Makes entities engaged in countermeasure research eligible for tax incentives, participation in the Bioterrorism Countermeasures Purchase Fund, and patent extension and liability protections, as specified.
Sets forth the tax incentives which include limited partnerships, total exclusion for gain from stock, and special countermeasure research credits.
Provides for the establishment of the Bioterrorism Countermeasures Purchase Fund to purchase countermeasures. Provides for such countermeasures' distribution by the Director of the Centers for Disease Control and Prevention.
Provides for the election of extended patent protection for eligible countermeasures, as specified.
Amends the Public Health Service Act to indemnify and defend persons and entities engaged in the research, production, or use of countermeasures.
Authorizes the Director of the National Institutes of Health to award grants and contracts for the construction of certain biosafety research facilities.
Authorizes the Director to award partnership challenge grants to promote joint ventures between the public and private sectors for the development of countermeasures and research tools.
[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 1764 Introduced in Senate (IS)]
107th CONGRESS
1st Session
S. 1764
To provide incentives to increase research by commercial, for-profit
entities to develop vaccines, microbicides, diagnostic technologies,
and other drugs to prevent and treat illnesses associated with a
biological or chemical weapons attack.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
December 4, 2001
Mr. Lieberman introduced the following bill; which was read twice and
referred to the Committee on Finance
_______________________________________________________________________
A BILL
To provide incentives to increase research by commercial, for-profit
entities to develop vaccines, microbicides, diagnostic technologies,
and other drugs to prevent and treat illnesses associated with a
biological or chemical 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 ``Robert Stevens,
Thomas Morris Jr., Joseph Curseen, Kathy Nguyen, Ottilie Lundgren, and
Lisa J. Raines Biological and Chemical Weapons Research Act''.
(b) 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. Definitions.
Sec. 4. Biological and chemical agent research priority list.
Sec. 5. Research registration requirements.
Sec. 6. Federal tax incentives.
Sec. 7. Bioterrorism Countermeasure Purchase Fund.
Sec. 8. Patent term protection.
Sec. 9. Liability and indemnification.
Sec. 10. Construction of biosafety research facilities.
Sec. 11. National Institutes of Health countermeasures partnership
challenge grants.
Sec. 12. Expanded human clinical trials qualifying for orphan drug
credit.
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
and chemical weapons by terrorists and others against both
military personnel and 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 1992,
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 only
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
botulium toxin.
(D) 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.
(E) The Office of Technology Assessment estimated
than 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 United States must take steps to prevent access to
the biological or chemical agents 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 treat those who are exposed to, or infected
by, the agents.
(4) 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 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.
(5) The possibility exists that terrorists or others will
use biotechnology techniques to enhance the lethality of a
biological agent.
(6) Vaccines exist for some of the biological agents that
might be used by terrorists and others. The current United
States vaccine against anthrax was formulated in the 1960s and
licensed in 1970, 2 years before efficacy data were required
for licensing. Three problems with this vaccine have stimulated
interest in an improved human anthrax vaccine:
(A) The immunization schedule involves six initial
doses over 18 months followed by yearly boosters.
(B) Immunity is not protective against all natural
anthrax strains in guinea pigs.
(C) There is a high incidence of local reactions
(30 percent according to the package insert).
The vaccine is an undefined mix of bacterial products.
Furthermore, the potency of both the UK and MDPH-PA vaccines is
found to vary significantly between lots. Some are concerned
that the vaccine might lead to chronic fatigue syndrome,
fibromyalgia, multiple chemical sensitivity, autoimmune
illnesses, or neuropathies. There is no vaccine against plague
or most of the other bacteria and viruses that might be used as
biological weapons.
(7) Treatments for those who are not protected by vaccines
are often not effective. Inhalation anthrax (woolsorters'
disease) results from inhaling anthrax spores and, if
untreated, it is about 90 percent fatal. Antibiotics and
standard interventions provided after symptoms have developed
rarely prevent a fatal outcome.
(8) Vaccines and treatments for exposure to nerve toxins do
not exist or are ineffective.
(9) The United States Government is directly funding
biomedical research on vaccines and treatments for biological
and chemical agents. These funding efforts could be matched
many-fold if the 1,300 biotechnology companies were able to
secure the funding from private investors to conduct this
research. Most biotechnology 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 investment opportunities.
(10) Biotechnology companies are justifiably reluctant to
modify their ongoing research priorities and devote scare
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.
(11) 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.
(12) Successful research and development of countermeasures
will necessitate breakthroughs in virology, immunology,
antibiotics, genetic analysis, and many other disciplines in
biology. There is no established market or appropriate Food and
Drug Administration approval process for most countermeasures.
