Public Health Security and Bioterrorism Preparedness and Response Act (P.L. 107-188): Provisions and Changes to Preexisting Law

Report for Congress
Public Health Security and Bioterrorism
Preparedness and Response Act (P.L. 107-188):
Provisions and Changes to Preexisting Law
Updated August 21, 2002
C. Stephen Redhead
Donna U. Vogt
Domestic Social Policy Division
Mary E. Tiemann
Resources, Science, & Industry Division


Congressional Research Service ˜ The Library of Congress

Public Health Security and Bioterrorism Preparedness
and Response Act (P.L. 107-188): Provisions and
Changes to Preexisting Law
Summary
Last fall’s anthrax attacks, though small in scale compared to the scenarios
envisioned by bioterrorism experts, strained the public health system and raised
concern that the nation is insufficiently prepared to respond to bioterrorist attacks.
Improving public health preparedness and response capacity offers protection not
only from bioterrorist attacks, but also from naturally occurring public health
emergencies.
On June 12, 2002, the President signed into law the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 (P.L. 107-188, H.R. 3448),
which is intended to bolster the nation’s ability to respond effectively to bioterrorist
threats and other public health emergencies. The act builds on the programs and
authorities established in Title III of the Public Health Service (PHS) Act by the
Public Health Threats and Emergencies Act of 2000 (P.L. 106-505, Title I).
P.L. 107-188 is a 5-year authorization bill, which calls for a total of $2.4 billion
in funding in FY2002, $2.0 billion in FY2003, and such sums as may be necessary
for the remaining years. The act authorizes the Secretary of Health and Human
Services (HHS) to upgrade and renovate facilities at the Centers for Disease Control
and Prevention (CDC), purchase smallpox vaccine, expand the national stockpile of
drugs, vaccines, and other emergency medical supplies, and provide grants to state
and local governments and hospitals to improve preparedness and planning. The
Secretaries of HHS and Agriculture are required to register and regulate facilities that
handle potentially dangerous biological agents.
The anti-bioterrorism legislation also includes provisions to protect the nation’s
food and drug supply and enhance agricultural security, including new regulatory
powers for the Food and Drug Administration (FDA) to block the importation of
unsafe foods. To protect the drinking water supply, the act requires community water
systems to conduct vulnerability assessments and develop emergency response plans.
P.L. 107-188 also reauthorizes the Prescription Drug Use Fee Act through FY2007.
The following analysts may be contacted for additional information:
Stephen Redhead (7-2261)HHS/CDC programs and policies
& Pamela Smith (7-7048)
Donna Vogt (7-7285)Food safety (FDA)
Jean Rawson (7-7283)Agriculture safety and security (USDA)
Mary Tiemann (7-5937)Drinking water safety and security (EPA)



Contents
In troduction ......................................................1
Public Health Security and Bioterrorism Preparedness and Response Act......2
Legislative History.............................................2
Overview of P.L. 107-188.......................................3
Appendix A. Bioterrorism-Related Hearings
107th Congress...............................................31
Appendix B. Bioterrorism-Related Web Sites..........................34
Department of Health and Human Services.........................34
Department of Defense........................................34
State and Local Health Departments..............................34
Professional Associations......................................34
Academic Resources..........................................35
List of Tables
Table 1. P.L. 107-188: Authorizations of Appropriations for FY2002
and FY2003..................................................4
Table 2. Comparison of P.L. 107-188 with Preexisting Law................6



Public Health Security and Bioterrorism
Preparedness and Response Act
(P.L. 107-188): Provisions and
Changes to Preexisting Law
Introduction
The September 11, 2001 terrorist attacks and the subsequent deliberate release
of anthrax spores in the mail have focused policymakers’ attention on the
preparedness and response capability of the U.S. public health system. Though small
in scale compared to the scenarios envisioned by bioterrorism experts and played out
in recent government exercises, the recent anthrax attacks strained the public health
system and exposed weaknesses at the federal, state, and local levels. Many
bioterrorism experts believe that had those responsible for the anthrax attacks
employed a more sophisticated delivery mechanism or released a deadly
communicable biological agent such as smallpox, the health care system may have
been overwhelmed.
Bioterrorism poses a unique challenge to the medical care and public health
systems. Unlike an explosion or chemical attack, which results in immediate and
visible casualties, the public health impact of a biological attack can unfold gradually
over time. Until a sufficient number of people arrive at emergency rooms and
doctors’ offices complaining of similar illnesses, there may be no sign that an attack
has taken place. The speed and accuracy with which doctors and laboratories reach
the correct diagnoses and report their findings to public health authorities has a direct
impact on the number of people who become ill and the number that die. The
nation’s ability to respond to a bioterrorist attack, therefore, depends crucially on the
state of preparedness of its medical care systems and public health infrastructure.
Public health experts have for years complained about the deterioration of the
public health system through neglect and lack of funding. They warn that the nation
is ill-equipped and insufficiently prepared to respond to a bioterrorist attack. For
example, they point out that there are too few medical personnel trained to spot
biological attacks, a shortage of sophisticated laboratories to identify the agents, and
inadequate supplies of drugs and vaccines to counteract the threat. They also contend
that inadequate plans exist for setting up quarantines and emergency facilities to
handle the sick and infectious victims. Improving public health preparedness and
response capacity offers protection not only from bioterrorist attacks, but also from
naturally occurring public health emergencies. Public health officials are
increasingly concerned about our exposure and susceptibility to infectious disease
and food-borne illness because of global travel, ubiquitous food imports, and the
evolution of antibiotic-resistant pathogens.



On June 12, 2002, the President signed into law the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 (P.L. 107-188, H.R. 3448),
which is intended to bolster the nation’s ability to respond effectively to bioterrorist
threats and other public health emergencies. This report provides a brief overview
and legislative history of P.L. 107-188, followed by a detailed side-by-side
comparison of the act’s provisions with preexisting law. Appendix A lists, by
committee, all the bioterrorism-related hearings held in the 107th Congress prior to
enactment of P.L. 107-188. In most cases, hearing testimony is available on the
committee Web sites. Appendix B provides a list of bioterrorism-related Web sites.
For a discussion of bioterrorism preparedness issues, see CRS Report RL31225,
Bioterrorism: Summary of a CRS/National Health Policy Forum Seminar on
Federal, State, and Local Public Health Preparedness.
Public Health Security and Bioterrorism
Preparedness and Response Act
Legislative History
Representatives Tauzin (R-LA) and Dingell (D-MI) introduced the Public
Health Security and Bioterrorism Response Act (H.R. 3448) on December 11, 2001.
The bill was immediately considered under suspension of the rules and passed by the
House the following day on a vote of 418-2. H.R. 3448 built on the provisions of a
bipartisan Senate bill, the Bioterrorism Preparedness Act (S. 1765), which had been
introduced by Senators Frist and Kennedy on November 15, 2001. S. 1765
incorporated ideas and objectives from several other Senate bioterrorism bills
introduced in the wake of the anthrax attacks.1 The Senate took up H.R. 3448 on
December 20, 2001, following its passage in the House, substituted the text of S.
1765 and passed H.R. 3448, as amended, by unanimous consent. A conference
report (H.Rept. 107-481) was filed on May 21, 2002. The next day the House agreed
to the conference report by a vote of 425-1. The Senate approved the conference
report 98-0 on May 23, 2002. The President signed H.R. 3448 into law (P.L. 107-

188) on June 12, 2002.


1 Senate bioterrorism preparedness bills introduced in response to the September 11 attacks
and the anthrax incidents include: the Biological and Chemical Weapons Preparedness Act
of 2001 (S. 1486) introduced by Senator Edwards on October 3, 2001; the Biological and
Chemical Attack Preparedness Act (S. 1508) introduced by Senator Corzine on October. 4,
2001; the State Bioterrorism Preparedness Act (S. 1520) introduced by Senator Bayh on
October 9, 2001; the Protecting America’s Children Against Terrorism Act (S. 1539)
introduced by Senator Clinton on October 11, 2001; the Bioterrorism Awareness Act (S.
1548) introduced by Senator Carnahan on October 15, 2001; the Protecting the Food Supply
from Bioterrorism Act (S. 1551) introduced by Senator Clinton on October 15, 2001; the
Agricultural Bioterrorism Countermeasures Act of 2001 (S. 1563) introduced by Senator
Hutchison on October 17, 2001; the Public Health Emergency Planning and Information Act
of 2001 (S. 1574) introduced by Senator Rockefeller on October 25, 2001; the Pathogen
Research, Emergency Preparedness and Response Efforts (PREPARE) Act of 2001 (S.
1635) introduced by Senator Hutchinson on November 6, 2001; and the Deadly Biological
Agent Control Act of 2001 (S. 1661) introduced by Senator Feinstein on November 8, 2001.

Overview of P.L. 107-188
As enacted, P.L. 107-188 incorporates many of the provisions in the original
House and Senate-passed bills. It adds to the programs and authorities established
in Title III of the Public Health Service (PHS) Act by the Public Health Threats and
Emergencies Act of 2000 (P.L. 106-505, Title I) and creates a new PHS Act Title
XXVIII: National Preparedness for Bioterrorism and Other Public Health
Emergencies. P.L. 107-188 is a 5-year authorization act, which calls for a total of
$2.4 billion in funding for FY2002, $2.0 billion for FY2003, and such sums as may
be necessary for the remaining years. The act authorizes grants to state and local
health departments and hospitals to improve planning and preparedness activities,
enhance laboratory capacity, and educate and train health care personnel. It also
directs the Secretary to upgrade and renovate CDC’s facilities. In addition, the act
authorizes the HHS Secretary to purchase smallpox vaccine and expand the national
stockpile of medicine and medical supplies to meet the nation’s health security needs.
To help prevent bioterrorism and to establish a national database of potentially
dangerous pathogens, P.L. 107-188 requires the HHS Secretary to register facilities
and individuals in possession of 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. The act grants authority to the Secretary of
Agriculture to establish a parallel set of requirements for facilities that handle agents
and toxins that threaten crops and livestock. The bioterrorism legislation also
incorporates language taken from S. 1275 that authorizes grants to states and
localities to increase public access to defibrillators (i.e., devices that restore normal
heart rhythm to patients in cardiac arrest by administering a controlled electric
shock).
P.L. 107-188 contains several provisions to protect the nation’s food and drug
supply and enhance agricultural security. The act authorizes $545 million for FDA
and USDA to hire new border inspectors, develop new methods of detecting
contaminated foods, work with state food safety regulators, and protect crops and
livestock. It also provides FDA with new regulatory powers to require prior notice
of all imported foods and detain suspicious foods for inspection. All foreign and
domestic food facilities are required to register with the FDA. Finally, P.L. 107-188
includes a set of provisions aimed at protecting the nation’s drinking water supply,
including authorizing $160 million to provide financial assistance to community
water systems to conduct vulnerability assessments and prepare response plans.
The bioterrorism legislation also includes language reauthorizing the
Prescription Drug User Fee Act (PDUFA), which was set to expire on September 30,
2002. Congress first enacted PDUFA in 1992.2 The original law authorized the
FDA to collect fees from pharmaceutical companies and use the funds to hire
additional reviewers to expedite the drug review and approval process, in accordance
with performance goals developed by the agency in consultation with the industry
prior to PDUFA enactment. The 1992 law directed the FDA to provide Congress
with an annual report on the agency’s progress in achieving those goals. Encouraged


