In the House of Representatives, U. S., 

July 22, 2020. 

Resolved, 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 

HOUSE AMENDMENTS TO SENATE AMENDMENT: 

Ω1æIn the matter proposed to be inserted by the amendment of the Senate, strike sections 1, 2, and 3 and insert 

the following: 

1 TITLE I—NO BAN ACT 

2 SEC. 101. SHORT TITLES. 

3 This title may be cited as the ‘‘National Origin-Based 

4 Antidiscrimination for Nonimmigrants Act’’ or the ‘‘NO 

5 BAN Act’’. 

6 SEC. 102. EXPANSION OF NONDISCRIMINATION PROVISION. 

7 Section 202(a)(1)(A) of the Immigration and Nation8 ality Act (8 U.S.C. 1152(a)(1)(A)) is amended— 

9 (1) by inserting ‘‘or a nonimmigrant visa, ad10 mission or other entry into the United States, or the 

11 approval or revocation of any immigration benefit’’ 

12 after ‘‘immigrant visa’’; 
2 

•HR 2486 EAH 

1 (2) by inserting ‘‘religion,’’ after ‘‘sex,’’; and 

2 (3) by inserting ‘‘, except if expressly required by 

3 statute, or if a statutorily authorized benefit takes 

4 into consideration such factors’’ before the period at 

5 the end. 

6 SEC. 103. TRANSFER AND LIMITATIONS ON AUTHORITY TO 

7 SUSPEND OR RESTRICT THE ENTRY OF A 

8 CLASS OF ALIENS. 

9 Section 212(f) of the Immigration and Nationality Act 

10 (8 U.S.C. 1182(f)) is amended to read as follows: 

11 ‘‘(f) AUTHORITY TO SUSPEND OR RESTRICT THE

12 ENTRY OF A CLASS OF ALIENS.— 

13 ‘‘(1) IN GENERAL.—Subject to paragraph (2), if 

14 the Secretary of State, in consultation with the Sec15 retary of Homeland Security, determines, based on 

16 specific and credible facts, that the entry of any 

17 aliens or any class of aliens into the United States 

18 would undermine the security or public safety of the 

19 United States or the preservation of human rights, 

20 democratic processes or institutions, or international 

21 stability, the President may temporarily— 

22 ‘‘(A) suspend the entry of such aliens or 

23 class of aliens as immigrants or nonimmigrants; 

24 or 
3 

•HR 2486 EAH 

1 ‘‘(B) impose any restrictions on the entry of 

2 such aliens that the President deems appro3 priate. 

4 ‘‘(2) LIMITATIONS.—In carrying out paragraph 

5 (1), the President, the Secretary of State, and the Sec6 retary of Homeland Security shall— 

7 ‘‘(A) only issue a suspension or restriction 

8 when required to address specific acts impli9 cating a compelling government interest in a 

10 factor identified in paragraph (1); 

11 ‘‘(B) narrowly tailor the suspension or re12 striction, using the least restrictive means, to 

13 achieve such compelling government interest; 

14 ‘‘(C) specify the duration of the suspension 

15 or restriction; and 

16 ‘‘(D) consider waivers to any class-based re17 striction or suspension and apply a rebuttable 

18 presumption in favor of granting family-based 

19 and humanitarian waivers. 

20 ‘‘(3) CONGRESSIONAL NOTIFICATION.— 

21 ‘‘(A) IN GENERAL.—Prior to the President 

22 exercising the authority under paragraph (1), 

23 the Secretary of State and the Secretary of 

24 Homeland Security shall consult Congress and 

25 provide Congress with specific evidence sup-
4 

•HR 2486 EAH 

1 porting the need for the suspension or restriction 

2 and its proposed duration. 

3 ‘‘(B) BRIEFING AND REPORT.—Not later 

4 than 48 hours after the President exercises the 

5 authority under paragraph (1), the Secretary of 

6 State and the Secretary of Homeland Security 

7 shall provide a briefing and submit a written re8 port to Congress that describes— 

9 ‘‘(i) the action taken pursuant to para10 graph (1) and the specified objective of such 

11 action; 

12 ‘‘(ii) the estimated number of individ13 uals who will be impacted by such action; 

14 ‘‘(iii) the constitutional and legislative 

15 authority under which such action took 

16 place; and 

17 ‘‘(iv) the circumstances necessitating 

18 such action, including how such action com19 plies with paragraph (2), as well as any in20 telligence informing such actions. 

21 ‘‘(C) TERMINATION.—If the briefing and re22 port described in subparagraph (B) are not pro23 vided to Congress during the 48 hours that begin 

24 when the President exercises the authority under 

25 paragraph (1), the suspension or restriction shall 
5 

•HR 2486 EAH 

1 immediately terminate absent intervening con2 gressional action. 