Biotechnology 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
prices and patents. They are especially sensitive to the terms
of sales that may arise when the only market for a product is
the Federal Government. These are risks that companies,
employees and investors in other sectors of the economy do not
face and that may affect the willingness of investors and
capital markets to fund this critical medical research.
(13) The enactment of tax, patent, liability and other
incentives will enable the biotechnology industry to raise
equity and other capital from investors to fund research on
countermeasures for biological and chemical 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.
SEC. 3. DEFINITIONS.
In this Act:
(1) Countermeasures.--The term ``countermeasures'' means a
vaccine, microbicide, diagnostic technology, drug, or other
technology that can be used to diagnose, treat, or prevent
infection with, or the spread of, a biological agent or toxin
on the list described in section 4, or a research tool used to
develop such countermeasure, and that has been approved for use
in accordance with applicable provisions of 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) Director.--The term ``Director'', except as provided in
section 6, means the Director of the Office of Homeland
Security.
(3) Office.--The term ``Office'' means the Office of
Homeland Security.
SEC. 4. BIOLOGICAL AND CHEMICAL AGENT RESEARCH PRIORITY LIST.
(a) Development.--Not later than 90 days after the date of
enactment of this Act, the Director, in consultation with the Secretary
of Defense and the Secretary of Health and Human Services, shall
develop and publish in the Federal Register, or otherwise make
available to holders of approved applications or other potential
manufacturers of bioterrorism countermeasures, a list of biological and
chemical agents and toxins that may be used as weapons of mass
destruction. In determining which agents or toxins to place on the
list, the Director shall consider whether the agent or toxin poses a
significant security or medical threat to the United States military
and intelligence personnel or civilians and whether countermeasures are
more likely to be developed with the availability of the tax, purchase,
patent, or liability provisions of this Act.
(b) Initial List.--The initial list published under subsection (a)
may, at the discretion of the Director, contain the following
biological and chemical agents and toxins:
(1) Variola major confluent pox, flat pox, and hemorrhagic
smallpox.
(2) Bacillus anthracis (anthrax).
(3) Clostridium botulinum toxin (botulism).
(4) Francisella tularensis (tularaemia).
(5) Ebola hemorrhagic fever.
(6) Marbug hemorrhagic fever.
(7) Lassa fever.
(8) Julin (Argentine hemmorrhagic fever).
(9) Crimean-Congo Hemmorrhagic Fever.
(10) Coxiella burnetti (Q fever).
(11) Brucella species (brucellosis).
(12) Burkholderia mallei (glanders).
(13) Venezuelan encephalomyelitis.
(14) Eastern and Western equine encephalomyelitis.
(15) Ricin toxin from ricinus commuinis (castor beans).
(16) Epsilon toxin of colostridium perfringens.
(17) Staphylococcus enterotoxin B.
(18) Salmonella species.
(19) Shigella dysenteriae.
(20) Escherichia coli 0157:H7.
(21) Vibrio cholerae (colera).
(22) Cryptosporidium parvum.
(23) Nipah virus.
(24) Hantaviruses.
(25) Tickborn homorrhagic fever viruses.
(26) Tickborn encephalitis virus.
(27) Yellow fever.
(28) Malaria.
(29) Antibiotic resistant tuberculosis.
(30) Acquired immune deficiency syndrome (AIDS).
(31) Entamoeba histoytica.
(32) Bacillary dystentary.
(33) Giardiasis.
(34) Trichomoniasis.
(35) Trypanosomiasis.
(36) Leishmaniasis.
(37) Nerve agents (including tabun, sarin, soman, GF, and
VX).
(38) Blood agents (including hydrogen cyanide and cyanogen
chloride).
(39) Blister agents (including lewisite, nitrogenadn and
sulfur mustards).
(40) Heavy metals (including arsenic, lead, and mercury).
(41) Colatile toxins (including benzene, chloroform, and
trihalomethanes).
(42) Pulmonary agents (including phosgene and chlorine
vinly chloride).
(43) Incapacitating agents (BZ).
(c) Revisions.--The Director shall revise the list published under
subsection (a) on at least an annual basis, and publish such revised
list in the Federal Register, or otherwise make such list available to
holders of approved applications or other potential manufacturers of
bioterrorism countermeasures.
(d) No Judicial Review.--Notwithstanding any other provision of
law, there shall be no judicial review of the list, or revised list,
published by the Director under this section.
SEC. 5. RESEARCH REGISTRATION REQUIREMENTS.
(a) In General.--On or before December 31 of each year each entity
that operates any commercial, for-profit establishment in any State
that seeks to be eligible for the tax, procurement, intellectual
property, and liability incentives provided for in this Act, and that
is engaged in the conduct of research to develop countermeasures, shall
register with the Food and Drug Administration. 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 or toxin with respect to which
the entity seeks to develop countermeasures;
(4) a description of the research that is being, or that
will be, conducted to develop countermeasures to such agent or
toxin;
(5) the name of each individual who is conducting the
research involved; and
(6) any other information required under regulations
promulgated by the Director.
