Académique Documents
Professionnel Documents
Culture Documents
107TH CONGRESS
2D SESSION
S. 3148
A BILL
To provide incentives to increase research by private sector
entities to develop antivirals, antibiotics and other drugs,
vaccines, microbicides, and diagnostic technologies to prevent and treat illnesses associated with a biological,
chemical, or radiological weapons attack.
1
5 Biological, Chemical, and Radiological Weapons Counter6 measures Research Act of 2002.
2
1
(c) TABLE
OF
201.
202.
203.
204.
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8
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
211.
212.
213.
214.
215.
216.
217.
Sec.
Sec.
Sec.
Sec.
218.
219.
220.
221.
SEC. 2. FINDINGS.
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civilians.
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conjunctivitis.
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weapons is real.
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Kandahar.
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nium.
unaccounted for.
Russian
general
Alexander
Ledbed
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world.
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died.
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Americium-241 to decay.
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additional
medical
responses,
including
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ening
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Mycobacleriumn
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nations.
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illnesses
(Enterococcus
tuberculosis
and
faecalis,
Pseudomonas
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1
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efficacy.
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quarantine.
or are ineffective.
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ed countermeasures.
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SEC. 3. DEFINITIONS.
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In this Act:
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(1) BIOLOGICAL
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NUCLEAR
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WEAPON.The
OR
RADIOLOGICAL
MATERIAL;
TERROR
term
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measures means
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and
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ples.
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(6) RESEARCH
TOOL.The
term research
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rity.
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(a) DEVELOPMENT.
(1) IN
GENERAL.Not
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United States.
(2) REQUIREMENTS.
(A) IN
GENERAL.The
Secretary shall
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(B) CERTAIN
DETERMINATIONS.For
pur-
countermeasure;
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tion;
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(3) USE
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(4) INFORMATION
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Secretary shall
re-
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countermeasures; and
this Act).
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(5) EXEMPTION.
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(A) IN
GENERAL.The
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(B) SUFFICIENCY
OF INFORMATION.In
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8 subsection (a) may, at the discretion of the Secretary, con9 tain the following biological agents and diseases caused by
10 biological agents, chemical toxins, and nuclear and radio11 logical materials:
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(5)
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plague).
Yersina
pestis
(Black
Death/bubonic
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2
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(20)
Eastern
and
Western
equine
encephalomyelitis.
(21) Ricin toxin from ricinus communis (castor
beans).
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(24) Aflatoxins.
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(34) Hantaviruses.
(38) Malaria.
(39) Typhus.
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(43) Giardiasis.
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(44) Trichomoniasis.
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(45) Trypanosomiasis.
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(e) PROCUREMENT.
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Act).
(2) FEDERAL
KET DETERMINATION.Not
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determine
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other countermeasure;
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by this Act).
(3) DETERMINATIONS.
(A) IN
GENERAL.The
Secretary shall
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termeasures
11
102(e)(3).
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in
(B) TESTING
accordance
with
section
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countermeasure involved.
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(C)
NO
JUDICIAL
REVIEW.Notwith-
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countermeasures.
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18 year each entity that operates any private sector establish19 ment in any State that seeks to be eligible for the tax,
20 procurement, intellectual property, and liability provisions
21 in title II (and the amendments made by such title), and
22 that is engaged in the conduct of research to develop coun23 termeasures, diagnostics (as provided for in section 103),
24 or research tools (as provided for in section 104) shall reg-
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1 ister with the Department. Such registration shall con2 tain
3
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by the Secretary;
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(6) the name of each individual who is conducting the research involved;
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(1) IN
GENERAL.Not
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(3) CERTAIN
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(4) NO
JUDICIAL
REVIEW.Notwithstanding
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25
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cilities.
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2
logical attack.
(e) CERTIFICATION.
(1) IN
GENERAL.With
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mine
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the development of a
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101;
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and
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(3) SUCCESSFUL
DEVELOPMENT.Not
later
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(i)
procurement
of
the
counter-
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(4)
TION.The
REQUIRED
AFFIRMATIVE
DETERMINA-
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sionate use; or
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(5) JUDICIAL
REVIEW.An
adverse determina-
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(f) ELIGIBILITY
OF
(1) AUTHORITY
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(2) WAIVER
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of 1986).
