[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 415 Enrolled Bill (ENR)]
S.415
One Hundred Seventeenth Congress
of the
United States of America
AT THE FIRST SESSION
Begun and held at the City of Washington on Sunday,
the third day of January, two thousand and twenty one
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)''.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.