended by striking ``and'' at the
end of paragraph (9), by striking the period at the end
of paragraph (10) and inserting ``, and'', and by
adding at the end the following new paragraph:
``(11) the countermeasures research credit determined under
section 45G(a) (other than such credit determined under the
rules of section 280C(d)(2)).''.
(E) Technical amendment.--The table of sections for
subpart D of part IV of subchapter A of chapter 1 of
such Code is amended by adding at the end the following
new item:
``Sec. 45G. Credit for medical research
related to developing
countermeasures.''.
(2) Tax credit to fund countermeasure research at certain
qualified non-profit and academic institutions including
teaching hospitals.--
(A) In general.--Subpart D of part IV of subchapter
A of chapter 1 of the Internal Revenue Code of 1986
(relating to business related credits) is amended by
inserting after section 41 the following:
``SEC. 41A. CREDIT FOR COUNTERMEASURES RESEARCH EXPENSES.
``(a) General Rule.--For purposes of section 38, in the case of any
certified entity under section 1812(d) of the Biological, Chemical, and
Radiological Weapons Countermeasures Research Act of 2003 which makes
an election under section 1821(b) of such Act to apply this section,
the countermeasures research credit determined under this section for
the taxable year shall be an amount equal to 35 percent of the excess
(if any) of--
``(1) the qualified countermeasures research expenses for
the taxable year, over
``(2) the countermeasures base period amount.
``(b) Qualified Countermeasures Research Expenses.--For purposes of
this section--
``(1) In general.--The term `qualified countermeasures
research expenses' means the amounts which are paid or incurred
by the taxpayer during the taxable year directly or indirectly
to any qualified non-profit or academic institution for
countermeasures research activities certified under section
1812(d) of such Act.
``(2) Countermeasures research activities.--
``(A) In general.--The term `countermeasures
research activities' means research to develop
countermeasures, detection equipment, diagnostics, or
research tools conducted at any qualified non-profit or
academic institution in the development of any product,
which occurs before--
``(i) the date on which an application with
respect to such product is approved under
section 505(b), 506, or 507 of the Federal
Food, Drug, and Cosmetic Act,
``(ii) the date on which a license for such
product is issued under section 351 of the
Public Health Service Act, or
``(iii) the date classification or approval
of such product which is a device intended for
human use is given under section 513, 514, or
515 of the Federal Food, Drug, and Cosmetic
Act.
``(B) Definitions.--
``(i) Countermeasures; detection equipment;
diagnostics; research tools.--The terms
`countermeasures', `detection equipment',
`diagnostics', and `research tools' have the
meanings given such terms by section 1802 of
the Biological, Chemical, and Radiological
Weapons Countermeasures Research Act of 2003.
``(ii) Product.--The term `product' means
any drug, biologic, medical device, or research
tool.
``(3) Qualified non-profit or academic institution.--The
term `qualified non-profit or academic institution' means any
of the following institutions:
``(A) Educational institution.--A qualified
organization described in section 170(b)(1)(A)(iii)
which is owned or affiliated with an institution of
higher education as described in section 3304(f).
``(B) Teaching hospital.--A teaching hospital
which--
``(i) is publicly supported or owned by an
organization described in section 501(c)(3),
and
``(ii) is affiliated with an organization
meeting the requirements of subparagraph (A).
``(C) Foundation.--A medical research organization
described in section 501(c)(3) (other than a private
foundation) which is affiliated with, or owned by--
``(i) an organization meeting the
requirements of subparagraph (A), or
``(ii) a teaching hospital meeting the
requirements of subparagraph (B).
``(D) Charitable research hospital.--A hospital
that is designated as a cancer center by the National
Cancer Institute.
``(E) Other institutions.--A qualified organization
(as defined in section 41(e)(6)).
``(4) Exclusion for amounts funded by grants, etc.--The
term `qualified countermeasures research expenses' shall not
include any amount to the extent such amount is funded by any grant,
contract, or otherwise by another person (or any governmental entity).
``(c) Countermeasures Research Base Period Amount.--For purposes of
this section, the term `countermeasures research base period amount'
means the average annual qualified countermeasures research expenses
paid by the taxpayer during the 3-taxable year period ending with the
taxable year immediately preceding the first taxable year of the
taxpayer beginning after December 31, 2002.
``(d) Special Rules.--
``(1) Certain rules made applicable.--Rules similar to the
rules of subsections (f) and (g) of section 41 shall apply for
purposes of this section.
``(2) Coordination with credit for increasing research
expenditures and with credit for clinical testing expenses for
certain drugs for rare diseases.--Any qualified countermeasures
research expense for a taxable year shall not be taken into
account for purposes of determining the credit allowable under
section 41 or 45C for such taxable year.
