[117th Congress Public Law 9]
[From the U.S. Government Publishing Office]
[[Page 254]]
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Public Law 117-9
117th Congress
An Act
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
scope of new chemical exclusivity. <<NOTE: Apr. 23, 2021 - [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) <<NOTE: Deadline.>> 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) <<NOTE: Review.>> 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
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``(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) <<NOTE: Summary.>> 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
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(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)''.
Approved April 23, 2021.
LEGISLATIVE HISTORY--S. 415:
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CONGRESSIONAL RECORD, Vol. 167 (2021):
Mar. 10, considered and passed Senate.
Apr. 14, considered and passed House.
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