II 

110TH CONGRESS 

1ST SESSION S. 1082 

To amend the Federal Food, Drug, and Cosmetic Act to reauthorize and 

amend the prescription drug user fee provisions, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

APRIL 10, 2007 

Mr. KENNEDY introduced the following bill; which was read twice and referred 

to the Committee on Health, Education, Labor, and Pensions 

A BILL 

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

reauthorize and amend the prescription drug user fee 

provisions, and for other purposes. 

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; REFERENCES IN ACT. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Prescription Drug User Fee Amendments of 2007’’. 

6 (b) REFERENCES IN ACT.—Except as otherwise spec7 ified, whenever in this Act an amendment is expressed in 

8 terms of an amendment to a section or other provision, 

9 the reference shall be considered to be made to a section 

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1 or other provision of the Federal Food, Drug, and Cos2 metic Act (21 U.S.C. 301 et seq.). 

3 SEC. 2. DRUG FEES. 

4 Section 735 (21 U.S.C. 379g) is amended— 

5 (1) by striking the section designation and all 

6 that follows through ‘‘For purposes of this sub7 chapter:’’ and inserting the following: 

8 ‘‘SEC. 735. DRUG FEES. 

9 ‘‘(a) PURPOSE.—It is the purpose of this part that 

10 the fees authorized under this part be dedicated toward 

11 expediting the drug development process, the process for 

12 the review of human drug applications, and postmarket 

13 drug safety, as set forth in the goals identified for pur14 poses of this subchapter in the letters from the Secretary 

15 to the Chairman of the Committee on Health, Education, 

16 Labor, and Pensions of the Senate and the Chairman of 

17 the Committee on Energy and Commerce of the House 

18 of Representatives, as set forth in the Congressional 

19 Record. 

20 ‘‘(b) REPORTS.— 

21 ‘‘(1) PERFORMANCE REPORT.—For fiscal years 

22 2008 through 2012, not later than 120 days after 

23 the end of each fiscal year during which fees are col24 lected under this part, the Secretary shall prepare 

25 and submit to the Committee on Health, Education, 

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1 Labor, and Pensions of the Senate and the Com2 mittee on Energy and Commerce of the House of 

3 Representatives, a report concerning the progress of 

4 the Food and Drug Administration in achieving the 

5 goals identified in the letters described in subsection 

6 (a) during such fiscal year and the future plans of 

7 the Food and Drug Administration for meeting the 

8 goals. The report for a fiscal year shall include infor9 mation on all previous cohorts for which the Sec10 retary has not given a complete response on all 

11 human drug applications and supplements in the co12 hort. 

13 ‘‘(2) FISCAL REPORT.—For fiscal years 2008 

14 through 2012, not later than 120 days after the end 

15 of each fiscal year during which fees are collected 

16 under this part, the Secretary shall prepare and sub17 mit to the Committee on Health, Education, Labor, 

18 and Pensions of the Senate and the Committee on 

19 Energy and Commerce of the House of Representa20 tives, a report on the implementation of the author21 ity for such fees during such fiscal year and the use, 

22 by the Food and Drug Administration, of the fees 

23 collected during such fiscal year for which the report 

24 is made. 

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1 ‘‘(3) PUBLIC AVAILABILITY.—The Secretary 

2 shall make the reports required under paragraphs 

3 (1) and (2) available to the public on the Internet 

4 website of the Food and Drug Administration. 

5 ‘‘(c) REAUTHORIZATION.— 

6 ‘‘(1) CONSULTATION.—In developing rec7 ommendations to present to Congress with respect to 

8 the goals, and plans for meeting the goals, for the 

9 process for the review of human drug applications 

10 for the first 5 fiscal years after fiscal year 2012, and 

11 for the reauthorization of this part for such fiscal 

12 years, the Secretary shall consult with— 

13 ‘‘(A) the Committee on Energy and Com14 merce of the House of Representatives; 

15 ‘‘(B) the Committee on Health, Education, 

16 Labor, and Pensions of the Senate; 

17 ‘‘(C) scientific and academic experts; 

18 ‘‘(D) health care professionals; 

19 ‘‘(E) representatives of patient and con20 sumer advocacy groups; and 

21 ‘‘(F) the regulated industry. 

22 ‘‘(2) PUBLIC REVIEW OF RECOMMENDA23 TIONS.—After negotiations with the regulated indus24 try, the Secretary shall— 

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1 ‘‘(A) present the recommendations devel2 oped under paragraph (1) to the Congressional 

3 committees specified in such paragraph; 

4 ‘‘(B) publish such recommendations in the 

5 Federal Register; 

6 ‘‘(C) provide for a period of 30 days for 

7 the public to provide written comments on such 

8 recommendations; 

9 ‘‘(D) hold a meeting at which the public 

10 may present its views on such recommenda11 tions; and 

12 ‘‘(E) after consideration of such public 

13 views and comments, revise such recommenda14 tions as necessary. 

15 ‘‘(3) TRANSMITTAL OF RECOMMENDATIONS.— 

16 Not later than January 15, 2012, the Secretary 

17 shall transmit to Congress the revised recommenda18 tions under paragraph (2), a summary of the views 

19 and comments received under such paragraph, and 

20 any changes made to the recommendations in re21 sponse to such views and comments. 

