166
‘‘(1) 
EMERGENCY
USES.—Notwith-
standing sections 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 (re-
ferred to in this section as an ‘emergency 
use’). 
‘‘(2) APPROVAL
STATUS
OF
PRODUCT.—
An authorization 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 provi-
167
sion 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 para-
graph (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 prod-
uct’ has the meaning indicated for 
such term in paragraph (2)(A). 
‘‘(D) The term ‘unapproved use of 
an approved product’ has the mean-
ing indicated for such term in para-
graph (2)(B). 
‘‘(b) DECLARATION OF EMERGENCY.—
168
‘‘(1) IN GENERAL.—The Secretary may 
declare an emergency justifying the au-
thorization under this subsection for a 
product on the basis of—
‘‘(A) a determination by the Sec-
retary of Homeland Security that 
there is a national emergency, or a 
significant potential for a national 
emergency, involving a heightened 
risk of attack with a specified biologi-
cal, chemical, radiological, or nuclear 
agent or agents; 
‘‘(B) a determination by the Sec-
retary of Defense that there is a mili-
tary emergency, or a significant po-
tential for a military emergency, in-
volving 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 Sec-
retary of a public health emergency 
under section 319 of the Public 
Health Service Act, affecting national 
security and involving a specified bio-
169
logical, chemical, radiological, or nu-
clear 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 ap-
propriate with the Secretary of 
Homeland Security or the Sec-
retary of Defense, that the cir-
cumstances described in para-
graph (1) have ceased to exist; or 
‘‘(ii) the expiration of the one-
year period beginning on the date 
on which the declaration is made. 
‘‘(B) 
RENEWAL.—Notwithstanding 
subparagraph (A), the Secretary may 
renew a declaration under this sub-
section, and this paragraph shall 
apply to any such renewal. 
‘‘(3) 
ADVANCE
NOTICE
OF
TERMI-
NATION.—In terminating a declaration
170
under this section, the Secretary shall 
provide advance notice that the declara-
tion will be terminated. The period of ad-
vance notice shall be a period reasonably 
determined to provide—
‘‘(A) in the case of an unapproved 
product, a sufficient period for dis-
position of shipments of the product, 
including the return of such ship-
ments to the manufacturer (in the 
case of a manufacturer that chooses 
to have the shipments returned); and 
‘‘(B) in the case of unapproved 
uses of approved products, a suffi-
cient period for the disposition of any 
labeling that was provided with re-
spect to the emergency use involved. 
‘‘(4) 
PUBLICATION.—The 
Secretary 
shall promptly publish in the Federal 
Register each declaration, determination, 
and renewal under this subsection. 
‘‘(c) CRITERIA FOR ISSUANCE OF AUTHORIZA-
TION.—The Secretary may issue an authoriza-
tion under this section with respect to the 
emergency use of a product only if, after con-
171
sultation with the Director of the National In-
stitutes of Health and the Director of the Cen-
ters for Disease Control and Prevention, to 
the extent feasible and appropriate given the 
circumstances of the emergency involved, the 
Secretary concludes—
‘‘(1) that an agent specified in a dec-
laration under subsection (b) can cause a 
serious or life-threatening disease or con-
dition; 
‘‘(2) that, based on the totality of sci-
entific evidence available to the Sec-
retary, including data from adequate and 
well-controlled clinical trials, if available, 
it is reasonable to believe that—
‘‘(A) the product may be effective 
in detecting, diagnosing, treating, or 
preventing—
‘‘(i) such disease or condition; 
or 
‘‘(ii) a serious or life-threat-
ening disease or condition caused 
by a product authorized under 
this section or approved under 
this Act or the Public Health
172
Service Act, for detecting, diag-
nosing, treating, or preventing 
such 
a 
disease 
or 
condition 
caused by such an agent; and 
‘‘(B) the known and potential ben-
efits of the product, when used to de-
tect, diagnose, prevent, or treat such 
disease or condition, outweigh the 
known and potential risks of the 
product; 
‘‘(3) that there is no adequate, ap-
proved, and available alternative to the 
product for detecting, diagnosing, pre-
venting, 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 product under this section shall state—
‘‘(A) each disease or condition 
that the product may be used to de-
tect, diagnose, prevent, or treat with-
in the scope of the authorization;
173
‘‘(B) the Secretary’s conclusions, 
made under subsection (c)(2)(B), that 
the known and potential benefits of 
the product, when used to detect, di-
agnose, 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), 
con-
cerning the safety and potential effec-
tiveness of the product in detecting, 
diagnosing, preventing, or treating 
such diseases or conditions, including 
an assessment of the available sci-
entific 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 
respect to the emergency use of an
174
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 section as the Secretary finds 
necessary or appropriate to protect 
the public health, including the fol-
lowing: 
‘‘(i) 
Appropriate 
conditions 
designed to ensure that, to the ex-
tent 
feasible 
given 
the 
cir-
cumstances 
of 
the 
emergency, 
health care professionals admin-
istering 
the 
product 
are 
in-
formed—
‘‘(I) that the Secretary has 
authorized 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
175
extent to which such benefits 
and risks are unknown; and 
‘‘(III) of the alternatives to 
the product that are avail-
able, and of their benefits and 
risks. 
