,i #aacth ,,congress #ast ,session ,h4 ,r4 #bjca ,,in ,,the ,,house ,,of ,,representatives ,may #af1 #bjac ,mr4 ,markey 7for himself1 ,mr4 ,waxman1 ,ms4 ,de,lauro1 and ,ms4 ,schakowsky7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend title ,,iv of the ,public ,health ,service ,act to expand the clinical trial registry data bank1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,trial and ,experimental ,studies ,transparency ,act of #bjab or the ,,test ,act4 #b4 ,expanded clinical trial registry data bank 7a7 ,in general ,section #djb7;j7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb7;j77 is amended-- 7#a7 in paragraph 7#a77;,a7-- 7,a7 in clause 7ii7-- 7i7 by amending subclause 7,i7 to read as follows3 7,i7 an interventional study of a device subject to section #eaj7k71 #eae1 or #ebj7m7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 including any interventional study of a device conducted outside of the ,united ,states the results of which are submitted to the ,secretary in support of a ,,pma 7as such term is defined in section #had4c7;e7 of title #ba1 ,code of ,federal ,regulations72 a premarket notification required under section #eaj7k7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 or a ,,hde 7as such term is defined in section #had4c7m7 of title #ba1 ,code of ,federal ,regulations74 2 and 7ii7 in subclause 7,,ii7-- 7,i7 by striking pediatric2 and 7,,ii7 by inserting that involves data collection from human subjects before the period at the end2 7,b7 by amending clause 7iii7 to read as follows3 7iii7 ,applicable drug clinical trial ,the term applicable drug clinical trial means an interventional study of a drug subject to section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or to section #cea of this ,act1 including any interventional study of a drug conducted outside of the ,united ,states the results of which are submitted to the ,secretary in support of-- 7,i7 an ,,ind 7as such term is defined in section #cab4c of title #ba1 ,code of ,federal ,regulations72 7,,ii7 an application filed under subsection 7b7 or 7j7 of such section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 or 7,,iii7 an application for a license under section #cea4 2 7,c7 by redesignating clauses 7iv7 through 7ix7 as clauses 7v7 through 7x71 respectively2 7,d7 after clause 7iii71 by inserting the following new clause3 7iv7 ,interventional study ,for purposes of clauses 7ii7 and 7iii71 the term interventional study means a study in human beings in which individuals are assigned by an investigator1 based on a protocol1 to receive specific interventions to evaluate their effects on biomedical or health-related outcomes4 2 and 7,e7 in clause 7vi71 as redesignated by subparagraph 7,c7-- 7i7 in the heading1 by inserting 2 primary completion date after date2 and 7ii7 by inserting 1 also referred to as primary completion date1 before means2 7#b7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a77ii7-- 7i7 by redesignating subclauses 7,,ii71 7,,iii71 and 7,,iv7 as subclauses 7,,iii71 7,,iv71 and 7,v71 respectively2 7ii7 by inserting after subclause 7,i7 the following3 7,,ii7 supporting documents1 including-- 7aa7 consent documents used to enroll subjects into the trial1 as approved by the ,institutional ,review ,board or equivalent committee prior to the start of the trial2 and 7bb7 protocol documents1 as approved by the ,institutional ,review ,board or equivalent committee prior to the start of the trial2 2 and 7iii7 in subclause 7,,iv71 as so redesignated1 in item 7cc71 by inserting 7or1 in the case of a location outside of the ,united ,states1 other appropriate location information7 after zip code2 7,b7 in subparagraph 7,c77ii7 by striking #ba days after and inserting before2 and 7,c7 by amending subparagraph 7,d7 to read as follows3 7,d7 ,posting of ,data ,the ,director of ,,nih shall ensure that clinical trial information for an applicable clinical trial submitted in accordance with this paragraph is posted publically in the registry data bank not later than #cj days after such submission is determined to meet the quality criteria established by the ,director of ,,nih4 2 7#c7 in paragraph 7#c7-- 7,a7 in subparagraph 7,c7-- 7i7 by striking ,not later than #a year and all that follows through the colon and inserting ,subject to subparagraph 7#b77;,c71 the ,secretary shall include in the registry and results data bank the following elements for an applicable clinical trial32 and 7ii7 by adding at the end the following new clause3 7v7 ,supporting documents ,final consent and protocol documents1 including all dated amendments to the initial version of such documents1 as approved by the ,institutional ,review ,board or equivalent committee4 2 7,b7 in subparagraph 7,d7-- 7i7 by striking clauses 7ii7 and 7iv72 7ii7 in clause 7iii7-- 7,i7 by striking subclause 7,,iii72 and 7,,ii7 by redesignating subclause 7,,iv7 as subclause 7,,iii72 and 7iii7 by redesignating-- 7,i7 clause 7iii7 as clause 7ii72 and 7,,ii7 clauses 7v7 through 7vii7 as clauses 7iii7 through 7v71 respectively2 7,c7 in subparagraph 7,e7-- 7i7 by striking clauses 7i7 through 7v7 and inserting the following3 7i7 ,in general ,except as provided in clauses 7ii7 and 7iii71 the responsible party for an applicable clinical trial shall submit to the ,director of ,,nih for inclusion in the registry and results data bank the clinical trial information described in subparagraph 7,c7 not later than #a year after the primary completion date of such trial4 7ii7 ,delayed submission of results with certification ,if the responsible party for an applicable clinical trial submits a certification that an applicable clinical trial involves a drug described in clause 7iii7 or a device described in clause 7iv71 the responsible party shall submit to the ,director of ,,nih1 for inclusion in the registry and results data bank1 the clinical trial information described in subparagraphs 7,c7 and 7,d7 not later than the earliest of the following3 7,i7 ,the later of-- 7aa7 #cj days after the drug or device is approved1 licensed1 or cleared1 as applicable2 or 7bb7 #a year after the primary completion date of the applicable clinical trial4 7,,ii7 ,the date that is #b years after the primary completion date of the applicable clinical trial4 7iii7 ,drug described ,a drug described in this clause is a drug that contains an active ingredient1 including any ester or salt1 that has not been an ingredient in a drug approved in any other application under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensed for any use under section #cea of this ,act4 7iv7 ,device described ,a device described in this clause is a device that has not been approved or cleared for any use under section #eaj7k7 or under section #eae or #ebj7m7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 2 7ii7 by redesignating clause 7vi7 as clause 7v72 and 7iii7 by adding at the end the following3 7vi7 ,public postings related to delays and extensions ,information submitted by the responsible party as part of a certification for delayed submission of results submitted under clause 7ii7 or a request for extension submitted under clause 7v7 shall be posted publically in the registry data bank4 2 7,d7 by striking subparagraph 7,f72 7,e7 by redesignating subparagraphs 7,g7 through 7,i7 as subparagraphs 7,f7 through 7,h71 respectively2 and 7,f7 in subparagraph 7,f71 as so redesignated1 by inserting before the period at the end the following3 is determined to meet the quality criteria established by the ,director of ,,nih2 and 7#d7 in paragraph 7#d77;,b7-- 7,a7 in clause 7i77,,ii71 by striking 7#c77;,e77iii7 and inserting 7#c77;,e77ii72 and 7,b7 in clause 7ii77,,ii7-- 7i7 by striking by both2 and 7ii7 by striking and paragraph 7#c77;,d77ii77,,ii774 7b7 ,implementation ,the ,secretary of ,health and ,human ,services shall implement the amendments made by subsection 7a7 not later than #f months after the date of enactment of this ,act4 #c4 ,reporting requirement ,not later than #b years after the date of the enactment of this ,act1 and annually thereafter1 the ,director of the ,national ,institutes of ,health and the ,commissioner of the ,food and ,drug ,administration shall each submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a report that includes the following3 7#a7 ,based on information that is readily available in the data bank described in section #djb7;j7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb7;j77-- 7,a7 the number of trials that the ,director or ,commissioner1 as applicable1 has identified as trials that are likely to be subject to the reporting requirements of such section2 7,b7 of the trials identified under subparagraph 7,a71 the estimated numbers and percentages of such trials-- 7i7 that have complete registration information2 and 7ii7 that have met the result reporting requirements of section #djb7;j7 of the ,public ,health ,service ,act2 and 7,c7 whether results of the trials have been submitted by the responsible party by the due dates outlined in section #djb7;j7 of the ,public ,health ,service ,act and1 if not1 whether certifications for delayed submission of such results1 or requests for extensions1 have been submitted by the responsible party4 ,for purposes of this paragraph1 the ,secretary may use an algorithm or other technique for efficiently reviewing large amounts of data4 7#b7 ,a description of any actions taken to consult with other ,federal agencies under #djb7;j77#e77;,a77iv7 of the ,public ,health ,service ,act4 7#c7 ,in the case of a report submitted by the ,commissioner of the ,food and ,drug ,administration1 a description of any enforcement actions taken for violations of section #cja7;jj7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7;jj771 including-- 7,a7 warning letters or fines imposed related to reporting requirements2 and 7,b7 any inquiries made to responsible parties to inform those parties of any potential enforcement action4 7#d7 ,in the case of a report submitted by the ,director of the ,national ,institutes of ,health1 a description of any actions taken to withhold grant funds from responsible parties that are not compliant with the requirements of this section as indicated in #djb7;j77#e77;,a7 of the ,public ,health ,service ,act4 #d4 ,rulemaking related to foreign clinical studies 7a7 ,drugs ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue final regulations to amend section #cab4abj of title #ba1 ,code of ,federal ,regulations 7relating to foreign clinical studies not conducted under an ,,ind7 to require that clinical trial information for such a foreign clinical study be submitted for inclusion in the registry and results data bank in accordance with section #djb7;j7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb7;j771 as amended by this ,act1 as a condition for the acceptance of such study as support for an ,,ind 7as such term is defined in section #cab4c of title #ba1 ,code of ,federal ,regulations7 or application for marketing approval 7an application under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb774 7b7 ,devices ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue final regulations 7including regulations amending section #had4ae of title #ba1 ,code of ,federal ,regulations 7relating to research conducted outside the ,united ,states77 to require that clinical trial information for studies conducted outside the ,united ,states be submitted for inclusion in the registry and results data bank in accordance with section #djb7;j7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb7;j771 as amended by this ,act1 as a condition for the acceptance of such studies to support a ,,pma 7as such term is defined in section #had4c7;e7 of title #ba1 ,code of ,federal ,regulations71 a premarket notification required under section #eaj7k7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7k771 or ,,hde 7as such term is defined in section #had4c7m7 of title #ba1 ,code of ,federal ,regulations74