In the nature of a substitute.

SA 2707. Mr. McCONNELL (for Mr. Alexander) proposed an amendment to
the bill S. 1636, to amend the Federal Food, Drug, and Cosmetic Act
with respect to the scope of new chemical exclusivity; as follows:

Strike all after the enacting clause and insert the
following:

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.'';

[[Page S7468]]

(4) in section 529(a)(4) (21 U.S.C. 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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