1.This Act may be cited as the
Medical Device User Fee Stabilization
Act of 2005
.
2.Amendments to the
Federal Food, Drug, and Cosmetic Act
(a)Section 738 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amended—
(1)in subsection (b)—
(A)after 2004;
, by inserting
and
; and
(B)by striking 2005;
and all
that follows through 2007
and inserting
2005
;
(2)in subsection (c)—
(A)by striking paragraphs (1), (2), and
(3);
(B)by redesignating paragraphs (4), (5), and
(6) as paragraphs (1), (2), and (3), respectively;
(C)in paragraph (1), as so redesignated,
by—
(i)striking the paragraph heading and
inserting 2007
increase
;
(ii)striking , in addition to
adjustments under paragraphs (1) and (2), further
;
(iii)striking established in subsection
(b)
and inserting under subsection (a)
; and
(iv)striking adjustment
each
place it appears and inserting increase
; and
(D)in paragraph (2), as so redesignated,
by—
(i)striking establish, for the next
fiscal year, and
and all that follows through the fees
and inserting publish in the Federal Register fees under subsection (a).
The fees
;
(ii)striking 2003
and inserting
2006
; and
(iii)striking $154,000.
and
inserting $259,600, and the fees established for fiscal year 2007 shall
be based on a premarket application fee of $281,600.
;
(3)in subsection (d)(2)(A)—
(A)in clause (i), by striking
$30,000,000
and inserting $75,000,000
; and
(B)by striking clause (ii) and inserting the
following:
(ii)
(I)If the Secretary has
evidence from actual experience that the $75,000,000 threshold established in
clause (i) results in a reduction in revenues from premarket applications,
premarket reports, and supplements that is 26 percent or more than would occur
without small business exemptions and lower fee rates, the Secretary
may—
- (aa)use the operating reserves in an amount not
to exceed the lesser of—
(AA)10 percent of the fees collected in fiscal
year 2005; or
(BB)$2,500,000; and
- (bb)upon the exhaustion of the amount described
under item (aa), adjust the $75,000,000 threshold as provided for under
subclause (II).
(II)To adjust the
threshold described in subclause (I)(bb), the Secretary shall publish a notice
in the Federal Register setting out the rationale for the adjustment, and the
new threshold. Such adjusted threshold may not be less than $30,000,000 and may
not be
retroactive.
;
(4)in subsection (e)(2)(A), by striking
$30,000,000
and inserting $75,000,000
;
(5)in subsection (g)(1)—
(A)in subparagraph (B)—
(i)by striking clause (i) and inserting the
following:
(i)For fiscal year 2005, the Secretary is
expected to meet all of the performance goals identified for the fiscal year if
the amount so appropriated for such fiscal year, excluding the amount of fees
appropriated for such fiscal year, is equal to or greater than $205,720,000
multiplied by the adjustment factor applicable to the fiscal
year.
;
and
(ii)in clause (ii), by striking the matter
preceding subclause (I) and inserting the following:
(ii)For fiscal year 2005, if the amount so
appropriated for such fiscal year, excluding the amount of fees appropriated
for such fiscal year, is more than 1 percent less than the amount that applies
under clause (i), the following
applies:
;
and
(B)in subparagraph (C)—
(i)in the matter preceding clause (i),
by—
(I)striking 2003 through
and
inserting 2005 and
; and
(II)inserting more than 1
percent
after years, is
; and
(ii)in clause (ii), by striking
sum
and inserting amount
;
(6)in subsection (h)(3)—
(A)in subparagraph (C), by striking the
semicolon and inserting ; and
; and
(B)by striking subparagraphs (D) and (E) and
inserting the following:
(D)such sums as may be necessary for each of
fiscal years 2006 and 2007.
;
and
(7)by striking subsection
(c)(5)
each place it appears and inserting subsection
(c)(2)
.
(b)
(1)Section 502(u) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(u)) is amended to read as
follows:
(u)(1)Subject to paragraph (2), if it is a
reprocessed single-use device, unless it, or an attachment thereto, prominently
and conspicuously bears the name of the manufacturer of the reprocessed device,
a generally recognized abbreviation of such name, or a unique and generally
recognized symbol identifying such manufacturer.