``(3) Qualified countermeasures research expenses not
treated as unrelated business taxable income.--For purposes of
section 511, qualified countermeasures research expenses paid
or incurred by the taxpayer directly or indirectly to any
qualified non-profit or academic institution shall not be
considered unrelated business taxable income of such
institution.''.
(B) Credit to be part of general business credit.--
(i) In general.--Section 38(b) of such Code
(relating to current year business credits), as
amended by this section, is amended by striking
``plus'' at the end of paragraph (15), by
striking the period at the end of paragraph
(16) and inserting ``, plus'', and by adding at
the end the following:
``(17) the countermeasures research credit determined under
section 41A(a).''.
(ii) Transition rule.--Section 39(d) of
such Code, as amended by this section, is
amended by adding at the end the following new
paragraph:
``(12) No carryback of section 41a credit before
enactment.--No portion of the unused business credit for any
taxable year which is attributable to the countermeasures
research credit determined under section 41A may be carried
back to a taxable year beginning before January 1, 2003.''.
(C) Denial of double benefit.--Section 280C of such
Code, as amended by this section, is amended by adding
at the end the following new subsection:
``(e) Credit for Countermeasures Research Expenses.--
``(1) In general.--No deduction shall be allowed for that
portion of the qualified countermeasures research expenses (as
defined in section 41A(b)) otherwise allowable as a deduction
for the taxable year which is equal to the amount of the credit
determined for such taxable year under section 41A(a).
``(2) Certain rules to apply.--Rules similar to the rules
of paragraphs (2), (3), and (4) of subsection (c) shall apply
for purposes of this subsection.''.
(D) Deduction for unused portion of credit.--
Section 196(c) of such Code (defining qualified
business credits), as amended by this section, is
amended by striking ``and'' at the end of paragraph
(10), by striking the period at the end of paragraph
(11) and inserting ``, and'', and by adding at the end
the following new paragraph:
``(5) the countermeasures research expenses credit
determined under section 41A(a) (other than such credit
determined under the rules of section 280C(e)(2)),''.
(E) Clerical amendment.--The table of sections for
subpart D of part IV of subchapter A of chapter 1 of
such Code is amended by adding after the item relating
to section 41 the following:
``Sec. 41A. Credit for countermeasures
research expenses.''.
(c) Effective Date.--The amendments made by this section shall
apply to taxable years beginning after December 31, 2002.
SEC. 5. PATENT TERM PROTECTION AND EXCLUSIVE MARKETING.
(a) Purpose.--The purpose of this section is to provide patent
incentives to protect inventions from expropriation by competitors and
to provide an incentive for capital formation to fund countermeasures
research.
(b) Limitation.--Private sector entities are entitled to the
intellectual property and marketing exclusivity incentives provided for
in this Act (and the amendments made by this Act) only when such
entities successfully develop a countermeasure that meets the
specifications of the Director and upon execution of a contract with
the Secretary with respect to procurement of the countermeasure in
accordance with section 1822 of the Biological, Chemical, and
Radiological Weapons Countermeasures Research Act of 2003.
(c) Restoration of Patent Terms Relating to Countermeasures for
Certain Biological or Chemical Agents or Toxins or Radiological
Materials.--
(1) In general.--Chapter 14 of title 35, United States
Code, is amended by inserting after section 156 the following:
``Sec. 156a. Restoration of patent terms relating to countermeasures
for certain biological or chemical agents or toxins
``(a) Definitions.--In this section, the term--
``(1) `product' means a new drug, antibiotic drug, or human
biological product (as those terms are used in the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and the
Public Health Service Act (42 U.S.C. 201 et seq.));
``(2) `regulatory review period' means--
``(A) the period beginning on the date a patent is
issued through the date of the first filing of an
application relating to human clinical trials for the
subject of that patent with the Food and Drug
Administration under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.) or the Public
Health Service Act (42 U.S.C. 201 et seq.), and
includes any period prior to such issuance during which
the Food and Drug Administration is reviewing such
application;
``(B) the period beginning on the date an exemption
under section 505(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(i)) became effective for
the approved product and ending on the date an
application was initially submitted for such product
under section 351 of the Public Health Service Act (42
U.S.C. 262) or section 505 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355); and
``(C) the period beginning on the date the
application was initially submitted for the approved
product under section 351 of the Public Health Service
Act (42 U.S.C. 262) or section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355) and ending on
the date such application was approved under the
applicable section; and
``(3) `Research Act' means the Biological, Chemical, and
Radiological Weapons Countermeasures Research Act of 2003.
