SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Rapid Pathogen Iden-
tification to Delivery of Cures Act’’. 
SEC. 2. FINDINGS AND POLICY. 
(a) FINDINGS.—The Congress finds as follows: 
(1) The possibility exists today that terrorists 
or others who intend harm to United States forces 
deployed abroad or to the homeland will use tech-
niques in biotechnology to enhance the trans-
missibility, stability, virulence, or host range of a bi-
ological agent, or to render existing diagnostic, 
therapeutic, and vaccine strategies or innate immune 
responses against a biological agent less effective. 
(2) This possibility will likely grow over time as 
such techniques develop, improve, and spread as an 
inevitable result of biotechnology innovation. 
(3) Natural processes can also lead to the emer-
gence of previously unknown and harmful pathogens 
or render known pathogens resistant to existing di-
agnostic, therapeutic, or adaptive immune ap-
proaches. 
(4) Long delays in developing new and effective 
responses to pathogens are typical. The discovery, 
development, and approval process for new drugs 
and vaccines typically requires 10 to 20 years and 
costs an average of $800 million. These constraints
reflect the long, costly research and development 
process, including the failure of most drug or vac-
cine candidates to demonstrate favorable characteris-
tics in pre-clinical testing, as well as the expensive, 
time-consuming clinical trials required to prove the 
safety and effectiveness of new treatments. 
(5) Congress has already authorized the 
abridgement of the long testing and approval process 
required to ensure safety and efficacy under the 
emergency conditions of a severe outbreak of a 
harmful pathogen. However, it will likely still take 
years for even an experimental treatment or vaccine 
to become available. 
(6) There is no coordinated, focused research 
and development program or overall national strat-
egy to achieve significant and dramatic reductions in 
the timeframe from the identification of a pathogen 
to the development and emergency approval for 
human use of reasonably safe and effective new bio-
defense medical countermeasures against a pre-
viously unknown or engineered pathogen or toxin. 
(7) Even utilizing existing technologies, there is 
no organized capability in the public or private sec-
tor to rapidly screen drug candidates for potential 
therapeutic activity against pathogens, develop and
manufacture drug, biological, or medical device prod-
ucts, or test already approved treatments for efficacy 
against a previously unknown or engineered biologi-
cal threat that puts our deployed armed forces or 
the homeland at risk. 
(8) In the area of infectious disease in par-
ticular, private sector firms are abandoning all types 
of innovation and research and development in favor 
of investments in more profitable medical markets. 
(9) Tremendous potential exists for benefits to 
health by concerted, targeted public-private invest-
ment to dramatically reduce the timeframe for the 
development of new countermeasures. The pharma-
ceutical and biotechnology industries are fundamen-
tally innovative and are quick to integrate new tech-
nologies. Useful and important discoveries and tech-
nological advances will be rapidly absorbed by the 
private sector, leading to faster delivery of new 
medicines and reductions in the costs of drug devel-
opment. 
(b) POLICY.—The Congress hereby declares it to be 
the national policy of the United States to promote techno-
logical advancements that will dramatically reduce the 
timeframe for the development of new medical counter-
measures to treat or prevent disease caused by infectious
disease agents or toxins that, through natural processes 
or intentional introduction, may pose a significant risk to 
public health now or in the future. 
SEC. 3. RAPID BIODEFENSE COUNTERMEASURES DEVELOP-
MENT NATIONAL STRATEGY. 
Title III of the Homeland Security Act of 2002 (6 
U.S.C. 181 et seq.) (Public Law 107–296) is amended by 
inserting after section 304 the following section: 
‘‘SEC. 304A. RAPID BIODEFENSE COUNTERMEASURES DE-
VELOPMENT NATIONAL STRATEGY. 
‘‘(a) NATIONAL STRATEGY FOR SHORTENING THE 
MEDICAL
COUNTERMEASURE
DEVELOPMENT
TIME-
FRAME.—Not later than 180 days after the date of the 
enactment of the Rapid Pathogen Identification to Deliv-
ery of Cures Act, the Secretaries of Homeland Security, 
Health and Human Services, and Defense shall submit to 
Congress a report setting forth a strategy to achieve dra-
matic reductions in the timeframe from pathogen identi-
fication to the development and emergency approval for 
human use of reasonably safe and effective priority coun-
termeasure against a novel or unknown pathogen or toxin. 
