110TH CONGRESS 

1ST SESSION S. 1082

AN ACT

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

the Public Health Service Act to reauthorize drug and 

device user fees and ensure the safety of medical products, 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. 

4 This Act may be cited as the ‘‘Food and Drug Ad5 ministration Revitalization Act’’. 
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1 TITLE I—PRESCRIPTION DRUG 

2 USER FEES 

3 SEC. 101. SHORT TITLE; REFERENCES IN TITLE. 

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

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

6 (b) REFERENCES IN TITLE.—Except as otherwise 

7 specified, whenever in this title an amendment is ex8 pressed in terms of an amendment to a section or other 

9 provision, the reference shall be considered to be made to 

10 a section or other provision of the Federal Food, Drug, 

11 and Cosmetic Act (21 U.S.C. 301 et seq.). 

12 SEC. 102. DRUG FEES. 

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

14 (1) by striking the section designation and all 

15 that follows through ‘‘For purposes of this sub16 chapter:’’ and inserting the following: 

17 ‘‘SEC. 735. DRUG FEES. 

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

19 the fees authorized under this part be dedicated toward 

20 expediting the drug development process, the process for 

21 the review of human drug applications, and postmarket 

22 drug safety, as set forth in the goals identified for pur23 poses of this part in the letters from the Secretary to the 

24 Chairman of the Committee on Health, Education, Labor, 

25 and Pensions of the Senate and the Chairman of the Com-
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1 mittee on Energy and Commerce of the House of Rep2 resentatives, as set forth in the Congressional Record. 

3 ‘‘(b) REPORTS.—

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

5 2008 through 2012, not later than 120 days after 

6 the end of each fiscal year during which fees are col7 lected under this part, the Secretary shall prepare 

8 and submit to the Committee on Health, Education, 

9 Labor, and Pensions of the Senate and the Com10 mittee on Energy and Commerce of the House of 

11 Representatives, a report concerning the progress of 

12 the Food and Drug Administration in achieving the 

13 goals identified in the letters described in subsection 

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

15 the Food and Drug Administration for meeting the 

16 goals. The report for a fiscal year shall include infor17 mation on all previous cohorts for which the Sec18 retary has not given a complete response on all 

19 human drug applications and supplements in the co20 hort. 

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

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

23 of each fiscal year during which fees are collected 

24 under this part, the Secretary shall prepare and sub25 mit to the Committee on Health, Education, Labor, 
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1 and Pensions of the Senate and the Committee on 

2 Energy and Commerce of the House of Representa3 tives, a report on the implementation of the author4 ity for such fees during such fiscal year and the use, 

5 by the Food and Drug Administration, of the fees 

6 collected during such fiscal year for which the report 

7 is made. 

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

9 shall make the reports required under paragraphs 

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

11 website of the Food and Drug Administration. 

12 ‘‘(c) REAUTHORIZATION.—

13 ‘‘(1) CONSULTATION.—In developing rec14 ommendations to present to Congress with respect to 

15 the goals, and plans for meeting the goals, for the 

16 process for the review of human drug applications 

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

18 for the reauthorization of this part for such fiscal 

19 years, the Secretary shall consult with—

20 ‘‘(A) the Committee on Energy and Com21 merce of the House of Representatives; 

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

23 Labor, and Pensions of the Senate; 

24 ‘‘(C) scientific and academic experts; 

25 ‘‘(D) health care professionals; 
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1 ‘‘(E) representatives of patient and con2 sumer advocacy groups; and 

3 ‘‘(F) the regulated industry. 

4 ‘‘(2) PUBLIC REVIEW OF RECOMMENDA5 TIONS.—After negotiations with the regulated indus6 try, the Secretary shall—

7 ‘‘(A) present the recommendations devel8 oped under paragraph (1) to the Congressional 

9 committees specified in such paragraph; 

10 ‘‘(B) publish such recommendations in the 

11 Federal Register; 

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

13 the public to provide written comments on such 

14 recommendations; 

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

16 may present its views on such recommenda17 tions; and 

18 ‘‘(E) after consideration of such public 

19 views and comments, revise such recommenda20 tions as necessary. 

21 ‘‘(3) TRANSMITTAL OF RECOMMENDATIONS.—

22 Not later than January 15, 2012, the Secretary 

23 shall transmit to Congress the revised recommenda24 tions under paragraph (2), a summary of the views 

25 and comments received under such paragraph, and 
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1 any changes made to the recommendations in re2 sponse to such views and comments. 

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

4 (2) in subsection (d)—

5 (A) in paragraph (1)—

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

7 ‘‘505(b)(1),’’ and inserting ‘‘505(b), or’’; 

8 (ii) by striking subparagraph (B); 

9 (iii) by redesignating subparagraph 

10 (C) as subparagraph (B); and 

11 (iv) in the matter following subpara12 graph (B), as so redesignated, by striking 

13 ‘‘subparagraph (C)’’ and inserting ‘‘sub14 paragraph (B)’’; 

15 (B) in paragraph (3)(C), by—

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

17 ‘‘the list (not including the discontinued 

18 section of such list)’’; and 

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

20 list (not including the discontinued section 

21 of such a list)’’; 

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

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

24 capsules, tablets, and lyophilized products be25 fore reconstitution)’’; 
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1 (D) by amending paragraph (6)(F) to read 

2 as follows: 

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

4 human drug applications or supplements, 

5 postmarket safety activities, including—

6 ‘‘(i) collecting, developing, and review7 ing safety information on approved drugs 

8 (including adverse event reports); 

9 ‘‘(ii) developing and using improved 

10 adverse event data collection systems (in11 cluding information technology systems); 

12 and 

13 ‘‘(iii) developing and using improved 

14 analytical tools to assess potential safety 

15 problems (including by accessing external 

16 data bases).’’; 

17 (E) in paragraph (8)—

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

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

20 preceding fiscal year’’; and 

21 (ii) by striking ‘‘April 1997’’ and in22 serting ‘‘October 1996’’; 

23 (F) by redesignating paragraph (9) as 

24 paragraph (10); and 
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1 (G) by inserting after paragraph (8) the 

2 following: 

3 ‘‘(9) The term ‘person’ includes an affiliate of 

4 such person.’’. 

5 SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES. 

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

7 379h(a)) is amended—

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

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

10 (2) in paragraph (1)—

11 (A) in subparagraph (D)—

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

13 WITHDRAWN BEFORE FILING’’ after ‘‘RE14 FUND OF FEE IF APPLICATION REFUSED

15 FOR FILING’’; and 

16 (ii) by inserting before the period at 

17 the end the following: ‘‘or withdrawn with18 out a waiver before filing’’; 

19 (B) by redesignating subparagraphs (E) 

20 and (F) as subparagraphs (F) and (G), respec21 tively; and 

22 (C) by inserting after subparagraph (D) 

23 the following: 

24 ‘‘(E) FEE FOR APPLICATION PREVIOUSLY

25 REFUSED FOR FILING OR WITHDRAWN BEFORE
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1 FILING.—An application or supplement that 

2 has been refused for filing or that was with3 drawn before filing, if filed under protest or re4 submitted, shall be subject to the fee under sub5 paragraph (A) (unless an exception under sub6 paragraph (C) or (F) applies or the fee is 

7 waived or reduced under subsection (d)), with8 out regard to previous payment of such a fee 

9 and the refund of 75 percent of that fee under 

10 subparagraph (D).’’; and 

11 (3) in paragraph (2)—

12 (A) in subparagraph (A), by striking ‘‘sub13 paragraph (B)’’ and inserting ‘‘subparagraphs 

14 (B) and (C)’’; and 

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

16 ‘‘(C) SPECIAL RULES FOR COMPOUNDED

17 POSITRON EMISSION TOMOGRAPHY DRUGS.—

18 ‘‘(i) IN GENERAL.—Except as pro19 vided in clause (ii), each person who is 

20 named as the applicant in an approved 

21 human drug application for a compounded 

22 positron emission tomography drug shall 

23 be subject under subparagraph (A) to one24 fifth of an annual establishment fee with 

25 respect to each such establishment identi-
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1 fied in the application as producing com2 pounded positron emission tomography 

3 drugs under the approved application. 

4 ‘‘(ii) EXCEPTION FROM ANNUAL ES5 TABLISHMENT FEE.—Each person who is 

6 named as the applicant in an application 

7 described in clause (i) shall not be assessed 

8 an annual establishment fee for a fiscal 

9 year if the person certifies to the Sec10 retary, at a time specified by the Secretary 

11 and using procedures specified by the Sec12 retary, that—

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

14 medical center that has only 1 estab15 lishment for the production of com16 pounded positron emission tomog17 raphy drugs; and 

18 ‘‘(II) at least 95 percent of the 

19 total number of doses of each com20 pounded positron emission tomog21 raphy drug produced by such estab22 lishment during such fiscal year will 

23 be used within the medical center.’’. 

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

25 U.S.C. 379h(b)) is amended to read as follows: 
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1 ‘‘(b) FEE REVENUE AMOUNTS.—Except as provided 

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

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

4 amounts, in each fiscal year beginning with fiscal year 

5 2008 and continuing through fiscal year 2012: 

6 $392,783,000, plus an adjustment for workload on 

7 $354,893,000 of this amount. Such adjustment shall be 

8 made in accordance with the workload adjustment provi9 sions in effect for fiscal year 2007, except that instead 

10 of commercial investigational new drug applications sub11 mitted to the Secretary, all commercial investigational new 

12 drug applications with a submission during the previous 

13 12-month period shall be used in the determination. One14 third of the revenue amount shall be derived from applica15 tion fees, one-third from establishment fees, and one-third 

16 from product fees.’’. 

17 (c) ADJUSTMENTS TO FEES.—

18 (1) INFLATION ADJUSTMENT.—Section 

19 736(c)(1) (21 U.S.C. 379h(c)(1)) is amended—

20 (A) in the matter preceding subparagraph 

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

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

23 fiscal year 2009, the revenues established in 

24 subsection (b)’’; 
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1 (B) in subparagraph (A) by striking ‘‘or’’ 

2 at the end; 

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

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

5 (D) by inserting after subparagraph (B) 

6 the following: 

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

8 cost, per full-time equivalent position of the 

9 Food and Drug Administration, of all personnel 

10 compensation and benefits paid with respect to 

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

12 previous 6 fiscal years.’’; and 

13 (E) in the matter following subparagraph 

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

15 ‘‘fiscal year 2003’’ and inserting ‘‘fiscal year 

16 2008’’. 

17 (2) WORKLOAD ADJUSTMENT.—Section 

18 736(c)(2) (21 U.S.C. 379h(c)(2)) is amended—

19 (A) in the matter preceding subparagraph 

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

21 (B) in the first sentence of subparagraph 

22 (A)—

23 (i) by striking ‘‘, commercial inves24 tigational new drug applications’’ and in-
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1 serting ‘‘(adjusted for changes in review 

2 activities)’’; and 

3 (ii) by inserting before the period at 

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

5 of commercial investigational new drug ap6 plications with a submission during the 

7 previous 12-month period (adjusted for 

8 changes in review activities)’’; 

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

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

11 adjustment for changes in review activities 

12 made in setting fees and fee revenue amounts 

13 for fiscal year 2009 may not result in the total 

14 workload adjustment being more than 2 per15 centage points higher than it would be absent 

16 the adjustment for changes in review activi17 ties.’’; and 

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

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

20 independent accounting firm to study the ad21 justment for changes in review activities applied 

22 in setting fees for fiscal year 2009 and to make 

23 recommendations, if warranted, on future 

24 changes in the methodology for calculating the 

25 adjustment for changes in review activity. After 
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1 review of the recommendations by the inde2 pendent accounting firm, the Secretary shall 

3 make appropriate changes to the workload ad4 justment methodology in setting fees for fiscal 

5 years 2010 through 2012. If the study is not 

6 conducted, no adjustment for changes in review 

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

8 (3) RENT AND RENT-RELATED COST ADJUST9 MENT.—Section 736(c) (21 U.S.C. 379h(c)) is 

10 amended—

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

12 and (5) as paragraphs (4), (5), and (6), respec13 tively; and 

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

15 following: 

16 ‘‘(3) RENT AND RENT-RELATED COST ADJUST17 MENT.—Beginning with fiscal year 2010, the Sec18 retary shall, before making the adjustments under 

19 paragraphs (1) and (2), reduce the fee amounts es20 tablished in subsection (b), if actual costs paid for 

21 rent and rent-related expenses are less than 

22 $11,721,000. The reductions made under this para23 graph, if any, shall not exceed the amounts by which 

24 costs fell below $11,721,000, and shall not exceed 

25 $11,721,000 in any fiscal year.’’. 
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1 (4) FINAL YEAR ADJUSTMENT.—Section 736(c) 

2 (21 U.S.C. 379h(c)) is amended—

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

4 this subsection—

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

6 appears and inserting ‘‘2012’’; and 

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

8 ‘‘2013’’; and 

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

10 this subsection, by striking ‘‘2002’’ and insert11 ing ‘‘2007’’. 

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

13 (21 U.S.C. 379h(d)) is amended—

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

15 subparagraph (A), by—

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

17 the applicant’’ after ‘‘The Secretary shall 

18 grant’’; 

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

20 waiver from or a reduction of one or more fees 

21 assessed’’; and 

22 (C) striking ‘‘finds’’ and inserting ‘‘deter23 mines’’; 

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

25 paragraphs (3) and (4), respectively; 
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1 (3) by inserting after paragraph (1) the fol2 lowing: 

3 ‘‘(2) EVALUATION.—For the purpose of deter4 mining whether to grant a waiver or reduction of a 

5 fee under paragraph (1), the Secretary shall con6 sider only the circumstances and assets of the appli7 cant and any affiliate of the applicant.’’; and 

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

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

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

11 drug product that has been approved under a human 

12 drug application and introduced or delivered for in13 troduction into interstate commerce’’. 

14 (e) CREDITING AND AVAILABILITY OF FEES.—

15 (1) AUTHORIZATION OF APPROPRIATIONS.—

16 Section 736(g)(3) (21 U.S.C. 379h(g)(3)) is amend17 ed to read as follows: 

18 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—

19 There are authorized to be appropriated for fees 

20 under this section such sums as are authorized to be 

21 assessed and collected under this section in each of 

22 fiscal years 2008 through 2012.’’. 

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

24 379h(g)(4)) is amended to read as follows: 
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1 ‘‘(4) OFFSET.—If the cumulative amount of 

2 fees collected during fiscal years 2008, 2009, and 

3 2010, plus the amount estimated to be collected for 

4 fiscal year 2011, exceeds the amount of fees speci5 fied in aggregate in appropriation Acts for such fis6 cal years, the aggregate amount in excess shall be 

7 credited to the appropriation account of the Food 

8 and Drug Administration as provided in paragraph 

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

10 that would otherwise be authorized to be collected 

11 under this section pursuant to appropriation Acts 

12 for fiscal year 2012.’’. 

13 (f) CONFORMING AMENDMENTS.—

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

15 amended by this section, is amended—

16 (A) in paragraph (1)(A), by striking ‘‘sub17 section (c)(4)’’ each place it appears and insert18 ing ‘‘subsection (c)(5)’’; 

19 (B) in paragraph (2), by striking ‘‘sub20 section (c)(4)’’ and inserting ‘‘subsection 

21 (c)(5)’’; and 

22 (C) in paragraph (3), by striking ‘‘sub23 section (c)(4)’’ and inserting ‘‘subsection 

24 (c)(5)’’. 
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1 (2) Section 736A(h)(3), as added by section 

2 104 of this title, is amended by striking ‘‘735(3)’’ 

3 and inserting ‘‘735(d)(3)’’. 

4 SEC. 104. AUTHORITY TO ASSESS AND USE PRESCRIPTION 

5 DRUG ADVERTISING FEES. 

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

7 et seq.) is amended by adding after section 736 the fol8 lowing new section: 

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

10 ADVISORY REVIEW OF PRESCRIPTION DRUG 

11 ADVERTISING. 

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

13 ADVERTISEMENT REVIEW FEES.—Beginning with fiscal 

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

15 accordance with this section as follows: 

16 ‘‘(1) ADVISORY REVIEW FEE.—

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

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

19 October 1, 2007, submits a proposed direct-to20 consumer television advertisement for advisory 

21 review by the Secretary prior to its initial public 

22 dissemination shall be subject to a fee estab23 lished under subsection (c)(3). 

24 ‘‘(B) EXCEPTION FOR REQUIRED SUBMIS25 SIONS.—A direct-to-consumer television adver-
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1 tisement that is required to be submitted to the 

2 Secretary prior to initial public dissemination 

3 shall not be assessed a fee unless the sponsor 

4 designates it as a submission for advisory re5 view. 

6 ‘‘(C) PAYMENT.—The fee required by sub7 paragraph (A) shall be due not later than Octo8 ber 1 of the fiscal year in which the direct-to9 consumer television advertisement shall be sub10 mitted to the Secretary for advisory review. 

11 ‘‘(D) MODIFICATION OF ADVISORY REVIEW

12 FEE.—

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

14 November 1 of the fiscal year in which the 

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

16 that were due and payable for advisory re17 views identified in response to the Federal 

18 Register notice described in subsection 

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

20 late. Such fees shall be due and payable 20 

21 days before any direct-to-consumer tele22 vision advertisement is submitted by such 

23 person to the Secretary for advisory re24 view. Notwithstanding any other provision 

25 of this section, such fees shall be due and 
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1 payable for each of those advisory reviews 

2 in the amount of 150 percent of the advi3 sory review fee established for that fiscal 

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

5 ‘‘(ii) LATE NOTICE OF SUBMISSION.—

6 If any person submits any direct-to-con7 sumer television advertisements for advi8 sory review that are in excess of the num9 ber identified by that person in response to 

10 the Federal Register notice described in 

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

12 a fee for each of those advisory reviews in 

13 the amount of 150 percent of the advisory 

14 review fee established for that fiscal year 

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

16 this subparagraph shall be due 20 days be17 fore the direct-to-consumer television ad18 vertisement is submitted by such person to 

19 the Secretary for advisory review. 

20 ‘‘(E) LIMITS.—

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

22 fee under this paragraph for a fiscal year 

23 entitles the person that pays the fee to ac24 ceptance for advisory review by the Sec25 retary of 1 direct-to-consumer television 
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1 advertisement and acceptance of 1 resub2 mission for advisory review of the same ad3 vertisement. The advertisement shall be 

4 submitted for review in the fiscal year for 

5 which the fee was assessed, except that a 

6 person may carry over no more than 1 

7 paid advisory review submission to the next 

8 fiscal year. Resubmissions may be sub9 mitted without regard to the fiscal year of 

10 the initial advisory review submission. 

11 ‘‘(ii) NO REFUND.—Except as pro12 vided by subsection (f), fees paid under 

13 this paragraph shall not be refunded. 

14 ‘‘(iii) NO WAIVER, EXEMPTION, OR

15 REDUCTION.—The Secretary shall not 

16 grant a waiver, exemption, or reduction of 

17 any fees due or payable under this section. 

18 ‘‘(iv) NON-TRANSFERABILITY.—The 

19 right to an advisory review is not transfer20 able, except to a successor in interest. 

21 ‘‘(2) OPERATING RESERVE FEE.—

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

23 or after October 1, 2007, is assessed an advi24 sory review fee under paragraph (1) shall be 

25 subject to an operating reserve fee established 
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1 under subsection (d)(2) only in the first fiscal 

2 year in which an advisory review fee is assessed. 

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

4 subparagraph (C), the fee required by subpara5 graph (A) shall be due not later than October 

6 1 of the first fiscal year in which the person is 

7 required to pay an advisory review fee under 

8 paragraph (1). 

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

10 the first fiscal year of a person’s participation 

11 in the Program, that person submits any direct12 to-consumer television advertisements for advi13 sory review that are in excess of the number 

14 identified by that person in response to the 

15 Federal Register notice described in subsection 

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

17 reserve fee for each of those advisory reviews 

18 equal to the advisory review fee for each sub19 mission established under paragraph (1)(D)(ii). 

20 Fees required by this subparagraph shall be in 

21 addition to the fees required under subpara22 graph (B), if any. Fees under this subpara23 graph shall be due 20 days before any direct24 to-consumer television advertisement is sub-
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1 mitted by such person to the Secretary for advi2 sory review. 

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

4 Fees under subsection (a)(1) shall be established to gen5 erate revenue amounts of $6,250,000 for each of fiscal 

6 years 2008 through 2012, as adjusted pursuant to sub7 section (c). 

8 ‘‘(c) ADJUSTMENTS.—

9 ‘‘(1) INFLATION ADJUSTMENT.—Beginning 

10 with fiscal year 2009, the revenues established in 

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

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

13 year to reflect the greater of—

14 ‘‘(A) the total percentage change that oc15 curred in the Consumer Price Index for all 

16 urban consumers (all items; United States city 

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

18 30 preceding the fiscal year for which fees are 

19 being established; 

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

21 previous fiscal year in basic pay under the Gen22 eral Schedule in accordance with section 5332 

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

24 comparability payment pursuant to section 
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1 5304 of such title for Federal employees sta2 tioned in the District of Columbia; or 

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

4 cost, per full-time equivalent position of the 

5 Food and Drug Administration, of all personnel 

6 compensation and benefits paid with respect to 

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

8 previous 6 fiscal years. 

9 The adjustment made each fiscal year by this para10 graph shall be added on a compounded basis to the 

11 sum of all adjustments made each fiscal year after 

12 fiscal year 2008 under this subsection. 

13 ‘‘(2) WORKLOAD ADJUSTMENT.—

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

15 year 2009, after the fee revenues established in 

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

17 fiscal year for inflation in accordance with para18 graph (1), the fee revenues shall be adjusted 

19 further for such fiscal year to reflect changes in 

20 the workload of the Secretary with respect to 

21 the submission of proposed direct-to-consumer 

22 television advertisements for advisory review 

23 prior to initial broadcast. 

24 ‘‘(B) DETERMINATION OF WORKLOAD AD25 JUSTMENT.—
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1 ‘‘(i) IN GENERAL.—The workload ad2 justment under this paragraph for a fiscal 

3 year shall be determined by the Sec4 retary—

5 ‘‘(I) based upon the number of 

6 direct-to-consumer television adver7 tisements identified pursuant to para8 graph (3)(A) for that fiscal year, ex9 cluding allowable previously paid carry 

10 over submissions; and 

11 ‘‘(II) by multiplying the number 

12 of such advertisements projected for 

13 that fiscal year that exceeds 150 by 

14 $27,600 (adjusted each year begin15 ning with fiscal year 2009 for infla16 tion in accordance with paragraph 

17 (1)). 

18 ‘‘(ii) PUBLICATION IN FEDERAL REG19 ISTER.—The Secretary shall publish in the 

20 Federal Register, as part of the notice de21 scribed in paragraph (1), the fee revenues 

22 and fees resulting from the adjustment 

23 made under this paragraph and the sup24 porting methodologies. 
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1 ‘‘(C) LIMITATION.—Under no cir2 cumstances shall the adjustment made under 

3 this paragraph result in fee revenues for a fiscal 

4 year that are less than the fee revenues estab5 lished for the prior fiscal year. 

6 ‘‘(3) ANNUAL FEE SETTING.—

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

8 Secretary shall, 120 days before the start of 

9 each fiscal year, publish a notice in the Federal 

10 Register requesting any person to notify the 

11 Secretary within 30 days of the number of di12 rect-to-consumer television advertisements the 

13 person intends to submit for advisory review by 

14 the Secretary in the next fiscal year. Notifica15 tion to the Secretary of the number of adver16 tisements a person intends to submit for advi17 sory review prior to initial broadcast shall be a 

18 legally binding commitment by that person to 

19 pay the annual advisory review fee for that 

20 number of submissions on or before October 1 

21 of the fiscal year in which the advertisement is 

22 intended to be submitted. A person shall at the 

23 same time also notify the Secretary if such per24 son intends to use a paid submission from the 

25 previous fiscal year under subsection 
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1 (a)(1)(E)(i). If such person does not so notify 

2 the Secretary, all submissions for advisory re3 view shall be subject to advisory review fees. 

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

5 60 days before the start of each fiscal year, es6 tablish, for the next fiscal year, the direct-to7 consumer television advertisement advisory re8 view fee under subsection (a)(1), based on the 

9 revenue amounts established under subsection 

10 (b), the adjustments provided under this sub11 section and the number of direct-to-consumer 

12 television advertisements identified pursuant to 

13 subparagraph (A), excluding allowable pre14 viously paid carry over submissions. The annual 

15 advisory review fee shall be established by divid16 ing the fee revenue for a fiscal year (as ad17 justed pursuant to this subsection) by the num18 ber of direct-to-consumer television advertise19 ments identified pursuant to subparagraph (A), 

20 excluding allowable previously paid carry over 

21 submissions. 

22 ‘‘(C) FISCAL YEAR 2008 FEE LIMIT.—Not23 withstanding subsection (b), the fee established 

24 under subparagraph (B) for fiscal year 2008 
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1 may not be more than $83,000 per submission 

2 for advisory review. 

3 ‘‘(D) ANNUAL FEE LIMIT.—Notwith4 standing subsection (b), the fee established 

5 under subparagraph (B) for a fiscal year after 

6 fiscal year 2008 may not be more than 50 per7 cent more than the fee established for the prior 

8 fiscal year. 

9 ‘‘(E) LIMIT.—The total amount of fees ob10 ligated for a fiscal year may not exceed the 

11 total costs for such fiscal year for the resources 

12 allocated for the process for the advisory review 

13 of prescription drug advertising. 

14 ‘‘(d) OPERATING RESERVES.—

15 ‘‘(1) IN GENERAL.—The Secretary shall estab16 lish in the Food and Drug Administration salaries 

17 and expenses appropriation account without fiscal 

18 year limitation a Direct-to-Consumer Advisory Re19 view Operating Reserve, of at least $6,250,000 in 

20 fiscal year 2008, to continue the Program in the 

21 event the fees collected in any subsequent fiscal year 

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

23 revenue amount established for that fiscal year. 

24 ‘‘(2) FEE SETTING.—The Secretary shall estab25 lish the operating reserve fee under subsection 
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1 (a)(2)(A) for each person required to pay the fee by 

2 multiplying the number of direct-to-consumer tele3 vision advertisements identified by that person pur4 suant to subsection (c)(3)(A) by the advisory review 

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

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

7 assessed be less than the operating reserve fee as8 sessed if the person had first participated in the 

9 Program in fiscal year 2008. 

10 ‘‘(3) USE OF OPERATING RESERVE.—The Sec11 retary may use funds from the reserves under this 

12 subsection only to the extent necessary in any fiscal 

13 year to make up the difference between the fee rev14 enue amount established for that fiscal year under 

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

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

17 costs of ending the Program if it is terminated pur18 suant to subsection (f) or if it is not reauthorized 

19 after fiscal year 2012. 

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

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

22 if the Program is terminated pursuant to subsection 

23 (f), the Secretary, after setting aside sufficient oper24 ating reserve amounts to terminate the Program, 

25 shall refund all amounts remaining in the operating 
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1 reserve on a pro rata basis to each person that paid 

2 an operating reserve fee assessment. In no event 

3 shall the refund to any person exceed the total 

4 amount of operating reserve fees paid by such per5 son pursuant to subsection (a)(2). 

6 ‘‘(e) EFFECT OF FAILURE TO PAY FEES.—Notwith7 standing any other law or regulation of the Secretary, a 

8 submission for advisory review of a direct-to-consumer tel9 evision advertisement submitted by a person subject to 

10 fees under subsection (a) shall be considered incomplete 

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

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

13 paid. 

14 ‘‘(f) EFFECT OF INADEQUATE FUNDING OF PRO15 GRAM.—

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

17 2007, or 120 days after enactment of the Prescrip18 tion Drug User Fee Amendments of 2007, whichever 

19 is later, the Secretary has received less than 

20 $11,250,000 in advisory review fees and operating 

21 reserve fees combined, the Program shall be termi22 nated and all collected fees shall be refunded. 

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

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

25 year, the combination of the operating reserves, an-
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1 nual fee revenues from that fiscal year, and unobli2 gated fee revenues from prior fiscal years is less 

3 than $9,000,000, adjusted for inflation (in accord4 ance with subsection (c)(1)), the Program shall be 

5 terminated, and the Secretary shall notify all partici6 pants, retain any money from the unused advisory 

7 review fees and the operating reserves needed to ter8 minate the Program, and refund the remainder of 

9 the unused fees and operating reserves. To the ex10 tent required to terminate the Program, the Sec11 retary shall first use unobligated advisory review fee 

12 revenues from prior fiscal years, then the operating 

13 reserves, and then unused advisory review fees from 

14 the relevant fiscal year. 

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

16 ‘‘(1) IN GENERAL.—Fees authorized under sub17 section (a) shall be collected and available for obliga18 tion only to the extent and in the amount provided 

19 in advance in appropriations Acts. Such fees are au20 thorized to remain available until expended. Such 

21 sums as may be necessary may be transferred from 

22 the Food and Drug Administration salaries and ex23 penses appropriation account without fiscal year lim24 itation to such appropriation account for salaries 

25 and expenses with such fiscal year limitation. The 
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1 sums transferred shall be available solely for the 

2 process for the advisory review of prescription drug 

3 advertising. 

4 ‘‘(2) COLLECTIONS AND APPROPRIATION

5 ACTS.—The fees authorized by this section—

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

7 an amount not to exceed the amount specified 

8 in appropriation Acts, or otherwise made avail9 able for obligation for such fiscal year; and 

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

11 if appropriated budget authority continues to 

12 support at least the total combined number of 

13 full-time equivalent employees in the Food and 

14 Drug Administration, Center for Drug Evalua15 tion and Research, Division of Drug Marketing, 

16 Advertising, and Communications, and the Cen17 ter for Biologics Evaluation and Research, Ad18 vertising and Promotional Labeling Branch 

19 supported in fiscal year 2007. 

20 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—

21 There are authorized to be appropriated for fees 

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

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

24 as adjusted to reflect adjustments in the total fee 
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1 revenues made under this section, plus amounts col2 lected for the reserve fund under subsection (d). 

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

4 for a fiscal year under this section that exceeds the 

5 amount of fees specified in appropriation Acts for 

6 such fiscal year shall be credited to the appropria7 tion account of the Food and Drug Administration 

8 as provided in paragraph (1), and shall be sub9 tracted from the amount of fees that would other10 wise be collected under this section pursuant to ap11 propriation Acts for a subsequent fiscal year. 

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

13 ‘‘(1) The term ‘advisory review’ means review14 ing and providing advisory comments regarding com15 pliance of a proposed advertisement with the re16 quirements of this Act prior to its initial public dis17 semination. 

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

19 submission for an advisory review for which a fee 

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

21 in the following fiscal year. 

22 ‘‘(3) The term ‘direct-to-consumer television ad23 vertisement’ means an advertisement for a prescrip24 tion drug product as defined in section 735(3) in-
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1 tended to be displayed on any television channel for 

2 less than 2 minutes. 

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

4 a partnership, a corporation, and an association, and 

5 any affiliate thereof or successor in interest. 

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

7 of prescription drug advertising’ means the activities 

8 necessary to review and provide advisory comments 

9 on proposed direct-to-consumer television advertise10 ments prior to public dissemination and, to the ex11 tent the Secretary has additional staff resources 

12 available under the Program that are not necessary 

13 for the advisory review of direct-to-consumer tele14 vision advertisements, the activities necessary to re15 view and provide advisory comments on other pro16 posed advertisements and promotional material prior 

17 to public dissemination. 

18 ‘‘(6) The term ‘Program’ means the Program 

19 to assess, collect, and use fees for the advisory re20 view of prescription drug advertising established by 

21 this section. 

22 ‘‘(7) The term ‘resources allocated for the proc23 ess for the advisory review of prescription drug ad24 vertising’ means the expenses incurred in connection 
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1 with the process for the advisory review of prescrip2 tion drug advertising for—

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

4 and Drug Administration, contractors of the 

5 Food and Drug Administration, advisory com6 mittees, and costs related to such officers, em7 ployees, and committees, and to contracts with 

8 such contractors; 

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

10 acquisition, maintenance, and repair of com11 puter resources; 

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

13 repair of facilities and acquisition, maintenance, 

14 and repair of fixtures, furniture, scientific 

15 equipment, and other necessary materials and 

16 supplies; 

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

18 and accounting for resources allocated for the 

19 advisory review of prescription drug advertising; 

20 and 

21 ‘‘(E) terminating the Program under sub22 section (f)(2), if necessary. 

23 ‘‘(8) The term ‘resubmission’ means a subse24 quent submission for advisory review of a direct-to25 consumer television advertisement that has been re-
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1 vised in response to the Secretary’s comments on an 

2 original submission. A resubmission may not intro3 duce significant new concepts or creative themes into 

4 the television advertisement. 

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

6 means an original submission of a direct-to-con7 sumer television advertisement for which the sponsor 

8 voluntarily requests advisory comments before the 

9 advertisement is publicly disseminated. 

10 ‘‘SEC. 736B. SUNSET. 

11 ‘‘This part shall cease to be effective on October 1, 

12 2012, except that subsection (b) of section 736 with re13 spect to reports shall cease to be effective on January 31, 

14 2013.’’. 

15 SEC. 105. SAVINGS CLAUSE. 

16 Notwithstanding section 509 of the Prescription 

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

18 note), and notwithstanding the amendments made by this 

19 title, part 2 of subchapter C of chapter VII of the Federal 

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

21 before the date of enactment of this title, shall continue 

22 to be in effect with respect to human drug applications 

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

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

25 2007, were accepted by the Food and Drug Administra-
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1 tion for filing with respect to assessing and collecting any 

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

3 year 2008. 

4 SEC. 106. TECHNICAL AMENDMENT. 

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

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

7 and inserting ‘‘part’’. 

8 SEC. 107. EFFECTIVE DATES. 

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

10 (b), the amendments made by this title shall take effect 

11 October 1, 2007. 

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

13 104 of this title shall take effect on the date of enactment 

14 of this title. 

15 TITLE II—DRUG SAFETY 

16 SEC. 200. SHORT TITLE. 

17 This title may be cited as the ‘‘Enhancing Drug Safe18 ty and Innovation Act of 2007’’. 

19 Subtitle A—Risk Evaluation and 

20 Mitigation Strategies 

21 SEC. 201. ROUTINE ACTIVE SURVEILLANCE AND ASSESS22 MENT. 

23 (a) IN GENERAL.—Subsection (k) of section 505 of 

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

25 355) is amended by adding at the end the following: 
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1 ‘‘(3) ROUTINE ACTIVE SURVEILLANCE AND AS2 SESSMENT.—

3 ‘‘(A) DEVELOPMENT OF THE POSTMARKET

4 RISK IDENTIFICATION AND ANALYSIS SYS5 TEM.—The Secretary shall, not later than 2 

6 years after the date of enactment of the En7 hancing Drug Safety and Innovation Act of 

8 2007, act in collaboration with academic insti9 tutions and private entities to—

10 ‘‘(i) establish minimum standards for 

11 collection and transmission of post12 marketing data elements from electronic 

13 health data systems; and 

14 ‘‘(ii) establish, through partnerships, 

15 a validated and integrated postmarket risk 

16 identification and analysis system to inte17 grate and analyze safety data from mul18 tiple sources, with the goals of including, 

19 in aggregate—

20 ‘‘(I) at least 25,000,000 patients 

21 by July 1, 2010; and 

22 ‘‘(II) at least 100,000,000 pa23 tients by July 1, 2012. 

24 ‘‘(B) DATA COLLECTION ACTIVITIES.—
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1 ‘‘(i) IN GENERAL.—The Secretary 

2 shall, not later than 1 year after the estab3 lishment of the minimum standards and 

4 the identification and analysis system 

5 under subparagraph (A), establish and 

6 maintain an active surveillance infrastruc7 ture—

8 ‘‘(I) to collect and report data for 

9 pharmaceutical postmarket risk iden10 tification and analysis, in compliance 

11 with the regulations promulgated 

12 under section 264(c) of the Health In13 surance Portability and Accountability 

14 Act of 1996; and 

15 ‘‘(II) that includes, in addition to 

16 the collection and monitoring (in a 

17 standardized form) of data on all seri18 ous adverse drug experiences (as de19 fined in subsection (o)(2)(C)) required 

20 to be submitted to the Secretary 

21 under paragraph (1), and those events 

22 voluntarily submitted from patients, 

23 providers, and drug, when appro24 priate, procedures to—
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1 ‘‘(aa) provide for adverse 

2 event surveillance by collecting 

3 and monitoring Federal health4 related electronic data (such as 

5 data from the Medicare program 

6 and the health systems of the 

7 Department of Veterans Affairs); 

8 ‘‘(bb) provide for adverse 

9 event surveillance by collecting 

10 and monitoring private sector 

11 health-related electronic data 

12 (such as pharmaceutical purchase 

13 data and health insurance claims 

14 data); 

15 ‘‘(cc) provide for adverse 

16 event surveillance by monitoring 

17 standardized electronic health 

18 records, as available; 

19 ‘‘(dd) provide for adverse 

20 event surveillance by collecting 

21 and monitoring other information 

22 as the Secretary deems necessary 

23 to create a robust system to iden24 tify adverse events and potential 

25 drug safety signals; 
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1 ‘‘(ee) enable the program to 

2 identify certain trends and pat3 terns with respect to data re4 ported to the program; 

5 ‘‘(ff) enable the program to 

6 provide regular reports to the 

7 Secretary concerning adverse 

8 event trends, adverse event pat9 terns, incidence and prevalence of 

10 adverse events, laboratory data, 

11 and other information determined 

12 appropriate, which may include 

13 data on comparative national ad14 verse event trends; and 

15 ‘‘(gg) enable the program to 

16 export data in a form appropriate 

17 for further aggregation, statis18 tical analysis, and reporting. 

