(b)(2), 360cc(a), (b), 379g(1)(D), (3), (6)(D),
382(a)(1)(B), (b)(1)(A)(ii)(II), (b)(1)(C), (c)(1)(C),
(d)(3), (d)(4), 392(c)) are each amended by striking
‘‘section 351 of the Public Health Service Act’’
wherever it appears and inserting ‘‘section 506’’.
(8) SECTION
201.—Section 201(ff)(3)(A) (21
U.S.C 321(ff)(3)(A)) is amended by striking ‘‘under
section 351 of the Public Health Service Act (42
U.S.C.262)’’ and inserting ‘‘section 506’’.
(9) SECTION
503.—Section 503(g)(4)(A) (21
U.S.C 353(g)(4)(A)) is amended by striking ‘‘in sec-
tion 351(a) of the Public Health Service Act (42
U.S.C. 262(a))’’ and inserting ‘‘in section 506’’.
(10) SECTION 503.—Section 503(g)(4)(B) (21
U.S.C. 353(g)(4)(B)) is amended to read as follows:
‘‘(B) As used in this subsection, the term ‘mar-
ket clearance’ includes—
‘‘(i) approval of an application under sec-
tion 505, 507, 511, 515, or 520(g) and
‘‘(ii) a finding of substantial equivalence
under this subchapter.’’.
(11) PUBLIC HEALTH SERVICE ACT.—The fol-
lowing sections of the Public Health Service Act are
amended as follows:
(A) 
Section 
227(c)(5) 
(42 
U.S.C.
236(c)(5)) is amended by striking ‘‘under sec-
tion 351 of this Act’’ and inserting ‘‘under sec-
tion 506 of such Act’’.
(B) Sections 352(a) and 352(b) (42 U.S.C.
263(a), 263(b)) are each amended by striking
‘‘in section 351’’ and inserting ‘‘in section 506
of the Federal Food, Drug, and Cosmetic Act’’.
(C) Section 2122(b)(2) (42 U.S.C. 360aa–
22(b)(2)) is amended by striking ‘‘section 351
of the Public Health Service Act’’ and inserting
‘‘section 506 of the Federal Food, Drug, and
Cosmetic Act’’.
(D) Section 2123(d)(2)(A) (42 U.S.C
360aa–23(d)(2)(A)) is amended by striking
‘‘under section 351’’ and inserting ‘‘under sec-
tion 506 of the Federal Food, Drug, and Cos-
metic Act’’.
(12) SECTION 1927.—Section 1927(k)(2)(B) of
the 
Social 
Security 
Act 
(42 
U.S.C. 
1396r–
8(k)(2)(B)) is amended by striking ‘‘under section
351 of the Public Health Service Act’’ and inserting
‘‘under section 506 of the Federal Food, Drug, and
Cosmetic Act’’.
(13) ORPHAN DRUG ACT.—Sections 5(b)(1)(A)
and 5(b)(1)(B) of the Orphan Drug Act (21 U.S.C.
360ee(b)(1)(A), 360ee(b)(1)(B)) are each amended
by striking ‘‘section 351 of the Public Health Serv-
ice Act’’ and inserting ‘‘section 506 of the Federal
Food, Drug, and Cosmetic Act’’.
(14) PATENTS.—Section 156 of title 35, United
States Code, is amended—
(A) in subsection (f)(2)(A), by striking
‘‘and the Public Health Service Act’’;
(B) in subsection (f)(4)—
(i) by striking subparagraph (A) and
redesignating subparagraphs (B) and (C)
as subparagraphs (A) and (B), respec-
tively; and
(ii) by inserting ‘‘506,’’ after ‘‘505,’’
each place it appears in subparagraph (A)
(as so redesignated); and
(C) in subsection (g)(1)(B)(ii), by striking
‘‘under section 351, subsection (b) of section
505’’ and inserting ‘‘under subsection (b) of
section 505, 506’’.
(15) INTERNAL REVENUE CODE OF 1986.—Sec-
tion 28(b)(2)(A)(ii)(II) of the Internal Revenue Code
of 1986 is amended by striking ‘‘under section 351
of the Public Health Service Act’’ and inserting
‘‘under section 506 of such Act’’.
(d) LICENSES.—All licenses effective under section
351 of the Public Health Service Act as of the date of
enactment of the Drug and Biological Products Reform
Act of 1996 shall be deemed to have been granted under
the applicable provisions of this Act as of such date and
shall be subject to the provisions of this Act as of such
date.
Æ