contracts for such procurement or other matters 
relating to awards of such contracts. 
‘‘(7) PROCUREMENT.—
‘‘(A) IN GENERAL.—For purposes of a pro-
curement under this subsection that is approved 
by the President under paragraph (6), the 
Homeland Security Secretary and the Secretary 
shall have responsibilities in accordance with 
subparagraphs (B) and (C). 
‘‘(B) INTERAGENCY AGREEMENTS.—
‘‘(i) FOR PROCUREMENT.—The Home-
land Security Secretary shall enter into an 
agreement with the Secretary for procure-
ment of a security countermeasure in ac-
cordance with the provisions of this para-
graph. The special reserve fund under para-
graph (10) shall be available for the Sec-
retary’s costs of such procurement, other 
than as provided in clause (ii). 
‘‘(ii) FOR
ADMINISTRATIVE
COSTS.—
The agreement entered into between the 
Homeland Security Secretary and the Sec-
retary for managing the stockpile under 
subsection (a) shall provide for reimburse-
ment of the Secretary’s administrative costs
relating to procurements under this sub-
section. 
‘‘(C) PROCUREMENT.—
‘‘(i) IN GENERAL.—The Secretary shall 
be responsible for—
‘‘(I) arranging for procurement of 
a security countermeasure, including 
negotiating terms (including quantity, 
production schedule, and price) of, and 
entering into, contracts and coopera-
tive agreements, and for carrying out 
such other activities as may reasonably 
be required, in accordance with the 
provisions of this subparagraph; and 
‘‘(II) promulgating regulations to 
implement clauses (v), (vi), and (vii), 
and any other provisions of this sub-
section. 
‘‘(ii) CONTRACT
TERMS.—A contract 
for procurements under this subsection shall 
(or, as specified below, may) include the fol-
lowing terms: 
‘‘(I) PAYMENT
CONDITIONED
ON 
SUBSTANTIAL DELIVERY.—The contract 
shall provide that no payment may be
made until delivery has been made of 
a substantial portion (as determined 
by 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 is necessary to ensure success 
of a project, the Secretary may pay an 
amount, not to exceed 10 percent of the 
contract amount, in advance of deliv-
ery. The contract shall provide that 
such advance payment is required to be 
repaid if there is a failure to perform 
under the contract, except in special 
circumstances as determined by the 
Secretary on a contract by contract 
basis. 
‘‘(II) CONTRACT DURATION.—The 
contract shall be for a period not to ex-
ceed five years, except that, in first 
awarding the contract, the Secretary 
may provide for a longer duration, not 
exceeding eight years, if the Secretary
determines that complexities or other 
difficulties in performance under the 
contract justify such a period. The con-
tract shall be renewable for additional 
periods, none of which shall exceed five 
years.
‘‘(III) STORAGE
BY
VENDOR.—
The contract may provide that the ven-
dor will provide storage for stocks of a 
product delivered to the ownership of 
the Federal Government under the con-
tract, for such period and under such 
terms and conditions as the Secretary 
may specify, and in such case amounts 
from the special reserve fund under 
paragraph (10) shall be available for 
costs of shipping, handling, storage, 
and related costs for such product. 
‘‘(iii) AVAILABILITY OF SIMPLIFIED AC-
QUISITION PROCEDURES.—
‘‘(I) IN
GENERAL.—If the Sec-
retary determines that there is a press-
ing need for a procurement of a spe-
cific countermeasure, the amount of the 
procurement 
under 
this 
subsection
shall be deemed to be below the thresh-
old amount specified in section 4(11) 
of the Office of Federal Procurement 
Policy Act (41 U.S.C. 403(11)), for 
purposes of application to such pro-
curement, pursuant to section 302A(a) 
of the Federal Property and Adminis-
trative Services Act of 1949 (41 U.S.C. 
252a(a)), of—
‘‘(aa) section 303(g)(1)(A) of 
the Federal Property and Admin-
istrative Services Act of 1949 (41 
U.S.C. 253(g)(1)(A)) and its im-
plementing regulations; and 
‘‘(bb) section 302A(b) of such 
Act (41 U.S.C. 252a(b)) and its 
implementing regulations. 