19 ‘‘(ii) TIMELINESS OF REPORTING.—

20 The procedures developed under clause (i) 

21 shall ensure that such data are collected, 

22 monitored, and reported in a timely, rou23 tine, and automatic manner, taking into 

24 consideration the need for data complete25 ness, coding, cleansing, and transmission. 
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1 ‘‘(iii) PRIVATE SECTOR RESOURCES.—

2 To ensure the establishment of the active 

3 surveillance infrastructure by the date de4 scribed under clause (i), the Secretary 

5 may, on a temporary or permanent basis, 

6 implement systems or products developed 

7 by private entities. 

8 ‘‘(iv) COMPLEMENTARY AP9 PROACHES.—To the extent the active sur10 veillance infrastructure established under 

11 clause (i) is not sufficient to gather data 

12 and information relevant to priority drug 

13 safety questions, the Secretary shall de14 velop, support, and participate in com15 plementary approaches to gather and ana16 lyze such data and information, includ17 ing—

18 ‘‘(I) approaches that are com19 plementary with respect to assessing 

20 the safety of use of a drug in domestic 

21 populations not included in the trials 

22 used to approve the drug (such as 

23 older people, people with 

24 comorbidities, pregnant women, or 

25 children); and 
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1 ‘‘(II) existing approaches such as 

2 the Vaccine Adverse Event Reporting 

3 System and the Vaccine Safety 

4 Datalink or successor databases. 

5 ‘‘(v) AUTHORITY FOR CONTRACTS.—

6 The Secretary may enter into contracts 

7 with public and private entities to fulfill 

8 the requirements of this subparagraph. 

9 ‘‘(C) RISK IDENTIFICATION AND ANAL10 YSIS.—

11 ‘‘(i) PURPOSE.—To carry out this 

12 paragraph, the Secretary shall establish 

13 collaborations with other Government, aca14 demic, and private entities, including the 

15 Centers for Education and Research on 

16 Therapeutics under section 912 of the 

17 Public Health Service Act, to provide for 

18 the risk identification and analysis of the 

19 data collected under subparagraph (B) and 

20 data that is publicly available or is pro21 vided by the Secretary, in order to—

22 ‘‘(I) improve the quality and effi23 ciency of postmarket drug safety risk24 benefit analysis; 
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1 ‘‘(II) provide the Secretary with 

2 routine access to expertise to study 

3 advanced drug safety data; and 

4 ‘‘(III) enhance the ability of the 

5 Secretary to make timely assessments 

6 based on drug safety data. 

7 ‘‘(ii) PUBLIC PROCESS FOR PRIORITY

8 QUESTIONS.—At least biannually, the Sec9 retary shall seek recommendations from 

10 the Drug Safety and Risk Management 

11 Advisory Committee (or successor com12 mittee) and from other advisory commit13 tees, as appropriate, to the Food and Drug 

14 Administration on—

15 ‘‘(I) priority drug safety ques16 tions; and 

17 ‘‘(II) mechanisms for answering 

18 such questions, including through—

19 ‘‘(aa) routine active surveil20 lance under subparagraph (B); 

21 and 

22 ‘‘(bb) when such surveillance 

23 is not sufficient, postmarket 

24 studies under subsection 

25 (o)(4)(B) and postapproval clin-
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1 ical trials under subsection 

2 (o)(4)(C). 

3 ‘‘(iii) PROCEDURES FOR THE DEVEL4 OPMENT OF DRUG SAFETY COLLABORA5 TIONS.—

6 ‘‘(I) IN GENERAL.—Not later 

7 than 180 days after the date of the 

8 establishment of the active surveil9 lance infrastructure under subpara10 graph (B), the Secretary shall estab11 lish and implement procedures under 

12 which the Secretary may routinely col13 laborate with a qualified entity to—

14 ‘‘(aa) clean, classify, or ag15 gregate data collected under sub16 paragraph (B) and data that is 

17 publicly available or is provided 

18 by the Secretary; 

19 ‘‘(bb) allow for prompt in20 vestigation of priority drug safety 

21 questions, including—

22 ‘‘(AA) unresolved safety 

23 questions for drugs or class24 es of drugs; and 
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1 ‘‘(BB) for a newly-ap2 proved drug: safety signals 

3 from clinical trials used to 

4 approve the drug and other 

5 preapproval trials; rare, seri6 ous drug side effects; and 

7 the safety of use in domestic 

8 populations not included in 

9 the trials used to approve 

10 the drug (such as older peo11 ple, people with 

12 comorbidities, pregnant 

13 women, or children); 

14 ‘‘(cc) perform advanced re15 search and analysis on identified 

16 drug safety risks; 

17 ‘‘(dd) convene an expert ad18 visory committee to oversee the 

19 establishment of standards for 

20 the ethical and scientific uses for, 

21 and communication of, post22 marketing data collected under 

23 subparagraph (B), including ad24 vising on the development of ef-
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1 fective research methods for the 

2 study of drug safety questions; 

3 ‘‘(ee) focus postmarket stud4 ies under subsection (o)(4)(B) 

5 and postapproval clinical trials 

6 under subsection (o)(4)(C) more 

7 effectively on cases for which re8 ports under paragraph (1) and 

9 other safety signal detection is 

10 not sufficient to resolve whether 

11 there is an elevated risk of a seri12 ous adverse event associated with 

13 the use of a drug; and 

14 ‘‘(ff) carry out other activi15 ties as the Secretary deems nec16 essary to carry out the purposes 

17 of this paragraph. 

18 ‘‘(II) REQUEST FOR SPECIFIC

19 METHODOLOGY.—The procedures de20 scribed in subclause (I) shall permit 

21 the Secretary to request that a spe22 cific methodology be used by the 

23 qualified entity. The qualified entity 

24 shall work with the Secretary to final25 ize the methodology to be used. 
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1 ‘‘(iv) USE OF ANALYSES.—The Sec2 retary shall provide the analyses described 

3 under this subparagraph, including the 

4 methods and results of such analyses, 

5 about a drug to the sponsor or sponsors of 

6 such drug. 

7 ‘‘(v) QUALIFIED ENTITIES.—

8 ‘‘(I) IN GENERAL.—The Sec9 retary shall enter into contracts with 

10 a sufficient number of qualified enti11 ties to develop and provide informa12 tion to the Secretary in a timely man13 ner. 

14 ‘‘(II) QUALIFICATION.—The Sec15 retary shall enter into a contract with 

16 an entity under subclause (I) only if 

17 the Secretary determines that the en18 tity—

19 ‘‘(aa) has the research capa20 bility and expertise to conduct 

21 and complete the activities under 

22 this paragraph; 

23 ‘‘(bb) has in place an infor24 mation technology infrastructure 

25 to support adverse event surveil-
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1 lance data and operational stand2 ards to provide security for such 

3 data; 

4 ‘‘(cc) has experience with, 

5 and expertise on, the develop6 ment of drug safety and effec7 tiveness research using electronic 

8 population data; 

9 ‘‘(dd) has an understanding 

10 of drug development and risk/

11 benefit balancing in a clinical set12 ting; and 

13 ‘‘(ee) has a significant busi14 ness presence in the United 

15 States. 

16 ‘‘(vi) CONTRACT REQUIREMENTS.—

17 Each contract with a qualified entity shall 

18 contain the following requirements: 

19 ‘‘(I) ENSURING PRIVACY.—The 

20 qualified entity shall provide assur21 ances that the entity will not use the 

22 data provided by the Secretary in a 

23 manner that violates—

24 ‘‘(aa) the regulations pro25 mulgated under section 264(c) of 
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1 the Health Insurance Portability 

2 and Accountability Act of 1996; 

3 or 

4 ‘‘(bb) sections 552 or 552a 

5 of title 5, United States Code, 

6 with regard to the privacy of in7 dividually-identifiable beneficiary 

8 health information. 

9 ‘‘(II) COMPONENT OF ANOTHER

10 ORGANIZATION.—If a qualified entity 

11 is a component of another organiza12 tion—

13 ‘‘(aa) the qualified entity 

14 shall maintain the data related to 

15 the activities carried out under 

16 this paragraph separate from the 

17 other components of the organi18 zation and establish appropriate 

19 security measures to maintain 

20 the confidentiality and privacy of 

21 such data; and 

22 ‘‘(bb) the entity shall not 

23 make an unauthorized disclosure 

24 of such data to the other compo25 nents of the organization in 
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1 breach of such confidentiality and 

2 privacy requirement. 

3 ‘‘(III) TERMINATION OR NON4 RENEWAL.—If a contract with a 

5 qualified entity under this subpara6 graph is terminated or not renewed, 

7 the following requirements shall apply: 

8 ‘‘(aa) CONFIDENTIALITY

9 AND PRIVACY PROTECTIONS.—

10 The entity shall continue to com11 ply with the confidentiality and 

12 privacy requirements under this 

13 paragraph with respect to all 

14 data disclosed to the entity. 

15 ‘‘(bb) DISPOSITION OF

16 DATA.—The entity shall return 

17 to the Secretary all data dis18 closed to the entity or, if return19 ing the data is not practicable, 

20 destroy the data. 

21 ‘‘(vii) COMPETITIVE PROCEDURES.—

22 The Secretary shall use competitive proce23 dures (as defined in section 4(5) of the 

24 Federal Procurement Policy Act) to enter 

25 into contracts under clause (v). 
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1 ‘‘(viii) REVIEW OF CONTRACT IN THE

2 EVEN OF A MERGER OR ACQUISITION.—

3 The Secretary shall review the contract 

4 with a qualified entity under this para5 graph in the event of a merger or acquisi6 tion of the entity in order to ensure that 

7 the requirements under this subparagraph 

8 will continue to be met. 

9 ‘‘(D) COORDINATION.—In carrying out 

10 this paragraph, the Secretary shall provide for 

11 appropriate communications to the public, sci12 entific, public health, and medical communities, 

13 and other key stakeholders, and provide for the 

14 coordination of the activities of private entities, 

15 professional associations, or other entities that 

16 may have sources of surveillance data.’’. 

17 (b) AUTHORIZATION OF APPROPRIATIONS.—To carry 

18 out activities under the amendment made by this section 

19 for which funds are made available under section 736 of 

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

21 379h), there are authorized to be appropriated to carry 

22 out the amendment made by this section, in addition to 

23 such funds, $25,000,000 for each of fiscal years 2008 

24 through 2012. 
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1 SEC. 202. RISK EVALUATION AND MITIGATION STRATEGIES. 

2 Section 505 of the Federal Food, Drug, and Cosmetic 

3 Act (21 U.S.C. 355) is amended by adding at the end the 

4 following: 

5 ‘‘(o) RISK EVALUATION AND MITIGATION STRAT6 EGY.—

7 ‘‘(1) IN GENERAL.—In the case of any drug 

8 subject to subsection (b) or to section 351 of the 

9 Public Health Service Act for which a risk evalua10 tion and mitigation strategy is approved as provided 

11 for in this subsection, the applicant shall comply 

12 with the requirements of such strategy. 

13 ‘‘(2) DEFINITIONS.—In this subsection: 

14 ‘‘(A) ADVERSE DRUG EXPERIENCE.—The 

15 term ‘adverse drug experience’ means any ad16 verse event associated with the use of a drug in 

17 humans, whether or not considered drug re18 lated, including—

19 ‘‘(i) an adverse event occurring in the 

20 course of the use of the drug in profes21 sional practice; 

22 ‘‘(ii) an adverse event occurring from 

23 an overdose of the drug, whether acci24 dental or intentional; 

25 ‘‘(iii) an adverse event occurring from 

26 abuse of the drug; 
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1 ‘‘(iv) an adverse event occurring from 

2 withdrawal of the drug; and 

3 ‘‘(v) any failure of expected pharma4 cological action of the drug. 

5 ‘‘(B) NEW SAFETY INFORMATION.—The 

6 term ‘new safety information’ with respect to a 

7 drug means information about—

8 ‘‘(i) a serious risk or an unexpected 

9 serious risk with use of the drug that the 

10 Secretary has become aware of since the 

11 later of—

12 ‘‘(I) the date of initial approval 

13 of the drug under this section or ini14 tial licensure of the drug under sec15 tion 351 of the Public Health Service 

16 Act; or 

17 ‘‘(II) if applicable, the last as18 sessment of the approved risk evalua19 tion and mitigation strategy for the 

20 drug; or 

21 ‘‘(ii) the effectiveness of the approved 

22 risk evaluation and mitigation strategy for 

23 the drug obtained since the later of—

24 ‘‘(I) the approval of such strat25 egy; or 
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1 ‘‘(II) the last assessment of such 

2 strategy. 

3 ‘‘(C) SERIOUS ADVERSE DRUG EXPERI4 ENCE.—The term ‘serious adverse drug experi5 ence’ is an adverse drug experience that—

6 ‘‘(i) results in—

7 ‘‘(I) death; 

8 ‘‘(II) the placement of the pa9 tient at immediate risk of death from 

10 the adverse drug experience as it oc11 curred (not including an adverse drug 

12 experience that might have caused 

13 death had it occurred in a more severe 

14 form); 

15 ‘‘(III) inpatient hospitalization or 

16 prolongation of existing hospitaliza17 tion; 

18 ‘‘(IV) a persistent or significant 

19 incapacity or substantial disruption of 

20 the ability to conduct normal life 

21 functions; or 

22 ‘‘(V) a congenital anomaly or 

23 birth defect; or 

24 ‘‘(ii) based on appropriate medical 

25 judgment, may jeopardize the patient and 
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1 may require a medical or surgical interven2 tion to prevent an outcome described under 

3 clause (i). 

4 ‘‘(D) SERIOUS RISK.—The term ‘serious 

5 risk’ means a risk of a serious adverse drug ex6 perience. 

7 ‘‘(E) SIGNAL OF A SERIOUS RISK.—The 

8 term ‘signal of a serious risk’ means informa9 tion related to a serious adverse drug experi10 ence derived from—

11 ‘‘(i) a clinical trial; 

12 ‘‘(ii) adverse event reports under sub13 section (k)(1); 

14 ‘‘(iii) routine active surveillance under 

15 subsection (k)(3); 

16 ‘‘(iv) a postapproval study, including a 

17 study under paragraph (4)(B); or 

18 ‘‘(v) peer-reviewed biomedical lit19 erature. 

20 ‘‘(F) UNEXPECTED SERIOUS RISK.—The 

21 term ‘unexpected serious risk’ means a serious 

22 adverse drug experience that—

23 ‘‘(i) is not listed in the labeling of a 

24 drug; or 
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1 ‘‘(ii) is symptomatically and 

2 pathophysiologically related to an adverse 

3 drug experience listed in the labeling of the 

4 drug, but differs from such adverse drug 

5 experience because of greater severity, 

6 specificity, or prevalence. 

7 ‘‘(3) REQUIRED ELEMENTS OF A RISK EVALUA8 TION AND MITIGATION STRATEGY.—If a risk evalua9 tion and mitigation strategy for a drug is required, 

10 such strategy shall include—

11 ‘‘(A) the labeling for the drug for use by 

12 health care providers as approved under sub13 section (c); 

14 ‘‘(B) a timetable for submission of assess15 ments of the strategy, that—

16 ‘‘(i) for a drug no active ingredient 

17 (including any ester or salt of the active 

18 ingredient) of which has been approved in 

19 any other application under this section or 

20 section 351 of the Public Health Service 

21 Act—

22 ‘‘(I) shall be no less frequently 

23 than 18 months and 3 years after the 

24 drug is initially approved and at a fre-
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1 quency specified in the strategy for 

2 subsequent years; and 

3 ‘‘(II) may be eliminated after the 

4 first 3 years if the Secretary deter5 mines that serious risks of the drug 

6 have been adequately identified and 

7 assessed and are being adequately 

8 managed; 

9 ‘‘(ii) for a drug other than a drug de10 scribed under clause (i), shall occur at a 

11 frequency determined by the Secretary; 

12 and 

13 ‘‘(iii) may be increased or reduced in 

14 frequency as necessary as provided for in 

15 paragraph (7)(B)(v)(VI). 

16 ‘‘(4) ADDITIONAL POTENTIAL EVALUATION

17 ELEMENTS OF A RISK EVALUATION AND MITIGATION

18 STRATEGY.—

19 ‘‘(A) RISK EVALUATION.—If a risk evalua20 tion and mitigation strategy for a drug is re21 quired, such strategy may include 1 or more of 

22 the additional evaluation elements described in 

23 this paragraph, so long as the Secretary makes 

24 the determination required with respect to each 

25 additional included element. 
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1 ‘‘(B) POSTAPPROVAL STUDIES.—If the 

2 Secretary determines that the reports under 

3 subsection (k)(1) and routine active surveillance 

4 as available under subsection (k)(3) (including 

5 available complementary approaches under sub6 section (k)(3)(B)(iv)) will not be sufficient to—

7 ‘‘(i) assess a signal of a serious risk 

8 with use of a drug; or 

9 ‘‘(ii) identify, based on a review of a 

10 demonstrated pattern of use of the drug, 

11 unexpected serious risks in a domestic pop12 ulation, including older people, people with 

13 comorbidities, pregnant women, or chil14 dren, 

15 the risk evaluation and mitigation strategy for 

16 the drug may require that the applicant con17 duct an appropriate postapproval study, such as 

18 a prospective or retrospective observational 

19 study, of the drug (which shall include a time20 frame specified by the Secretary for completing 

21 the study and reporting the results to the Sec22 retary). 

23 ‘‘(C) POSTAPPROVAL CLINICAL TRIALS.—If 

24 the Secretary determines that the reports under 

25 subsection (k)(1), routine active surveillance as 
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1 available under subsection (k)(3) (including 

2 available complementary approaches under sub3 section (k)(3)(B)(iv)), and a study or studies 

4 under subparagraph (B) will likely be inad5 equate to assess a signal of a serious risk with 

6 use of a drug, and there is no effective ap7 proved application for the drug under sub8 section (j) as of the date that the requirement 

9 is first imposed, the risk evaluation and mitiga10 tion strategy for the drug may require that the 

11 applicant conduct an appropriate postapproval 

12 clinical trial of the drug (which shall include a 

13 timeframe specified by the Secretary for com14 pleting the clinical trial and reporting the re15 sults to the Secretary) to be included in the 

16 clinical trial registry data bank provided for 

17 under subsections (i) and (j) of section 402 of 

18 the Public Health Service Act. 

19 ‘‘(5) ADDITIONAL POTENTIAL COMMUNICATION

20 ELEMENTS OF A RISK EVALUATION AND MITIGATION

21 STRATEGY.—

22 ‘‘(A) RISK COMMUNICATION.—If a risk 

23 evaluation and mitigation strategy for a drug is 

24 required, such strategy may include 1 or more 

25 of the additional communication elements de-
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1 scribed in this paragraph, so long as the Sec2 retary makes the determination required with 

3 respect to each additional included element. 

4 ‘‘(B) MEDGUIDE; PATIENT PACKAGE IN5 SERT.—The risk evaluation and mitigation 

6 strategy for a drug may require that the appli7 cant develop for distribution to each patient 

8 when the drug is dispensed either or both of the 

9 following: 

10 ‘‘(i) A Medication Guide, as provided 

11 for under part 208 of title 21, Code of 

12 Federal Regulations (or any successor reg13 ulations). 

14 ‘‘(ii) A patient package insert, if the 

15 Secretary determines that such insert may 

16 help mitigate a serious risk listed in the la17 beling of the drug. 

18 ‘‘(C) COMMUNICATION PLAN.—If the Sec19 retary determines that a communication plan to 

20 health care providers may support implementa21 tion of an element of the risk evaluation and 

22 mitigation strategy for a drug, such as a label23 ing change, the strategy may require that the 

24 applicant conduct such a plan, which may in25 clude—
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1 ‘‘(i) sending letters to health care pro2 viders; 

3 ‘‘(ii) disseminating information about 

4 the elements of the strategy to encourage 

5 implementation by health care providers of 

6 components that apply to such health care 

7 providers, or to explain certain safety pro8 tocols (such as medical monitoring by peri9 odic laboratory tests); or 

10 ‘‘(iii) disseminating information to 

11 health care providers through professional 

12 societies about any serious risks of the 

13 drug and any protocol to assure safe use. 

14 ‘‘(D) PREREVIEW.—

15 ‘‘(i) IN GENERAL.—If the Secretary 

16 determines that prereview of advertise17 ments is necessary to ensure the inclusion 

18 of a true statement in such advertisements 

19 of information in brief summary relating to 

20 a serious risk listed in the labeling of a 

21 drug, or relating to a protocol to ensure 

22 the safe use described in the labeling of the 

23 drug, the risk evaluation and mitigation 

24 strategy for the drug may require that the 

25 applicant submit to the Secretary adver-
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1 tisements of the drug for prereview not 

2 later than 45 days before dissemination of 

3 the advertisement 

4 ‘‘(ii) SPECIFICATION OF ADVERTISE5 MENTS.—The Secretary may specify the 

6 advertisements required to be submitted 

7 under clause (i). 

8 ‘‘(E) SPECIFIC DISCLOSURES.—

9 ‘‘(i) SERIOUS RISK; SAFETY PRO10 TOCOL.—If the Secretary determines that 

11 advertisements lacking a specific disclosure 

12 about a serious risk listed in the labeling 

13 of a drug or about a protocol to ensure 

14 safe use described in the labeling of the 

15 drug would be false or misleading, the risk 

16 evaluation and mitigation strategy for the 

17 drug may require that the applicant in18 clude in advertisements of the drug such 

19 disclosure. 

20 ‘‘(ii) DATE OF APPROVAL.—If the 

21 Secretary determines that advertisements 

22 lacking a specific disclosure of the date a 

23 drug was approved and disclosure of a se24 rious risk would be false or misleading, the 

25 risk evaluation and mitigation strategy for 
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1 the drug may require that the applicant in2 clude in advertisements of the drug such 

3 disclosure. 

4 ‘‘(iii) SPECIFICATION OF ADVERTISE5 MENTS.—The Secretary may specify the 

6 advertisements required to include a spe7 cific disclosure under clause (i) or (ii). 

8 ‘‘(iv) REQUIRED SAFETY SURVEIL9 LANCE.—If the approved risk evaluation 

10 and mitigation strategy for a drug requires 

11 the specific disclosure under clause (ii), the 

12 Secretary shall—

13 ‘‘(I) consider identifying and as14 sessing all serious risks of using the 

15 drug to be a priority safety question 

16 under subsection (k)(3)(B); 

17 ‘‘(II) not less frequently than 

18 every 3 months, evaluate the reports 

19 under subsection (k)(1) and the rou20 tine active surveillance as available 

21 under subsection (k)(3) with respect 

22 to such priority drug safety question 

23 to determine whether serious risks 

24 that might occur among patients ex25 pected to be treated with the drug 
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1 have been adequately identified and 

2 assessed; 

3 ‘‘(III) remove such specific dis4 closure requirement as an element of 

5 such strategy if such serious risks 

6 have been adequately identified and 

7 assessed; and 

8 ‘‘(IV) consider whether a specific 

9 disclosure under clause (i) should be 

10 required. 

11 ‘‘(6) PROVIDING SAFE ACCESS FOR PATIENTS

12 TO DRUGS WITH KNOWN SERIOUS RISKS THAT

13 WOULD OTHERWISE BE UNAVAILABLE.—

14 ‘‘(A) ALLOWING SAFE ACCESS TO DRUGS

15 WITH KNOWN SERIOUS RISKS.—The Secretary 

16 may require that the risk evaluation and miti17 gation strategy for a drug include such ele18 ments as are necessary to assure safe use of the 

19 drug, because of its inherent toxicity or poten20 tial harmfulness, if the Secretary determines 

21 that—

22 ‘‘(i) the drug, which has been shown 

23 to be effective, but is associated with a se24 rious adverse drug experience, can be ap25 proved only if, or would be withdrawn un-
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1 less, such elements are required as part of 

2 such strategy to mitigate a specific serious 

3 risk listed in the labeling of the drug; and 

4 ‘‘(ii) for a drug initially approved 

5 without elements to assure safe use, other 

6 elements under paragraphs (3), (4), and 

7 (5) are not sufficient to mitigate such seri8 ous risk. 

9 ‘‘(B) ASSURING ACCESS AND MINIMIZING

10 BURDEN.—Such elements to assure safe use 

11 under subparagraph (A) shall—

12 ‘‘(i) be commensurate with the spe13 cific serious risk listed in the labeling of 

14 the drug; 

15 ‘‘(ii) within 30 days of the date on 

16 which any element under subparagraph (A) 

17 is imposed, be posted publicly by the Sec18 retary with an explanation of how such ele19 ments will mitigate the observed safety 

20 risk; 

21 ‘‘(iii) considering such risk, not be un22 duly burdensome on patient access to the 

23 drug, considering in particular—
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1 ‘‘(I) patients with serious or life2 threatening diseases or conditions; 

3 and 

4 ‘‘(II) patients who have difficulty 

5 accessing health care (such as pa6 tients in rural or medically under7 served areas); and 

8 ‘‘(iv) to the extent practicable, so as 

9 to minimize the burden on the health care 

10 delivery system—

11 ‘‘(I) conform with elements to as12 sure safe use for other drugs with 

13 similar, serious risks; and 

14 ‘‘(II) be designed to be compat15 ible with established distribution, pro16 curement, and dispensing systems for 

17 drugs. 

18 ‘‘(C) ELEMENTS TO ASSURE SAFE USE.—

19 The elements to assure safe use under subpara20 graph (A) shall include 1 or more goals to miti21 gate a specific serious risk listed in the labeling 

22 of the drug and, to mitigate such risk, may re23 quire that—

24 ‘‘(i) health care providers who pre25 scribe the drug have particular training or 
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1 experience, or are specially certified (which 

2 training or certification with respect to the 

3 drug shall be available to any willing pro4 vider from a frontier area in a widely avail5 able training or certification method (in6 cluding an on-line course or via mail) as 

7 approved by the Secretary at minimal cost 

8 to the provider); 

9 ‘‘(ii) pharmacies, practitioners, or 

10 health care settings that dispense the drug 

11 are specially certified (which certification 

12 shall be available to any willing provider 

13 from a frontier area); 

14 ‘‘(iii) the drug be dispensed to pa15 tients only in certain health care settings, 

16 such as hospitals; 

17 ‘‘(iv) the drug be dispensed to pa18 tients with evidence or other documenta19 tion of safe-use conditions, such as labora20 tory test results; 

21 ‘‘(v) each patient using the drug be 

22 subject to certain monitoring; or 

23 ‘‘(vi) each patient using the drug be 

24 enrolled in a registry. 
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1 ‘‘(D) IMPLEMENTATION SYSTEM.—The ele2 ments to assure safe use under subparagraph 

3 (A) that are described in clauses (ii), (iii), or 

4 (iv) of subparagraph (C) may include a system 

5 through which the applicant is able to take rea6 sonable steps to—

7 ‘‘(i) monitor and evaluate implementa8 tion of such elements by health care pro9 viders, pharmacists, and other parties in 

10 the health care system who are responsible 

11 for implementing such elements; and 

12 ‘‘(ii) work to improve implementation 

13 of such elements by such persons. 

14 ‘‘(E) EVALUATION OF ELEMENTS TO AS15 SURE SAFE USE.—The Secretary, through the 

16 Drug Safety and Risk Management Advisory 

17 Committee (or successor committee) of the 

18 Food and Drug Administration, shall—

19 ‘‘(i) seek input from patients, physi20 cians, pharmacists, and other health care 

21 providers about how elements to assure 

22 safe use under this paragraph for 1 or 

23 more drugs may be standardized so as not 

24 to be—
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1 ‘‘(I) unduly burdensome on pa2 tient access to the drug; and 

3 ‘‘(II) to the extent practicable, 

4 minimize the burden on the health 

5 care delivery system; 

6 ‘‘(ii) at least annually, evaluate, for 1 

7 or more drugs, the elements to assure safe 

8 use of such drug to assess whether the ele9 ments—

10 ‘‘(I) assure safe use of the drug; 

11 ‘‘(II) are not unduly burdensome 

12 on patient access to the drug; and 

13 ‘‘(III) to the extent practicable, 

14 minimize the burden on the health 

15 care delivery system; and 

16 ‘‘(iii) considering such input and eval17 uations—

18 ‘‘(I) issue or modify agency guid19 ance about how to implement the re20 quirements of this paragraph; and 

21 ‘‘(II) modify elements under this 

22 paragraph for 1 or more drugs as ap23 propriate. 

24 ‘‘(F) ADDITIONAL MECHANISMS TO AS25 SURE ACCESS.—The mechanisms under section 
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1 561 to provide for expanded access for patients 

2 with serious or life-threatening diseases or con3 ditions may be used to provide access for pa4 tients with a serious or life-threatening disease 

5 or condition, the treatment of which is not an 

6 approved use for the drug, to a drug that is 

7 subject to elements to assure safe use under 

8 this paragraph. The Secretary shall promulgate 

9 regulations for how a physician may provide the 

10 drug under the mechanisms of section 561. 

11 ‘‘(G) WAIVER IN PUBLIC HEALTH EMER12 GENCIES.—The Secretary may waive any re13 quirement of this paragraph during the period 

14 described in section 319(a) of the Public Health 

15 Service Act with respect to a qualified counter16 measure described under section 319F–1(a)(2) 

17 of such Act, to which a requirement under this 

18 paragraph has been applied, if the Secretary 

19 has—

20 ‘‘(i) declared a public health emer21 gency under such section 319; and 

22 ‘‘(ii) determined that such waiver is 

23 required to mitigate the effects of, or re24 duce the severity of, such public health 

25 emergency. 
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1 ‘‘(7) SUBMISSION AND REVIEW OF RISK EVAL2 UATION AND MITIGATION STRATEGY.—

3 ‘‘(A) PROPOSED RISK EVALUATION AND

4 MITIGATION STRATEGY.—

5 ‘‘(i) VOLUNTARY PROPOSAL.—If there 

6 is a signal of a serious risk with a drug, 

7 an applicant may include a proposed risk 

8 evaluation and mitigation strategy for the 

9 drug in an application, including in a sup10 plemental application, for the drug under 

11 subsection (b) or section 351 of the Public 

12 Health Service Act. 

13 ‘‘(ii) REQUIRED PROPOSAL.—

14 ‘‘(I) DETERMINATION NEC15 ESSARY TO REQUIRE A PROPOSAL.—

16 ‘‘(aa) IN GENERAL.—The 

17 Secretary may require that the 

18 applicant for a drug submit a 

19 proposed risk evaluation and 

20 mitigation strategy for a drug if 

21 the Secretary (acting through the 

22 office responsible for reviewing 

23 the drug and the office respon24 sible for postapproval safety with 

25 respect to the drug) determines 
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1 that, based on a signal of a seri2 ous risk with the drug, a risk 

3 evaluation and mitigation strat4 egy is necessary to assess such 

5 signal or mitigate such serious 

6 risk. 

7 ‘‘(bb) NON-DELEGATION.—A 

8 determination under item (aa) 

9 for a drug shall be made by indi10 viduals at or above the level of 

11 individuals empowered to approve 

12 a drug (such as division directors 

13 within the Center for Drug Eval14 uation and Research). 

15 ‘‘(II) CIRCUMSTANCES IN WHICH

16 A PROPOSAL MAY BE REQUIRED.—

17 The applicant shall submit a proposed 

18 risk evaluation and mitigation strat19 egy for a drug—

20 ‘‘(aa) in response to a letter 

21 from the Secretary (acting 

22 through the office responsible for 

23 reviewing the drug and the office 

24 responsible for postapproval safe25 ty with respect to the drug) sent 
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1 regarding an application, includ2 ing a supplemental application, 

3 for the drug, if the Secretary de4 termines that data or information 

5 in the application indicates that 

6 an element under paragraph (4), 

7 (5), or (6) should be included in 

8 a strategy for the drug; 

9 ‘‘(bb) within a timeframe 

10 specified by the Secretary, not to 

11 be less than 45 days, when or12 dered by the Secretary (acting 

13 through such offices), if the Sec14 retary determines that new safety 

15 information indicates that—

16 ‘‘(AA) the labeling of 

17 the drug should be changed; 

18 or 

19 ‘‘(BB) an element 

20 under paragraph (4) or (5) 

21 should be included in a 

22 strategy for the drug; or 

23 ‘‘(cc) within 90 days when 

24 ordered by the Secretary (acting 

25 through such offices), if the Sec-
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1 retary determines that new safety 

2 information indicates that an ele3 ment under paragraph (6) should 

4 be included in a strategy for the 

5 drug. 

6 ‘‘(iii) CONTENT OF LETTER.—A letter 

7 under clause (ii)(II)(aa) shall describe—

8 ‘‘(I) the data or information in 

9 the application that warrants the pro10 posal of a risk evaluation and mitiga11 tion strategy for the drug; and 

12 ‘‘(II) what elements under para13 graphs (4), (5), or (6) should be in14 cluded in a strategy for the drug. 

15 ‘‘(iv) CONTENT OF ORDER.—An order 

16 under item (aa) or (bb) of clause (ii)(II) 

17 shall describe—

18 ‘‘(I) the new safety information 

19 with respect to the drug that warrants 

20 the proposal of a risk evaluation and 

21 mitigation strategy for the drug; and 

22 ‘‘(II) whether and how the label23 ing of the drug should be changed and 

24 what elements under paragraphs (4), 
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1 (5), or (6) should be included in a 

2 strategy for the drug. 

3 ‘‘(v) CONTENT OF PROPOSAL.—A pro4 posed risk evaluation and mitigation strat5 egy—

6 ‘‘(I) shall include a timetable as 

7 described under paragraph (3)(B); 

8 and 

9 ‘‘(II) may also include additional 

10 elements as provided for under para11 graphs (4), (5), and (6). 

12 ‘‘(B) ASSESSMENT AND MODIFICATION OF

13 A RISK EVALUATION AND MITIGATION STRAT14 EGY.—

15 ‘‘(i) VOLUNTARY ASSESSMENTS.—If a 

16 risk evaluation and mitigation strategy for 

17 a drug is required, the applicant may sub18 mit to the Secretary an assessment of, and 

19 propose a modification to, such approved 

20 strategy for the drug at any time. 

21 ‘‘(ii) REQUIRED ASSESSMENTS.—If a 

22 risk evaluation and mitigation strategy for 

23 a drug is required, the applicant shall sub24 mit an assessment of, and may propose a 
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1 modification to, such approved strategy for 

2 the drug—

3 ‘‘(I) when submitting an applica4 tion, including a supplemental appli5 cation, for a new indication under 

6 subsection (b) or section 351 of the 

7 Public Health Service Act; 

8 ‘‘(II) when required by the strat9 egy, as provided for in the timetable 

10 under paragraph (3)(B); 

11 ‘‘(III) within a timeframe speci12 fied by the Secretary, not to be less 

13 than 45 days, when ordered by the 

14 Secretary (acting through the offices 

15 described in subparagraph (A)(ii)(I)), 

16 if the Secretary determines that new 

17 safety information indicates that an 

18 element under paragraph (3) or (4) 

19 should be modified or added to the 

20 strategy; 

21 ‘‘(IV) within 90 days when or22 dered by the Secretary (acting 

23 through such offices), if the Secretary 

24 determines that new safety informa25 tion indicates that an element under 
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1 paragraph (6) should be modified or 

2 added to the strategy; or 

3 ‘‘(V) within 15 days when or4 dered by the Secretary (acting 

5 through such offices), if the Secretary 

6 determines that there may be a cause 

7 for action by the Secretary under sub8 section (e). 

9 ‘‘(iii) CONTENT OF ORDER.—An order 

10 under subclauses (III), (IV), or (V) of 

11 clause (ii) shall describe—

12 ‘‘(I) the new safety information 

13 with respect to the drug that warrants 

14 an assessment of the approved risk 

15 evaluation and mitigation strategy for 

16 the drug; and 

17 ‘‘(II) whether and how such 

18 strategy should be modified because of 

19 such information. 