22 ‘‘(d) DEFINITIONS.—For purposes of this part:’’; 

23 (2) in subsection (d)— 

24 (A) in paragraph (1)— 

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1 (i) in subparagraph (A), by striking 

2 ‘‘505(b)(1),’’ and inserting ‘‘505(b), or’’; 

3 (ii) by striking subparagraph (B); 

4 (iii) by redesignating subparagraph 

5 (C) as subparagraph (B); and 

6 (iv) in the matter following subpara7 graph (B), as so redesignated, by striking 

8 ‘‘subparagraph (C)’’ and inserting ‘‘sub9 paragraph (B)’’; 

10 (B) in paragraph (3)(C), by— 

11 (i) striking ‘‘the list’’ and inserting 

12 ‘‘the list (not including the discontinued 

13 section of such list)’’; and 

14 (ii) striking ‘‘a list’’ and inserting ‘‘a 

15 list (not including the discontinued section 

16 of such a list)’’; 

17 (C) in paragraph (4), by inserting before 

18 the period at the end the following: ‘‘(such as 

19 capsules, tablets, and lyophilized products be20 fore reconstitution)’’; 

21 (D) by amending paragraph (6)(F) to read 

22 as follows: 

23 ‘‘(F) In the case of drugs approved under 

24 human drug applications or supplements, 

25 postmarket safety activities, including— 

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1 ‘‘(i) collecting, developing, and review2 ing safety information on approved drugs 

3 (including adverse event reports); 

4 ‘‘(ii) developing and using improved 

5 adverse event data collection systems (in6 cluding information technology systems); 

7 and 

8 ‘‘(iii) developing and using improved 

9 analytical tools to assess potential safety 

10 problems (including by accessing external 

11 data bases).’’; 

12 (E) in paragraph (8)— 

13 (i) by striking ‘‘April of the preceding 

14 fiscal year’’ and inserting ‘‘October of the 

15 preceding fiscal year’’; and 

16 (ii) by striking ‘‘April 1997’’ and in17 serting ‘‘October 1996’’; 

18 (F) by redesignating paragraph (9) as 

19 paragraph (10); and 

20 (G) by inserting after paragraph (8) the 

21 following: 

22 ‘‘(9) The term ‘person’ includes an affiliate 

23 thereof.’’. 

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1 SEC. 3. AUTHORITY TO ASSESS AND USE DRUG FEES. 

2 (a) TYPES OF FEES.—Section 736(a) (21 U.S.C. 

3 379h(a)) is amended— 

4 (1) in the matter preceding paragraph (1), by 

5 striking ‘‘2003’’ and inserting ‘‘2008’’; 

6 (2) in paragraph (1)— 

7 (A) in subparagraph (D)— 

8 (i) in the heading, by inserting ‘‘OR

9 WITHDRAWN BEFORE FILING’’ after ‘‘RE10 FUND OF FEE IF APPLICATION REFUSED

11 FOR FILING’’; and 

12 (ii) by inserting before the period at 

13 the end the following: ‘‘or withdrawn with14 out a waiver before filing’’; 

15 (B) by redesignating subparagraphs (E) 

16 and (F) as subparagraphs (F) and (G), respec17 tively; and 

18 (C) by inserting after subparagraph (D) 

19 the following: 

20 ‘‘(E) FEE FOR APPLICATION PREVIOUSLY

21 REFUSED FOR FILING OR WITHDRAWN BEFORE

22 FILING.—An application or supplement that 

23 has been refused for filing or that was with24 drawn before filing, if filed under protest or re25 submitted, shall be subject to the fee under sub26 paragraph (A) (unless an exception under submstockstill on PROD1PC66 with BILLS

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1 paragraph (C) or (F) applies or the fee is 

2 waived or reduced under subsection (d)), with3 out regard to previous payment of such a fee 

4 and the refund of 75 percent of that fee under 

5 subparagraph (D).’’; and 

6 (3) in paragraph (2)— 

7 (A) in subparagraph (A), by striking ‘‘sub8 paragraph (B)’’ and inserting ‘‘subparagraphs 

9 (B) and (C)’’; and 

10 (B) by adding at the end the following: 

11 ‘‘(C) SPECIAL RULES FOR COMPOUNDED

12 POSITRON EMISSION TOMOGRAPHY DRUGS.— 

13 ‘‘(i) IN GENERAL.—Except as pro14 vided in clause (ii), each person who is 

15 named as the applicant in an approved 

16 human drug application for a compounded 

17 positron emission tomography drug shall 

18 be subject under subparagraph (A) to one19 quarter of an annual establishment fee 

20 with respect to each such establishment 

21 identified in the application as producing 

22 compounded positron emission tomography 

23 drugs under the approved application. 

24 ‘‘(ii) EXCEPTION FROM ANNUAL ES25 TABLISHMENT FEE.—Each person who is 

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1 named as the applicant in an application 

2 described in clause (i) shall not be assessed 

3 an annual establishment fee for a fiscal 

4 year if the person certifies to the Sec5 retary, at a time specified by the Secretary 

6 and using procedures specified by the Sec7 retary, that— 

8 ‘‘(I) the person is a not-for-profit 

9 medical center that has only 1 estab10 lishment for the production of com11 pounded positron emission tomog12 raphy drugs; and 

13 ‘‘(II) at least 95 percent of the 

14 total number of doses of each com15 pounded positron emission tomog16 raphy drug produced by such estab17 lishment during such fiscal year will 

18 be used within the medical center.’’. 