‘‘(ii) Appropriate conditions 
designed to ensure that, to the ex-
tent 
feasible 
given 
the 
cir-
cumstances of the emergency, in-
dividuals to whom the product is 
administered are informed—
‘‘(I) that the Secretary has 
authorized 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 ben-
efits and risks are unknown; 
and 
‘‘(III) of the option to ac-
cept or refuse administration 
of the product, of the con-
sequences, if any, of refusing
176
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 
product, appropriate conditions 
concerning recordkeeping and re-
porting, including records access 
by the Secretary, with respect to 
the emergency use of the product. 
‘‘(B) AUTHORITY
FOR
ADDITIONAL 
CONDITIONS.—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 ac-
tivities for which the authorization is 
issued, establish such conditions on 
an authorization under this section
177
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 respect to the emer-
gency use of the product (includ-
ing limitation to distribution by 
government entities), and on how 
distribution is to be performed. 
‘‘(ii) Appropriate conditions 
on who may administer the prod-
uct 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 
manufacturers of the product, ap-
propriate conditions concerning 
recordkeeping and reporting, in-
cluding records access by the Sec-
178
retary, with respect to the emer-
gency use of the product. 
‘‘(iv) With respect to the emer-
gency use of the product, waive 
or limit, to the extent appropriate 
given the circumstances of the 
emergency, conditions regarding 
current good manufacturing prac-
tice otherwise applicable to the 
manufacture, processing, packing, 
or holding of products subject to 
regulation under this Act, includ-
ing 
such 
requirements 
estab-
lished in section 501. 
‘‘(2) UNAPPROVED
USE.—With respect 
to the emergency use of a product that is 
an unapproved use of an approved prod-
uct: 
‘‘(A) The Secretary may, for manu-
facturers of the product who choose 
to carry out one or more activities for 
which the authorization is issued, es-
tablish any of the conditions de-
scribed in clauses (i) through (iv) of 
paragraph (1)(A).
179
‘‘(B)(i) If the authorization under 
this section regarding the emergency 
use authorizes a change in the label-
ing of the product, but the manufac-
turer of the product chooses not to 
make such change, such authoriza-
tion 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 de-
scribed 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 in-
formation on the product in addition 
to the labeling provided by the manu-
facturer, subject to compliance with 
clause (i). Such additional informa-
tion shall not be considered labeling 
for purposes of section 502. 
‘‘(f) DURATION OF AUTHORIZATION.—
180
‘‘(1) IN GENERAL.—Except as provided 
in paragraph (2), an authorization under 
this section shall be effective until the 
earlier of the termination of the declara-
tion under subsection (b) or a revocation 
under subsection (g). 
‘‘(2) CONTINUED USE AFTER END OF EF-
FECTIVE
PERIOD.—An authorization shall 
continue to be effective for continued use 
with respect to patients to whom it was 
administered during the period described 
by paragraph (1), to the extent found nec-
essary by such patients’ attending physi-
cians. 
