The Pandemic and All-Hazards Preparedness Act (P.L. 109-417): Provisions and Changes to Preexisting Law

^Pr^ep^ar^{ed f}^o^r^M^e^m^b^ers^an^d^Com^mⁱ^t^t^ees^of^C^ong^r^e^ss

Authorities to direct federal preparedness for and response to public health emergencies are found
principally in the Public Health Service Act (PHS Act), and are administered by the Secretary of
Health and Human Services (HHS). Three recent laws provided the core of these authorities. P.L.
106-505, the Public Health Threats and Emergencies Act of 2000 (Title I of the Public Health
Improvement Act), established a number of new programs and authorities, including grants to
states to build public health preparedness. P.L. 107-188, the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002, was passed in the aftermath of the 2001
terror attacks. It reauthorized several existing programs and established new ones, including
grants to states to build hospital and health system preparedness. P.L. 108-276, the Project
BioShield Act of 2004, established authorities to encourage the development of specific
countermeasures (such as drugs and vaccines for bioterrorism agents) that would not otherwise
have a commercial market.
The laws above built upon existing broad authorities allowing or requiring the Secretary of HHS
to prepare for or respond to outbreaks of infectious disease and other unanticipated health threats.
Other laws—such as P.L. 107-296, creating a new Department of Homeland Security (DHS)—
have added to the slate of public health preparedness and response authorities as well. Further, the
Robert T. Stafford Disaster Relief and Emergency Assistance Act (the Stafford Act, administered
by DHS), which authorizes federal assistance and other activities in response to presidentially
declared emergencies and major disasters, is also, to some extent, a source of federal authority for
the response to public health threats.
The 109^th Congress passed P.L. 109-417, the Pandemic and All-Hazards Preparedness Act. The
act reauthorized a number of expiring preparedness and response programs in the PHS Act, and
established some new authorities, including the creation of a Biomedical Advanced Research and
Development Authority (BARDA), a new office in HHS to support, coordinate, and provide
oversight of advanced development of vaccines and biodefense countermeasures. The act’s ^th
provisions reflected the concerns of Members of the 109 Congress and others regarding the
flawed response to Hurricane Katrina in 2005, and the threat of a possible influenza pandemic. A
comparison of provisions in P.L. 109-417 with preexisting law is provided in Table 1 later in this
report.
The 110^th Congress will likely be interested in the implementation of provisions in P.L. 109-417,
and in the continued evolution of relationships between HHS, DHS, the states, and others among
whom coordination is essential in a time of heightened concern about national security. Members ^th
of the 110 Congress may wish to consider legislation to address additional expiring public health
authorities, such as the Select Agent program to control access to pathogens that could be used for
bioterrorism, which expires at the end of FY2007. Congress may also wish to examine the
adequacy of certain permanent emergency response and funding authorities of the Secretary of
HHS.

Introduc tion ..................................................................................................................................... 1
Legislative History..........................................................................................................................2
The 109^th Congress....................................................................................................................2 ^th^th
Major Legislation in the 107 and 108 Congresses................................................................5
Major Legislation Prior to the 2001 Terrorist Attacks...............................................................6
Additional Congressional Research Service (CRS) Reports...........................................................7
Table 1. Provisions of P.L. 109-417, the Pandemic and All-Hazards Preparedness Act, and
Comparison with Preexisting Law...............................................................................................8
Author Contact Information..........................................................................................................29

On December 19, 2006, President George W. Bush signed S. 3678, the Pandemic and All-Hazards
Preparedness Act (P.L. 109-417), which authorizes appropriations through FY2011 to improve
bioterrorism and other public health emergency preparedness and response activities, and
establishes the Biomedical Advanced Research and Development Authority (BARDA) within the
Department of Health and Human Services (HHS) for the advanced research and development of
medical countermeasures.
The Pandemic and All-Hazards Preparedness Act effected the second comprehensive
reauthorization of federal programs designed to improve the nation’s readiness for public health
threats such as bioterrorism or pandemic influenza. Many of these authorities, found principally
in the Public Health Service Act and implemented by the Secretary of Health and Human
Services (HHS), were first explicitly authorized in 2000 (P.L. 106-505), amid growing concerns
about global terrorist activity and emerging infectious diseases. Congress reviewed, extended and
expanded many of these authorities following the terrorist attacks of 2001 (P.L. 107-188). The
anthrax attacks, in particular, had put a harsh spotlight on a public health system that was poorly ^st
coordinated and otherwise unfit for 21 century challenges.
As the 109^th Congress began its consideration of the Pandemic and All-Hazards Preparedness Act
in 2005, Hurricane Katrina slammed into the Gulf Coast, while a new strain of avian flu, on a
steady march across Europe and Asia, threatened a global pandemic. In this context, Members of
Congress considered the challenges of bolstering a public health system that is based largely in
state authority, and a healthcare system that is largely in private hands. Congress grappled, on the
federal level, with integrating the new Department of Homeland Security (DHS) into the nation’s
preparedness and response activities. The challenges of building effective, coordinated systems
across federal agencies, with state and local governments, with private industry, with citizens, and
with foreign nations, were formidable as well.
The 110^th Congress will likely be interested in the implementation of provisions in P.L. 109-417,
and in the continued evolution of relationships between HHS, DHS, the states, and others among
whom coordination is essential in a time of heightened concern about national security. Members ^th
of the 110 Congress may wish to consider legislation to address additional expiring public health
authorities, such as the Select Agent program to control access to pathogens that could be used for
bioterrorism, which expires at the end of FY2007. Congress may also wish to examine certain ¹
permanent emergency response and funding authorities of the Secretary of HHS.
This report discusses some key provisions in the Pandemic and All-Hazards Preparedness Act
(P.L. 109-417), and provides a history of prior public health and medical preparedness and
response legislation. A comparison of provisions in P.L. 109-417 with preexisting law is provided
in Table 1 later in this report.

¹^For^m^o^r^e^inf^o^r^m^a^{tion, s}^e^e^C^R^S^R^e^por^{t R}^S²²⁶⁰^2,^Pu^blic^H^e^alt^h^a^{nd M}^e^dic^a^l^Pr^e^par^e^d^ne^s^s^a^{nd Re}^s^pons^e^:^I^s^s^u^e^sⁱⁿ
^the¹¹⁰^th^C^o^ng^ress^{, by}^Sa^ra^{h A}^.^Lis^t^e^r^.

In July 2006, Senator Burr introduced S. 3678, the Pandemic and All-Hazards Preparedness Act.
This bill proposed a comprehensive reauthorization of health preparedness and response
programs in Title I of P.L. 107-188, the Public Health Security and Bioterrorism Preparedness and ^th
Response Act of 2002. In addition, several bills were introduced in the 109 Congress to enhance
Project BioShield, the HHS program to develop and procure specific countermeasures (such as
drugs and vaccines for victims of bioterrorism) for the Strategic National Stockpile. These
included S. 3 (Gregg), S. 975 (Lieberman), S. 1873 (Burr), S. 1880 (Kennedy), S. 2564 (Burr), ²
and H.R. 5533 (Rogers). The two legislative initiatives proceeded along parallel tracks until
December 2006, when BioShield provisions were attached to S. 3678 as a new Title IV, and the
amended bill passed in both chambers. The bill was signed by the President on December 19,
2006, and became P.L. 109-417. Some key provisions of this law are discussed below. A
comparison of provisions in P.L. 109-417 with preexisting law is provided in Table 1 later in this
report.
One of the most difficult challenges faced by Congress and other policymakers following the
2001 terror attacks was to envision those catastrophic threats for which the nation must be
prepared, define the capabilities needed to assure national preparedness, and determine the
appropriate federal activities and incentives needed to achieve these goals among federal, state,
and local governments, and the private sector. Both of the earlier bioterrorism laws, P.L. 106-505
and P.L. 107-188, had called on the Secretary of HHS, in collaboration with other stakeholders, to
define core national capacities for preparedness and response for public health and medical
emergencies. The process has been a challenge. However, recent efforts at DHS, to develop
national preparedness goals and target capabilities, have helped to define certain large-scale
public health and medical capabilities—such as rapid disease detection, mass prophylaxis, and
medical surge—that would be required for an effective response to mass casualty incidents, and ³
that would require a substantial federal coordinating effort. The Pandemic and All-Hazards
Preparedness Act would require the Secretary of HHS to prepare a quadrennial National Health
Security Strategy and implementation plan, to include preparedness goals for federal, state, and
local governments in harmony with national preparedness and response efforts at DHS.
In October 2006, the President signed P.L. 109-295, the Post-Katrina Emergency Management
Reform Act of 2006 (called the “Post-Katrina Act,” included in DHS appropriations for FY2007).
The act reauthorized and reorganized programs in the Federal Emergency Management Agency ⁴
(FEMA, in DHS). Among other things, the law also codified the position of Chief Medical
Officer (CMO) at DHS, the individual who coordinates all departmental activities regarding
medical and public health aspects of disasters. Since the Secretary of DHS serves as the federal
lead for a coordinated national response to disasters, including terrorism, Members of Congress

²^For^m^o^r^e^inf^o^r^m^a^{tion, s}^e^e^C^R^S^R^e^por^{t R}^S²¹⁵⁰^7,^Proje^c^t^Bi^oS^hie^l^d^:^Purp^ose^s^an^{d A}^u^th^oritie^s^,^by^Fr^aⁿ^k^G^o^ttr^on.
³^For^m^o^r^e^inf^o^r^m^a^{tion, s}^e^e^C^R^S^R^e^por^{t R}^L³²⁸⁰^3,^The^N^a^tio^nal^P^r^e^par^e^dne^s^s^Sy^s^t^e^m^:^I^s^s^u^e^sⁱⁿ^the¹⁰⁹^th^C^o^ng^ress^,
^by^Ke^{ith Be}^a^.
⁴^Se^e^C^R^S^R^e^por^{t R}^L³³⁷²⁹^,^Fe^de^r^a^{l Em}^e^r^ge^nc^y^M^aⁿ^age^m^e^{nt P}^o^li^c^y^C^han^ge^s^Afte^r^H^u^r^rⁱ^c^ane^K^a^tr^ina:^{A S}^u^m^m^a^r^y^of
^Stat^utor^y^Pr^ov^is^io^ns^,^b^y^Kei^t^h^{Bea et}^al^.

were interested in clarifying the relationship between the CMO and the Secretary of HHS in
disaster preparedness and response. The Post-Katrina Act provides that the CMO “shall have the
primary responsibility within the Department for medical issues related to natural disasters, acts ⁵
of terrorism, and other man-made disasters.” (Emphasis added.) The Pandemic and All-Hazards
Preparedness Act provides that “The Secretary of Health and Human Services shall lead all
Federal public health and medical response to public health emergencies and incidents covered ⁶
by the National Response Plan....” (Emphasis added.) Members of Congress will likely be
interested in how this statutory division of authority is implemented by the two departments.
The 109^th Congress considered several measures to improve Project BioShield, a program to
encourage the development of promising chemical, biological, radiological, or nuclear ^th
countermeasures that the private sector might not otherwise develop. The 108 Congress
launched the program in the Project BioShield Act of 2004 (P.L. 108-276), providing $5.6 billion
for the program over 10 years. Project BioShield allows the government to guarantee a market for
specified amounts of particular countermeasures. Under this program, HHS can solicit bids for
specific countermeasures and execute contracts for the delivery of countermeasures at guaranteed ⁷
prices even if the countermeasure has up to eight more years of development. The government
only pays for the countermeasure on delivery. As time has passed with little perceived progress on
some major identified countermeasure targets, criticism of this program has mounted. The
cancellation of the next-generation anthrax vaccine contract, the largest BioShield contract to
date, has highlighted these criticisms.
The 109^th Congress considered several measures to improve Project BioShield results, including
S. 3 (Gregg), S. 975 (Lieberman), S. 1873 (Burr), S. 1880 (Kennedy), S. 2564 (Burr), and H.R.
5533 (Rogers). Congress incorporated some of the proposals in these bills into the Pandemic and
All-Hazards Preparedness Act, Title IV. This law requires the HHS Secretary to develop and
make public a strategic plan to guide HHS research and development and procurement of
countermeasures. It also creates the Biodefense Advanced Research and Development Authority
(BARDA) in HHS. This office is to help implement the strategic plan, directly support
countermeasure advanced development, and facilitate communication between the government
and countermeasure developers. This law allows HHS to make milestone-based payments for
Project BioShield contracts which do not have to be repaid even if the product is never delivered.
It also permits the HHS Secretary to hold meetings and execute specific agreements with multiple
potential countermeasure developers that would otherwise violate antitrust laws, contingent on
prior approval of the Attorney General and the Chairman of the Federal Trade Commission.
Since FY2002, Congress has provided approximately $7 billion in grants to states to build public
health and hospital preparedness for public health threats. Presumably due to national security
concerns and other sensitivities, HHS has not published comprehensive or state-specific
information regarding states’ performance toward meeting the objectives for these grant
programs. Congress has been keenly interested in the management of these grants, on topics
ranging from the relevance of broad program goals in achieving national preparedness, to the

⁵^P^.^L^.¹⁰^9-²⁹⁵^,¹²⁰^ST^A^T¹⁴⁰⁹^.
⁶^P^.^L^.¹⁰^9-⁴¹⁷^,^Se^c^tioⁿ¹⁰^1.
⁷^For^m^o^r^e^inf^o^r^m^a^{tion, s}^e^e^C^R^S^R^e^por^{t R}^S²¹⁵⁰^7,^Proje^c^t^Bi^oS^hie^l^d^:^Purp^ose^s^an^{d A}^u^th^oritie^s^,^by^Fr^aⁿ^k^G^o^ttr^{on; a}ⁿ^d
^C^R^S^R^e^por^t^R^L³³⁹^07,^Pr^oje^c^t^Bⁱ^oSh^ie^ld:^A^ppr^oprⁱ^a^ti^ons^,^Ac^quisⁱ^tⁱ^ons^,^an^{d P}^o^lic^y^I^m^ple^m^eⁿ^t^a^ti^{on I}^s^s^u^e^s^for
^C^ongr^e^s^s^{, by}^Fraⁿ^k^G^o^ttron^.

rigor of fiscal accounting mechanisms, to the balance of federal vs. state funding shares, to issues
of program transparency. The Pandemic and All-Hazards Preparedness Act extended the
programs, adding certain new program elements including federal authority to withhold funds for
failure to meet program requirements, a state matching requirement, and a requirement that the
Secretary of HHS publish certain information about program activities and performance on a
federal Internet website available to the public.
There was considerable discussion in the 109^th Congress regarding whether a medical disaster
response could function effectively when the National Disaster Medical System (NDMS), a key ⁸
federal medical response asset, was based at DHS rather than at HHS. NDMS had been
transferred from HHS to DHS in P.L. 107-296, the Homeland Security Act, effective when the
new department was created in 2003. In studying the response to Hurricane Katrina,
Congressional and White House investigators found that, among other problems, NDMS ⁹
deployments were made by FEMA without the knowledge or involvement of personnel at HHS.
The Pandemic and All-Hazards Preparedness Act transferred NDMS back to HHS, effective ¹⁰
January 1, 2007. (Congress also made this transfer in the Post-Katrina Act. The transfer was ¹¹
supported by the Administration.)
A key to the management of incidents of bioterrorism or emerging infectious disease threats is the
ability to detect the incidents early, and to distribute countermeasures to affected populations in
time to prevent or cure illness. An element of early detection are the information systems used to
report and compare a variety of types of relevant information in a timely manner across
jurisdictions. The Pandemic and All-Hazards Preparedness Act requires the Secretary of HHS to
establish a national electronic network for sharing of public health surveillance information in
near-real time, and authorizes grants to states to establish or operate systems in this network. The
act also requires the Secretary to establish a nationwide system to track influenza vaccine that
may be used during a pandemic, and to identify ways to expand the use of telehealth capabilities
in emergency response. Achieving near-real-time national information systems for disease
detection or resource tracking is complicated by the need to develop a common set of data
standards to serve multiple purposes. At the same time, the systems must address concerns about
the privacy and security of personal health information, as well as commercially sensitive
information such as the health status of food-producing animals, or the quantities and distribution ¹²
pathways of patented medicines.

