<enum>I</enum><header>NO BAN Act</header> <section id="H16C6697EDFBC448494B4468C476DD277" section-type="subsequent-section"><enum>101.</enum><header>Short titles</header><text display-inline="no-display-inline">This title may be cited as the <quote><short-title>National Origin-Based Antidiscrimination for Nonimmigrants Act</short-title></quote> or the <quote><short-title>NO BAN Act</short-title></quote>.</text></section> <section id="H8D9413ABE0B04B718FCBD6DCAB6D927A" section-type="subsequent-section"><enum>102.</enum><header>Expansion of nondiscrimination provision</header><text display-inline="no-display-inline">Section 202(a)(1)(A) of the Immigration and Nationality Act (<external-xref legal-doc="usc" parsable-cite="usc/8/1152">8 U.S.C. 1152(a)(1)(A)</external-xref>) is amended—</text> <paragraph id="H3D265E8AF2004E668410B7504FBF1C5C"><enum>(1)</enum><text display-inline="yes-display-inline">by inserting <quote>or a nonimmigrant visa, admission or other entry into the United States, or the approval or revocation of any immigration benefit</quote> after <quote>immigrant visa</quote>;</text></paragraph> <paragraph id="H2056CFB365A945099BF16A05EEF1C323"><enum>(2)</enum><text>by inserting <quote>religion,</quote> after <quote>sex,</quote>; and</text></paragraph> <paragraph id="H5CDC960CABBA49A59DFA02574A05CAB9"><enum>(3)</enum><text>by inserting <quote>, except if expressly required by statute, or if a statutorily authorized benefit takes into consideration such factors</quote> before the period at the end.</text></paragraph></section> <section id="HBC754D225A21447592000C2274C5B351"><enum>103.</enum><header>Transfer and limitations on authority to suspend or restrict the entry of a class of aliens</header><text display-inline="no-display-inline">Section 212(f) of the Immigration and Nationality Act (<external-xref legal-doc="usc" parsable-cite="usc/8/1182">8 U.S.C. 1182(f)</external-xref>) is amended to read as follows:</text> <quoted-block id="HFA17F578581B43628EC68C98517D6884" style="OLC"> <subsection id="H84FD905B30FF40CBAE74B05B8CD65FC1"><enum>(f)</enum><header>Authority to suspend or restrict the entry of a class of aliens</header> <paragraph id="HE90C283E77044E608FDC91743A3149BD"><enum>(1)</enum><header>In general</header><text>Subject to paragraph (2), if the Secretary of State, in consultation with the Secretary of Homeland Security, determines, based on specific and credible facts, that the entry of any aliens or any class of aliens into the United States would undermine the security or public safety of the United States or the preservation of human rights, democratic processes or institutions, or international stability, the President may temporarily—</text> <subparagraph id="HCE3C37C47F2B4004962895A68E80FE4A"><enum>(A)</enum><text>suspend the entry of such aliens or class of aliens as immigrants or nonimmigrants; or</text></subparagraph> <subparagraph id="H83240C54936E4DC1917BBF4AB72EE404"><enum>(B)</enum><text>impose any restrictions on the entry of such aliens that the President deems appropriate.</text></subparagraph></paragraph> <paragraph id="H301DE4601814457CB85B88C67DE49A09"><enum>(2)</enum><header>Limitations</header><text>In carrying out paragraph (1), the President, the Secretary of State, and the Secretary of Homeland Security shall—</text> <subparagraph id="HB2ABAADC94C54B40878E7238BBC904CA"><enum>(A)</enum><text display-inline="yes-display-inline">only issue a suspension or restriction when required to address specific acts implicating a compelling government interest in a factor identified in paragraph (1);</text></subparagraph> <subparagraph id="H1A58EC552B984DC6B86EB8079A8392EE"><enum>(B)</enum><text>narrowly tailor the suspension or restriction, using the least restrictive means, to achieve such compelling government interest;</text></subparagraph> <subparagraph id="H074E0861D9A1406D819F2658A489F9C4"><enum>(C)</enum><text>specify the duration of the suspension or restriction; and</text></subparagraph> <subparagraph id="H4D97909343DD4D9098328ACACEA18C0E"><enum>(D)</enum><text>consider waivers to any class-based restriction or suspension and apply a rebuttable presumption in favor of granting family-based and humanitarian waivers.</text></subparagraph></paragraph> <paragraph id="HAA16CAD8230F4BF1B6A1F109E562C85E"><enum>(3)</enum><header>Congressional notification</header> <subparagraph id="H731DEEBE80564F40B69F59DFB31008B7"><enum>(A)</enum><header>In general</header><text>Prior to the President exercising the authority under paragraph (1), the Secretary of State and the Secretary of Homeland Security shall consult Congress and provide Congress with specific evidence supporting the need for the suspension or restriction and its proposed duration.</text></subparagraph> <subparagraph id="H89982BE9C35C4D2B9AF9693E608FB7C1"><enum>(B)</enum><header>Briefing and report</header><text>Not later than 48 hours after the President exercises the authority under paragraph (1), the Secretary of State and the Secretary of Homeland Security shall provide a briefing and submit a written report to Congress that describes—</text> <clause id="HE213566DCAC14D84A058577CD11925DD"><enum>(i)</enum><text display-inline="yes-display-inline">the action taken pursuant to paragraph (1) and the specified objective of such action;</text></clause> <clause id="H3CD516C3EFD243C9A98741D4892F34D3"><enum>(ii)</enum><text>the estimated number of individuals who will be impacted by such action;</text></clause> <clause id="HE55A9F29F4B64FCCAA3CB316F155F4A1"><enum>(iii)</enum><text>the constitutional and legislative authority under which such action took place; and</text></clause> <clause id="HF2A27B591D424CE2901DCD081FD9C8A0"><enum>(iv)</enum><text>the circumstances necessitating such action, including how such action complies with paragraph (2), as well as any intelligence informing such actions.</text></clause></subparagraph> <subparagraph id="HF6E55BC9197443CF8AA7BFA4AF3846AC"><enum>(C)</enum><header>Termination</header><text display-inline="yes-display-inline">If the briefing and report described in subparagraph (B) are not provided to Congress during the 48 hours that begin when the President exercises the authority under paragraph (1), the suspension or restriction shall immediately terminate absent intervening congressional action.</text></subparagraph> <subparagraph id="HDCCB7ADCEB084D4C9FEE77065B1E730D"><enum>(D)</enum><header>Congressional committees</header><text>The term <quote>Congress</quote>, as used in this paragraph, refers to the Select Committee on Intelligence of the Senate, the Committee on Foreign Relations of the Senate, the Committee on the Judiciary of the Senate, the Committee on Homeland Security and Governmental Affairs of the Senate, the Permanent Select Committee on Intelligence of the House of Representatives, the Committee on Foreign Affairs of the House of Representatives, the Committee on the Judiciary of the House of Representatives, and the Committee on Homeland Security of the House of Representatives.</text></subparagraph></paragraph> <paragraph id="H920BC87CCB0E4DBEAFBDCB2D176A4AA5"><enum>(4)</enum><header>Publication</header><text>The Secretary of State and the Secretary of Homeland Security shall publicly announce and publish an unclassified version of the report described in paragraph (3)(B) in the Federal Register.</text></paragraph> <paragraph id="HF39A96E879F842668577790C355B3CFA"><enum>(5)</enum><header>Judicial review</header> <subparagraph id="H35938952D35B498090439A03A0FD093F"><enum>(A)</enum><header>In general</header><text>Notwithstanding any other provision of law, an individual or entity who is present in the United States and has been harmed by a violation of this subsection may file an action in an appropriate district court of the United States to seek declaratory or injunctive relief.</text></subparagraph> <subparagraph id="H5A12C0FE90E548DF83DA2DD08AACD5A7"><enum>(B)</enum><header>Class action</header><text>Nothing in this Act may be construed to preclude an action filed pursuant to subparagraph (A) from proceeding as a class action.</text></subparagraph></paragraph> <paragraph id="HE74A107A0EA641459BFDA5E0537C5CC7"><enum>(6)</enum><header>Treatment of commercial airlines</header><text display-inline="yes-display-inline">Whenever the Secretary of Homeland Security finds that a commercial airline has failed to comply with regulations of the Secretary of Homeland Security relating to requirements of airlines for the detection of fraudulent documents used by passengers traveling to the United States (including the training of personnel in such detection), the Secretary of Homeland Security may suspend the entry of some or all aliens transported to the United States by such airline.