authorize distributors of the product or any 
other person to alter or obscure the labeling 
provided by the manufacturer. 
‘‘(ii) In the circumstances described in 
clause (i), an authorization under this section 
regarding the emergency use may, for persons 
who do not manufacture the product and who 
choose to act under this clause, authorize such 
persons to provide information on the product 
in addition to the labeling provided by the man-
ufacturer, subject to compliance with clause (i). 
Such additional information shall not be consid-
ered labeling for purposes of section 502. 
‘‘(f) DURATION OF AUTHORIZATION.—
‘‘(1) IN GENERAL.—Except as provided in para-
graph (2), an authorization under this section shall 
be effective until the earlier of the termination of the 
declaration under subsection (b) or a revocation 
under subsection (g). 
‘‘(2) CONTINUED USE AFTER END OF EFFEC-
TIVE PERIOD.—An authorization shall continue to be 
effective for continued use with respect to patients 
to whom it was administered during the period de-
scribed by paragraph (1), to the extent found nec-
essary by such patients’ attending physicians.
‘‘(g) REVOCATION OF AUTHORIZATION.—
‘‘(1) REVIEW.—The Secretary shall periodically 
review the circumstances and the appropriateness of 
an authorization under this section. 
‘‘(2) REVOCATION.—The Secretary may revoke 
an authorization under this section if, in the Sec-
retary’s unreviewable discretion, the criteria under 
subsection (c) for issuance of such authorization are 
no longer met. 
‘‘(h) PUBLICATION.—The Secretary shall promptly 
publish in the Federal Register a notice of each authoriza-
tion, and each termination or revocation of an authoriza-
tion, and an explanation of the reasons therefor, under 
this section. 
‘‘(i) ACTIONS COMMITTED
TO AGENCY DISCRE-
TION.—Actions under the authority of this section by the 
Secretary, by the Secretary of Defense, or by the Sec-
retary of Homeland Security are committed to agency dis-
cretion. 
‘‘(j) RULES OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to impair or otherwise affect—
‘‘(1) the authority of the President as Com-
mander in Chief of the Armed Forces of the United 
States under article II, section 2 of the United 
States Constitution;
‘‘(2) the authority of the Secretary of Defense 
with respect to the Department of Defense, includ-
ing the armed forces, under other provisions of Fed-
eral law; or 
‘‘(3) the authority of the Secretary under sec-
tion 319F–2 to manage the stockpile under such 
section. 
‘‘(k) 
APPLICATION
TO
MEMBERS
OF
ARMED 
FORCES.—
‘‘(1) WAIVER OF REQUIREMENT RELATING TO 
OPTION TO REFUSE.—In the case of administration 
of a countermeasure to members of the armed 
forces, 
a 
requirement, 
under 
subsection 
(e)(1)(A)(ii)(III), designed to ensure that individuals 
are informed of an option to accept or refuse admin-
istration of a product, may be waived by the Presi-
dent if the President determines, in writing, that 
complying with such requirement is not feasible, is 
contrary to the best interests of the members af-
fected, or is not in the interests of national security. 
‘‘(2) PROVISION OF INFORMATION TO MEMBER 
OF THE ARMED FORCES.—If the Secretary makes a 
determination that it is not feasible for the informa-
tion required by subsection (e)(1)(A)(ii) to be pro-
vided to a member of the armed forces prior to the
administration of the product, such information shall 
be provided to such member of the armed forces (or 
next-of-kin in the case of the death of a member) to 
whom the product was administered as soon as pos-
sible, but not later than 30 days, after such adminis-
tration. Information concerning the administration 
of the product shall be recorded in the medical 
record of the member. 
‘‘(3) EFFECT ON STATUTE PERTAINING TO IN-
VESTIGATIONAL NEW DRUGS.—In the case of an au-
thorization based on a determination by the Sec-
retary of Defense under subsection (b)(1)(B), sec-
tion 1107 of title 10, United States Code, shall not 
apply to use of a product that is the subject of such 
authorization, within the scope of such authorization 
and while such authorization is effective. 
‘‘(l) RELATION TO OTHER PROVISIONS.—If a prod-
uct is the subject of an authorization under this section, 
the use of such product within the scope of the authoriza-
tion —
‘‘(1) shall not be subject to any requirements 
pursuant to section 505(i) or 520(g); and 
‘‘(2) shall not be subject to any requirements 
otherwise applicable to clinical investigations pursu-
ant to other provisions of this Act.
‘‘(m) DISCRETION REGARDING USE OF AUTHORIZA-
TION.—Nothing in this section provides the Secretary any 
authority to require any person to carry out any activity 
that becomes lawful pursuant to an authorization under 
this section, and no person is required to inform the Sec-
retary that the person will not be carrying out such activ-
ity, except that a manufacturer of a sole-source unap-
proved product authorized for emergency use shall notify 
the Secretary within a reasonable period of time after the 
issuance by the Secretary of such authorization if such 
manufacturer does not intend to carry out an activity or 
activities under the authorization. This section does not 
have any legal effect on a person who does not carry out 
any activity for which an authorization under this section 
is issued, or who carries out such an activity pursuant to 
other provisions of this Act or section 351 of the Public 
Health Service Act. 
‘‘(n) ENFORCEMENT.—A person who carries out an 
activity pursuant to an authorization under this section, 
but who fails to comply with applicable conditions under 
subsection (e), is with respect to that act of noncompliance 
subject to the provisions of law specified in subsection (a) 
and to the enforcement of such provisions under section 
301.’’.
SEC. 5. REPORTS REGARDING AUTHORITIES UNDER THIS 
ACT. 
(a) SECRETARY
OF HEALTH
AND HUMAN SERV-
ICES.—
(1) ANNUAL REPORTS ON PARTICULAR EXER-
CISES OF AUTHORITY.—
(A) RELEVANT
AUTHORITIES.—The Sec-
retary of Health and Human Services (referred 
to in this subsection as the ‘‘Secretary’’) shall 
submit reports in accordance with subpara-
graph (B) regarding the exercise of authority 
under the following provisions of law: 
(i) With respect to section 319F–1 of 
the Public Health Service Act (as added by 
section 2 of this Act): 
(I) Subsection (b)(1) (relating to 
increased 
simplified 
acquisition 
threshold). 
(II) Subsection (b)(2) (relating to 
use of noncompetitive procedures). 
(III) Subsection (c) (relating to 
expedited peer review procedures). 
(ii) With respect to section 319F–2 of 
the Public Health Service Act (as added by 
section 3 of this Act):
(I) Subsection (c)(7)(C)(iii) (re-
lating to simplified acquisition proce-
dures). 
(II) Subsection (c)(7)(C)(iv) (re-
lating to use of noncompetitive proce-
dures). 
(III) Subsection (c)(7)(C)(v) (re-
lating to premium provision in mul-
tiple-award contracts). 
(iii) With respect to section 564 of the 
Federal Food, Drug, and Cosmetic Act (as 
added by section 4 of this Act): 
(I) Subsection (a)(1) (relating to 
emergency uses of certain drugs and 
devices). 
(II) Subsection (b)(1) (relating to 
a declaration of an emergency). 
(III) Subsection (e) (relating to 
conditions on authorization). 
(B) CONTENTS
OF
REPORTS.—The Sec-
retary shall annually submit to the Congress a 
report that summarizes—
(i) the particular actions that were 
taken under the authorities specified in 
subparagraph (A), including, as applicable,