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

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

Order Code RL32067
CRS Report for Congress
Received through the CRS Web
Side-by-Side Comparison of
Project BioShield Legislation:
H.R. 2122, S. 15, and S. 1504
September 5, 2003
Frank Gottron
Analyst in Science and Technology Policy
Resources, Science, and Industry Division
Eric Fischer
Senior Specialist in Science and Technology Policy
Domestic Social Policy Division
Congressional Research Service ˜ The Library of Congress

Side-by-Side Comparison of Project BioShield
Legislation, H.R. 2122, S. 15 and S. 1504
Summary
During his 2003 State of the Union Address, President Bush proposed that
Congress enact legislation to establish Project BioShield to stimulate the
development of countermeasures to protect against chemical and biological terrorism.
Three bills have been introduced that incorporate many of the President’s
suggestions. S. 15 (Gregg) was reported by the Senate Health, Education, Labor and
Pensions Committee on March 25, 2003 with a substitute amendment. H.R. 2122
(Tauzin) passed the House, amended, on July 16, 2003. S. 1504 (Gregg) was
introduced directly for floor consideration on July 30, 2003.
Each bill would
! provide the Secretary of Health and Human Services (HHS)
expedited procurement procedures for bioterrorism-related products
and services;
! allow the use of an expedited review process for bioterrorism-related
research and development proposals;
! attempt to encourage companies to develop countermeasures by
allowing the HHS Secretary to contract to purchase countermeasures
up to five years before the product is expected to be delivered; and
! allow the HHS Secretary to permit the emergency use of
countermeasures that lack Food and Drug Administration approval.
The bills differ in how Project BioShield countermeasure procurement would
be funded. S. 15 grants a permanent, indefinite appropriation, to be spent at the
President’s discretion, for the purchase of countermeasures, as was proposed by the
Administration.
This mandatory funding would not be subject to the annual
appropriations process. In contrast, H.R. 2122 and S. 1504 each authorize specific
appropriations of $5.593 billion for FY2004-FY2013. The Congressional Budget
Office estimated that S. 15 would cost approximately $8.1 billion to implement for
that period, while the Administration predicted that the cost would be $5.6 billion.
The House and Senate versions differ in which countermeasures would qualify
for procurement under Project BioShield.
In both Senate versions, any
countermeasure that had a significant market other than as a countermeasure or that
was not likely to be approved for use within 5 years would not be eligible for
procurement under the project. In contrast, under H.R. 2122, countermeasures with
other significant markets would be eligible for procurement under Project BioShield.
H.R. 2122 requires that countermeasures be likely to be approved eventually but does
not specify a time limit.
This report will be updated in response to legislative developments. For more
analysis of Project BioShield, see CRS Report RS21507, Project BioShield, by Frank
Gottron.

Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Similarities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Differences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
List of Tables
Table 1. Short Title . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Table 2. New Health and Human Services Secretary Authorities for
Countermeasure Research and Development . . . . . . . . . . . . . . . . . . . . . . . . 4
Table 3. Biomedical Countermeasures Procurement . . . . . . . . . . . . . . . . . . . . . 15
Table 4. Authorization for Medical Products for Use in Emergencies . . . . . . . . 33
Table 5. Required Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Table 6. Outreach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Table 7. Export Control Recommendation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Table 8. Interagency Coordination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Table 9. Smallpox- Related Amendments to the
Homeland Security Act and Public Health Services Act . . . . . . . . . . . . . . . 73
Table 10. Additional HHS Secretary Authorities During
National Emergencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Table 11. Special Senate Funding Language . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

Side-by-Side Comparison of Project
BioShield Legislation, H.R. 2122, S. 15 and
S. 1504
Introduction
The anthrax attacks in the fall of 2001 underscored the nation’s vulnerability to
biological terrorism. Five people were killed by those attacks and thousands required
prophylactic antibiotic treatment. If there had not been effective medical
countermeasures for this strain of anthrax, the death toll would probably have been
higher. Effective countermeasures do not exist for many of the biological threats
deemed the most dangerous by the Centers for Disease Control and Prevention
(CDC). For example, botulinum toxin, plague, tularemia, and many viral
hemorrhagic viral fevers (VHFs) lack licensed vaccines, while smallpox and VHFs
lack any specific treatments. The Department of Health and Human Services (HHS)
recognizes a need for better vaccines for anthrax and smallpox and better treatments
for anthrax, plague and botulism.1
Many attribute the paucity of bioterrorism countermeasures to the lack of a
significant commercial market for them.2 Because these diseases occur infrequently,
there has been little economic incentive for investment of the millions of dollars
required to bring a new treatment to market.3
To encourage the development of new bioterrorism countermeasures, President
Bush proposed Project Bioshield in his 2003 State of the Union address. In response
to this call for legislation, three bills entitled “Project BioShield Act of 2003,” have
been introduced. S. 15 (Gregg) was introduced on March 11, 2003, and reported by
the Senate committee on Health, Education Labor and Pensions on March 25, with
an amendment in the nature of a substitute. H.R. 2122 (Tauzin) was introduced May
15, 2003, reported by the House Committees on Energy and Commerce (June 10),
Government Reform (June 12, amended), and Homeland Security (July 8, amended),
and passed the House (421-2) with a substitute amendment on July 17, 2003. S.
1504 (Gregg) was introduced July 30, 2003 and placed directly on the Senate
Legislative Calendar.
1 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.
2
Ceci Connolly, “U.S. Hopes Incentives Will Push Vaccine Development,” Washington
Post, January 30, 2003, p. A08.
3 See CRS Report RL30913, Pharmaceutical Research and Development: A Description
and Analysis of the Process.

CRS-2
Similarities
These bills share many provisions. Each would provide expedited procurement
procedures for bioterrorism-related products and services and an expedited peer-
review process for research and development (R&D) proposals, making it easier for
HHS to quickly commit substantial funds to countermeasure projects. Each bill
would provide a market guarantee by allowing the HHS Secretary to contract to
procure a countermeasure up to five years before it is expected to be delivered. Each
bill would allow the HHS Secretary to allow the emergency use of countermeasures
that lack Food and Drug Administration approval.
Differences
The three bills differ in how funds would be appropriated for countermeasure
procurement. S. 15 grants a permanent, indefinite appropriation to be spent at the
President’s discretion for the purchase of countermeasures. This mandatory funding,
which was 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. The Congressional Budget Office
estimated that approximately $8.1 billion would be spent over that time period. H.R.
2122 and S. 1504 provide specific funding authorization for the program but do not
appropriate funds. H.R. 2122 authorizes the appropriation of $5.593 billion for
FY2004-FY2013. Money appropriated pursuant to H.R. 2122 would go into a
special fund that would be available for obligation only through FY2013. S. 1504
authorizes the appropriation of amounts identical to those in H.R. 2122. As in the
House bill, funds appropriated pursuant to S. 1504 could be obligated through 2013,
although no special reserve fund is explicitly created by S. 1504.
The House and Senate versions differ in which countermeasures would qualify
for procurement under Project BioShield.
Under both Senate bills, any
countermeasure that has a significant market other than as a countermeasure or that
is not likely to be approved for use within 5 years would not be eligible for
procurement under Project BioShield. In contrast, under H.R. 2122, countermeasures
with other significant markets are eligible.
H.R. 2122 further requires that
countermeasures be likely to be approved eventually but does not set a specific time
limit.
H.R. 2122 authorizes appropriations to hire more biological and chemical
terrorism analysts in the Department of Homeland Security’s Directorate for
Information Analysis and Infrastructure Protection (IAIP) and to acquire and deploy
facilities that permit the Undersecretary of IAIP to access all classified information
to which he is entitled. The Senate versions have no similar provisions.
S. 1504 grants the HHS Secretary authority 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 during a national emergency,
while H.R. 2122 and S. 15 lack this provision. These include provisions designed
to protect patient privacy and to allow patients to be directed to or away from certain
hospitals pursuant to a state emergency plan.

CRS-3
Several other notable differences, including in reporting and recordkeeping
requirements, are detailed the tables below. The italics in the tables highlight
language differences between the bills.

CRS-4
Table 1. Short Title
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Short Title
Sec. 1.
Sec. 1.
Sec. 1.
“Project BioShield Act of 2003.”
Same as H.R. 2122.
Same as H.R. 2122.
Table 2. New Health and Human Services Secretary Authorities for
Countermeasure Research and Development
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Amendment of
Sec. 2.
Sec. 2.
Sec. 2.
the Public
Amends Part B of title III of the
Amends Part B of title IV of the
Same as S. 15.
Health Services
Public Health Service Act (PHSA, 42
PHSA (42 U.S.C. 284 et seq.) by
Act
U.S.C. 243 et seq.) by inserting “Sec.
adding “Sec. 409J Biomedical
319F-1 Authority for Use of Certain
Countermeasure Research and
Procedures Regarding Biomedical
Development.”
Countermeasure Research and
Development Activities.”
Defining
Sec. 319F-1 (a)(2) and
Sec. 3 and Sec. 319A-1 (h)(1).
Sec. 409J (g).
The Senate
Counter-
Sec. 2 (e).
Defines qualified countermeasure as
Same as S. 15.
version excludes
measures
Defines a qualified countermeasure
a biomedical countermeasure for use
countermeasures
as a countermeasure as defined by
against a CBRN agent that poses a
that are not
the PHSA that can act against a
material threat to the United States,
approved,
chemical, biological, radiological, or
that is approved, licensed or cleared
licensed, cleared
nuclear (CBRN) agent whose use
for use or for which the HHS
or are unlikely to
would affect national security.
Secretary determines that there is
be within 5
enough data to support a reasonable
years.
conclusion that the product will
qualify for approval or licensing
within 5 years.
Note: Italics highlight language differences between the bills.

