term shall be returned to the United States Treas-
ury and shall not be available for subsequent obliga-
tion for any purpose. 
‘‘(2) INITIAL
AVAILABILITY
FOR
PARTICULAR 
PROCUREMENTS.—Amounts appropriated under sub-
section (a) become available for a procurement 
under the security countermeasures program only 
upon the approval by the President of such avail-
ability for the procurement in accordance with para-
graph (6)(B) of such program.’’. 
(c) CONFORMING AMENDMENT.—Section 121 of the 
Public Health Security and Bioterrorism Preparedness 
and Response Act of 2002 (116 Stat. 611; 42 U.S.C. 
300hh–12) is repealed. With respect to the program estab-
lished under former section 121 of such Act, the repeal 
of such section under the preceding sentence applies as 
a modification of the program in accordance with the 
amendment made by subsection (a) of this section, and 
not as the termination of the program and the establish-
ment of a different program. 
SEC. 4. AUTHORIZATION FOR MEDICAL PRODUCTS FOR 
USE IN EMERGENCIES. 
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 section:
‘‘SEC. 564. AUTHORIZATION FOR MEDICAL PRODUCTS FOR 
USE IN EMERGENCIES. 
‘‘(a) IN GENERAL.—
‘‘(1) EMERGENCY USES.—Notwithstanding sec-
tions 505, 510(k), and 515 of this Act and section 
351 of the Public Health Service Act, and subject to 
the provisions of this section, the Secretary may au-
thorize the introduction into interstate commerce, 
during the effective period of a declaration under 
subsection (b), of a drug or device intended for use 
in an actual or potential emergency (referred to in 
this section as an ‘emergency use’). 
‘‘(2) APPROVAL STATUS OF PRODUCT.—An au-
thorization under paragraph (1) may authorize an 
emergency use of a product that—
‘‘(A) is not approved, licensed, or cleared 
for commercial distribution under a provision of 
law referred to in such paragraph (referred to 
in this section as an ‘unapproved product’); or 
‘‘(B)
is
approved,
licensed,
or
cleared 
under such a provision, but which use is not 
under such provision an approved, licensed, or 
cleared use of the product (referred to in this 
section as an ‘unapproved use of an approved 
product’).
‘‘(3) RELATION
TO
OTHER
USES.—An emer-
gency use authorized under paragraph (1) for a 
product is in addition to any other use that is au-
thorized for the product under a provision of law re-
ferred to in such paragraph. 
‘‘(4) DEFINITIONS.—For purposes of this sec-
tion: 
‘‘(A) The term ‘emergency use’ has the 
meaning indicated for such term in paragraph 
(1). 
‘‘(B) The term ‘product’ means a drug or 
device. 
‘‘(C) The term ‘unapproved product’ has 
the meaning indicated for such term in para-
graph (2)(A). 
‘‘(D) The term ‘unapproved use of an ap-
proved product’ has the meaning indicated for 
such term in paragraph (2)(B). 
‘‘(b) DECLARATION OF EMERGENCY.—
‘‘(1) IN GENERAL.—The Secretary may declare 
an emergency justifying the authorization under this 
subsection for a product on the basis of—
‘‘(A) a determination by the Secretary of 
Homeland Security that there is a national 
emergency, or a significant potential for a na-
tional emergency, involving a heightened risk of 
attack with a specified biological, chemical, ra-
diological, or nuclear agent or agents; 
‘‘(B) a determination by the Secretary of 
Defense that there is a military emergency, or 
a significant potential for a military emergency, 
involving a heightened risk to United States 
military forces of attack with a biological, 
chemical,
radiological,
or
nuclear
agent
or 
agents; or 
‘‘(C) a determination by the Secretary of a 
public health emergency under section 319 of 
the Public Health Service Act, affecting na-
tional security and involving a specified biologi-
cal, chemical, radiological, or nuclear agent or 
agents, or a specified disease or condition that 
may be attributable to such agent or agents. 
‘‘(2) TERMINATION OF DECLARATION.—
‘‘(A) IN GENERAL.—A declaration under 
this subsection shall terminate upon the earlier 
of—
‘‘(i) a determination by the Secretary, 
in consultation as appropriate with the 
Secretary of Homeland Security or the 
Secretary
of
Defense,
that
the
cir-
cumstances
described
in
paragraph
(1) 
have ceased to exist; or 
‘‘(ii) the expiration of the one-year pe-
riod beginning on the date on which the 
declaration is made. 