``(b) Patent.--A patent referred to under subsection (c) or (d) is
any patent that--
``(1) encompasses within its scope a composition of matter,
a method of using such composition, a method of manufacturing
such composition, or a process for using such composition
relating to a product;
``(2) is for an eligible countermeasure as defined under
section 1822(b)(1) of the Research Act; and
``(3) is held by an entity (or is exclusively licensed to
an entity by a not-for-profit organization or is exclusively
licensed to an entity under section 209(e) of this title or
section 12(b)(7) of the Stevenson-Wydler Technology Innovation
Act of 1980 (15 U.S.C. 3710a(b)(1)(7)) that has entered into a
contract for sale of that countermeasure under section
1812(d)(3)(B)(i) of the Research Act.
``(c) Certain Action Not Necessary.--With respect to the owner of
record of a patent described under subsection (b), it shall be presumed
that no action under this section is necessary to effect the policies
and objectives of title 18.
``(d) Patent Extension.--Notwithstanding any specific limitations
on the terms of patent extensions under section 156, the term of a
patent described under subsection (b) shall be extended under this
section from the original expiration date of the patent by the period
of time that is equal to the full regulatory review period for the
product, and which shall include any patent term adjustment under
section 154(b).
``(e) Administrative Provisions.--
``(1) In general.--To obtain an extension of the term of a
patent under this section, the owner of record of the patent or
the agent of the owner shall submit an application to the
Patent and Trademark Office.
``(2) Content.--The application shall contain--
``(A) the identity of the approved product and the
Federal statute under which regulatory review occurred;
``(B) the identity of the patent for which an
extension applies;
``(C) documentation that the product is an eligible
countermeasure as defined under section 1822(b)(1) of
the Research Act; and
``(D) such patent or other information as the
Office may require.
``(3) Submission of application.--An application may only
be submitted within the 60-day period beginning on the date the
product became eligible for purchase under section 1822 of the
Research Act. The submission of an application under this
section is an irrevocable election of the application of this
section to a patent consistent with paragraph (4).
``(4) Exclusive application.--Sections 156 and 158 shall
not apply to any patent for which an application is filed under
this section. This section shall not apply to any patent the
term of which has been extended under section 156.
``(5) Rule of construction.--Nothing in this section shall
be construed to prohibit an extension of the term of patent
relating to a product that, before the effective date of this
section--
``(A) was approved for commercial marketing for
non-countermeasure uses; or
``(B) was approved for commercial marketing.''.
(2) Technical and conforming amendment.--The table of
sections for chapter 14 of title 35, United States Code, is
amended by inserting after the item relating to section 156 the
following:
``156a. Restoration of patent terms relating to countermeasures for
certain biological or chemical agents or
toxins.''.
(d) General Extension of Certain Patent Terms for Patents Held by
Entities That Have Successfully Developed Countermeasures.--
(1) In general.--Chapter 14 of title 35, United States
Code, is amended by adding at the end the following:
``Sec. 158. Patent term for patents held by entities with certain
research certifications
``(a) Definitions.--In this section, the term--
``(1) `product' means a new drug, antibiotic drug, or human
biological product (as those terms are used in the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and the
Public Health Service Act (42 U.S.C. 201 et seq.)); and
``(2) `Research Act' means the Biological, Chemical, and
Radiological Weapons Countermeasures Research Act of 2003.
``(b) Patent Term.--The term of a patent described under subsection
(c) shall be for a period of 2 years in addition to the term which
would otherwise apply except for this section.
``(c) Patent.--
``(1) In general.--A patent referred to under subsection
(b) or (d) is any patent that--
``(A) is held by an entity (or is exclusively
licensed to an entity by a not-for-profit organization
or is exclusively licensed to an entity under section
209(e) of this title or section 12(b)(7) of the
Stevenson-Wydler Technology Innovation Act of 1980 (15
U.S.C. 3710a(b)(1)(7)) that--
``(i) holds a certification under section
1812(d) of the Research Act with respect to a
product, a method of manufacturing such
product, or a method of using such product;
``(ii) has entered into a contract for the
sale of that product or method under section
1812(d)(3)(B) of the Research Act; and
``(iii) is a qualified small business as
determined under section 1202(d) of the
Internal Revenue Code of 1986, by substituting
`$750,000,000' for `$50,000,000' each place it
appears;
``(B) subject to subsections (d) and (e), is
designated by that entity as the patent to which this
section applies.
``(2) Waiver.--The Secretary of Health and Human Services
may waive the requirement of paragraph (1)(A)(iii).
``(d) Certain Action Not Necessary.--With respect to the owner of
record of a patent described under subsection (c)(1), it shall be
presumed that no action under this section is necessary to effect the
policies and objectives of title 18.
