Project BioShield: Legislative History and Side-by-Side Comparison of H.R. 2122, S. 15, and S. 1504

CRS Report for Congress
Project BioShield: Legislative History
and Side-by-Side Comparison of
H.R. 2122, S. 15, and S. 1504
August 27, 2004
Frank Gottron
Analyst in Science and Technology Policy
Resources, Science, and Industry Division
Eric Fischer
Senior Specialist in Science and Technology Policy
Resources, Science, and Industry Division


Congressional Research Service ˜ The Library of Congress

Project BioShield: Legislative History and Side-by-Side
Comparison of H.R. 2122, S. 15, and S. 1504
Summary
Few effective countermeasures currently exist to deal with chemical, biological,
radiological, and nuclear terror agents. In early 2003, the Bush administration
proposed Project BioShield to stimulate the development of such countermeasures
and to procure them for the Strategic National Stockpile (SNS). Congress considered
three bills that incorporated much of the administration’s proposal: S. 15 (Gregg),
H.R. 2122 (Tauzin), and S. 1504 (Gregg). H.R. 2122 passed the House on July 16,

2003. S. 15 passed the Senate on May 25, 2004 in an amended form similar to H.R.


2122. This version of S. 15 passed the House on July 14, 2004. President Bush
signed S. 15 into law as the Project BioShield Act of 2004 (P.L. 108-276) on July 21,

2004.


Although many of the details of Project BioShield changed during
Congressional consideration, all the proposals shared similar key provisions. Each
bill would have provided expedited hiring, procurement, and grant awarding
procedures for bioterrorism-related products and services. Each bill would have
provided a market guarantee for countermeasure producers by allowing the Secretary
of Health and Human Services (HHS) to contract to procure countermeasures still in
development. Thus, several years before a company plans to be able to deliver a
countermeasure, the company would have been assured that if they successfully
develop the countermeasure the government is obligated to purchase a set amount of
it at a set price. Each bill would have authorized the HHS Secretary to allow the
emergency use of countermeasures that lack Food and Drug Administration approval.
Congress changed many important aspects of the Administration’s proposal.
The most important change related to the funding mechanism. The Administration
requested a permanent, indefinite appropriation, to be spent at the President’s
discretion, for the purchase of countermeasures. The enacted version of Project
BioShield authorizes the appropriation of $5.593 billion for FY2004-FY2013. The
Department of Homeland Security (DHS) Appropriations Act (P.L. 108-90)
appropriated this amount.
The Project BioShield Act of 2004 (P.L. 108-276) also: transfers the SNS from
DHS to HHS, permits procurement of countermeasures with commercial markets,
permits countermeasure procurement contracts to be written up to eight years before
countermeasures are expected to be deliverable, and authorizes appropriations to
allow DHS to improve its ability to perform threat analysis. A provision that would
have allowed HHS to develop countermeasures directly was excluded from the
enacted version Project BioShield.
This report will not be updated. For more analysis and the current status of
Project BioShield, see CRS Report RS21507, Project BioShield, by Frank Gottron.



Contents
In troduction ..................................................1
Legislative History.............................................2
Senate Action.............................................2
House Action.............................................3
Presidential Action.........................................3
Related Legislation........................................3
Comparison of the Bills.........................................4
Similarities ...............................................4
Differences ...............................................4
List of Tables
Table 1. Short Title................................................7
Table 2. New Health and Human Services Secretary Authorities for
Countermeasure Research and Development ........................7
Table 3. Biomedical Countermeasures Procurement.....................25
Table 4. Authorization for Medical Products for Use in Emergencies........57
Table 5. Required Reports.........................................90
Table 6. Outreach...............................................104
Table 7. Export Control Recommendation............................105
Table 8. Interagency Coordination..................................106
Table 9. Smallpox- Related Amendments to the
Homeland Security Act and Public Health Services Act..............108
Table 10. Additional HHS Secretary Authorities During
National Emergencies........................................109
Table 11. Special Funding Language................................112



Project BioShield: Legislative History and
Side-by-Side Comparison of
H.R. 2122, S. 15, and S. 1504
Introduction
Several high profile incidents since 2001 have highlighted the nation’s
vulnerability to bioterrorism. Most prominent of these were the anthrax mailings of

2001. These caused five deaths, required thousands to take prophylactic antibiotics,


and cost millions of dollars to clean up. If there had not been an effective antibiotic
treatment for this strain of anthrax, the death toll would have been even higher.
Other prominent incidents include the discovery of the toxin ricin in Senator
Frist’s office in the Dirksen Senate Office Building office in February 2004 and in
a postal facility in Greenville, South Carolina, in October 2003. The Secret Service
also intercepted a letter containing ricin addressed to the White House in October

2003. Ricin, a deadly toxin, lacks any Food and Drug Administration (FDA)


approved treatments or prophylaxis.1
Many of the other biological threats deemed most dangerous by the Centers for
Disease Control and Prevention (CDC) also lack effective FDA-approved treatments
and prophylactics. For example, botulinum toxin, plague, tularemia, and many viral
hemorrhagic fevers (VHFs) lack licensed vaccines, while smallpox and VHFs lack
any specific treatment.2 Additionally, many of the vaccines and treatments that
currently exist are suboptimal for responding to bioterrorism. For example, the
Department of Health and Human Services (HHS) has called for better vaccines for3
anthrax and smallpox and better treatments for anthrax, plague, and botulism.


1 For more information on ricin, see CRS Report RS21383, Ricin: Technical Background
and Potential Role in Terrorism, by Dana A. Shea and Frank Gottron.
2 For more information on potential chemical and biological terrorism agents and the
availability of countermeasures, see CRS Report RL32391, Small-scale Terrorist Attacks
Using Chemical and Biological Agents: An Assessment Framework and Preliminary
Comparisons, by Dana A. Shea and Frank Gottron.
3 National Institute of Allergy and Infectious Disease, NIAID Biodefense Research Agenda
for CDC Category A Agents, Department of Health and Human Services, Washington, DC,
February, 2002.

Several factors likely contribute to this paucity of bioterrorism countermeasures,
including a lack of a financial incentives to develop countermeasures,4 the perception
of a relatively high threat of litigation stemming from adverse reactions to the
countermeasures,5 and the lack of success of a Department of Defense effort to
develop such countermeasures.6 In addition, because these diseases are rare, many
companies apparently have balked at spending millions of dollars developing a
product with such a small potential market.7
To encourage the development of new biomedical countermeasures, President
Bush proposed Project BioShield in his 2003 State of the Union address. The 108th
Congress considered three bills that incorporated the administration’s proposal: S.
15 (Gregg), H.R. 2122 (Tauzin), and S. 1504 (Gregg). Most of the attention garnered
by Project BioShield has focused on countermeasures against bioterrorism.
However, Project BioShield also applies to countermeasures against chemical,
radiological, and nuclear attacks.
This report provides a brief legislative history and a side-by-side comparison of
the three bills, including versions of S. 15 as initially reported and as enacted. Such
a comparison may be useful both with respect to congressional oversight of Project
BioShield activities and with respect to future legislative initiatives relating to
countermeasure procurement.
Legislative History
Senate Action. Senator Gregg introduced S. 15 on March 11, 2003. The
Senate Committee on Health, Education, Labor, and Pensions (HELP) reported S. 15
on March 25, 2003, with an amendment in the nature of a substitute and without a
written report. In the comparison tables below, this version is referred to as “S. 15
as Reported by Committee.”
Senator Gregg introduced S. 1504 on July 30, 2003. It shared many of the
provisions found in H.R. 2122, which the House had passed on June 16, 2003. S.
1504 was placed directly on the Senate Legislative Calendar. In the comparison
tables below, this version is listed as “S. 1504 as Introduced.”


4 Alan Pemberton, Pharmaceutical Research and Manufacturers of America, Testimony
before the U.S. House of Representatives Select Committee on Homeland Security, May 15,

2003.


5 Dr. Kim Bush, President Vaccines Division, Baxter Healthcare Corp, Testimony before
the U.S. Senate Committee on Health, Education, Labor, and Pensions, Health
Subcommittee, January 30, 2003.
6 Institute of Medicine and National Research Council, Giving Full Measure to
Countermeasures: Addressing Problems in the DoD Program to Develop Medical
Countermeasures Against Biological Warfare Agents, National Academy Press, Washington
DC, 2004.
7 See CRS Report RL30913, Pharmaceutical Research and Development: A Description and
Analysis of the Process by Richard Rowberg.

On May 19, 2004 the Senate passed S. 15 with an amendment in the nature of
a substitute (99-0). The amended and passed version of S. 15 had relatively minor
differences from H.R. 2122 (see below). This version of S. 15 was passed by the
House and became the Project BioShield Act of 2004 (P.L. 108-276). In the
comparison tables below, this version is referred to as “S. 15 as Enacted.”
House Action. Representative Tauzin introduced H.R. 2122 on May 15,
2003. It was referred to the Committee on Energy and Commerce, Committee on
Government Reform, Committee on Armed Services, and the Select Committee on
Homeland Security. The Committee on the Judiciary chose not to seek a serial8
referral.
Committee Hearings. The House Committee on Energy and Commerce
Subcommittee on Health held a joint hearing with the House Select Committee on
Homeland Security Subcommittee on Emergency Preparedness and Response entitled
“Furthering Public Health Security: Project BioShield” on March 27, 2003.
The House Committee on Government Reform held a hearing to consider the
“Project Bioshield Act” on April 4, 2003.
The House Select Committee on Homeland Security held a hearing on
“BioShield: Countering the Bioterrorist Threat” on May 15, 2003. The House Select
Committee on Homeland Security Subcommittee on Emergency Preparedness and
Response and the Subcommittee on Intelligence and Counterterrorism held a joint
hearing on “Does the Homeland Security Act of 2002 Give the Department the Tools
It Needs To Determine Which Bio-Warfare Threats Are Most Serious?” on June 5,
2003. On June 6, 2003 the House Select Committee on Homeland Security held a
hearing on “Bioshield: Lessons from Current Efforts To Develop Bio-Warfare
Countermeasures.”
Committee Reports and Amendments. The House Committee on Energy
and Commerce reported H.R .2122 (H.Rept. 108-147, Part 1) on June 10, 2003. The
House Committee on Armed Services discharged H.R. 2122 on June 11, 2003. The
House Committee on Government Reform reported H.R. 2122 with amendments on
June 12, 2003 (see H.Rept. 108-147, Part 2). The House Select Committee on
Homeland Security reported H.R. 2122 with amendments on July 8, 2003 (see
H.Rept. 108-147, Part 3). The version reported by the House Select Committee on
Homeland Security is the version that passed the House. In the comparison charts
below, this is the version referred to as “H.R. 2122 as Passed by the House.”
Floor Action. The House of Representatives passed H.R. 2122 on July 16,

2003 (421-2). The House passed S. 15 on July 14, 2004 (414-2).


Presidential Action. S. 15 was signed into law by President Bush on July 21,

2004 (P.L. 108-276).


8 U.S. Congress, Project BioShield Act of 2003: H.Rept. 108-147 Part I, 108th Congress,
first session, pp. 20-21.

Related Legislation. The Department of Homeland Security Appropriations
Act, 2004 (P.L. 108-90, enacted October 1, 2003) appropriated $5.593 billion for
FY2004-FY2013 to procure medical countermeasures against biological terror
attacks. Of this amount, up to $890 million may be obligated in FY2004 and no
more than $3.418 billion may be obligated through FY2008. The enactment of this
law effectively resolved the funding differences that had been pending between S. 15
and H.R. 2122 at that time. S. 15 as reported by the Senate HELP Committee called
for a permanent indefinite spending appropriation, while H.R. 2122 authorized a
specific appropriation amount. P.L. 108-90 contained funding levels identical to
those authorized in H.R. 2122. Although P.L. 108-90 specified that those funds were
only for medical countermeasures against biological terror attacks, the Project
BioShield Act of 2004 (P.L. 108-276) changed this to allow countermeasures against
chemical, biological, radiological, and nuclear terrorism.
The National Defense Authorization Act for Fiscal Year 2004 (P.L. 108-136,
enacted November 24, 2003) contained some Department of Defense-related
language similar to that found in S. 15 as reported by the Senate HELP Committee
and H.R. 2122. It gave the Secretary of Defense some authorities similar to those
given to the Secretary of Health and Human Services by the Project BioShield Act
of 2004. These new authorities relate to the hiring of biomedical countermeasure
consultants, the procurement of biomedical countermeasures, and the emergency use
of unapproved countermeasures for the military. The Defense Secretary’s authorities
relate to Department of Defense programs and military personnel, whereas the HHS
Secretary’s authorities relate to HHS programs and to civilian populations.
The Consolidated Appropriations Act, 2004 (P.L. 108-199, enacted January 23,
2004), reduced the funds available for obligation in FY2004 from $890 million to
$885 million.
Comparison of the Bills
All of the Project BioShield-related legislative proposals shared the same goal
of increasing the development and purchase of biomedical countermeasures for the
SNS. Each also largely reflected the Administration’s proposals on a broad scale.
However, Congress, through its deliberative process, changed many of the details in
each bill.
Similarities. These bills shared many provisions. Each would have provided
expedited hiring, procurement, and grant awarding procedures for bioterrorism-
related products and services. These provisions were designed to make it easier for
HHS to quickly commit substantial funds to biomedical countermeasure projects.
Each bill would have provided a market guarantee for countermeasure producers by
allowing the HHS Secretary to contract to procure countermeasures still in
development. Thus, several years before a company plans to be able to deliver a
countermeasure, the company would be assured that if they successfully develop the
countermeasure the government is obligated to purchase a set amount of it at a set
price. Under each bill, the manufacturing company can only receive payment upon
countermeasure delivery, with some minor exceptions. Each bill would have
authorized the HHS Secretary to allow the emergency use of countermeasures that
lack FDA approval.



Differences.
Funding. The largest difference among the bills was the difference in funding
mechanism. S. 15 as reported by the Senate HELP Committee would have granted
a permanent, indefinite appropriation for purchasing countermeasures to be spent at
the President’s discretion. This mandatory funding, which was also part of the
original Administration proposal, would not be subject to the annual appropriations
process. The Administration predicted that it would spend approximately $5.6
billion for FY2004-FY2013 for BioShield-related countermeasure procurement. The
Congressional Budget Office estimated that approximately $8.1 billion would be
spent over that time period.9
H.R. 2122, S. 1504, and S. 15 as amended and enacted authorize specific
funding for the program but do not appropriate funds. All three of these authorize
the exact appropriation amounts found in the Department of Homeland Security
Appropriation Act, 2004 (P.L. 108-90) that was passed while the Project BioShield
legislation was under consideration. There were minor differences in the
mechanisms of funding between H.R. 2122 and S. 1504. S. 15 as enacted adopted
the H.R. 2122 mechanism.
SNS Transfer. Congress created the National Pharmaceutical Stockpile
(NPS), the forerunner to the SNS, in the Omnibus Consolidated and Emergency
Supplemental Appropriations Act, 1999 (P.L. 105-277). The Public Health Security
and Bioterrorism Preparedness and Response Act of 2002 (P.L. 107-188) essentially
redesignated the NPS as the SNS and listed specific requirements regarding SNS
management and maintenance. The Homeland Security Act of 2002 (P.L. 107-296)
transferred the SNS program to the Department of Homeland Security. S. 15 as
enacted transferred the SNS back to HHS. This provision was not in any of the other
bills.
Countermeasure Qualifications. The bills differed in which
countermeasures qualify for procurement under Project BioShield. S. 15 as reported
by the Senate HELP Committee and S. 1504 would have excluded any
countermeasure that has a significant market other than as a countermeasure. H.R.
2122 and S. 15 as enacted allow the purchase of countermeasures even if they have
other significant markets. This change may encourage the development of
countermeasures that can protect against more than one agent, such as new wide-
spectrum antibiotics. Such products are more likely to have other commercial
applications and markets. Thus, while very desirable for the SNS, they would have
been excluded from Project BioShield funding under S. 15 as reported and S. 1504.
S. 15 as reported by the Senate HELP Committee and S. 1504 required that
products be likely to have FDA approval within five years. H.R. 2122 required that
countermeasures be likely to be approved sometime in the future. S. 15 as enacted
requires that countermeasures be likely to be approved within eight years. The
enacted language will allow the HHS Secretary to contract to purchase


9 U.S. Congress. Cost Estimate: S. 15 Project BioShield Act of 2003. Congressional Budget
Office. May 7, 2003.

countermeasures that are earlier in the development process than would the other
Senate versions, but not as early as H.R. 2122 would have allowed.
H.R. 2122, S. 1504, and S. 15 as reported by the Senate HELP Committee
specify that countermeasures should be deliverable within five years. S. 15 as
enacted specifies that countermeasures should be deliverable within eight years.
HHS Countermeasure Development Program. H.R. 2122 would have
authorized the HHS Secretary to “initiate and sustain a program that results in the
delivery of priority countermeasures for placement in the stockpile.” This provision
would have allowed the government to directly develop countermeasures. This could
be done through several mechanisms including government owned-government
operated (GO-GO) facilities or government owned-contractor operated (GO-CO)
facilities. This provision was not included in S. 15 as enacted.
Patient Protection during Emergencies. S. 1504 and S. 15 as enacted
grant the HHS Secretary authority, during a national emergency, to temporarily waive
or modify some patient protection provisions of the Social Security Act and the
Public Health Security and Bioterrorism Preparedness Act of 2002. These provisions
concern patient privacy and which hospitals patients can be directed to or away from
pursuant to a state emergency plan. H.R. 2122 and S. 15 as reported by the Senate
HELP Committee lacked this provision.
DHS Terrorism Analyst Hiring. H.R. 2122 and S. 15 as enacted authorize
appropriations to hire more biological and chemical terrorism analysts in the
Department of Homeland Security’s Directorate for Information Analysis and
Infrastructure Protection (IAIP). They also authorize appropriations to acquire and
deploy facilities that permit the Undersecretary of IAIP to access all classified
information to which he is entitled. S. 15 as reported by the Senate HELP
Committee and S. 1504 lacked similar provisions.
Other Differences. Several other notable differences, including reporting and
recordkeeping requirements, are detailed the tables below. The italics in the tables
highlight language differences between the bills.



