IB 
Union Calendar No. 26 
116TH CONGRESS 
1ST SESSION H. R. 1520 
[Report No. 116–48] 
To amend the Public Health Service Act to provide for the publication 
of a list of licensed biological products, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 5, 2019 
Ms. ESHOO introduced the following bill; which was referred to the Committee 
on Energy and Commerce 
MAY 3, 2019 
Additional sponsors: Mrs. CRAIG, Mrs. DINGELL, Mr. RUIZ, Mr. RUSH, Mr. 
PALLONE, Mr. KENNEDY, Mr. BURGESS, Ms. MATSUI, Ms. CLARKE of 
New York, Mr. VAN DREW, Mr. WALDEN, and Ms. MUCARSEL-POWELL 
MAY 3, 2019 
Reported with an amendment, committed to the Committee of the Whole 
House on the State of the Union, and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on March 5, 2019] 
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A BILL 
To amend the Public Health Service Act to provide for 
the publication of a list of licensed biological products, 
and for other purposes. 
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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 ‘‘Purple Book Continuity 
Act of 2019’’. 
SEC. 2. PUBLIC LISTING. 
Section 351(k) of the Public Health Service Act (42 
U.S.C. 262(k)) is amended by adding at the end the fol-
lowing: 
‘‘(9) PUBLIC LISTING.— 
‘‘(A) IN GENERAL.— 
‘‘(i) INITIAL PUBLICATION.—Not later 
than 180 days after the date of enactment 
of the Purple Book Continuity Act of 2019, 
the Secretary shall publish and make avail-
able to the public in a searchable, electronic 
format— 
‘‘(I) a list in alphabetical order of 
the nonproprietary or proper name of 
each biological product for which a bio-
logics license under subsection (a) or 
this subsection is in effect, or that has 
been deemed to be licensed under this 
section pursuant to section 7002(e)(4) 
of the Biologics Price Competition and 
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Innovation Act of 2009, as of such date 
of enactment; 
‘‘(II) the date of approval of the 
marketing application and the appli-
cation number; and 
‘‘(III) the marketing or licensure 
status of the biological product for 
which a biologics license under sub-
section (a) or this subsection is in ef-
fect or that has been deemed to be li-
censed under this section pursuant to 
section 7002(e)(4) of the Biologics 
Price Competition and Innovation Act 
of 2009. 
‘‘(ii) REVISIONS.—Every 30 days after 
the publication of the first list under clause 
(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. 
‘‘(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 
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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 
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 
that is applicable and has not concluded 
under paragraph (6) or paragraph (7). 
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SEC. 3. 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 section 2; 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. 
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Union Calendar No. 26 
116TH CONGRESS 
1ST SESSION 
H. R. 1520 
[Report No. 116–48] 
A BILL 
To amend the Public Health Service Act to provide 
for the publication of a list of licensed biological 
products, and for other purposes. 
MAY 3, 2019 
Reported with an amendment, committed to the Com-
mittee of the Whole House on the State of the Union, 
and ordered to be printed 
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