#aafth ,,congress #b;d ,session ,in the ,house of ,representatives1 ,u4 ,s41 ,july #bb1 #bjbj ,,house ,,amendments ,,to ,,senate ,,amendment3 ,that the ,house agree to the amendment of the ,senate to the bill 7,h4,r4 #bdhf7 entitled ,an ,act to reauthorize mandatory funding programs for historically ,black colleges and universities and other minority-serving institutions41 with the following 7#a7 ,in the matter proposed to be inserted by the amendment of the ,senate1 strike sections #a1 #b1 and #c and insert the following3 ,i ,,no ,,ban ,act #aja4 ,short titles ,this title may be cited as the ,national ,origin-,based ,antidiscrimination for ,nonimmigrants ,act or the ,,no ,,ban ,act4 #ajb4 ,expansion of nondiscrimination provision ,section #bjb7;a77#a77;,a7 of the ,immigration and ,nationality ,act 7#h ,u4,s4,c4 #aaeb7;a77#a77;,a77 is amended-- 7#a7 by inserting or a nonimmigrant visa1 admission or other entry into the ,united ,states1 or the approval or revocation of any immigration benefit after immigrant visa2 7#b7 by inserting religion1 after sex12 and 7#c7 by inserting 1 except if expressly required by statute1 or if a statutorily authorized benefit takes into consideration such factors before the period at the end4 #ajc4 ,transfer and limitations on authority to suspend or restrict the entry of a class of aliens ,section #bab7;f7 of the ,immigration and ,nationality ,act 7#h ,u4,s4,c4 #aahb7;f77 is amended to read as follows3 7f7 ,authority to suspend or restrict the entry of a class of aliens 7#a7 ,in general ,subject to paragraph 7#b71 if the ,secretary of ,state1 in consultation with the ,secretary of ,homeland ,security1 determines1 based on specific and credible facts1 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 rights1 democratic processes or institutions1 or international stability1 the ,president may temporarily-- 7,a7 suspend the entry of such aliens or class of aliens as immigrants or nonimmigrants2 or 7,b7 impose any restrictions on the entry of such aliens that the ,president deems appropriate4 7#b7 ,limitations ,in carrying out paragraph 7#a71 the ,president1 the ,secretary of ,state1 and the ,secretary of ,homeland ,security shall-- 7,a7 only issue a suspension or restriction when required to address specific acts implicating a compelling government interest in a factor identified in paragraph 7#a72 7,b7 narrowly tailor the suspension or restriction1 using the least restrictive means1 to achieve such compelling government interest2 7,c7 specify the duration of the suspension or restriction2 and 7,d7 consider waivers to any class-based restriction or suspension and apply a rebuttable presumption in favor of granting family-based and humanitarian waivers4 7#c7 ,congressional notification 7,a7 ,in general ,prior to the ,president exercising the authority under paragraph 7#a71 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 duration4 7,b7 ,briefing and report ,not later than #dh hours after the ,president exercises the authority under paragraph 7#a71 the ,secretary of ,state and the ,secretary of ,homeland ,security shall provide a briefing and submit a written report to ,congress that describes-- 7i7 the action taken pursuant to paragraph 7#a7 and the specified objective of such action2 7ii7 the estimated number of individuals who will be impacted by such action2 7iii7 the constitutional and legislative authority under which such action took place2 and 7iv7 the circumstances necessitating such action1 including how such action complies with paragraph 7#b71 as well as any intelligence informing such actions4 7,c7 ,termination ,if the briefing and report described in subparagraph 7,b7 are not provided to ,congress during the #dh hours that begin when the ,president exercises the authority under paragraph 7#a71 the suspension or restriction shall immediately terminate absent intervening congressional action4 7,d7 ,congressional committees ,the term ,congress1 as used in this paragraph1 refers to the ,select ,committee on ,intelligence of the ,senate1 the ,committee on ,foreign ,relations of the ,senate1 the ,committee on the ,judiciary of the ,senate1 the ,committee on ,homeland ,security and ,governmental ,affairs of the ,senate1 the ,permanent ,select ,committee on ,intelligence of the ,house of ,representatives1 the ,committee on ,foreign ,affairs of the ,house of ,representatives1 the ,committee on the ,judiciary of the ,house of ,representatives1 and the ,committee on ,homeland ,security of the ,house of ,representatives4 7#d7 ,publication ,the ,secretary of ,state and the ,secretary of ,homeland ,security shall publicly announce and publish an unclassified version of the report described in paragraph 7#c77;,b7 in the ,federal ,register4 7#e7 ,judicial review 7,a7 ,in general ,notwithstanding any other provision of law1 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 relief4 7,b7 ,class action ,nothing in this ,act may be construed to preclude an action filed pursuant to subparagraph 7,a7 from proceeding as a class action4 