I 
117TH CONGRESS 
1ST SESSION H. R. 4511 
To amend the Federal Food, Drug, and Cosmetic Act to authorize the 
use of emergency use authorization data and real world evidence gathered 
during an emergency to support premarket applications for drugs, biologi-
cal products, and devices, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 19, 2021 
Mr. BURGESS (for himself and Ms. CRAIG) 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 
authorize the use of emergency use authorization data 
and real world evidence gathered during an emergency 
to support premarket applications for drugs, biological 
products, and devices, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘FDA Advancing Col-
lection of Transformative Science Act’’ or the ‘‘FACTS 
Act’’. 
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SEC. 2. USING EMERGENCY USE AUTHORIZATION DATA 
AND REAL WORLD EVIDENCE GATHERED 
DURING AN EMERGENCY TO SUPPORT PRE-
MARKET APPLICATIONS FOR DRUGS, BIO-
LOGICAL PRODUCTS, AND DEVICES. 
Section 564(k) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360bbb–3(k)) is amended— 
(1) by striking ‘‘If a product’’ and inserting the 
following: 
‘‘(1) IN GENERAL.—If a product’’; and 
(2) by adding at the end the following: 
‘‘(2) DATA RELATING TO A DRUG, BIOLOGICAL 
PRODUCT, OR DEVICE GENERATED DURING EMER-
GENCY USE.—Emergency use-related data submitted 
by a sponsor in an application for, or submission re-
lating to, the approval, licensure, or clearance of a 
drug, biological product, or device may constitute 
valid scientific evidence or otherwise satisfy the 
standard of evidence for approval, licensure, or 
clearance of such drug, biological product, or device, 
and shall be considered for purposes of— 
‘‘(A) reviewing submissions and approving, 
licensing, or clearing such drug, biological prod-
uct, or device pursuant to, as applicable, sec-
tions 505, 510(k), 513(f), and 515 of this Act 
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and section 351 of the Public Health Service 
Act; and 
‘‘(B) otherwise meeting the requirements 
of this Act or section 351 of the Public Health 
Service Act. 
‘‘(3) APPLICABILITY OF CERTAIN CATEGORIZA-
TIONS
FOR
PREMARKET
DEVICE
REVIEW.—In the 
case of a device receiving an authorization under 
this section for which the Secretary has determined, 
in accordance with subsection (m), that a laboratory 
examination or procedure associated with such de-
vice is deemed to be in the category of examinations 
and procedures described in section 353(d)(3) of the 
Public Health Service Act, such determination shall 
apply with regard to a submission pursuant to sec-
tion 510(k), 513(f), or 515 for such device, unless 
the Secretary (taking into account any applicable 
conditions specified pursuant to subsection (m)(2) of 
this section) identifies new information not included 
in the request for authorization that indicates that 
the criteria under section 353(d)(3) of the Public 
Health Service Act are not met. 
‘‘(4) RULE
OF
CONSTRUCTION.—Nothing in 
this subsection shall be construed as altering the re-
view standards or otherwise affecting the require-
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ments under section 505, 510(k), 513(f), or 515 of 
this Act, or section 351 of the Public Health Service 
Act for the approval, licensure, or clearance of a 
drug, biological product, or device. 
‘‘(5) EMERGENCY
USE-RELATED
DATA
DE-
FINED.— 
‘‘(A) IN GENERAL.—In this subsection, the 
term ‘emergency use-related data’ means— 
‘‘(i) data that is used to support the 
issuance of an authorization under this 
section with respect to a drug, biological 
product, or device; 
‘‘(ii) data generated during the period 
under which such authorization is in effect, 
with respect to such drug, biological prod-
uct, or device; and 
‘‘(iii) real world evidence relating to 
such drug, biological product, or device 
used pursuant to such authorization. 
‘‘(B) EXCLUSION.—Such term does not in-
clude data previously reviewed and determined 
to be inadequate or insufficient to support such 
an authorization.’’. 
Æ 
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