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[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.
```