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(3) IMPLEMENTING
entity obtaining a
RULES.The
Secretary
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(4) NO
JUDICIAL
REVIEW.Notwithstanding
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(g) RULE
OF
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SULTS.An
TO
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1 by section 125 of the Public Health Security and Bioter2 rorism Preparedness and Response Act of 2002.
3
(j) PRIORITY
ANCE.An
FOR
TECHNICAL
AND
OTHER ASSIST-
11 be given priority for receiving technical and other assist12 ance to provide security for their personnel and facilities
13 that conduct development, production, distribution, or
14 storage of countermeasures under section 319K of the
15 Public Health Service Act (as added by section 124 of the
16 Public Health Security and Bioterrorism Preparedness
17 and Response Act of 2002).
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fective;
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rently available;
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biothreat agents;
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fectious disease;
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10
differential diagnosis;
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organism;
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physicians; and
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25 the date of enactment of this Act, the Secretary shall deS 3148 IS
49
1 velop and make available to potential manufacturers, a list
2 of the diagnostics and diagnostics for contraindicators to
3 vaccines or drugs that need to be developed to prepare
4 the United States for a terrorist attack with a biological
5 or chemical agent or toxin or nuclear or radiological mate6 rials. The Secretary shall provide such information as the
7 Secretary determines to be necessary to enable such poten8 tial manufacturers to structure and focus their research
9 and development programs for the development of such
10 diagnostics.
11
GENERAL.The
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23
diseases.
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25
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and
12
(C)
promote
the
advancement
of
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(e) UTILIZATION
OF
DIAGNOSTICS
BY
HEALTH CARE
2 PROVIDERS.
3
(1) IN
GENERAL.The
eases.
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diseases.
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1 an application for a determination that the entity has suc2 cessfully developed a terror weapons diagnostic in accord3 ance with this section and section 102, the Secretary shall
4 notify the entity
5
9
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204.
21
22 the Secretary with respect to the development by a manu23 facturer of a terror weapons diagnostic in accordance with
24 this section, shall be subject to appropriate judicial review.
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1
2
States;
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11
weaponized;
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26
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1
fective
neered agent.
biodefense
measures
for
treatment
or
10 the date of enactment of this Act, the Secretary shall de11 velop and make available to potential manufacturers, a list
12 of the research tools that need to be developed to prepare
13 the United States for a terrorist attack with a biological
14 or chemical agent or toxin or nuclear or radiological mate15 rials. The list developed by the Secretary shall include re16 search tools for which there is a need for development in
17 order to understand why certain countermeasures may
18 cause adverse events, how to minimize such adverse
19 events, and how to treat such adverse events. The Sec20 retary shall provide such information as the Secretary de21 termines to be necessary to enable such potential manufac22 turers to structure and focus their research and develop23 ment programs for the development of such diagnostics.
24
55
1 and make such list available to potential manufacturers
2 of research tools under terms and conditions consistent
3 with the security interests of the United States.
4
15
16
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24
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204.
7 the Secretary with respect to the development by a manu8 facturer of a terror weapons research tool in accordance
9 with this section, shall be subject to appropriate judicial
10 review.
11
12
GENERAL.Entities
with respect to
13
14
15
16
17
18
19
measures.
20
(2) RULE
OF CONSTRUCTION.Nothing
in this
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25
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or
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8
9
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portunities.
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countermeasures.
(1) RESEARCH
15
PARTNERSHIPS
16
SEARCH.The
17
nership
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22
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24
S 3148 IS
for
TO
FUND
COUNTERMEASURE
RE-
certified
countermeasures,
61
1
graph.
(2) CAPITAL
(A) INCREASED
enti-
10
PORATE TAXPAYERS.Subsection
11
12
13
(B) APPLICATION
TO
(a) of section
CORPORATE
TAX-
14
PAYERS.Subsection
15
16
17
(C) STOCK
18
19
20
21
22
it appears.
23
24
(D) REDUCTION
(1) of sec-
IN HOLDING PERIOD.
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5 years.
(E) NONAPPLICATION
OF PER-ISSUER LIM-
ITATION.Section
ble gain).
8
9
10
(F) MODIFICATION
LIMITATION.Section
OF WORKING CAPITAL
shall be applied
11
12
13
14
tence.
