[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3423 Enrolled Bill (ENR)]
H.R.3423
One Hundred Ninth Congress
of the
United States of America
AT THE FIRST SESSION
Begun and held at the City of Washington on Tuesday,
the fourth day of January, two thousand and five
An Act
To amend the Federal Food, Drug, and Cosmetic Act with respect to
medical device user fees.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. 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.
``(B) 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.'';
(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) Annual Reports.--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) 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) 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 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 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), is
amended to read as follows:
``(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) shall apply only to devices reprocessed and introduced or
delivered for introduction in interstate commerce after such
applicable effective date.''.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.