‘‘(B) ensure that adequate procedures are 
followed with respect to such stockpile for in-
ventory management and accounting, and for 
the physical security of the stockpile; 
‘‘(C) in consultation with Federal, State, 
and local officials, take into consideration the 
timing and location of special events; 
‘‘(D) review and revise, as appropriate, the 
contents of the stockpile on a regular basis to 
ensure that emerging threats, advanced tech-
nologies, and new countermeasures are ade-
quately considered; 
‘‘(E) devise plans for the effective and 
timely supply-chain management of the stock-
pile, in consultation with appropriate Federal, 
State and local agencies, and the public and 
private health care infrastructure; and 
‘‘(F) ensure the adequate physical security 
of the stockpile. 
‘‘(b) SMALLPOX VACCINE DEVELOPMENT.—
‘‘(1) IN GENERAL.—The Secretary shall award 
contracts, enter into cooperative agreements, or 
carry out such other activities as may reasonably be 
required in order to ensure that the stockpile under 
subsection (a) includes an amount of vaccine against
smallpox as determined by such Secretary to be suf-
ficient to meet the health security needs of the 
United States. 
‘‘(2) RULE
OF
CONSTRUCTION.—Nothing in 
this section shall be construed to limit the private 
distribution, purchase, or sale of vaccines from 
sources other than the stockpile described in sub-
section (a). 
‘‘(c) ADDITIONAL
AUTHORITY
REGARDING
PRO-
CUREMENT
OF
CERTAIN
BIOMEDICAL
COUNTER-
MEASURES; 
AVAILABILITY
OF
SPECIAL
RESERVE 
FUND.—
‘‘(1) IN GENERAL.—
‘‘(A) USE OF FUND.—A security counter-
measure may, in accordance with this sub-
section, be procured with amounts in the special 
reserve fund under paragraph (10). 
‘‘(B) SECURITY
COUNTERMEASURE.—For 
purposes of this subsection, the term ‘security 
countermeasure’ means a priority counter-
measure (as defined in section 319F(h))—
‘‘(i) that affects national security; 
‘‘(ii) that is determined under para-
graph (2)(B)(ii) to be a necessary counter-
measure; and
‘‘(iii)(I) that is approved or cleared 
under chapter V of the Federal Food, 
Drug, and Cosmetic Act, or licensed under 
section 351 of this Act, for use as a coun-
termeasure to a chemical, biological, radio-
logical, or nuclear agent identified as a 
material threat under paragraph (2)(A)(ii); 
or 
‘‘(II) for which the Secretary deter-
mines that sufficient and satisfactory clin-
ical experience or research data (including 
data, if available, from pre-clinical and 
clinical trials) support a reasonable conclu-
sion that the countermeasure will qualify 
for approval or licensing after the date of 
a determination under paragraph (5).
‘‘(2) 
DETERMINATION
OF
MATERIAL 
THREATS.—
‘‘(A) MATERIAL THREAT.—The Homeland 
Security Secretary, in consultation with the 
heads of other agencies as appropriate, shall on 
an ongoing basis—
‘‘(i) assess current and emerging 
threats of chemical, biological, radiological, 
and nuclear agents; and
‘‘(ii) determine which of such agents 
present a material threat against the 
United States population. 
‘‘(B) PUBLIC HEALTH IMPACT; NECESSARY 
COUNTERMEASURES.—The Secretary shall on 
an ongoing basis—
‘‘(i) assess the potential public health 
consequences of use against the United 
States population of agents identified 
under subparagraph (A)(ii); and 
‘‘(ii) determine, on the basis of such 
assessment, the agents for which priority 
countermeasures are necessary to protect 
the public health from a material threat. 
‘‘(3) ASSESSMENT OF AVAILABILITY AND AP-
PROPRIATENESS OF COUNTERMEASURES.—The Sec-
retary, in consultation with the Homeland Security 
Secretary, shall assess on an ongoing basis the avail-
ability and appropriateness of specific counter-
measures to address specific threats identified under 
paragraph (2). 
