Further Extension of Continuing Appropriations Act, 2021

Bill: 116-hr-1520
Sponsor: full_name: Rep. Eshoo, Anna G. [D-CA-18]
Introduced: 2019-03-05
Policy area: Economics and Public Finance
Subjects: Appropriations

Congressional oversight

Drug safety, medical device, and laboratory regulation

Executive agency funding and structure

Government information and archives

Health

Licensing and registrations
Latest action: action_date: 2020-12-22
text: Became Public Law No: 116-246.

Summaries:
action_date: 2019-03-05
action_desc: Introduced in House
text: <p><b>Purple Book Continuity Act of 2019</b></p> <p>This bill modifies requirements for the Food and Drug Administration to publish information regarding biological products.</p>

action_date: 2020-12-21
action_desc: Senate agreed to House amendment
text: <p><b>Further Extension of Continuing Appropriations Act, 2021</b></p> <p>This bill provides continuing FY2021 appropriations to federal agencies through December 28, 2020. It is known as a continuing resolution (CR) and prevents a government shutdown that would otherwise occur if the FY2021 appropriations bills have not been enacted when the existing CR expires on December 21, 2020.</p>

action_date: 2020-12-22
action_desc: Public Law
text: <p><b>Further Extension of Continuing Appropriations Act, 2021</b></p> <p>This bill provides continuing FY2021 appropriations to federal agencies through December 28, 2020. It is known as a continuing resolution (CR) and prevents a government shutdown that would otherwise occur if the FY2021 appropriations bills have not been enacted when the existing CR expires on December 21, 2020.</p>

tv_txt: I 116th CONGRESS 1st Session H. R. 1520 IN THE HOUSE OF REPRESENTATIVES March 5, 2019 Ms. Eshoo introduced the following bill; which was referred to the Committee on Energy and Commerce 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.

1. Short title This Act may be cited as the Purple Book Continuity Act of 2019 . 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 following: (9) Public listing (A) In general (i) Initial publication Not later than 60 days after the date of enactment of the Purple Book Continuity Act of 2019 , the Secretary shall publish and make available to the public electronically— (I) a list in alphabetical order of the official and proprietary name of each biological product for which a biologics license under subsection (a) or this subsection is in effect as of such date of enactment; (II) the date of licensing if the biological product is licensed after 1981 and the number of the application which was approved; and (III) whether in vitro or in vivo bioequivalence studies, or both such studies, are required for applications filed under this subsection which will refer to the biological product published. (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. (iii) Patent information When patent information 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 Secretary shall, in revisions made under clause (ii), include such information for such biological product. (B) Date of publication A biological product for which a license is in effect under subsection (a) or this subsection shall, for purposes of this subsection, be considered to have been published under subparagraph (A) on the later of— (i) the date of its licensing; or (ii) the date of its publication in the list that— (I) was published under this section before the initial publication of the list under subparagraph (A); and (II) was equivalent to the list published under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act and comprised of patents associated with applications filed under subsection (a) of this section or under this subsection. (C) Withdrawal or suspension of licensure If the licensing of a biological product was withdrawn or suspended for safety, purity, or potency reasons, it may not be published in the list under subparagraph (A). If the withdrawal or suspension occurred after its publication in such list— (i) it shall be immediately removed from such list— (I) for the same period as the withdrawal or suspension; or (II) if the listed drug has been withdrawn from sale, for the period of withdrawal from sale or, if earlier, the period ending on the date the Secretary determines that the withdrawal from sale is not for safety, purity, or potency reasons; and (ii) a notice of the removal shall be published in the Federal Register. . 3. Review and report on types of biological product patents 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) complete a review of, and formulate recommendations on, the types of biological product patents that should be included in 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 section 2; and (2) report such recommendations to the Congress.

tv_txt: IB 116th CONGRESS 1st Session H. R. 1520 IN THE HOUSE OF REPRESENTATIVES 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.

1. Short title This Act may be cited as the Purple Book Continuity Act of 2019 . 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 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 2019 , the Secretary shall publish and make available 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 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 application number; and (III) the marketing or licensure status of the 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. (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. (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 that is applicable and has not concluded under paragraph (6) or paragraph (7). (B) Withdrawal or suspension of licensure If the licensing of a biological product was withdrawn or suspended for safety, purity, or potency reasons, it may not be published 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 immediately 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 period of withdrawal from sale or, if earlier, the period ending on the date the Secretary determines that the withdrawal from sale is not for safety, purity, or potency reasons; and (ii) a notice of the removal shall be published in the Federal Register. . 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 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 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 removed from the list.

Passed the House of Representatives May 8, 2019. Karen L. Haas, Clerk.

tv_txt: IIB 116th CONGRESS 1st Session H. R. 1520 IN THE SENATE OF THE UNITED STATES May 9, 2019 Received; read twice and referred to the Committee on Health, Education, Labor, and Pensions 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.

1. Short title This Act may be cited as the Purple Book Continuity Act of 2019 . 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 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 2019 , the Secretary shall publish and make available 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 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 application number; and (III) the marketing or licensure status of the 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. (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. (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 that is applicable and has not concluded under paragraph (6) or paragraph (7). (B) Withdrawal or suspension of licensure If the licensing of a biological product was withdrawn or suspended for safety, purity, or potency reasons, it may not be published 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 immediately 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 period of withdrawal from sale or, if earlier, the period ending on the date the Secretary determines that the withdrawal from sale is not for safety, purity, or potency reasons; and (ii) a notice of the removal shall be published in the Federal Register. . 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 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 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 removed from the list.

Passed the House of Representatives May 8, 2019. Cheryl L. Johnson, Clerk.

tv_txt: IB Union Calendar No. 26 116th CONGRESS 1st Session H. R. 1520 [Report No. 116–48] 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 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.

1. Short title This Act may be cited as the Purple Book Continuity Act of 2019 . 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 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 2019 , the Secretary shall publish and make available 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 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 application number; and (III) the marketing or licensure status of the 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. (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. (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 that is applicable and has not concluded under paragraph (6) or paragraph (7). (B) Withdrawal or suspension of licensure If the licensing of a biological product was withdrawn or suspended for safety, purity, or potency reasons, it may not be published 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 immediately 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 period of withdrawal from sale or, if earlier, the period ending on the date the Secretary determines that the withdrawal from sale is not for safety, purity, or potency reasons; and (ii) a notice of the removal shall be published in the Federal Register. . 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 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 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 removed from the list.

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

tv_txt: 116th CONGRESS 2d Session In the House of Representatives, U. S., December 21, 2020 HOUSE AMENDMENT TO SENATE AMENDMENT:

That the House agree to the amendment of the Senate to the bill (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. , with the following In lieu of the matter proposed to be inserted by the amendment of 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 .

Lorraine Miller Clerk.

tv_txt: 116th CONGRESS 2d Session H.R. 1520 In the Senate of the United States, December 10, 2020. Amendment:

That the bill from the House of Representatives (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 Strike all after the enacting clause and insert the following: 1. Short title The Act may be cited as the Purple Book Continuity Act of 2020 . 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.

Secretary

tv_txt: IB One Hundred Sixteenth Congress of the United States of America At the Second Session Begun and held at the City of Washington on Friday, the third day of January, two thousand and twenty H. R. 1520 AN ACT Making further continuing appropriations for fiscal year 2021, and for other purposes.

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 .

Speaker of the House of Representatives. Vice President of the United States and President of the Senate.