⁸^N^D^M^{S c}^ons^is^ts^of^a^num^be^r^of^m^e^dic^a^l^r^e^s^pons^e^te^a^m^s^tha^t^c^aⁿ^de^ploy^{to a}^s^c^eⁿ^e^r^a^pidly^a^{nd s}^e^{t u}^p^s^e^lf^-^s^us^ta^ining
^fⁱ^e^l^{d ope}^ra^tio^{ns f}^o^{r up}^to⁷²^h^our^{s, unt}^{il a}^d^diti^ona^{l f}^e^de^ra^{l sup}^port^a^rriv^e^s.^A^dditio^na^{l i}ⁿ^f^o^rm^a^{tion a}^bou^{t NDMS}^is
^a^v^a^ila^ble^{in C}^R^S^R^e^p^o^r^t^R^L³³⁰⁹^6,²⁰⁰⁵^G^u^{lf C}^oas^{t H}^u^r^rⁱ^c^ane^s^:^T^h^e^Pu^blic^H^e^alt^h^an^{d M}^e^dic^a^{l Re}^s^pons^e^{, by}^Sa^r^a^h
^A^.^Lⁱ^s^t^e^r^.
⁹^Se^e^the^U.S.^Ho^use^of^Re^pre^s^eⁿ^ta^tiv^e^s^,^A^Fa^ilure^of^Initia^tiv^e^:^T^h^e^Fina^{l Re}^p^o^rt^of^the^Se^le^c^t^Bipa^r^tisaⁿ^Com^m^itte^e^to
^Inv^e^s^tig^a^t^e^the^P^r^e^p^a^r^a^tⁱ^{on f}^o^{r a}ⁿ^{d Re}^s^p^oⁿ^s^e^{to H}^u^rric^aⁿ^e^K^a^trina^,^{p. 2}⁹⁷^,^Fe^br^ua^ry²⁰⁰⁶^{, a}^t^http^://k^a^t^rina^.h^ous^e^.^g^o^v^/;
^{U.S. Se}^na^te^{, C}^o^m^m^itte^e^{on Hom}^e^la^{nd Se}^c^u^ri^ty^a^{nd G}^o^v^e^rn^m^e^nta^l^Aff^a^{irs, Hurric}^aⁿ^e^Ka^trina^:^A^Na^tⁱ^on^Still
^U^npre^p^a^r^e^d^{, c}^h^a^p^te^r^24,^p.²⁹^{, M}^a^y²⁰⁰⁶^{, a}^t^http^://hs^g^a^c^.^s^e^na^te^.g^ov^{/; a}^{nd t}^h^e^W^h^ite^H^ous^e^,^T^h^e^Fe^d^e^ra^{l Re}^s^pons^e^to
^H^u^r^rⁱ^c^aⁿ^e^K^a^tr^ina^:^L^e^s^s^ons^L^e^a^r^ne^{d, p.}⁴⁷^{, Fe}^br^ua^r^y²⁰⁰^{6, a}^t^htt^p^:/^/w^w^w^.^w^hite^hous^e^.^g^o^v^/^r^e^por^ts^/^k^a^t^rⁱ^na^-^l^e^s^s^ons^-
^le^a^r^ne^d/.
¹⁰^Se^e^H^H^S^N^D^M^{S h}^o^m^e^pa^g^e^a^t^http://w^w^w^.ndm^s^.^dhhs^.g^ov^/.
¹¹^O^f^fⁱ^c^e^o^f^Ma^na^g^e^m^e^{nt a}^{nd B}^udg^e^t^{, “}^S^ta^te^m^e^{nt of}^A^d^mⁱ^nis^t^r^a^tion^Polic^y^:^H^.^R^.⁵⁴^41—^D^e^pa^r^t^m^e^{nt of}^H^o^m^e^la^nd
^Se^c^u^rity^A^ppropria^ti^ons^B^ill,^FY²⁰⁰^7,”^Se^na^te^v^e^rs^{ion, J}^u^ly^{12, 2}⁰⁰⁶^{, p}^.²^,^a^t^http^://w^w^w^.^w^hite^hous^e^.^g^o^v^/^om^b/
^le^gⁱ^s^l^a^tiv^e^/^s^a^p/10^9-^2/^hr⁵⁴⁴¹^s^a^p-^s^.^pdf^.
¹²^{For m}^o^re^inf^o^rm^a^{tion, s}^e^e^the^H^H^{S H}^e^a^{lth Inf}^o^rm^a^ti^{on T}^e^c^hnolo^g^y^hom^e^pa^ge^a^t^http://w^w^w^.hhs^.g^ov^/he^a^lthit/^{, a}^nd
⁽^c^onti^nue^d.^..)

Authority for health professions programs in Title VII of the Public Health Service Act expired in
2002. These programs, administered by the Health Resources and Services Administration
(HRSA), an agency in HHS, are primarily intended to alleviate shortages and maldistributions of
healthcare workers. The public health workforce has, in contrast, received little federal attention ¹³
over the years. The Pandemic and All-Hazards Preparedness Act would authorize a loan
repayment demonstration project for individuals who serve in health professional shortage areas
or areas at high risk of a public health emergency. S. 506, the Public Health Preparedness
Workforce Development Act of 2005, introduced in the Senate, proposed broader provisions to
provide scholarship and loan repayment programs for health professionals who work in ^th
government public health agencies. The bill did not advance in the 109 Congress.

Following the terror attacks of 2001, the 107^th Congress passed the Public Health Security and
Bioterrorism Preparedness and Response Act (P.L. 107-188, signed in June 2002, often called
“the Bioterrorism Act”) to improve the nation’s readiness for bioterrorism, emerging infectious
diseases, and other public health threats. A program of grants for state and local public health
capacity, administered by the Centers for Disease Control and Prevention (CDC), was ¹⁴
reauthorized at $1.08 billion for FY2003, and such sums as may be necessary through FY2006.
(The program had previously been authorized at $50 million for FY2001, prior to the terror
attacks.) The law stipulated a funding formula, including a base amount plus an amount
determined by population, with the intent that every state and territory receive funding for a
variety of core public health preparedness activities. Under prior statutory authority (see below),
the grants had been competitive.
The Bioterrorism Act also established, for the first time, a program of grants to states to prepare
hospitals, clinics and other healthcare facilities for bioterrorism and other mass-casualty events, to
be administered by HRSA. Congress authorized $520 million for this program in FY2003, and
such sums as may be necessary through FY2006.
The Bioterrorism Act contained a number of other provisions for public health preparedness. Title
I of the act included numerous additional provisions for building federal public health capacity,
including creation of the position of Assistant Secretary for Public Health Emergency ¹⁵
Preparedness (ASPHEP) at HHS, and expansion of security and preparedness activities at CDC.

^(...c^on^tin^ue^d)
^the^bi^os^urv^e^illa^nc^e^w^o^rk^g^r^{oup pa}^g^e^a^t^http://w^w^w^.hhs^.g^ov^/he^a^lthit^/a^hic^/^bi^o_m^aⁱ^n.htm^l^{. Se}^e^a^l^s^o^{CRS Re}^port^RL³²⁸⁵⁸^,
^H^e^{alth I}ⁿ^for^m^a^tio^{n Te}^c^h^nol^ogy^:^Pr^om^oti^ng^Ele^c^t^r^onic^C^oⁿⁿ^e^c^tiv^ity^{in H}^e^alt^h^c^a^r^e^{, by}^C^.^Ste^p^he^{n R}^e^dhe^a^d^.
¹³^F^o^{r m}^o^{re i}ⁿ^f^o^rm^atⁱ^oⁿ^,^{see t}^h^{e sect}ⁱ^oⁿ^“T^ren^d^s^A^f^f^e^ctⁱⁿ^{g t}^h^{e Heal}^t^h^W^o^rkf^o^rce:^E^m^er^gen^c^y^P^r^ep^aredⁿ^e^ss,^{” i}ⁿ^CR^S
^R^e^por^{t R}^L³²⁵⁴^6,^Title^{VII He}^a^lth^Profe^ssions^Ed^uc^ati^on^an^{d Tr}^ainⁱ^{ng: Iss}^u^e^s^{in Re}^aut^horiz^atioⁿ^,^b^y^Bern^{ice Re}^y^e^s-
^Ak^inbile^je^.
¹⁴^T^h^e^a^u^thor^iz^a^tⁱ^{on f}^o^r^FY²⁰⁰²^f^unds^w^a^s^sⁱ^gⁿ^e^d^{in J}^u^ne²⁰⁰²^{, a}^f^te^r^the^e^m^e^r^g^e^ncy^s^upple^m^eⁿ^ta^{l a}^ppr^o^p^rⁱ^a^tio^{n f}^o^r
^FY²⁰^{02 w}^a^s^pa^s^s^e^{d in J}^aⁿ^u^a^r^y^{2002 a}ⁿ^d^dis^t^rⁱ^buti^oⁿ^of^a^w^a^r^ds^{to s}^t^a^t^e^s^w^a^sⁱ^m^mⁱ^ne^{nt. C}^onf^e^r^e^e^s^r^e^por^te^d⁽ⁱⁿ^H^.^R^e^pt.
¹⁰⁷^-48¹^,^acco^m^p^an^yⁱⁿ^g^P^.^L^.¹⁰^7-1⁸⁸⁾^t^h^at^t^h^ey^dⁱ^dⁿ^o^tⁱⁿ^t^eⁿ^d^t^o^del^a^y^o^r^dⁱ^srup^t^t^h^{e on}^goⁱⁿ^{g aw}^ard^s^p^r^o^cess,^an^d
^dⁱ^rect^ed^t^h^{e A}^d^mⁱⁿⁱ^st^ratⁱ^oⁿ^t^o^c^oⁿ^tⁱⁿ^u^eⁱ^t^s^cu^rreⁿ^t^app^r^o^ach^t^o^t^h^e^award^s^.
¹⁵^T^hⁱ^s^p^o^sⁱ^tⁱ^oⁿ^w^a^{s ren}^a^m^e^d^t^h^{e Assi}^st^an^t^S^ecret^ar^y^f^o^r^P^r^ep^aredⁿ^e^s^s^an^d^Resp^on^se,^and^t^h^{e au}^t^h^o^rⁱ^tⁱ^{es were a}^m^en^d^e^d^,
ⁱⁿ^t^h^e^P^a^nd^emⁱ^c^an^d^A^l^l^-^Ha^zard^s^P^r^e^p^aredⁿ^e^{ss A}^c^t^.

Title I also expanded the program for the Strategic National Stockpile (SNS) of countermeasures
to diagnose and treat potential victims of terrorism or other public health emergencies. Title II of
the act called on the Secretary of HHS to register laboratories and individuals in possession of
Select Agents, those biological agents and toxins that pose a severe threat to public health and
safety, and to promulgate new safety and security requirements for such facilities and individuals.
Title III contained several provisions to protect the nation’s food and drug supply and enhance
agricultural security. Finally, Title IV of the act included provisions aimed at protecting the
nation’s drinking water supply, including authorizing $160 million to provide financial assistance ¹⁶
to community water systems to conduct vulnerability assessments and prepare response plans.
The Project BioShield Act of 2004 (P.L. 108-276, signed in July 2004) created market incentives
for the development of drugs, vaccines, biologics, other treatments and tests for biological and
chemical agents—collectively called countermeasures—that would not otherwise be attractive to ¹⁷
entrepreneurs. In addition, budget authority for the SNS was transferred from DHS back to HHS
in the act, though both the Secretaries of HHS and of DHS retain authority to deploy SNS assets
in an emergency. CDC continues to provide administrative management of the SNS, as it always
has.
In creating the new Department of Homeland Security, the 107^th Congress considered a variety of
public health preparedness programs and where they would best be located. In the end, the
Homeland Security Act (P.L. 107-296, signed in November 2002) transferred to the new
department only the Metropolitan Medical Response System (a municipal grant program),
NDMS, and budget authority for the SNS, leaving most public health preparedness and response
activities in HHS. The act directed the Secretary of HHS to collaborate with the Secretary of DHS
in setting priorities for human health-related countermeasures research and development, and for
all public health-related activities to improve state, local, and hospital preparedness and response,
though these programmatic activities remained at HHS.
Prior to the terrorist attacks of 2001, Congress passed the Public Health Threats and
Emergencies Act of 2000 (Title I of the Public Health Improvement Act, P.L. 106-505, signed
in November 2000) to address growing concerns about bioterrorism and emerging infectious
diseases, and about the ability of the public health system to respond. Among other provisions,
the law authorized $50 million for FY2001 (and such sums as may be necessary through FY2006)
for competitive grants to build capacity in state and local health departments. This and other
provisions would augment several public health infrastructure programs begun by CDC in the
1990s, including grants to states for epidemiology and laboratory capacity, and the creation of the
Laboratory Response Network to assure nationwide capability for testing of biological agents
during an actual or suspected bioterrorism incident.

¹⁶^For^a^s^u^m^m^a^r^y^of^P^.^L^.¹⁰^7-¹⁸⁸^,^s^e^e^C^R^S^R^e^por^{t R}^L³¹²⁶^3,^P^u^{blic Hea}^lth^S^ecu^{rity an}^{d Bioterro}^{rism Prep}^a^r^edⁿ^e^ss
^aⁿ^d^R^e^sp^on^{se A}^c^t⁽^P^.^L^.¹⁰⁷^-¹⁸⁸⁾^:^P^r^o^vⁱ^sⁱ^oⁿ^s^an^d^C^h^an^g^e^{s t}^o^P^r^eexi^stⁱⁿ^{g L}^a^w^{, by}^C^.^Ste^p^he^{n R}^e^d^h^e^a^d^{, D}^o^nna^U^.
^Vog^t^{, a}^nd^Ma^r^y^Tⁱ^em^a^nn.
¹⁷^For^m^o^r^e^inf^o^r^m^a^{tion o}ⁿ^P^r^oje^c^t^Bⁱ^oShⁱ^e^l^{d, s}^e^e^C^R^S^R^e^por^{t R}^S²¹⁵⁰⁷^,^Pro^j^e^c^t^Bio^Shie^l^{d: P}^u^rp^ose^s^and^Au^th^oritie^s^,
^by^Fr^aⁿ^k^G^o^ttr^{on a}^{nd C}^R^{S R}^e^p^o^r^t^R^L³²⁵^49,^Pr^oje^c^t^Bi^oS^hie^l^d:^Le^gis^l^ativ^e^Hⁱ^s^t^or^y^an^d^Side^-^b^y^-^Sid^e^C^o^m^par^is^on^of
^H^.^R.²¹²²^{, S. 15,}^a^{nd S. 15}⁰⁴^{, by}^Fr^aⁿ^k^G^o^ttr^{on a}ⁿ^{d Er}^ic^A^.^Fis^c^he^r^.

In the Antiterrorism and Effective Death Penalty Act of 1996 (P.L. 104-132, signed in April
1996), Congress called on the Secretary of HHS to establish a program to identify and list
specific infectious agents that could be used for bioterrorism, and to require the registration of
facilities (typically laboratories) shipping those agents. The resultant Select Agent program is
overseen by CDC and the U.S. Department of Agriculture (USDA). Program authority was
expended and extended through FY2007 in P.L. 107-188, in the aftermath of the anthrax attack.

For more information regarding provisions in P.L. 107-188, see
• CRS Report RL31263, Public Health Security and Bioterrorism Preparedness
and Response Act (P.L. 107-188): Provisions and Changes to Preexisting Law, by
C. Stephen Redhead, Donna U. Vogt, and Mary Tiemann.
• For more information regarding Project BioShield, seeCRS Report RS21507,
Project BioShield: Purposes and Authorities, by Frank Gottron.
• CRS Report RL33907, Project BioShield: Appropriations, Acquisitions, and
Policy Implementation Issues for Congress, by Frank Gottron.
For more information regarding public health preparedness and response authorities and
programs in general, and in the context of specific threats, see:
• CRS Report RS22602, Public Health and Medical Preparedness and Response: ^th
Issues in the 110 Congress, by Sarah A. Lister;
• CRS Report RL33579, The Public Health and Medical Response to Disasters:
Federal Authority and Funding, by Sarah A. Lister;
• CRS Report RL31719, An Overview of the U.S. Public Health System in the
Context of Emergency Preparedness, by Sarah A. Lister;
• CRS Report RL33096, 2005 Gulf Coast Hurricanes: The Public Health and
Medical Response, by Sarah A. Lister;
• CRS Report RL33145, Pandemic Influenza: Domestic Preparedness Efforts, by
Sarah A. Lister;
• CRS Report RL33738, Gulf Coast Hurricanes: Addressing Survivors’ Mental
Health and Substance Abuse Treatment Needs, by Ramya Sundararaman, Sarah
A. Lister, and Erin D. Williams.
For more information regarding the Stafford Act and related preparedness and response planning
activities in DHS, see:
• CRS Report RL33729, Federal Emergency Management Policy Changes After
Hurricane Katrina: A Summary of Statutory Provisions, by Keith Bea et al.
• CRS Report RL33053, Federal Stafford Act Disaster Assistance: Presidential
Declarations, Eligible Activities, and Funding, by Keith Bea.

