,,ii #aafth ,,congress #b;d ,session ,s4 #cgha ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,may #bj1 #bjbj,mr4 ,peters introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to increase reporting of1 help mitigate potential shortages related to1 and promote1 accountability and transparency for pharmaceuticals and medical devices4 #a4 ,short title ,this ,act may be cited as the ,pharmaceutical ,accountability1 ,responsibility1 and ,transparency ,act or the ,,part ,act4 #b4 ,,fda increased demand reporting with respect to drugs ,section #ejf;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c71 as amended by the ,,cares ,act 7,public ,law #aaf-acf71 is further amended-- 7#a7 in subsections 7c71 7e71 7f71 7g71 and 7j71 by inserting or 7k7 after subsection 7a7 each place such term appears2 and 7#b7 by adding at the end the following3 7k7 ,increased demand reporting 7#a7 ,in general ,the manufacturer of a drug described in subsection 7a7 or a biological product subject to subsection 7i77#c7 shall notify the ,secretary1 in accordance with paragraph 7#b71 of any-- 7,a7 increase in demand for the drug that the manufacturer likely will be unable to meet2 or 7,b7 export restrictions or other limitations imposed1 on or after the date of enactment of the ,,part ,act1 on manufacturing or shipment of the drug or any of its active pharmaceutical ingredients by the country in which such drug or any such ingredient is manufactured4 7#b7 ,timing ,a notice required under paragraph 7#a7 shall be submitted to the ,secretary as soon as practicable but not later than #e calendar days after the manufacturer becomes aware of the issue requiring notification under such paragraph4 7#c7 ,notification of resolution of issue ,a manufacturer of a drug who submits a notification to the ,secretary under paragraph 7#a7 shall notify the ,secretary after the issue giving rise to such notification has been resolved or when the manufacturer is able to meet demand4 4 #c4 ,,fda increased demand reporting with respect to devices ,section #ejf;,j of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c7 is amended-- 7#a7 in subsections 7c71 7e71 and 7f71 by inserting or 7j7 after subsection 7a7 each place such term appears2 and 7#b7 by adding at the end the following3 7j7 ,increased demand reporting 7#a7 ,in general ,the manufacturer of a device described in subsection 7a7 shall notify the ,secretary1 in accordance with paragraph 7#b71 of any-- 7,a7 increase in demand for the device that the manufacturer likely will be unable to meet2 or 7,b7 export restrictions or other limitations imposed1 on or after the date of enactment of the ,,part ,act1 on manufacturing or export of the device by the country in which such device or any component of the device is manufactured4 7#b7 ,timing ,a notice required under paragraph 7#a7 shall be submitted to the ,secretary as soon as practicable but not later than #e calendar days after the manufacturer becomes aware of the issue requiring notification under such paragraph4 7#c7 ,notification of resolution of issue ,a manufacturer of a device who submits a notification to the ,secretary under paragraph 7#a7 shall notify the ,secretary after the issue giving rise to such notification has been resolved or when the manufacturer is able to meet demand4 4 #d4 ,quarterly manufacturer reporting with respect to drugs and devices 7a7 ,registration of certain foreign establishments ,section #eaj7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;i77 is amended by inserting at the end the following new paragraph3 7#e7 ,the requirements of paragraphs 7#a7 and 7#b7 shall apply to establishments within a foreign country engaged in the manufacture1 preparation1 propagation1 compounding1 or processing of any drug1 including the active pharmaceutical ingredient1 or device that is required to be listed pursuant to subsection 7j74 ,such requirements shall apply regardless of whether the drug1 active pharmaceutical ingredient1 or device undergoes further manufacture1 preparation1 propagation1 compounding1 or processing at a separate establishment or establishments outside the ,united ,states prior to being imported or offered for import into the ,united ,states4 4 7b7 ,listing of drugs ,section #eaj7;j77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;j77#a77 is amended-- 7#a7 in subparagraph 7,d71 by striking and at the end2 7#b7 in subparagraph 7,e71 by striking the period at the end and inserting 2 and2 and 7#c7 by adding at the end the following new subparagraph3 7,f7 in the case of a drug contained in the applicable list1 a certification that the registrant has-- 7i7 identified every other establishment where manufacturing is performed for the drug2 and 7ii7 notified each known foreign establishment engaged in the manufacture1 preparation1 propagation1 compounding1 or processing of the drug1 including the active pharmaceutical ingredient1 of the inclusion of the drug in the list and the obligation to register under subsection 7i77#e74 4 7c7 ,quarterly reporting ,paragraph 7#c7 of section #eaj7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;j771 as amended by the ,,cares ,act 7,public ,law #aaf-acf71 is amended to read as follows3 7#c7 7,a7 ,subject to subparagraph 7,c7 each person who registers with the ,secretary under this section shall submit to the ,secretary quarterly reports1 in such electronic data format as the ,secretary requires1 containing the following information1 as applicable1 with respect to all drugs1 drug substances1 and devices