CRS-7
Table 1. Short Title
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
Sec. 1 Sec. 1 Sec. 1Sec. 1
“Project BioShield Act ofSame as S. 15 as Reported bySame as S. 15 as Reported by“Project BioShield Act of

2003.” Committee. Committee 2004.”


: Italics highlight language differences between the bills.
Table 2. New Health and Human Services Secretary Authorities for
Countermeasure Research and Development
iki/CRS-RL32549rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
g/wC o mmi t t e e House
s.orendmentSec. 2 Sec. 2 Sec. 2 Sec. 2
leake PublicAmends Part B of title IV ofAmends Part B of title III ofSame as S. 15 as Reported bySame as H.R. 2122.


://wikithe Public Health Service Actthe PHSA, (42 U.S.C. 243 etCommittee.
httpct(PHSA, 42 U.S.C. 284 etseq.) by inserting “Sec.
seq.) by adding “Sec. 409J319F-1 Authority for Use of
Biomedical CountermeasureCertain Procedures
Research and Development.”Regarding Biomedical
Countermeasure Research
and Development Activities.”

CRS-8
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
iningSec. 2 (a) “Sec. 409J (g)”Sec. 2 (a) “Sec. 319F-1Sec. 2 (a) “Sec. 409J (g)”Sec. 2 (a) “Sec. 319F-1
unter-Defines a qualified(a)(2)” and Sec. 2 (e)Same as S. 15 as Reported by(a)(2)” and Sec. 2 (d)
countermeasure as a drug (asDefines qualifiedCommittee.Same as S. 15 as Reported by
that term is defined bycountermeasure as a priorityCommittee.


section 201(g)(1) of thecountermeasure (as defined
Federal Food, Drug, andin section 319F(h) and as
Cosmetic Act (21 U.S.C.determined by the Secretary
321(g)(1))), biologicalin accordance with such
product (as that term issection and consistent with
defined by section 351(i) ofsections 302(2) and 304(a) of
this Act (42 U.S.C. 262(i))),the Homeland Security Act
iki/CRS-RL32549or device (as that term isof 2002)
g/wdefined by section 201(h) ofagainst a chemical,
s.orthe Federal Food, Drug, andbiological, radiological, or
leakCosmetic Act (21 U.S.C.nuclear agent that may cause
://wiki321(h))) that the Secretarydetermines to be a prioritya public health emergencyaffecting national security.
http(consistent with sections
302(2) and 304(a) of the
Homeland Security Act of

2002) to —



CRS-9
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
iningSec. 2 (e)Sec. 2 (a) “Sec. 409J (g)” Sec. 2 (d)
unter-Defines a countermeasure asSame as S. 15 as Reported bySame as H.R. 2122.
a drug, biological product,Committee.
tinued)device, vaccine, vaccine
adjuvant, antiviral, or
diagnostic test that can be
used to —
(A) treat, identify, or prevent(1) to treat, identify, orSame as S. 15 as Reported bySame as H.R. 2122.
harm from any biological,prevent infection by aCommittee.
chemical, radiological, orbiological agent or toxin or
iki/CRS-RL32549nuclear agent that may causeharm from any other agent
g/wa public health emergencythat may cause a public
s.oraffecting national security; orhealth emergency; or
leak
://wiki(B) treat, identify, or preventharm from a condition that(2) to treat, identify, orprevent harm from aSame as H.R. 2122.Same as H.R. 2122.


httpmay result in adverse healthcondition that may result in
consequences or death andadverse health consequences
may be caused byor death and may be caused
administering a drug,by the administering of a
biological product, or devicecountermeasure described in
that is used as described in(1).
subparagraph (A).

CRS-10
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
adSec. 2 (a) “Sec. 409J (a)(2)” No similar provision.Sec. 2 (a) “Sec. 409J (a)(2)” No similar provision.
The Director of the NationalSame as S. 15 as Reported by
Institutes of Health (NIH)Committee.
shall carry out these
authorities. The National
Institute of Allergy and
Infectious Diseases (NIAID)
shall be the lead institute
within NIH for performing,
administering, or supporting
biomedical countermeasure
iki/CRS-RL32549research and development.
g/wThe NIH Director may
s.ordelegate to the NIAID
leakDirector authorities as are
://wikinecessary to carry out thisfunction. The HHS Secretary
httpmay authorize the NIH
Director to work through any
national research institute.
Sec. 2 (a) “Sec. 409J (a)(3)” Sec. 2 (a) “Sec. 319F-1Sec. 2 (a) “Sec. 409J (a)(3)” Sec. 2 (a) “Sec. 319F-1
Authorizes the HHS(a)(3)” Same as S. 15 as Reported by(a)(3)”
Secretary to enter intoAuthorizes the HHSCommittee.Same as H.R. 2122.


interagency agreements forSecretary to enter into
countermeasure research andinteragency agreements for
development and to use othercountermeasure research and
HHS agencies.development.

CRS-11
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
Sec. 2 (a) “Sec. 409JSec. 2 (a) “Sec. 319F-1Sec. 2 (a) “Sec. 409JSec. 2 (a) “Sec. 319F-1
ility(a)(2)(D)” (a)(4)” (a)(2)(D)” (a)(4)”
eHHS Secretary can makeSame as S. 15 as Reported bySame as S. 15 as Reported bySame as S. 15 as Reported by
funding for countermeasureCommittee.Committee.Committee.
research and development
facilities dependent on
allowing future emergency
use of facilities by the
Secretary.
portNo similar provision.Sec. 2 (a) “Sec. 319F-1No similar provision.Sec. 2 (a) “Sec. 319F-1
iki/CRS-RL32549rols(a)(5)” (a)(5)”
g/wEach award agreement mustSame as H.R. 2122.


s.orstate that any products
leakdeveloped with BioShield
funding must comply with
://wikiexport-related controls.
http

CRS-12
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
peditedSec. 2 (a) “Sec. 409J (b)(1)”Sec. (a) “Sec. 319F-1 (b)(1)” Sec. 2 (a) “Sec. 409J (b)(1)”Sec. (a) “Sec. 319F-1 (b)(1)”Maximum
ocure-(A) Procurements less than(A) Same as S. 15 as(A) Same as S. 15 as(A) Same as S. 15 aswould
t$25 million for property orReported by Committee.Reported by Committee.Reported by Committee.otherwise be
services related to pressing$100,000.


countermeasure research and
development needs can
follow simplified acquisition
regulations.
No similar provision.(B) These purchases must(B) These purchases must(B)These purchases must
comply with laws andcomply with laws andcomply with laws and
iki/CRS-RL32549regulations relating toregulations relating toregulations relating to
g/wcontract work hours andcontract work hours andcontract work hours and
s.orsafety standards, examinationsafety standards, examinationsafety standards, examination
leakof contractor records, and theof contractor records, theof contractor records, the
://wikiAnti-Kickback Act (21 U. S.C. 57(a) and (b).Anti-Kickback Act, bonds ofcontractors of publicAnti-Kickback Act, bonds ofcontractors of public
httpbuildings, limits onbuildings, middlemen fees
subcontractor sales,solid waste disposal, and
middlemen fees, andveterans’ employment
veterans’ employmentreporting requirements.
reporting requirements.
(B) Appropriate internal(C) Same as S. 15 as(C) Same as S. 15 as(C) Same as S. 15 as
controls shall be developedReported by Committee.Reported by Committee.Reported by Committee.
for the use of this authority.

CRS-13
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
peditedSec. (a) “Sec. 409J (b)(2)” Sec. 2 (a) “Sec. 319F-1Sec. (a) “Sec. 409J (b)(2)” Sec. 2 (a) “Sec. 319F-1
ocure-Authorizes the use of “other(b)(2)” Same as S. 15 as Reported by(b)(2)”
tthan competitive procedures”Authorizes the use of “otherCommittee.Same as H.R. 2122.


in awarding contracts if thatthan competitive procedures”
tinued)which is being procured isin awarding contracts if that
available from a limitedwhich is being procured is
number of responsibleavailable from a limited
sources and no other type ofnumber of responsible
property or services willsources.
meet the need.
iki/CRS-RL32549
g/w
s.or
leak
://wiki
http

CRS-14
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
peditedNo similar provision.Sec. 2 (a) “Sec. 319F-1No similar provision.Sec. 2 (a) “Sec. 319F-1
ocure- (b)(2)(C)” (b)(2)(C)”
tAwards must comply withAwards must comply with
government-widegovernment-wide regulations
tinued)regulations, including(including requirements that
requirements that offers beoffers be solicited from as
solicited from as manymany potential sources as is
potential sources as ispracticable under the
practicable under thecircumstances, that required
circumstances, that requirednotices be published, and that
notices be published, and thatsubmitted offers be
iki/CRS-RL32549submitted offers beconsidered) as such
g/wconsidered.regulations apply to
s.orprocurements for which an
leakagency has authority to use
://wikiprocedures other thancompetitive procedures when
httpthe property or services
needed by the agency are
available from only one
responsible source or only
from a limited number of
responsible sources and no
other type of property or
services will satisfy the needs
of the agency.



CRS-15
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
peditedSec. 2 (a) “Sec. 409J (b)(3)”Sec. 2 (a) “Sec. 319F-1Sec. 2 (a) “Sec. 409J (b)(3)”Sec. 2 (a) “Sec. 319F-1Micro-
ocure-Procurements less than(b)(3)”Same as S. 15 as Reported by(b)(3)”purchase
t$15,000 for property orSame as S. 15 as Reported byCommittee.Same as S. 15 as Reported bymaximum
services related to pressingCommittee.Committee.would
tinued)countermeasure research andotherwise be
development needs can$2,500.


follow micropurchase
regulations. Appropriate
internal controls shall be
developed for the use of this
authority. Government
iki/CRS-RL32549purchase card preferences do
g/wnot apply to these purchases
s.orif they are greater than
leak$2,500.
://wiki
http

CRS-16
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
estingNo similar provision.Sec. 2 (a) “Sec. 319F-1No similar provision.Sec. 2 (a) “Sec. 319F-1
(b)(4)” (b)(4)”
Notwithstanding any otherNotwithstanding 28
seprovision of law, contractingU.S.C.18(f), 28 U.S.C. 1491
thoritiesagency decisions relating tosubsection (f), and 31 U.S.C.
countermeasure research and3556, contracting agency
development procurementdecisions relating to
can be reviewed by filing acountermeasure research and
protest with the contractingdevelopment procurement
agency or the Comptrollercan be reviewed by filing a
General. If there is a writtenprotest with the contracting
iki/CRS-RL32549finding that a review-relatedagency or the Comptroller
g/wdelay would harm the UnitedGeneral. If there is a written
s.orStates, the decision to makefinding that a review-related
leakthe award or procurement isdelay would harm the United
://wikicommitted to agencydiscretion. States, the decision to makethe award or procurement is
httpcommitted to agency
discretion.



CRS-17
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
peditedSec. (a) “Sec. 409J (c)” Sec. 2 (a) “Sec. 319F-1Sec. (a) “Sec. 409J (c)”Sec. 2 (a) “Sec. 319F-1
eviewAllows the HHS Secretary to(c)(1)” Same as S. 15 as Reported by(c)(1)”
use an expedited awardSame as S. 15 as Reported byCommittee.Same as S. 15 as Reported by
process, rather than theCommittee.Committee.
normal peer review process,
for grants, contracts, and
cooperative agreements less
than $1.5 million related to
biomedical countermeasure
R&D activity, if the
Secretary deems there is a
iki/CRS-RL32549pressing need for an
g/wexpedited award.
s.or
leakNo similar provision.Sec. 2 (a) “Sec. 319F-1No similar provision.Sec. 2 (a) “Sec. 319F-1
://wiki(c)(2)”Determination of whether to(c)(2)”Same as H.R. 2122.


httpemploy expedited peer
review with respect to
subsequent awards shall be
determined without regard to
the peer review procedures
used for any prior peer
review of that same award.

CRS-18
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
encySec. 2(a) “Sec. 409J (d)”No similar provision.Sec. 2(a) “Sec. 409J (d)”No similar provision.


HHS Secretary may acquire,Same as S. 15 as Reported by
lease, construct, improve,Committee.
renovate, remodel, repair,
operate, and maintain
laboratories, other research
facilities and equipment, and
other real or personal
property as the Secretary
determines necessary for the
purpose of performing,
iki/CRS-RL32549administering, and
g/wsupporting biomedical
s.orcountermeasure research and
leakdevelopment.
://wiki
http

CRS-19
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
Sec. 2 (a) “Sec. 409J (e)(1)” Sec. 2 (a) “Sec. 319F-1 (d)” Sec. 2 (a) “Sec. 409J (e)(1)”Sec. 2 (a) “Sec. 319F-1 (d)”
Authorizes the HHSSame as S. 15 as Reported bySame as S. 15 as Reported bySame as S. 15 as Reported by
ntractsSecretary to enter intoCommittee.Committee.Committee.
personal services contracts
with up to 30 experts or
consultants with no limit on
period of service.
No similar provision.Sec. 2 (a) “Sec. 319F-1No similar provision.Sec. 2 (a) “Sec. 319F-1
(d)(1)” (d)(1)”
Pay cannot exceed that of theSame as H.R. 2122.
iki/CRS-RL32549U. S. President.
g/w
s.orSec. 2 (a) “Sec. 409J (e)(2)” Sec. 2 (a) “Sec. 319F-1Sec. 2 (a) “Sec. 409J (e)(2)” Sec. 2 (a) “Sec. 319F-1
leakThese contractors are treated(d)(2)” Same as S. 15 as Reported by(d)(2)”
://wikias employees of HHS forFederal Tort Claims ActSame as S. 15 as Reported byCommittee.Committee.Same as S. 15 as Reported byCommittee.
httppurposes.
Sec. 2 (a) “Sec. 409J (e)(3)” Sec. 2 (a) “Sec. 319F-1Sec. 2 (a) “Sec. 409J (e)(3)” Sec. 2 (a) “Sec. 319F-1
Internal controls for this(d)(3)” Same as S. 15 as Reported by(d)(3)”
authority will beSame as S. 15 as Reported byCommittee.Same as S. 15 as Reported by
implemented. Committee. Committee.