CRS-5
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Defining
Sec. 2 (e).
Sec. 409J (g).
Sec. 409J (g).
Counter-
The PHSA, as modified by this
Defines biomedical countermeasure
Same as S. 15.
measures
legislation, defines a countermeasure
as a drug, biological product, or
(continued)
as a drug, biological product, device,
device used
vaccine, vaccine adjuvant, antiviral,
or diagnostic test that can be used
(1) to treat, identify, or prevent
(1) to treat, identify, or prevent harm
Same as S. 15.
infection by a biological agent or
from any CBRN agent that may
toxin or harm from any other agent
cause a public health emergency
that may cause a public health
affecting national security; or
emergency; or
(2) to treat, identify, or prevent harm
(2) Same as H.R. 2122.
Same as H.R. 2122.
from a condition that may result in
adverse health consequences or death
and may be caused by the
administering of a countermeasure
described in (1).

CRS-6
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Lead Institute
No similar provision.
Sec. 409J (a)(2).
Sec. 409J (a)(2).
The Director of the National
Same as S. 15.
Institutes of Health (NIH) 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 research
and development. The NIH Director
may delegate to the NIAID Director
authorities as are necessary to carry
out this function. The HHS Secretary
may authorize the NIH Director to
work through any national research
institute.
Interagency
Sec. 319F-1 (a)(3).
Sec. 409J (a)(3).
Sec. 409J (a)(3).
Cooperation
Authorizes the HHS Secretary to
Authorizes the HHS Secretary to
Same as S. 15.
enter into interagency agreements for
enter into interagency agreements for
countermeasure research and
countermeasure research and
development.
development and to use other HHS
agencies.
Facility
Sec. 319F-1 (a)(4).
Sec. 409J (a)(2)(D).
Sec. 409J (a)(2)(D).
Availability to
HHS Secretary can make BioShield
Same as H.R. 2122.
Same as H.R. 2122.
the Secretary
funding for countermeasure research
and development facilities dependent
on allowing future emergency use of
facilities by the Secretary.

CRS-7
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Export Controls
Sec. 319F-1 (a)(5).
No similar provision.
No similar provision.
Each award agreement must state that
any products developed with
BioShield funding must comply with
export-related controls.
Expedited
Sec. 319F-1 (b)(1).
Sec. 409J (b)(1).
Sec. 409J (b)(1).
Current
Procurement
(A) Procurements less than $25
(A) Same as H.R. 2122.
(A) Same as H.R. 2122.
maximum is
Authority
million for property or services
$100,000.
related to pressing countermeasure
research and development needs can
follow simplified acquisition
regulations.
(B) These purchases must comply
No similar provision.
(B) These purchases must comply
with laws and regulations relating to
with laws and regulations relating to
contract work hours and safety
contract work hours and safety
standards, examination of contractor
standards, examination of contractor
records, and the Anti-Kickback Act
records, the Anti-Kickback Act,
(21 U. S. C. 57(a) and (b).
bonds of contractors of public
buildings, limits on subcontractor
sales, middlemen fees, and veterans’
employment reporting requirements.
(C) Appropriate internal controls
(B) Same as H.R. 2122.
(C) Same as H.R. 2122.
shall be developed for the use of this
authority.

CRS-8
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Expedited
Sec. 319F-1 (b)(2).
Sec. 409J (b)(2).
Sec. 409J (b)(2).
Procurement
Authorizes the use of “other than
Authorizes the use of “other than
Same as S. 15.
Authority
competitive procedures” in awarding
competitive procedures” in awarding
(continued)
contracts if that which is being
contracts if that which is being
procured is available from a limited
procured is available from a limited
number of responsible sources
number of responsible sources and
no other type of property or services
will meet the need.
Sec. 319F-1 (b)(2)(C).
No similar provision.
No similar provision.
Awards must comply with
government-wide regulations,
including requirements that offers be
solicited from as many potential
sources as is practicable under the
circumstances, that required notices
be published, and that submitted
offers be considered.
Sec. 319F-1 (b)(3).
Sec. 409J (b)(3).
Sec. 409J (b)(3).
Current
Procurements less than $15,000 for
Same as H.R. 2122.
Same as H.R. 2122.
micropurchase
property or services related to
threshold is
pressing countermeasure research
$2,500.
and development needs can follow
micropurchase regulations.
Appropriate internal controls shall be
developed for the use of this
authority. Government purchase card
preferences do not apply to these
purchases if they are greater than
$2,500.

CRS-9
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Contesting
Sec. 319F-1 (b)(4).
No similar provision.
No similar provision.
Decisions Made
Contracting agency decisions relating
Under These
to countermeasure research and
Authorities
development procurement can be
reviewed by filing a protest with the
contracting agency or the
Comptroller General. If there is a
written finding that a review-related
delay would harm the United States,
the decision to make the award or
procurement is committed to agency
discretion.
Expedited Peer
Sec. 319F-1 (c)(1).
Sec. 409J (c).
Sec. 409J (c).
Review
Allows the HHS Secretary to use an
Same as H.R. 2122.
Same as H.R. 2122.
expedited award process, rather than
the 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 pressing need for an
expedited award.
Sec. 319F-1 (c)(2). Determination of
No similar provision.
No similar provision.
whether to employ 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-10
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Agency
No similar provision.
Sec. 409J (d).
Sec. 409J (d).
Facilities
HHS Secretary may acquire, lease,
Same as S. 15.
construct, improve, 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,
administering, and supporting
biomedical countermeasure research
and development.
Personal
Sec. 319F-1 (d).
Sec. 409J (e)(1).
Sec. 409J (e)(1).
Services
Authorizes the HHS Secretary to
Same as H.R. 2122.
Same as H.R. 2122.
Contracts
enter into personal services contracts
with up to 30 experts or consultants
with no limit on period of service.
Sec. 319F-1 (d)(1).
No similar provision.
No similar provision.
Pay cannot exceed that of the U. S.
President.
Sec. 319F-1 (d)(2).
Sec. 409J (e)(2).
Sec. 409J (e)(2).
These contractors are treated as
Same as H.R. 2122
Same as H.R. 2122
employees of HHS for Federal Tort
Claims Act purposes.
Sec. 319F-1 (d)(3).
Sec. 409J (e)(3).
Sec. 409J (e)(3).
Internal controls for this authority
Same as in H.R. 2122.
Same as in H.R. 2122.
will be implemented.

CRS-11
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Personal
No similar provision.
Sec. 409J (e)(2)(C).
Sec. 409J (e)(2)(C).
Services
The United States has the right to sue
Same as S. 15.
Contracts
these contractors to recover payments
(continued)
(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 United States in which such
contractor resides or has its principal
place of business.

CRS-12
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Streamlined
Sec. 319F-1 (e).
Sec. 409J (f).
Sec. 409J (f)(1).
Personnel
The HHS Secretary may appoint up
Same as H.R. 2122.
Same as H.R. 2122.
Authority
to 30 professional and technical
employees to help NIH respond to
pressing qualified countermeasure
research and development needs
without regard to provisions
governing appointments in the
competitive service or pay rates.
No similar provision.
No similar provision.
Sec. 409J (f)(2).
These U.S.C.
Provisions in U.S.C. title 5 relating to
provisions
merit system principles, prohibited
include
personnel practices and preference
protections
eligibility apply to these
regarding
appointments.
discrimination on
the basis of
political
affiliation, race,
color, religion,
national origin,
sex, marital
status, age, or
handicap.
Sec. 319F-1 (e)(2).
Sec. 409J (f)(2).
Sec. 409J (f)(3).
Internal controls for this authority
Same as H.R. 2122.
Same as H.R. 2122.
will be implemented.

CRS-13
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Actions
Sec. 319F-1 (f).
Sec. 409J (h).
Sec. 409J (h).
Committed to
All actions by the HHS Secretary
All actions by the HHS Secretary
Same as S. 15.
Agency
under the authority of this section are
under the authority of this section are
Discretion
committed to agency discretion,
committed to agency discretion.
except those deemed reviewable
under Sec. 319F-1 (b)(4).
Technical
Sec. 2 (b).
Sec. 2 (b).
Sec. 2 (b).
Amendment
(1) Amends the PHSA (42 U.S.C.
Same as H.R. 2122.
Same as H.R. 2122.
287a-2) to allow the 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 federal share from 50%
to 75% for NIAID funded projects
and from 40% to 75% of costs
associated with NIAID use for
multipurpose facilities.
(2) Authorizes such sums as may be
No similar provision.
No similar provision.
necessary for FY2003 and FY2004 to
fund these improvements.