Table 1. Provisions of P.L. 109-417, the Pandemic and All-Hazards Preparedness Act, and Comparison with Preexisting Law
^Preexis^{ting Law}^{P.L. 1}^09-4¹⁷
^{TITLE I: NATIONAL PR}^{EPAREDNESS AND RESPONS}^{E, LEADERSHIP, ORGANIZ}^{ATION AND PLANNING}
^{Federal leadership for p}^ublic^{No applicable p}^rovision.^{Repeals the e}^{xisting Section 28}⁰¹^{of the Pu}^{blic Health Service}
^{health and medical}^{(PHS) Act and establishes a}^new^{Section 280}^{1 re}^{quiring t}^he
^{preparedness an}^{d resp}^onse:^{Secretary to lead all federal public health a}^{nd medical response to}
^functions^{of the Secretary o}^f^{public healt}^{h emerge}^{ncies and in}^c^{idents covered by t}^{he Na}^tional
^{Health and Human Services}^{Response Plan (NRP) or any s}^ucc^{essor plan. The Secreta}^{ry s}^hall,
^(HHS)^{in collaboration with the Secreta}^{ries of Veterans Af}^{fairs (VA),}
^{Defense (DOD), Transportation, the Depa}^{rtment of}^Homeland
^{Security (DHS), and the head of a}^{ny other}^relevant^federal
^{agency, and consiste}^{nt with t}^he^{NRP or successor}^{plan, establish}
^{an interage}^{ncy agre}^ement^unde^r^{which th}^{e Secretary}^{shall assume}
^{operational control of emergency}^pu^{blic health and m}^edical
^{response a}^{ssets (ex}^cepting^memb^{ers of the a}^{rmed forces}^u^nder
^{the aut}^{hority of the Sec}^{retary of}^{Defense, and an}^{y associated}
ⁱ^{ki/CRS-RL33589}^{assets), as necessa}^{ry, in the}^event^{of a pu}^{blic health eme}^rgenc^y.^{[Section 101]}
^g/w
^s^.or^{Assistant Secretary for}^{Section 281}^{1(a) of the PHS Act a}^{uthorized the ap}^pointment^{of an}^{Redesignates the existing P}^{HS Act Section 281}^{1 as Section}²⁸¹²
^le^ak^{Preparedness and}^Response^{Assistant Secretary}^{for Pu}^{blic Health Emerge}^{ncy Pre}^pared^ness^{(ASPHEP) in HHS to: coordinate}^{all HHS prepared}^{ness a}^{nd res}^pon^se^{and creates a}^{new Section 2}⁸¹¹^t^o^{establish within HHS t}^he^{position of Assistant Secretary fo}^{r Prepared}^{ness a}^{nd Response}
^://wiki^{activities related to bioterrorism}^{and other}^pu^{blic health emerge}^nc^ies;^{coordinate HHS efforts to bolste}^{r state and local emergen}^cy^(ASPR)^{, to be appointed by t}^{he P}^{resident and con}^{firmed by t}^he^{Senate. Upon enact}^{ment, tra}^nsfer^{s to the ASPR all functions,}
^h^ttp^prepa^redness^{for a bioterrorist a}^{ttack or other}^pu^{blic health}^person^{nel, assets and liabilities of}^{the ASPHEP. The ASPR shall:}
^{emergency, a}^{nd evaluate t}^{he p}^{rogress of su}^{ch e}^{ntities in meeting t}^he^{(1) advise the Secretary}^{on matte}^{rs relating to p}^{ublic health a}^nd
^benc^hmarks^{and other}^outcome^measures^{contained in t}^{he nation}^al^{medical preparedne}^{ss and}^respon^{se; (2) manage a}^{nd have}^the
^{plan and in m}^{eeting the}^{core p}^ubl^{ic health capa}^{bilities established}^{authority to deploy federal p}^{ublic health and}^{medical personnel}
^purs^uant^{to Sec. 319A; a}^{nd inter}^f^{ace with other}^{federal agencies a}^nd^{including the National Disaster M}^{edical System (NDMS); (3)}
^{state and local entities. The positi}^{on did not require Senat}^e^{oversee the adva}^{nced resea}^{rch, d}^{evelopment and}^procu^rement
^{confirmation. Authorized such}^su^{ms as may}^{be n}^ecessary^{for FY20}^02-^{of countermea}^sure^{s p}^urs^{uant to}^{Sections 319F-1}^{and 3}^19F-^{3; (4)}
^{FY2006. [}^{42 U.S.C. § 300h}^h-1^1]^{coordinate with relevant federal,}^{state, local and tribal health}
^{officials to ensure integration of}^prepa^{redness a}^{nd res}^ponse
^{activities, and to promote improved emergency}^{medical services}
^{with respe}^{ct to pu}^{blic health em}^e^{rgencies; (5) p}^{rovide logist}^ical
^sup^{port for medical and p}^{ublic he}^{alth aspects of}^{federal res}^ponse
^{to public health}^emerge^{ncies, in c}^{oordination with the Secretaries}
^{of VA and Homeland Security, th}^{e Gene}^{ral Services}
^{Administration and other p}^{ublic a}^{nd private e}^{ntities; and (6)}
^{provide leadership in inter}^nationa^{l programs, initiatives and}
^{policies deal}^{ing with pu}^{blic health}^{and medical emergency}

^Preexis^{ting Law}^{P.L. 1}^09-4¹⁷
^prepa^{redness a}^{nd res}^{ponse. The}^{ASPR shall have authority over}
^{and respo}^{nsibility for the f}^{unctions, person}^{nel, assets and}
^liabil^{ities of NDMS, the Hospital Preparednes}^{s Cooperative}
^{Agreement (}^pur^suan^{t to Section 319C-}^{2, as designated in this}
^{act); and shall coordinate the Me}^{dical Reserve Corps (pur}^sua^nt
^{to Section 281}^{3, as designated in}^{this act), the Em}^ergen^{cy System}
^{for the Advan}^{ce Registration of Volunteer Health Profe}^ssionals
^(purs^{uant to Section 3}¹⁹^{I), the St}^{rategic National Stockpile (SNS)}
^{and the Cities Readiness Initiative; and other duties as}
^{determined app}^{ropriate b}^y^the^{Secretary. Repeals Section 3}^19A.
^{Authorizes the a}^p^p^{ropriation of s}^{uch s}^{ums a}^s^may^{be ne}^cessary
^{for FY200}^7-FY20^{11. [Section 1}⁰²^]
^{Strategic National Stockpile}^{PHS Act Section 319F-2}^{provided statutory a}^{uthority for a Strategi}^c^{Amends Section 31}^{9F-2(a)(1) of t}^{he PHS Act [4}^{2 U.S.C. § 247d-}
^{National Stockpile (SNS}^{) of drugs, vaccines, medical devices, and o}^ther^{6b(a)(1)] to req}^{uire th}^{e Secretar}^{y to collaborate with Director of}
^sup^{plies to meet the}^{nation’s health sec}^{urity needs in}^{the e}^{vent of}^a^{the Cente}^{rs for Disease Control}^{and Prevention in}^maintaining
^{bioterrorist attack or other}^pu^{blic health eme}^rgenc^{y. Required the}^{the SNS. Requires t}^{he Secretar}^y^{to conduct an a}ⁿⁿ^{ual review}
^{Secretary to manage}^{the SNS, in}^{coordination with the Secretaries}^of^{(taking into account at-risk individuals) of the conten}^{ts of the}
ⁱ^{ki/CRS-RL33589}^{DHS and VA, and ensu}^{re its p}^hys^{ical security. Protected information}^{on stockpile locations from discl}^{osure u}^{nder t}^{he Freedom of}^{stockpile, including non-pharma}^c^{eutical sup}^{plies, and make}^necessar^{y additions or modificat}ⁱ^{ons to the conte}^nts^{based on}
^g/w^{Information Act. Both the}^Secret^{ary of HHS}^[^{42 U.S.C. § 247d-}^{such review.}
^s^.or^{6b(a)(2)(G)] and t}^{he Secretar}^{y of}^{DHS [6 U.S.C. § 312] have a}^utho^rity
^le^ak^{to deploy the SNS. Authorized $640}^{million for FY2002 a}^{nd suc}^h^sums^{Does not extend a}^ppro^{priations authority for t}^{he SNS, which}^{expired in FY2}⁰⁰^{6. [Section 10}^2]
^{as may be}^neces^{sary for FY2}⁰⁰^3-^{FY2006, in addition to amounts i}ⁿ^a
^://wiki^{special reserve}^fu^{nd, and aut}^{horized, for smallpox vaccine}
^h^ttp^{development, $5}^{09 million for FY200}^{2 a}^{nd suc}^{h s}^{ums as}^{may be}^necessar^{y for FY20}^03-FY2⁰⁰^{6. [4}^{2 U.S.C.}^{§ 247d-6}^b]
^At-^{risk individuals}^{No comparable}^{provision. P.L. 107-18}^{8 re}^{quired, in 2}⁰⁰^{2, the}^{Establishes a}^{new Section 2}⁸¹⁴^of^{the PHS Act to address t}^he
^{establishment of t}^he^{National Advisory Committee on Children and}^{needs of}^{at-risk individuals}^{, defined}^{as children, preg}^nant^women,
^{Terrorism, which su}^{nset a}^{fter on}^{e year. Additional provisi}^{ons in the}^{senior citizens and other individu}^{als who have s}^{pecial needs in}
^{PHS Act req}^{uired the Secreta}^{ry t}^o^{consider the needs of}^children^and^{the eve}^{nt of a p}^{ublic health}^emer^{gency, as determined}^{by t}^he
^{other vulne}^rable^{populations whe}^{n conducting}^{a variety of}^{Secretary. Requires t}^{he Secreta}^ry^{to take the}^{needs of at-risk}
^prepa^{redness a}^ctivities.^{individuals into account in managi}^{ng several}^prepa^redness
^{programs, including th}^{e SNS and}^prepa^{redness g}^rants^{to states.}
^{Requires t}^{he Secretary,}^{not later}^{than one}^{year aft}^{er e}^nactment,
^{to prepar}^{e and s}^{ubmit to Congre}^{ss a report}^{describing t}^he
^{progress made on}^{implementing t}^{he duties described in}^this
^{section. Amends Section 31}^9F(b)^{(2) to require t}^{he Secreta}^{ry to}
^{establish an Advisory Committee}^{on At-Risk Individuals and}
^{Public Health Em}^ergen^{cies. For the Advisory Committee, does}
^{not explicitly authorize fu}^{nding fo}^{r FY200}^{7, b}^{ut aut}^{horizes the}
^approp^{riation of such}^sum^{s as ma}^{y be}^necessar^{y for FY2}⁰⁰^{8 and}

^Preexis^{ting Law}^{P.L. 1}^09-4¹⁷
^{each s}^ubse^que^{nt fiscal year. [Sect}^{ions 102}^and³⁰^1]
^{National Heal}^{th Security}^{Section 280}^{1 of the}^{PHS Act re}^q^{uired the Secreta}^{ry of H}^{HS, purs}^uant^{Repeals existing Sections 3}^{19A a}^{nd 28}⁰¹^{of the PHS Act.}
^Strategy^{to PHS Act Section 319A, to dev}^{elop and implement a}^{national plan to}^{Establishes a}^{new Section 2}⁸⁰^{2(a) of the PHS Act, re}^{quiring t}^he
^prepa^{re for a}^{nd res}^{pond to bioterrorism and other}^p^{ublic health}^{Secretary, begin}^{ning in 2}⁰⁰⁹^a^nd^{every fou}^{r years}^therea^{fter, to}
^{emergencies. Esta}^{blished five nati}^{onal prepar}^{edness goals: (i) assist}^prepa^{re and s}^u^b^{mit to Congress}^{a coordinated National Health}
^{state and local governments}^{in th}^{e event of}^{bioterrorism or other}^{Security Strategy and im}^plementa^{tion plan for p}^{ublic health}
^{public healt}^{h emerge}^{ncies; (ii) ensure t}^{hat state a}^{nd local governm}^ents^emergency^pre^pared^{ness a}^{nd res}^{ponse. The strat}^{egy shall identify}
^{have the}^{capacity to detect a}^{nd r}^{espond to suc}^{h eme}^{rgencies; (iii)}^{the p}^{rocess for ac}^{hieving the}^pre^paredness^{goals described in}
^{develop and maintain coun}^terme^{asures; (iv) ens}^{ure coordination a}^nd^subsec^{tion (b) and be}^consistent^{with the National Prepa}^redness
^{minimize duplication of federal, st}^{ate, and local planning, prepa}^redn^ess,^{Goal, the National Incident Ma}^na^{gement System a}^{nd the}^NRP,
^{and respo}^{nse activities; and (v) enhan}^{ce hos}^{pital and other h}^ealth^care^{developed by the De}^partme^{nt of}^{Homeland Security (DHS), or}
^{facility readiness. Required the Se}^{cretary to coordinate with state}^and^{any su}^ccessor^{plan. The strateg}^y^{and plan s}^{hall include an}
^{local governments and develop o}^{utcome meas}^{ures to evaluate}^{evaluation of progress}^{made by}^f^{ederal, state, loca}^{l, and tribal}
^{progress in im}^{plementing t}^{he na}^{tional plan and ac}^{hieving its five goals.}^{entities toward prepa}^{redness, a}ⁿ^d^{a strategy to establish a}
^{Required the Sec}^{retary to re}^port^{to Congress within one}^{year, an}^d^prepa^{red p}^{ublic health work}^force^.
^{biennially thereafte}^{r, on progre}^ss^{made towards meeting the}^national^{Establishes a}^{new Section 2}⁸⁰^2(b^{) requiring t}^{hat t}^{he National}
^prepa^{redness goals, including rec}^{ommendations for new legislative}^{Health Security Strategy}^include^prepa^{redness goals for: (1)}
ⁱ^{ki/CRS-RL33589}^{authority to protect}^pu^{blic health}^{. [42 U.S.C. § 300hh]}^{integration of respon}^{se capa}^biliti^{es and system}^{s; (2) capa}^bilities
^g/w^{Section 319A of t}^{he PHS Act}^req^{uired the Secreta}^{ry, together wit}^h^{for pu}^{blic health}^prepa^redness^an^{d response; (3)}^capa^{bilities for}
^s^.or^{state and local health officials, to}^{establish those ca}^{pacities needed}^for^{medical preparedne}^{ss and}^respon^{se; (4) provisions for th}^{e needs}
^le^ak^{national, state, and local public health systems to}^{be able to detect,}^{diagnose, and contain outbreaks}^{of infectious disease, drug-resista}^nt^{of at-risk individuals; (5) coord}^{ination of federal, state, loca}^{l, and}^{tribal planning, p}^repa^{redness, and}^response^{activities; and (6)}
^://wiki^pathoge^{ns, or acts}^{of bioterroris}^{m. Authorized $4 million for FY2001,}^{and suc}^{h su}^{ms as ma}^{y be}^neces^sa^{ry for FY20}^02-FY2⁰⁰^{6. [42}^U.S.C^{. §}^{continuity of federal, state, local,}^{and tribal operations in t}^he^{event of a}^pu^{blic health emerg}^en^{cy. [Section 103]}
^h^ttp^247d-^1]
^{TITLE II: PUBLIC HEALTH SECURITY PREP}^AREDNES^S
^{Grants to states for p}^ublic^{Section 319C-1}^{of the PHS Act}^r^{equired th}^{e Secretary}^{to make a}^wards^{Repeals PHS Act Sections 31}^{9B a}^{nd 31}^{9C. Repeals and re}^places
^{health preparedness: eligible}^{to eligible entities to}^{improve pu}^{blic health p}^repared^{ness a}^{nd res}^p^onse^{PHS Act subs}^{ections 3}^{19C-1(a) t}^hrough^{(i) and adds or}
^entit^{ies and authority for}^{to bioterrorism and other}^pu^{blic health emerge}^{ncies. Eligible entities}^{redesignates su}^{bsections (i) thro}^{ugh (k). Defines eligible entities}
^appr^opriations^{were states, political subdivisions of states, or consortia of su}^bdivisions.^{as states, consortia of states, or c}^{ertain political subdivisions of}
^{Eligible entities must have}^{completed a Section 319B e}^{valuation of core}^{states. Grante}^{es shall p}^repare^an^{d submit to the}^{Secretary, as}
^{public healt}^{h capacity}^{needs a}^{nd must, within 6}⁰^{days of}^receiving^an^{required, an All-Hazards Public H}^{ealth Emerge}^{ncy Pre}^pared^ness
^{award, submit an}^emerge^ncy^pre^paredness^{and re}^sponse^plan^{and Response Plan, to contain inf}^{ormation including pandemic}
^{describing the a}^{ctivities to be car}^{ried out. Use of funds}^for^{influenza plan}^{ning a}^{nd certain add}^{itional criteria}^{. Grantees s}^hall
^prepa^{redness a}^{nd res}^{ponse to}^{bioterrorism and outb}^{reaks of infe}^ctious^{submit to the}^{Secretary, as}^req^{uired, reports rega}^{rding the a}ⁿⁿ^ual
^{disease was to take priority over}^{other p}^{ublic health e}^merge^ncies,^{conduct of drills, grantees’ perfor}^{mance according to sta}^ndards
^{subject to an}^{y modification in the assessme}^{nt of risk b}^y^the^Secret^ary.^{defined by th}^{e Secretary, a}^{nd oth}^{er information. Eligible entities}
^{Authorized $1.0}^{8 billion for FY20}^{03 for}^{block grants}^{to states and}^{shall, by FY200}^{9, participate in}^th^{e Emerge}^{ncy System}^for
^{territories, and such}^sums^{as may}^{be ne}^cessary^{for FY20}^04-FY2⁰⁰^6.^{Advance Registration of Volunteer Health Professionals. Awards}
^{Note: The req}^uirement^that^pu^{blic health}^prepa^redness^fu^{nding be}^{shall be used to ac}^{hieve the}^pre^p^{aredness goals described}^under