(b) Availability of Information.--
(1) In general.--Not later than 90 days after the date of
enactment of this Act, the Secretary of Health and Human
Services shall promulgate regulations with respect to the
availability of information under this subsection.
(2) Inspections.--Subject to regulations promulgated under
paragraph (1), the Food and Drug Administration 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 Director shall
promulgate regulations to exempt certain information from
disclosure under paragraph (2), including proprietary
commercial information of the registrant, national security
information, and information affecting the security of research
and other facilities.
(c) Inspections.--Every establishment in any State registered with
the Food and Drug Administration pursuant to this section shall be
subject to inspection, limited to such information as may be necessary
relating to the development of countermeasures and facility security,
pursuant to regulations promulgated by the Director.
(d) Certification.--
(1) In general.--With respect to each entity that registers
with the Food and Drug Administration under this section, the
Director, in consultation with the Food and Drug
Administration, shall determine whether the research to be
conducted under such registration is intended to lead to the
development of countermeasures (other than a research tool as
defined in paragraph (3)).
(2) Determination.--If the Director makes an affirmative
determination under paragraph (1) with respect to an entity,
the Director shall certify the entity as being eligible--
(A) for the tax incentive provisions described in
section 6;
(B) for participating in the Bioterrorism
Countermeasures Purchase Fund program under section 7;
(C) for patent extension protection under section
156a or 158 of title 35, United States Code, as added
by section 8; and
(D) for the liability protections provided for
under the amendment made by section 9.
(3) Determinations regarding research tools.--The Director
may accept a registration under this section from a commercial,
for-profit establishment in a State, and may provide a
certification under this section if the Director determines
that the establishment intends to conduct research that is
designed to lead to the development of a research tool that
will make it possible to expeditiously develop a countermeasure
to an agent or toxin that is not included on the list published
under section 4. An establishment that is certified under this
paragraph shall be eligible for the tax incentive provisions
described in section 6.
(e) Rule of Construction.--Nothing in this section shall be
construed to prohibit a commercial, for-profit establishment from
filing more than 1 registration concerning research and from obtaining
more than 1 certification of eligibility under this section.
SEC. 6. FEDERAL TAX INCENTIVES.
Any entity certified as eligible for any taxable year under section
5(d) may irrevocably elect 1 of the following Federal tax incentives to
fund research to develop countermeasures:
(1) Limited partnership.--The entity may establish a
limited partnership for the certified countermeasures 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 that such 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) 100-percent exclusion for gain from stock.--The entity
may issue a class of stock for the certified research under
section 1202 of the Internal Revenue Code of 1986 with the
following modifications:
(A) Increased exclusion.--Subsection (a) of section
1202 of such Code shall be applied by substituting
``100 percent'' for ``50 percent''.
(B) 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.
(C) Reduction in holding period.--Subsection (a) of
section 1202 of such Code shall be applied by
substituting ``3 years'' for ``5 years''.
(D) 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).
(E) 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.
(F) Nonapplication of minimum tax preference.--
Section 57(a) of such Code shall be applied without
regard to paragraph (7).
(3) Breakthrough research refundable credit.--
(A) In general.--The Internal Revenue Code of 1986
is amended by redesignating section 35 as section 36
and by inserting after section 34 the following new
section:
``SEC. 35. BREAKTHROUGH RESEARCH CREDIT.
``(a) General Rule.--There shall be allowed as a credit against the
tax imposed by this subtitle an amount equal to the sum of a qualified
research corporation's discounted research credits and discounted
research NOL's.
``(b) Qualified Research Corporation.--
``(1) In general.--For the purposes of this section, the
term `qualified research corporation' means any domestic
corporation subject to tax under subchapter C of this chapter--
``(A) which has not incurred regular tax liability
(as defined in section 55(c)) under this chapter for a
period of at least 3 consecutive taxable years (other
than short taxable years) immediately prior to the
commencement of the taxable year as to which any
election is made under this section,
``(B) which has not been controlled by, or been
under common control (as determined under section
267(b)) with, a corporation which has incurred regular
tax liability (as so defined) under this chapter for
any taxable year commencing during the period described
in subparagraph (A),
``(C) at all times during the period described in
subparagraph (A) has met the requirements of subsection
(h), and
``(D) which is not the subject of any proceeding
under Federal or State bankruptcy or insolvency laws.