19 (b) FEE REVENUE AMOUNTS.—Section 736(b) (21 

20 U.S.C. 379h(b)) is amended to read as follows: 

21 ‘‘(b) FEE REVENUE AMOUNTS.—Except as provided 

22 in subsections (c), (d), (f), and (g), fees under subsection 

23 (a) shall be established to generate the following revenue 

24 amounts, in each fiscal year beginning with fiscal year 

25 2008 and continuing through fiscal year 2012: 

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1 $392,783,000, plus an adjustment for workload on 

2 $354,893,000 of this amount. Such adjustment shall be 

3 made in accordance with the workload adjustment provi4 sions in effect for fiscal year 2007, except that instead 

5 of commercial investigational new drug applications sub6 mitted to the Secretary, all commercial investigational new 

7 drug applications with a submission during the previous 

8 12-month period shall be used in the determination. One9 third of the revenue amount shall be derived from applica10 tion fees, one-third from establishment fees, and one-third 

11 from product fees.’’. 

12 (c) ADJUSTMENTS TO FEES.— 

13 (1) INFLATION ADJUSTMENT.—Section 

14 736(c)(1) (21 U.S.C. 379h(c)(1)) is amended— 

15 (A) in the matter preceding subparagraph 

16 (A) by striking ‘‘The revenues established in 

17 subsection (b)’’ and inserting ‘‘Beginning with 

18 fiscal year 2009, the revenues established in 

19 subsection (b)’’; 

20 (B) in subparagraph (A) by striking ‘‘or’’ 

21 at the end; 

22 (C) in subparagraph (B) by striking the 

23 period at the end and inserting ‘‘, or,’’; 

24 (D) by inserting after subparagraph (B) 

25 the following: 

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1 ‘‘(C) the average annual change in the 

2 cost, per full-time equivalent position of the 

3 Food and Drug Administration, of all personnel 

4 compensation and benefits paid with respect to 

5 such positions, for the first 5 fiscal years of the 

6 previous 6 fiscal years.’’; and 

7 (E) in the matter following subparagraph 

8 (C) (as added by this paragraph), by striking 

9 ‘‘fiscal year 2003’’ and inserting ‘‘fiscal year 

10 2008’’. 

11 (2) WORKLOAD ADJUSTMENT.—Section 

12 736(c)(2) (21 U.S.C. 379h(c)(2)) is amended— 

13 (A) in the matter preceding subparagraph 

14 (A,) by striking ‘‘2004’’ and inserting ‘‘2009’’; 

15 (B) in the first sentence of subparagraph 

16 (A)— 

17 (i) by striking ‘‘, commercial inves18 tigational new drug applications’’ and in19 serting ‘‘(adjusted for changes in review 

20 activities)’’; and 

21 (ii) by inserting before the period at 

22 the end ‘‘, and the change in the number 

23 of commercial investigational new drug ap24 plications with a submission during the 

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1 previous 12-month period (adjusted for 

2 changes in review activities)’’; 

3 (C) in subparagraph (B), by adding at the 

4 end the following new sentence: ‘‘Further, any 

5 adjustment for changes in review activities 

6 made in setting fees and fee revenue amounts 

7 for fiscal year 2009 may not result in the total 

8 workload adjustment being more than 2 per9 centage points higher than it would be absent 

10 the adjustment for changes in review activi11 ties.’’; and 

12 (D) by adding at the end the following: 

13 ‘‘(C) The Secretary shall contract with an 

14 independent accounting firm to study the ad15 justment for changes in review activities applied 

16 in setting fees for fiscal year 2009 and to make 

17 recommendations, if warranted, on future 

18 changes in the methodology for calculating the 

19 adjustment for changes in review activity. After 

20 review of the recommendations by the inde21 pendent accounting firm, the Secretary shall 

22 make appropriate changes to the workload ad23 justment methodology in setting fees for fiscal 

24 years 2010 through 2012. If the study is not 

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1 conducted, no adjustment for changes in review 

2 activities shall be made after fiscal year 2009.’’. 

3 (3) RENT AND RENT-RELATED COST ADJUST4 MENT.—Section 736(c) (21 U.S.C. 379h(c)) is 

5 amended— 

6 (A) by redesignating paragraphs (3), (4), 

7 and (5) as paragraphs (4), (5), and (6), respec8 tively; and 

9 (B) by inserting after paragraph (2) the 

10 following: 

11 ‘‘(3) RENT AND RENT-RELATED COST ADJUST12 MENT.—Beginning in fiscal year 2010, the Secretary 

13 shall, before making the adjustments under para14 graphs (1) and (2), reduce the fee amounts estab15 lished in subsection (b), if actual costs paid for rent 

16 and rent-related expenses are less than $11,721,000. 

17 The reductions made under this paragraph, if any, 

18 shall not exceed the amounts by which costs fell 

19 below $11,721,000, and shall not exceed 

20 $11,721,000 in any fiscal year.’’. 

21 (4) FINAL YEAR ADJUSTMENT.—Section 736(c) 

22 (21 U.S.C. 379h(c)) is amended— 

23 (A) in paragraph (4), as redesignated by 

24 this subsection— 

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1 (i) by striking ‘‘2007’’ each place it 

2 appears and inserting ‘‘2012’’; and 

3 (ii) by striking ‘‘2008’’ and inserting 

4 ‘‘2013’’; and 

5 (B) in paragraph (5), as redesignated by 

6 this subsection, by striking ‘‘2002’’ and insert7 ing ‘‘2007’’. 