‘‘(g) REVOCATION OF AUTHORIZATION.—
‘‘(1) REVIEW.—The Secretary shall pe-
riodically review the circumstances and 
the appropriateness of an authorization 
under this section. 
‘‘(2) REVOCATION.—The Secretary may 
revoke an authorization under this sec-
tion if, in the Secretary’s unreviewable 
discretion, the criteria under subsection 
(c) for issuance of such authorization are 
no longer met.
181
‘‘(h) PUBLICATION.—The Secretary shall 
promptly publish in the Federal Register a 
notice of each authorization, and each termi-
nation or revocation of an authorization, and 
an explanation of the reasons therefor, under 
this section. 
‘‘(i) ACTIONS COMMITTED
TO AGENCY DIS-
CRETION.—Actions under the authority of this 
section by the Secretary, by the Secretary of 
Defense, or by the Secretary of Homeland Se-
curity are committed to agency discretion. 
‘‘(j) RULES OF CONSTRUCTION.—Nothing in 
this section shall be construed to impair or 
otherwise affect—
‘‘(1) the authority of the President as 
Commander in Chief of the Armed Forces 
of the United States under article II, sec-
tion 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.
182
‘‘(k) APPLICATION TO MEMBERS OF ARMED 
FORCES.—
‘‘(1) WAIVER OF REQUIREMENT RELATING 
TO OPTION TO REFUSE.—In the case of ad-
ministration of a countermeasure to 
members of the armed forces, a require-
ment, under subsection (e)(1)(A)(ii)(III), 
designed to ensure that individuals are 
informed of an option to accept or refuse 
administration of a product, may be 
waived by the President if the President 
determines, in writing, that complying 
with such requirement is not feasible, is 
contrary to the best interests of the mem-
bers 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 determination 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 administration of the 
product, such information shall be pro-
vided to such member of the armed
183
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 admin-
istration. Information concerning the ad-
ministration of the product shall be re-
corded in the medical record of the mem-
ber. 
‘‘(3) EFFECT ON STATUTE PERTAINING TO 
INVESTIGATIONAL NEW DRUGS.—In the case 
of an authorization based on a deter-
mination by the Secretary of Defense 
under subsection (b)(1)(B), section 1107 of 
title 10, United States Code, shall not 
apply to use of a product that is the sub-
ject 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 re-
quirements pursuant to section 505(i) or 
520(g); and
184
‘‘(2) shall not be subject to any re-
quirements otherwise applicable to clin-
ical investigations pursuant to other pro-
visions of this Act. 
‘‘(m) DISCRETION REGARDING USE
OF AU-
THORIZATION.—Nothing in this section pro-
vides the Secretary any authority to require 
any person to carry out any activity that be-
comes lawful pursuant to an authorization 
under this section, and no person is required 
to inform the Secretary that the person will 
not be carrying out such activity, except that 
a manufacturer of a sole-source unapproved 
product authorized for emergency use shall 
notify the Secretary within a reasonable pe-
riod of time after the issuance by the Sec-
retary of such authorization if such manufac-
turer 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.
185
‘‘(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 noncompli-
ance 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 
SERVICES.—
(1) ANNUAL
REPORTS
ON
PARTICULAR 
EXERCISES OF AUTHORITY.—
(A) RELEVANT
AUTHORITIES.—The 
Secretary of Health and Human Serv-
ices (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 Serv-
ice Act (as added by section 2 of 
this Act):
186
(I) Subsection (b)(1) (relat-
ing to increased simplified ac-
quisition threshold). 
(II) Subsection (b)(2) (re-
lating to use of noncompeti-
tive procedures). 
(III) Subsection (c) (relat-
ing to expedited peer review 
procedures). 
(ii) With respect to section 
319F–2 of the Public Health Serv-
ice Act (as added by section 3 of 
this Act): 
(I) Subsection (c)(7)(C)(iii) 
(relating to simplified acquisi-
tion procedures). 
(II) 
Subsection 
(c)(7)(C)(iv) (relating to use of 
noncompetitive procedures). 
