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‘‘(E) 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
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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—
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‘‘(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;
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‘‘(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.
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‘‘(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.—
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‘‘(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
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‘‘(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
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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.
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‘‘(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.