,i #aafth ,,congress #b;d ,session ,h4 ,r4 #fjfb ,,in ,,the ,,house ,,of ,,representatives ,march #c1 #bjbj,mr4 ,schneider 7for himself1 ,mr4 ,hice of ,georgia1 and ,ms4 ,schakowsky7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend certain provisions in the ,federal ,food1 ,drug1 and ,cosmetic ,act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices1 and for other purposes4 #a4 ,discontinuance or interruption in the production of life-saving devices 7a7 ,notification requirement ,section #ejf;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c7 is amended-- 7#a7 in the section heading1 by striking life-saving drugs and inserting life-saving drugs and devices2 7#b7 in the matter preceding paragraph 7#a7 in subsection 7a71 by striking a drug and inserting a drug or device2 7#c7 in subsection 7a77#a77;,c71 by striking such drug and inserting such drug or device2 7#d7 in the matter following paragraph 7#b7 in subsection 7a71 by striking the drug each place it appears and inserting the drug or device2 7#e7 in subsection 7c71 by striking the drugs and inserting the drugs or devices2 7#f7 in the matter before paragraph 7#a7 in subsection 7g71 by striking a drug shortage of a drug described in subsection 7a7 and inserting a drug or device shortage of a drug or device described in subsection 7a72 7#g7 in subsection 7g77#a71 by striking or a supplement to such an application submitted under section #eje7;j71 that could help mitigate or prevent such shortage and inserting a supplement to such an application submitted under section #eje7;j71 or a submission for clearance of a device under section #eaj7k71 classification of a device under section #eac7;f77#b71 or approval of a device under section #eae1 that could help mitigate or prevent such shortage2 7#h7 in subsection 7g77#b71 by striking such drug shortage and inserting such drug or device shortage2 7#i7 in subsection 7h71 by amending paragraph 7#b7 to read as follows3 7#b7 the term drug or device shortage or shortage1 with respect to a drug or device1 means a period of time when the demand or projected demand for the drug or device within the ,united ,states exceeds the supply of the drug or device2 and 2 and 7#aj7 in subsection 7h77#c77;,a71 by striking a drug and inserting a drug or device4 7b7 ,annual reporting on shortages ,section #ejf;,c-#a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c-#a7 is amended-- 7#a7 in the section heading1 by striking drug shortages and inserting drug and device shortages2 7#b7 in subsections 7a7 and 7b71 by striking drug shortages each place it appears and inserting drug and device shortages2 7#c7 in subsection 7a77#b71 by striking the staff of the ,center for ,drug ,evaluation and ,research's ,office of ,compliance and ,drug ,shortage ,program and inserting the staffs of the ,center for ,drug ,evaluation and ,research's ,office of ,compliance and ,drug ,shortage ,program and the ,center for ,devices and ,radiological ,health2 7#d7 in subsection 7a77#c77;,b77i71 by striking applications and supplements and inserting applications1 supplements1 and submissions2 and 7#e7 in subsections 7a77#e7 and 7c71 by striking drug shortage and inserting drug or device shortage4 #b4 ,device shortage list 7a7 ,in general ,section #ejf;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;e7 is amended-- 7#a7 in the section heading1 by striking ,drug ,shortage ,list and inserting ,drug and ,device ,shortage ,list2 and 7#b7 in subsection 7a71 by striking list of drugs and inserting list of drugs and devices4 7b7 ,contents ,section #ejf;,e7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;e7b77 is amended-- 7#a7 in the matter before paragraph 7#a71 by striking each drug and inserting each drug and device2 7#b7 by striking the drug each place it appears and inserting the drug or device2 7#c7 in paragraph 7#a71 by striking the ,national ,drug ,code number for such drug and inserting the ,national ,drug ,code number for any such drug2 and 7#d7 in paragraph 7#b71 by striking such drug and inserting such device4 7c7 ,public availability public health exception ,section #ejf;,e7c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;e7b77 is amended by striking drug products and inserting drug products or devices4 7d7 ,technical corrections ,effective as if included in the enactment of the #bast ,century ,cures ,act 7,public ,law #aad-bee71 section #caja7;a77#b77;,g7 of such ,act is amended1 in the amendments made by such section to section #ejf;,e7b77#c77;,e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;e7b77#c77;,e77-- 7#a7 by striking discontinuation and inserting ,discontinuation2 and 7#b7 by striking discontinuance and inserting ,discontinuance4 #c4 ,importation of devices in shortage ,section #hja7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;d77 is amended-- 7#a7 in paragraph 7#a71 by adding at the end the following subparagraph3 7,c7 ,except as authorized by the ,secretary in the case of a device that appears on the drug and device shortage list under section #ejf;,e1 no device may be imported into the ,united ,states for commercial use if such device is manufactured outside the ,united ,states1 unless the manufacturer has authorized the device to be marketed in the ,united ,states and has caused the device to be labeled to be marketed in the ,united ,states4 2 and 7#b7 in paragraph 7#b71 by striking drug each place it appears and inserting drug or device4