(ii) by inserting a comma after
‘‘means’’;
(iii) by striking ‘‘requirements of law
and, that’’ and inserting ‘‘requirements of
law, and that’’;
(iv) by striking ‘‘the manufacturer af-
fords health care facilities the opportunity’’
and inserting ‘‘the manufacturer affords
such users the opportunity’’; and
(v) by striking ‘‘the health care facil-
ity’’.
(c) TITLE III; ADDITIONAL AMENDMENTS.—
(1) EFFECTIVE DATE.—Section 301(b) of Pub-
lic Law 107–250 (116 Stat. 1616), is amended by
striking ‘‘18 months’’ and inserting ‘‘36 months’’.
(2) 
PREMARKET
NOTIFICATION.—Section
510(o) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360(o)), as added by section 302(b) of
Public 
Law 
107–250 
(116 
Stat. 
1616), 
is
amended—
(A) in paragraph (1)(B), by striking ‘‘,
adulterated’’ and inserting ‘‘or adulterated’’;
and
(B) in paragraph (2)—
(i) in subparagraph (B), by striking ‘‘,
adulterated’’ and inserting ‘‘or adulter-
ated’’; and
(ii) in subparagraph (E), by striking
‘‘semicritical’’ and inserting ‘‘semi-crit-
ical’’.
(d) MISCELLANEOUS CORRECTIONS.—
(1) CERTAIN AMENDMENTS TO SECTION 515.—
(A) IN GENERAL.—
(i) TECHNICAL CORRECTION.—Section
515(c) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360e(c)), as
amended by sections 209 and 302(c)(2)(A)
of Public Law 107–250 (116 Stat. 1613,
1618), is amended by redesignating para-
graph (3) (as added by section 209 of such
Public Law) as paragraph (4).
(ii) 
MODULAR
REVIEW.—Section
515(c)(4)(B) of the Federal Food, Drug,
and 
Cosmetic 
Act 
(21 
U.S.C.
360e(c)(4)(B)) is amended by striking
‘‘unless an issue of safety’’ and inserting
‘‘unless a significant issue of safety’’.
(B) CONFORMING
AMENDMENT.—Section
210 of Public Law 107–250 (116 Stat. 1614)
is amended by striking ‘‘, as amended’’ and all
that follows through ‘‘by adding’’ and inserting
‘‘is amended in paragraph (3), as redesignated
by section 302(c)(2)(A) of this Act, by adding’’.
(2) CERTAIN AMENDMENTS TO SECTION 738.—
(A) IN GENERAL.—Section 738(a) of the
Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j(a)), as amended by subsection (a),
is amended—
(i) in the matter preceding paragraph
(1)—
(I) by striking ‘‘(a) TYPES
OF
FEES.—Beginning on’’ and inserting
the following:
‘‘(a) TYPES OF FEES.—
‘‘(1) IN GENERAL.—Beginning on’’; and
(II) by striking ‘‘this section as
follows:’’ and inserting ‘‘this section.’’;
and
(ii) by striking ‘‘(1) PREMARKET AP-
PLICATION,’’ and inserting the following:
‘‘(2) PREMARKET APPLICATION,’’.
(B) CONFORMING AMENDMENTS.—Section
738 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379j), as amended by subpara-
graph (A), is amended—
(i) in subsection (d)(1), in the last
sentence, 
by 
striking 
‘‘subsection
(a)(1)(A)’’ 
and 
inserting 
‘‘subsection
(a)(2)(A)’’;
(ii) in subsection (e)(1), by striking
‘‘subsection (a)(1)(A)(vii)’’ and inserting
‘‘subsection (a)(2)(A)(vii)’’;
(iii) in subsection (e)(2)(C)—
(I) in each of clauses (i) and (ii),
by striking ‘‘subsection (a)(1)(A)(vii)’’
and 
inserting 
‘‘subsection
(a)(2)(A)(vii)’’; and
(II) in clause (ii), by striking
‘‘subsection (a)(1)(A)(i)’’ and insert-
ing ‘‘subsection (a)(2)(A)(i)’’; and
(iv) in subsection (j), by striking
‘‘subsection 
(a)(1)(D),’’ 
and 
inserting
‘‘subsection (a)(2)(D),’’.
(C) ADDITIONAL
CONFORMING
AMEND-
MENT.—Section 102(b)(1) of Public Law 107–
250 (116 Stat. 1600) is amended, in the matter
preceding subparagraph (A), by striking ‘‘sec-