7#f7 ,treatment of commercial airlines ,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 7including the training of personnel in such detection71 the ,secretary of ,homeland ,security may suspend the entry of some or all aliens transported to the ,united ,states by such airline4 7#g7 ,rule of construction ,nothing in this section may be construed as authorizing the ,president1 the ,secretary of ,state1 or the ,secretary of ,homeland ,security to act in a manner inconsistent with the policy decisions expressed in the immigration laws4 7#h7 ,clarification ,for purposes of paragraph 7#a71 the term public safety of the ,united ,states includes efforts necessary to contain a communicable disease of public health significance 7as defined in section #cd4b7;b7 of title #db1 ,code of ,federal ,regulations 7or any successor regulation774 4 #ajd4 ,termination of certain executive actions 7a7 ,termination ,presidential ,proclamations #ifde1 #ihbb1 and #iihc and ,executive ,orders #acgfi1 #acghj1 and #achae shall be void beginning on the date of the enactment of this ,act4 7b7 ,effect ,all actions taken pursuant to any proclamation or executive order terminated under subsection 7a7 shall cease on the date of the enactment of this ,act4 #aje4 ,visa applicants report 7a7 ,initial reports 7#a7 ,in general ,not later than #ij days after the date of the enactment of this ,act1 the ,secretary of ,state1 in coordination with the ,secretary of ,homeland ,security and the heads of other relevant ,federal agencies1 shall submit a report to the congressional committees referred to in section #bab7;f77#c77;,d7 of the ,immigration and ,nationality ,act1 as amended by section #ajc of this title1 that describes the implementation of each of the presidential proclamations and executive orders referred to in section #ajd4 7#b7 ,presidential proclamation #ifde and #iihc ,in addition to the content described in paragraph 7#a71 the report submitted with respect to ,presidential ,proclamation #ifde1 issued on ,september #bd1 #bjag1 and ,presidential ,proclamation #iihc1 issued on ,january #ca1 #bjbj1 shall include1 for each country listed in such proclamation-- 7,a7 the total number of individuals who applied for a visa during the time period the proclamation was in effect1 disaggregated by country and visa category2 7,b7 the total number of visa applicants described in subparagraph 7,a7 who were approved1 disaggregated by country and visa category2 7,c7 the total number of visa applicants described in subparagraph 7,a7 who were refused1 disaggregated by country and visa category1 and the reasons they were refused2 7,d7 the total number of visa applicants described in subparagraph 7,a7 whose applications remain pending1 disaggregated by country and visa category2 7,e7 the total number of visa applicants described in subparagraph 7,a7 who were granted a waiver1 disaggregated by country and visa category2 7,f7 the total number of visa applicants described in subparagraph 7,a7 who were denied a waiver1 disaggregated by country and visa category1 and the reasons such waiver requests were denied2 7,g7 the total number of refugees admitted1 disaggregated by country2 and 7,h7 the complete reports that have been submitted to the ,president every #ahj days in accordance with section #d of ,presidential ,proclamation #ifde in its original form1 and as amended by ,presidential ,proclamation #iihc4 7b7 ,additional reports ,not later than #cj days after the date on which the ,president exercises the authority under section #bab7;f7 of the ,immigration and ,nationality ,act 7#h ,u4,s4,c4 #aahb7;f771 as amended by section #ajc of this title1 and every #cj days thereafter1 the ,secretary of ,state1 in coordination with the ,secretary of ,homeland ,security and heads of other relevant ,federal agencies1 shall submit a report to the congressional committees referred to in paragraph 7#c77;,d7 of such section #bab7;f7 that identifies1 with respect to countries affected by a suspension or restriction1 the information described in subparagraphs 7,a7 through 7,h7 of subsection 7a77#b7 of this section and specific evidence supporting the need for the continued exercise of presidential authority under such section #bab7;f71 including the information described in paragraph 7#c77;,b7 of such section #bab7;f74 ,if the report described in this subsection is not provided to ,congress in the time specified1 the suspension or restriction shall immediately terminate absent intervening congressional action4 ,a final report with such information shall be prepared and submitted to such congressional committees not later than #cj days after the suspension or restriction is lifted4 7c7 ,form2 availability ,the reports required under subsections 7a7 and 7b7 shall be made publicly available online in unclassified form4 ,,ii ,affordable ,prescriptions for ,patients ,act of #bjbj #bja4 ,short title ,this title may be cited as the ,affordable ,prescriptions for ,patients ,act of #bjbj4 #bjb4 ,product hopping 7a7 ,in general ,the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #da et seq47 is amended by inserting after section #bf 7#ae ,u4,s4,c4 #eg;c-#b7 the following3 #bg4 ,product hopping 7a7 ,definitions ,in this section3 7#a7 ,abbreviated new drug application ,the term abbreviated new drug application means an application under subsection 7b77#b7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee74 7#b7 ,biosimilar biological product ,the term biosimilar biological product means a biological product licensed under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k774 7#c7 ,biosimilar biological product license application ,the term biosimilar biological product license application means an application submitted under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k774 7#d7 ,follow-on product ,the term follow-on product-- 7,a7 means a drug approved through an application or supplement to an application submitted under section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 or a biological product licensed through an application or supplement to an application submitted under section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a77 for a change1 modification1 or reformulation to the same manufacturer's previously approved drug or biological product that treats the same medical condition2 and 7,b7 excludes such an application or supplement to an application for a change1 modification1 or reformulation of a drug or biological product that is requested by the ,secretary or necessary to comply with law1 including sections #eje;,a and #eje;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a1 #cee;c74 7#e7 ,generic drug ,the term generic drug means a drug approved under an application submitted under subsection 7b77#b7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee74 7#f7 ,listed drug ,the term listed drug means a drug listed under section #eje7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g774 7#g7 ,manufacturer ,the term manufacturer means the holder1 licensee1 or assignee of-- 7,a7 an approved application for a drug under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c772 or 7,b7 a biological product license under section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a774 7#h7 ,reference product ,the term reference product has the meaning given the term in section #cea7;i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;i774 7#i7 ,secretary ,the term ,secretary means the ,secretary of ,health and ,human ,services4 7#aj7 ,ultimate parent entity ,the term ultimate parent entity has the meaning given the term in section #hja4a of title #af1 ,code of ,federal ,regulations1 or any successor regulation4 7b7 ,prohibition on product hopping 7#a7 ,prima facie ,except as provided in paragraph 7#b71 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 #e7;a7 if the ,commission demonstrates by a preponderance of the evidence in a proceeding initiated by the ,commission under subsection 7c77#a77;,a71 or in a suit brought under subparagraph 7,b7 or 7,c7 of subsection 7c77#a71 that1 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 #ahj days after the date on which that generic drug or biosimilar biological product is first marketed1 the manufacturer engaged in either of the following actions3 7,a7 ,the manufacturer engaged in a hard switch1 which shall be established by demonstrating that the manufacturer engaged in either of the following actions3 7i7 ,upon the request of the manufacturer of the listed drug or reference product1 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 product4 7ii7 ,the manufacturer of the listed drug or reference product-- 7,i7 7aa7 announced withdrawal of1 discontinuance of the manufacture of1 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 product1 as established by objective circumstances2 or 7bb7 destroyed the inventory of the listed drug or reference product in a manner that impedes competition from a generic drug or a biosimilar biological product1 which may be established by objective circumstances2 and 7,,ii7 marketed or sold a follow-on product4 7,b7 ,the manufacturer engaged in a soft switch1 which shall be established by demonstrating that the manufacturer engaged in both of the following actions3 7i7 ,the manufacturer took actions with respect to the listed drug or reference product other than those described in subparagraph 7,a7 that unfairly disadvantage the listed drug or reference product relative to the follow-on product described in clause 7ii7 in a manner that impedes competition from a generic drug or a biosimilar biological product that is highly similar to1 and has no clinically meaningful difference with respect to safety1 purity1 and potency from1 the reference product1 which may be established by objective circumstances4 7ii7 ,the manufacturer marketed or sold a follow-on product4 7#b7 ,justification 7,a7 ,in general ,subject to paragraph 7#c71 the actions described in paragraph 7#a7 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-- 7i7 the manufacturer demonstrates to the ,commission or a district court of the ,united ,states1 as applicable1 by a preponderance of the evidence in a proceeding initiated by the ,commission under subsection 7c77#a77;,a71 or in a suit brought under subparagraph 7,b7 or 7,c7 of subsection 7c77#a71 that-- 7,i7 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 market2 and 7,,ii7 7aa7 with respect to a hard switch under paragraph 7#a77;,a71 the manufacturer took the action for reasons relating to the safety risk to patients of the listed drug or reference product2 7bb7 with respect to an action described in item 7aa7 or 7bb7 of paragraph 7#a77;,a77ii77,i71 there is a supply disruption that-- 7,,aa7 is outside of the control of the manufacturer2 7,,bb7 prevents the production or distribution of the applicable listed drug or reference product2 and 7,,cc7 cannot be remedied by reasonable efforts2 or 7cc7 with respect to a soft switch under paragraph 7#a77;,b71 the manufacturer had legitimate pro-competitive reasons1 apart from the financial effects of reduced competition1 to take the action4 7,b7 ,rule of construction ,nothing in subparagraph 7,a7 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 section4 7#c7 ,response ,with respect to a justification offered by a manufacturer under paragraph 7#b71 the ,commission may-- 7,a7 rebut any evidence presented by a manufacturer during that justification2 or 7,b7 establish by a preponderance of the evidence that1 on balance1 the pro-competitive benefits from the conduct described in subparagraph 7,a7 or 7,b7 of paragraph 7#a71 as applicable1 do not outweigh any anticompetitive effects of the conduct1 even in consideration of the justification so offered4 7c7 ,enforcement 7#a7 ,in general ,if the ,commission has reason to believe that any manufacturer has violated1 is violating1 or is about to violate this section1 the ,commission may take any of the following actions3 7,a7 ,institute a proceeding-- 7i7 that1 except as provided in paragraph 7#b71 complies with the requirements under section #e7;b72 and 7ii7 in which the ,commission may impose on the manufacturer any penalty that the ,commission may impose for a violation of section #e4 7,b7 ,in the same manner and to the same extent as provided in section #ac7;b71 bring suit in a district court of the ,united ,states to temporarily enjoin the action of the manufacturer4 7,c7 ,bring suit in a district court of the ,united ,states1 in which the ,commission may seek-- 7i7 to permanently enjoin the action of the manufacturer2 7ii7 any of the remedies described in paragraph 7#c72 and 7iii7 any other equitable remedy1 including ancillary equitable relief4 7#b7 ,judicial review 7,a7 ,in general ,notwithstanding any provision of section #e1 any manufacturer that is subject to a final order of the ,commission that is issued in a proceeding instituted under paragraph 7#a77;,a7 may1 not later than #cj days after the date on which the ,commission issues the order1 petition for review of the order in-- 7i7 the ,united ,states ,court of ,appeals for the ,district of ,columbia ,circuit2 or 7ii7 the court of appeals of the ,united ,states for the circuit in which the ultimate parent entity of the manufacturer is incorporated4 7,b7 ,treatment of findings ,in a review of an order issued by the ,commission conducted by a court of appeals of the ,united ,states under subparagraph 7,a71 the factual findings of the ,commission shall be conclusive if those facts are supported by the evidence4 7#c7 ,equitable remedies 7,a7 ,disgorgement 7i7 ,in general ,in a suit brought under paragraph 7#a77;,c71 the ,commission may seek1 and the court may order1 disgorgement of any unjust enrichment that a person obtained as a result of the violation that gives rise to the suit4 7ii7 ,calculation ,any disgorgement that is ordered with respect to a person under clause 7i7 shall be offset by any amount of restitution ordered under subparagraph 7,b74 7iii7 ,limitations period ,the ,commission may seek disgorgement under this subparagraph not later than #e 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 disgorgement4 7,b7 ,restitution 7i7 ,in general ,in a suit brought under paragraph 7#a77;,c71 the ,commission may seek1 and the court may order1 restitution with respect to the violation that gives rise to the suit4 7ii7 ,limitations period ,the ,commission may seek restitution under this subparagraph not later than #e 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 restitution4 7#d7 ,rules of construction ,nothing in this subsection may be construed as-- 7,a7 requiring the ,commission to bring a suit seeking a temporary injunction under paragraph 7#a77;,b7 before bringing a suit seeking a permanent injunction under paragraph 7#a77;,c72 or 7,b7 affecting any other authority of the ,commission under this ,act to seek relief or obtain a remedy with respect to a violation of this ,act4 4 7b7 ,applicability ,section #bg of the ,federal ,trade ,commission ,act1 as added by subsection 7a71 shall apply with respect to any-- 7#a7 conduct that occurs on or