^Preexis^{ting Law}^{P.L. 1}^09-4¹⁷
^{awarded as block grants}^ap^{plied only to FY2003; g}^{reater fle}^xibilityⁱⁿ^{the following subsections of Secti}^{on 28}⁰²⁽^{b) (as established in}
^{awarding fu}^{nding was p}^{rovided to the Secretary}^{beyond FY2}⁰⁰^{3. [42}^{this act) regarding: (1) integration}^{; (2) pu}^{blic health capa}^{bility; (3)}
^U.S.C^{. § 247d-3a]}^{the needs of at-}^{risk individuals; (4) coordination; and (5)}
^{Note: The fu}^{nding formula a}^{nd c}^{ertain other administrative}^{continuity of operations. (Note: Goal #3, medical capability, is}^{not a req}^{uired activity for thes}^{e g}^{rants.) The Secretar}^{y shall}
^requirem^{ents we}^{re esta}^{blished jointly for both t}^{he p}^{ublic health}^an^d^{consult with th}^{e Secretary}^{of DH}^{S to assure the}^{coordination of}
^{hospital prepa}^redness^{grants, a}^{nd are described in later}^sections.^{relevant activities. Authorizes $8}^{24 million for awards for}
^{FY2007, of w}^{hich $}^35,⁰⁰^0,00^{0 sh}^{all be used for Real-Time}
^{Disease Detection Improveme}^nt^{grants, and s}^uch^sums^{as may}^be
^necessar^{y for FY20}^08-FY2⁰¹^{1, an}^{d $10}^milli^{on for FY200}^{7 for a}
^{study of best}^pra^{ctices for re}^quir^{ed drills}^{, and for activities to}
^assure^pre^parednes^{s for t}^{he ne}^{eds of at-risk individuals. [Secti}^on
²⁰¹^]
^{Note: The fu}^{nding formula a}^{nd c}^{ertain other administrative a}^nd
^{fiscal requireme}^{nts ar}^{e establishe}^{d jointly for both the p}^ublic
^{health p}^repar^{edness g}^{rants des}^{cribed here}^{and t}^{he hos}^pital
^prepa^{redness g}^rants^described^be^{low. These administrative and}
ⁱ^{ki/CRS-RL33589}^{fiscal requireme}^{nts, in Sections 3}^{19C-1(g), (j) and (k), as}^{established in this act, are des}^crib^{ed in later sections.}
^g/w
^s^.or^{Grants fo}^{r Real-Time}^{No comparable}^provision.^{Established a}^{new PHS Act Section 3}^19C-1(^{h) authorizing the}
^le^ak^{Disease De}^tect^ion^Improvement^{Secretary to award gra}^{nts to hos}^{pitals, clinica}^{l laboratories,}^{universities or poison control ce}^{nter t}^{hat pa}^{rticipate in the}
^://wiki^{interoperable}^{network of data sy}^{stems established in Section}^319D^{by t}^{his act, for pilot demonstration projects to use}
^h^ttp^{advanced diagnostic medical equipment to a}^{nalyze real-time}
^{clinical specimens for pat}^hogens^{of pu}^{blic health or bioterrorism}
^{significance, and to report a}^{ny re}^{sults from s}^uch^{project to state,}
^local^{, and tribal pu}^{blic health enti}^{ties. Authorizes the}
^approp^{riations of $3}^{5 million for FY2007, a}^{nd suc}^{h s}^{ums as}^may
^{be nec}^essary^{for FY20}^08-FY20^11.^{[Section 201]}
^{Grants fo}^{r pu}^{blic health and}^{Note: Provisions described here}^{applied to both the}^pu^{blic health}^and^{Note: Provisions described here}^{apply to both t}^he^pu^{blic health}
^{hospital preparedness—}^{hospital prepa}^redness^grants^esta^{blished in PHS Act Section 31}^9C-^1.^prepa^{redness g}^rants^{established i}ⁿ^{Section 20}^{1 of t}^{his act, and the}
^funding^fo^{rmula, risk-based}^{PHS Act Section 319C-}^{1(j) requir}^{ed the Secretary, for FY2}⁰⁰^{3, to}^{hospital prepa}^redness^part^ners^{hip grant}^{s established in Section}
^{funding, a}^{nd p}^ass-thro^ugh^{award block grants to state}^{s and}^{territories for pu}^{blic health a}^nd³⁰⁵^{of this act.}
^requirement^{hospital prepa}^{redness, with ea}^ch^{grantee g}^uarante^{ed a minimum le}^vel^{Amends PHS Act Section 3}^19C-1^{, redesignating sub}^{section (j) as}
^{of funding}^{plus a}ⁿ^{additional amo}^unt^{based on}^{population. Establis}^hed^subsec^{tion (h), and req}^{uiring that}^{the Secretar}^{y maintain t}^he
^{different minimu}^{m amoun}^{ts for s}^{tates and ter}^{ritories based u}^pon^the^{funding for}^{mula, as it applied in p}^{reexisting law to FY200}^3,
^{available appropriation. The District of Columbia and the}^through^FY20^11.
^{Commonwealth of Puerto Rico were considered states}^{for the}^{Authorizes the Secr}^{etary, for FY}²⁰⁰^{7, to make awards}^{for certain}

^pur^{poses of this s}^{ection. Authori}^{zed the Secretary, for FY2}⁰⁰^{3, to}

^Preexis^{ting Law}^{P.L. 1}^09-4¹⁷
^{make awards for ce}^{rtain political subdivisions, as follows}^{: the Secre}^tary^politica^{l subdivisions, as such a}^u^t^{hority applied in pre}^{existing law}
^{may reserv}^{e a portion of a}^ppro^pr^{iations to make awards to not more}^{to FY2003.}
^than^{3 political subdivisions that have a s}^ubsta^{ntial num}^{ber of}^residents,^{Authorizes the Secr}^{etary, for FY}²⁰⁰^{7, to make awards}^for
^{have a s}^ubsta^{ntial local infrastruct}^{ure for}^{responding to}^pu^{blic health}^additi^{onal unmet ne}^{ed, as suc}^{h au}^{thority applied in pre}^existing
^{emergencies, and fa}^{ce a hig}^{h degr}^{ee of risk from}^{bioterrorist attacks or}^{law to FY2003.}
^{other p}^{ublic health e}^merge^ncies.
^{Authorized the Secretar}^{y, for FY200}^{3, to reser}^{ve a portion of}^{Requires t}^{he Secretary}^{to ens}^ure^{that awardees}^{make available}^approp^{riate portions of awards t}^o^politica^{l subdivisions and local}
^approp^{riations for awards to eligi}^{ble entities that}^{have an}^additiona^l^department^{s of p}^{ublic health t}^hro^{ugh a}^{process in}^{volving the}
^unmet^{need to b}^{uild capacity to identify, detect, monitor, and resp}^ond^consens^{us, app}^{roval or concur}^re^{nce with s}^uch^{local entities.}
^{to public health}^threat^{s, and that}^{face a pa}^{rticularly high degree}^of^risk^{[Section 201]}
^{of such t}^hreat^{s. The Secretary}^sh^{all consider the District of Columbia}
^{to have a significant}^unmet^need,^{and to face a pa}^{rticularly high deg}^ree
^{of risk for suc}^h^pur^{poses, on the}^{basis of the co}^ncent^{ration of enti}^ties
^{of national significance located wi}^{thin the District.}
^{Required the Sec}^{retary, for FY2}⁰^{03, to ens}^{ure t}^{hat ap}^prop^riate
^{portions of suc}^{h awards we}^{re ma}^{de available to polit}^{ical subdivisi}^o^ns,
^{local health departments,}^{hospitals (including children’s hospitals),}
ⁱ^{ki/CRS-RL33589}^{clinics, health centers, or}^primary^{care facilities, or consortia of such}
^g/w^{entities. [42 U.S.C. § 247d-3a]}
^s^.or^{Grants fo}^{r pu}^{blic health and}^{Note: Provisions described here}^{apply to both t}^he^pu^{blic health an}^d^{Note: Provisions described here}^{apply to both t}^he^pu^{blic health}
^le^ak^{hospital preparedness—}^{hospital prepa}^redness^grants^esta^{blished in PHS Act Section 31}^9C-^1.^prepa^{redness g}^rants^{established i}ⁿ^{Section 20}^{1 of t}^{his act, and the}
^perfor^man^{ce measurement}^{Section 319A of t}^{he PHS Act}^req^{uired the Secreta}^{ry to establish,}^by^{hospital prepa}^redness^part^ners^{hip grant}^{s established in Section}
^://wiki^{and withh}^{olding o}^f^f^unds^June²⁰^{03, a}^{nd to revise ever}^{y fiv}^{e years, capacities for}^{national, state}³⁰⁵^{of this act.}
^h^ttp^{and local public health sy}^{stems to}^{combat p}^{ublic health t}^hreat^{s. Section}^{Establishes a}^{new PHS Act Section 3}^{19C-1(g) re}^{quiring t}^he
^319B^req^{uired the Sec}^{retary to a}^{ward grants to state}^{s to conduct}^{Secretary, within 1}^{80 days}^{of ena}^{ctment, to: (1) develop and}
^assessment^{s of their stat}^{us with}^r^{espect to th}^{ese ca}^{pacities. [42 U.S.C.}^{apply meas}^ura^{ble evidence-based}^benc^hmark^{s and objective}
^{§§ 247d-1, d-2]}^{standards to measu}^{re gra}^{ntees’ p}^reparedn^{ess, including an}^nual
^{test and exe}^{rcise re}^quireme^{nts; a}^{nd, (2) develop criteria for state}
^{pandemic influe}^{nza plans. The Se}^{cretary s}^{hall provide appro}^priate
^{technical assistance}^{to grantees, a}^{nd develop and implement a}
^{process to notify gra}^{ntees of t}^hei^{r failure to meet r}^equire^ments
^{established in (1) and (}^{2). Establishes form}^{ulas by w}^{hich t}^he
^{Secretary shall withhold portions}^{of awards from gra}^{ntees t}^hat
^{fail to meet requireme}^{nts. Requir}^{es the Secreta}^{ry to reallocate}
^{any su}^{ch amo}^{unts to}^{hospital and health syste}^{m “pa}^rtner^ship”
^{entities described in Section 31}⁹^{C-2(b)(1) (as established in t}^his
^{act), giving prefere}^{nce to entities}^{in states from w}^{hich amou}^nts
^{are withheld. Amounts with}^held^{are increased for}^consec^utive
^{failures. Authorizes the Sec}^retary^{to waive or reduce with}^holding
^{for one or more gra}^{ntees if t}^here^{are mitigating factors. [Section}

^Preexis^{ting Law}^{P.L. 1}^09-4¹⁷
²⁰¹^]
^{Grants fo}^{r pu}^{blic health and}^{No applicable p}^rovision.^{Note: Provisions described here}^{apply to both t}^he^pu^{blic health}
^{hospital preparedness—}^prepa^{redness g}^rants^{established i}ⁿ^{Section 20}^{1 of t}^{his act, and the}
^{matching req}^uirement^{hospital prepa}^redness^part^ners^{hip grant}^{s established in Section}
³⁰⁵^{of this act.}
^{Amends PHS Act Section 3}^19C-1^{, adding a new req}^uirement,
^{beginning in}^FY20^{09, that awa}^rde^{es make available non-federal}
^{funds to s}^u^p^{port the}^cooperative^{agreements, in t}^{he amou}^{nt of}
^{5% of t}^{he total amount for t}^{he fir}^{st fiscal year, and 1}^{0% of t}^he
^{total amount for the}^{second and}^subse^que^{nt fiscal year}^{s. Non-}
^{federal amounts ma}^{y be}^{provided directly or through}^p^{ublic or}
^{private donations, and may}^{be in}^{cash or in kind. [Section 2}^01]
^{Grants fo}^{r pu}^{blic health and}^{Note: Provisions described here}^{apply to both t}^he^pu^{blic health an}^d^{Note: Provisions described here}^{apply to both t}^he^pu^{blic health}
^{hospital preparedness—}^{hospital prepa}^redness^grants^esta^{blished in PHS Act Section 31}^9C-^1.^prepa^{redness g}^rants^{established i}ⁿ^{Section 20}^{1 of t}^{his act, and the}
^{maintenance of state fun}^ding^{PHS Act Section 319C-}^{1, sub}^sect^{ion (j)}^{, requires t}^{hat amou}^nts^{hospital prepa}^redness^part^ners^{hip grant}^{s established in Section}
³⁰⁵^{of this act.}
ⁱ^{ki/CRS-RL33589}^approp^{riated to states for p}^ublic^{health and}^{hospital pre}^parednes^s^be^{used to su}^pplement^and^{not sup}^p^{lant other state a}^{nd local public f}^unds^{For awards for p}^{ublic health a}^nd^{hospital prepa}^redness^made
^g/w^{provided for activities under this}^{section. [42 U.S.C. § 247d-3a(j)]}^purs^uant^{to PHS Act Sections 31}^{9C-1(i) and 31}^{9C-2(h), as}
^s^.or^{established in this act, gra}^{ntees s}^{hall maintain expe}^nditures^for
^le^ak^{public healt}^{h or health}^care^pre^p^{aredness, res}^{pectively, at a level}
^{not less than}^{the ave}^{rage level of}^such^ex^penditures^maintained
^://wiki^{by the}^grante^{e for t}^{he p}^receding^{two-year period. Clarifies that}^{awards may be}^{used to}^{pay salary}^{and related ex}^penses^{of p}^ublic
^h^ttp^{health and othe}^{r p}^{rofessionals employed by state, local, or tribal}
^{agencies, who are car}^{rying out a}^c^{tivities supported by}^suc^h
^{awards, regardless of whet}^{her t}^h^e^{primary as}^signment^{of suc}^h
^person^{nel is to carry out}^suc^{h ac}^{tivities. [}^{Sections 201 a}^{nd 3}^05]
^Grant^{s fo}^{r pu}^{blic health and}^{No applicable p}^rovisions.^{Note: Provisions described here}^{apply to both t}^he^pu^{blic health}
^{hospital preparedness—}^prepa^{redness g}^rants^{established i}ⁿ^{Section 20}^{1 of t}^{his act, and the}
^{additional fiscal an}^d^{hospital prepa}^redness^grants^esta^{blished in Section 30}^{5 of this}
^{administrative provisions}^act.
^Establishes^{new PHS Act Section}^319C-^{1(j), requiring gra}^{ntees to}
^{submit to the}^{Secretary a}ⁿⁿ^{ual re}^{ports describing}^fu^nded
^{activities, performance with}^resp^{ect to program goals and}
^{objectives, appropriate}^{budget inf}^{ormation, and other reporting}
^requirem^{ents, whic}^{h are to}^{be de}^{termined by t}^{he Secreta}^ry
^{within 18}^{0 days of e}^nactme^{nt .}
^Grantee^{s shall, not less tha}^{n ever}^{y two years, conduct a}ⁿ