CRS-20
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
Sec. 2 (a) “Sec. 409JNo similar provision.Sec. 2 (a) “Sec. 409JSec. 2 (a) “Sec. 319F-1
(e)(2)(C)” (e)(2)(C)” (d)(2)(C)”
ntractsThe United States has theSame as S. 15 as Reported bySame as S. 15 as Reported by
tinued)right to sue these contractorsCommittee.Committee.
to recover payments (and
litigation costs) made to any
claimant stemming from the
job-related gross misconduct
of these contractors. The
venue for this action will be
in the district court of the
iki/CRS-RL32549United States in which such
g/wcontractor resides or has its
s.orprincipal place of business.
leak
Sec. 2 (a) “Sec. 409J (f)” Sec. 2 (a) “Sec. 319F-1 (e)” Sec. 2 (a) “Sec. 409J (f)(1)” Sec. 2 (a) “Sec. 319F-1
://wikiThe HHS Secretary maySame as S. 15 as Reported bySame as S. 15 as Reported by(e)(1)”
httpappoint up to 30 professionalCommittee.Committee.Same as S. 15 as Reported by
and technical employees toCommittee.


help NIH respond to pressing
qualified countermeasure
research and development
needs without regard to
provisions governing
appointments in the
competitive service or pay
rates.

CRS-21
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
No similar provision.No similar provision.No similar provision.Sec. 2 (a) “Sec. 319F-1
(e)(2)”
(A) Recruitment and
tinued)appointments must be based
solely on the individual’s
abilities, knowledge, and
skills.
No similar provision.No similar provision.Sec. 2 (a) “Sec. 409J (f)(2)” (B) Same as S. 1504.These U.S.C.
Provisions in U.S.C. title 5provisions
relating to merit systeminclude
iki/CRS-RL32549principles, prohibitedprotections
g/wpersonnel practices andregarding
s.orpreference eligibility apply todiscrimin-
leakthese appointments. ation on the
://wikibasis ofpolitical
http affiliation,
race, color,
religion,
national
origin, sex,
marital
status, age,
or handicap.
This section
of U.S. Code
prohibits
appointment
of relatives.



CRS-22
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
Sec. 2 (a) “Sec. 409J (f)(2)”Sec. 2 (a) “Sec. 319F-1Sec. 2 (a) “Sec. 409J (f)(3)”Sec. 2 (a) “Sec. 319F-1
Internal controls for this(e)(2)” Same as S. 15 as Reported by(e)(3)
authority will beSame as S. 15 as Reported byCommittee.Same as S. 15 as Reported by
tinued) implemented. Committee. Committee.
Sec. 2 (a) “Sec. 409J (h)” Sec. 2 (a) “Sec. 319F-1 (f)”Sec. 2 (a) “Sec. 409J (h)” Sec. 2 (a) “Sec. 319F-1 (f)”
mmittedAll actions by the HHSAll actions by the HHSSame as S. 15 as Reported bySame as S. 15 as Reported by
gencySecretary under the authoritySecretary under the authorityCommittee.Committee.


scretionof this section are committedof this section are committed
to agency discretion.to agency discretion, except
iki/CRS-RL32549those deemed reviewable
g/wunder Sec. 319F-1 (b)(4).
s.or
leak
://wiki
http

CRS-23
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
Sec. 2 (b). Sec. 2 (b). Sec. 2 (b). Sec. 2 (b).
endment(1) Amends the PHSA (42(1) Same as S. 15 asSame as S. 15 as Reported by(1) Same as S. 15 as
U.S.C. 287a-2) to allow theReported by Committee.Committee.Reported by Committee.
Director of NIH to work
through the Director of
NIAID to fund public or
nonprofit entities to expand,
remodel, renovate or alter
existing research facilities or
construct new research
facilities. Increases the
iki/CRS-RL32549federal share from 50% to
g/w75% for NIAID funded
s.orprojects and from 40% to
leak75% of costs associated with
://wikiNIAID use for multipurposefacilities.
http
No similar provision.(2) Authorizes such sums asNo similar provision.(2) Authorizes such sums as
may be necessary for FY2003may be necessary for FY2004
and FY2004 to fund theseand FY2005 to fund these
improvements. improvements.



CRS-24
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
No similar provision.Sec. 2 (c) No similar provision.No similar provision.
ogram toThe HHS Secretary may
initiate and sustain a program
unter — that results in the delivery of
priority countermeasures for
placement in the Strategic
National Stockpile (SNS).
Authorizes the appropriation
of such sums as may be
necessary for each of the
fiscal years 2004 through
iki/CRS-RL32549 2013.
g/w
s.orNo similar provision.Sec. 2 (d)No similar provision.No similar provision.
leakccineAuthorizes the appropriation
ogram of such sums as may be
://wikinecessary for each of the
httpfiscal years 2004 through
2013 for the National
Vaccine Program.
No similar provision.Sec. 2 (e) No similar provision.Sec. 2 (d)
endmentAmends the PHSA to add theSame as H.R. 2122.


Secretary of Homeland
Security to the working
group on the preparedness,
prevention, and response to
bioterrorism and other public
health emergencies.

CRS-25
Table 3. Biomedical Countermeasures Procurement
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
Sec. 3 Sec. 3 Sec. 3 Sec. 3
Amends PHSA by addingAmends PHSA by addingSame as S. 15 as Reported bySame as H.R. 2122.
Sec. 319A-1.Sec. 319F-2.Committee.
er ofNo similar provision.Sec. 3 (a)No similar provision.Sec. 3 (a)
Transfers and amends theSame as H.R. 2122.


section of the Public Health
ockpileSecurity and Bioterrorism
Preparedness and Response
Act of 2002 (P.L. 107-188,
iki/CRS-RL3254942 U.S.C. 300hh-12) dealing
g/wwith the Strategic National
s.orStockpile (SNS, Sec. 121) to
leakthe Public Health Services
Act as section 319F-2.
://wiki
http

CRS-26
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
ockpileNo similar provision.Sec. 3 (a) “Sec. 319F-2No similar provision.Sec. 3 (a) “Sec. 319F-2S. 15 as
(a)(1)” (a)(1)” Enact e d
tDHS Secretary inHHS Secretary intransfers the
coordination with HHScoordination with DHSSNS from
Secretary and VA SecretarySecretary shall maintain theDHS to
shall maintain the StrategicStrategic National Stockpile. HHS.


National Stockpile.
No similar provision.In managing the StockpileNo similar provision.Same as H.R. 2122.
DHS Secretary shall:
iki/CRS-RL32549No similar provision.(A) consult with the WorkingNo similar provision.Same as H.R. 2122.
g/wGroup on Bioterrorism
s.ordefined in PHSA Sec. 319F
leak (a);
://wikiNo similar provision.(B) ensure adequateNo similar provision.Same as H.R. 2122.
httpprocedures for inventory
management and accounting,
and for the physical security
of the stockpile;
No similar provision.(C) take into considerationNo similar provision.Same as H.R. 2122.
the timing and location of
special events;

CRS-27
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
ockpileNo similar provision.(D) review and revise, theNo similar provision.Same as H.R. 2122.
contents of the stockpile on a
tregular basis to ensure that
tinued)emerging threats, advanced
technologies, and new
countermeasures are
adequately considered;
No similar provision.(E) devise plans for theNo similar provision.Same as H.R. 2122.


effective and timely supply-
chain management of the
iki/CRS-RL32549stockpile, in consultation
g/wwith appropriate Federal,
s.orState and local agencies, and
leakthe public and private health
care infrastructure;
://wiki
http

CRS-28
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
ockpileNo similar provision.No similar provision.No similar provision.(F) deploy the stockpile as
required by the Secretary of
tHomeland Security to
tinued)respond to an actual or
potential emergency;
No similar provision.No similar provision.No similar provision.(G) deploy the stockpile at
the discretion of the
Secretary to respond to an
actual or potential public
health emergency or other
iki/CRS-RL32549situation in which
g/wdeployment is necessary to
s.orprotect the public health or
leaksafety; and
://wikiNo similar provision.(F) ensure adequate stockpileNo similar provision.(H)Same as H.R. 2122.
httpphysical security.
ocure-No similar provision.Sec. 3 (a) “Sec. 319F-2No similar provision.Sec. 3 (a) “Sec. 319F-2
t (c)(1)(A)” (c)(1)(A)”
The special reserve fundSame as H.R. 2122.


defined in Sec. 319F-2
(c)(10) can be used to
procure security
countermeasures for the
SNS.

CRS-29
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
initionsSec. 3 “Sec. 319A-1 (h)(1)”Sec. 3 (a) “Sec. 319F-2Sec. 3 (a) “Sec. 319A-1Sec. 3 (a) “Sec. 319F-2H.R. 2122’s
SecurityDefines a qualified(c)(1)(B)”(h)(1)”(c)(1)(B)”definition of
unter — countermeasure as aDefines a securitySame as S. 15 as Reported byDefines a securitya priority
biomedical countermeasurecountermeasure as a priorityCommittee.countermeasure as a drug,counter-
for use against a CBRN agentcountermeasure against abiological product, or device measure is
alifiedidentified as a material threatCBRN agent identified as acountermeasure against afrom Sec.
unter — that is approved or cleared bymaterial threat, that isCBRN agent identified as a319F(h) of
the Food and Drugdetermined to be a necessarymaterial threat, that isthe Public
Administration (FDA) or acountermeasure under 391F-determined to be a necessaryHealth
biological product licensed2(c)(2)(B), and is approvedcountermeasure under 391F-Service Act.


by the HHS Secretary underor cleared by the Food and2(B)(ii), and is approved or
iki/CRS-RL3254942 U.S.C. 262,Drug Administration (FDA)cleared by the Food and Drug
g/wor a biological productAdministration (FDA) or a
s.orlicensed by the HHSbiological product licensed
leakSecretary under 42 U.S.C.by the HHS Secretary under

262,42 U.S.C. 262,


://wiki
httpor is a priorityor is a prioritySame as S. 15 as Reported byor is a countermeasure for
countermeasure for which thecountermeasure for which theCommittee.which the HHS Secretary
HHS Secretary determinesHHS Secretary determinesdetermines that sufficient and
that sufficient andthat sufficient andsatisfactory clinical
satisfactory clinicalsatisfactory clinicalexperience or research data
experience or research dataexperience or research datasupport a reasonable
support a reasonablesupport a reasonableconclusion that the
conclusion that theconclusion that thecountermeasure will qualify
countermeasure will qualifycountermeasure will qualifyfor approval or licensing
for approval or licensingfor approval or licensing inwithin eight years,
within five years.the future,

CRS-30
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
initionsNo similar provision.or is authorized forNo similar provision.Same as H.R. 2122.
Securityemergency use by the HHS
unter — Secretary.
alified
unter —
tinued)
termina-Sec. 3 “Sec. 319A-1 (a)(1)”Sec. 3 (a) “Sec. 319F-2Sec. 3 “Sec. 319A-1 (a)(1)”Sec. 3 (a) “Sec. 319F-2
iki/CRS-RL32549Requires the DHS Secretary(c)(2)(A)”Same as S. 15 as Reported by(c)(2)(A)”
g/wto determine, on an ongoingRequires the DHS SecretaryCommittee.Same as H.R. 2122.
s.orreatbasis, which CBRN agentsto determine, on an ongoing
leakpose a material risk of usebasis, which CBRN agents
against the U.S. population. pose a material threat.
://wiki
httptermina-Sec. 3 “Sec. 319A-1Sec. 3 (a) “Sec. 319F-2Sec. 3 “Sec. 319A-1Sec. 3 (a) “Sec. 319F-2
(a)(2)(A)”(c)(2)(B)” (a)(2)(A)”(c)(2)(B)”
blicRequires the HHS Secretary,Requires the HHS SecretarySame as S. 15 as Reported bySame as H.R. 2122.


in consultation with the DHSto determine the publicCommittee.
Secretary, to determine thehealth consequences of use
public health consequencesof any of the agents
of use of any of the agentsidentified by the DHS
identified by the DHSSecretary to pose a material
Secretary to pose a materialthreat, and to determine the
threat, and to determine theagents for which priority
agents for which prioritycountermeasures are
countermeasures arenecessary to protect the
necessary to protect thepublic health from a material
public health from a materialthreat.
threat.

CRS-31
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
tificationNo similar provision.Sec. 3 (a) “Sec. 319F-2No similar provision.Sec. 3 (a) “Sec. 319F-2
ongress (c)(2)(C)” (c)(2)(C)”
The DHS and HHSThe DHS and HHS
Secretaries will notifySecretaries will notify
Congress when any materialCongress when any material
threat, public health impact,threat, public health impact,
or necessary countermeasureor necessary countermeasure
determination is made. Suchdetermination is made.
notice shall be in unclassified
or, if necessary classified
form.
iki/CRS-RL32549
g/wNo similar provision.Sec. 3 (a) “Sec. 319F-2No similar provision.Sec. 3 (a) “Sec. 319F-2
s.or(c)(2)(D)” (c)(2)(D)”
leakreatAll information to which theSame as H.R. 2122.
ormationDHS Secretary is entitled,
://wikiregardless of classification
httplevel, will be used in making
material threat
determinations.
Sec. 3 “Sec. 319A-1 (b)”Sec. 3 (a) “Sec. 319F-2Sec. 3 “Sec. 319A-1 (b)”Sec. 3 (a) “Sec. 319F-2
The HHS Secretary, in(c)(3)” Same as S. 15 as Reported by(c)(3)”
ilityconsultation with the DHSSame as S. 15 as Reported byCommittee.Same as S. 15 as Reported by
Secretary, shall assess theCommittee.Committee.


availability and
unter — appropriateness of
countermeasures to address
identified material threats.