20 ‘‘(iv) ASSESSMENT.—An assessment 

21 of the approved risk evaluation and mitiga22 tion strategy for a drug shall include—

23 ‘‘(I) a description of new safety 

24 information, if any, with respect to 

25 the drug; 
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1 ‘‘(II) whether and how to modify 

2 such strategy because of such infor3 mation; 

4 ‘‘(III) with respect to any post5 approval study required under para6 graph (4)(B) or otherwise undertaken 

7 by the applicant to investigate a safe8 ty issue, the status of such study, in9 cluding whether any difficulties com10 pleting the study have been encoun11 tered; 

12 ‘‘(IV) with respect to any post13 approval clinical trial required under 

14 paragraph (4)(C) or otherwise under15 taken by the applicant to investigate a 

16 safety issue, the status of such clinical 

17 trial, including whether enrollment 

18 has begun, the number of participants 

19 enrolled, the expected completion date, 

20 whether any difficulties completing 

21 the clinical trial have been encoun22 tered, and registration information 

23 with respect to requirements under 

24 subsections (i) and (j) of section 402 

25 of the Public Health Service Act; and 
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1 ‘‘(V) with respect to any goal 

2 under paragraph (6) and considering 

3 input and evaluations, if applicable, 

4 under paragraph (6)(E), an assess5 ment of how well the elements to as6 sure safe use are meeting the goal of 

7 increasing safe access to drugs with 

8 known serious risks or whether the 

9 goal or such elements should be modi10 fied. 

11 ‘‘(v) MODIFICATION.—A modification 

12 (whether an enhancement or a reduction) 

13 to the approved risk evaluation and mitiga14 tion strategy for a drug may include the 

15 addition or modification of any element 

16 under subparagraph (A) or (B) of para17 graph (3) or the addition, modification, or 

18 removal of any element under paragraph 

19 (4), (5), or (6), such as—

20 ‘‘(I) a labeling change, including 

21 the addition of a boxed warning; 

22 ‘‘(II) adding a postapproval 

23 study or clinical trial requirement; 

24 ‘‘(III) modifying a postapproval 

25 study or clinical trial requirement 
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1 (such as a change in trial design due 

2 to legitimate difficulties recruiting 

3 participants); 

4 ‘‘(IV) adding, modifying, or re5 moving an element on advertising 

6 under subparagraph (D), (E), or (F) 

7 of paragraph (5); 

8 ‘‘(V) adding, modifying, or re9 moving an element to assure safe use 

10 under paragraph (6); or 

11 ‘‘(VI) modifying the timetable for 

12 assessments of the strategy under 

13 paragraph (3)(B), including to elimi14 nate assessments. 

15 ‘‘(C) REVIEW.—The Secretary (acting 

16 through the offices described in subparagraph 

17 (A)(ii)(I)) shall promptly review the proposed 

18 risk evaluation and mitigation strategy for a 

19 drug submitted under subparagraph (A), or an 

20 assessment of the approved risk evaluation and 

21 mitigation strategy for a drug submitted under 

22 subparagraph (B). 

23 ‘‘(D) DISCUSSION.—The Secretary (acting 

24 through the offices described in subparagraph 

25 (A)(ii)(I)) shall initiate discussions of the pro-
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1 posed risk evaluation and mitigation strategy 

2 for a drug submitted under subparagraph (A), 

3 or of an assessment of the approved risk eval4 uation and mitigation strategy for a drug sub5 mitted under subparagraph (B), with the appli6 cant to determine a strategy—

7 ‘‘(i) if the proposed strategy or assess8 ment is submitted as part of an application 

9 (including a supplemental application) 

10 under subparagraph (A)(i), (A)(ii)(II)(aa), 

11 or (B)(ii)(I), by the target date for com12 munication of feedback from the review 

13 team to the applicant regarding proposed 

14 labeling and postmarketing study commit15 ments, as set forth in the letters described 

16 in section 735(a); 

17 ‘‘(ii) if the proposed strategy is sub18 mitted under subparagraph (A)(ii)(II)(bb) 

19 or the assessment is submitted under sub20 clause (II) or (III) of subparagraph 

21 (B)(ii), not later than 20 days after such 

22 submission; 

23 ‘‘(iii) if the proposed strategy is sub24 mitted under subparagraph (A)(ii)(II)(cc) 

25 or the assessment is submitted under sub-
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1 paragraph (B)(i) or under subparagraph 

2 (B)(ii)(IV), not later than 30 days after 

3 such submission; or 

4 ‘‘(iv) if the assessment is submitted 

5 under subparagraph (B)(ii)(V), not later 

6 than 10 days after such submission. 

7 ‘‘(E) ACTION.—

8 ‘‘(i) IN GENERAL.—Unless the appli9 cant requests the dispute resolution proc10 ess as described under subparagraph (F) 

11 or (G), the Secretary (acting through the 

12 offices described in subparagraph 

13 (A)(ii)(I)) shall approve and include the 

14 risk evaluation and mitigation strategy for 

15 a drug, or any modification to the strategy 

16 (including a timeframe for implementing 

17 such modification), with—

18 ‘‘(I) the action letter on the ap19 plication, if a proposed strategy is 

20 submitted under subparagraph (A)(i) 

21 or (A)(ii)(II)(aa) or an assessment of 

22 the strategy is submitted under sub23 paragraph (B)(ii)(I); or 

24 ‘‘(II) an order, which shall be 

25 made public, issued not later than 50 
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1 days after the date discussions of such 

2 proposed strategy or modification 

3 begin under subparagraph (D), if a 

4 proposed strategy is submitted under 

5 item (bb) or (cc) of subparagraph 

6 (A)(ii)(II) or an assessment of the 

7 strategy is submitted under subpara8 graph (B)(i) or under subclause (II), 

9 (III), (IV), or (V) of subparagraph 

10 (B)(ii). 

11 ‘‘(ii) INACTION.—An approved risk 

12 evaluation and mitigation strategy shall re13 main in effect until the Secretary acts, if 

14 the Secretary fails to act as provided under 

15 clause (i). 

16 ‘‘(F) DISPUTE RESOLUTION AT INITIAL

17 APPROVAL.—If a proposed risk evaluation and 

18 mitigation strategy is submitted under subpara19 graph (A)(i) or (A)(ii)(II)(aa) in an application 

20 for initial approval of a drug and there is a dis21 pute about the strategy, the applicant shall use 

22 the major dispute resolution procedures as set 

23 forth in the letters described in section 735(a). 

24 ‘‘(G) DISPUTE RESOLUTION IN ALL OTHER

25 CASES.—
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1 ‘‘(i) REQUEST FOR REVIEW.—In any 

2 case other than a submission under sub3 paragraph (A)(i) or (A)(ii)(II)(aa) in an 

4 application for initial approval of a drug if 

5 there is a dispute about the strategy, not 

6 earlier than 15 days, and not later than 35 

7 days, after discussions under subparagraph 

8 (D) have begun, the applicant shall request 

9 in writing that the dispute be reviewed by 

10 the Drug Safety Oversight Board. 

11 ‘‘(ii) SCHEDULING REVIEW.—If the 

12 applicant requests review under clause (i), 

13 the Secretary—

14 ‘‘(I)(aa) shall schedule the dis15 pute for review at 1 of the next 2 reg16 ular meetings of the Drug Safety 

17 Oversight Board, whichever meeting 

18 date is more practicable; or 

19 ‘‘(bb) may convene a special 

20 meeting of the Drug Safety Oversight 

21 Board to review the matter more 

22 promptly, including to meet an action 

23 deadline on an application (including 

24 a supplemental application); 
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1 ‘‘(II) shall give advance notice to 

2 the public through the Federal Reg3 ister and on the Internet website of 

4 the Food and Drug Administration—

5 ‘‘(aa) that the drug is to be 

6 discussed by the Drug Safety 

7 Oversight Board; and 

8 ‘‘(bb) of the date on which 

9 the Drug Safety Oversight Board 

10 shall discuss such drug; and 

11 ‘‘(III) shall apply section 301(j), 

12 section 552 of title 5, and section 

13 1905 of title 18, United States Code, 

14 to any request for information about 

15 such review. 

16 ‘‘(iii) AGREEMENT AFTER DISCUSSION

17 OR ADMINISTRATIVE APPEALS.—

18 ‘‘(I) FURTHER DISCUSSION OR

19 ADMINISTRATIVE APPEALS.—A re20 quest for review under clause (i) shall 

21 not preclude—

22 ‘‘(aa) further discussions to 

23 reach agreement on the risk eval24 uation and mitigation strategy; 

25 or 
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1 ‘‘(bb) the use of administra2 tive appeals within the Food and 

3 Drug Administration to reach 

4 agreement on the strategy, in5 cluding the major dispute resolu6 tion procedures as set forth in 

7 the letters described in section 

8 735(a). 

9 ‘‘(II) AGREEMENT TERMINATES

10 DISPUTE RESOLUTION.—At any time 

11 before a decision and order is issued 

12 under clause (vi), the Secretary (act13 ing through the offices described in 

14 subparagraph (A)(ii)(I)) and the ap15 plicant may reach an agreement on 

16 the risk evaluation and mitigation 

17 strategy through further discussion or 

18 administrative appeals, terminating 

19 the dispute resolution process, and the 

20 Secretary shall issue an action letter 

21 or order, as appropriate, that de22 scribes the strategy. 

23 ‘‘(iv) MEETING OF THE BOARD.—At 

24 the meeting of the Drug Safety Oversight 
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1 Board described in clause (ii), the Board 

2 shall—

3 ‘‘(I) hear from both parties; and 

4 ‘‘(II) review the dispute. 

5 ‘‘(v) RECOMMENDATION OF THE

6 BOARD.—Not later than 5 days after such 

7 meeting of the Drug Safety Oversight 

8 Board, the Board shall provide a written 

9 recommendation on resolving the dispute 

10 to the Secretary. 

11 ‘‘(vi) ACTION BY THE SECRETARY.—

12 ‘‘(I) ACTION LETTER.—With re13 spect to a proposed risk evaluation 

14 and mitigation strategy submitted 

15 under subparagraph (A)(i) or 

16 (A)(ii)(II)(aa) or to an assessment of 

17 the strategy submitted under subpara18 graph (B)(ii)(I), the Secretary shall 

19 issue an action letter that resolves the 

20 dispute not later than the later of—

21 ‘‘(aa) the action deadline for 

22 the action letter on the applica23 tion; or 
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1 ‘‘(bb) 7 days after receiving 

2 the recommendation of the Drug 

3 Safety Oversight Board. 

4 ‘‘(II) ORDER.—With respect to a 

5 proposed risk evaluation and mitiga6 tion strategy submitted under item 

7 (bb) or (cc) of subparagraph 

8 (A)(ii)(II) or an assessment of the 

9 risk evaluation and mitigation strat10 egy under subparagraph (B)(i) or 

11 under subclause (II), (III), (IV), or 

12 (V) of subparagraph (B)(ii), the Sec13 retary shall issue an order, which 

14 (with the recommendation of the 

15 Drug Safety Oversight Board) shall 

16 be made public, that resolves the dis17 pute not later than 7 days after re18 ceiving the recommendation of the 

19 Drug Safety Oversight Board. 

20 ‘‘(vii) INACTION.—An approved risk 

21 evaluation and mitigation strategy shall re22 main in effect until the Secretary acts, if 

23 the Secretary fails to act as provided for 

24 under clause (vi). 
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1 ‘‘(viii) EFFECT ON ACTION DEAD2 LINE.—With respect to the application or 

3 supplemental application in which a pro4 posed risk evaluation and mitigation strat5 egy is submitted under subparagraph 

6 (A)(i) or (A)(ii)(II)(aa) or in which an as7 sessment of the strategy is submitted 

8 under subparagraph (B)(ii)(I), the Sec9 retary shall be considered to have met the 

10 action deadline for the action letter on 

11 such application if the applicant requests 

12 the dispute resolution process described in 

13 this subparagraph and if the Secretary—

14 ‘‘(I) has initiated the discussions 

15 described under subparagraph (D) by 

16 the target date referred to in subpara17 graph (D)(i); and 

18 ‘‘(II) has complied with the tim19 ing requirements of scheduling review 

20 by the Drug Safety Oversight Board, 

21 providing a written recommendation, 

22 and issuing an action letter under 

23 clauses (ii), (v), and (vi), respectively. 

24 ‘‘(ix) DISQUALIFICATION.—No indi25 vidual who is an employee of the Food and 
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1 Drug Administration and who reviews a 

2 drug or who participated in an administra3 tive appeal under clause (iii)(I) with re4 spect to such drug may serve on the Drug 

5 Safety Oversight Board at a meeting under 

6 clause (iv) to review a dispute about the 

7 risk evaluation and mitigation strategy for 

8 such drug. 

9 ‘‘(x) ADDITIONAL EXPERTISE.—The 

10 Drug Safety Oversight Board may add 

11 members with relevant expertise from the 

12 Food and Drug Administration, including 

13 the Office of Pediatrics, the Office of 

14 Women’s Health, or the Office of Rare 

15 Diseases, or from other Federal public 

16 health or health care agencies, for a meet17 ing under clause (iv) of the Drug Safety 

18 Oversight Board. 

19 ‘‘(H) USE OF ADVISORY COMMITTEES.—

20 The Secretary (acting through the offices de21 scribed in subparagraph (A)(ii)(I)) may convene 

22 a meeting of 1 or more advisory committees of 

23 the Food and Drug Administration to—

24 ‘‘(i) review a concern about the safety 

25 of a drug or class of drugs, including be-
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1 fore an assessment of the risk evaluation 

2 and mitigation strategy or strategies of 

3 such drug or drugs is required to be sub4 mitted under subclause (II), (III), (IV), or 

5 (V) of subparagraph (B)(ii); 

6 ‘‘(ii) review the risk evaluation and 

7 mitigation strategy or strategies of a drug 

8 or group of drugs; or 

9 ‘‘(iii) with the consent of the appli10 cant, review a dispute under subparagraph 

11 (G). 

12 ‘‘(I) PROCESS FOR ADDRESSING DRUG

13 CLASS EFFECTS.—

14 ‘‘(i) IN GENERAL.—When a concern 

15 about a serious risk of a drug may be re16 lated to the pharmacological class of the 

17 drug, the Secretary (acting through the of18 fices described in subparagraph (A)(ii)(I)) 

19 may defer assessments of the approved 

20 risk evaluation and mitigation strategies 

21 for such drugs until the Secretary has—

22 ‘‘(I) convened, after appropriate 

23 public notice, 1 or more public meet24 ings to consider possible responses to 

25 such concern; or 
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1 ‘‘(II) gathered additional infor2 mation or data about such concern. 

3 ‘‘(ii) PUBLIC MEETINGS.—Such public 

4 meetings may include—

5 ‘‘(I) 1 or more meetings of the 

6 applicants for such drugs; 

7 ‘‘(II) 1 or more meetings of 1 or 

8 more advisory committees of the Food 

9 and Drug Administration, as provided 

10 for under subparagraph (H); or 

11 ‘‘(III) 1 or more workshops of 

12 scientific experts and other stake13 holders. 

14 ‘‘(iii) ACTION.—After considering the 

15 discussions from any meetings under 

16 clause (ii), the Secretary may—

17 ‘‘(I) announce in the Federal 

18 Register a planned regulatory action, 

19 including a modification to each risk 

20 evaluation and mitigation strategy, for 

21 drugs in the pharmacological class; 

22 ‘‘(II) seek public comment about 

23 such action; and 
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1 ‘‘(III) after seeking such com2 ment, issue an order addressing such 

3 regulatory action. 

4 ‘‘(J) INTERNATIONAL COORDINATION.—

5 The Secretary (acting through the offices de6 scribed in subparagraph (A)(ii)(I)) may coordi7 nate the timetable for submission of assess8 ments under paragraph (3)(B), a study under 

9 paragraph (4)(B), or a clinical trial under para10 graph (4)(C), with efforts to identify and assess 

11 the serious risks of such drug by the marketing 

12 authorities of other countries whose drug ap13 proval and risk management processes the Sec14 retary deems comparable to the drug approval 

15 and risk management processes of the United 

16 States. 

17 ‘‘(K) EFFECT.—Use of the processes de18 scribed in subparagraphs (I) and (J) shall not 

19 delay action on an application or a supplement 

20 to an application for a drug. 

21 ‘‘(L) NO EFFECT ON LABELING CHANGES

22 THAT DO NOT REQUIRE PREAPPROVAL.—In the 

23 case of a labeling change to which section 

24 314.70 of title 21, Code of Federal Regulations 

25 (or any successor regulation), applies for which 
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1 the submission of a supplemental application is 

2 not required or for which distribution of the 

3 drug involved may commence upon the receipt 

4 by the Secretary of a supplemental application 

5 for the change, the submission of an assessment 

6 of the approved risk evaluation and mitigation 

7 strategy for the drug under this subsection is 

8 not required. 

9 ‘‘(8) DRUG SAFETY OVERSIGHT BOARD.—

10 ‘‘(A) IN GENERAL.—There is established a 

11 Drug Safety Oversight Board. 

12 ‘‘(B) COMPOSITION; MEETINGS.—The 

13 Drug Safety Oversight Board shall—

14 ‘‘(i) be composed of scientists and 

15 health care practitioners appointed by the 

16 Secretary, each of whom is an employee of 

17 the Federal Government; 

18 ‘‘(ii) include representatives from of19 fices throughout the Food and Drug Ad20 ministration (including the offices respon21 sible for postapproval safety of drugs); 

22 ‘‘(iii) include at least 1 representative 

23 each from the National Institutes of 

24 Health, the Department of Health and 

25 Human Services (other than the Food and 
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1 Drug Administration), and the Veterans 

2 Health Administration; and 

3 ‘‘(iv) meet at least monthly to provide 

4 oversight and advice to the Secretary on 

5 the management of important drug safety 

6 issues. 

7 ‘‘(9) CIVIL MONETARY PENALTY.—Notwith8 standing any other provision of this Act, an appli9 cant (as such term is defined for purposes of this 

10 section) that knowingly fails to comply with a re11 quirement of an approved risk evaluation and miti12 gation strategy under this subsection shall be subject 

13 to a civil money penalty of $250,000 for the first 

14 30-day period that the applicant is in noncompli15 ance, and such amount shall double for every 30-day 

16 period thereafter that the requirement is not com17 plied with, not to exceed $2,000,000.’’. 

18 SEC. 203. ENFORCEMENT. 

19 (a) MISBRANDING.—Section 502 of the Federal 

20 Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amend21 ed by adding at the end the following: 

22 ‘‘(x) If it is a drug subject to an approved risk evalua23 tion and mitigation strategy under section 505(o) and the 

24 applicant for such drug fails to—
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1 ‘‘(1) make a labeling change required by such 

2 strategy after the Secretary has approved such strat3 egy or completed review of, and acted on, an assess4 ment of such strategy under paragraph (7) of such 

5 section; or 

6 ‘‘(2) comply with a requirement of such strat7 egy with respect to advertising as provided for under 

8 subparagraph (D), (E), or (F) of paragraph (5) of 

9 such section.’’. 

10 (b) CIVIL PENALTIES.—Section 303(f) of the Federal 

11 Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)) is 

12 amended—

13 (1) by redesignating paragraphs (3), (4), and 

14 (5) as paragraphs (4), (5), and (6), respectively; 

15 (2) by inserting after paragraph (2) the fol16 lowing: 

17 ‘‘(3) An applicant (as such term is used in sec18 tion 505(o)) who knowingly fails to comply with a 

19 requirement of an approved risk evaluation and miti20 gation strategy under such section 505(o) shall be 

21 subject to a civil money penalty of not less than 

22 $15,000 and not more than $250,000 per violation, 

23 and not to exceed $1,000,000 for all such violations 

24 adjudicated in a single proceeding.’’; 
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1 (3) in paragraph (2)(C), by striking ‘‘paragraph 

2 (3)(A)’’ and inserting ‘‘paragraph (4)(A)’’; 

3 (4) in paragraph (4), as so redesignated, by 

4 striking ‘‘paragraph (1) or (2)’’ each place it ap5 pears and inserting ‘‘paragraph (1), (2), or (3)’’; 

6 and 

7 (5) in paragraph (6), as so redesignated, by 

8 striking ‘‘paragraph (4)’’ each place it appears and 

9 inserting ‘‘paragraph (5)’’. 

10 SEC. 204. REGULATION OF DRUGS THAT ARE BIOLOGICAL 

11 PRODUCTS. 

12 Section 351 of the Public Health Service Act (42 

13 U.S.C. 262) is amended—

14 (1) in subsection (a)(2), by adding at the end 

15 the following: 

16 ‘‘(D) RISK EVALUATION AND MITIGATION STRAT17 EGY.—A person that submits an application for a license 

18 for a drug under this paragraph may submit to the Sec19 retary as part of the application a proposed risk evaluation 

20 and mitigation strategy as described under section 505(o) 

21 of the Federal Food, Drug, and Cosmetic Act.’’; and 

22 (2) in subsection (j), by inserting ‘‘, including 

23 the requirements under section 505(o) of such Act,’’ 

24 after ‘‘, and Cosmetic Act’’. 
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1 SEC. 205. NO EFFECT ON WITHDRAWAL OR SUSPENSION OF 

2 APPROVAL. 

3 Section 505(e) of the Federal Food, Drug, and Cos4 metic Act (21 U.S.C. 355(e)) is amended by adding at 

5 the end the following: ‘‘The Secretary may withdraw the 

6 approval of an application submitted under this section, 

7 or suspend the approval of such an application, as pro8 vided under this subsection, without first ordering the ap9 plicant to submit an assessment of the approved risk eval10 uation and mitigation strategy for the drug under sub11 section (o)(7)(B)(ii)(V).’’. 

12 SEC. 206. DRUGS SUBJECT TO AN ABBREVIATED NEW DRUG 

13 APPLICATION. 

14 Section 505(j)(2) of the Federal Food, Drug, and 

15 Cosmetic Act (21 U.S.C. 355(j)(2)) is amended by adding 

16 at the end the following: 

17 ‘‘(E) RISK EVALUATION AND MITIGATION STRATEGY

18 REQUIREMENT.—

19 ‘‘(i) IN GENERAL.—A drug that is the subject 

20 of an abbreviated new drug application under this 

21 subsection shall be subject to only the following ele22 ments of the approved risk evaluation and mitigation 

23 strategy if required under subsection (o) for the ap24 plicable listed drug: 

25 ‘‘(I) Labeling, as required under subsection 

26 (o)(3)(A) for the applicable listed drug. 
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1 ‘‘(II) A Medication Guide or patient pack2 age insert, if required under subsection 

3 (o)(5)(B) for the applicable listed drug. 

4 ‘‘(III) Prereview of advertising, if required 

5 under subsection (o)(5)(D) for the applicable 

6 listed drug. 

7 ‘‘(IV) Specific disclosures in advertising, if 

8 required under subsection (o)(5)(E) for the ap9 plicable listed drug. 

10 ‘‘(V) Elements to assure safe use, if re11 quired under subsection (o)(6) for the applica12 ble listed drug, except that such drug may use 

13 a different, comparable aspect of such elements 

14 as are necessary to assure safe use of such drug 

15 if—

16 ‘‘(aa) the corresponding aspect of the 

17 elements to assure safe use for the applica18 ble listed drug is claimed by a patent that 

19 has not expired or is a method or process 

20 that as a trade secret is entitled to protec21 tion; and 

22 ‘‘(bb) the applicant certifies that it 

23 has sought a license for use of such aspect 

24 of the elements to assure safe use for the 

25 applicable listed drug. 
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1 ‘‘(ii) ACTION BY SECRETARY.—For an applica2 ble listed drug for which a drug is approved under 

3 this subsection, the Secretary—

4 ‘‘(I) shall undertake any communication 

5 plan to health care providers required under 

6 section (o)(5)(C) for the applicable listed drug; 

7 ‘‘(II) shall conduct, or contract for, any 

8 postapproval study required under subsection 

9 (o)(4)(B) for the applicable listed drug; 

10 ‘‘(III) shall inform the applicant for a drug 

11 approved under this subsection if the approved 

12 risk evaluation and mitigation strategy for the 

13 applicable listed drug is modified; and 

14 ‘‘(IV) in order to minimize the burden on 

15 the health care delivery system of different ele16 ments to assure safe use for the drug approved 

17 under this subsection and the applicable listed 

18 drug, may seek to negotiate a voluntary agree19 ment with the owner of the patent, method, or 

20 process for a license under which the applicant 

21 for such drug may use an aspect of the ele22 ments to assure safe use, if required under sub23 section (o)(6) for the applicable listed drug, 

24 that is claimed by a patent that has not expired 
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1 or is a method or process that as a trade secret 

2 is entitled to protection.’’. 

3 SEC. 207. RESOURCES. 

4 (a) USER FEES.—Subparagraph (F) of section 

5 735(d)(6) of the Federal Food, Drug, and Cosmetic Act 

6 (21 U.S.C. 379g(d)(6)), as amended by section 103, is 

7 amended—

8 (1) in clause (ii), by striking ‘‘systems); and’’ 

9 and inserting ‘‘systems);’’

10 (2) in clause (iii), by striking ‘‘bases).’’ and in11 serting ‘‘bases); and’’; and 

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

13 ‘‘(iv) reviewing, implementing, and en14 suring compliance with risk evaluation and 

15 mitigation strategies.’’. 

16 (b) ADDITIONAL FEE REVENUES FOR DRUG SAFE17 TY.—Section 736 of the Federal Food, Drug, and Cos18 metic Act (21 U.S.C. 379h), as amended by section 103, 

19 is amended by—

20 (1) striking the subsection designation and all 

21 that follows through ‘‘.—Except’’ and inserting the 

22 following: 

23 ‘‘(b) FEE REVENUE AMOUNTS.—

24 ‘‘(1) IN GENERAL.—Except’’; and 

25 (2) adding at the end the following: 
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1 ‘‘(2) ADDITIONAL FEE REVENUES FOR DRUG

2 SAFETY.—

3 ‘‘(A) IN GENERAL.—Subject to subpara4 graph (C), in each of fiscal years 2008 through 

5 2012, paragraph (1) shall be applied by sub6 stituting the amount determined under sub7 paragraph (B) for ‘$392,783,000’. 

8 ‘‘(B) AMOUNT DETERMINED.—For any fis9 cal year 2008 through 2012, the amount deter10 mined under this subparagraph is the sum of—

11 ‘‘(i) $392,783,000; plus 

12 ‘‘(ii) the amount equal to—

13 ‘‘(I)(aa) for fiscal year 2008, 

14 $25,000,000; 

15 ‘‘(bb) for fiscal year 2009, 

16 $35,000,000; 

17 ‘‘(cc) for fiscal year 2010, 

18 $45,000,000; 

19 ‘‘(dd) for fiscal year 2011, 

20 $55,000,000; and 

21 ‘‘(ee) for fiscal year 2012, 

22 $65,000,000; minus 

23 ‘‘(II) the amount equal to one-fifth of 

24 the excess amount in item (bb), provided 

25 that—
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1 ‘‘(aa) the amount of the total ap2 propriation for the Food and Drug 

3 Administration for such fiscal year 

4 (excluding the amount of fees appro5 priated for such fiscal year) exceeds 

6 the amount of the total appropriation 

7 for the Food and Drug Administra8 tion for fiscal year 2007 (excluding 

9 the amount of fees appropriated for 

10 such fiscal year), adjusted as provided 

11 under subsection (c)(1); and 

12 ‘‘(bb) the amount of the total ap13 propriations for the process of human 

14 drug review at the Food and Drug 

15 Administration for such fiscal year 

16 (excluding the amount of fees appro17 priated for such fiscal year) exceeds 

18 the amount of appropriations for the 

19 process of human drug review at the 

20 Food and Drug Administration for 

21 fiscal year 2007 (excluding the 

22 amount of fees appropriated for such 

23 fiscal year), adjusted as provided 

24 under subsection (c)(1). 
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1 In making the adjustment under subclause 

2 (II) for any fiscal year 2008 through 2012, 

3 subsection (c)(1) shall be applied by sub4 stituting ‘2007’ for ‘2008.’

5 ‘‘(C) LIMITATION.—This paragraph shall 

6 not apply for any fiscal year if the amount de7 scribed under subparagraph (B)(ii) is less than 

8 0.’’. 

9 (c) STRATEGIC PLAN FOR INFORMATION TECH10 NOLOGY.—Not later than 1 year after the date of enact11 ment of this title, the Secretary of Health and Human 

12 Services (referred to in this title as the ‘‘Secretary’’) shall 

13 submit to the Committee on Health, Education, Labor, 

14 and Pensions and the Committee on Appropriations of the 

15 Senate and the Committee on Energy and Commerce and 

16 the Committee on Appropriations of the House of Rep17 resentatives, a strategic plan on information technology 

18 that includes—

19 (1) an assessment of the information technology 

20 infrastructure, including systems for data collection, 

21 access to data in external health care databases, 

22 data mining capabilities, personnel, and personnel 

23 training programs, needed by the Food and Drug 

24 Administration to—
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1 (A) comply with the requirements of this 

2 subtitle (and the amendments made by this 

3 subtitle); 

4 (B) achieve interoperability within and 

5 among the centers of the Food and Drug Ad6 ministration and between the Food and Drug 

7 Administration and product application spon8 sors; 

9 (C) utilize electronic health records; 

10 (D) implement routine active surveillance 

11 under section 505(k)(3) (including complemen12 tary approaches under subsection (c) of such 

13 section) of the Federal Food, Drug, and Cos14 metic Act, as added by section 201 of this Act; 

15 and 

16 (E) communicate drug safety information 

17 to physicians and other health care providers; 

18 (2) an assessment of the extent to which the 

19 current information technology assets of the Food 

20 and Drug Administration are sufficient to meet the 

21 needs assessments under paragraph (1); 

22 (3) a plan for enhancing the information tech23 nology assets of the Food and Drug Administration 

24 toward meeting the needs assessments under para25 graph (1); and 
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1 (4) an assessment of additional resources need2 ed to so enhance the information technology assets 

3 of the Food and Drug Administration. 

4 SEC. 208. SAFETY LABELING CHANGES. 

5 (a) IN GENERAL.—Subchapter A of chapter V of the 

6 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 

7 et seq.) is amended by inserting after section 506C the 

8 following: 

9 ‘‘SEC. 506D. SAFETY LABELING CHANGES. 

10 ‘‘(a) NEW SAFETY INFORMATION.—

11 ‘‘(1) NOTIFICATION.—The holder of an ap12 proved application under section 505 of this Act or 

13 a license under section 351 of the Public Health 

14 Service Act (referred to in this section as a ‘holder’) 

15 shall promptly notify the Secretary if the holder be16 comes aware of new safety information that the 

17 holder believes should be included in the labeling of 

18 the drug. The Secretary shall promptly notify the 

19 holder if the Secretary becomes aware of new safety 

20 information that the Secretary believes should be in21 cluded in the labeling of the drug. 

22 ‘‘(2) DISCUSSION REGARDING LABELING

23 CHANGES.—Following notification pursuant to para24 graph (1), the Secretary and holder shall initiate 

25 discussions of the new safety information in order to 
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1 reach agreement on whether the labeling for the 

2 drug should be modified to reflect the new safety in3 formation and, if so, on the contents of such labeling 

4 changes. 

5 ‘‘(3) SUPPLEMENT.—If the Secretary deter6 mines that there is reasonable scientific evidence 

7 that an adverse event is associated with use of the 

8 drug, the Secretary may request the holder to sub9 mit a supplement to an application under section 

10 505 of this Act or to a license under section 351 of 

11 the Public Health Service Act (referred to in this 

12 section as a ‘supplement’) proposing changes to the 

13 approved labeling to reflect the new safety informa14 tion, including changes to boxed warnings, contra15 indications, warnings, precautions, or adverse reac16 tions (referred to in this section as a ‘safety labeling 

17 change’). If the Secretary determines that no safety 

18 labeling change is necessary or appropriate based 

19 upon the new safety information, the Secretary shall 

20 notify the holder of this determination in writing. 

21 ‘‘(b) LABELING SUPPLEMENTS.—

22 ‘‘(1) IN GENERAL.—The holder shall submit a 

23 supplement whenever the holder seeks, either at the 

24 holder’s own initiative or at the request of the Sec25 retary, to make a safety labeling change. 
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1 ‘‘(2) NONACCELERATED PROCESS.—Unless the 

2 accelerated labeling review process described in sub3 section (c) is initiated, any supplement proposing a 

4 safety labeling change shall be reviewed and acted 

5 upon by the Secretary not later than 30 days after 

6 the date the Secretary receives the supplement. 

7 Until the Secretary acts on such a supplement pro8 posing a safety labeling change, the existing ap9 proved labeling shall remain in effect and be distrib10 uted by the holder without change. 

11 ‘‘(3) NEW SAFETY INFORMATION.—Nothing in 

12 this section shall prohibit the Secretary from inform13 ing health care professionals or the public about new 

14 safety information prior to approval of a supplement 

15 proposing a safety labeling change. 

16 ‘‘(c) ACCELERATED LABELING REVIEW PROCESS.—

17 An accelerated labeling review process shall be available 

18 to resolve disagreements in a timely manner between the 

19 Secretary and a holder about the need for, or content of, 

20 a safety labeling change, as follows: 

21 ‘‘(1) REQUEST TO INITIATE ACCELERATED

22 PROCESS.—The accelerated labeling review process 

23 shall be initiated upon the written request of either 

24 the Secretary or the holder. Such request may be 

25 made at any time after the notification described in 
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1 subsection (a)(1), including during the Secretary’s 

2 review of a supplement proposing a safety labeling 

3 change. 

4 ‘‘(2) SCIENTIFIC DISCUSSION AND MEETINGS.—

5 ‘‘(A) IN GENERAL.—Following initiation of 

6 the accelerated labeling review process, the Sec7 retary and holder shall immediately initiate dis8 cussions to review and assess the new safety in9 formation and to reach agreement on whether 

10 safety labeling changes are necessary and ap11 propriate and, if so, the content of such safety 

12 labeling changes. 

13 ‘‘(B) TIME PERIOD.—The discussions 

14 under this paragraph shall not extend for more 

15 than 45 calendar days after the initiation of the 

16 accelerated labeling review process. 

17 ‘‘(C) DISPUTE PROCEEDINGS.—If the Sec18 retary and holder do not reach an agreement 

19 regarding the safety labeling changes by not 

20 later than 25 calendar days after the initiation 

21 of the accelerated labeling review process, the 

22 dispute automatically shall be referred to the 

23 director of the drug evaluation office respon24 sible for the drug under consideration, who 
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1 shall be required to take an active role in such 

2 discussions. 

3 ‘‘(3) REQUEST FOR SAFETY LABELING CHANGE

4 AND FAILURE TO AGREE.—If the Secretary and 

5 holder fail to reach an agreement on appropriate 

6 safety labeling changes by not later than 45 calendar 

7 days after the initiation of the accelerated labeling 

8 review process—

9 ‘‘(A) on the next calendar day (other than 

10 a weekend or Federal holiday) after such pe11 riod, the Secretary shall—

12 ‘‘(i) request in writing that the holder 

13 make any safety labeling change that the 

14 Secretary determines to be necessary and 

15 appropriate based upon the new safety in16 formation; or 

17 ‘‘(ii) notify the holder in writing that 

18 the Secretary has determined that no safe19 ty labeling change is necessary or appro20 priate; and 

21 ‘‘(B) if the Secretary fails to act within the 

22 specified time, or if the holder does not agree 

23 to make a safety labeling change requested by 

24 the Secretary or does not agree with the Sec25 retary’s determination that no labeling change 
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1 is necessary or appropriate, the Secretary (on 

2 his own initiative or upon request by the hold3 er) shall refer the matter for expedited review 

4 to the Drug Safety Oversight Board. 

5 ‘‘(4) ACTION BY THE DRUG SAFETY OVERSIGHT

6 BOARD.—Not later than 45 days after receiving a 

7 referral under paragraph (3)(B), the Drug Safety 

8 Oversight Board shall—

9 ‘‘(A) review the new safety information; 

10 ‘‘(B) review all written material submitted 

11 by the Secretary and the holder; 

12 ‘‘(C) convene a meeting to hear oral pres13 entations and arguments from the Secretary 

14 and holder; and 

15 ‘‘(D) make a written recommendation to 

16 the Secretary—

17 ‘‘(i) concerning appropriate safety la18 beling changes, if any; or 

19 ‘‘(ii) stating that no safety labeling 

20 changes are necessary or appropriate based 

21 upon the new safety information. 

22 ‘‘(5) CONSIDERATION OF RECOMMENDA23 TIONS.—

24 ‘‘(A) ACTION BY THE SECRETARY.—The 

25 Secretary shall consider the recommendation of 
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1 the Drug Safety Oversight Board made under 

2 paragraph (4)(D) and, not later than 20 days 

3 after receiving the recommendation—

4 ‘‘(i) issue an order requiring the hold5 er to make any safety labeling change that 

6 the Secretary determines to be necessary 

7 and appropriate; or 

8 ‘‘(ii) if the Secretary determines that 

9 no safety labeling change is necessary or 

10 appropriate, the Secretary shall notify the 

11 holder of this determination in writing. 