``(e) Limitations and Conditions.--In the administration of this
section--
``(1) only 1 patent may be designated with respect to each
certification held by an entity;
``(2) no redesignation of another patent may be made; and
``(3) the patent designated by the entity--
``(A) shall be issued before the date of a filing
of an application under subsection (e);
``(B) shall be held by that entity for at least 1
year before the date of the filing under subsection
(e);
``(C) may not have been acquired by that entity
from another entity for the purpose of the treatment of
that patent under subsection (b); and
``(D) is not required to be related to the subject
of the certification held by the entity.
``(f) Application.--
``(1) In general.--An entity that holds a certification
under section 1812(d) of the Research Act, may file an
application with the Patent and Trademark Office under this
section.
``(2) Content.--The application shall contain--
``(A) a copy of the certification under section
1812(d) of the Research Act;
``(B) a copy of any waiver granted under subsection
(c)(2); and
``(C) a designation of the patent to which this
section applies.
``(3) Submission of application.--An application may only
be submitted within the 60-day period beginning on the date
that the applicable product is eligible for purchase under
section 1822 of the Research Act.
``(4) Irrevocable and exclusive.--
``(A) Irrevocable election.--A filing of an
application under this section is an irrevocable
election of the application of this section to a patent
consistent with subparagraph (B).
``(B) Exclusive.--Sections 156 and 156a shall not
apply to any patent for which there is a filing under
this section. This section shall not apply to any
patent the term of which has been extended under
section 156.''.
(2) Technical and conforming amendment.--The table of
sections for chapter 14 of title 35, United States Code, is
amended by adding at the end the following:
``158. Patent term for patents held by entities with certain research
certifications.''.
(e) Exclusive Licensing.--
(1) In general.--Notwithstanding sections 200, 203, and 209
of title 35, United States Code, an entity that holds a
certification under section 1812(d) of the Biological,
Chemical, and Radiological Weapons Countermeasures Research Act
of 2003 with respect to a product that is an eligible
countermeasure as defined under section 1822(b)(1) of such Act
may exclusively license such patented product.
(2) Federally owned inventions.--Section 209 of title 35,
United States Code, is amended--
(A) by redesignating subsections (e) and (f) as
subsections (f) and (g), respectively; and
(B) by inserting after subsection (d) the
following:
``(e) Terms and Conditions of Exclusive License.--Each exclusive
license granted under section 207(a)(2) shall include a provision that,
at the discretion of the licensee, the licensee may act as the agent
for the licensor with respect to any patent for the licensed invention
for purposes of extending a patent under section 156a or 158.''.
(3) Cooperative research and development agreements.--
Section 12(b) of the Stevenson-Wydler Technology Innovation Act
of 1980 (15 U.S.C. 3710a(b)) is amended by adding at the end
the following:
``(7) Each exclusive license for a patent granted under an
agreement entered into under subsection (a)(1) shall include a
provision that, at the discretion of the licensee, the licensee may act
as the agent for the licensor with respect to that patent for purposes
of extending a patent under section 156a or 158 of title 35, United
States Code.''.
(4) Applicable licenses.--The amendments made by paragraphs
(2) and (3) shall apply only to exclusive licenses granted on
or after 60 days after the date of enactment of this Act.
(f) Exclusive Marketing.--Subchapter A of chapter V of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by
inserting after section 505A, the following:
``SEC. 505B. MARKET EXCLUSIVITY FOR TERROR WEAPONS COUNTERMEASURES.
``(a) In General.--If, prior to approval of an application that is
submitted under section 505(b)(1), the Secretary determines that the
new drug involved is a countermeasure (as defined in section 1802(1) of
the Biological, Chemical, and Radiological Weapons Countermeasures
Research Act of 2003) that meets the requirements of subparagraphs (A)
through (C) of section 1822(b)(1) of such Act, the provisions of
subsection (b) shall apply.
``(b) Exclusivity.--With respect to a new drug described in
subsection (a)--
``(1)(A)(i) the period referred to in subsection
(c)(3)(D)(ii) of section 505, and in subsection (j)(5)(D)(ii)
of such section, is deemed to be 10 years rather than five
years, and the references in subsections (c)(3)(D)(ii) and
(j)(5)(D)(ii) of such section to four years, to forty-eight
months, and to seven and one-half years are deemed to be nine
years, 108 months, and nine years, respectively; or
``(ii) the period referred to in clauses (iii) and (iv) of
subsection (c)(3)(D) of such section, and in clauses (iii) and
(iv) of subsection (j)(5)(D) of such section, is deemed to be
10 years rather than three years; and
``(B) if the drug is designated under section 526 for a
rare disease or condition, the period referred to in section
527(a) is deemed to be 10 years rather than seven years; and
``(2)(A) if the drug is the subject of--
``(i) a listed patent for which a certification has
been submitted under subsection (b)(2)(A)(ii) or
(j)(2)(A)(vii)(II) of section 505; or
``(ii) a listed patent for which a certification
has been submitted under subsections (b)(2)(A)(iii) or
(j)(2)(A)(vii)(III) of section 505,
the period during which an application may not be approved
under section 505(c)(3) or section 505(j)(4)(B) shall be
extended by a period of 5 years after the date the patent
expires (including any patent extensions); or
``(B) if the drug is the subject of a listed patent for
which a certification has been submitted under subsection
(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the
patent infringement litigation resulting from the certification
the court determines that the patent is valid and would be
infringed, the period during which an application may not be
approved under section 505(c)(3) or section 505(j)(4)(B) shall
be extended by a period of 5 years after the date the patent
expires (including any patent extensions).''.