8 (d) FEE WAIVER OR REDUCTION.—Section 736(d) 

9 (21 U.S.C. 379h(d)) is amended— 

10 (1) in paragraph (1), in the matter preceding 

11 subparagraph (A), by— 

12 (A) inserting ‘‘to a person who is named as 

13 the applicant’’ after ‘‘The Secretary shall 

14 grant’’; 

15 (B) inserting ‘‘to that person’’ after ‘‘a 

16 waiver from or a reduction of one or more fees 

17 assessed’’; and 

18 (C) striking ‘‘finds’’ and inserting ‘‘deter19 mines’’; 

20 (2) by redesignating paragraphs (2) and (3) as 

21 paragraphs (3) and (4), respectively; 

22 (3) by inserting after paragraph (1) the fol23 lowing: 

24 ‘‘(2) EVALUATION.—For the purpose of deter25 mining whether to grant a waiver or reduction of a 

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1 fee under paragraph (1), the Secretary shall con2 sider only the circumstances and assets of the appli3 cant and any affiliate of the applicant.’’; and 

4 (4) in paragraph (4), as redesignated by this 

5 subsection, in subparagraph (A), by inserting before 

6 the period at the end ‘‘, and that does not have a 

7 drug product that has been approved under a human 

8 drug application and introduced or delivered for in9 troduction into interstate commerce’’. 

10 (e) CREDITING AND AVAILABILITY OF FEES.— 

11 (1) AUTHORIZATION OF APPROPRIATIONS.— 

12 Section 736(g)(3) (21 U.S.C. 379h(g)(3)) is amend13 ed to read as follows: 

14 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

15 There are authorized to be appropriated for fees 

16 under this section such sums as are authorized to be 

17 assessed and collected under this section in each of 

18 fiscal years 2008 through 2012.’’. 

19 (2) OFFSET.—Section 736(g)(4) (21 U.S.C. 

20 379h(g)(4)) is amended to read as follows: 

21 ‘‘(4) OFFSET.—If the cumulative amount of 

22 fees collected during fiscal years 2008, 2009, and 

23 2010, plus the amount estimated to be collected for 

24 fiscal year 2011, exceeds the amount of fees speci25 fied in aggregate in appropriation Acts for such fismstockstill on PROD1PC66 with BILLS

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1 cal years, the aggregate amount in excess shall be 

2 credited to the appropriation account of the Food 

3 and Drug Administration as provided in paragraph 

4 (1), and shall be subtracted from the amount of fees 

5 that would otherwise be authorized to be collected 

6 under this section pursuant to appropriation Acts 

7 for fiscal year 2012.’’. 

8 (f) CONFORMING AMENDMENTS.— 

9 (1) Section 736(a) (21 U.S.C. 379h(a)), as 

10 amended by this section, is amended— 

11 (A) in paragraph (1)(A), by striking ‘‘sub12 section (c)(4)’’ each place it appears and insert13 ing ‘‘subsection (c)(5)’’; 

14 (B) in paragraph (2), by striking ‘‘sub15 section (c)(4)’’ and inserting ‘‘subsection 

16 (c)(5)’’; and 

17 (C) in paragraph (3), by striking ‘‘sub18 section (c)(4)’’ and inserting ‘‘subsection 

19 (c)(5)’’. 

20 (2) Section 736A(h)(3), as added by section 4 

21 of this Act, is amended by striking ‘‘735(3)’’ and in22 serting ‘‘735(d)(3)’’. 

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1 SEC. 4. AUTHORITY TO ASSESS AND USE PRESCRIPTION 

2 DRUG ADVERTISING FEES. 

3 Chapter VII, subchapter C, part 2 (21 U.S.C. 379g 

4 et seq.) is amended by adding after section 736 the fol5 lowing new section: 

6 ‘‘SEC. 736A. PROGRAM TO ASSESS AND USE FEES FOR THE 

7 ADVISORY REVIEW OF PRESCRIPTION DRUG 

8 ADVERTISING. 

9 ‘‘(a) TYPES OF DIRECT-TO-CONSUMER TELEVISION

10 ADVERTISEMENT REVIEW FEES.—Beginning in fiscal 

11 year 2008, the Secretary shall assess and collect fees in 

12 accordance with this section as follows: 

13 ‘‘(1) ADVISORY REVIEW FEE.— 

14 ‘‘(A) IN GENERAL.—Except as provided in 

15 subparagraph (B), each person that on or after 

16 October 1, 2007, submits a proposed direct-to17 consumer television advertisement for advisory 

18 review by the Secretary prior to its initial public 

19 dissemination shall be subject to a fee estab20 lished under subsection (c)(3). 

21 ‘‘(B) EXCEPTION FOR REQUIRED SUBMIS22 SIONS.—A direct-to-consumer television adver23 tisement that is required to be submitted to the 

24 Secretary prior to initial public dissemination 

25 shall not be assessed a fee unless the sponsor 

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1 designates it as a submission for advisory re2 view. 

3 ‘‘(C) PAYMENT.—The fee required by sub4 paragraph (A) shall be due no later than Octo5 ber 1 of the fiscal year in which the direct-to6 consumer television advertisement shall be sub7 mitted to the Secretary for advisory review. 