15
(G) NONAPPLICATION
OF MINIMUM TAX
16
PREFERENCE.Section
17
18
(7).
19
(3) TAX
20
RESEARCH.
21
(A) IN
GENERAL.Subpart
D of part IV
22
23
24
25
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2
3
DEVELOPING COUNTERMEASURES.
13
PENSES.For
14
(1)
15
COUNTERMEASURES
RE-
SEARCH EXPENSES.
16
(A) IN
GENERAL.Except
as otherwise
17
18
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20
21
22
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24
25
(B) MODIFICATIONS;
INCREASED INCEN-
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subsection.
10
(C) EXCLUSION
11
BY GRANTS, ETC.The
12
13
14
15
16
(2)
COUNTERMEASURES
RESEARCH.The
17
18
19
20
21
22
FOR INCREASING
23 RESEARCH EXPENDITURES.
24
25
(1) IN
GENERAL.Except
as provided in para-
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(2) EXPENSES
INCLUDED IN DETERMINING
10
11
12
taxable years.
13
14
(1) LIMITATIONS
qualified
ON FOREIGN TESTING.No
15
16
17
18
States.
19
(2) PRE-CLINICAL
RESEARCH.No
credit shall
20
21
22
23
24
25
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graph.
(3) CERTAIN
RULES
MADE
APPLICABLE.
tion.
(4) COORDINATION
10
11
RARE DISEASES.Any
12
13
14
15
16
(B) INCLUSION
IN
GENERAL
BUSINESS
CREDIT.
17
(i) IN
GENERAL.Section
38(b) of
18
19
20
21
22
23
24
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(ii)
TRANSITION
RULE.Section
(11) NO
BEFORE ENACTMENT.No
10
(C) DENIAL
OF DOUBLE BENEFIT.Sec-
11
12
13
(d) CREDIT
FOR
QUALIFIED COUNTERMEASURES
14 RESEARCH EXPENSES.
15
(1) IN
GENERAL.No
16
17
18
19
20
21
tion 45G(a).
22
(2) CERTAIN
RULES TO APPLY.Rules
similar
23
24
25
section..
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(D) DEDUCTION
CREDIT.Section
10
11
280C(d)(2))..
12
(E) TECHNICAL
AMENDMENT.The
table
13
14
15
16
(4) TAX
17
18
ACADEMIC
19
HOSPITALS.
20
INSTITUTIONS
(A) IN
INCLUDING
GENERAL.Subpart
TEACHING
D of part IV
21
22
23
24
69
1
2
3
EXPENSES.
(1) the qualified countermeasures research expenses for the taxable year, over
13
14
15
16
PENSES.For
(1) IN
GENERAL.The
17
18
19
20
21
22
23
24
(2) COUNTERMEASURES
ACTIVI-
TIES.
25
26
RESEARCH
(A) IN
GENERAL.The
term counter-
70
1
10
11
12
13
14
15
16
17
(B) DEFINITIONS.
18
(i) COUNTERMEASURES;
RESEARCH
19
TOOLS.The
20
21
22
23
S 3148 IS
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or research tool.
(3) QUALIFIED
STITUTION.The
tions:
(A)
EDUCATIONAL
INSTITUTION.A
10
11
12
13
(B) TEACHING
14
HOSPITAL.A
teaching
hospital which
15
16
an
17
501(c)(3), and
organization
described
in
section
18
19
20
(A).
21
22
23
24
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(D)
CHARITABLE
RESEARCH
HOS-
PITAL.A
(E) OTHER
INSTITUTIONS.A
qualified
10
(4) EXCLUSION
11
GRANTS, ETC.The
12
13
14
15
ernmental entity).
16
17 AMOUNT.For purposes of this section, the term coun18 termeasures research base period amount means the aver19 age annual qualified countermeasures research expenses
20 paid by the taxpayer during the 3-taxable year period end21 ing with the taxable year immediately preceding the first
22 taxable year of the taxpayer beginning after December 31,
23 2002.
24
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(1) LIMITATION
ON FOREIGN TESTING.No
(2) CERTAIN
RULES
MADE
APPLICABLE.