</text></paragraph> <paragraph id="HE489B4A540804EC3A2EA7E5D9666CF25"><enum>(7)</enum><header>Rule of construction</header><text display-inline="yes-display-inline">Nothing in this section may be construed as authorizing the President, the Secretary of State, or the Secretary of Homeland Security to act in a manner inconsistent with the policy decisions expressed in the immigration laws.</text></paragraph> <paragraph id="HACABA9A4B199471D815C4E951714F80E"><enum>(8)</enum><header>Clarification</header><text display-inline="yes-display-inline">For purposes of paragraph (1), the term <quote>public safety of the United States</quote> includes efforts necessary to contain a communicable disease of public health significance (as defined in section 34.2(b) of title 42, Code of Federal Regulations (or any successor regulation)).</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></section> <section id="H05118338E60340B8A804AE14A91C3E1F"><enum>104.</enum><header>Termination of certain executive actions</header> <subsection id="H3D094DD562B1467D9DDDE3D8ECDD6B3F"><enum>(a)</enum><header>Termination</header><text>Presidential Proclamations 9645, 9822, and 9983 and Executive Orders 13769, 13780, and 13815 shall be void beginning on the date of the enactment of this Act.</text></subsection> <subsection id="HDB0DE535EF8B445383A52E3623A9E677"><enum>(b)</enum><header>Effect</header><text>All actions taken pursuant to any proclamation or executive order terminated under subsection (a) shall cease on the date of the enactment of this Act.</text></subsection></section> <section id="HA8F0CD67428D43D3BB18761B3958B6BB"><enum>105.</enum><header>Visa applicants report</header> <subsection id="HA41CF9C16A4646AE83997940978EA20D"><enum>(a)</enum><header>Initial reports</header> <paragraph id="HB00565F94992433EAA97EC14B757E005"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than 90 days after the date of the enactment of this Act, the Secretary of State, in coordination with the Secretary of Homeland Security and the heads of other relevant Federal agencies, shall submit a report to the congressional committees referred to in section 212(f)(3)(D) of the Immigration and Nationality Act, as amended by section 103 of this title, that describes the implementation of each of the presidential proclamations and executive orders referred to in section 104.</text></paragraph> <paragraph id="HDBB8F7B2BB5A482C8321879842FCE91E"><enum>(2)</enum><header>Presidential proclamation 9645 and 9983</header><text>In addition to the content described in paragraph (1), the report submitted with respect to Presidential Proclamation 9645, issued on September 24, 2017, and Presidential Proclamation 9983, issued on January 31, 2020, shall include, for each country listed in such proclamation—</text> <subparagraph id="H1C25ECDE8C154658BFD2B6E777588151"><enum>(A)</enum><text>the total number of individuals who applied for a visa during the time period the proclamation was in effect, disaggregated by country and visa category;</text></subparagraph> <subparagraph id="H7BBDA6FC06B249A9ADD1AAEF0C2687DB"><enum>(B)</enum><text>the total number of visa applicants described in subparagraph (A) who were approved, disaggregated by country and visa category;</text></subparagraph> <subparagraph id="HFCD46FF3455840A99B308B0F97D5386F"><enum>(C)</enum><text>the total number of visa applicants described in subparagraph (A) who were refused, disaggregated by country and visa category, and the reasons they were refused;</text></subparagraph> <subparagraph id="H62CF5593F37B440FA8E96525AD103894"><enum>(D)</enum><text display-inline="yes-display-inline">the total number of visa applicants described in subparagraph (A) whose applications remain pending, disaggregated by country and visa category;</text></subparagraph> <subparagraph id="H0761337F4182440283ED5D9EB6A4E242"><enum>(E)</enum><text>the total number of visa applicants described in subparagraph (A) who were granted a waiver, disaggregated by country and visa category;</text></subparagraph> <subparagraph id="H6CE4091714B54DE3B2189FD2EA76EDE0"><enum>(F)</enum><text>the total number of visa applicants described in subparagraph (A) who were denied a waiver, disaggregated by country and visa category, and the reasons such waiver requests were denied;</text></subparagraph> <subparagraph id="H51002F416C4D4BDC913FC3ED4F7BDB73"><enum>(G)</enum><text>the total number of refugees admitted, disaggregated by country; and</text></subparagraph> <subparagraph id="H5F919167ACE74AE3AA16332224FB41ED"><enum>(H)</enum><text>the complete reports that have been submitted to the President every 180 days in accordance with section 4 of Presidential Proclamation 9645 in its original form, and as amended by Presidential Proclamation 9983.</text></subparagraph></paragraph></subsection> <subsection id="H1F2A8C350776430AA985BC5FC5469E37"><enum>(b)</enum><header>Additional reports</header><text display-inline="yes-display-inline">Not later than 30 days after the date on which the President exercises the authority under section 212(f) of the Immigration and Nationality Act (<external-xref legal-doc="usc" parsable-cite="usc/8/1182">8 U.S.C. 1182(f)</external-xref>), as amended by section 103 of this title, and every 30 days thereafter, the Secretary of State, in coordination with the Secretary of Homeland Security and heads of other relevant Federal agencies, shall submit a report to the congressional committees referred to in paragraph (3)(D) of such section 212(f) that identifies, with respect to countries affected by a suspension or restriction, the information described in subparagraphs (A) through (H) of subsection (a)(2) of this section and specific evidence supporting the need for the continued exercise of presidential authority under such section 212(f), including the information described in paragraph (3)(B) of such section 212(f). If the report described in this subsection is not provided to Congress in the time specified, the suspension or restriction shall immediately terminate absent intervening congressional action. A final report with such information shall be prepared and submitted to such congressional committees not later than 30 days after the suspension or restriction is lifted.</text></subsection> <subsection id="H72B0BAFF25E04A19B07D3C829F17519B"><enum>(c)</enum><header>Form; availability</header><text>The reports required under subsections (a) and (b) shall be made publicly available online in unclassified form.</text></subsection></section>

116 HR 2486 EAH: National Origin-Based Antidiscrimination for Nonimmigrants Act U.S. House of Representatives 2020-07-22 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

116th CONGRESS2d Session

In the House of Representatives, U. S.,

July 22, 2020

HOUSE AMENDMENTS TO SENATE AMENDMENT:

That the House agree to the amendment of the Senate to the bill (H.R. 2486) entitled An Act to reauthorize mandatory funding programs for historically Black colleges and universities and other minority-serving institutions., with the following

(1)In the matter proposed to be inserted by the amendment of the Senate, strike sections 1, 2, and 3 and insert the following:

<enum>I</enum><header>NO BAN Act</header> <section id="H16C6697EDFBC448494B4468C476DD277" section-type="subsequent-section"><enum>101.</enum><header>Short titles</header><text display-inline="no-display-inline">This title may be cited as the <quote><short-title>National Origin-Based Antidiscrimination for Nonimmigrants Act</short-title></quote> or the <quote><short-title>NO BAN Act</short-title></quote>.</text></section> <section id="H8D9413ABE0B04B718FCBD6DCAB6D927A" section-type="subsequent-section"><enum>102.</enum><header>Expansion of nondiscrimination provision</header><text display-inline="no-display-inline">Section 202(a)(1)(A) of the Immigration and Nationality Act (<external-xref legal-doc="usc" parsable-cite="usc/8/1152">8 U.S.C. 1152(a)(1)(A)</external-xref>) is amended—</text> <paragraph id="H3D265E8AF2004E668410B7504FBF1C5C"><enum>(1)</enum><text display-inline="yes-display-inline">by inserting <quote>or a nonimmigrant visa, admission or other entry into the United States, or the approval or revocation of any immigration benefit</quote> after <quote>immigrant visa</quote>;</text></paragraph> <paragraph id="H2056CFB365A945099BF16A05EEF1C323"><enum>(2)</enum><text>by inserting <quote>religion,</quote> after <quote>sex,</quote>; and</text></paragraph> <paragraph id="H5CDC960CABBA49A59DFA02574A05CAB9"><enum>(3)</enum><text>by inserting <quote>, except if expressly required by statute, or if a statutorily authorized benefit takes into consideration such factors</quote> before the period at the end.