such purpose. Amounts appropriated under the preceding 
sentence are available until expended. 
‘‘(e) DEFINITIONS.—For purposes of this section: 
‘‘(1) BARDA.—The term ‘BARDA’ means the 
Biomedical Advanced Research and Development 
Authority. 
‘‘(2) OTHER TRANSACTIONS.—The term ‘other 
transactions’ means transactions, other than pro-
curement contracts, grants, and cooperative agree-
ments, such as the Secretary of Defense may enter 
into under section 2371 of title 10, United States 
Code. 
‘‘(3) QUALIFIED COUNTERMEASURE.—The term 
‘qualified countermeasure’ has the meaning given 
such term in section 319F–1. 
‘‘(4) QUALIFIED PANDEMIC OR EPIDEMIC PROD-
UCT.—The term ‘qualified pandemic or epidemic 
product’ has the meaning given the term in section 
319F–3. 
‘‘(5) ADVANCED
RESEARCH
AND
DEVELOP-
MENT.—
‘‘(A) IN GENERAL.—The term ‘advanced 
research and development’ means, with respect 
to a product that is or may become a qualified
countermeasure or a qualified pandemic or epi-
demic product, activities that predominantly—
‘‘(i) are conducted after basic research 
and preclinical development of the product; 
and 
‘‘(ii) are related to manufacturing the 
product on a commercial scale and in a 
form that satisfies the regulatory require-
ments under the Federal Food, Drug, and 
Cosmetic Act or under section 351 of this 
Act. 
‘‘(B) ACTIVITIES
INCLUDED.—The term 
under subparagraph (A) includes—
‘‘(i) testing of the product to deter-
mine whether the product may be ap-
proved, cleared, or licensed under the Fed-
eral Food, Drug, and Cosmetic Act or 
under section 351 of this Act for a use 
that is or may be the basis for such prod-
uct becoming a qualified countermeasure 
or qualified pandemic or epidemic product, 
or to help obtain such approval, clearance, 
or license;
‘‘(ii) design and development of tests 
or models, including animal models, for 
such testing; 
‘‘(iii) activities to facilitate manufac-
ture of the product on a commercial scale 
with consistently high quality, as well as to 
improve and make available new tech-
nologies to increase manufacturing surge 
capacity; 
‘‘(iv) activities to improve the shelf-life 
of the product or technologies for admin-
istering the product; and 
‘‘(v) such other activities as are part 
of the advanced stages of testing, refine-
ment, improvement, or preparation of the 
product for such use and as are specified 
by the Secretary. 
‘‘(6) RESEARCH
TOOL.—The term ‘research 
tool’ means a device, technology, biological material, 
reagent, animal model, computer system, computer 
software, or analytical technique that is developed to 
assist in the discovery, development, or manufacture 
of qualified countermeasures or qualified pandemic 
or epidemic products.
‘‘(7) PROGRAM MANAGER.—The term ‘program 
manager’ means an individual appointed to carry out 
functions under this section and authorized to pro-
vide project oversight and management of strategic 
initiatives. 
‘‘(8) PERSON.—The term ‘person’ includes an 
individual, partnership, corporation, association, en-
tity, or public or private corporation, and a Federal, 
State, or local government agency or department. 
‘‘SEC. 319M. NATIONAL BIODEFENSE SCIENCE BOARD AND 
WORKING GROUPS. 
‘‘(a) IN GENERAL.—
‘‘(1) ESTABLISHMENT
AND
FUNCTION.—The 
Secretary shall establish the National Biodefense 
Science Board (referred to in this section as the 
‘Board’) to provide expert advice and guidance to 
the Secretary on scientific, technical and other mat-
ters of special interest to the Department of Health 
and Human Services regarding current and future 
chemical, biological, nuclear, and radiological agents, 
whether naturally occurring, accidental, or delib-
erate. 