3 ‘‘(D) CONGRESSIONAL COMMITTEES.—The 

4 term ‘Congress’, as used in this paragraph, refers 

5 to the Select Committee on Intelligence of the 

6 Senate, the Committee on Foreign Relations of 

7 the Senate, the Committee on the Judiciary of 

8 the Senate, the Committee on Homeland Secu9 rity and Governmental Affairs of the Senate, the 

10 Permanent Select Committee on Intelligence of 

11 the House of Representatives, the Committee on 

12 Foreign Affairs of the House of Representatives, 

13 the Committee on the Judiciary of the House of 

14 Representatives, and the Committee on Home15 land Security of the House of Representatives. 

16 ‘‘(4) PUBLICATION.—The Secretary of State and 

17 the Secretary of Homeland Security shall publicly an18 nounce and publish an unclassified version of the re19 port described in paragraph (3)(B) in the Federal 

20 Register. 

21 ‘‘(5) JUDICIAL REVIEW.— 

22 ‘‘(A) IN GENERAL.—Notwithstanding any 

23 other provision of law, an individual or entity 

24 who is present in the United States and has been 

25 harmed by a violation of this subsection may file 
6 

•HR 2486 EAH 

1 an action in an appropriate district court of the 

2 United States to seek declaratory or injunctive 

3 relief. 

4 ‘‘(B) CLASS ACTION.—Nothing in this Act 

5 may be construed to preclude an action filed 

6 pursuant to subparagraph (A) from proceeding 

7 as a class action. 

8 ‘‘(6) TREATMENT OF COMMERCIAL AIRLINES.— 

9 Whenever the Secretary of Homeland Security finds 

10 that a commercial airline has failed to comply with 

11 regulations of the Secretary of Homeland Security re12 lating to requirements of airlines for the detection of 

13 fraudulent documents used by passengers traveling to 

14 the United States (including the training of personnel 

15 in such detection), the Secretary of Homeland Secu16 rity may suspend the entry of some or all aliens 

17 transported to the United States by such airline. 

18 ‘‘(7) RULE OF CONSTRUCTION.—Nothing in this 

19 section may be construed as authorizing the Presi20 dent, the Secretary of State, or the Secretary of 

21 Homeland Security to act in a manner inconsistent 

22 with the policy decisions expressed in the immigra23 tion laws. 

24 ‘‘(8) CLARIFICATION.—For purposes of para25 graph (1), the term ‘public safety of the United 
7 

•HR 2486 EAH 

1 States’ includes efforts necessary to contain a commu2 nicable disease of public health significance (as de3 fined in section 34.2(b) of title 42, Code of Federal 

4 Regulations (or any successor regulation)).’’. 

5 SEC. 104. TERMINATION OF CERTAIN EXECUTIVE ACTIONS. 

6 (a) TERMINATION.—Presidential Proclamations 9645, 

7 9822, and 9983 and Executive Orders 13769, 13780, and 

8 13815 shall be void beginning on the date of the enactment 

9 of this Act. 

10 (b) EFFECT.—All actions taken pursuant to any proc11 lamation or executive order terminated under subsection (a) 

12 shall cease on the date of the enactment of this Act. 

13 SEC. 105. VISA APPLICANTS REPORT. 

14 (a) INITIAL REPORTS.— 

15 (1) IN GENERAL.—Not later than 90 days after 

16 the date of the enactment of this Act, the Secretary of 

17 State, in coordination with the Secretary of Home18 land Security and the heads of other relevant Federal 

19 agencies, shall submit a report to the congressional 

20 committees referred to in section 212(f)(3)(D) of the 

21 Immigration and Nationality Act, as amended by sec22 tion 103 of this title, that describes the implementa23 tion of each of the presidential proclamations and ex24 ecutive orders referred to in section 104. 
8 

•HR 2486 EAH 

1 (2) PRESIDENTIAL PROCLAMATION 9645 AND

2 9983.—In addition to the content described in para3 graph (1), the report submitted with respect to Presi4 dential Proclamation 9645, issued on September 24, 

5 2017, and Presidential Proclamation 9983, issued on 

6 January 31, 2020, shall include, for each country list7 ed in such proclamation— 

8 (A) the total number of individuals who ap9 plied for a visa during the time period the proc10 lamation was in effect, disaggregated by country 

11 and visa category; 

12 (B) the total number of visa applicants de13 scribed in subparagraph (A) who were approved, 

14 disaggregated by country and visa category; 

15 (C) the total number of visa applicants de16 scribed in subparagraph (A) who were refused, 

17 disaggregated by country and visa category, and 

18 the reasons they were refused; 

19 (D) the total number of visa applicants de20 scribed in subparagraph (A) whose applications 

21 remain pending, disaggregated by country and 

22 visa category; 

23 (E) the total number of visa applicants de24 scribed in subparagraph (A) who were granted a 
9 

•HR 2486 EAH 

1 waiver, disaggregated by country and visa cat2 egory; 

3 (F) the total number of visa applicants de4 scribed in subparagraph (A) who were denied a 

5 waiver, disaggregated by country and visa cat6 egory, and the reasons such waiver requests were 

7 denied; 

8 (G) the total number of refugees admitted, 

9 disaggregated by country; and 

10 (H) the complete reports that have been sub11 mitted to the President every 180 days in ac12 cordance with section 4 of Presidential Procla13 mation 9645 in its original form, and as amend14 ed by Presidential Proclamation 9983. 