</text></paragraph></section> <section id="HBC754D225A21447592000C2274C5B351"><enum>103.</enum><header>Transfer and limitations on authority to suspend or restrict the entry of a class of aliens</header><text display-inline="no-display-inline">Section 212(f) of the Immigration and Nationality Act (<external-xref legal-doc="usc" parsable-cite="usc/8/1182">8 U.S.C. 1182(f)</external-xref>) is amended to read as follows:</text> <quoted-block id="HFA17F578581B43628EC68C98517D6884" style="OLC"> <subsection id="H84FD905B30FF40CBAE74B05B8CD65FC1"><enum>(f)</enum><header>Authority to suspend or restrict the entry of a class of aliens</header> <paragraph id="HE90C283E77044E608FDC91743A3149BD"><enum>(1)</enum><header>In general</header><text>Subject to paragraph (2), if the Secretary of State, in consultation with the Secretary of Homeland Security, determines, based on specific and credible facts, that the entry of any aliens or any class of aliens into the United States would undermine the security or public safety of the United States or the preservation of human rights, democratic processes or institutions, or international stability, the President may temporarily—</text> <subparagraph id="HCE3C37C47F2B4004962895A68E80FE4A"><enum>(A)</enum><text>suspend the entry of such aliens or class of aliens as immigrants or nonimmigrants; or</text></subparagraph> <subparagraph id="H83240C54936E4DC1917BBF4AB72EE404"><enum>(B)</enum><text>impose any restrictions on the entry of such aliens that the President deems appropriate.</text></subparagraph></paragraph> <paragraph id="H301DE4601814457CB85B88C67DE49A09"><enum>(2)</enum><header>Limitations</header><text>In carrying out paragraph (1), the President, the Secretary of State, and the Secretary of Homeland Security shall—</text> <subparagraph id="HB2ABAADC94C54B40878E7238BBC904CA"><enum>(A)</enum><text display-inline="yes-display-inline">only issue a suspension or restriction when required to address specific acts implicating a compelling government interest in a factor identified in paragraph (1);</text></subparagraph> <subparagraph id="H1A58EC552B984DC6B86EB8079A8392EE"><enum>(B)</enum><text>narrowly tailor the suspension or restriction, using the least restrictive means, to achieve such compelling government interest;</text></subparagraph> <subparagraph id="H074E0861D9A1406D819F2658A489F9C4"><enum>(C)</enum><text>specify the duration of the suspension or restriction; and</text></subparagraph> <subparagraph id="H4D97909343DD4D9098328ACACEA18C0E"><enum>(D)</enum><text>consider waivers to any class-based restriction or suspension and apply a rebuttable presumption in favor of granting family-based and humanitarian waivers.</text></subparagraph></paragraph> <paragraph id="HAA16CAD8230F4BF1B6A1F109E562C85E"><enum>(3)</enum><header>Congressional notification</header> <subparagraph id="H731DEEBE80564F40B69F59DFB31008B7"><enum>(A)</enum><header>In general</header><text>Prior to the President exercising the authority under paragraph (1), the Secretary of State and the Secretary of Homeland Security shall consult Congress and provide Congress with specific evidence supporting the need for the suspension or restriction and its proposed duration.</text></subparagraph> <subparagraph id="H89982BE9C35C4D2B9AF9693E608FB7C1"><enum>(B)</enum><header>Briefing and report</header><text>Not later than 48 hours after the President exercises the authority under paragraph (1), the Secretary of State and the Secretary of Homeland Security shall provide a briefing and submit a written report to Congress that describes—</text> <clause id="HE213566DCAC14D84A058577CD11925DD"><enum>(i)</enum><text display-inline="yes-display-inline">the action taken pursuant to paragraph (1) and the specified objective of such action;</text></clause> <clause id="H3CD516C3EFD243C9A98741D4892F34D3"><enum>(ii)</enum><text>the estimated number of individuals who will be impacted by such action;</text></clause> <clause id="HE55A9F29F4B64FCCAA3CB316F155F4A1"><enum>(iii)</enum><text>the constitutional and legislative authority under which such action took place; and</text></clause> <clause id="HF2A27B591D424CE2901DCD081FD9C8A0"><enum>(iv)</enum><text>the circumstances necessitating such action, including how such action complies with paragraph (2), as well as any intelligence informing such actions.</text></clause></subparagraph> <subparagraph id="HF6E55BC9197443CF8AA7BFA4AF3846AC"><enum>(C)</enum><header>Termination</header><text display-inline="yes-display-inline">If the briefing and report described in subparagraph (B) are not provided to Congress during the 48 hours that begin when the President exercises the authority under paragraph (1), the suspension or restriction shall immediately terminate absent intervening congressional action.</text></subparagraph> <subparagraph id="HDCCB7ADCEB084D4C9FEE77065B1E730D"><enum>(D)</enum><header>Congressional committees</header><text>The term <quote>Congress</quote>, as used in this paragraph, refers to the Select Committee on Intelligence of the Senate, the Committee on Foreign Relations of the Senate, the Committee on the Judiciary of the Senate, the Committee on Homeland Security and Governmental Affairs of the Senate, the Permanent Select Committee on Intelligence of the House of Representatives, the Committee on Foreign Affairs of the House of Representatives, the Committee on the Judiciary of the House of Representatives, and the Committee on Homeland Security of the House of Representatives.</text></subparagraph></paragraph> <paragraph id="H920BC87CCB0E4DBEAFBDCB2D176A4AA5"><enum>(4)</enum><header>Publication</header><text>The Secretary of State and the Secretary of Homeland Security shall publicly announce and publish an unclassified version of the report described in paragraph (3)(B) in the Federal Register.</text></paragraph> <paragraph id="HF39A96E879F842668577790C355B3CFA"><enum>(5)</enum><header>Judicial review</header> <subparagraph id="H35938952D35B498090439A03A0FD093F"><enum>(A)</enum><header>In general</header><text>Notwithstanding any other provision of law, an individual or entity who is present in the United States and has been harmed by a violation of this subsection may file an action in an appropriate district court of the United States to seek declaratory or injunctive relief.</text></subparagraph> <subparagraph id="H5A12C0FE90E548DF83DA2DD08AACD5A7"><enum>(B)</enum><header>Class action</header><text>Nothing in this Act may be construed to preclude an action filed pursuant to subparagraph (A) from proceeding as a class action.</text></subparagraph></paragraph> <paragraph id="HE74A107A0EA641459BFDA5E0537C5CC7"><enum>(6)</enum><header>Treatment of commercial airlines</header><text display-inline="yes-display-inline">Whenever the Secretary of Homeland Security finds that a commercial airline has failed to comply with regulations of the Secretary of Homeland Security relating to requirements of airlines for the detection of fraudulent documents used by passengers traveling to the United States (including the training of personnel in such detection), the Secretary of Homeland Security may suspend the entry of some or all aliens transported to the United States by such airline.</text></paragraph> <paragraph id="HE489B4A540804EC3A2EA7E5D9666CF25"><enum>(7)</enum><header>Rule of construction</header><text display-inline="yes-display-inline">Nothing in this section may be construed as authorizing the President, the Secretary of State, or the Secretary of Homeland Security to act in a manner inconsistent with the policy decisions expressed in the immigration laws.</text></paragraph> <paragraph id="HACABA9A4B199471D815C4E951714F80E"><enum>(8)</enum><header>Clarification</header><text display-inline="yes-display-inline">For purposes of paragraph (1), the term <quote>public safety of the United States</quote> includes efforts necessary to contain a communicable disease of public health significance (as defined in section 34.2(b) of title 42, Code of Federal Regulations (or any successor regulation)).</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></section> <section id="H05118338E60340B8A804AE14A91C3E1F"><enum>104.</enum><header>Termination of certain executive actions</header> <subsection id="H3D094DD562B1467D9DDDE3D8ECDD6B3F"><enum>(a)</enum><header>Termination</header><text>Presidential Proclamations 9645, 9822, and 9983 and Executive Orders 13769, 13780, and 13815 shall be void beginning on the date of the enactment of this Act.