II 

Calendar No. 173 

109TH CONGRESS 

1ST SESSION S. 1420 

[Report No. 109–107] 

To amend the Federal Food, Drug, and Cosmetic Act with respect to medical 

device user fees. 

IN THE SENATE OF THE UNITED STATES 

JULY 18, 2005 

Mr. ENZI (for himself, Mr. KENNEDY, Mr. BURR, Mr. DEWINE, Ms. MIKULSKI, Mr. DODD, Mrs. MURRAY, and Mr. HATCH) introduced the following 

bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

JULY 25, 2005 

Reported by Mr. ENZI, with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

A BILL 

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, 

3 SECTION 1. SHORT TITLE. 

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

5 Fee Stabilization Act of 2005’’. 
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1 SEC. 2. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND 

2 COSMETIC ACT. 

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

4 Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amend5 ed— 

6 (1) in subsection (b)— 

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

8 (B) by striking ‘‘2005;’’ and all that fol9 lows through ‘‘2007’’ and inserting ‘‘2005’’; 

10 (2) in subsection (c)— 

11 (A) by striking paragraphs (1), (2), and 

12 (3); 

13 (B) by redesignating paragraphs (4), (5), 

14 and (6) as paragraphs (1), (2), and (3), respec15 tively; 

16 (C) in paragraph (1), as so redesignated, 

17 by— 

18 (i) striking the paragraph heading 

19 and inserting ‘‘2007 INCREASE’’; 

20 (ii) striking ‘‘, in addition to adjust21 ments under paragraphs (1) and (2), fur22 ther’’; 

23 (iii) striking ‘‘established in sub24 section (b)’’ and inserting ‘‘under sub25 section (a)’’; and 
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1 (iv) striking ‘‘adjustment’’ each place 

2 it appears and inserting ‘‘increase’’; and 

3 (D) in paragraph (2), as so redesignated, 

4 by— 

5 (i) striking ‘‘establish, for the next fis6 cal year, and’’ and all that follows through 

7 ‘‘the fees’’ and inserting ‘‘publish in the 

8 Federal Register fees under subsection (a). 

9 The fees’’; 

10 (ii) striking ‘‘2003’’ and inserting 

11 ‘‘2006’’; and 

12 (iii) striking ‘‘$154,000.’’ and insert13 ing ‘‘$259,600, and the fees established for 

14 fiscal year 2007 shall be based on a pre15 market application fee of $281,600.’’; 

16 (3) in subsection (d)(2)(A)— 

17 (A) in clause (i), by striking 

18 ‘‘$30,000,000’’ and inserting ‘‘$75,000,000’’; 

19 and 

20 (B) by striking clause (ii) and inserting the 

21 following: 

22 ‘‘(ii) ADJUSTMENTS.— 

23 ‘‘(I) IN GENERAL.—If the Sec24 retary has evidence from actual expe25 rience that the $75,000,000 threshold 
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1 established in clause (i) results in a 

2 reduction in revenues from premarket 

3 applications, premarket reports, and 

4 supplements that is 26 percent or 

5 more than would occur without small 

6 business exemptions and lower fee 

7 rates, the Secretary may— 

8 ‘‘(aa) use the operating re9 serves in an amount not to ex10 ceed the lesser of— 

11 ‘‘(AA) 10 percent of the 

12 fees collected in fiscal year 

13 2005; or 

14 ‘‘(BB) $2,500,000; and 

15 ‘‘(bb) upon the exhaustion of 

16 the amount described under item 

17 (aa), adjust the $75,000,000 

18 threshold as provided for under 

19 subclause (II). 

20 ‘‘(II) ADJUSTMENT OF THRESH21 OLD.—To adjust the threshold de22 scribed in subclause (I)(bb), the Sec23 retary shall publish a notice in the 

24 Federal Register setting out the ra25 tionale for the adjustment, and the 
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1 new threshold. Such adjusted thresh2 old may not be less than $30,000,000 

3 and may not be retroactive.’’; 

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

5 ‘‘$30,000,000’’ and inserting ‘‘$75,000,000’’; 

6 (5) in subsection (g)(1)— 

7 (A) in subparagraph (B)— 

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

9 the following: 

10 ‘‘(i) For fiscal year 2005, the Sec11 retary is expected to meet all of the per12 formance goals identified for the fiscal year 

13 if the amount so appropriated for such fis14 cal year, excluding the amount of fees ap15 propriated for such fiscal year, is equal to 

16 or greater than $205,720,000 multiplied 

17 by the adjustment factor applicable to the 

18 fiscal year.’’; and 

19 (ii) in clause (ii), by striking the mat20 ter preceding subclause (I) and inserting 

21 the following: 

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

23 amount so appropriated for such fiscal 

24 year, excluding the amount of fees appro25 priated for such fiscal year, is more than 
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1 1 percent less than the amount that ap2 plies under clause (i), the following ap3 plies:’’; and 

4 (B) in subparagraph (C)— 

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

6 by— 

7 (I) striking ‘‘2003 through’’ and 

8 inserting ‘‘2005 and’’; and 

9 (II) inserting ‘‘more than 1 per10 cent’’ after ‘‘years, is’’; and 

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

12 and inserting ‘‘amount’’; 

13 (6) in subsection (h)(3)— 

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

15 semicolon and inserting ‘‘; and’’; and 

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

17 and inserting the following: 

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

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

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

21 appears and inserting ‘‘subsection (c)(2)’’. 

