II
Calendar No. 173
109th CONGRESS
1st Session
S. 1420
[Report No. 109–107]
IN THE SENATE OF THE UNITED STATES
July 18, 2005
Mr. Enzi (for himself, Mr. Kennedy, Mr. Burr, Mr. DeWine, Ms. Mikulski, Mr. Dodd, Mrs. Murray, and Mr. Hatch) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions
July 25, 2005
Reported by Mr. Enzi, with an amendment
Strike out all after the enacting clause and insert the part printed in italic
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with respect to medical device user fees.
Short title
This Act may be cited as the
Medical Device User Fee Stabilization
Act of 2005
.
Amendments to the Federal Food, Drug, and Cosmetic Act
Device user fees
Section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amended—
in subsection (b)—
after 2004;
, by inserting
and
; and
by striking 2005;
and all
that follows through 2007
and inserting
2005
;
in subsection (c)—
by striking paragraphs (1), (2), and (3);
by redesignating paragraphs (4), (5), and (6) as paragraphs (1), (2), and (3), respectively;
in paragraph (1), as so redesignated, by—
striking the paragraph heading and
inserting 2007
increase
;
striking , in addition to
adjustments under paragraphs (1) and (2), further
;
striking established in subsection
(b)
and inserting under subsection (a)
; and
striking adjustment
each
place it appears and inserting increase
; and
in paragraph (2), as so redesignated, by—
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
;
striking 2003
and inserting
2006
; and
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.
;
in subsection (d)(2)(A)—
in clause (i), by striking
$30,000,000
and inserting $75,000,000
; and
by striking clause (ii) and inserting the following:
Adjustments
In general
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—
use the operating reserves in an amount not to exceed the lesser of—
10 percent of the fees collected in fiscal year 2005; or
$2,500,000; and
upon the exhaustion of the amount described under item (aa), adjust the $75,000,000 threshold as provided for under subclause (II).
Adjustment of threshold
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.
;
in subsection (e)(2)(A), by striking
$30,000,000
and inserting $75,000,000
;
in subsection (g)(1)—
in subparagraph (B)—
by striking clause (i) and inserting the following:
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
in clause (ii), by striking the matter preceding subclause (I) and inserting the following:
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
in subparagraph (C)—
in the matter preceding clause (i), by—
striking 2003 through
and
inserting 2005 and
; and
inserting more than 1
percent
after years, is
; and
in clause (ii), by striking
sum
and inserting amount
;
in subsection (h)(3)—
in subparagraph (C), by striking the
semicolon and inserting ; and
; and
by striking subparagraphs (D) and (E) and inserting the following:
such sums as may be necessary for each of fiscal years 2006 and 2007.
; and
by striking subsection
(c)(5)
each place it appears and inserting subsection
(c)(2)
.
Misbranded devices
Reprocessed devices
Section 502(u) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(u)) is amended to read as follows:
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.
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—
is not feasible due to the physical characteristics of the device or category of devices; or
would compromise the provision of reasonable assurance of the safety or effectiveness of the device or category of devices.
.
Guidance
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)).
Effective date
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—
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
inserting reprocessed and
before introduced
.
Short title
This Act may be cited as the
Medical Device User Fee Stabilization
Act of 2005
.
Amendments to the Federal Food, Drug, and Cosmetic Act
Device user fees
Section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amended—
in subsection (b)—
after
2004;
, by inserting and
; and
by striking
2005;
and all that follows through 2007
and
inserting 2005
;
in subsection (c)—
by striking the heading
and inserting Annual Fee
Setting.—
;
by striking paragraphs (1), (2), (3), and (4);
by redesignating paragraphs (5) and (6) as paragraphs (1) and (2), respectively;
in paragraph (1), as so redesignated, by—
striking the heading and
inserting In
general.—
;
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
;
striking
2003
and inserting 2006
; and
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
by adding at the end the following:
Supplement
In general
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.
Notice to Congress
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.
;
in subsection (d)—
in paragraph (1), by
inserting after the first sentence the following: For the purposes of
this paragraph, the term
; andsmall 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.
in paragraph (2)(A), by—
striking (i)
In
general.—
;
striking
subsection,
and inserting paragraph,
;
striking
$30,000,000
and inserting $100,000,000
;
and
striking clause (ii);
in subsection (e)(2)(A),
by striking $30,000,000
and inserting
$100,000,000
;
in subsection (g)(1)—
in subparagraph (B)—
by striking clause (i) and inserting the following:
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
in clause (ii), by striking the matter preceding subclause (I) and inserting the following:
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:
;
in subparagraph (C)—
in the matter preceding clause (i), by—
striking 2003
through
and inserting 2005 and
; and
inserting more
than 1 percent
after years, is
; and
in clause (ii), by
striking sum
and inserting amount
; and
in subparagraph (D)(i),
by inserting more than 1 percent
after year,
is
;
in subsection (h)(3)—
in subparagraph (C), by
striking the semicolon and inserting ; and
; and
by striking subparagraphs (D) and (E) and inserting the following:
such sums as may be necessary for each of fiscal years 2006 and 2007.
; and
by striking
subsection (c)(5)
each place it appears and inserting
subsection (c)(1)
.
Annual reports
Section 103 of the Medical Device User Fee and Modernization Act of 2002 (Public Law 107–250 (116 Stat. 1600)) is amended—
by striking
Beginning with
and inserting (a)
In
general.—Beginning with
; and
by adding at the end the following:
Additional information
For fiscal years 2006 and 2007, the report described under subsection (a)(2) shall include—
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
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.
.
Misbranded devices
In general
Section 502(u) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(u)) is amended to read as follows:
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.
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.
.
Guidance
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)).
Effective date
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:
Effective date
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)—
shall be effective—
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
with respect to devices described under paragraph (2) of such section 502(u), 12 months after such date of enactment; and
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