,,ii #aagth ,,congress #ast ,session ,s4 #dae ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,february #bd1 #bjba ,mr4 ,cassidy 7for himself1 ,ms4 ,smith1 and ,mr4 ,marshall7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act with respect to the scope of new chemical exclusivity4 #a4 ,clarifying the meaning of new chemical entity 7a7 ,in general ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended-- 7#a7 in section #eje 7#ba ,u4,s4,c4 #cee7-- 7,a7 in subsection 7c77#c77;,e71 by striking active ingredient 7including any ester or salt of the active ingredient7 each place it appears and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 7,b7 in subsection 7j77#e77;,f71 by striking active ingredient 7including any ester or salt of the active ingredient7 each place it appears and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 7,c7 in subsection 7l77#b77;,a7-- 7i7 by amending clause 7i7 to read as follows3 7i7 not later than #cj days after the date of approval of such applications-- 7,i7 for a drug1 no active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations77 of which has been approved in any other application under this section2 or 7,,ii7 for a biological product1 no active ingredient of which has been approved in any other application under section #cea of the ,public ,health ,service ,act2 and 2 and 7ii7 in clause 7ii71 by inserting or biological product before the period2 7,d7 by amending subsection 7s7 to read as follows3 7s7 ,referral to advisory committee ,the ,secretary shall-- 7#a7 refer a drug or biological product to a ,food and ,drug ,administration advisory committee for review at a meeting of such advisory committee prior to the approval of such drug or biological if it is-- 7,a7 a drug1 no active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations77 of which has been approved in any other application under this section2 or 7,b7 a biological product1 no active ingredient of which has been approved in any other application under section #cea of the ,public ,health ,service ,act2 or 7#b7 if the ,secretary does not refer a drug or biological product described in paragraph 7#a7 to a ,food and ,drug ,administration advisory committee prior to such approval1 provide in the action letter on the application for the drug or biological product a summary of the reasons why the ,secretary did not refer the drug or biological product to an advisory committee prior to approval4 2 and 7,e7 in subsection 7u77#a71 in the matter preceding subparagraph 7,a7-- 7i7 by striking active ingredient 7including any ester or salt of the active ingredient7 and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 and 7ii7 by striking same active ingredient and inserting same active moiety2 7#b7 in section #eab7;c77#b77;,f7 7#ba ,u4,s4,c4 #cfj;b7c77#b77;,f771 by striking active ingredient 7including any ester or salt of the active ingredient7 each place it appears and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 7#c7 in section #ebd7;a77#d7 7#ba ,u4,s4,c4 #cfjn7a77#d771 by amending subparagraph 7,c7 to read as follows3 7,c7 is for-- 7i7 a human drug1 no active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations77 of which has been approved in any other application under section #eje7;b77#a72 or 7ii7 a biological product1 no active ingredient of which has been approved in any other application under section #cea of the ,public ,health ,service ,act4 2 7#d7 in section #ebi7;a77#d7 7#ba ,u4,s4,c4 #cfj;ff7a77#d771 by striking subparagraphs 7,a7 and 7,b7 and inserting the following3 7,a7 is for a drug or biological product that is for the prevention or treatment of a rare pediatric disease2 7,b7 7i7 is for such a drug-- 7,i7 that contains no active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations77 that has been previously approved in any other application under subsection 7b77#a71 7b77#b71 or 7j7 of section #eje2 and 7,,ii7 that is the subject of an application submitted under section #eje7;b77#a72 or 7ii7 is for such a biological product-- 7,i7 that contains no active ingredient that has been previously approved in any other application under section #cea7;a7 or #cea7k7 of the ,public ,health ,service ,act2 and 7,,ii7 that is the subject of an application submitted under section #cea7;a7 of the ,public ,health ,service ,act2 2 and 7#e7 in section #efe;,a7a77#d7 7#ba ,u4,s4,c4 #cfj;bbb-#d;a7a77#d771 by amending subparagraph 7,d7 to read as follows3 7,d7 is for-- 7i7 a human drug1 no active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations77 of which has been approved in any other application under section #eje7;b77#a72 or 7ii7 a biological product1 no active ingredient of which has been approved in any other application under section #cea of the ,public ,health ,service ,act4 4 7b7 ,technical corrections ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended-- 7#a7 in section #eje 7#ba ,u4,s4,c4 #cee7-- 7,a7 in subsection 7c77#c77;,e71 by repealing clause 7i72 and 7,b7 in subsection 7j77#e77;,f71 by repealing clause 7i72 and 7#b7 in section #eje;,a7c77#a77;,a77i77,,ii7 7#ba ,u4,s4,c4 #cee;a7c77#a77;,a77i77,,ii771 by striking 7c77#c77;,d7 and inserting 7c77#c77;,e74