‘‘(b) ELEMENTS.—The report under subsection (a) 
shall include the following: 
‘‘(1) The identification of the technical impedi-
ments to reductions in the timeframe from pathogen
identification to priority countermeasure develop-
ment and approval under emergency conditions. 
‘‘(2) The identification of the research, develop-
ment, and technology needs and clinical research 
needs to address these impediments. 
‘‘(3) The identification of existing research and 
development efforts in Federal agencies, academia 
and industry that are addressing the needs identified 
in subsection (c)(2). 
‘‘(4) The identification of facilities, programs 
and resources that can be utilized to address these 
research, development, and technology needs and 
clinical research needs among—
‘‘(A) Federal agencies; 
‘‘(B) colleges and universities; 
‘‘(C) not-for-profit institutions; 
‘‘(D) industry, including information tech-
nology, software, robotics, pharmaceutical and 
biotechnology companies and their consortia; 
and 
‘‘(E) foreign research and technological in-
stitutions. 
‘‘(5) A proposal for the establishment of a co-
ordinated and integrated federal program to address
these research, development, and technology needs, 
including—
‘‘(A) the application of Federal Govern-
ment resources, including recommendations for 
the allocation and prioritization of Federal 
funds; 
‘‘(B) interagency management and coordi-
nation mechanisms; 
‘‘(C) the establishment of partnerships be-
tween private corporations and Federal agencies 
or Federally funded entities; 
‘‘(D) information and technology sharing 
and coordination mechanisms among public, 
private, academic, not-for-profit, and inter-
national institutions; 
‘‘(E) the use of incentives to promote pri-
vate sector participation; and 
‘‘(F) the adjustment of Federal regulatory 
requirements to promote private sector innova-
tion. 
‘‘(6) The identification of potential liability con-
cerns stemming from distribution of rapidly-devel-
oped priority countermeasures under emergency con-
ditions and a proposal for regulatory or legislative 
approaches to eliminating these concerns.
‘‘(7) A proposal for managing the transfer of 
new technologies and associated intellectual property 
rights. 
‘‘(c) CONSIDERATIONS.—In developing the national 
strategy under subsection (a), the Secretaries shall con-
sider—
‘‘(1) the research, development, and technology 
needs and clinical research needs of the entire 
pathogen identification to priority countermeasures 
discovery, development, production, and approval 
process, including—
‘‘(A) initial identification and characteriza-
tion of a pathogen or toxin, including the iden-
tification of any genetic or other manipulations; 
‘‘(B) priority countermeasures discovery; 
‘‘(C) pre-clinical testing and evaluation of 
priority countermeasures; 
‘‘(D) safety and efficacy animal testing, in-
cluding the needs for approval under emergency 
conditions and accelerated approval of new pri-
ority countermeasure under the final rule ‘New 
Drug and Biological Drug Products; Evidence 
Needed to Demonstrate Effectiveness of New 
Drugs When Human Efficacy Studies Are Not 
Ethical or Feasible’ published in the Federal
Register on May 31, 2002 (67 Fed. Reg. 
37988); 
‘‘(E) safety and efficacy human testing, in-
cluding mechanisms for the conduct of clinical 
trials under emergency conditions; 
‘‘(F) research-scale and full production-
scale manufacturing, including biologics manu-
facturing sciences; and 
‘‘(G) the approval of priority counter-
measure under emergency conditions; 
‘‘(2) the potential importance of advanced tech-
nologies such as automation, computer modeling and 
simulation, bioinformatics, pharmacogenomics, and 
bioengineering techniques for manufacturing; 
‘‘(3) the availability of sufficient manufacturing 
capacity for priority countermeasures production to 
meet potential public demand under emergency con-
ditions; and 
‘‘(4) the current state of national and inter-
national collaborative research networks and applica-
tions to facilitate and encourage the rapid and co-
ordinated development and sharing of laboratory and 
clinical research planning and results. 
‘‘(d) AUTHORITY TO CONTRACT.—The Secretary of 
Homeland Security, after consultation with the Secre-
taries of Health and Human Services and Defense and 
the working group established under section 319F(a) of 
the Public Health Service Act, may contract with any one 
or more for-profit or non-profit firm or institution to con-
duct the necessary research and analysis needed to com-
plete any one or more of the elements described in sub-
section (b) of the report required in this section, provided 
the considerations described in subsection (c) are met. 