SEC. 6. APPROVALS OF CERTAIN DRUGS BASED ON ANIMAL TRIALS.
(a) Federal Food, Drug, and Cosmetic Act.--Section 505(d) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)) is amended by
adding at the end the following: ``In the case of drugs and diagnostic
devices for use against lethal or permanently disabling toxic chemical,
biological, radiological, nuclear, or other substances, when adequate
and well-controlled studies of effectiveness in humans cannot ethically
be conducted because the studies would involve administering a
potentially lethal or permanently disabling toxic substance or organism
to healthy human volunteers, and when adequate field trials assessing
use of the drug or diagnostic device (in situations such as after
accidental or hostile exposure to the substance) have not been feasible
or where adequate volumes of human samples for diagnosis from previous
exposures is not available, the Secretary may grant approval based on
evidence of effectiveness derived from appropriate studies in animals.
The Secretary may promulgate regulations establishing standards,
criteria, and procedures for use of the authority contained in the
preceding sentence.''.
(b) Public Health Service Act.--Section 351 of the Public Health
Service Act (42 U.S.C. 262) is amended by adding at the end the
following:
``(k) Approval of Certain Products and Diagnostic Devices Based on
Animal Trials.--In the case of biological products and diagnostic
devices for use against lethal or permanently disabling toxic chemical,
biological, radiological, nuclear, or other substances, when definitive
human effectiveness studies in humans cannot ethically be conducted
because the studies would involve administering a potentially lethal or
permanently disabling toxic substance or organism to healthy human
volunteers, and when adequate field trials assessing use of the drug
(in situations such as after accidental or hostile exposure to the
substance) have not been feasible, the Secretary may grant approval
based on evidence of effectiveness derived from appropriate studies in
animals. The Secretary may promulgate regulations establishing
standards, criteria, and procedures for use of the authority provided
under this subsection.''.
SEC. 7. LIMITED ANTITRUST EXEMPTION.
Section 2 of the Clayton Act (15 U.S.C. 13) is amended by adding at
the end the following:
``(g) Limited Antitrust Exemption.--
``(1) Countermeasures development meetings.--
``(A) Countermeasures development meetings and
consultations.--The Secretary may conduct meetings and
consultations with parties involved in the development
of countermeasures for the purpose of the development,
manufacture, distribution, purchase, or sale of
countermeasures consistent with the purposes of this
title. The Secretary shall give notice of such meetings
and consultations to the Attorney General and the
Chairperson of the Federal Trade Commission (referred to in this
subsection as the `Chairperson').
``(B) Meeting and consultation conditions.--A
meeting or consultation conducted under subparagraph
(A) shall--
``(i) be chaired or, in the case of a
consultation, facilitated by the Secretary;
``(ii) be open to parties involved in the
development, manufacture, distribution,
purchase, or sale of countermeasures, as
determined by the Secretary;
``(iii) be open to the Attorney General and
the Chairperson;
``(iv) be limited to discussions involving
the development, manufacture, distribution, or
sale of countermeasures, consistent with the
purposes of this title; and
``(v) be conducted in such manner as to
ensure that national security, confidential,
and proprietary information is not disclosed
outside the meeting or consultation.
``(C) Minutes.--The Secretary shall maintain
minutes of meetings and consultations under this
subsection, which shall not be disclosed under section
552 of title 5, United States Code.
``(D) Exemption.--The antitrust laws shall not
apply to meetings and consultations under this
paragraph, except that any agreement or conduct that
results from a meeting or consultation and that does
not receive an exemption pursuant to this subsection
shall be subject to the antitrust laws.