15 (b) ADDITIONAL REPORTS.—Not later than 30 days 

16 after the date on which the President exercises the authority 

17 under section 212(f) of the Immigration and Nationality 

18 Act (8 U.S.C. 1182(f)), as amended by section 103 of this 

19 title, and every 30 days thereafter, the Secretary of State, 

20 in coordination with the Secretary of Homeland Security 

21 and heads of other relevant Federal agencies, shall submit 

22 a report to the congressional committees referred to in para23 graph (3)(D) of such section 212(f) that identifies, with re24 spect to countries affected by a suspension or restriction, 

25 the information described in subparagraphs (A) through 
10 

•HR 2486 EAH 

1 (H) of subsection (a)(2) of this section and specific evidence 

2 supporting the need for the continued exercise of presi3 dential authority under such section 212(f), including the 

4 information described in paragraph (3)(B) of such section 

5 212(f). If the report described in this subsection is not pro6 vided to Congress in the time specified, the suspension or 

7 restriction shall immediately terminate absent intervening 

8 congressional action. A final report with such information 

9 shall be prepared and submitted to such congressional com10 mittees not later than 30 days after the suspension or re11 striction is lifted. 

12 (c) FORM; AVAILABILITY.—The reports required under 

13 subsections (a) and (b) shall be made publicly available on14 line in unclassified form. 

15 TITLE II—AFFORDABLE PRE16 SCRIPTIONS FOR PATIENTS 

17 ACT OF 2020 

18 SEC. 201. SHORT TITLE. 

19 This title may be cited as the ‘‘Affordable Prescriptions 

20 for Patients Act of 2020’’. 

21 SEC. 202. PRODUCT HOPPING. 

22 (a) IN GENERAL.—The Federal Trade Commission Act 

23 (15 U.S.C. 41 et seq.) is amended by inserting after section 

24 26 (15 U.S.C. 57c–2) the following: 
11 

•HR 2486 EAH 

1 ‘‘SEC. 27. PRODUCT HOPPING. 

2 ‘‘(a) DEFINITIONS.—In this section: 

3 ‘‘(1) ABBREVIATED NEW DRUG APPLICATION.— 

4 The term ‘abbreviated new drug application’ means 

5 an application under subsection (b)(2) or (j) of sec6 tion 505 of the Federal Food, Drug, and Cosmetic Act 

7 (21 U.S.C. 355). 

8 ‘‘(2) BIOSIMILAR BIOLOGICAL PRODUCT.—The 

9 term ‘biosimilar biological product’ means a biologi10 cal product licensed under section 351(k) of the Public 

11 Health Service Act (42 U.S.C. 262(k)). 

12 ‘‘(3) BIOSIMILAR BIOLOGICAL PRODUCT LICENSE

13 APPLICATION.—The term ‘biosimilar biological prod14 uct license application’ means an application sub15 mitted under section 351(k) of the Public Health 

16 Service Act (42 U.S.C. 262(k)). 

17 ‘‘(4) FOLLOW-ON PRODUCT.—The term ‘follow-on 

18 product’— 

19 ‘‘(A) means a drug approved through an 

20 application or supplement to an application sub21 mitted under section 505(b) of the Federal Food, 

22 Drug, and Cosmetic Act (21 U.S.C. 355(b)) or a 

23 biological product licensed through an applica24 tion or supplement to an application submitted 

25 under section 351(a) of the Public Health Service 

26 Act (42 U.S.C. 262(a)) for a change, modifica-
12 

•HR 2486 EAH 

1 tion, or reformulation to the same manufactur2 er’s previously approved drug or biological prod3 uct that treats the same medical condition; and 

4 ‘‘(B) excludes such an application or sup5 plement to an application for a change, modi6 fication, or reformulation of a drug or biological 

7 product that is requested by the Secretary or nec8 essary to comply with law, including sections 

9 505A and 505B of the Federal Food, Drug, and 

10 Cosmetic Act (21 U.S.C. 355a, 355c). 

11 ‘‘(5) GENERIC DRUG.—The term ‘generic drug’ 

12 means a drug approved under an application sub13 mitted under subsection (b)(2) or (j) of section 505 of 

14 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

15 355). 

16 ‘‘(6) LISTED DRUG.—The term ‘listed drug’ 

17 means a drug listed under section 505(j)(7) of the 

18 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

19 355(j)(7)). 