‘‘(2) MEMBERSHIP.—The membership of the 
Board shall be comprised of individuals who rep-
resent the Nation’s preeminent scientific, public 
health, and medical experts, as follows—
‘‘(A) such Federal officials as the Sec-
retary may determine are necessary to support 
the functions of the Board; 
‘‘(B) four individuals representing the 
pharmaceutical, biotechnology, and device in-
dustries; 
‘‘(C) four individuals representing aca-
demia; and 
‘‘(D) five other members as determined ap-
propriate by the Secretary. 
‘‘(3) TERM OF APPOINTMENT.—A member of 
the Board described in subparagraph (B), (C), or 
(D) of paragraph (2) shall serve for a term of 3 
years, except that the Secretary may adjust the 
terms of the initial Board appointees in order to 
provide for a staggered term of appointment for all 
members. 
‘‘(4) CONSECUTIVE APPOINTMENTS; MAXIMUM 
TERMS.—A member may be appointed to serve not 
more than 3 terms on the Board and may serve not 
more than 2 consecutive terms. 
‘‘(5) DUTIES.—The Board shall—
‘‘(A) advise the Secretary on current and 
future trends, challenges, and opportunities pre-
sented by advances in biological and life 
sciences, biotechnology, and genetic engineering 
with respect to threats to biodefense or public 
health security posed by naturally occurring in-
fectious diseases and chemical, biological, radio-
logical, and nuclear agents; 
‘‘(B) at the request of the Secretary, re-
view and consider any information and findings 
received from the working groups established 
under subsection (b); and 
‘‘(C) at the request of the Secretary, pro-
vide recommendations and findings for ex-
panded, intensified, and coordinated biodefense 
research and development activities. 
‘‘(6) MEETINGS.—
‘‘(A) INITIAL
MEETING.—Not later than 
one year after the date of enactment of the Bio-
defense and Pandemic Vaccine and Drug Devel-
opment Act of 2006, the Secretary shall hold 
the first meeting of the Board. 
‘‘(B) 
SUBSEQUENT
MEETINGS.—The 
Board shall meet at the call of the Secretary, 
but in no case less than twice annually.
‘‘(7) VACANCIES.—Any vacancy in the Board 
shall not affect its powers, but shall be filled in the 
same manner as the original appointment. 
‘‘(8) CHAIRPERSON.—The Secretary shall ap-
point a chairperson from among the members of the 
Board. 
‘‘(9) POWERS.—
‘‘(A) HEARINGS.—The Board may hold 
such hearings, sit and act at such times and 
places, take such testimony, and receive such 
evidence as the Board considers advisable to 
carry out this subsection. 
‘‘(B) POSTAL SERVICES.—The Board may 
use the United States mails in the same man-
ner and under the same conditions as other de-
partments and agencies of the Federal Govern-
ment. 
‘‘(10) PERSONNEL.—
‘‘(A) EMPLOYEES OF THE FEDERAL GOV-
ERNMENT.—A member of the Board that is an 
employee of the Federal Government may not 
receive additional pay, allowances, or benefits 
by reason of the member’s service on the 
Board.
‘‘(B) OTHER MEMBERS.—A member of the 
Board that is not an employee of the Federal 
Government may be compensated at a rate not 
to exceed the daily equivalent of the annual rate 
of basic pay prescribed for level IV of the Exec-
utive Schedule under section 5315 of title 5, 
United States Code, for each day (including 
travel time) during which the member is en-
gaged in the actual performance of duties as a 
member of the Board. 
‘‘(C) TRAVEL
EXPENSES.—Each member 
of the Board shall receive travel expenses, in-
cluding per diem in lieu of subsistence, in ac-
cordance with applicable provisions under sub-
chapter I of chapter 57 of title 5, United States 
Code. 
‘‘(D) DETAIL OF GOVERNMENT EMPLOY-
EES.—Any Federal Government employee may 
be detailed to the Board with the approval for 
the contributing agency without reimbursement, 
and such detail shall be without interruption or 
loss of civil service status or privilege. 
‘‘(b) DEFINITIONS.—Any term that is defined in sec-
tion 319L and that is used in this section shall have the
same meaning in this section as such term is given in sec-
tion 319L. 
‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated $1,000,000 to carry out 
this section for each of the fiscal years 2007 and 2008.’’. 
