In the Senate of the United States, 
December 10, 2020. 
Resolved, That the bill from the House of Representa-
tives (H.R. 1520) entitled ‘‘An Act to amend the Public 
Health Service Act to provide for the publication of a list of 
licensed biological products, and for other purposes.’’, do pass 
with the following 
AMENDMENT: 
Strike all after the enacting clause and insert the 
following: 
SECTION 1. SHORT TITLE. 
The Act may be cited as the ‘‘Purple Book Continuity 
Act of 2020’’. 
SEC. 2. BIOLOGICAL PRODUCT PATENT TRANSPARENCY. 
(a) IN GENERAL.—Section 351(k) of the Public Health 
Service Act (42 U.S.C. 262(k)) is amended by adding at 
the end the following: 
‘‘(9) PUBLIC LISTING.— 
‘‘(A) IN GENERAL.—
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‘‘(i) INITIAL PUBLICATION.—Not later 
than 180 days after the date of enactment 
of the Purple Book Continuity Act of 2020, 
the Secretary shall publish and make avail-
able to the public in a searchable, electronic 
format— 
‘‘(I) a list of each biological prod-
uct, by nonproprietary name (proper 
name), for which, as of such date of en-
actment, a biologics license under sub-
section (a) or this subsection is in ef-
fect, or that, as of such date of enact-
ment, is deemed to be licensed under 
this 
section 
pursuant 
to 
section 
7002(e)(4) of the Biologics Price Com-
petition and Innovation Act of 2009; 
‘‘(II) the date of licensure of the 
marketing application and the appli-
cation number; and 
‘‘(III) with respect to each biologi-
cal product described in subclause (I), 
the licensure status, and, as available, 
the marketing status. 
‘‘(ii) REVISIONS.—Every 30 days after 
the publication of the first list under clause
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(i), the Secretary shall revise the list to in-
clude each biological product which has been 
licensed under subsection (a) or this sub-
section during the 30-day period or deemed 
licensed under this section pursuant to sec-
tion 7002(e)(4) of the Biologics Price Com-
petition and Innovation Act of 2009. 
‘‘(iii) 
PATENT
INFORMATION.—Not 
later than 30 days after a list of patents 
under subsection (l)(3)(A), or a supplement 
to such list under subsection (l)(7), has been 
provided by the reference product sponsor to 
the subsection (k) applicant respecting a bi-
ological product included on the list pub-
lished under this subparagraph, the ref-
erence product sponsor shall provide such 
list of patents (or supplement thereto) and 
their corresponding expiry dates to the Sec-
retary, and the Secretary shall, in revisions 
made under clause (ii), include such infor-
mation for such biological product. Within 
30 days of providing any subsequent or 
supplemental list of patents to any subse-
quent subsection (k) applicant under sub-
section (l)(3)(A) or (l)(7), the reference
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product sponsor shall update the informa-
tion provided to the Secretary under this 
clause with any additional patents from 
such subsequent or supplemental list and 
their corresponding expiry dates. 
‘‘(iv) LISTING OF EXCLUSIVITIES.—For 
each biological product included on the list 
published under this subparagraph, the Sec-
retary shall specify each exclusivity period 
under paragraph (6) or paragraph (7) for 
which the Secretary has determined such bi-
ological product to be eligible and that has 
not concluded. 
‘‘(B) REVOCATION OR SUSPENSION OF LI-
CENSE.—If the license of a biological product is 
determined by the Secretary to have been revoked 
or suspended for safety, purity, or potency rea-
sons, it may not be published in the list under 
subparagraph (A). If such revocation or suspen-
sion occurred after inclusion of such biological 
product in the list published under subparagraph 
(A), the reference product sponsor shall notify the 
Secretary that— 
‘‘(i) the biological product shall be im-
mediately removed from such list for the
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same period as the revocation or suspension; 
and 
‘‘(ii) a notice of the removal shall be 
published in the Federal Register.’’. 
(b) REVIEW AND REPORT ON TYPES OF INFORMATION 
TO BE LISTED.—Not later than 3 years after the date of 
enactment of this Act, the Secretary of Health and Human 
Services shall— 
(1) solicit public comment regarding the type of 
information, if any, that should be added to or re-
moved from the list required by paragraph (9) of sec-
tion 351(k) of the Public Health Service Act (42 
U.S.C. 262(k)), as added by subsection (a); and 
(2) transmit to Congress an evaluation of such 
comments, including any recommendations about the 
types of information that should be added to or re-
moved from the list. 
Attest: 
Secretary.