[109th Congress Public Law 43]
[From the U.S. Government Printing Office]
[DOCID: f:publ043.109]
[[Page 119 STAT. 439]]
Public Law 109-43
109th Congress
An Act
To amend the Federal Food, Drug, and Cosmetic Act with respect to
medical device user fees. <<NOTE: Aug. 1, 2005 - [H.R. 3423]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. <<NOTE: 21 USC 301 note.>> SHORT TITLE.
This Act may be cited as the ``Medical Device User Fee Stabilization
Act of 2005''.
SEC. 2. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.
(a) Device User Fees.--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) Supplement.--
``(A) 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.
[[Page 119 STAT. 440]]
``(B) Notice to congress.--
Not <<NOTE: Deadline.>> 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:
[[Page 119 STAT. 441]]
``(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) Annual Reports.--Section 103 of the Medical Device User Fee and
Modernization Act of 2002 (Public Law 107-250 (116 Stat.
1600)) <<NOTE: 21 USC 379i note.>> is amended--
(1) by striking ``Beginning with'' and inserting ``(a) In
General.--Beginning with''; and
(2) by adding at the end the following:
``(b) Additional Information.--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) <<NOTE: Certification.>> 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) Misbranded <<NOTE: Labeling.>> Devices.--
(1) 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:
``(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) Guidance.--Not <<NOTE: Deadline. 21 USC 352
note.>> 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) 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), <<NOTE: 21 USC 352 note.>> is amended to read as follows:
[[Page 119 STAT. 442]]
``(b) 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)--
``(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) <<NOTE: Applicability.>> shall apply only to devices
reprocessed and introduced or delivered for introduction in
interstate commerce after such applicable effective date.''.
Approved August 1, 2005.
LEGISLATIVE HISTORY--H.R. 3423 (S. 1420):
---------------------------------------------------------------------------
SENATE REPORTS: No. 109-107 accompanying S. 1420 (Comm. on Health,
Education, Labor, and Pensions).
CONGRESSIONAL RECORD, Vol. 151 (2005):
July 26, considered and passed House.
July 27, considered and passed Senate.
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