20 ‘‘(7) MANUFACTURER.—The term ‘manufacturer’ 

21 means the holder, licensee, or assignee of— 

22 ‘‘(A) an approved application for a drug 

23 under section 505(c) of the Federal Food, Drug, 

24 and Cosmetic Act (21 U.S.C. 355(c)); or 
13 

•HR 2486 EAH 

1 ‘‘(B) a biological product license under sec2 tion 351(a) of the Public Health Service Act (42 

3 U.S.C. 262(a)). 

4 ‘‘(8) REFERENCE PRODUCT.—The term ‘reference 

5 product’ has the meaning given the term in section 

6 351(i) of the Public Health Service Act (42 U.S.C. 

7 262(i)). 

8 ‘‘(9) SECRETARY.—The term ‘Secretary’ means 

9 the Secretary of Health and Human Services. 

10 ‘‘(10) ULTIMATE PARENT ENTITY.—The term ‘ul11 timate parent entity’ has the meaning given the term 

12 in section 801.1 of title 16, Code of Federal Regula13 tions, or any successor regulation. 

14 ‘‘(b) PROHIBITION ON PRODUCT HOPPING.— 

15 ‘‘(1) PRIMA FACIE.—Except as provided in para16 graph (2), a manufacturer of a reference product or 

17 listed drug shall be considered to have engaged in an 

18 unfair method of competition in or affecting com19 merce in violation of section 5(a) if the Commission 

20 demonstrates by a preponderance of the evidence in a 

21 proceeding initiated by the Commission under sub22 section (c)(1)(A), or in a suit brought under subpara23 graph (B) or (C) of subsection (c)(1), that, during the 

24 period beginning on the date on which the manufac25 turer of the reference product or listed drug first re-
14 

•HR 2486 EAH 

1 ceives notice that an applicant has submitted to the 

2 Commissioner of Food and Drugs an abbreviated new 

3 drug application or biosimilar biological product li4 cense application and ending on the date that is 180 

5 days after the date on which that generic drug or bio6 similar biological product is first marketed, the man7 ufacturer engaged in either of the following actions: 

8 ‘‘(A) The manufacturer engaged in a hard 

9 switch, which shall be established by dem10 onstrating that the manufacturer engaged in ei11 ther of the following actions: 

12 ‘‘(i) Upon the request of the manufac13 turer of the listed drug or reference product, 

14 the Commissioner of Food and Drugs with15 drew the approval of the application for the 

16 listed drug or reference product or placed 

17 the listed drug or reference product on the 

18 discontinued products list and the manufac19 turer marketed or sold a follow-on product. 

20 ‘‘(ii) The manufacturer of the listed 

21 drug or reference product— 

22 ‘‘(I)(aa) announced withdrawal 

23 of, discontinuance of the manufacture 

24 of, or intent to withdraw the applica25 tion with respect to the drug or ref-
15 

•HR 2486 EAH 

1 erence product in a manner that im2 pedes competition from a generic drug 

3 or a biosimilar biological product, as 

4 established by objective circumstances; 

5 or 

6 ‘‘(bb) destroyed the inventory of 

7 the listed drug or reference product in 

8 a manner that impedes competition 

9 from a generic drug or a biosimilar bi10 ological product, which may be estab11 lished by objective circumstances; and 

12 ‘‘(II) marketed or sold a follow-on 

13 product. 

14 ‘‘(B) The manufacturer engaged in a soft 

15 switch, which shall be established by dem16 onstrating that the manufacturer engaged in 

17 both of the following actions: 

18 ‘‘(i) The manufacturer took actions 

19 with respect to the listed drug or reference 

20 product other than those described in sub21 paragraph (A) that unfairly disadvantage 

22 the listed drug or reference product relative 

23 to the follow-on product described in clause 

24 (ii) in a manner that impedes competition 

25 from a generic drug or a biosimilar biologi-
16 

•HR 2486 EAH 

1 cal product that is highly similar to, and 

2 has no clinically meaningful difference with 

3 respect to safety, purity, and potency from, 

4 the reference product, which may be estab5 lished by objective circumstances. 

6 ‘‘(ii) The manufacturer marketed or 

7 sold a follow-on product. 

