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 
S. 415—2 

‘‘(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 
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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)’’. 

Speaker of the House of Representatives. 

Vice President of the United States and

President of the Senate.