^Preexis^{ting Law}^{P.L. 1}^09-4¹⁷
^{independent a}^{udit of program}^ex^{penditures. For activities not in}
^{accordance with}^{program r}^e^q^{uirements, and afte}^{r notice and}
^opportu^{nity for a hea}^{ring, grante}^{es shall repay to t}^{he United}
^{States such a}^mounts^{as determin}^{ed by the}^{Secretary; a}^{nd the}
^{Secretary may with}^{hold payment}^{of funds}^{for suc}^{h activities.}
^{Requires t}^{he Secretary, in}^consul^{tation with states and}^political
^{subdivisions, to determine maxim}^{um an}^nual^perce^{ntages of}
^{awards that may}^{be ca}^{rried over}^{into the ne}^{xt fiscal year.}
^{Amounts e}^{xceeding this}^perce^nta^{ge shall be ret}^ur^{ned to the}
^{Secretary for r}^{eallocation to hos}^{pital and health syst}^em
^“partne^rship”^{entities described i}ⁿ^{Section 31}^{9C-2(b)(1) (as}
^{established in this act), giving pre}^f^{erence to e}^{ntities in states f}^rom
^{which amou}^{nts are}^{withheld. Provides for grantees to a}^{ppeal s}^uch
^{withholdings, and for the Secreta}^{ry to grant waiver}^s.
^Establishes^{new PHS Act Section}^319C-^{1(k), requiring t}^he
^{Secretary to compile the data s}^u^{bmitted by gra}^{ntees a}^{nd make}
^{such data a}^{vailable in a timely manner}^{on a p}^{ublic I}^ntern^et
ⁱ^{ki/CRS-RL33589}^{website in a u}^{seful format}^{to pro}^{vide information on those}
^g/w^{activities that are best}^contrib^{uting to the ac}^hievement^of
^s^.or^{outcome goals. [Secti}^{ons 20}^{1 and}³⁰^5]
^le^ak^{Public health surveillance}^{PHS Act Section 319D(a) recogni}^{zed CDC’s essential role in defending}^{Amends PHS Act Section 3}^19D(a^{) to recognize CDC’s role}ⁱⁿ
^{and inf}^{ormation tech}^nolo^gy^{against and combating}^{bioterrorism and other}^pu^{blic health}^{defending against and}^combating^{public healt}^{h th}^{reats bot}^h
^://wiki^networks^{emergencies. Section 3}^{19D(b) p}^r^{ovided for the establishment}^{of p}^ublic^{domestically and abroad. Creates a new PHS Act Section}
^h^ttp^{health alert commu}^{nications and}^{surveillance networks}^{and re}^quir^ed^{319D(d) to req}^{uire that}^{the Sec}^r^{etary: within two years of}
^{the Secretary, within}^{one year}^an^{d in cooperation with health ca}^re^{enactment, esta}^{blish a na}^{tionwide interopera}^{ble near}^real-time
^{providers and state a}^{nd local pub}^{lic health officials, to establish}^{electronic pu}^{blic health “situation}^{al awareness” (s}^urveillance)
^{technical and re}^{porting sta}^ndards^{for suc}^{h ne}^{tworks. Section 31}⁹^D(c)^{network; within 1}⁸⁰^{days of ena}^c^{tment, su}^{bmit to Congress a}
^{authorized such}^sum^{s as may}^be^necessar^{y for FY20}^02-FY2⁰⁰^{6 to}^{strategic plan outlining ste}^{ps to d}^{evelop, implement, and evaluate}
^{national communications and s}^u^r^{veillance networks. [42 U.S.C. § 247d-}^{the network; a}^{nd develop progra}^{m elements a}^{nd req}^uired
^4(b)]^{activities. Creates a new Section 319D(e) aut}^{horizing the}
^{Secretary to award gra}^{nts to stat}^{es or consortia of states to}
^enha^{nce s}^{urveillance capa}^{bility, fo}^{r activities consistent with}
^{interoperability and other}^tech^nologica^{l standards, and other}
^requirem^{ents dete}^{rmined by}^the^{Secretary. Requires, within}^four
^{years of ena}^{ctment, t}^{hat the}^Gov^ernme^{nt Accou}^{ntability Office}
^{conduct an}^independe^{nt evaluation, and su}^{bmit to the Secreta}^ry
^{and the Congr}^{ess a re}^{port conc}^e^{rning t}^{he activities conducted}
^{under s}^u^b^{sections (d) and (e). Requires t}^{he Secreta}^{ry, in}
^{consultation with the Federal Co}^{mmunications Commission and}
^{other relevant}^{federal agencies, t}^o^{evaluate and re}^{port to}
^{Congress on t}^{he stat}^{us of nation}^{al telehealth capabilities, and}

^Preexis^{ting Law}^{P.L. 1}^09-4¹⁷
^{means to integrate}^{and ex}^{pand t}^h^{ese capa}^{bilities to address}
^{public healt}^{h th}^{reats. Authorizes}^{the ap}^{propriation of s}^{uch s}^ums
^{as may be}^neces^{sary for FY2}⁰⁰^8-^{FY2011. [Section 2}^02]
^{Public health workf}^or^ce^{Section 319}^{H of the P}^{HS Act aut}^{horized a grant p}^{rogram to provi}^de^{Amends Section 33}^{8L of t}^{he PHS}^{Act to req}^{uire the Sec}^retary,
^enhancements^{financial assistance for t}^{he edu}^cat^{ion and training of individuals in any}^{depending u}^{pon a}ⁿ^ap^propriation^{, to establish a demonstration}
^{category of the}^health^profession^{s where t}^here^{is a shortage t}^{hat t}^he^{project for the}^{participation of in}^{dividuals who are eligible for the}
^{Secretary determine}^{s should be}^a^{lleviated to}^{improve pu}^{blic health}^{NHSC loan repaym}^ent^program^{described in PHS Act Section}
^emergency^{readiness. Aut}^{horized such}^sum^{s as may}^be^necessa^{ry f}^or^{338B e}^t^{seq. [}^{42 U.S.C. §§ 254l-1 et seq.] and w}^{ho agree to serv}^e
^FY2002-FY2⁰⁰^{6. [42}^U.S.C.^{§ 247}^d-7a]^{in a state health}^departme^{nt t}^hat^{serves a significant}ⁿ^umbe^{r of}
^{Section 338L}^{of the PHS Act}^aut^h^{orized demonstration projects for}^{health p}^{rofessional shortage area}^{s or areas at risk of a}^p^ublic^{health emerge}^{ncy, as dete}^rmined^{by th}^{e Secretary, or in a}^local
^{loan repayme}^{nt p}^{rograms for c}^{hiropractic doctors and p}^harma^cists,^{health depart}^{ment t}^{hat se}^{rves a}^{health p}^{rofessional shortage area}
^{subject to the}^{eligibility criteria}^{, service obligations and breac}^{h of}^{or an area at}^{risk of a p}^{ublic healt}^{h emerge}^{ncy. Eligible individuals}
^{contract p}^{rovisions of the Nation}^{al Health Service Corps (N}^HSC)^{must ha}^{ve a degree, or}^{be en}^roll^{ed in an ap}^{proved cour}^{se of}
^{program. [4}^{2 U.S.C. § 254t]}^{study, in medicine, osteopathic m}^{edicine, dentistry, an}
^approp^{riate program}^{of be}^{havioral and mental health, or a}^nother
^{health p}^{rofession, or be ce}^{rtified as a nu}^{rse midwife, nu}^rse
ⁱ^{ki/CRS-RL33589}^{practitioner, or ph}^{ysician assistan}^{t. Health professionals receiving}^{such a}^{ssistance s}^{hall comply with}^{the service obligations, breac}^h
^g/w^{of contract, and other}^relevant^p^{rovisions of the NHSC p}^rogram,
^s^.or^{and shall agree to serve}^{for a}^{period of not less than two year}^s.
^le^ak^{Individuals placed pur}^suan^{t to thi}^{s demonstration p}^{roject shall}
^{not be considered}^{by th}^{e Secreta}^{ry in making s}^hortage
^://wiki^{designations during FY20}^07—FY²⁰¹^{0. The Secreta}^{ry s}^{hall report}
^h^ttp^{to Congress not later t}^{han t}^hree^{years after}^enact^ment^regarding^{participation in the}^{project and t}^{he impact of s}^u^c^h^pa^rticipation
^{on state, local and tribal health departme}^{nts. Authorizes s}^uch
^{sums as}^{may be}^nece^ssary^{for FY200}^7-FY20^10.
^{Authorizes the Secr}^{etary to mak}^{e awards to states to assist th}^em
^{in operating loan re}^paymen^{t prog}^{rams for individuals who agree}
^{to serve in state, local, or tribal health departme}^{nts t}^{hat serve}
^{health p}^{rofessional shortage area}^{s or other area}^{s at risk of a}
^{public healt}^{h emerge}^{ncy, as desig}^{nated by t}^{he Secreta}^ry.
^{Establishes loan eligibility criteria.}^{Authorizes su}^{ch s}^{ums as}^may
^{be nec}^essary^{for FY20}^07-FY20^10.^{[Section 203]}
^{Influenza vac}^{cine tracking}^{No applicable p}^rovision.^{Repeals existing Section 31}^{9A of}^{the PHS Act and}^{creates a}^new
^{and distribution}^{Section 319A, whic}^{h aut}^{horizes the Secretary}^{of HHS, with the}
^{voluntary cooperation of ma}^nufa^{cturers, w}^{holesalers, and}
^{distributors, to track the initial distribution of federally p}^urc^hased
^{influenza vaccine}^{during a}ⁿ^influe^{nza pandemic. Req}^{uires the}
^{Secretary to promote comm}^unic^{ation between stat}^{e, local, and}

^Preexis^{ting Law}^{P.L. 1}^09-4¹⁷
^{tribal pu}^{blic health officials and su}^{ch man}^ufact^ure^{rs, wholesalers,}
^{and distributors as ag}^{ree to parti}^{cipate in the t}^racking^program,
^{regarding the e}^{ffective distributio}^{n of seasonal influe}^{nza vaccine.}
^{Vaccine distribution information}^{submitted to the Sec}^{retary or}
^{his contractors, if any,}^{under t}^his^{act, shall remain confidential in}
^{accordance with t}^{he ex}^{ception t}^o^{the Freedom of In}^formation
^{Act (FOIA) governing trade}^secr^{ets and commercial or fina}^ncial
^{information obtained from a}^pers^{on and privileged or confidential}
^{[5 U.S.C. § 552(b)(4)]. Any p}^{ublic disclosure by th}^{e agenc}^{y of}
^{vaccine distribution information i}^s^{subject to t}^{he criminal}
^{penalties for the}^{ft of trade se}^cret^{s under}¹⁸^{U.S.C. § 1832 and}
^{the exc}^{eption to the}^prohibition^{on economic espionage and}
^{theft of trade s}^ecrets^unde^{r 1}⁸^U^.S.C^{. § 1833 (an}^{y otherwise}
^{lawful activity conducted by a}^fed^{eral or state governme}^ntal
^{entity, or the re}^{porting of a s}^usp^{ected violati}^{on of law to any}
^{federal or state governm}^{ental ent}^ity).^b^{Information submitted}
^{shall also be subject to p}^{rivacy p}^r^{otections consistent with t}^he
ⁱ^{ki/CRS-RL33589}^{regulations promulgated}^{under S}^{ection 26}^{4(c) of the H}^ealth^Insu^rance^{Portability and Accoun}^{tability Act of 199}^{6 (P.L. 104-}
^g/w^{191). Req}^{uires th}^{e Secretary}^{to develop guidelines to ensure}^the
^s^.or^{confidentiality of information obtained for tracking}^pur^poses.
^le^ak^{Requires t}^{he Secretary}^{to provide updates on}^{implementation of}
^://wiki^{this section in its q}^uadren^{nial rep}^{orts to the Congress, according}^{to provisions for the}^{National Health Security Strategy}
^h^ttp^{established in Section 10}^{3 of t}^{his act. Authorizes suc}^{h s}^{ums as}
^{may be}^necessa^{ry for FY2}⁰⁰^7-FY201^{1. [Section 20}^4]
^{National Science Advisory}^{No applicable p}^{rovision. (The National Science Advisory Board for}^{The National Science Advisory Board for Biosecurity shall, when}
^{Board f}^{or Biosecu}^rity^{Biosecurity, which does not have}^{an ex}^{plicit authority in stat}^{ute, is}^reque^{sted by t}^{he Secreta}^{ry of H}^{HS, provide to relevant federal}
^{administered by the}^{Office of Biotechnology Activities in the National}^department^{s and age}^{ncies, advice, guidance, or recommendations}
^{Institutes of}^{Health. The Board a}^{dvises all federal departments a}ⁿ^d^{concerning: a core}^cur^{riculum a}ⁿ^d^{training req}^uireme^{nts for}
^{agencies on ways to minimize the}^{possibility that knowledge and}^{workers in ma}^{ximum contain}^men^{t biologica}^{l laboratories; and,}
^{technologies stemming from vitally important}^biologica^{l research w}^ill^{periodic evaluations of maximum}^containment^biologica^l
^{be misused to t}^hreate^{n p}^{ublic he}^{alth or national security. See}^{laboratory capacity nationwide a}^{nd assessme}^{nts of t}^{he f}^utur^e
^{http://www.biosecurityboard.gov/ for more information.)}^{need for increa}^{sed laboratory ca}^{pacity. [Section 205]}
^Revital^{ization of the PHS}^{No generally ap}^{plicable provision. The Commissioned Corps of th}^e^{Establishes a}^{new PHS Act Section 2}^03A^{regarding deployment}
^{Commissioned C}^orps^{PHS is authorized in PHS Act Sections 203-}²²^{1 [4}^{2 U.S.C. §}^§^{204 e}^t^{readiness for a}ⁿ^{urgent or emerge}^{ncy public health care need}^of
^{seq.], which esta}^{blish grades, ran}^{ks and titles, appointments,}^{pay a}^nd^{national, state or local signif}^{icance, defined as: (1) a national}
^{allowances, promotion, separatio}^{n and retire}^{ment, and othe}^r^emergency^{declared by t}^{he Presi}^{dent u}^{nder the}^National
^provisions.^Emerge^{ncies Act [5}^{0 U.S.C. §§ 1601 et}^{seq.]; (2) an}^emerge^{ncy or}
^{major disaster declared by the Pr}^{esident under}^{the Robe}^{rt T.}

^Preexis^{ting Law}^{P.L. 1}^09-4¹⁷
^Staffor^{d Disaster Relief and Emer}^{gency Assistan}^{ce Act [}^{42 U.S.C.}
^{§§ 5121}^{et seq]; a}^p^{ublic health e}^mergency^{declared by t}^he
^{Secretary u}^{nder PHS Act s}^{ection 31}^{9; or (3) an}^{y emerge}^{ncy t}^hat,
^{in the judgme}^{nt of the Sec}^retary,^{is approp}^{riate for the}
^{deployment of mem}^{bers of t}^{he C}^{orps. Requires t}^{he Secreta}^{ry to}
^{establish readiness}^req^uirement^s^{(including training and medical}
^{exams) for t}^{he active-duty Regula}^{r Corps a}^{nd Active Reserves,}
^{and means of a}^ssessme^{nt a}^{nd acc}^{ountability, and to establish}
^approp^{riate procedu}^{res for de}^ployment.
^{Amends PHS Act Section 2}^{14 to}^{grant th}^{e Secretary}^{the sole}
^{authority to deploy any Commiss}^{ioned Corps officer assigned}
^{under t}^{his section to an e}^{ntity ou}^{tside of the HHS (exce}^{pt with}
^{respect to t}^{he United States Coast Gua}^{rd and th}^{e Departm}^{ent of}
^{Defense, and e}^{xcept a}^s^p^{rovided in agreement}^{s negotiated with}
^{officials at agencies where officer}^{s of the Commissioned Corps}
^{may be assig}^{ned) for service}^und^{er the Secr}^{etary’s direction in}
^response^{to an u}^{rgent or}^emerge^{ncy p}^{ublic healt}^{h care}^need.
ⁱ^{ki/CRS-RL33589}^{Amends PHS Act Section 3}^{31(f) t}^o^{authorize the eme}^rgency
^g/w^{deployment of Commissioned Corps pe}^{rsonnel se}^{rving in t}^he
^s^.or^{National Health Service Corps d}^{uring t}^{heir period of obligated}
^le^ak^{service, providing that th}^{e Secret}^{ary determines t}^{hat deployme}^nt^{would not cause u}^nreaso^{nable disruption to}^{health care}^services
^://wiki^{provided in the commu}^{nity in w}^h^{ich suc}^{h officer is}^providing^{health care}^{services. [Section 20}⁶^]
^h^ttp
^{TITLE III: ALL-HAZARDS MEDICAL SURGE}^CAP^ACITY
^{National Disaster Med}^ical^{Section 281}^{1(b) of the}^{PHS Act a}^{uthorized NDMS, to be coordinated}^Transfers^the^fu^{nctions, person}ⁿ^{el, assets, and liabil}^{ities of NDMS}
^{System (ND}^MS)^{by HHS, DOD, VA and the Feder}^{al Emergenc}^{y Ma}^nagemen^{t Agenc}^y^{to HHS, under t}^{he res}^{ponsibility of the ASPR, effective Jan. 1,}
^{(FEMA) in collaboration with states and other a}^p^p^{ropriate p}^{ublic or}²⁰⁰^{7. Require}^{s the Sec}^{retary of}^{HHS, within 18}^{0 days of}
^{private entities. Required t}^{he Sec}^{retary of H}^{HS to conduct e}^xercis^es^{enactment, to cond}^{uct a joint rev}^{iew of NDMS, in coordination}
^{to test the ca}^{pability and timeliness of the}^{NDMS to mobilize and}^{with DHS, VA, and DOD, and submit a report}^{to Congress}
^{respond ef}^{fectively to a bioterror}^{ist attack or other}^pu^{blic health}^{describing the}^{roles, missions, appropriate size and st}^ruct^{ure of}
^{emergency. A}^{ppointed activated}^{NDMS volunteers}^{as tem}^porary^{NDMS in the}^fut^{ure. Aut}^{horizes such}^sums^{as may}^be^necessar^y
^{federal employees. Established liability protections, compensation f}^or^{for FY200}^7-FY20^{11. [Section 3}⁰¹^]
^{work injuries, and employment a}^{nd re-employment}^{rights for}^ND^MS^{Note: P.L. 109-29}^{5, Departme}^nt^{of Homeland Security}
^{volunteers. Aut}^{horized such s}^u^m^s^{as may}^{be ne}^cessary^{for FY20}⁰²^—^Approp^{riations Act, 20}^{07, also tr}^ansfer^{red NDMS to HHS,}
^FY2006^{for ND}^{MS operations an}^{d for the H}^{HS ASPHEP. [42 U.S.C. §}^{effective Jan}^uary^{1, 2}⁰⁰^{7. The tra}^nsfer^has^been^{carried out. See}
³⁰⁰^hh-^11]^{http://www.ndms.dhhs.gov/index.html.}

