text: 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.
target: Medical Device User Fee Stabilization Act of 2005 - Amends the Federal Food, Drug, and Cosmetic Act to adjust medical device user fees (e.g., premarket application, premarket report, supplement, and submission fees).
  
  Repeals the fee revenue target amounts for FY2006 and FY2007.
  
  Eliminates the inflation, workload, compensating, and final year adjustments of revenues used for setting fees.
  
  Sets the premarket application fee for devices for FY2006 and FY2007.
  
  Allows the Secretary of Health and Human Services to use unobligated carryover balances from fees collected in previous fiscal years with notice to the appropriate congressional committees.
  
  Increases the annual gross receipts or sales threshold below which businesses are eligible for reduced fees or a waiver of fees by the Secretary.
  
  Removes the prohibition against the Secretary assessing fees unless certain cumulative fee revenues were met for FY2003 through 2006.
  
  Requires the Secretary to include in annual reports to Congress: (1) information on the number and total amount of fees paid for each different type of application or notification from small businesses; and (2) a certification that the amounts obligated for the performance of functions other than the review of device applications is not less than such amount for FY2002 multiplied by the adjustment factor.
  
  Deems as branded any reprocessed single use device unless it identifies the manufacturer, but allows such information to be provided by a detachable label intended to be affixed to the medical record of a patient.
feat_title: To amend the Federal Food, Drug, and Cosmetic Act with respect to medical device user fees.