8 ‘‘(2) JUSTIFICATION.— 

9 ‘‘(A) IN GENERAL.—Subject to paragraph 

10 (3), the actions described in paragraph (1) by a 

11 manufacturer of a listed drug or reference prod12 uct shall not be considered to be an unfair meth13 od of competition in or affecting commerce if— 

14 ‘‘(i) the manufacturer demonstrates to 

15 the Commission or a district court of the 

16 United States, as applicable, by a prepon17 derance of the evidence in a proceeding ini18 tiated by the Commission under subsection 

19 (c)(1)(A), or in a suit brought under sub20 paragraph (B) or (C) of subsection (c)(1), 

21 that— 

22 ‘‘(I) the manufacturer would have 

23 taken the actions regardless of whether 

24 a generic drug that references the listed 

25 drug or biosimilar biological product 
17 

•HR 2486 EAH 

1 that references the reference product 

2 had already entered the market; and 

3 ‘‘(II)(aa) with respect to a hard 

4 switch under paragraph (1)(A), the 

5 manufacturer took the action for rea6 sons relating to the safety risk to pa7 tients of the listed drug or reference 

8 product; 

9 ‘‘(bb) with respect to an action de10 scribed in item (aa) or (bb) of para11 graph (1)(A)(ii)(I), there is a supply 

12 disruption that— 

13 ‘‘(AA) is outside of the con14 trol of the manufacturer; 

15 ‘‘(BB) prevents the produc16 tion or distribution of the appli17 cable listed drug or reference 

18 product; and 

19 ‘‘(CC) cannot be remedied by 

20 reasonable efforts; or 

21 ‘‘(cc) with respect to a soft switch 

22 under paragraph (1)(B), the manufac23 turer had legitimate pro-competitive 

24 reasons, apart from the financial ef-
18 

•HR 2486 EAH 

1 fects of reduced competition, to take the 

2 action. 

3 ‘‘(B) RULE OF CONSTRUCTION.—Nothing in 

4 subparagraph (A) may be construed to limit the 

5 information that the Commission may otherwise 

6 obtain in any proceeding or action instituted 

7 with respect to a violation of this section. 

8 ‘‘(3) RESPONSE.—With respect to a justification 

9 offered by a manufacturer under paragraph (2), the 

10 Commission may— 

11 ‘‘(A) rebut any evidence presented by a 

12 manufacturer during that justification; or 

13 ‘‘(B) establish by a preponderance of the 

14 evidence that, on balance, the pro-competitive 

15 benefits from the conduct described in subpara16 graph (A) or (B) of paragraph (1), as applica17 ble, do not outweigh any anticompetitive effects 

18 of the conduct, even in consideration of the jus19 tification so offered. 

20 ‘‘(c) ENFORCEMENT.— 

21 ‘‘(1) IN GENERAL.—If the Commission has rea22 son to believe that any manufacturer has violated, is 

23 violating, or is about to violate this section, the Com24 mission may take any of the following actions: 

25 ‘‘(A) Institute a proceeding— 
19 

•HR 2486 EAH 

1 ‘‘(i) that, except as provided in para2 graph (2), complies with the requirements 

3 under section 5(b); and 

4 ‘‘(ii) in which the Commission may 

5 impose on the manufacturer any penalty 

6 that the Commission may impose for a vio7 lation of section 5. 

8 ‘‘(B) In the same manner and to the same 

9 extent as provided in section 13(b), bring suit in 

10 a district court of the United States to tempo11 rarily enjoin the action of the manufacturer. 

12 ‘‘(C) Bring suit in a district court of the 

13 United States, in which the Commission may 

14 seek— 

15 ‘‘(i) to permanently enjoin the action 

16 of the manufacturer; 

17 ‘‘(ii) any of the remedies described in 

18 paragraph (3); and 

19 ‘‘(iii) any other equitable remedy, in20 cluding ancillary equitable relief. 

21 ‘‘(2) JUDICIAL REVIEW.— 

22 ‘‘(A) IN GENERAL.—Notwithstanding any 

23 provision of section 5, any manufacturer that is 

24 subject to a final order of the Commission that 

25 is issued in a proceeding instituted under para-
20 

•HR 2486 EAH 

1 graph (1)(A) may, not later than 30 days after 

2 the date on which the Commission issues the 

3 order, petition for review of the order in— 

4 ‘‘(i) the United States Court of Appeals 

5 for the District of Columbia Circuit; or 

6 ‘‘(ii) the court of appeals of the United 

7 States for the circuit in which the ultimate 

8 parent entity of the manufacturer is incor9 porated. 

10 ‘‘(B) TREATMENT OF FINDINGS.—In a re11 view of an order issued by the Commission con12 ducted by a court of appeals of the United States 

13 under subparagraph (A), the factual findings of 

14 the Commission shall be conclusive if those facts 

15 are supported by the evidence. 

16 ‘‘(3) EQUITABLE REMEDIES.— 

17 ‘‘(A) DISGORGEMENT.— 

18 ‘‘(i) IN GENERAL.—In a suit brought 

19 under paragraph (1)(C), the Commission 

20 may seek, and the court may order, 

21 disgorgement of any unjust enrichment that 

22 a person obtained as a result of the viola23 tion that gives rise to the suit. 

24 ‘‘(ii) CALCULATION.—Any 

25 disgorgement that is ordered with respect to 
21 

•HR 2486 EAH 

1 a person under clause (i) shall be offset by 

2 any amount of restitution ordered under 

3 subparagraph (B). 