8 ‘‘(D) MODIFICATION OF ADVISORY REVIEW

9 FEE.— 

10 ‘‘(i) LATE PAYMENT.—If, on or before 

11 November 1 of the fiscal year in which the 

12 fees are due, a person has not paid all fees 

13 that were due and payable for advisory re14 views identified in response to the Federal 

15 Register notice described in subsection 

16 (c)(3)(A), the fees shall be regarded as 

17 late. Such fees shall be due and payable 20 

18 days before any direct-to-consumer tele19 vision advertisement is submitted by such 

20 person to the Secretary for advisory re21 view. Notwithstanding any other provision 

22 of this section, such fees shall be due and 

23 payable for each of those advisory reviews 

24 in the amount of 150 percent of the advimstockstill on PROD1PC66 with BILLS

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1 sory review fee established for that fiscal 

2 year pursuant to subsection (c)(3). 

3 ‘‘(ii) LATE NOTICE OF SUBMISSION.— 

4 If any person submits any direct-to-con5 sumer television advertisements for advi6 sory review that are in excess of the num7 ber identified by that person in response to 

8 the Federal Register notice described in 

9 subsection (c)(3)(A), that person must pay 

10 a fee for each of those advisory reviews in 

11 the amount of 150 percent of the advisory 

12 review fee established for that fiscal year 

13 pursuant to subsection (c)(3). Fees under 

14 this subparagraph shall be due 20 days be15 fore the direct-to-consumer television ad16 vertisement is submitted by such person to 

17 the Secretary for advisory review. 

18 ‘‘(E) LIMITS.— 

19 ‘‘(i) IN GENERAL.—The payment of a 

20 fee under this paragraph for a fiscal year 

21 entitles the person that pays the fee to ac22 ceptance for advisory review by the Sec23 retary of 1 direct-to-consumer television 

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1 vertisement. The advertisement shall be 

2 submitted for review in the fiscal year for 

3 which the fee was assessed, except that a 

4 person may carry over no more than 1 

5 paid advisory review submission to the next 

6 fiscal year. Resubmissions may be sub7 mitted without regard to the fiscal year of 

8 the initial advisory review submission. 

9 ‘‘(ii) NO REFUND.—Except as pro10 vided by subsection (f), fees paid under 

11 this paragraph shall not be refunded. 

12 ‘‘(iii) NO WAIVER, EXEMPTION, OR

13 REDUCTION.—The Secretary shall not 

14 grant a waiver, exemption, or reduction of 

15 any fees due or payable under this section. 

16 ‘‘(iv) NON-TRANSFERABILITY.—The 

17 right to an advisory review is not transfer18 able, except to a successor in interest. 

19 ‘‘(2) OPERATING RESERVE FEE.— 

20 ‘‘(A) IN GENERAL.—Each person that, on 

21 or after October 1, 2007, is assessed an advi22 sory review fee under paragraph (1) shall be 

23 subject to an operating reserve fee established 

24 under subsection (d)(2) only in the first fiscal 

25 year in which an advisory review fee is assessed. 

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1 ‘‘(B) PAYMENT.—Except as provided in 

2 subparagraph (C), the fee required by subpara3 graph (A) shall be due no later than October 1 

4 of the first fiscal year in which the person is re5 quired to pay an advisory review fee under 

6 paragraph (1). 

7 ‘‘(C) LATE NOTICE OF SUBMISSION.—If, in 

8 the first fiscal year of a person’s participation 

9 in the Program, that person submits any direct10 to-consumer television advertisements for advi11 sory review that are in excess of the number 

12 identified by that person in response to the 

13 Federal Register notice described in subsection 

14 (c)(3)(A), that person must pay an operating 

15 reserve fee for each of those advisory reviews 

16 equal to the advisory review fee for each sub17 mission established under paragraph (1)(D)(ii). 

18 Fees required by this subparagraph shall be in 

19 addition to the fees required under subpara20 graph (B), if any. Fees under this subpara21 graph shall be due 20 days before any direct22 to-consumer television advertisement is sub23 mitted by such person to the Secretary for advi24 sory review. 

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1 ‘‘(b) ADVISORY REVIEW FEE REVENUE AMOUNTS.— 

2 Fees under subsection (a)(1) shall be established to gen3 erate revenue amounts of $6,250,000 for each of fiscal 

4 years 2008 through 2012, as adjusted pursuant to sub5 section (c). 

6 ‘‘(c) ADJUSTMENTS.— 

7 ‘‘(1) INFLATION ADJUSTMENT.—Beginning 

8 with fiscal year 2009, the revenues established in 

9 subsection (b) shall be adjusted by the Secretary by 

10 notice, published in the Federal Register, for a fiscal 

11 year to reflect the greater of— 

12 ‘‘(A) the total percentage change that oc13 curred in the Consumer Price Index for all 

14 urban consumers (all items; United States city 

15 average), for the 12-month period ending June 

16 30 preceding the fiscal year for which fees are 

17 being established; 

18 ‘‘(B) the total percentage change for the 

19 previous fiscal year in basic pay under the Gen20 eral Schedule in accordance with section 5332 

21 of title 5, as adjusted by any locality-based 

22 comparability payment pursuant to section 

23 5304 of such title for Federal employees sta24 tioned in the District of Columbia; or 

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1 ‘‘(C) the average annual change in the 

2 cost, per full-time equivalent position of the 

3 Food and Drug Administration, of all personnel 

4 compensation and benefits paid with respect to 

5 such positions, for the first 5 fiscal years of the 

6 previous 6 fiscal years. 

