[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 415 Engrossed in Senate (ES)]
<DOC>
117th CONGRESS
1st Session
S. 415
_______________________________________________________________________
AN ACT
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
scope of new chemical exclusivity.
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)''.
Passed the Senate March 10, 2021.
Attest:
Secretary.
117th CONGRESS
1st Session
S. 415
_______________________________________________________________________
AN ACT
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
scope of new chemical exclusivity.