</text></subsection> <subsection id="HDB0DE535EF8B445383A52E3623A9E677"><enum>(b)</enum><header>Effect</header><text>All actions taken pursuant to any proclamation or executive order terminated under subsection (a) shall cease on the date of the enactment of this Act.</text></subsection></section> <section id="HA8F0CD67428D43D3BB18761B3958B6BB"><enum>105.</enum><header>Visa applicants report</header> <subsection id="HA41CF9C16A4646AE83997940978EA20D"><enum>(a)</enum><header>Initial reports</header> <paragraph id="HB00565F94992433EAA97EC14B757E005"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than 90 days after the date of the enactment of this Act, the Secretary of State, in coordination with the Secretary of Homeland Security and the heads of other relevant Federal agencies, shall submit a report to the congressional committees referred to in section 212(f)(3)(D) of the Immigration and Nationality Act, as amended by section 103 of this title, that describes the implementation of each of the presidential proclamations and executive orders referred to in section 104.</text></paragraph> <paragraph id="HDBB8F7B2BB5A482C8321879842FCE91E"><enum>(2)</enum><header>Presidential proclamation 9645 and 9983</header><text>In addition to the content described in paragraph (1), the report submitted with respect to Presidential Proclamation 9645, issued on September 24, 2017, and Presidential Proclamation 9983, issued on January 31, 2020, shall include, for each country listed in such proclamation—</text> <subparagraph id="H1C25ECDE8C154658BFD2B6E777588151"><enum>(A)</enum><text>the total number of individuals who applied for a visa during the time period the proclamation was in effect, disaggregated by country and visa category;</text></subparagraph> <subparagraph id="H7BBDA6FC06B249A9ADD1AAEF0C2687DB"><enum>(B)</enum><text>the total number of visa applicants described in subparagraph (A) who were approved, disaggregated by country and visa category;</text></subparagraph> <subparagraph id="HFCD46FF3455840A99B308B0F97D5386F"><enum>(C)</enum><text>the total number of visa applicants described in subparagraph (A) who were refused, disaggregated by country and visa category, and the reasons they were refused;</text></subparagraph> <subparagraph id="H62CF5593F37B440FA8E96525AD103894"><enum>(D)</enum><text display-inline="yes-display-inline">the total number of visa applicants described in subparagraph (A) whose applications remain pending, disaggregated by country and visa category;</text></subparagraph> <subparagraph id="H0761337F4182440283ED5D9EB6A4E242"><enum>(E)</enum><text>the total number of visa applicants described in subparagraph (A) who were granted a waiver, disaggregated by country and visa category;</text></subparagraph> <subparagraph id="H6CE4091714B54DE3B2189FD2EA76EDE0"><enum>(F)</enum><text>the total number of visa applicants described in subparagraph (A) who were denied a waiver, disaggregated by country and visa category, and the reasons such waiver requests were denied;</text></subparagraph> <subparagraph id="H51002F416C4D4BDC913FC3ED4F7BDB73"><enum>(G)</enum><text>the total number of refugees admitted, disaggregated by country; and</text></subparagraph> <subparagraph id="H5F919167ACE74AE3AA16332224FB41ED"><enum>(H)</enum><text>the complete reports that have been submitted to the President every 180 days in accordance with section 4 of Presidential Proclamation 9645 in its original form, and as amended by Presidential Proclamation 9983.</text></subparagraph></paragraph></subsection> <subsection id="H1F2A8C350776430AA985BC5FC5469E37"><enum>(b)</enum><header>Additional reports</header><text display-inline="yes-display-inline">Not later than 30 days after the date on which the President exercises the authority under section 212(f) of the Immigration and Nationality Act (<external-xref legal-doc="usc" parsable-cite="usc/8/1182">8 U.S.C. 1182(f)</external-xref>), as amended by section 103 of this title, and every 30 days thereafter, the Secretary of State, in coordination with the Secretary of Homeland Security and heads of other relevant Federal agencies, shall submit a report to the congressional committees referred to in paragraph (3)(D) of such section 212(f) that identifies, with respect to countries affected by a suspension or restriction, the information described in subparagraphs (A) through (H) of subsection (a)(2) of this section and specific evidence supporting the need for the continued exercise of presidential authority under such section 212(f), including the information described in paragraph (3)(B) of such section 212(f). If the report described in this subsection is not provided to Congress in the time specified, the suspension or restriction shall immediately terminate absent intervening congressional action. A final report with such information shall be prepared and submitted to such congressional committees not later than 30 days after the suspension or restriction is lifted.</text></subsection> <subsection id="H72B0BAFF25E04A19B07D3C829F17519B"><enum>(c)</enum><header>Form; availability</header><text>The reports required under subsections (a) and (b) shall be made publicly available online in unclassified form.</text></subsection></section> <enum>II</enum><header>Affordable Prescriptions for Patients Act of 2020</header> <section id="H324B3F4276694797B832311708991776" section-type="subsequent-section"><enum>201.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote><short-title>Affordable Prescriptions for Patients Act of 2020</short-title></quote>.</text></section> <section id="H0EE65B2DB6C64311B382AD47DD82B6E8"><enum>202.</enum><header>Product hopping</header> <subsection id="H3F35698512D64B25887A37970EA2299A"><enum>(a)</enum><header>In general</header><text>The Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/41">15 U.S.C. 41</external-xref> et seq.) is amended by inserting after section 26 (<external-xref legal-doc="usc" parsable-cite="usc/15/57c-2">15 U.S.C. 57c–2</external-xref>) the following:</text> <quoted-block act-name="" id="H0ACFA3B6AE564153A1320DBCCDFEBBF8" style="OLC"> <section id="HC981CCB3FB2948AA8F456F9977F22945"><enum>27.</enum><header>Product hopping</header> <subsection id="HAABB4E69487E4129AFCB3A0977687800"><enum>(a)</enum><header>Definitions</header><text>In this section:</text> <paragraph commented="no" display-inline="no-display-inline" id="HB1A66BAD5CC4478896FD0966B403E37A"><enum>(1)</enum><header display-inline="yes-display-inline">Abbreviated new drug application</header><text display-inline="yes-display-inline">The term <term>abbreviated new drug application</term> means an application under subsection (b)(2) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>).</text></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="H4F65AE3D19FE4F589B550C99FC96B5AB"><enum>(2)</enum><header>Biosimilar biological product</header><text>The term <term>biosimilar biological product</term> means a biological product licensed under section 351(k) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(k)</external-xref>).</text></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="H222BF6E325FC495595688BFF3C17EDB5"><enum>(3)</enum><header display-inline="yes-display-inline">Biosimilar biological product license application</header><text display-inline="yes-display-inline">The term <term>biosimilar biological product license application</term> means an application submitted under section 351(k) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(k)</external-xref>).</text></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="H890A8DFC5A4C4C7D90BFAFA4491734E4"><enum>(4)</enum><header display-inline="yes-display-inline">Follow-on product</header><text display-inline="yes-display-inline">The term <term>follow-on product</term>—</text> <subparagraph commented="no" display-inline="no-display-inline" id="HE76A3561969C4403B398732E41AF7281"><enum>(A)</enum><text display-inline="yes-display-inline">means a drug approved through an application or supplement to an application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(b)</external-xref>) or a biological product licensed through an application or supplement to an application submitted under section 351(a) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(a)</external-xref>) for a change, modification, or reformulation to the same manufacturer's previously approved drug or biological product that treats the same medical condition; and</text></subparagraph> <subparagraph commented="no" display-inline="no-display-inline" id="HCE7BAA4D708F49FEBDCECFCE8954B4C2"><enum>(B)</enum><text display-inline="yes-display-inline">excludes such an application or supplement to an application for a change, modification, or reformulation of a drug or biological product that is requested by the Secretary or necessary to comply with law, including sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355a">21 U.S.C. 355a</external-xref>, 355c).