[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.