CRS-14
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
HHS Program
Sec. 2 (c).
No similar provision.
No similar provision.
to Develop
The HHS Secretary may initiate and
Counter–
sustain a program that results in the
measures
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 2013.
National
Sec. 2 (d).
No similar provision.
No similar provision.
Vaccine
Authorizes the appropriation of such
Program
sums as may be necessary for each of
the fiscal years 2004 through 2013
for the National Vaccine Program.
Technical
Sec. 2 (e).
No similar provision.
No similar provision.
Amendment
Amends the PHSA to add the
Secretary of Homeland Security to
the working group on the
preparedness, prevention, and
response to bioterrorism and other
public health emergencies.

CRS-15
Table 3. Biomedical Countermeasures Procurement
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Sec. 3.
Sec. 3.
Sec. 3.
Amends PHSA by adding Sec. 319F-
Amends PHSA by adding Sec. 319A-
Same as S. 15.
2.
1.
Transfer of
Sec. 3 (a).
No similar provision.
No similar provision.
Strategic
Transfers and amends the section of
National
the Public Health Security and
Stockpile
Bioterrorism Preparedness and
Language
Response Act of 2002 (P.L. 107-188,
42 U.S.C. 300hh-12) dealing with the
Strategic National Stockpile (SNS,
Sec. 121) to the Public Health
Services Act as section 319F-2.
Procurement
Sec. 319F-2 (c)(1)(A).
No similar provision.
No similar provision.
Authority
The special reserve fund defined in
Sec. 319F-2 (c)(10) can be used to
procure security countermeasures for
the SNS.

CRS-16
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Definitions of
Sec. 319F-2 (c)(1)(B).
Sec. 319A-1 (h)(1).
Sec. 319A-1 (h)(1).
The House bill’s
Security
Defines a security countermeasure as
Defines a qualified countermeasure
Same as S. 15.
definition of
Counter–
a priority countermeasure against a
as a biomedical countermeasure for
priority
measures and
CBRN agent identified as a material
use against a CBRN agent identified
countermeasure
Qualified
threat, that is determined to be a
as a material threat that
is from Sec.
Counter–
necessary countermeasure under
is approved or cleared by the Food
319F(h) of the
measures
391F-2(c)(2)(B), and is approved or
and Drug Administration (FDA) or a
PHSA.
cleared by the Food and Drug
biological product licensed by the
Administration (FDA) or a biological
HHS Secretary under 42 U.S.C. 262,
product licensed by the HHS
Secretary under 42 U.S.C. 262,
or is a priority countermeasure for
or is a priority countermeasure for
Same as S. 15.
which the HHS Secretary determines
which the HHS Secretary determines
that sufficient and satisfactory
that sufficient and satisfactory
clinical experience or research data
clinical experience or research data
support a reasonable conclusion that
support a reasonable conclusion that
the countermeasure will qualify for
the countermeasure will qualify for
approval or licensing in the future,
approval or licensing within 5 years.
or is authorized for emergency use by
No similar provision.
No similar provision.
the HHS Secretary.
Determination
Sec. 319F-2 (c)(2)(A).
Sec. 319A-1 (a)(1).
Sec. 319A-1 (a)(1).
of Material
Requires the DHS Secretary to
Requires the DHS Secretary to
Same as S. 15.
Threat
determine, on an ongoing basis,
determine, on an ongoing basis,
which CBRN agents pose a material
which CBRN agents pose a material
threat.
risk of use against the U.S.
population.

CRS-17
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Determination
Sec. 319F-2 (c)(2)(B).
Sec. 319A-1 (a)(2)(A).
Sec. 319A-1 (a)(2)(A).
of Public Health
Requires the HHS Secretary to
Requires the HHS Secretary, in
Same as S. 15.
Impact
determine the public health
consultation with the DHS Secretary,
consequences of use of any of the
to determine the public health
agents identified by the DHS
consequences of use of any of the
Secretary to pose a material threat,
agents identified by the DHS
and to determine the agents for which
Secretary to pose a material threat,
priority countermeasures are
and to determine the agents for which
necessary to protect the public health
priority countermeasures are
from a material threat.
necessary to protect the public health
from a material threat.
Notification to
Sec. 319F-2 (c)(2)(C).
No similar provision.
No similar provision.
Congress
The DHS and HHS Secretaries will
notify Congress when any material
threat, public health impact, or
necessary countermeasure
determination is made.
Assuring Access
Sec. 319F-2 (c)(2)(D).
No similar provision.
No similar provision.
to Threat
All information to which the DHS
Information
Secretary is entitled, regardless of
classification level, will be used in
making a material threat
determinations.
Assessment of
Sec. 319F-2 (c)(3).
Sec. 319A-1 (b).
Sec. 319A-1 (b).
Availability and
The HHS Secretary, in consultation
Same as H.R. 2122.
Same as H.R. 2122.
Appro-
with the DHS Secretary, shall assess
priateness of
the availability and appropriateness
Counter–
of countermeasures to address
measures
identified material threats.

CRS-18
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Call for
Sec. 319F-2 (c)(4)(A).
Sec. 319A-1 (c)(1).
Sec. 319A-1 (c)(1).
Development of
If a countermeasure is found
If a countermeasure is found
Same as S. 15.
Counter–
appropriate but not available or
appropriate but not available, the
measures
available but cleared only for
DHS and HHS Secretaries may
alternative purposes, the DHS and
submit, for presidential approval, a
HHS Secretaries may jointly submit,
call for the development of such
for presidential approval, a call for
countermeasure and a commitment to
the development of such
recommend the procurement of the
countermeasure and a commitment to
first developed appropriate
recommend the procurement of the
countermeasure.
first developed appropriate
countermeasure, using the fund
created by Sec. 319-F(c)(10).
Counter–
Sec. 319F-2 (c)(4)(B).
Sec. 319A-1 (b)(2).
Sec. 319A-1 (b)(2).
measure
The HHS and DHS Secretaries will,
Same as H.R. 2122.
Same as H.R. 2122.
Specifications
to the extent practicable, include in
the 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 research,
development, and manufacture of the
countermeasure or to provide
specifications for it.

CRS-19
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Notifying
Sec. 319F-2 (c)(4)(C).
Sec. 319A-1 (c)(3).
Sec. 319A-1 (c)(3).
Potential
If the President approves a proposal
Same as H.R. 2122.
Same as H.R. 2122.
Developers
the DHS and HHS Secretaries shall
make known to persons who may
respond to a call for the
countermeasure involved–
the call for the countermeasure;
Same as H.R. 2122.
Same as H.R. 2122.
the required specifications for the
Same as H.R. 2122.
Same as H.R. 2122.
countermeasure; and
the commitment described in
a commitment for a recommendation
Same as S. 15.
subparagraph (A)(ii).
for procurement of the first such
specific countermeasure that meets
the conditions for procurement under
subsection (d) and the specifications
under paragraph (2).
Secretary’s
Sec. 319F-2 (c)(5)(A).
Sec. 319A-1 (d)(1).
Sec. 319A-1 (d)(1).
Determination
The HHS Secretary, in consultation
The HHS Secretary, in consultation
Same as S. 15.
of Counter–
with the DHS Secretary, will
with the DHS Secretary, will
measures
determine if specific
determine if specific
Appropriate for
countermeasures are appropriate for
countermeasures are appropriate for
Funding
procurement using the special
procurement using the
reserve fund defined in Sec. 319F-2
appropriations specified in Sec.
(c)(10).
319A-1 (i).

CRS-20
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Secretary’s
Sec. 319F-2 (c)(5)(B).
Sec. 319A-1 (d)(2).
Sec. 319A-1 (d)(2).
The Senate
Determination
In making this determination the
For countermeasures to qualify for
Same as S. 15.
versions exclude
of Counter–
HHS Secretary will determine and
this funding the HHS Secretary must
countermeasures
measures
consider:
determine:
that have another
Appropriate for
market. The
Funding
(i) quantities of the product that will
(B)(i) Same as H.R. 2122.
Same as H.R. 2122.
House version
(continued)
be needed for the SNS,
requires the
Secretary only to
(iii) feasibility of delivery of
(B)(ii) Same as H.R. 2122.
Same as H.R. 2122.
consider if
sufficient quantities within 5 years,
products have
and
other significant
markets.
(iii)whether there is a lack of a
(C) that there is no significant
Same as S. 15.
Therefore,
significant commercial market for the
commercial market for the product,
products that
product at time of procurement other
at the time of this determination,
have another
than as a countermeasure.
other than as a countermeasure. This
market could be
must be annually redetermined.
procured under
the House
version but not
the Senate
versions.

CRS-21
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Presidential
Sec. 319F-2 (c)(6).
Sec. 319A-1 (e).
Sec. 319A-1 (e).
Approval
(A) If a countermeasure is deemed
If a countermeasure is deemed
Same as S. 15.
Required for
appropriate, the HHS and DHS
appropriate, the HHS and DHS
Procurement
Secretaries, in coordination with the
Secretaries, in coordination with the
Director of Office of Management
Director of Office of Management
and Budget, will submit to the
and Budget, will submit to the
President a proposal to procure the
President a proposal to procure the
countermeasure using the special
countermeasure.
reserve fund defined in Sec. 319F-2
(c)(10).
(B) Presidential approval is required
Sec. 319A-1 (e)(2).
Sec. 319A-1 (e)(2).
to procure countermeasures under
Same as H.R. 2122.
Same as H.R. 2122.
this Act.
Notice to
Sec. 319F-2 (c)(6)(C).
Sec. 319A-1 (e)(3).
Sec. 319A-1 (e)(3).
Congress
The HHS and DHS Secretaries will
The DHS Secretary will notify
Same as S. 15.
notify designated congressional
Congress of each presidential
committees of each presidential
decision to approve the procurement
decision to approve the use of the
of countermeasures under this Act.
special reserve fund. This notice will
include:
an explanation of the decision to use
No similar provision.
No similar provision.
the special reserve fund, the potential
countermeasure supplier or suppliers
(when available), and whether other
potential suppliers were considered
and reasons for any rejection of them.