22 (b) MISBRANDED DEVICES.— 

23 (1) REPROCESSED DEVICES.—Section 502(u) of 

24 the Federal Food, Drug, and Cosmetic Act (21 

25 U.S.C. 352(u)) is amended to read as follows: 
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1 ‘‘(u)(1) Subject to paragraph (2), if it is a reproc2 essed single-use device, unless it, or an attachment there3 to, prominently and conspicuously bears the name of the 

4 manufacturer of the reprocessed device, a generally recog5 nized abbreviation of such name, or a unique and generally 

6 recognized symbol identifying such manufacturer. 

7 ‘‘(2) The Secretary may by guidance waive any re8 quirement under paragraph (1) for a reprocessed device 

9 or category of reprocessed devices if the Secretary deter10 mines that compliance with such a requirement— 

11 ‘‘(A) is not feasible due to the physical charac12 teristics of the device or category of devices; or 

13 ‘‘(B) would compromise the provision of reason14 able assurance of the safety or effectiveness of the 

15 device or category of devices.’’. 

16 (2) GUIDANCE.—Not later than 150 days after 

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

18 Health and Human Services shall issue guidance 

19 specifying the device or category of devices that 

20 qualify for a waiver under section 502(u) of the Fed21 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

22 352(u)) (as amended by paragraph (1)). 

23 (3) EFFECTIVE DATE.—Section 301(b) of Pub24 lic 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), 

2 is amended by— 

3 (A) striking ‘‘36 months after the date of 

4 enactment of this Act’’ and inserting ‘‘9 months 

5 after the date of enactment of the Medical De6 vice User Fee Stabilization Act of 2005’’; and 

7 (B) inserting ‘‘reprocessed and’’ before 

8 ‘‘introduced’’. 

9 SECTION 1. SHORT TITLE. 

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

11 Fee Stabilization Act of 2005’’. 

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

13 COSMETIC ACT. 

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

15 Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amend16 ed— 

17 (1) in subsection (b)— 

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

19 (B) by striking ‘‘2005;’’ and all that follows 

20 through ‘‘2007’’ and inserting ‘‘2005’’; 

21 (2) in subsection (c)— 

22 (A) by striking the heading and inserting 

23 ‘‘ANNUAL FEE SETTING.—’’; 

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

25 and (4); 
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1 (C) by redesignating paragraphs (5) and 

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

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

4 by— 

5 (i) striking the heading and inserting 

6 ‘‘IN GENERAL.—’’; 

7 (ii) striking ‘‘establish, for the next fis8 cal year, and’’ and all that follows through 

9 ‘‘the fees’’ and inserting ‘‘publish in the 

10 Federal Register fees under subsection (a). 

11 The fees’’; 

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

13 ‘‘2006’’; and 

14 (iv) striking ‘‘$154,000.’’ and inserting 

15 ‘‘$259,600, and the fees established for fiscal 

16 year 2007 shall be based on a premarket 

17 application fee of $281,600.’’; and 

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

19 ‘‘(3) SUPPLEMENT.— 

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

21 and 2007, the Secretary may use unobligated 

22 carryover balances from fees collected in previous 

23 fiscal years to ensure that sufficient fee revenues 

24 are available in that fiscal year, so long as the 

25 Secretary maintains unobligated carryover bal-
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1 ances of not less than 1 month of operating re2 serves for the first month of fiscal year 2008. 

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

4 than 14 days before the Secretary anticipates the 

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

6 Secretary shall provide notice to the Committee 

7 on Health, Education, Labor, and Pensions and 

8 the Committee on Appropriations of the Senate 

9 and the Committee on Energy and Commerce 

10 and the Committee on Appropriations of the 

11 House of Representatives.’’; 

12 (3) in subsection (d)— 

13 (A) in paragraph (1), by inserting after the 

14 first sentence the following: ‘‘For the purposes of 

15 this paragraph, the term ‘small business’ means 

16 an entity that reported $30,000,000 or less of 

17 gross receipts or sales in its most recent Federal 

18 income tax return for a taxable year, including 

19 such returns of all of its affiliates, partners, and 

20 parent firms.’’; and 

21 (B) in paragraph (2)(A), by— 

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

23 (ii) striking ‘‘subsection,’’ and insert24 ing ‘‘paragraph,’’; 
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1 (iii) striking ‘‘$30,000,000’’ and in2 serting ‘‘$100,000,000’’; and 

3 (iv) striking clause (ii); 

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

5 ‘‘$30,000,000’’ and inserting ‘‘$100,000,000’’; 

6 (5) in subsection (g)(1)— 

7 (A) in subparagraph (B)— 

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

9 the following: 

10 ‘‘(i) For fiscal year 2005, the Secretary 

11 is expected to meet all of the performance 

12 goals identified for the fiscal year if the 

13 amount so appropriated for such fiscal 

14 year, excluding the amount of fees appro15 priated for such fiscal year, is equal to or 