SEC. 4. CLARIFICATION OF COUNTERMEASURES COVERED 
BY PROJECT BIOSHIELD. 
(a) 
QUALIFIED
COUNTERMEASURES.—Section 
319F–1(a)(2) of the Public Health Service Act (42 U.S.C. 
247d–6a(a)(2)) is amended—
(1) by amending subparagraph (A) to read as 
follows: 
‘‘(A) diagnose, mitigate, prevent, or treat 
harm from any biological agent (including orga-
nisms that cause an infectious disease) or toxin, 
or from any chemical, radiological, or nuclear 
agent, that may cause a public health emer-
gency affecting national security; or’’; 
(2) in subparagraph (B), by striking ‘‘treat, 
identify, or prevent harm’’ and inserting ‘‘diagnose, 
mitigate, prevent, or treat harm’’; and 
(3) by adding after and below subparagraph 
(B) the following: 
‘‘If through publication in the Federal Register the 
Secretary makes a determination that there is cred-
ible evidence that a biological agent has the potential 
to cause an epidemic or pandemic that may con-
stitute a public health emergency, a countermeasure 
to such agent shall, without further administrative 
action, be considered a qualified countermeasure 
within the meaning of this paragraph.’’. 
(b) SECURITY COUNTERMEASURES.—Section 319F–
2(c)(1)(B)(i)(I) of the Public Health Service Act (42 
U.S.C. 247d–6b(c)(1)(B)(i)(I)) is amended by striking ‘‘to 
treat’’ the first place such term appears and all that fol-
lows through ‘‘from a condition’’ and inserting the fol-
lowing: ‘‘to diagnose, mitigate, prevent, or treat harm 
from any biological agent (including organisms that cause 
an infectious disease) or toxin or from any chemical, radio-
logical, or nuclear agent identified as a material threat 
under paragraph (2)(A)(ii), or to diagnose, mitigate, pre-
vent, or treat harm from a condition’’. 
SEC. 5. TECHNICAL ASSISTANCE. 
Subchapter E of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is 
amended by adding at the end the following: 
‘‘SEC. 565. TECHNICAL ASSISTANCE. 
‘‘The Secretary, in consultation with the Commis-
sioner of Food and Drugs, shall establish within the Food 
and Drug Administration a team of experts on manufac-
turing and regulatory activities (including compliance with 
current Good Manufacturing Practice) to provide both off-
site and on-site technical assistance to the manufacturers 
of qualified countermeasures (as defined in section 319F–
1 of the Public Health Service Act), security counter-
measures (as defined in section 319F–2 of such Act), or 
vaccines, at the request of such a manufacturer and at 
the discretion of the Secretary, if the Secretary determines 
that a shortage or potential shortage may occur in the 
United States in the supply of such vaccines or counter-
measures and that the provision of such assistance would 
be beneficial in helping alleviate or avert such shortage.’’. 
SEC. 6. PROCUREMENT. 
Section 319F–2 of the Public Health Service Act (42 
U.S.C. 247d–6b) is amended—
(1) in the section heading, by inserting ‘‘AND 
SECURITY
COUNTERMEASURE
PROCURE-
MENTS’’ before the period; and 
(2) in subsection (c)—
(A) in the subsection heading, by striking 
‘‘BIOMEDICAL’’; 
(B) in paragraph (5)(B)(i), by striking ‘‘to 
meet the needs of the stockpile’’ and inserting 
‘‘to meet the stockpile needs’’; 
(C) in paragraph (7)(B)—
(i) by striking the subparagraph head-
ing and all that follows through ‘‘Home-
land Security Secretary’’ and inserting the 
following: 
‘‘INTERAGENCY
AGREEMENT; 
COST.—The 
Homeland 
Security 
Sec-
retary’’; and 
(ii) by striking clause (ii); 
(D) in paragraph (7)(C)(ii)—
(i) by amending clause (I) to read as 
follows: 
‘‘(I) PAYMENT CONDITIONED ON 
DELIVERY.—The contract shall pro-
vide that no payment may be made 
until delivery of a portion, acceptable 
to the Secretary, of the total number 
of units contracted for, except that, 
notwithstanding any other provision of 
law, the contract may provide that, if 
the Secretary determines (in the Sec-
retary’s discretion) that an advance 
payment, partial payment for signifi-
cant milestones, or payment to in-
crease manufacturing capacity is nec-
essary to ensure success of a project, 
the Secretary shall pay an amount,
not to exceed 10 percent of the con-
tract amount, in advance of delivery. 