(III) 
Subsection 
(c)(7)(C)(v) (relating to pre-
mium provision in multiple-
award contracts). 
(iii) With respect to section 
564 of the Federal Food, Drug,
187
and Cosmetic Act (as added by 
section 4 of this Act): 
(I) Subsection (a)(1) (relat-
ing to emergency uses of cer-
tain drugs and devices). 
(II) Subsection (b)(1) (re-
lating to a declaration of an 
emergency). 
(III) Subsection (e) (relat-
ing to conditions on author-
ization). 
(B) CONTENTS
OF
REPORTS.—The 
Secretary shall annually submit to 
the designated congressional commit-
tees (as defined in subsection (e)) a 
report that summarizes—
(i) the particular actions that 
were taken under the authorities 
specified in subparagraph (A), in-
cluding, as applicable, the identi-
fication of the threat agent, emer-
gency, or the biomedical counter-
measure with respect to which 
the authority was used;
188
(ii) the reasons underlying the 
decision to use such authorities, 
including, as applicable, the op-
tions that were considered and 
rejected with respect to the use of 
such authorities; 
(iii) the identification of each 
person or entity that received, or 
was considered and rejected for, 
grants, cooperative agreements, 
or contracts pursuant to the use 
of such authorities; and 
(iv) whether, with respect to 
each procurement that is ap-
proved by the President under 
section 319F–2(c)(6) of the Public 
Health Service Act (as added by 
section 3 of this Act), a contract 
was not entered into within one 
year after such approval by the 
President. 
(2) ANNUAL SUMMARIES REGARDING CER-
TAIN ACTIVITY.—The Secretary shall annu-
ally submit to the designated congres-
sional committees a report that summa-
189
rizes 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 
increased micropurchase threshold). 
(B) Subsection (d) (relating to au-
thority for personal services con-
tracts). 
(C) Subsection (e) (relating to 
streamlined personnel authority). 
With respect to subparagraph (B), the re-
port shall include a provision specifying, 
for the one-year period for which the re-
port 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 RE-
VIEW.—
(1) IN GENERAL.—Not later than four 
years after the date of the enactment of 
this Act, the Secretary of Health and 
Human Services shall request the Na-
190
tional Academy of Sciences to enter into 
an agreement for a review of the bio-
medical countermeasure research and de-
velopment authorities established in this 
Act to determine whether and to what ex-
tent activities undertaken pursuant to 
such authorities have enhanced the de-
velopment 
of 
biomedical 
counter-
measures affecting national security, and 
to recommend any legislative or adminis-
trative 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 designated congres-
sional committees not later than five 
years after such date of enactment. 
(2) CERTAIN
CONTENTS.—The report 
under paragraph (1) shall include—
(A) a summary of the most recent 
analysis by the Department of Home-
land Security and the intelligence 
community of the domestic threat 
from 
chemical, 
biological, 
radio-
logical, and nuclear agents;
191
(B) the Academy’s assessment of 
the current availability of counter-
measures to address such threats; 
(C) the Academy’s assessment of 
the extent to which programs and ac-
tivities under this Act will reduce any 
gap between the threat and the avail-
ability of countermeasures to an ac-
ceptable level of risk; and 
(D)(i) the Academy’s assessment 
of threats to national security that 
are posed by technology that will en-
able, during the 10-year period begin-
ning on the date of the enactment of 
this Act, the development of anti-
biotic resistant, mutated, and bioengi-
neered strains of biological agents; 
and 
(ii) recommendations on short-
term 
and 
long-term 
governmental 
strategies 
for 
addressing 
such 
threats, including recommendations 
for Federal policies regarding re-
search priorities, the development of
192
countermeasures, and investments in 
technology. 
(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 granted under this Act 
with respect to simplified acquisition 
procedures, use of noncompetitive proce-
dures, increased micropurchase thresh-
olds, personal services contracts, stream-
lined personnel authority, and the pur-
chase of security countermeasures under 
the special reserve fund; and 
(B) to recommend any legislative or 
administrative changes necessary to im-
prove 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