``(2) Special rule.--A qualified research corporation, in
claiming the credit provided for in this section, shall not
take into account any expenditures for which it is reimbursed
by another taxpayer, except to the extent that the reimbursing
taxpayer provides a certification to the qualified research
corporation that--
``(A) the reimbursing taxpayer would be entitled to
take such expenditures into account in the same manner,
and
``(B) the reimbursing taxpayer shall not take such
expenditures into account in claiming any credits under
this section.
``(c) Definitions.--For the purposes of this section--
``(1) Research credit.--The term `research credit' means
the sum of those portions of a qualified research corporation's
current year business credit and business credit carryforwards,
as determined under section 38(a), which are attributable to
the credit determined under section 41 (for increases in
research activities) and which are attributable to
countermeasures research activities.
``(2) Research nol.--The term `research NOL' means that
portion of a qualified research corporation's net operating
loss (as defined in section 172(c)) attributable to qualified
countermeasure research expenditures.
``(3) Discounted research credit.--The term `discounted
research credit' shall mean the research credit amounts subject
to an election under this section multiplied by 75 percent.
``(4) Discounted research nol.--The term `discounted
research NOL' shall mean the research NOL subject to an
election under this section multiplied by 75 percent of the
highest marginal tax rate in effect under section 11.
``(5) Ordering rule.--For purposes of determining the
portion of a taxpayer's net operating loss that is attributable
to research expenditures (within the meaning of paragraph (2))
for any taxable year, research expenditures shall be considered
to be offset against the taxpayer's gross income on a pro rata
basis with all other allowable expenses and charges paid or incurred in
the taxable year.
``(d) Election To Relinquish Research-Related Net Operating Losses
and Tax Credits for Cash Refunds.--
``(1) General rule; benefits arising in current year.--A
qualified research corporation may make an election under this
section to relinquish all of its current year research NOL's
and research credits in exchange for cash refunds. The
corporation shall make the election on its timely filed tax
return (including extensions) for the taxable year in which the
research NOL's and research credits arise.
``(2) Special rule; net operating loss and unused tax
credit carryforwards.--
``(A) In general.--If a qualified research
corporation has unabsorbed research NOL's or research
credits not subject to an election under this section,
which arose in a previous taxable year and which the
qualified research corporation would be entitled to
carry forward to a taxable year for which it makes an
election under paragraph (1), then the taxpayer shall
designate such research NOL carryforwards and such
research credit carryforwards to be covered by its
election under this section.
``(B) Limitation.--For any taxable year, the amount
of research NOL carryforwards and research credit
carryforwards to the taxable year which may be
designated as covered by an election under this section
shall be the greater of--
``(i) the average of the annual amounts of
the qualified research corporation's research
NOL's and research credits arising in the 3
taxable years ending prior to the taxable year
of the election, or
``(ii) 20 percent of the qualified research
corporation's research NOL carryforwards and
research credit carryforwards.
``(3) Procedures and recordkeeping by electing
corporation.--An election under this section may be revoked by
the taxpayer only with the consent of the Secretary. Qualified
research corporations making such an election shall provide
such information in connection with such election as may be
required by the Secretary and shall maintain records sufficient
to permit the Secretary to identify and to audit the specific
research credits and research NOL's that are subject to an
election under this section.
``(e) Extinguishment of Relinquished Tax Benefits.--
``(1) Deductions.--No deduction shall be allowed to a
qualified research corporation under the alternative minimum
tax provisions of section 56(a)(4) or the net operating loss
provisions of section 172 with respect to that portion of a net
operating loss for which an election under this section is in
effect.
``(2) Credits.--No credit shall be allowed to a qualified
research corporation under section 38(a) with respect to any
credit amounts determined under section 41 for which an
election under this section is in effect.
``(f) Limitation on Use of Nonrelinquished Tax Benefits by Electing
Corporation.--A qualified research corporation which has received
refunds pursuant to an election under this section shall not be
entitled to utilize any carrybacks or carryforwards of net operating
losses or tax credits (which are not subject to an election under this
section and are otherwise available to be utilized in the taxable year)
to reduce taxable income or to offset any tax liability for taxable
years after the year of such election, until such corporation has paid
tax imposed under this chapter for such taxable years in an aggregate
amount equal to the aggregate amount of the refunds previously
received, less any underpayment amount determined under subsection (g).
``(g) Credit Proceeds From Exchange of Research Credits and
Research NOL's Must Be Used Exclusively for Research or Experimentation
Purposes; Recapture.--
``(1) Recapture of credit in the event of failure to
increase research and experimentation activity.--If--
``(A) the sum of--
``(i) the credit received by a qualified
research corporation from an election under
this section made on its tax return for a
taxable year (the election year), plus
``(ii) the amount of its research or
experimental expenditures (within the meaning
of section 174, but prior to application of
section 280C) paid or incurred during the
election year, exceeds
``(B) the amount of such research or experimental
expenditures paid or incurred by the qualified research
corporation during the taxable year immediately
following the election year,
then the election shall be void to the extent of the excess,
and the excess shall be treated as an underpayment of tax
imposed by this chapter for the election year without regard to
any credit otherwise allowable under this chapter.