12 ‘‘(B) FAILURE TO ACT.—If the Secretary 

13 fails to act by not later than 20 days after re14 ceiving the recommendation of the Drug Safety 

15 Oversight Board, the written recommendation 

16 of the Drug Safety Oversight Board shall be 

17 considered the order of the Secretary under this 

18 paragraph. 

19 ‘‘(C) NONDELEGATION.—The Secretary’s 

20 authority under this paragraph shall not be re21 delegated to an individual below the level of the 

22 Director of the Center for Drug Evaluation and 

23 Research, or the Director of the Center for Bio24 logics Evaluation and Research, of the Food 

25 and Drug Administration. 
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1 ‘‘(6) MISBRANDING.—If the holder, not later 

2 than 10 days after receiving an order under sub3 paragraph (A) or (B) of paragraph (5), does not 

4 agree to make a safety labeling change ordered by 

5 the Secretary, the Secretary may deem the drug that 

6 is the subject of the request to be misbranded. 

7 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec8 tion shall be construed to change the standards in exist9 ence on the date of enactment of this section for deter10 mining whether safety labeling changes are necessary or 

11 appropriate.’’. 

12 (b) CONFORMING AMENDMENT.—Section 502 of the 

13 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352 

14 et seq.), as amended by section 203, is further amended 

15 by adding at the end the following: 

16 ‘‘(y) If it is a drug and the holder does not agree 

17 to make a safety labeling change ordered by the Secretary 

18 under section 506D(c) within 10 days after issuance of 

19 such an order.’’. 

20 SEC. 209. POSTMARKET DRUG SAFETY INFORMATION FOR 

21 PATIENTS AND PROVIDERS. 

22 Section 505 of the Federal Food, Drug, and Cosmetic 

23 Act (21 U.S.C. 355), as amended by section 251, is 

24 amended by adding at the end the following: 
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1 ‘‘(r) POSTMARKET DRUG SAFETY INFORMATION FOR

2 PATIENTS AND PROVIDERS.—

3 ‘‘(1) ESTABLISHMENT.—Not later than 1 year 

4 after the date of enactment of the Enhancing Drug 

5 Safety and Innovation Act of 2007, the Secretary 

6 shall improve the transparency of pharmaceutical 

7 data and allow patients and health care providers 

8 better access to pharmaceutical data by developing 

9 and maintaining an Internet website that—

10 ‘‘(A) provides comprehensive drug safety 

11 information for prescription drugs that are ap12 proved by the Secretary under this section or li13 censed under section 351 of the Public Health 

14 Service Act; and 

15 ‘‘(B) improves communication of drug 

16 safety information to patients and providers. 

17 ‘‘(2) INTERNET WEBSITE.—The Secretary shall 

18 carry out paragraph (1) by—

19 ‘‘(A) developing and maintaining an acces20 sible, consolidated Internet website with easily 

21 searchable drug safety information, including 

22 the information found on United States Govern23 ment Internet websites, such as the United 

24 States National Library of Medicine’s Daily 

25 Med and Medline Plus websites, in addition to 
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1 other such websites maintained by the Sec2 retary; 

3 ‘‘(B) ensuring that the information pro4 vided on the Internet website is comprehensive 

5 and includes, when available and appropriate—

6 ‘‘(i) patient labeling and patient pack7 aging inserts; 

8 ‘‘(ii) a link to a list of each drug, 

9 whether approved under this section or li10 censed under such section 351, for which 

11 a Medication Guide, as provided for under 

12 part 208 of title 21, Code of Federal Regu13 lations (or any successor regulations), is 

14 required; 

15 ‘‘(iii) a link to the clinical trial reg16 istry data bank provided for under sub17 sections (i) and (j) of section 402 of the 

18 Public Health Service Act; 

19 ‘‘(iv) the most recent safety informa20 tion and alerts issued by the Food and 

21 Drug Administration for drugs approved 

22 by the Secretary under this section, such 

23 as product recalls, warning letters, and im24 port alerts; 
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1 ‘‘(v) publicly available information 

2 about implemented RiskMAPs and risk 

3 evaluation and mitigation strategies under 

4 subsection (o); 

5 ‘‘(vi) guidance documents and regula6 tions related to drug safety; and 

7 ‘‘(vii) other material determined ap8 propriate by the Secretary; 

9 ‘‘(C) including links to non-Food and Drug 

10 Administration Internet resources that provide 

11 access to relevant drug safety information, such 

12 as medical journals and studies; 

13 ‘‘(D) providing access to summaries of the 

14 assessed and aggregated data collected from the 

15 active surveillance infrastructure under sub16 section (k)(3) to provide information of known 

17 and serious side-effects for drugs approved by 

18 the Secretary under this section or licensed 

19 under such section 351; 

20 ‘‘(E) enabling patients, providers, and 

21 drug sponsors to submit adverse event reports 

22 through the Internet website; 

23 ‘‘(F) providing educational materials for 

24 patients and providers about the appropriate 
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1 means of disposing of expired, damaged, or un2 usable medications; and 

3 ‘‘(G) supporting initiatives that the Sec4 retary determines to be useful to fulfill the pur5 poses of the Internet website. 

6 ‘‘(3) POSTING OF DRUG LABELING.—The Sec7 retary shall post on the Internet website established 

8 under paragraph (1) the approved professional label9 ing and any required patient labeling of a drug ap10 proved under this section or licensed under such sec11 tion 351 not later than 21 days after the date the 

12 drug is approved or licensed, including in a supple13 mental application with respect to a labeling change. 

14 ‘‘(4) PRIVATE SECTOR RESOURCES.—To ensure 

15 development of the Internet website by the date de16 scribed in paragraph (1), the Secretary may, on a 

17 temporary or permanent basis, implement systems 

18 or products developed by private entities. 

19 ‘‘(5) AUTHORITY FOR CONTRACTS.—The Sec20 retary may enter into contracts with public and pri21 vate entities to fulfill the requirements of this sub22 section. 

23 ‘‘(6) REVIEW.—The Advisory Committee on 

24 Risk Communication under section 566 shall, on a 

25 regular basis, perform a comprehensive review and 
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1 evaluation of the types of risk communication infor2 mation provided on the Internet website established 

3 under paragraph (1) and, through other means, 

4 shall identify, clarify, and define the purposes and 

5 types of information available to facilitate the effi6 cient flow of information to patients and providers, 

7 and shall recommend ways for the Food and Drug 

8 Administration to work with outside entities to help 

9 facilitate the dispensing of risk communication infor10 mation to patients and providers.’’. 

11 SEC. 210. ACTION PACKAGE FOR APPROVAL. 

12 Section 505(l) of the Federal Food, Drug, and Cos13 metic Act (21 U.S.C. 355(l)) is amended by—

14 (1) redesignating paragraphs (1), (2), (3), (4), 

15 and (5) as subparagraphs (A), (B), (C), (D), and 

16 (E), respectively; 

17 (2) striking ‘‘(l) Safety and’’ and inserting 

18 ‘‘(l)(1) Safety and’’; and 

19 (3) adding at the end the following: 

20 ‘‘(2) ACTION PACKAGE FOR APPROVAL.—

21 ‘‘(A) ACTION PACKAGE.—The Secretary shall 

22 publish the action package for approval of an appli23 cation under subsection (b) or section 351 of the 

24 Public Health Service Act on the Internet website of 

25 the Food and Drug Administration—
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1 ‘‘(i) not later than 30 days after the date 

2 of approval of such application for a drug no 

3 active ingredient (including any ester or salt of 

4 the active ingredient) of which has been ap5 proved in any other application under this sec6 tion or section 351 of the Public Health Service 

7 Act; and 

8 ‘‘(ii) not later than 30 days after the third 

9 request for such action package for approval re10 ceived under section 552 of title 5, United 

11 States Code, for any other drug. 

12 ‘‘(B) IMMEDIATE PUBLICATION OF SUMMARY

13 REVIEW.—Notwithstanding subparagraph (A), the 

14 Secretary shall publish, on the Internet website of 

15 the Food and Drug Administration, the materials 

16 described in subparagraph (C)(iv) not later than 48 

17 hours after the date of approval of the drug, except 

18 where such materials require redaction by the Sec19 retary. 

20 ‘‘(C) CONTENTS.—An action package for ap21 proval of an application under subparagraph (A) 

22 shall be dated and shall include the following: 

23 ‘‘(i) Documents generated by the Food and 

24 Drug Administration related to review of the 

25 application. 
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1 ‘‘(ii) Documents pertaining to the format 

2 and content of the application generated during 

3 drug development. 

4 ‘‘(iii) Labeling submitted by the applicant. 

5 ‘‘(iv) A summary review that documents 

6 conclusions from all reviewing disciplines about 

7 the drug, noting any critical issues and dis8 agreements with the applicant and how they 

9 were resolved, recommendation for action, and 

10 an explanation of any nonconcurrence with re11 view conclusions. 

12 ‘‘(v) If applicable, a separate review from 

13 a supervisor who does not concur with the sum14 mary review. 

15 ‘‘(vi) Identification by name of each officer 

16 or employee of the Food and Drug Administra17 tion who—

18 ‘‘(I) participated in the decision to ap19 prove the application; and 

20 ‘‘(II) consents to have his or her name 

21 included in the package. 

22 ‘‘(D) DISAGREEMENTS.—A scientific review of 

23 an application is considered the work of the reviewer 

24 and shall not be altered by management or the re25 viewer once final. Disagreements by team leaders, 
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1 division directors, or office directors with any or all 

2 of the major conclusions of a reviewer shall be docu3 ment in a separate review or in an addendum to the 

4 review. 

5 ‘‘(E) CONFIDENTIAL INFORMATION.—This 

6 paragraph does not authorize the disclosure of any 

7 trade secret or confidential commercial or financial 

8 information described in section 552(b)(4) of title 5, 

9 United States Code, unless the Secretary declares an 

10 emergency under section 319 of the Public Health 

11 Service Act and such disclosure is necessary to miti12 gate the effects of such emergency.’’. 

13 SEC. 211. RISK COMMUNICATION. 

14 Subchapter E of chapter V of the Federal Food, 

15 Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is 

16 amended by adding at the end the following: 

17 ‘‘SEC. 566. RISK COMMUNICATION. 

18 ‘‘(a) ADVISORY COMMITTEE ON RISK COMMUNICA19 TION.—

20 ‘‘(1) IN GENERAL.—The Secretary shall estab21 lish an advisory committee to be known as the ‘Advi22 sory Committee on Risk Communication’ (referred 

23 to in this section as the ‘Committee’). 

24 ‘‘(2) DUTIES OF COMMITTEE.—The Committee 

25 shall advise the Commissioner on methods to effec-
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1 tively communicate risks associated with the prod2 ucts regulated by the Food and Drug Administra3 tion. 

4 ‘‘(3) MEMBERS.—The Secretary shall ensure 

5 that the Committee is composed of experts on risk 

6 communication, experts on the risks described in 

7 subsection (b), and representatives of patient, con8 sumer, and health professional organizations. 

9 ‘‘(4) PERMANENCE OF COMMITTEE.—Section 

10 14 of the Federal Advisory Committee Act shall not 

11 apply to the Committee established under this sub12 section. 

13 ‘‘(b) PARTNERSHIPS FOR RISK COMMUNICATION.—

14 ‘‘(1) IN GENERAL.—The Secretary shall partner 

15 with professional medical societies, medical schools, 

16 academic medical centers, and other stakeholders to 

17 develop robust and multi-faceted systems for com18 munication to health care providers about emerging 

19 postmarket drug risks. 

20 ‘‘(2) PARTNERSHIPS.—The systems developed 

21 under paragraph (1) shall—

22 ‘‘(A) account for the diversity among phy23 sicians in terms of practice, affinity for tech24 nology, and focus; and 
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1 ‘‘(B) include the use of existing commu2 nication channels, including electronic commu3 nications, in place at the Food and Drug Ad4 ministration.’’. 

5 SEC. 212. REFERRAL TO ADVISORY COMMITTEE. 

6 Section 505 of the Federal Food, Drug, and Cosmetic 

7 Act, as amended by section 202, is further amended by 

8 adding at the end the following: 

9 ‘‘(p) REFERRAL TO ADVISORY COMMITTEE.—

10 ‘‘(1) IN GENERAL.—Prior to the approval of a 

11 drug no active ingredient (including any ester or salt 

12 of the active ingredient) of which has been approved 

13 in any other application under this section or section 

14 351 of the Public Health Service Act, the Secretary 

15 shall refer such drug to a Food and Drug Adminis16 tration advisory committee for review at a meeting 

17 of such advisory committee. 

18 ‘‘(2) EXCEPTION.—Notwithstanding paragraph 

19 (1), an advisory committee review of a drug de20 scribed under such paragraph may occur within 1 

21 year after approval of such a drug if—

22 ‘‘(A) the clinical trial that formed the pri23 mary basis of the safety and efficacy determina24 tion was halted by a drug safety monitoring 

25 board or an Institutional Review Board before 
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1 its scheduled completion due to early unantici2 pated therapeutic results; or 

3 ‘‘(B) the Secretary determines that it 

4 would be beneficial to the public health.’’. 

5 SEC. 213. RESPONSE TO THE INSTITUTE OF MEDICINE. 

6 (a) IN GENERAL.—Not later than 1 year after the 

7 date of enactment of this title, the Secretary shall issue 

8 a report responding to the 2006 report of the Institute 

9 of Medicine entitled ‘‘The Future of Drug Safety—Pro10 moting and Protecting the Health of the Public’’. 

11 (b) CONTENT OF REPORT.—The report issued by the 

12 Secretary under subsection (a) shall include—

13 (1) an update on the implementation by the 

14 Food and Drug Administration of its plan to re15 spond to the Institute of Medicine report described 

16 under such subsection; and 

17 (2) an assessment of how the Food and Drug 

18 Administration has implemented—

19 (A) the recommendations described in such 

20 Institute of Medicine report; and 

21 (B) the requirement under paragraph (7) 

22 of section 505(o) of the Federal Food, Drug, 

23 and Cosmetic Act (as added by this title), that 

24 the appropriate office responsible for reviewing 

25 a drug and the office responsible for post-
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1 approval safety with respect to the drug act to2 gether to assess, implement, and ensure compli3 ance with the requirements of such section 

4 505(o). 

5 SEC. 214. EFFECTIVE DATE AND APPLICABILITY. 

6 (a) EFFECTIVE DATES.—

7 (1) IN GENERAL.—Except as provided in para8 graph (2), this subtitle shall take effect 180 days 

9 after the date of enactment of this title. 

10 (2) USER FEES.—The amendments made by 

11 subsections (a) through (c) of section 207 shall take 

12 effect on October 1, 2007. 

13 (b) DRUGS DEEMED TO HAVE RISK EVALUATION

14 AND MITIGATION STRATEGIES.—

15 (1) IN GENERAL.—A drug that was approved 

16 before the effective date of this subtitle shall be 

17 deemed to have an approved risk evaluation and 

18 mitigation strategy under section 505(o) of the Fed19 eral Food, Drug, and Cosmetic Act (as added by 

20 this subtitle) if there are in effect on the effective 

21 date of this subtitle restrictions on distribution or 

22 use—

23 (A) required under section 314.520 or sec24 tion 601.42 of title 21, Code of Federal Regula25 tions; or 
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1 (B) otherwise agreed to by the applicant 

2 and the Secretary for such drug. 

3 (2) RISK EVALUATION AND MITIGATION STRAT4 EGY.—The approved risk evaluation and mitigation 

5 strategy deemed in effect for a drug under para6 graph (1) shall consist of the elements described in 

7 subparagraphs (A) and (B) of paragraph (3) of such 

8 section 505(o) and any other additional elements 

9 under paragraphs (4), (5), and (6) in effect for such 

10 drug on the effective date of this subtitle. 

11 (3) NOTIFICATION.—Not later than 30 days 

12 after the effective date of this subtitle, the Secretary 

13 shall notify the applicant for each drug described in 

14 paragraph (1)—

15 (A) that such drug is deemed to have an 

16 approved risk evaluation and mitigation strat17 egy pursuant to such paragraph; and 

18 (B) of the date, which, unless a safety 

19 issue with the drug arises, shall be no earlier 

20 than 6 months after the applicant is so notified, 

21 by which the applicant shall submit to the Sec22 retary an assessment of such approved strategy 

23 under paragraph (7)(B) of such section 505(o), 

24 except with respect to the drug Mifeprex 

25 (mifepristone), such assessment shall be sub-
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1 mitted 6 months after the applicant is so noti2 fied. 

3 (4) ENFORCEMENT ONLY AFTER ASSESSMENT

4 AND REVIEW.—Neither the Secretary nor the Attor5 ney General may seek to enforce a requirement of a 

6 risk evaluation and mitigation strategy deemed in ef7 fect under paragraph (1) before the Secretary has 

8 completed review of, and acted on, the first assess9 ment of such strategy under such section 505(o). 

10 (c) NO EFFECT ON VETERINARY MEDICINE.—This 

11 subtitle, and the amendments made by this subtitle, shall 

12 have no effect on the use of drugs approved under section 

13 505 of the Federal Food, Drug, and Cosmetic Act by, or 

14 on the lawful written or oral order of, a licensed veteri15 narian within the context of a veterinarian-client-patient 

16 relationship, as provided for under section 512(a)(5) of 

17 such Act. 

18 Subtitle B—Reagan-Udall Founda19 tion for the Food and Drug Ad20 ministration 

21 SEC. 221. THE REAGAN-UDALL FOUNDATION FOR THE 

22 FOOD AND DRUG ADMINISTRATION. 

23 (a) IN GENERAL.—Chapter VII of the Federal Food, 

24 Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amend25 ed by adding at the end the following: 
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1 ‘‘Subchapter I—Reagan-Udall Foundation for 

2 the Food and Drug Administration 

3 ‘‘SEC. 770. ESTABLISHMENT AND FUNCTIONS OF THE FOUN4 DATION. 

5 ‘‘(a) IN GENERAL.—A nonprofit corporation to be 

6 known as the Reagan-Udall Foundation for the Food and 

7 Drug Administration (referred to in this subchapter as the 

8 ‘Foundation’) shall be established in accordance with this 

9 section. The Foundation shall be headed by an Executive 

10 Director, appointed by the members of the Board of Direc11 tors under subsection (e). The Foundation shall not be 

12 an agency or instrumentality of the United States Govern13 ment. 

14 ‘‘(b) PURPOSE OF FOUNDATION.—The purpose of 

15 the Foundation is to advance the mission of the Food and 

16 Drug Administration to modernize medical, veterinary, 

17 food, food ingredient, and cosmetic product development, 

18 accelerate innovation, and enhance product safety. 

19 ‘‘(c) DUTIES OF THE FOUNDATION.—The Founda20 tion shall—

21 ‘‘(1) taking into consideration the Critical Path 

22 reports and priorities published by the Food and 

23 Drug Administration, identify unmet needs in the 

24 development, manufacture, and evaluation of the 

25 safety and effectiveness, including postapproval, of 
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1 devices, including diagnostics, biologics, and drugs, 

2 and the safety of food, food ingredients, and cos3 metics; 

4 ‘‘(2) establish goals and priorities in order to 

5 meet the unmet needs identified in paragraph (1); 

6 ‘‘(3) in consultation with the Secretary, identify 

7 existing and proposed Federal intramural and extra8 mural research and development programs relating 

9 to the goals and priorities established under para10 graph (2), coordinate Foundation activities with 

11 such programs, and minimize Foundation duplica12 tion of existing efforts; 

13 ‘‘(4) award grants to, or enter into contracts, 

14 memoranda of understanding, or cooperative agree15 ments with, scientists and entities, which may in16 clude the Food and Drug Administration, university 

17 consortia, public-private partnerships, institutions of 

18 higher education, entities described in section 

19 501(c)(3) of the Internal Revenue Code (and exempt 

20 from tax under section 501(a) of such Code), and 

21 industry, to efficiently and effectively advance the 

22 goals and priorities established under paragraph (2); 

23 ‘‘(5) recruit meeting participants and hold or 

24 sponsor (in whole or in part) meetings as appro-
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1 priate to further the goals and priorities established 

2 under paragraph (2); 

3 ‘‘(6) release and publish information and data 

4 and, to the extent practicable, license, distribute, 

5 and release material, reagents, and techniques to 

6 maximize, promote, and coordinate the availability of 

7 such material, reagents, and techniques for use by 

8 the Food and Drug Administration, nonprofit orga9 nizations, and academic and industrial researchers 

10 to further the goals and priorities established under 

11 paragraph (2); 

12 ‘‘(7) ensure that—

13 ‘‘(A) action is taken as necessary to obtain 

14 patents for inventions developed by the Founda15 tion or with funds from the Foundation; 

16 ‘‘(B) action is taken as necessary to enable 

17 the licensing of inventions developed by the 

18 Foundation or with funds from the Foundation; 

19 and 

20 ‘‘(C) executed licenses, memoranda of un21 derstanding, material transfer agreements, con22 tracts, and other such instruments, promote, to 

23 the maximum extent practicable, the broadest 

24 conversion to commercial and noncommercial 

25 applications of licensed and patented inventions 
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1 of the Foundation to further the goals and pri2 orities established under paragraph (2); 

3 ‘‘(8) provide objective clinical and scientific in4 formation to the Food and Drug Administration 

5 and, upon request, to other Federal agencies to as6 sist in agency determinations of how to ensure that 

7 regulatory policy accommodates scientific advances 

8 and meets the agency’s public health mission; 

9 ‘‘(9) conduct annual assessments of the unmet 

10 needs identified in paragraph (1); and 

11 ‘‘(10) carry out such other activities consistent 

12 with the purposes of the Foundation as the Board 

13 determines appropriate. 

14 ‘‘(d) BOARD OF DIRECTORS.—

15 ‘‘(1) ESTABLISHMENT.—

16 ‘‘(A) IN GENERAL.—The Foundation shall 

17 have a Board of Directors (referred to in this 

18 subchapter as the ‘Board’), which shall be com19 posed of ex officio and appointed members in 

20 accordance with this subsection. All appointed 

21 members of the Board shall be voting members. 

22 ‘‘(B) EX OFFICIO MEMBERS.—The ex offi23 cio members of the Board shall be the following 

24 individuals or their designees: 

25 ‘‘(i) The Commissioner. 
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1 ‘‘(ii) The Director of the National In2 stitutes of Health. 

3 ‘‘(iii) The Director of the Centers for 

4 Disease Control and Prevention. 

5 ‘‘(iv) The Director of the Agency for 

6 Healthcare Research and Quality. 

7 ‘‘(C) APPOINTED MEMBERS.—

8 ‘‘(i) IN GENERAL.—The ex officio 

9 members of the Board under subparagraph 

10 (B) shall, by majority vote, appoint to the 

11 Board 12 individuals, from a list of can12 didates to be provided by the National 

13 Academy of Sciences. Of such appointed 

14 members—

15 ‘‘(I) 4 shall be representatives of 

16 the general pharmaceutical, device, 

17 food, cosmetic, and biotechnology in18 dustries; 

19 ‘‘(II) 3 shall be representatives of 

20 academic research organizations; 

21 ‘‘(III) 2 shall be representatives 

22 of Government agencies, including the 

23 Food and Drug Administration and 

24 the National Institutes of Health; 
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1 ‘‘(IV) 2 shall be representatives 

2 of patient or consumer advocacy orga3 nizations; and 

4 ‘‘(V) 1 shall be a representative 

5 of health care providers. 

6 ‘‘(ii) REQUIREMENT.—The ex officio 

7 members shall ensure the Board member8 ship includes individuals with expertise in 

9 areas including the sciences of developing, 

10 manufacturing, and evaluating the safety 

11 and effectiveness of devices, including 

12 diagnostics, biologics, and drugs, and the 

13 safety of food, food ingredients, and cos14 metics. 

15 ‘‘(D) INITIAL MEETING.—

16 ‘‘(i) IN GENERAL.—Not later than 30 

17 days after the date of the enactment of the 

18 Enhancing Drug Safety and Innovation 

19 Act of 2007, the Secretary shall convene a 

20 meeting of the ex officio members of the 

21 Board to—

22 ‘‘(I) incorporate the Foundation; 

23 and 
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1 ‘‘(II) appoint the members of the 

2 Board in accordance with subpara3 graph (C). 

4 ‘‘(ii) SERVICE OF EX OFFICIO MEM5 BERS.—Upon the appointment of the 

6 members of the Board under clause (i)(II), 

7 the terms of service of the ex officio mem8 bers of the Board as members of the 

9 Board shall terminate. 

10 ‘‘(iii) CHAIR.—The ex officio members 

11 of the Board under subparagraph (B) shall 

12 designate an appointed member of the 

13 Board to serve as the Chair of the Board. 

14 ‘‘(2) DUTIES OF BOARD.—The Board shall—

15 ‘‘(A) establish bylaws for the Foundation 

16 that—

17 ‘‘(i) are published in the Federal Reg18 ister and available for public comment; 

19 ‘‘(ii) establish policies for the selection 

20 of the officers, employees, agents, and con21 tractors of the Foundation; 

22 ‘‘(iii) establish policies, including eth23 ical standards, for the acceptance, solicita24 tion, and disposition of donations and 

25 grants to the Foundation and for the dis-
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1 position of the assets of the Foundation, 

2 including appropriate limits on the ability 

3 of donors to designate, by stipulation or re4 striction, the use or recipient of donated 

5 funds; 

6 ‘‘(iv) establish policies that would sub7 ject all employees, fellows, and trainees of 

8 the Foundation to the conflict of interest 

9 standards under section 208 of title 18, 

10 United States Code; 

11 ‘‘(v) establish licensing, distribution, 

12 and publication policies that support the 

13 widest and least restrictive use by the pub14 lic of information and inventions developed 

15 by the Foundation or with Foundation 

16 funds to carry out the duties described in 

17 paragraphs (6) and (7) of subsection (c), 

18 and may include charging cost-based fees 

19 for published material produced by the 

20 Foundation; 

21 ‘‘(vi) specify principles for the review 

22 of proposals and awarding of grants and 

23 contracts that include peer review and that 

24 are consistent with those of the Founda25 tion for the National Institutes of Health, 
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1 to the extent determined practicable and 

2 appropriate by the Board; 

3 ‘‘(vii) specify a cap on administrative 

4 expenses for recipients of a grant, con5 tract, or cooperative agreement from the 

6 Foundation; 

7 ‘‘(viii) establish policies for the execu8 tion of memoranda of understanding and 

9 cooperative agreements between the Foun10 dation and other entities, including the 

11 Food and Drug Administration; 

12 ‘‘(ix) establish policies for funding 

13 training fellowships, whether at the Foun14 dation, academic or scientific institutions, 

15 or the Food and Drug Administration, for 

16 scientists, doctors, and other professionals 

17 who are not employees of regulated indus18 try, to foster greater understanding of and 

19 expertise in new scientific tools, 

20 diagnostics, manufacturing techniques, and 

21 potential barriers to translating basic re22 search into clinical and regulatory practice; 

23 ‘‘(x) specify a process for annual 

24 Board review of the operations of the 

25 Foundation; and 
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1 ‘‘(xi) establish specific duties of the 

2 Executive Director; 

3 ‘‘(B) prioritize and provide overall direc4 tion to the activities of the Foundation; 

5 ‘‘(C) evaluate the performance of the Exec6 utive Director; and 

7 ‘‘(D) carry out any other necessary activi8 ties regarding the functioning of the Founda9 tion. 

10 ‘‘(3) TERMS AND VACANCIES.—

11 ‘‘(A) TERM.—The term of office of each 

12 member of the Board appointed under para13 graph (1)(C) shall be 4 years, except that the 

14 terms of offices for the initial appointed mem15 bers of the Board shall expire on a staggered 

16 basis as determined by the ex officio members. 

17 ‘‘(B) VACANCY.—Any vacancy in the mem18 bership of the Board—

19 ‘‘(i) shall not affect the power of the 

20 remaining members to execute the duties 

21 of the Board; and 

22 ‘‘(ii) shall be filled by appointment by 

23 the appointed members described in para24 graph (1)(C) by majority vote. 
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1 ‘‘(C) PARTIAL TERM.—If a member of the 

2 Board does not serve the full term applicable 

3 under subparagraph (A), the individual ap4 pointed under subparagraph (B) to fill the re5 sulting vacancy shall be appointed for the re6 mainder of the term of the predecessor of the 

7 individual. 

8 ‘‘(D) SERVING PAST TERM.—A member of 

9 the Board may continue to serve after the expi10 ration of the term of the member until a suc11 cessor is appointed. 

12 ‘‘(4) COMPENSATION.—Members of the Board 

13 may not receive compensation for service on the 

14 Board. Such members may be reimbursed for travel, 

15 subsistence, and other necessary expenses incurred 

16 in carrying out the duties of the Board, as set forth 

17 in the bylaws issued by the Board. 

18 ‘‘(e) INCORPORATION.—The ex officio members of the 

19 Board shall serve as incorporators and shall take whatever 

20 actions necessary to incorporate the Foundation. 

21 ‘‘(f) NONPROFIT STATUS.—The Foundation shall be 

22 considered to be a corporation under section 501(c) of the 

23 Internal Revenue Code of 1986, and shall be subject to 

24 the provisions of such section. 

25 ‘‘(g) EXECUTIVE DIRECTOR.—
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1 ‘‘(1) IN GENERAL.—The Board shall appoint an 

2 Executive Director who shall serve at the pleasure of 

3 the Board. The Executive Director shall be respon4 sible for the day-to-day operations of the Foundation 

5 and shall have such specific duties and responsibil6 ities as the Board shall prescribe. 

7 ‘‘(2) COMPENSATION.—The compensation of 

8 the Executive Director shall be fixed by the Board 

9 but shall not be greater than the compensation of 

10 the Commissioner. 

11 ‘‘(h) ADMINISTRATIVE POWERS.—In carrying out 

12 this subchapter, the Board, acting through the Executive 

13 Director, may—

14 ‘‘(1) adopt, alter, and use a corporate seal, 

15 which shall be judicially noticed; 

16 ‘‘(2) hire, promote, compensate, and discharge 

17 1 or more officers, employees, and agents, as may be 

18 necessary, and define their duties; 

19 ‘‘(3) prescribe the manner in which—

20 ‘‘(A) real or personal property of the 

21 Foundation is acquired, held, and transferred; 

22 ‘‘(B) general operations of the Foundation 

23 are to be conducted; and 

24 ‘‘(C) the privileges granted to the Board 

25 by law are exercised and enjoyed; 
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1 ‘‘(4) with the consent of the applicable executive 

2 department or independent agency, use the informa3 tion, services, and facilities of such department or 

4 agencies in carrying out this section; 

5 ‘‘(5) enter into contracts with public and pri6 vate organizations for the writing, editing, printing, 

7 and publishing of books and other material; 

8 ‘‘(6) hold, administer, invest, and spend any 

9 gift, devise, or bequest of real or personal property 

10 made to the Foundation under subsection (i); 

11 ‘‘(7) enter into such other contracts, leases, co12 operative agreements, and other transactions as the 

13 Board considers appropriate to conduct the activities 

14 of the Foundation; 

15 ‘‘(8) modify or consent to the modification of 

16 any contract or agreement to which it is a party or 

17 in which it has an interest under this subchapter; 

18 ‘‘(9) take such action as may be necessary to 

19 obtain patents and licenses for devices and proce20 dures developed by the Foundation and its employ21 ees; 

22 ‘‘(10) sue and be sued in its corporate name, 

23 and complain and defend in courts of competent ju24 risdiction; 
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1 ‘‘(11) appoint other groups of advisors as may 

2 be determined necessary to carry out the functions 

3 of the Foundation; and 

4 ‘‘(12) exercise other powers as set forth in this 

5 section, and such other incidental powers as are nec6 essary to carry out its powers, duties, and functions 

7 in accordance with this subchapter. 

8 ‘‘(i) ACCEPTANCE OF FUNDS FROM OTHER

9 SOURCES.—The Executive Director may solicit and accept 

10 on behalf of the Foundation, any funds, gifts, grants, de11 vises, or bequests of real or personal property made to the 

12 Foundation, including from private entities, for the pur13 poses of carrying out the duties of the Foundation. 

14 ‘‘(j) SERVICE OF FEDERAL EMPLOYEES.—Federal 

15 Government employees may serve on committees advisory 

16 to the Foundation and otherwise cooperate with and assist 

17 the Foundation in carrying out its functions, so long as 

18 such employees do not direct or control Foundation activi19 ties. 

20 ‘‘(k) DETAIL OF GOVERNMENT EMPLOYEES; FEL21 LOWSHIPS.—

22 ‘‘(1) DETAIL FROM FEDERAL AGENCIES.—Fed23 eral Government employees may be detailed from 

24 Federal agencies with or without reimbursement to 

25 those agencies to the Foundation at any time, and 
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1 such detail shall be without interruption or loss of 

2 civil service status or privilege. Each such employee 

3 shall abide by the statutory, regulatory, ethical, and 

4 procedural standards applicable to the employees of 

5 the agency from which such employee is detailed and 

6 those of the Foundation. 

7 ‘‘(2) VOLUNTARY SERVICE; ACCEPTANCE OF

8 FEDERAL EMPLOYEES.—

9 ‘‘(A) FOUNDATION.—The Executive Direc10 tor of the Foundation may accept the services 

11 of employees detailed from Federal agencies 

12 with or without reimbursement to those agen13 cies. 

14 ‘‘(B) FOOD AND DRUG ADMINISTRATION.—

15 The Commissioner may accept the uncompen16 sated services of Foundation fellows or trainees. 

17 Such services shall be considered to be under18 taking an activity under contract with the Sec19 retary as described in section 708. 

20 ‘‘(l) ANNUAL REPORTS.—

21 ‘‘(1) REPORTS TO FOUNDATION.—Any recipient 

22 of a grant, contract, fellowship, memorandum of un23 derstanding, or cooperative agreement from the 

24 Foundation under this section shall submit to the 

25 Foundation a report on an annual basis for the du-
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1 ration of such grant, contract, fellowship, memo2 randum of understanding, or cooperative agreement, 

3 that describes the activities carried out under such 

4 grant, contract, fellowship, memorandum of under5 standing, or cooperative agreement. 

6 ‘‘(2) REPORT TO CONGRESS AND THE FDA.—

7 Beginning with fiscal year 2009, the Executive Di8 rector shall submit to Congress and the Commis9 sioner an annual report that—

10 ‘‘(A) describes the activities of the Foun11 dation and the progress of the Foundation in 

12 furthering the goals and priorities established 

13 under subsection (c)(2), including the practical 

14 impact of the Foundation on regulated product 

15 development; 

16 ‘‘(B) provides a specific accounting of the 

17 source and use of all funds used by the Foun18 dation to carry out such activities; and 

19 ‘‘(C) provides information on how the re20 sults of Foundation activities could be incor21 porated into the regulatory and product review 

22 activities of the Food and Drug Administration. 

23 ‘‘(m) SEPARATION OF FUNDS.—The Executive Di24 rector shall ensure that the funds received from the Treas-
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1 ury are held in separate accounts from funds received 

2 from entities under subsection (i). 

3 ‘‘(n) FUNDING.—From amounts appropriated to the 

4 Food and Drug Administration for each fiscal year, the 

5 Commissioner shall transfer not less than $500,000 and 

6 not more than $1,250,000, to the Foundation to carry out 

7 subsections (a), (b), and (d) through (m).’’. 

8 (b) OTHER FOUNDATION PROVISIONS.—Chapter VII 

9 (21 U.S.C. 371 et seq.) (as amended by subsection (a)) 

10 is amended by adding at the end the following: 

11 ‘‘SEC. 771. LOCATION OF FOUNDATION. 

12 ‘‘The Foundation shall, if practicable, be located not 

13 more than 20 miles from the District of Columbia. 

14 ‘‘SEC. 772. ACTIVITIES OF THE FOOD AND DRUG ADMINIS15 TRATION. 

16 ‘‘(a) IN GENERAL.—The Commissioner shall receive 

17 and assess the report submitted to the Commissioner by 

18 the Executive Director of the Foundation under section 

19 770(l)(2). 

20 ‘‘(b) REPORT TO CONGRESS.—Beginning with fiscal 

21 year 2009, the Commissioner shall submit to Congress an 

22 annual report summarizing the incorporation of the infor23 mation provided by the Foundation in the report described 

24 under section 770(l)(2) and by other recipients of grants, 

25 contracts, memoranda of understanding, or cooperative 
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1 agreements into regulatory and product review activities 

2 of the Food and Drug Administration. 