CRS-32
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
ll forSec. 3 “Sec. 319A-1 (c)(1)”Sec. 3 (a) “Sec. 319F-2Sec. 3 “Sec. 319A-1 (c)(1)”Sec. 3 (a) “Sec. 319F-2
velop-If a countermeasure is found(c)(4)(A)” Same as S. 15 as Reported by(c)(4)(A)”
appropriate but not available,If a countermeasure is foundCommittee.Same as H.R. 2122.


unter — the DHS and HHSappropriate but not available
Secretaries may jointlyor available but cleared only
submit, for presidentialfor alternative purposes, the
approval, a call for theDHS and HHS Secretaries
development of suchmay jointly submit, for
countermeasure and apresidential approval, a call
commitment to recommendfor the development of such
the procurement of the firstcountermeasure and a
iki/CRS-RL32549developed appropriatecommitment to recommend
g/wcountermeasure.the procurement of the first
s.ordeveloped appropriate
leakcountermeasure, using the
fund created by Sec. 319-
://wiki F(c)(10).
http

CRS-33
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
unter — Sec. 3 “Sec. 319A-1 (b)(2)”Sec. 3 (a) “Sec. 319F-2Sec. 3 “Sec. 319A-1 (b)(2)”Sec. 3 (a) “Sec. 319F-2
The HHS and DHS(c)(4)(B)” Same as S. 15 as Reported by(c)(4)(B)”
ica-Secretaries will, to the extentSame as S. 15 as Reported byCommittee.Same as S. 15 as Reported by
practicable, include in theCommittee.Committee.


proposal the estimated
quantity and price of the
future purchase, necessary
measures of minimum safety
and effectiveness, and any
other information necessary
to encourage and facilitate
iki/CRS-RL32549research, development, and
g/wmanufacture of the
s.orcountermeasure or to provide
leakspecifications for it.
://wiki
http

CRS-34
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
ifyingSec. 3 “Sec. 319A-1 (c)(3)”Sec. 3 (a) “Sec. 319F-2Sec. 3 “Sec. 319A-1 (c)(3)”Sec. 3 (a) “Sec. 319F-2
tentialIf the President approves a(c)(4)(C)”Same as S. 15 as Reported by(c)(4)(C)”
velopersproposal the DHS and HHSSame as S. 15 as Reported byCommittee.Same as S. 15 as Reported by
Secretaries shall make knownCommittee.Committee.
to persons who may respond
to a call for the
countermeasure involved —
the call for theSame as S. 15 as Reported bySame as S. 15 as Reported bySame as S. 15 as Reported by
countermeasure; Committee. Committee. Committee.
iki/CRS-RL32549the required specificationsSame as S. 15 as Reported bySame as S. 15 as Reported bySame as S. 15 as Reported by
g/wfor the countermeasure; and Committee.Committee.Committee.
s.or
leaka commitment for athe commitment described inSame as S. 15 as Reported bySame as H.R. 2122.


recommendation forSec. 3 (a) “Sec. 319F-2Committee.
://wikiprocurement of the first such(c)(4)(A)”
httpspecific countermeasure that[see above]
meets the conditions for
procurement under
subsection (d) and the
specifications under Sec. 3
“Sec. 319A-1 (d)(2)”
[see below]

CRS-35
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
Sec. 3 “Sec. 319A-1 (d)(1)”Sec. 3 (a) “Sec. 319F-2Sec. 3 “Sec. 319A-1 (d)(1)”Sec. 3 (a) “Sec. 319F-2
termina-The HHS Secretary, in(c)(5)(A)” Same as S. 15 as Reported by(c)(5)(A)”
consultation with the DHSThe HHS Secretary, inCommittee.Same as H.R. 2122.


unter — Secretary, will determine ifconsultation with the DHS
specific countermeasures areSecretary, will determine if
appropriate for procurementspecific countermeasures are
r Fundingusing the appropriationsappropriate for procurement
specified in Sec. 319A-1 (i).using the special reserve
fund defined in Sec. 319F-2
(c)(10).
iki/CRS-RL32549
g/w
s.or
leak
://wiki
http

CRS-36
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
Sec. 319A-1 (d)(2).Sec. 319F-2 (c)(5)(B).Sec. 319A-1 (d)(2).Sec. 3 (a) “Sec. 319F-2Both H.R.
termina-For countermeasures toIn making this determinationSame as S. 15 as Reported by(c)(5)(B)”2122 and S.
qualify for this funding thethe HHS Secretary willCommittee.Same as H.R. 2122.15 as
unter — HHS Secretary mustdetermine and consider:Enacted
determine:require the
Secretary
r Funding(B)(i) quantities of the(i) Same as S. 15 as ReportedSame as S. 15 as Reported by(i) Same as S. 15 as Reportedonly to
tinued)product that will be needed by Committee.Committee.by Committee.consider
for the SNS,whether
products
(B)(ii) feasibility of delivery(iii) Same as S. 15 asSame as S. 15 as Reported by(ii) feasibility of delivery ofhave other
iki/CRS-RL32549of sufficient quantities withinReported by Committee. Committee.sufficient quantities withinsignificant
g/wfive years, andeight years, andmarkets.
s.orThis allows
leak(C) that there is no(iii) whether there is a lack ofSame as S. 15 as Reported by(iii) Same as H.R. 2122.procurement
significant commerciala significant commercialCommittee.of products
://wikimarket for the product, at themarket for the product atthat have
httptime of this determination,time of procurement otheranother
other than as athan as a countermeasure.market.


countermeasure. This must
be annually redetermined.

CRS-37
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
Sec. 3. “Sec. 319A-1 (e)”Sec. 3 (a) “Sec. 319F-2Sec. 3. “Sec. 319A-1 (e)”Sec. 3 (a) “Sec. 319F-2
(1) If a countermeasure is(c)(6)”Same as S.15 as Reported by(c)(6)”
quireddeemed appropriate, the HHS(A) If a countermeasure isCommittee.Same as S.15 as Reported by
r Procure-and DHS Secretaries, indeemed appropriate, the HHSCommittee.
tcoordination with theand DHS Secretaries, in
Director of Office ofcoordination with the
Management and Budget,Director of Office of
will submit to the President aManagement and Budget,
proposal to procure thewill submit to the President a
countermeasure.proposal to procure the
countermeasure using the
iki/CRS-RL32549special reserve fund defined
g/win Sec. 319F-2 (c)(10).
s.or
leak(2) Presidential approval is(B) Same as S. 15 asSame as S.15 as Reported bySame as S.15 as Reported by
required to procureReported by Committee.Committee.Committee.


://wikicountermeasures under this
httpact.

CRS-38
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
tice toSec. 3 “Sec. 319A-1 (e)(3)”Sec. 3 (a) “Sec. 319F-2Sec. 3 “Sec. 319A-1 (e)(3)”Sec. 3 (a) “Sec. 319F-2
ngressThe DHS Secretary will(c)(6)(C)” Same as S.15 as Reported by(c)(6)(C)”
notify Congress of eachThe HHS and DHSCommittee.Same as H.R. 2122.
presidential decision toSecretaries will notify
approve the procurement ofdesignated congressional
countermeasures under thiscommittees of each
act.presidential decision to
approve the use of the special
reserve fund. This notice will
include:
iki/CRS-RL32549No similar provision.an explanation of theNo similar provision.Same as H.R. 2122.


g/wdecision to use the special
s.orreserve fund, the potential
leakcountermeasure supplier or
suppliers (when available),
://wikiand whether other potential
httpsuppliers were considered
and reasons for any rejection
of them.

CRS-39
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
Sec. 3 “Sec. 319A-1 (c)(4)”Sec. 3 (a) “Sec. 319F-2Sec. 3 “Sec. 319A-1 (c)(4)”Sec. 3 (a) “Sec. 319F-2
icCountermeasures developed(c)(6)(D)” Same as S.15 as Reported by(c)(6)(D)”
unter — after a procurement can alsoSame as S.15 as Reported byCommittee.Same as S.15 as Reported by
be procured under this act ifCommittee.Committee.
they represent an
improvement over the
original countermeasure.
Examples of qualifying
improvements are better
safety or effectiveness.
iki/CRS-RL32549No similar provision.Determination of anNo similar provision.Same as H.R. 2122.
g/wimprovement is committed to
s.oragency discretion.
leak
No similar provision.Sec. 3 (a) “Sec. 319F-2No similar provision.Sec. 3 (a) “Sec. 319F-2
://wiki(c)(6)(E)” (c)(6)(E)”
httpRecommendations andSame as H.R. 2122.


approvals under Sec. 319F-2
(c)(6) are to the
determination that the special
reserve fund will be used for
a procurement; not to the
substance of contracts nor
other matters relating to
awards.

CRS-40
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
No similar provision.Sec. 3 (a) “Sec. 319F-2No similar provision.Sec. 3 (a) “Sec. 319F-2
reements(c)(7)(A)-(B)” (c)(7)(A)-(B)”
r Procure-The DHS Secretary willSame as H.R. 2122.
treimburse the HHS Secretary
for all costs of presidentially
approved countermeasure
procurements.
Sec. 3 “Sec. 319A-1However, the special reserveSame as S. 15 as Reported bySame as H.R. 2122.
(i)(2)(C)”fund cannot be used toCommittee.
Funds appropriated underreimburse administrative
iki/CRS-RL32549this subsection cannot becosts.
g/wused for administrative costs.
s.or
leakocure-Sec. 3 “Sec. 319A-1 (f)(1)”Sec 3 (a) “Sec. 319F-2Sec. 3 “Sec. 319A-1 (f)(1)”Sec 3 (a) “Sec. 319F-2
t The HHS Secretary is(c)(7)(C)(i)” Same as S. 15 as Reported by(c)(7)(C)(i)”
://wikiresponsible for arranging forSame as S. 15 as Reported byCommittee.Same as S. 15 as Reported by
httpcountermeasure procurement,Committee.Committee.
including negotiating terms
of (including quantity,
production schedule, and
price), and entering into,
contracts and cooperative
agreements, and for carrying
out such other activities as
may reasonably be required.
The HHS Secretary willSame as S. 15 as Reported bySame as S. 15 as Reported bySame as S. 15 as Reported by
promulgate any regulationsCommittee.Committee.Committee.


necessary to implement these
procurement provisions.

CRS-41
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
ntractSec. 3 “Sec. 319A-1 (f)(2)”Sec. 3 (a) “Sec. 319F-2Sec. 3 “Sec. 319A-1 (f)(2)”Sec 3 (a) “Sec. 319F-2
The procurement contracts(c)(7)(C)(ii)”Same as S. 15 as Reported by(c)(7)(C)(ii)”
will include the followingSame as S. 15 as Reported byCommittee.Same as S. 15 as Reported by
terms: Committee. Committee.
Payment conditioned onSame as S. 15 as Reported bySame as S. 15 as Reported bySame as S. 15 as Reported by
delivery of a substantialCommittee.Committee.Committee.
portion of the number of
contracted units.
No similar provision.Up to a 10% advanceNo similar provision.Up to a 10% advance
iki/CRS-RL32549payment to ensure success ofpayment to ensure success of
g/wa project can be made at thea project can be made at the
s.ordiscretion of HHS Secretary. discretion of HHS Secretary.
leakThis advance payment mustThis advance payment must
be refunded if the contractorbe refunded if the contractor
://wikifails to perform under thefails to perform under the
httpterms of the contract exceptterms of the contract.
in special circumstances as
determined by the Secretary.
The contract period cannotThe contract period cannotSame as S. 15 as Reported bySame as H.R. 2122.


be longer than five years. be longer than five years, orCommittee.
up to eight years if the HHS
Secretary determines at the
time of initial award that a
longer period is justified.

CRS-42
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
ntractContracts may be renewedSame as S. 15 as Reported bySame as S. 15 as Reported bySame as S. 15 as Reported by
for additional periods of upCommittee.Committee.Committee.
tinued)to five years each.
No similar provisions.The vendor must complyNo similar provisions.Same as H.R. 2122.
with all applicable export-
related controls.
The vendor must seekNo similar provisions.Same as S. 15 as Reported bySame as S. 15 as Reported by
approval, clearance orCommittee.Committee.


licensing of product. The
iki/CRS-RL32549HHS Secretary may waive
g/wthis provision.
s.or
leak
://wiki
http

CRS-43
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
ntractThe contract may specify: The contract may specify: The contract may specify: The contract may specify:
tinued)That the vendor must storeSame as S. 15 as Reported bySame as S. 15 as Reported bySame as S. 15 as Reported by
the countermeasure. In thisCommittee.Committee.Committee.
case the special fund can be
used to pay the vendor for
the costs of shipping,
handling, storage and related
costs of the countermeasure
a discounted price for a No similar provision.Same as S. 15 as Reported bySame as S. 15 as Reported by
iki/CRS-RL32549product that has not beenCommittee.Committee.
g/wlicensed or approved at the
s.ortime of delivery, and
leak
that the HHS Secretary mayNo similar provision.Same as S. 15 as Reported byNo similar provision.


://wikiterminate the contract for theCommittee.
httpfailure to deliver a reasonable
number (as determined by
the Secretary) of units of
product by three years after
the contract commenced.

CRS-44
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
ilitySec. 3 “Sec. 319A-1 (f)(3)”Sec. 3 (a) “Sec. 319F-2Sec. 3 “Sec. 319A-1 (f)(3)”Sec 3 (a) “Sec. 319F-2
Simplified acquisition(c)(7)(C)(iii)(I)”Same as S. 15 as Reported by(c)(7)(C)(iii)(I)”
mplifiedprocedures will apply to allSimplified acquisitionCommittee.Same as H.R. 2122.
quisitioncountermeasureprocedures will apply to
oceduresprocurements under thiscountermeasure
section.procurements for which the
HHS Secretary determines
that there is pressing need.
No similar provision.Sec. 3 (a) “Sec. 319F-2Sec. 3 “Sec. 319A-1Sec. 3 (a) “Sec. 319F-2
(c)(7)(C)(iii)(II)” (f )(3)(B)” (c)(7)(C)(iii)(II)”
iki/CRS-RL32549These purchases mustThese purchases mustThese purchases must
g/wcomply with laws andcomply with laws andcomply with laws and
s.orregulations relating toregulations relating toregulations relating to
leakcontract work hours andcontract work hours andcontract work hours and
safety standards, examinationsafety standards, examinationsafety standards, examination
://wikiof contractor records, and theof contractor records, theof contractor records, the
httpAnti-Kickback Act. Anti-Kickback Act, bonds ofAnti-Kickback Act, bonds of
contractors of publiccontractors of public
buildings, limits onbuildings, middlemen fees,
subcontractor sales,the Solid Waste Disposal Act,
middlemen fees, andand veterans’ employment
veterans’ employmentreporting requirements.
reporting requirements.
No similar provision.No similar provision.No similar provision.Sec 3 (a) “Sec. 319F-2
(c)(7)(C)(iii)(III)”
The Secretary shall establish
appropriate internal controls
for procurements under this
clause.



CRS-45
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
No similar provision.No similar provision.No similar provision.Sec. 3 (a) “”Sec. 319F-2
m i t (c)(7)(C)(iii)(IV) ”
mpetitionIf the Secretary determines
that the mission of the
BioShield Program under the
Project BioShield Act of
2004 would be seriously
impaired by fair and open
competition, the Secretary
may conduct a procurement
using other than fair and
iki/CRS-RL32549open competition.
g/w
s.ore ofSec. 3 “Sec. 319A-1 (f)(4)”Sec. 3 (a) “Sec. 319F-2Sec. 3 “Sec. 319A-1 (f)(4)”Sec. 3 (a) “Sec. 319F-2
leakoceduresAuthorizes the use of(c)(7)(C)(iv)”Same as S. 15 as Reported by(c)(7)(C)(iv)”
noncompetitive procedures toAuthorizes the use of otherCommittee.Same as H.R. 2122.


://wikill andprocure a product availablethan competitive procedures
httpenfrom a limited number ofto procure a product
mpetitionresponsible sources. available from a limited
number of responsible
sources.

CRS-46
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
e ofNo similar provision.The Secretary shallNo similar provision.The Secretary shall
oceduresimplement this clause inimplement this clause in
accordance withaccordance with
ll andgovernment-wide regulationsgovernment-wide regulations
enincluding requirements thatincluding requirements that
mpetitionoffers be solicited from asoffers be solicited from as
tinued)many potential sources as ismany potential sources as is
practicable under thepracticable under the
circumstances, that requiredcircumstances, that required
notices be published, and thatnotices be published, and that
submitted offers besubmitted offers be
iki/CRS-RL32549considered.considered, as such
g/wregulations apply to
s.orprocurements for which an
leakagency has authority to use
procedures other than
://wikicompetitive procedures when
httpthe property or services
needed by the agency are
available from only one
responsible source or only
from a limited number of
responsible sources and no
other type of property or
services will satisfy the needs
of the agency.



CRS-47
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
Sec. 3 “Sec. 319A-1 (f)(5)”Sec. 3 (a) “Sec. 319F-2Sec. 3 “Sec. 319A-1 (f)(5)”Sec. 3 (a) “Sec. 319F-2
ovision inThe HHS Secretary may(c)(7)(C)(v)”Same as S. 15 as Reported by(c)(7)(C)(v)”
ltipleenter into contracts for aSame as S. 15 as Reported byCommittee.Same as S. 15 as Reported by
ardsingle countermeasure withCommittee.Committee.
ntractsmore than one vendor. In
these cases contracts may be
constructed to award a
greater share of the
procurement to the first
vendor to successfully meet
the terms of the contract.
iki/CRS-RL32549
g/wDeterminations of theSame as S. 15 as Reported bySame as S. 15 as Reported bySame as S. 15 as Reported by
s.orsuccess of meeting all of theCommittee.Committee.Committee.
leakrequirements by the HHS
Secretary are committed to
://wikiagency discretion.
http
tension ofSec. 3 “Sec. 319A-1 (f)(6)”Sec. 3 (a) “Sec. 319F-2Sec. 3 “Sec. 319A-1 (f)(6)”Sec. 3 (a) “Sec. 319F-2
A decision by the HHS(c)(7)(C)(vi)”Same as S. 15 as Reported by(c)(7)(C)(vi)”
e forSecretary to extend theSame as S. 15 as Reported byCommittee.Same as S. 15 as Reported by
closing date for receipt ofCommittee.Committee.


oposals isproposals for a procurement
is committed to agency
ablediscretion.

