PUBLIC LAW 109–43—AUG. 1, 2005 119 STAT. 439

Public Law 109–43

109th Congress

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.

21 USC 301 note.

Aug. 1, 2005

[H.R. 3423]

119 STAT. 440 PUBLIC LAW 109–43—AUG. 1, 2005

‘‘(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:

Deadline.

PUBLIC LAW 109–43—AUG. 1, 2005 119 STAT. 441

‘‘(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 singleuse 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: 21 USC 352 note.

Deadline.

21 USC 352 note.

Labeling.

Certification.

21 USC 379i

note.

119 STAT. 442 PUBLIC LAW 109–43—AUG. 1, 2005

LEGISLATIVE HISTORY—H.R. 3423 (S. 1420):

SENATE REPORTS: No. 109–107 accompanying S. 1420 (Comm. on Health, Education, Labor, and Pensions).

CONGRESSIONAL RECORD, Vol. 151 (2005):

July 26, considered and passed House.

July 27, considered and passed Senate.

Æ

‘‘(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.’’.

Approved August 1, 2005.

Applicability.