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








109th CONGRESS
  1st Session
                                S. 1420

   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, and Mrs. Murray) introduced the following bill; which was 
 read twice and referred to the Committee on Health, Education, Labor, 
                              and Pensions

_______________________________________________________________________

                                 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 paragraphs (1), (2), and (3);
                    (B) by redesignating paragraphs (4), (5), and (6) 
                as paragraphs (1), (2), and (3), respectively;
                    (C) in paragraph (1), as so redesignated, by--
                            (i) striking the paragraph heading and 
                        inserting ``2007 increase'';
                            (ii) striking ``, in addition to 
                        adjustments under paragraphs (1) and (2), 
                        further'';
                            (iii) striking ``established in subsection 
                        (b)'' and inserting ``under subsection (a)''; 
                        and
                            (iv) striking ``adjustment'' each place it 
                        appears and inserting ``increase''; and
                    (D) in paragraph (2), as so redesignated, by--
                            (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'';
                            (ii) striking ``2003'' and inserting 
                        ``2006''; and
                            (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.'';
            (3) in subsection (d)(2)(A)--
                    (A) in clause (i), by striking ``$30,000,000'' and 
                inserting ``$75,000,000''; and
                    (B) by striking clause (ii) and inserting the 
                following:
                            ``(ii) Adjustments.--
                                    ``(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--
                                            ``(aa) use the operating 
                                        reserves in an amount not to 
                                        exceed the lesser of--

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

                                                    ``(BB) $2,500,000; 
                                                and

                                            ``(bb) upon the exhaustion 
                                        of the amount described under 
                                        item (aa), adjust the 
                                        $75,000,000 threshold as 
                                        provided for under subclause 
                                        (II).
                                    ``(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.'';
            (4) in subsection (e)(2)(A), by striking ``$30,000,000'' 
        and inserting ``$75,000,000'';
            (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:''; and
                    (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'';
            (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)(2)''.
    (b) Misbranded Devices.--
            (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:
    ``(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) 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--
            ``(A) is not feasible due to the physical characteristics 
        of the device or category of devices; or
            ``(B) would compromise the provision of reasonable 
        assurance of the safety or effectiveness of the device or 
        category of devices.''.
            (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)).
            (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--
                    (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
                    (B) inserting ``reprocessed and'' before 
                ``introduced''.
                                 <all>