‘‘(B)
RENEWAL.—Notwithstanding
sub-
paragraph (A), the Secretary may renew a dec-
laration under this subsection, and this para-
graph shall apply to any such renewal. 
‘‘(3) ADVANCE NOTICE OF TERMINATION.—In 
terminating a declaration under this section, the 
Secretary shall provide advance notice that the dec-
laration will be terminated. The period of advance 
notice shall be a period reasonably determined to 
provide—
‘‘(A) in the case of an unapproved product, 
a sufficient period for disposition of shipments 
of the product, including the return of such 
shipments to the manufacturer (in the case of 
a manufacturer that chooses to have the ship-
ments returned); and 
‘‘(B) in the case of unapproved uses of ap-
proved products, a sufficient period for the dis-
position of any labeling that was provided with 
respect to the emergency use involved.
‘‘(4)
PUBLICATION.—The
Secretary
shall 
promptly publish in the Federal Register each dec-
laration, determination, and renewal under this sub-
section. 
‘‘(c) CRITERIA FOR ISSUANCE OF AUTHORIZATION.—
The Secretary may issue an authorization under this sec-
tion with respect to the emergency use of a product only 
if, after consultation with the Director of the National In-
stitutes of Health and the Director of the Centers for Dis-
ease Control and Prevention, to the extent feasible and 
appropriate given the circumstances of the emergency in-
volved, the Secretary concludes—
‘‘(1) that an agent specified in a declaration 
under subsection (b) can cause a serious or life-
threatening disease or condition; 
‘‘(2) that, based on the totality of scientific evi-
dence available to the Secretary, including data from 
adequate and well-controlled clinical trials, if avail-
able, it is reasonable to believe that—
‘‘(A) the product may be effective in de-
tecting, diagnosing, treating, or preventing—
‘‘(i) such disease or condition; or 
‘‘(ii) a serious or life-threatening dis-
ease or condition caused by a product au-
thorized under this section or approved
under this Act or the Public Health Serv-
ice Act, for detecting, diagnosing, treating, 
or preventing such a disease or condition 
caused by such an agent; and 
‘‘(B) the known and potential benefits of 
the product, when used to detect, diagnose, pre-
vent, or treat such disease or condition, out-
weigh the known and potential risks of the 
product; 
‘‘(3) that there is no adequate, approved, and 
available alternative to the product for detecting, di-
agnosing, preventing, or treating such disease or 
condition; and 
‘‘(4) that such other criteria as the Secretary 
may by regulation prescribe are satisfied. 
‘‘(d) SCOPE OF AUTHORIZATION.—
‘‘(1) IN GENERAL.—An authorization of a prod-
uct under this section shall state—
‘‘(A) each disease or condition that the 
product may be used to detect, diagnose, pre-
vent, or treat within the scope of the authoriza-
tion; 
‘‘(B) the Secretary’s conclusions, made 
under subsection (c)(2)(B), that the known and 
potential benefits of the product, when used to
detect, diagnose, prevent, or treat such disease 
or condition, outweigh the known and potential 
risks of the product; and 
‘‘(C)
the
Secretary’s
conclusions,
made 
under subsection (c), concerning the safety and 
potential effectiveness of the product in detect-
ing, diagnosing, preventing, or treating such 
diseases or conditions, including an assessment 
of the available scientific evidence. 
‘‘(2)
CONFIDENTIAL
INFORMATION.—Nothing 
in this section alters or amends section 1905 of title 
18, United States Code, or section 552(b)(4) of title 
5 of such Code. 
‘‘(e) CONDITIONS OF AUTHORIZATION.—
‘‘(1) UNAPPROVED PRODUCT.—
‘‘(A) REQUIRED
CONDITIONS.—With re-
spect to the emergency use of an unapproved 
product, the Secretary, to the extent feasible 
given the circumstances of the emergency, shall, 
for persons who choose to carry out one or 
more activities for which the authorization is 
issued, establish such conditions on an author-
ization under this section as the Secretary finds 
necessary or appropriate to protect the public 
health, including the following:
‘‘(i) Appropriate conditions designed 
to ensure that, to the extent feasible given 
the circumstances of the emergency, health 
care professionals administering the prod-
uct are informed—
‘‘(I) that the Secretary has au-
thorized the emergency use of the 
product; 
‘‘(II) of the significant known 
and potential benefits and risks of the 
emergency use of the product, and of 
the extent to which such benefits and 
risks are unknown; and 
‘‘(III) of the alternatives to the 
product that are available, and of 
their benefits and risks. 