</text></subparagraph></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="HF6D9C833A7424C35A7F508A3499FC021"><enum>(5)</enum><header display-inline="yes-display-inline">Generic drug</header><text display-inline="yes-display-inline">The term <term>generic drug</term> means a drug approved under an application submitted under subsection (b)(2) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>).</text></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="H1851D23AA9764E768A5D56E10C0867A5"><enum>(6)</enum><header>Listed drug</header><text>The term <term>listed drug</term> means a drug listed under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(j)(7)</external-xref>).</text></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="H9B3E336B268745C19D32D81F30CD10AF"><enum>(7)</enum><header>Manufacturer</header><text>The term <term>manufacturer</term> means the holder, licensee, or assignee of—</text> <subparagraph commented="no" display-inline="no-display-inline" id="H913CA9BEAD9A49A2A409C210FE7EF2A6"><enum>(A)</enum><text>an approved application for a drug under section 505(c) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(c)</external-xref>); or</text></subparagraph> <subparagraph commented="no" display-inline="no-display-inline" id="H8580D985C5814F8DA18B0F4A83726824"><enum>(B)</enum><text>a biological product license under section 351(a) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(a)</external-xref>).</text></subparagraph></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="HAE710EBD3FBA470DB1B4060F293DB2DB"><enum>(8)</enum><header display-inline="yes-display-inline">Reference product</header><text display-inline="yes-display-inline">The term <term>reference product</term> has the meaning given the term in section 351(i) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(i)</external-xref>).</text></paragraph> <paragraph id="HCFE9632F595E423E9C4B2F2B86871160"><enum>(9)</enum><header>Secretary</header><text display-inline="yes-display-inline">The term <quote>Secretary</quote> means the Secretary of Health and Human Services.</text></paragraph> <paragraph id="H45B9EA6C10ED4D5BBF51E767CBE16EBA"><enum>(10)</enum><header>Ultimate parent entity</header><text>The term <term>ultimate parent entity</term> has the meaning given the term in section 801.1 of title 16, Code of Federal Regulations, or any successor regulation.</text></paragraph></subsection> <subsection id="HC88127703CA0457A95A9C806DFDEAE7A"><enum>(b)</enum><header>Prohibition on product hopping</header> <paragraph id="H076E42AC16044096ACB986AAD8905105"><enum>(1)</enum><header>Prima facie</header><text>Except as provided in paragraph (2), a manufacturer of a reference product or listed drug shall be considered to have engaged in an unfair method of competition in or affecting commerce in violation of section 5(a) if the Commission demonstrates by a preponderance of the evidence in a proceeding initiated by the Commission under subsection (c)(1)(A), or in a suit brought under subparagraph (B) or (C) of subsection (c)(1), that, during the period beginning on the date on which the manufacturer of the reference product or listed drug first receives notice that an applicant has submitted to the Commissioner of Food and Drugs an abbreviated new drug application or biosimilar biological product license application and ending on the date that is 180 days after the date on which that generic drug or biosimilar biological product is first marketed, the manufacturer engaged in either of the following actions:</text> <subparagraph id="HC0875F0AF6EA4195B750705D86E1208B"><enum>(A)</enum><text>The manufacturer engaged in a hard switch, which shall be established by demonstrating that the manufacturer engaged in either of the following actions:</text> <clause id="HDEDB355FE0F74C5586F5F3240E53CD40"><enum>(i)</enum><text>Upon the request of the manufacturer of the listed drug or reference product, the Commissioner of Food and Drugs withdrew the approval of the application for the listed drug or reference product or placed the listed drug or reference product on the discontinued products list and the manufacturer marketed or sold a follow-on product.</text></clause> <clause id="H0B6CE3791F2C444EB18A7283F4F256B2"><enum>(ii)</enum><text>The manufacturer of the listed drug or reference product—</text> <subclause id="HA121719CF7B14C16AF0627A0D0813653"><enum>(I)</enum> <item commented="no" display-inline="yes-display-inline" id="HD603050324EC4B62A8878E15DE2B97B9"><enum>(aa)</enum><text>announced withdrawal of, discontinuance of the manufacture of, or intent to withdraw the application with respect to the drug or reference product in a manner that impedes competition from a generic drug or a biosimilar biological product, as established by objective circumstances; or</text></item> <item id="H2733CB7B0B5A4396AF9F59C14D5AEA2C" indent="up1"><enum>(bb)</enum><text>destroyed the inventory of the listed drug or reference product in a manner that impedes competition from a generic drug or a biosimilar biological product, which may be established by objective circumstances; and</text></item></subclause> <subclause id="H1451E92A367F4AAA96A02F9454BC5ABB"><enum>(II)</enum><text>marketed or sold a follow-on product.</text></subclause></clause></subparagraph> <subparagraph id="H6286194595ED4EC9B5E06E1AE02D9189"><enum>(B)</enum><text>The manufacturer engaged in a soft switch, which shall be established by demonstrating that the manufacturer engaged in both of the following actions:</text> <clause id="H9780D7135A93440ABD3844FDCB275052"><enum>(i)</enum><text>The manufacturer took actions with respect to the listed drug or reference product other than those described in subparagraph (A) that unfairly disadvantage the listed drug or reference product relative to the follow-on product described in clause (ii) in a manner that impedes competition from a generic drug or a biosimilar biological product that is highly similar to, and has no clinically meaningful difference with respect to safety, purity, and potency from, the reference product, which may be established by objective circumstances.</text></clause> <clause id="H7422DF4AEEBB4187BDFFC955373D0F1E"><enum>(ii)</enum><text>The manufacturer marketed or sold a follow-on product.</text></clause></subparagraph></paragraph> <paragraph id="HF94491623CE34878AAA508AE1B889EE6"><enum>(2)</enum><header>Justification</header> <subparagraph id="HE6C7E74AAD934A3B89596BC18B5432BC"><enum>(A)</enum><header>In general</header><text>Subject to paragraph (3), the actions described in paragraph (1) by a manufacturer of a listed drug or reference product shall not be considered to be an unfair method of competition in or affecting commerce if—</text> <clause id="H8D508A4D5BD840F08AE3013AEE8D109E"><enum>(i)</enum><text>the manufacturer demonstrates to the Commission or a district court of the United States, as applicable, by a preponderance of the evidence in a proceeding initiated by the Commission under subsection (c)(1)(A), or in a suit brought under subparagraph (B) or (C) of subsection (c)(1), that—</text> <subclause id="H87C2B59A3C18465E9113DD566216EA20"><enum>(I)</enum><text>the manufacturer would have taken the actions regardless of whether a generic drug that references the listed drug or biosimilar biological product that references the reference product had already entered the market; and</text></subclause> <subclause id="HAAA25B175A9D46E3B6A95CC5614BA5AE"><enum>(II)</enum> <item commented="no" display-inline="yes-display-inline" id="HFE5AC4A1E04E47408E635C6524A30BB6"><enum>(aa)</enum><text>with respect to a hard switch under paragraph (1)(A), the manufacturer took the action for reasons relating to the safety risk to patients of the listed drug or reference product;</text></item> <item id="H6542771CAAD84105B3CB852C62F47914" indent="up1"><enum>(bb)</enum><text>with respect to an action described in item (aa) or (bb) of paragraph (1)(A)(ii)(I), there is a supply disruption that—</text> <subitem id="HB8494C2989A444F492F3D6A9F857D170"><enum>(AA)</enum><text>is outside of the control of the manufacturer;</text></subitem> <subitem id="H79522ECAE8E34353985A0C4980FA0B29"><enum>(BB)</enum><text>prevents the production or distribution of the applicable listed drug or reference product; and</text></subitem> <subitem id="HFF7CDBC7671D484AA9448C90E60DBB86"><enum>(CC)</enum><text>cannot be remedied by reasonable efforts; or</text></subitem></item> <item id="H6D721757F4D943859CC4C24EDD0B7CEF" indent="up1"><enum>(cc)</enum><text>with respect to a soft switch under paragraph (1)(B), the manufacturer had legitimate pro-competitive reasons, apart from the financial effects of reduced competition, to take the action.