4 ‘‘(iii) LIMITATIONS PERIOD.—The 

5 Commission may seek disgorgement under 

6 this subparagraph not later than 5 years 

7 after the latest date on which the person 

8 from which the disgorgement is sought re9 ceives any unjust enrichment from the ef10 fects of the violation that gives rise to the 

11 suit in which the Commission seeks the 

12 disgorgement. 

13 ‘‘(B) RESTITUTION.— 

14 ‘‘(i) IN GENERAL.—In a suit brought 

15 under paragraph (1)(C), the Commission 

16 may seek, and the court may order, restitu17 tion with respect to the violation that gives 

18 rise to the suit. 

19 ‘‘(ii) LIMITATIONS PERIOD.—The Com20 mission may seek restitution under this sub21 paragraph not later than 5 years after the 

22 latest date on which the person from which 

23 the restitution is sought receives any unjust 

24 enrichment from the effects of the violation 
22 

•HR 2486 EAH 

1 that gives rise to the suit in which the Com2 mission seeks the restitution. 

3 ‘‘(4) RULES OF CONSTRUCTION.—Nothing in this 

4 subsection may be construed as— 

5 ‘‘(A) requiring the Commission to bring a 

6 suit seeking a temporary injunction under para7 graph (1)(B) before bringing a suit seeking a 

8 permanent injunction under paragraph (1)(C); 

9 or 

10 ‘‘(B) affecting any other authority of the 

11 Commission under this Act to seek relief or ob12 tain a remedy with respect to a violation of this 

13 Act.’’. 

14 (b) APPLICABILITY.—Section 27 of the Federal Trade 

15 Commission Act, as added by subsection (a), shall apply 

16 with respect to any— 

17 (1) conduct that occurs on or after the date of en18 actment of this Act; and 

19 (2) action or proceeding that is commenced on or 

20 after the date of enactment of this Act. 

21 (c) ANTITRUST LAWS.—Nothing in this section, or the 

22 amendments made by this section, shall modify, impair, 

23 limit, or supersede the applicability of the antitrust laws 

24 as defined in subsection (a) of the first section of the Clay25 ton Act (15 U.S.C. 12(a)), and of section 5 of the Federal 
23 

•HR 2486 EAH 

1 Trade Commission Act (15 U.S.C. 45) to the extent that 

2 it applies to unfair methods of competition. 

3 (d) RULEMAKING.—The Federal Trade Commission 

4 may issue rules under section 553 of title 5, United States 

5 Code, to carry out section 27 of the Federal Trade Commis6 sion Act, as added by subsection (a), including by defining 

7 any terms used in such section 27 (other than terms that 

8 are defined in subsection (a) of such section 27). 

9 (e) CONFIRMATION.—Upon the request of the Commis10 sion, the Secretary shall provide confirmation of— 

11 (1) any request made by the Secretary to the 

12 manufacturer for an application or supplement to an 

13 application for a change, modification, or reformula14 tion of a drug or biological product; 

15 (2) any withdrawal by the manufacturer of an 

16 application for a drug or reference product; or 

17 (3) any request made by a manufacturer to the 

18 Secretary for withdrawal of an approval of the appli19 cation for a drug or reference product or a request for 

20 placement of a drug or reference product on the dis21 continued products list. 

22 SEC. 203. TITLE 35 AMENDMENTS. 

23 (a) IN GENERAL.—Section 271(e) of title 35, United 

24 States Code, is amended— 
24 

•HR 2486 EAH 

1 (1) in paragraph (2)(C), in the flush text fol2 lowing clause (ii), by adding at the end the following: 

3 ‘‘With respect to a submission described in clause (ii), 

4 the act of infringement shall extend to any patent 

5 that claims the biological product, a method of using 

6 the biological product, or a method or product used 

7 to manufacture the biological product.’’; and 

8 (2) by adding at the end the following: 

9 ‘‘(7)(A) Subject to subparagraphs (C), (D), and (E), 

10 if the sponsor of an approved application for a reference 

11 product, as defined in section 351(i) of the Public Health 

12 Service Act (42 U.S.C. 262(i)) (referred to in this para13 graph as the ‘reference product sponsor’), brings an action 

14 for infringement under this section against an applicant 

15 for approval of a biological product under section 351(k) 

16 of such Act that references that reference product (referred 

17 to in this paragraph as the ‘subsection (k) applicant’), the 

18 reference product sponsor may assert in the action a total 

19 of not more than 20 patents of the type described in sub20 paragraph (B), not more than 10 of which shall have issued 

21 after the date specified in section 351(l)(7)(A) of such Act. 

22 ‘‘(B) The patents described in this subparagraph are 

23 patents that satisfy each of the following requirements: 

24 ‘‘(i) Patents that claim the biological product 

25 that is the subject of an application under section 
25 

•HR 2486 EAH 

1 351(k) of the Public Health Service Act (42 U.S.C. 