‘‘(e) DEFINITIONS.—In this section: 
‘‘(1) The term ‘emergency conditions’ refers to 
a declaration of emergency under section 564 of the 
Federal Food, Drug, and Cosmetic Act. 
‘‘(2) The term ‘pathogen identification’ means 
the point in time in which a specific agent that can 
be reasonably assumed to be the cause of (or has the 
potential to be the cause of) an infectious disease or 
toxin-induced syndrome has been identified and par-
tially or wholly characterized scientifically. 
‘‘(3) The term ‘priority countermeasure’ has 
the same meaning given such term in section 
319F(h) of the Public Health Service Act. 
‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—For the 
purpose of carrying out this section, there is authorized 
to be appropriated $10,000,000 for fiscal year 2005.’’.
SEC. 4. CLINICAL RESEARCH UNDER EMERGENCY CONDI-
TIONS. 
(a) IN GENERAL.—Not later than 180 days after the 
date of the enactment of this Act, the Secretary of Health 
and Human Services shall establish a system for the rapid 
establishment of clinical research programs to examine the 
safety and efficacy of new or existing treatments for novel, 
unknown, or bioengineered pathogens or toxins. The Sec-
retary shall also provide the means for rapid dissemination 
of results and recommendations to clinicians nationwide. 
(b) EMERGENCY FUND.—A fund is authorized to be 
established for use, at the discretion of the Secretary, sole-
ly for the support of clinical research as described in sub-
section (a). 
SEC. 5. INTERAGENCY WORKING GROUP. 
Section 319F(a) of the Public Health Service Act, as 
amended by Public Law 107–188, is amended—
(1) by inserting ‘‘the Secretary of Homeland 
Security,’’ after ‘‘in coordination with the’’; 
(2) 
by 
redesignating 
subparagraphs 
(D) 
through (L) as subparagraphs (E) through (M), re-
spectively; and 
(3) by inserting after subparagraph (C) the fol-
lowing subparagraph: 
‘‘(D) development of a national strategy to 
achieve dramatic reductions in the timeframe
from the identification of a pathogen to the de-
velopment and approval for human use under 
emergency 
conditions 
of 
priority 
counter-
measures against a novel, unknown, or engi-
neered pathogen or toxin;’’. 
SEC. 6. DEVELOPING THE CAPABILITY FOR RAPID BIO-
DEFENSE 
COUNTERMEASURE 
DEVELOP-
MENT. 
(a) RESEARCH.—Section 319F(h)(1) of the Public 
Health Service Act, as amended by Public Law 107–188, 
is amended—
(1) in subparagraph (C), by striking ‘‘and’’ 
after the semicolon; 
(2) by redesignating subparagraph (D) as sub-
paragraph (E); and 
(3) by inserting after subparagraph (C) the fol-
lowing subparagraph: 
‘‘(D) the development of a capability to 
rapidly identify, develop, produce, and approve 
for human use under emergency conditions pri-
ority countermeasures against a novel, un-
known, or engineered pathogen or toxin; and’’. 
(b) RESEARCH AND DEVELOPMENT AT THE DEPART-
MENT OF DEFENSE.—Section 1601(a) of the National 
Defense Authorization Act for Fiscal Year 2004 (Public
Law 108–136) is amended by adding at the end the fol-
lowing: ‘‘The program shall also include research, develop-
ment, and procurement to provide the Federal Govern-
ment with the capability to rapidly identify, develop, 
produce, and approve for human use under emergency 
conditions priority countermeasures against a novel, un-
known, or engineered pathogen or toxin, and for which no 
existing countermeasure has been determined to be safe 
or efficacious.’’. 
(c) RESEARCH AND DEVELOPMENT AT THE DEPART-
MENT OF HOMELAND SECURITY.—Title III of the Home-
land Security Act of 2002, as amended by section 3 of 
this Act, is amended by inserting after section 304A the 
following section: 
‘‘SEC. 304B. DEVELOPING THE CAPABILITY FOR RAPID BIO-
DEFENSE 
COUNTERMEASURE 
DEVELOP-
MENT. 
‘‘The Secretary, in collaboration with the Secretaries 
of Defense and Health and Human Services, shall carry 
out a program for research, development, and procure-
ment to provide the Federal Government with the capa-
bility to rapidly identify, develop, produce, and approve for 
human use under emergency conditions priority counter-
measures against a novel, unknown, or engineered patho-