H.R. 3423House109th Congress (2005-2007)Enacted

Medical Device User Fee Stabilization Act of 2005

Introduced July 25, 2005

Legislative Activity

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14 earlier actions
Became Law Latest Action

Became Public Law No: 109-43.

August 1, 2005

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HouseIntro Referral

Introduced in House

July 25, 2005

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

July 25, 2005

HouseCommittee

Committee on Energy and Commerce discharged.

July 26, 2005

HouseFloor

Considered by unanimous consent. (consideration: CR H6510-6511)

July 26, 2005 • 6:42 PM

HouseFloor

Mr. Deal (GA) asked unanimous consent to discharge from committee and consider.

July 26, 2005 • 6:42 PM

HouseFloor

Passed/agreed to in House: On passage Passed without objection.(text: CR H6510-6511)

July 26, 2005 • 6:46 PM

HouseFloor

On passage Passed without objection. (text: CR H6510-6511)

July 26, 2005 • 6:46 PM

HouseFloor

Motion to reconsider laid on the table Agreed to without objection.

July 26, 2005 • 6:46 PM

SenateFloor

Received in the Senate, read twice, considered, read the third time, and passed without amendment by Unanimous Consent. (consideration: CR S9196-9197)

July 27, 2005

HouseAction

Cleared for White House.

July 27, 2005

SenateFloor

Message on Senate action sent to the House.

July 28, 2005

HouseCommittee

Referred to the Subcommittee on Health.

July 29, 2005

President

Presented to President.

July 29, 2005

Became Law

Signed by President.

August 1, 2005

Became Law

Became Public Law No: 109-43.

August 1, 2005

Floor Debate

14 members

What members said about H.R. 3423 on the floor

10 Republicans4 Democrats
Michael B. Enzi
Sen. Michael B. EnziR-WY · Sep 26, 2006

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded. Mr. President, in a moment I will request unanimous consent that the Senate pass S. 2823, the Ryan White…

Richard J. Durbin
Sen. Richard J. DurbinD-IL · Sep 26, 2006

I thank the chair. Mental Health Parity Act Mr. President, in just a few weeks while we are in recess, we will mark the fourth anniversary of the untimely death of our former colleague from…

Lamar Alexander
Sen. Lamar AlexanderR-TN · Sep 26, 2006

I ask unanimous consent to speak as in morning business. Mr. President, I thank the Senator from New Mexico. He is overly generous. I learned as a staff aide in the Senate that if an idea has many…

John Thune
Sen. John ThuneR-SD · Sep 26, 2006

Mr. President, I suggest the absence of a quorum. Mr. President, I ask unanimous consent that the order for the quorum call be rescinded. Mr. President, as we wind down this legislative session in…

Richard Burr
Sen. Richard BurrR-NC · Sep 26, 2006

Mr. President, this is, plain and simple, about whether this Senate is going to allow legislation to go forward to reauthorize Ryan White, that allows the funding to follow the patients. What an…

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Tom Harkin
Sen. Tom HarkinD-IA · Sep 26, 2006

Mr. President, I ask unanimous consent that the order for the quorum call be dispensed with. Mr. President, earlier today, my colleague, Senator Durbin of Illinois, took the floor to describe a…

Mark Dayton
Sen. Mark DaytonD-MN · Sep 26, 2006

Mr. President, I thank and commend my friend and colleague, the assistant Democratic leader from Illinois, Senator Durbin, for submitting the Senate resolution honoring the memory of the late Senator…

Tom Coburn
Sen. Tom CoburnR-OK · Sep 26, 2006

Mr. President, by objecting to moving this bill, we need to look at the real lives that are getting ready to be harmed. Not only is the funding for the program going to be cut to the poorest of the…

Michael B. Enzi
Sen. Michael B. EnziR-WY · Jul 27, 2005

Mr. President, I rise today to voice my support for the Medical Device User Fee Stabilization Act of 2005. This legislation preserves a valuable program for the review of innovative medical…

Joe Barton
Rep. Joe BartonR-TX-6 · Jul 29, 2005

Mr. Speaker, on October 26, 2002, the Medical Device User Fee and Modernization Act, MDUFMA, was signed into law. I. background and need for legislation MDUFMA amended the Federal Food Drug and…

Anna G. Eshoo
Rep. Anna G. EshooD-CA-14 · Jul 26, 2005

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. Further reserving the right to object, Mr.…

Pete V. Domenici
Sen. Pete V. DomeniciR-NM · Sep 26, 2006

Mr. President, I ask unanimous consent I have 2 minutes as in morning business. Mr. President, I note that the distinguished Senator from Tennessee, Senator Lamar Alexander, is in the Chamber. I am…

Norm Coleman
Sen. Norm ColemanR-MN · Sep 26, 2006

Mr. President, I thank my colleague from Illinois for submitting this resolution both on the legacy of Paul Wellstone and, in particular, focusing on this issue of mental health parity. Paul…

Show 3 more
Nathan Deal
Rep. Nathan DealR-GA-10 · Jul 26, 2005

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…

Mitch McConnell
Sen. Mitch McConnellR-KY · Jul 27, 2005

Mr. President, I ask unanimous consent that the Senate proceed to the immediate consideration of H.R. 3423 which was received from the House. Mr. President, I ask unanimous consent that the bill be…

Nathan Deal
Rep. Nathan DealR-GA-10 · Jul 26, 2005

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days within which to revise and extend their remarks on H.R. 3423, the bill just passed.

Bill Text

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Enrolled BillIssued July 28, 2005
        [Congressional Bills 109th Congress]
[From the U.S. Government Printing Office]
[H.R. 3423 Enrolled Bill (ENR)]

H.R.3423

One Hundred Ninth Congress

of the

United States of America

AT THE FIRST SESSION

Begun and held at the City of Washington on Tuesday,
the fourth day of January, two thousand and five

An Act

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 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.