8
9
(3) COORDINATION
CREASING
RESEARCH
WITH
CREDIT
EXPENDITURES
FOR
AND
IN-
WITH
10
11
12
13
14
15
16
(4)
QUALIFIED
qualified
COUNTERMEASURES
RE-
17
18
19
20
21
22
23
24
25
(B) CREDIT
TO BE PART OF GENERAL
BUSINESS CREDIT.
S 3148 IS
purposes of sec-
74
1
(i) IN
GENERAL.Section
38(b) of
lowing:
10
11
(ii)
TRANSITION
RULE.Section
12
13
14
15
(12) NO
16
BEFORE ENACTMENT.No
17
18
19
20
21
(C) DENIAL
OF DOUBLE BENEFIT.Sec-
22
23
24
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1
(e) CREDIT
COUNTERMEASURES RESEARCH
FOR
2 EXPENSES.
3
(1) IN
GENERAL.No
tion 41A(a).
10
(2) CERTAIN
RULES TO APPLY.Rules
similar
11
12
13
section..
14
(D) DEDUCTION
15
CREDIT.Section
16
17
18
19
20
21
new paragraph:
22
23
24
25
280C(e)(2)),.
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(E) CLERICAL
AMENDMENT.The
table of
following:
Sec. 41A. Credit for countermeasures research expenses..
10
11
12
13
14
15
16
17
18
19
20
21
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2
3
4
FUND.
10
countermeasures;
11
12
13
14
15
purchasing power;
16
17
18
19
20
21
22
23
24
25
26
search.
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1
2
nuclear
10
and
radiological
materials,
or
11
12
13
14
15
16
17
18
19
20
by the Secretary.
21
22
(1) ELIGIBLE
COUNTERMEASURE, DIAGNOSTIC,
23
OR RESEARCH TOOL.The
24
25
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3
4
8
9
has
been
provided
under
section
10
11
12
13
14
(d) INVESTMENT
OF
GENERAL.The
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1
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
S 3148 IS
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1
manufacturer; and
10
(3) CONDITIONS
FOR
PURCHASE.Payments
11
12
13
14
15
16
17
18
19
20
21
22
23
24
S 3148 IS
82
1
2
(4) ADVANCE,
PAYMENTS.
(A) IN
GENERAL.The
Secretary of the
9
10
(B) BASIS
FOR
PAYMENTS.Payments
11
12
13
14
15
16
17
18
19
20
21
22
23
ury; or
24
25
S 3148 IS
83
1
(C) NUMBER,
MENTS.
(i) IN
GENERAL.The
Secretary of
10
11
12
13
14
15
16
17
18
19
20
ment involved.
21
(D) CONDITIONS
FOR
PAYMENT.The
22
23
24
25
S 3148 IS
84
1
10
11
(5) THIRD
PARTY
MANUFACTURER.In
the
12
13
14
15
16
17
18
19
20
21
22
manufacturer.
23
24
25
S 3148 IS
85
1
(A) consideration of
gible countermeasure; or
10
11
and
12
13
14
15
(7) PUSH
PACKS.The
Secretary of the
16
17
18
19
20
21
(8) RULE
OF CONSTRUCTION.Nothing
in this
22
23
24
25
S 3148 IS
86
1
102(e).
(f) APPROPRIATIONS.
10
(1) IN
GENERAL.Subject
to paragraph (2),
11
12
13
14
15
16
17
18
19
(2) TRANSFER
TO FUND.The
Secretary of the
20
21
22
(3)
AVAILABILITY.Amounts
appropriated
23
24
pended.
S 3148 IS
87
1
(g) TERMS
OF
CONTRACTS.Notwithstanding any
2 other provision of law, a multi-year contract may be en3 tered into by the Secretary under this section, except that
4 any such contract shall be for a period of not to exceed
5 10 years.
6
(h) RULE
OF
12
13
14
15
MARKETING.
16
17
18
19
20
21
22
23
24
25
S 3148 IS
88
1
10
11
12
13
14
15
16
17
18
19
20
in their portfolio.
21
(D)
Biotechnology
and
pharmaceutical
22
23
24
25
S 3148 IS
89
1
ents.
measures research.
10
11
12
13
14
15
16
17
(b) RESTORATION
18 COUNTERMEASURES
19 CHEMICAL AGENTS
20
21
OF
FOR
OR
TOXINS
OR
BIOLOGICAL
TO
OR
RADIOLOGICAL MATE-
RIALS.