2 P.L. 102-571, 21 U.S.C. Section 379(g).

by the success of the user fee program, Congress in 1997 reauthorized PDUFA
through FY2002.3 Under PDUFA II, the FDA tried to meet tighter performance
goals, as well as achieve more transparency in the drug review process and better
communication with drug makers and patient advocacy groups. For more
information on PDUFA, see CRS Report RL31453, The Prescription Drug User Fee
Act: Structure and Reauthorization Issues.
Table 1 below summarizes the bioterrorism legislation’s authorizations of
appropriations for FY2002 and FY2003. Only those authorizations that specify a
dollar amount are included.
Table 1. P.L. 107-188: Authorizations of Appropriations for
FY2002 and FY2003
($ millions)
FY2002 FY2003
Title I: National Preparedness for Bioterrorism and
Other Public Health Emergencies
Grants to state and local governmentsNo provision$1,080
Grants for hospital preparednessNo provision$520
Upgrading CDC$300$300
Strategic National Stockpile$640Such sums as may
be necessary
Smallpox vaccine$509Such sums as may
be necessary
Antimicrobial resistance$25$25
Emergency health professional verification$2Such sums as may
systembe necessary
Public access defibrillation programs$5$30
Dept. of Veterans Affairs emergency$133Such sums as may
preparednessbe necessary
Title IIIA: Food Supply Safety and Security$130Such sums as may
be necessary
Title IIIC: Agricultural Security$415Such sums as may
be necessary
Title IV: Drinking water Safety and Security$210Such sums as may
be necessary
Title V: FDA Drug-Related AuthorizationsNo provision$10
TOTAL $2,369 $1,965


3 PDUFA reauthorization was included in Title I of the Food and Drug Administration
Modernization Act of 1997, P.L. 105-115.

Table 2, beginning on page 6, provides a detailed side-by-side comparison of
the provisions of P.L. 107-188 with preexisting law, where applicable. All the PHS
Act Title III provisions relating to public health emergencies that were established
by P.L. 106-505 (i.e., Sections 319, 319A–319G) are included in the table, regardless
of whether they are amended by the bioterrorism bill. Unless specifically noted
otherwise, the term Secretary refers to the Secretary of HHS.



Table 2. Comparison of P.L. 107-188 with Preexisting Law
picPreexisting LawP.L. 107-188
s for Bioterrorism and Other Public Health Emergencies
reparedness Plan, reportsNo statutory provisions.Adds a new Title XXVIII (Section 2801) to the Public Health Service
ngress(PHS) Act that requires the Secretary, building on existing authority in
PHS Act Section 319A, to develop and implement a national plan to
prepare for and respond to bioterrorism and other public health
emergencies. Establishes five national preparedness goals: (i) assist
state and local governments in the event of bioterrorism or other public
health emergencies; (ii) ensure that state and local governments have the
capacity to detect and respond to such emergencies; (iii) develop and
maintain countermeasures; (iv) ensure coordination and minimize
duplication of federal, state, and local planning, preparedness, and
response activities; and (v) enhance hospital and other health care
facility readiness. Requires the Secretary to coordinate with the
activities of state and local governments and develop outcome measures
iki/CRS-RL31263to evaluate progress in implementing the national plan and achieving its
g/wfive goals.
s.or
leakRequires the Secretary to report to Congress within 1 year, and
biennially thereafter, on progress made towards meeting the national
://wikipreparedness goals, including recommendations for new legislative
httpauthority to protect public health. Clarifies that the Act does not expand
or limit any of the Secretarys preexisting authorities. Requires the
Secretary to report to Congress within 1 year on: (i) the findings and
recommendations of the National Advisory Committee on Children and
Terrorism and the EPIC Advisory Committee; (ii) the vulnerability of
rural and medically underserved communities to bioterrorism; (iii)
recommendations for new legislative authority to strengthen rural and
medically underserved communities; and (iv) the need for and benefits
of a private-sector, community-based rapid response corps of medical
volunteers. Requires the Secretary to conduct a study of best practices
in local emergency response and report to Congress within 180 days.
[Section 101]
lishing public health capacitiesPublic Health Service (PHS) Act Section 319A requires theNo provisions.


Secretary, together with state and local health officials, to
establish what capacities are needed for national, state, and local
public health systems to be able to detect, diagnose, and contain
outbreaks of infectious disease, drug-resistant pathogens, or acts
of bioterrorism. Authorizes $4 million for FY2001, and such sums
as may be necessary for FY2002–FY2006.

picPreexisting LawP.L. 107-188
sessing public health needsPHS Act Section 319B authorizes grants to states and local publicNo provisions.
health departments to evaluate the extent to which they can
achieve the capacities identified pursuant to Section 319A.
Requires the Secretary to develop a national framework for the
evaluations. Authorizes $45 million for FY2001, and such sums
as may be necessary for FY2002–FY2003.
sistant Secretary for Public HealthNo statutory provisions.Adds a new Section 2811(a) to the PHS Act authorizing the
ergency Preparednessappointment of an Assistant Secretary for Public Health Emergency
Preparedness to oversee the National Disaster Medical System (see
below) and coordinate all HHS response activities related to
bioterrorism and other public health emergencies and interface with
other federal agencies and state and local entities. [Section 102(a)]
blic health emergenciesPHS Act Section 319 authorizes the Secretary to respond to publicRequires the Secretary to notify Congress within 48 hours of declaring
health emergencies, including diseases, disorders, or bioterrorista public health emergency. Provides that public health emergencies
attacks, by supporting grants, contracts, and investigations.expire by announcement of the Secretary or after 90 days, whichever
iki/CRS-RL31263Establishes the Public Health Emergency Fund and authorizessuch sums as may be necessary. Requires an annual report tocomes first, and permits the Secretary to renew emergency declarations,subject to the same 90-day limitation. [Section 144]
g/wCongress on expenditures from the Fund.
s.orAllows the Secretary during a public health emergency to waive
leakdeadlines for the submission of data and reports by individuals or public
://wikior private entities pursuant to any law administered by the Secretary.Requires the Secretary to notify Congress of such an action and publish
httpa notice in the Federal Register. [Section 141]
al Disaster Medical SystemNo statutory provisions. The NDMS was established in 1984 asAdds a new Section 2811(b) to the PHS Act providing statutory
a partnership of four federal agencies (HHS, FEMA, DOD, VA),authorization for the NDMS, to be coordinated by HHS, FEMA, DOD,
state and local governments, and the private sector to provideand the VA, in collaboration with states and other appropriate public or
medical assistance and hospitalization for mass casualties in theprivate entities. Requires the Secretary within 1 year, and periodically
event of a natural or man-made disaster. It consists of more thanthereafter, to conduct exercises to test the capability and timeliness of
7,000 volunteer health professionals and support personnelthe NDMS to mobilize and respond effectively to a bioterrorist attack
organized into medical response teams. For more information, goor other public health emergency. Appoints activated NDMS volunteers
to [http://ndms.dhhs.gov/NDMS/ndms.html].as temporary federal employees. Establishes liability protections,
compensation for work injuries, and employment and reemployment
rights for NDMS volunteers. Authorizes such sums as may be necessary
for FY2002–FY2006 for NDMS operations and for the Assistant
Secretary for Public Health Emergency Preparedness. [Section 102(b)]
Requires the VA Secretary, in consultation with the Secretaries of HHS
and DOD and the FEMA Director, to establish a training program to
facilitate the participation of VA medical center staff in the NDMS.
[Section 154(e)]



picPreexisting LawP.L. 107-188
grading CDC, national publicPHS Act Section 319D authorizes funds for the construction andAmends PHS Act Section 319D by recognizing CDCs essential role in
h communications andrenovation of CDC facilities, and to support the agencys activitiesdefending against and combating bioterrorism and other public health
rveillance networksto combat threats to public health. Authorizes $180 million foremergencies. Provides CDC’s Director with multi-year contracting
FY2001, and such sums as may be necessary forauthority for facility construction, renovation, and security. Requires
FY2002–FY2010. the Secretary to improve CDC’s preparedness and response capacities.
Provides for the establishment of public health communications and
Since FY1999, CDC has awarded grants to all 50 states and somesurveillance networks and requires the Secretary, within 1 year and in
metropolitan health departments to enhance state and localcooperation with health care providers and state and local public health
laboratory capacity and to help develop the Health Alert Networkofficials, to establish technical and reporting standards for such
(NAH), a national electronic communications network connectingnetworks. Authorizes $300 million for FY2002 and for FY2003, and
all the components of the public health community. For moresuch sums as may be necessary for FY2004–FY2006, to upgrade CDCs
information, go to [http://www.bt.cdc.gov].facilities. Authorizes such sums as may be necessary for
FY2002–FY2006 for improving CDCs capacities and establishing
national communications and surveillance networks. [Section 103]
deral working groups and advisoryPHS Act Section 319F requires the Secretary to: (i) establish,Amends PHS Act Section 319F by replacing the two existing working
mitteeswith the Secretary of Defense, an interagency working group ongroups with a single interagency working group on the prevention,
iki/CRS-RL31263bioterrorism preparedness, and (ii) establish, in collaboration withpreparedness, and response to bioterrorism and other public health
g/wthe Director of FEMA, the Attorney General, and the Secretary ofAgriculture, an interagency working group to address the publicemergencies, to be established by the Secretary in coordination with theAttorney General, the Directors of FEMA and Central Intelligence, the
s.orhealth and medical consequences of a bioterrorist attack.Secretaries of Agriculture, Defense, Energy, Labor, and Veterans
leakAffairs, the EPA Administrator, and with other federal officials, as
://wikiappropriate. Requires the working group, or its subcommittees, to meetperiodically for the purpose of consultation on, assisting in, and making
httprecommendations on a range of specified topics related to preparedness
for and response to bioterrorism and other public health emergencies
(including research and development of countermeasures to treat,
prevent, and identify exposure to biological agents). [Section 108]
Amends PHS Act Section 319F as follows: (i) establishes the National
Advisory Committee on Children and Terrorism, and the Emergency
Public Information and Communications (EPIC) Advisory Committee
(both of which sunset after 1 year); (ii) requires the Secretary to develop
a strategy for effectively communicating information on bioterrorism
and other public health emergencies; and (iii) recommends establishing
a federal web site on bioterrorism with links to state and local
government sites. Requires the Secretary, in consultation with other
federal agencies, to conduct a study of the ability of local public health
entities to maintain communications during a bioterrorist attack or other
public health emergency. [Sections 104]