2 262(k)) (or a use of that product) or a method or 

3 product used in the manufacture of such biological 

4 product. 

5 ‘‘(ii) Patents that are included on the list of pat6 ents described in section 351(l)(3)(A) of the Public 

7 Health Service Act (42 U.S.C. 262(l)(3)(A)), includ8 ing as provided under section 351(l)(7) of such Act. 

9 ‘‘(iii) Patents that— 

10 ‘‘(I) have an actual filing date of more than 

11 4 years after the date on which the reference 

12 product is approved; or 

13 ‘‘(II) include a claim to a method in a 

14 manufacturing process that is not used by the 

15 reference product sponsor. 

16 ‘‘(C) The court in which an action described in sub17 paragraph (A) is brought may increase the number of pat18 ents limited under that subparagraph— 

19 ‘‘(i) if the request to increase that number is 

20 made without undue delay; and 

21 ‘‘(ii)(I) if the interest of justice so requires; or 

22 ‘‘(II) for good cause shown, which— 

23 ‘‘(aa) shall be established if the subsection 

24 (k) applicant fails to provide information re25 quired under section 351(l)(2)(A) of the Public 
26 

•HR 2486 EAH 

1 Health Service Act (42 U.S.C. 262(l)(2)(A)) that 

2 would enable the reference product sponsor to 

3 form a reasonable belief with respect to whether 

4 a claim of infringement under this section could 

5 reasonably be asserted; and 

6 ‘‘(bb) may be established— 

7 ‘‘(AA) if there is a material change to 

8 the biological product (or process with re9 spect to the biological product) of the sub10 section (k) applicant that is the subject of 

11 the application; 

12 ‘‘(BB) if, with respect to a patent on 

13 the supplemental list described in section 

14 351(l)(7)(A) of Public Health Service Act 

15 (42 U.S.C. 262(l)(7)(A)), the patent would 

16 have issued before the date specified in such 

17 section 351(l)(7)(A) but for the failure of the 

18 Office to issue the patent or a delay in the 

19 issuance of the patent, as described in para20 graph (1) of section 154(b) and subject to 

21 the limitations under paragraph (2) of such 

22 section 154(b); or 

23 ‘‘(CC) for another reason that shows 

24 good cause, as determined appropriate by 

25 the court. 
27 

•HR 2486 EAH 

1 ‘‘(D) In determining whether good cause has been 

2 shown for the purposes of subparagraph (C)(ii)(II), a court 

3 may consider whether the reference product sponsor has pro4 vided a reasonable description of the identity and relevance 

5 of any information beyond the subsection (k) application 

6 that the court believes is necessary to enable the court to 

7 form a belief with respect to whether a claim of infringe8 ment under this section could reasonably be asserted. 

9 ‘‘(E) The limitation imposed under subparagraph 

10 (A)— 

11 ‘‘(i) shall apply only if the subsection (k) appli12 cant completes all actions required under paragraphs 

13 (2)(A), (3)(B)(ii), (5), (6)(C)(i), (7), and (8)(A) of 

14 section 351(l) of the Public Health Service Act (42 

15 U.S.C. 262(l)); and 

16 ‘‘(ii) shall not apply with respect to any patent 

17 that claims, with respect to a biological product, a 

18 method for using that product in therapy, diagnosis, 

19 or prophylaxis, such as an indication or method of 

20 treatment or other condition of use.’’. 

21 (b) APPLICABILITY.—The amendments made by sub22 section (a) shall apply with respect to an application sub23 mitted under section 351(k) of the Public Health Service 

24 Act (42 U.S.C. 262(k)) on or after the date of enactment 

25 of this Act. 
28 

•HR 2486 EAH 

Ω2æIn the matter proposed to be inserted by the amendment of the Senate, strike sections 4, 5, and 6 and insert 

the following: 

1 TITLE III—ACCESS TO COUNSEL 

2 ACT OF 2020 

3 SEC. 301. SHORT TITLE. 

4 This title may be cited as the ‘‘Access to Counsel Act 

5 of 2020’’. 

6 SEC. 302. ACCESS TO COUNSEL AND OTHER ASSISTANCE AT 

7 PORTS OF ENTRY AND DEFERRED INSPEC8 TION. 

9 (a) ACCESS TO COUNSEL AND OTHER ASSISTANCE

10 DURING INSPECTION.—Section 235 of the Immigration and 

11 Nationality Act (8 U.S.C. 1225) is amended by adding at 

12 the end the following: 

13 ‘‘(e) ACCESS TO COUNSEL AND OTHER ASSISTANCE

14 DURING INSPECTION.— 

15 ‘‘(1) IN GENERAL.—The Secretary of Homeland 

16 Security shall ensure that a covered individual has a 

17 meaningful opportunity to consult with counsel and 

18 an interested party during the inspection process. 