CRS-22
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Subsequent
Sec. 319F-2 (c)(6)(D).
Sec. 319A-1 (c)(4).
Sec. 319A-1 (c)(4).
Specific
Countermeasures developed after a
Same as H.R. 2122.
Same as H.R. 2122.
Counter–
procurement can also be procured
measures
under this Act if they represent an
improvement over the original
countermeasure. Examples of
qualifying improvements are better
safety or effectiveness.
Determination of an improvement is
No similar provision.
No similar provision.
committed to agency discretion.
Rule of
Sec. 319F-2 (c)(6)(E).
No similar provision.
No similar provision.
Construction
Recommendations and 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.
Interagency
Sec. 319F-2 (c)(7)(A)-(B).
No similar provision.
No similar provision.
Agreements for
The DHS Secretary will reimburse
Procurement
the HHS Secretary for the costs,
including administrative costs, of
presidentially approved
countermeasure procurements.
The special reserve fund cannot be
Sec. 319A-1 (i)(2)(C).
Sec. 319A-1 (i)(2)(C).
used to reimburse administrative
Funds appropriated under this
Same as S.15.
costs.
subsection cannot be used for
administrative costs.

CRS-23
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Procurement
Sec. 319F-2 (c)(7)(C)(i).
Sec. 319A-1 (f)(1).
Sec. 319A-1 (f)(1).
The HHS Secretary is responsible for
Same as H.R. 2122.
Same as H.R. 2122.
arranging for countermeasure
procurement, 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 will
Same as H.R. 2122.
Same as H.R. 2122.
promulgate any regulations necessary
to implement these procurement
provisions.

CRS-24
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Contract Terms
Sec. 319F-2 (c)(7)(C)(ii).
Sec. 319A-1 (f)(2).
Sec. 319A-1 (f)(2).
The procurement contracts will
Same as H.R. 2122.
Same as H.R. 2122.
include the following terms:
Payment conditioned on delivery of a
Same as H.R. 2122.
Same as H.R. 2122.
substantial portion of the number of
contracted units.
However, up to a 10% advance
No similar provision.
No similar provision.
payment to ensure success of a
project can be made at the discretion
of HHS Secretary. This advance
payment must be refunded if a
substantial delivery is not made.
This language cannot be construed as
affecting rights of vendors under
provisions of law or regulation
relating to termination of contracts
for the convenience of the federal
government.

CRS-25
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Contract Terms
The contract period cannot be longer
The contract period cannot be longer
Same as S. 15.
(continued)
than 5 years, or up to 8 years if the
than 5 years.
HHS Secretary determines at the time
of initial award that a longer period
is justified.
Contracts may be renewed for
Same as H.R. 2122.
Same as H.R. 2122.
additional periods of up to 5 years
each.
The vendor must comply with all
No similar provisions.
No similar provisions.
applicable export-related controls.
No similar provisions.
The vendor must seek approval,
Same as S. 15.
clearance or licensing of product.
The HHS Secretary may waive this
provision.
The contract may specify:
The contract may specify:
The contract may specify:
That the vendor must store the
Same as H.R. 2122,
Same as H.R. 2122,
countermeasure. In this case the
special fund can be used to pay the
vendor for the costs of shipping,
handling, storage and related costs of
the countermeasure.

CRS-26
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Contract Terms
No similar provision.
a discounted price for a product that
Same as S. 15,
(continued)
has not been licensed or approved at
the time of delivery, and
No similar provision.
that the HHS Secretary may
Same as S. 15.
terminate the contract for the failure
to deliver a reasonable number (as
determined by the Secretary) of units
of product by 3 years after the
contract commenced.
Availability of
Sec. 319F-2 (c)(7)(C)(iii)(I).
Sec. 319A-1 (f)(3).
Sec. 319A-1 (f)(3).
Simplified
Simplified acquisition procedures
Simplified acquisition procedures
Same as S. 15.
Acquisition
will apply to countermeasure
will apply to all countermeasure
Procedures
procurements for which the HHS
procurements under this section.
Secretary determines that there is
pressing need.
Sec. 319F-2 (c)(7)(C)(iii)(II).
No similar provision.
Sec. 319A-1 (f)(3)(B).
These purchases must comply with
These purchases must comply with
laws and regulations relating to
laws and regulations relating to
contract work hours and safety
contract work hours and safety
standards, examination of contractor
standards, examination of contractor
records, and the Anti-Kickback Act.
records, the Anti-Kickback Act,
bonds of contractors of public
buildings, limits on subcontractor
sales, middlemen fees, and veterans’
employment reporting requirements.

CRS-27
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Use of
Sec. 319F-2 (c)(7)(C)(iv).
Sec. 319A-1 (f)(4).
Sec. 319A-1 (f)(4).
Procedures
Authorizes the use of other than
Authorizes the use of noncompetitive
Same as S. 15.
Other than Full
competitive procedures to procure a
procedures to procure a product
and Open
product available from a limited
available from a limited number of
Competition
number of responsible sources.
responsible sources.
Awards must comply with
No similar provision.
No similar provision.
government-wide regulations,
including requirements that offers be
solicited from as many potential
sources as practicable, that required
notices be published, and that
submitted offers be considered.
Premium
Sec. 319F-2 (c)(7)(C)(v).
Sec. 319A-1 (f)(5).
Sec. 319A-1 (f)(5).
Provision in
The HHS Secretary may enter into
Same as H.R. 2122.
Same as H.R. 2122.
Multiple Award
contracts for a single countermeasure
Contracts
with more 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.
Determinations of the success of
Same as H.R. 2122.
Same as H.R. 2122.
meeting all of the requirements by
the HHS Secretary are committed to
agency discretion.

CRS-28
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Extension of
Sec. 319F-2 (c)(7)(C)(vi).
Sec. 319A-1 (f)(6).
Sec. 319A-1 (f)(6).
Closing Date for
A decision by the HHS Secretary to
Same as H.R. 2122.
Same as H.R. 2122.
Receipt of
extend the closing date for receipt of
Proposals is not
proposals for a procurement is
Reviewable
committed to agency discretion.
Limiting
Sec. 319F-2 (c)(7)(C)(vii).
Sec. 319A-1 (f)(7).
Sec. 319A-1 (f)(7).
Competition to
The HHS Secretary may stipulate
Same as H.R. 2122.
Same as H.R. 2122.
Sources
that all potential sources must
Responding to
provide, on request, information that
Information
would allow the HHS to use advance
Requests
procurement planning or market
research. Vendors who do not
provide such information can be
excluded from consideration.
Interagency
Sec. 319F-2 (c)(8).
Sec. 319A-1 (g).
Sec. 319A-1 (g).
Agreements
HHS and DHS Secretaries may enter
Same as H.R. 2122.
Same as H.R. 2122.
into interagency agreements with
other federal agencies to facilitate
procuring these countermeasures.
Only the DHS and HHS Secretaries
Same as H.R. 2122.
Same as H.R. 2122.
may exercise the authorities provided
by this section.

CRS-29
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Restrictions on
Sec. 319F-2 (c)(9).
Sec. 319A-1 (i)(2).
Sec. 319A-1 (i)(2).
Use of Funds
The special reserve fund cannot be
Amounts appropriated under this Act
Same as S. 15.
used to pay for:
cannot be used to pay for:
(A) vaccines under procurement
(A) vaccines under procurement
Same as S. 15.
contracts entered into before the
contracts entered into before January
enactment of this Act or
1, 2003, or
No similar provision.
(B) new contracts or obligations for
Same as S. 15.
procuring a countermeasure after a
determination that it has significant
commercial market other than as a
countermeasure and;
(B) administrative costs.
(C) Same as H.R. 2122.
Same as H.R. 2122.
Definitions
Sec. 319F-2 (c)(10)(A).
No similar provision.
No similar provision.
Special reserve fund in this 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.)
Designates specific congressional
No similar provision.
No similar provision.
committees for reporting purposes.

CRS-30
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Definitions
Sec. 2 (e).
Sec. 319A-1 (h)(2).
Sec. 319A-1 (h)(2).
H.R. 2122
(continued)
The PHSA, as modified by this
Defines biomedical countermeasure
Same as S. 15.
defines
legislation, defines a countermeasure
as a drug, biological product, or
countermeasures
as a drug, biological product, device,
device used
only in Sec. 2.
vaccine, vaccine adjuvant, antiviral,
The Senate
or diagnostic test that can be used
versions define
countermeasures
(1) to treat, identify, or prevent
(1) to treat, identify, or prevent harm
Same as S. 15.
in Sec. 2 and
infection by a biological agent or
from any CBRN agent that may
repeat the
toxin or harm from any other agent
cause a public health emergency
definition here.
that may cause a public health
affecting national security; or
emergency; or
(2) to treat, identify, or prevent harm
(2) Same as H.R. 2122.
Same as H.R. 2122.
from a condition that may result in
adverse health consequences or death
and may be caused by the
administering of a countermeasure
described in (1).
Technical
Sec. 319F-2 (d-f).
No similar provision.
No similar provision.
Amendments
These subsections make 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.