(2)The Secretary may by guidance waive any
requirement under paragraph (1) for a reprocessed device or category of
reprocessed devices if the Secretary determines that compliance with such a
requirement—
(A)is not feasible due to the physical
characteristics of the device or category of devices; or
(B)would compromise the provision of
reasonable assurance of the safety or effectiveness of the device or category
of
devices.
.
(2)Not later than 150 days after the date of
enactment of this Act, the Secretary of Health and Human Services shall issue
guidance specifying the device or category of devices that qualify for a waiver
under section 502(u) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
352(u)) (as amended by paragraph (1)).
(3)Section 301(b) of Public
Law 107–250 (116 Stat. 1616), as amended by section 2(c) of Public Law 108–214
(118 Stat. 575), is amended by—
(A)striking 36 months after the date of
enactment of this Act
and inserting 9 months after the date of
enactment of the Medical Device User Fee
Stabilization Act of 2005
; and
(B)inserting reprocessed and
before introduced
.
1.This Act may be cited as the
Medical Device User Fee Stabilization
Act of 2005
.
2.Amendments to the
Federal Food, Drug, and Cosmetic Act
(a)Section 738 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j) is amended—
(1)in subsection (b)—
(A)after
2004;
, by inserting and
; and
(B)by striking
2005;
and all that follows through 2007
and
inserting 2005
;
(2)in subsection (c)—
(A)by striking the heading
and inserting Annual Fee
Setting.—
;
(B)by striking paragraphs
(1), (2), (3), and (4);
(C)by redesignating
paragraphs (5) and (6) as paragraphs (1) and (2), respectively;
(D)in paragraph (1), as so
redesignated, by—
(i)striking the heading and
inserting In
general.—
;
(ii)striking
establish, for the next fiscal year, and
and all that follows
through the fees
and inserting publish in the Federal
Register fees under subsection (a). The fees
;
(iii)striking
2003
and inserting 2006
; and
(iv)striking
$154,000.
and inserting $259,600, and the fees
established for fiscal year 2007 shall be based on a premarket application fee
of $281,600.
; and
(E)by adding at the end the
following:
(3)
(A)For fiscal years 2006 and 2007, the Secretary may use
unobligated carryover balances from fees collected in previous fiscal years to
ensure that sufficient fee revenues are available in that fiscal year, so long
as the Secretary maintains unobligated carryover balances of not less than 1
month of operating reserves for the first month of fiscal year 2008.
(B)Not later than 14 days before the Secretary anticipates
the use of funds described in subparagraph (A), the Secretary shall provide
notice to the Committee on Health, Education, Labor, and Pensions and the
Committee on Appropriations of the Senate and the Committee on Energy and
Commerce and the Committee on Appropriations of the House of
Representatives.
;
(3)in subsection (d)—
(A)in paragraph (1), by
inserting after the first sentence the following: For the purposes of
this paragraph, the term small business
means an entity that
reported $30,000,000 or less of gross receipts or sales in its most recent
Federal income tax return for a taxable year, including such returns of all of
its affiliates, partners, and parent firms.
; and
(B)in paragraph (2)(A),
by—
(i)striking (i)
In
general.—
;
(ii)striking
subsection,
and inserting paragraph,
;
(iii)striking
$30,000,000
and inserting $100,000,000
;
and
(iv)striking clause
(ii);
(4)in subsection (e)(2)(A),
by striking $30,000,000
and inserting
$100,000,000
;
(5)in subsection
(g)(1)—
(A)in subparagraph
(B)—
(i)by striking clause (i)
and inserting the following:
(i)For fiscal year 2005, the
Secretary is expected to meet all of the performance goals identified for the
fiscal year if the amount so appropriated for such fiscal year, excluding the
amount of fees appropriated for such fiscal year, is equal to or greater than
$205,720,000 multiplied by the adjustment factor applicable to the fiscal
year.