picPreexisting LawP.L. 107-188
cation and training of health carePHS Act Section 319F requires the Secretary to develop programsAmends PHS Act Section 319F by requiring the Secretary, in
onnelto educate health professionals in recognizing and caring forcollaboration with the interagency working group and professional
victims of bioterrorist attacks, and programs to train laboratoryorganizations, to award grants: (i) to develop education materials to
personnel in identifying bioweapons.teach health officials and other emergency personnel to identify
potential bioweapons and other dangerous agents and to care for victims
of public health emergencies, recognizing the special needs of children
and other vulnerable populations; (ii) to develop education materials for
community-wide planning to respond to bioterrorism or other public
health emergencies; (iii) to develop materials for proficiency testing of
lab and other public health personnel for the recognition and
identification of potential bioweapons and other dangerous agents; and
(iv) to provide for the dissemination and teaching of these materials.
Authorizes the Secretary, in consultation with the Attorney General and
the FEMA Director, to provide technical assistance for emergency
response personnel training carried out by the Justice Department and
FEMA. [Section 105]
iki/CRS-RL31263al Pharmaceutical StockpileNo statutory provisions. The NPS, which was established and isProvides statutory authorization for a Strategic National Stockpile of
g/wS)managed by the CDC, includes pharmaceuticals, vaccines, andmedical supplies that can be deployed anywhere in the country indrugs, vaccines, medical devices, and other supplies to meet the nationshealth security needs in the event of a bioterrorist attack or other public
s.orresponse to a public health emergency. For more information, gohealth emergency. Requires the Secretary to manage the stockpile, in
leakto [http://www.cdc.gov/nceh/nps/default.htm].coordination with the VA Secretary, and ensure its physical security.
://wikiProtects information on stockpile locations from disclosure under theFreedom of Information Act. Authorizes $640 million for FY2002, and
httpsuch sums as may be necessary for FY2003–FY2006. [Section 121]
ants to address national shortagesNo applicable provisions, although PHS Act Titles VII (HealthAdds a new Section 319H to the PHS Act establishing a grant program
specific types of healthProfessionals Education) and VIII (Nursing Workforceto provide financial assistance for the education and training of
essionalsDevelopment) authorize federal support for training of healthindividuals in any category of the health professions where there is a
professionals for specific purposes.shortage that the Secretary determines should be alleviated to improve
public health emergency readiness. Authorizes sums as may be
necessary for FY2002–FY2006. [Section 106]
alth professional volunteersNo applicable provisions.Adds a new Section 319I to the PHS Act requiring the Secretary to
establish a electronic database for the advance registration of health
professionals to verify their credentials, licenses, accreditations, and
hospital privileges when they volunteer to respond during public health
emergencies. Authorizes the Secretary to encourage states to permit
out-of-state health professionals to provide health services during public
health emergencies. Authorizes $2 million for FY2002, and such sums
as may be necessary for FY2003–FY2006. [Section 107]



picPreexisting LawP.L. 107-188
ublic emergencyThe Stafford Act (42 U.S.C. 5121 et seq.) authorizes federalAmends Section 613(b) of the Stafford Act by requiring states to
nouncementsassistance when the President determines that a natural or man-include a plan for providing a coordinated public communications
made disaster has overwhelmed state and local resources.response in their submission for federal funds to help pay for state
Stafford assistance is administered by the Federal Emergencyemergency preparedness personnel and administrative expenses.
Management Agency (FEMA).[Section 151]
arantine and inspectionPHS Act Section 361 authorizes the Surgeon General, inAmends PHS Act Sections 361 and 363 by expanding the authority of
consultation with the Secretary, to develop quarantine, inspection,the Secretary, in consultation with the Surgeon General, to issue a
fumigation, sanitation, and pest extermination regulations toquarantine rule or a rule providing for the apprehension of individuals
prevent the introduction, transmission, or spread of communicableduring wartime. Permits federal regulations under Sections 361 and
diseases. Section 363 authorizes the development of regulations363, as amended, to preempt state laws that conflict with the exercise of
for the apprehension and examination of infected individuals insuch federal authority. [Section 142]
times of war.
O ReportPHS Act Section 319F requires a GAO report to Congress, withinRequires a new GAO report to Congress on federal bioterrorism-related
6 months, on federal bioterrorism-related activities, includingactivities, including research, preparedness, and response. [Section 157]
research, preparedness, and response. [This report, GAO-01-915,
iki/CRS-RL31263was issued by GAO on September 28, 2001.]
g/wpational safety and healthSection 22 of the Occupational Safety and Health Act of 1970 (29Requires the Secretary, acting through the Director of NIOSH, to
s.orU.S.C. 671) created the National Institute for Occupational Safetyexpand research on bioterrorism threats and attacks in the workplace.
leakand Health (NIOSH) as the federal agency responsible for[Section 153]
conducting research and making recommendations for the
://wikiprevention of work-related disease and injury. NIOSH is part of
httpthe CDC.
partment of Veterans AffairsNo statutory provisions.Directs the VA Secretary to enhance the readiness of VA medical
centers and research facilities to respond to a chemical or biological
attack, based on the results of an evaluation of the security needs at
these facilities. Requires the VA Secretary to develop a centralized
tracking system for pharmaceuticals and medical supplies and
equipment throughout the VA health care system, and train VA health
care personnel in emergency medical response. Authorizes $100
million for FY2002, and such sums as may be necessary for
FY2003–FY2006.
Requires the VA Secretary, in consultation with the HHS Secretary, the
American Red Cross, and the interagency working group, to provide
mental health counseling to individuals seeking care at a VA medical
center following a bioterrorist attack or other public health emergency.
Authorizes $33 million for FY2002, and such sums as may be necessary
for FY2003–FY2006. [Section 154]



picPreexisting LawP.L. 107-188
pplies and services in lieu ofNo applicable provisions.Adds a new Section 319J to the PHS Act allowing the Secretary to
eral grant fundsprovide supplies, equipment, or services instead of, or in conjunction
with, grants awarded under Sections 319 through 319I, or Section 319K.
[Section 110]
ychological impact of traumaPHS Act Section 582 authorizes the Secretary to award grants toExtends grant authority and authorizes such sums as may be necessary
study the psychological impact of trauma, in order to improve thefor FY2003–FY2006. [Section 155]
treatment children and youth that suffer from psychiatric disorders
as a result of witnessing or experiencing traumatic events.
Authorizes $50 million for FY2001, and such sums as may be
necessary for FY2002–FY2003.
blic access to automated externalPHS Act Section 247 requires the Secretary, in consultation withCommunity Access to Emergency Defibrillation Act of 2002: Adds a
fibrillatorsother federal agencies and appropriate public and private entities,new Section 312 to the PHS Act authorizing grants to develop and
to establish guidelines for placing automated externalimplement public access defibrillation programs. Funds may be used
defibrillators (AEDs) in federal buildings, and to publish in theto purchase AEDs, to provide training in AED usage, to provide
Federal Register recommendations for AED placement.information to community members about the public access
iki/CRS-RL31263PHS Act Section 248 establishes the conditions under which adefibrillation program, to provide information to local emergencymedical services on AED placement, and to encourage private
g/wperson who uses or attempts to use an AED in a medicalcompanies to purchase AEDs. Authorizes $25 million for FY2003, and
s.oremergency is immune from civil liability for any resulting harmsuch sums as may be necessary for FY2004–FY2006.
leakto the victim.
://wikiAdds a new Section 313 to the PHS Act authorizing grants to developand implement innovative, community-based public access
httpdefibrillation demonstration projects. Authorizes $5 million for each of
FY2002–FY2006. [Section 159]
edicare, Medicaid, and the State Children’s Health Insurance Program (SCHIP)
ergency waiversMedicare covers medically necessary acute care and follow-upAuthorizes the Secretary to temporarily waive conditions of
services (hospital, short-term nursing home care, physicianparticipation and other certification requirements for any entity that
services, home health and a variety of outpatient services) for allfurnishes health care items or services to Medicare, Medicaid, or SCHIP
persons age 65 and over, as well as certain disabled persons.beneficiaries in an emergency area during a declared disaster or public
Medicare beneficiaries may receive services through thehealth emergency. In addition, during such an emergency, authorizes
traditional fee-for-service setting or may enroll in a Medicarethe Secretary to waive: (i) participation, state licensing (as long as
managed care plan through the Medicare + Choice (M+C)equivalent licensure from another state is held and there is no exclusion
program. Medicaid covers acute and long-term care services forfrom practicing in that state or any state in the emergency area), and
low-income persons who are aged, blind, disabled, members ofpre-approval requirements for physicians and other practitioners; (ii)
families with dependent children, and certain other pregnantsanctions for failing to meet requirements for emergency transfers
women and children. The State Childrens Health Insurancebetween hospitals; (iii) sanctions for physician self-referral; and (iv)
Program (SCHIP) covers uninsured children living in familieslimitations on payments for health care and services furnished to
with income above applicable Medicaid standards, typically up toindividuals enrolled in M+C plans when services are provided outside
or above 200% of the federal poverty level. In all three programs,the plan. To the extent possible, the Secretary shall ensure that M+C
providers must meet certain standards in order to participate andenrollees do not pay more than would have been required had they



picPreexisting LawP.L. 107-188
receive reimbursement for services rendered to programreceived care within their plan network. Requires the Secretary to
beneficiaries. For example, hospitals and other facilities mustprovide Congress with certification and written notice at least 2 days
meet established conditions of participation, and laboratories mustprior to exercising this waiver authority. Provides for the waiver
be certified under the Clinical Laboratories Improvement Actauthority to continue for 60 days. Permits the Secretary to extend the
(CLIA). Physicians must be licensed to provide medical serviceswaiver period. Requires the Secretary, within 1 year after the end of the
in the state where medical care is rendered, and must followemergency, to provide Congress with an evaluation of this approach and
established rules for obtaining prior approval to deliver certainrecommendations for improvements under this waiver authority.
types of services. Also, physicians must not refer patients to[Section 143]
medical entities with which they have a financial relationship.
Other statutory provisions require hospitals to fully stabilize
patients receiving emergency care prior to transfer to another
medical facility.
gulation of the Use, Possession, and Transfer of Potentially Dangerous Biological Agents and Toxins
S regulation of biological agentsThe 1996 Antiterrorism and Effective Death Penalty Act (P.L.Codifies and expands provisions of P.L. 104-132 in the PHS Act under
d toxins that pose a threat to public104-132, Section 511(d)-(g)) required the Secretary to: (i)a new Section 351A. Requires the Secretary to: (i) establish and, at
iki/CRS-RL31263 and safetyestablish a list of biological agents that may pose a severe threatto public health and safety; and (ii) establish safety procedures forleast biennially, review and, if necessary, revise a list of biologicalagents and toxins that may pose a severe threat to public health and
g/wtransferring listed agents and toxins, including measures to protectsafety; (ii) establish safety procedures for transferring listed agents and
s.orpublic safety, prevent access by terrorists, and ensure thetoxins, including measures to protect public safety, prevent access by
leakavailability of bioagents for research, education, and otherterrorists, and ensure the availability of agents and toxins for research,
://wikilegitimate purposes. The regulations issued pursuant to the Act(i.e., 42 C.F.R. 72.6) include: (i) a list of 36 agents and toxins; (ii)education, and other legitimate purposes; (iii) establish standards andprocedures for the possession and use of listed agents and toxins,
httpregistration requirements for facilities transferring these agents;including the same measures listed in (ii); (iv) require registration for
(iii) transfer requirements; (iv) verification procedures includingthe possession, use, and transfer of listed agents and toxins; and (v)
audit and quality control; (v) agent disposal requirements; and (vi)maintain a national database of registered facilities and the location of
research and clinical exemptions. listed agents and toxins.
Directs the Secretary, in consultation with the Attorney General, to
establish appropriate safety and security requirements for registered
entities and individuals, commensurate with the level of risk to public
health and safety. These requirements must ensure that persons
registering facilities: (i) limit access to listed agents and toxins to only
those individuals (employees) with a legitimate need; (ii) identify such
individuals to the Secretary and the Attorney General for background
screening; (iii) deny access to individuals determined by the Attorney
General to berestricted individuals” (see Criminal Penalties below);
and (iv) limit or deny access to individuals found to meet other specified
criteria. Requires prompt screening and notification by the Attorney
General and Secretary and provides for an expedited screening process
where the registered person has demonstrated good cause. Establishes
procedures for the review of denials based on the screening process.