manufactured1 prepared1 propagated1 compounded1 or processed at the establishment1 whether for import into the ,united ,states or distribution in another country3 7i7 ,with respect to a finished drug product-- 7,i7 the number of dosage units manufactured at each establishment since the last report1 broken down by-- 7aa7 the number of dosage units manufactured at each establishment at which final manufacturing occurred1 and the unique facility identifier of each such establishment2 7bb7 the number of dosage units from each such establishment that were distributed 7or are intended to be distributed7 for use in the ,united ,states and the number of dosage units that were distributed 7or are intended to be distributed7 for use outside of the ,united ,states2 and 7,,ii7 the sources of drug substances used in the manufacturing of the finished drug product1 and1 for each such source-- 7aa7 the unique facility identifier of each source of drug substance2 and 7bb7 the number of dosage units of the finished drug product manufactured using that drug substance from each source of drug substance2 and 7,,iii7 the ,national ,drug ,code number4 7ii7 ,with respect to a drug substance-- 7,i7 the amount of drug substance manufactured at each establishment since the last report and the unique facility identifier of each such establishment2 7,,ii7 the amount of the drug substance manufactured at each such establishment that was distributed 7or are intended to be distributed7 for use in the ,united ,states and the amount that was distributed 7or are intended to be distributed7 for use outside of the ,united ,states2 and 7,,iii7 the ,national ,drug ,code number4 7iii7 ,with respect to a device1 the number of units manufactured at each establishment since the last report1 broken down by-- 7,i7 the number of units manufactured at each establishment at which final manufacturing occurred1 and the establishment identification number of each such establishment2 and 7,,ii7 the number of units from each such establishment that were distributed 7or are intended to be distributed7 for use in the ,united ,states and the number of units that were distributed 7or are intended to be distributed7 for use outside of the ,united ,states4 7,b7 ,by order of the ,secretary1 certain biological products or categories of biological products may be exempt from some or all of the reporting requirements under subparagraph 7,a71 if the ,secretary determines1 at the ,secretary's sole discretion1 that applying such reporting requirements to such biological products or categories is not necessary to protect the public health4 7,c7 ,the determination of the appropriate structured electronic data format by the ,secretary under subparagraph 7,a71 whether to exempt certain biological products or categories of biological products under subparagraph 7,b71 and the date on which reporting begins under this section shall be exempt from the requirements of section #eec of title #e1 ,united ,states ,code4 4 7d7 ,effective date ,the amendments made by this section shall take effect on ,september #bc1 #bjbj4 7e7 ,confidentiality ,nothing in the amendments made by this section shall be construed as authorizing the ,secretary to disclose any information that is a trade secret or confidential information subject to section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code4 #e4 ,requiring ,,fda to share manufacturing information with ,,aspr and the ,assistant ,secretary of ,defense for ,health ,affairs 7a7 ,in general ,beginning as soon as practicable1 but not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall provide to the ,assistant ,secretary for ,preparedness and ,response and the ,assistant ,secretary of ,defense for ,health ,affairs all drug and device manufacturing data described in subsection 7b71 as appropriate and applicable1 for any of the following purposes3 7#a7 ,maintaining the strategic national stockpile under section #cai;,f-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b74 7#b7 ,evaluating health infrastructure under the ,division of ,critical ,infrastructure ,protection of the ,office of the ,assistant ,secretary for ,preparedness and ,response4 7#c7 ,preparing for and responding to public health emergencies and national security concerns4 7#d7 ,mitigating potential drug shortages4 7b7 ,reporting provisions ,the drug and device manufacturing data required to be provided as described in subsection 7a7 includes-- 7#a7 information reported by any manufacturer under subsection 7a7 or 7k7 of section #ejf;,c7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c7 or subsection 7a7 or 7j7 of section #ejf;,j of such ,act 7#ba ,u4,s4,c4 #cef;j72 7#b7 any risk management plan under section #ejf;,c7j7 of such ,act 7#ba ,u4,s4,c4 #cef;c7j77 that is made available to the ,secretary pursuant to such section2 7#c7 records or other information provided under section #gjd7;a77#d7 of such ,act 7#ba ,u4,s4,c4 #cgd7;a77#d772 and 7#d7 to the extent not already provided1 the locations where each drug that is a subject of a report or plan under paragraph 7#a71 7#b71 or 7#c7 is manufactured4 7c7 ,memoranda of understanding ,the ,commissioner of ,food and ,drugs and the ,assistant ,secretary for ,preparedness and ,response1 and the ,commissioner of ,food and ,drugs and the ,assistant ,secretary of ,defense for ,health ,affairs1 shall enter into memoranda of understanding to set forth the manner in which data will be shared under this section and the procedures for protecting any nonpublic data from further disclosure4