3 ‘‘(c) EXTRAMURAL GRANTS.—The provisions of this 

4 subchapter shall have no effect on any grant, contract, 

5 memorandum of understanding, or cooperative agreement 

6 between the Food and Drug Administration and any other 

7 entity entered into before, on, or after the date of enact8 ment of the Enhancing Drug Safety and Innovation Act 

9 of 2007.’’. 

10 (c) CONFORMING AMENDMENT.—Section 742(b) of 

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

12 379l(b)) is amended by adding at the end the following: 

13 ‘‘Any such fellowships and training programs under this 

14 section or under section 770(d)(2)(A)(ix) may include pro15 vision by such scientists and physicians of services on a 

16 voluntary and uncompensated basis, as the Secretary de17 termines appropriate. Such scientists and physicians shall 

18 be subject to all legal and ethical requirements otherwise 

19 applicable to officers or employees of the Department of 

20 Health and Human Services.’’. 

21 SEC. 222. OFFICE OF THE CHIEF SCIENTIST. 

22 Chapter IX of the Federal Food, Drug, and Cosmetic 

23 Act (21 U.S.C. 391 et seq.) is amended by adding at the 

24 end the following: 
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1 ‘‘SEC. 910. OFFICE OF THE CHIEF SCIENTIST. 

2 ‘‘(a) ESTABLISHMENT; APPOINTMENT.—The Sec3 retary shall establish within the Office of the Commis4 sioner an office to be known as the Office of the Chief 

5 Scientist. The Secretary shall appoint a Chief Scientist to 

6 lead such Office. 

7 ‘‘(b) DUTIES OF THE OFFICE.—The Office of the 

8 Chief Scientist shall—

9 ‘‘(1) oversee, coordinate, and ensure quality and 

10 regulatory focus of the intramural research pro11 grams of the Food and Drug Administration; 

12 ‘‘(2) track and, to the extent necessary, coordi13 nate intramural research awards made by each cen14 ter of the Administration or science-based office 

15 within the Office of the Commissioner, and ensure 

16 that there is no duplication of research efforts sup17 ported by the Reagan-Udall Foundation for the 

18 Food and Drug Administration; 

19 ‘‘(3) develop and advocate for a budget to sup20 port intramural research; 

21 ‘‘(4) develop a peer review process by which in22 tramural research can be evaluated; and 

23 ‘‘(5) identify and solicit intramural research 

24 proposals from across the Food and Drug Adminis25 tration through an advisory board composed of em26 ployees of the Administration that shall include—
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1 ‘‘(A) representatives of each of the centers 

2 and the science-based offices within the Office 

3 of the Commissioner; and 

4 ‘‘(B) experts on trial design, epidemiology, 

5 demographics, pharmacovigilance, basic science, 

6 and public health.’’. 

7 Subtitle C—Clinical Trials 

8 SEC. 231. EXPANDED CLINICAL TRIAL REGISTRY DATA 

9 BANK. 

10 (a) IN GENERAL.—Section 402 of the Public Health 

11 Service Act (42 U.S.C. 282) is amended by—

12 (1) redesignating subsections (j) and (k) as 

13 subsections (k) and (l), respectively; and 

14 (2) inserting after subsection (i) the following: 

15 ‘‘(j) EXPANDED CLINICAL TRIAL REGISTRY DATA

16 BANK.—

17 ‘‘(1) DEFINITIONS; REQUIREMENT.—

18 ‘‘(A) DEFINITIONS.—In this subsection: 

19 ‘‘(i) APPLICABLE DEVICE CLINICAL

20 TRIAL.—The term ‘applicable device clin21 ical trial’ means—

22 ‘‘(I) a prospective study of health 

23 outcomes comparing an intervention 

24 against a control in human subjects 

25 intended to support an application 
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1 under section 515 or 520(m), or a re2 port under section 510(k), of the Fed3 eral Food, Drug, and Cosmetic Act 

4 (other than a limited study to gather 

5 essential information used to refine 

6 the device or design a pivotal trial and 

7 that is not intended to determine safe8 ty and effectiveness of a device); and 

9 ‘‘(II) a pediatric postmarket sur10 veillance as required under section 

11 522 of the Federal Food, Drug, and 

12 Cosmetic Act. 

13 ‘‘(ii) APPLICABLE DRUG CLINICAL

14 TRIAL.—

15 ‘‘(I) IN GENERAL.—The term 

16 ‘applicable drug clinical trial’ means a 

17 controlled clinical investigation, other 

18 than a phase I clinical investigation, 

19 of a product subject to section 505 of 

20 the Federal Food, Drug, and Cos21 metic Act or to section 351 of this 

22 Act. 

23 ‘‘(II) CLINICAL INVESTIGA24 TION.—For purposes of subclause (I), 

25 the term ‘clinical investigation’ has 
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1 the meaning given that term in sec2 tion 312.3 of title 21, Code of Federal 

3 Regulations. 

4 ‘‘(III) PHASE I.—The term 

5 ‘phase I’ has the meaning given that 

6 term in section 312.21 of title 21, 

7 Code of Federal Regulations. 

8 ‘‘(iii) CLINICAL TRIAL INFORMA9 TION.—The term ‘clinical trial information’ 

10 means those data elements that are nec11 essary to complete an entry in the clinical 

12 trial registry data bank under paragraph 

13 (2). 

14 ‘‘(iv) COMPLETION DATE.—The term 

15 ‘completion date’ means, with respect to an 

16 applicable drug clinical trial or an applica17 ble device clinical trial, the date on which 

18 the last patient enrolled in the clinical trial 

19 has completed his or her last medical visit 

20 of the clinical trial, whether the clinical 

21 trial concluded according to the 

22 prespecified protocol plan or was termi23 nated. 

24 ‘‘(v) DEVICE.—The term ‘device’ 

25 means a device as defined in section 
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1 201(h) of the Federal Food, Drug, and 

2 Cosmetic Act. 

3 ‘‘(vi) DRUG.—The term ‘drug’ means 

4 a drug as defined in section 201(g) of the 

5 Federal Food, Drug, and Cosmetic Act or 

6 a biological product as defined in section 

7 351 of this Act. 

8 ‘‘(vii) RESPONSIBLE PARTY.—The 

9 term ‘responsible party’, with respect to a 

10 clinical trial of a drug or device, means—

11 ‘‘(I) the sponsor of the clinical 

12 trial (as defined in section 50.3 of 

13 title 21, Code of Federal Regulations 

14 (or any successor regulations)) or the 

15 principal investigator of such clinical 

16 trial if so designated by such sponsor; 

17 or 

18 ‘‘(II) if no sponsor exists, the 

19 grantee, contractor, or awardee for a 

20 trial funded by a Federal agency or 

21 the principal investigator of such clin22 ical trial if so designated by such 

23 grantee, contractor, or awardee. 

24 ‘‘(B) REQUIREMENT.—The Secretary shall 

25 develop a mechanism by which—
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1 ‘‘(i) the responsible party for each ap2 plicable drug clinical trial and applicable 

3 device clinical trial shall submit the iden4 tity and contact information of such re5 sponsible party to the Secretary at the 

6 time of submission of clinical trial informa7 tion under paragraph (2); and 

8 ‘‘(ii) other Federal agencies may iden9 tify the responsible party for an applicable 

10 drug clinical trial or applicable device clin11 ical trial. 

12 ‘‘(2) EXPANSION OF CLINICAL TRIAL REGISTRY

13 DATA BANK WITH RESPECT TO CLINICAL TRIAL IN14 FORMATION.—

15 ‘‘(A) IN GENERAL.—

16 ‘‘(i) EXPANSION OF DATA BANK.—To 

17 enhance patient enrollment and provide a 

18 mechanism to track subsequent progress of 

19 clinical trials, the Secretary, acting 

20 through the Director of NIH, shall expand, 

21 in accordance with this subsection, the 

22 clinical trials registry of the data bank de23 scribed under subsection (i)(3)(A) (re24 ferred to in this subsection as the ‘registry 

25 data bank’). The Director of NIH shall en-
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1 sure that the registry data bank is made 

2 publicly available through the Internet. 

3 ‘‘(ii) CONTENT.—Not later than 18 

4 months after the date of enactment of the 

5 Enhancing Drug Safety and Innovation 

6 Act of 2007, and after notice and com7 ment, the Secretary shall promulgate regu8 lations to expand the registry data bank to 

9 require the submission to the registry data 

10 bank of clinical trial information for appli11 cable drug clinical trials and applicable de12 vice clinical trials that—

13 ‘‘(I) conforms to the Inter14 national Clinical Trials Registry Plat15 form trial registration data set of the 

16 World Health Organization; 

17 ‘‘(II) includes the city, State, and 

18 zip code for each clinical trial location, 

19 or a toll-free number through which 

20 such location information may be 

21 accessed; 

22 ‘‘(III) if the drug is not approved 

23 under section 505 of the Federal 

24 Food, Drug, and Cosmetic Act or li25 censed under section 351 of this Act, 
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1 specifies whether or not there is ex2 panded access to the drug under sec3 tion 561 of the Federal Food, Drug, 

4 and Cosmetic Act for those who do 

5 not qualify for enrollment in the clin6 ical trial and how to obtain informa7 tion about such access; 

8 ‘‘(IV) requires the inclusion of 

9 such other data elements to the reg10 istry data bank as appropriate; and 

11 ‘‘(V) becomes effective 90 days 

12 after issuance of the final rule. 

13 ‘‘(B) FORMAT AND STRUCTURE.—

14 ‘‘(i) SEARCHABLE CATEGORIES.—The 

15 Director of NIH shall ensure that the pub16 lic may search the entries in the registry 

17 data bank by 1 or more of the following 

18 criteria: 

19 ‘‘(I) The disease or condition 

20 being studied in the clinical trial, 

21 using Medical Subject Headers 

22 (MeSH) descriptors. 

23 ‘‘(II) The treatment being stud24 ied in the clinical trial. 
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1 ‘‘(III) The location of the clinical 

2 trial. 

3 ‘‘(IV) The age group studied in 

4 the clinical trial, including pediatric 

5 subpopulations. 

6 ‘‘(V) The study phase of the clin7 ical trial. 

8 ‘‘(VI) The source of support for 

9 the clinical trial, which may be the 

10 National Institutes of Health or other 

11 Federal agency, a private industry 

12 source, or a university or other orga13 nization. 

14 ‘‘(VII) The recruitment status of 

15 the clinical trial. 

16 ‘‘(VIII) The National Clinical 

17 Trial number or other study identi18 fication for the clinical trial. 

19 ‘‘(ii) FORMAT.—The Director of the 

20 NIH shall ensure that the registry data 

21 bank is easily used by the public, and that 

22 entries are easily compared. 

23 ‘‘(C) DATA SUBMISSION.—The responsible 

24 party for an applicable drug clinical trial shall 

25 submit to the Director of NIH for inclusion in 
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1 the registry data bank the clinical trial informa2 tion described in subparagraph (A)(ii). 

3 ‘‘(D) TRUTHFUL CLINICAL TRIAL INFOR4 MATION.—

5 ‘‘(i) IN GENERAL.—The clinical trial 

6 information submitted by a responsible 

7 party under this paragraph shall not be 

8 false or misleading in any particular. 

9 ‘‘(ii) EFFECT.—Clause (i) shall not 

10 have the effect of requiring clinical trial in11 formation with respect to an applicable 

12 drug clinical trial or an applicable device 

13 clinical trial to include information from 

14 any source other than such clinical trial in15 volved. 

16 ‘‘(E) CHANGES IN CLINICAL TRIAL STA17 TUS.—

18 ‘‘(i) ENROLLMENT.—The responsible 

19 party for an applicable drug clinical trial 

20 or an applicable device clinical trial shall 

21 update the enrollment status not later than 

22 30 days after the enrollment status of such 

23 clinical trial changes. 

24 ‘‘(ii) COMPLETION.—The responsible 

25 party for an applicable drug clinical trial 
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1 or applicable device clinical trial shall re2 port to the Director of NIH that such clin3 ical trial is complete not later than 30 days 

4 after the completion date of the clinical 

5 trial. 

6 ‘‘(F) TIMING OF SUBMISSION.—The clin7 ical trial information for an applicable drug 

8 clinical trial or an applicable device clinical trial 

9 required to be submitted under this paragraph 

10 shall be submitted not later than 21 days after 

11 the first patient is enrolled in such clinical trial. 

12 ‘‘(G) POSTING OF DATA.—

13 ‘‘(i) APPLICABLE DRUG CLINICAL

14 TRIAL.—The Director of NIH shall ensure 

15 that clinical trial information for an appli16 cable drug clinical trial submitted in ac17 cordance with this paragraph is posted 

18 publicly within 30 days of such submission. 

19 ‘‘(ii) APPLICABLE DEVICE CLINICAL

20 TRIAL.—The Director of NIH shall ensure 

21 that clinical trial information for an appli22 cable device clinical trial submitted in ac23 cordance with this paragraph is posted 

24 publicly within 30 days of clearance under 

25 section 510(k) of the Federal Food, Drug, 
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1 and Cosmetic Act, or approval under sec2 tion 515 or section 520(m) of such Act, as 

3 applicable. 

4 ‘‘(H) VOLUNTARY SUBMISSIONS.—A re5 sponsible party for a clinical trial that is not an 

6 applicable drug clinical trial or an applicable de7 vice clinical trial may submit clinical trial infor8 mation to the registry data bank in accordance 

9 with this subsection. 

10 ‘‘(3) EXPANSION OF REGISTRY DATA BANK TO

11 INCLUDE RESULTS OF CLINICAL TRIALS.—

12 ‘‘(A) LINKING REGISTRY DATA BANK TO

13 EXISTING RESULTS.—

14 ‘‘(i) IN GENERAL.—Beginning not 

15 later than 90 days after the date of enact16 ment of the Enhancing Drug Safety and 

17 Innovation Act of 2007, for those clinical 

18 trials that form the primary basis of an ef19 ficacy claim or are conducted after the 

20 drug involved is approved or after the de21 vice involved is cleared or approved, the 

22 Secretary shall ensure that the registry 

23 data bank includes links to results infor24 mation for such clinical trial—
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1 ‘‘(I) not earlier than 30 days 

2 after the date of the approval of the 

3 drug involved or clearance or approval 

4 of the device involved; or 

5 ‘‘(II) not later than 30 days after 

6 such information becomes publicly 

7 available, as applicable. 

8 ‘‘(ii) REQUIRED INFORMATION.—

9 ‘‘(I) FDA INFORMATION.—The 

10 Secretary shall ensure that the reg11 istry data bank includes links to the 

12 following information: 

13 ‘‘(aa) If an advisory com14 mittee considered at a meeting 

15 an applicable drug clinical trial 

16 or an applicable device clinical 

17 trial, any posted Food and Drug 

18 Administration summary docu19 ment regarding such applicable 

20 drug clinical trial or applicable 

21 clinical device trial. 

22 ‘‘(bb) If an applicable drug 

23 clinical trial was conducted under 

24 section 505A or 505B of the 

25 Federal Food, Drug, and Cos-
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1 metic Act, a link to the posted 

2 Food and Drug Administration 

3 assessment of the results of such 

4 trial. 

5 ‘‘(cc) Food and Drug Ad6 ministration public health 

7 advisories regarding the drug or 

8 device that is the subject of the 

9 applicable drug clinical trial or 

10 applicable device clinical trial, re11 spectively, if any. 

12 ‘‘(dd) For an applicable 

13 drug clinical trial, the Food and 

14 Drug Administration action 

15 package for approval document 

16 required under section 505(l)(2) 

17 of the Food Drug and Cosmetic 

18 Act. 

19 ‘‘(ee) For an applicable de20 vice clinical trial, in the case of a 

21 premarket application, the de22 tailed summary of information 

23 respecting the safety and effec24 tiveness of the device required 

25 under section 520(h)(1) of the 
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1 Federal Food, Drug, and Cos2 metic Act, or, in the case of a re3 port under section 510(k) of such 

4 Act, the section 510(k) summary 

5 of the safety and effectiveness 

6 data required under section 

7 807.95(d) of title 21, Code of 

8 Federal Regulations (or any suc9 cessor regulations). 

10 ‘‘(II) NIH INFORMATION.—The 

11 Secretary shall ensure that the reg12 istry data bank includes links to the 

13 following information: 

14 ‘‘(aa) Medline citations to 

15 any publications regarding each 

16 applicable drug clinical trial and 

17 applicable device clinical trial. 

18 ‘‘(bb) The entry for the drug 

19 that is the subject of an applica20 ble drug clinical trial in the Na21 tional Library of Medicine data22 base of structured product labels, 

23 if available. 

24 ‘‘(iii) RESULTS FOR EXISTING DATA

25 BANK ENTRIES.—The Secretary may in-
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1 clude the links described in clause (ii) for 

2 data bank entries for clinical trials sub3 mitted to the data bank prior to enactment 

4 of the Enhancing Drug Safety and Innova5 tion Act of 2007, as available. 

6 ‘‘(B) FEASIBILITY STUDY.—The Director 

7 of NIH shall—

8 ‘‘(i) conduct a study to determine the 

9 best, validated methods of making the re10 sults of clinical trials publicly available 

11 after the approval of the drug that is the 

12 subject of an applicable drug clinical trial; 

13 and 

14 ‘‘(ii) not later than 18 months after 

15 initiating such study, submit to the Sec16 retary any findings and recommendations 

17 of such study. 

18 ‘‘(C) NEGOTIATED RULEMAKING.—

19 ‘‘(i) IN GENERAL.—The Secretary 

20 shall establish a negotiated rulemaking 

21 process pursuant to subchapter IV of chap22 ter 5 of title 5, United States Code, to de23 termine, for applicable drug clinical 

24 trials—
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1 ‘‘(I) how to ensure quality and 

2 validate methods of expanding the 

3 registry data bank to include clinical 

4 trial results information for trials not 

5 within the scope of this Act; 

6 ‘‘(II) the clinical trials of which 

7 the results information is appropriate 

8 for adding to the expanded registry 

9 data bank; and 

10 ‘‘(III) the appropriate timing of 

11 the posting of such results informa12 tion. 

13 ‘‘(ii) TIME REQUIREMENT.—The proc14 ess described in paragraph (1) shall be 

15 conducted in a timely manner to ensure 

16 that—

17 ‘‘(I) any recommendation for a 

18 proposed rule—

19 ‘‘(aa) is provided to the Sec20 retary not later than 21 months 

21 after the date of the enactment 

22 of the Enhancing Drug Safety 

23 and Innovation Act of 2007; and 
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1 ‘‘(bb) includes an assess2 ment of the benefits and costs of 

3 the recommendation; and 

4 ‘‘(II) a final rule is promulgated 

5 not later than 30 months after the 

6 date of the enactment of the Enhanc7 ing Drug Safety and Innovation Act 

8 of 2007, taking into account the rec9 ommendations under subclause (I) 

10 and the results of the feasibility study 

11 conducted under subparagraph (B). 

12 ‘‘(iii) REPRESENTATION ON NEGO13 TIATED RULEMAKING COMMITTEE.—The 

14 negotiated rulemaking committee estab15 lished by the Secretary pursuant to clause 

16 (i) shall include members representing—

17 ‘‘(I) the Food and Drug Adminis18 tration; 

19 ‘‘(II) the National Institutes of 

20 Health; 

21 ‘‘(III) other Federal agencies as 

22 the Secretary determines appropriate; 

23 ‘‘(IV) patient advocacy and 

24 health care provider groups; 
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1 ‘‘(V) the pharmaceutical indus2 try; 

3 ‘‘(VI) contract clinical research 

4 organizations; 

5 ‘‘(VII) the International Com6 mittee of Medical Journal Editors; 

7 and 

8 ‘‘(VIII) other interested parties, 

9 including experts in privacy protec10 tion, pediatrics, health information 

11 technology, health literacy, commu12 nication, clinical trial design and im13 plementation, and health care ethics. 

14 ‘‘(iv) CONTENT OF REGULATIONS.—

15 The regulations promulgated pursuant to 

16 clause (i) shall establish—

17 ‘‘(I) procedures to determine 

18 which clinical trials results informa19 tion data elements shall be included in 

20 the registry data bank, taking into ac21 count the needs of different popu22 lations of users of the registry data 

23 bank; 
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1 ‘‘(II) a standard format for the 

2 submission of clinical trials results to 

3 the registry data bank; 

4 ‘‘(III) a standard procedure for 

5 the submission of clinical trial results 

6 information, including the timing of 

7 submission and the timing of posting 

8 of results information, to the registry 

9 data bank, taking into account the 

10 possible impacts on publication of 

11 manuscripts based on the clinical 

12 trial; 

13 ‘‘(IV) a standard procedure for 

14 the verification of clinical trial results 

15 information, including ensuring that 

16 free text data elements are non-pro17 motional; and 

18 ‘‘(V) an implementation plan for 

19 the prompt inclusion of clinical trials 

20 results information in the registry 

21 data bank. 

22 ‘‘(D) CONSIDERATION OF WORLD HEALTH

23 ORGANIZATION DATA SET.—The Secretary shall 

24 consider the status of the consensus data ele25 ments set for reporting clinical trial results of 
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1 the World Health Organization when promul2 gating the regulations under subparagraph (C). 

3 ‘‘(E) TRUTHFUL CLINICAL TRIAL INFOR4 MATION.—

5 ‘‘(i) IN GENERAL.—The clinical trial 

6 information submitted by a responsible 

7 party under this paragraph shall not be 

8 false or misleading in any particular. 

9 ‘‘(ii) EFFECT.—Clause (i) shall not 

10 have the effect of requiring clinical trial in11 formation with respect to an applicable 

12 drug clinical trial or an applicable device 

13 clinical trial to include information from 

14 any source other than such clinical trial in15 volved. 

16 ‘‘(F) WAIVERS REGARDING CERTAIN CLIN17 ICAL TRIAL RESULTS.—The Secretary may 

18 waive any applicable requirements of this para19 graph for an applicable drug clinical trial or an 

20 applicable device clinical trial, upon a written 

21 request from the responsible person, if the Sec22 retary determines that extraordinary cir23 cumstances justify the waiver and that pro24 viding the waiver is in the public interest, con25 sistent with the protection of public health, or 
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1 in the interest of national security. Not later 

2 than 30 days after any part of a waiver is 

3 granted, the Secretary shall notify, in writing, 

4 the appropriate committees of Congress of the 

5 waiver and provide an explanation for why the 

6 waiver was granted. 

7 ‘‘(4) COORDINATION AND COMPLIANCE.—

8 ‘‘(A) CLINICAL TRIALS SUPPORTED BY

9 GRANTS FROM FEDERAL AGENCIES.—

10 ‘‘(i) IN GENERAL.—No Federal agen11 cy may release funds under a research 

12 grant to an awardee who has not complied 

13 with paragraph (2) for any applicable drug 

14 clinical trial or applicable device clinical 

15 trial for which such person is the respon16 sible party. 

17 ‘‘(ii) GRANTS FROM CERTAIN FED18 ERAL AGENCIES.—If an applicable drug 

19 clinical trial or applicable device clinical 

20 trial is funded in whole or in part by a 

21 grant from the Food and Drug Adminis22 tration, National Institutes of Health, the 

23 Agency for Healthcare Research and Qual24 ity, or the Department of Veterans Affairs, 

25 any grant or progress report forms re-
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1 quired under such grant shall include a 

2 certification that the responsible party has 

3 made all required submissions to the Di4 rector of NIH under paragraph (2). 

5 ‘‘(iii) VERIFICATION BY FEDERAL

6 AGENCIES.—The heads of the agencies re7 ferred to in clause (ii), as applicable, shall 

8 verify that the clinical trial information for 

9 each applicable drug clinical trial or appli10 cable device clinical trial for which a grant11 ee is the responsible party has been sub12 mitted under paragraph (2) before releas13 ing any remaining funding for a grant or 

14 funding for a future grant to such grantee. 

15 ‘‘(iv) NOTICE AND OPPORTUNITY TO

16 REMEDY.—If the head of an agency re17 ferred to in clause (ii), as applicable, 

18 verifies that a grantee has not submitted 

19 clinical trial information as described in 

20 clause (iii), such agency head shall provide 

21 notice to such grantee of such non-compli22 ance and allow such grantee 30 days to 

23 correct such non-compliance and submit 

24 the required clinical trial information. 
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1 ‘‘(v) CONSULTATION WITH OTHER

2 FEDERAL AGENCIES.—The Secretary 

3 shall—

4 ‘‘(I) consult with other agencies 

5 that conduct research involving 

6 human subjects in accordance with 

7 any section of part 46 of title 45, 

8 Code of Federal Regulations (or any 

9 successor regulations), to determine if 

10 any such research is an applicable 

11 drug clinical trial or an applicable de12 vice clinical trial under paragraph (1); 

13 and 

14 ‘‘(II) develop with such agencies 

15 procedures comparable to those de16 scribed in clauses (ii), (iii), and (iv) to 

17 ensure that clinical trial information 

18 for such applicable drug clinical trials 

19 and applicable device clinical trial is 

20 submitted under paragraph (2). 

21 ‘‘(B) CERTIFICATION TO ACCOMPANY

22 DRUG, BIOLOGICAL PRODUCT, AND DEVICE SUB23 MISSIONS.—At the time of submission of an ap24 plication under section 505 of the Federal 

25 Food, Drug, and Cosmetic Act, section 515 of 
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1 such Act, section 520(m) of such Act, or section 

2 351 of this Act, or submission of a report under 

3 section 510(k) of such Act, such application or 

4 submission shall be accompanied by a certifi5 cation that all applicable requirements of this 

6 subsection have been met. Where available, such 

7 certification shall include the appropriate Na8 tional Clinical Trial control numbers. 

9 ‘‘(C) VERIFICATION OF SUBMISSION PRIOR

10 TO POSTING.—In the case of clinical trial infor11 mation that is submitted under paragraph (2), 

12 but is not made publicly available pending regu13 latory approval or clearance, as applicable, the 

14 Director of NIH shall respond to inquiries from 

15 other Federal agencies and peer-reviewed sci16 entific journals to confirm that such clinical 

17 trial information has been submitted but has 

18 not yet been posted. 

19 ‘‘(5) LIMITATION ON DISCLOSURE OF CLINICAL

20 TRIAL INFORMATION.—

21 ‘‘(A) IN GENERAL.—Nothing in this sub22 section (or under section 552 of title 5, United 

23 States Code) shall require the Secretary to pub24 licly disclose, from any record or source other 

25 than the registry data bank expanded under 
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1 this subsection, information described in sub2 paragraph (B). 

3 ‘‘(B) INFORMATION DESCRIBED.—Infor4 mation described in this subparagraph is—

5 ‘‘(i) information submitted to the Di6 rector of NIH under this subsection, or in7 formation of the same general nature as 

8 (or integrally associated with) the informa9 tion so submitted; and 

10 ‘‘(ii) not otherwise publicly available, 

11 including because it is protected from dis12 closure under section 552 of title 5, United 

13 States Code. 

14 ‘‘(6) AUTHORIZATION OF APPROPRIATIONS.—

15 There are authorized to be appropriated to carry out 

16 this subsection $10,000,000 for each fiscal year.’’. 

17 (b) CONFORMING AMENDMENTS.—

18 (1) PROHIBITED ACTS.—Section 301 of the 

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

20 331) is amended by adding at the end the following: 

21 ‘‘(jj)(1) The failure to submit the certification re22 quired by section 402(j)(4)(B) of the Public Health Serv23 ice Act, or knowingly submitting a false certification under 

24 such section. 
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1 ‘‘(2) The submission of clinical trial information 

2 under subsection (i) or (j) of section 402 of the Public 

3 Health Service Act that is promotional or false or mis4 leading in any particular under paragraph (2) or (3) of 

5 such subsection (j).’’. 

6 (2) CIVIL MONEY PENALTIES.—Section 303(f) 

7 of the Federal Food, Drug, and Cosmetic Act (21 

8 U.S.C. 333(f)), as amended by section 203, is fur9 ther amended by—

10 (A) redesignating paragraphs (4), (5), and 

11 (6) as paragraphs (5), (6), and (7), respec12 tively; 

13 (B) inserting after paragraph (3) the fol14 lowing: 

15 ‘‘(4) Any person who violates section 301(jj) shall be 

16 subject to a civil monetary penalty of not more than 

17 $10,000 for the first violation, and not more than $20,000 

18 for each subsequent violation.’’; 

19 (C) in paragraph (2)(C), by striking 

20 ‘‘paragraph (4)(A)’’ and inserting ‘‘paragraph 

21 (5)(A)’’; 

22 (D) in paragraph (5), as so redesignated, 

23 by striking ‘‘paragraph (1), (2), or (3)’’ each 

24 place it appears and inserting ‘‘paragraph (1), 

25 (2), (3), or (4)’’; and 
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1 (E) in paragraph (7), as so redesignated, 

2 by striking ‘‘paragraph (5)’’ each place it ap3 pears and inserting ‘‘paragraph (6)’’. 

4 (3) NEW DRUGS AND DEVICES.—

5 (A) INVESTIGATIONAL NEW DRUGS.—Sec6 tion 505(i) of the Federal Food, Drug, and 

7 Cosmetic Act (21 U.S.C. 355(i)) is amended in 

8 paragraph (4), by adding at the end the fol9 lowing: ‘‘The Secretary shall update such regu10 lations to require inclusion in the informed con11 sent form a statement that clinical trial infor12 mation for such clinical investigation has been 

13 or will be submitted for inclusion in the registry 

14 data bank pursuant to subsections (i) and (j) of 

15 section 402 of the Public Health Service Act.’’. 

16 (B) NEW DRUG APPLICATIONS.—Section 

17 505(b) of the Federal, Food, Drug, and Cos18 metic Act (21 U.S.C. 355(b)) is amended by 

19 adding at the end the following: 

20 ‘‘(6) An application submitted under this sub21 section shall be accompanied by the certification re22 quired under section 402(j)(4)(B) of the Public 

23 Health Service Act. Such certification shall not be 

24 considered an element of such application.’’. 
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1 (C) DEVICE REPORTS UNDER SECTION

2 510(k).—Section 510(k) of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 360(k)) is 

4 amended by adding at the end the following: 

5 ‘‘A notification submitted under this subsection that con6 tains clinical trial data for an applicable device clinical 

7 trial (as defined in section 402(j)(1) of the Public Health 

8 Service Act) shall be accompanied by the certification re9 quired under section 402(j)(4)(B) of such Act. Such cer10 tification shall not be considered an element of such notifi11 cation.’’. 

12 (D) DEVICE PREMARKET APPROVAL APPLI13 CATION.—Section 515(c) of the Federal Food, 

14 Drug, and Cosmetic Act (21 U.S.C. 360e(c)) is 

15 amended—

16 (i) in subparagraph (F), by striking ‘‘; 

17 and’’ and inserting a semicolon; 

18 (ii) by redesignating subparagraph 

19 (G) as subparagraph (H); and 

20 (iii) by inserting after subparagraph 

21 (F) the following: 

22 ‘‘(G) the certification required under sec23 tion 402(j)(4)(B) of the Public Health Service 

24 Act (which shall not be considered an element 

25 of such application); and’’. 
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1 (E) HUMANITARIAN DEVICE EXEMP2 TION.—Section 520(m)(2) of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 360e(c)) is 

4 amended in the first sentence in the matter fol5 lowing subparagraph (C), by inserting at the 

6 end before the period ‘‘and such application 

7 shall include the certification required under 

8 section 402(j)(4)(B) of the Public Health Serv9 ice Act (which shall not be considered an ele10 ment of such application)’’. 

11 (c) PREEMPTION.—

12 (1) IN GENERAL.—No State or political subdivi13 sion of a State may establish or continue in effect 

14 any requirement for the registration of clinical trials 

15 or for the inclusion of information relating to the re16 sults of clinical trials in a database. 

17 (2) RULE OF CONSTRUCTION.—The fact of sub18 mission of clinical trial information, if submitted in 

19 compliance with subsection (i) and (j) of section 402 

20 of the Public Health Service Act (as amended by 

21 this section), that relates to a use of a drug or de22 vice not included in the official labeling of the ap23 proved drug or device shall not be construed by the 

24 Secretary or in any administrative or judicial pro25 ceeding, as evidence of a new intended use of the 
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1 drug or device that is different from the intended 

2 use of the drug or device set forth in the official la3 beling of the drug or device. The availability of clin4 ical trial information through the data bank under 

5 such subsections (i) and (j), if submitted in compli6 ance with such subsections, shall not be considered 

7 as labeling, adulteration, or misbranding of the drug 

8 or device under the Federal Food, Drug, and Cos9 metic Act (21 U.S.C. 301 et seq.). 

10 (d) TRANSITION RULE; EFFECTIVE DATE OF FUND11 ING RESTRICTIONS.—

12 (1) TRANSITION RULE FOR CLINICAL TRIALS

13 INITIATED PRIOR TO EXPANSION OF REGISTRY DATA

14 BANK.—The responsible party (as defined in para15 graph (1) of section 402(j) of the Public Health 

16 Service Act (as added by this section)) for an appli17 cable drug clinical trial or applicable device clinical 

18 trial (as defined under such paragraph (1)) that is 

19 initiated after the date of enactment of this subtitle 

20 and before the effective date of the regulations pro21 mulgated under paragraph (2) of such section 

22 402(j), shall submit required clinical trial informa23 tion under such section not later than 120 days 

24 after such effective date. 
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1 (2) FUNDING RESTRICTIONS.—Subparagraph 

2 (A) of paragraph (4) of such section 402(j) shall 

3 take effect 210 days after the effective date of the 

4 regulations promulgated under paragraph (2) of 

5 such section 402(j). 

6 (e) EFFECTIVE DATE.—

7 (1) IN GENERAL.—Beginning 90 days after the 

8 date of enactment of this title, the responsible party 

9 for an applicable drug clinical trial or an applicable 

10 device clinical trial (as that term is defined in such 

11 section 402(j)) that is initiated after the date of en12 actment of this title and before the effective date of 

13 the regulations issued under subparagraph (A) of 

14 paragraph (2) of such subsection, shall submit clin15 ical trial information under such paragraph (2). 

16 (2) RULEMAKING.—

17 (A) IN GENERAL.—Except as provided in 

18 subparagraph (B), subsection (c)(1) shall be19 come effective on the date on which the regula20 tion promulgated pursuant to section 

21 402(j)(3)(C)(i) of the Public Health Service 

22 Act, as added by this section, becomes effective. 

23 (B) EXCEPTION.—Subsection (c)(1) shall 

24 apply with respect to any clinical trial for which 

25 the registry data bank includes links to results 
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1 information, as provided for under section 

2 402(j)(3)(A) of such Act, as added by this sec3 tion. 

4 Subtitle D—Conflicts of Interest 

5 SEC. 241. CONFLICTS OF INTEREST. 

6 (a) IN GENERAL.—Subchapter A of chapter VII of 

7 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 

8 et seq.) is amended by inserting at the end the following: 

9 ‘‘SEC. 712. CONFLICTS OF INTEREST. 

10 ‘‘(a) DEFINITIONS.—For purposes of this section: 

11 ‘‘(1) ADVISORY COMMITTEE.—The term ‘advi12 sory committee’ means an advisory committee under 

13 the Federal Advisory Committee Act that provides 

14 advice or recommendations to the Secretary regard15 ing activities of the Food and Drug Administration. 

16 ‘‘(2) FINANCIAL INTEREST.—The term ‘finan17 cial interest’ means a financial interest under section 

18 208(a) of title 18, United States Code. 

19 ‘‘(b) APPOINTMENTS TO ADVISORY COMMITTEES.—

20 ‘‘(1) RECRUITMENT.—

21 ‘‘(A) IN GENERAL.—Given the importance 

22 of advisory committees to the review process at 

23 the Food and Drug Administration, the Sec24 retary shall carry out informational and recruit25 ment activities for purposes of recruiting indi-
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1 viduals to serve as advisory committee mem2 bers. The Secretary shall seek input from pro3 fessional medical and scientific societies to de4 termine the most effective informational and re5 cruitment activities. The Secretary shall also 

6 take into account the advisory committees with 

7 the greatest number of vacancies. 

8 ‘‘(B) RECRUITMENT ACTIVITIES.—The re9 cruitment activities under subparagraph (A) 

10 may include—

11 ‘‘(i) advertising the process for becom12 ing an advisory committee member at med13 ical and scientific society conferences; 

14 ‘‘(ii) making widely available, includ15 ing by using existing electronic commu16 nications channels, the contact information 

17 for the Food and Drug Administration 

18 point of contact regarding advisory com19 mittee nominations; and 

20 ‘‘(iii) developing a method through 

21 which an entity receiving National Insti22 tutes of Health funding can identify a per23 son who the Food and Drug Administra24 tion can contact regarding the nomination 
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1 of individuals to serve on advisory commit2 tees. 