CRS-48
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
mitingSec. 3 “Sec. 319A-1 (f)(7)”Sec. 3 (a) “Sec. 319F-2Sec. 3 “Sec. 319A-1 (f)(7)”Sec. 3 (a) “Sec. 319F-2
mpetitionThe HHS Secretary may(c)(7)(C)(vii)” Same as S. 15 as Reported by(c)(7)(C)(vii)”
stipulate that all potentialSame as S. 15 as Reported byCommittee.Same as S. 15 as Reported by
ngsources must provide, onCommittee.Committee.
request, information that
ormationwould allow the HHS to use
questsadvance procurement
planning or market research.
Vendors who do not provide
such information can be
excluded from consideration.
iki/CRS-RL32549
g/wSec. 3 “Sec. 319A-1 (g)”Sec. 3 (a) “Sec. 319F-2Sec. 3 “Sec. 319A-1 (g)”Sec. 3 (a) “Sec. 319F-2
s.orreementsHHS and DHS Secretaries(c)(8)”Same as S. 15 as Reported by(c)(8)”
leakmay enter into interagencySame as S. 15 as Reported byCommittee.Same as S. 15 as Reported by
agreements with otherCommittee.Committee.
://wikifederal agencies to facilitate
httpprocuring these
countermeasures.
Only the DHS and HHSSame as S. 15 as Reported bySame as S. 15 as Reported bySame as S. 15 as Reported by
Secretaries may exercise theCommittee.Committee.Committee.


authorities provided by this
section.

CRS-49
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
strictionsSec. 3 “Sec. 319A-1 (i)(2)”Sec. 3 (a) “Sec. 319F-2Sec. 3 “Sec. 319A-1 (i)(2)”Sec. 3 (a) “Sec. 319F-2
Amounts appropriated under(c)(9)”Same as S. 15 as Reported by(c)(9)”
ndsthis Act cannot be used toThe special reserve fundCommittee.Same as H.R. 2122.
pay for:cannot be used to pay for:
(A) vaccines under(A) vaccines underSame as S. 15 as Reported bySame as H.R. 2122.
procurement contractsprocurement contractsCommittee.
entered into before Januaryentered into before the
1, 2003, orenactment of this Act or
(B) new contracts orNo similar provision.Same as S. 15 as Reported byNo similar provision.
iki/CRS-RL32549obligations for procuring aCommittee.
g/wcountermeasure after a
s.ordetermination that it has
leaksignificant commercial
market other than as a
://wikicountermeasure and;
http
(C) administrative costs.(B) Same as S. 15 asSame as S. 15 as Reported by(B) costs other than
Reported by Committee.Committee.payments made by the
Secretary to a vendor for a
procurement of a security
countermeasure under Sec.

319F-2 (c)(7).



CRS-50
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
initionsNo similar provision.Sec. 3 (a) “Sec. 319F-2No similar provision.Sec. 3 (a) “Sec. 319F-2
(c)(10)(A)” (c)(10)(A)”
Special reserve fund in thisSame as H.R. 2122.
section has the same meaning
as special reserve fund in
Sec. 510 of the Homeland
Security Act of 2002 (6
U.S.C. 311 et seq.)
No similar provision.Designates specificNo similar provision.Designates specific
congressional committees forcongressional committees for
iki/CRS-RL32549reporting purposes:reporting purposes:
g/w
s.orIn the House of Same as H.R. 2122.
leakRepresentatives: the
Committee on Energy and
://wikiCommerce, the Committee
httpon Appropriations, the
Committee on Government
Reform, and the Select
Committee on Homeland
Security (or any successor to
the Select Committee).
In the Senate: the CommitteeIn the Senate: the
on Health, Education, Labor,appropriate committees.


and Pensions, the Committee
on Appropriations, and the
Committee on Government
Affairs.

CRS-51
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
initionsSec. 3 “Sec. 319A-1 (h)(2)”Sec. 2 (e).Sec. 3 “Sec. 319A-1 (h)(2)”Sec. 2 (a) “Sec. 319F-1
tinued)Defines biomedicalThe PHSA, as modified bySame as S. 15 as Reported by(a)(2)” and Sec. 2 (d)
countermeasure as a drug,this legislation, defines aCommittee.Same as S. 15 as Reported by
biological product, or devicecountermeasure as a drug,Committee.
used:biological product, device,
vaccine, vaccine adjuvant,
antiviral, or diagnostic test
that can be used
(1) to treat, identify, or(1) to treat, identify, orSame as S. 15 as Reported bySame as S. 15 as Reported by
prevent harm from anyprevent infection by aCommittee.Committee.
iki/CRS-RL32549CBRN agent that may causebiological agent or toxin or
g/wa public health emergencyharm from any other agent
s.oraffecting national security; or that may cause a public
leakhealth emergency; or
://wiki(2) to treat, identify, or(2) Same as S. 15 asSame as S. 15 as Reported bySame as S. 15 as Reported by
httpprevent harm from aReported by Committee.Committee.Committee.


condition that may result in
adverse health consequences
or death and may be caused
by the administering of a
countermeasure described in
(1).

CRS-52
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
No similar provision.Sec. 3 (a) “Sec. 319F-2 (d-No similar provision.Sec. 3 (a) “Sec. 319F-2 (d-
end- f)” f)”
tsThese subsections makeSame as H.R. 2122.
technical amendments
required by the transfer of
the SNS from the Public
Health Security and
Bioterrorism Preparedness
and Response Act of 2002 to
the PHSA.
iki/CRS-RL32549endmentNo similar provision.Sec. 3 (b)No similar provision.Sec. 3 (b)
g/wNo similar provision.(1) Amends Homeland
s.ordSecurity Act (P.L. 107-296)
leakctto be consistent with the
transfer of the Strategic
://wikiNational Stockpile to the
httpdirect control of the HHS
Secretary.
Adds to the HomelandSame as H.R. 2122.


Security Act of 2002 (P.L.
107-296, 6 U.S.C. 311 et
seq.) “Sec. 510 Procurement
of Security Countermeasures
for the Strategic National
Stockpile.”

CRS-53
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
-Sec. 3 “Sec. 319A-1 (i)”Sec. 3 (b) “Sec. 510 (a)”Sec. 3 “Sec. 319A-1 (i)”Sec. 3 (b) “Sec. 510 (a)”The 2004
Appropriates, out of anyAuthorizes the appropriationAuthorizes the appropriationSame as H.R. 2122.DHS
a-moneys in the Treasury notof up to $5.593 billion forof up to $5.593 billion forAppropri-
otherwise appropriated, forFY2004-2013 forFY2004-2013 forations Act
FY2003 and for each fiscalpresidentially approvedpresidentially approved(P.L. 108-90)
year thereafter, such sums ascountermeasures.countermeasures.appropriated
may be necessary for the$5.593
costs incurred by the HHSbillion for
Secretary in the procurementFY2004-
of presidentially approvedFY2013 for
countermeasures. “Biodefense
iki/CRS-RL32549 Counter-
g/wOf this total, not more thanOf this total, not more thanSame as H.R. 2122.measures”
s.or$3.418 billion may be$3.418 billion may bewith
leakobligated for FY2004-2008authorized for FY2004-2008identical
and not more than $890and not more than $890obligation
://wikimillion for FY2004. Thismillion for FY2004.constraints.
httpmoney goes into the special
reserve fund as defined in
Sec. 510 (b).
inition ofNo similar provision.Sec. 3 (b) “Sec. 510 (b)”No similar provision.Sec. 3 (b) “Sec. 510 (b)”S. 15 as
Special reserve fund meansSpecial reserve fund meansEnacted uses
servethe appropriations accountthe “Biodefensethe identical
ndestablished as a result of anyCountermeasures”language
appropriations made underappropriations account orused in the
Sec. 510 (a). any other appropriation made2004 DHS
under Sec. 510 (a).Appropria-
tions Act.



CRS-54
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
mits onNo similar provision.Sec. 3 (b) “Sec. 510 (c)”No similar provision.Sec. 3 (b) “Sec. 510 (c)”
(1) It is the intent of theNo similar provision.
serveCongress that unobligated
nd amounts in this fund will not
be applied, through
reprogramming or otherwise,
to any other purpose.
No similar provision.(2)Appropriations to theNo similar provision.Same as H.R. 2122.


special reserve fund are
available to be obligated
iki/CRS-RL32549through FY2013 and only for
g/wpresidentially approved
s.or countermeasures.
leak
://wiki
http

CRS-55
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
latedNo similar provision.Sec. 3 (b) “Sec. 510 (d)(1)”No similar provision.Sec. 3 (b) “Sec. 510 (d)(1)”
Authorizes the appropriationAuthorizes the appropriation
of $5 million for FY2003 andof such sums as may be
a-such sums as may benecessary for FY2004-2006
necessary for FY2004-2006for the hiring of CBRN
for the hiring of Chemical,threat assessment analysts
Biological, Radiological, andwithin the DHS IAIP.
Nuclear (CBRN) threat
assessment analysts within
the DHS Directorate for
Information Analysis and
iki/CRS-RL32549Infrastructure Protection
g/w (IAIP).
s.or
leakNo similar provision.Sec. 3 (b) “Sec. 510 (d)(2)”No similar provision.Sec. 3 (b) “Sec. 510 (d)(2)”
Authorizes the appropriationAuthorizes the appropriation
://wikiof such sums as may beof such sums as may be
httpnecessary for FY2003-necessary for FY2004-
FY2006 for the acquisitionFY2006 for the acquisition
and deployment of secureand deployment of secure
facilities to permit the DHSfacilities to permit the DHS
Secretary to receive (by theSecretary to receive (not
end of 2003) all classifiedlater than 180 days after
information and products toenactment) all classified
which the Undersecretary forinformation and products to
IAIP is entitled.which the Undersecretary for
IAIP is entitled.



CRS-56
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
ockpileNo similar provision.No similar provision.No similar provision.Sec. 3 (c)
nctionsThe functions, personnel,
ansferredassets, unexpended balances,
om DHSand liabilities of the Strategic
National Stockpile are
transferred from the DHS
Secretary to the HHS
Secretary.
Exceptions: Duties of the
DHS Secretary described in
iki/CRS-RL32549this act and the “Biodefense
g/wCountermeasure” funds
s.orappropriated in the 2004
leakDHS Appropriations Act
(P.L. 108-90) are not
://wiki transferred.


http

CRS-57
Table 4. Authorization for Medical Products for Use in Emergencies
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
Sec. 4 Sec. 4Sec. 4 Sec. 4
Authorization for MedicalSame as S. 15 as Reported bySame as S. 15 as Reported bySame as S. 15 as Reported by
Products for Use inCommittee.Committee.Committee.
Emergencies. Amends
Subchapter E of chapter V of
the Federal Food, Drug, and
Cosmetic Act (21 U.S.C.
360bbb et seq.) by adding
“Sec. 564. Authorization for
iki/CRS-RL32549Medical Products for Use in
g/wEmerge ncies.”
s.or
leaka-Sec. 4 (a) “Sec. 564 (a)”Sec. 4 (a) “Sec. 564 (a)”Sec. 4 (a) “Sec. 564 (a)”Sec. 4 (a) “Sec. 564 (a)”
toThe HHS Secretary maySame as S. 15 as Reported bySame as S. 15 as Reported bySame as S. 15 as Reported by
://wiki the authorize the temporaryCommittee.Committee.Committee.


httpergencyintroduction into interstate
acommerce, of a drug, device,
unter-or biological product
intended for use in an actual
or potential emergency.

CRS-58
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
No similar provision.Sec. 4 (a) “Sec. 564 (a)(2)”No similar provision.Sec. 4 (a) “Sec. 564 (a)(2)”
The HHS Secretary maySame as H.R. 2122.
oductmake emergency use
authorizations for products
that are not approved,
licensed, or cleared for
commercial distribution
(unapproved products) and
for products that are
approved for other uses
(unapproved use of an
iki/CRS-RL32549approved product).
g/w
s.orlation toNo similar provision.Sec. 4 (a) “Sec. 564 (a)(3)”No similar provision.Sec. 4 (a) “Sec. 564 (a)(3)”
leaksesEmergency useSame as H.R. 2122.


authorizations are in addition
://wikito any other approved uses of
httpthe product.

CRS-59
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
initionsNo similar provision.Sec. 4 (a) “Sec. 564 (a)(4)”No similar provision.Sec. 4 (a) “Sec. 564 (a)(4)”The PHSA
Biological product has theSame as H.R. 2122.defines
meaning given in sec. 351 ofbiological
the PHSA.product as “a
virus,
Emergency use means theSame as H.R. 2122.therapeutic
use of a product during anserum, toxin,
actual emergency or potentialantitoxin,
emergency. vaccine,
blood, blood
Product means a drug, deviceSame as H.R. 2122.component
iki/CRS-RL32549or biological product.or derivative,
g/w allergenic
s.orAn unapproved product is aSame as H.R. 2122.product, or
leakproduct without approval,analogous
://wikilicense, or clearance forcommercial distribution.product, or ...any trivalent
http organic
An unapproved use of anSame as H.R. 2122.arsenic
approved product is the usecompound,
of a product that is notapplicable to
approved for that use but hasthe
been approved for anotherprevention,
use.treatment, or
cure of a
disease or
condition of
human
beings .”



CRS-60
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
ergencySec. 4 (a) “Sec. 564 (b)(1)”Sec. 4 (a) “Sec. 564 (b)(1)”Sec. 4 (a) “Sec. 564 (b)(1)”Sec. 4 (a) “Sec. 564 (b)(1)”
The HHS Secretary mayThe HHS Secretary mayThe HHS Secretary mayThe HHS Secretary may
declare an emergency if:declare an emergency if:declare an emergency if:declare an emergency if:
(A) The Homeland Security(A) The Homeland SecuritySame as S. 15 as Reported bySame as S. 15 as Reported by
(DHS) Secretary determines(DHS) Secretary determinesCommittee.Committee.
that there is a domesticthat there is a national
emergency or significantemergency or significant
potential for one involvingpotential for one involving
the heightened risk of attackthe heightened risk of attack
with a specified biological,with a specified biological,
iki/CRS-RL32549chemical, radiological orchemical, radiological or
g/wnuclear (CBRN) agent, ornuclear (CBRN) agent, or
s.or
leak(B) The Defense Secretary(B) The Defense SecretarySame as S. 15 as Reported bySame as S. 15 as Reported by
://wikidetermines that there is amilitary emergency ordetermines that there is amilitary emergency orCommittee.Committee.


httpsignificant potential for onesignificant potential for one
involving the heightened riskinvolving the heightened risk
to U.S. military forces ofto U.S. military forces of
attack with a CBRN agent, orattack with a specified CBRN
agent, or

CRS-61
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
ergency(C) the HHS SecretarySame as S. 15 as Reported bySame as S. 15 as Reported bySame as S. 15 as Reported by
determines that there is aCommittee.Committee.Committee.
tinued)public health emergency
under Section 319 of the
PHSA affecting national
security and involving a
specified CBRN agent, or a
specified disease or condition
that may be attributable to
such agent.
iki/CRS-RL32549Sec. 4 (a) “Sec. 564Sec. 4 (a) “Sec. 564Sec. 4 (a) “Sec. 564Sec. 4 (a) “Sec. 564
g/wation (b)(2)(A)” (b)(2)(A)” (b)(2)(A)” (b)(2)(A)”
s.orAn emergency declarationSame as S. 15 as Reported bySame as S. 15 as Reported bySame as S. 15 as Reported by
leakwill terminate on the earlierCommittee.Committee.Committee.


of:
://wiki
http(i) a determination by the
HHS Secretary, in
consultation with the DHS
Secretary or Defense
Secretary that the
circumstances requiring the
declaration no longer exist,
or
(ii) one year from the
declaration date.