^{The Homeland Security Act of}²⁰⁰²^{(P.L. 107-2}^{96), tra}^nsfer^{red th}^e
^{functions, p}^erson^{nel, assets, and liabilit}^{ies of NDMS to the Secreta}^{ry of}

^Preexis^{ting Law}^{P.L. 1}^09-4¹⁷
^{Homeland Security effec}^{tive in M}^arch²⁰^{03, without othe}^r
^amendments^{to program a}^uthorit^{y. [6 U.S.C.}^{§ 313].}
^{Required the VA Secreta}^{ry, in co}^{nsultation with the}^{Secretaries of}
^{HHS and DOD and t}^{he FE}^{MA Director, to establish a training}^pro^gram
^{to facilitate the participation of VA medical center staff}^{in NDMS.}^[38
^U.S.C^{. § 8117]}
^Enhan^{cing medi}^{cal sur}^ge^{No applicable p}^rovision.^{Establishes a}^{new PHS Act Section 2}⁸⁰^{3, req}^{uiring the}^Secretary
^capa^city^{to conduct an a}^{nalysis of: (1) the}^{benefits a}^{nd feasibility of}
^{improving the ca}^{pacity of H}^{HS to provide additional med}^ical
^{surge ca}^{pacity to local communities in the e}^{vent of a}^pu^{blic health}
^{emergency, t}^hroug^{h the}^acq^uisiti^{on and operation of mobile}
^{medical assets, and other strategi}^{es; and (2) whet}^{her t}^here^are
^{federal facilities which, in the eve}^{nt of a p}^{ublic health}^emerge^ncy,
^{could be used as}^healthcar^{e facilities. Authorizes the Secretary}^to
^{acquire mo}^{bile medical assets. Re}^{quires t}^{he Secreta}^{ry to develop}
^approp^{riate memoranda of}^under^{standing with res}^{pect to a}^ny
^{federal facilities i}^{dentified by the}^{Secretary’s analysis. [Section}
ⁱ^{ki/CRS-RL33589}³⁰²^]
^g/w^{Emergency Medical}^{When t}^{here is a con}^cur^rent^pu^{blic health eme}^rgenc^{y determination}^{Amends Section 11}³⁵⁽^{b) of the S}^{ocial Security Act [42 U.S.C. §}
^s^.or^{Treatment and Active Labor}^purs^uant^{to PHS Act Section 31}⁹^{[42 U.S.C. § 247d] AND a}ⁿ¹³²^0b-^{5(b)] rega}^{rding the waiver}^{of EMTALA r}^e^q^uirements^wheⁿ
^le^ak^{Act (EMTAL}^A)^a^emergency^{or disaster declaration by t}^{he President}^p^ursua^{nt to ei}^ther^{there is a con}^cur^rent^pu^{blic health emerge}^{ncy dete}^rmination
^{the National Eme}^{rgencies Act}^[5^{0 U.S.C.}^{§ 160}^{1] or the}^Stafford^Act^purs^uant^{to PHS Act Section 31}⁹^{AND an eme}^rgenc^{y or disaster}
^://wiki^{[42 U.S.C. §§ 5121 et se}^{q.], the S}^{ecretary ma}^{y waive certain}^EMT^ALA^{declaration by the Pre}^{sident p}^urs^{uant to th}^{e National}
^h^ttp^requirem^{ents [}⁴²^U.S.C.^{§ 139}^{5dd] as follows:}^{if a hospital within such}^Emerge^{ncies Act or t}^{he Stafford}^{Act, as follows}^{: If the}^pu^blic
^{a declared emergency}^{area imple}^{ments its disaster}^{protocol as a}^{health emerge}^{ncy declared}^pu^rsu^{ant to Section 31}^{9 of the}^PHS
^consequ^{ence of t}^{he em}^ergen^{cy, the hospital may}^{be e}^{xempt, for}⁷²^{Act involves a pandemic in}^{fectious disease: (1) the Secretary’s}
^{hours, from t}^he^{prohibitions against the}^tran^{sfer of a}^{non-stabilized}^{waiver or modification of EMTALA require}^ments^regarding
^individual^{, and the direction or re}^{location of indiv}^{iduals to an alternate}^{direction of individuals to a}^{lternate locations for medical}
^{location for medical screening pu}^rsuant^{to an a}^pprop^{riate state}^screening^{shall be}^purs^uan^{t to th}^{e app}^{ropriate state eme}^rgenc^y
^emergency^pre^pared^ness^{plan. [4}^{2 U.S.C.}^{§ 132}^0b-5]^prepa^{redness or}^pa^{ndemic plan; a}^{nd (2) if a hospital within s}^uch^a
^{declared emergency a}^{rea implem}^{ents its disaster p}^{rotocol as a}
^consequ^{ence of t}^{he em}^ergen^{cy, the hospital may}^{be e}^{xempt, for}
^{60 days or}^{until the t}^ermination^{of the Secretary’s declaration,}
^whichever^{is sooner, from the}^pr^{ohibitions against the tra}^nsfer^of
^{an individual who has not}^been^st^{abilized and the direction of}
^{individuals to an alternate locatio}^{n for medical scree}^{ning. This}
^{provision is effective u}^{pon e}^nact^{ment. [Section 30}^2]
^Enc^oura^{ging health}^{Section 319I}^{to the PHS Act}^req^u^{ired the Secretary to esta}^{blish an}^{Amends PHS Act Section 3}^19I^{to req}^{uire the}^{HHS Secretar}^{y to}
^profession^{al volunteers}^{electronic database for t}^{he advan}^{ce registration of health}^professi^onals^{link existing state verification syst}^{ems to maintain a single national}
^{to verify their cr}^{edentials, licenses, accreditations, and hospital}^{interoperable}^{network of syst}^em^{s (the “verification network”),}

^Preexis^{ting Law}^{P.L. 1}^09-4¹⁷
^{privileges when t}^{hey volu}^{nteer to}^{respond du}^{ring p}^{ublic healt}^h^{each syste}^{m being}^{maintained by}^{a state or grou}^{p of states, for}
^{emergencies. Aut}^{horized the Sec}^{retary to en}^{courage state}^{s to per}^mit^{the p}^u^r^{pose of verifying t}^{he cr}^{edentials and licenses of health}
^{out-of-state health p}^{rofessionals to provide health services d}^uring^{care profe}^{ssionals who volunteer}^{to provide health ser}^vices
^{public healt}^{h emerge}^{ncies. Aut}^{horized $2 million for FY2002, and}^such^{during a p}^{ublic health}^emerge^ncy.^{The Secretary}^{shall: establish}
^{sums as}^{may be}^nece^ssary^{for FY200}^3-FY20^{06. [4}^{2 U.S.C. § 247d-7b]}^{system re}^quireme^{nts; incor}^porat^{e the mem}^bers^{hips of}^NDMS
^{and Medical Reserve Corps (}^{MRC); assure state ac}^{cess to and}
^{confidentiality of data; assess the}^{feasibility of integrating with}
^{comparable syst}^{ems in t}^{he VA an}^{d DHS; and encourage}^{states to}
^{establish and impleme}^{nt mec}^hani^{sms to waive the a}^{pplication of}
^{licensing req}^uirements^{for volunt}^{eer health}^{professionals.}
^{Clarifies that inclusion of an indiv}^{idual in the database does not}
^{constitute an a}^ppointme^{nt as a}^fe^{deral employee. Authorizes}
^such^sums^{as may}^be^necessar^{y t}^hrough^FY20^11.
^{Creates a new}^{Section 28}^{13 of}^th^{e PHS Act req}^{uiring the}^HHS
^{Secretary, within 1}^{80 days}^{and in}^{consultation with state, local,}
^{and tribal officials, to establish and maintain a MRC of health}
^{professions voluntee}^{rs, and to de}^{velop an identification card for}
ⁱ^{ki/CRS-RL33589}^{each mem}^{ber of t}^he^{MRC that d}^{escribes releva}^{nt licensu}^{re and}^{certification information. Requires the Secreta}^{ry to ap}^{point a}
^g/w^{Director who shall develop drills}^{and certification req}^uirements,
^s^.or^{not to supe}^{rsede state}^req^uirem^{ents. Authorizes t}^{he Secretary}^to
^le^ak^{appoint selected individuals to serve as inter}^{mittent p}^erson^{nel of}
^{the MRC in accorda}^{nce with a}^ppl^{icable civil service laws and}
^://wiki^{regulations, and to deploy will}^{ing members}^{of the}^{MRC with the}
^h^ttp^concur^{rence of t}^{he state, local, o}^r^{tribal officials from the area}^{where t}^{he mem}^bers^{reside and c}^{over app}^{ropriate ex}^pen^{ses that}
^{result p}^urs^{uant to a}ⁿ^assignme^nt^{by the}^{Secretary. Aut}^horizes
^$22^{million for FY2007 a}^{nd suc}^h^{sums as}^{may be}^nece^ssary^for
^FY2008-FY2⁰¹^{1. [Section 30}^3]
^{Core educ}^{ation and}^training^{PHS Act Section 319F(g) re}^quire^{d the Secretary, in collaboration with}^{Repeals the e}^{xisting PHS Act Section 319F(g) and c}^reates^new
^{the interage}^{ncy working g}^roup^{and professional organizations, to}^{Sections 319F(a)-(e), requiring t}^h^e^{Secretary, in collaboration}
^{award grants: (1) to develop edu}^{cation materials to teach health}^{with DOD, to develop core health and medical respo}^nse
^{officials and other emergen}^{cy pe}^r^{sonnel to identify potential}^{curricula a}^{nd trainings, by}^adaptin^{g applicable existing}^programs,
^{bioweapons and othe}^{r dangerou}^s^{agents a}^{nd to care for victims of}^{to improve respon}^{ses to p}^{ublic h}^{ealth emergen}^{cies, and}
^{public healt}^{h emerge}^{ncies, recog}^{nizing the spe}^{cial needs of children and}^{authorizes $1}^{2 million for FY200}^{7 and s}^uch^sums^{as may}^be
^{other vulne}^rable^{populations; (2)}^{to develop education materials for}^necessar^{y for FY20}⁰⁸^{and eac}^{h s}^ubse^que^{nt fiscal year. Aut}^horizes
^{community-wide planning to}^resp^{ond to bioterrorism or other p}^u^blic^{the Secretary}^{to expa}^{nd the}^E^{pidemic Intelligence Service by}
^{health emerge}^{ncies; (3) to develop materials for p}^{roficiency testing}^of^{placing officers in}^{health s}^hortage^{areas, and aut}^{horizes $3}^milli^on
^{lab and other}^pu^{blic health p}^erso^{nnel for t}^{he recognition and}^{for FY200}^{7 and}^suc^{h su}^{ms as ma}^{y be}^necessar^{y for FY2}⁰⁰^{8 and}
^{identification of potential biowea}^{pons and oth}^{er dange}^{rous age}^nts^{; and}^{each s}^ubse^que^{nt fiscal year. Aut}^h^{orizes the Secretary to esta}^blish
^{(4) to provide for the disseminati}^{on and teaching}^{of these}^materials.^{Centers for P}^{ublic Health Pre}^par^{edness at acc}^{redited schools of}

^Preexis^{ting Law}^{P.L. 1}^09-4¹⁷
^{Authorized the Secretar}^{y, in con}^{sultation with the Attor}^{ney Ge}^ne^ral^{public healt}^{h, and aut}^{horizes $3}¹^mill^{ion for FY2007}^{and s}^uch
^{and the FE}^{MA Director, to provide technical assistance}^{for emerg}^ency^{sums as}^{may be}^nece^ssary^{for FY200}^{8 a}^{nd each}^su^bseq^uent^fiscal
^response^perso^{nnel training}^carri^{ed out by t}^{he J}^{ustice Departm}^ent^and^{year. [Section 304]}
^{FEMA. [42}^U.S.C.^{§ 247d-6(g)]}
^{Partnerships fo}^{r state and}^{Section 319C-1}^{of the PHS Act}^r^{equired th}^{e Secretary}^{to make a}^wards^{Repeals the e}^{xisting PHS Act Section 319C-2}^{and s}^ubstitut^{es a}
^{regional hos}^pital^{to eligible entities to enhance the}^pre^paredness^{of hospitals (includ}^ing^{new Section 31}^{9C-2, whic}^{h re}^qui^{res the Sec}^{retary to award}
^{preparedness to imp}^rove^{children’s hospitals), clinics, healt}^{h cente}^{rs, and}^{primary ca}^{re facilities,}^{competitive grants to eligible entities to improve surge}^capacity
^{surge ca}^pacit^y^{for bioterrorism and othe}^{r p}^{ublic health eme}^{rgencies, and for}^related^{and enha}^{nce comm}^{unity a}^{nd hos}^{pital prepar}^edness^{for p}^ublic
^{planning a}^{nd administrative activities. Eligible entities were states,}^{health emerge}^{ncies. Eligible entities shall be: (1) “pa}^rtner^{ships” of:}
^politica^{l subdivisions of states, or consortia of subdivisions. Authorized}^{(i) one or more hospitals, at least one of which}^{shall be a}
^$52^{0 million for FY2003}^{and s}^u^c^h^sum^{s as may}^be^necessa^{ry for}^{designated trauma ce}^{nter; A}^{ND (ii) one or more other local}
^FY2004—^FY2⁰⁰^{6. [4}^{2 U.S.C. § 2}^47d-3a]^{health care}^{facilities, including clin}^{ics, health center}^{s, primary}^care
^{Note: The fu}^{nding formula a}^{nd c}^{ertain other administrative}^facilities^{, mental health ce}^nters,^{mobile medical assets, or nursing}^{homes; AND (iii) one or more states, one or more political}
^requirem^{ents a}^{re esta}^{blished jointly for both t}^{he p}^{ublic health a}^nd^{subdivisions of states, or consortia of the two; or (2) states,}
^{hospital prepa}^redness^{grants. Th}^{ese provisions are desc}^{ribed in e}^arlier^politica^{l subdivisions of states, or consortia of the two, that are}
^{sections of this table, along with}^{other provisions in Title II of P.L. 10}^9-^{eligible for public health}^prepa^red^{ness gra}^nts^pur^sua^{nt to Section}
^417.^319C-^{1(b)(1) (as designated in t}^{his act), provided that suc}^h
ⁱ^{ki/CRS-RL33589}^{entities provide assura}^{nce t}^{hat th}^{ey will adhere to any ap}^plicable
^g/w^{Section 319C-2}^{of the PHS Act a}^{uthorized grants to imp}^rove^{community and}^{hospital pre}^pared^{ness for}^{bioterrorism and othe}^r^{guidelines established by t}^{he Secr}^etary.
^s^.or^{public healt}^{h emerge}^{ncies. Eligible entities were pa}^rtne^rships^bet^ween
^le^ak^{one or more hospitals (or other}^healthcare^{facilities) and one or more}^{Eligible entities shall submit applic}^{ations for awards to include}^{such in}^{formation as th}^{e Secretary}^{may req}^{uire, and consiste}^nt
^{states and/or local governments.}^Grant^{proposals m}^{ust b}^e^coordinated^{with the states’ All-Hazards Public Health E}^merge^ncy
^://wiki^{and consistent with}^{the sta}^{te’s e}^mergency^pre^pared^{ness a}^{nd resp}^onse^Preparednes^{s and Res}^{ponse Plan}^{and other releva}^{nt state a}^nd
^h^ttp^{plan. Use of fu}^{nds for}^pre^paredne^{ss and res}^{ponse to}^{bioterrorism and}^{local activ}^{ities. Awards shall be used to achieve the}^pre^paredne^ss
^{outbreaks of in}^{fectious disease took priority over other p}^{ublic heal}^th^{goals described under t}^{he followi}^{ng su}^{bsections of Section}
^{emergencies, su}^{bject to any}^{modification in the assess}^{ment of}^risk^by²⁸⁰^{2(b), as esta}^{blished in this act:}^{(1) integration; (2) medical}
^{the Secretary. A}^{uthorized suc}^{h s}^{ums as ma}^{y be}^neces^{sary for FY2}^004-^{capability; (3) the ne}^{eds of at-risk individuals; (4) coord}^ination;
^{FY2006. [}^{42 U.S.C. § 247d-3b]}^{and (5) continuity of op}^{erations. (Note: Goal #2, public health}
^{capability, is not a required activit}^{y for these}^grant^{s.) In making}
^{awards the Secreta}^{ry s}^{hall consider whet}^her^{proposals: would}
^enha^{nce coordination among the}^{variety of health s}^ystem
^partne^{rs in t}^{he area; would inclu}^{de one or more NDMS-}
^{participating hos}^{pitals; and are fo}^{r areas t}^{hat, as determined}^by
^{the Secretary}^{in cons}^{ultation with the Sec}^{retary of DHS, face a}
^{high degree of risk or}^{have a}^{significant need for}^fu^{nds to achieve}
^{the re}^{quired p}^repa^{redness goals.}
^{Authorizes $4}⁷⁴^{million for FY2007 a}^{nd suc}^{h s}^{ums as}^{may be}
^necessar^{y for FY20}^08—FY2⁰¹^1.^{The Secretary ma}^{y rese}^{rve a}
^{portion of this amount}^{to make a}^{wards for “pa}^rtner^{ship” e}^ntities
^{as described in s}^{ubsection (}^{b)(1)(A), as established in this act.}