(1) IN
GENERAL.Chapter
14 of title 35,
22
23
S 3148 IS
90
1 156a. Restoration of patent terms relating to coun2
termeasures
for
certain
biological
or
10
11
12
13
14
15
16
17
18
19
20
21
such application;
22
23
24
25
26
91
1
355); and
10
11
12
13
14
15
Chemical,
16
17
and
Radiological
Weapons
Counter-
20
21
22
23
product;
S 3148 IS
92
1
and
10
11
12
S 3148 IS
93
1
(1) IN
GENERAL.To
obtain an extension of
mark Office.
6
7
10
review occurred;
11
12
an extension applies;
13
14
15
16
17
18
(3) SUBMISSION
OF APPLICATION.An
appli-
19
20
21
22
23
24
25
(4).
S 3148 IS
94
1
(4) EXCLUSIVE
APPLICATION.Sections
156
(5) RULE
OF
CONSTRUCTION.Nothing
in
10
11
12
13
keting..
14
(2) TECHNICAL
AND
CONFORMING
AMEND-
15
MENT.The
16
17
156a. Restoration of patent terms relating to countermeasures for certain biological or chemical agents or toxins..
18
19 TERMS
FOR
PATENTS HELD
BY
OF
CERTAIN PATENT
(1) IN
GENERAL.Chapter
14 of title 35,
22
23
S 3148 IS
95
1 158. Patent term for patents held by entities with
2
10
Chemical,
11
12
and
Radiological
Weapons
Counter-
(c) PATENT.
17
(1) IN
18
GENERAL.A
19
20
21
22
23
24
Innovation
25
3710a(b)(1)(7)) that
S 3148 IS
Act
of
1980
(15
U.S.C.
96
1
product;
Act; and
10
11
12
13
14
15
16
17
18
19
20
of paragraph (1)(A)(iii).
21
97
1
(e) LIMITATIONS
AND
(1) only 1 patent may be designated with respect to each certification held by an entity;
(2) no redesignation of another patent may be
made; and
(3) the patent designated by the entity
8
9
10
11
12
subsection (e);
13
14
15
16
(b); and
17
18
19
20
GENERAL.An
21
22
23
24
25
S 3148 IS
98
1
2
(A) a copy of the certification under section 102(e) of the Research Act;
3
4
(3) SUBMISSION
OF APPLICATION.An
appli-
10
11
Research Act.
12
(4) IRREVOCABLE
13
AND EXCLUSIVE.
(A) IRREVOCABLE
ELECTION.A
filing of
14
15
16
17
18
19
20
21
22
(2) TECHNICAL
AND
CONFORMING
AMEND-
23
MENT.The
24
25
S 3148 IS
99
158. Patent term for patents held by entities with certain research certifications..
(1) IN
GENERAL.Notwithstanding
sections
(2) FEDERALLY
OWNED INVENTIONS.Section
10
11
12
13
14
15
following:
(e) TERMS
CENSE.Each
AND
CONDITIONS
OF
EXCLUSIVE LI-
(3) COOPERATIVE
22
MENT AGREEMENTS.Section
23
S 3148 IS
100
1
the following:
10
(4) APPLICABLE
LICENSES.The
amendments
11
12
13
14
19
20
COUNTERMEASURES.
21 cation that is submitted under section 505(b)(1), the Sec22 retary determines that the new drug involved is a counter23 measure (as defined in section 3(1) of the Biological,
24 Chemical, and Radiological Weapons Countermeasures
25 Research Act of 2002) that meets the requirements of
S 3148 IS
101
1 subparagraphs (A) through (C) of section 202(b)(1) of
2 such Act, the provisions of subsection (b) shall apply.
3
10
11
12
13
14
15
16
17
years; and
18
19
20
21
22
23
24
S 3148 IS
been
submitted
under
subsection
102
1
or
505,
approved
10
11
under
section
505(c)(3)
or
section
12
13
14
15
16
17
18
19
proved
20
21
22
23
24
under
section
505(c)(3)
S 3148 IS
or
section
103
1
2
(A)
Many
countermeasures
to
terror
been conducted.
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
S 3148 IS
104
1
panies.
countermeasures.