``(2) Written agreements.--The Secretary shall file a
written agreement regarding covered activities, made pursuant
to meetings or consultations conducted under paragraph (1) and
that is consistent with this paragraph, with the Attorney
General and the Chairperson for a determination of the
compliance of such agreement with antitrust laws. In addition
to the proposed agreement itself, any such filing shall
include--
``(A) an explanation of the intended purpose of the
agreement;
``(B) a specific statement of the substance of the
agreement;
``(C) a description of the methods that will be
utilized to achieve the objectives of the agreement;
``(D) an explanation of the necessity of a
cooperative effort among the particular participating
parties to achieve the objectives of the agreement; and
``(E) any other relevant information determined
necessary by the Secretary in consultation with the
Attorney General and the Chairperson.
``(3) Determination.--The Attorney General, in consultation
with the Chairperson, shall determine whether an agreement
regarding covered activities referred to in paragraph (2) would
likely--
``(A) be in compliance with the antitrust laws, and
so inform the Secretary and the participating parties;
or
``(B) violate the antitrust laws, in which case,
the filing shall be deemed to be a request for an
exemption from the antitrust laws, limited to the
performance of the agreement consistent with the
purposes of this title.
``(4) Action on request for exemption.--
``(A) In general.--The Attorney General, in
consultation with the Chairperson, shall grant, deny,
grant in part and deny in part, or propose
modifications to a request for exemption from the
antitrust laws under paragraph (3) within 15 days of
the receipt of such request.
``(B) Extension.--The Attorney General may extend
the 15-day period referred to in subparagraph (A) for
an additional period of not to exceed 10 days. Such
additional period may be further extended only by the
United States district court, upon an application by
the Attorney General after notice to the Secretary and
the parties involved.
``(C) Determination.--In granting an exemption
under this paragraph, the Attorney General, in
consultation with the Chairperson and the Secretary--
``(i) must find--
``(I) that the agreement involved
is necessary to ensure the availability
of countermeasures;
``(II) that the exemption from the
antitrust laws would promote the public
interest; and
``(III) that there is no
substantial competitive impact to areas
not directly related to the purposes of
the agreement; and
``(ii) may consider any other factors
determined relevant by the Attorney General and
the Chairperson.
``(5) Limitation on and renewal of exemptions.--An
exemption granted under paragraph (4) shall be limited to
covered activities, and shall expire on the date that is 3
years after the date on which the exemption becomes effective
(and at 3 year intervals thereafter, if renewed) unless the
Attorney General in consultation with the Chairperson
determines that the exemption should be renewed (with
modifications, as appropriate) considering the factors
described in paragraph (4).
``(6) Limitation on parties.--The use of any information
acquired under an exempted agreement by the parties to such an
agreement for any purposes other than those specified in the
antitrust exemption granted by the Attorney General shall be
subject to the antitrust laws and any other applicable laws.
``(7) Guidelines.--The Attorney General and the Chairperson
may develop and issue guidelines to implement this subsection.
``(8) Report.--Not later than 1 year after the date of
enactment of the Biological, Chemical, and Radiological Weapons
Countermeasures Research Act of 2003, and annually thereafter,
the Attorney General and the Chairperson shall report to
Congress on the use and continuing need for the exemption from
the antitrust laws provided by this subsection.
``(9) Sunset.--The authority of the Attorney General to
grant or renew a limited antitrust exemption under this
subsection shall expire at the end of the 10-year period that
begins on the date of enactment of the Biological, Chemical,
and Radiological Weapons Countermeasures Research Act of 2003.
``(h) Definitions.--In this section:
``(1) Antitrust laws.--The term `antitrust laws'--
``(A) has the meaning given such term in subsection
(a) of the first section of the Clayton Act (15 U.S.C.
12(a)), except that such term includes the Act of June
19, 1936 (15 U.S.C. 13 et seq.) commonly known as the
Robinson-Patman Act), and section 5 of the Federal
Trade Commission Act (15 U.S.C. 45) to the extent such
section 5 applies to unfair methods of competition; and
``(B) includes any State law similar to the laws
referred to in subparagraph (A).
``(2) Countermeasure.--The term `countermeasure' has the
meaning given such term in section 1802(2) of the Biological,
Chemical, and Radiological Weapons Countermeasures Research Act
of 2003.
``(3) Covered activities.--
``(A) In general.--Except as provided in
subparagraph (B), the term `covered activities' means
any group of activities or conduct, including
attempting to make, making, or performing a contract or
agreement or engaging in other conduct, for the purpose
of--
``(i) theoretical analysis,
experimentation, or the systematic study of
phenomena or observable facts necessary to the
development of countermeasures;
``(ii) the development or testing of basic
engineering techniques necessary to the
development of countermeasures;
``(iii) the extension of investigative
findings or theory of a scientific or technical
nature into practical application for
experimental and demonstration purposes,
including the experimental production and
testing of models, prototypes, equipment,
materials, and processes necessary to the
development of countermeasures;
``(iv) the production, distribution, or
marketing of a product, process, or service
that is a countermeasures;
``(v) the testing in connection with the
production of a product, process, or services
necessary to the development of
countermeasures;
``(vi) the collection, exchange, and
analysis of research or production information
necessary to the development of
countermeasures; or
``(vii) any combination of the purposes
described in clauses (i) through (vi);
and such term may include the establishment and
operation of facilities for the conduct of covered
activities described in clauses (i) through (vi), the
conduct of such covered activities on a protracted and
proprietary basis, and the processing of applications
for patents and the granting of licenses for the
results of such covered activities.