‘‘(II) APPLICATION
OF
CERTAIN 
PROVISIONS.—Notwithstanding 
sub-
clause (I) and the provision of law and 
regulations referred to in such clause, 
each of the following provisions shall 
apply to procurements described in 
this clause to the same extent that such 
provisions would apply to such pro-
curements in the absence of subclause 
(I): 
‘‘(aa) Chapter 37 of title 40, 
United States Code (relating to 
contract work hours and safety 
standards). 
‘‘(bb) Subsections (a) and (b) 
of section 7 of the Anti-Kickback 
Act of 1986 (41 U.S.C. 57(a) and 
(b)). 
‘‘(cc) Section 304C of the 
Federal Property and Adminis-
trative Services Act of 1949 (41 
U.S.C. 254d) (relating to the ex-
amination of contractor records).
‘‘(iv) OTHER
THAN
FULL
AND
OPEN 
COMPETITION.—(I) In using the authority 
provided in section 303(c)(1) of title III of 
the Federal Property and Administrative 
Services Act of 1949 (41 U.S.C. 253(c)(1)) 
to use procedures other than competitive 
procedures in the case of a procurement 
under 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 respon-
sible sources’. 
‘‘(II) The authority under subclause (I) 
is in addition to any other authority to use 
procedures other than competitive proce-
dures. 
‘‘(III) The Secretary shall implement 
this clause in accordance with applicable 
government-wide regulations, including re-
quirements that offers be solicited from as 
many potential sources as is practicable 
under the circumstances, that required no-
tices be published, and that submitted offers 
be considered. 
‘‘(v) PREMIUM PROVISION IN MULTIPLE 
AWARD CONTRACTS.—
‘‘(I) IN GENERAL.—If, under this 
subsection, the Secretary enters into 
contracts with more than one vendor to 
procure a security countermeasure, 
such Secretary may, notwithstanding 
any other provision of law, include in 
each of such contracts a provision 
that—
‘‘(aa) identifies an increment 
of the total quantity of security 
countermeasure required, whether 
by percentage or by numbers of 
units; and
‘‘(bb) promises to pay one or 
more specified premiums based on 
the priority of such vendors’ pro-
duction and delivery of the incre-
ment identified under item (aa), 
in accordance with the terms and 
conditions of the contract. 
‘‘(II) DETERMINATION
OF
GOV-
ERNMENT’S
REQUIREMENT
NOT
RE-
VIEWABLE.—If the Secretary includes 
in each of a set of contracts a provision 
as described in subclause (I), such Sec-
retary’s determination of the total 
quantity of security countermeasure re-
quired, and any amendment of such 
determination, is committed to agency 
discretion. 
‘‘(vi) EXTENSION
OF
CLOSING
DATE 
FOR RECEIPT OF PROPOSALS NOT REVIEW-
ABLE.—A decision by the Secretary to ex-
tend the closing date for receipt of proposals 
for a procurement under this subsection is 
committed to agency discretion. 
‘‘(vii) 
LIMITING
COMPETITION
TO 
SOURCES RESPONDING TO REQUEST FOR IN-
FORMATION.—In conducting a procurement 
under this subsection, the Secretary may ex-
clude a source that has not responded to a 
request 
for 
information 
under 
section 
303A(a)(1)(B) of the Federal Property and 
Administrative Services Act of 1949 (41 
U.S.C. 253a(a)(1)(B)) if such request has 
given notice that the Secretary may so ex-
clude such a source. 
‘‘(8) INTERAGENCY COOPERATION.—
‘‘(A) IN GENERAL.—In carrying out activi-
ties under this section, the Homeland Security 
Secretary and the Secretary are authorized, sub-
ject to subparagraph (B), to enter into inter-
agency agreements and other collaborative under-
takings 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 to the Homeland Security 
Secretary or to the Secretary. 
‘‘(9) RESTRICTIONS
ON
USE
OF
FUNDS.—
Amounts in the special reserve fund under paragraph 
(10) shall not be used to pay—
‘‘(A) costs for the purchase of vaccines 
under procurement contracts entered into before 
the date of the enactment of the Project Bio-
Shield Act of 2003; or 
‘‘(B) administrative costs. 
‘‘(10) SPECIAL RESERVE FUND.—For purposes of 
this subsection, the term ‘special reserve fund’ has the 
meaning given such term in section 510 of the Home-
land Security Act of 2002. 