3 ‘‘(2) EVALUATION AND CRITERIA.—When con4 sidering a term appointment to an advisory com5 mittee, the Secretary shall review the expertise of 

6 the individual and the financial disclosure report 

7 filed by the individual pursuant to the Ethics in 

8 Government Act of 1978 for each individual under 

9 consideration for the appointment, so as to reduce 

10 the likelihood that an appointed individual will later 

11 require a written determination as referred to in sec12 tion 208(b)(1) of title 18, United States Code, a 

13 written certification as referred to in section 

14 208(b)(3) of title 18, United States Code, or a waiv15 er as referred to in subsection (c)(3) of this section 

16 for service on the committee at a meeting of the 

17 committee. 

18 ‘‘(c) GRANTING AND DISCLOSURE OF WAIVERS.—

19 ‘‘(1) IN GENERAL.—Prior to a meeting of an 

20 advisory committee regarding a ‘particular matter’ 

21 (as that term is used in section 208 of title 18, 

22 United States Code), each member of the committee 

23 who is a full-time Government employee or special 

24 Government employee shall disclose to the Secretary 
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1 financial interests in accordance with subsection (b) 

2 of such section 208. 

3 ‘‘(2) FINANCIAL INTEREST OF ADVISORY COM4 MITTEE MEMBER OR FAMILY MEMBER.—No member 

5 of an advisory committee may vote with respect to 

6 any matter considered by the advisory committee if 

7 such member (or an immediate family member of 

8 such member) has a financial interest that could be 

9 affected by the advice given to the Secretary with re10 spect to such matter, excluding interests exempted 

11 in regulations issued by the Director of the Office of 

12 Government Ethics as too remote or inconsequential 

13 to affect the integrity of the services of the Govern14 ment officers or employees to which such regulations 

15 apply. 

16 ‘‘(3) WAIVER.—The Secretary may grant a 

17 waiver of the prohibition in paragraph (2) if such 

18 waiver is necessary to afford the advisory committee 

19 essential expertise. 

20 ‘‘(4) LIMITATION.—The Secretary may not 

21 grant a waiver under paragraph (3) for a member 

22 of an advisory committee when the member’s own 

23 scientific work is involved. 
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1 ‘‘(5) DISCLOSURE OF WAIVER.—Notwith2 standing section 107(a)(2) of the Ethics in Govern3 ment Act (5 U.S.C. App.), the following shall apply: 

4 ‘‘(A) 15 OR MORE DAYS IN ADVANCE.—As 

5 soon as practicable, but in no case later than 

6 15 days prior to a meeting of an advisory com7 mittee to which a written determination as re8 ferred to in section 208(b)(1) of title 18, United 

9 States Code, a written certification as referred 

10 to in section 208(b)(3) of title 18, United 

11 States Code, or a waiver as referred to in para12 graph (3) applies, the Secretary shall disclose 

13 (other than information exempted from disclo14 sure under section 552 of title 5, United States 

15 Code, and section 552a of title 5, United States 

16 Code (popularly known as the Freedom of In17 formation Act and the Privacy Act of 1974, re18 spectively)) on the Internet website of the Food 

19 and Drug Administration—

20 ‘‘(i) the type, nature, and magnitude 

21 of the financial interests of the advisory 

22 committee member to which such deter23 mination, certification, or waiver applies; 

24 and 
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1 ‘‘(ii) the reasons of the Secretary for 

2 such determination, certification, or waiv3 er. 

4 ‘‘(B) LESS THAN 30 DAYS IN ADVANCE.—

5 In the case of a financial interest that becomes 

6 known to the Secretary less than 30 days prior 

7 to a meeting of an advisory committee to which 

8 a written determination as referred to in section 

9 208(b)(1) of title 18, United States Code, a 

10 written certification as referred to in section 

11 208(b)(3) of title 18, United States Code, or a 

12 waiver as referred to in paragraph (3) applies, 

13 the Secretary shall disclose (other than infor14 mation exempted from disclosure under section 

15 552 of title 5, United States Code, and section 

16 552a of title 5, United States Code) on the 

17 Internet website of the Food and Drug Admin18 istration, the information described in clauses 

19 (i) and (ii) of subparagraph (A) as soon as 

20 practicable after the Secretary makes such de21 termination, certification, or waiver, but in no 

22 case later than the date of such meeting. 

23 ‘‘(d) PUBLIC RECORD.—The Secretary shall ensure 

24 that the public record and transcript of each meeting of 

25 an advisory committee includes the disclosure required 
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1 under subsection (c)(5) (other than information exempted 

2 from disclosure under section 552 of title 5, United States 

3 Code, and section 552a of title 5, United States Code). 

4 ‘‘(e) ANNUAL REPORT.—Not later than February 1 

5 of each year, the Secretary shall submit to the Inspector 

6 General of the Department of Health and Human Serv7 ices, the Committee on Appropriations and the Committee 

8 on Health, Education, Labor, and Pensions of the Senate, 

9 and the Committee on Appropriations and the Committee 

10 on Energy and Commerce of the House of Representa11 tives, a report that describes—

12 ‘‘(1) with respect to the fiscal year that ended 

13 on September 30 of the previous year, the number 

14 of vacancies on each advisory committee, the number 

15 of nominees received for each committee, and the 

16 number of such nominees willing to serve; 

17 ‘‘(2) with respect to such year, the aggregate 

18 number of disclosures required under subsection 

19 (c)(5) for each meeting of each advisory committee 

20 and the percentage of individuals to whom such dis21 closures did not apply who served on such committee 

22 for each such meeting; 

23 ‘‘(3) with respect to such year, the number of 

24 times the disclosures required under subsection 
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1 (c)(5) occurred under subparagraph (B) of such sub2 section; and 

3 ‘‘(4) how the Secretary plans to reduce the 

4 number of vacancies reported under paragraph (1) 

5 during the fiscal year following such year, and mech6 anisms to encourage the nomination of individuals 

7 for service on an advisory committee, including those 

8 who are classified by the Food and Drug Adminis9 tration as academicians or practitioners. 

10 ‘‘(f) PERIODIC REVIEW OF GUIDANCE.—Not less 

11 than once every 5 years, the Secretary shall review guid12 ance of the Food and Drug Administration regarding con13 flict of interest waiver determinations with respect to advi14 sory committees and update such guidance as necessary.’’. 

15 (b) CONFORMING AMENDMENT.—Section 505(n) of 

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

17 355(n)) is amended by—

18 (1) striking paragraph (4); and 

19 (2) redesignating paragraphs (5), (6), (7), and 

20 (8) as paragraphs (4), (5), (6), and (7), respectively. 

21 (c) EFFECTIVE DATE.—The amendments made by 

22 this section shall take effect on October 1, 2007. 
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1 Subtitle E—Other Drug Safety 

2 Provisions 

3 SEC. 251. DATABASE FOR AUTHORIZED GENERIC DRUGS. 

4 Section 505 of the Federal Food, Drug, and Cosmetic 

5 Act (21 U.S.C. 355), as amended by this title, is further 

6 amended by adding at the end the following: 

7 ‘‘(q) DATABASE FOR AUTHORIZED GENERIC

8 DRUGS.—

9 ‘‘(1) IN GENERAL.—

10 ‘‘(A) PUBLICATION.—The Commissioner 

11 shall—

12 ‘‘(i) not later than 9 months after the 

13 date of enactment of the Enhancing Drug 

14 Safety and Innovation Act of 2007, publish 

15 a complete list on the Internet website of 

16 the Food and Drug Administration of all 

17 authorized generic drugs (including drug 

18 trade name, brand company manufacturer, 

19 and the date the authorized generic drug 

20 entered the market); and 

21 ‘‘(ii) update the list quarterly to in22 clude each authorized generic drug in23 cluded in an annual report submitted to 

24 the Secretary by the sponsor of a listed 

25 drug during the preceding 3-month period. 
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1 ‘‘(B) NOTIFICATION.—The Commissioner 

2 shall notify relevant Federal agencies, including 

3 the Centers for Medicare & Medicaid Services 

4 and the Federal Trade Commission, any time 

5 the Commissioner updates the information de6 scribed in subparagraph (A). 

7 ‘‘(2) INCLUSION.—The Commissioner shall in8 clude in the list described in paragraph (1) each au9 thorized generic drug included in an annual report 

10 submitted to the Secretary by the sponsor of a listed 

11 drug after January 1, 1999. 

12 ‘‘(3) AUTHORIZED GENERIC DRUG.—In this 

13 section, the term ‘authorized generic drug’ means a 

14 listed drug (as that term is used in subsection (j)) 

15 that—

16 ‘‘(A) has been approved under subsection 

17 (c); and 

18 ‘‘(B) is marketed, sold, or distributed di19 rectly or indirectly to retail class of trade under 

20 a different labeling, packaging (other than re21 packaging as the listed drug in blister packs, 

22 unit doses, or similar packaging for use in insti23 tutions), product code, labeler code, trade name, 

24 or trade mark than the listed drug.’’. 
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1 SEC. 252. MEDICAL MARIJUANA. 

2 The Secretary shall require that State-legalized med3 ical marijuana be subject to the full regulatory require4 ments of the Food and Drug Administration, including a 

5 risk evaluation and mitigation strategy and all other re6 quirements and penalties of the Federal Food, Drug, and 

7 Cosmetic Act (21 U.S.C. 301 et seq.) regarding safe and 

8 effective reviews, approval, sale, marketing, and use of 

9 pharmaceuticals. 

10 Subtitle F—Antibiotic Access and 

11 Innovation 

12 SEC. 261. INCENTIVES FOR THE DEVELOPMENT OF, AND 

13 ACCESS TO, CERTAIN ANTIBIOTICS. 

14 (a) IN GENERAL.—Section 505 of the Federal Food, 

15 Drug, and Cosmetic Act (21 U.S.C. 355), as amended by 

16 this Act, is further amended by adding at the end the fol17 lowing: 

18 ‘‘(s) ANTIBIOTIC DRUGS SUBMITTED BEFORE NO19 VEMBER 21, 1997.—

20 ‘‘(1) ANTIBIOTIC DRUGS APPROVED BEFORE

21 NOVEMBER 21, 1997.—

22 ‘‘(A) IN GENERAL.—Notwithstanding any 

23 provision of the Food and Drug Administration 

24 Modernization Act of 1997 or any other provi25 sion of law, a sponsor of a drug that is the sub26 ject of an application described in subparagraph 
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1 (B)(i) shall be eligible for, with respect to the 

2 drug, the 3-year exclusivity period referred to 

3 under clauses (iii) and (iv) of subsection 

4 (c)(3)(E) and under clauses (iii) and (iv) of 

5 subsection (j)(5)(F), subject to the require6 ments of such clauses, as applicable. 

7 ‘‘(B) APPLICATION; ANTIBIOTIC DRUG DE8 SCRIBED.—

9 ‘‘(i) APPLICATION.—An application 

10 described in this clause is an application 

11 for marketing submitted under this section 

12 after the date of enactment of this sub13 section in which the drug that is the sub14 ject of the application contains an anti15 biotic drug described in clause (ii). 

16 ‘‘(ii) ANTIBIOTIC DRUG.—An anti17 biotic drug described in this clause is an 

18 antibiotic drug that was the subject of an 

19 application approved by the Secretary 

20 under section 507 of this Act (as in effect 

21 before November 21, 1997). 

22 ‘‘(2) ANTIBIOTIC DRUGS SUBMITTED BEFORE

23 NOVEMBER 21, 1997, BUT NOT APPROVED.—

24 ‘‘(A) IN GENERAL.—Notwithstanding any 

25 provision of the Food and Drug Administration 
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1 Modernization Act of 1997 or any other provi2 sion of law, a sponsor of a drug that is the sub3 ject of an application described in subparagraph 

4 (B)(i) may elect to be eligible for, with respect 

5 to the drug—

6 ‘‘(i)(I) the 3-year exclusivity period re7 ferred to under clauses (iii) and (iv) of 

8 subsection (c)(3)(E) and under clauses (iii) 

9 and (iv) of subsection (j)(5)(F), subject to 

10 the requirements of such clauses, as appli11 cable; and 

12 ‘‘(II) the 5-year exclusivity period re13 ferred to under clause (ii) of subsection 

14 (c)(3)(E) and under clause (ii) of sub15 section (j)(5)(F), subject to the require16 ments of such clauses, as applicable; or 

17 ‘‘(ii) a patent term extension under 

18 section 156 of title 35, United States 

19 Code, subject to the requirements of such 

20 section. 

21 ‘‘(B) APPLICATION; ANTIBIOTIC DRUG DE22 SCRIBED.—

23 ‘‘(i) APPLICATION.—An application 

24 described in this clause is an application 

25 for marketing submitted under this section 
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1 after the date of enactment of this sub2 section in which the drug that is the sub3 ject of the application contains an anti4 biotic drug described in clause (ii). 

5 ‘‘(ii) ANTIBIOTIC DRUG.—An anti6 biotic drug described in this clause is an 

7 antibiotic drug that was the subject of 1 or 

8 more applications received by the Secretary 

9 under section 507 of this Act (as in effect 

10 before November 21, 1997), none of which 

11 was approved by the Secretary under such 

12 section. 

13 ‘‘(3) LIMITATIONS.—

14 ‘‘(A) EXCLUSIVITIES AND EXTENSIONS.—

15 Paragraphs (1)(A) and (2)(A) shall not be con16 strued to entitle a drug that is the subject of 

17 an approved application described in subpara18 graphs (1)(B)(i) or (2)(B)(i), as applicable, to 

19 any market exclusivities or patent extensions 

20 other than those exclusivities or extensions de21 scribed in paragraph (1)(A) or (2)(A). 

22 ‘‘(B) CONDITIONS OF USE.—Paragraphs 

23 (1)(A) and (2)(A)(i) shall not apply to any con24 dition of use for which the drug referred to in 

25 subparagraph (1)(B)(i) or (2)(B)(i), as applica-
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1 ble, was approved before the date of enactment 

2 of this subsection. 

3 ‘‘(4) APPLICATION OF CERTAIN PROVISIONS.—

4 Notwithstanding section 125, or any other provision, 

5 of the Food and Drug Administration Modernization 

6 Act of 1997, or any other provision of law, and sub7 ject to the limitations in paragraphs (1), (2), and 

8 (3), the provisions of the Drug Price Competition 

9 and Patent Term Restoration Act of 1984 shall 

10 apply to any drug subject to paragraph (1) or any 

11 drug with respect to which an election is made under 

12 paragraph (2)(A).’’. 

13 (b) TRANSITION RULE.—With respect to a patent 

14 issued on or before the date of enactment of this Act, any 

15 patent information required to be filed with the Secretary 

16 under subsection (b)(1) or (c)(2) of section 505 of the 

17 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 

18 to be listed on a drug to which subsection (s)(1) of such 

19 section 505 (as added by this section) applies shall be filed 

20 with such Secretary not later than 60 days after the date 

21 of enactment of this Act. 

22 SEC. 262. ANTIBIOTICS AS ORPHAN PRODUCTS. 

23 (a) PUBLIC MEETING.—The Commissioner of Food 

24 and Drugs shall convene a public meeting and, if appro25 priate, issue guidance, regarding which serious and life-
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1 threatening infectious diseases, such as diseases due to 

2 gram-negative bacteria and other diseases due to anti3 biotic-resistant bacteria, potentially qualify for available 

4 grants and contracts under subsection (a) of section 5 of 

5 the Orphan Drug Act (21 U.S.C. 360ee(a)) or other incen6 tives for development. 

7 (b) GRANTS AND CONTRACTS FOR THE DEVELOP8 MENT OF ORPHAN DRUGS.—Subsection (c) of section 5 

9 of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended 

10 to read as follows: 

11 ‘‘(c) For grants and contracts under subsection (a) 

12 there are authorized to be appropriated—

13 ‘‘(1) such sums as already have been appro14 priated for fiscal year 2007; and 

15 ‘‘(2) $35,000,000 for each of fiscal years 2008 

16 through 2012.’’. 

17 SEC. 263. IDENTIFICATION OF CLINICALLY SUSCEPTIBLE 

18 CONCENTRATIONS OF ANTIMICROBIALS. 

19 (a) DEFINITION.—In this section, the term ‘‘clinically 

20 susceptible concentrations’’ means specific values which 

21 characterize bacteria as clinically susceptible, inter22 mediate, or resistant to the drug (or drugs) tested. 

23 (b) IDENTIFICATION.—The Secretary of Health and 

24 Human Services (referred to in this section as the ‘‘Sec25 retary’’), through the Commissioner of Food and Drugs, 
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1 shall identify and periodically update clinically susceptible 

2 concentrations. 

3 (c) PUBLIC AVAILABILITY.—The Secretary, through 

4 the Commissioner of Food and Drugs, shall make such 

5 clinically susceptible concentrations publicly available 

6 within 30 days of the date of identification and any update 

7 under this section. 

8 (d) EFFECT.—Nothing in this section shall be con9 strued to restrict, in any manner, the prescribing of anti10 biotics by physicians, or to limit the practice of medicine, 

11 including for diseases such as Lyme and tick-borne dis12 eases. 

13 SEC. 264. EXCLUSIVITY OF CERTAIN DRUGS CONTAINING 

14 SINGLE ENANTIOMERS. 

15 Section 505 of the Federal Food, Drug, and Cosmetic 

16 Act (21 U.S. C. 355), as amended by this subtitle, is 

17 amended by adding at the end the following: 

18 ‘‘(t) CERTAIN DRUGS CONTAINING SINGLE

19 ENANTIOMERS.—

20 ‘‘(1) IN GENERAL.—For purposes of sub21 sections (c)(3)(E)(ii) and (j)(5)(F)(ii), if an applica22 tion is submitted under subsection (b) for a non-ra23 cemic drug containing as an active ingredient a sin24 gle enantiomer that is contained in a racemic drug 

25 approved in another application under subsection 
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1 (b), the applicant may, in the application for such 

2 non-racemic drug, elect to have the single 

3 enantiomer not be considered the same active ingre4 dient as that contained in the approved racemic 

5 drug, if—

6 ‘‘(A)(i) the single enantiomer has not been 

7 previously approved except in the approved ra8 cemic drug; and 

9 ‘‘(ii) the application submitted under sub10 section (b) for such non-racemic drug—

11 ‘‘(I) includes full reports of new clin12 ical investigations (other than bio13 availability studies)—

14 ‘‘(aa) necessary for the approval 

15 of the application under subsections 

16 (c) and (d); and 

17 ‘‘(bb) conducted or sponsored by 

18 the applicant; and 

19 ‘‘(II) does not rely on any investiga20 tions that are part of an application sub21 mitted under subsection (b) for approval of 

22 the approved racemic drug; and 

23 ‘‘(B) the application submitted under sub24 section (b) for such non-racemic drug is not 

25 submitted for approval of a condition of use—
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1 ‘‘(i) in a therapeutic category in which 

2 the approved racemic drug has been ap3 proved; or 

4 ‘‘(ii) for which any other enantiomer 

5 of the racemic drug has been approved. 

6 ‘‘(2) LIMITATION.—

7 ‘‘(A) NO APPROVAL IN CERTAIN THERA8 PEUTIC CATEGORIES.—Until the date that is 10 

9 years after the date of approval of a non-race10 mic drug described in paragraph (1) and with 

11 respect to which the applicant has made the 

12 election provided for by such paragraph, the 

13 Secretary shall not approve such non-racemic 

14 drug for any condition of use in the therapeutic 

15 category in which the racemic drug has been 

16 approved. 

17 ‘‘(B) LABELING.—If applicable, the label18 ing of a non-racemic drug described in para19 graph (1) and with respect to which the appli20 cant has made the election provided for by such 

21 paragraph shall include a statement that the 

22 non-racemic drug is not approved, and has not 

23 been shown to be safe and effective, for any 

24 condition of use of the racemic drug. 

25 ‘‘(3) DEFINITION.—
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1 ‘‘(A) IN GENERAL.—For purposes of this 

2 subsection, the term ‘therapeutic category’ 

3 means a therapeutic category identified in the 

4 list developed by the United States Pharma5 copeia pursuant to section 1860D–

6 4(b)(3)(C)(ii) of the Social Security Act and as 

7 in effect on the date of enactment of this sub8 section. 

9 ‘‘(B) PUBLICATION BY SECRETARY.—The 

10 Secretary shall publish the list described in sub11 paragraph (A) and may amend such list by reg12 ulation. 

13 ‘‘(4) AVAILABILITY.—The election referred to 

14 in paragraph (1) may be made only in an application 

15 that is submitted to the Secretary after the date of 

16 enactment of this subsection and before October 1, 

17 2012.’’. 

18 SEC. 265. REPORT. 

19 Not later than January 1, 2012, the Comptroller 

20 General of the United States shall submit a report to the 

21 Committee on Health, Education, Labor, and Pensions of 

22 the Senate and the Committee on Energy and Commerce 

23 of the House of Representatives that examines whether 

24 and how this subtitle has—
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1 (1) encouraged the development of new anti2 biotics and other drugs; and 

3 (2) prevented or delayed timely generic drug 

4 entry into the market. 

5 TITLE III—MEDICAL DEVICES 

6 SEC. 300. REFERENCES. 

7 Except as otherwise specified, whenever in this title 

8 an amendment is expressed in terms of an amendment to 

9 a section or other provision, the reference shall be consid10 ered to be made to a section or other provision of the Fed11 eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 

12 seq.). 

13 Subtitle A—Device User Fees 

14 SEC. 301. SHORT TITLE. 

15 This subtitle may be cited as the ‘‘Medical Device 

16 User Fee Amendments of 2007’’. 

17 SEC. 302. DEVICE FEES. 

18 Section 737 (21 U.S.C. 379i) is amended—

19 (1) by striking the section designation and all 

20 that follows through ‘‘For purposes of this sub21 chapter’’ and inserting the following: 

22 ‘‘SEC. 737. DEVICE FEES. 

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

24 the fees authorized under this part be dedicated toward 

25 expediting the process for the review of device applications 
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1 and for assuring the safety and effectiveness of devices, 

2 as set forth in the goals identified for purposes of this 

3 part in the letters from the Secretary to the Chairman 

4 of the Committee on Health, Education, Labor, and Pen5 sions of the Senate and the Chairman of the Committee 

6 on Energy and Commerce of the House of Representa7 tives, as set forth in the Congressional Record. 

8 ‘‘(b) REPORTS.—

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

10 2008 through 2012, not later than 120 days after 

11 the end of each fiscal year during which fees are col12 lected under this part, the Secretary shall prepare 

13 and submit to the Committee on Health, Education, 

14 Labor, and Pensions of the Senate and the Com15 mittee on Energy and Commerce of the House of 

16 Representatives, a report concerning the progress of 

17 the Food and Drug Administration in achieving the 

18 goals identified in the letters described in subsection 

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

20 the Food and Drug Administration for meeting the 

21 goals. The report for a fiscal year shall include infor22 mation on all previous cohorts for which the Sec23 retary has not given a complete response on all de24 vice premarket applications, supplements, and pre25 market notifications in the cohort. 
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1 ‘‘(2) FISCAL REPORT.—For fiscal years 2008 

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

3 of each fiscal year during which fees are collected 

4 under this part, the Secretary shall prepare and sub5 mit to the Committee on Health, Education, Labor, 

6 and Pensions of the Senate and the Committee on 

7 Energy and Commerce of the House of Representa8 tives, a report on the implementation of the author9 ity for such fees during such fiscal year and the use, 

10 by the Food and Drug Administration, of the fees 

11 collected during such fiscal year for which the report 

12 is made. 

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

14 shall make the reports required under paragraphs 

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

16 website of the Food and Drug Administration. 

17 ‘‘(c) REAUTHORIZATION.—

18 ‘‘(1) CONSULTATION.—In developing rec19 ommendations to present to Congress with respect to 

20 the goals, and plans for meeting the goals, for the 

21 process for the review of device applications for the 

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

23 reauthorization of this part for such fiscal years, the 

24 Secretary shall consult with—
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1 ‘‘(A) the Committee on Energy and Com2 merce of the House of Representatives; 

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

4 Labor, and Pensions of the Senate; 

5 ‘‘(C) scientific and academic experts; 

6 ‘‘(D) health care professionals; 

7 ‘‘(E) representatives of patient and con8 sumer advocacy groups; and 

9 ‘‘(F) the regulated industry. 

10 ‘‘(2) PUBLIC REVIEW OF RECOMMENDA11 TIONS.—After negotiations with the regulated indus12 try, the Secretary shall—

13 ‘‘(A) present the recommendations devel14 oped under paragraph (1) to the Congressional 

15 committees specified in such paragraph; 

16 ‘‘(B) publish such recommendations in the 

17 Federal Register; 

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

19 the public to provide written comments on such 

20 recommendations; 

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

22 may present its views on such recommenda23 tions; and 
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1 ‘‘(E) after consideration of such public 

2 views and comments, revise such recommenda3 tions as necessary. 

4 ‘‘(3) TRANSMITTAL OF RECOMMENDATIONS.—

5 Not later than January 15, 2012, the Secretary 

6 shall transmit to Congress the revised recommenda7 tions under paragraph (2), a summary of the views 

8 and comments received under such paragraph, and 

9 any changes made to the recommendations in re10 sponse to such views and comments. 

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

12 (2) by redesignating paragraphs (5), (6), (7), 

13 and (8), as paragraphs (7), (8), (9), and (11), re14 spectively; 

15 (3) in paragraph (4)—

16 (A) in subparagraph (A), by striking ‘‘or 

17 an efficacy supplement,’’ and inserting ‘‘an effi18 cacy supplement, or a 30-day notice,’’; and 

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

20 ‘‘(F) The term ‘30-day notice’ means a supple21 ment to an approved premarket application or pre22 market report under section 515 that is limited to 

23 a request to make modifications to manufacturing 

24 procedures or methods of manufacture affecting the 

25 safety and effectiveness of the device.’’; 
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1 (4) by inserting after paragraph (4) the fol2 lowing: 

3 ‘‘(5) The term ‘request for classification infor4 mation’ means a request made under section 513(g) 

5 for information respecting the class in which a de6 vice has been classified or the requirements applica7 ble to a device. 

8 ‘‘(6) The term ‘annual fee for periodic reporting 

9 concerning a class III device’ means the fee associ10 ated with reports imposed by a premarket applica11 tion approval order (as described in section 

12 814.82(a)(7) of title 21, Code of Federal Regula13 tions), usually referred to as ‘annual reports.’ ’’; 

14 (5) in paragraph (9), as redesignated by para15 graph (2)—

16 (A) by striking ‘‘April of’’ and inserting 

17 ‘‘October of’’; and 

18 (B) by striking ‘‘April 2002’’ and inserting 

19 ‘‘October 2001’’; 

20 (6) by inserting after paragraph (9), as redesig21 nated by paragraph (2), the following: 

22 ‘‘(10) The term ‘person’ includes an affiliate of 

23 such person.’’; and 

24 (7) by adding at the end the following: 
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1 ‘‘(12) The term ‘establishment subject to a reg2 istration fee’ means an establishment required to 

3 register with the Secretary under section 510 at 

4 which any of the following types of activities are 

5 conducted: 

6 ‘‘(A) MANUFACTURER.—An establishment 

7 that makes by any means any article that is a 

8 device including an establishment that sterilizes 

9 or otherwise makes such article for or on behalf 

10 of a specification developer or any other person. 

11 ‘‘(B) SINGLE-USE DEVICE REPROC12 ESSOR.—An establishment that performs manu13 facturing operations on a single-use device that 

14 has previously been used on a patient. 

15 ‘‘(C) SPECIFICATION DEVELOPER.—An es16 tablishment that develops specifications for a 

17 device that is distributed under the establish18 ment’s name but that performs no manufac19 turing, including establishments that, in addi20 tion to developing specifications, arrange for the 

21 manufacturing of devices labeled with another 

22 establishment’s name by a contract manufac23 turer. 

24 ‘‘(13) The term ‘establishment registration fee’ 

25 means a fee assessed under section 738(a)(3) for the 
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1 registration of an establishment subject to a reg2 istration fee. 

3 ‘‘(e) SUNSET.—This part shall cease to be effective 

4 on October 1, 2012, except that subsection (b) with re5 spect to reports shall cease to be effective January 31, 

6 2013.’’. 

7 SEC. 303. AUTHORITY TO ASSESS AND USE DEVICE FEES. 

8 Section 738 (21 U.S.C. 379j) is amended—

9 (1) in subsection (a)—

10 (A) in paragraph (2)—

11 (i) in the header, by inserting ‘‘, AND

12 ANNUAL FEE FOR PERIODIC REPORTING

13 CONCERNING A CLASS III DEVICE’’ after 

14 ‘‘FEE’’; 

15 (ii) in subparagraph (A)—

16 (I) in clause (iii), by inserting 

17 ‘‘75 percent of’’ after ‘‘a fee equal 

18 to’’; 

19 (II) in clause (iv), by striking 

20 ‘‘21.5’’ and inserting ‘‘15’’; 

21 (III) in clause (v), by striking 

22 ‘‘7.2’’ and inserting ‘‘7’’; 

23 (IV) by redesignating clauses (vi) 

24 and (vii) as clauses (vii) and (viii), re25 spectively; 
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1 (V) by inserting after clause (v) 

2 the following: 

3 ‘‘(vi) For a 30-day notice, a fee equal 

4 to 1.6 percent of the fee that applies under 

5 clause (i).’’; 

6 (VI) in clause (viii), as redesig7 nated by subclause (IV)—

8 (aa) by striking ‘‘1.42’’ and 

9 inserting ‘‘1.84’’; and 

10 (bb) by striking ‘‘, subject to 

11 any adjustment under subsection 

12 (e)(2)(C)(ii)’’; and 

13 (VII) by adding at the end the 

14 following: 

15 ‘‘(ix) For a request for classification 

16 information, a fee equal to 1.35 percent of 

17 the fee that applies under clause (i). 

18 ‘‘(x) For periodic reporting concerning 

19 a class III device, the annual fee shall be 

20 equal to 3.5 percent of the fee that applies 

21 under clause (i).’’; 

22 (iii) in subparagraph (C)—

23 (I) in the first sentence—

24 (aa) by striking ‘‘or’’; and 
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1 (bb) by striking ‘‘except 

2 that’’ and all that follows 

3 through the period and inserting 

4 ‘‘, 30-day notice, request for clas5 sification information, or periodic 

6 report concerning a class III de7 vice.’’; and 

8 (II) by striking the third sen9 tence; and 

10 (iv) in subparagraph (D)—

11 (I) in clause (iii), by striking the 

12 last two sentences; and 

13 (II) by adding at the end the fol14 lowing: 

15 ‘‘(iv) MODULAR APPLICATION WITH16 DRAWN BEFORE FIRST ACTION.—The Sec17 retary shall refund 75 percent of the appli18 cation fee paid for a modular application 

19 submitted under section 515(c)(4) that is 

20 withdrawn before a second module is sub21 mitted and before a first action on the first 

22 module. If the modular application is with23 drawn after a second or subsequent module 

24 is submitted but before any first action, 

25 the Secretary may return a portion of the 
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1 fee. The amount of refund, if any, shall be 

2 based on the level of effort already ex3 pended on the review of the modules sub4 mitted. 

5 ‘‘(v) SOLE DISCRETION TO REFUND.—

6 The Secretary shall have sole discretion to 

7 refund a fee or portion of the fee under 

8 this subparagraph. A determination by the 

9 Secretary concerning a refund under this 

10 paragraph shall not be reviewable.’’; and 

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

12 ‘‘(3) ANNUAL ESTABLISHMENT REGISTRATION

13 FEE.—

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

15 subparagraph (B), each establishment subject 

16 to a registration fee shall be subject to a fee for 

17 each initial or annual registration beginning 

18 with its registration for fiscal year 2008. 

19 ‘‘(B) EXCEPTION FOR FEDERAL OR STATE

20 GOVERNMENT ESTABLISHMENT.—No fee shall 

21 be required under subparagraph (A) for an es22 tablishment operated by a Federal or State gov23 ernment entity unless a device manufactured by 

24 the establishment is to be distributed commer25 cially. 
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1 ‘‘(C) PAYMENT.—The annual establish2 ment registration fee shall be due once each fis3 cal year, upon the initial registration of the es4 tablishment or upon the annual registration 

5 under section 510.’’; 

6 (2) by striking subsection (b) and inserting the 

7 following: 

8 ‘‘(b) FEE AMOUNTS.—Except as provided in sub9 sections (c), (d), and (e), the fees under subsection (a) 

10 shall be based on the following fee amounts:

Fee Type 

Fiscal 

Year 

2008

Fiscal 

Year 

2009

Fiscal 

Year 

2010

Fiscal 

Year 

2011

Fiscal 

Year 

2012

Premarket Application $185,000 $200,725 $217,787 $236,298 $256,384

................

Establishment 

Registration 

Fee $1,706 $1,851 $2,008 $2,179 $2,364’’; 

11 (3) in subsection (c)—

12 (A) in the heading, by striking ‘‘Annual 

13 Fee Setting.—’’ and inserting ‘‘ANNUAL FEE

14 SETTING.—’’; 

15 (B) in paragraph (1), by striking the sec16 ond sentence; 

17 (C) by redesignating paragraphs (2) and 

18 (3) as paragraphs (3) and (4), respectively; 
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1 (D) by inserting after paragraph (1) the 

2 following: 

3 ‘‘(2) ADJUSTMENT OF ANNUAL ESTABLISH4 MENT REGISTRATION FEE.—

5 ‘‘(A) IN GENERAL.—When setting the fees 

6 for fiscal year 2010, the Secretary may increase 

7 the establishment registration fee specified in 

8 subsection (b) only if the Secretary estimates 

9 that the number of establishments submitting 

10 fees for fiscal year 2009 is less than 12,250. 

11 The percent increase shall be the percent by 

12 which the estimate of establishments submitting 

13 fees in fiscal year 2009 is less than 12,750, but 

14 in no case shall the percent increase be more 

15 than 8.5 percent over the amount for such fee 

16 specified in subsection (b) for fiscal year 2010. 

17 If the Secretary makes any adjustment to the 

18 establishment registration fee for fiscal year 

19 2010, then the establishment registration fee 

20 for fiscal years 2011 and 2012 under sub21 section (b) shall be adjusted as follows: the fee 

22 for fiscal year 2011 shall be equal to the ad23 justed fee for fiscal year 2010, increased by 8.5 

24 percent, and the fee for fiscal year 2012 shall 
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1 be equal to the adjusted fee for fiscal year 

2 2011, increased by 8.5 percent. 

3 ‘‘(B) PUBLICATION IN THE FEDERAL REG4 ISTER.—The Secretary shall publish any deter5 mination with respect to any establishment reg6 istration fee adjustment made under subpara7 graph (A), and the rationale for such deter8 mination, in the Federal Register.’’; and 

9 (E) in paragraph (4)(A), as so redesig10 nated—

11 (i) by striking ‘‘For fiscal years 2006 

12 and 2007, the’’ and inserting ‘‘The’’; and 

13 (ii) by striking ‘‘of fiscal year 2008’’ 

14 and inserting ‘‘of the next fiscal year’’; 

15 (4) in subsection (d)—

16 (A) in paragraph (1), by striking ‘‘, part17 ners, and parent firms’’; 

18 (B) in paragraph (2)—

19 (i) in subparagraph (A), by striking ‘‘, 

20 partners, and parent firms’’; 

21 (ii) in subparagraph (B)—

22 (I) by striking ‘‘An applicant 

23 shall’’ and inserting the following: 

24 ‘‘(i) IN GENERAL.—An applicant 

25 shall’’; 
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1 (II) by striking ‘‘The applicant 

2 shall support’’ and inserting the fol3 lowing: 

4 ‘‘(ii) FIRMS SUBMITTING TAX RE5 TURNS TO THE UNITED STATES INTERNAL

6 REVENUE SERVICE.—The applicant shall 

7 support’’; 

8 (III) by striking ‘‘, partners, and 

9 parent firms’’ both places the term 

10 appears; 

11 (IV) by striking ‘‘partners, or 

12 parent firms, the’’ and inserting 

13 ‘‘the’’; 

14 (V) by striking ‘‘, partners, or 

15 parent firms, respectively’’; and 

16 (VI) by adding at the end the fol17 lowing: 

18 ‘‘(iii) FIRMS NOT SUBMITTING TAX

19 RETURNS TO THE UNITED STATES INTER20 NAL REVENUE SERVICE.—The applicant 

21 shall support its claim that it meets the 

22 definition under subparagraph (A) by sub23 mission of the following: 

24 ‘‘(I) A signed certification, in 

25 such form as the Secretary may direct 
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1 through a notice published in the Fed2 eral Register, that the applicant meets 

3 the criteria for a small business. 

4 ‘‘(II) A certification, in English, 

5 from the national taxing authority of 

6 the country in which it is 

7 headquartered. Such certification shall 

8 provide the applicant’s gross receipts 

9 and sales for the most recent year, in 

10 both the local currency and in United 

11 States dollars, the exchange rate used 

12 in making this conversion to dollars, 

13 and the dates during which these re14 ceipts and sales were collected, and it 

15 shall bear the official seal of the na16 tional taxing authority. 