7 The adjustment made each fiscal year by this sub8 section shall be added on a compounded basis to the 

9 sum of all adjustments made each fiscal year after 

10 fiscal year 2008 under this subsection. 

11 ‘‘(2) WORKLOAD ADJUSTMENT.— 

12 ‘‘(A) IN GENERAL.—Beginning with fiscal 

13 year 2009, after the fee revenues established in 

14 subsection (b) of this section are adjusted for a 

15 fiscal year for inflation in accordance with para16 graph (1), the fee revenues shall be adjusted 

17 further for such fiscal year to reflect changes in 

18 the workload of the Secretary with respect to 

19 the submission of proposed direct-to-consumer 

20 television advertisements for advisory review 

21 prior to initial broadcast. 

22 ‘‘(B) DETERMINATION OF WORKLOAD AD23 JUSTMENT.— 

24 ‘‘(i) IN GENERAL.—The workload ad25 justment under this paragraph for a fiscal 

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1 year shall be determined by the Sec2 retary— 

3 ‘‘(I) based upon the number of 

4 direct-to-consumer television adver5 tisements identified pursuant to para6 graph (3)(A) for that fiscal year, ex7 cluding allowable previously paid carry 

8 over submissions; and 

9 ‘‘(II) by multiplying the number 

10 of such advertisements projected for 

11 that fiscal year that exceeds 150 by 

12 $27,600 (adjusted each year begin13 ning with fiscal year 2009 for infla14 tion in accordance with paragraph 

15 (1)). 

16 ‘‘(ii) PUBLICATION IN FEDERAL REG17 ISTER.—The Secretary shall publish in the 

18 Federal Register the fee revenues and fees 

19 resulting from the adjustment and the sup20 porting methodologies. 

21 ‘‘(C) LIMITATION.—Under no cir22 cumstances shall the adjustment result in fee 

23 revenues for a fiscal year that are less than the 

24 fee revenues established for the prior fiscal 

25 year. 

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1 ‘‘(3) ANNUAL FEE SETTING.— 

2 ‘‘(A) NUMBER OF ADVERTISEMENTS.—The 

3 Secretary shall, 120 days before the start of 

4 each fiscal year, publish a notice in the Federal 

5 Register requesting any person to notify the 

6 Secretary within 30 days of the number of di7 rect-to-consumer television advertisements the 

8 person intends to submit for advisory review by 

9 the Secretary in the next fiscal year. Notifica10 tion to the Secretary of the number of adver11 tisements a person intends to submit for advi12 sory review prior to initial broadcast shall be a 

13 legally binding commitment by that person to 

14 pay the annual advisory review fee for that 

15 number of submissions on or before October 1 

16 of the fiscal year in which the advertisement is 

17 intended to be submitted. A person shall at the 

18 same time also notify the Secretary if such per19 son intends to use a paid submission from the 

20 previous fiscal year under subsection 

21 (a)(1)(E)(i). If such person does not so notify 

22 the Secretary, all submissions for advisory re23 view shall be subject to advisory review fees. 

24 ‘‘(B) ANNUAL FEE.—The Secretary shall, 

25 60 days before the start of each fiscal year, esmstockstill on PROD1PC66 with BILLS

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1 tablish, for the next fiscal year, the direct-to2 consumer television advertisement advisory re3 view fee under subsection (a)(1), based on the 

4 revenue amounts established under subsection 

5 (b), the adjustments provided under this sub6 section and the number of direct-to-consumer 

7 television advertisements identified pursuant to 

8 subparagraph (A), excluding allowable pre9 viously paid carry over submissions. The annual 

10 advisory review fee shall be established by divid11 ing the fee revenue for a fiscal year (as ad12 justed pursuant to this subsection) by the num13 ber of direct-to-consumer television advertise14 ments identified pursuant to subparagraph (A), 

15 excluding allowable previously paid carry over 

16 submissions. 

17 ‘‘(C) FISCAL YEAR 2008 FEE LIMIT.—Not18 withstanding subsection (b), the fee established 

19 under subparagraph (B) for fiscal year 2008 

20 may not be more than $83,000 per submission 

21 for advisory review. 

22 ‘‘(D) ANNUAL FEE LIMIT.—Notwith23 standing subsection (b), the fee established 

24 under subparagraph (B) for a fiscal year after 

25 fiscal year 2008 may not be more than 50 permstockstill on PROD1PC66 with BILLS

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•S 1082 IS

1 cent more than the fee established for the prior 

2 fiscal year. 

3 ‘‘(E) LIMIT.—The total amount of fees ob4 ligated for a fiscal year may not exceed the 

5 total costs for such fiscal year for the resources 

6 allocated for the process for the advisory review 

7 of prescription drug advertising. 

8 ‘‘(d) OPERATING RESERVES.— 

9 ‘‘(1) IN GENERAL.—The Secretary shall estab10 lish in the Food and Drug Administration salaries 

11 and expenses appropriation account without fiscal 

12 year limitation a Direct-to-Consumer Advisory Re13 view Operating Reserve, of at least $6,250,000 in 

14 fiscal year 2008, to continue the Program in the 

15 event the fees collected in any subsequent fiscal year 

16 pursuant to subsection (c)(3) do not generate the fee 

17 revenue amount established for that fiscal year. 