16 greater than $205,720,000 multiplied by the 

17 adjustment factor applicable to the fiscal 

18 year.’’; and 

19 (ii) in clause (ii), by striking the mat20 ter preceding subclause (I) and inserting the 

21 following: 

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

23 amount so appropriated for such fiscal 

24 year, excluding the amount of fees appro25 priated for such fiscal year, is more than 1 
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1 percent less than the amount that applies 

2 under clause (i), the following applies:’’; 

3 (B) in subparagraph (C)— 

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

5 by— 

6 (I) striking ‘‘2003 through’’ and 

7 inserting ‘‘2005 and’’; and 

8 (II) inserting ‘‘more than 1 per9 cent’’ after ‘‘years, is’’; and 

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

11 and inserting ‘‘amount’’; and 

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

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

14 (6) in subsection (h)(3)— 

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

16 semicolon and inserting ‘‘; and’’; and 

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

18 and inserting the following: 

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

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

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

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

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

24 Device User Fee and Modernization Act of 2002 (Public 

25 Law 107–250 (116 Stat. 1600)) is amended— 
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1 (1) by striking ‘‘Beginning with’’ and inserting 

2 ‘‘(a) IN GENERAL.—Beginning with’’; and 

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

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

5 2006 and 2007, the report described under subsection (a)(2) 

6 shall include— 

7 ‘‘(1) information on the number of different 

8 types of applications and notifications, and the total 

9 amount of fees paid for each such type of application 

10 or notification, from businesses with gross receipts or 

11 sales from $0 to $100,000,000, with such businesses 

12 categorized in $10,000,000 intervals; and 

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

14 amounts appropriated for salaries and expenses of the 

15 Food and Drug Administration for such fiscal year 

16 and obligated by the Secretary for the performance of 

17 any function relating to devices that is not for the 

18 process for the review of device applications, as de19 fined in paragraph (5) of section 737 of the Federal 

20 Food, Drug, and Cosmetic Act (21 U.S.C. 379i), are 

21 not less than such amounts for fiscal year 2002 multi22 plied by the adjustment factor, as defined in para23 graph (7) of such section 737.’’. 

24 (c) MISBRANDED DEVICES.— 
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1 (1) IN GENERAL.—Section 502(u) of the Federal 

2 Food, Drug, and Cosmetic Act (21 U.S.C. 352(u)) is 

3 amended to read as follows: 

4 ‘‘(u)(1) Subject to paragraph (2), if it is a reprocessed 

5 single-use device, unless it, or an attachment thereto, promi6 nently and conspicuously bears the name of the manufac7 turer of the reprocessed device, a generally recognized abbre8 viation of such name, or a unique and generally recognized 

9 symbol identifying such manufacturer. 

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

11 does not prominently and conspicuously bear the name of 

12 the manufacturer of the original device, a generally recog13 nized abbreviation of such name, or a unique and generally 

14 recognized symbol identifying such manufacturer, a reproc15 essed device may satisfy the requirements of paragraph (1) 

16 through the use of a detachable label on the packaging that 

17 identifies the manufacturer and is intended to be affixed 

18 to the medical record of a patient.’’. 

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

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

21 Health and Human Services shall issue guidance to 

22 identify circumstances in which the name of the man23 ufacturer of the original device, a generally recognized 

24 abbreviation of such name, or a unique and generally 

25 recognized symbol identifying such manufacturer, is 
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1 not ‘‘prominent and conspicuous’’, as used in section 

2 502(u) of Federal Food, Drug, and Cosmetic Act (as 

3 amended by paragraph (1)). 

4 (d) EFFECTIVE DATE.—Section 301(b) of the Medical 

5 Device User Fee and Modernization Act of 2002 (Public 

6 Law 107–250 (116 Stat. 1616)), as amended by section 2(c) 

7 of Public Law 108–214 (118 Stat. 575), is amended to read 

8 as follows: 

9 ‘‘(b) EFFECTIVE DATE.—Section 502(u) of the Federal 

10 Food, Drug, and Cosmetic Act (as amended by section 2(c) 

11 of the Medical Device User Fee Stabilization Act of 2005)— 

12 ‘‘(1) shall be effective— 

13 ‘‘(A) with respect to devices described under 

14 paragraph (1) of such section, 12 months after 

15 the date of enactment of the Medical Device User 

16 Fee Stabilization Act of 2005, or the date on 

17 which the original device first bears the name of 

18 the manufacturer of the original device, a gen19 erally recognized abbreviation of such name, or 

20 a unique and generally recognized symbol identi21 fying such manufacturer, whichever is later; and 

22 ‘‘(B) with respect to devices described under 

23 paragraph (2) of such section 502(u), 12 months 

24 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.’’. 

Calendar No. 173 

109TH CONGRESS 

1ST SESSION S. 1420 

[Report No. 109–107] 

A BILL 

To amend the Federal Food, Drug, and Cosmetic 

Act with respect to medical device user fees. 

JULY 25, 2005 

Reported with an amendment