‘‘(ii) Appropriate conditions designed 
to ensure that, to the extent feasible given 
the circumstances of the emergency, indi-
viduals to whom the product is adminis-
tered are informed—
‘‘(I) that the Secretary has au-
thorized the emergency use of the 
product;
‘‘(II) of the significant known 
and potential benefits and risks of 
such use, and of the extent to which 
such benefits and risks are unknown; 
and 
‘‘(III) of the option to accept or 
refuse administration of the product, 
of the consequences, if any, of refus-
ing administration of the product, and 
of the alternatives to the product that 
are available and of their benefits and 
risks. 
‘‘(iii) Appropriate conditions for the 
monitoring and reporting of adverse events 
associated with the emergency use of the 
product. 
‘‘(iv) For manufacturers of the prod-
uct, appropriate conditions concerning rec-
ordkeeping
and
reporting,
including 
records access by the Secretary, with re-
spect to the emergency use of the product. 
‘‘(B) AUTHORITY FOR ADDITIONAL CONDI-
TIONS.—With respect to the emergency use of 
an unapproved product, the Secretary, to the 
extent feasible given the circumstances of the
emergency, may, for persons who choose to 
carry out one or more activities for which the 
authorization is issued, establish such condi-
tions on an authorization under this section as 
the Secretary finds necessary or appropriate to 
protect the public health, including the fol-
lowing: 
‘‘(i) Appropriate conditions on which 
entities may distribute the product with re-
spect to the emergency use of the product 
(including limitation to distribution by gov-
ernment entities), and on how distribution 
is to be performed. 
‘‘(ii) Appropriate conditions on who 
may administer the product with respect to 
the emergency use of the product, and on 
the categories of individuals to whom, and 
the circumstances under which, the prod-
uct may be administered with respect to 
such use. 
‘‘(iii) For persons other than manu-
facturers of the product, appropriate con-
ditions concerning recordkeeping and re-
porting, including records access by the
Secretary, with respect to the emergency 
use of the product. 
‘‘(iv) With respect to the emergency 
use of the product, waive or limit, to the 
extent appropriate given the circumstances 
of
the
emergency,
conditions
regarding 
current good manufacturing practice other-
wise applicable to the manufacture, proc-
essing, packing, or holding of products 
subject to regulation under this Act, in-
cluding such requirements established in 
section 501. 
‘‘(2) UNAPPROVED USE.—With respect to the 
emergency use of a product that is an unapproved 
use of an approved product: 
‘‘(A) The Secretary may, for manufactur-
ers of the product who choose to carry out one 
or more activities for which the authorization is 
issued, establish any of the conditions described 
in clauses (i) through (iv) of paragraph (1)(A). 
‘‘(B)(i) If the authorization under this sec-
tion regarding the emergency use authorizes a 
change in the labeling of the product, but the 
manufacturer of the product chooses not to 
make such change, such authorization may not
authorize distributors of the product or any 
other person to alter or obscure the labeling 
provided by the manufacturer. 
‘‘(ii) In the circumstances described in 
clause (i), an authorization under this section 
regarding the emergency use may, for persons 
who do not manufacture the product and who 
choose to act under this clause, authorize such 
persons to provide information on the product 
in addition to the labeling provided by the man-
ufacturer, subject to compliance with clause (i). 
Such additional information shall not be consid-
ered labeling for purposes of section 502. 
‘‘(f) DURATION OF AUTHORIZATION.—
‘‘(1) IN GENERAL.—Except as provided in para-
graph (2), an authorization under this section shall 
be effective until the earlier of the termination of the 
declaration under subsection (b) or a revocation 
under subsection (g). 