``(2) Underpayment not subject to certain penalties.--An
underpayment of tax determined under paragraph (1) shall not be
taken into account in determining any penalties or additions to
tax under sections 6655 and 6662.
``(3) Recapture penalty limited to the amount of exchange
election payments received.--An underpayment of tax determined
under paragraph (1) shall not exceed the amount taken into
account under paragraph (1)(A)(i).
``(4) Exception.--No increase in the aggregate amounts paid
by a qualified research corporation to a person with whom the
corporation has a relationship specified in section 267(b)
shall be taken into account in determining the amount of any
excess under paragraph (1).
``(h) Additional Requirements for a Qualified Research
Corporation.--
``(1) In general.--A corporation shall be considered as
meeting the requirements of this subsection for any taxable
year if during such taxable year--
``(A) at least 80 percent (by value) of the assets
of such corporation are used by such corporation in the
active conduct of 1 or more qualified trades or
businesses,
``(B) such corporation is an eligible corporation,
and
``(C) such corporation has aggregate gross assets
(as defined in section 1202(d)(2)) of not more than
$750,000,000.
``(2) Special rule for certain activities.--For purposes of
paragraph (1), if, in connection with any future qualified
trade or business, a corporation is engaged in--
``(A) startup activities described in section
195(c)(1)(A),
``(B) activities resulting in the payment or
incurring of expenditures which may be treated as
research and experimental expenditures under section
174, or
``(C) activities with respect to in-house research
expenses described in section 41(b)(4),
assets used in such activities shall be treated as used in the
active conduct of a qualified trade or business. Any
determination under this paragraph shall be made without regard
to whether a corporation has any gross income from such
activities at the time of the determination.
``(3) Qualified trade or business.--For purposes of this
subsection, the term `qualified trade or business' means any
trade or business other than--
``(A) any trade or business involving the
performance of services in the fields of health, law,
engineering, architecture, accounting, actuarial
science, performing arts, consulting, athletics,
financial services, brokerage services, or any trade or
business where the principal asset of such trade or
business is the reputation or skill of 1 or more of its
employees,
``(B) any banking, insurance, financing, leasing,
investing, or similar business,
``(C) any farming business (including the business
of raising or harvesting trees),
``(D) any business involving the production or
extraction of products of a character with respect to
which a deduction is allowable under section 613 or
613A, and
``(E) any business of operating a hotel, motel,
restaurant, or similar business.
``(4) Eligible corporation.--For purposes of this
subsection, the term `eligible corporation' means any domestic
corporation, except that such term shall not include--
``(A) a DISC or former DISC,
``(B) a corporation with respect to which an
election under section 936 is in effect or which has a
direct or indirect subsidiary with respect to which
such an election is in effect,
``(C) a FSC (as defined in section 922, as in
effect on the day before the date of the enactment of
the FSC Repeal and Extraterritorial Income Exclusion
Act of 2000),
``(D) a regulated investment company, real estate
investment trust, REMIC, or FASIT, or
``(E) a cooperative.
``(5) Stock in other corporations.--
``(A) Look-thru in case of subsidiaries.--For
purposes of this subsection, stock and debt in any
subsidiary corporation shall be disregarded and the
parent corporation shall be deemed to own its ratable
share of the subsidiary's assets, and to conduct its
ratable share of the subsidiary's activities.
``(B) Portfolio stock or securities.--A corporation
shall be treated as failing to meet the requirements of
paragraph (1) for any period during which more than 10
percent of the value of its assets (in excess of
liabilities) consist of stock or securities in other
corporations which are not subsidiaries of such
corporation (other than assets described in paragraph
(7)).
``(C) Subsidiary.--For purposes of this paragraph,
a corporation shall be considered a subsidiary if the
parent owns more than 50 percent of the combined voting
power of all classes of stock entitled to vote, or more
than 50 percent in value of all outstanding stock, of
such corporation.
``(6) Working capital.--For purposes of paragraph (2)(A),
any assets which--
``(A) are held as a part of the reasonably required
working capital needs of a qualified trade or business
of the corporation, or
``(B) are held for investment and are reasonably
expected to be used within 5 years to finance research
and experimentation in a qualified trade or business or
increases in working capital needs of a qualified trade
or business,
shall be treated as used in the active conduct of a qualified
trade or business. For periods after the corporation has been
in existence for at least 5 years, in no event may more than 50
percent of the assets of the corporation qualify as used in the
active conduct of a qualified trade or business by reason of
this paragraph.
