I 
109TH CONGRESS 
1ST SESSION H. R. 3423 
To amend the Federal Food, Drug, and Cosmetic Act with respect to medical 
device user fees. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 25, 2005 
Mr. PITTS (for himself, Ms. ESHOO, Mrs. BONO, Mr. WHITFIELD, Mr. 
UPTON, Mr. PICKERING, Mr. FERGUSON, Mr. NORWOOD, Mr. STRICK-
LAND, and Mr. DAVIS of Florida) introduced the following bill; which was 
referred to the Committee on Energy and Commerce 
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 Representa-
tives 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 amend-
ed— 
(1) in subsection (b)— 
(A) after ‘‘2004;’’, by inserting ‘‘and’’; and 
(B) by striking ‘‘2005;’’ and all that fol-
lows 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 sub-
section (a). The fees’’;
(iii) striking ‘‘2003’’ and inserting 
‘‘2006’’; and 
(iv) striking ‘‘$154,000.’’ and insert-
ing ‘‘$259,600, and the fees established for 
fiscal year 2007 shall be based on a pre-
market 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 pre-
vious 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 Com-
mittee on Health, Education, Labor, and Pen-
sions and the Committee on Appropriations of 
the Senate and the Committee on Energy and
Commerce and the Committee on Appropria-
tions of the House of Representatives.’’; 
(3) in subsection (d)— 
(A) in paragraph (1), by inserting after 
the first sentence the following: ‘‘For the pur-
poses of this paragraph, the term ‘small busi-
ness’ 
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 insert-
ing ‘‘paragraph,’’; 
(iii) striking ‘‘$30,000,000’’ and in-
serting ‘‘$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: