[House Report 108-147]
[From the U.S. Government Publishing Office]
108th Congress Rept. 108-147
HOUSE OF REPRESENTATIVES
1st Session Part 1
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PROJECT BIOSHIELD ACT OF 2003
_______
June 10, 2003.--Ordered to be printed
_______
Mr. Tauzin, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 2122]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 2122) to enhance research, development,
procurement, and use of biomedical countermeasures to respond
to public health threats affecting national security, and for
other purposes, having considered the same, report favorably
thereon without amendment and recommend that the bill do pass.
CONTENTS
Page
Purpose and Summary.............................................. 1
Background and Need for Legislation.............................. 2
Hearings......................................................... 2
Committee Consideration.......................................... 3
Committee Votes.................................................. 3
Committee Oversight Findings..................................... 3
Statement of General Performance Goals and Objectives............ 3
New Budget Authority, Entitlement Authority, and Tax Expenditures 3
Committee Cost Estimate.......................................... 3
Congressional Budget Office Estimate............................. 3
Federal Mandates Statement....................................... 13
Advisory Committee Statement..................................... 13
Constitutional Authority Statement............................... 13
Applicability to Legislative Branch.............................. 13
Section-by-Section Analysis of the Legislation................... 13
Committee Correspondence......................................... 20
Changes in Existing Law Made by the Bill, as Reported............ 21
Purpose and Summary
The purpose of the Project BioShield Act of 2003 is to
provide the Secretary of Health and Human Services with greater
authority and flexibility to facilitate the research and
development of biomedical countermeasures; to authorize the
appropriation of funding for the procurement of security
countermeasures through the creation of a special reserve fund;
and to authorize the emergency use of unapproved drugs,
devices, and biologics and the emergency unapproved use of
approved drugs, devices, and biologics.
Background and Need for Legislation
During times of nation, military, or public health
emergency, the American people may be placed at risk of
exposure to biological, chemical, radiological, or nuclear
agents, and the diseases caused by such agents. Unfortunately,
there may not be approved or available countermeasures to treat
diseases or conditions caused by such agents. Currently,
companies have little incentive to research, develop, or
produce vaccines or other drugs simply for a possible one-time
purchase by the Federal government for the Strategic National
Stockpile. Most current private sector research and development
dollars go for drugs or devices that will have continuous
commercial application. In addition, some of the current
generation of drugs or devices may have special uses as
countermeasures to biological agents like Ebola, but there is
little incentive to perform the research or development or
production activities that might tailor the drug or drug
approvals for such a purpose.
Even if a product has been developed to treat such diseases
or conditions, if the product has not yet been approved by the
Food and Drug Administration (FDA), access to the therapy is
greatly limited. Nothing in the Food and Drug Act allows the
Secretary to suspend the approval requirements to ensure access
to unapproved drugs and devices on a large-scale basis in times
of emergency.
Under present law, if a product is not approved by the FDA,
then it is unlawful to provide that product to an individual,
unless the product has been authorized for distribution under
an investigational new drug (IND) application (for a drug and
biologic) or an investigational device exemption (IDE). When a
drug or device is available under such procedures, a number of
conditions apply that make the use of an IND or IDE infeasible
in times of national emergency, where drugs and devices may
need to be deployed at rapid rates. Even if a drug, biologic,
or device is highly promising in treating a disease or
condition associated with biological chemical radiological or
nuclear agents, and even if it is the only therapy available,
current FDA law does not allow for rapid deployment of the
product.
The Project Bioshield Act is designed to help resolve these
problems and make our nation more secure. Like the Public
Health Security and Bioterrorism Preparedness and Response Act,
the project Bioshield Act is designed to help the
administration and the nation in public health emergency
preparedness, but relies on the ingenuity and hard work of
Americans in the private and public sector to achieve these
goals.
Hearings
The Subcommittee on Health held a joint hearing with the
Subcommittee on Emergency Preparedness and Response of the
Select Committee on Homeland Security on ``Furthering Public
Health Security: Project Bioshield'' on March 27, 2003. The
Subcommittee received testimony from: The Honorable Tommy
Thompson, Secretary, U.S. Department of Health and Human
Services; Mr. Leighton Read M.D., General Partner, Alloy
Ventures, on behalf of Biotechnology Industry Organization; Mr.
Michael Friedman M.D., Chief Medical Officer for Biomedical
Preparedness, PhRMA; Mr. James Baker Jr., Ruth Dow Doan
Professor, Center for Biological Nanotechnology; and, Mr. Gary
Noble M.D., Vice President of Medical and Public Affairs,
Johnson & Johnson, on behalf of AdvaMed.
Committee Consideration
On Thursday, May 15, 2003, the Full Committee met in open
markup session and ordered a Committee Print reported to the
House, as amended, by voice vote. A request by Mr. Tauzin to
allow a report to be filed on a bill to be introduced by Mr.
Tauzin, and that the actions of the Committee be deemed as
actions on that bill, was agreed to by unanimous consent.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the record votes
on the motion to report legislation and amendments thereto.
There were no record votes taken in connection with ordering
the Committee Print reported. A motion by Mr. Tauzin to order
the Committee Print reported to the House, as amended, was
agreed to by a voice vote.
Committee Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee has held oversight
hearings and made findings that are reflected in this report.
Statement of General Performance Goals and Objectives
The purpose of the Project BioShield Act of 2003 is to
provide the Secretary of Health and Human Services with greater
authority and flexibility to facilitate the research and
development of biomedical countermeasures.
New Budget Authority, Entitlement Authority, and Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that H.R.
2212, the Project Bioshield Act of 2003, would result in no new
or increased budget authority, entitlement authority, or tax
expenditures or revenues.
Committee Cost Estimate
The Committee adopts as its own the cost estimate prepared
by the Director of the Congressional Budget Office pursuant to
section 402 of the Congressional Budget Act of 1974.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, the following is the cost estimate
provided by the Congressional Budget Office pursuant to section
402 of the Congressional Budget Act of 1974:
U.S. Congress,
Congressional Budget Office,
Washington, DC, June 6, 2003.
Hon. W. J. ``Billy'' Tauzin,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 2122, the Project
BioShield Act of 2003.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contacts are Jeanne De
Sa and Sam Papenfuss.
Sincerely,
Douglas Holtz-Eakin,
Director.
Enclosure.
H.R. 2122--Project BioShield Act of 2003
Summary: H.R. 2122 would amend the Public Health Service
Act (PHSA) to authorize appropriations of up to $5.6 billion
for fiscal year 2004 through 2013 for procurement of certain
security countermeasures (drugs, devices, and biological
products to treat, identify, and prevent the public health
consequences of terrorism). Of that amount, $890 million could
be obligated in fiscal year 2004 and up to $3.4 billion could
be obligated during fiscal year 2004 through 2008. Funding to
buy these security countermeasures would be provided to the
Department of Homeland Security (DHS), but the Department of
Health and Human Services (HHS) would be responsible for
procuring and stockpiling the countermeasures.
Assuming appropriation of authorized amount and including
administrative costs, CBO estimates that implementing H.R. 2122
would increase discretionary spending by $0.3 billion in 2004,
$3.1 billion for fiscal years 2004 through 2008, and $5.6
billion over the 2004-2013 period. In addition, H.R. 2122 would
relax certain requirements for federal agencies related to the
development and approval of countermeasures. The bill would
provide HHS with increased authority and flexibility to award
contracts and grants for research and development of qualified
countermeasures, hire technical experts, and procure items
necessary for research. Those provisions might result in higher
discretionary spending, but CBO does not have sufficient
information to estimate their budgetary effect.
The bill also would authorize the Food and Drug
Administration (FDA) to approve the use of certain security
countermeasures during emergencies designated by the Secretary
of HHS. CBO estimates this provision would have no budgetary
effect.
H.R. 2122 contains no intergovernmental or private-sector
mandates as defined in the Unfunded Mandates Reform Act (UMRA)
and would impose no costs on state, local, or tribal
governments.
Estimated Cost to the Federal Government: The estimated
budgetary impact of H.R. 2122 is shown in the following table.
The costs of this legislation fall within budget function 550
(health). CBO assumes that H.R. 2112 would be enacted by
October 1, 2003.
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By fiscal year, in millions of dollars--
-------------------------------------------------------------------------
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
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CHANGES IN DISCRETIONARY SPENDING
Project BioShield:
Estimated Authorization Level..... 890 2,528 0 0 0 2,175 0 0 0 0
Estimated Outlays................. 270 680 870 770 510 440 560 650 490 250
Administrative Costs:
Estimated Authorization Level..... 9 9 9 9 10 10 10 10 11 11
Estimated Outlays................. 7 8 9 9 10 10 10 10 11 11
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Basis of estimate
CBO assumes that this bill will be enacted during fiscal
year 2003 and will take effect in October 2003.
Procurement of security countermeasures: Project BioShield
Under current law, HHS administers the Strategic National
Stockpile (SNS), which contains drugs, diagnostic devices,
vaccines, and other biological products to combat the public
health consequences of a terrorist attack or other public
health emergencies. DHS currently provides the financing for
those efforts, which include the procurement of a new smallpox
vaccine and stockpiling of that vaccine and older versions of
the vaccine. Authorization for those programs was established
in the Public Health Security and Bioterrorism Preparedness
Response Act of 2002 (Public Law 107-88). That act authorized
appropriations of $640 million in 2002 and such sums as may be
necessary for fiscal years 2003 through 2006 for the SNS and
$509 million in 2002 and such sums as may be necessary for
fiscal years 2003 and 2006 for the development of the smallpox
vaccine. About $400 million was appropriated in 2003 for those
activities.
H.R. 2122 would modify the existing authorizations for the
SNS and for the development of the smallpox vaccine by
codifying the provision in the PHSA instead of in Public Law
107-88. CBO estimates that this modification would have no
budgetary effect.
H.R. 2122 also would authorize DHS to augment the SNS with
certain additional products. That effort, called Project
BioShield, would allow the federal government to enter into
contracts to procure security countermeasures, which are
defined in the bill as drugs, devices, biological products,
vaccines, vaccine adjuvants, antivirals, or diagnostic tests
used to treat, identify, or prevent harm from an agent that the
Secretary determines may cause a public health emergency
affecting national security. Such drugs, devices, or biological
products would have to be licensed or approved by the FDA, or
otherwise determined by the Secretary of HHS to have the
potential to be licensed or approval by the FDA. The federal
government also could acquire products used to treat the
adverse effects of drugs or biologic products used as security
countermeasures.
The rate at which the funding authorized by the bill would
be appropriated and spent would depend upon many factors,
including the nature of advances in biotechnology, the degree
of industry interest and capacity, the threat environment, and
government priorities. Assuming appropriation of the authorized
amounts, current and future Administrations would have the
discretion to enter into multiple contracts for the manufacture
of security countermeasures or to cease contracting altogether
for a period of years.
To estimate spending under H.R. 2122, CBO consulted with
Administration officials about activities they are planning or
would consider if Project BioShield were enacted. Officials
described plans to acquire and maintain stockpiles of seven
security countermeasures to combat five biological agents. The
Administration estimates that the cost of procuring, storing,
and replacing those countermeasures would be about $5.6 billion
over the 2004-2013 period if there were no constraints on
funding.
Those currently planned acquisitions do not include any
countermeasures for chemical, radiological, or nuclear agents,
and they address only a subset of the threats for which
research and development activities on countermeasures is being
conducted or funded by HHS, the Department of Defense (DoD),
and the private sector. Based on information provided by
government officials and in consultation with outside experts,
CBO has concluded that it is likely that drugs, devices, or
biological products addressing some of those other threats will
be developed in the coming decade and that some of those
countermeasures would be stockpiled under Project Bioshield if
funds were appropriated for that purpose. CBO's estimate does
not assume that any specific product would be developed and
procured at any specific time. It does, however, account for a
range of possibilities that would be available to the
government if the authorized funds are appropriated.