``(B) Exception.--The term `covered activities'
shall not include the following activities involving 2
or more persons:
``(i) Exchanging information among
competitors relating to costs, sales,
profitability, prices, marketing, or
distribution of any product, process, or
service if such information is not reasonably
necessary to carry out the purposes of covered
activities.
``(ii) Entering into any agreement or
engaging in any other conduct--
``(I) to restrict or require the
sale, licensing, or sharing of
inventions, developments, products,
processes, or services not developed
through, produced by, or distributed or
sold through such covered activities;
or
``(II) to restrict or require
participation by any person who is a
party to such covered activities in
other research and development
activities, that is not reasonably
necessary to prevent the
misappropriation of proprietary
information contributed by any person
who is a party to such covered
activities or of the results of such
covered activities.
``(iii) Entering into any agreement or
engaging in any other conduct allocating a
market with a competitor that is not expressly
exempted from the antitrust laws by a
determination under subsection (i)(4).
``(iv) Exchanging information among
competitors relating to production (other than
production by such covered activities) of a
product, process, or service if such
information is not reasonably necessary to
carry out the purpose of such covered
activities.
``(v) Entering into any agreement or
engaging in any other conduct restricting,
requiring, or otherwise involving the
production of a product, process, or service
that is not so expressly exempted from the
antitrust laws by a determination under
subsection (i)(4).
``(vi) Except as otherwise provided in this
subsection, entering into any agreement or
engaging in any other conduct to restrict or
require participation by any person who is a
party to such activities, in any unilateral or
joint activity that is not reasonably necessary
to carry out the purpose of such covered
activities.
``(4) Development.--The term `development' includes the
identification of suitable compounds or biological materials,
the conduct of preclinical and clinical studies, the
preparation of an application for marketing approval, and any
other actions related to preparation of a countermeasure.
``(5) Person.--The term `person' has the meaning given such
term in subsection (a) of the first section of this Act.
``(6) Secretary.--The term `Secretary' means the Secretary
of Health and Human Services.''.
SEC. 8. INCENTIVES FOR THE CONSTRUCTION OF BIOLOGICS MANUFACTURING
FACILITIES AVAILABLE FOR THE PRODUCTION OF
COUNTERMEASURES.
(a) Biologics Manufacturing Facilities Investment Tax Credit.--
(1) Allowance of credit.--Section 46(a) of the Internal
Revenue Code of 1986 (relating to amount of investment credit)
is amended by striking ``and'' at the end of paragraph (2), by
striking the period at the end of paragraph (3) and inserting
``, and'', and by adding at the end the following new
paragraph:
``(4) the biologics manufacturing facilities investment
credit.''.
(2) Amount of credit.--Section 48 of such Code is amended
by adding at the end the following new subsection:
``(c) Biologics Manufacturing Facilities Investment Credit.--
``(1) In general.--For purposes of section 46, in the case
of any entity selected under section 1832(d) of the Biological,
Chemical, and Radiological Weapons Countermeasures Research Act
of 2003, the biologics manufacturing facilities investment
credit for any taxable year is an amount equal to 20 percent of
the qualified investment for such taxable year.
``(2) Qualified investment.--For purposes of paragraph (1),
the qualified investment for any taxable year is the basis of
each biologics manufacturing facilities property placed in
service by the taxpayer during such taxable year.
``(3) Biologics manufacturing facilities property.--For
purposes of this subsection, the term `biologics manufacturing
facilities property' means real and tangible personal
property--
``(A)(i) the original use of which commences with
the taxpayer, or
``(ii) which is acquired through purchase (as
defined by section 179(d)(2)),
``(B) which is depreciable under section 167, and
``(C) which is used for the manufacture,
distribution, or research and development of vaccines
and other biologics.
``(4) Certain progress expenditure rules made applicable.--
Rules similar to rules of subsection (c)(4) and (d) of section
46 (as in effect on the day before the date of the enactment of
the Revenue Reconciliation Act of 1990) shall apply for
purposes of this subsection.''.