10
11
12
13
14
15
16
17
18
(b)
19
INDEMNIFICATION
MENTS.Notwithstanding
AND
DEFENSE
AGREE-
24
25
S 3148 IS
105
1
10
11
12
13
14
15
16
17
18
19
ment.
20
21 agreement shall protect against claims or civil actions (in22 cluding reasonable expenses of litigation or settlement) by
23 third persons, for damages (including death, bodily injury,
24 economic losses, non-economic losses, or loss of or damage
25 to property or punitive damages), allegedly caused by the
S 3148 IS
106
1 research, development, production, or use of a counter2 measure, diagnostic, or research tool purchased under sec3 tion 202 or for claims or civil actions or research relating
4 to countermeasures developed under a certification under
5 section 102. Such contracts and protection against claims
6 or civil actions shall apply only when the manufacturer
7 of the countermeasure has entered into a contract with
8 the Secretary, for procurement of the countermeasure in
9 accordance with section 202. Such contracts and protec10 tion against claims or civil actions shall apply only to the
11 administration or use of a countermeasure, diagnostic, or
12 research tool by the Federal Government or another entity
13 with respect to a biological agent or toxin or a nuclear
14 or radiological material used as a terror weapon.
15
S 3148 IS
107
1
10
11
12
13
14
15
16
tion.
17
OF
LAW;
AND
DAMAGES.
18
19
20
21
22
23
24
S 3148 IS
108
1
(2) APPLICATION
OF LAW.An
exclusive civil
10
11
12
13
14
or dismissed, as appropriate.
15
(3) LIMITATIONS
ON DAMAGES.In
an exclu-
16
17
18
19
20
21
(4) REDUCTION
IN AMOUNTS.In
an exclusive
22
23
24
25
S 3148 IS
109
1
4 this section shall not apply in the case of an entity de5 scribed in subsection (b)(1) if
6
10
11
12
13
(1) EXCLUSIVE
CIVIL ACTION.The
term ex-
14
15
subsection (c)(1).
16
(2) INDEMNIFICATION
17
MENTS.The
18
19
subsection (b).
20
21
SEC.
211.
22
23
ACCELERATED
APPROVAL
OF
COUNTER-
MEASURES.
110
1 Food, Drug, and Cosmetic Act (21 U.S.C. 356) or as a
2 device granted priority review pursuant to section
3 515(d)(5) of such Act (21 U.S.C. 366e(d)(5)). Such a des4 ignation may be made prior to the submission of
5
6
(b) USE
OF
GENERAL.A
countermeasure that is a
21
22
23
24
products.
S 3148 IS
111
1
1997.
MAL TRIALS.
AND
COSMETIC ACT.
112
1 in animals.The Secretary may promulgate regulations es2 tablishing standards, criteria, and procedures for use of
3 the authority contained in the preceding sentence..
4
(k) APPROVAL
NOSTIC
OF
CERTAIN PRODUCTS
DEVICES BASED
ON
AND
DIAG-
S 3148 IS
113
1
2
DEVELOPMENT MEET-
INGS.
(A) COUNTERMEASURES
DEVELOPMENT
MEETINGS
10
11
12
13
14
15
16
17
18
19
AND
CONSULTATIONS.The
(B) MEETING
20
DITIONS.A
21
22
Sec-
23
24
25
development,
S 3148 IS
manufacture,
distribution,
114
1
10
11
12
13
(C)
MINUTES.The
Secretary
shall
14
15
16
17
States Code.
18
19
20
21
22
23
24
S 3148 IS
115
1
(2) WRITTEN
AGREEMENTS.The
Secretary
10
11
12
13
14
15
16
agreement;
17
18
19
20
agreement; and
21
22
23
24
person.
S 3148 IS
116
1
ticipating parties; or
10
11
12
13
(4) ACTION
14
(A) IN
Attorney General,
15
16
17
18
19
20
quest.
21
22
23
24
25
S 3148 IS
117
1
10
11
of countermeasures;
12
13
14
15
16
17
18
agreement; and
19
20
21
22
(5) LIMITATION
23
TIONS.An
24
25
S 3148 IS
118
1
(6) LIMITATION
ON PARTIES.The
use of any
10
11
12
13
ble laws.