Authorities and Requirements Under H.R. 2122. H.R. 2122
would authorize appropriations of up to $5.6 billion for fiscal
years 2004 through 2013 for the federal government to enter
into contracts to procure security countermeasures. Of that
amount, $890 million could be obligated in fiscal year 2004 and
up to $3.4 billion could be obligated during fiscal years 2004
through 2008.
Decisions regarding what types of security countermeasures
to procure would be made by the President after reviewing
recommendations of the Secretaries of DHS and HHS. Subject to
Presidential approval and a determination that inclusion of
certain countermeasures in the stockpile is appropriate, the
Secretaries of DHS and HHS would seek potential vendors to
produce the countermeasures and enter into contracts to buy the
countermeasures from those vendors. In making that
determination, the Secretary would determine and consider
several factors, including the quantity of the product
necessary for the stockpile, the feasibility of obtaining
sufficient quantities of the product within five years, and
whether there is a significant commercial market for the
product other than as a security countermeasure. Those factors
would not be requirements for procurement, but considerations
in determining the appropriateness for inclusion of the
countermeasure in the stockpile.
The Secretary of HHS would be responsible for arranging the
procurement, including negotiating the quantity, price, and
production schedule in five-year contracts or cooperative
agreements, though eight-year contracts would be permitted for
first awards. Payment would be conditioned on the delivery of a
substantial portion of promised units. However, the Secretary
could provide an advance payment of not to exceed 10 percent of
the contract if the Secretary determines such payment is
necessary to the project's success. The Secretary could pay
vendors for storage, shipping, and handling and would be
permitted to use noncompetitive procedures if the product is
available only from a limited number of sources. Additional
countermeasures for the same threat also could be procured, if
they were to provide improved safety or effectiveness or
otherwise enhance public health preparedness.
The authorized funds could not be used for the purchase of
vaccines under contracts entered into prior to enactment, or
for administrative costs. Based on information from
Administration officials, CBO expects that funding would not be
available specifically for research and development, although
the price for the completed products would probably cover some
development costs.
The Administration's Plans to Implement Project BioShield.
Based on existing science and a current assessment of potential
threats to public health, the Administration has identified
several agents for which countermeasures are needed to protect
the public health and could be included in Project BioShield.
Those agents are smallpox, anthrax, botulinum toxin, plague,
and Ebola. The Administration estimates that spending for
countermeasures under Project BioShield, including purchase,
storage, and replacement costs, would total about $5.6 billion
over the 2004-2013 period, assuming the successful development
of those countermeasures and no constraints on funding. More
than half of those costs would be for the improved smallpox and
anthrax vaccines. A brief description follows of the security
countermeasures the Administration plans to acquire and
stockpile.
Smallpox. Under Project BioShield, the Administration plans
to procure a next-generation version of the smallpox vaccine
called modified vaccinia Ankara (MVA). This new vaccine is an
attenuated version of the existing vaccine and may be used to
safely vaccinate about 30 million individuals with compromised
immune systems, eczema, or certain other high-risk conditions.
Under the authority provided for Project BioShield, HHS plans
to purchase 60 million doses of the new vaccine at about $15
per dose over a three-year period for a cost of about $900
million. The Administration expects to be able to enter into
contracts and begin acquiring the vaccine in 2004. Additional
costs for inventory management and replacement of expired
stocks over the 2007-2013 period would likely add another $1
billion, according to Administration estimates, but could be
lower if long-term refrigerated storage proves to be effective.
Anthrax. The Administration also expects to purchase about
60 million doses of a next-generation anthrax vaccine, called a
recombinant protective antigent (rPA) vaccine, under Project
BioShield. The rPA vaccine would require fewer doses per person
than the current vaccine, and potentially could be effective
for people who have already been exposed to anthrax, giving the
government the ability to vaccinate about 20 million people.
The Administration anticipates beginning the procurement
process in the next few years and spending about $700 million
on the vaccine over a three-year period. Because the rPA
anthrax vaccine has an expected shelf life of five to six
years, additional costs would be incurred for inventory
management and replacement. The Administration estimates that
costs for the rPA vaccine could total $1.4 billion over the
2004-2013 period.
Botulinum Toxin. Under current law, HHS has stockpiled some
antitoxins to treat botulism, a paralytic and often fatal
illness caused by a nerve toxin produced by the botulinum
bacteria. However, those antitoxins are no longer manufactured,
and the manufacturing process, which requires horse serum, is
complicated and time intensive. After identifying a
manufacturer, the Administration plans to spend about $800
million acquiring newly produced antitoxin at a cost of about
$2,000 per dose as part of Project BioShield. Acquisition would
be spread over a three-year period, beginning in the next few
years. This antitoxin would require specialized storage and
refrigeration.
In addition, the Administration has indicated that it would
like to purchase both a vaccine that would protect against
botulism and monoclonal antibodies to neutralize the effects
ofthe toxin. (Monoclonal antibodies are engineered proteins that can
neutralize and destroy certain pathogens and toxins.) The
Administration anticipates buying vaccine and monoclonal antibodies by
2007 or 2008, at a cost of about $140 million for 750,000 doses of the
vaccine and $750 million for monoclonal antibodies. The Administration
estimates that spending for botulinum countermeasures, including the
cost of storage and inventory management, would total $1.8 billion over
the 2004-2013 period.
Plague. Plague is an infectious disease caused by a
bacterium. Plague has several forms--pneumonic, bubonic, and
septicemic--and can be treated by existing antibiotics. A
vaccine for the plague is currently in the research and
development phase, with the expectation that a product
potentially could reach the advanced development phase next
year. Beginning in 2005, the Administration expects to procure
about 2 million doses (enough to treat people in areas
surrounding any outbreak) at an estimated cost of about $40 per
dose--for a total cost of about $80 million. With additional
costs related to the acquisition of the vaccine, the
Administration estimates spending on plague countermeasures
would total about $220 million over the 2004-2013 period.
Ebola. There is no current treatment for Ebola, one of
several viral hemorrhagic fevers, but the National Institutes
of Health (NIH) is conducting research on a vaccine that the
Administration would be interested in purchasing when it
reaches an advanced development stage. Under current plans, the
Administration intends to purchase enough vaccine for 3 million
individuals to prevent the spread of an outbreak. Because this
vaccine is still in the research and development phase, when
the vaccine would become available and the potential cost per
dose are unclear. The Administration assumes the vaccine will
become available in 2005, and estimates the price to be about
$30 per dose, for a total acquisition cost of $90 million.
Combined with other costs related to the Ebola vaccine,
including storage and replacement, the Administration
anticipates spending would total about $260 million over the
2004-2013 period for this aspect of Project BioShield.
CBO's Estimate of the Potential Cost of Project BioShield.
CBO has estimated both the cost of implementing the
Administration's plan and the potential cost of acquiring other
products not encompassed by that plan.
CBO's Estimate of the Administration's Plan. Without any
funding constraints, CBO expects that the Administration's
plans for MVA smallpox vaccine, the anthrax rPA vaccine, and
the botulism antitoxins would likely take shape as described,
albeit more slowly than the Administration estimates. CBO
estimates that spending for vaccines and monoclonal antibodies
for botulism and vaccines for plague and Ebola would likely be
lower than the Administration estimates, even without funding
constraints. CBO's lower estimate reflects the possibility that
development of those vaccines and monoclonal antibodies might
not succeed as quickly as the Administration's estimate
assumes. It also reflects the possibility that Project
BioShield would spend less on some of the botulism
countermeasures if all three countermeasures (vaccine,
antitoxins, and monoclonal antibodies) became available.
CBO estimates that about $5.2 billion would be required to
procure products identified by the Administration over the
2004-2013 period.
Estimated Spending for Products Not Listed in the
Administration's Plan. Under the bill, other countermeasures
not in the Administration's plan could be purchased with
appropriations provided through Project BioShield.
Consequently, the specific security countermeasures that would
be acquired under H.R. 2122 are likely to evolve over time as
the result of many factors, including scientific advances, the
interest and cooperation of biotech and other manufacturing
companies, the emergence of new threats, and changes in this
and future Administrations' assessments of which potential
countermeasures should be a priority. Barriers to technological
advance such as restricted laboratory space or shortage of
primates for testing could slow development of countermeasures
for certain agents. At the same time, rapid advances in
products currently in the early-stage research and development
could present the government with unforseen countermeasure
options. Acquisition of countermeasures would also be affected
by whether this and future Administrations decide to procure
products that require more than five years to be licensed or
have a significant commercial market.
Acquisitions under the bill might include additional
countermeasures for agents addressed by the Administration's
plan. For instance, potential emerging treatments include the
use of monoclonal antibodies. This technology has had initial
application in the treatment of cancer, and possibly could be
applied to anthrax, the plague, or viral hemorrhagic fevers in
the coming years. Other potential countermeasures include new
antiviral drugs to treat smallpox and viral hemorrhagic fever
(both biodefense research priorities for NIH) and a narrow-
spectrum antibiotic for anthrax.
In addition, CBO's research indicates there are numerous
other biological agents for which countermeasures ultimately
could be purchased under Project BioShield. HHS has established
three classes of biological agents that pose significant risks
to national security and the public health. Category A agents
pose the greatest risk due to their ease of transmission,
mortality rates, and overall risk to the public. All of the
agents included in the Administration's plan are considered
Category A agents, but that initial plan does not address such
Category A agents as tularemia, a bacterial infection affecting
the respiratory system, and viral hemorrhagic fevers other than
Ebola. Vaccines for both of those agents arebiodefense research
priorities of NIH. Further, the government might seek countermeasures
for some Category B and C agents, including toxins such as ricin,
certain bacteria such as brucellosis, and several forms of viral
encephalitis.
Also, under the authority provided by the bill, the
government could procure countermeasures against chemical
agents (nerve, blister, blood, and pulmonary agents) and
radiological and nuclear agents. The Administration currently
does not plan to use the bill's authority to purchase agents
that could mitigate threats from these sources, but it could do
so if the perceived threat from these agents changed or if
certain treatments became scientifically feasible.
Countermeasures that could be acquired under Project BioShield
include existing treatments for many nerve gases (including VX,
Sarin, and Soman gas), Prussian Blue (a treatment for certain
types of radiation poisoning), and hydroxycobalamin (a
treatment for cyanide poisoning that is in an advanced stage of
development).
Finally, under H.R. 2122, Project BioShield would be able
to purchase devices to detect and diagnose pathogens and other
agents. Costs for such devices are also not included in the
Administration's estimate.
To estimate potential spending for additional
countermeasures not mentioned in the Administration's plan, CBO
identified several category A, B, and C biological agents and
chemical and radiological agents for which countermeasures
exist or are under development. The set of selected agents and
countermeasures is not intended as a prediction of which
countermeasures would be acquired by Project BioShield. Rather,
it is intended to be representative of the countermeasures that
would be eligible for acquisition if current research and
development activities succeed in producing qualified
countermeasures during the coming decade.
For each of the representative biological agents, CBO
determined whether the countermeasure is likely to be a
vaccine, an antitoxin or antiviral, or a monoclonal antibody,
the dosage and method of delivery (intravenously or in pill
form), and the amount necessary to treat the population that
could potentially be affected. the estimate assumes that
vaccines would cost $30 to $40 per dose, on average, with
Project BioShield acquiring 500,000 to 2 million doses of
qualified vaccines, depending on whether the agent is
infectious. CBO estimates that monoclonal antibodies would cost
$5,000 per treatment, and that Project BioShield would acquire
enough to treat several hundred thousand people if qualified
products became available. The estimate assumes that, if other
types of qualified antivirals or antitoxins became available,
Project BioShield would acquire enough to treat 500,000 people,
at costs ranging from $2,000 to $5,000 per person for certain
intravenously-administered forms. Other countermeasures could
be less expensive on a per-person basis. For example, certain
antivirals or narrow-spectrum antibiotics in pill form could
cost about $100 per treatment, CBO estimates. Additionally, CBO
estimates that per-person costs would average $50 for Prussian
Blue, $100 for intravenous treatments for hydrogen cyanide, and
$300 per treatment for countermeasures for certain radiological
and nuclear agents. If Project BioShield acquired those types
of countermeasures, CBO assumes that the quantity procured
would be sufficient to respond to simultaneous events in
several large cities.