</text></item></subclause></clause></subparagraph> <subparagraph id="H7ADD691B730D4AA884CA98E1669E3EE4"><enum>(B)</enum><header>Rule of construction</header><text>Nothing in subparagraph (A) may be construed to limit the information that the Commission may otherwise obtain in any proceeding or action instituted with respect to a violation of this section.</text></subparagraph></paragraph> <paragraph id="H4A2B696E69884EE49C6B2F2628ED0838"><enum>(3)</enum><header>Response</header><text>With respect to a justification offered by a manufacturer under paragraph (2), the Commission may—</text> <subparagraph id="HC4DCB6E72ACB4652A6C6AA147405EDD1"><enum>(A)</enum><text>rebut any evidence presented by a manufacturer during that justification; or</text></subparagraph> <subparagraph id="HCF4A9C9FDDA448FD92C7F9FA6B4FE5C1"><enum>(B)</enum><text>establish by a preponderance of the evidence that, on balance, the pro-competitive benefits from the conduct described in subparagraph (A) or (B) of paragraph (1), as applicable, do not outweigh any anticompetitive effects of the conduct, even in consideration of the justification so offered.</text></subparagraph></paragraph></subsection> <subsection id="H84C898D20ACB4A0092568785BFE660D7"><enum>(c)</enum><header>Enforcement</header> <paragraph id="HDC4143C11B1E4521A5936F0DA358E0E5"><enum>(1)</enum><header>In general</header><text>If the Commission has reason to believe that any manufacturer has violated, is violating, or is about to violate this section, the Commission may take any of the following actions:</text> <subparagraph id="H27F181796FCB4FD88C5C5659228B5F32"><enum>(A)</enum><text>Institute a proceeding—</text> <clause id="H034DD9E2697A489CA6612EF6B3169EF7"><enum>(i)</enum><text>that, except as provided in paragraph (2), complies with the requirements under section 5(b); and</text></clause> <clause id="HC389F6EFD60F46748A371AF035BD045F"><enum>(ii)</enum><text>in which the Commission may impose on the manufacturer any penalty that the Commission may impose for a violation of section 5.</text></clause></subparagraph> <subparagraph id="HD435ABA613464BF2B851609C6243A67E"><enum>(B)</enum><text>In the same manner and to the same extent as provided in section 13(b), bring suit in a district court of the United States to temporarily enjoin the action of the manufacturer.</text></subparagraph> <subparagraph id="H2EFB1CF0037745C4849E3417DA6E5A89"><enum>(C)</enum><text>Bring suit in a district court of the United States, in which the Commission may seek—</text> <clause id="HD767A55335684C92839E8FCBDFB40C0F"><enum>(i)</enum><text>to permanently enjoin the action of the manufacturer;</text></clause> <clause id="H0C8610963BFB4F8297B7F471C24DFE0C"><enum>(ii)</enum><text>any of the remedies described in paragraph (3); and</text></clause> <clause id="HD0B4B5A4103B4D3AAB55BCF321132DAE"><enum>(iii)</enum><text>any other equitable remedy, including ancillary equitable relief.</text></clause></subparagraph></paragraph> <paragraph id="H8CBE2D1DF0AE4CE486DE246509A43ED0"><enum>(2)</enum><header>Judicial review</header> <subparagraph id="H5C8142E222874F21988E13AB29387EFD"><enum>(A)</enum><header>In general</header><text>Notwithstanding any provision of section 5, any manufacturer that is subject to a final order of the Commission that is issued in a proceeding instituted under paragraph (1)(A) may, not later than 30 days after the date on which the Commission issues the order, petition for review of the order in—</text> <clause id="H52B07B1737244FB6A7E50307F92D0C71"><enum>(i)</enum><text>the United States Court of Appeals for the District of Columbia Circuit; or</text></clause> <clause id="H5FEEA9177B8E49AAA84D985D5811C146"><enum>(ii)</enum><text>the court of appeals of the United States for the circuit in which the ultimate parent entity of the manufacturer is incorporated.</text></clause></subparagraph> <subparagraph id="H24BFFF0C91804B6E8CDC7FE4D91A803D"><enum>(B)</enum><header>Treatment of findings</header><text>In a review of an order issued by the Commission conducted by a court of appeals of the United States under subparagraph (A), the factual findings of the Commission shall be conclusive if those facts are supported by the evidence.</text></subparagraph></paragraph> <paragraph id="H463F4FCFF07C49F98406F04E27762697"><enum>(3)</enum><header>Equitable remedies</header> <subparagraph id="H87A36BB03FCA45E2BA189FDFF48A58AC"><enum>(A)</enum><header>Disgorgement</header> <clause id="HA6154E3D9CD44DA59A8935BD67C9F371"><enum>(i)</enum><header>In general</header><text>In a suit brought under paragraph (1)(C), the Commission may seek, and the court may order, disgorgement of any unjust enrichment that a person obtained as a result of the violation that gives rise to the suit.</text></clause> <clause id="H834AE6A679A447F5ADFEEA878967A571"><enum>(ii)</enum><header>Calculation</header><text>Any disgorgement that is ordered with respect to a person under clause (i) shall be offset by any amount of restitution ordered under subparagraph (B).</text></clause> <clause id="HA928861CA5ED4B40B41EF18908CBFBC6"><enum>(iii)</enum><header>Limitations period</header><text>The Commission may seek disgorgement under this subparagraph not later than 5 years after the latest date on which the person from which the disgorgement is sought receives any unjust enrichment from the effects of the violation that gives rise to the suit in which the Commission seeks the disgorgement.</text></clause></subparagraph> <subparagraph id="HD85246B45C1F44D895B8AC0317471F46"><enum>(B)</enum><header>Restitution</header> <clause id="HEA7E0C1752E54F149009437890C6CD59"><enum>(i)</enum><header>In general</header><text>In a suit brought under paragraph (1)(C), the Commission may seek, and the court may order, restitution with respect to the violation that gives rise to the suit.</text></clause> <clause id="HA47198274E6D4990A189A278A9CF038C"><enum>(ii)</enum><header>Limitations period</header><text>The Commission may seek restitution under this subparagraph not later than 5 years after the latest date on which the person from which the restitution is sought receives any unjust enrichment from the effects of the violation that gives rise to the suit in which the Commission seeks the restitution.</text></clause></subparagraph></paragraph> <paragraph id="H23887780E2A5434B996FB1BCB05B4D78"><enum>(4)</enum><header>Rules of construction</header><text>Nothing in this subsection may be construed as—</text> <subparagraph id="H4AABA64271FD40FFA227B3406F643960"><enum>(A)</enum><text>requiring the Commission to bring a suit seeking a temporary injunction under paragraph (1)(B) before bringing a suit seeking a permanent injunction under paragraph (1)(C); or</text></subparagraph> <subparagraph id="H2AE96FBF60634C8EB7C02D1762D3F539"><enum>(B)</enum><text>affecting any other authority of the Commission under this Act to seek relief or obtain a remedy with respect to a violation of this Act.</text></subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="HDCFE332EAF3946D79D956A36E3F51AF7"><enum>(b)</enum><header>Applicability</header><text>Section 27 of the Federal Trade Commission Act, as added by subsection (a), shall apply with respect to any—</text> <paragraph id="HF938F3472B3F4C4D91EA2D7FD5A7916F"><enum>(1)</enum><text>conduct that occurs on or after the date of enactment of this Act; and</text></paragraph> <paragraph id="HF6DAB4D91FD64CD2BA9D5FF4C44F3D26"><enum>(2)</enum><text>action or proceeding that is commenced on or after the date of enactment of this Act.</text></paragraph></subsection> <subsection id="HC7DE5241E04D4DCE9E67BEED8CA2681B"><enum>(c)</enum><header>Antitrust laws</header><text>Nothing in this section, or the amendments made by this section, shall modify, impair, limit, or supersede the applicability of the antitrust laws as defined in subsection (a) of the first section of the Clayton Act (<external-xref legal-doc="usc" parsable-cite="usc/15/12">15 U.S.C. 12(a)</external-xref>), and of section 5 of the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/45">15 U.S.C. 45</external-xref>) to the extent that it applies to unfair methods of competition.