18 ‘‘(2) FEE SETTING.—The Secretary shall estab19 lish the operating reserve fee under subsection 

20 (a)(2)(A) for each person required to pay the fee by 

21 multiplying the number of direct-to-consumer tele22 vision advertisements identified by that person pur23 suant to subsection (c)(3)(A) by the advisory review 

24 fee established pursuant to subsection (c)(3) for that 

25 fiscal year. In no case shall the operating reserve fee 

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1 assessed be less than the operating reserve fee as2 sessed if the person had first participated in the 

3 Program in fiscal year 2008. 

4 ‘‘(3) USE OF OPERATING RESERVE.—The Sec5 retary may use funds from the reserves under this 

6 subsection only to the extent necessary in any fiscal 

7 year to make up the difference between the fee rev8 enue amount established for that fiscal year under 

9 subsection (b) and the amount of fees collected for 

10 that fiscal year pursuant to subsection (a), or to pay 

11 costs of ending the Program if it is terminated pur12 suant to subsection (f) or if it is not reauthorized 

13 after fiscal year 2012. 

14 ‘‘(4) REFUND OF OPERATING RESERVES.— 

15 Within 120 days of the end of fiscal year 2012, or 

16 if the Program is terminated pursuant to subsection 

17 (f), the Secretary, after setting aside sufficient oper18 ating reserve amounts to terminate the Program, 

19 shall refund all amounts remaining in the operating 

20 reserve on a pro rata basis to each person that paid 

21 an operating reserve fee assessment. In no event 

22 shall the refund to any person exceed the total 

23 amount of operating reserve fees paid by such per24 son pursuant to subsection (a)(2). 

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1 ‘‘(e) EFFECT OF FAILURE TO PAY FEES.—Notwith2 standing any other law or regulation of the Secretary, a 

3 submission for advisory review of a direct-to-consumer tel4 evision advertisement submitted by a person subject to 

5 fees under subsection (a) shall be considered incomplete 

6 and shall not be accepted for review by the Secretary until 

7 all fees owed by such person under this section have been 

8 paid. 

9 ‘‘(f) EFFECT OF INADEQUATE FUNDING OF PRO10 GRAM.— 

11 ‘‘(1) FIRST FISCAL YEAR.—If on November 1, 

12 2007, or 120 days after enactment of the Prescrip13 tion Drug User Fee Amendments of 2007, whichever 

14 is later, the Secretary has received less than 

15 $11,250,000 in advisory review fees and operating 

16 reserve fees combined, the Program shall be termi17 nated and all collected fees shall be refunded. 

18 ‘‘(2) SUBSEQUENT FISCAL YEARS.—Beginning 

19 in fiscal year 2009, if, on November 1 of a fiscal 

20 year, the combination of the operating reserves, an21 nual fee revenues from that fiscal year, and unobli22 gated fee revenues from prior fiscal years is less 

23 than $9,000,000, adjusted for inflation (in accord24 ance with subsection (c)(1)), the Program shall be 

25 terminated, and the Secretary shall notify all particimstockstill on PROD1PC66 with BILLS

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•S 1082 IS

1 pants, retain any money from the unused advisory 

2 review fees and the operating reserves needed to ter3 minate the Program, and refund the remainder of 

4 the unused fees and operating reserves. To the ex5 tent required to terminate the Program, the Sec6 retary shall first use unobligated advisory review fee 

7 revenues from prior fiscal years, then the operating 

8 reserves, and then unused advisory review fees from 

9 the relevant fiscal year. 

10 ‘‘(g) CREDITING AND AVAILABILITY OF FEES.— 

11 ‘‘(1) IN GENERAL.—Fees authorized under sub12 section (a) shall be collected and available for obliga13 tion only to the extent and in the amount provided 

14 in advance in appropriations Acts. Such fees are au15 thorized to remain available until expended. Such 

16 sums as may be necessary may be transferred from 

17 the Food and Drug Administration salaries and ex18 penses appropriation account without fiscal year lim19 itation to such appropriation account for salaries 

20 and expenses with such fiscal year limitation. The 

21 sums transferred shall be available solely for the 

22 process for the advisory review of prescription drug 

23 advertising. 

24 ‘‘(2) COLLECTIONS AND APPROPRIATION

25 ACTS.—The fees authorized by this section— 

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1 ‘‘(A) shall be retained in each fiscal year in 

2 an amount not to exceed the amount specified 

3 in appropriation Acts, or otherwise made avail4 able for obligation for such fiscal year; and 

5 ‘‘(B) shall be available for obligation only 

6 if appropriated budget authority continues to 

7 support at least the total combined number of 

8 full-time equivalent employees in the Food and 

9 Drug Administration, Center for Drug Evalua10 tion and Research, Division of Drug Marketing, 

11 Advertising, and Communications, and the Cen12 ter for Biologics Evaluation and Research, Ad13 vertising and Promotional Labeling Branch 

14 supported in fiscal year 2007. 

15 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

16 There are authorized to be appropriated for fees 

17 under this section not less than $6,250,000 for each 

18 of fiscal years 2008, 2009, 2010, 2011, and 2012, 

19 as adjusted to reflect adjustments in the total fee 

20 revenues made under this section, plus amounts col21 lected for the reserve fund under subsection (d). 