Under optimistic assumptions about when countermeasures for
the representative agents would become available, the cost of
acquiring, storing, and replacing all qualified countermeasures
for those agents could total $10 billion to $20 billion during
the 2004-2013 period. However, CBO assumes that research and
development efforts for some countermeasures will proceed
slowly or be unsuccessful, and that the Administration would
not acquire all products that could be designated as security
countermeasures.
Assuming appropriation of the authorized amount, CBO
estimates that discretionary spending to acquire and store
BioShield products would total $0.3 billion in 2004 and $5.5
billion over the 2004-2013 period. Acquisition costs would
comprise 70 percent to 80 percent of that amount, while
inventory management and replacement costs would make up the
balance.
CBO also estimates that implementing Project BioShield
would add to the administrative costs of HHS and DHS, both for
the contracting process and managing the stockpile. Funding for
those costs would come from appropriated funds. Based on
current spending for program support services for bioterrorism-
related activities (including the SNS) at the Centers for
Disease Control and Prevention, CBO estimates that
administrative costs would be about $10 million a year. Subject
to the appropriation of necessary amounts, CBO estimates that
discretionary spending for such costs would increase by $7
million in 2004 and $0.1 billion over the 2004-2013 period.
Research and development into qualified countermeasures
H.R. 2122 would authorize the Secretary of HHS to expedite
procurement and peer review for research related to qualified
countermeasures. The bill also would allow the Secretary to
secure the services of experts or consultants with relevant
expertise. Implementation of these measures could increase the
resources required by the agency, accelerate spending, or both.
CBO does not have sufficient information to estimate the
additional resources that might be required by the agency or
the rate at which spending might accelerate under the bill.
Such spending would come from appropriated funds.
Authorization for medical products for use in emergencies
The FDA's regulatory process allows for expedited approval
of security countermeasures under current law. Pursuant to the
Public Health Security and Bioterrorism Preparedness and
Response Act of 2002, the FDA may allow certain drugs, devices,
and biologics defined as priority countermeasures to move more
quickly through the agency's regulatory process. To further
expedite the development of security countermeasures, the FDA
has implemented a rule that allows approval of certain drugs
based on tests in animals.
H.R. 2122 would allow the Secretary of HHS to authorize the
FDA to approve the use of certain drugs or devices for use
during designated as emergencies by the Secretary of HHS, DHS,
or Defense. The authorization would remain in effect for no
more than one year, unless the Secretary determines otherwise
based on the nature of the emergency. When the Secretary
authorizes the emergency use of a product that is an unapproved
use of an approved product, the bill would provide some
flexibility to manufacturers in carrying out activities under
the emergency use authorization.
Based on information from Administration officials, CBO
expects that implementing this provision in H.R. 2122 would not
increase costs to the FDA. Over the past year, the FDA has
hired about 100 people to review drug applications and provide
assistance to companies engaged in research and development
into security countermeasures. Thus, the agency already has the
infrastructure to handle the additional authority related to
the proposed emergency-use authorization and would not require
additional resources. Therefore, CBO estimates that this
provision of H.R. 2122 would have no budgetary effect.
Previous CBO estimate: S. 15, the Project BioShield Act of
2003, as reported by the Senate Committee on Health, Education,
Labor and Pensions on March 25, 2003, would amend the Public
Health Service Act (PHSA) to create permanent, indefinite
funding authority for the procurement of certain biomedical
countermeasures. In its cost estimate dated May 7, 2003, CBO
estimated that enacting S. 15 would increase direct spending by
$270 million in 2004 and $8.1 billion over the 2004-2013
period.
Although both H.R. 2122 and S. 15 would authorize programs
to procure countermeasures to protect the public health against
terrorism, H.R. 2122 would not have an effect on direct
spending; instead, the bill would authorize appropriations of
up to $5.6 billion over the 2004-2013 period. Estimated
spending under H.R. 2122 is less than under S. 15 because the
House bill would authorize a set amount of appropriations,
whereas the Senate bill would provide unlimited direct spending
authority.
In several areas, H.R. 2122 would allow the Secretary more
flexibility in terms of what products could be procured and how
contracts would be structured. H.R. 2122 would allow the
procurement of countermeasures even if they have a significant
commercial application, while S. 15 would restrict the
procurement authority to those without such application. While
S. 15 would require the Secretary to determine that a
countermeasure is likely to be approved by the FDA within five
years as a condition of procurement, H.R. 2122 would require
only that the Secretary consider whether a five-year limit is
feasible. H.R. 2122 would provide additional flexibility in
contracting by permitting the Secretary to extend first-time
contracts to eight years (versus five in S. 15) and would allow
the Secretary discretion to provide a 10 percent advance to
companies developing new products. Those provisions would
accelerate spending relative to S. 15.
Intergovernmental and private-sector impact: H.R. 2122
contains no intergovernmental or private-sector mandates as
defined in UMRA and would impose no costs on state, local, or
tribal governments.
Estimate prepared by: Federal costs: Jeanne De Sa and Sam
Papenfuss: impact on state, local, and tribal governments: Leo
Lex; impact on the private sector: Samuel Kina.
Estimate approved by: Robert A. Sunshine, Assistant
Director for Budget Analysis.
Federal Mandates Statement
The Committee adopts as its own estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Constitutional Authority Statement
Pursuant to clause 3(d)(1) of rule XIII of the Rules of the
House of Representatives, the Committee finds that the
Constitutional authority for this legislation is provided in
Article I, section 8, clause 3, which grants Congress the power
to regulate commerce with foreign nations, among the several
States, and with the Indian tribes.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 establishes the short title of the Act as the
``Project BioShield Act of 2003.''
Section 2. Biomedical countermeasure research and development
authorities
Section 2(a) of the Project BioShield Act of 2003 amends
the Public Health Service Act to add a new section 319F-1. The
section grants the Secretary of Health and Human Services (HHS)
additional flexibility and authority in conducting research and
development with respect to biomedical countermeasures against
biological, chemical, nuclear and radiological agents that may
affect national security.
The Act defines the scope of the new authorities set forth
in this section as applying to countermeasures against agents
that ``may cause a public health emergency affecting national
security.'' In making a determination about whether a potential
public health emergency could affect national security, the
Secretary of HHS may consider all information deemed pertinent
and appropriate, and nothing in this Act requires that such
Secretary of HHS consult with other executive branch officials
prior to making such a determination. The Committee expects
that the Secretary of HHS will consider the threat of use of
such agents by terrorists against the U.S. population to be a
significant factor in making scope determinations under these
provisions. However, the Committee also recognizes and
encourages the Secretary of HHS to consider the emerging
threats to public health and national security that may be
caused by the spread of antibiotic resistant organisms or
dangerous viruses that may spread rapidly and lack effective
countermeasures today. These threats may affect national
security whether by terrorists or through natural conditions.
The Secretary of HHS should consider such factors in
determining whether to use these new authorities to promote
research, development, and production of specific security
countermeasures.
Indeed, antimicrobial-resistant infectious microbes are
viable biological agents that could be used by both domestic
and foreign terrorists to wreak havoc and injury upon U.S.
citizens. In addition, the emergency of drug resistance in one
organism may have the effect of limiting that drug's ability to
treat other biological agents, as genetic material may be
transferred naturally or purposefully from one infectious agent
to another. Advancing the discovery of new antimicrobial drugs
to treat resistant organisms, through Bioshield and other
research and development initiatives, through Bioshield and
other research and development initiatives, may well pay
dividends for both national security and public health.
New subsection 319F-1(b) provides general authority.
Proposed subparagraph 319F-1(a)(4) makes the facilities of
entities that enter into a grant or cooperative agreement with
the Secretary of HHS under this section available as needed to
such Secretary of HHS to respond to public health emergencies
affecting national security.
New subsection 319F-1(b) provides expedited authority for
governmental procurements used to perform, administer, or
support pressing research and development activities under this
section, by (1) increasing the simplified acquisition threshold
from $100,000 to $25 million; (2) authorizing the use of
procedures providing for less than full and open competition
when there are only a limited number of responsible sources and
no other type of services will satisfy the Secretary of HHS
needs; and (3) increasing the micropurchase threshold for such
procurements to $15,000.
New subsection 319F-1(c) authorizes the Secretary of HHS to
use expedited peer-review procedures in lieu of otherwise
applicable peer-review procedures in the case of grants and
contracts for biomedical countermeasure research and
development activity, if such grants and contracts do not
exceed $1,500,000 and are necessary to respond to pressing
research needs.
New subsection 319F-1(d) provides additional flexibility to
the Secretary of HHS with respect to the hiring of experts and
consultants when necessary to respond to pressing qualified
countermeasure research and development needs. Under paragraph
319F-1(d)(2), such experts and consultants are deemed to be
employees of HHS for purposes of the Federal Torts Claims Act,
which provides the exclusive remedy against such personnel for
claims relating to the performance of covered duties.
New subsection 319F-1(e) provides streamlined personnel
authority for the HHS Secretary to appoint up to 30 people to
positions in the National Institutes of Health without regard
to ordinary classificationcriteria, when necessary to respond
to pressing qualified countermeasure research and development needs.
New subsection 391F-1(f) provides that actions by the
Secretary of HHS under the section are committed to agency
discretion.
Section 2(b) of the Project BioShield Act of 2003 amends
section 481A of the Public Health Service act to add the
Director of the National Institute of Allergy and Infectious
Diseases to that section, and thus provide to that Director
certain authorities concerning modernization and construction
of research facilities. Section 2(b) further authorizes such
sums as may be necessary for such purposes.
Section 3. Biomedical countermeasures procurement
Section 3(a) of the Project BioShield Act of 2003 adds a
new section 319F-2 to the Public Health Service Act. Several
provisions of new section 319F-2 simply transfer existing
provisions of law from the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002, as amended
by the Homeland Security Act of 2002. Proposed Subsection 319F-
2(a) contains language from existing law establishing the
Strategic National Stockpile. New section 319F-2(b) contains
language from existing law concerning authorizing procurement
of smallpox vaccine for the National Strategic Stockpile.
New section 319F-2(c) requires the Secretary of the
Department of Homeland Security (DHS) to assess threats that
may be posed by chemical, biological, radiological, and nuclear
agents, and requires the HHS Secretary to assess the public
health consequences of such agents and the availability and
appropriateness of countermeasures for the threats identified.
After these steps, the Secretaries jointly may determine and
recommend to the President that funding for procurement of such
a countermeasure for the nation's stockpile is appropriate from
the special reserve funds established by this Act.
Under section 319F-2(c)(4), the Secretaries of HHS and DHS
may recommend to the President a proposal to issue a call for
the development of a security countermeasure. Such a call, at a
minimum, includes a commitment from the Secretaries to make a
recommendation for funding of such a countermeasure from the
special reserve funds, if government specifications for the
product are achieved. The Secretaries also may secure a
Presidential approval for funding prior to, or without,
conducting a call.
New section 319F-2(c)(4)(B) provides that the Secretaries
should include in any call for proposals for countermeasure
production information that may be necessary to encourage or
facilitate research and development into such countermeasures.
The Committee recognizes that an important factor companies
will consider in determining whether to invest scarce research
and development dollars into security countermeasures is
whether and to what extent they may face liability relating to
the development or production of such countermeasures. The
Committee thus encourages the Secretaries to indicate in any
call for proposals the potential availability of
indemnification or liability protections under other laws.
Under section 319F-2(c)(7), if the President approves a
recommendation for funding from the special reserve funds, DHS
would then enter into an agreement with HHS under which HHS may
procure the countermeasure for the stockpile using the DHS
special reserve fund. Contracts under this paragraph are
subject to certain conditions. The Secretary of HHS may use
simplified acquisition procedures or procedures providing for
less than full and open competition under certain
circumstances. Certain determinations of the Secretary are
committed to agency discretion.