</text></subsection> <subsection id="H16491DB5FE2F42AE9B6F2361DD17A27A"><enum>(d)</enum><header>Rulemaking</header><text>The Federal Trade Commission may issue rules under section 553 of title 5, United States Code, to carry out section 27 of the Federal Trade Commission Act, as added by subsection (a), including by defining any terms used in such section 27 (other than terms that are defined in subsection (a) of such section 27).</text></subsection> <subsection id="HFCF73955EE12486886A929284CAE74B3"><enum>(e)</enum><header>Confirmation</header><text display-inline="yes-display-inline">Upon the request of the Commission, the Secretary shall provide confirmation of—</text> <paragraph id="HBD43F178DCB2436FB7B7DE1BF14B1CDB"><enum>(1)</enum><text>any request made by the Secretary to the manufacturer for an application or supplement to an application for a change, modification, or reformulation of a drug or biological product;</text></paragraph> <paragraph id="HAFC844C415804B969562B4081C232363"><enum>(2)</enum><text>any withdrawal by the manufacturer of an application for a drug or reference product; or</text></paragraph> <paragraph id="H2FF85CCCD4314F0D8956B1E9BF2DD537"><enum>(3)</enum><text>any request made by a manufacturer to the Secretary for withdrawal of an approval of the application for a drug or reference product or a request for placement of a drug or reference product on the discontinued products list.</text></paragraph></subsection></section> <section id="H6C832EFCE5334B7CBC3705FDAB42E67E"><enum>203.</enum><header>Title 35 amendments</header> <subsection id="H0017A5123F504FD29F11C7874C106F56"><enum>(a)</enum><header>In general</header><text>Section 271(e) of title 35, United States Code, is amended—</text> <paragraph id="H6D0FDA7A913A412D8E3C0316A9FE161F"><enum>(1)</enum><text>in paragraph (2)(C), in the flush text following clause (ii), by adding at the end the following: <quote>With respect to a submission described in clause (ii), the act of infringement shall extend to any patent that claims the biological product, a method of using the biological product, or a method or product used to manufacture the biological product.</quote>; and</text></paragraph> <paragraph id="HACA37F6DCD3A4974B681FE10115730A0"><enum>(2)</enum><text>by adding at the end the following:</text> <quoted-block act-name="" display-inline="no-display-inline" id="HCCE8A686DEEE4026AC963E4D86B260D5" style="OLC"> <paragraph id="H96AB402C42C143FBABCC9930022F7452" indent="up1"><enum>(7)</enum> <subparagraph commented="no" display-inline="yes-display-inline" id="HD43BAD9E98A0418CACF3E7A5B76273F0"><enum>(A)</enum><text>Subject to subparagraphs (C), (D), and (E), if the sponsor of an approved application for a reference product, as defined in section 351(i) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(i)</external-xref>) (referred to in this paragraph as the <quote>reference product sponsor</quote>), brings an action for infringement under this section against an applicant for approval of a biological product under section 351(k) of such Act that references that reference product (referred to in this paragraph as the <quote>subsection (k) applicant</quote>), the reference product sponsor may assert in the action a total of not more than 20 patents of the type described in subparagraph (B), not more than 10 of which shall have issued after the date specified in section 351(l)(7)(A) of such Act.</text></subparagraph> <subparagraph id="H69284029C9EC4D2A9EC2954692B0AEB8" indent="up1"><enum>(B)</enum><text>The patents described in this subparagraph are patents that satisfy each of the following requirements:</text> <clause id="H697B5A1A8C0D4B198C2CB8E5F845A0C2"><enum>(i)</enum><text>Patents that claim the biological product that is the subject of an application under section 351(k) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(k)</external-xref>) (or a use of that product) or a method or product used in the manufacture of such biological product.</text></clause> <clause id="H7D05F008B186466688925439B8E62B52"><enum>(ii)</enum><text>Patents that are included on the list of patents described in section 351(l)(3)(A) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(l)(3)(A)</external-xref>), including as provided under section 351(l)(7) of such Act.</text></clause> <clause id="H6F4E15C9C7F34CE3BDD8600F0DFA089D"><enum>(iii)</enum><text>Patents that—</text> <subclause id="H39D407A4D10B4F9AABCAAA7846C0FC3E"><enum>(I)</enum><text>have an actual filing date of more than 4 years after the date on which the reference product is approved; or</text></subclause> <subclause id="H6976321E86F14C85876456A7A2548B56"><enum>(II)</enum><text>include a claim to a method in a manufacturing process that is not used by the reference product sponsor.</text></subclause></clause></subparagraph> <subparagraph id="H1D34E2F3A2F64E31A400B3C4CFA735CA" indent="up1"><enum>(C)</enum><text>The court in which an action described in subparagraph (A) is brought may increase the number of patents limited under that subparagraph—</text> <clause id="HCACC7932E5A14E1BA900CED5CE8712A6"><enum>(i)</enum><text>if the request to increase that number is made without undue delay; and</text></clause> <clause id="HA2BB149CF837462DB481B02A0CE65993"><enum>(ii)</enum> <subclause commented="no" display-inline="yes-display-inline" id="HF516C7F657E442449B8C77E6976547BD"><enum>(I)</enum><text>if the interest of justice so requires; or</text></subclause> <subclause id="H209183593D1944DB9078D9516650B5A7" indent="up1"><enum>(II)</enum><text>for good cause shown, which—</text> <item id="HE8291F19E0AD436BB4C025B84FE8FDBE"><enum>(aa)</enum><text>shall be established if the subsection (k) applicant fails to provide information required under section 351(l)(2)(A) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(l)(2)(A)</external-xref>) that would enable the reference product sponsor to form a reasonable belief with respect to whether a claim of infringement under this section could reasonably be asserted; and</text></item> <item id="HE35997ADC42F45DFBA223737A308E52E"><enum>(bb)</enum><text>may be established—</text> <subitem id="H2FCB5C86DE6D4A36AA08E7B0913EF680"><enum>(AA)</enum><text>if there is a material change to the biological product (or process with respect to the biological product) of the subsection (k) applicant that is the subject of the application;</text></subitem> <subitem id="HD31BFD6B0E0C4E9D9030165030CA0C11"><enum>(BB)</enum><text>if, with respect to a patent on the supplemental list described in section 351(l)(7)(A) of Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(l)(7)(A)</external-xref>), the patent would have issued before the date specified in such section 351(l)(7)(A) but for the failure of the Office to issue the patent or a delay in the issuance of the patent, as described in paragraph (1) of section 154(b) and subject to the limitations under paragraph (2) of such section 154(b); or</text></subitem> <subitem id="H401F9430B3624A0794054B59595D3790"><enum>(CC)</enum><text>for another reason that shows good cause, as determined appropriate by the court.</text></subitem></item></subclause></clause></subparagraph> <subparagraph id="HCA425CF4D2BB4B37980E2DB3FDAFB5E0" indent="up1"><enum>(D)</enum><text>In determining whether good cause has been shown for the purposes of subparagraph (C)(ii)(II), a court may consider whether the reference product sponsor has provided a reasonable description of the identity and relevance of any information beyond the subsection (k) application that the court believes is necessary to enable the court to form a belief with respect to whether a claim of infringement under this section could reasonably be asserted.</text></subparagraph> <subparagraph id="H60758299410A48B1AC60A612974C161A" indent="up1"><enum>(E)</enum><text>The limitation imposed under subparagraph (A)—</text> <clause id="HC9C793E1EBB1430C9B8F46297D16A5FE"><enum>(i)</enum><text>shall apply only if the subsection (k) applicant completes all actions required under paragraphs (2)(A), (3)(B)(ii), (5), (6)(C)(i), (7), and (8)(A) of section 351(l) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(l)</external-xref>); and</text></clause> <clause id="HE67AC052F32044639D49F43E0173B475"><enum>(ii)</enum><text>shall not apply with respect to any patent that claims, with respect to a biological product, a method for using that product in therapy, diagnosis, or prophylaxis, such as an indication or method of treatment or other condition of use.</text></clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection> <subsection id="HF36FEA4B1F5E4D309D76A1BCDBFB847F"><enum>(b)</enum><header>Applicability</header><text>The amendments made by subsection (a) shall apply with respect to an application submitted under section 351(k) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(k)</external-xref>) on or after the date of enactment of this Act.</text></subsection></section>