14
15
16
17
18
19
20
21
22
23
24
section.
S 3148 IS
119
1
8
9
(1) ANTITRUST
LAWS.The
term antitrust
laws
10
11
12
13
14
15
16
17
18
of competition; and
19
20
21
22
23
24
25
(3) COVERED
S 3148 IS
ACTIVITIES.
120
1
(A) IN
GENERAL.Except
as provided in
10
11
12
13
14
15
16
17
18
19
20
21
development of countermeasures;
22
23
24
that is a countermeasures;
S 3148 IS
121
1
termeasures;
termeasures; or
10
11
12
13
14
15
16
17
18
covered activities.
19
20
21
22
23
24
25
S 3148 IS
122
1
ties.
esses,
or
services
not
developed
10
11
12
ties; or
13
14
15
16
17
18
19
20
21
22
23
24
25
S 3148 IS
123
1
tivities.
10
11
12
13
14
15
16
subsection (i)(4).
17
18
19
20
21
22
23
24
S 3148 IS
124
1
preparation of a countermeasure.
10
11
12
13
TIVES.
14
15 ings:
16
17
logically
18
19
20
21
22
23
of such materials.
derived
materials,
including
vaccines,
24
25
S 3148 IS
125
1
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
dures.
S 3148 IS
126
1
10
materials.
11
12
13
14
15
16
veloped.
17
(b) SURVEY
AND
21
22
23
24
25
S 3148 IS
127
1
(c) SUBMISSION
TO
9 submit the plan developed under subsection (b)(2) to Con10 gress together with recommendations concerning the man11 ner in which to ensure that the needed biologics manufac12 turing facilities available for the production of counter13 measures under this Act are constructed and available, in14 cluding the siting, design and certification costs, costs of
15 training and recruitment of expert staff, and other costs
16 associated with such facilities.
17
(d) INCENTIVES
18
LOGICS
19
THE
20
OF
BIO-
FOR
FOR THE
CONSTRUCTION
PRODUCTION OF COUNTERMEASURES.
(1) IN
GENERAL.The
21
22
23
24
25
S 3148 IS
128
1
and the terms for the use for the production of such
such countermeasures.
8
9
(2) BIOLOGICS
10
(A)
ALLOWANCE
OF
CREDIT.Section
11
12
13
14
15
16
17
18
vestment credit..
19
(B) AMOUNT
OF CREDIT.Section
48 of
20
21
22
23
24
25
CREDIT.
(1) IN
GENERAL.For
S 3148 IS
129
1
taxable year.
(2) QUALIFIED
INVESTMENT.For
purposes
10
11
12
(3) BIOLOGICS
MANUFACTURING FACILITIES
13
PROPERTY.For
14
15
16
17
18
19
20
21
22
23
24
S 3148 IS
130
1
(4) CERTAIN
MADE APPLICABLE.Rules
(C) TECHNICAL
(i)
AMENDMENTS.
Subparagraph
(C)
of
section
10
11
12
13
14
15
16
17
18
19
20
21
22
lows:
23
24
25
S 3148 IS
131
1
the following:
Sec. 48. Other Credits..
(e) PREEMPTION
OF
ZONING LAWS
FOR
SITING
OF
5 BIOLOGICS MANUFACTURING FACILITIES.The provi6 sions of this section relating to the operation and location
7 of biologics manufacturing facilities, in accordance with
8 the plan developed under subsection (b)(2), shall preempt
9 State and local laws relating to zoning. State and local
10 laws relating to the construction and maintenance of such
11 facilities shall be preempted to the extent that such laws
12 conflict with such plan and the purposes of this section.
13
14
15
16
17
TIVES.
18
19
20
21
(3)
technical
advances
in
manufacturing
22
23
24
S 3148 IS
132
1
cines; and
of
tion;
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
S 3148 IS
133
1
ties;
10
11
12
13
(b) SURVEY
AND
17
18
19
20
21
22
23
24
S 3148 IS
134
1
(c) SUBMISSION
TO
4 submit the plan developed under subsection (b)(2) to Con5 gress together with recommendations concerning the pro6 vision of funding or incentives for the conduct of scientific
7 research to develop new technologies relating to biologics
8 manufacturing sciences.
9
15
16
SEARCH FACILITIES.