CRS-62
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
Sec. 4 (a) “Sec. 564Sec. 4 (a) “Sec. 564Sec. 4 (a) “Sec. 564Sec. 4 (a) “Sec. 564
ne w a l (b)(2)(B)” (b)(2)(B)” (b)(2)(B)” (b)(2)(B)”
The HHS Secretary maySame as S. 15 as Reported bySame as S. 15 as Reported bySame as S. 15 as Reported by
renew a declaration. Committee.Committee.Committee.
Renewed declarations will be
subject to termination under
the above conditions and
may also be renewed.
spositionNo similar provision.No similar provision.No similar provision.Sec. 4 (a) “Sec. 564
P r oduct (b)(2)(C)”
iki/CRS-RL32549If an emergency use
g/wauthorization of an
s.orunapproved product is
leakterminated, the Secretary
shall consult with the
://wikimanufacturer of such product
httpwith respect to the
appropriate disposition of the
product.



CRS-63
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
No similar provision. Sec. 4 (a) “Sec. 564 (b)(3)”No similar provision. Sec. 4 (a) “Sec. 564 (b)(3)”
tice ofThe HHS Secretary mustSame as H.R. 2122.
ationprovide advanced
notification that the
declaration will be
terminated to allow enough
time to:
(A) allow removal of
unapproved products from
distribution channels and
iki/CRS-RL32549
g/w(B) allow labeling changes
s.orfor products used for
leakunapproved uses.
://wikiblicationSec. 4 (a) “Sec. 564 (b)(3)”Sec. 4 (a) “Sec. 564 (b)(4)”Sec. 4 (a) “Sec. 564 (b)(3)”Sec. 4 (a) “Sec. 564 (b)(4)”H.R. 2122
httpThe HHS Secretary mustThe HHS Secretary mustSame as S. 15 as Reported byThe HHS Secretary mustSec. 5
publish in the Federalpublish in the FederalCommittee.publish in the Federal(a)(1)(A)(iii)
Register and notify theRegister each declaration,Register each declaration,(II) requires
appropriate congressionaldetermination and renewal.determination, advancedan annual
committees of eachnotice of termination, andreport to
declaration, determinationrenewal.Congress
and renewal.detailing any
such
declaration.
See below.



CRS-64
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
ergencySec. 4 “Sec. 564 (c)” Sec. 4 “Sec. 564 (c)” Sec. 4 “Sec. 564 (c)” Sec. 4 “Sec. 564 (c)”
a-The HHS Secretary mayThe HHS Secretary maySame as S. 15 as Reported bySame as H.R. 2122.
authorize the emergency useauthorize the emergency useCommittee.
of a product only if the of a product only if, after
Secretary concludes — consultation with the
Director of the National
Institutes of Health and the
Director of the Centers for
Disease Control and
Prevention, the Secretary
concludes —
iki/CRS-RL32549
g/w(1) that an agent specified inSame as S. 15 as Reported bySame as S. 15 as Reported bySame as S. 15 as Reported by
s.orthe emergency declarationCommittee.Committee.Committee.
leakcan cause a serious or life-
://wikithreatening disease orcondition;
http
(2) that, based on the totalitySame as S. 15 as Reported bySame as S. 15 as Reported bySame as S. 15 as Reported by
of scientific evidenceCommittee.Committee.Committee.
available to the Secretary, it
is reasonable to believe that

Same as S. 15 as Reported bySame as S. 15 as Reported by(A) the product may be
(A) the product may beCommittee.Committee.effective in diagnosing,
effective in detecting,treating, or preventing a life-
diagnosing, treating, orthreatening disease or
preventing a life-threateningcondition caused by that
disease or condition causedagent or by a countermeasure
by that agent or by aagainst that agent; and


countermeasure against that

CRS-65
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
ergency(B) the known and potentialSame as S. 15 as Reported bySame as S. 15 as Reported bySame as S. 15 as Reported by
a-benefits of the product Committee.Committee.Committee.
outweigh its known and
tinued)potential risks.
(3) that there is no adequate,Same as S. 15 as Reported bySame as S. 15 as Reported by(3) that there is no adequate,
approved, and availableCommittee.Committee.approved, and available
alternative to the product foralternative to the product for
detecting, diagnosing,diagnosing, preventing, or
preventing, or treating suchtreating such disease or
disease or condition; andcondition; and
iki/CRS-RL32549
g/w
s.or(4) that such other criteria asSame as S. 15 as Reported bySame as S. 15 as Reported bySame as S. 15 as Reported by
leakthe Secretary may byCommittee.Committee.Committee.


://wikiregulation prescribe aresatisfied.
http

CRS-66
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
ergencySec. 4 “Sec. 564 (d)”Sec. 564 (d)(1).Sec. 4 “Sec. 564 (d)”Sec. 4 (a) “Sec. 564 (d)”
a-An authorization of a productSame as S. 15 as Reported bySame as S. 15 as Reported bySame as S. 15 as Reported by
under this section shall stateCommittee.Committee.Committee.

(A) each disease or condition(1)Same as S. 15 as Reported(1) Same as S. 15 as
(1) each disease or conditionfor which the product may beby Committee.Reported by Committee.
and the intended use of theused within the scope of the
product within the scope ofauthorization;
the authorization; and
(B) the Secretary’sNo similar provision.(2) Same as H.R. 2122
No similar provision.conclusions, that the known
iki/CRS-RL32549and potential benefits of the
g/wproduct, outweigh the known
s.orand potential risks of the
leakproduct; and
://wiki(C) Same as S. 15 as(2) Same as S. 15 as(3) the Secretary’s
http(2) the Secretary’sReported by Committee.Reported by Committee.conclusions, concerning the
conclusions, concerning thesafety and potential
safety and potentialeffectiveness of the product
effectiveness of the productin diagnosing, preventing, or
in detecting, diagnosing,treating such diseases or
preventing, or treating suchconditions, including an
diseases or conditions,assessment of the available
including an assessment ofscientific evidence.


the available scientific
evidence.

CRS-67
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
identialNo similar provision.Sec. 564 (d)(2).No similar provision.No similar provision.These
ormationNothing in this section alterssections of
or amends 18 U.S.C. 1905 orthe United
5 U.S.C. 552(b)(4).States Code
require the
confidential
handling of
financial
information
of any
person, firm,
iki/CRS-RL32549 partnership,
g/w corporation,
s.or association.
leakThis includes
://wikitrade secretsand
http information
on processes
and
operations.



CRS-68
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
quiredSec. 4 “Sec. 564 (e)”Sec. 4(a) “Sec. 564Sec. 4 “Sec. 564 (e)”Sec. 4(a) “Sec. 564
nditionsThe HHS Secretary will(e)(1)(A)”Same as S. 15 as Reported by(e)(1)(A)”
impose requirementsWith respect to emergencyCommittee.With respect to emergency
(including requirementsuse of an unapproveduse of an unapproved
oductconcerning product labelingproduct, the HHS Secretaryproduct, the HHS Secretary
ergencyand the provision ofwill establish authorizationwill establish authorization
a-information) designed toconditions to protect publicconditions to protect public
ensure that — health including — health including —
(1) to the extent feasible,(i) to the extent feasible,Same as S. 15 as Reported by(i) to the extent practical,
ensuring those administeringensuring that thoseCommittee.ensuring that those
iki/CRS-RL32549the countermeasure knowadministering theadministering the
g/wthat the Secretary hascountermeasure knowcountermeasure know that
s.orauthorized the product solelythat the Secretary hasthe Secretary has authorized
leakfor emergency use, theauthorized the emergency usethe emergency use of the
://wikisignificant known andpotential benefits and risks ofof the product, the significantknown and potential benefitsproduct, the significantknown and potential benefits
httpthe product (and the extent toand risks of the product (andand risks of the product (and
which these are unknown),the extent to which these arethe extent to which these are
and of any availableunknown), and of anyunknown), and of any
alternatives and their risksavailable alternatives andavailable alternatives and
and benefits.their risks and benefits.their risks and benefits.



CRS-69
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
quired(2) to the extent feasible,(ii) to the extent feasible,(2) Same as S. 15 as(ii) to the extent practical,
nditions(including requirementsensuring that those receivingReported by Committee.ensuring that those receiving
concerning product labelingthe product know — the product know —
and the provision of
oductinformation) ensuring that
ergencythose receiving the product
a-know —
tinued)that the Secretary hasthat the Secretary hasSame as S. 15 as Reported bythat the Secretary has
authorized the product solelyauthorized the emergency useCommittee.authorized the emergency use
for emergency use, theof the product, the significantof the product, the significant
iki/CRS-RL32549significant known andknown and potential benefitsknown and potential benefits
g/wpotential benefits and risks ofand risks of the product (andand risks of the product (and
s.orthe product (and the extent tothe extent to which these arethe extent to which these are
leakwhich these are unknown), ofunknown), of any availableunknown), of any available
://wikiany available alternatives andtheir risks and benefits, andalternatives and their risksand benefits, and of thealternatives and their risksand benefits, and of the
httpof the option to accept oroption to accept or refuseoption to accept or refuse
refuse administration of theadministration of the productadministration of the product
product and anyand any consequences ofand any consequences of
consequences of doing so;doing so;doing so;
Sec. 4 “Sec. 564 (e)(8)”(iii) appropriate conditionsSec. 4 “Sec. 564 (e)(8)”(iii) Same as H.R. 2122.


Same as H.R. 2122.for the monitoring andSame as H.R. 2122.
reporting of adverse events
associated with use of the
product;

CRS-70
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
quiredSec. 4 “Sec. 564 (e)(6)”(iv) For manufacturers of theSec. 4 “Sec. 564 (e)(6)”(iv) Same as H.R. 2122.


nditionsRequirements concerningproduct, appropriateSame as S. 15 as Reported by
recordkeeping and reporting,conditions concerning recordCommittee.
including records access bykeeping and reporting
oductthe Secretary and publicationincluding records access by
ergencyof data.the Secretary.
a-
tinued)
iki/CRS-RL32549
g/w
s.or
leak
://wiki
http

CRS-71
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
Sec. 4 “Sec. 564 (e)”Sec. 4 (a) “Sec. 564Sec. 4 “Sec. 564 (e)”Sec. 4 (a) “Sec. 564S. 15 as
nditionsThe HHS Secretary is(e)(1)(B)”Same as S. 15 as Reported by(e)(1)(B)”Reported by
authorized to impose suchWith respect to emergencyCommittee.With respect to theCommittee
conditions on anuse of an unapprovedemergency use of anand
oductauthorization as theproduct, The HHS Secretaryunapproved product, theS. 1504 do
ergencySecretary determines aremay establish additionalSecretary may, for a personnot
a-necessary to protect publicconditions on authorizationswho carries out any activitydistinguish
health including — to protect public healthfor which the authorization isbetween
including — issued, establish suchunapproved
conditions on anproducts and
authorization under thisunapproved
iki/CRS-RL32549section as the Secretary findsuses of
g/wnecessary or appropriate toapproved
s.orprotect the public health,products.


leakincluding the following:
://wiki(3) impose limitations on(i) on which entities may(3) Same as S. 15 as(i) Same as H.R. 2122.
httpwhich entities may distributedistribute the product forReported by Committee.
the product for emergencyemergency use and on how
use and on how distributiondistribution is to be
is to be performed;performed;
(4) impose limitations on(ii) on who may administer(4) Same as H.R. 2122.(ii) Same as H.R. 2122.
who may administer thethe product for emergency
product for emergency use,use, and on the categories of
and on the categories ofindividuals to whom, and the
individuals to whom, and thecircumstances under which,
circumstances under which,the product may be
the product may beadministered.;
administered;

CRS-72
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
No similar provision.No similar provision.No similar provision.(iii) Appropriate conditionsS. 15 as
nditionswith respect to the collectionReported by
and analysis of information,Committee
during the period when theand
oductauthorization is in effect,S. 1504
ergencyconcerning the safety andrequire the
a-effectiveness of the productimposition of
with respect to its emergencyrecord-
tinued) use; keeping
require-
(5) condition theNo similar provision.(5) Same as S. 15 asNo similar provision.ments.
iki/CRS-RL32549authorization on theReported by Committee.H.R. 2122
g/wperformance of studies,and S. 15 as
s.orclinical trials, or otherenacted
leakresearch needed to supportpermit but do
://wikimarketing approval of theproduct.not require such require-
httpments.


(6) The Secretary shall(iii) for persons other than(6) Same as S. 15 as(iv) Same as H.R. 2122.
impose, to the extent feasiblemanufacturers of theReported by Committee.
and appropriate,product, appropriate
requirements concerningconditions concerning
recordkeeping and reporting,recordkeeping and reporting,
including records access byincluding records access by
the Secretary and publicationthe Secretary with respect to
of data.the emergency use of the
product.

CRS-73
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
(7) The HHS Secretary may(iv) with respect to the(7) Same as S. 15 asSec. 4 (a) “Sec. 564 (e)(3)”The FFDCA
nditionswaive, to the extentemergency use of theReported by Committee.Same as H.R. 2122.Sec. 501
appropriate given theproduct, waive or limit, todefines
circumstances of thethe extent appropriate givenadulterated
oductemergency, requirements,the circumstances of thedrugs and
ergencywith respect to the product,emergency, conditionsdevices.


a-of current goodregarding current good
manufacturing practicemanufacturing practice
tinued)otherwise applicable to theotherwise applicable to the
manufacture, processing,manufacture, processing,
packing, or holding ofpacking, or holding of these
iki/CRS-RL32549products subject to regulationproducts subject to regulation
g/wunder this act.under this act, including such
s.orrequirements established in
leaksection 501 of the Federal
://wikiFood, Drug, and CosmeticAct (FFDCA).
http

CRS-74
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
Sec. 4 “Sec. 564 (e)(1-8)”Sec. 4 (a) “Sec. 564 (e)(2)”Sec. 564 (e)(1-8).Sec. 4 (a) “Sec. 564 (e)(2)”S. 15 as
eSee above.For unapproved use of anSee above.Same as H.R. 2122.Reported by
ergencyapproved productCommittee
a- authorization: and
S. 1504 do
nditions See above.The Secretary may, forSee above.For a manufacturer of thenot
manufacturers of the productproduct who carries out anydistinguish
who choose to carry out oneactivity for which thebetween
or more activities for whichauthorization is issued, theunapproved
the authorization is issued,Secretary shall, to the extentproducts and
establish any of thepracticable given theunapproved
iki/CRS-RL32549conditions described incircumstances of theuses of
g/wclauses Sec. 564 (e)(1)(A)(i -emergency, establishapproved
s.oriv)conditions described inproducts.


leakclauses (i) and (ii) of Sec.
://wiki564 (e)(1)(A) (1)(A), andmay establish conditions
httpdescribed in clauses (iii) and
(iv) of such paragraph.
No similar provision.(i) If the manufacturer of theNo similar provision.(i) Same as H.R. 2122.
product chooses not to make
an authorized change to the
product label to reflect the
emergency authorization, the
authorization may not allow
the product distributors or
any other person to alter or
obscure the labeling provided
by the manufacturer.

CRS-75
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
No similar provision.(ii) In the circumstancesNo similar provision.(ii) In the circumstances
edescribed in clause (i), andescribed in clause (i), for a
ergencyauthorization under thisperson who does not
a-section regarding themanufacture the product and
emergency use may, forwho chooses to act under this
nditionspersons who do notclause, an authorization
tinued)manufacture the product andunder this section regarding
who choose to act under thisthe emergency use shall, to
clause, authorize suchthe extent practicable,
persons to provideauthorize such person to
information on the product inprovide appropriate
iki/CRS-RL32549addition to the labelinginformation with respect to
g/wprovided by thesuch product in addition to
s.ormanufacturer, subject tothe labeling provided by the
leakcompliance with clause (i).manufacturer, subject to
://wikiSuch additional informationshall not be consideredcompliance with clause (i).While the authorization
httplabeling for purposes ofunder this section is effective,
section 502.such additional information
shall not be considered
labeling for purposes of
section 502.



