IIB 

109TH CONGRESS 

1ST SESSION H. R. 3423 

IN THE SENATE OF THE UNITED STATES 

JULY 27, 2005 

Received 

AN ACT 

To amend the Federal Food, Drug, and Cosmetic Act with 

respect to medical device user fees. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 
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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Medical Device User 

3 Fee Stabilization Act of 2005’’. 

4 SEC. 2. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND 

5 COSMETIC ACT. 

6 (a) DEVICE USER FEES.—Section 738 of the Federal 

7 Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amend8 ed— 

9 (1) in subsection (b)— 

10 (A) after ‘‘2004;’’, by inserting ‘‘and’’; and 

11 (B) by striking ‘‘2005;’’ and all that fol12 lows through ‘‘2007’’ and inserting ‘‘2005’’; 

13 (2) in subsection (c)— 

14 (A) by striking the heading and inserting 

15 ‘‘Annual Fee Setting.—’’; 

16 (B) by striking paragraphs (1), (2), (3), 

17 and (4); 

18 (C) by redesignating paragraphs (5) and 

19 (6) as paragraphs (1) and (2), respectively; 

20 (D) in paragraph (1), as so redesignated, 

21 by— 

22 (i) striking the heading and inserting 

23 ‘‘IN GENERAL.—’’; 

24 (ii) striking ‘‘establish, for the next 

25 fiscal year, and’’ and all that follows 

26 through ‘‘the fees’’ and inserting ‘‘publish 
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1 in the Federal Register fees under sub2 section (a). The fees’’; 

3 (iii) striking ‘‘2003’’ and inserting 

4 ‘‘2006’’; and 

5 (iv) striking ‘‘$154,000.’’ and insert6 ing ‘‘$259,600, and the fees established for 

7 fiscal year 2007 shall be based on a pre8 market application fee of $281,600.’’; and 

9 (E) by adding at the end the following: 

10 ‘‘(3) SUPPLEMENT.— 

11 ‘‘(A) IN GENERAL.—For fiscal years 2006 

12 and 2007, the Secretary may use unobligated 

13 carryover balances from fees collected in pre14 vious fiscal years to ensure that sufficient fee 

15 revenues are available in that fiscal year, so 

16 long as the Secretary maintains unobligated 

17 carryover balances of not less than 1 month of 

18 operating reserves for the first month of fiscal 

19 year 2008. 

20 ‘‘(B) NOTICE TO CONGRESS.—Not later 

21 than 14 days before the Secretary anticipates 

22 the use of funds described in subparagraph (A), 

23 the Secretary shall provide notice to the Com24 mittee on Health, Education, Labor, and Pen25 sions and the Committee on Appropriations of 
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1 the Senate and the Committee on Energy and 

2 Commerce and the Committee on Appropria3 tions of the House of Representatives.’’; 

4 (3) in subsection (d)— 

5 (A) in paragraph (1), by inserting after 

6 the first sentence the following: ‘‘For the pur7 poses of this paragraph, the term ‘small busi8 ness’ means an entity that reported 

9 $30,000,000 or less of gross receipts or sales in 

10 its most recent Federal income tax return for a 

11 taxable year, including such returns of all of its 

12 affiliates, partners, and parent firms.’’; and 

13 (B) in paragraph (2)(A), by— 

14 (i) striking ‘‘(i) IN GENERAL.—’’; 

15 (ii) striking ‘‘subsection,’’ and insert16 ing ‘‘paragraph,’’; 

17 (iii) striking ‘‘$30,000,000’’ and in18 serting ‘‘$100,000,000’’; and 

19 (iv) striking clause (ii); 

20 (4) in subsection (e)(2)(A), by striking 

21 ‘‘$30,000,000’’ and inserting ‘‘$100,000,000’’; 

22 (5) in subsection (g)(1)— 

23 (A) in subparagraph (B)— 

24 (i) by striking clause (i) and inserting 

25 the following: 
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1 ‘‘(i) For fiscal year 2005, the Sec2 retary is expected to meet all of the per3 formance goals identified for the fiscal year 

4 if the amount so appropriated for such fis5 cal year, excluding the amount of fees ap6 propriated for such fiscal year, is equal to 

7 or greater than $205,720,000 multiplied 

8 by the adjustment factor applicable to the 

9 fiscal year.’’; and 

10 (ii) in clause (ii), by striking the mat11 ter preceding subclause (I) and inserting 

12 the following: 

13 ‘‘(ii) For fiscal year 2005, if the 

14 amount so appropriated for such fiscal 

15 year, excluding the amount of fees appro16 priated for such fiscal year, is more than 

17 1 percent less than the amount that ap18 plies under clause (i), the following ap19 plies:’’; 

20 (B) in subparagraph (C)— 

21 (i) in the matter preceding clause (i), 

22 by— 

23 (I) striking ‘‘2003 through’’ and 

24 inserting ‘‘2005 and’’; and 
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1 (II) inserting ‘‘more than 1 per2 cent’’ after ‘‘years, is’’; and 

3 (ii) in clause (ii), by striking ‘‘sum’’ 

4 and inserting ‘‘amount’’; and 

5 (C) in subparagraph (D)(i), by inserting 

6 ‘‘more than 1 percent’’ after ‘‘year, is’’; 

7 (6) in subsection (h)(3)— 

8 (A) in subparagraph (C), by striking the 

9 semicolon and inserting ‘‘; and’’; and 

10 (B) by striking subparagraphs (D) and (E) 

11 and inserting the following: 

12 ‘‘(D) such sums as may be necessary for 

13 each of fiscal years 2006 and 2007.’’; and 

14 (7) by striking ‘‘subsection (c)(5)’’ each place it 

15 appears and inserting ‘‘subsection (c)(1)’’. 