(3) Technical amendments.--
(A) Subparagraph (C) of section 49(a)(1) of such
Code is amended by striking ``and'' at the end of
clause (ii), by striking the period at the end of
clause (iii) and inserting ``, and'', and by adding at
the end the following new clause:
``(iv) the basis of any biologics
manufacturing facilities property.''.
(B) Subparagraph (E) of section 50(a)(2) of such
Code is amended by striking ``section 48(a)(5)(A)'' and
inserting ``section 48(a)(5) or 48(c)(4)''.
(C)(i) The section heading for section 48 of such
Code is amended to read as follows:
``SEC. 48. OTHER CREDITS.''.
(ii) The table of sections for subpart E of part IV
of subchapter A of chapter 1 of such Code is amended by
striking the item relating to section 48 and inserting
the following:
``Sec. 48. Other Credits.''.
(b) Preemption of Zoning Laws for Siting of Biologics Manufacturing
Facilities.--The provisions of this section relating to the operation
and location of biologics manufacturing facilities, in accordance with
the plan developed under section 1832(b)(2) of the Biological,
Chemical, and Radiological Weapons Countermeasures Research Act of
2003, shall preempt State and local laws relating to zoning. State and
local laws relating to the construction and maintenance of such
facilities shall be preempted to the extent that such laws conflict
with such plan and the purposes of this section. Any action that is
commenced in any State relating to this subsection shall be removed to
the appropriate Federal district court.
SEC. 9. HUMAN CLINICAL TRIALS AND DRUGS FOR RARE DISEASES AND
CONDITIONS.
(a) Expanded Human Clinical Trials Qualifying for Orphan Drug
Credit.--
(1) In general.--Subclause (I) of section 45C(b)(2)(A)(ii)
of the Internal Revenue Code of 1986 is amended to read as
follows:
``(I) after the date that the
application is filed for designation
under such section 526, and''.
(2) Conforming amendment.--Clause (i) of section
45C(b)(2)(A) of the Internal Revenue Code of 1986 is amended by
inserting ``which is'' before ``being'' and by inserting before
the comma at the end ``and which is designated under section
526 of such Act''.
(3) Effective date.--The amendments made by this subsection
shall apply to amounts paid or incurred after December 31,
2003.
(b) Publication of Filing and Approval of Requests for Designation
of Drugs for Rare Diseases or Conditions.--Subsection (c) of section
526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb) is
amended to read as follows:
``(c) Not less than monthly, the Secretary shall publish in the
Federal Register, and otherwise make available to the public, notice of
requests for designation of a drug under subsection (a) and approvals
of such requests. Such notice shall include--
``(1) the name and address of the manufacturer and the
sponsor;
``(2) the date of the request for designation or of the
approval of such request;
``(3) the nonproprietary name of the drug and the name of
the drug under which an application is filed under section
505(b) or section 351 of the Public Health Service Act;
``(4) the rare disease or condition for which the
designation is requested or approved; and
``(5) the proposed indication for use of the product.''.
SEC. 10. LIABILITY.
Section 224(p) of the Public Health Service Act (42 U.S.C. 233(p))
is amended by adding at the end the following:
``(8) Application of provision to other countermeasures.--
``(A) Covered countermeasures and eligible
persons.--For purposes of this subsection--
``(i) the term `covered countermeasure'
includes a countermeasure as defined in section
1802(2) of the Biological, Chemical, and
Radiological Weapons Countermeasures Research
Act of 2003; and
``(ii) the term `eligible person' includes
any individual or entity who--
``(I) is a manufacturer or
distributor of a covered countermeasure
that is subject to indemnification from
the United States under a contract
between such manufacturer or
distributor and the United States for
such covered countermeasure; or
``(II) is a health care entity
under whose auspices such a covered
countermeasure was administered.
``(B) Application of provision.--The provisions of
this subsection shall apply to eligible persons (as
defined in subparagraph (A)) with respect to liability
arising out of the use or administration of a covered
countermeasure (as defined in subparagraph (A)), except
that the Secretary need not make a declaration with
respect to such a person or countermeasure under
paragraph (2)(A).
``(C) Limitation.--This paragraph shall only apply
to an eligible person (as defined in subparagraph (A))
who has entered into a contract with the Secretary of
Homeland Security, for procurement of the covered
countermeasure in accordance with section 1812 of the
Biological, Chemical, and Radiological Weapons
Countermeasures Research Act of 2003. Such contracts
and any protection under this subsection against claims
or civil actions shall apply only to the administration
or use of a countermeasure, detection equipment,
diagnostic, or research tool by the Federal Government
or another entity with respect to a biological agent or
toxin or a nuclear or radiological material used as a
terror weapon and to products sold to the Federal
Government under a contract pursuant to section 1812(e)
of such Act.''.
<all>