[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3423 Introduced in House (IH)]
109th CONGRESS
1st Session
H. R. 3423
To amend the Federal Food, Drug, and Cosmetic Act with respect to
medical device user fees.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
July 25, 2005
Mr. Pitts (for himself, Ms. Eshoo, Mrs. Bono, Mr. Whitfield, Mr. Upton,
Mr. Pickering, Mr. Ferguson, Mr. Norwood, Mr. Strickland, and Mr. Davis
of Florida) introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
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.''.
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