The Committee recognizes that existing procurement
authorities may allow for a single agreement that provides for
research and development as well as production of a
countermeasure or vaccine. Nothing in this Act shall limit the
use of these existing authorities where a single agreement
(including a contract, grant, cooperative agreement or other
acquisition instrument) for research, development, and
production of a countermeasure or vaccine is deemed appropriate
by the contracting officer, including when a separate funding
source is authorized and used for the research and development
and it is different than the funding source authorized and used
for production. The Committee recognizes that such agreements
providing express linkage between research, development, and
production may be necessary in order to encourage entities to
enter the government market for countermeasures and vaccines in
accordance with the authorities provided by Project Bioshield.
Similarly, existing procurement authorities may allow the
Secretaries to limit competition for a production contract
under section 3 of this Act to those entities that successfully
competed for research and development contracts under section 2
of this Act or other provisions of law. However, the Committee
emphasizes that the monies obligated from the special reserve
fund created under section 3 of this Act may not be use to pay
for research or development activities, but only for
procurement of countermeasures paid upon substantial delivery
of product--consistent with the express limitation contained in
the Homeland Security Act of 2002 excluding from the DHS
Secretary's responsibilities the conduct or support of human
health-related countermeasure research and development.
Section 319F-2(d) contains prohibitions on disclosure of
information transferred from existing law. Section 319F-3(e)
contains definitions transferred from existing law.
Section 319F-2(f) contains authorization of appropriations
for the Strategic National Stockpile and smallpox vaccine
development transferred from existing law with one addition.
The new paragraph makes clear that such existing authorizations
are in addition to amounts authorized under the special reserve
fund. Nothing in the Act would restrict or alter the
Secretaries' existing authority to purchase items for the
stockpile using existing discretionary appropriations for such
purpose.
Section 3(b) of the Project BioShield Act of 2003 adds a
new section 510 to the Homeland Security Act of 2002. This new
section authorizes appropriations for the special reserve fund
referenced in the new section 319F-2(c) of the Public Health
Service Act. The bill authorizes $890 million in FY 04 for such
procurements, and aggregate amounts of $3.4 billion and $5.6
billion over the next five and ten fiscal yearsrespectively.
All amounts appropriated under this authorization would be available
for obligation through the end of FY 2013.
The act defines the scope of the new authorities set forth
in this section as applying to countermeasures against agents
that the Secretary of HHS believes ``may cause a public health
emergency affecting national security,'' and about which the
HHS and DHS Secretaries make certain additional findings. In
making a determination about whether a potential public health
emergency could affect national security, the Secretary of HHS
may consider all information deemed pertinent and appropriate,
and nothing in this Act requires that such Secretary of HHS
consult with other executive branch officials prior to making
such a determination. The Committee expects that both
Secretaries will consider the threat of use of such agents by
terrorists against the U.S. population to be a significant
factor in making their respective scope determinations under
these provisions. However, the Committee also recognizes and
encourages the Secretaries to consider the emerging threats to
public health and national security that may be caused by the
spread of antibiotic resistant organisms or dangerous viruses
that may spread rapidly and lack effective countermeasures
today. These threats may affect national security whether by
terrorists or through natural conditions. The Secretaries
should consider such factors in determining whether to use
these new authorities to promote research, development, and
production of specific security countermeasures.
Section 4. Authorization for medical products for use in emergencies
Section 4 adds a new section 564 to the Federal Food, Drug,
and Cosmetic Act. New section 564(a) allows the Secretary of
Health and Human Services to authorize for introduction into
interstate commerce unapproved drugs, devices, and biological
products or unapproved uses of approved drugs, approved/cleared
devices, and biological products intended for use in an actual
or potential emergency during the effective period of a
declaration.
New section 564(b) allows the Secretary of HHS to declare
an emergency justifying an emergency use authorization based
upon a determination by the Secretary of Homeland Security that
there is a national emergency or the significant potential of
one, or by a determination of the Secretary of Defense that
there is a military emergency, or a significant potential of
one. Such emergencies must involve a heightened risk of attack
with biological, chemical, radiological, or nuclear agents.
Similarly, an emergency use authorization can be based upon a
determination of the Secretary of HHS that there is a public
health emergency affecting national security and involving
biological, chemical, radiological, or nuclear agents. In
making a determination about whether a public health emergency
under section 319 of the Public Health Service Act affects
national security, the Secretary may consider all information
he deems pertinent and appropriate, and nothing in this Act
requires that the Secretary consult with other executive branch
officials prior to making such a determination.
Under this section, any declaration of emergency will last
for one year, unless the Secretary of HHS terminates it at an
earlier time. The Secretary of HHS may renew a declaration. The
Secretary of HHS must publish all declarations, determinations,
and renewals in the Federal Register, and the Secretary must
provide reasonable advanced notice that declarations are to be
terminated under this section. The Committee intends that,
after a declaration is terminated, final disposition of
labeling or intrastate disposition of a product may occur.
Further, the Committee believes that the Commissioner of the
Food and Drug Administration may exercise enforcement
discretion not to object to interstate shipment of an
unapproved product for return to a manufacturer. A
determination of what is a ``reasonable'' period for advanced
notice of termination should consider all factors, so in some
cases notice immediately preceding termination may be
reasonable, while in other circumstances it may not.
Section 564(c) details the criteria for issuance of an
emergency use authorization. Under this new section, the
Secretary of HHS, acting through the Commissioner, may issue an
authorization upon concluding (1) that a biological, chemical,
radiological, or nuclear agent or agents can cause a serious or
life-threatening disease or condition; (2) that the drug,
device or biological product may be effective in detecting,
diagnosing, treating, or preventing such disease or condition
(or a serious disease or condition caused by taking a product
already approved, licensed or cleared by FDA for treating or
preventing such disease or condition), and the benefits of the
product outweigh risks; (3) that there is no adequate,
approved, and available alternative to the product; and (4)
other criteria the Secretary may by regulation specify. The
Commissioner should consult with the Directors of the National
Institutes of Health and the Centers for Disease Control and
Prevention prior to issuing an authorization, but such
consultation is limited by considerations of feasibility and
appropriateness given the circumstances of the emergency.
Section 564(d) concerns the scope of an emergency use
authorization. Under this section, the authorization shall
state the disease or condition that the product may be used to
detect, diagnose, prevent, or treat, as well as the
Commissioner's conclusions about known benefits and risks of
the product and conclusions concerning safety and potential
effectiveness. The Committee intends that before issuing an
authorization under this section, the Commissioner will, where
feasible given the nature and the extent of the emergency,
notify the holder of any relevant application under this
chapter or under section 351 of the Public Health Service Act.
The purpose of such notification is to allow for discussion of
the conditions of this authorization as required by subsection
(e), as well as discussion of whether such product should be
delivered pursuant to section 319F-2(c) of the Public Health
Service Act.
Section 564(e) pertains to products that have never been
approved, licensed, or cleared by FDA. Under this subsection,
conditions shall, to the extent feasible given the
circumstances of the emergency, be applied to persons who
choose to carry out an activity for which the authorization is
issued. Such mandatory conditions include information to
providers about the emergency use of the product as well as
significant knownpotential risks and benefits, as well as
appropriate conditions designed to ensure that to the maximum extent
feasible given the circumstances of the emergency, individuals to whom
the product is administered are informed of the emergency use of the
product, risks and benefits of the product, and of the option to accept
or refuse the product. Further, the Commissioner is given the authority
to impose other conditions on those who carry out activities for which
the authorization is issued. Such conditions imposed by the
Commissioner should be designed to provide maximum flexibility to
ensure that those who wish to take the product can indeed take the
product, if made available by the manufacturer.
Section 564(e) also applies to unapproved uses of approved
products and the Commissioner may, for manufacturers who choose
to carry out one or more activities pursuant to an emergency
use authorization, apply certain conditions. This subsection
makes clear that manufacturers do not have to avail themselves
of the emergency use authorization for unapproved uses of
approved products, and it makes clear that no individual may
alter or obscure the labeling of already approved products. It
does authorize, however, persons other than the manufacturer to
provide information about the product concerning the emergency
use of the product.
Under section 564(e), the Commissioner may establish
conditions regarding product labeling and information
conveyance concerning unapproved products. Further, the
Committee intends that the Commissioner may establish
conditions regarding product labeling and information
conveyance on manufacturers that carry out one or more
activities pursuant to an emergency use authorization with
respect to the emergency use of that product that is an
unapproved use of an approved product.
Subsection (f) makes clear that an emergency use
authorization is effective until the declaration is terminated
or revoked, but allows patients to continue using such products
in certain instances. Nothing in this subsection is intended to
require manufacturers or others to provide such products to
patients.
Subsection (g) makes clear that the Commissioner shall
periodically review the appropriations of an authorization, and
it provides the Commissioner needed flexibility to revoke an
authorization if the criteria justifying the authorization are
no longer met.
Subsection (h) ensures that the Commissioner shall promptly
publish in the Federal Register notices of all authorizations,
terminations, and revocations, Subsection (i) makes clear that
all determinations under this new section are committed to
agency discretion. Subsection (j) is a rule of construction
nothing that this new section does not impair or otherwise
affect certain existing authorities.
New section 564(k) pertains to members of the Armed Forces
and, among other things, it specifies that the President may
waive requirements designed to ensure that such members are
informed of the option to accept or refuse administration of an
emergency use product, upon certain findings (which are
identical to the findings found in section 1107 of Title 10).
Further, the subsection requires that if certain information is
not provided to members of the Armed Forces prior to an
emergency use product being administered to them, then
information concerning the administration of the product shall
be placed in the medical record of the member.
Subsection (l) makes clear that if a product is authorized
for emergency use under this new section, the investigational
sections of the Act shall not apply to the products.
Subsection (m) ensures that no authority in new section 564
can require a manufacturer of a drug, device, or biological
product to perform any activity that becomes lawful pursuant to
the new section. That is, the Commissioner in no way is goven
the authority to, among other things, require a manufacturer to
introduce into interstate commerce or deliver for introduction
into interstate commerce any unapproved product or an approved
product for an unapproved use under this section. Further, even
if the Commissioner authorizes the emergency use of an already-
approved, licensed or cleared product, a manufacturer can
refuse to avail themselves of such emergency use authorization
and continue introducing into interstate commerce its approved
or cleared product under the Federal Food, Drug and Cosmetic
Act, or licensed product pursuant to the Public Health Service
Act. The only obligation in subsection (m) is that if the
Commissioner authorizes the emergency use of a sole-source
unapproved product, then the manufacturer of such product must
inform the Commissioner of its intention not to carry out any
activity under the authorization within a reasonable period of
time. Nothing in this section shall be construed as authorizing
the Commissioner to establish conditions on the distribution,
administration, or labeling of any other product in any other
circumstance.
Subsection (n) ensures that the present enforcement regime
of the Federal Food, Drug, and Cosmetic Act will apply to
individuals who carry out an activity or activities pursuant to
an authorization, but fail to comply with applicable
conditions. If any person carries out an activity pursuant to
section 564, but violates a condition imposed by the
Commissioner, then that person will be subject to Chapter III
of the Act, where the ``prohibited acts'' are found. If a
person is found to be in violation of a prohibited act found in
section 301, then the Committee intends for that person to be
subject to the enforcement provisions found in sections 302,
303, and 304. A violation of any condition applied to an
emergency use product in no way alters or affects the emergency
use status of the underlying product.
The Committee intends that new section 564, as made clear
in section 903(d)(2) of the Federal Food, Drug, and Cosmetic
Act, the Secretary, through the Commissioner of Food and Drugs,
shall be responsible for executing the Federal Food Drug, and
Cosmetic Act as amended by the Project BioShield Act.
Section 5. Reports
Section 5(a) requires the Secretary of HHS to submit annual
reports to Congress concerning the exercise of many of the new
authorities under the Act. Section 5(b) requires a report from
the National Academy of Sciences concerning whether and to what
extent the research authorities granted under the Act have
enhanced the development of biomedical countermeasures
affecting national security. Section 5(c) requires the General
Accounting Office to issue a report concerning the Secretary of
HHS utilization of these new authorities.