‘‘(4) CALL FOR SECURITY COUNTERMEASURES; 
COMMITMENT
FOR
RECOMMENDATION
FOR
PRO-
CUREMENT.—
‘‘(A) PROPOSAL TO THE PRESIDENT.—If, 
pursuant to an assessment under paragraph 
(3), the Homeland Security Secretary and the 
Secretary make a determination that a security 
countermeasure would be appropriate, such Sec-
retaries may jointly submit to the President a 
proposal to—
‘‘(i) issue a call for the development of 
such security countermeasure; and 
‘‘(ii) make a commitment that, upon 
the first development of such security 
countermeasure that meets the conditions 
for procurement under paragraph (5), the 
Secretaries will, based in part on informa-
tion obtained pursuant to such call, make 
a recommendation under paragraph (6) 
that the special reserve fund under para-
graph (10) be made available for the pro-
curement of such security countermeasure. 
‘‘(B) 
COUNTERMEASURE
SPECIFICA-
TIONS.—The Homeland Security Secretary and 
the Secretary shall, to the extent practicable, 
include in the proposal under subparagraph 
(A)—
‘‘(i) estimated quantity of purchase 
(in the form of number of doses or number 
of effective courses of treatments regard-
less of dosage form); 
‘‘(ii) necessary measures of minimum 
safety and effectiveness; 
‘‘(iii) estimated price for each dose or 
effective course of treatment regardless of 
dosage form; and 
‘‘(iv) other information that may be 
necessary to encourage and facilitate re-
search, development, and manufacture of 
the countermeasure or to provide specifica-
tions for the countermeasure. 
‘‘(C) PRESIDENTIAL
APPROVAL.—If the 
President approves a proposal under subpara-
graph (A), the Homeland Security Secretary 
and the Secretary shall make known to persons 
who may respond to a call for the security 
countermeasure involved—
‘‘(i) the call for the countermeasure; 
‘‘(ii) specifications for the counter-
measure under subparagraph (B); and 
‘‘(iii) a commitment described in sub-
paragraph (A)(ii).
‘‘(5) SECRETARY’S DETERMINATION OF COUN-
TERMEASURES
APPROPRIATE
FOR
FUNDING
FROM 
SPECIAL RESERVE FUND.—
‘‘(A) IN GENERAL.—The Secretary, in ac-
cordance with the provisions of this paragraph, 
shall identify specific security countermeasures 
that the Secretary determines, in consultation 
with the Homeland Security Secretary, to be 
appropriate for inclusion in the stockpile under 
subsection (a) pursuant to procurements made 
with amounts in the special reserve fund under 
paragraph (10) (referred to in this subsection 
individually as a ‘procurement under this sub-
section’). 
‘‘(B) REQUIREMENTS.—In making a deter-
mination under subparagraph (A) with respect 
to a security countermeasure, the Secretary 
shall determine and consider the following: 
‘‘(i) The quantities of the product 
that will be needed to meet the needs of 
the stockpile. 
‘‘(ii) The feasibility of production and 
delivery within five years of sufficient 
quantities of the product.
‘‘(iii) Whether there is a lack of a sig-
nificant commercial market for the product 
at the time of procurement, other than as 
a security countermeasure. 
‘‘(6) RECOMMENDATION FOR PRESIDENT’S AP-
PROVAL.—
‘‘(A) RECOMMENDATION
FOR
PROCURE-
MENT.—In the case of a security counter-
measure that the Secretary has, in accordance 
with paragraphs (2), (3), and (5), determined 
to be appropriate for procurement under this 
subsection, the Homeland Security Secretary 
and the Secretary shall jointly submit to the 
President, in coordination with the Director of 
the Office of Management and Budget, a rec-
ommendation that the special reserve fund 
under paragraph (10) be made available for the 
procurement of such countermeasure.