‘‘(2) CONTINUED USE AFTER END OF EFFEC-
TIVE PERIOD.—An authorization shall continue to be 
effective for continued use with respect to patients 
to whom it was administered during the period de-
scribed by paragraph (1), to the extent found nec-
essary by such patients’ attending physicians.
‘‘(g) REVOCATION OF AUTHORIZATION.—
‘‘(1) REVIEW.—The Secretary shall periodically 
review the circumstances and the appropriateness of 
an authorization under this section. 
‘‘(2) REVOCATION.—The Secretary may revoke 
an authorization under this section if, in the Sec-
retary’s unreviewable discretion, the criteria under 
subsection (c) for issuance of such authorization are 
no longer met. 
‘‘(h) PUBLICATION.—The Secretary shall promptly 
publish in the Federal Register a notice of each authoriza-
tion, and each termination or revocation of an authoriza-
tion, and an explanation of the reasons therefor, under 
this section. 
‘‘(i) ACTIONS COMMITTED
TO AGENCY DISCRE-
TION.—Actions under the authority of this section by the 
Secretary, by the Secretary of Defense, or by the Sec-
retary of Homeland Security are committed to agency dis-
cretion. 
‘‘(j) RULES OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to impair or otherwise affect—
‘‘(1) the authority of the President as Com-
mander in Chief of the Armed Forces of the United 
States under article II, section 2 of the United 
States Constitution;
‘‘(2) the authority of the Secretary of Defense 
with respect to the Department of Defense, includ-
ing the armed forces, under other provisions of Fed-
eral law; or 
‘‘(3) the authority of the Secretary under sec-
tion 319F–2 to manage the stockpile under such 
section. 
‘‘(k)
APPLICATION
TO
MEMBERS
OF
ARMED 
FORCES.—
‘‘(1) WAIVER OF REQUIREMENT RELATING TO 
OPTION TO REFUSE.—In the case of administration 
of a countermeasure to members of the armed 
forces,
a
requirement,
under
subsection 
(e)(1)(A)(ii)(III), designed to ensure that individuals 
are informed of an option to accept or refuse admin-
istration of a product, may be waived by the Presi-
dent if the President determines, in writing, that 
complying with such requirement is not feasible, is 
contrary to the best interests of the members af-
fected, or is not in the interests of national security. 
‘‘(2) PROVISION OF INFORMATION TO MEMBER 
OF THE ARMED FORCES.—If the Secretary makes a 
determination that it is not feasible for the informa-
tion required by subsection (e)(1)(A)(ii) to be pro-
vided to a member of the armed forces prior to the
administration of the product, such information shall 
be provided to such member of the armed forces (or 
next-of-kin in the case of the death of a member) to 
whom the product was administered as soon as pos-
sible, but not later than 30 days, after such adminis-
tration. Information concerning the administration 
of the product shall be recorded in the medical 
record of the member. 
‘‘(3) EFFECT ON STATUTE PERTAINING TO IN-
VESTIGATIONAL NEW DRUGS.—In the case of an au-
thorization based on a determination by the Sec-
retary of Defense under subsection (b)(1)(B), sec-
tion 1107 of title 10, United States Code, shall not 
apply to use of a product that is the subject of such 
authorization, within the scope of such authorization 
and while such authorization is effective. 
‘‘(l) RELATION TO OTHER PROVISIONS.—If a prod-
uct is the subject of an authorization under this section, 
the use of such product within the scope of the authoriza-
tion —
‘‘(1) shall not be subject to any requirements 
pursuant to section 505(i) or 520(g); and 
‘‘(2) shall not be subject to any requirements 
otherwise applicable to clinical investigations pursu-
ant to other provisions of this Act.
‘‘(m) DISCRETION REGARDING USE OF AUTHORIZA-
TION.—Nothing in this section provides the Secretary any 
authority to require any person to carry out any activity 
that becomes lawful pursuant to an authorization under 
this section, and no person is required to inform the Sec-
retary that the person will not be carrying out such activ-
ity, except that a manufacturer of a sole-source unap-
proved product authorized for emergency use shall notify 
the Secretary within a reasonable period of time after the 
issuance by the Secretary of such authorization if such 
manufacturer does not intend to carry out an activity or 
activities under the authorization. This section does not 
have any legal effect on a person who does not carry out 
any activity for which an authorization under this section 
is issued, or who carries out such an activity pursuant to 
other provisions of this Act or section 351 of the Public 
Health Service Act. 