^Preexis^{ting Law}^{P.L. 1}^09-4¹⁷
^{Remaining amounts}^{for award to}^{states and political subdivisions}
^{shall be allocated according to the formula and othe}^r
^requirem^{ents in}^{Section 31}^9C-1(^{h), as established in this act.}
^{[Section 305]}
^{Note: The fu}^{nding formula a}^{nd c}^{ertain other administrative a}^nd
^{fiscal requireme}^{nts ar}^{e establishe}^{d jointly for both the hos}^pital
^prepa^{redness g}^rants^described^he^{re, and the}^pu^{blic health}
^prepa^{redness g}^rants^{in Section 2}^{01. These administrative a}^nd
^{fiscal requireme}^{nts, in PHS Act S}^{ections 31}^{9C-1(g), (j) and (k), as}
^{established in this act, are des}^crib^{ed in earlier sections of this}
^{table, along with other provisions}^{in Title II of P.L. 109-4}^17.
^{Department of Veterans}^{Directed the VA Secretary to e}ⁿ^{hance t}^{he readine}^{ss of VA medical}^{Amends [3}^{8 U.S.C. § 8117] to c}^h^{ange refe}^rence^{s to VA readiness}
^Affairs^{centers a}^{nd resea}^rch^{facilities to}^{protect staff}^{and re}^{spond to a}^{for chemical and}^biolog^{ical attack to readiness for a}^pu^{blic health}
^{chemical or biologica}^{l attack, based on the re}^{sults of an}^evaluation^of^{emergency. Req}^{uires t}^{he VA Sec}^{retary to en}^hanc^{e the}^readiness
^{the sec}^{urity needs}^{at these}^faciliti^{es. Required the VA Secreta}^{ry to}^{of VA medical centers and re}^sear^{ch facilities by: organizing,}
^{develop a centralized tracking sys}^{tem for p}^harmace^{uticals and med}^ical^equip^{ping and t}^{raining staff}^{for th}^{e app}^{ropriate su}^{pport of}^the
^sup^{plies and eq}^uipment^thro^ugho^{ut the VA}^{health car}^{e system, a}ⁿ^d^{HHS Secretary in}^{the ev}^{ent of}^pu^{blic health emerge}^{ncies and}
ⁱ^{ki/CRS-RL33589}^{train VA health ca}^{re pe}^rsonn^{el in emergenc}^{y medical respons}^e.^{incidents covered by}^the^{NRP; an}^{d, providing medical l}^ogist^ical
^g/w^{Required the VA Secreta}^{ry, in co}^{llaboration with the Secretaries of}^sup^{port to NDMS and t}^{he Secret}^{ary of HHS, as ne}^{cessary, on a}
^s^.or^{Defense and}^{HHS, and the}^{Director of FEMA, to establish a traini}^ng^reimbur^{sable basis a}^{nd in coordination with other designated}
^le^ak^{program to facilitate VA participa}^{tion in NDMS. Required the VA}^{Secretary, in cons}^{ultation with th}^{e HHS Secretary, t}^{he America}ⁿ^Red^{federal agencies. Requires t}^{he VA}^{Secretary, thro}^{ugh e}^xisting^procure^{ment co}^{ntracts a}^{nd on a}^reimbur^{sable basis, to make}
^://wiki^{Cross, and the interage}^{ncy worki}^{ng grou}^{p, to provide mental healt}^h^{counseling to individuals seeking care at a VA medical center}^follo^wing^{available, as needed, medical supplies, equipment, and}^pharma^{ceuticals in res}^{ponse to a}^{public healt}^{h emerge}^{ncy in}
^h^ttp^{a bioterrorist attack or other}^pu^{blic health emerge}^{ncy. Aut}^horized^sup^{port of the}^{Secretary of}^{HHS. Authorizes su}^{ch s}^{ums as}^may
^$13^{3 million for FY2002, a}^{nd suc}^{h sum}^{s as may}^be^necessa^{ry for}^{be nec}^essary^{for FY20}^07-FY20^11.^{[Section 306]}
^FY2003-^FY2⁰⁰^{6. [38}^U.S.C.^{§ 811}^7]
^{TITLE IV: PANDEMIC AND}^{BIODEFENSE VACCINE}^A^{ND DRUG DEVELOPMENT}
^{Biomedical Advanced}^{No applicable p}^rovision.^{Creates a new}^{section 3}¹⁹^L^{of th}^{e PHS Act req}^{uiring the}
^{Research an}^{d Development}^{Secretary to develop and p}^ublish^{a strategic plan to integra}^te
^Authority^{biodefense and eme}^{rging infectio}^{us disease re}^quireme^{nts with}
^{advanced resear}^{ch a}^{nd developm}^{ent, strategic innovation}
^{initiatives, and the procure}^ment^{of countermea}^sure^{s. This plan is}
^{due by}^Ju^{ne 2}⁰⁰^{7. The plan}^{will g}^{uide HHS’s R&D, innovation}
^sup^{port, and proc}^ureme^{nt of cou}^ntermeas^{ures to c}^hemical,
^biolog^{ical, rad}^iol^ogica^{l, and nuclear (CBRN) agents and em}^erging
^{infectious diseases.}
^{Establishes t}^{he Biomedical Advanced Research a}^{nd Development}
^{Authority (BARDA) in HHS. The director of this office, guided by}

^Preexis^{ting Law}^{P.L. 1}^09-4¹⁷
^{the strategic}^{plan, will: faci}^{litate c}^ollaborati^{on between}^HHS,
^{other federal agen}^{cies, industry, a}^{nd academia; promote and}
^{financially sup}^{port counte}^rmeas^u^{re advanced R&D; facilitate FDA}
^{advice to countermeas}^ure^produ^{cers to promote}^product
^{approval; and fina}^{ncially sup}^{port innovation to reduce}
^countermea^sure^{development ti}^{me and p}^rice.
^Grants^{the Sec}^{retary “othe}^{r tra}ⁿ^{saction” authority for BARDA}
^{activities, sim}^{ilar to that of the DOD Secretary fou}^{nd in}¹⁰
^U.S.C^{. § 2371.}
^{Provides the Secretary sev}^{eral au}^{thorities when awa}^rding
^{BARDA-related grants, contracts, cooperative agreements, or}
^{other tran}^{sactions. These include}^{the u}^{se of: increased simplified}
^{acquisition and micropu}^rcha^{se th}^{resholds; expedited peer}^review;
^{personal services}^{contracts, a}^nd^{competition limits}^{. The}
^{Secretary may}^req^{uest t}^{hat any}^{data generated t}^hroug^{h this}
^sup^{port be}^{provided to the H}^{HS on demand.}
ⁱ^{ki/CRS-RL33589}^{Allows BA}^{RDA to: make advanced payments}^{and milestone-}
^g/w^{based paym}^{ents; make}^{awards to}^{foreign nationals; and esta}^blish^researc^{h cente}^rs.
^s^.or
^le^ak^{Allows the Secretary to give priority to countermea}^sure^{s that a}^r^e
^{likely to be safe and effective}^for^{children, pregna}^{nt wome}^{n, the}
^://wiki^{elderly, and other at-risk individuals.}
^h^ttp^{Allows the Secretary to appoint}^{highly qualified individuals to}
^{scientific or professional positions or as spe}^{cial consultants for}
^{BARDA at the highest level of se}^{nior level pay for term}^{s not to}
^{exceed five year}^{s. The Secretary}^{can hire}^{no more tha}ⁿ¹⁰^{0 su}^ch
^{individuals or 50% of the}^{total nu}^{mber of BARDA employees,}
^whichever^{is less. The Secretary}^{will report use of thes}^{e hiring}
^{authorities to Congress}^biennially.
^{Establishes t}^{he “Biodefense Medi}^{cal Countermeas}^ure
^{Development Fund” to f}^{und BAR}^{DA activities and authorizes the}
^approp^{riation of $1.0}^{7 billion for FY2006—FY2}⁰⁰^{8 to remai}ⁿ
^{available until expended.}
^Exem^{pts tec}^{hnical and scie}^{ntific data generated t}^hroug^{h BARDA}
^{activities from disclosure under t}^{he Freedom of In}^{formation Act}
^{(FOIA) if the data reveal significa}^{nt and}^{not otherwise p}^ublicly
^{known v}^{ulnerabilities to CBRN threats. In}^{formation exem}^pted
^{will be reviewed every five year}^s^{to determine the}^{need for}

^Preexis^{ting Law}^{P.L. 1}^09-4¹⁷
^{continued nondisclosure. This e}^x^{emption su}^{nsets se}^ven^years
^{after ena}^ctment.
^{Allows working groups unde}^{r BA}^{RDA or the National}
^{Biodefense Science Board (see be}^{low) to expire after five yea}^rs.
^{[Section 401]}
^{National Biodefense Science}^{No applicable p}^rovision.^{Creates a new}^{Section 31}^{9M of t}^{he PHS Act esta}^{blishing the}
^Board^{National Biodefense Science Boa}^{rd, to provide the Secretary with}
^expert^{advice and guidance}^{on sci}^{entific, technical matters}^related
^{to curre}^{nt and f}^utu^{re CBRN age}^{nts, including those t}^{hat occu}^r
^{naturally. Board members}^{hip will include preemine}^{nt scie}^ntific,
^{public healt}^{h, and medical expe}^rt^{s. This will}^{include such}^federal
^{officials as necessary to s}^u^p^{port t}^{he fu}^{nctions of t}^{he board; fou}^r
^{individuals from industry; four in}^{dividuals from academia; five}
^{other mem}^{bers, one of w}^{hich m}^u^{st be a}^practicing^healthcare
^{provider and anoth}^{er w}^{hich m}^ust^{be from a}ⁿ^organization
^represe^{nting healthcare consu}^me^rs.
ⁱ^{ki/CRS-RL33589}^{Board members may}^serve^{no m}^{ore than two con}^{secutive t}^hree-
^g/w^{year terms}^{or a total of three}^nonconsec^{utive terms. The initial}^{board meeting will occur within}^{one year of e}^nactme^{nt and at}
^s^.or^{least twice annually the}^{reafter. V}^{acancies will be filled in the same}
^le^ak^manne^{r as th}^{e initial appointment}^{s and will have no affect}^{on the}
^{powers of the}^{board. The Secret}^{ary will appoint one of the}
^://wiki^members^{as the}^chair^{person. The}^{board may hold hearing}^{s and}
^h^ttp^{take testimony as it deems advisa}^ble.
^{The membe}^{rs of t}^{he board w}^{ho are federal governm}^ent
^{employees may not}^{receive additi}^{onal pay. Other}^membe^{rs will}
^{receive pay}^{not to exceed t}^{he daily rate equivalent of}^Ex^ecutive
^{Schedule level IV for each day e}ⁿ^{gaged in board work. Each}
^{member will receive travel e}^xpeⁿ^{ses and pe}^{r diem whe}ⁿ
^approp^{riate. Federal government}^{employees can}^{be detailed to}
^{the board without}^{loss of civil se}^{rvice status or}^privilege.
^{The Secretary ma}^{y create}^workin^{g groups to identify in}^novative
^countermea^sure^resear^{ch, to identify accep}^{ted animal models for}
^countermea^sure^resear^{ch or oth}^{er resear}^{ch tools that may}
^{accelerate counte}^rmeas^{ure devel}^{opment, and to obtain advice}
^{regarding development of co}^unte^rmeasur^{es likely to be safe a}^nd
^{effective for c}^{hildren, preg}^{nant w}^{omen, and other v}^ulnera^ble
^populations.
^{Authorizes ap}^{propriation of $}¹^mill^{ion for FY2007}^{and eac}^h

^Preexis^{ting Law}^{P.L. 1}^09-4¹⁷
^subse^que^{nt fiscal year. [Section 4}^02]
^{Clarification o}^f^{Section 319F-}^{1(a) of th}^{e PHS Act}^{[42 U.S.C. § 247d-6a(a)] defined}^a^{Amends Section 31}^{9F-1(a) of the}^{PHS Act [42}^U.S.C.^{§ 247d-}
^countermeasu^{res covered by}^{“qualified countermeas}^{ure” a}^s^a^{drug, biologica}^{l product, or device that}^{6a(a)] to define a “qualified count}^ermeasu^{re” as a dr}^{ug, biological}
^{Project BioShield}^{the Secretary}^{determines is a}^pri^{ority to treat, identify, or prevent}^{product, or device that t}^{he Secre}^{tary determines is a}^{priority to}
^{harm f}^{rom any CBRN age}^{nt t}^hat^{may cause a}^p^{ublic health e}^merge^ncy^{diagnose, mitigate}^{, to treat harm}^{from any CBRN age}^{nt (including}
^{affecting national sec}^{urity or adve}^{rse health}^conseq^ue^{nces ca}^used^by^{those that ca}^{use in}^{fectious disease) that may ca}^{use a}^pu^{blic health}
^{use of s}^uch^products.^emergency^affecting^{national secu}^{rity or adverse healt}^h
^consequ^ences^caused^by^{use of s}^uch^{products. Defines i}^nfectious^{disease as a disease acquired}^{by a}^{person a}^{nd that}^rep^{roduces in}
^{that pe}^rson.
^{Section 319F-2(c)(1)(B) of the P}^{HS Act [42}^U.S.C.^{§ 247d-6}^b(c)(1^)(B)]^{Amends Section 31}^{9F-2(c)(1)(B) of the PHS Act [4}^{2 U.S.C. §}
^{defines “secu}^{rity counte}^rmeas^ure^{” to mean a dr}^{ug, biologica}^{l product}^247d-^{6b(c)(1)(B)], striking “treat, identify, or prevent”}^each^place
^{or device that the Sec}^{retary dete}^{rmines to be a}^{priority to treat,}^{it appears a}^{nd inserting}^{“diagnose, mitigate, prevent, or treat.”}
^{identify, or prevent}^harm^{from a}ⁿ^y^{CBRN agent identified as a mat}^erial
^{threat, or to treat, identify, or pr}^{event adverse}^health^conseq^uen^c^es
^{caused by}^{use of}^suc^{h p}^{roducts; t}^{he Secretary}^{determines it is a}
^necessar^{y count}^ermeas^{ure; a}^{nd is app}^{roved for the}^{market or is a}
ⁱ^{ki/CRS-RL33589}^countermea^sure^{that t}^{he Secreta}^{ry has dete}^{rmined will likely quali}^fy
^g/w^{for suc}^{h ap}^{proval within eight ye}^{ars or has}^bee^{n aut}^{horized for an}
^s^.or^emergency^use^{by t}^{he Secreta}^ry.
^le^ak^{Section 510(a) of the}^Homeland^{Security Act of 2}⁰⁰²^{is the}^{Amends Section 51}^{0(a) of the}^H^{omeland Security Act of 2}⁰⁰²^[6
^{authorization for app}^{ropriations f}^{or Project Bio}^{Shield countermeasure}^U.S.C^{.§ 320(a)] by adding at the}^e^{nd “None of t}^{he Fu}^{nds made}
^://wiki^{acquisitions.}^{available under this s}^ubs^{ection sh}^{all be used to procu}^re
^h^ttp^countermea^sure^{s to diagnose, mitigate, prevent, or treat}^harm
^{resulting from a}^ny^{naturally occu}^{rring infectious disease or othe}^r
^{public healt}^{h th}^{reat that a}^{re not s}^{ecurity cou}^ntermeas^ures^u^nder
^{Section 319F-2(c)(1)(B).” [Sectio}^{n 4}^03]
^{Technical assistance}^{No applicable p}^rovision.^{Amends the}^{Federal Food, Drug,}^{and Cosmetic Act cha}^{pter V}
^subc^hapte^{r E}^[21^U.S.C.^{§ 360}^bb^b^{et seq.] b}^y^{adding section 5}⁶⁵
^{“Technical Assistance.” This esta}^{blishes a team of e}^xpe^{rts in t}^he
^{Food and Drug Administration to provide counter}^measu^re
^manufa^cture^{rs with off-site a}^{nd on-site assistance. [Section 40}^4]
^{Collaboration}^and^{No applicable p}^rovision.^{Allows the Secretary to conduct}^{meetings and cons}^{ultations with}
^coo^rdination^{multiple countermea}^sure^{developers regarding t}^{he developme}^nt,
^manufa^{cture, distribu}^{tion, purc}^ha^{se, or storage of}
^countermea^sure^{s that wo}^{uld otherwise violate antitrust laws.}
^{The Secretary m}^ust^{notify (including topics to be discussed) t}^he
^{Attorney Ge}^{neral, the C}^hairman^{of the Federal Trade}
^{Commission (FTC}^{), and the DHS Secretary}^{before s}^uch