picPreexisting LawP.L. 107-188
Requires persons seeking to register a facility, as well as individuals
seeking to register themselves, to be screened in the same manner as
individuals working at a registered facility, but without the option of
expedited review. Allows the Secretary to exempt federal, state, and
local government facilities from screening. Requires that the Secretary
be promptly notified of the theft or loss of listed agents or toxins.
Authorizes the Secretary to conduct compliance inspections.
Exempts from the above requirements clinical and diagnostic labs
presented with a listed agent or toxin for diagnosis, verification, or
proficiency testing, provided that they report the identification of the
agent or toxin to the Secretary and transfer or destroy it. Exempts
agents or toxins licensed or approved under specified federal laws,
unless the Secretary determines that additional regulation is necessary
to protect public health and safety. Permits the Secretary to exempt
investigational products being used in research or clinical trials and
requires the Secretary to make a prompt (within 14 days) determination
iki/CRS-RL31263on a request for such an exemption. Permits the Secretary to grant
g/wtemporary exemptions during public health and agriculturalemergencies. Protects information collected under the above
s.orrequirements for the possession, use, and transfer of listed agents and
leaktoxins from disclosure under the Freedom of Information Act.
://wikiEstablishes civil penalties of up to $500,000 for violations of Section351A. Requires prompt notification of the Secretary in the event of an
httpunintentional release of a listed agent or toxin. Requires the Secretary
to report to Congress within 1 year. Authorizes such sums as may be
necessary for FY2002–FY2007. [Section 201]
plementation time frame for HHSNo statutory provisions.Requires that all persons in possession of listed agents or toxins notify
ationsthe Secretary within 90 days, based on guidance issued by the Secretary
within 30 days. Requires the Secretary within 180 days to issue an
interim final rule for carrying out Section 351A (including time frames
for the applicability of the rule to minimize disruption of research and
education). [Section 202]
Repeals current law (i.e., P.L. 104-132, Section 511(d)-(g)). [Section
204]



picPreexisting LawP.L. 107-188
DA regulation of biologicalNo statutory provisions.Gives USDA comparable regulatory authority to that provided to HHS
ents and toxins that pose a threat tounder Section 201 of the Act for regulating the use, possession, and
riculturetransfer of listed biological agents and toxins that may pose a severe
threat to animal or plant health, or to animal or plant products. The
USDA provisions differ from those of HHS in the criteria used to
develop a list of agriculturally significant biological agents and toxins.
Also, there is no mandated denial of access for “restricted individuals
because possession of USDA-listed agents by such persons is not a
federal crime. Additional provisions address overlap agents and toxins
that appear in both the HHS and the USDA list. [Section 212]
plementation time frame forNo statutory provisions.Requires the USDA Secretary to issue an interim final rule establishing
DA regulationsthe initial list of agents and toxins within 60 days and, no later than 60
days after that date, requires all persons in possession of listed agents or
toxins to notify the Secretary. Requires the USDA Secretary within 180
days to issue an interim final rule for carrying out Section 212 of the
Act (including time frames for the applicability of the rule to minimize
iki/CRS-RL31263disruption of research and education). [Section 213]
g/wUSDA coordinationNo statutory provisions.Requires the Secretaries of HHS and Agriculture to coordinate activities
s.orregarding overlap agents and toxins that appear in both lists, so as to
leakminimize the administrative burden on those persons subject to both sets
://wikiof regulations. Requires both Secretaries, within 180 days, to enter intoa memorandum of understanding providing for the development of a
httpsingle system of registration for persons who use, possess, or transfer
overlap agents or toxins, and to coordinate inspections and enforcement.
Requires the Secretaries to issue joint regulations for the use,
possession, and transfer of overlap agents and toxins within 18 months.
[Section 221]
iminal penaltiesSection 175 of the U.S. Criminal Code (i.e., 18 U.S.C. 175): (i)Amends 18 U.S.C. 175b by adding the following criminal penalties: (i)
prohibits the production, stockpiling, transfer, acquisition, orfines and/or up to 5 years imprisonment for anyone who transfers a
possession of biological agents for use as a weapon, subject tolisted agent or toxin to a person whom the transferor knows or has
fines and/or imprisonment for life or any term of years; and (ii)reasonable cause to believe has not obtained a registration; and (ii) fines
establishes fines and/or up to 10 years imprisonment forand/or up to 5 years imprisonment for unregistered persons in
individuals who knowingly possess any biological agent, toxin, orpossession of listed agents or toxins. Note: These new penalties apply
delivery system of a type and in a quantity not reasonably justifiedto both the HHS and USDA regulations described above. [Section 231]


by research or other peaceful purposes. Section 175b prohibits
restricted individuals” (i.e., indicted criminals, illegal aliens, and
other specified individuals) from possessing, shipping, or
receiving listed agents or toxins, subject to fines and/or up to 10
years imprisonment. Section 176 provides for the seizure,
forfeiture, and destruction of biological weapons.

picPreexisting LawP.L. 107-188
ate and Local Preparedness and Response Capacity
re capacity grants to state andPHS Act Section 319C authorizes grants to states and localDeletes PHS Act Section 319C(f) (i.e., Authorization of
blic health agenciesgovernments, after they have completed a Section 319BAppropriations). [Section 131(b)]
evaluation, to address core public health capacity needs. Requires
the Secretary to report to Congress on activities carried out under
Sections 319A, 319B, and 319C by January 1, 2005. Authorizes
$50 million for FY2001, and such sums as may be necessary for
FY2002–FY2006.
oterrorism preparedness grants toPHS Act Section 319F(c) authorizes grants to states, localities,Adds a new Section 319C-1 to the PHS Act authorizing grants to states
and local public healthand health care facilities to increase their capacity to detect,and local governments to improve preparedness and response to
encies, and health care facilities diagnose, and respond to bioterrorist attacks, including training ofbioterrorism and other public health emergencies. Eligible entities must
personnel. [Note: For all activities under Section 319F, authorizeshave completed a Section 319B evaluation of core public health
$215 million for FY2001, and such sums as may be necessary forcapacity needs and must, within 60 days of receiving an award, submit
FY2002–FY2006.]an emergency preparedness and response plan (including performance
measures) describing the activities to be carried out by the entity to
iki/CRS-RL31263address identified needs. Use of funds for preparedness and responseto bioterrorism and outbreaks of infectious disease takes priority over
g/wother public health emergencies, subject to any modification in the
s.orassessment of risk by the Secretary. Authorizes $1.6 billion for
leakFY2003: $1.08 billion for block grants to states and territories based on
://wikipopulation, with each state/territory guaranteed a minimum level offunding; and $520 million for grants to states for hospital preparedness.
httpAuthorizes such sums as may be necessary for FY2004–FY2006. Note:
The requirement that public health preparedness funding be awarded as
block grants applies only to FY2003; greater flexibility in awarding
funding is provided to the Secretary beyond FY2003. [Section 131(a)]
ants to hospitalsNo applicable provisions.Adds a new Section 319C-2 to the PHS Act authorizing grants to
improve community and hospital preparedness for bioterrorism and
other public health emergencies. Eligible entities must be a partnership
between one or more hospitals (or other health care facilities) and one
or more states and/or local governments. Grant proposals must be
coordinated and consistent with the state’s emergency preparedness and
response plan. Use of funds for preparedness and response to
bioterrorism and outbreaks of infectious disease takes priority over
other public health emergencies, subject to any modification in the
assessment of risk by the Secretary. Authorizes such sums as may be
necessary for FY2004–FY2006. [Section 131(a)]



picPreexisting LawP.L. 107-188
monstration grantsPHS Act Section 319G authorizes up to three demonstrationNo provisions.
grants for up to 5 years to states, localities, or non-profit
organizations to carry out programs to improve biopathogen
detection, develop plans for responding to bioterrorist attacks, and
train response personnel. Requires a GAO report to Congress at
the conclusion of the demonstration programs describing the
capabilities of the grantees. Authorizes $6 million for FY2001,
and such sums as may be necessary for FY2002–FY2006.
easures (Research, Development, and Production of New Vaccines, Drugs, and Technologies)
allpox vaccineNo statutory provisions. Existing supplies of smallpox vaccineRequires the Secretary to ensure that the national stockpile contains
consist of 15.4 million doses of freeze-dried vaccine (produced byenough smallpox vaccine to meet the nations health security needs.
Wyeth Laboratories) that HHS indicates could be expanded to 77Authorizes $509 million for FY2002, and such sums as may be
million doses by 1:5 dilution, plus another 75–90 million doses ofnecessary for FY2003–FY2006, to purchase smallpox vaccine. [Section
a different vaccine (produced by Aventis Pasteur) that HHS is121]
testing for safety and effectiveness. In addition, HHS has
iki/CRS-RL31263contracted with Acambis Inc. to produce a total of 209 milliondoses of a new type of smallpox vaccine by the end of 2002 (the
g/wnew vaccine needs FDA approval before it can be used).
s.or
leakA approval of drugs and biologicsUnder the Federal Food, Drug, and Cosmetic Act (FFDCA; 21Authorizes the Secretary to designate a priority countermeasure as a
U.S.C. 301 et seq.), manufacturers of drugs and biologics (e.g.,fast-track product for accelerated approval by the FDA. Permits a drug
://wikivaccines) must provide clinical trial data to demonstrate that theirfor which FDA approval is being sought on the basis of animal data to
httpproduct is safe and effective, in order to obtain FDA marketingbe designated a fast-track product. Requires the FDA, within 90 days,
approval. The FFDCA provides for the designation of productsto issue as a final rule the October 5, 1999 proposed rule (64 Fed. Reg.
as fast track to expedite the approval process.53960) permitting the use of animal data for demonstrating the
effectiveness of new drugs and vaccines when ethical issues preclude
conducting human clinical trials. (Note: FDA published a final rule on
May 31, 2002 (67 Fed. Reg. 37988).) [Section 122, 123]
rity at research and productionNo applicable provisions.Adds a new Section 319K to the PHS Act authorizing the Secretary, in
consultation with the Secretary of Defense and the Attorney General, to
provide technical or other assistance to enhance security at facilities that
develop, produce, distribute, or store priority countermeasures. [Section
124]



