[Congressional Record Volume 166, Number 218 (Monday, December 21, 2020)]
[House]
[Page H7300]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                   PURPLE BOOK CONTINUITY ACT OF 2019

  The SPEAKER pro tempore. Pursuant to the adoption of House Resolution 
1271, the Senate amendment to H.R. 1520 is considered as agreed to with 
an amendment consisting of the text of the Rules Committee Print 116-
69.
  Senate 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.--
       ``(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 available to the 
     public in a searchable, electronic format--

       ``(I) a list of each biological product, by nonproprietary 
     name (proper name), for which, as of such date of enactment, 
     a biologics license under subsection (a) or this subsection 
     is in effect, or that, as of such date of enactment, is 
     deemed to be licensed under this section pursuant to section 
     7002(e)(4) of the Biologics Price Competition and Innovation 
     Act of 2009;
       ``(II) the date of licensure of the marketing application 
     and the application number; and
       ``(III) with respect to each biological 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 (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 or deemed licensed under this section pursuant 
     to section 7002(e)(4) of the Biologics Price Competition 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 biological product included on the list 
     published under this subparagraph, the reference product 
     sponsor shall provide such list of patents (or supplement 
     thereto) and their corresponding expiry dates to the 
     Secretary, and the Secretary shall, in revisions made under 
     clause (ii), include such information for such biological 
     product. Within 30 days of providing any subsequent 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 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 Secretary shall specify each exclusivity 
     period under paragraph (6) or paragraph (7) for which the 
     Secretary has determined such biological product to be 
     eligible and that has not concluded.
       ``(B) Revocation or suspension of license.--If the license 
     of a biological product is determined by the Secretary to 
     have been revoked or suspended for safety, purity, or potency 
     reasons, it may not be published in the list under 
     subparagraph (A). If such revocation or suspension 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 immediately removed 
     from such list for the 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 removed 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 
     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 removed from the list.

  The text of the House amendment to the Senate amendment is as 
follows:

       In lieu of the matter proposed to be inserted by the 
     Senate, insert the following:
       That the Continuing Appropriations Act, 2021 (division A of 
     Public Law 116-159) is further amended by striking the date 
     specified in section 106(3) and inserting ``December 28, 
     2020''.
       This Act may be cited as the ``Further Extension of 
     Continuing Appropriations Act, 2021''.

     

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