17 ‘‘(III) Identical certifications 

18 shall be provided for each of the appli19 cant’s affiliates. 

20 ‘‘(IV) A statement signed by the 

21 head of the applicant or its chief fi22 nancial officer that it has submitted 

23 certifications for all of its affiliates, or 

24 that it had no affiliates, whichever is 

25 applicable.’’; and 
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1 (iii) in subparagraph (C)—

2 (I) by striking ‘‘reduced rate of’’ 

3 and inserting ‘‘reduced rate of—’’; 

4 and 

5 (II) by striking ‘‘38 percent’’ and 

6 all that follows through the period and 

7 inserting the following: 

8 ‘‘(i) 25 percent of the fee established 

9 under such subsection for a premarket ap10 plication, a premarket report, a supple11 ment, or a periodic report concerning a 

12 class III device; and 

13 ‘‘(ii) 50 percent of the fee established 

14 under such subsection for a 30-day notice 

15 or a request for classification informa16 tion.’’; 

17 (5) in subsection (e)—

18 (A) in paragraph (1), by striking ‘‘2004’’ 

19 and inserting ‘‘2008’’; and 

20 (B) in paragraph (2)—

21 (i) in subparagraph (A), by striking ‘‘, 

22 partners, and parent firms’’; 

23 (ii) by striking subparagraph (B) and 

24 inserting the following: 

25 ‘‘(B) EVIDENCE OF QUALIFICATION.—
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1 ‘‘(i) IN GENERAL.—An applicant shall 

2 pay the higher fees established by the Sec3 retary each year unless the applicant sub4 mits evidence that it qualifies for the lower 

5 fee rate. 

6 ‘‘(ii) FIRMS SUBMITTING TAX RE7 TURNS TO THE UNITED STATES INTERNAL

8 REVENUE SERVICE.—The applicant shall 

9 support its claim that it meets the defini10 tion under subparagraph (A) by submis11 sion of a copy of its most recent Federal 

12 income tax return for a taxable year, and 

13 a copy of such returns of its affiliates, 

14 which show an amount of gross sales or re15 ceipts that is less than the maximum es16 tablished in subparagraph (A). The appli17 cant, and each of such affiliates, shall cer18 tify that the information provided is a true 

19 and accurate copy of the actual tax forms 

20 they submitted to the Internal Revenue 

21 Service. If no tax forms are submitted for 

22 affiliates, the applicant shall certify that 

23 the applicant has no affiliates. 

24 ‘‘(iii) FIRMS NOT SUBMITTING TAX

25 RETURNS TO THE UNITED STATES INTER-
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1 NAL REVENUE SERVICE.—The applicant 

2 shall support its claim that it meets the 

3 definition under subparagraph (A) by sub4 mission of the following: 

5 ‘‘(I) A signed certification, in 

6 such form as the Secretary may direct 

7 through a notice published in the Fed8 eral Register, that the applicant meets 

9 the criteria for a small business. 

10 ‘‘(II) A certification, in English, 

11 from the national taxing authority of 

12 the country in which it is 

13 headquartered. Such certification shall 

14 provide the applicant’s gross receipts 

15 and sales for the most recent year, in 

16 both the local currency and in United 

17 States dollars, and the exchange rate 

18 used in making such conversion to 

19 dollars, and the dates during which 

20 such receipts and sales were collected, 

21 and it shall bear the official seal of 

22 the national taxing authority. 

23 ‘‘(III) Identical certifications 

24 shall be provided for each of the appli25 cant’s affiliates. 
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1 ‘‘(IV) A statement signed by the 

2 head of the applicant or its chief fi3 nancial officer that it has submitted 

4 certifications for all of its affiliates, or 

5 that it had no affiliates, whichever is 

6 applicable.’’; and 

7 (iii) by striking subparagraph (C) and 

8 inserting the following: 

9 ‘‘(C) REDUCED FEES.—For fiscal year 

10 2008 and each subsequent fiscal year, where 

11 the Secretary finds that the applicant involved 

12 meets the definition under subparagraph (A), 

13 the fee for a premarket notification submission 

14 may be paid at 50 percent of the fee that ap15 plies under subsection (a)(2)(A)(viii) and as es16 tablished under subsection (c)(1).’’; 

17 (6) by striking subsection (f) and inserting the 

18 following: 

19 ‘‘(f) EFFECT OF FAILURE TO PAY FEES.—

20 ‘‘(1) IN GENERAL.—A premarket application, 

21 premarket report, supplement, or premarket notifi22 cation submission, 30-day notice, request for classi23 fication information, or periodic report concerning a 

24 class III device submitted by a person subject to fees 

25 under paragraphs (2) and (3) of subsection (a) shall 
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1 be considered incomplete and shall not be accepted 

2 by the Secretary until all fees owed by such person 

3 have been paid. 

4 ‘‘(2) REGISTRATION INFORMATION.—Registra5 tion information submitted by an establishment sub6 ject to a registration fee under subsection (a)(3) 

7 shall be considered incomplete and shall not be ac8 cepted by the Secretary until the registration fee 

9 owed for the establishment has been paid. Until the 

10 fee is paid and the registration is complete, the es11 tablishment shall be deemed to have failed to reg12 ister in accordance with section 510.’’; 

13 (7) in subsection (g)—

14 (A) by striking paragraph (1) and insert15 ing the following: 

16 ‘‘(1) PERFORMANCE GOALS; TERMINATION OF

17 PROGRAM.—With respect to the amount that, under 

18 the salaries and expenses account of the Food and 

19 Drug Administration, is appropriated for a fiscal 

20 year for devices and radiological products, fees may 

21 not be assessed under subsection (a) for the fiscal 

22 year, and the Secretary is not expected to meet any 

23 performance goals identified for the fiscal year, if—

24 ‘‘(A) the amount so appropriated for the 

25 fiscal year, excluding the amount of fees appro-
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1 priated for the fiscal year, is more than 1 per2 cent less than $205,720,000 multiplied by the 

3 adjustment factor applicable to such fiscal year; 

4 or 

5 ‘‘(B) fees were not assessed under sub6 section (a) for the previous fiscal year.’’; and 

7 (B) in paragraph (2), by striking ‘‘and 

8 premarket notification submissions, and’’ and 

9 inserting ‘‘premarket notification submissions, 

10 30-day notices, requests for classification infor11 mation, periodic reports concerning a class III 

12 device, and establishment registrations’’; and 

13 (8) in subsection (h), by striking paragraphs 

14 (3) and (4) and inserting the following: 

15 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—

16 There are authorized to be appropriated for fees 

17 under this section—

18 ‘‘(A) $48,431,000 for fiscal year 2008; 

19 ‘‘(B) $52,547,000 for fiscal year 2009; 

20 ‘‘(C) $57,014,000 for fiscal year 2010; 

21 ‘‘(D) $61,860,000 for fiscal year 2011; 

22 and 

23 ‘‘(E) $67,118,000 for fiscal year 2012. 

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

25 fees collected during fiscal years 2008, 2009, and 
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1 2010, added to the amount estimated to be collected 

2 for fiscal year 2011 (which estimate shall be based 

3 upon the amount of fees received by the Secretary 

4 through June 30, 2011), exceeds the amount of fees 

5 specified in aggregate in paragraph (3) for such 4 

6 fiscal years, the aggregate amount in excess shall be 

7 credited to the appropriation account of the Food 

8 and Drug Administration as provided in paragraph 

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

10 that would otherwise be authorized to be collected 

11 under this section pursuant to appropriation Acts 

12 for fiscal year 2012.’’. 

13 SEC. 304. SAVINGS CLAUSE. 

14 Notwithstanding section 107 of the Medical Device 

15 User Fee and Modernization Act of 2002 (Public Law 

16 107–250), and notwithstanding the amendments made by 

17 this subtitle, part 3 of subchapter C of chapter VII of the 

18 Federal Food, Drug, and Cosmetic Act, as in effect on 

19 the day before the date of enactment of this subtitle, shall 

20 continue to be in effect with respect to premarket applica21 tions, premarket reports, premarket notification submis22 sions, and supplements (as defined in such part as of such 

23 day) that on or after October 1, 2002, but before October 

24 1, 2007, were accepted by the Food and Drug Administra25 tion for filing with respect to assessing and collecting any 
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1 fee required by such part for a fiscal year prior to fiscal 

2 year 2008. 

3 SEC. 305. EFFECTIVE DATE. 

4 The amendments made by this subtitle shall take ef5 fect on October 1, 2007. 

6 Subtitle B—Amendments Regard7 ing Regulation of Medical De8 vices 

9 SEC. 311. INSPECTIONS BY ACCREDITED PERSONS. 

10 Section 704(g) (21 U.S.C. 374(g)) is amended—

11 (1) in paragraph (1), by striking ‘‘Not later 

12 than one year after the date of enactment of this 

13 subsection, the Secretary’’ and inserting ‘‘The Sec14 retary’’; 

15 (2) in paragraph (2), by—

16 (A) striking ‘‘Not later than 180 days 

17 after the date of enactment of this subsection, 

18 the’’ and inserting ‘‘The Secretary’’; and 

19 (B) striking the fifth sentence; 

20 (3) in paragraph (3), by adding at the end the 

21 following: 

22 ‘‘(F) Such person shall notify the Sec23 retary of any withdrawal, suspension, restric24 tion, or expiration of certificate of conformance 

25 with the quality systems standard referred to in 
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1 paragraph (7) for any device establishment that 

2 such person inspects under this subsection not 

3 later than 30 days after such withdrawal, sus4 pension, restriction, or expiration. 

5 ‘‘(G) Such person may conduct audits to 

6 establish conformance with the quality systems 

7 standard referred to in paragraph (7).’’; 

8 (4) by amending paragraph (6) to read as fol9 lows: 

10 ‘‘(6)(A) Subject to subparagraphs (B) and (C), a de11 vice establishment is eligible for inspection by persons ac12 credited under paragraph (2) if the following conditions 

13 are met: 

14 ‘‘(i) The Secretary classified the results of the 

15 most recent inspection of the establishment as ‘no 

16 action indicated’ or ‘voluntary action indicated’. 

17 ‘‘(ii) With respect to inspections of the estab18 lishment to be conducted by an accredited person, 

19 the owner or operator of the establishment submits 

20 to the Secretary a notice that—

21 ‘‘(I) provides the date of the last inspection 

22 of the establishment by the Secretary and the 

23 classification of that inspection; 
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1 ‘‘(II) states the intention of the owner or 

2 operator to use an accredited person to conduct 

3 inspections of the establishment; 

4 ‘‘(III) identifies the particular accredited 

5 person the owner or operator intends to select 

6 to conduct such inspections; and 

7 ‘‘(IV) includes a certification that, with re8 spect to the devices that are manufactured, pre9 pared, propagated, compounded, or processed in 

10 the establishment—

11 ‘‘(aa) at least 1 of such devices is 

12 marketed in the United States; and 

13 ‘‘(bb) at least 1 of such devices is 

14 marketed, or is intended to be marketed, 

15 in 1 or more foreign countries, 1 of which 

16 countries certifies, accredits, or otherwise 

17 recognizes the person accredited under 

18 paragraph (2) and identified under sub19 clause (III) as a person authorized to con20 duct inspections of device establishments. 

21 ‘‘(B)(i) Except with respect to the requirement of 

22 subparagraph (A)(i), a device establishment is deemed to 

23 have clearance to participate in the program and to use 

24 the accredited person identified in the notice under sub25 paragraph (A)(ii) for inspections of the establishment un-
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1 less the Secretary, not later than 30 days after receiving 

2 such notice, issues a response that—

3 ‘‘(I) denies clearance to participate as provided 

4 under subparagraph (C); or 

5 ‘‘(II) makes a request under clause (ii). 

6 ‘‘(ii) The Secretary may request from the owner or 

7 operator of a device establishment in response to the no8 tice under subparagraph (A)(ii) with respect to the estab9 lishment, or from the particular accredited person identi10 fied in such notice—

11 ‘‘(I) compliance data for the establishment in 

12 accordance with clause (iii)(I); or 

13 ‘‘(II) information concerning the relationship 

14 between the owner or operator of the establishment 

15 and the accredited person identified in such notice in 

16 accordance with clause (iii)(II). 

17 The owner or operator of the establishment, or such 

18 accredited person, as the case may be, shall respond 

19 to such a request not later than 60 days after receiv20 ing such request. 

21 ‘‘(iii)(I) The compliance data to be submitted by the 

22 owner or operation of a device establishment in response 

23 to a request under clause (ii)(I) are data describing wheth24 er the quality controls of the establishment have been suf25 ficient for ensuring consistent compliance with current 
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1 good manufacturing practice within the meaning of section 

2 501(h) and with other applicable provisions of this Act. 

3 Such data shall include complete reports of inspectional 

4 findings regarding good manufacturing practice or other 

5 quality control audits that, during the preceding 2-year 

6 period, were conducted at the establishment by persons 

7 other than the owner or operator of the establishment, to8 gether with all other compliance data the Secretary deems 

9 necessary. Data under the preceding sentence shall dem10 onstrate to the Secretary whether the establishment has 

11 facilitated consistent compliance by promptly correcting 

12 any compliance problems identified in such inspections. 

13 ‘‘(II) A request to an accredited person under clause 

14 (ii)(II) may not seek any information that is not required 

15 to be maintained by such person in records under sub16 section (f)(1). 

17 ‘‘(iv) A device establishment is deemed to have clear18 ance to participate in the program and to use the accred19 ited person identified in the notice under subparagraph 

20 (A)(ii) for inspections of the establishment unless the Sec21 retary, not later than 60 days after receiving the informa22 tion requested under clause (ii), issues a response that de23 nies clearance to participate as provided under subpara24 graph (C). 
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1 ‘‘(C)(i) The Secretary may deny clearance to a device 

2 establishment if the Secretary has evidence that the cer3 tification under subparagraph (A)(ii)(IV) is untrue and 

4 the Secretary provides to the owner or operator of the es5 tablishment a statement summarizing such evidence. 

6 ‘‘(ii) The Secretary may deny clearance to a device 

7 establishment if the Secretary determines that the estab8 lishment has failed to demonstrate consistent compliance 

9 for purposes of subparagraph (B)(iii)(I) and the Secretary 

10 provides to the owner or operator of the establishment a 

11 statement of the reasons for such determination. 

12 ‘‘(iii)(I) The Secretary may reject the selection of the 

13 accredited person identified in the notice under subpara14 graph (A)(ii) if the Secretary provides to the owner or op15 erator of the establishment a statement of the reasons for 

16 such rejection. Reasons for the rejection may include that 

17 the establishment or the accredited person, as the case 

18 may be, has failed to fully respond to the request, or that 

19 the Secretary has concerns regarding the relationship be20 tween the establishment and such accredited person. 

21 ‘‘(II) If the Secretary rejects the selection of an ac22 credited person by the owner or operator of a device estab23 lishment, the owner or operator may make an additional 

24 selection of an accredited person by submitting to the Sec25 retary a notice that identifies the additional selection. 
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1 Clauses (i) and (ii) of subparagraph (B), and subclause 

2 (I) of this clause, apply to the selection of an accredited 

3 person through a notice under the preceding sentence in 

4 the same manner and to the same extent as such provi5 sions apply to a selection of an accredited person through 

6 a notice under subparagraph (A)(ii). 

7 ‘‘(iv) In the case of a device establishment that is de8 nied clearance under clause (i) or (ii) or with respect to 

9 which the selection of the accredited person is rejected 

10 under clause (iii), the Secretary shall designate a person 

11 to review the statement of reasons, or statement summa12 rizing such evidence, as the case may be, of the Secretary 

13 under such clause if, during the 30-day period beginning 

14 on the date on which the owner or operator of the estab15 lishment receives such statement, the owner or operator 

16 requests the review. The review shall commence not later 

17 than 30 days after the owner or operator requests the re18 view, unless the Secretary and the owner or operator oth19 erwise agree.’’; 

20 (5) in paragraph (7)—

21 (A) by amending subparagraph (A) to read 

22 as follows: 

23 ‘‘(A) Persons accredited under paragraph 

24 (2) to conduct inspections shall record in writ25 ing their inspection observations and shall 
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1 present the observations to the device establish2 ment’s designated representative and describe 

3 each observation. Additionally, such accredited 

4 person shall prepare an inspection report in a 

5 form and manner designated by the Secretary 

6 to conduct inspections, taking into consider7 ation the goals of international harmonization 

8 of quality systems standards. Any official classi9 fication of the inspection shall be determined by 

10 the Secretary.’’; and 

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

12 ‘‘(F) For the purpose of setting risk-based 

13 inspectional priorities, the Secretary shall ac14 cept voluntary submissions of reports of audits 

15 assessing conformance with appropriate quality 

16 systems standards set by the International Or17 ganization for Standardization (ISO) and iden18 tified by the Secretary in public notice. If the 

19 owner or operator of an establishment elects to 

20 submit audit reports under this subparagraph, 

21 the owner or operator shall submit all such 

22 audit reports with respect to the establishment 

23 during the preceding 2-year periods.’’; and 

24 (6) in paragraphs (10)(C)(iii), by striking 

25 ‘‘based’’ and inserting ‘‘base’’. 
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1 SEC. 312. EXTENSION OF AUTHORITY FOR THIRD PARTY 

2 REVIEW OF PREMARKET NOTIFICATION. 

3 Section 523(c) (21 U.S.C. 360m(c)) is amended by 

4 striking ‘‘2007’’ and inserting ‘‘2012’’. 

5 SEC. 313. REGISTRATION. 

6 (a) ANNUAL REGISTRATION OF PRODUCERS OF

7 DRUGS AND DEVICES.—Section 510(b) (21 U.S.C. 

8 359(b)) is amended—

9 (1) by redesignating the existing text as para10 graph (1), and indenting and relocating it appro11 priately; 

12 (2) in paragraph (1), as so redesignated, by 

13 striking ‘‘or a device or devices’’; and 

14 (3) by adding at the end the following new 

15 paragraph: 

16 ‘‘(2) Between October 1 and December 31 of 

17 each year every person who owns or operates any es18 tablishment in any State engaged in the manufac19 ture, preparation, propagation, compounding, or 

20 processing of a device or devices shall register with 

21 the Secretary his name, places of business, and all 

22 such establishments.’’. 

23 (b) REGISTRATION OF FOREIGN ESTABLISH24 MENTS.—Section 510(i)(1) (21 U.S.C. 359(i)(1)) is 

25 amended—
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1 (1) by redesignating the existing text as sub2 paragraph (A), and indenting and relocating it ap3 propriately; 

4 (2) in subparagraph (A), as so redesignated—

5 (A) by striking ‘‘processing of a drug or a 

6 device that is imported’’ and inserting ‘‘proc7 essing of a drug that is imported’’; and 

8 (B) by striking ‘‘or device’’ each place it 

9 appears; and 

10 (3) by adding after such subparagraph (A) the 

11 following new subparagraph: 

12 ‘‘(B) Between October 1 and December 31 

13 of each year, any establishment within any for14 eign country engaged in the manufacture, prep15 aration, propagation, compounding, or proc16 essing of a device that is imported or offered 

17 for import into the United States shall, through 

18 electronic means in accordance with the criteria 

19 of the Secretary, register with the Secretary the 

20 name and place of business of the establish21 ment, the name of the United States agent for 

22 the establishment, the name of each importer of 

23 such device in the United States that is known 

24 to the establishment, and the name of each per25 son who imports or offers for import such de-
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1 vice to the United States for purposes of impor2 tation.’’. 

3 SEC. 314. FILING OF LISTS OF DRUGS AND DEVICES MANU4 FACTURED PREPARED, PROPAGATED AND 

5 COMPOUNDED BY REGISTRANTS; STATE6 MENTS; ACCOMPANYING DISCLOSURES. 

7 Section 510(j)(2) (21 U.S.C. 360(j)(2) is amended, 

8 in the matter preceding subparagraph (A), to read as fol9 lows: 

10 ‘‘(2) Each person who registers with the Sec11 retary under this section shall report to the Sec12 retary (i) with regard to drugs, once during the 

13 month of June of each year and once during the 

14 month of December of each year, and (ii) with re15 gard to devices, once each year between October 1 

16 and December 31, the following information:’’. 

17 SEC. 315. ELECTRONIC REGISTRATION AND LISTING. 

18 Section 510(p) (21 U.S.C. 360(p)) is amended to 

19 read as follows: 

20 ‘‘(p)(1) With regard to any establishment engaged in 

21 the manufacture, preparation, propagation, compounding, 

22 or processing of a drug, registrations under subsections 

23 (b), (c), (d), and (i) of this section (including the submis24 sion of updated information) shall be submitted to the 

25 Secretary by electronic means, upon a finding by the Sec-
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1 retary that the electronic receipt of such registrations is 

2 feasible, unless the Secretary grants a request for waiver 

3 of such requirement because use of electronic means is not 

4 reasonable for the person requesting such waiver. 

5 ‘‘(2) With regard to any establishment engaged in the 

6 manufacture, preparation, propagation, compounding, or 

7 processing of a device, the registration and listing infor8 mation required by this section shall be submitted to the 

9 Secretary by electronic means, unless the Secretary grants 

10 a waiver because electronic registration and listing is not 

11 reasonable for the person requesting such waiver.’’. 

12 TITLE IV—PEDIATRIC MEDICAL 

13 PRODUCTS 

14 Subtitle A—Best Pharmaceuticals 

15 for Children 

16 SEC. 401. SHORT TITLE. 

17 This subtitle may be cited as the ‘‘Best Pharma18 ceuticals for Children Amendments of 2007’’. 

19 SEC. 402. PEDIATRIC STUDIES OF DRUGS. 

20 (a) IN GENERAL.—Section 505A of the Federal 

21 Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is 

22 amended—

23 (1) in subsection (a), by inserting before the pe24 riod at the end the following: ‘‘, and, at the discre-
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1 tion of the Secretary, may include preclinical stud2 ies’’; 

3 (2) in subsection (b)—

4 (A) in paragraph (1)(A)(i), by striking 

5 ‘‘(D)’’ both places it appears and inserting 

6 ‘‘(E)’’; 

7 (B) in paragraph (1)(A)(ii), by striking 

8 ‘‘(D)’’ and inserting ‘‘(E)’’; 

9 (C) by striking ‘‘(1)(A)(i)’’ and inserting 

10 ‘‘(A)(i)(I)’’; 

11 (D) by striking ‘‘(ii) the’’ and inserting 

12 ‘‘(II) the’’; 

13 (E) by striking ‘‘(B) if the drug is des14 ignated’’ and inserting ‘‘(ii) if the drug is des15 ignated’’; 

16 (F) by striking ‘‘(2)(A)’’ and inserting 

17 ‘‘(B)(i)’’; 

18 (G) by striking ‘‘(i) a listed patent’’ and 

19 inserting ‘‘(I) a listed patent’’; 

20 (H) by striking ‘‘(ii) a listed patent’’ and 

21 inserting ‘‘(II) a listed patent’’; 

22 (I) by striking ‘‘(B) if the drug is the sub23 ject’’ and inserting ‘‘(ii) if the drug is the sub24 ject’’; 
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1 (J) by striking ‘‘If’’ and all that follows 

2 through ‘‘subsection (d)(3)’’ and inserting the 

3 following: 

4 ‘‘(1) IN GENERAL.—Except as provided in para5 graph (2), if, prior to approval of an application that 

6 is submitted under section 505(b)(1), the Secretary 

7 determines that information relating to the use of a 

8 new drug in the pediatric population may produce 

9 health benefits in that population, the Secretary 

10 makes a written request for pediatric studies (which 

11 shall include a timeframe for completing such stud12 ies), the applicant agrees to the request, such stud13 ies are completed using appropriate formulations for 

14 each age group for which the study is requested 

15 within any such timeframe, and the reports thereof 

16 are submitted and accepted in accordance with sub17 section (d)(3), and if the Secretary determines that 

18 labeling changes are appropriate, such changes are 

19 made within the timeframe requested by the Sec20 retary—’’; and 

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

22 ‘‘(2) EXCEPTION.—The Secretary shall not ex23 tend a period referred to in paragraph (1)(A) or in 

24 paragraph (1)(B) if the determination made under 
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1 subsection (d)(3) is made less than 9 months prior 

2 to the expiration of such period.’’; 

3 (3) in subsection (c)—

4 (A) in paragraph (1)(A)(i), by striking 

5 ‘‘(D)’’ both places it appears and inserting 

6 ‘‘(E)’’; 

7 (B) in paragraph (1)(A)(ii), by striking 

8 ‘‘(D)’’ and inserting ‘‘(E)’’; 

9 (C) by striking ‘‘(1)(A)(i)’’ and inserting 

10 ‘‘(A)(i)(I)’’; 

11 (D) by striking ‘‘(ii) the’’ and inserting 

12 ‘‘(II) the’’; 

13 (E) by striking ‘‘(B) if the drug is des14 ignated’’ and inserting ‘‘(ii) if the drug is des15 ignated’’; 

16 (F) by striking ‘‘(2)(A)’’ and inserting 

17 ‘‘(B)(i)’’; 

18 (G) by striking ‘‘(i) a listed patent’’ and 

19 inserting ‘‘(I) a listed patent’’; 

20 (H) by striking ‘‘(ii) a listed patent’’ and 

21 inserting ‘‘(II) a listed patent’’; 

22 (I) by striking ‘‘(B) if the drug is the sub23 ject’’ and inserting ‘‘(ii) if the drug is the sub24 ject’’; 
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1 (J) by striking ‘‘If’’ and all that follows 

2 through ‘‘subsection (d)(3)’’ and inserting the 

3 following: 

4 ‘‘(1) IN GENERAL.—Except as provided in para5 graph (2), if the Secretary determines that informa6 tion relating to the use of an approved drug in the 

7 pediatric population may produce health benefits in 

8 that population and makes a written request to the 

9 holder of an approved application under section 

10 505(b)(1) for pediatric studies (which shall include 

11 a timeframe for completing such studies), the holder 

12 agrees to the request, such studies are completed 

13 using appropriate formulations for each age group 

14 for which the study is requested within any such 

15 timeframe, and the reports thereof are submitted 

16 and accepted in accordance with subsection (d)(3), 

17 and if the Secretary determines that labeling 

18 changes are appropriate, such changes are made 

19 within the timeframe requested by the Secretary—

20 ’’; and 

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

22 ‘‘(2) EXCEPTION.—The Secretary shall not ex23 tend a period referred to in paragraph (1)(A) or in 

24 paragraph (1)(B) if the determination made under 
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1 subsection (d)(3) is made less than 9 months prior 

2 to the expiration of such period.’’; 

3 (4) by striking subsection (d) and inserting the 

4 following: 

5 ‘‘(d) CONDUCT OF PEDIATRIC STUDIES.—

6 ‘‘(1) REQUEST FOR STUDIES.—

7 ‘‘(A) IN GENERAL.—The Secretary may, 

8 after consultation with the sponsor of an appli9 cation for an investigational new drug under 

10 section 505(i), the sponsor of an application for 

11 a new drug under section 505(b)(1), or the 

12 holder of an approved application for a drug 

13 under section 505(b)(1), issue to the sponsor or 

14 holder a written request for the conduct of pedi15 atric studies for such drug. In issuing such re16 quest, the Secretary shall take into account 

17 adequate representation of children of ethnic 

18 and racial minorities. Such request to conduct 

19 pediatric studies shall be in writing and shall 

20 include a timeframe for such studies and a re21 quest to the sponsor or holder to propose pedi22 atric labeling resulting from such studies. 

23 ‘‘(B) SINGLE WRITTEN REQUEST.—A sin24 gle written request—
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1 ‘‘(i) may relate to more than 1 use of 

2 a drug; and 

3 ‘‘(ii) may include uses that are both 

4 approved and unapproved. 

5 ‘‘(2) WRITTEN REQUEST FOR PEDIATRIC STUD6 IES.—

7 ‘‘(A) REQUEST AND RESPONSE.—

8 ‘‘(i) IN GENERAL.—If the Secretary 

9 makes a written request for pediatric stud10 ies (including neonates, as appropriate) 

11 under subsection (b) or (c), the applicant 

12 or holder, not later than 180 days after re13 ceiving the written request, shall respond 

14 to the Secretary as to the intention of the 

15 applicant or holder to act on the request 

16 by—

17 ‘‘(I) indicating when the pediatric 

18 studies will be initiated, if the appli19 cant or holder agrees to the request; 

20 or 

21 ‘‘(II) indicating that the appli22 cant or holder does not agree to the 

23 request and the reasons for declining 

24 the request. 
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1 ‘‘(ii) DISAGREE WITH REQUEST.—If, 

2 on or after the date of enactment of the 

3 Best Pharmaceuticals for Children Amend4 ments of 2007, the applicant or holder 

5 does not agree to the request on the 

6 grounds that it is not possible to develop 

7 the appropriate pediatric formulation, the 

8 applicant or holder shall submit to the Sec9 retary the reasons such pediatric formula10 tion cannot be developed. 

11 ‘‘(B) ADVERSE EVENT REPORTS.—An ap12 plicant or holder that, on or after the date of 

13 enactment of the Best Pharmaceuticals for 

14 Children Amendments of 2007, agrees to the 

15 request for such studies shall provide the Sec16 retary, at the same time as submission of the 

17 reports of such studies, with all postmarket ad18 verse event reports regarding the drug that is 

19 the subject of such studies and are available 

20 prior to submission of such reports. 

21 ‘‘(3) MEETING THE STUDIES REQUIREMENT.—

22 Not later than 180 days after the submission of the 

23 reports of the studies, the Secretary shall accept or 

24 reject such reports and so notify the sponsor or 

25 holder. The Secretary’s only responsibility in accept-
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1 ing or rejecting the reports shall be to determine, 

2 within the 180 days, whether the studies fairly re3 spond to the written request, have been conducted in 

4 accordance with commonly accepted scientific prin5 ciples and protocols, and have been reported in ac6 cordance with the requirements of the Secretary for 

7 filing. 

8 ‘‘(4) EFFECT OF SUBSECTION.—Nothing in this 

9 subsection alters or amends section 301(j) of this 

10 Act or section 552 of title 5 or section 1905 of title 

11 18, United States Code.’’; 

12 (5) by striking subsections (e) and (f) and in13 serting the following: 

14 ‘‘(e) NOTICE OF DETERMINATIONS ON STUDIES RE15 QUIREMENT.—

16 ‘‘(1) IN GENERAL.—The Secretary shall publish 

17 a notice of any determination, made on or after the 

18 date of enactment of the Best Pharmaceuticals for 

19 Children Amendments of 2007, that the require20 ments of subsection (d) have been met and that sub21 missions and approvals under subsection (b)(2) or 

22 (j) of section 505 for a drug will be subject to the 

23 provisions of this section. Such notice shall be pub24 lished not later than 30 days after the date of the 

25 Secretary’s determination regarding market exclu-
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1 sivity and shall include a copy of the written request 

2 made under subsection (b) or (c). 

3 ‘‘(2) IDENTIFICATION OF CERTAIN DRUGS.—

4 The Secretary shall publish a notice identifying any 

5 drug for which, on or after the date of enactment of 

6 the Best Pharmaceuticals for Children Amendments 

7 of 2007, a pediatric formulation was developed, 

8 studied, and found to be safe and effective in the pe9 diatric population (or specified subpopulation) if the 

10 pediatric formulation for such drug is not introduced 

11 onto the market within 1 year of the date that the 

12 Secretary publishes the notice described in para13 graph (1). Such notice identifying such drug shall be 

14 published not later than 30 days after the date of 

15 the expiration of such 1 year period. 

16 ‘‘(f) INTERNAL REVIEW OF WRITTEN REQUESTS

17 AND PEDIATRIC STUDIES.—

18 ‘‘(1) INTERNAL REVIEW.—

19 ‘‘(A) IN GENERAL.—The Secretary shall 

20 create an internal review committee to review 

21 all written requests issued and all reports sub22 mitted on or after the date of enactment of the 

23 Best Pharmaceuticals for Children Amendments 

24 of 2007, in accordance with paragraphs (2) and 

25 (3). 
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1 ‘‘(B) MEMBERS.—The committee under 

2 subparagraph (A) shall include individuals, each 

3 of whom is an employee of the Food and Drug 

4 Administration, with the following expertise: 

5 ‘‘(i) Pediatrics. 

6 ‘‘(ii) Biopharmacology. 

7 ‘‘(iii) Statistics. 

8 ‘‘(iv) Drugs and drug formulations. 

9 ‘‘(v) Legal issues. 

10 ‘‘(vi) Appropriate expertise, such as 

11 expertise in child and adolescent psychi12 atry, pertaining to the pediatric product 

13 under review. 

14 ‘‘(vii) One or more experts from the 

15 Office of Pediatric Therapeutics, which 

16 may include an expert in pediatric ethics. 

17 ‘‘(viii) Other individuals as designated 

18 by the Secretary. 

19 ‘‘(C) ACTION BY COMMITTEE.—The com20 mittee established under this paragraph may 

21 perform a function under this section using ap22 propriate members of the committee under sub23 paragraph (B) and need not convene all mem24 bers of the committee under subparagraph (B) 
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1 in order to perform a function under this sec2 tion. 

3 ‘‘(D) DOCUMENTATION OF COMMITTEE AC4 TION.—The committee established under this 

5 paragraph shall document for each function 

6 under paragraphs (2) and (3), which members 

7 of the committee participated in such function. 

8 ‘‘(2) REVIEW OF WRITTEN REQUESTS.—All 

9 written requests under this section shall be reviewed 

10 and approved by the committee established under 

11 paragraph (1) prior to being issued. 

12 ‘‘(3) REVIEW OF PEDIATRIC STUDIES.—The 

13 committee established under paragraph (1) shall re14 view all studies conducted pursuant to this section to 

15 make a recommendation to the Secretary whether to 

16 accept or reject such reports under subsection 

17 (d)(3). 

18 ‘‘(4) TRACKING PEDIATRIC STUDIES AND LA19 BELING CHANGES.—The committee established 

20 under paragraph (1) shall be responsible for track21 ing and making available to the public, in an easily 

22 accessible manner, including through posting on the 

23 website of the Food and Drug Administration—

24 ‘‘(A) the number of studies conducted 

25 under this section; 
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1 ‘‘(B) the specific drugs and drug uses, in2 cluding labeled and off-labeled indications, stud3 ied under this section; 

4 ‘‘(C) the types of studies conducted under 

5 this section, including trial design, the number 

6 of pediatric patients studied, and the number of 

7 centers and countries involved; 

8 ‘‘(D) the number of pediatric formulations 

9 developed and the number of pediatric formula10 tions not developed and the reasons such for11 mulations were not developed; 

12 ‘‘(E) the labeling changes made as a result 

13 of studies conducted under this section; 

14 ‘‘(F) an annual summary of labeling 

15 changes made as a result of studies conducted 

16 under this section for distribution pursuant to 

17 subsection (k)(2); 

18 ‘‘(G) information regarding reports sub19 mitted on or after the date of enactment of the 

20 Best Pharmaceuticals for Children Amendments 

21 of 2007; and 

22 ‘‘(H) the number of times the committee 

23 established under paragraph (1) made a rec24 ommendation to the Secretary under paragraph 

25 (3), the number of times the Secretary did not 
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1 follow such a recommendation to accept reports 

2 under subsection (d)(3), and the number of 

3 times the Secretary did not follow such a rec4 ommendation to reject such reports under sec5 tion (d)(3). 

6 ‘‘(5) COMMITTEE.—The committee established 

7 under paragraph (1) is the committee established 

8 under section 505B(f)(1).’’; 

9 (6) in subsection (g)—

10 (A) in paragraph (1)—

11 (i) by striking ‘‘(c)(1)(A)(ii)’’ and in12 serting ‘‘(c)(1)(A)(i)(II)’’; and 

13 (ii) by striking ‘‘(c)(2)’’ and inserting 

14 ‘‘(c)(1)(B)’’; 

15 (B) in paragraph (2), by striking 

16 ‘‘(c)(1)(B)’’ and inserting ‘‘(c)(1)(A)(ii)’’; 

17 (C) by redesignating paragraphs (1) and 

18 (2) as subparagraphs (A) and (B), respectively; 

19 (D) by striking ‘‘LIMITATIONS.—A drug’’ 

20 and inserting ‘‘LIMITATIONS.—

21 ‘‘(1) IN GENERAL.—Notwithstanding subsection 

22 (c)(2), a drug’’; and 

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

24 ‘‘(2) EXCLUSIVITY ADJUSTMENT.—

25 ‘‘(A) ADJUSTMENT.—
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1 ‘‘(i) IN GENERAL.—With respect to 

2 any drug, if the organization designated 

3 under subparagraph (B) notifies the Sec4 retary that the combined annual gross 

5 sales for all drugs with the same active 

6 moiety exceeded $1,000,000,000 in any 

7 calendar year prior to the time the sponsor 

8 or holder agrees to the initial written re9 quest pursuant to subsection (d)(2), then 

10 each period of market exclusivity deemed 

11 or extended under subsection (b) or (c) 

12 shall be reduced by 3 months for such 

13 drug. 