‘‘(n) ENFORCEMENT.—A person who carries out an 
activity pursuant to an authorization under this section, 
but who fails to comply with applicable conditions under 
subsection (e), is with respect to that act of noncompliance 
subject to the provisions of law specified in subsection (a) 
and to the enforcement of such provisions under section 
301.’’.
SEC. 5. REPORTS REGARDING AUTHORITIES UNDER THIS 
ACT. 
(a) SECRETARY
OF HEALTH
AND HUMAN SERV-
ICES.—
(1) ANNUAL REPORTS ON PARTICULAR EXER-
CISES OF AUTHORITY.—
(A) RELEVANT
AUTHORITIES.—The Sec-
retary of Health and Human Services (referred 
to in this subsection as the ‘‘Secretary’’) shall 
submit reports in accordance with subpara-
graph (B) regarding the exercise of authority 
under the following provisions of law: 
(i) With respect to section 319F–1 of 
the Public Health Service Act (as added by 
section 2 of this Act): 
(I) Subsection (b)(1) (relating to 
increased
simplified
acquisition 
threshold). 
(II) Subsection (b)(2) (relating to 
use of noncompetitive procedures). 
(III) Subsection (c) (relating to 
expedited peer review procedures). 
(ii) With respect to section 319F–2 of 
the Public Health Service Act (as added by 
section 3 of this Act):
(I) Subsection (c)(7)(C)(iii) (re-
lating to simplified acquisition proce-
dures). 
(II) Subsection (c)(7)(C)(iv) (re-
lating to use of noncompetitive proce-
dures). 
(III) Subsection (c)(7)(C)(v) (re-
lating to premium provision in mul-
tiple-award contracts). 
(iii) With respect to section 564 of the 
Federal Food, Drug, and Cosmetic Act (as 
added by section 4 of this Act): 
(I) Subsection (a)(1) (relating to 
emergency uses of certain drugs and 
devices). 
(II) Subsection (b)(1) (relating to 
a declaration of an emergency). 
(III) Subsection (e) (relating to 
conditions on authorization). 
(B) CONTENTS
OF
REPORTS.—The Sec-
retary shall annually submit to the Congress a 
report that summarizes—
(i) the particular actions that were 
taken under the authorities specified in 
subparagraph (A), including, as applicable,
the
identification
of
the
threat
agent, 
emergency,
or
the
biomedical
counter-
measure with respect to which the author-
ity was used; 
(ii) the reasons underlying the deci-
sion to use such authorities, including, as 
applicable, the options that were consid-
ered and rejected with respect to the use of 
such authorities; and 
(iii) the identification of each person 
or entity that received, or was considered 
and rejected for, grants, cooperative agree-
ments, or contracts pursuant to the use of 
such authorities. 
(2) ANNUAL SUMMARIES REGARDING CERTAIN 
ACTIVITY.—The Secretary shall annually submit to 
the Congress a report that summarizes the activity 
undertaken pursuant to the following authorities 
under section 319F–1 of the Public Health Service 
Act (as added by section 2 of this Act): 
(A)
Subsection
(b)(3)
(relating
to
in-
creased micropurchase threshold). 
(B) Subsection (d) (relating to authority 
for personal services contracts).
(C) Subsection (e) (relating to streamlined 
personnel authority). 
With respect to subparagraph (B), the report shall 
include a provision specifying, for the one-year pe-
riod for which the report is submitted, 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. 
(b) NATIONAL ACADEMY OF SCIENCES REVIEW.—
Not later than three years after the date of the enactment 
of this Act, the Secretary of Health and Human Services 
shall request the National Academy of Sciences to enter 
into an agreement for a review of the biomedical counter-
measure research and development authorities established 
in this Act to determine whether and to what extent activi-
ties undertaken pursuant to such authorities have en-
hanced the development of biomedical countermeasures af-
fecting 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 Congress not later than five years 
after such date of enactment. 
