[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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