CRS-31
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Amendment to
Sec. 3 (b).
No similar provision.
No similar provision.
Homeland
Adds to the Homeland Security Act
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.
Appropriation
Sec. 510 (a).
Sec. 319A-1 (i).
Sec. 319A-1 (i).
H.R. 2122 sets
Authorization
Authorizes the appropriation of up to
Appropriates, out of any moneys in
Authorizes the appropriation of up to
up a special
$5.593 billion for FY2004-2013 for
the Treasury not otherwise
$5.593 billion for FY2004-2013 for
reserve fund that
presidentially approved
appropriated, for FY2003 and for
presidentially approved
sunsets in
countermeasures.
each fiscal year thereafter, such sums
countermeasures.
FY2013. S. 15
Of this total, not more than $3.418
as may be necessary for the costs
Of this total, not more than $3.418
has a permanent,
billion may be obligated for FY2004-
incurred by the HHS Secretary in the
billion may be authorized for
indefinite,
2008 and not more than $890 million
procurement of presidentially
FY2004-2008 and not more than
appropriation.
for FY2004. This money goes into
approved countermeasures.
$890 million for FY2004.
S. 1507
the special reserve fund as defined in
authorizes
Sec. 510 (b).
identical levels
of funding as
H.R. 2122, but
does not set up a
special reserve
fund.
Definition of
Sec. 510 (b).
No similar provision.
No similar provision.
Special Reserve
Special reserve fund means the
Fund
appropriations account established as
a result of any appropriations made
under Sec. 510 (a).

CRS-32
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Limits on
Sec. 510 (c).
No similar provision.
No similar provision.
Special Reserve
Appropriations to the special reserve
Fund
fund are available to be obligated
through FY2013 and only for
presidentially approved
countermeasures.
It is the intent of the Congress that
No similar provision.
No similar provision.
unobligated amounts in this fund will
not be applied, through
reprogramming or otherwise, to any
other purpose.
Related
Sec. 510 (d)(1).
No similar provision.
No similar provision.
Appropriation
Authorizes the appropriation of $5
Authorizations
million for FY2003 and such sums as
may be necessary for FY2004-2006
for the hiring of CBRN threat
assessment analysts within the DHS
Directorate for Information Analysis
and Infrastructure Protection (IAIP).
Sec. 510 (d)(2).
No similar provision.
No similar provision.
Authorizes the appropriation of such
sums as may be necessary for
FY2003-2006 for the acquisition and
deployment of secure facilities to
permit the DHS Secretary to receive
(by the end of 2003) all classified
information and products to which
the Undersecretary for IAIP is
entitled.

CRS-33
Table 4. Authorization for Medical Products for Use in Emergencies
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Sec. 4.
Sec. 4.
Sec. 4.
Authorization for Medical Products
Same as H.R. 2122.
Same as H.R. 2122.
for Use in 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
Medical Products for Use in
Emergencies.”
Authorization
Sec. 564 (a).
Sec. 564 (a).
Sec. 564 (a).
to Allow the
The HHS Secretary may authorize
Same as H.R. 2122.
Same as H.R. 2122.
Emergency Use
the temporary introduction into
of a Counter-
interstate commerce, of a drug,
measure
device, or biological product
intended for use in an actual or
potential emergency.
Approval Status
Sec. 564 (a)(2).
No similar provision.
No similar provision.
of Product
The HHS Secretary may make
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
approved product).
Relation to
Sec. 564 (a)(3).
No similar provision.
No similar provision.
Other Uses
Emergency use authorizations are in
addition to any other approved uses
of the product.

CRS-34
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Definitions
Sec. 564 (a)(4).
No similar provision.
No similar provision.
The PHSA
Biological product has the meaning
defines
given in sec. 351 of the PHSA.
biological
product as “a
Emergency use means the use of a
virus, therapeutic
product during an actual emergency
serum, toxin,
or potential emergency.
antitoxin,
vaccine, blood,
Product means a drug, device or
blood component
biological product.
or derivative,
allergenic
An unapproved product is a product
product, or
without approval, license, or
analogous
clearance for commercial
product, or... any
distribution.
trivalent organic
arsenic
An unapproved use of an approved
compound,
product is the use of a product that is
applicable to the
not approved for that use but has
prevention,
been approved for another use.
treatment, or
cure of a disease
or condition of
human beings.”

CRS-35
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Emergency
Sec. 564 (b)(1).
Sec. 564 (b)(1).
Sec. 564 (b)(1).
Declaration
The HHS Secretary may declare an
Same as H.R. 2122.
Same as H.R. 2122.
emergency if:
(A) The Homeland Security (DHS)
(A) The Homeland Security (DHS)
Same as S. 15.
Secretary determines that there is a
Secretary determines that there is a
national emergency or significant
domestic emergency or significant
potential for one involving the
potential for one involving the
heightened risk of attack with a
heightened risk of attack with a
specified biological, chemical,
specified biological, chemical,
radiological or nuclear (CBRN)
radiological or nuclear (CBRN)
agent, or
agent, or
(B) The Defense Secretary
Same as H.R. 2122.
Same as H.R. 2122.
determines that there is a military
emergency or significant potential for
one involving the heightened risk to
U.S. military forces of attack with a
CBRN agent, or
(C) the HHS Secretary determines
Same as H.R. 2122.
Same as H.R. 2122.
that there is a public health
emergency under sec. 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.

CRS-36
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Declaration
Sec. 564 (b)(2)(A).
Sec. 564 (b)(2)(A).
Sec. 564 (b)(2)(A).
Termination
An emergency declaration will
Same as H.R. 2122.
Same as H.R. 2122.
terminate on the earlier of:
(i) a determination by the HHS
Same as H.R. 2122.
Same as H.R. 2122.
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
Same as H.R. 2122.
Same as H.R. 2122.
date.
Declaration
Sec. 564 (b)(2)(B).
Sec. 564 (b)(2)(B).
Sec. 564 (b)(2)(B).
Renewal
The HHS Secretary may renew a
Same as H.R. 2122.
Same as H.R. 2122.
declaration. Renewed declarations
will be subject to termination under
the above conditions and may also be
renewed.
Advance Notice
Sec. 564 (b)(3).
No similar provision.
No similar provision.
of Termination
The HHS Secretary must provide
advanced notification that the
declaration will be terminated to
allow enough time to:
(A) allow removal of unapproved
No similar provision.
No similar provision.
products from distribution channels
and
(B) allow labeling changes for
No similar provision.
No similar provision.
products used for unapproved uses.

CRS-37
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Publication
Sec. 564 (b)(4).
Sec. 564 (b)(3).
Sec. 564 (b)(3).
H.R. 2122 Sec. 5
The HHS Secretary must publish in
The HHS Secretary must publish in
Same as S. 15.
(a)(1)(A)(iii)(II)
the Federal Register each declaration,
the Federal Register and notify the
requires an
determination and renewal.
appropriate congressional
annual report to
committees of each declaration,
Congress
determination and renewal.
detailing any
such declaration.
See below.

CRS-38
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Emergency
Sec. 564 (c).
Sec. 564 (c).
Sec. 564 (c).
Authorization
The HHS Secretary may authorize
The HHS Secretary may authorize
Same as S. 15.
Criteria
the emergency use of a product only
the emergency use of a product only
if, after consultation with the
if the Secretary concludes–
Director of the National Institutes of
Health and the Director of the
Centers for Disease Control and
Prevention, the Secretary concludes–
(1) that an agent specified in the
Same as H.R. 2122.
Same as H.R. 2122.
emergency declaration can cause a
serious or life-threatening disease or
condition;
(2) that, based on the totality of
Same as H.R. 2122.
Same as H.R. 2122.
scientific evidence available to the
Secretary, it is reasonable to believe
that –
(A) the product may be effective in
Same as H.R. 2122.
Same as H.R. 2122.
detecting, diagnosing, treating, or
preventing a life-threatening disease
or condition caused by that agent or
by a countermeasure against that
agent; and

CRS-39
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Emergency
(B) the known and potential benefits
Same as H.R. 2122.
Same as H.R. 2122.
Authorization
of the product outweigh its known
Criteria
and potential risks.
(continued)
(3) that there is no adequate,
Same as H.R. 2122.
Same as H.R. 2122.
approved, and available alternative to
the product for detecting, diagnosing,
preventing, or treating such disease
or condition; and
(4) that such other criteria as the
Same as H.R. 2122.
Same as H.R. 2122.
Secretary may by regulation
prescribe are satisfied.

CRS-40
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Emergency
Sec. 564 (d)(1).
Sec. 564 (d).
Sec. 564 (d).
Authorization
An authorization of a product under
Same as H.R. 2122.
Same as H.R. 2122.
Scope
this section shall state–
(A) each disease or condition for
(1) each disease or condition and the
(1) Same as S. 15.
which the product may be used
intended use of the product within the
within the scope of the authorization;
scope of the authorization; and
(B) the Secretary’s conclusions, that
No similar provision.
No similar provision.
the known and potential benefits of
the product, outweigh the known and
potential risks of the product; and
(C) the Secretary’s conclusions,
(2) Same as H.R. 2122.
(2) Same as H.R. 2122.
concerning the safety and potential
effectiveness of the product in
detecting, diagnosing, preventing, or
treating such diseases or conditions,
including an assessment of the
available scientific evidence.