picPreexisting LawP.L. 107-188
search and developmentPHS Act Section 319F requires the Secretary, in consultation withDirects the Secretary to accelerate research and development on priority
the interagency working group, to conduct research on thepathogens (as determined by the NIH Director in consultation with the
epidemiology and pathogenesis of biopathogens, diagnostic testsinteragency working group) and priority countermeasures. Requires the
for biopathogens, and vaccines and other therapeutics.Secretary to consider research collaboration with the VA. Defines
priority countermeasures as any drug, vaccine, biological product,
device, or diagnostic test that the Secretary determines to be a priority
to treat, identify, or prevent infection by a listed biological agent or
toxin, or harm from any other agent that may cause a public health
emergency. [Section 125]
n, identification, diagnosis,No applicable provisions.Requires the Secretary of Energy and the Administrator of the National
d surveillance technologiesNuclear Safety Administration, in coordination with the interagency
working group, to expand research on the rapid detection and
identification of biopathogens and other agents that may cause a public
health emergency, and report to Congress within 180 days. Authorizes
such sums as may be necessary for FY2002–FY2006. [Section 152]
iki/CRS-RL31263Requires the Secretary, in consultation with the interagency working
g/wgroup, to evaluate new and emerging technologies for improvingsurveillance of public health emergencies and report to Congress within
s.or180 days, and periodically thereafter. [Section 126]
leak
://wikiassium iodideUnder general authority provided by the Atomic Energy Act of1954 (42 U.S.C. 2011 et seq.) and the Energy Reorganization ActDirects the President to provide KI from the national stockpile to stateand local governments that submit a plan for the local stockpiling and
httpof 1974 (42 U.S.C. 5801 et seq.), the Nuclear Regulatorydistribution to everyone within 20 miles of a nuclear power plant.
Commission (NRC) requires that the use of potassium iodide (KI)Additional eligibility requirements apply to local government plans.
by the public be considered during development of nuclear powerRequires the President within 1 year, in consultation with appropriate
plant emergency plans (see 10 C.F.R. 50.47). Under a policyfederal, state, and local agencies, to establish guidelines on stockpiling,
adopted December 22, 2000, NRC will pay for state KI stockpiles.distributing, and using KI in the event of a nuclear incident. Requires
the President within 6 months to report to Congress on state and local
Note: Taking KI in the event of a nuclear attack or accident slowsKI stockpiles. Directs the President to request a study by the National
a persons uptake of radioactive iodine by flooding the thyroidAcademy of Sciences on the safest and most effective way to distribute
gland with nonradioactive iodine.and administer KI on a large scale, to be submitted to Congress within
6 months. Permits the program to be terminated if the President
determines that there are more effective measures to protect against
thyroid disease. [Section 127]



picPreexisting LawP.L. 107-188
icrobial Resistance
mbating antimicrobial resistancePHS Act 319E requires the Secretary to establish an AntimicrobialAmends PHS Act Section 319E to authorize additional research on
Resistance Task Force to coordinate federal programs onpriority pathogens. Authorizes $25 million for FY2002 and for
antimicrobial resistance and to work on surveillance plans andFY2003, and such sums as may be necessary for FY2004–FY2006.
information systems for detection and control of drug-resistant[Section 109]
pathogens. Authorizes research and development initiatives for
new antimicrobial drugs and diagnostics. Directs the Secretary to
conduct a nationwide campaign to educate the public and health
care professionals about the appropriate use of antibiotics.
Authorizes grants for public health agencies to combat
antimicrobial resistance. Authorizes demonstration grants for
hospitals, clinics, and other entities to promote the judicious use
of antibiotics and to control the spread of resistant infections.
Authorizes $40 million for FY2001, and such sums as may be
necessary for FY2002–FY2006.
iki/CRS-RL31263 and Device Supply Safety and Security
g/wug and device importationFFDCA Section 510(i) requires foreign drug and deviceAmends Section 510(i) of the FFDCA by requiring annual registration,
s.ormanufacturers that import into the United States to register withthrough electronic means, of foreign manufacturers importing drugs and
leakthe Secretary their name, place of business, and the name of theirdevices into the United States. Requires the registration to include the
U.S. agent. Section 801 governs the import and export of food,name of each importer and agent used by the manufacturer, and the
://wikidrugs, devices, and other items, and specifies the circumstancesname of each person who imports or offers for import such drugs or
httpunder which imported articles are inspected, detained, or refuseddevices. Amends Section 801 by refusing entry to drugs or devices that
entry into the United States.are offered for importation, if the import declaration does not include
registration information about the manufacturer. Requires refused
articles to be held at the port of entry or removed to a secure facility, as
appropriate, until registration information is provided. [Section 321]
port components intended forFFDCA Section 301 is the prohibited acts and penalties section ofAmends Section 801 of the FFDCA mandating a chain-of-possession
portthe statute. Section 801 governs the import and export of food,identification and a customs bond for firms seeking to import
drugs, devices, and other items, and specifies the circumstancescomponents of drugs, devices, food additives, color additives, or dietary
under which imported articles are inspected, detained, or refusedsupplements for further processing and export. Requires certificates of
entry into the United States.analysis to identify such components, except for components of devices
and blood and tissue components. Permits the Secretary to exclude
from importation any article for which there is credible evidence or
information indicating that the article is not intended to be imported for
export. Amends Section 301 making it illegal to knowingly submit
false statements, certificates, records, or reports required under Section
801, as amended. [Section 322]



picPreexisting LawP.L. 107-188
ditional Authorizations of Appropriations for FDA Drug Regulation
ug safetyThe Office of Drug Safety in FDAs Center for Drug EvaluationAuthorizes the following amounts for the Office of Drug Safety (ODS):
and Research (CDER) conducts postmarket surveillance andFY2003=ODS FY2002 appropriation + $5 million; FY2004=ODS
monitors adverse drug reactions and medication errors.FY2002 appropriation + $10 million; each subsequent fiscal year=ODS
FY2004 appropriation adjusted for inflation since beginning of FY2004.
[Section 521]
ug marketing, advertising, andFDA/CDER’s Division of Drug Marketing, Advertising, andAuthorizes the following amounts for the Division of Drug Marketing,
mmunicationsCommunications is responsible for ensuring that prescription drugAdvertising, and Communications, expressed as an increase over its
information provided by manufacturers is truthful, balanced, andFY2002 appropriation: FY2003=$2.5 million; FY2004=$4 million;
accurate.FY2005=$5.5 million; FY2006=$7.5 million; FY2007= $7.5 million.
[Section 522]
neric drugsFDA/CDERs Office of Generic Drugs is responsible forAuthorizes the following amounts for the Office of Generic Drugs,
reviewing and approving generic product applications.expressed as an increase over its FY2002 appropriation: FY2003=$3
million; FY2004=$6 million; FY2005=$9 million; FY2006=$12
iki/CRS-RL31263million; FY2007=$15 million. [Section 523]
g/wod Supply Safety and Security
s.or
leakafety and security strategy.Executive Order 13100 created the Presidents Council on FoodRequires the Council, in consultation with the Secretaries of
Safety, headed by the Secretaries of Agriculture and HHS, theTransportation and Treasury, other interested federal agencies, states,
://wikiEPA Administrator, and the Assistant to the President for Sciencethe food industry, scientific organizations, and consumer and producer
httpand Technology. On January 18, 2001, the Council published agroups to develop a crisis communications and education strategy
strategic plan for food safety, which contained recommendationsagainst bioterrorist threats to the food supply. Requires the strategic
on making statutory changes to unify federal food safetyplan to address threat assessments, technologies and procedures for
regulations.securing food processing facilities, modes of transportation of foods,
response and notification procedures, and public risk communication
plans. Authorizes $750,000 for FY2002, and such sums as may be
necessary in each subsequent fiscal year, to implement the strategy.
[Section 301]
otection against adulteration ofFFDCA Chapter IV prohibits the entry into interstate commerceAmends FFDCA Section 801 to create a new subsection (h): to
of adulterated or misbranded foods. FDA monitors throughauthorize the Secretary to increase inspections for the detection of
inspections whether food manufacturers adhere to their legalintentional adulteration of imported food; to give high priority to
responsibility to produce food that is not defective, unsafe, filthy,improving FDAs food import information management systems; to
or produced under unsanitary conditions. FFDCA Section 801improve linkages with other federal regulatory agencies, states and
gives general authority to the Secretary to sample and regulateIndian tribes (under the Indian Self-Determination and Education
imported products. Assistance Act) that share responsibility for food safety; to fund
research on improved testing and sampling methods to rapidly detect
intentionally adulterated food at ports of entry; to coordinate with the
heads of CDC, NIH, EPA and USDA on the research; and to provide an
annual report to Congress on the research findings. Requires the



picPreexisting LawP.L. 107-188
Secretary, acting through FDA and not later than 6 months after
enactment, to complete an assessment of threats to food posed by
intentional adulteration and report to Congress. Authorizes a total of
$100 million for FY2002, and such sums as are necessary for
FY2003–FY2006, to carry out these activities. [Section 302]
ministrative detentionFFDCA Section 304 allows for the seizure of food in interstateAmends FFDCA Section 304 to add a new subsection (h) to authorize
commerce under restricted circumstances. FFDCA Section 301the detention of food for 20 days, and if needed for 30 days and to
lists prohibited acts; Section 801 is the general authority forinstitute an action if an officer or qualified employee of FDA has
regulating imports and exports. credible evidence (and the Secretary or Secretarys designee approves)
showing the food presents a threat of serious adverse health
consequences or death to humans or animals, with expedited procedures
for perishable foods. A detained food may be placed in a secure
facility, may be marked or labeled as detained, and cannot be
transferred out of detention unless it is released by the Secretary or the
detention period expires, whichever occurs first. The person
responsible for the detained food can appeal the decision to the
iki/CRS-RL31263Secretary. After an appeal is filed, within 5 days the Secretary must
g/wprovide for an informal hearing to confirm or end the detention order.If the Secretary fails to act, the detention is terminated. An appeal is
s.oralso terminated if the district court files an injunction or restraining
leakorder on the food. Amends FFDCA Section 301 prohibiting the
://wikiremoval of a detained product or any mark or label identifying theproduct as detained. Amends FFDCA Section 801to authorize an FDA
httpofficer or qualified employee to request the Treasury Secretary to
temporarily hold imported food at a port for 24 hours, if FDA has
credible evidence indicating that the food presents a threat of serious
adverse health consequences or death to humans or animals, and the
FDA official is unable to inspect, examine, or investigate the import to
determine whether to detain the food. If necessary, the Treasury
Secretary may remove the food to a secure facility from where it will
not be delivered pursuant to the execution of a bond. Requires that the
Secretary notify the state in which the involved port is located. [Section
303]
ent for repeated or seriousFFDCA Section 306 gives the Secretary authority to debar,Amends FFDCA Section 306 to debar from importing foods any person
mport violations.temporarily deny approval, or suspend the rights of individualswho is convicted of a felony related to the importation of food or who
who have been convicted of a felony to submit an application forrepeatedly imports, or knows, or should have known, that the imported
approval of a drug. food was adulterated. Requires food imported by a debarred person to
be refused admission and held in a secure facility, as appropriate, unless
a non-debarred person establishes that the food complies with the
requirements of the FFDCA, as determined by the Secretary. Imported
food that is refused admission may not be delivered pursuant to the