Committee Correspondence
Committee on the Judiciary,
Washington, DC, June 10, 2003.
Hon. Billy Tauzin,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Chairman Tauzin: In recognition of the desire to
expedite floor consideration of H.R. 2122, the ``Project
BioShield Act of 2003,'' the Committee on the Judiciary hereby
waives consideration of the bill. Section 2 of the bill creates
a new section 319F-1 of the Public Health Service Act. New
subsection 319F-1(d) gives the Secretary of Health and Human
Services new authority to enter into personal services
contracts with scientists and consultants for limited periods
of time for the purposes of expedited research on
countermeasures against biological weapons. New subsection
319F-1(d) further provides that scientists and consultants who
receive contracts under this provision shall have the
protections of the Federal Tort Claims Act as if they were
regular federal employees. These FTCA provisions fall within
the Committee on the Judiciary's Rule X jurisdiction. However,
given the need to expedite this legislation, I will not seek a
sequential referral based on their inclusion.
The Committee on the Judiciary takes this action with the
understanding that the Committee's jurisdiction over these
provisions is in no way diminished or altered. I would
appreciate your including this letter in the Congressional
Record during consideration of H.R. 2122 on the House floor.
Sincerely,
F. James Sensenbrenner, Jr.,
Chairman.
------
Committee on Energy and Commerce,
Washington, DC, June 10, 2003.
Hon. F. James Sensenbrenner, Jr.,
Chairman, Committee on the Judiciary,
House of Representatives, Washington, DC.
Dear Chairman Sensenbrenner: Thank you for your letter
regarding H.R. 2122, the ``Project BioShield Act of 2003.'' As
you noted, new subsection 319F-1(d) of the Public Health
Service Act as added by the bill contains provisions that fall
within the Rule X jurisdiction of the Committee on the
Judiciary.
I appreciate your willingness not to seek a referral on
H.R. 2122. I agree that your decision to forego action on the
bill will not prejudice the Committee on the Judiciary with
respect to its jurisdictional prerogatives on this or similar
legislation.
I will include a copy of your letter and this response in
the Congressional Record during consideration of H.R. 2122 of
the House floor.
Sincerely,
W.J. ``Billy'' Tauzin,
Chairman.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules
of the House of Representatives, changes in existing law made
by the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italics, existing law in which no change
is proposed is shown in roman):
PUBLIC HEALTH SERVICE ACT
* * * * * * *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE
* * * * * * *
Part B--Federal-State Cooperation
* * * * * * *
SEC. 319F-1. AUTHORITY FOR USE OF CERTAIN PROCEDURES REGARDING
BIOMEDICAL COUNTERMEASURE RESEARCH AND DEVELOPMENT
ACTIVITIES.
(a) In General.--
(1) Authority.--In conducting and supporting research
and development activities regarding biomedical
countermeasures under section 319F(h), the Secretary
may conduct and support such activities in accordance
with this section if the activities concern qualified
countermeasures.
(2) Qualified countermeasure.--For purposes of this
section, the term ``qualified countermeasure'' means a
priority countermeasure (as defined in section 319F(h))
that affects national security.
(3) Interagency cooperation.--
(A) In general.--In carrying out activities
under this section, the Secretary is
authorized, subject to subparagraph (B), to
enter into interagency agreements and other
collaborative undertakings with other agencies
of the United States Government.
(B) Limitation.--An agreement or undertaking
under this paragraph shall not authorize
another agency to exercise the authorities
provided by this section.
(4) Availability of facilities to the secretary.--In
any grant or cooperative agreement entered into under
the authority provided in this section with respect to
a biocontainment laboratory or other related or
ancillary specialized research facility that the
Secretary determines necessary for the purpose of
performing, administering, and supporting qualified
countermeasure research and development, the Secretary
may provide that the facility that is the object of
such grant or cooperative agreement shall be available
as needed to the Secretary to respond to public health
emergencies affecting national security.
(b) Expedited Procurement Authority.--
(1) Increased simplified acquisition threshold for
biomedical countermeasure procurements.--
(A) In general.--For any procurement by the
Secretary of property or services for use (as
determined by the Secretary) in performing,
administering, or supporting qualified
countermeasure research or development
activities under this section that the
Secretary determines necessary to respond to
pressing research and development needs under
this section, the amount specified in section
4(11) of the Office of Federal Procurement
Policy Act (41 U.S.C. 403(11)), as applicable
pursuant to section 302A(a) of the Federal
Property and Administrative Services Act of
1949 (41 U.S.C. 252a(a)), shall be deemed to be
$25,000,000 in the administration, with respect
to such procurement, of--
(i) section 303(g)(1)(A) of the
Federal Property and Administrative
Services Act of 1949 (41 U.S.C.
253(g)(1)(A)) and its implementing
regulations; and
(ii) section 302A(b) of such Act (41
U.S.C. 252a(b)) and its implementing
regulations.
(B) Application of certain provisions.--
Notwithstanding subparagraph (A) and the
provision of law and regulations referred to in
such subparagraph, each of the following
provisions shall apply to procurements
described in this paragraph to the same extent
that such provisions would apply to such
procurements in the absence of subparagraph
(A):
(i) Chapter 37 of title 40, United
States Code (relating to contract work
hours and safety standards).
(ii) Subsections (a) and (b) of
Section 7 of the Anti-Kickback Act of
1986 (41 U.S.C. 57(a) and (b)).
(iii) Section 304C of the Federal
Property and Administrative Services
Act of 1949 (41 U.S.C. 254d) (relating
to the --- examination of contractor
records).
(C) Internal controls to be instituted.--The
Secretary shall institute appropriate internal
controls for procurements that are under this
paragraph, including requirements with regard
to documenting the justification for use of the
authority in this paragraph.
(2) Use of noncompetitive procedures.--In addition to
any other authority to use procedures other than
competitive procedures, the Secretary may use such
other procedures when--
(A) the procurement is as described by
paragraph (1); and
(B) the property or services needed by the
Secretary are available from only one
responsible source or only from a limited
number of responsible sources, and no other
type of property or services will satisfy the
Secretary's needs.
(3) Increased micropurchase threshold.--
(A) In general.--For a procurement described
by paragraph (1), the amount specified in
subsections (c), (d), and (f) of section 32 of
the Office of Federal Procurement Policy Act
(41 U.S.C. 428) shall be deemed to be $15,000in
the administration of that section with respect to such procurement.
(B) Internal controls to be instituted.--The
Secretary shall institute appropriate internal
controls for purchases that are under this
paragraph and that are greater than $2,500.
(C) Exception to preference for purchase card
mechanism.--No provision of law establishing a
preference for using a Government purchase card
method for purchases shall apply to purchases
that are under this paragraph and that are
greater than $2,500.
(c) Authority To Expedite Peer Review.--
(1) In general.--The Secretary may, as the Secretary
determines necessary to respond to pressing qualified
countermeasure research and development needs under
this section, employ such expedited peer review
procedures (including consultation with appropriate
scientific experts) as the Secretary, in consultation
with the Director of NIH, deems appropriate to obtain
assessment of scientific and technical merit and likely
contribution to the field of qualified countermeasure
research, in place of the peer review and advisory
council review procedures that would be required under
sections 301(a)(3), 405(b)(1)(B), 405(b)(2),
406(a)(3)(A), 492, and 494, as applicable to a grant,
contract, or cooperative agreement--
(A) that is for performing, administering, or
supporting qualified countermeasure research
and development activities; and
(B) the amount of which is not greater than
$1,500,000.
(2) Subsequent phases of research.--The Secretary's
determination of whether to employ expedited peer
review with respect to subsequent phases of a research
grant or cooperative agreement under this section shall
be determined without regard to the peer review
procedures used for any prior peer review of that same
grant or cooperative agreement.
(d) Authority for Personal Services Contracts.--
(1) In general.--For the purpose of performing,
administering, and supporting qualified countermeasure
research and development activities, the Secretary may,
as the Secretary determines necessary to respond to
pressing qualified countermeasure research and
development needs under this section, obtain by
contract (in accordance with section 3109 of title 5,
United States Code, but without regard to the
limitations in such section on the period of service
and on pay) the personal services of experts or
consultants who have scientific or other professional
qualifications, except that in no case shall the
compensation provided to any such expert or consultant
exceed the daily equivalent of the annual rate of
compensation for the President.
(2) Federal tort claims act coverage.--
(A) In general.--A person carrying out a
contract under paragraph (1), and an officer,
employee, or governing board member of such
person, shall be deemed to be an employee of
the Department of Health and Human Services for
purposes of claims under sections 1346(b) and
2672 of title 28, United States Code, for money
damages for personal injury, including death,
resulting from performance of functions under
such contract.
(B) Exclusivity of remedy.--The remedy
provided by subparagraph (A) shall be exclusive
of any other civil action or proceeding by
reason of the same subject matter against the
person, officer, employee, or governing board
member.
(3) Internal controls to be instituted.--
(A) In general.--The Secretary shall
institute appropriate internal controls for
contracts under this subsection, including
procedures for the Secretary to make a
determination of whether a person, or an
officer, employee, or governing board member of
a person, is deemed to be an employee of the
Department of Health and Human Services
pursuant to paragraph (2).
(B) Determination of employee status to be
final.--A determination by the Secretary under
subparagraph (A) that a person, or an officer,
employee, or governing board member of a
person, is or is not deemed to be an employee
of the Department of Health and Human Services
shall be final and binding on the Secretary and
the Attorney General and other parties to any
civil action or proceeding.
(4) Number of personal services contracts limited.--
The number of experts and consultants whose personal
services are obtained under paragraph (1) shall not
exceed 30 at any time.
(e) Streamlined Personnel Authority.--
(1) In general.--In addition to any other personnel
authorities, the Secretary may, as the Secretary
determines necessary to respond to pressing qualified
countermeasure research and development needs under
this section, without regard to such provisions of
title 5, United States Code, governing appointments in
the competitive service, and without regard to the
provisions of chapter 51 and subchapter III of chapter
53 of such title relating to classification and General
Schedule pay rates, appoint professional and technical
employees, not to exceed 30 such employees at any time,
to positions in the National Institutes of Health to
perform, administer, or support qualified
countermeasure research and development activities in
carrying out this section.
(2) Internal controls to be instituted.--The
Secretary shall institute appropriate internal controls
for appointments under this subsection.
(f) Actions Committed to Agency Discretion.--Actions by the
Secretary under the authority of this section are committed to
agency discretion.
SEC. 319F-2. STRATEGIC NATIONAL STOCKPILE.
(a) Strategic National Stockpile.--
(1) In general.--The Secretary of Homeland Security
(referred to in this section as the ``Homeland Security
Secretary''), in coordination with the Secretary and
the Secretary of Veterans Affairs, shall maintain a
stockpile or stockpiles of drugs, vaccines and other
biological products, medical devices, and other
supplies in such numbers, types, and amounts as are
determined by the Secretary to be appropriate and
practicable, taking into account other available
sources, to provide for the emergency health security
of the United States, including the emergency health
security of children and other vulnerable populations,
in the event of a bioterrorist attack or other public
health emergency.
(2) Procedures.--The Secretary, in managing the
stockpile under paragraph (1), shall--
(A) consult with the working group under
section 319F(a);
(B) ensure that adequate procedures are
followed with respect to such stockpile for
inventory management and accounting, and for
the physical security of the stockpile;
(C) in consultation with Federal, State, and
local officials, take into consideration the
timing and location of special events;
(D) review and revise, as appropriate, the
contents of the stockpile on a regular basis to
ensure that emerging threats, advanced
technologies, and new countermeasures are
adequately considered;
(E) devise plans for the effective and timely
supply-chain management of the stockpile, in
consultation with appropriate Federal, State
and local agencies, and the public and private
health care infrastructure; and
(F) ensure the adequate physical security of
the stockpile.
(b) Smallpox Vaccine Development.--
(1) In general.--The Secretary shall award contracts,
enter into cooperative agreements, or carry out such
other activities as may reasonably be required in order
to ensure that the stockpile under subsection (a)
includes an amount of vaccine against smallpox as
determined by such Secretary to be sufficient to meet
the health security needs of the United States.