(2)In the matter proposed to be inserted by the amendment of the Senate, strike sections 4, 5, and 6 and insert the following:

<enum>III</enum><header>Access to Counsel Act of 2020</header> <section id="HE50F074221154359B6311D46DE042319" section-type="subsequent-section"><enum>301.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote>Access to Counsel Act of 2020</quote>.</text></section> <section id="H34842ED66B7543F586EE431BF3D1A9C0"><enum>302.</enum><header>Access to counsel and other assistance at ports of entry and deferred inspection</header> <subsection id="H056BB9BD589D4D4F99A42EE5D4C1891C"><enum>(a)</enum><header>Access to counsel and other assistance during inspection</header><text display-inline="yes-display-inline">Section 235 of the Immigration and Nationality Act (<external-xref legal-doc="usc" parsable-cite="usc/8/1225">8 U.S.C. 1225</external-xref>) is amended by adding at the end the following:</text> <quoted-block id="H56B4622FB52344A49924C878C4A886EF" style="OLC"> <subsection id="HEDCBF12C2D184266B308E4850C5AC3F3"><enum>(e)</enum><header>Access to counsel and other assistance during inspection</header> <paragraph id="H7166272EF7724A598D09ABFA7B3BB78F"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary of Homeland Security shall ensure that a covered individual has a meaningful opportunity to consult with counsel and an interested party during the inspection process. </text></paragraph> <paragraph id="H3564265443E04599AF027C05868A2715"><enum>(2)</enum><header>Scope of assistance</header><text>The Secretary of Homeland Security shall—</text> <subparagraph id="H203ED26AD4234596B72AEA429EF2C0E6"><enum>(A)</enum><text display-inline="yes-display-inline">provide the covered individual a meaningful opportunity to consult with counsel and an interested party not later than one hour after the secondary inspection process commences and as necessary throughout the inspection process, including, as applicable, during deferred inspection; </text></subparagraph> <subparagraph id="H4C89C5859F5940FBB0CFD90097F281A9"><enum>(B)</enum><text display-inline="yes-display-inline">allow counsel and an interested party to advocate on behalf of the covered individual, including by providing to the examining immigration officer information, documentation, and other evidence in support of the covered individual; and</text></subparagraph> <subparagraph id="H9C9006DEF6F94C009EA1D787556F4178"><enum>(C)</enum><text display-inline="yes-display-inline">to the greatest extent practicable, accommodate a request by the covered individual for counsel or an interested party to appear in-person at the secondary or deferred inspection site. </text></subparagraph></paragraph> <paragraph id="H0925AD1211864E1D9BDEE6B378C77189"><enum>(3)</enum><header>Special rule for lawful permanent residents</header> <subparagraph id="HBF56E0916F4445AFB5DD42784873C2E3"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary of Homeland Security may not accept Form I-407 Record of Abandonment of Lawful Permanent Resident Status (or a successor form) from a lawful permanent resident subject to secondary or deferred inspection without providing such lawful permanent resident a reasonable opportunity to seek advice from counsel prior to the submission of the form. </text></subparagraph> <subparagraph id="HCF045444AEEA4FE9A1DEAE25AC1E1164"><enum>(B)</enum><header>Exception</header><text display-inline="yes-display-inline">The Secretary of Homeland Security may accept Form I-407 Record of Abandonment of Lawful Permanent Resident Status (or a successor form) from a lawful permanent resident subject to secondary or deferred inspection if such lawful permanent resident knowingly, intelligently, and voluntarily waives, in writing, the opportunity to seek advice from counsel.</text></subparagraph></paragraph> <paragraph id="HA084F70F058E4EA993885CB65A5974A0"><enum>(4)</enum><header>Definitions</header><text display-inline="yes-display-inline">In this section:</text> <subparagraph id="H34F9C3F31C9E44ECBD3F8E8C83B02768"><enum>(A)</enum><header>Counsel</header><text>The term <quote>counsel</quote> means—</text> <clause id="HAC951EF7220B4465B265A5FFF5839561"><enum>(i)</enum><text display-inline="yes-display-inline">an attorney who is a member in good standing of the bar of any State, the District of Columbia, or a territory or a possession of the United States and is not under an order suspending, enjoining, restraining, disbarring, or otherwise restricting the attorney in the practice of law; or</text></clause> <clause id="HF5EAB193C9F04332948FC790BE5CF621"><enum>(ii)</enum><text display-inline="yes-display-inline">an individual accredited by the Attorney General, acting as a representative of an organization recognized by the Executive Office for Immigration Review, to represent a covered individual in immigration matters. </text></clause></subparagraph> <subparagraph id="HC8B2515B33674C328BBA6F5AF2C7A11A"><enum>(B)</enum><header>Covered individual</header><text display-inline="yes-display-inline">The term <quote>covered individual</quote> means an individual subject to secondary or deferred inspection who is—</text> <clause id="HC768B6F66E3140F2A49EC771E285115B"><enum>(i)</enum><text>a national of the United States; </text></clause> <clause id="H2BAF60DF23F24E82A71D23ABCA6B03B9"><enum>(ii)</enum><text display-inline="yes-display-inline">an immigrant, lawfully admitted for permanent residence, who is returning from a temporary visit abroad;</text></clause> <clause id="HBE942943B26F45788BC03845D2853AF4"><enum>(iii)</enum><text display-inline="yes-display-inline">an alien seeking admission as an immigrant in possession of a valid unexpired immigrant visa;</text></clause> <clause id="H68388A7955FC48598F40B2164B8E943D"><enum>(iv)</enum><text>an alien seeking admission as a non-immigrant in possession of a valid unexpired non-immigrant visa; </text></clause> <clause id="H88D76E2644074C39A7353BC6406FA76A"><enum>(v)</enum><text>a refugee;</text></clause> <clause id="H97D4F42D7FF04609BC3FB5BFB6AF2151"><enum>(vi)</enum><text>a returning asylee; or </text></clause> <clause id="H92AF240EFD27405F8D6C1AD55DF7C70B"><enum>(vii)</enum><text>an alien who has been approved for parole under section 212(d)(5)(A), including an alien who is returning to the United States in possession of a valid advance parole document. </text></clause></subparagraph> <subparagraph id="HE3E85872DF9C4827BC2D0A84E2C8CA86"><enum>(C)</enum><header>Interested party</header><text>The term <quote>interested party</quote> means—</text> <clause id="H099C7A10A4094C6F973C2DA3BBB63BC2" commented="no"><enum>(i)</enum><text>a relative of the covered individual;</text></clause> <clause id="HF42BED7AB6774FB3BEBD437EC9CE1E11" commented="no"><enum>(ii)</enum><text display-inline="yes-display-inline">in the case of a covered individual to whom an immigrant or non-immigrant visa has been issued, the petitioner or sponsor thereof (including an agent of such petitioner or sponsor); or</text></clause> <clause id="HB05C02D4D49E48EB85D36326B195D353" commented="no"><enum>(iii)</enum><text>a person, organization, or entity in the United States with a bona fide connection to the covered individual.</text></clause></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H019C0F34EB9A485B9B0EFD3296BD59AA"><enum>(b)</enum><header>Effective date</header><text>The amendment made by subsection (a) shall take effect 180 days after the date of the enactment of this Act.</text></subsection> <subsection id="H00B4970EAEAA4082989D2D241952EC2B"><enum>(c)</enum><header>Savings provision</header><text display-inline="yes-display-inline">Nothing in this title, or in any amendment made by this title, may be construed to limit a right to counsel or any right to appointed counsel under—</text> <paragraph id="HFC019139D812443189EBFBB6C98A75C7"><enum>(1)</enum><text>section 240(b)(4)(A) (<external-xref legal-doc="usc" parsable-cite="usc/8/1229a">8 U.S.C. 1229a(b)(4)(A)</external-xref>),</text></paragraph> <paragraph id="HBADF4FF4DB5A443CAACF6F0973E51B96"><enum>(2)</enum><text>section 292 of the Immigration and Nationality Act (<external-xref legal-doc="usc" parsable-cite="usc/8/1362">8 U.S.C. 1362</external-xref>), or</text></paragraph> <paragraph id="HCB1170598A61440AAA754CCDA9B47371"><enum>(3)</enum><text>any other provision of law, including any final court order securing such rights,</text></paragraph><continuation-text continuation-text-level="subsection">as in effect on the day before the date of the enactment of this Act.</continuation-text></subsection></section>

Lorraine MillerClerk.