#aafth ,,congress #b;d ,session ,s4 #afcf ,,an ,,act ,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 #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 seq7 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 ,passed the ,senate ,december #ad1 #bjbj4,secretary