picPreexisting LawP.L. 107-188
execution of a bond under Section 801(b). Amends FFDCA Section
301 prohibiting the importing of a food by a debarred person. Amends
FFDCA Section 801 to include in the definition ofadulterated food”
any food imported by debarred persons as a prohibited act under Section
301. The prohibited act is not intended to include an innocent purchaser
who did not know of the importer’s debarred status. Authorizes the
Secretary to terminate the debarment of companies or persons. [Section
304]
gistration of food facilities.Currently, only states have records of food processing, packingCreates a new Section 415 in the FFDCA requiring all facilities,
and holding facilities. The federal government must ask the statesdomestic and foreign, that manufacture, process, and handle food to
for this information. register with the Secretary on a one-time basis and give timely updates
of all the identities (trade names) under which business is conducted,
names and addresses of the facilities, and general food categories (as
identified in 21 C.F.R. 170.3). Foreign registrants must name a U.S.
agent. Requires the Secretary to give each facility a number and the
failure of a facility to register is a prohibited act under FFDCA Section
iki/CRS-RL31263301. Protect the list of registrants from disclosure under the Freedom
g/wof Information Act. Exempts restaurants, certain retail stores, nonprofitfood establishments, fishing vessels, and farms from registration
s.orrequirements. Registration does not imply a license. Amends 801 to
leakprohibit foods from being imported from unregistered foreign facilities.
://wikiAdds that the Secretary may provide for and encourage the use ofelectronic submissions to register as long as there are authorization
httpprotocols used to identify the registrant and validate the data. Requires
the Secretary within 18 months to promulgate regulations for facilities
to register. If the final regulations had not become effective after 18
months, the requirements for registration will be self-executing.
[Section 305]
tenance and inspection ofFDCA Section 701(a) authorizes FDA to promulgate regulationsAdds a new Section 414 to the FFDCA allowing the Secretary to inspect
for foodsto enforce the Act. FFDCA Section 704 authorizes FDA torecords, if a food is believed to be adulterated and presents a threat of
conduct factory inspections. Currently, FDA inspectors haveserious adverse health consequences or death to humans or animals.
access to company records but can only request access to copy,Inspectors must present credentials and written notice in a reasonable
and verify records for restricted medical devices, prescriptionmanner to access and copy all records related to the food to help the
drugs, not for foods. Inspectors may not require that records beSecretary decide if the food is a threat to health. Excludes restaurants
kept nor do officials have authority to copy records found duringand farms. The Secretary is to consider the size of a business in
inspections.promulgating regulations. Requires records by persons who
manufacture, process, pack, transport, distribute, receive, hold, or
import food to be kept no longer than 2 years. The Secretary will use
the records to identify the immediate previous sources and immediate
subsequent recipients of food. including its packaging. Excludes
records on USDA-regulated foods (meat, poultry, and egg products).



picPreexisting LawP.L. 107-188
Requires procedures to protect trade secrets or confidential information.
Inspection of records does not extend to recipes for food, or financial,
pricing, personnel, research, or sales data (other than shipment data
regarding sales). Amends FFDCA Section 704(a) to add a clause to
allow the inspection of all records and other information described in
the new Section 414. Requires final record keeping rules to be issued
within 18 months. [Section 306]
or notice of imported foodUnder FFDCA Section 801, a food that (i) is found to beAdds a new section 801(m)(1) to the FFDCA to require the Secretary,
mentsmanufactured, processed, or packed under unsanitary conditions,after consultation with the Secretary of the Treasury, to promulgate
(ii) is forbidden or restricted in the producing country or fromregulations, not later than 18 months after enactment, requiring that the
where it was exported, or (iii) is adulterated or misbranded at theimporter give notice that a food will be presented for import. Requires
border, can have its admission deferred while the food isthat the notice include the following: a description of the food; the
reconditioned, relabeled or destroyed.identity of the manufacturer and shipper and, if possible, the grower; the
country of origin of the food; the country from which the article is
shipped; and the anticipated U.S. port of entry. Requires the Secretary
to establish by regulation the period of time for prior notice, that must
iki/CRS-RL31263be no less than the minimum amount of time necessary for the Secretary
g/wto receive, review, and respond to the notice, but that may not exceed5 days. In developing these regulations, the Secretary should consider
s.orthe effect on commerce, locations of U.S. ports, the transport modes, the
leaktypes of food, and other such considerations. Requires that food
://wikiwithout a notice be held at the port of entry until such notice is deliveredto the Secretary and found to be in order. Food so held may not be
httpdelivered pursuant to the execution of a bond under Section 801(b) and
may be taken to a secure facility, as appropriate. During this period, the
Secretary will decide if there is evidence or information on whether the
food presents a threat to health. All USDA-regulated foods (i.e., meat,
poultry, and egg products) are exempt from this section. Amends
Section 301 prohibiting imports of food without prior notice. If the
final rules are not effective within 18 months, the requirement for an
import notice is self executing and will take effect so that notice must
be given not less than 8 hours nor more than 5 days when a food is be
offered for import. [Section 307]



picPreexisting LawP.L. 107-188
thority to mark articles refusedFFDCA Section 403 defines misbranded foods as food whoseAmends Sections 403 and 801(a) definitions of misbranded food to
mission into the United States. labeling or advertising is false or misleading. Section 801(a)include food that has been refused admission to the United States and
gives the Secretary the general authority to refuse imports deemednot destroyed, and which presents a threat of serious adverse health
adulterated or misbranded.consequences or death, unless the packaging is clearly and
conspicuously labeled United States: Refused Entry at the expense of
the food’s owner until the food is brought into compliance. If there is
an adverse health threat, the Secretary must notify the owner or
consignee that the food presents a threat. Nothing in this section limits
the Secretaries of HHS or Treasury to require marketing the refused
articles under any other provision of law. [Section 308]
ohibition against port shoppingFFDCA Section 402 defines “adulterated” food as any food thatAmends FFDCA Section 402 to require that an importer offering food
bears or contains any poisonous or deleterious substance whichthat has been refused admission prove at his own expense that the food
may render it injurious to health. is in compliance with the applicable requirements of the Act. [Section
309]
tices to states regarding importedNo statutory provisions.Amends Chapter IX of the FFDCA to add a new Section 908 to require
iki/CRS-RL31263that the Secretary notify the states that hold or will hold imported food,and the states where the manufacturer, packer, or distributor of the
g/wimported food is located, when there is credible evidence that it presents
s.ora threat of serious adverse health consequences or death to humans or
leakanimals. Requires the Secretary to request that states take appropriate
://wikiaction to protect the public health. [Section 310]
httpants to states for inspectionsFFDCA Section 702 states that the Secretary is authorized toAmends Chapter IX of the FFDCA to add a new Section 909
conduct food inspections (examinations and investigations)authorizing the Secretary to make grant to states for increased food
through officers and employees of HHS, or any health, food, orsafety inspection, examinations, and investigations under Section 702,
drug officer of a state that has been duly commissioned by theand to cover the costs of taking appropriate actions to protect the public
Secretary as an officer of the Department.health as required under Section 908. Authorizes $10 million for
FY2002, and such sums as may be necessary for FY2003–FY2006.
[Section 311]
rveillance and information grantsFoodNet, established in 1995 by USDA and FDA, tracks theAmends PHS Act Title III, Part B to create a new Section 317R to
d authoritiesincidence of illnesses caused by nine pathogens in nineauthorize $19.5 million for FY2002, and such sums as may be necessary
geographic areas across the United States. PulseNet comparesfor FY2003–FY2006, in grants to states, and Indian tribes to expand the
genetic patterns of bacteria isolated from patients with foodbornenumber participating in FoodNet and PulseNet and other surveillance
illness and/or contaminated food.networks and to maintain technical and laboratory capacity needed for
such participation. [Section 312]
rveillance of zoonotic diseases.CDC has more than 20 surveillance programs that monitorRequires the Secretary to coordinate surveillance of zoonotic diseases
outbreaks of food borne illness caused by specific pathogens. (i.e., animal diseases communicable to man) through FDA, CDC, and
USDA. [Section 313]



picPreexisting LawP.L. 107-188
thority to commission otherFFDCA Section 702 states that the Secretary is authorized toAmends FFDCA Section 702 to authorize the Secretary to commission
deral officials to conductconduct food inspections (examinations and investigations)other federal officials to conduct inspections, examinations, and
ections.through officers and employees of HHS, or any health, food, orinvestigations, pursuant to a memorandum of understanding (MOU)
drug officer of a state that has been duly commissioned by thebetween the Secretary and the head of the agency to which the other
Secretary as an officer of the Department.officials belong. Inspections can take place only at facilities or other
locations that are jointly regulated by HHS and the other agency.
Requires the Secretary and the other agency head to report to Congress
on the number of persons that carried out activities under the MOU, and
the number of additional investigations and foods inspected or
examined as a result of the MOU. [Section 314]
e of construction.USDA regulates meat under the Federal Meat Inspection Act (21Prohibits FDA from regulating any food under USDAs jurisdiction.
U.S.C. 601 et seq.), poultry under the Poultry Products Inspection[Section 315]
Act (21 U.S.C. 451 et seq.), and processed egg products under the
Egg Products Inspection Act (21 U.S.C. 1031 et seq.).
iki/CRS-RL31263 activitiesUSDAs Food Safety and Inspection Service (FSIS) inspects meat,Authorizes $15 million for FY2002, and such sums as may be necessary
g/wpoultry, and processed egg products sold for human consumptionfor each subsequent fiscal year, for enhanced FSIS inspections
s.orfor safety, wholesomeness, and proper labeling. The Animal anddomestically and internationally and collaboration with other federal
leakPlant Inspection Service (APHIS) inspects cargo and passengersagencies. Authorizes $30 million for FY2002, and such sums as may
at U.S. ports for animal and plant pests, quarantines some of thesebe necessary for each subsequent fiscal year, for APHIS for increased
://wikiproducts, and responds to animal disease outbreaks. Theinspections, cooperative agreements with state and private veterinarians,
httpAgricultural Research Service (ARS) conducts research on animaland an automated, integrated, interagency emergency warning,
diseases and food safety to support other USDA regulatoryresponse, and record-keeping system. Authorizes $180 million for
responsibilities.FY2002, and such sums as may be necessary for FY2003–FY2006, to
upgrade biosecurity at ARS labs in New York and Iowa. Authorizes the
appropriation of such sums as necessary for: (i) grants not exceeding
$50,000 to land grant colleges of agriculture for reviewing security
standards and practices; and (ii) grants not exceeding $100,000 to
agricultural producer groups to develop and implement on-farm
biosecurity education programs. Authorizes $190 million for FY2002,
and such sums as may be necessary in subsequent years, to support ARS
and federal-state cooperative research on bioterrorism prevention,
preparedness, and response; to strengthen coordination with U.S.
intelligence agencies; and to develop an early warning surveillance
system for agricultural bioterrorism. Establishes civil fines and criminal
penalties for acts of terrorism against animal enterprises. [Sections
331–336]