‘‘(B) PRESIDENTIAL APPROVAL.—The spe-
cial reserve fund under paragraph (10) is avail-
able for a procurement of a security counter-
measure only if the President has approved a 
recommendation under subparagraph (A) re-
garding the countermeasure.
‘‘(C) NOTICE
TO
CONGRESS.—The Sec-
retary and the Homeland Security Secretary 
shall notify the Congress of each decision of the 
President to approve a recommendation under 
subparagraph (A). Such notice shall include an 
explanation of the decision to make available 
the special reserve fund under paragraph (10) 
for procurement of such a countermeasure, in-
cluding, where available, the identification of 
the potential supplier or suppliers of such coun-
termeasure, and whether other potential sup-
pliers of the same or similar countermeasures 
were considered and rejected for procurement 
under this section and the reasons therefor. 
‘‘(D) SUBSEQUENT
SPECIFIC
COUNTER-
MEASURES.—Procurement 
under 
this 
sub-
section of a security countermeasure for a par-
ticular purpose does not preclude the subse-
quent procurement under this subsection of any 
other security countermeasure for such purpose 
if the Secretary has determined under para-
graph (5)(A) that such countermeasure is ap-
propriate for inclusion in the stockpile and if, 
as determined by the Secretary, such counter-
measure provides improved safety or effective-
ness, or for other reasons enhances prepared-
ness to respond to threats of use of a biological, 
chemical, radiological, or nuclear agent. Such a 
determination by the Secretary is committed to 
agency discretion. 
‘‘(E) 
RULE
OF
CONSTRUCTION.—Rec-
ommendations and approvals under this para-
graph apply solely to determinations that the 
special reserve fund under paragraph (10) will 
be made available for a procurement of a secu-
rity countermeasure, and not to the substance 
of contracts for such procurement or other mat-
ters relating to awards of such contracts. 
‘‘(7) PROCUREMENT.—
‘‘(A) IN
GENERAL.—For purposes of a 
procurement under this subsection that is ap-
proved by the President under paragraph (6), 
the Homeland Security Secretary and the Sec-
retary shall have responsibilities in accordance 
with subparagraphs (B) and (C). 
‘‘(B) INTERAGENCY AGREEMENTS.—
‘‘(i) 
FOR
PROCUREMENT.—The 
Homeland Security Secretary shall enter 
into an agreement with the Secretary for 
procurement of a security countermeasure
in accordance with the provisions of this 
paragraph. The special reserve fund under 
paragraph (10) shall be available for the 
Secretary’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 
subsection. 
‘‘(C) PROCUREMENT.—
‘‘(i) IN
GENERAL.—The Secretary 
shall be responsible for—
‘‘(I) arranging for procurement 
of a security countermeasure, includ-
ing negotiating terms (including quan-
tity, production schedule, and price) 
of, and entering into, contracts and 
cooperative agreements, and for car-
rying out such other activities as may 
reasonably be required, in accordance
with the provisions of this subpara-
graph; 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 following terms: 
‘‘(I) PAYMENT CONDITIONED ON 
SUBSTANTIAL
DELIVERY.—The con-
tract shall provide that no payment 
may be made until delivery has been 
made of a substantial portion (as de-
termined 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 de-
termines (in the Secretary’s discre-
tion) that an advance payment is nec-
essary to ensure success of a project, 
the Secretary may pay an amount, not 
to exceed 10 percent of the contract
amount, in advance of delivery. The 
contract shall provide that such ad-
vance payment is required to be re-
paid 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 exceed five years, except that, in 
first awarding the contract, the Sec-
retary may provide for a longer dura-
tion, not exceeding eight years, if the 
Secretary determines that complexities 
or other difficulties in performance 
under the contract justify such a pe-
riod. The contract shall be renewable
for additional periods, none of which 
shall exceed five years. 
‘‘(III) STORAGE
BY
VENDOR.—
The contract may provide that the 
vendor will provide storage for stocks 
of a product delivered to the owner-
ship of the Federal Government under
the contract, 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 ship-
ping, handling, storage, and related 
costs for such product. 