CRS-41
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Confidential
Sec. 564 (d)(2).
No similar provision.
No similar provision.
These sections of
Information
Nothing in this section alters or
U.S.C. require
amends 18 U.S.C. 1905 or 5 U.S.C.
the confidential
552(b)(4).
handling of
financial
information of
any person, firm,
partnership,
corporation,
association. This
includes trade
secrets,
processes and
operations.

CRS-42
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Required
Sec. 564 (e)(1)(A).
Sec. 564 (e).
Sec. 564 (e).
The Senate
Conditions on
With respect to emergency use of an
The HHS Secretary will impose
Same as S. 15.
versions do not
Unapproved
unapproved product, the HHS
requirements (including requirements
distinguish
Product
Secretary will establish authorization
concerning product labeling and the
between
Emergency
conditions to protect public health
provision of information) designed to
unapproved
Authorization
including –
ensure that–
products and
unapproved uses
Sec. 564 (e)(1)(A)(i).
Sec. 564 (e)(1).
Same as S. 15.
of approved
to the extent feasible, ensuring that
to the extent feasible, ensuring those
products.
those administering the
administering the countermeasure
countermeasure know
know
that the Secretary has authorized the
that the Secretary has authorized the
emergency use of the product, the
product solely for emergency use, the
significant known and potential
significant known and potential
benefits and risks of the product (and
benefits and risks of the product (and
the extent to which these are
the extent to which these are
unknown), and of any available
unknown), and of any available
alternatives and their risks and
alternatives and their risks and
benefits.
benefits.

CRS-43
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Required
Sec. 564 (e)(1)(A)(ii).
Sec. 564 (e)(2).
Sec. 564 (e)(2).
Conditions on
to the extent feasible, ensuring that
to the extent feasible, (including
Same as S. 15.
Unapproved
those receiving the product know–
requirements concerning product
Product
labeling and the provision of
Emergency
information) ensuring that those
Authorization
receiving the product know –
(continued)
that the Secretary has authorized the
that the Secretary has authorized the
Same as S. 15.
emergency use of the product, the
product solely for emergency use, the
significant known and potential
significant known and potential
benefits and risks of the product (and
benefits and risks of the product (and
the extent to which these are
the extent to which these are
unknown), of any available
unknown), of any available
alternatives and their risks and
alternatives and their risks and
benefits, and of the option to accept
benefits, and of the option to accept
or refuse administration of the
or refuse administration of the
product and any consequences of
product and any consequences of
doing so.
doing so.
Sec. 564 (e)(1)(A)(iii). appropriate
Sec. 564 (e)(8).
Sec. 564 (e)(8).
conditions for the monitoring and
Same as H.R. 2122.
Same as H.R. 2122.
reporting of adverse events
associated with use of the product.

CRS-44
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Required
Sec. 564 (e)(1)(A)(iv).
Sec. 564 (e)(6).
Sec. 564 (e)(6).
The Senate
Conditions on
For manufacturers of the product,
Requirements concerning
Same as S. 15.
versions do not
Unapproved
appropriate conditions concerning
recordkeeping and reporting,
have separate
Product
record keeping and reporting
including records access by the
sections
Emergency
including records access by the
Secretary and publication of data.
specifically for
Authorization
Secretary.
manufacturers
(continued)
regarding
recordkeeping
and reporting.

CRS-45
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Optional
Sec. 564 (e)(1)(B).
Sec. 564 (e)(3-5).
Sec. 564 (e)(3-8).
The Senate
Conditions on
With respect to emergency use of an
The HHS Secretary is authorized to
Same as S. 15.
versions do not
Unapproved
unapproved product, The HHS
impose such conditions on an
distinguish
Product
Secretary may establish additional
authorization as the Secretary
between
Emergency
conditions on authorizations to
determines are necessary to protect
unapproved
Authorization
protect public health including –
public health including –
products and
unapproved uses
Sec. 564 (e)(1)(B)(i).
Sec. 564 (e)(3).
Sec. 564 (e)(3).
of approved
on which entities may distribute the
impose limitations on which entities
Same as H.R. 2122.
products.
product for emergency use and on
may distribute the product for
how distribution is to be performed.
emergency use and on how
distribution is to be performed.
Sec. 564 (e)(1)(B)(ii).
Sec. 564 (e)(4).
Sec. 564 (e)(4).
on who may administer the product
impose limitations on who may
Same as H.R. 2122.
for emergency use, and on the
administer the product for emergency
categories of individuals to whom,
use, and on the categories of
and the circumstances under which,
individuals to whom, and the
the product may be administered.
circumstances under which, the
product may be administered.
No similar provision.
Sec. 564 (e)(5).
Sec. 564 (e)(5).
condition the authorization on the
Same as S. 15.
performance of studies, clinical trials,
or other research needed to support
marketing approval of the product.

CRS-46
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Optional
Sec. 564 (e)(1)(B)(iii).
Sec. 564 (e)(6).
Sec. 564 (e)(6).
The Senate
Conditions on
for persons other than manufacturers
The Secretary shall impose, to the
Same as S. 15.
versions require
Unapproved
of the product, appropriate
extent feasible and appropriate
the imposition of
Product
conditions concerning recordkeeping
requirements concerning
recordkeeping
Emergency
and reporting, including records
recordkeeping and reporting,
requirements.
Authorization
access by the Secretary with respect
including records access by the
H.R. 2122
(continued)
to the emergency use of the product.
Secretary and publication of data.
permits but does
not demand such
requirements.
The Senate
versions do not
have separate
sections for
manufacturers
and non-
manufacturers
regarding
recordkeeping.

CRS-47
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Optional
Sec. 564 (e)(1)(B)(iv).
Sec. 564 (e)(7).
Sec. 564 (e)(7).
The FFDCA Sec.
Conditions on
with respect to the emergency use of
The HHS Secretary may waive, to the
Same as S. 15.
501 defines
Unapproved
the product, waive or limit, to the
extent appropriate given the
adulterated
Product
extent appropriate given the
circumstances of the emergency,
drugs and
Emergency
circumstances of the emergency,
requirements, with respect to the
devices.
Authorization
conditions regarding current good
product, of current good
(continued)
manufacturing practice otherwise
manufacturing practice otherwise
applicable to the manufacture,
applicable to the manufacture,
processing, packing, or holding of
processing, packing, or holding of
these products subject to regulation
products subject to regulation under
under this Act, including such
this Act.
requirements established in section
501 of the Federal Food, Drug, and
Cosmetic Act (FFDCA).

CRS-48
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Unapproved
Sec. 564 (e)(2).
Sec. 564 (e)(1-8).
Sec. 564 (e)(1-8).
The Senate
Use Emergency
For unapproved use of an approved
See above.
Same as S. 15.
versions do not
Authorization
product authorization:
distinguish
Conditions
between
The Secretary may, for
See above.
Same as S. 15.
unapproved
manufacturers of the product
products and
establish any of the conditions
unapproved uses
described in Sec. 564 (e)(1)(A)(i - iv)
of approved
[see Unapproved Product Emergency
products.
Authorization Conditions above]
If the manufacturer of the product
No similar provision.
No similar provision.
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.
However, emergency authorizations
may allow such persons to supply
additional information with the
product. Such additional information
shall not be considered labeling.

CRS-49
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Emergency Use
Sec. 564 (f).
Sec. 564 (f).
Sec. 564 (f).
Authorization
Emergency authorizations will
Same as H.R. 2122.
Same as H.R. 2122.
Duration
continue until the earlier of a
termination of the emergency
declaration or a revocation of
emergency use authorization by the
HHS Secretary under Sec. 564 (g).
After authorization terminates,
Same as H.R. 2122.
Same as H.R. 2122.
patients already receiving the product
may continue to do so for as long as
is deemed necessary by the patient’s
attending physician.
Emergency Use
Sec. 564 (g).
Sec. 564 (g).
Sec. 564 (g).
Authorization
The HHS Secretary will periodically
Same as H.R. 2122.
Same as H.R. 2122.
Revocation
review the circumstances and
appropriateness of these emergency
use authorizations.
The HHS Secretary may revoke an
The HHS Secretary may revoke an
Same as S. 15.
authorization if the authorization
authorization if the authorization
criteria under Sec. 564 (c) are no
criteria under Sec. 564 (c) are no
longer met.
longer met or other circumstances
make such a revocation appropriate.
This decision is not reviewable.
Same as H.R. 2122.
Same as H.R. 2122.

CRS-50
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Publication
Sec. 564 (h).
Sec. 564 (h).
Sec. 564 (h).
H.R. 2122 Sec. 5
The HHS Secretary will promptly
The HHS Secretary will promptly
Same as S. 15.
(a)(1)(A)(iii)(I)
publish in the Federal Register a
publish in the Federal Register, and
requires an
notice of each authorization,
provide to the appropriate
annual report to
authorization termination and
congressional committees, a notice of
Congress
authorization revocation. This
each authorization, authorization
detailing such
publication must include the reasons
termination and authorization
authorizations.
for the action.
revocation.
See below.

