SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Purple Book Con-
tinuity 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 available to the public in a search-
able, electronic format— 
‘‘(I) a list in alphabetical order of 
the nonproprietary or proper name of 
each biological product for which a 
biologics 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 Innovation Act of 
2009, as of such date of enactment;
‘‘(II) the date of approval of the 
marketing application and the applica-
tion 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 
days 
after the publication of the first list under 
clause (i), the Secretary shall revise the list 
to include each biological product which 
has been licensed under subsection (a) or 
this subsection 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 supple-
ment to such list under subsection (l)(7), 
has been provided by the reference product 
sponsor to the subsection (k) applicant re-
specting a biological product included on
the list published under this subparagraph, 
the reference product sponsor shall provide 
such list of patents (or supplement there-
to) and their corresponding expiry dates to 
the Secretary, and the Secretary shall, in 
revisions made under clause (ii), include 
such information for such biological prod-
uct. Within 30 days of providing any sub-
sequent or supplemental list of patents to 
any subsequent subsection (k) applicant 
under subsection (l)(3)(A) or (l)(7), the 
reference product sponsor shall update the 
information provided to the Secretary 
under this clause with any additional pat-
ents 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 
Secretary shall specify each exclusivity pe-
riod that is applicable and has not con-
cluded under paragraph (6) or paragraph 
(7). 
‘‘(B) WITHDRAWAL OR SUSPENSION OF LI-
CENSURE.—If the licensing of a biological prod-
uct was withdrawn or suspended for safety, pu-
rity, or potency reasons, it may not be pub-
lished in the list under subparagraph (A). If the 
withdrawal or suspension occurred after its 
publication in such list, the reference product 
sponsor shall notify the Secretary that— 
‘‘(i) the biological product shall be im-
mediately removed from such list— 
‘‘(I) for the same period as the 
withdrawal or suspension; or 
‘‘(II) if the biological product has 
been withdrawn from sale, for the pe-
riod of withdrawal from sale or, if ear-
lier, the period ending on the date the 
Secretary determines that the with-
drawal from sale is not for safety, pu-
rity, or potency reasons; and 
‘‘(ii) a notice of the removal shall be 
published in the Federal Register.’’. 
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 
section 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. 
Passed the House of Representatives May 8, 2019. 
Attest: 
Clerk.
116TH CONGRESS 
1ST SESSION 
H. R. 1520 
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.