;
and
(ii)in clause (ii), by
striking the matter preceding subclause (I) and inserting the following:
(ii)For fiscal year 2005, if
the amount so appropriated for such fiscal year, excluding the amount of fees
appropriated for such fiscal year, is more than 1 percent less than the amount
that applies under clause (i), the following
applies:
;
(B)in subparagraph
(C)—
(i)in the matter preceding
clause (i), by—
(I)striking 2003
through
and inserting 2005 and
; and
(II)inserting more
than 1 percent
after years, is
; and
(ii)in clause (ii), by
striking sum
and inserting amount
; and
(C)in subparagraph (D)(i),
by inserting more than 1 percent
after year,
is
;
(6)in subsection
(h)(3)—
(A)in subparagraph (C), by
striking the semicolon and inserting ; and
; and
(B)by striking subparagraphs
(D) and (E) and inserting the following:
(D)such sums as may be
necessary for each of fiscal years 2006 and
2007.
;
and
(7)by striking
subsection (c)(5)
each place it appears and inserting
subsection (c)(1)
.
(b)Section 103 of the Medical Device User Fee and
Modernization Act of 2002 (Public Law 107–250 (116 Stat. 1600)) is
amended—
(1)by striking
Beginning with
and inserting (a)
In
general.—Beginning with
; and
(2)by adding at the end the
following:
(b)For fiscal years 2006 and 2007, the report described
under subsection (a)(2) shall include—
(1)information on the number
of different types of applications and notifications, and the total amount of
fees paid for each such type of application or notification, from businesses
with gross receipts or sales from $0 to $100,000,000, with such businesses
categorized in $10,000,000 intervals; and
(2)a certification by the
Secretary that the amounts appropriated for salaries and expenses of the Food
and Drug Administration for such fiscal year and obligated by the Secretary for
the performance of any function relating to devices that is not for the process
for the review of device applications, as defined in paragraph (5) of section
737 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i), are not less
than such amounts for fiscal year 2002 multiplied by the adjustment factor, as
defined in paragraph (7) of such section
737.
.
(c)
(1)Section 502(u) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 352(u)) is amended to read as follows:
(u)(1)Subject to
paragraph (2), if it is a reprocessed single-use device, unless it, or an
attachment thereto, prominently and conspicuously bears the name of the
manufacturer of the reprocessed device, a generally recognized abbreviation of
such name, or a unique and generally recognized symbol identifying such
manufacturer.
(2)If
the original device or an attachment thereto does not prominently and
conspicuously bear the name of the manufacturer of the original device, a
generally recognized abbreviation of such name, or a unique and generally
recognized symbol identifying such manufacturer, a reprocessed device may
satisfy the requirements of paragraph (1) through the use of a detachable label
on the packaging that identifies the manufacturer and is intended to be affixed
to the medical record of a
patient.
.
(2)Not
later than 180 days after the date of enactment of this Act, the Secretary of
Health and Human Services shall issue guidance to identify circumstances in
which the name of the manufacturer of the original device, a generally
recognized abbreviation of such name, or a unique and generally recognized
symbol identifying such manufacturer, is not prominent and
conspicuous
, as used in section 502(u) of Federal Food, Drug, and
Cosmetic Act (as amended by paragraph (1)).
(d)Section 301(b) of the Medical Device User Fee and
Modernization Act of 2002 (Public Law 107–250 (116 Stat. 1616)), as amended by
section 2(c) of Public Law 108–214 (118 Stat. 575), is amended to read as
follows:
(b)Section 502(u) of the Federal Food, Drug, and Cosmetic Act
(as amended by section 2(c) of the Medical
Device User Fee Stabilization Act of 2005)—
(1)shall be
effective—
(A)with respect to devices
described under paragraph (1) of such section, 12 months after the date of
enactment of the Medical Device User Fee
Stabilization Act of 2005, or the date on which the original
device first bears the name of the manufacturer of the original device, a
generally recognized abbreviation of such name, or a unique and generally
recognized symbol identifying such manufacturer, whichever is later; and
(B)with respect to devices
described under paragraph (2) of such section 502(u), 12 months after such date
of enactment; and
(2)shall apply only to
devices reprocessed and introduced or delivered for introduction in interstate
commerce after such applicable effective
date.
.
July 25, 2005
Reported with an amendment