‘‘(iii) AVAILABILITY
OF
SIMPLIFIED 
ACQUISITION PROCEDURES.—
‘‘(I) IN GENERAL.—The amount 
of any procurement under this sub-
section shall be deemed to be below 
the threshold amount specified in sec-
tion 4(11) of the Office of Federal 
Procurement Policy Act (41 U.S.C. 
403(11)), for purposes of application 
to such procurement, pursuant to sec-
tion 302A(a) of the Federal Property 
and Administrative Services Act of 
1949 (41 U.S.C. 252a(a)), of—
‘‘(aa) section 303(g)(1)(A) 
of the Federal Property and Ad-
ministrative Services Act of 1949
(41 U.S.C. 253(g)(1)(A)) and its 
implementing 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 provi-
sions shall apply to procurements de-
scribed in this clause to the same ex-
tent that such provisions would apply 
to such procurements 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-Kick-
back 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) USE OF NONCOMPETITIVE PRO-
CEDURES.—In addition to any other au-
thority to use procedures other than com-
petitive procedures, the Secretary may use 
such other procedures for a procurement 
under this subsection if the product is 
available from only one responsible source 
or only from a limited number of respon-
sible sources, and no other type of product 
will satisfy the Secretary’s needs. 
‘‘(v) PREMIUM
PROVISION
IN
MUL-
TIPLE 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, wheth-
er by percentage or by numbers 
of units; and 
‘‘(bb) promises to pay one or 
more specified premiums based 
on the priority of such vendors’ 
production and delivery of the in-
crement identified under item 
(aa), in accordance with the 
terms and conditions of the con-
tract. 
‘‘(II) DETERMINATION
OF
GOV-
ERNMENT’S
REQUIREMENT
NOT
RE-
VIEWABLE.—If the Secretary includes 
in each of a set of contracts a provi-
sion as described in subclause (I), 
such Secretary’s determination of the 
total quantity of security counter-
measure required, and any amend-
ment of such determination, is com-
mitted 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 pro-
posals for a procurement under this sub-
section is committed to agency discretion. 
‘‘(vii) LIMITING
COMPETITION
TO 
SOURCES RESPONDING TO REQUEST FOR 
INFORMATION.—In conducting a procure-
ment under this subsection, the Secretary 
may exclude a source that has not re-
sponded 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 exclude 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, 
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 un-
dertaking under this paragraph shall not au-
thorize another agency to exercise the authori-
ties provided 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 para-
graph (10) shall not be used to pay—
‘‘(A) costs for the purchase of vaccines 
under procurement contracts entered into be-
fore the date of the enactment of the Project 
BioShield 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 Homeland Security Act of 2002. 
‘‘(d) DISCLOSURES.—No Federal agency shall dis-
close under section 552, United States Code, any informa-
tion 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 
locations) of the supplies described in subsection (a); 
or 
‘‘(2) a contractual agreement between the 
Homeland Security Secretary and a vendor or ven-
dors under which such vendor or vendors agree to 
provide to such Secretary supplies described in sub-
section (a). 
‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—
‘‘(1) STRATEGIC
NATIONAL
STOCKPILE.—For 
the purpose of carrying out subsection (a), there are 
authorized to be appropriated $640,000,000 for fis-
cal year 2002, and such sums as may be necessary 
for each of fiscal years 2003 through 2006. Such 
authorization is in addition to amounts in the special 
reserve 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 fis-
cal 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 add-
ing at the end the following: 
‘‘SEC. 
510. 
PROCUREMENT 
OF 
SECURITY 
COUNTER-
MEASURES 
FOR 
STRATEGIC 
NATIONAL 
STOCKPILE. 
‘‘(a) AUTHORIZATION
OF
APPROPRIATIONS.—For 
procurement 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 appropriated under the preceding sen-
tence, not to exceed $3,418,000,000 may be obligated dur-
ing 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 re-
serve fund’ means the appropriations account established 
as a result 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 unob-
ligated for such purposes on the expiration of such 
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