CRS-51
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Recordkeeping
No similar provision.
Sec. 564 (i)(1).
Sec. 564 (i)(1).
The HHS Secretary may require
Same as S. 15.
persons, including a 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–
No similar provision.
data that is obtained from such
Same as S. 15.
activity and that pertains to the
effectiveness or safety of such
product;
No similar provision.
such records as are necessary to
Same as S. 15.
determine, or facilitate a
determination, whether there may be
any violation of this section or of a
regulation promulgated under this
section; and
No similar provision.
such additional records as the
Same as S. 15.
Secretary may determine necessary.

CRS-52
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Access to
No similar provision.
Sec. 564 (i)(2).
Sec. 564 (i)(2).
Records by
The HHS Secretary may require a
Same as S. 15.
HHS Secretary
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
provide to the Secretary all data that
is obtained from such activity and
that pertains to the safety or
effectiveness of such product.
No similar provision.
Every person required under this
Same as S. 15.
section to establish or 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.
Actions
Sec. 564 (i).
Sec. 564 (k).
Sec. 564 (k).
Committed to
All HHS Secretary, Defense
Same as H.R. 2122.
Same as H.R. 2122.
Agency
Secretary and DHS Secretary actions
Discretion
under the authority of this section are
committed to agency discretion.
Regulations
No similar provision.
Sec. 564 (l).
Sec. 564 (l).
The HHS Secretary may promulgate
Same as S. 15.
regulations to implement this section.

CRS-53
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Rules of
Sec. 564 (j).
Sec. 564 (m).
Sec. 564 (m).
Construction
Nothing in this section shall be
Same as H.R. 2122.
Same as H.R. 2122.
construed to impair or otherwise
affect–
the authority of the President as
Same as H.R. 2122.
Same as H.R. 2122.
Commander in Chief of the Armed
Forces of the United States;
the authority of the Secretary of
Same as H.R. 2122.
Same as H.R. 2122.
Defense with respect to the
Department of Defense, including the
armed forces, under other provisions
of federal law; or
the authority of the HHS Secretary
No similar provision.
No similar provision.
under section 319F-2 of the Public
Health Services Act to manage the
stockpile under such section.

CRS-54
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Application to
Sec. 564 (k)(1).
Sec. 564 (n)(1).
Sec. 564 (n)(1)(A).
Members of the
With respect to members of the
Same as H.R. 2122.
Same as H.R. 2122.
Armed Forces
armed forces, the President may
waive any requirement designed to
ensure that individuals are informed
of an option to accept or refuse the
product if the President determines,
in writing, that complying with such
requirement is not feasible, is
contrary to the best interests of the
members affected, or is not in the
interests of national security.

CRS-55
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Application to
Sec. 564 (k)(2).
No similar provision.
Sec. 564 (n)(1)(B).
10 U.S.C. 1107
Members of the
If the HHS Secretary determines that
Same as H.R. 2122.
addresses the
Armed Forces
it is not feasible to provide a member
procedures
(continued)
of the armed forces information
required for
required by Sec. 564 (e)(1)(A)(ii)
using
[see above] prior to the use of the
investigational
product, such information will be
new drugs (IND)
provided to the individual or next-of-
on the members
kin as soon as possible and within 30
of the armed
days of use. This information must
services. Among
be recorded in the medical record of
other provisions,
the member.
it requires
notification that
Sec. 564 (k)(3).
it is an IND, or a
10 U.S.C. 1107 does not apply for the
Sec. 564 (n)(2).
Sec. 564 (n)(2).
drug unapproved
emergency use of products if the
Same as H.R. 2122.
Same as H.R. 2122.
for its use, the
basis for an emergency declaration is
reasons for the
the Defense Secretary’s conclusion of
drug’s use, and
a military emergency or potential for
potential side
one under Sec. 564 (b)(1)(B).
effects.
Relation to
Sec. 564 (l).
Sec. 564 (o).
Sec. 564 (o).
These sections of
Other
Products within the scope of an
Same as H.R. 2122.
Same as H.R. 2122.
U.S.C. relate to
Provisions
emergency authorization are not
testing IND in
subject to section 505(i) or 520(g) of
humans.
the Federal Food Drug and Cosmetic
Act (21 U.S.C. 360bbb et seq.) nor
any requirements otherwise
applicable to clinical investigations
pursuant to other provisions of that
Act.

CRS-56
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Discretion
Sec. 564 (m).
No similar provision.
No similar provision.
Regarding Use
The HHS Secretary cannot require
of
any person to carry out any activity
Authorization
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 been
authorized for emergency use. In this
case the manufacturer must notify the
HHS Secretary of the choice not to
participate in the program, within a
reasonable time from the
emergency-use authorization.
Enforcement
Sec. 564 (n).
Sec. 564 (j).
Sec. 564 (j).
A person who carries out an activity
A person who violates a requirement
Same as S. 15.
pursuant to an authorization under
of this section or of a regulation or
this section, but who fails to comply
order promulgated pursuant to this
with applicable conditions under
section shall be subject to a civil
subsection (e), is in violation of the
money penalty of not more than
Federal Food, Drug, and Cosmetic
$100,000 in the case of an individual,
Act.
and not more than $250,000 in the
case of any other person, for each
violation, not to exceed $1,000,000
for all such violations adjudicated in
a single proceeding.

CRS-57
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Enforcement
No similar provision.
Sec. 4(b).
Sec. 4(b).
(continued)
Technical amendments to Section
Same as S. 15.
301 of the Food, 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.
(1) Promote or use a product that is
the subject of an authorization under
section 564 other than as stated in the
authorization, or other than during
the period described by section
564(g), unless such promotion or use
is permitted under another provision
of this Act;
(2) Fail to comply with an
Same as S. 15.
information requirement under
section 564(e).

CRS-58
Table 5. Required Reports
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Sec. 5 Reports Regarding
No similar provision.
No similar provision.
Authorities Under this Act.
Annual Reports
Sec. 5 (a)(1)(A).
No similar provision.
No similar provision.
The HHS Secretary will submit
annual reports regarding the exercise
of the following authorities (under
Sections 2, 3 and 4 of this Act):
use of simplified acquisition
No similar provision.
No similar provision.
authority,
use of other than full and open
No similar provision.
competition,
No similar provision.
use of expedited peer review,
No similar provision.
No similar provision.
use of premium provision in
No similar provision.
multiple-award contracts,
No similar provision.
authorization of the emergency use of
Sec. 564 (h).
Sec. 564 (h).
The Senate
drugs,
The HHS Secretary will promptly
Same as S. 15.
versions require
publish in the Federal Register, and
case-by-case
provide to the appropriate
congressional committees, a notice of
notification
each authorization, authorization
rather than
termination and authorization
annual reports
revocation.
with respect to
these actions.

CRS-59
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Annual Reports
declaration of any emergency, and
Sec. 564 (b)(3).
Sec. 564 (b)(3).
(continued)
The HHS Secretary must publish in
Same as S. 15.
the Federal Register and notify the
appropriate congressional
committees each declaration,
determination and renewal.
conditions placed on emergency use
No similar provision.
No similar provision.
of drugs emergency.

CRS-60
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Contents of
Sec. 5 (a)(1)(B).
No similar provision.
No similar provision.
Reports
These reports will be submitted to the
designated congressional committees
and summarize–
the particular actions that were taken
No similar provision.
No similar provision.
under the authorities specified in
subparagraph (A), including, the
identification of the threat agent,
emergency, or the biomedical
countermeasure with respect to which
the authority was used;
the reasons underlying the decision to
No similar provision.
No similar provision.
use such authorities, including any
options that were considered and
rejected with respect to the use of
such authorities;
the identification of each person or
No similar provision.
No similar provision.
entity that received, or was
considered and rejected for, grants,
cooperative agreements, or contracts
pursuant to the use of such
authorities; and
whether, with respect to each
No similar provision.
No similar provision.
procurement that is approved by the
President, a contract was entered into
within one year after such
presidential approval.

CRS-61
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Annual
Sec. 5 (a)(2).
No similar provision.
No similar provision.
Summaries
The HHS Secretary shall annually
Regarding
submit a report to the designated
Certain Activity
congressional committees that
summarizes the activity relating to
the exercise of the following
authorities granted by Sec. 2 of this
Act:
use of increased micropurchase
No similar provision.
No similar provision.
threshold,
use of authority for personal services
No similar provision.
No similar provision.
contracts (including the number of
persons who were paid amounts
greater than $100,000 and the
number of persons who were paid
amounts between $50,000 and
$100,000), and
use of streamlined personnel
No similar provision.
No similar provision.
authority.

CRS-62
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
National
Sec. 5 (b)(1).
No similar provision.
No similar provision.
Academy of
Not later than 4 years after the date
Sciences Review
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 what extent activities
undertaken pursuant to such
authorities have enhanced the
development of biomedical
countermeasures affecting national
security, and to recommend 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 5 years after enactment.