after the date of enactment of this ,act2 and 7#b7 action or proceeding that is commenced on or after the date of enactment of this ,act4 7c7 ,antitrust laws ,nothing in this section1 or the amendments made by this section1 shall modify1 impair1 limit1 or supersede the applicability of the antitrust laws as defined in subsection 7a7 of the first section of the ,clayton ,act 7#ae ,u4,s4,c4 #ab7;a771 and of section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to the extent that it applies to unfair methods of competition4 7d7 ,rulemaking ,the ,federal ,trade ,commission may issue rules under section #eec of title #e1 ,united ,states ,code1 to carry out section #bg of the ,federal ,trade ,commission ,act1 as added by subsection 7a71 including by defining any terms used in such section #bg 7other than terms that are defined in subsection 7a7 of such section #bg74 7e7 ,confirmation ,upon the request of the ,commission1 the ,secretary shall provide confirmation of-- 7#a7 any request made by the ,secretary to the manufacturer for an application or supplement to an application for a change1 modification1 or reformulation of a drug or biological product2 7#b7 any withdrawal by the manufacturer of an application for a drug or reference product2 or 7#c7 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 list4 #bjc4 ,title #ce amendments 7a7 ,in general ,section #bga7;e7 of title #ce1 ,united ,states ,code1 is amended-- 7#a7 in paragraph 7#b77;,c71 in the flush text following clause 7ii71 by adding at the end the following3 ,with respect to a submission described in clause 7ii71 the act of infringement shall extend to any patent that claims the biological product1 a method of using the biological product1 or a method or product used to manufacture the biological product42 and 7#b7 by adding at the end the following3 7#g7 7,a7 ,subject to subparagraphs 7,c71 7,d71 and 7,e71 if the sponsor of an approved application for a reference product1 as defined in section #cea7;i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;i77 7referred to in this paragraph as the reference product sponsor71 brings an action for infringement under this section against an applicant for approval of a biological product under section #cea7k7 of such ,act that references that reference product 7referred to in this paragraph as the subsection 7k7 applicant71 the reference product sponsor may assert in the action a total of not more than #bj patents of the type described in subparagraph 7,b71 not more than #aj of which shall have issued after the date specified in section #cea7l77#g77;,a7 of such ,act4 7,b7 ,the patents described in this subparagraph are patents that satisfy each of the following requirements3 7i7 ,patents that claim the biological product that is the subject of an application under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77 7or a use of that product7 or a method or product used in the manufacture of such biological product4 7ii7 ,patents that are included on the list of patents described in section #cea7l77#c77;,a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7l77#c77;,a771 including as provided under section #cea7l77#g7 of such ,act4 7iii7 ,patents that-- 7,i7 have an actual filing date of more than #d years after the date on which the reference product is approved2 or 7,,ii7 include a claim to a method in a manufacturing process that is not used by the reference product sponsor4 7,c7 ,the court in which an action described in subparagraph 7,a7 is brought may increase the number of patents limited under that subparagraph-- 7i7 if the request to increase that number is made without undue delay2 and 7ii7 7,i7 if the interest of justice so requires2 or 7,,ii7 for good cause shown1 which-- 7aa7 shall be established if the subsection 7k7 applicant fails to provide information required under section #cea7l77#b77;,a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7l77#b77;,a77 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 asserted2 and 7bb7 may be established-- 7,,aa7 if there is a material change to the biological product 7or process with respect to the biological product7 of the subsection 7k7 applicant that is the subject of the application2 7,,bb7 if1 with respect to a patent on the supplemental list described in section #cea7l77#g77;,a7 of ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7l77#g77;,a771 the patent would have issued before the date specified in such section #cea7l77#g77;,a7 but for the failure of the ,office to issue the patent or a delay in the issuance of the patent1 as described in paragraph 7#a7 of section #aed7;b7 and subject to the limitations under paragraph 7#b7 of such section #aed7;b72 or 7,,cc7 for another reason that shows good cause1 as determined appropriate by the court4 7,d7 ,in determining whether good cause has been shown for the purposes of subparagraph 7,c77ii77,,ii71 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 7k7 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 asserted4 7,e7 ,the limitation