(c) GENERAL ACCOUNTING OFFICE REVIEW.—Four 
years after the date of the enactment of this Act, the
Comptroller General of the United States shall initiate a 
study—
(1)(A) to review the Secretary of Health and 
Human Services’ utilization of the authorities grant-
ed under this Act with respect to simplified acquisi-
tion procedures, use of noncompetitive procedures, 
increased micropurchase thresholds, personal serv-
ices contracts, streamlined personnel authority, and 
the purchase of security countermeasures under the 
special reserve fund; and 
(B) to recommend any legislative or administra-
tive changes necessary to improve the utilization or 
effectiveness of such authorities in the future; 
(2)(A) to review the internal controls instituted 
by such Secretary with respect to such authorities, 
where required by this Act; and 
(B) to recommend any legislative or administra-
tive changes necessary to improve the effectiveness 
of such controls; and 
(3)(A) to review such Secretary’s utilization of 
the authority granted under this Act to authorize an 
emergency use of a biomedical countermeasure, in-
cluding the means by which the Secretary deter-
mines 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 
(B) to recommend any legislative or administra-
tive changes necessary to improve the utilization or 
effectiveness of such authority and to enhance pro-
tection of the public health. 
The results of the study shall be submitted to the Con-
gress not later than five years after the date of the enact-
ment of this Act.
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Project BioShield Act 
of 2003’’. 
SEC. 2. BIOMEDICAL COUNTERMEASURE RESEARCH AND 
DEVELOPMENT AUTHORITIES. 
(a) IN GENERAL.—Part B of title III of the Public 
Health Service Act (42 U.S.C. 243 et seq.) is amended by 
inserting after section 319F the following section: 
‘‘SEC. 319F–1. AUTHORITY FOR USE OF CERTAIN PROCE-
DURES REGARDING BIOMEDICAL COUNTER-
MEASURE RESEARCH AND DEVELOPMENT AC-
TIVITIES. 
‘‘(a) IN GENERAL.—
‘‘(1) AUTHORITY.—In conducting and sup-
porting research and development activities regarding 
biomedical countermeasures under section 319F(h),
the Secretary may conduct and support such activi-
ties in accordance with this section if the activities 
concern qualified countermeasures. 
‘‘(2) QUALIFIED COUNTERMEASURE.—For pur-
poses of this section, the term ‘qualified counter-
measure’ means a priority countermeasure (as defined 
in section 319F(h)) that affects national security. 
‘‘(3) INTERAGENCY COOPERATION.—
‘‘(A) IN GENERAL.—In carrying out activi-
ties under this section, the Secretary is author-
ized, subject to subparagraph (B), to enter into 
interagency agreements and other collaborative 
undertakings with other agencies of the United 
States Government. 
‘‘(B) LIMITATION.—An agreement or under-
taking under this paragraph shall not authorize 
another agency to exercise the authorities pro-
vided by this section. 
‘‘(4) AVAILABILITY OF FACILITIES TO THE SEC-
RETARY.—In any grant or cooperative agreement en-
tered into under the authority provided in this section 
with respect to a biocontainment laboratory or other 
related or ancillary specialized research facility that 
the Secretary determines necessary for the purpose of 
performing, administering, and supporting qualified
countermeasure research and development, the Sec-
retary may provide that the facility that is the object 
of such grant or cooperative agreement shall be avail-
able as needed to the Secretary to respond to public 
health emergencies affecting national security. 
‘‘(b) EXPEDITED PROCUREMENT AUTHORITY.—
‘‘(1) 
INCREASED
SIMPLIFIED
ACQUISITION 
THRESHOLD
FOR
BIOMEDICAL
COUNTERMEASURE 
PROCUREMENTS.—
‘‘(A) IN GENERAL.—For any procurement 
by the Secretary of property or services for use 
(as determined by the Secretary) in performing, 
administering, or supporting qualified counter-
measure research or development activities under 
this section that the Secretary determines nec-
essary to respond to pressing research and devel-
opment needs under this section, the amount 
specified in section 4(11) of the Office of Federal 
Procurement Policy Act (41 U.S.C. 403(11)), as 
applicable pursuant to section 302A(a) of the 
Federal Property and Administrative Services 
Act of 1949 (41 U.S.C. 252a(a)), shall be deemed 
to be $25,000,000 in the administration, with re-
spect to such procurement, of—
‘‘(i) section 303(g)(1)(A) of the Federal 
Property and Administrative Services Act 
of 1949 (41 U.S.C. 253(g)(1)(A)) and its 
implementing regulations; and
‘‘(ii) section 302A(b) of such Act (41 
U.S.C. 252a(b)) and its implementing regu-
lations. 