^Preexis^{ting Law}^{P.L. 1}^09-4¹⁷
^{meetings. The Secretary}^{will lead}^{the meetings. The}^meetings
^{must b}^e^open^{to the Attor}^{ney G}^{eneral; the FTC Chairma}^{n; the}
^{DHS Secretary; and individuals involved in the development,}
^manufa^cture,^pur^{chase, storage,}^{or distribution of}
^countermea^sure^{s. Discussions will be limited t}^o^“covered
^{activities” (defined below)}^{, and held in a manner}^{to ens}^{ure t}^hat
^{no national security, confidential commercial, or proprietary}
^{information is disclosed outside t}^{he meeting.}
^{The Secretary ca}^nnot^req^{uire par}^{ticipants to reveal confidential,}
^{commercial, or proprietary infor}^{mation. The Secretary will keep}
^{a verbatim tra}^nscri^{pt of the}^meet^{ing. If a determination is made}
^{that disclosing the tran}^{script ma}^y^harm^{national security, the}
^transcript^{will not be su}^{bject to FOIA re}^quests.
^{Participation in these meetings}^{will not vio}^{late antitrust laws.}
^{Conduct or agreeme}^{nts r}^esulting^{from these}^{meetings ma}^{y also}
^{be exe}^{mpt f}^{rom antitr}^{ust laws su}^{bject to the ap}^{proval of the}
^{Attorney Ge}^{neral in con}^{sultation with the FTC Chairma}^n.
ⁱ^{ki/CRS-RL33589}^{Written agreeme}^{nts b}^{etween ind}^{ividuals or companies resulting}
^g/w^{from these}^{meetings ca}^{n b}^e^su^bm^{itted by the Secreta}^{ry for}
^s^.or^{approval by}^{the Attor}^ney^Gene^ra^{l in consultation with the FTC}
^le^ak^{Chairman. Conduct in a}^ccordanc^{e with suc}^{h ap}^proved^agreements^{will not be violati}^{on of antitrust laws. In}^{addition to}
^://wiki^{the p}^{roposed agreeme}^{nt, the Sec}^{retary will provide to the}^{Attorney Ge}^{neral an}^ex^planation^{of the intended}^pur^{pose of t}^he
^h^ttp^{agreement, a s}^{pecific stateme}^{nt of the s}^ubsta^{nce of t}^he
^{agreement, a descri}^{ption of the}^{methods use to ac}^{hieve the}
^{agreement’s objectives, an e}^xplan^{ation of why su}^{ch a}ⁿ^agreeme^nt
^{is necessary, a}^{nd any othe}^{r releva}^{nt information. The Attorne}^y
^General^{has 1}⁵^{days to den}^{y, gra}^{nt in whole or in}^{part, or}
^{propose modifications to submitt}^{ed agreements. A}ⁿ^exem^ption
^{to the antitru}^{st laws will be grant}^{ed only to the exte}^{nt that}^the
^{Attorney Ge}^{neral determine}^{s tha}^{t covered conduct will not have}
^{a substa}^{ntial anticompetitive effec}^{t that is not rea}^sonably
^necessar^{y for e}^nsuri^{ng the a}^{vailability of the countermeas}^ure
^{involved. Exemptions will be auto}^{matically renewed after t}^hree
^{years u}^{nless the}^Attorney^Gen^er^{al and the FTC Chairman}
^{determine it should not b}^e^re^ne^{wed. Consideration by the}
^{Attorney Ge}^{neral for g}^{ranting or}^{renewing a}ⁿ^e^{xemption will be}
^{considered an antitr}^{ust investigation under}^{the A}^ntitrust^Civil
^{Process Act [1}^{5 U.S.C. § 1311 et}^{seq.]. The use of a}^ny
^{information acquired}^under^suc^h^agreement^{for p}^urposes^other

^Preexis^{ting Law}^{P.L. 1}^09-4¹⁷
^{than in t}^{he agre}^{ement a}^{re s}^ubject^{to antitrust laws. The Attorn}^ey
^{General a}^{nd the FTC Chair s}^{hall report th}^{e use}^{of these}
^exemptions^{biennially, starting on}^{e year afte}^{r enact}^ment.
^{Defines “antitru}^{st laws” as the}^sa^{me as that give}^{n by}^{the Clayton}
^{Act [12 U.S.C. § 12(a)], the Federal Trade Commission Act [15}
^U.S.C^{. § 45], and any similar state}^{laws. Defines “covered}
^{activities” as any activity relating to the development,}
^manufa^{cture, distribu}^{tion, purc}^ha^{se, or storage of a}
^countermea^sure^ex^{pressly e}^xem^{pted in the Attor}^ney^Gene^ral-
^{approved agree}^{ments. This e}^xclu^{des allocating market share,}
^{setting prices or e}^x^c^{hanging in}^for^{mation between}^competitors
^{that is not reasona}^{bly ne}^cessary^t^o^{execute t}^{he e}^xempted
^agreements.
^{Authority for t}^{his section shall ex}^{pire six year}^{s after}^enactm^ent
^{(December 1}^{9, 2}⁰¹^{2). [Section 405]}
^{Changes to SNS and Pr}^oject^{42 U.S.C. § 247d-}^{6b Strategic}^Na^{tional Stockpile}^{Amends PHS Act section}³¹^9F-2^{[42 U.S.C. § 247d-6b] so t}^hat
ⁱ^{ki/CRS-RL33589}^{BioShield procurement}^{the heading is “Sec. 2}^47d-6^{b. Strategic National Stockpile and}
^g/w^{Security Counter}^measu^res.”
^s^.or^{(c) Addit}^{ional authority regarding}^procu^rement^{of certain}^biomedical^{Amends su}^{bsection (c) h}^{eading to remove the word}
^le^ak^countermea^sure^{s; availability of s}^{pecial reserve f}^und^{“biomedical}^.”
^://wiki^{(c)(3) Assessment of a}^{vailability a}^{nd app}^ropriatenes^{s of}^countermea^sure^{s The Secreta}^ry,^{in consultation with the}^Homelan^d^{Amends su}^{bsection (c) pa}^ragrap^h^{(3) by adding a}^{new pa}^ragrap^h^{(B). The Secretary will institute a process to make in}^formation
^h^ttp^{Security Secretary, s}^{hall assess on an ongoing}^{basis the a}^vailability^and^{regarding these}^assessme^nts^pu^{blicly available as long as it does}
^approp^{riateness of}^{specific cou}^nt^ermeasu^{res to address s}^{pecific th}^reats^{not reveal information that}^{the S}^{ecretary judges wo}^{uld tend to}
^{identified under parag}^rap^{h (2).}^harm^{national security or}^{be exe}^{mpt from FO}^{IA re}^quest^s.
^{(c)(4)(A) Proposal to the Preside}^nt^Inserts^{“not developed or” befor}^{e “curr}^ently.”

^{If, pu}^rsua^{nt to an as}^sessme^{nt u}ⁿ^d^{er parag}^rap^{h (3), the}^Homeland
^{Security Secretary a}^{nd the}^Secret^{ary make a deter}^{mination that a}
^countermea^sure^{would be ap}^pro^{priate b}^{ut is either c}^u^r^rently
^{unavailable for p}^rocurem^{ent as a}^{security cou}^ntermea^sure^{or is}
^{approved, licensed, or cleared only for alternative uses, s}^uch
^{Secretaries may jointly submit to}^{the President a}^{proposal to -}
^{(i) issue a call for the development of suc}^{h cou}^nterm^easur^{e; and}
^{(ii) make a commitment that, upo}^{n the}^{first development of}^suc^h
^countermea^sure^{that me}^{ets the}^c^{onditions for procureme}^nt^under
^paragra^{ph (5), th}^{e Secretaries will, based in part on in}^formation
^{obtained pur}^sua^{nt to suc}^{h call, make a recommendation}^under

^Preexis^{ting Law}^{P.L. 1}^09-4¹⁷
^paragra^{ph (6) t}^{hat t}^{he sp}^{ecial reserve fu}^{nd u}^nder^paragra^{ph (}¹⁰⁾^b^e
^{made available for the p}^rocurem^{ent of su}^{ch cou}^nter^measu^re.
^{(c)(5)(B) Requirements}^{Replaces “to meet the}^{needs of t}^{he stockpile” with “to meet t}^he
^{In making a dete}^{rmination u}^nder^sub^paragra^{ph (A) with}^respe^{ct to a}^{stockpile needs.”}
^{security cou}^ntermea^{sure, t}^{he Sec}^{retary s}^{hall determine and consid}^er
^{the following: (}^{i) The quantities of the}^{product t}^{hat will be needed}^to
^{meet the}^{needs of t}^{he stockpile.}
^{(c)(7)(B) Interagency ag}^reement;^costs^{Strikes clause (ii). Under the prev}^{ious law, other Project}
^{(i) Interagency ag}^reeme^nt^BioShie^{ld acquisitions costs to HHS were paid from t}^{he f}^unds^approp^{riated for the Strategic}^Na^{tional Stockpile}^{. Authorization}
^{The Homeland Security Secreta}^r^y^{shall enter into a}ⁿ^agreeme^{nt w}^ith^{for those f}^{unds e}^{xpired in FY2}⁰⁰^6.
^{the Secretary}^{for p}^rocure^{ment of}^{a security}^counte^rmeasu^{re in}
^{accordance with t}^{he p}^{rovisions of this pa}^ragrap^{h. The s}^{pecial rese}^rve
^fund^under^parag^rap^{h (10) s}^{hall b}^e^{available for payment}^{s made b}^y^the
^{Secretary to a ve}^{ndor for suc}^h^pr^ocurement.
ⁱ^{ki/CRS-RL33589}^{(ii) Other costs}
^g/w^{The actual costs to the}^Secretary^{under t}^{his section, other t}^{han t}^h^e
^s^.or^{costs described in clause (i), shall be paid from t}^{he a}^ppro^priation
^le^ak^{provided for under}^su^{bsection (f)}^{(1) of this section.}
^(c)(7)(C)(^{ii) C}^{ontract terms}^{Amends the}^{contract t}^{erms in}^pa^ragrap^{h (I) to allow HHS to pay}
^://wiki^{A contract for}^procu^reme^{nts u}ⁿ^d^{er this s}^{ubsection s}^{hall (or, as}^{vendors milestone payme}^nts^befo^{re product}^{delivery. These}
^h^ttp^{specified below, may) include the}^follow^{ing terms:}^payment^{s shall not ex}^{ceed 5}^{0% o}^f^{the total contract}^{cost and do}^{not have to b}^e^re^{paid if the vend}^{or fails to del}^{iver finished}
^{(I) Payment conditioned on deliv}^ery^product.

^{The contract s}^{hall provide that}ⁿ^o^payment^{may be}^{made u}^{ntil del}^ivery
^{has bee}^{n made of a}^{portion, acce}^{ptable to the Sec}^{retary, of the}^total
^num^{ber of}^{units cont}^{racted for, e}^{xcept t}^{hat, notwithsta}^{nding any o}^ther
^{provision of law, the contract ma}^{y provide that, if the Sec}^retary
^{determines (in the}^{Secretary’s dis}^{cretion) that an adva}^nce^payme^nt^is
^necessar^{y to ens}^{ure s}^uccess^{of a}^{project, the Secretary}^may^{pay an}
^{amount, not to exceed}¹⁰^per^cen^{t of the cont}^{ract amou}^{nt, in advance}
^{of delivery. The contract shall pr}^{ovide that such adva}^nce^payme^nt^is
^{required to}^{be re}^{paid if there is a}^{failure to perfor}^{m by}^{the ve}^ndor
^{under t}^{he cont}^{ract. Nothing in}^th^{is subclause}^may^{be constr}^{ued as}
^{affecting rights}^{of vendors}^under^{provisions of law or regulation}
^{(including the Federal Acq}^{uisition Regulation) relating to termination of}
^{contracts for t}^{he con}^venience^of^{the Gover}^nme^nt.

^Preexis^{ting Law}^{P.L. 1}^09-4¹⁷
^{No applicable p}^rovision.^{Adds new su}^{bsections to the}^con^{tract terms}^parag^rap^{h allowing}
^{HHS to include new}^req^uirement^{s in Project BioShie}^ld
^{acquisitions. HHS may sp}^{ecify in t}^{he acq}^{uisition contract that}^the
^{vendor is the e}^{xclusive gover}^nme^{nt su}^{pplier of th}^{e p}^{roduct for}
^{the duration of t}^{he cont}^{ract, as long as the v}^{endor can}^{meet t}^he
^{government’s}^{needs. The compa}^{ny can}^{not assign t}^{his exclu}^sivity
^{to another e}^{ntity without the}^{Secretary’s ap}^{proval. HHS may}
^{require t}^{hat a Project BioShield product man}^ufact^{urer e}^{stablish a}
^{domestic manufact}^{uring ca}^{pability to be able to q}^{uickly res}^pond
^{to an emerge}^{ncy re}^qu^{est for a s}^u^{rge of product.}
^{HHS may s}^{pecify cou}^ntermeas^ur^{e characte}^{ristics the gover}^nme^nt
^requires^{for acce}^ptanc^{e, including dosing and administration}
^{properties. HHS ma}^{y spe}^{cify the}^{amount of f}^{unding t}^{hat H}^{HS will}
^{spend to develop the}^product.
^{(8) Interage}^{ncy coope}^ration^{Amends su}^bpa^ragrap^{h (8) to allow other ex}^{ecutive age}^{ncies to}
^{(A) In general}^obtain^counter^measu^{res under p}^rocureme^nt^contra^cts
ⁱ^{ki/CRS-RL33589}^{In car}^{rying out activities u}^{nder th}^{is section, the Homeland Security}^{Secretary and t}^{he Secreta}^{ry are a}^{uthorized, subject to su}^bpa^ragrap^h^{established by}^HHS.
^g/w^{(B), to enter into interagency ag}^r^{eements a}^{nd other collaborative}
^s^.or^undertakings^{with other}^agencies^{of the United States Gove}^rnmeⁿ^t.
^le^ak^Note:^{Unless otherwise stated, “the Secretary”}^refe^{rs to the Sec}^r^{etary of HHS, and sec}^{tions in law refer to sections i}ⁿ^{the P}^{ublic H}^{ealth Service Act.}
^://wiki^a.^{Information p}^{rovided by Kathlee}^{n S. Swendiman, Legislative Attor}^{ney, American}^{Law Division of CRS.}
^h^ttp^b.^{Information p}^{rovided by Brian T. Yeh, Legislative Attorney, American Law Division of CRS.}

^Sar^a^{h A}^.^Lⁱ^ster ^Fr^a^{nk G}^o^t^t^r^oⁿ
^Sp^{ecialist i}ⁿ^P^u^b^{lic Healt}^h^an^d^Ep^id^em^io^lo^g^y^Specialis^{t i}ⁿ^Scieⁿ^{ce an}^{d T}^echⁿ^o^logy^P^o^lic^y
^s^lⁱ^s^t^e^r^@^crs^.^l^o^c.g^o^v^,⁷^-⁷³²⁰^f^g^ot^t^r^on@^crs^.^l^o^c.^g^o^v^,^7-⁵⁸⁵⁴