(2) Rule of construction.--Nothing in this section
shall be construed to limit the private distribution,
purchase, or sale of vaccines from sources other than
the stockpile described in subsection (a).
(c) Additional Authority Regarding Procurement of Certain
Biomedical Countermeasures; Availability of Special Reserve
Fund.--
(1) In general.--
(A) Use of fund.--A security countermeasure
may, in accordance with this subsection, be
procured with amounts in the special reserve
fund under paragraph (10).
(B) Security countermeasure.--For purposes of
this subsection, the term ``security
countermeasure'' means a priority
countermeasure (as defined in section
319F(h))--
(i) that affects national security;
(ii) that is determined under
paragraph (2)(B)(ii) to be a necessary
countermeasure; and
(iii)(I) that is approved or cleared
under chapter V of the Federal Food,
Drug, and Cosmetic Act, or licensed
under section 351 of this Act, for use
as a countermeasure to a chemical,
biological, radiological, or nuclear
agent identified as a material threat
under paragraph (2)(A)(ii); or
(II) for which the Secretary
determines that sufficient and
satisfactory clinical experience or
research data (including data, if
available, from pre-clinical and
clinical trials) support a reasonable
conclusion that the countermeasure will
qualify for approval or licensing after
the date of a determination under
paragraph (5).
(2) Determination of material threats.--
(A) material threat.--The Homeland Security
Secretary, in consultation with the heads of
other agencies as appropriate, shall on an
ongoing basis--
(i) assess current and emerging
threats of chemical, biological,
radiological, and nuclear agents; and
(ii) determine which of such agents
present a material threat against the
United States population.
(B) Public health impact; necessary
countermeasures.--The Secretary shall on an
ongoing basis--
(i) assess the potential public
health consequences of use against the
United States population of agents
identified under subparagraph (A)(ii);
and
(ii) determine, on the basis of such
assessment, the agents for which
priority countermeasures are necessary
to protect the public health from a
material threat.
(3) Assessment of availability and appropriateness of
countermeasures.--The Secretary, in consultation with
the Homeland Security Secretary, shall assess on an
ongoing basis the availability and appropriateness of
specific countermeasures to address specific threats
identified under paragraph (2).
(4) Call for security countermeasures; commitment for
recommendation for procurement.--
(A) Proposal to the president.--If, pursuant
to an assessment under paragraph (3), the
Homeland Security Secretary and the Secretary
make a determination that a security
countermeasure would be appropriate, such
Secretaries may jointly submit to the President
a proposal to--
(i) issue a call for the development
of such security countermeasure; and
(ii) make a commitment that, upon the
first development of such security
countermeasure that meets the
conditions for procurement under
paragraph (5), the Secretaries will,
based in part on information obtained
pursuant to such call, make a
recommendation under paragraph (6) that
the special reserve fund under
paragraph (10) be made available for
the procurement of such security
countermeasure.
(B) Countermeasure specifications.--The
Homeland Security Secretary and the Secretary
shall, to the extent practicable, include in
the proposal under subparagraph (A)--
(i) estimated quantity of purchase
(in the form of number of doses or
number of effective courses of
treatments regardless of dosage form);
(ii) necessary measures of minimum
safety and effectiveness;
(iii) estimated price for each dose
or effective course of treatment
regardless of dosage form; and
(iv) other information that may be
necessary to encourage and facilitate
research, development, and manufacture
of the countermeasure or to provide
specifications for the countermeasure.
(C) Presidential approval.--If the President
approves a proposal under subparagraph (A), the
Homeland Security Secretary and the Secretary
shall make known to persons who may respond to
a call for the security countermeasure
involved--
(i) the call for the countermeasure;
(ii) specifications for the
countermeasure under subparagraph (B);
and
(iii) a commitment described in
subparagraph (A)(ii).
(5) Secretary's determination of countermeasures
appropriate for funding from special reserve fund.--
(A) In general.--The Secretary, in accordance
with the provisions of this paragraph, shall
identify specific security countermeasures that
the Secretary determines, in consultation with
the Homeland Security Secretary, to be
appropriate for inclusion in the stockpile
under subsection (a) pursuant to procurements
made with amounts in the special reserve fund
under paragraph (10) (referred to in this
subsection individually as a ``procurement
under this subsection'').
(B) Requirements.--In making a determination
under subparagraph (A) with respect to a
security countermeasure, the Secretary shall
determine and consider the following:
(i) The quantities of the product
that will be needed to meet the needs
of the stockpile.
(ii) The feasibility of production
and delivery within five years of
sufficient quantities of the product.
(iii) Whether there is a lack of a
significant commercial market for the
product at the time of procurement,
other than as a security
countermeasure.
(6) Recommendation for president's approval.--
(A) Recommendation for procurement.--In the
case of a security countermeasure that the
Secretary has, in accordance with paragraphs
(2), (3), and (5), determined to be appropriate
for procurement under this subsection, the
Homeland Security Secretary and the Secretary
shall jointly submit to the President, in
coordination with the Director of the Office of
Management and Budget, a recommendation that
the special reserve fund under paragraph(10) be
made available for the procurement of such countermeasure.
(B) Presidential approval.--The special
reserve fund under paragraph (10) is available
for a procurement of a security countermeasure
only if the President has approved a
recommendation under subparagraph (A) regarding
the countermeasure.
(C) Notice to congress.--The Secretary and
the Homeland Security Secretary shall notify
the Congress of each decision of the President
to approve a recommendation under subparagraph
(A). Such notice shall include an explanation
of the decision to make available the special
reserve fund under paragraph (10) for
procurement of such a countermeasure,
including, where available, the identification
of the potential supplier or suppliers of such
countermeasure, and whether other potential
suppliers of the same or similar
countermeasures were considered and rejected
for procurement under this section and the
reasons therefor.
(D) Subsequent specific countermeasures.--
Procurement under this subsection of a security
countermeasure for a particular purpose does
not preclude the subsequent procurement under
this subsection of any other security
countermeasure for such purpose if the
Secretary has determined under paragraph (5)(A)
that such countermeasure is appropriate for
inclusion in the stockpile and if, as
determined by the Secretary, such
countermeasure provides improved safety or
effectiveness, or for other reasons enhances
preparedness to respond to threats of use of a
biological, chemical, radiological, or nuclear
agent. Such a determination by the Secretary is
committed to agency discretion.
(E) Rule of construction.--Recommendations
and approvals under this paragraph apply solely
to determinations that the special reserve fund
under paragraph (10) will be made available for
a procurement of a security countermeasure, and
not to the substance of contracts for such
procurement or other matters relating to awards
of such contracts.
(7) Procurement.--
(A) In general.--For purposes of a
procurement under this subsection that is
approved by the President under paragraph (6),
the Homeland Security Secretary and the
Secretary shall have responsibilities in
accordance with subparagraphs (B) and (C).
(B) Interagency agreements.--
(i) For procurement.--The Homeland
Security Secretary shall enter into an
agreement with the Secretary for
procurement of a security
countermeasure in accordance with the
provisions of this paragraph. The
special reserve fund under paragraph
(10) shall be available for the
Secretary's costs of such procurement,
other than as provided in clause (ii).
(ii) For administrative costs.--The
agreement entered into between the
Homeland Security Secretary and the
Secretary for managing the stockpile
under subsection (a) shall provide for
reimbursement of the Secretary's
administrative costs relating to
procurements under this subsection.
(C) Procurement.--
(i) In general.--The Secretary shall
be responsible for--
(I) arranging for procurement
of a security countermeasure,
including negotiating terms
(including quantity, production
schedule, and price) of, and
entering into, contracts and
cooperative agreements, and for
carrying out such other
activities as may reasonably be
required, in accordance with
the provisions of this
subparagraph; and
(II) promulgating regulations
to implement clauses (v), (vi),
and (vii), and any other
provisions of this subsection.
(ii) Contract terms.--A contract for
procurements under this subsection
shall (or, as specified below, may)
include the following terms:
(I) Payment conditioned on
substantial delivery.--The
contract shall provide that no
payment may be made until
delivery has been made of a
substantial portion (as
determined by the Secretary) of
the total number of units
contracted for, except that,
notwithstanding any other
provision of law, the contract
may provide that, if the
Secretary determines (in the
Secretary's discretion) that an
advance payment is necessary to
ensure success of a project,
the Secretary may pay an
amount, not to exceed 10
percent of the contract amount,
in advance of delivery. The
contract shall provide that
such advance payment is
required to be repaid if there
is a failure to perform under
the contract, except in special
circumstances as determined by
the Secretary on a contract by
contract basis.
(II) Contract duration.--The
contract shall be for a period
not to exceed five years,
except that, in first awarding
the contract, the Secretary may
provide for a longer duration,
not exceeding eight years, if
the Secretary determines that
complexities or other
difficulties in performance
under the contract justify such
a period. The contract shall be
renewable for additional
periods, none of which shall
exceed five years.
(III) Storage by vendor.--The
contract may provide that the
vendor will provide storage for
stocks of a product delivered
to the ownership of the Federal
Government under the contract,
for such period and under such
terms and conditions as the
Secretary may specify, and in
such case amounts from the
special reserve fund under
paragraph (10) shall be
available for costs of
shipping,handling, storage, and
related costs for such product.
(iii) Availability of simplified
acquisition procedures.--
(I) In general.--The amount
of any procurement under this
subsection shall be deemed to
be below the threshold amount
specified in section 4(11) of
the Office of Federal
Procurement Policy Act (41
U.S.C. 403(11)), for purposes
of application to such
procurement, pursuant to
section 302A(a) of the Federal
Property and Administrative
Services Act of 1949 (41 U.S.C.
252a(a)), of--
(aa) section
303(g)(1)(A) of the
Federal Property and
Administrative Services
Act of 1949 (41 U.S.C.
253(g)(1)(A)) and its
implementing
regulations; and
(bb) section 302A(b)
of such Act (41 U.S.C.
252a(b)) and its
implementing
regulations.
(II) Application of certain
provisions.--Notwithstanding
subclause (I) and the provision
of law and regulations referred
to in such clause, each of the
following provisions shall
apply to procurements described
in this clause to the same
extent that such provisions
would apply to such
procurements in the absence of
subclause (I):
(aa) Chapter 37 of
title 40, United States
Code (relating to
contract work hours and
safety standards).
(bb) Subsections (a)
and (b) of Section 7 of
the Anti-Kickback Act
of 1986 (41 U.S.C.
57(a) and (b)).
(cc) Section 304C of
the Federal Property
and Administrative
Services Act of 1949
(41 U.S.C. 254d)
(relating to the ---
examination of
contractor records).
(iv) Use of noncompetitive
procedures.--In addition to any other
authority to use procedures other than
competitive procedures, the Secretary
may use such other procedures for a
procurement under this subsection if
the product is available from only one
responsible source or only from a
limited number of responsible sources,
and no other type of product will
satisfy the Secretary's needs.
(v) Premium provision in multiple
award contracts.--
(I) In general.--If, under
this subsection, the Secretary
enters into contracts with more
than one vendor to procure a
security countermeasure, such
Secretary may, notwithstanding
any other provision of law,
include in each of such
contracts a provision that--
(aa) identifies an
increment of the total
quantity of security
countermeasure
required, whether by
percentage or by
numbers of units; and
(bb) promises to pay
one or more specified
premiums based on the
priority of such
vendors' production and
delivery of the
increment identified
under item (aa), in
accordance with the
terms and conditions of
the contract.
(II) Determination of
government's requirement not
reviewable.--If the Secretary
includes in each of a set of
contracts a provision as
described in subclause (I),
such Secretary's determination
of the total quantity of
security countermeasure
required, and any amendment of
such determination, is
committed to agency discretion.
(vi) Extension of closing date for
receipt of proposals not reviewable.--A
decision by the Secretary to extend the
closing date for receipt of proposals
for a procurement under this subsection
is committed to agency discretion.