19 ‘‘(2) SCOPE OF ASSISTANCE.—The Secretary of 

20 Homeland Security shall— 

21 ‘‘(A) provide the covered individual a 

22 meaningful opportunity to consult with counsel 
29 

•HR 2486 EAH 

1 and an interested party not later than one hour 

2 after the secondary inspection process commences 

3 and as necessary throughout the inspection proc4 ess, including, as applicable, during deferred in5 spection; 

6 ‘‘(B) allow counsel and an interested party 

7 to advocate on behalf of the covered individual, 

8 including by providing to the examining immi9 gration officer information, documentation, and 

10 other evidence in support of the covered indi11 vidual; and 

12 ‘‘(C) to the greatest extent practicable, ac13 commodate a request by the covered individual 

14 for counsel or an interested party to appear in15 person at the secondary or deferred inspection 

16 site. 

17 ‘‘(3) SPECIAL RULE FOR LAWFUL PERMANENT

18 RESIDENTS.— 

19 ‘‘(A) IN GENERAL.—The Secretary of Home20 land Security may not accept Form I-407 

21 Record of Abandonment of Lawful Permanent 

22 Resident Status (or a successor form) from a 

23 lawful permanent resident subject to secondary 

24 or deferred inspection without providing such 

25 lawful permanent resident a reasonable oppor-
30 

•HR 2486 EAH 

1 tunity to seek advice from counsel prior to the 

2 submission of the form. 

3 ‘‘(B) EXCEPTION.—The Secretary of Home4 land Security may accept Form I-407 Record of 

5 Abandonment of Lawful Permanent Resident 

6 Status (or a successor form) from a lawful per7 manent resident subject to secondary or deferred 

8 inspection if such lawful permanent resident 

9 knowingly, intelligently, and voluntarily waives, 

10 in writing, the opportunity to seek advice from 

11 counsel. 

12 ‘‘(4) DEFINITIONS.—In this section: 

13 ‘‘(A) COUNSEL.—The term ‘counsel’ 

14 means— 

15 ‘‘(i) an attorney who is a member in 

16 good standing of the bar of any State, the 

17 District of Columbia, or a territory or a 

18 possession of the United States and is not 

19 under an order suspending, enjoining, re20 straining, disbarring, or otherwise restrict21 ing the attorney in the practice of law; or 

22 ‘‘(ii) an individual accredited by the 

23 Attorney General, acting as a representative 

24 of an organization recognized by the Execu25 tive Office for Immigration Review, to rep-
31 

•HR 2486 EAH 

1 resent a covered individual in immigration 

2 matters. 

3 ‘‘(B) COVERED INDIVIDUAL.—The term ‘cov4 ered individual’ means an individual subject to 

5 secondary or deferred inspection who is— 

6 ‘‘(i) a national of the United States; 

7 ‘‘(ii) an immigrant, lawfully admitted 

8 for permanent residence, who is returning 

9 from a temporary visit abroad; 

10 ‘‘(iii) an alien seeking admission as an 

11 immigrant in possession of a valid unex12 pired immigrant visa; 

13 ‘‘(iv) an alien seeking admission as a 

14 non-immigrant in possession of a valid un15 expired non-immigrant visa; 

16 ‘‘(v) a refugee; 

17 ‘‘(vi) a returning asylee; or 

18 ‘‘(vii) an alien who has been approved 

19 for parole under section 212(d)(5)(A), in20 cluding an alien who is returning to the 

21 United States in possession of a valid ad22 vance parole document. 

23 ‘‘(C) INTERESTED PARTY.—The term ‘inter24 ested party’ means— 
32 

•HR 2486 EAH 

1 ‘‘(i) a relative of the covered indi2 vidual; 

3 ‘‘(ii) in the case of a covered indi4 vidual to whom an immigrant or non-im5 migrant visa has been issued, the petitioner 

6 or sponsor thereof (including an agent of 

7 such petitioner or sponsor); or 

8 ‘‘(iii) a person, organization, or entity 

9 in the United States with a bona fide con10 nection to the covered individual.’’. 

11 (b) EFFECTIVE DATE.—The amendment made by sub12 section (a) shall take effect 180 days after the date of the 

13 enactment of this Act. 

14 (c) SAVINGS PROVISION.—Nothing in this title, or in 

15 any amendment made by this title, may be construed to 

16 limit a right to counsel or any right to appointed counsel 

17 under— 

18 (1) section 240(b)(4)(A) (8 U.S.C. 

19 1229a(b)(4)(A)), 

20 (2) section 292 of the Immigration and Nation21 ality Act (8 U.S.C. 1362), or 

22 (3) any other provision of law, including any 

23 final court order securing such rights, 
33 

•HR 2486 EAH 

1 as in effect on the day before the date of the enactment of 

2 this Act. 

Attest: 

Clerk. 
116TH CONGRESS 

2D SESSION H.R. 2486 

HOUSE AMENDMENTS TO 

SENATE AMENDMENT