``(7) Maximum real estate holdings.--A corporation shall
not be treated as meeting the requirements of paragraph (2) for
any period during which more than 10 percent of the total value
of its assets consists of real property which is not used in
the active conduct of a qualified trade or business. For
purposes of the preceding sentence, the ownership of, dealing
in, or renting of real property shall not be treated as the
active conduct of a qualified trade or business.
``(8) Computer software royalties.--For purposes of
paragraph (2), rights to computer software which produces
active business computer software royalties (within the meaning
of section 543(d)(1)) shall be treated as an asset used in the
active conduct of a trade or business.
``(i) Regulations.--The Secretary may prescribe such regulations as
may be necessary to carry out the purposes of this section, including
regulations coordinating the application of this section with the
consolidated return regulations and regulations providing for the
application of this section to short taxable years.''.
(B) Conforming amendments.--
(i) Section 55(c)(1) of the Internal
Revenue Code of 1986 is amended by striking
``section 49(b)'' and inserting ``section
35(g), 49(b),''.
(ii) Section 1324(b)(2) of title 31, United
States Code, is amended by striking ``or''
before ``enacted'' and by inserting before the
period at the end ``, or from section 35 of
such Code''.
(C) Clerical amendment.--The table of sections for
subpart C of part IV of subchapter A of chapter 1 of
the Internal Revenue Code of 1986 is amended by
striking the item relating to section 35 and inserting
the following new items:
``Sec. 35. Breakthrough research credit.
``Sec. 36. Overpayments of tax.''.
(D) Effective date.--The amendments made by this
paragraph shall apply to taxable years beginning after
December 31, 2001.
SEC. 7. BIOTERRORISM COUNTERMEASURE PURCHASE FUND.
(a) Purpose.--It is the purpose of this section to create
incentives for private for-profit sector research that is intended to
lead to the development of countermeasures to respond to an attack with
biological agents or toxins.
(b) Definitions.--In this section:
(1) Director.--The term ``Director'' means the Director of
the Centers for Disease Control and Prevention.
(2) Eligible countermeasure.--The term ``eligible
countermeasure'' means a countermeasure (as defined in section
3(1)) developed by an entity that has been certified under
section 5(d) (other than a research tool).
(3) Fund.--The term ``Fund'' means the Bioterrorism
Countermeasure Purchase Fund established under subsection (c).
(4) Secretary.--The term ``Secretary'' means the Secretary
of the Treasury.
(c) Establishment of Fund.--As of the date that the Secretary
determines that any eligible countermeasure is available for purchase,
there is established in the Treasury of the United States a fund to be
known as the ``Bioterrorism 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 is authorized to expend
amounts in the Fund for purchases of eligible countermeasures.
Such countermeasures shall be made available to the Director
and distributed as the Director, in consultation with the
Director of the Office of Homeland Security and the Secretary
of Health and Human Services, determines appropriate.
(2) Purchase and distribution of countermeasures.--
Countermeasures purchased by the Fund--
(A) shall be purchased at a negotiated unit price;
(B) shall be approved by the Food and Drug
Administration; and
(C) shall be made under a formula establishing a
minimum price per dose, minimum number of doses, and
minimum technical requirements for the eligible
countermeasure.
(3) Distribution.--Eligible countermeasures purchased by
the Fund shall be distributed as provided for by the Director,
in consultation with the Director of Homeland Security and the
Secretary of Health and Human Services, determines appropriate
after--
(A) consideration of the prevalence of the
infection to be treated by the eligible countermeasure;
and
(B) consideration of the ability of the recipient
to effectively and safely deliver the countermeasures.
(4) Rule of construction.--Nothing in this subsection shall
be construed to require that the Fund purchase more than one
eligible countermeasure for each agent or toxin contained on the
Biological and Chemical Agent Priority List developed under section 4.
(5) Regulations.--The Director 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
determines that any eligible countermeasure is available for
purchase by the Fund.
(2) Transfer to fund.--The Secretary 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) Terms of Contracts.--Notwithstanding any other provision of
law, a contract entered into by the Director under this section shall
be for a period of not to exceed 10 years.
(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 to any other entity or individual.
SEC. 8. PATENT TERM PROTECTION.
(a) Election.--
(1) In general.--An entity that is certified under section
5(d) may elect to receive patent protection under either
section 156a or 158 of title 35, United States Code, (as
amended by this section) if the countermeasure involved is an
eligible countermeasure as defined under section 7. An entity
that is not a qualified small business as defined in section
1202 of the Internal Revenue Code of 1986 (as amended by
section 6) may elect only the first of these provisions.