CRS-76
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
No similar provision.No similar provision.No similar provision.Sec. 4 (a) “Sec. 564 (e)(4)”
eThe Secretary may establish
ergencyconditions on advertisements
a-and other promotional
descriptive printed matter
nditionsthat relate to the emergency
tinued)use of a product for which an
authorization under this
section is issued (whether an
unapproved product or an
unapproved use of an
iki/CRS-RL32549approved product)
g/w
s.orergencySec. 4 “Sec. 564 (f)”Sec. 4 “Sec. 564 (f)”Sec. 4 “Sec. 564 (f)”Sec. 4 “Sec. 564 (f)”
leake Emergency authorizationsSame as S. 15 as Reported bySame as S. 15 as Reported bySame as S. 15 as Reported by
a-will continue until the earlierCommittee.Committee.Committee.
://wikiof a termination of the
httpationemergency declaration or a
revocation of emergency use
authorization by the HHS
Secretary under Sec. 564 (g).
After authorizationSame as S. 15 as Reported bySame as S. 15 as Reported byAfter authorization
terminates, patients alreadyCommittee.Committee.terminates, patients already
receiving the product mayreceiving the product may
continue to do so for as longcontinue to do so for as long
as is deemed necessary byas is deemed necessary by
the patients’ attendingthe patient’s attending
physicians. physician.



CRS-77
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
ergencySec. 4 (a) “Sec. 564 (g)”Sec. 4 (a) “Sec. 564 (g)”Sec. 4 (a) “Sec. 564 (g)”Sec. 4 (a) “Sec. 564 (g)”
eThe HHS Secretary willSame as S. 15 as Reported bySame as S. 15 as Reported bySame as S. 15 as Reported by
a-periodically review theCommittee.Committee.Committee.
circumstances and
appropriateness of these
emergency use
authorizations.
The HHS Secretary mayThe HHS Secretary maySame as S. 15 as Reported bySame as S. 15 as Reported by
revoke an authorization if therevoke an authorization if theCommittee.Committee.
authorization criteria underauthorization criteria under
iki/CRS-RL32549Sec. 564 (c) are no longerSec. 564 (c) are no longer
g/wmet or other circumstancesmet.
s.ormake such a revocation
leakappropriate.
://wikiThis decision is notSame as S. 15 as Reported bySame as S. 15 as Reported bySame as S. 15 as Reported by
httprevi ewable. Committee. Committee. Committee.



CRS-78
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
blicationSec. 4 (a) “Sec. 564 (h)”Sec. 4 (a) “Sec. 564 (h)”Sec. 4 (a) “Sec. 564 (h)”Sec. 4 (a) “Sec. 564 (h)”H.R. 2122
The HHS Secretary willThe Secretary shall promptlySame as S. 15 as Reported byThe Secretary shall promptlySec. 5
promptly publish in thepublish in the FederalCommittee.publish in the Federal(a)(1)(A)(iii)
Federal Register, and provideRegister a notice of eachRegister a notice of each(I) requires
to the appropriateauthorization, and eachauthorization, and eachan annual
congressional committees, atermination or revocation oftermination or revocation ofreport to
notice of each authorization,an authorization, and anan authorization under thisCongress
authorization termination andexplanation of the reasonssection, and an explanationdetailing
authorization revocation. therefor, under this section.of the reasons thereforsuch
(which may include aauthoriza-
summary of data ortions.
iki/CRS-RL32549information that has beenSee below.


g/wsubmitted to the Secretary in
s.oran application under section
leak505(i) or section 520(g), even
://wikiif such summary mayindirectly reveal the
httpexistence of such
application).
No similar provision.No similar provision.No similar provision.Nothing in this section alters
or amends section 1905 of
title 18, United States Code,
or section 552(b)(4) of title 5
of such Code.

CRS-79
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
Sec. 4 (a) “Sec. 564 (i)(1)” No similar provision.Sec. 4 (a) “Sec. 564 (i)(1)” No similar provision.
The HHS Secretary maySame as S. 15 as Reported by
require persons, including aCommittee.
person who holds an
authorization under this
section, or who
manufactures, distributes,
prescribes, or administers a
product that is the subject of
such an authorization, to
establish and maintain —
iki/CRS-RL32549
g/wdata that is obtained fromNo similar provision.Same as S. 15 as Reported byNo similar provision.
s.orsuch activity and thatCommittee.
leakpertains to the effectiveness
://wikior safety of such product;
httpsuch records as are necessaryNo similar provision.Same as S. 15 as Reported byNo similar provision.
to determine, or facilitate aCommittee.
determination, whether there
may be any violation of this
section or of a regulation
promulgated under this
section; and
such additional records as theNo similar provision.Same as S. 15 as Reported byNo similar provision.


Secretary may determineCommittee.
necessary.

CRS-80
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
Sec. 4 (a) “Sec. 564 (i)(2)” No similar provision.Sec. 4 (a) “Sec. 564 (i)(2)” No similar provision.
The HHS Secretary maySame as S. 15 as Reported by
require a person who holdsCommittee.
an authorization under this
section, or who
manufactures, distributes,
prescribes, or administers a
product that is the subject of
such an authorization, to
provide to the Secretary all
data that is obtained from
iki/CRS-RL32549such activity and that
g/wpertains to the safety or
s.oreffectiveness of such
leakproduct.
://wikiEvery person required underNo similar provision.Same as S. 15 as Reported byNo similar provision.


httpthis section to establish orCommittee.
maintain records, and every
person in charge or custody
of such records, shall, upon
request by the Secretary,
permit the Secretary at all
reasonable times to have
access to, to copy, and to
verify such records.

CRS-81
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
Sec. 4 (a) “Sec. 564 (k)”Sec. 4 (a) “Sec. 564 (i)”Sec. 4 (a) “Sec. 564 (k)”Sec. 4 (a) “Sec. 564 (i)”
mmittedAll HHS Secretary, DefenseSame as S. 15 as Reported bySame as S. 15 as Reported bySame as S. 15 as Reported by
gencySecretary and DHS SecretaryCommittee.Committee.Committee.
scretionactions under the authority of
this section are committed to
agency discretion.
Sec. 4 (a) “Sec. 564 (l)” No similar provision.Sec. 4 (a) “Sec. 564 (l)” No similar provision.


The HHS Secretary maySame as S. 15 as Reported by
promulgate regulations toCommittee.
implement this section.
iki/CRS-RL32549
g/w
s.or
leak
://wiki
http

CRS-82
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
es ofSec. 4 (a) “Sec. 564 (m)”Sec 4 (a) “Sec. 564 (j)”Sec. 4 (a) “Sec. 564 (m)”Sec 4 (a) “Sec. 564 (j)”
Nothing in this section shallSame as S. 15 as Reported bySame as S. 15 as Reported byNothing in this section
be construed to impair orCommittee.Committee.impairs the authority of —
otherwise affect the authority
of —
the President as CommanderSame as S. 15 as Reported bySame as S. 15 as Reported bySame as S. 15 as Reported by
in Chief of the Armed ForcesCommittee;Committee;Committee;
of the United States;
the Secretary of Defense withSame as S. 15 as Reported bySame as S. 15 as Reported bySame as S. 15 as Reported by
iki/CRS-RL32549respect to the Department ofCommittee;Committee.Committee;
g/wDefense, including the armed
s.orforces, under other
leakprovisions of Federal law.
://wikiNo similar provision.or the HHS Secretary underNo similar provision.the United States to use or
httpsection 319F-2 of the Publicmanage quantities of a
Health Services Act toproduct that are owned or
manage the stockpile undercontrolled by the United
such section.States (including quantities
in the stockpile maintained
under section 319F-2 of the
Public Health Service Act).



CRS-83
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
plicationSec. 4 (a) “Sec. 564 (n)(1)”Sec. 4 (a) “Sec. 564 (k)(1)”Sec. 4 (a) “Sec. 564No similar provision.Similar
With respect to members ofSame as S. 15 as Reported by(n)(1)(A)”provisions
thethe armed forces, theCommittee.Same as S. 15 as Reported bywere enacted
medPresident may waive anyCommittee.by the
rcesrequirement designed toNational
ensure that individuals areDefense
informed of an option toAuthoriza-
accept or refuse the producttion Act for
if the President determines,Fiscal Year
in writing, that complying2004
with such requirement is not(P.L.108-
iki/CRS-RL32549feasible, is contrary to the136)
g/wbest interests of the membersSec. 1603 (b)
s.oraffected, or is not in the(10 U.S.C.
leakinterests of national security. 1107a).


://wiki
http

CRS-84
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
plicationNo similar provision. Sec. 4 (a) “Sec. 564 (k)(2)”Sec. 4 (a) “Sec. 564No similar provision. 10 U.S.C.
If the HHS Secretary(n)(1)(B)”1107
thedetermines that it is notSame as H.R. 2122.addresses the
medfeasible to provide a memberprocedures
rcesof the armed forces required for
tinued)information required by Sec.using

564 (e)(1)(A)(ii) [see above]investiga-


prior to the use of thetional new
product, such informationdrugs (IND)
will be provided to theon the
individual or next-of-kin asmembers of
iki/CRS-RL32549soon as possible and withinthe armed
g/w30 days of use. Thisservices.
s.orinformation must be recordedAmong other
leakin the medical record of theprovisions, it
://wiki me mb e r . requiresnotification
httpSec. 4 (a) “Sec. 564 (n)(2)”Sec. 4 (a) “Sec. 564 (k)(3)”Sec. 4 (a) “Sec. 564 (n)(2)”No similar provision. that it is an
10 U.S.C. 1107 does notSame as S. 15 as Reported bySame as S. 15 as Reported byIND, or a
apply for the emergency useCommittee.Committee.drug
of products if the basis for anunapproved
emergency declaration is thefor its use,
Defense Secretary’sthe reasons
conclusion of a militaryfor the
emergency or potential fordrug’s use,
one under Sec. 564 (b)(1)(B).and potential
side effects.



CRS-85
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
lation toSec. 4 (a) “Sec. 564 (o)”Sec. 4 (a) “Sec. 564 (l)”Sec. 4 (a) “Sec. 564 (o)”Sec. 4 (a) “Sec. 564 (k)”These
erIf a product is the subject ofSame as S. 15 as Reported bySame as S. 15 as Reported byIf a product is the subject ofsections of
ovisionsan authorization under thisCommittee.Committee.an authorization under thisU.S.C. relate
section, the use of suchsection, the use of suchto testing
product within the scope ofproduct within the scope ofIND in
the authorization — the authorization — humans.


shall not be subject to anySame as S. 15 as Reported bySame as S. 15 as Reported byshall not be considered to
requirements pursuant toCommittee;Committee;constitute a clinical
section 505(i) or 520(g); andinvestigation for purposes of
section 505(i), section
iki/CRS-RL32549 520(g) ;
g/w
s.orshall not be subject to anySame as S. 15 as Reported bySame as S. 15 as Reported byor any other provision of this
leakrequirements otherwiseCommittee.Committee.act or section 351 of the
://wikiapplicable to clinicalinvestigations pursuant toPublic Health Service Act.
httpother provisions of this act.

CRS-86
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
scretionNo similar provision.Sec. 4 (a) “Sec. 564 (m)”No similar provision.Sec. 4 (a) “Sec. 564 (l)”
ngThe HHS Secretary cannotSame as H.R. 2122.


e ofrequire any person to carry
a-out any activity this section
makes lawful. People who
choose not to carry out such
activity are not required to
inform the HHS Secretary of
this choice, unless they are
the sole source of an
unapproved product that has
iki/CRS-RL32549been authorized for
g/wemergency use. In this case
s.orthe manufacturer must notify
leakthe HHS Secretary of the
://wikichoice not to participate inthe program, within a
httpreasonable time from the
emergency-use authorization.

CRS-87
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
force-Sec. 4 (a) “Sec. 564 (j)” Sec. 4 (a) “Sec. 564 (n)”Sec. 4 (a) “Sec. 564 (j)”No similar provision.


tA person who violates aA person who carries out anSame as S. 15 as Reported by
requirement of this section oractivity pursuant to anCommittee.
of a regulation or orderauthorization under this
promulgated pursuant to thissection, but who fails to
section shall be subject to acomply with applicable
civil money penalty of notconditions under subsection
more than $100,000 in the(e), is in violation of the
case of an individual, and notFederal Food, Drug, and
more than $250,000 in theCosmetic Act.
case of any other person, for
iki/CRS-RL32549each violation, not to exceed
g/w$1,000,000 for all such
s.orviolations adjudicated in a
leaksingle proceeding.
://wiki
http

CRS-88
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
force-Sec. 4 (b)No similar provision.Sec. 4 (b)No similar provision.


tTechnical amendments toSame as S. 15 as Reported by
tinued)Section 301 of the Food,Committee.
Drug and Cosmetic Act (21
U.S.C. 331) to allow
enforcement of the new Sec.

564.


Makes it a crime to:Same as S. 15 as Reported by
Committee.
(1) Promote or use a product
iki/CRS-RL32549that is the subject of an
g/wauthorization under section
s.or564 other than as stated in
leakthe authorization, or other
://wikithan during the perioddescribed by section 564(g),
httpunless such promotion or use
is permitted under another
provision of this act;
(2) Fail to comply with anSame as S. 15 as Reported by
information requirementCommittee.
under section 564(e).

CRS-89
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
No similar provision.No similar provision.No similar provision.Sec. 4 (b)Subsection
ationSubsection (d) of section(d) specified
ovision1603 of the National Defensethat
Authorization Act for Fiscalenactment of
Year 2004 (10 U.S.C. 1107aProject
note) is repealed.BioShield
would
terminate the
described
“Application
to Members
iki/CRS-RL32549of the Armed
g/wForces” in
s.orthe National
leak Defense
://wikiAuthoriza-tion Act
httpSection 1603
(similar to S.
15 as
Reported
Sec. 4 (a)
“Sec. 564
(n)(1)” see
above).
Therefore
with this
repeal, those
provisions
remain in
effect.



CRS-90
Table 5. Required Reports
ovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
No similar provision.Sec. 5 Reports RegardingNo similar provision.Sec. 5 Reports Regarding
Authorities Under this act.Authorities Under this act.
No similar provision.Sec. 5 (a)(1)(A)No similar provision.Sec. 5 (a)(1)(A)
The HHS Secretary willSame as H.R. 2122.
portssubmit annual reports
regarding the exercise of the
following authorities (under
Sections 2, 3 and 4 of this
act):
iki/CRS-RL32549
g/wNo similar provision.use of simplified acquisitionNo similar provision.Same as H.R. 2122,
s.or authority,
leak
No similar provision.use of other than full andNo similar provision.Same as H.R. 2122,
://wikiopen competition,
http
No similar provision.use of expedited peer review,No similar provision.Same as H.R. 2122,
No similar provision.use of premium provision inNo similar provision.Same as H.R. 2122,
multiple-award contracts,



CRS-91
ovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
Sec. 4 (a) “Sec. 564 (h)”authorization of theSec. 4 (a) “Sec. 564 (h)”Same as H.R. 2122,The S. 15 as
The HHS Secretary willemergency use of drugs,Same as S. 15 as Reported byReported by
portspromptly publish in theCommittee.Committee
tinued)Federal Register, and provideand S. 1504
to the appropriaterequire case-
congressional committees, aby-case
notice of each authorization,notification
authorization termination andrather than
authorization revocation.annual
reports with
respect to
iki/CRS-RL32549these actions.


g/wSec. 4 “Sec. 564 (b)(3)”declaration of anySec. 4 “Sec. 564 (b)(3)”Same as H.R. 2122,
s.orThe HHS Secretary mustemergency, and Same as S. 15 as Reported by
leakpublish in the FederalCommittee.
Register and notify the
://wikiappropriate congressional
httpcommittees each declaration,
determination and renewal.
No similar provision.conditions placed onNo similar provision.Same as H.R. 2122.
emergency use of drugs
emergency.