picPreexisting LawP.L. 107-188
ing Water Security and Safety
lnerability assessments andPHS Act Title XIV, the Safe Drinking Water Act (SDWA),Adds a new Section 1433 to the SDWA to require each community
ergency response plansauthorizes federal regulation of public water systems, particularlywater system serving 3,300 or more individuals to conduct a
through a program that regulates contaminants in public watervulnerability assessment. Requires EPA, not later than August 1, 2002,
supplies. The Act defines a community water system as a publicto provide information to these systems concerning probable threats.
water system that serves at least 15 service connections used byEstablishes deadlines for community water systems to certify to EPA
year-round residents or that regularly serves at least 25 year-roundthat they have conducted vulnerability assessments and to submit to
residents. The SDWA is administered and enforced by theEPA a copy of the assessment. Certifications and submissions must be
Environmental Protection Agency (EPA).made before March 31, 2003, by systems serving 100,000+ persons;
December 31, 2003, by systems serving 50,000–99,999 persons; and
June 30, 2004, by systems serving 3,300–49,999 persons. Exempts
assessments from disclosure under the Freedom of Information Act and
requires EPA to develop protocols to protect the assessments from
unauthorized disclosure. Provides that any individual designated by the
Administrator who acquires assessments or information from them and
who knowingly or recklessly reveals such information to unauthorized
iki/CRS-RL31263individuals shall be subject to up to 1 year imprisonment or a fine,
g/wunless the information is revealed for specified purposes.
s.orRequires each community water system serving 3,300+ individuals to
leakprepare or revise an emergency response plan incorporating the results
://wikiof the vulnerability assessment. Systems must certify to EPA, within 6months of completing an assessment, that they have completed response
httpplans, and each system must keep a copy of its plan for 5 years. Directs
EPA to provide guidance to community water systems serving fewer
than 3,300 individuals on how to conduct vulnerability assessments,
prepare emergency response plans, and address threats. Authorizes
$160 million for FY2002, and such sums as may be necessary for
FY2003–FY2005, to provide financial assistance to community water
systems to conduct assessments and prepare response plans, and to
address basic security enhancements and significant threats. Security
enhancements may include purchase and installation of intruder
detection equipment and lighting, enhancing security of automated
systems, personnel training and security screening. Authorizes EPA to
use not more than $5 million of the funds to make grants to community
water systems to assist in responding to and alleviating any vulnerability
to an attack or intentional act, which the Administrator determines to
present an immediate and urgent security need. Further authorizes EPA
to use not more than $5 million of the funds made available to make
grants to community water systems serving fewer than 3,300 persons
for activities and projects undertaken in accordance with the guidance
for small systems that EPA must provide. [Section 401]



picPreexisting LawP.L. 107-188
ntaminant prevention, detection,No statutory provisions.Adds a new Section 1434 to the SDWA directing the EPA
d responseAdministrator, in consultation with CDC, and after consultation with
other federal departments and state and local governments, to review
(directly or through contracts or cooperative agreements) current and
future methods to prevent, detect and respond to the intentional
introduction of chemical, biological or radiological contaminants into
community water systems and their source waters. The review must
cover methods, means and equipment, including real time monitoring
systems, for monitoring and detecting levels of contaminants; methods
for providing sufficient notice to water system operators and those
served by the system of the introduction of contaminants; methods,
means and equipment for preventing the flow of contaminated water to
people served by a system and for mitigating adverse effects on public
health; methods and means for developing educational and awareness
programs for water systems; and biomedical research on the public
health impact of various contaminants that may be used in attacks on
water systems. Funding is authorized under Section 1435. [Section 402]
iki/CRS-RL31263
g/wpply disruption: prevention,ection and responseNo statutory provisions.Adds a new Section 1435 to the SDWA directing the EPAAdministrator, in coordination with appropriate federal departments
s.orand agencies, to review methods and means by which terrorists or others
leakcould disrupt the drinking water supply or render it unsafe. This review
://wikimust include a review of methods and means by which water systemscould be destroyed, impaired, or made subject to cross-contamination,
httpor by which information systems, including process controls,
supervisory control and data acquisition (SCADA) and computer
systems could be disrupted. EPA must also review methods and means
by which systems could be reasonably protected from attacks, and by
which alternative drinking water supplies could be provided if a water
system was destroyed, impaired or contaminated. Requires EPA to
ensure that these reviews reflect the needs of water systems of various
sizes and geographic locations; EPA may consider the vulnerability of
a specific region or service area, including the National Capital area.
Directs EPA to share, as appropriate, the information developed under
this section and Section 1434 with community water systems through
the Information Sharing and Analysis Center (ISAC). Authorizes $15
million for FY2002, and such sums as may be necessary for
FY2003–FY2005 to carry out Sections 1434 and 1435. [Section 402]
forceable requirementsSDWA Section 1414(i)(1) identifies the sections of SDWA forAmends SDWA Section 1414(i)(1) to include a new Section 1433
which the Act’s enforcement authorities apply.requiring community water systems to conduct vulnerability
assessments and to prepare emergency response plans, as an applicable
and enforceable requirement under the Act. [Section 403]



picPreexisting LawP.L. 107-188
ergency powersSDWA Section 1431 grants the EPA Administrator emergencyAmends SDWA Section 1431 to specify that EPAs emergency powers
powers to take such actions as deemed necessary to protectinclude the authority to act when there is a threatened or potential
persons served by a public water system upon receipt ofterrorist attack or other intentional act to disrupt the provision of safe
information that a contaminant that is present in, or is likely todrinking water or to impact the safety of a communitys drinking water
enter, a public water system or an underground source of drinkingsupply. [Section 403]
water may present an imminent and substantial endangerment to
health of those persons.
nalties for tampering with publicSDWA Section 1432 authorizes criminal and civil penalties forAmends SDWA Section 1432 to increase criminal and civil penalties
ter systemspersons who tamper, attempt to tamper, or threaten to tamper withfor tampering, attempting to tamper, or making threats to tamper with
public water supplies. Provides that any person who tampers withpublic water supplies. The maximum prison sentence for tampering is
a public water system shall be imprisoned for not more than 5increased from 5 to 20 years. The maximum prison sentence for
years, or fined, or both. Any person who attempts to tamper, orattempting to tamper, or making threats to tamper, is increased from 3
threatens to tamper, with a system shall be imprisoned for notto 10 years. The maximum fine that may be imposed for tampering is
more than 3 years. Provides that EPA may bring a civil action andincreased from $50,000 to $1 million. The maximum fine for
that the appropriate federal court may impose a penalty of notattempting to tamper, or threatening to tamper, is increased from
more than $50,000 for tampering or not more than $20,000 for$20,000 to $100,000. [Section 403]
iki/CRS-RL31263such attempt or threat.
g/wnical assistanceSDWA Section 1442(b) authorizes EPA to provide technicalAmends SDWA Section 1442(d) to authorize appropriations to carry
s.orassistance and to make grants to states and public water systemsout Section 1442(b) of not more than $35 million for FY2002, and such
leakto assist in responding to and alleviating emergency situations.sums as may be necessary for each fiscal year thereafter. [Section 403]
://wikithorization of the Prescription Drug User Fee Act (FFDCA Sections 735–736)
http
pes of feesFFDCA Section 736(a) authorizes the Secretary to assess andAmends FFDCA Section 736(a) by requiring the annual establishment
collect three types of fees. First, a human drug application andand product fees to be paid by October 1. Reduces by 50% the
supplement fee is due upon submission of the application orapplication and supplement fee for applications that contain no clinical
supplement. The Secretary may refund 75% of the fee if thedata to review, and for filing a supplement. Eliminates the waiver for
application is not accepted. In the event the application issupplements for pediatric indications. Clarifies that the sponsor of the
withdrawn after being filed, the Secretary may refund the fee ordrug application is responsible for paying the annual product fee.
a portion of the fee if no substantial work was performed on it.Exempts from the product fee those products that are listed in the
The fee is waived for orphan drug applications and forOrange Book” with a potency described in terms of per 100mL, or
supplements to drug applications that propose a new use forwhich are the same as another approved products. [Section 504(a)]


children. Second, annual establishment fees are assessed on each
manufacturer of an approved drug for each fiscal year that an
establishment manufactures the drug. Third, annual product fees
are assessed on certain drugs registered under the FFDCA. Both
establishment and product fees are due on Jan. 31 of each year.

picPreexisting LawP.L. 107-188
e amountsUnder FFDCA Section 736(b), the application fee shall beAmends FFDCA Section 736(b) by substituting a table setting out
$250,704 in FY1998, $256,338 in FY1999 and in FY2000,application/supplement, establishment, and product fee revenue, and
$267,606 in FY2001, and $258,451 in FY2002. The fee for antotal fee revenue, for FY2003 through FY2007. If subsequent
application that contains no clinical data to review, or for filing alegislation requires the Secretary to fund the additional costs of
supplement, is 50% of the application fee. Total establishment feeretirement of federal personnel, fee revenue amounts may be increased
revenues shall be $35.6 million in FY1998, $36.4 million into fully fund the portion of the added costs attributable to the process of
FY1999 and in FY2000, $38 million in FY2001, and $36.7review of drug applications. [Section 504(b)]
million in FY2002. Total product fee revenues must equal the
total establishment fee revenues.
adjustmentsFFDCA Section 736(c) requires the Secretary each fiscal year toAmends FFDCA Section 736(c) as follows: (i) requires the inflation
adjust fees and total fee revenues for inflation using either theadjustment to use the CPI for the 12-month period ending June 30 of the
average urban Consumer Price Index (CPI) or the increase in theyear preceding the fiscal year for which the fees are being established
civil service base pay for federal employees in Washington DC,or the civil service base pay as stated in the current law, whichever is
whichever is greater. Each year’s adjustment is added on agreater; (ii) beginning in FY2004, creates a new workload adjustment
compounded basis to the sum of all the adjustments made for prior(in addition to the inflation adjustment) to reflect changes in review
fiscal years. Requires the Secretary to adjust the annualworkload; (iii) creates a new final year adjustment that permits the
iki/CRS-RL31263establishment and product fees to ensure that the total amountFDA, if necessary, to make a one-time fee increase in FY2007 to ensure
g/wcollected equals that collected from application/supplement fees.Total fees collected for a fiscal year, as adjusted, may not exceedthat the agency has enough funds to operate for up to 3 months inFY2008 if there is a delay in reauthorizing PDUFA at the end of
s.orthe total costs of reviewing drug applications for that year.FY2007; and (iv) requires that the application/supplement,
leakestablishment, and product fees be established 60 days before the start
://wikiof the fiscal year, based on the revenue amounts set out in Section736(b) and the adjustments enumerated above. [Section 504(c)]
http
waiver or reductionFFDCA Section 736(d) permits the Secretary to reduce or waiveAmends FFDCA Section 736(d) by eliminating the waiver for brand-
one or more fees to protect public health or to remove barriers toname drug manufacturers that claim the fee would put them at an
innovation. Brand-name drug makers may seek a waiver if the feeeconomic disadvantage relative to generic drug producers. [Section
would put them at an economic disadvantage relative to a generic504(d)]
drug manufacturer. The Secretary may also waive the application
fee for first-time drug applications from small businesses with
fewer than 500 employees.
sessment of feesUnder FFDCA Section 736(f), fees may only be assessed for aChanges the title of Section 736(f) but leaves the trigger as is. [Section
fiscal year if the FDAs annual appropriation for salaries and504(e)]


expenses for that year is equal to or greater than its FY1997
appropriation, multiplied by whichever inflation adjustment factor
is applicable for the fiscal year in question. Thistrigger” ensures
that PDUFA fees are not a substitute for the agencys annual
appropriatio ns.