(vii) Limiting competition to sources
responding to request for
information.--In conducting a
procurement under this subsection, the
Secretary may exclude a source that has
not responded to a request for
information under section 303A(a)(1)(B)
of the Federal Property and
Administrative Services Act of 1949 (41
U.S.C. 253a(a)(1)(B)) if such request
has given notice that the Secretary may
so exclude such a source.
(8) Interagency cooperation.--
(A) In general.--In carrying out activities
under this section, the Homeland Security
Secretary and the Secretary are authorized,
subject to subparagraph (B), to enter into
interagency agreements and other collaborative
undertakings with other agencies of the United
States Government.
(B) Limitation.--An agreement or undertaking
under this paragraph shall not authorize
another agency to exercise the authorities
provided by this section to the Homeland
Security Secretary or to the Secretary.
(9) Restrictions on use of funds.--Amounts in the
special reserve fund under paragraph (10) shall not be
used to pay--
(A) costs for the purchase of vaccines under
procurement contracts entered into before the
date of the enactment of the Project BioShield
Act of 2003; or
(B) administrative costs.
(10) Special reserve fund.--For purposes of this
subsection, the term ``special reserve fund'' has the
meaning given such term in section 510 of the Homeland
Security Act of 2002.
(d) Disclosures.--No Federal agency shall disclose under
section 552, United States Code, any information identifying
the location at which materials in the stockpile under
subsection (a) are stored.
(e) Definition.--For purposes of subsection (a), the term
``stockpile'' includes--
(1) a physical accumulation (at one or more
locations) of the supplies described in subsection (a);
or
(2) a contractual agreement between the Homeland
Security Secretary and a vendor or vendors under which
such vendor or vendors agree to provide to such
Secretary supplies described in subsection (a).
(f) Authorization of Appropriations.--
(1) Strategic national stockpile.--For the purpose of
carrying out subsection (a), there are authorized to be
appropriated $640,000,000 for fiscal year 2002, and
such sums as may be necessary for each of fiscal years
2003 through 2006. Such authorization is in addition to
amounts in the special reserve fund under subsection
(c)(10).
(2) Smallpox vaccine development.--For the purpose of
carrying out subsection (b), there are authorized to be
appropriated $509,000,000 for fiscal year 2002, and
such sums as may be necessary for each of fiscal years
2003 through 2006.
* * * * * * *
TITLE IV--NATIONAL RESEARCH INSTITUTES
* * * * * * *
Part E--Other Agencies of NIH
* * * * * * *
SEC. 481A. BIOMEDICAL AND BEHAVIORAL RESEARCH FACILITIES.
(a) Modernization and Construction of Facilities.--
(1) In general.--The Director of NIH, acting through
the Director of the Center or the Director of the
National Institute of Allergy and Infectious Diseases,
may make grants or contracts to public and nonprofit
private entities to expand, remodel, renovate, or alter
existing research facilities or construct new research
facilities, subject to the provisions of this section.
* * * * * * *
(c) Requirements for Grants.--
(1) In general.--The Director of the Center or the
Director of the National Institute of Allergy and
Infectious Diseases may make a grant under subsection
(a) only if the applicant for the grant meets the
following conditions:
(A) * * *
* * * * * * *
(2) Institutions of emerging excellence.--From the
amount appropriated under [subsection (i)] subsection
(i)(1) for a fiscal year up to $50,000,000, the
Director of the Center shall make available 25 percent
of such amount, and from the amount appropriated under
such subsection for a fiscal year that is over
$50,000,000, the Director of the Center shall make
available up to 25 percent of such amount, for grants
under subsection (a) to applicants that in addition to
meeting the requirements established in paragraph (1),
have demonstrated emerging excellence in biomedical or
behavioral research, as follows:
(A) * * *
* * * * * * *
(d) Requirement of Application.--The Director of the Center
or the Director of the National Institute of Allergy and
Infectious Diseases may make a grant under subsection (a) only
if an application for the grant is submitted to the Director
and the application is in such form, is made in such manner,
and contains such agreements, assurances, and information as
the Director determines to be necessary to carry out this
section.
(e) Amount of Grant; Payments.--
(1) Amount.--The amount of any grant awarded under
subsection (a) shall be determined by the Director of
the Center or the Director of the National Institute of
Allergy and Infectious Diseases, except that such
amount shall not exceed--
(A) 50 percent (or, in the case of the
Institute, 75 percent) of the necessary cost of
the construction of a proposed facility as
determined by the Director; or
(B) in the case of a multipurpose facility,
40 percent (or, in the case of the Institute,
75 percent) of that part of the necessary cost
of construction that the Director determines to
be proportionate to the contemplated use of the
facility.
(2) Reservation of amounts.--On the approval of any
application for a grant under subsection (a), the
Director of the Center or the Director of the National
Institute of Allergy and Infectious Diseases shall
reserve, from any appropriation available for such
grants, the amount of such grant, and shall pay such
amount, in advance or by way of reimbursement, and in
such installments consistent with the construction
progress, as the Director may determine appropriate.
The reservation of any amount by the Director under
this paragraph may be amended by the Director, either
on the approval of an amendment of the application or
on the revision of the estimated cost of construction
of the facility.
* * * * * * *
(4) Waiver of limitations.--The limitations imposed
under paragraph (1) may be waived at the discretion of
the Director of the Center or the Director of the
National Institute of Allergy and Infectious Diseases
for applicants meeting the conditions described in
subsection (c).
(f ) Recapture of Payments.--If, not later than 20 years
after the completion of construction for which a grant has been
awarded under subsection (a)--
(1) in the case of an award by the Director of the
Center, the applicant or other owner of the facility
shall cease to be a public or non profit private
entity; or
(2) the facility shall cease to be used for the
research purposes for which it was constructed (unless
the Director of the Center or the Director of the
National Institute of Allergy and Infectious Diseases
determines, in accordance with regulations,that there
is good cause for releasing the applicant or other owner from
obligation to do so),
the United States shall be entitled to recover from the
applicant or other owner of the facility the amount bearing the
same ratio to the current value (as determined by an agreement
between the parties or by action brought in the United States
District Court for the district in which such facility is
situated) of the facility as the amount of the Federal
participation bore to the cost of the construction of such
facility.
* * * * * * *
(i) Authorization of [Appropriations.--For the purpose of
carrying out this section,] Appropriations.--
(1) Center.--For the purpose of carrying out this
section with respect to the Center, there are
authorized to be appropriated $250,000,000 for fiscal
year 2001, and such sums as may be necessary for each
of the fiscal years 2002 and 2003.
(2) National institute of allergy and infectious
diseases.--For the purpose of carrying out this section
with respect to the National Institute of Allergy and
Infectious Diseases, there are authorized to be
appropriated such sums as may be necessary for fiscal
year 2003.
----------
SECTION 510 OF THE HOMELAND SECURITY ACT OF 2002
SEC. 510. PROCUREMENT OF SECURITY COUNTERMEASURES FOR STRATEGIC
NATIONAL STOCKPILE.
(a) Authorization of Appropriations.--For procurement of
security countermeasures under section 319F-2(c) of the Public
Health Service Act (referred to in this section as the
``security countermeasures program''), there is authorized to
be appropriated up to $5,593,000,000 for the fiscal years 2004
through 2013. Of the amounts appropriated under the preceding
sentence, not to exceed $3,418,000,000 may be obligated during
the fiscal years 2004 through 2008, of which not to exceed
$890,000,000 may be obligated during fiscal year 2004.
(b) Special Reserve Fund.--For purposes of the security
countermeasures program, the term ``special reserve fund''
means the appropriations account established as a result of any
appropriations made under subsection (a).
(c) Availability.--
(1) Duration of availability for obligation.--Subject
to paragraph (2), all amounts appropriated under
subsection (a) are available for obligation through the
end of fiscal year 2013, provided that any portion of
such amount that remains unobligated for such purposes
on the expiration of such term shall be returned to the
United States Treasury and shall not be available for
subsequent obligation for any purpose.
(2) Initial availability for particular
procurements.--Amounts appropriated under subsection
(a) become available for a procurement under the
security countermeasures program only upon the approval
by the President of such availability for the
procurement in accordance with paragraph (6)(B) of such
program.
----------
SECTION 121 OF THE PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS
AND RESPONSE ACT OF 2002
[SEC. 121. STRATEGIC NATIONAL STOCKPILE.
[(a) Strategic National Stockpile.--
[(1) In general.--The Secretary of Health and Human
Services (referred to in this section as the
``Secretary''), in coordination with the Secretary of
Veterans Affairs, shall maintain a stockpile or
stockpiles of drugs, vaccines and other biological
products, medical devices, and other supplies in such
numbers, types, and amounts as are determined by the
Secretary to be appropriate and practicable, taking
into account other available sources, to provide for
the emergency health security of the United States,
including the emergency health security of children and
other vulnerable populations, in the event of a
bioterrorist attack or other public health emergency.
[(2) Procedures.--The Secretary, in managing the
stockpile under paragraph (1), shall--
[(A) consult with the working group under
section 319F(a) of the Public Health Service
Act;
[(B) ensure that adequate procedures are
followed with respect to such stockpile for
inventory management and accounting, and for
the physical security of the stockpile;
[(C) in consultation with Federal, State, and
local officials, take into consideration the
timing and location of special events;
[(D) review and revise, as appropriate, the
contents of the stockpile on a regular basis to
ensure that emerging threats, advanced
technologies, and new countermeasures are
adequately considered;
[(E) devise plans for the effective and
timely supply-chain management of the
stockpile, in consultation with appropriate
Federal, State and local agencies, and the
public and private health care infrastructure;
and
[(F) ensure the adequate physical security of
the stockpile.
[(b) Smallpox Vaccine Development.--
[(1) In general.--The Secretary shall award
contracts, enter into cooperative agreements, or carry
out such other activities as may reasonably be required
in order to ensure that the stockpile under subsection
(a) includes an amount of vaccine against smallpox as
determined by the Secretary to be sufficient to meet
the health security needs of the United States.
[(2) Rule of construction.--Nothing in this section
shall be construed to limit the private distribution,
purchase, or sale of vaccines from sources other than
the stockpile described in subsection (a).
[(c) Disclosures.--No Federal agency shall disclose under
section 552, United States Code, any information identifying
the location at which materials in the stockpile under
subsection (a) are stored.
[(d) Definition.--For purposes of subsection (a), the term
``stockpile'' includes--
[(1) a physical accumulation (at one or more
locations) of the supplies described in subsection (a);
or
[(2) a contractual agreement between the Secretary
and a vendor or vendors under which such vendor or
vendors agree to provide to the Secretary supplies
described in subsection (a).
[(e) Authorization of Appropriations.--
[(1) Strategic national stockpile.--For the purpose
of carrying out subsection (a), there are authorized to
be appropriated $640,000,000 for fiscal year 2002, and
such sums as may be necessary for each of fiscal years
2003 through 2006.
[(2) Smallpox vaccine development.--For the purpose
of carrying out subsection (b), there are authorized to
be appropriated $509,000,000 for fiscal year 2002, and
such sums as may be necessary for each of fiscal years
2003 through 2006.]
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SECTION 564 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT
SEC. 564. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMERGENCIES.
(a) In General.--
(1) Emergency uses.--Notwithstanding sections 505,
510(k), and 515 of this Act and section 351 of the
Public Health Service Act, and subject to the
provisions of this section, the Secretary may authorize
the introduction into interstate commerce, during the
effective period of a declaration under subsection (b),
of a drug or device intended for use in an actual or
potential emergency (referred to in this section as an
``emergency use'').
(2) Approval status of product.--An authorization
under paragraph (1) may authorize an emergency use of a
product that--
(A) is not approved, licensed, or cleared for
commercial distribution under a provision of
law referred to in such paragraph (referred to
in this section as an ``unapproved product'');
or
(B) is approved, licensed, or cleared under
such a provision, but which use is not under
such provision an approved, licensed, or
cleared use of the product (referred to in this
section as an ``unapproved use of an approved
product'').