CRS-63
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
National
Sec. 5 (b)(2).
No similar provision.
No similar provision.
Academy of
This report shall include–
Sciences Review
Report
a summary of the most recent
No similar provision.
No similar provision.
Contents
analysis by the Department of
Homeland Security and the
intelligence community of the
domestic threat from chemical,
biological, radiological, and nuclear
agents;
the Academy’s assessment of the
No similar provision.
No similar provision.
current availability of
countermeasures to address such
threats;
the Academy’s assessment of the
No similar provision.
No similar provision.
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-64
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
National
the Academy’s assessment of threats
No similar provision.
No similar provision.
Academy of
to national security that are posed by
Sciences Review
technology that will enable, during
Report
the 10-year period beginning on the
Contents
date of the enactment of this Act, the
(continued)
development of antibiotic- resistant,
mutated, or bioengineered strains of
biological agents; and
recommendations on short-term and
No similar provision.
No similar provision.
long-term governmental strategies for
addressing such threats, including
recommendations for federal policies
regarding research priorities, the
development of countermeasures, and
investments in technology.

CRS-65
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
General
Sec. 5 (c).
Sec. 6 .
Sec. 6 .
Accounting
4 years after the date of the
Not later than 4 years after the date
Same as S. 15.
Office Review
enactment of this Act, the
of the enactment of this Act, the
Comptroller General of the United
Comptroller General of the United
States shall initiate a study–
States shall initiate a study that–
(1)(A) to review the HHS Secretary’s
(1) describes the activities conducted
Same as S. 15.
The provisions
use of the authorities granted under
under the authorities provided for in
cited in the
this Act with respect to simplified
section 409J(b)(1) of the Public
Senate bills refer
acquisition procedures, procedures
Health Service Act (as added by
to simplified
other than full and open competition,
section 2) and section 319A-1(f)(3)
acquisition
increased micropurchase thresholds,
and (4) of such Act (as added by
procedures and
personal services contracts,
section 3);
use of non-
streamlined personnel authority, and
competitive
the purchase of security
procedures.
countermeasures under the special
reserve fund; and
(1)(B) to recommend any legislative
No similar provision.
No similar provision.
or administrative changes necessary
to improve the use or effectiveness of
such authorities in the future;

CRS-66
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
General
No similar provision.
(2) identifies any procurements that
Same as S. 15.
Accounting
would have been prohibited except
Office Review
for the authorities provided by this
(continued)
Act; and.
(2)(A) to review the internal controls
(3) to assess the adequacy of internal
Same as S. 15.
instituted by the HHS Secretary with
controls instituted by the HHS
respect to such authorities, where
Secretary with respect to such
required by this Act; and
authorities, where required by this
Act.
(2)(B) to recommend any legislative
No similar provision.
No similar provision.
or administrative changes necessary
to improve the effectiveness of such
controls; and

CRS-67
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
General
(3)(A) to review the Secretary’s use
No similar provision.
No similar provision.
Accounting
of the authority granted under this
Office Review
Act to authorize an emergency use of
(continued)
a biomedical countermeasure,
including the means by which the
Secretary determines whether and
under what conditions any such
authorizations should be granted and
the benefits and adverse impacts, if
any, resulting from the use of such
authority; and
(3)(B) to recommend any legislative
No similar provision.
No similar provision.
or administrative changes necessary
to improve the utilization or
effectiveness of such authority and to
enhance protection of the public
health.
The results of the study shall be
No similar provision.
No similar provision.
submitted to the designated
congressional committees not later
than 5 years after the enactment of
this Act.

CRS-68
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Report
Sec. 5 (d)(1).
No similar provision.
No similar provision.
Regarding
Not later than 120 days after
Security
enactment of this Act, the DHS and
Counter-
HHS Secretaries will jointly report to
measures
the designated congressional
Procurement
committees whether there is a lack of
Barriers
adequate large-scale biocontainment
facilities necessary for the testing of
security countermeasures in
accordance with Food and Drug
Administration requirements.
Sec. 5 (d)(2).
No similar provision.
No similar provision.
Not later than 1 year after enactment
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.
Report
Sec. 5 (e).
No similar provision.
No similar provision.
Regarding
Not later than 270 days after
Status of
enactment of this Act, the DHS
Program for
Secretary will submit to the
Chemical
designated congressional committees
Terrorism
a report describing the status of the
Preparedness
program carried out by the Secretary
to enhance the preparedness of the
United States to respond to terrorist
attacks involving chemical agents.

CRS-69
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Designated
Sec. 5 (f).
No similar provision.
No similar provision.
The Senate
Congressional
The term `designated congressional
versions use the
Committees
committees’ means the following
phrase
committees of Congress:
“appropriate
congressional
the House Committees on Energy
No similar provision.
No similar provision.
committees,”
and Commerce, Appropriations,
elsewhere in the
Government Reform, and the Select
bills, without
Committee on Homeland Security (or
specifying which
any successor to the Select
committees they
Committee);
are.
the Senate Committees on Health,
No similar provision.
No similar provision.
Education, Labor, and Pensions;
Appropriations; and Government
Affairs.

CRS-70
Table 6. Outreach
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Outreach
Sec. 6.
No similar provision.
No similar provision.
The HHS Secretary will develop
outreach measures to ensure to the
extent practicable that diverse
institutions, including Historically
Black Colleges and Universities and
those serving large proportions of
Hispanics, Native Americans, Asian-
Pacific Americans, or other
underrepresented populations, are
meaningfully aware of available
research and development grants,
contracts, cooperative agreements,
and procurements conducted under
sections 2 and 3 of this Act.

CRS-71
Table 7. Export Control Recommendation
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Recom-
Sec. 7.
No similar provision.
No similar provision.
mendation for
Upon the award of any grant,
Export Controls
contract, or cooperative agreement
on Certain
under section 2 or 3 of this Act for
Biomedical
the research, development, or
Counter-
procurement of a countermeasure the
measures
HHS Secretary will, in consultation
with the heads of other appropriate
federal agencies, determine whether
such countermeasure is subject to
existing export-related controls and,
if not, may make a recommendation
that such countermeasure should be
included on the list of controlled
items subject to export-related
controls.

CRS-72
Table 8. Interagency Coordination
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Ensuring
Sec. 8 (a).
No similar provision.
No similar provision.
Coordination,
The HHS, DHS and Defense
Cooperation
Secretaries will ensure that the
and the
activities of their respective
Elimination of
Departments coordinate,
Unnecessary
complement, and do not
Duplication in
unnecessarily duplicate programs to
Programs
identify potential domestic threats
from biological, chemical,
radiological or nuclear agents, detect
domestic incidents involving such
agents, analyze such incidents, and
develop necessary countermeasures.
The Secretaries will ensure that
information and technology
possessed by their Departments
relevant to these activities are shared
with the other Departments.
Designation of
Sec. 8 (b).
No similar provision.
No similar provision.
Agency
The HHS, DHS and Defense
Coordination
Secretaries will each designate an
Officer
officer or employee of their
respective Departments who shall
coordinate, through regular meetings
and communications, with the other
aforementioned Departments such
programs and activities carried out by
their Departments.

CRS-73
Table 9. Smallpox- Related Amendments to the
Homeland Security Act and Public Health Services Act
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Smallpox-
No similar provision.
Sec. 5.
No similar provision.
Related
These provisions concern smallpox
Amendments to
countermeasures and were
the Homeland
considered by other legislation. The
Security Act
Smallpox Emergency Personnel
and Public
Protection Act of 2003 (P.L.108-020)
Health Services
has incorporated many of these
Act
provisions.

CRS-74
Table 10. Additional HHS Secretary Authorities During
National Emergencies
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Authority of the
No similar provision.
No similar provision.
Sec. 5.
HHS Secretary
Amends section 1135(b) of the Social
During National
Security Act that was added by the
Emergencies
Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002 (P.L. 107-
188).
No similar provision.
No similar provision.
Allows the HHS Secretary in
emergencies to waive or modify –
No similar provision.
No similar provision.
sanctions relating to the examination
and treatment of emergency 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 that arise
from noncompliance with the
following requirements,

CRS-75
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Authority of the
No similar provision.
No similar provision.
to obtain a patient’s agreement to
HHS Secretary
speak with family members or
During National
friends; and
Emergencies
(continued)
No similar provision.
No similar provision.
to honor a request to opt out of the
facility directory;
No similar provision.
No similar provision.
requirement to distribute a notice; or
No similar provision.
No similar provision.
relating to the patient’s right to
request privacy restrictions; and
confidential communications.
No similar provision.
No similar provision.
These waivers shall be limited to a
72-hour period beginning upon
implementation of a hospital disaster
protocol. The waiver or modification
shall be withdrawn after such period
and the provider shall comply with
the requirements under such
paragraph for any patient still under
the care of the provider.

CRS-76
Table 11. Special Senate Funding Language
Provision
H.R. 2122 as Passed by House
S. 15 as Reported by Committee
S. 1504 as Introduced
Comments
Special Senate
No similar provision.
No similar provision.
Sec. 7.
Funding
In the Senate, for purposes of points
Language for
of order under a concurrent
Project
resolution on the budget and the
BioShield
Congressional Budget Act of 1974,
provisions contained in any bill,
resolution, amendment, motion, or
conference report that change the
availability of any amounts
appropriated pursuant to this Act (or
an amendment made by this Act)
shall not be scored with respect to the
level of budget authority or outlays
contained in such bill, resolution,
amendment, motion, or conference
report.
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