[Congressional Record Volume 167, Number 45 (Wednesday, March 10, 2021)]
[Senate]
[Page S1435]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




 AMENDING THE FEDERAL FOOD, DRUG, AND COSMETIC ACT WITH RESPECT TO THE 
                   SCOPE OF NEW CHEMICAL EXCLUSIVITY

  Mr. SCHUMER. Mr. President, I ask unanimous consent that the 
Committee on Health, Education, Labor, and Pensions be discharged from 
further consideration of S. 415 and the Senate proceed to its immediate 
consideration.
  The ACTING PRESIDENT pro tempore. The clerk will report the bill by 
title.
  The senior assistant legislative clerk read as follows:

       A bill (S. 415) to amend the Federal Food, Drug, and 
     Cosmetic Act with respect to the scope of new chemical 
     exclusivity.

  There being no objection, the committee was discharged, and the 
Senate proceeded to consider the bill.
  Mr. SCHUMER. I ask unanimous consent that the bill be considered read 
a third time and passed and that the motion to reconsider be considered 
made and laid upon the table.
  The ACTING PRESIDENT pro tempore. Without objection, it is so 
ordered.
  The bill (S. 415) was ordered to be engrossed for a third reading, 
was read the third time, and passed, as follows

                                 S. 415

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. CLARIFYING THE MEANING OF NEW CHEMICAL ENTITY.

       (a) In General.--Chapter V of the Federal Food, Drug, and 
     Cosmetic Act is amended--
       (1) in section 505 (21 U.S.C. 355)--
       (A) in subsection (c)(3)(E), by striking ``active 
     ingredient (including any ester or salt of the active 
     ingredient)'' each place it appears and inserting ``active 
     moiety (as defined by the Secretary in section 314.3 of title 
     21, Code of Federal Regulations (or any successor 
     regulations))'';
       (B) in subsection (j)(5)(F), by striking ``active 
     ingredient (including any ester or salt of the active 
     ingredient)'' each place it appears and inserting ``active 
     moiety (as defined by the Secretary in section 314.3 of title 
     21, Code of Federal Regulations (or any successor 
     regulations))'';
       (C) in subsection (l)(2)(A)--
       (i) by amending clause (i) to read as follows:
       ``(i) not later than 30 days after the date of approval of 
     such applications--
       ``(I) for a drug, no active moiety (as defined by the 
     Secretary in section 314.3 of title 21, Code of Federal 
     Regulations (or any successor regulations)) of which has been 
     approved in any other application under this section; or
       ``(II) for a biological product, no active ingredient of 
     which has been approved in any other application under 
     section 351 of the Public Health Service Act; and''; and
       (ii) in clause (ii), by inserting ``or biological product'' 
     before the period;
       (D) by amending subsection (s) to read as follows:
       ``(s) Referral to Advisory Committee.--The Secretary 
     shall--
       ``(1) 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--
       ``(A) a drug, no active moiety (as defined by the Secretary 
     in section 314.3 of title 21, Code of Federal Regulations (or 
     any successor regulations)) of which has been approved in any 
     other application under this section; or
       ``(B) a biological product, no active ingredient of which 
     has been approved in any other application under section 351 
     of the Public Health Service Act; or
       ``(2) if the Secretary does not refer a drug or biological 
     product described in paragraph (1) to a Food and Drug 
     Administration advisory committee prior to such approval, 
     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 approval.''; and
       (E) in subsection (u)(1), in the matter preceding 
     subparagraph (A)--
       (i) by striking ``active ingredient (including any ester or 
     salt of the active ingredient)'' and inserting ``active 
     moiety (as defined by the Secretary in section 314.3 of title 
     21, Code of Federal Regulations (or any successor 
     regulations))''; and
       (ii) by striking ``same active ingredient'' and inserting 
     ``same active moiety'';
       (2) in section 512(c)(2)(F) (21 U.S.C. 360b(c)(2)(F)), by 
     striking ``active ingredient (including any ester or salt of 
     the active ingredient)'' each place it appears and inserting 
     ``active moiety (as defined by the Secretary in section 314.3 
     of title 21, Code of Federal Regulations (or any successor 
     regulations))'';
       (3) in section 524(a)(4) (21 U.S.C. 360n(a)(4)), by 
     amending subparagraph (C) to read as follows:
       ``(C) is for--
       ``(i) a human drug, no active moiety (as defined by the 
     Secretary in section 314.3 of title 21, Code of Federal 
     Regulations (or any successor regulations)) of which has been 
     approved in any other application under section 505(b)(1); or
       ``(ii) a biological product, no active ingredient of which 
     has been approved in any other application under section 351 
     of the Public Health Service Act.'';
       (4) in section 529(a)(4) (21 U.S.C. 360ff(a)(4)), by 
     striking subparagraphs (A) and (B) and inserting the 
     following:
       ``(A) is for a drug or biological product that is for the 
     prevention or treatment of a rare pediatric disease;
       ``(B)(i) is for such a drug--
       ``(I) that contains no active moiety (as defined by the 
     Secretary in section 314.3 of title 21, Code of Federal 
     Regulations (or any successor regulations)) that has been 
     previously approved in any other application under subsection 
     (b)(1), (b)(2), or (j) of section 505; and
       ``(II) that is the subject of an application submitted 
     under section 505(b)(1); or
       ``(ii) is for such a biological product--
       ``(I) that contains no active ingredient that has been 
     previously approved in any other application under section 
     351(a) or 351(k) of the Public Health Service Act; and
       ``(II) that is the subject of an application submitted 
     under section 351(a) of the Public Health Service Act;''; and
       (5) in section 565A(a)(4) (21 U.S.C. 360bbb-4a(a)(4)), by 
     amending subparagraph (D) to read as follows:
       ``(D) is for--
       ``(i) a human drug, no active moiety (as defined by the 
     Secretary in section 314.3 of title 21, Code of Federal 
     Regulations (or any successor regulations)) of which has been 
     approved in any other application under section 505(b)(1); or
       ``(ii) a biological product, no active ingredient of which 
     has been approved in any other application under section 351 
     of the Public Health Service Act.''.
       (b) Technical Corrections.--Chapter V of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended--
       (1) in section 505 (21 U.S.C. 355)--
       (A) in subsection (c)(3)(E), by repealing clause (i); and
       (B) in subsection (j)(5)(F), by repealing clause (i); and
       (2) in section 505A(c)(1)(A)(i)(II) (21 U.S.C. 
     355a(c)(1)(A)(i)(II)), by striking ``(c)(3)(D)'' and 
     inserting ``(c)(3)(E)''.

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