‘‘(B) APPLICATION
OF
CERTAIN
PROVI-
SIONS.—Notwithstanding subparagraph (A) and 
the provision of law and regulations referred to 
in such subparagraph, each of the following pro-
visions shall apply to procurements described in 
this paragraph to the same extent that such pro-
visions would apply to such procurements in the 
absence of subparagraph (A): 
‘‘(i) Chapter 37 of title 40, United 
States Code (relating to contract work hours 
and safety standards). 
‘‘(ii) Subsections (a) and (b) of section 
7 of the Anti-Kickback Act of 1986 (41 
U.S.C. 57(a) and (b)). 
‘‘(iii) Section 304C of the Federal 
Property and Administrative Services Act 
of 1949 (41 U.S.C. 254d) (relating to the 
examination of contractor records).
‘‘(C) INTERNAL
CONTROLS
TO
BE
INSTI-
TUTED.—The Secretary shall institute appro-
priate internal controls for procurements that 
are under this paragraph, including require-
ments with regard to documenting the justifica-
tion for use of the authority in this paragraph.
‘‘(2) OTHER THAN FULL AND OPEN COMPETI-
TION.—(A) In using the authority provided in section 
303(c)(1) of title III of the Federal Property and Ad-
ministrative Services Act of 1949 (41 U.S.C. 
253(c)(1)) to use procedures other than competitive 
procedures in the case of a procurement described in 
paragraph (1) of this subsection, the phrase ‘available 
from only one responsible source’ in such section 
303(c)(1) shall be deemed to mean ‘available from 
only one responsible source or only from a limited 
number of responsible sources’. 
‘‘(B) The authority under subparagraph (A) is 
in addition to any other authority to use procedures 
other than competitive procedures. 
‘‘(C) The Secretary shall implement this para-
graph in accordance with applicable government-wide 
regulations, including requirements that offers be so-
licited from as many potential sources as is prac-
ticable under the circumstances, that required notices 
be published, and that submitted offers be considered. 
‘‘(3) 
INCREASED
MICROPURCHASE
THRESH-
OLD.—
‘‘(A) IN GENERAL.—For a procurement de-
scribed by paragraph (1), the amount specified 
in subsections (c), (d), and (f) of section 32 of the 
Office of Federal Procurement Policy Act (41 
U.S.C. 428) shall be deemed to be $15,000 in the 
administration of that section with respect to 
such procurement.
‘‘(B) INTERNAL
CONTROLS
TO
BE
INSTI-
TUTED.—The Secretary shall institute appro-
priate internal controls for purchases that are 
under this paragraph and that are greater than 
$2,500. 
‘‘(C) EXCEPTION TO PREFERENCE FOR PUR-
CHASE CARD MECHANISM.—No provision of law 
establishing a preference for using a Government 
purchase card method for purchases shall apply 
to purchases that are under this paragraph and 
that are greater than $2,500. 
‘‘(c) AUTHORITY TO EXPEDITE PEER REVIEW.—
‘‘(1) IN GENERAL.—The Secretary may, as the 
Secretary determines necessary to respond to pressing
qualified countermeasure research and development 
needs under this section, employ such expedited peer 
review procedures (including consultation with ap-
propriate scientific experts) as the Secretary, in con-
sultation with the Director of NIH, deems appro-
priate to obtain assessment of scientific and technical 
merit and likely contribution to the field of qualified 
countermeasure research, in place of the peer review 
and advisory council review procedures that would be 
required under sections 301(a)(3), 405(b)(1)(B), 
405(b)(2), 406(a)(3)(A), 492, and 494, as applicable 
to a grant, contract, or cooperative agreement—
‘‘(A) that is for performing, administering, 
or supporting qualified countermeasure research 
and development activities; and 
‘‘(B) the amount of which is not greater 
than $1,500,000. 
‘‘(2) SUBSEQUENT PHASES OF RESEARCH.—The 
Secretary’s determination of whether to employ expe-
dited peer review with respect to subsequent phases of 
a research grant or cooperative agreement under this 
section shall be determined without regard to the peer 
review procedures used for any prior peer review of 
that same grant or cooperative agreement.