[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 1420 Reported in Senate (RS)]







                                                       Calendar No. 173
109th CONGRESS
  1st Session
                                S. 1420

                          [Report No. 109-107]

   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
                       medical device user fees.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 18, 2005

Mr. Enzi (for himself, Mr. Kennedy, Mr. Burr, Mr. DeWine, Ms. Mikulski, 
 Mr. Dodd, Mrs. Murray, and Mr. Hatch) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

                             July 25, 2005

                Reported by Mr. Enzi, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 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,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Medical Device User Fee 
Stabilization Act of 2005''.</DELETED>

<DELETED>SEC. 2. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC 
              ACT.</DELETED>

<DELETED>    (a) Device User Fees.--Section 738 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j) is amended--</DELETED>
        <DELETED>    (1) in subsection (b)--</DELETED>
                <DELETED>    (A) after ``2004;'', by inserting ``and''; 
                and</DELETED>
                <DELETED>    (B) by striking ``2005;'' and all that 
                follows through ``2007'' and inserting 
                ``2005'';</DELETED>
        <DELETED>    (2) in subsection (c)--</DELETED>
                <DELETED>    (A) by striking paragraphs (1), (2), and 
                (3);</DELETED>
                <DELETED>    (B) by redesignating paragraphs (4), (5), 
                and (6) as paragraphs (1), (2), and (3), 
                respectively;</DELETED>
                <DELETED>    (C) in paragraph (1), as so redesignated, 
                by--</DELETED>
                        <DELETED>    (i) striking the paragraph heading 
                        and inserting ``2007 increase'';</DELETED>
                        <DELETED>    (ii) striking ``, in addition to 
                        adjustments under paragraphs (1) and (2), 
                        further'';</DELETED>
                        <DELETED>    (iii) striking ``established in 
                        subsection (b)'' and inserting ``under 
                        subsection (a)''; and</DELETED>
                        <DELETED>    (iv) striking ``adjustment'' each 
                        place it appears and inserting ``increase''; 
                        and</DELETED>
                <DELETED>    (D) in paragraph (2), as so redesignated, 
                by--</DELETED>
                        <DELETED>    (i) 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'';</DELETED>
                        <DELETED>    (ii) striking ``2003'' and 
                        inserting ``2006''; and</DELETED>
                        <DELETED>    (iii) 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.'';</DELETED>
        <DELETED>    (3) in subsection (d)(2)(A)--</DELETED>
                <DELETED>    (A) in clause (i), by striking 
                ``$30,000,000'' and inserting ``$75,000,000''; 
                and</DELETED>
                <DELETED>    (B) by striking clause (ii) and inserting 
                the following:</DELETED>
                        <DELETED>    ``(ii) Adjustments.--</DELETED>
                                <DELETED>    ``(I) In general.--If the 
                                Secretary has evidence from actual 
                                experience that the $75,000,000 
                                threshold established in clause (i) 
                                results in a reduction in revenues from 
                                premarket applications, premarket 
                                reports, and supplements that is 26 
                                percent or more than would occur 
                                without small business exemptions and 
                                lower fee rates, the Secretary may--
                                </DELETED>
                                        <DELETED>    ``(aa) use the 
                                        operating reserves in an amount 
                                        not to exceed the lesser of--
                                        </DELETED>

                                                <DELETED>    ``(AA) 10 
                                                percent of the fees 
                                                collected in fiscal 
                                                year 2005; or</DELETED>

                                                <DELETED>    ``(BB) 
                                                $2,500,000; 
                                                and</DELETED>

                                        <DELETED>    ``(bb) upon the 
                                        exhaustion of the amount 
                                        described under item (aa), 
                                        adjust the $75,000,000 
                                        threshold as provided for under 
                                        subclause (II).</DELETED>
                                <DELETED>    ``(II) Adjustment of 
                                threshold.--To adjust the threshold 
                                described in subclause (I)(bb), the 
                                Secretary shall publish a notice in the 
                                Federal Register setting out the 
                                rationale for the adjustment, and the 
                                new threshold. Such adjusted threshold 
                                may not be less than $30,000,000 and 
                                may not be retroactive.'';</DELETED>
        <DELETED>    (4) in subsection (e)(2)(A), by striking 
        ``$30,000,000'' and inserting ``$75,000,000'';</DELETED>
        <DELETED>    (5) in subsection (g)(1)--</DELETED>
                <DELETED>    (A) in subparagraph (B)--</DELETED>
                        <DELETED>    (i) by striking clause (i) and 
                        inserting the following:</DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    (ii) in clause (ii), by striking 
                        the matter preceding subclause (I) and 
                        inserting the following:</DELETED>
                        <DELETED>    ``(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:''; and</DELETED>
                <DELETED>    (B) in subparagraph (C)--</DELETED>
                        <DELETED>    (i) in the matter preceding clause 
                        (i), by--</DELETED>
                                <DELETED>    (I) striking ``2003 
                                through'' and inserting ``2005 and''; 
                                and</DELETED>
                                <DELETED>    (II) inserting ``more than 
                                1 percent'' after ``years, is''; 
                                and</DELETED>
                        <DELETED>    (ii) in clause (ii), by striking 
                        ``sum'' and inserting ``amount'';</DELETED>
        <DELETED>    (6) in subsection (h)(3)--</DELETED>
                <DELETED>    (A) in subparagraph (C), by striking the 
                semicolon and inserting ``; and''; and</DELETED>
                <DELETED>    (B) by striking subparagraphs (D) and (E) 
                and inserting the following:</DELETED>
                <DELETED>    ``(D) such sums as may be necessary for 
                each of fiscal years 2006 and 2007.''; and</DELETED>
        <DELETED>    (7) by striking ``subsection (c)(5)'' each place 
        it appears and inserting ``subsection (c)(2)''.</DELETED>
<DELETED>    (b) Misbranded Devices.--</DELETED>
        <DELETED>    (1) Reprocessed devices.--Section 502(u) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(u)) is 
        amended to read as follows:</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(2) The Secretary may by guidance waive any requirement 
under paragraph (1) for a reprocessed device or category of reprocessed 
devices if the Secretary determines that compliance with such a 
requirement--</DELETED>
        <DELETED>    ``(A) is not feasible due to the physical 
        characteristics of the device or category of devices; 
        or</DELETED>
        <DELETED>    ``(B) would compromise the provision of reasonable 
        assurance of the safety or effectiveness of the device or 
        category of devices.''.</DELETED>
        <DELETED>    (2) Guidance.--Not later than 150 days after the 
        date of enactment of this Act, the Secretary of Health and 
        Human Services shall issue guidance specifying the device or 
        category of devices that qualify for a waiver under section 
        502(u) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        352(u)) (as amended by paragraph (1)).</DELETED>
        <DELETED>    (3) Effective date.--Section 301(b) of Public Law 
        107-250 (116 Stat. 1616), as amended by section 2(c) of Public 
        Law 108-214 (118 Stat. 575), is amended by--</DELETED>
                <DELETED>    (A) striking ``36 months after the date of 
                enactment of this Act'' and inserting ``9 months after 
                the date of enactment of the Medical Device User Fee 
                Stabilization Act of 2005''; and</DELETED>
                <DELETED>    (B) inserting ``reprocessed and'' before 
                ``introduced''.</DELETED>

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.''.
                                                       Calendar No. 173

109th CONGRESS

  1st Session

                                S. 1420

                          [Report No. 109-107]

_______________________________________________________________________

                                 A BILL

   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
                       medical device user fees.

_______________________________________________________________________

                             July 25, 2005

                       Reported with an amendment