16 (b) ANNUAL REPORTS.—Section 103 of the Medical 

17 Device User Fee and Modernization Act of 2002 (Public 

18 Law 107–250 (116 Stat. 1600)) is amended— 

19 (1) by striking ‘‘Beginning with’’ and inserting 

20 ‘‘(a) In General.—Beginning with’’; and 

21 (2) by adding at the end the following: 

22 ‘‘(b) ADDITIONAL INFORMATION.—For fiscal years 

23 2006 and 2007, the report described under subsection 

24 (a)(2) shall include— 
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1 ‘‘(1) information on the number of different 

2 types of applications and notifications, and the total 

3 amount of fees paid for each such type of applica4 tion or notification, from businesses with gross re5 ceipts or sales from $0 to $100,000,000, with such 

6 businesses categorized in $10,000,000 intervals; and 

7 ‘‘(2) a certification by the Secretary that the 

8 amounts appropriated for salaries and expenses of 

9 the Food and Drug Administration for such fiscal 

10 year and obligated by the Secretary for the perform11 ance of any function relating to devices that is not 

12 for the process for the review of device applications, 

13 as defined in paragraph (5) of section 737 of the 

14 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

15 379i), are not less than such amounts for fiscal year 

16 2002 multiplied by the adjustment factor, as defined 

17 in paragraph (7) of such section 737.’’. 

18 (c) MISBRANDED DEVICES.— 

19 (1) IN GENERAL.—Section 502(u) of the Fed20 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

21 352(u)) is amended to read as follows: 

22 ‘‘(u)(1) Subject to paragraph (2), if it is a reproc23 essed single-use device, unless it, or an attachment there24 to, prominently and conspicuously bears the name of the 

25 manufacturer of the reprocessed device, a generally recog-
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1 nized abbreviation of such name, or a unique and generally 

2 recognized symbol identifying such manufacturer. 

3 ‘‘(2) If the original device or an attachment thereto 

4 does not prominently and conspicuously bear the name of 

5 the manufacturer of the original device, a generally recog6 nized abbreviation of such name, or a unique and generally 

7 recognized symbol identifying such manufacturer, a re8 processed device may satisfy the requirements of para9 graph (1) through the use of a detachable label on the 

10 packaging that identifies the manufacturer and is in11 tended to be affixed to the medical record of a patient.’’. 

12 (2) GUIDANCE.—Not later than 180 days after 

13 the date of enactment of this Act, the Secretary of 

14 Health and Human Services shall issue guidance to 

15 identify circumstances in which the name of the 

16 manufacturer of the original device, a generally rec17 ognized abbreviation of such name, or a unique and 

18 generally recognized symbol identifying such manu19 facturer, is not ‘‘prominent and conspicuous’’, as 

20 used in section 502(u) of Federal Food, Drug, and 

21 Cosmetic Act (as amended by paragraph (1)). 

22 (d) EFFECTIVE DATE.—Section 301(b) of the Med23 ical Device User Fee and Modernization Act of 2002 

24 (Public Law 107–250 (116 Stat. 1616)), as amended by 
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1 section 2(c) of Public Law 108–214 (118 Stat. 575), is 

2 amended to read as follows: 

3 ‘‘(b) EFFECTIVE DATE.—Section 502(u) of the Fed4 eral Food, Drug, and Cosmetic Act (as amended by sec5 tion 2(c) of the Medical Device User Fee Stabilization Act 

6 of 2005)— 

7 ‘‘(1) shall be effective— 

8 ‘‘(A) with respect to devices described 

9 under paragraph (1) of such section, 12 months 

10 after the date of enactment of the Medical De11 vice User Fee Stabilization Act of 2005, or the 

12 date on which the original device first bears the 

13 name of the manufacturer of the original de14 vice, a generally recognized abbreviation of such 

15 name, or a unique and generally recognized 

16 symbol identifying such manufacturer, which17 ever is later; and 

18 ‘‘(B) with respect to devices described 

19 under paragraph (2) of such section 502(u), 12 

20 months after such date of enactment; and 
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1 ‘‘(2) shall apply only to devices reprocessed and 

2 introduced or delivered for introduction in interstate 

3 commerce after such applicable effective date.’’. 

Passed the House of Representatives July 26, 2005. 

Attest: JEFF TRANDAHL, 

Clerk.