(2) Time for election.--An election shall be made by an
entity under paragraph (1) within 60 days after the date on
which the countermeasure involved is available for purchase
under section 7. An election under this subsection shall be
irrevocable.
(b) Extension of Patent Terms Relating to Countermeasures for
Certain Biological or Chemical Agents or Toxins.--
(1) In general.--Chapter 14 of title 35, United States
Code, is amended by inserting after section 156 the following:
``Sec. 156a. Extension of patent terms relating to countermeasures for
certain biological or chemical agents or toxins
``(a) Definitions.--In this section, the term--
``(1) `product' means the new drug, antibiotic drug, or
human biological product to which subsection (b) applies; and
``(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.
``(b) Patent.--A patent referred to under subsection (c) 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 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) is an eligible countermeasure as defined under
section 7 of the Robert Stevens, Thomas Morris Jr., Joseph
Curseen, Kathy Nguyen, Ottilie Lundgren, and Lisa J. Raines
Biological and Chemical Weapons Research Act.
``(c) 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).
``(d) 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
its agent 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 7 of the Robert
Stevens, Thomas Morris Jr., Joseph Curseen, Kathy
Nguyen, Ottilie Lundgren, Lisa J. Raines Biological and
Chemical Weapons 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 7 of the
Robert Stevens, Thomas Morris Jr., Joseph Curseen, Kathy
Nguyen, Ottilie Lundgren, and Lisa J. Raines Biological and
Chemical Weapons 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 shall not apply
to any patent for which an application is filed under this
section.
``(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. Extension of patent terms relating to countermeasures for
certain biological or chemical agents or
toxins.''.
(c) General Extension of Certain Patent Terms.--
(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) Patent Term.--The term of a patent described under subsection
(b) shall be for a period of 2 years in addition to the term which
would otherwise apply except for this section.
``(b) Patent.--A patent referred to under subsection (a) is any
patent that--
``(1) is held by an entity that holds a certification under
section 5(d)(2) of the Robert Stevens, Thomas Morris Jr.,
Joseph Curseen, Kathy Nguyen, Ottilie Lundgren, and Lisa J.
Raines Biological and Chemical Weapons Research Act with
respect to a product, a method of manufacturing such product,
and a method of using such product;
``(2) is an eligible countermeasure as defined under
section 7 of such Act; and
``(3) subject to subsections (c) and (d), is designated by
that entity as the patent to which this section applies.
``(c) 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
under subsection (d);
``(B) shall be held by that entity for at least 1
year before the date of the filing under subsection
(d);
``(C) may not have been acquired by that entity
from another entity for the purpose of the treatment of
that patent under subsection (a); and
``(D) is not required to be related to the subject
of the certification held by the entity.
``(d) Filing.--
``(1) In general.--An entity that holds a certification
under section 5(d)(2) of the Robert Stevens, Thomas Morris Jr.,
Joseph Curseen, Kathy Nguyen, Ottilie Lundgren, and Lisa J.
Raines Biological and Chemical Weapons Research Act shall, with
respect to a product that is an eligible countermeasure as
defined under section 7 of such Act, file with the Patent and
Trademark Office--
``(A) a copy of that certification; and
``(B) a designation of the patent to which this
section applies.
``(2) Irrevocable and exclusive.--
``(A) Irrevocable election.--A filing under this
section is an irrevocable election of the application
of this section to a patent consistent with
subparagraph (B).
``(B) Exclusive.--Sections 156 shall not apply to
any patent for which there is a filing under this
section.''.
(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.''.
(d) Exclusive Licensing.--Notwithstanding sections 200, 203, and
209 of title 35, United States Code, an establishment that is certified
under section 5(d) with respect to a product that is an eligible
countermeasure as defined under section 7 may exclusively license such
patented product.
SEC. 9. LIABILITY AND INDEMNIFICATION.
Title III of the Public Health Service Act is amended by inserting
after section 352 (42 U.S.C. 263) the following:
``SEC. 352A. LIABILITY AND INDEMNIFICATION.
``(a) Indemnification and Defense Agreements.--Notwithstanding
sections 1341, 1342, 1349, 1350, and 1351 and subchapter II of chapter
15, of title 31, United States Code, or any other provision of law, the
Secretary--
``(1) shall enter into agreements to indemnify and defend
persons or entities engaged in the research, development,
production, distribution, administration or use of
countermeasures (as defined in section 3(1) of the Robert
Stevens, Thomas Morris Jr., Joseph Curseen, Kathy Nguyen,
Ottilie Lundgren, and Lisa J. Raines Biological and Chemical
Weapons Research Act);
``(2) shall enter into agreements to indemnify and defend
persons or entities engaged in the research, development,
production, distribution, administration or use of
countermeasures; and
``(3) may enter into such agreements with other persons if
the Secretary determines that the national interest in
combating terrorism, or the protection of the public health, or
both, reasonably requires such an agreement.
``(b) Protections.--An indemnification and defense agreement shall
protect against claims or civil actions (including reasonable expenses
of litigation or settlement) by third persons, for damages (including
death, bodily injury, economic losses, non-economic losses, or loss of
or damage to property or punitive damages), allegedly caused by the
research, development, production, distribution, administration or use
of a countermeasure (including a vaccine or antitoxin).
``(c) Exclusive Remedy.--
``(1) In general.--This section shall constitute the
exclusive remedy with respect to a civil action filed against
persons or entities within the scope of an indemnification and
defense agreement entered into under subsection (a), for
damages (including bodily injury, death, economic losses, non-
economic losses or damage to property or punitive damages),
consistent with the limitations contained in paragraph (2), to
the extent that the civil action arises from the research,
development, production, distribution, administration or use of
a countermeasure (including vaccines and antitoxins).
``(2) Limitation.--No exclusive civil action under this
section shall be permitted unless the amount in controversy
exceeds $10,000.
``(d) Requirements.--An indemnification and defense agreement
shall--
``(1) require notice to be provided to the United States of
any claim or civil action (including an exclusive civil action)
that is filed against persons or entities who are parties to
such agreement for any alleged damages (including bodily
injury, death, economic losses, non-economic losses, and loss
of or damage to property or punitive damages) allegedly caused
by the research, development, production, distribution,
administration or use of a countermeasure; and
``(2) require control of, or assistance in, the defense by
the United States of such claim or civil action.
``(e) Venue; Application of Law; and Damages.--
``(1) Venue.--An exclusive civil action under this section
shall be filed in any United States district court of otherwise
appropriate jurisdiction. Appeals from appealable actions of
such courts in such actions shall be taken to the Court of
Appeals for the Federal Circuit and, as appropriate, to the
United States Supreme Court.
``(2) Application of law.--An exclusive civil action filed
under this section shall be governed by Federal law. No State
or political subdivision of a State shall have any authority to
enforce any other law or common law standard governing a civil
action for damages (including damages for bodily injury, death,
economic damages, noneconomic damages, or loss or damage to
property or punitive damages) arising out of the conduct or
actions covered by an indemnification and defense agreement.
Any civil action in State or Federal Court that is barred from
consideration by this section shall be removed or transferred
to the appropriate Federal district court or dismissed, as
appropriate.
``(3) Limitations on damages.--In an exclusive civil action
filed under this section an award for non-economic damages
shall not exceed $250,000 per plaintiff. In no such cases shall
punitive or exemplary damages be awarded.
``(4) Reduction in amounts.--In an exclusive civil action
under this section, an award to a plaintiff shall be reduced,
by the presiding judge, to the extent that the plaintiff has
otherwise received compensation for the damages at issue from a
government, an insurance provider, or other third party.
``(f) Definitions.--In this section:
``(1) Exclusive civil action.--The term `exclusive civil
action' means a civil action described in subsection (c)(1).
``(2) Indemnification and defense agreements.--The term
`indemnification and defense agreements' means the agreements
described in subsection (a).''.
SEC. 10. CONSTRUCTION OF BIOSAFETY RESEARCH FACILITIES.
(a) Findings.--Congress finds that--
(1) research to develop countermeasures requires the use of
special facilities where biological agents can be handled
safely;
(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 Director of the National Institutes of
Health 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
Director of the Office of Homeland Security;
(B) give priority for the use of the facility
involved to those entities that have been registered
and certified by the Director of the Office of Homeland
Security to develop countermeasures; and
(C) allow the National Institutes of Health to
inspect the facility involved at any time.
(3) Number of grants.--The Director of the Office of
Homeland Defense shall determine the number of facilities that
need to be constructed under this section, not to exceed 10
such facilities nationwide, and the Director of the National
Institutes of Health 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 Director an
application at such time, in such form and containing such
information, as the Director 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. 11. 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) Authorization of Appropriations.--There are authorized to be
appropriated $200,000,000 for each of fiscal years 2002, 2003, 2004,
2005, and 2006 for the purpose of carrying out this section.
SECTION 12. EXPANDED HUMAN CLINICAL TRIALS QUALIFYING FOR ORPHAN DRUG
CREDIT.
(a) 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''.
(b) 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''.
(c) Effective Date.--The amendments made by this section shall
apply to amounts paid or incurred after December 31, 2001.
<all>
Introduced in Senate
Sponsor introductory remarks on measure. (CR S12376-12385)
Read twice and referred to the Committee on Finance.
Llama 3.2 · runs locally in your browser
Ask anything about this bill. The AI reads the full text to answer.
Enter to send · Shift+Enter for new line