‘‘(d) DISCLOSURES.—No Federal agency shall disclose 
under section 552, United States Code, any information 
identifying the location at which materials in the stockpile 
under subsection (a) are stored. 
‘‘(e) DEFINITION.—For purposes of subsection (a), the 
term ‘stockpile’ includes—
‘‘(1) a physical accumulation (at one or more lo-
cations) of the supplies described in subsection (a); or 
‘‘(2) a contractual agreement between the Home-
land Security Secretary and a vendor or vendors
under which such vendor or vendors agree to provide 
to such Secretary supplies described in subsection (a). 
‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—
‘‘(1) STRATEGIC NATIONAL STOCKPILE.—For the 
purpose of carrying out subsection (a), there are au-
thorized to be appropriated $640,000,000 for fiscal 
year 2002, and such sums as may be necessary for 
each of fiscal years 2003 through 2006. Such author-
ization is in addition to amounts in the special re-
serve fund under subsection (c)(10). 
‘‘(2) SMALLPOX
VACCINE
DEVELOPMENT.—For 
the purpose of carrying out subsection (b), there are 
authorized to be appropriated $509,000,000 for fiscal 
year 2002, and such sums as may be necessary for 
each of fiscal years 2003 through 2006.’’. 
(b) AMENDMENT TO HOMELAND SECURITY ACT OF 
2002.—Title V of the Homeland Security Act of 2002 (116 
Stat. 2212; 6 U.S.C. 311 et seq.) is amended by adding at 
the end the following: 
‘‘SEC. 
510. 
PROCUREMENT 
OF 
SECURITY 
COUNTER-
MEASURES 
FOR 
STRATEGIC 
NATIONAL 
STOCKPILE. 
‘‘(a) AUTHORIZATION OF APPROPRIATIONS.—For pro-
curement of security countermeasures under section 319F–
2(c) of the Public Health Service Act (referred to in this
section as the ‘security countermeasures program’), there is 
authorized to be appropriated up to $5,593,000,000 for the 
fiscal years 2004 through 2013. Of the amounts appro-
priated under the preceding sentence, not to exceed 
$3,418,000,000 may be obligated during the fiscal years 
2004 through 2008, of which not to exceed $890,000,000 
may be obligated during fiscal year 2004. 
‘‘(b) SPECIAL RESERVE FUND.—For purposes of the 
security countermeasures program, the term ‘special reserve 
fund’ means the appropriations account established as a re-
sult of any appropriations made under subsection (a). 
‘‘(c) AVAILABILITY.—
‘‘(1) DURATION OF AVAILABILITY FOR OBLIGA-
TION.—Subject to paragraph (2), all amounts appro-
priated under subsection (a) are available for obliga-
tion through the end of fiscal year 2013, provided 
that any portion of such amount that remains unobli-
gated for such purposes on the expiration of such term 
shall be returned to the United States Treasury and 
shall not be available for subsequent obligation 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 availability for the 
procurement in accordance with paragraph (6)(B) of 
such program.’’. 
(c) CONFORMING AMENDMENTS.—(1) 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. 
(2) The item relating to section 121 in the table of 
contents (contained in section 1(b)) of such Act is repealed. 
(3) With respect to the program established under 
former section 121 of such Act, the repeal of such section 
under paragraph (1) applies as a modification of the pro-
gram in accordance with the amendment made by sub-
section (a) of this section, and not as the termination of 
the program and the establishment 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 authorize 
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 emergency 
use authorized under paragraph (1) for a product is 
in addition to any other use that is authorized for the 
product under a provision of law referred to in such 
paragraph. 
‘‘(4) DEFINITIONS.—For purposes of this section:
‘‘(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 paragraph 
(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, radi-
ological, 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, chem-
ical, 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 national se-
curity and involving a specified biological, chem-
ical, radiological, or nuclear agent or agents, or 
a specified disease or condition that may be at-
tributable 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 Sec-
retary of Homeland Security or the Sec-
retary of Defense, that the circumstances de-
scribed 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 subpara-
graph (A), the Secretary may renew a declara-
tion under this subsection, and this paragraph 
shall apply to any such renewal. 