22 ‘‘(4) OFFSET.—Any amount of fees collected 

23 for a fiscal year under this section that exceeds the 

24 amount of fees specified in appropriation Acts for 

25 such fiscal year shall be credited to the appropriamstockstill on PROD1PC66 with BILLS

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•S 1082 IS

1 tion account of the Food and Drug Administration 

2 as provided in paragraph (1), and shall be sub3 tracted from the amount of fees that would other4 wise be collected under this section pursuant to ap5 propriation Acts for a subsequent fiscal year. 

6 ‘‘(h) DEFINITIONS.—For purposes of this section: 

7 ‘‘(1) The term ‘advisory review’ means review8 ing and providing advisory comments regarding com9 pliance of a proposed advertisement with the re10 quirements of this Act prior to its initial public dis11 semination. 

12 ‘‘(2) The term ‘carry over submission’ means a 

13 submission for an advisory review for which a fee 

14 was paid in a fiscal year that is submitted for review 

15 in the following fiscal year. 

16 ‘‘(3) The term ‘direct-to-consumer television ad17 vertisement’ means an advertisement for a prescrip18 tion drug product as defined in section 735(3) in19 tended to be displayed on any television channel for 

20 less than 2 minutes. 

21 ‘‘(4) The term ‘person’ includes an individual, 

22 a partnership, a corporation, and an association, and 

23 any affiliate thereof or successor in interest. 

24 ‘‘(5) The term ‘Program’ means the Program 

25 to assess, collect, and use fees for the advisory remstockstill on PROD1PC66 with BILLS

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•S 1082 IS

1 view of prescription drug advertising established by 

2 this section. 

3 ‘‘(6) The term ‘process for the advisory review 

4 of prescription drug advertising’ means the activities 

5 necessary to review and provide advisory comments 

6 on proposed direct-to-consumer television advertise7 ments prior to public dissemination and, to the ex8 tent the Secretary has additional staff resources 

9 available under the Program that are not necessary 

10 for the advisory review of direct-to-consumer tele11 vision advertisements, the activities necessary to re12 view and provide advisory comments on other pro13 posed advertisements and promotional material prior 

14 to public dissemination. 

15 ‘‘(7) The term ‘resources allocated for the proc16 ess for the advisory review of prescription drug ad17 vertising’ means the expenses incurred in connection 

18 with the process for the advisory review of prescrip19 tion drug advertising for— 

20 ‘‘(A) officers and employees of the Food 

21 and Drug Administration, contractors of the 

22 Food and Drug Administration, advisory com23 mittees, and costs related to such officers, em24 ployees, and committees, and to contracts with 

25 such contractors; 

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1 ‘‘(B) management of information, and the 

2 acquisition, maintenance, and repair of com3 puter resources; 

4 ‘‘(C) leasing, maintenance, renovation, and 

5 repair of facilities and acquisition, maintenance, 

6 and repair of fixtures, furniture, scientific 

7 equipment, and other necessary materials and 

8 supplies; 

9 ‘‘(D) collection of fees under this section 

10 and accounting for resources allocated for the 

11 advisory review of prescription drug advertising; 

12 and 

13 ‘‘(E) terminating the Program under sub14 section (f)(2), if necessary. 

15 ‘‘(8) The term ‘resubmission’ means a subse16 quent submission for advisory review of a direct-to17 consumer television advertisement that has been re18 vised in response to the Secretary’s comments on an 

19 original submission. A resubmission may not intro20 duce significant new concepts or creative themes into 

21 the television advertisement. 

22 ‘‘(9) The term ‘submission for advisory review’ 

23 means an original submission of a direct-to-con24 sumer television advertisement for which the sponsor 

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1 voluntarily requests advisory comments before the 

2 advertisement is publicly disseminated.’’. 

3 SEC. 5. SAVINGS CLAUSE. 

4 Notwithstanding section 509 of the Prescription 

5 Drug User Fee Amendments of 2002 (21 U.S.C. 379g 

6 note), and notwithstanding the amendments made by this 

7 Act, part 2 of subchapter C of chapter VII of the Federal 

8 Food, Drug, and Cosmetic Act, as in effect on the day 

9 before the date of enactment of this Act, shall continue 

10 to be in effect with respect to human drug applications 

11 and supplements (as defined in such part as of such day) 

12 that on or after October 1, 2002, but before October 1, 

13 2007, were accepted by the Food and Drug Administra14 tion for filing with respect to assessing and collecting any 

15 fee required by such part for a fiscal year prior to fiscal 

16 year 2008. 

17 SEC. 6. TECHNICAL AMENDMENTS. 

18 (a) Section 737 (21 U.S.C. 379i) is amended in the 

19 matter preceding paragraph (1), by striking ‘‘subchapter’’ 

20 and inserting ‘‘part’’. 

21 (b) Section 739 (21 U.S.C. 379j–11) is amended in 

22 the matter preceding paragraph (1), by striking ‘‘sub23 chapter’’ and inserting ‘‘part’’. 

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1 SEC. 7. EFFECTIVE DATES. 

2 (a) IN GENERAL.—Except as provided in subsection 

3 (b), the amendments made by this Act shall take effect 

4 October 1, 2007. 

5 (b) EXCEPTION.—The amendment made by section 

6 4 of this Act shall take effect on the date of enactment 

7 of this Act. 

8 SEC. 8. SUNSET DATE. 

9 Sections 735, 736, and 736A of the Federal Food, 

10 Drug, and Cosmetic Act shall cease to be effective on Oc11 tober 1, 2012. 

Æ 

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