picPreexisting LawP.L. 107-188
editing and availability of feesFFDCA Section 736(g) permits FDA to transfer collected fees toAmends FFDCA Section 736(g) by providing FDA a 5% margin of
its salaries and expenses account, without fiscal year limitation, toerror for meeting the requirements of the second trigger. The intent of
be used solely for reviewing drug applications. Fees must bethis modification is to relieve FDA of the need to overspend each year,
collected in an amount equal to that specified in the annualwhich the agency has done consistently to ensure that its expenditures
appropriations act and may only be collected and available todo not fall below the trigger amount and cause it to lose the authority to
defray the increase in application review costs over the costs forcollect fees.
such activities in FY1997, adjusted for inflation. This second
trigger is intended to ensure that PDUFA fees are used toAuthorizes the following appropriations for fees: $222.9 million for
accelerate the drug application review process and not substituteFY2003; $231million for FY2004; $252 million for FY2005; $259.3
fornormal level” expenses.million for FY2006; and $259.3 million for FY2007, adjusting as
specified above. [Section 504(f)]
Authorizes the following appropriations for fees: $106.8 million
for FY1997; $109.2 million for FY1999 and for FY2000; $114
million for FY2001; and $110.1 million for FY2002, adjusting as
specified above. Collected fees that exceed the authorized amount
must be subtracted from the amount of fees authorized to be
collected in the subsequent fiscal year.
iki/CRS-RL31263
g/wntability and reportsThe Food and Drug Administration Modernization Act of 1997(FDAMA; P.L. 105-115, Section 104) required the Secretary toRequires the Secretary to consult with Congress and interested publicand private stakeholders in developing recommendations for the next
s.orprovide Congress with an annual performance report and anPDUFA reauthorization. Requires the Secretary to publish the
leakannual fiscal report.recommendations in the Federal Register for public comment. Requires
://wikithe Secretary to provide Congress with an annual performance reportand an annual fiscal report [Section 505]
http
ports of postmarketing studiesFFDCA Section 506B establishes annual reporting requirementsAmends FFDCA Section 506B to require the Secretary, in the event a
for drug sponsors who enter into agreements with the Secretary tosponsor fails to complete an agreed upon study, to post a statement on
conduct a postmarketing study.the FDAs Web site to that effect. Give the Secretary the authority to
require sponsors who fail to complete studies of fast-track drugs and
biological products for serious and life-threatening illnesses to notify
health care practitioners of the sponsors failure to complete the study
and of unanswered questions relating to the clinical benefits and safety
of the product. [Section 506]
fective date and sunsetFDAMA Sections 106–107 reauthorized PDUFA from October 1,The amendments made by this subtitle take effect on October 1, 2002,
1997 through September 30, 2002, with required annual reportsand sunset on September 30, 2007. The annual reporting requirements
due no later than 120 days thereafter.of Section 505 remain effective for an additional 120 days. [Sections
508–509]



picPreexisting LawP.L. 107-188
iscellaneous Provisions
gital televisionSection 201 of the Telecommunications Act of 1996 (P.L. 104-Requires the FCC to allot a digital channel to any requesting full-power
104) provided that digital television licenses issued by the Federaltelevision station that had an application pending for an analog
Communications Commission (FCC) should be limited to existingtelevision station construction permit as of October 24, 1991, and which
broadcasters. On April 3, 1997, the FCC allotted digital televisionhad its application granted after April 3, 1997. Any station receiving
spectrum to all eligible broadcasters existing at that time.digital spectrum under this provision is required to complete
construction of its digital facility within 18 months, without the
possibility of an extension. Stations are also prohibited from operating
an analog signal on their designated digital channel. [Section 531]
edicare + Choice Section 1853 of the Social Security Act (SSA) requires theMoves the CMS annual announcement of M+C payment rates from no
Centers for Medicare and Medicaid Services (CMS) to announcelater than March 1 to no later than the second Monday in May, effective
the annual Medicare + Choice (M+C) payment rates on March 1only in 2003 and 2004. Moves the deadline for plans to submit
of each year that will be applicable on January 1 of the followinginformation about ACRs, M+C premiums, cost sharing, and additional
year. Section 1854 requires that each M+C organization mustbenefits (if any) from no later than July 1 to no later than the second
submit to the Secretary for approval, for each of its M+C plans,Monday in September in 2002, 2003, and 2004. Changes the annual
iki/CRS-RL31263specific information about the adjusted community rate (ACR),M+C premiums, cost sharing, and additional benefits (if any) nocoordinated election period from the month of November to November15 – December 31 in 2002, 2003, and 2004.
g/wlater than July 1 of each year, also for the following year.
s.or
leakSection 1851 permits individuals to make and change election toAllows Medicare beneficiaries to make and change election to an M+C
://wikian M+C plan on an ongoing basis. Beginning in 2002, electionsand changes to elections are available on a more limited basis.plan on an ongoing basis through 2004. Beginning in 2005, individualswould only be able to make changes on the more limited basis,
httpIndividuals can make or change elections each November, duringoriginally scheduled to be phased in beginning in 2002. [Section 532]


the annual coordinated election period. Current Medicare
beneficiaries may also change their election at any time during the
first 6 months of 2002 (or first 3 months of any subsequent year).
Special enrollment rules apply to newly eligible aged
beneficiaries. Special enrollment periods apply to enrollees under
limited situations, such as a change in place of residence.

Appendix A. Bioterrorism-Related Hearings
107th Congress
Senate Appropriations Subcommittee on Labor, HHS, and Education
October 3, 2001Bioterrorism: Public health preparedness and response
October 23, 2001Public health response to anthrax attack
November 2, 2001Smallpox: Public health preparedness and response
November 29, 2001Funding for bioterrorism preparedness
Senate Appropriations Subcommittee on VA-HUD and Independent
Agencies
November 28, 2001Anthrax decontamination
Senate Armed Services Subcommittee on Emerging Threats and
Capabilities
October 25, 2001Bioterrorism and the Dark Winter exercise
Senate Commerce, Science and Transportation Committee
February 5, 2002Bioterrorism: Countermeasures R&D (Subcommittee on
Science, Technology, and Space)
Senate Environment and Public Works Committee
December 4, 2001Anthrax decontamination
Senate Foreign Relations Committee
September 5, 2001Bioterrorism threat and the spread of infectious diseases
Senate Governmental Affairs Committee
July 23, 2001Bioterrorism: FEMA’s role and public health
preparedness (Subcommittee on National Security,
Proliferation and Federal Services)
October 17, 2001Bioterrorism: Federal agency preparedness
October 30-31, 2001Anthrax in the mail: Protecting postal workers and the
public
April 18, 2002Public health preparedness



Senate Health, Education, Labor, and Pensions Committee
September 26, 2001Psychological trauma of terrorism
October 9, 2001Bioterrorism: Public health preparedness and response
November 2, 2001Kids and terrorism (Subcommittee on Children and
Families)
Senate Judiciary Committee
November 6, 2001Law enforcement and the domestic bioterrorism threat
(Subcommittee on Technology, Terrorism and
Government Information)
House Appropriations Subcommittee on Labor, HHS, and Education
May 1, 2002HHS bioterrorism preparedness
House Energy and Commerce Committee
October 10, 2001Bioterrorism preparedness and response (Subcommittee
on Oversight and Investigations)
November 1, 2001Public health early-warning surveillance systems
(Subcommittee on Oversight and Investigations)
November 7, 2001Physical security and NIH and CDC facilities
(Subcommittee on Oversight and Investigations)
November 15, 2001Bioterrorism: Public health preparedness and response
House Government Reform Committee
May 1, 2001Management of medical stockpiles (Subcommittee on
National Security, Veterans Affairs and International
Relations)
July 23, 2001Federal response to a bioterrorism attack: Dark Winter
(Subcommittee on National Security, Veterans Affairs
and International Relations)
October 5, 2001Bioterrorism: Federal, state, and local preparedness
(Subcommittee on Government Efficiency, Financial
Management and Intergovernmental Relations)
October 12, 2001Assessing the threat of bioterrorism (Subcommittee on
National Security, Veterans Affairs and International
Relations)
October 23, 2001Vaccine research and development (Subcommittee on
National Security, Veterans Affairs and International
Relations)
October 30, 2001Anthrax and postal worker safety



November 7, 2001DOD medical readiness for chemical and biological
warfare (Subcommittee on National Security, Veterans
Affairs and International Relations)
November 14, 2001Medical care for bioterrorism victims
November 29, 2001Risk communication: National security and public health
(Subcommittee on National Security, Veterans Affairs
and International Relations)
December 14, 2001Bioterrorism response: Information sharing between
local, state, and federal governments (Subcommittee on
Technology and Procurement Policy)
February 28, 2002Anthrax antitoxin research
March 1, 2002Federal, state, and local response to biological and
chemical attack (Subcommittee on Government
Efficiency, Financial Management and Intergovernmental
Relations)
March 21, 2002Combating terrorism (Subcommittee on National
Security, Veterans Affairs and International Relations)
House International Relations Committee
December 5, 2001Bioterrorism and potential sources of anthrax
House Science Committee
November 8, 2001Anthrax decontamination
December 5, 2001Bioterrorism: Federal preparedness and response
House Veterans’ Affairs Committee
April 10, 2002Bioterrorism legislation (H.R. 3253, H.R. 3254)



CRS-34
Appendix B. Bioterrorism-Related Web Sites
tment of Health and Human Services
dness [ http://www.hhs.gov/hottopics/healing]
Office of Emergency Preparedness[http://www.oep.dhhs.gov]
Preparedness [ h ttp://www.hhs.gov/ophp]
stems [ http://www.mmrs.hhs.gov]
ram [ http://www.cdc.gov/nceh/nps/default.htm]
ers for Disease Control and Prevention[http://www.bt.cdc.gov]
th Resources and Services Admin.[http://www.hrsa.gov/bioterrorism.htm]
Administration [ http://www.fda. gov/oc/opacom/hottopics/bioterrorism.html]
iki/CRS-RL31263nstitutes of Health[http://www.niaid.nih.gov/publications/bioterrorism.htm]ibrary of Medicine[http://www.nlm.nih.gov/medlineplus/biologicalandchemicalweapons.html]
g/w
s.or
leaktment of Defense
://wiki Medical Research Institute of Infectious Diseases[http://www.usamriid.army.mil]
http Vaccine Immunization Program[http://www.anthrax.osd.mil]
iological, Chemical Medical Reference Site[http://www.nbc-med.org/others]
Many health departments have included information on bioterrorism and public health preparedness on their Web sites. For links to state and local
o to [http://www.apha.org/state_local/afflinks.htm].
ssociations
e of Emergency Physicians[http://www.acep.org/1,4634,0.html]
rican College of Physicians[http://www.acponline.org/bioterro]
[ http://www.hospitalconnect.com/aha/key_issu es/disaster_readiness/index .html]



[ http://www.ama-assn.org/ ama/pub/category/ 6671.html]
for Microbiology[http://www.asmusa.org/pasrc/bioprep.htm]
rofessionals in Infection Control and Epidemiology[http://www.apic.org/bioterror]
Health Officials[http://www.astho.org]
itorial Epidemiologists[http://www.cste.org]
ration of American Scientists, Chemical & Biological Arms Control Program[http://fas.org/bwc/index.html]
& City Health Officials[http://www.naccho.org/files/documents/responds_to_bioterrorism.html]
iodefense Studies[http://www.hopkins-biodefense.org]
Henry L. Stimson Center[http://www.stimson.org/cbw]
rey Institute of International Studies[http://www.cns.miis.edu]
iological Arms Control Institute[http://www.cbaci.org]
A Center for Public Health and Disaster Relief[http://www.ph.ucla.edu/cphdr]
of Minnesota Center for Infectious Disease Research and Policy[http://www1.umn.edu/cidrap]
iki/CRS-RL31263ouis University Center for the Study of Bioterrorism and Emerging Infections[http://bioterrorism.slu.edu]
g/w University Center for Public Health Preparedness[http://cpmcnet.columbia.edu/dept/sph/CPHP/index.html]
s.or of North Carolina Center for Public Health Preparedness[http://www.sph.unc.edu/bioterrorism]


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