(3) Relation to other uses.--An emergency use
authorized under paragraph (1) for a product is in
addition to any other use that is authorized for the
product under a provision of law referred to in such
paragraph.
(4) Definitions.--For purposes of this section:
(A) The term ``emergency use'' has the
meaning indicated for such term in paragraph
(1).
(B) The term ``product'' means a drug or
device.
(C) The term ``unapproved product'' has the
meaning indicated for such term in paragraph
(2)(A).
(D) The term ``unapproved use of an approved
product'' has the meaning indicated for such
term in paragraph (2)(B).
(b) Declaration of Emergency.--
(1) In general.--The Secretary may declare an
emergency justifying the authorization under this
subsection for a product on the basis of--
(A) a determination by the Secretary of
Homeland Security that there is a national
emergency, or a significant potential for a
national emergency, involving a heightened risk
of attack with a specified biological,
chemical, radiological, or nuclear agent or
agents;
(B) a determination by the Secretary of
Defense that there is a military emergency, or
a significant potential for a military
emergency, involving a heightened risk to
United States military forces of attack with a
biological, chemical, radiological, or nuclear
agent or agents; or
(C) a determination by the Secretary of a
public health emergency under section 319 of
the Public Health Service Act, affecting
national security and involving a specified
biological, chemical, radiological, or nuclear
agent or agents, or a specified disease or
condition that may be attributable to such
agent or agents.
(2) Termination of declaration.--
(A) In general.--A declaration under this
subsection shall terminate upon the earlier
of--
(i) a determination by the Secretary,
in consultation as appropriate with the
Secretary of Homeland Security or the
Secretary of Defense, that the
circumstances described in paragraph
(1) have ceased to exist; or
(ii) the expiration of the one-year
period beginning on the date on which
the declaration is made.
(B) Renewal.--Notwithstanding subparagraph
(A), the Secretary may renew a declaration
under this subsection, and this paragraph shall
apply to any such renewal.
(3) Advance notice of termination.--In terminating a
declaration under this section, the Secretary shall
provide advance notice that the declaration will be
terminated. The period of advance notice shall be a
period reasonably determined to provide--
(A) in the case of an unapproved product, a
sufficient period for disposition of shipments
of the product, including the return of such
shipments to the manufacturer (in the case of a
manufacturer that chooses to have the shipments
returned); and
(B) in the case of unapproved uses of
approved products, a sufficient period for the
disposition of any labelingthat was provided
with respect to the emergency use involved.
(4) Publication.--The Secretary shall promptly
publish in the Federal Register each declaration,
determination, and renewal under this subsection.
(c) Criteria for Issuance of Authorization.--The Secretary
may issue an authorization under this section with respect to
the emergency use of a product only if, after consultation with
the Director of the National Institutes of Health and the
Director of the Centers for Disease Control and Prevention, to
the extent feasible and appropriate given the circumstances of
the emergency involved, the Secretary concludes--
(1) that an agent specified in a declaration under
subsection (b) can cause a serious or life-threatening
disease or condition;
(2) that, based on the totality of scientific
evidence available to the Secretary, including data
from adequate and well-controlled clinical trials, if
available, it is reasonable to believe that--
(A) the product may be effective in
detecting, diagnosing, treating, or
preventing--
(i) such disease or condition; or
(ii) a serious or life-threatening
disease or condition caused by a
product authorized under this section
or approved under this Act or the
Public Health Service Act, for
detecting, diagnosing, treating, or
preventing such a disease or condition
caused by such an agent; and
(B) the known and potential benefits of the
product, when used to detect, diagnose,
prevent, or treat such disease or condition,
outweigh the known and potential risks of the
product;
(3) that there is no adequate, approved, and
available alternative to the product for detecting,
diagnosing, preventing, or treating such disease or
condition; and
(4) that such other criteria as the Secretary may by
regulation prescribe are satisfied.
(d) Scope of Authorization.--
(1) In general.--An authorization of a product under
this section shall state--
(A) each disease or condition that the
product may be used to detect, diagnose,
prevent, or treat within the scope of the
authorization;
(B) the Secretary's conclusions, made under
subsection (c)(2)(B), that the known and
potential benefits of the product, when used to
detect, diagnose, prevent, or treat such
disease or condition, outweigh the known and
potential risks of the product; and
(C) the Secretary's conclusions, made under
subsection (c), concerning the safety and
potential effectiveness of the product in
detecting, diagnosing, preventing, or treating
such diseases or conditions, including an
assessment of the available scientific
evidence.
(2) Confidential information.--Nothing in this
section alters or amends section 1905 of title 18,
United States Code, or section 552(b)(4) of title 5 of
such Code.
(e) Conditions of Authorization.--
(1) Unapproved product.--
(A) Required conditions.--With respect to the
emergency use of an unapproved product, the
Secretary, to the extent feasible given the
circumstances of the emergency, shall, for
persons who choose to carry out one or more
activities for which the authorization is
issued, establish such conditions on an
authorization under this section as the
Secretary finds necessary or appropriate to
protect the public health, including the
following:
(i) Appropriate conditions designed
to ensure that, to the extent feasible
given the circumstances of the
emergency, health care professionals
administering the product are
informed--
(I) that the Secretary has
authorized the emergency use of
the product;
(II) of the significant known
and potential benefits and
risks of the emergency use of
the product, and of the extent
to which such benefits and
risks are unknown; and
(III) of the alternatives to
the product that are available,
and of their benefits and
risks.
(ii) Appropriate conditions designed
to ensure that, to the extent feasible
given the circumstances of the
emergency, individuals to whom the
product is administered are informed--
(I) that the Secretary has
authorized the emergency use of
the product;
(II) of the significant known
and potential benefits and
risks of such use, and of the
extent to which such benefits
and risks are unknown; and
(III) of the option to accept
or refuse administration of the
product, of the consequences,
if any, of refusing
administration of the product,
and of the alternatives to the
product that are available and
of their benefits and risks.
(iii) Appropriate conditions for the
monitoring and reporting of adverse
events associated with the emergency
use of the product.
(iv) For manufacturers of the
product, appropriate conditions
concerning recordkeeping and reporting,
including records access by the
Secretary, with respect to the
emergency use of the product.
(B) Authority for additional conditions.--
With respect to the emergency use of an
unapproved product, the Secretary, to the
extent feasible given the circumstances of the
emergency, may, for persons who choose to carry
out one or more activities for which the
authorization is issued, establish such
conditions on an authorization under this
section as the Secretary finds necessary or
appropriate to protect the public health,
including the following:
(i) Appropriate conditions on which
entities may distribute the product
with respect to the emergency use of
the product (including limitation to
distribution by government entities),
and on how distribution is to be
performed.
(ii) Appropriate conditions on who
may administer the product with respect
to the emergency use of the product,
and on the categories of individuals to
whom, and the circumstances under
which, the product may be administered
with respect to such use.
(iii) For persons other than
manufacturers of the product,
appropriate conditions concerning
recordkeeping and reporting, including
records access by the Secretary, with
respect to the emergency use of the
product.
(iv) With respect to the emergency
use of the product, waive or limit, to
the extent appropriate given the
circumstances of the emergency,
conditions regarding current good
manufacturing practice otherwise
applicable to the manufacture,
processing, packing, or holding of
products subject to regulation under
this Act, including such requirements
established in section 501.
(2) Unapproved use.--With respect to the emergency
use of a product that is an unapproved use of an
approved product:
(A) The Secretary may, for manufacturers of
the product who choose to carry out one or more
activities for which the authorization is
issued, establish any of the conditions
described in clauses (i) through (iv) of
paragraph (1)(A).
(B)(i) If the authorization under this
section regarding the emergency use authorizes
a change in the labeling of the product, but
the manufacturer of the product chooses not to
make such change, such authorization may not
authorize distributors of the product or any
other person to alter or obscure the labeling
provided by the manufacturer.
(ii) In the circumstances described in clause
(i), an authorization under this section
regarding the emergency use may, for persons
who do not manufacture the product and who
choose to act under this clause, authorize such
persons to provide information on the product
in addition to the labeling provided by the
manufacturer, subject to compliance with clause
(i). Such additional information shall not be
considered labeling for purposes of section
502.
(f) Duration of Authorization.--
(1) In general.--Except as provided in paragraph (2),
an authorization under this section shall be effective
until the earlier of the termination of the declaration
under subsection (b) or a revocation under subsection
(g).
(2) Continued use after end of effective period.--An
authorization shall continue to be effective for
continued use with respect to patients to whom it was
administered during the period described by paragraph
(1), to the extent found necessary by such patients'
attending physicians.
(g) Revocation of Authorization.--
(1) Review.--The Secretary shall periodically review
the circumstances and the appropriateness of an
authorization under this section.
(2) Revocation.--The Secretary may revoke an
authorization under this section if, in the Secretary's
unreviewable discretion, the criteria under subsection
(c) for issuance of such authorization are no longer
met.
(h) Publication.--The Secretary shall promptly publish in the
Federal Register a notice of each authorization, and each
termination or revocation of an authorization, and an
explanation of the reasons therefor, under this section.
(i) Actions Committed to Agency Discretion.--Actions under
the authority of this section by the Secretary, by the
Secretary of Defense, or by the Secretary of Homeland Security
are committed to agency discretion.
(j) Rules of Construction.--Nothing in this section shall be
construed to impair or otherwise affect--
(1) the authority of the President as Commander in
Chief of the Armed Forces of the United States under
article II, section 2 of the United States
Constitution;
(2) the authority of the Secretary of Defense with
respect to the Department of Defense, including the
armed forces, under other provisions of Federal law; or
(3) the authority of the Secretary under section
319F-2 to manage the stockpile under such section.
(k) Application to Members of Armed Forces.--
(1) Waiver of requirement relating to option to
refuse.--In the case of administration of a
countermeasure to members of the armed forces, a
requirement, under subsection (e)(1)(A)(ii)(III),
designed to ensure that individuals are informed of an
option to accept or refuse administration of a product,
may be waived by the President if the President
determines, in writing, that complying with such
requirement is not feasible, is contrary to the best
interests of the members affected, or is not in the
interests of national security.
(2) Provision of information to member of the armed
forces.--If the Secretary makes a determination that it
is not feasible for the information required by
subsection (e)(1)(A)(ii) to be provided to a member of
the armed forces prior to the administration of the
product, such information shall be provided to such
member of the armed forces (or next-of-kin in the case
of the death of a member) to whom the product was
administered as soon as possible, but not later than 30
days, after such administration. Information concerning
the administration of the product shall be recorded in
the medical record of the member.
(3) Effect on statute pertaining to investigational
new drugs.--In the case of an authorization based on a
determination by the Secretary of Defense under
subsection (b)(1)(B), section 1107 of title 10, United
States Code, shall not apply to use of a product that
is the subject of such authorization, within the scope
of such authorization and while such authorization is
effective.
(l) Relation to Other Provisions.--If a product is the
subject of an authorization under this section, the use of such
product within the scope of the authorization --
(1) shall not be subject to any requirements pursuant
to section 505(i) or 520(g); and
(2) shall not be subject to any requirements
otherwise applicable to clinical investigations
pursuant to other provisions of this Act.
(m) Discretion Regarding Use of Authorization.--Nothing in
this section provides the Secretary any authority to require
any person to carry out any activity that becomes lawful
pursuant to an authorization under this section, and no person
is required to inform the Secretary that the person will not be
carrying out such activity, except that a manufacturer of a
sole-source unapproved product authorized for emergency use
shall notify the Secretary within a reasonable period of time
after the issuance by the Secretary of such authorization if
such manufacturer does not intend to carry out an activity or
activities under the authorization. This section does not have
any legal effect on a person who does not carry out any
activity for which an authorization under this section is
issued, or who carries out such an activity pursuant to other
provisions of this Act or section 351 of the Public Health
Service Act.
(n) Enforcement.--A person who carries out an activity
pursuant to an authorization under this section, but who fails
to comply with applicable conditions under subsection (e), is
with respect to that act of noncompliance subject to the
provisions of law specified in subsection (a) and to the
enforcement of such provisions under section 301.