[Congressional Record Volume 151, Number 103 (Tuesday, July 26, 2005)]
[House]
[Pages H6510-H6511]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




           MEDICAL DEVICE USER FEE STABILIZATION ACT OF 2005

  Mr. DEAL of Georgia. Mr. Speaker, I ask unanimous consent that the 
Committee on Energy and Commerce be discharged from further 
consideration of the bill (H.R. 3423) to amend the Federal Food, Drug, 
and Cosmetic Act with respect to medical device user fees, and ask for 
its immediate consideration in the House.
  The Clerk read the title of the bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Georgia?
  Ms. ESHOO. Mr. Speaker, reserving the right to object, and I do not 
intend to object, I yield to the gentleman from Georgia to explain his 
unanimous consent request.
  Mr. DEAL of Georgia. Mr. Speaker, I thank the gentlewoman from 
California for yielding.
  In 2002, Congress passed the Medical Device User Fee and 
Modernization Act, and it allowed the Food and Drug Administration to 
collect user fees from manufacturers who would submit applications for 
medical devices. This legislation was in response to the fact that 
there were many applications for new devices, and we were falling 
behind in the approval process.
  With the passage of this legislation, the FDA was authorized to add 
additional personnel, and have done so and have speeded up the approval 
time for these new devices.
  However, the legislation provided that Congress had to set and reach 
certain marks of appropriations for fiscal year 2003 and through 2005 
for this program to continue; and in the event we did not reach those 
targeted appropriation levels, then the program would expire at the end 
of this September. Unfortunately, Congress did not meet those targeted 
appropriation levels.

                              {time}  1845

  Since Congress did not reach the targeted appropriations required to 
keep the program in place, this user fee program will cease at the end 
of September, and the FDA will be required to start sending out notices 
of termination.
  So this legislation is essential to keep this very successful program 
in place, and it will allow us to retain the medical personnel who are 
working and approving device applications in a much more speedy and 
rapid fashion than they would have been able to do without the user fee 
being in place.
  Mr. Speaker, that is the purpose of this legislation is to extend the 
program.
  Ms. ESHOO. Further reserving the right to object, Mr. Speaker, I 
would like to make a few comments about H.R. 3423, the Medical Device 
User Fee Stabilization Act, which is being considered today. I am the 
lead Democrat, along with my colleague, on the committee, the gentleman 
from Pennsylvania (Mr. Pitts), who is also my neighbor across the hall 
from me in the Cannon House Office Building.
  In 2002, former Representative Greenwood and myself introduced the 
Medical Devices User Fee Modernization Act. It passed the House 
unanimously, and it was signed into law by the President. The goal of 
the bill was to eliminate FDA's backlog in approving new medical 
devices so that doctors and patients could more quickly benefit from 
them.
  While the law required device manufacturers to contribute toward 
FDA's cost in evaluating and approving new devices, the program was 
contingent on the Federal Government paying its fair share. If Federal 
funding did not reach the trigger level, the program would be 
eliminated. This legislation fixes the trigger so that the user fee 
program can continue.
  Specifically the bill will reduce the rate of user fee increases to 
the single-digit range for the remaining 2 years of the program. It 
will help small medical device companies, which is very important, 
because the small companies operate differently under different 
circumstances than the larger ones. The small device companies, it 
helps them to afford the cost to submit new medical devices for FDA 
review and approval. And finally, the bill will enhance labeling and 
tracking of reprocessed single-use devices. So this legislation before 
us only authorizes the program for 2 more years.
  It really is a significant accomplishment, and it allows us to now 
concentrate on making the device approval process even better in 2007. 
And I know that both of my colleagues, both the gentleman from Georgia 
(Mr. Deal), the subcommittee chairman, as well as my colleague, the 
gentleman from Pennsylvania (Mr. Pitts), are committed to that.
  I want to thank Ryan Long with Chairman Barton's staff; John Ford, 
who is seated here to my left, with Ranking Member Dingell's staff; and 
for Vanessa Kramer of my staff who has worked so hard on this. And it 
is because of all of them and their hard work that this bill has 
successfully reached the floor today.
  Mr. Speaker, I withdraw my reservation of objection.
  The SPEAKER pro tempore (Mr. Hayes) Is there objection to the request 
of the gentleman from Georgia?
  There was no objection.
  The Clerk read the bill, as follows:

                               H.R. 3423

       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

[[Page H6511]]

     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.''.

  The bill was ordered to be engrossed and read a third time, was read 
the third time, and passed, and a motion to reconsider was laid on the 
table.

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