imposed under subparagraph 7,a7-- 7i7 shall apply only if the subsection 7k7 applicant completes all actions required under paragraphs 7#b77;,a71 7#c77;,b77ii71 7#e71 7#f77;,c77i71 7#g71 and 7#h77;,a7 of section #cea7l7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7l772 and 7ii7 shall not apply with respect to any patent that claims1 with respect to a biological product1 a method for using that product in therapy1 diagnosis1 or prophylaxis1 such as an indication or method of treatment or other condition of use4 4 7b7 ,applicability ,the amendments made by subsection 7a7 shall apply with respect to an application submitted under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77 on or after the date of enactment of this ,act4 7#b7 ,in the matter proposed to be inserted by the amendment of the ,senate1 strike sections #d1 #e1 and #f and insert the following3 ,,iii ,access to ,counsel ,act of #bjbj #cja4 ,short title ,this title may be cited as the ,access to ,counsel ,act of #bjbj4 #cjb4 ,access to counsel and other assistance at ports of entry and deferred inspection 7a7 ,access to counsel and other assistance during inspection ,section #bce of the ,immigration and ,nationality ,act 7#h ,u4,s4,c4 #abbe7 is amended by adding at the end the following3 7e7 ,access to counsel and other assistance during inspection 7#a7 ,in general ,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 process4 7#b7 ,scope of assistance ,the ,secretary of ,homeland ,security shall-- 7,a7 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 process1 including1 as applicable1 during deferred inspection2 7,b7 allow counsel and an interested party to advocate on behalf of the covered individual1 including by providing to the examining immigration officer information1 documentation1 and other evidence in support of the covered individual2 and 7,c7 to the greatest extent practicable1 accommodate a request by the covered individual for counsel or an interested party to appear in-person at the secondary or deferred inspection site4 7#c7 ,special rule for lawful permanent residents 7,a7 ,in general ,the ,secretary of ,homeland ,security may not accept ,form ,i-#djg ,record of ,abandonment of ,lawful ,permanent ,resident ,status 7or a successor form7 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 form4 7,b7 ,exception ,the ,secretary of ,homeland ,security may accept ,form ,i-#djg ,record of ,abandonment of ,lawful ,permanent ,resident ,status 7or a successor form7 from a lawful permanent resident subject to secondary or deferred inspection if such lawful permanent resident knowingly1 intelligently1 and voluntarily waives1 in writing1 the opportunity to seek advice from counsel4 7#d7 ,definitions ,in this section3 7,a7 ,counsel ,the term counsel means-- 7i7 an attorney who is a member in good standing of the bar of any ,state1 the ,district of ,columbia1 or a territory or a possession of the ,united ,states and is not under an order suspending1 enjoining1 restraining1 disbarring1 or otherwise restricting the attorney in the practice of law2 or 7ii7 an individual accredited by the ,attorney ,general1 acting as a representative of an organization recognized by the ,executive ,office for ,immigration ,review1 to represent a covered individual in immigration matters4 7,b7 ,covered individual ,the term covered individual means an individual subject to secondary or deferred inspection who is-- 7i7 a national of the ,united ,states2 7ii7 an immigrant1 lawfully admitted for permanent residence1 who is returning from a temporary visit abroad2 7iii7 an alien seeking admission as an immigrant in possession of a valid unexpired immigrant visa2 7iv7 an alien seeking admission as a non-immigrant in possession of a valid unexpired non-immigrant visa2 7v7 a refugee2 7vi7 a returning asylee2 or 7vii7 an alien who has been approved for parole under section #bab7;d77#e77;,a71 including an alien who is returning to the ,united ,states in possession of a valid advance parole document4 7,c7 ,interested party ,the term interested party means-- 7i7 a relative of the covered individual2 7ii7 in the case of a covered individual to whom an immigrant or non-immigrant visa has been issued1 the petitioner or sponsor thereof 7including an agent of such petitioner or sponsor72 or 7iii7 a person1 organization1 or entity in the ,united ,states with a bona fide connection to the covered individual4 4 7b7 ,effective date ,the amendment made by subsection 7a7 shall take effect #ahj days after the date of the enactment of this ,act4 7c7 ,savings provision ,nothing in this title1 or in any amendment made by this title1 may be construed to limit a right to counsel or any right to appointed counsel under-- 7#a7 section #bdj7;b77#d77;,a7 7#h ,u4,s4,c4 #abbi;a7b77#d77;,a771 7#b7 section #bib of the ,immigration and ,nationality ,act 7#h ,u4,s4,c4 #acfb71 or 7#c7 any other provision of law1 including any final court order securing such rights1 as in effect on the day before the date of the enactment of this ,act4 ,clerk4