CRS-92
ovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
No similar provision.Sec. 5 (a)(1)(B)No similar provision.Sec. 5 (a)(1)(B)
portsThese reports will beSame as H.R. 2122.
submitted to the designated
congressional committees
and summarize —
No similar provision.the particular actions thatNo similar provision.Same as H.R. 2122;
were taken under the
authorities specified in
subparagraph (A), including,
the identification of the threat
iki/CRS-RL32549agent, emergency, or the
g/wbiomedical countermeasure
s.orwith respect to which the
leakauthority was used;
://wikiNo similar provision.the reasons underlying theNo similar provision.Same as H.R. 2122;


httpdecision to use such
authorities, including any
options that were considered
and rejected with respect to
the use of such authorities;

CRS-93
ovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
No similar provision.the identification of eachNo similar provision.the number of, nature of, and
portsperson or entity thatother information concerning
tinued)received, or was consideredthe persons and entities that
and rejected for, grants,received a grant, cooperative
cooperative agreements, oragreement, or contract
contracts pursuant to the usepursuant to the use of such
of such authorities; and authorities, and the persons
and entities that were
considered and rejected for
such a grant, cooperative
agreement, or contract,
iki/CRS-RL32549except that the report need
g/wnot disclose the identity of
s.orany such person or entity;
leak and
://wikiNo similar provision.whether, with respect to eachNo similar provision.Same as H.R. 2122.


httpprocurement that is approved
by the President, a contract
was entered into within one
year after such presidential
approval.

CRS-94
ovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
No similar provision.Sec. 5 (a)(2) No similar provision.Sec. 5 (a)(2)
The HHS Secretary shallSame as H.R. 2122.
ngannually submit a report to
the designated congressional
tivity committees that summarizes
the activity relating to the
exercise of the following
authorities granted by Sec. 2
of this act:
No similar provision.use of increasedNo similar provision.Same as H.R. 2122.
iki/CRS-RL32549micropurchase threshold,
g/w
s.orNo similar provision.use of authority for personalNo similar provision.Same as H.R. 2122.
leakservices contracts (including
the number of persons who
://wikiwere paid amounts greater
httpthan $100,000 and the
number of persons who were
paid amounts between
$50,000 and $100,000), and
No similar provision.use of streamlined personnelNo similar provision.Same as H.R. 2122.


authority.

CRS-95
ovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
No similar provision.Sec. 5 (b)(1) No similar provision.No similar provision.


Not later than four years after
the date of the enactment of
this act, the HHS Secretary
will request the National
Academy of Sciences to
review the biomedical
countermeasure research and
development authorities
established in this act to
determine whether and to
iki/CRS-RL32549what extent activities
g/wundertaken pursuant to such
s.orauthorities have enhanced the
leakdevelopment of biomedical
countermeasures affecting
://wikinational security, and to
httprecommend any legislative or
administrative changes
necessary to improve the
ability of the Secretary to
carry out these activities in
the future. The Secretary
shall ensure that the results
of the study are submitted to
the designated congressional
committees not later than
five years after enactment.

CRS-96
ovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
No similar provision.Sec. 5 (b)(2)No similar provision.No similar provision.
This report shall include —
viewNo similar provision.a summary of the most recentNo similar provision.No similar provision.
portanalysis by the Department
ents of Homeland Security and
the intelligence community
of the domestic threat from
chemical, biological,
radiological, and nuclear
agents;
iki/CRS-RL32549
g/wNo similar provision.the Academy’s assessment ofNo similar provision.No similar provision.
s.orthe current availability of
leakcountermeasures to address
such threats;
://wiki
httpNo similar provision.the Academy’s assessment ofNo similar provision.No similar provision.


the extent to which programs
and activities under this act
will reduce any gap between
the threat and the availability
of countermeasures to an
acceptable level of risk; and

CRS-97
ovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
No similar provision.the Academy’s assessment ofNo similar provision.No similar provision.
threats to national security
that are posed by technology
viewthat will enable, during the
port10-year period beginning on
entsthe date of the enactment of
tinued)this act, the development of
antibiotic- resistant, mutated,
or bioengineered strains of
biological agents; and
iki/CRS-RL32549No similar provision.recommendations on short-No similar provision. No similar provision.


g/wterm and long-term
s.orgovernmental strategies for
leakaddressing such threats,
including recommendations
://wikifor federal policies regarding
httpresearch priorities, the
development of
countermeasures, and
investments in technology.

CRS-98
ovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
eneralSec. 6Sec. 5 (c)Sec. 6Sec. 5 (b)
Not later than four yearsfour years after the date ofSame as S. 15 as Reported bySame as H.R. 2122.
fficeafter the date of thethe enactment of this act, theCommittee.
viewenactment of this act, theComptroller General of the
Comptroller General of theUnited States shall initiate a
United States shall initiate astudy —
study that —
(1)(A) to review the HHSSame as S. 15 as Reported by(A)(i) Same as H.R. 2122.The
(1) describes the activitiesSecretary’s use of theCommittee.provisions
conducted under theauthorities granted undercited in S. 15
authorities provided for inthis Act with respect toas Reported
iki/CRS-RL32549section 409J(b)(1) of thesimplified acquisitionby
g/wPublic Health Service Act (asprocedures, procedures otherCommittee
s.oradded by section 2) andthan full and openand S. 1504
leaksection 319A-1(f)(3) and (4)competition, increasedrefer to
of such Act (as added bymicropurchase thresholds,simplified
://wikisection 3);personal services contracts,acquisition
httpstreamlined personnelprocedures
authority, and the purchaseand use of
of security countermeasuresnon-
under the special reservecompetitive
fund; andprocedures.


(1)(B) to recommend anyNo similar provision.(A)(ii) to make
No similar provision.legislative or administrativerecommendations to improve
changes necessary tothe utilization or
improve the use oreffectiveness of such
effectiveness of suchauthorities in the future;
authorities in the future;

CRS-99
ovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
eneral(2) identifies anyNo similar provision.Same as S. 15 as Reported byNo similar provision.
procurements that wouldCommittee;
fficehave been prohibited except
viewfor the authorities provided
tinued)by this act; and.
(3) to assess the adequacy of(2)(A) to review the internalSame as S. 15 as Reported by(B)(i) to review and assess
internal controls instituted bycontrols instituted by theCommittee.the adequacy of the internal
the HHS Secretary withHHS Secretary with respectcontrols instituted by such
respect to such authorities,to such authorities, whereSecretary with respect to
where required by this act.required by this act; andsuch authorities, where
iki/CRS-RL32549required by this act; and
g/w
s.orNo similar provision.(2)(B) to recommend anyNo similar provision.(B)(ii) to make
leaklegislative or administrativerecommendations to improve
changes necessary tothe effectiveness of such
://wikiimprove the effectiveness ofcontrols;


httpsuch controls; and

CRS-100
ovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
eneralNo similar provision.(3)(A) to review theNo similar provision.(C)(i) Same as H.R. 2122;
Secretary’s use of the
fficeauthority granted under this
viewact to authorize an
tinued)emergency use of a
biomedical countermeasure,
including the means by
which the Secretary
determines whether and
under what conditions any
such authorizations should be
iki/CRS-RL32549granted and the benefits and
g/wadverse impacts, if any,
s.orresulting from the use of
leaksuch authority; and
://wiki No similar provision.(3)(B) to recommend any No similar provision.(C)(ii) to make
httplegislative or administrativerecommendations to improve
changes necessary tothe utilization or
improve the utilization oreffectiveness of such
effectiveness of suchauthority and to enhance
authority and to enhanceprotection of the public
protection of the publichealth;
health.
No similar provision.The results of the study shallNo similar provision.Same as H.R. 2122.


be submitted to the
designated congressional
committees not later than
five years after the enactment
of this act.

CRS-101
ovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
portNo similar provision.Sec. 5 (d)(1)No similar provision.Sec. 5 (c)
ngNot later than 120 days afterSame as H.R. 2122.
enactment of this act, the
unter-DHS and HHS Secretaries
will jointly report to the
ocure-designated congressional
tcommittees whether there is
rriersa lack of adequate large-scale
biocontainment facilities
necessary for the testing of
security countermeasures in
iki/CRS-RL32549accordance with Food and
g/wDrug Administration
s.or requirements.
leak
No similar provision.Sec. 5 (d)(2)No similar provision.No similar provision.


://wikiNot later than one year after
httpenactment of this act, the
DHS and HHS Secretaries
shall jointly report to the
designated congressional
committees any other
potential barriers to the
procurement of security
countermeasures that have
not been addressed by this
act.

CRS-102
ovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
portNo similar provision.Sec. 5 (e)No similar provision.No similar provision.


ngNot later than 270 days after
enactment of this act, the
ogram forDHS Secretary will submit to
micalthe designated congressional
committees a report
describing the status of the
program carried out by the
Secretary to enhance the
preparedness of the United
States to respond to terrorist
iki/CRS-RL32549attacks involving chemical
g/w agents.
s.or
leak
://wiki
http

CRS-103
ovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
No similar provision.Sec. 5 (f) No similar provision.Sec. 5 (d) S. 15 as
ngress-The term “designatedSame as H.R. 2122.Reported by
alcongressional committees”Committee
mmitteesmeans the followingand S. 1504
committees of Congress:use the
phrase
No similar provision.the House Committees onNo similar provision.Same as H.R. 2122.“appropriate
Energy and Commerce,congress-
Appropriations, Governmentional
Reform, and the Selectcommittees,”
Committee on Homelandelsewhere in
iki/CRS-RL32549Security (or any successor tothe bills,
g/wthe Select Committee);without
s.or specifyi ng
leakNo similar provision.the Senate Committees onNo similar provision.In the Senate: thewhich
Health, Education, Labor,appropriate committeescommittees
://wikiand Pensions;they are.


httpAppropriations; and
Government Affairs.

CRS-104
Table 6. Outreach
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
No similar provision.Sec. 6No similar provision.Sec. 6
The HHS Secretary willThe HHS Secretary will
develop outreach measures todevelop outreach measures to
ensure to the extentensure to the extent
practicable that diversepracticable that diverse
institutions, includinginstitutions, including
Historically Black CollegesHistorically Black Colleges
and Universities and thoseand Universities and those
serving large proportions ofserving large proportions of
Hispanics, Native Americans,Black or African Americans,
iki/CRS-RL32549Asian-Pacific Americans, orAmerican Indians,
g/wother underrepresentedAppalachian Americans,
s.orpopulations, areAlaska Natives, Asians,
leakmeaningfully aware ofNative Hawaiians, other
://wikiavailable research anddevelopment grants,Pacific Islanders, Hispanicsor Latinos, or other
httpcontracts, cooperativeunderrepresented
agreements, andpopulations, are
procurements conductedmeaningfully aware of
under sections 2 and 3 of thisavailable research and
act.development grants,
contracts, cooperative
agreements, and
procurements conducted
under sections 2 and 3 of this
act.



CRS-105
Table 7. Export Control Recommendation
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
No similar provision.Sec. 7No similar provision.Sec. 7
dationUpon the award of any grant,Same as H.R. 2122.


r Exportcontract, or cooperative
agreement under section 2 or

3 of this act for the research,


omedicaldevelopment, or procurement
unter-of a countermeasure the HHS
Secretary will, in
consultation with the heads
of other appropriate federal
iki/CRS-RL32549agencies, determine whether
g/wsuch countermeasure is
s.orsubject to existing export-
leakrelated controls and, if not,
://wikimay make a recommendationthat such countermeasure
httpshould be included on the list
of controlled items subject to
export-related controls.

CRS-106
Table 8. Interagency Coordination
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
uringNo similar provision.Sec. 8 (a)No similar provision.Sec. 8 (a)
na-The HHS, DHS and DefenseSame as H.R. 2122.


Secretaries will ensure that
the activities of their
herespective Departments
ationcoordinate, complement, and
do not unnecessarily
duplicate programs to
plicationidentify potential domestic
rogramsthreats from biological,
iki/CRS-RL32549chemical, radiological or
g/wnuclear agents, detect
s.ordomestic incidents involving
leaksuch agents, analyze such
://wikiincidents, and developnecessary countermeasures.
httpThe Secretaries will ensure
that information and
technology possessed by
their Departments relevant to
these activities are shared
with the other Departments.

CRS-107
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
No similar provision.Sec. 8 (b) No similar provision.Sec. 8 (b)
AgencyThe HHS, DHS and DefenseSame as H.R. 2122.


n-Secretaries will each
designate an officer or
fficeremployee of their respective
Departments who shall
coordinate, through regular
meetings and
communications, with the
other aforementioned
Departments such programs
iki/CRS-RL32549and activities carried out by
g/wtheir Departments.
s.or
leak
://wiki
http

CRS-108
Table 9. Smallpox- Related Amendments to the
Homeland Security Act and Public Health Services Act
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
-Sec. 5No similar provision.No similar provision.No similar provision.The
latedThese provisions concernSmallpox
end-smallpox countermeasuresEmergency
ts to theand were considered by Personnel
dother legislation. Protection
ctAct of 2003
ubl i c (P.L.108-20)
incorporated
ctmany of the
iki/CRS-RL32549provisions in
g/wS. 15 as
s.or Reported.


leak
://wiki
http

CRS-109
Table 10. Additional HHS Secretary Authorities During
National Emergencies
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
No similar provision.No similar provision.Sec. 5Sec. 9
e HHSAmends section 1135(b) ofSame as S. 1504.
the Social Security Act that
ingwas added by the Public
Health Security and
er-Bioterrorism Preparedness
and Response Act of 2002
(P.L. 107-188).
iki/CRS-RL32549No similar provision.No similar provision.Allows the HHS Secretary inSame as S. 1504.
g/wemergencies to waive or
s.ormodify —
leak
://wikiNo similar provision.No similar provision.sanctions relating to theexamination and treatment ofSame as S. 1504.
httpemergency medical
conditions and women in
labor, if individuals are
directed to or relocated to
receive medical screening in
an alternative location
pursuant to an appropriate
State emergency
preparedness plan,
No similar provision.No similar provision.sanctions and penalties thatSame as S. 1504.


arise from noncompliance
with the following
requirements:

CRS-110
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
No similar provision.No similar provision.to obtain a patient’sSame as S. 1504.
e HHSagreement to speak with
family members or friends;
ingand
er-No similar provision.No similar provision.to honor a request to opt outSame as S. 1504.
of the facility directory;
tinued)
No similar provision.No similar provision.requirement to distribute aSame as S. 1504.
notice; or
iki/CRS-RL32549No similar provision.No similar provision.relating to the patient’s rightSame as S. 1504.


g/wto request privacy
s.orrestrictions; and confidential
leak communications.
://wiki
http

CRS-111
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
No similar provision.No similar provision.Such waivers orSuch waivers or
e HHSmodifications shall bemodifications shall only be in
limited to a 72-hour periodeffect if such actions are
ingbeginning upontaken in a manner that does
implementation of a hospitalnot discriminate among
er-disaster protocol. A waiver orindividuals on the basis of
modification shall betheir source of payment or of
tinued)withdrawn after such periodtheir ability to pay, and shall
and the provider shallbe limited to a 72-hour
comply with theperiod beginning upon
requirements under suchimplementation of a hospital
iki/CRS-RL32549paragraph for any patient stilldisaster protocol. A waiver or
g/wunder the care of themodification shall be
s.orprovider.withdrawn after such period
leakand the provider shall
comply with the
://wikirequirements under such
httpparagraph for any patient still
under the care of the
provider.



CRS-112
Table 11. Special Funding Language
rovisionS. 15 as Reported byH.R. 2122 as Passed byS. 1504 as IntroducedS. 15 as EnactedComments
CommitteeHouse
No similar provision.No similar provision.Sec. 7No similar provision.


ndingIn the Senate, for purposes of
points of order under a
r Projectconcurrent resolution on the
oShieldbudget and the Congressional
Budget Act of 1974,
provisions contained in any
bill, resolution, amendment,
motion, or conference report
that change the availability of
iki/CRS-RL32549any amounts appropriated
g/wpursuant to this act (or an
s.oramendment made by this act)
leakshall not be scored with
://wikirespect to the level of budgetauthority or outlays
httpcontained in such bill,
resolution, amendment,
motion, or conference report.