‘‘(3) ADVANCE
NOTICE
OF
TERMINATION.—In 
terminating a declaration under this section, the Sec-
retary shall provide advance notice that the declara-
tion 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 ship-
ments to the manufacturer (in the case of a man-
ufacturer that chooses to have the shipments re-
turned); 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 Insti-
tutes of Health and the Director of the Centers for Disease 
Control and Prevention, to the extent feasible and appro-
priate given the circumstances of the emergency involved, 
the Secretary concludes—
‘‘(1) that an agent specified in a declaration 
under subsection (b) can cause a serious or life-threat-
ening 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 detect-
ing, 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 Service 
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, prevent, 
or treat such disease or condition, outweigh the 
known and potential risks of the product;
100
‘‘(3) that there is no adequate, approved, and 
available alternative to the product for detecting, di-
agnosing, preventing, or treating such disease or con-
dition; 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, prevent, 
or treat within the scope of the authorization; 
‘‘(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 detecting, 
diagnosing, preventing, or treating such diseases 
or conditions, including an assessment of the 
available scientific evidence.
101
‘‘(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 respect 
to the emergency use of an unapproved product, 
the Secretary, to the extent feasible given the cir-
cumstances 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 authorization under this sec-
tion as the Secretary finds necessary or appro-
priate 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 product are 
informed—
‘‘(I) that the Secretary has au-
thorized the emergency use of the prod-
uct;
102
‘‘(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, individ-
uals to whom the product is administered 
are informed—
‘‘(I) that the Secretary has au-
thorized the emergency use of the prod-
uct; 
‘‘(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 refusing 
administration of the product, and of 
the alternatives to the product that are
103
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 respect 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 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 on which 
entities may distribute the product with re-
spect to the emergency use of the product 
(including limitation to distribution by
104
government entities), and on how distribu-
tion 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 product 
may be administered with respect to such 
use. 
‘‘(iii) For persons other than manufac-
turers of the product, appropriate condi-
tions concerning recordkeeping and report-
ing, including records access by the Sec-
retary, 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 otherwise ap-
plicable to the manufacture, processing, 
packing, or holding of products subject to 
regulation under this Act, including such 
requirements established in section 501.
105
‘‘(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 manufacturers 
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 author-
ize distributors of the product or any other per-
son 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 manu-
facturer, subject to compliance with clause (i).
106
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 EFFECTIVE 
PERIOD.—An authorization shall continue to be effec-
tive 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-
107
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 DISCRETION.—
Actions under the authority of this section by the Secretary, 
by the Secretary of Defense, or by the Secretary of Home-
land Security are committed to agency discretion. 
‘‘(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, including 
the armed forces, under other provisions of Federal 
law; or 
‘‘(3) the authority of the Secretary under section 
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), de-
108
signed to ensure that individuals are informed of an 
option to accept or refuse administration of a prod-
uct, may be waived by the President if the President 
determines, in writing, that complying with such re-
quirement is not feasible, is contrary to the best inter-
ests of the members affected, or is not in the interests 
of national security. 
‘‘(2) PROVISION OF INFORMATION TO MEMBER OF 
THE ARMED FORCES.—If the Secretary makes a deter-
mination that it is not feasible for the information re-
quired by subsection (e)(1)(A)(ii) to be provided to a 
member of the armed forces prior to the administra-
tion of the product, such information shall be pro-
vided 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 possible, but 
not later than 30 days, after such administration. In-
formation concerning the administration of the prod-
uct shall be recorded in the medical record of the 
member. 
‘‘(3) EFFECT ON STATUTE PERTAINING TO INVES-
TIGATIONAL NEW DRUGS.—In the case of an author-
ization based on a determination by the Secretary of 
Defense under subsection (b)(1)(B), section 1107 of 
title 10, United States Code, shall not apply to use
109
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 product 
is the subject of an authorization under this section, the
use of such product within the scope of the authorization—
‘‘(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 oth-
erwise applicable to clinical investigations pursuant 
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 unapproved 
product authorized for emergency use shall notify the Sec-
retary 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
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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 ac-
tivity pursuant to an authorization under this section, but 
who fails to comply with applicable conditions under sub-
section (e), is with respect to that act of noncompliance sub-
ject 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 SERVICES.—
(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 subparagraph 
(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 thresh-
old).