The Secretary shall, to the extent 
practicable, make the determination of 
advance payment at the same time as 
the issuance of a solicitation. The con-
tract shall provide that such advance 
payment is required to be repaid if 
there is a failure to perform by the 
vendor under the contract. The con-
tract may also provide for additional 
advance payments of 5 percent each 
for meeting the milestones specified in 
such contract. Provided that the spec-
ified milestones are reached, these ad-
vance payments of 5 percent shall not 
be required to be repaid. Nothing in 
this subclause shall be construed as 
affecting the rights of vendors under 
provisions of law or regulation (in-
cluding the Federal Acquisition Regu-
lation) relating to the termination of 
contracts for the convenience of the 
Government.’’; and
(ii) by adding at the end the fol-
lowing: 
‘‘(VII) PROCUREMENT OF MUL-
TIPLE
PRODUCTS
AND
TECH-
NOLOGIES.—The Secretary may enter 
into multiple transactions for the pro-
curement of multiple technologies and 
products from multiple manufacturers 
of security countermeasures in order 
to mitigate against the risks associ-
ated with dependence on a single sup-
plier or technology. 
‘‘(VIII) SALES
EXCLUSIVITY.—
The contract may provide that the 
vendor is the exclusive supplier of the 
product to the Federal Government 
for a specified period of time, not to 
exceed the term of the contract, on 
the condition that the vendor is able 
to satisfy the needs of the Govern-
ment. During the agreed period of 
sales exclusivity, the vendor shall not 
assign its rights of sales exclusivity to 
another entity or entities without ap-
proval by the Secretary. Such a sales
exclusivity provision in such a con-
tract shall constitute a valid basis for 
a sole source procurement under sec-
tion 303(c)(1) of the Federal Property 
and Administrative Services Act of 
1949 (41 U.S.C. 253(c)(1)). 
‘‘(IX) SURGE
CAPACITY.—The 
contract may provide that the vendor 
establish domestic manufacturing ca-
pacity of the product to ensure that 
additional production of the product is 
available in the event that the Sec-
retary determines that there is a need 
to quickly purchase additional quan-
tities of the product. Such contract 
may provide a fee to the vendor for 
establishing and maintaining such ca-
pacity in excess of the initial require-
ment for the purchase of the product. 
Additionally, the cost of maintaining 
the domestic manufacturing capacity 
shall be an allowable and allocable di-
rect cost of the contract. 
‘‘(X) 
ADDITIONAL
CONTRACT 
TERMS.—The Secretary, in any con-
tract for procurement under this sec-
tion, may specify—
‘‘(aa) the dosing and admin-
istration requirements for coun-
termeasures to be developed and 
procured; 
‘‘(bb) the amount of funding 
that will be dedicated by the Sec-
retary for development and ac-
quisition of the countermeasure; 
and 
‘‘(cc) the specifications the 
countermeasure must meet to 
qualify for procurement under a 
contract under this section.’’; and 
(E) in paragraph (8)(A), by adding at the 
end the following: ‘‘In the case of such agree-
ments by the Secretary, the Secretary may 
allow other executive agencies to order qualified 
and security countermeasures under procure-
ment contracts or other agreements established 
by the Secretary, and such ordering process (in-
cluding transfers of appropriated funds between 
an agency and the Department of Health and 
Human Services as reimbursements for such or-
ders for countermeasures) may be conducted 
under the authority of section 1535 of title 31, 
United States Code, except that all such orders 
shall be processed under the terms established 
under this section for the procurement of coun-
termeasures.’’
Passed the House of Representatives September 26, 
2006. 
Attest:
Clerk.