I 
117TH CONGRESS 
1ST SESSION H. R. 3705 
To amend the Federal Food, Drug, and Cosmetic Act to include a safe 
harbor for communication of information with respect to a vaccine au-
thorized for emergency use under such Act that is provided or distributed 
to a health care provider, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 4, 2021 
Mr. GRIFFITH introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
include a safe harbor for communication of information 
with respect to a vaccine authorized for emergency use 
under such Act that is provided or distributed to a 
health care provider, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SAFE HARBOR FOR COMMUNICATIONS ABOUT 
VACCINES AUTHORIZED FOR EMERGENCY 
USE. 
(a) IN GENERAL.—The Federal Food, Drug, and 
Cosmetic Act is amended by inserting after section 502 
(21 U.S.C. 352) the following: 
‘‘SEC. 502A. SAFE HARBOR FOR COMMUNICATIONS ABOUT 
VACCINES AUTHORIZED FOR EMERGENCY 
USE. 
‘‘(a) IN GENERAL.—The communication of informa-
tion (through written or oral means), described in sub-
section (b), with respect to the use of a vaccine authorized 
for emergency use under section 564 provided or distrib-
uted to a covered health care entity shall not be a basis 
for treating such vaccine as, or be treated as evidence that 
such vaccine is— 
‘‘(1) misbranded under subsection (a) or (f) of 
section 502; or 
‘‘(2) in violation of section 505 or 564 of this 
Act or subsection (a) or (k) of section 351(a)(1) of 
the Public Health Service Act, as applicable. 
‘‘(b) INFORMATION DESCRIBED.—Information de-
scribed in this subsection is any information relating to 
a use of a vaccine authorized for emergency use under sec-
tion 564 within the scope of that authorization that— 
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‘‘(1) is neither false nor misleading, when meas-
ured objectively against the information available at 
the time the statement is made; 
‘‘(2) is accompanied, as required, by an appro-
priate disclaimer, including— 
‘‘(A) a statement identifying any dif-
ferences between the information and any au-
thorized labeling of the vaccine; 
‘‘(B) a statement identifying contradictory 
evidence; and 
‘‘(C) such other information as may be re-
quired by regulation; and 
‘‘(3) is based on competent and reliable sci-
entific evidence, as described in subsection (e). 
‘‘(c) COVERAGE NOT EXCLUDED.—The distribution 
of information that otherwise meets the requirements of 
this section shall not fail to meet the requirements of sub-
section (a) because the manufacturer or distributor of the 
vaccine about which information is being distributed has— 
‘‘(1) knowledge that such vaccine is being used 
by patients or health care practitioners in a manner 
not described in any authorized labeling of the vac-
cine, as applicable; or 
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