17
18
19
20
21
(2) very few companies can capitalize the construction of these special facilities; and
22
23
24
25
S 3148 IS
135
1
(1) IN
GENERAL.The
Secretary is authorized
10
11
12
13
countermeasures; and
14
15
16
(3) NUMBER
OF GRANTS.The
Secretary of
17
18
19
20
21
22
(c) APPLICATION.
23
(1) IN
GENERAL.To
be eligible to receive a
24
25
S 3148 IS
136
1
3
4
10
11
12
13
and
14
15
16
17 tion
18
19
20
21
22
23
24
25
S 3148 IS
137
1
mission.
(e) AUTHORIZATION
OF
APPROPRIATIONS.There
MEASURES
GRANTS.
10
PARTNERSHIP
CHALLENGE
19 tions within 90 days of the date of enactment of this sec20 tion to implement the awarding of grants under subsection
21 (a).
22
(c) RULE
OF
S 3148 IS
138
1 being certified as being eligible for incentives under this
2 Act (and the amendments made by this Act).
3
(d) AUTHORIZATION
OF
APPROPRIATIONS.There
8
9
10
11
(1) IN
GENERAL.Subclause
(I) of section
12
13
14
15
16
17
(2) CONFORMING
AMENDMENT.Clause
(i) of
18
19
20
21
22
such Act.
23
(3) EFFECTIVE
DATE.The
amendments made
24
25
S 3148 IS
139
1
(b) PUBLICATION
QUESTS FOR
EASES OR
OF
FILING
DESIGNATION
OF
AND
APPROVAL
DRUGS
FOR
OF
RE -
RARE DIS-
15
16
17
18
19
20
21
22
23
24
140
1 profit entities relating to the development and use of adju2 vants to enhance the potency of, and increase the period
3 of protection and the number of useful doses from, a lim4 ited supply of antigen in response to an attack with a bio5 logical agent or toxin or nuclear or radiological material.
6
(b) DEFINITION
OF
11
(1) CRITERIA.
12
(A) IN
GENERAL.For
purposes of this
13
14
15
16
17
(i) consider
18
19
20
21
22
23
24
(II)
25
common
knowledge
con-
S 3148 IS
141
1
cines;
10
11
12
13
(ii) require
14
15
16
17
18
19
20
and
21
22
23
24
25
S 3148 IS
142
1
serum
immunogenicity);
chemistry,
and
10
(iii) histopathology;
11
12
(v) pyrogenicity.
13
hematology
(2) DEEMING
SAFE.An
14 Secretary to be safe under paragraph (1) shall, with re15 spect to any particular use or intended use of such adju16 vant, be deemed to be safe for the purposes of the applica17 tion of section 351 of the Public Health Service Act (42
18 U.S.C. 262) or section 505 of the Federal Food, Drug,
19 and Cosmetic Act (21 U.S.C. 355).
20
21
22
(d) ESTABLISHMENT
OF A
PREFERRED LIST
OF
AD -
JUVANTS.
(1) IN
GENERAL.The
23
24
25
production.
S 3148 IS
143
1
(1) IN
GENERAL.Any
10
11
12
subsection (d).
13
14
15
16
17
18
19
20
21
22
23
24
25
S 3148 IS
144
1
such investigations.
(3) ADDITIONAL
INFORMATION.Upon
the re-
10
11
12
13
14
15
16
(4) NOTIFICATION.
17
(A) IN
GENERAL.Except
as provided in
18
19
20
21
22
of such petition.
23
24
25
S 3148 IS
145
1
approval.
(1) ESTABLISHING
CONDITIONS.The
Sec-
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
S 3148 IS
146
1
S 3148 IS
147
1
10
11
12
13
14
15
16
17
18
19
20
sonnel;
21
22
23
24
213, 214, 215, 216, 217, 218, and 219 are being
S 3148 IS
148
1
try activity;
and
(b) LIMITATION
ON
17
DEVELOP COUNTERMEASURES.
18
(b) FOCUS
OF
149
1
4
5
incentives.
10
11
12
13
14
15
16
(c) AUTHORIZATION
OF
APPROPRIATIONS.There
17 are authorized to be appropriated, such sums as be nec18 essary in each fiscal year to carry out this section.
S 3148 IS