14 ‘‘(ii) DETERMINATION.—The deter15 mination under clause (i) of the combined 

16 annual gross sales shall be determined—

17 ‘‘(I) taking into account only 

18 those sales within the United States; 

19 and 

20 ‘‘(II) taking into account only the 

21 sales of all drugs with the same active 

22 moiety of the sponsor or holder and 

23 its affiliates. 

24 ‘‘(B) DESIGNATION.—The Secretary shall 

25 designate an organization other than the Food 
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1 and Drug Administration to evaluate whether 

2 the combined annual gross sales for all drugs 

3 with the same active moiety exceeded 

4 $1,000,000,000 in a calendar year as described 

5 in subparagraph (A). Prior to designating such 

6 organization, the Secretary shall determine that 

7 such organization is independent and is quali8 fied to evaluate the sales of pharmaceutical 

9 products. The Secretary shall re-evaluate the 

10 designation of such organization once every 3 

11 years. 

12 ‘‘(C) NOTIFICATION.—Once a year at a 

13 time designated by the Secretary, the organiza14 tion designated under subparagraph (B) shall 

15 notify the Food and Drug Administration of all 

16 drugs with the same active moiety with com17 bined annual gross sales that exceed 

18 $1,000,000,000 during the previous calendar 

19 year.’’; 

20 (7) in subsection (i)—

21 (A) in the heading, by striking ‘‘SUPPLE22 MENTS’’ and inserting ‘‘CHANGES’’; 

23 (B) in paragraph (1)—

24 (i) in the heading, by inserting ‘‘AP25 PLICATIONS AND’’ after ‘‘PEDIATRIC’’; 
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1 (ii) by inserting ‘‘application or’’ after 

2 ‘‘Any’’; 

3 (iii) by striking ‘‘change pursuant to a 

4 report on a pediatric study under’’ and in5 serting ‘‘change as a result of any pedi6 atric study conducted pursuant to’’; and 

7 (iv) by inserting ‘‘application or’’ after 

8 ‘‘to be a priority’’; and 

9 (C) in paragraph (2)(A), by—

10 (i) striking ‘‘If the Commissioner’’ 

11 and inserting ‘‘If, on or after the date of 

12 enactment of the Best Pharmaceuticals for 

13 Children Amendments of 2007, the Com14 missioner’’; and 

15 (ii) striking ‘‘an application with’’ and 

16 all that follows through ‘‘on appropriate’’ 

17 and inserting ‘‘the sponsor and the Com18 missioner have been unable to reach agree19 ment on appropriate’’; 

20 (8) by striking subsection (m); 

21 (9) by redesignating subsections (j), (k), (l), 

22 and (n), as subsections (k), (m), (o), and (p), respec23 tively; 

24 (10) by inserting after subsection (i) the fol25 lowing: 
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1 ‘‘(j) OTHER LABELING CHANGES.—If, on or after the 

2 date of enactment of the Best Pharmaceuticals for Chil3 dren Amendments of 2007, the Secretary determines that 

4 a pediatric study conducted under this section does or does 

5 not demonstrate that the drug that is the subject of the 

6 study is safe and effective, including whether such study 

7 results are inconclusive, in pediatric populations or sub8 populations, the Secretary shall order the labeling of such 

9 product to include information about the results of the 

10 study and a statement of the Secretary’s determination.’’; 

11 (11) in subsection (k), as redesignated by para12 graph (9)—

13 (A) in paragraph (1)—

14 (i) by striking ‘‘a summary of the 

15 medical and’’ and inserting ‘‘the medical, 

16 statistical, and’’; and 

17 (ii) by striking ‘‘for the supplement’’ 

18 and all that follows through the period and 

19 inserting ‘‘under subsection (b) or (c).’’; 

20 (B) by redesignating paragraph (2) as 

21 paragraph (3); and 

22 (C) by inserting after paragraph (1) the 

23 following: 

24 ‘‘(2) DISSEMINATION OF INFORMATION RE25 GARDING LABELING CHANGES.—Beginning on the 
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1 date of enactment of the Best Pharmaceuticals for 

2 Children Amendments of 2007, the Secretary shall 

3 require that the sponsors of the studies that result 

4 in labeling changes that are reflected in the annual 

5 summary developed pursuant to subsection (f)(4)(F) 

6 distribute, at least annually (or more frequently if 

7 the Secretary determines that it would be beneficial 

8 to the public health), such information to physicians 

9 and other health care providers.’’; 

10 (12) by inserting after subsection (k), as redes11 ignated by paragraph (9), the following: 

12 ‘‘(l) ADVERSE EVENT REPORTING.—

13 ‘‘(1) REPORTING IN YEAR ONE.—Beginning on 

14 the date of enactment of the Best Pharmaceuticals 

15 for Children Amendments of 2007, during the 1-year 

16 period beginning on the date a labeling change is 

17 made pursuant to subsection (i), the Secretary shall 

18 ensure that all adverse event reports that have been 

19 received for such drug (regardless of when such re20 port was received) are referred to the Office of Pedi21 atric Therapeutics established under section 6 of the 

22 Best Pharmaceuticals for Children Act (Public Law 

23 107–109). In considering such reports, the Director 

24 of such Office shall provide for the review of the re25 port by the Pediatric Advisory Committee, including 
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1 obtaining any recommendations of such Committee 

2 regarding whether the Secretary should take action 

3 under this section in response to such reports. 

4 ‘‘(2) REPORTING IN SUBSEQUENT YEARS.—Fol5 lowing the 1-year period described in paragraph (1), 

6 the Secretary shall, as appropriate, refer to the Of7 fice of Pediatric Therapeutics all pediatric adverse 

8 event reports for a drug for which a pediatric study 

9 was conducted under this section. In considering 

10 such reports, the Director of such Office may pro11 vide for the review of such reports by the Pediatric 

12 Advisory Committee, including obtaining any rec13 ommendation of such Committee regarding whether 

14 the Secretary should take action in response to such 

15 reports. 

16 ‘‘(3) EFFECT.—The requirements of this sub17 section shall supplement, not supplant, other review 

18 of such adverse event reports by the Secretary.’’; 

19 (13) by inserting after subsection (m), as redes20 ignated by paragraph (9), the following: 

21 ‘‘(n) REFERRAL IF PEDIATRIC STUDIES NOT COM22 PLETED.—

23 ‘‘(1) IN GENERAL.—Beginning on the date of 

24 enactment of the Best Pharmaceuticals for Children 

25 Amendments of 2007, if pediatric studies of a drug 
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1 have not been completed under subsection (d) and if 

2 the Secretary, through the committee established 

3 under subsection (f), determines that there is a con4 tinuing need for information relating to the use of 

5 the drug in the pediatric population (including neo6 nates, as appropriate), the Secretary shall carry out 

7 the following: 

8 ‘‘(A) For a drug for which a listed patent 

9 has not expired, make a determination regard10 ing whether an assessment shall be required to 

11 be submitted under section 505B. Prior to mak12 ing such determination, the Secretary may take 

13 not more than 60 days to certify whether the 

14 Foundation for the National Institutes of 

15 Health has sufficient funding at the time of 

16 such certification to initiate 1 or more of the 

17 pediatric studies of such drug referred to in the 

18 sentence preceding this paragraph and fund 1 

19 or more of such studies in their entirety. Only 

20 if the Secretary makes such certification in the 

21 affirmative, the Secretary shall refer such pedi22 atric study or studies to the Foundation for the 

23 National Institutes of Health for the conduct of 

24 such study or studies. 
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1 ‘‘(B) For a drug that has no listed patents 

2 or has 1 or more listed patents that have ex3 pired, the Secretary shall refer the drug for in4 clusion on the list established under section 

5 409I of the Public Health Service Act for the 

6 conduct of studies. 

7 ‘‘(2) PUBLIC NOTICE.—The Secretary shall give 

8 the public notice of—

9 ‘‘(A) a decision under paragraph (1)(A) 

10 not to require an assessment under section 

11 505B and the basis for such decision; and 

12 ‘‘(B) any referral under paragraph (1)(B) 

13 of a drug for inclusion on the list established 

14 under section 409I of the Public Health Service 

15 Act. 

16 ‘‘(3) EFFECT OF SUBSECTION.—Nothing in this 

17 subsection alters or amends section 301(j) of this 

18 Act or section 552 of title 5 or section 1905 of title 

19 18, United States Code.’’; and 

20 (14) in subsection (p), as redesignated by para21 graph (9)—

22 (A) striking ‘‘6-month period’’ and insert23 ing ‘‘3-month or 6-month period’’; 

24 (B) by striking ‘‘subsection (a)’’ and in25 serting ‘‘subsection (b)’’; and 
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1 (C) by striking ‘‘2007’’ both places it ap2 pears and inserting ‘‘2012’’. 

3 (b) EFFECTIVE DATE.—Except as otherwise provided 

4 in the amendments made by subsection (a), such amend5 ments shall apply to written requests under section 505A 

6 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

7 355a) made after the date of enactment of this subtitle. 

8 SEC. 403. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS. 

9 Section 409I of the Public Health Service Act (42 

10 U.S.C. 284m) is amended—

11 (1) by striking subsections (a) and (b) and in12 serting the following: 

13 ‘‘(a) LIST OF PRIORITY ISSUES IN PEDIATRIC

14 THERAPEUTICS.—

15 ‘‘(1) IN GENERAL.—Not later than 1 year after 

16 the date of enactment of the Best Pharmaceuticals 

17 for Children Amendments of 2007, the Secretary, 

18 acting through the Director of the National Insti19 tutes of Health and in consultation with the Com20 missioner of Food and Drugs and experts in pedi21 atric research, shall develop and publish a priority 

22 list of needs in pediatric therapeutics, including 

23 drugs or indications that require study. The list 

24 shall be revised every 3 years. 
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1 ‘‘(2) CONSIDERATION OF AVAILABLE INFORMA2 TION.—In developing and prioritizing the list under 

3 paragraph (1), the Secretary shall consider—

4 ‘‘(A) therapeutic gaps in pediatrics that 

5 may include developmental pharmacology, 

6 pharmacogenetic determinants of drug re7 sponse, metabolism of drugs and biologics in 

8 children, and pediatric clinical trials; 

9 ‘‘(B) particular pediatric diseases, dis10 orders or conditions where more complete 

11 knowledge and testing of therapeutics, including 

12 drugs and biologics, may be beneficial in pedi13 atric populations; and 

14 ‘‘(C) the adequacy of necessary infrastruc15 ture to conduct pediatric pharmacological re16 search, including research networks and trained 

17 pediatric investigators. 

18 ‘‘(b) PEDIATRIC STUDIES AND RESEARCH.—The 

19 Secretary, acting through the National Institutes of 

20 Health, shall award funds to entities that have the exper21 tise to conduct pediatric clinical trials or other research 

22 (including qualified universities, hospitals, laboratories, 

23 contract research organizations, practice groups, federally 

24 funded programs such as pediatric pharmacology research 

25 units, other public or private institutions, or individuals) 
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1 to enable the entities to conduct the drug studies or other 

2 research on the issues described in subsection (a). The 

3 Secretary may use contracts, grants, or other appropriate 

4 funding mechanisms to award funds under this sub5 section.’’; 

6 (2) in subsection (c)—

7 (A) in the heading, by striking ‘‘CON8 TRACTS’’ and inserting ‘‘PROPOSED PEDIATRIC

9 STUDY REQUESTS’’; 

10 (B) by striking paragraphs (4) and (12); 

11 (C) by redesignating paragraphs (1), (2), 

12 and (3), as paragraphs (2), (3), and (4); 

13 (D) by inserting before paragraph (2), as 

14 redesignated by subparagraph (C), the fol15 lowing: 

16 ‘‘(1) SUBMISSION OF PROPOSED PEDIATRIC

17 STUDY REQUEST.—The Director of the National In18 stitutes of Health shall, as appropriate, submit pro19 posed pediatric study requests for consideration by 

20 the Commissioner of Food and Drugs for pediatric 

21 studies of a specific pediatric indication identified 

22 under subsection (a). Such a proposed pediatric 

23 study request shall be made in a manner equivalent 

24 to a written request made under subsection (b) or 

25 (c) of section 505A of the Federal Food, Drug, and 
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1 Cosmetic Act, including with respect to the informa2 tion provided on the pediatric studies to be con3 ducted pursuant to the request. The Director of the 

4 National Institutes of Health may submit a pro5 posed pediatric study request for a drug for which—

6 ‘‘(A)(i) there is an approved application 

7 under section 505(j) of the Federal Food, 

8 Drug, and Cosmetic Act; or 

9 ‘‘(ii) there is a submitted application that 

10 could be approved under the criteria of section 

11 505(j) of the Federal Food, Drug, and Cos12 metic Act; 

13 ‘‘(B) there is no patent protection or mar14 ket exclusivity protection for at least 1 form of 

15 the drug under the Federal Food, Drug, and 

16 Cosmetic Act; and 

17 ‘‘(C) additional studies are needed to as18 sess the safety and effectiveness of the use of 

19 the drug in the pediatric population.’’; 

20 (E) in paragraph (2), as redesignated by 

21 subparagraph (C)—

22 (i) by inserting ‘‘based on the pro23 posed pediatric study request for the indi24 cation or indications submitted pursuant to 
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1 paragraph (1)’’ after ‘‘issue a written re2 quest’’; 

3 (ii) by striking ‘‘in the list described 

4 in subsection (a)(1)(A) (except clause 

5 (iv))’’ and inserting ‘‘under subsection 

6 (a)’’; and 

7 (iii) by inserting ‘‘and using appro8 priate formulations for each age group for 

9 which the study is requested’’ before the 

10 period at the end; 

11 (F) in paragraph (3), as redesignated by 

12 subparagraph (C)—

13 (i) in the heading, by striking ‘‘CON14 TRACT’’; 

15 (ii) by striking ‘‘paragraph (1)’’ and 

16 inserting ‘‘paragraph (2)’’; 

17 (iii) by striking ‘‘or if a referral de18 scribed in subsection (a)(1)(A)(iv) is 

19 made,’’; 

20 (iv) by striking ‘‘for contract pro21 posals’’ and inserting ‘‘for proposals’’; and 

22 (v) by inserting ‘‘in accordance with 

23 subsection (b)’’ before the period at the 

24 end; 
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1 (G) in paragraph (4), as redesignated by 

2 subparagraph (C)—

3 (i) by striking ‘‘contract’’; and 

4 (ii) by striking ‘‘paragraph (2)’’ and 

5 inserting ‘‘paragraph (3)’’; 

6 (H) in paragraph (5)—

7 (i) by striking the heading and insert8 ing ‘‘CONTRACTS, GRANTS, OR OTHER

9 FUNDING MECHANISMS’’; and 

10 (ii) by striking ‘‘A contract’’ and all 

11 that follows through ‘‘is submitted’’ and 

12 inserting ‘‘A contract, grant, or other 

13 funding may be awarded under this section 

14 only if a proposal is submitted’’; 

15 (I) in paragraph (6)(A)—

16 (i) by striking ‘‘a contract awarded’’ 

17 and inserting ‘‘an award’’; and 

18 (ii) by inserting ‘‘, including a written 

19 request if issued’’ after ‘‘with the study’’; 

20 and 

21 (3) by inserting after subsection (c) the fol22 lowing: 

23 ‘‘(d) DISSEMINATION OF PEDIATRIC INFORMA24 TION.—Not later than 1 year after the date of enactment 

25 of the Best Pharmaceuticals for Children Amendments of 
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1 2007, the Secretary, acting through the Director of the 

2 National Institutes of Health, shall study the feasibility 

3 of establishing a compilation of information on pediatric 

4 drug use and report the findings to Congress.’’

5 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—

6 ‘‘(1) IN GENERAL.—There are authorized to be 

7 appropriated to carry out this section—

8 ‘‘(A) $200,000,000 for fiscal year 2008; 

9 and 

10 ‘‘(B) such sums as are necessary for each 

11 of the 4 succeeding fiscal years. 

12 ‘‘(2) AVAILABILITY.—Any amount appropriated 

13 under paragraph (1) shall remain available to carry 

14 out this section until expended.’’. 

15 SEC. 404. REPORTS AND STUDIES. 

16 (a) GAO REPORT.—Not later than January 31, 

17 2011, the Comptroller General of the United States, in 

18 consultation with the Secretary of Health and Human 

19 Services, shall submit to Congress a report that addresses 

20 the effectiveness of section 505A of the Federal Food, 

21 Drug, and Cosmetic Act (21 U.S.C. 355a) in ensuring 

22 that medicines used by children are tested and properly 

23 labeled, including—

24 (1) the number and importance of drugs for 

25 children that are being tested as a result of the 
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1 amendments made by this subtitle and the impor2 tance for children, health care providers, parents, 

3 and others of labeling changes made as a result of 

4 such testing; 

5 (2) the number and importance of drugs for 

6 children that are not being tested for their use not7 withstanding the provisions of this subtitle and the 

8 amendments made by this subtitle, and possible rea9 sons for the lack of testing, including whether the 

10 number of written requests declined by sponsors or 

11 holders of drugs subject to section 505A(g)(2) of the 

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

13 355a(g)(2)), has increased or decreased as a result 

14 of the amendments made by this subtitle; 

15 (3) the number of drugs for which testing is 

16 being done and labeling changes required, including 

17 the date labeling changes are made and which label18 ing changes required the use of the dispute resolu19 tion process established pursuant to the amendments 

20 made by this subtitle, together with a description of 

21 the outcomes of such process, including a description 

22 of the disputes and the recommendations of the Pe23 diatric Advisory Committee; 

24 (4) any recommendations for modifications to 

25 the programs established under section 505A of the 
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1 Federal Food, Drug and Cosmetic Act (21 U.S.C. 

2 355a) and section 409I of the Public Health Service 

3 Act (42 U.S.C. 284m) that the Secretary determines 

4 to be appropriate, including a detailed rationale for 

5 each recommendation; and 

6 (5)(A) the efforts made by the Secretary to in7 crease the number of studies conducted in the 

8 neonate population; and 

9 (B) the results of those efforts, including efforts 

10 made to encourage the conduct of appropriate stud11 ies in neonates by companies with products that 

12 have sufficient safety and other information to make 

13 the conduct of the studies ethical and safe. 

14 (b) IOM STUDY.—Not later than 3 years after the 

15 date of enactment of this subtitle, the Secretary of Health 

16 and Human Services shall enter into a contract with the 

17 Institute of Medicine to conduct a study and report to 

18 Congress regarding the written requests made and the 

19 studies conducted pursuant to section 505A of the Federal 

20 Food, Drug, and Cosmetic Act. The Institute of Medicine 

21 may devise an appropriate mechanism to review a rep22 resentative sample of requests made and studies conducted 

23 pursuant to such section in order to conduct such study. 

24 Such study shall—
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1 (1) review such representative written requests 

2 issued by the Secretary since 1997 under sub3 sections (b) and (c) of such section 505A; 

4 (2) review and assess such representative pedi5 atric studies conducted under such subsections (b) 

6 and (c) since 1997 and labeling changes made as a 

7 result of such studies; and 

8 (3) review the use of extrapolation for pediatric 

9 subpopulations, the use of alternative endpoints for 

10 pediatric populations, neonatal assessment tools, and 

11 ethical issues in pediatric clinical trials. 

12 SEC. 405. TRAINING OF PEDIATRIC PHARMACOLOGISTS. 

13 (a) INVESTMENT IN TOMORROW’S PEDIATRIC RE14 SEARCHERS.—Section 452G(2) of the Public Health Serv15 ice Act (42 U.S.C. 285g–10(2)) is amended by adding be16 fore the period at the end the following: ‘‘, including pedi17 atric pharmacological research’’. 

18 (b) PEDIATRIC RESEARCH LOAN REPAYMENT PRO19 GRAM.—Section 487F(a)(1) of the Public Health Service 

20 Act (42 U.S.C. 288–6(a)(1)) is amended by inserting ‘‘in21 cluding pediatric pharmacological research,’’ after ‘‘pedi22 atric research,’’. 
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1 SEC. 406. FOUNDATION FOR THE NATIONAL INSTITUTES OF 

2 HEALTH. 

3 Section 499(c)(1)(C) of the Public Health Service Act 

4 (42 U.S.C. 290b(c)(1)(C)) is amended by striking ‘‘and 

5 studies listed by the Secretary pursuant to section 

6 409I(a)(1)(A) of the is Act and referred under section 

7 505A(d)(4)(C) of the Federal Food, Drug and Cosmetic 

8 Act (21 U.S.C. 355(a)(d)(4)(C)’’ and inserting ‘‘and stud9 ies for which the Secretary issues a certification under sec10 tion 505A(n)(1)(A) of the Federal Food, Drug, and Cos11 metic Act (21 U.S.C. 355a(n)(1)(A))’’. 

12 SEC. 407. CONTINUATION OF OPERATION OF COMMITTEE. 

13 Section 14 of the Best Pharmaceuticals for Children 

14 Act (42 U.S.C. 284m note) is amended by adding at the 

15 end the following: 

16 ‘‘(d) CONTINUATION OF OPERATION OF COM17 MITTEE.—Notwithstanding section 14 of the Federal Ad18 visory Committee Act (5 U.S.C. App.), the advisory com19 mittee shall continue to operate during the 5-year period 

20 beginning on the date of enactment of the Best Pharma21 ceuticals for Children Amendments of 2007.’’. 

22 SEC. 408. PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC 

23 DRUGS ADVISORY COMMITTEE. 

24 Section 15 of the Best Pharmaceuticals for Children 

25 Act (42 U.S.C. 284m note) is amended—

26 (1) in subsection (a)—
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1 (A) in paragraph (1)—

2 (i) in subparagraph (B), by striking 

3 ‘‘and’’ after the semicolon; 

4 (ii) in subparagraph (C), by striking 

5 the period at the end and inserting ‘‘; 

6 and’’; and 

7 (iii) by adding at the end the fol8 lowing: 

9 ‘‘(D) provide recommendations to the in10 ternal review committee created under section 

11 505A(f) of the Federal Food, Drug, and Cos12 metic Act (21 U.S.C. 355a(f)) regarding the 

13 implementation of amendments to sections 

14 505A and 505B of the Federal Food, Drug, 

15 and Cosmetic Act (21 U.S.C. 355a and 355c) 

16 with respect to the treatment of pediatric can17 cers.’’; and 

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

19 ‘‘(3) CONTINUATION OF OPERATION OF SUB20 COMMITTEE.—Notwithstanding section 14 of the 

21 Federal Advisory Committee Act (5 U.S.C. App.), 

22 the Subcommittee shall continue to operate during 

23 the 5-year period beginning on the date of enact24 ment of the Best Pharmaceuticals for Children 

25 Amendments of 2007.’’; and 
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1 (2) in subsection (d), by striking ‘‘2003’’ and 

2 inserting ‘‘2009’’. 

3 SEC. 409. EFFECTIVE DATE AND LIMITATION FOR RULE RE4 LATING TO TOLL-FREE NUMBER FOR AD5 VERSE EVENTS ON LABELING FOR HUMAN 

6 DRUG PRODUCTS. 

7 (a) IN GENERAL.—Notwithstanding subchapter II of 

8 chapter 5, and chapter 7, of title 5, United States Code 

9 (commonly known as the ‘‘Administrative Procedure Act’’) 

10 and any other provision of law, the proposed rule issued 

11 by the Commissioner of Food and Drugs entitled ‘‘Toll12 Free Number for Reporting Adverse Events on Labeling 

13 for Human Drug Products’’, 69 Fed. Reg. 21778, (April 

14 22, 2004) shall take effect on January 1, 2008, unless 

15 such Commissioner issues the final rule before such date. 

16 (b) LIMITATION.—The proposed rule that takes ef17 fect under subsection (a), or the final rule described under 

18 subsection (a), shall, notwithstanding section 17(a) of the 

19 Best Pharmaceuticals for Children Act (21 U.S.C. 

20 355b(a)), not apply to a drug—

21 (1) for which an application is approved under 

22 section 505 of the Federal Food, Drug, and Cos23 metic Act (21 U.S.C. 355); 

24 (2) that is not described under section 

25 503(b)(1) of such Act (21 U.S.C. 353(b)(1)); and 
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1 (3) the packaging of which includes a toll-free 

2 number through which consumers can report com3 plaints to the manufacturer or distributor of the 

4 drug. 

5 Subtitle B—Pediatric Research 

6 Improvement 

7 SEC. 411. SHORT TITLE. 

8 This subtitle may be cited as the ‘‘Pediatric Research 

9 Improvement Act’’. 

10 SEC. 412. PEDIATRIC FORMULATIONS, EXTRAPOLATIONS, 

11 AND DEFERRALS. 

12 Section 505B(a) of the Federal Food, Drug, and Cos13 metic Act (21 U.S.C. 355c(a)) is amended—

14 (1) in paragraph (4)(C), by adding at the end 

15 the following: ‘‘An applicant seeking either a partial 

16 or full waiver on this ground shall submit to the 

17 Secretary documentation detailing why a pediatric 

18 formulation cannot be developed, and, if the waiver 

19 is granted, the applicant’s submission shall promptly 

20 be made available to the public in an easily acces21 sible manner, including through posting on the 

22 website of the Food and Drug Administration’’; 

23 (2) in paragraph (2)(B), by adding at the end 

24 the following: 
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1 ‘‘(iii) INFORMATION ON EXTRAPO2 LATION.—A brief documentation of the sci3 entific data supporting the conclusion 

4 under clauses (i) and (ii) shall be included 

5 in any pertinent reviews for the application 

6 under section 505 or section 351 of the 

7 Public Health Service Act.’’; and 

8 (3) by striking paragraph (3) and inserting the 

9 following: 

10 ‘‘(3) DEFERRAL.—

11 ‘‘(A) IN GENERAL.—On the initiative of 

12 the Secretary or at the request of the applicant, 

13 the Secretary may defer submission of some or 

14 all assessments required under paragraph (1) 

15 until a specified date after approval of the drug 

16 or issuance of the license for a biological prod17 uct if—

18 ‘‘(i) the Secretary finds that—

19 ‘‘(I) the drug or biological prod20 uct is ready for approval for use in 

21 adults before pediatric studies are 

22 complete; 

23 ‘‘(II) pediatric studies should be 

24 delayed until additional safety or ef-
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1 fectiveness data have been collected; 

2 or 

3 ‘‘(III) there is another appro4 priate reason for deferral; and 

5 ‘‘(ii) the applicant submits to the Sec6 retary—

7 ‘‘(I) certification of the grounds 

8 for deferring the assessments; 

9 ‘‘(II) a description of the planned 

10 or ongoing studies; 

11 ‘‘(III) evidence that the studies 

12 are being conducted or will be con13 ducted with due diligence and at the 

14 earliest possible time; and 

15 ‘‘(IV) a timeline for the comple16 tion of such studies. 

17 ‘‘(B) ANNUAL REVIEW.—

18 ‘‘(i) IN GENERAL.—On an annual 

19 basis following the approval of a deferral 

20 under subparagraph (A), the applicant 

21 shall submit to the Secretary the following 

22 information: 

23 ‘‘(I) Information detailing the 

24 progress made in conducting pediatric 

25 studies. 
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1 ‘‘(II) If no progress has been 

2 made in conducting such studies, evi3 dence and documentation that such 

4 studies will be conducted with due 

5 diligence and at the earliest possible 

6 time. 

7 ‘‘(ii) PUBLIC AVAILABILITY.—The in8 formation submitted through the annual 

9 review under clause (i) shall promptly be 

10 made available to the public in an easily 

11 accessible manner, including through the 

12 website of the Food and Drug Administra13 tion.’’. 

14 SEC. 413. IMPROVING AVAILABILITY OF PEDIATRIC DATA 

15 FOR ALREADY MARKETED PRODUCTS. 

16 Section 505B(b) of the Federal Food, Drug, and Cos17 metic Act (21 U.S.C. 355c(b)) is amended—

18 (1) by striking paragraph (1) and inserting the 

19 following: 

20 ‘‘(1) IN GENERAL.—After providing notice in 

21 the form of a written request under section 505A 

22 that was declined by the sponsor or holder, or a let23 ter referencing such declined written request, and an 

24 opportunity for written response and a meeting, 

25 which may include an advisory committee meeting, 
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1 the Secretary may (by order in the form of a letter) 

2 require the sponsor or holder of an approved appli3 cation for a drug under section 505 or the holder of 

4 a license for a biological product under section 351 

5 of the Public Health Service Act (42 U.S.C. 262) to 

6 submit by a specified date the assessments described 

7 in subsection (a)(2) and the written request, as ap8 propriate, for the labeled indication or indications, if 

9 the Secretary finds that—

10 ‘‘(A)(i) the drug or biological product is 

11 used for a substantial number of pediatric pa12 tients for the labeled indications; and 

13 ‘‘(ii) adequate pediatric labeling could con14 fer a benefit on pediatric patients; 

15 ‘‘(B) there is reason to believe that the 

16 drug or biological product would represent a 

17 meaningful therapeutic benefit over existing 

18 therapies for pediatric patients for 1 or more of 

19 the claimed indications; or 

20 ‘‘(C) the absence of adequate pediatric la21 beling could pose a risk to pediatric patients.’’; 

22 (2) in paragraph (2)(C), by adding at the end 

23 the following: ‘‘An applicant seeking either a partial 

24 or full waiver shall submit to the Secretary docu25 mentation detailing why a pediatric formulation can-
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1 not be developed, and, if the waiver is granted, the 

2 applicant’s submission shall promptly be made avail3 able to the public in an easily accessible manner, in4 cluding through posting on the website of the Food 

5 and Drug Administration.’’; and 

6 (3) by striking paragraph (3) and inserting the 

7 following: 

8 ‘‘(3) EFFECT OF SUBSECTION.—Nothing in this 

9 subsection alters or amends section 301(j) of this 

10 Act or section 552 of title 5 or section 1905 of title 

11 18, United States Code.’’. 

12 SEC. 414. SUNSET; REVIEW OF PEDIATRIC ASSESSMENTS; 

13 ADVERSE EVENT REPORTING; LABELING 

14 CHANGES; AND PEDIATRIC ASSESSMENTS. 

15 Section 505B of the Federal Food, Drug, and Cos16 metic Act (21 U.S.C. 355c) is amended—

17 (1) redesignating subsection (h) as subsection 

18 (j); 

19 (2) in subsection (j), as so redesignated, by 

20 striking ‘‘505A(n)’’ and inserting ‘‘505A(p)’’; 

21 (3) by redesignating subsection (f) as sub22 section (k); 

23 (4) by redesignating subsection (g) as sub24 section (l); and 
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1 (5) by inserting after subsection (e) the fol2 lowing: 

3 ‘‘(f) REVIEW OF PEDIATRIC ASSESSMENT REQUESTS, 

4 PEDIATRIC ASSESSMENTS, DEFERRALS, AND WAIVERS.—

5 ‘‘(1) REVIEW.—The Secretary shall create an 

6 internal committee to review all pediatric assessment 

7 requests issued under this section, all pediatric as8 sessments conducted under this section, and all de9 ferral and waiver requests made pursuant to this 

10 section. Such internal committee shall include indi11 viduals, each of whom is an employee of the Food 

12 and Drug Administration, with the following exper13 tise: 

14 ‘‘(A) Pediatrics. 

15 ‘‘(B) Biopharmacology. 

16 ‘‘(C) Statistics. 

17 ‘‘(D) Drugs and drug formulations. 

18 ‘‘(E) Pediatric ethics. 

19 ‘‘(F) Legal issues. 

20 ‘‘(G) Appropriate expertise, such as exper21 tise in child and adolescent psychiatry, per22 taining to the pediatric product under review. 

23 ‘‘(H) 1 or more experts from the Office of 

24 Pediatric Therapeutics. 
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1 ‘‘(I) Other individuals as designated by the 

2 Secretary. 

3 ‘‘(2) ACTION BY THE COMMITTEE.—The com4 mittee established under paragraph (1) may perform 

5 a function under this section using appropriate 

6 members of the committee under paragraph (1) and 

7 need not convene all members of the committee 

8 under paragraph (1) in order to perform a function 

9 under this section. 

10 ‘‘(3) DOCUMENTATION OF COMMITTEE AC11 TION.—For each drug or biological product, the 

12 committee established under this paragraph shall 

13 document for each function under paragraph (4) or 

14 (5), which members of the committee participated in 

15 such function. 

16 ‘‘(4) REVIEW OF REQUESTS FOR PEDIATRIC AS17 SESSMENTS, DEFERRALS, AND WAIVERS.—All writ18 ten requests for a pediatric assessment issued pursu19 ant to this section and all requests for deferrals and 

20 waivers from the requirement to conduct a pediatric 

21 assessment under this section shall be reviewed and 

22 approved by the committee established under para23 graph (1). 

24 ‘‘(5) REVIEW OF ASSESSMENTS.—The com25 mittee established under paragraph (1) shall review 
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1 all assessments conducted under this section to de2 termine whether such assessments meet the require3 ments of this section. 

4 ‘‘(6) TRACKING OF ASSESSMENTS AND LABEL5 ING CHANGES.—The committee established under 

6 paragraph (1) is responsible for tracking and mak7 ing public in an easily accessible manner, including 

8 through posting on the website of the Food and 

9 Drug Administration—

10 ‘‘(A) the number of assessments conducted 

11 under this section; 

12 ‘‘(B) the specific drugs and drug uses as13 sessed under this section; 

14 ‘‘(C) the types of assessments conducted 

15 under this section, including trial design, the 

16 number of pediatric patients studied, and the 

17 number of centers and countries involved; 

18 ‘‘(D) the total number of deferrals re19 quested and granted under this section, and, if 

20 granted, the reasons for such deferrals, the 

21 timeline for completion, and the number com22 pleted and pending by the specified date, as 

23 outlined in subsection (a)(3); 
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1 ‘‘(E) the number of waivers requested and 

2 granted under this section, and, if granted, the 

3 reasons for the waivers; 

4 ‘‘(F) the number of pediatric formulations 

5 developed and the number of pediatric formula6 tions not developed and the reasons any such 

7 formulations were not developed; 

8 ‘‘(G) the labeling changes made as a result 

9 of assessments conducted under this section; 

10 ‘‘(H) an annual summary of labeling 

11 changes made as a result of assessments con12 ducted under this section for distribution pursu13 ant to subsection (i)(2); and 

14 ‘‘(I) an annual summary of the informa15 tion submitted pursuant to subsection 

16 (a)(3)(B). 

17 ‘‘(7) COMMITTEE.—The committee established 

18 under paragraph (1) is the committee established 

19 under section 505A(f)(1). 

20 ‘‘(g) LABELING CHANGES.—

21 ‘‘(1) PRIORITY STATUS FOR PEDIATRIC SUP22 PLEMENT.—Any supplement to an application under 

23 section 505 and section 351 of the Public Health 

24 Service Act proposing a labeling change as a result 
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1 of any pediatric assessments conducted pursuant to 

2 this section—

3 ‘‘(A) shall be considered a priority supple4 ment; and 

5 ‘‘(B) shall be subject to the performance 

6 goals established by the Commissioner for pri7 ority drugs. 

8 ‘‘(2) DISPUTE RESOLUTION.—

9 ‘‘(A) REQUEST FOR LABELING CHANGE

10 AND FAILURE TO AGREE.—If the Commissioner 

11 determines that a sponsor and the Commis12 sioner have been unable to reach agreement on 

13 appropriate changes to the labeling for the drug 

14 that is the subject of the application or supple15 ment, not later than 180 days after the date of 

16 the submission of the application or supple17 ment—

18 ‘‘(i) the Commissioner shall request 

19 that the sponsor make any labeling change 

20 that the Commissioner determines to be 

21 appropriate; and 

22 ‘‘(ii) if the sponsor does not agree to 

23 make a labeling change requested by the 

24 Commissioner, the Commissioner shall 
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1 refer the matter to the Pediatric Advisory 

2 Committee. 

3 ‘‘(B) ACTION BY THE PEDIATRIC ADVISORY

4 COMMITTEE.—Not later than 90 days after re5 ceiving a referral under subparagraph (A)(ii), 

6 the Pediatric Advisory Committee shall—

7 ‘‘(i) review the pediatric study reports; 

8 and 

9 ‘‘(ii) make a recommendation to the 

10 Commissioner concerning appropriate la11 beling changes, if any. 

12 ‘‘(C) CONSIDERATION OF RECOMMENDA13 TIONS.—The Commissioner shall consider the 

14 recommendations of the Pediatric Advisory 

15 Committee and, if appropriate, not later than 

16 30 days after receiving the recommendation, 

17 make a request to the sponsor of the applica18 tion or supplement to make any labeling 

19 changes that the Commissioner determines to 

20 be appropriate. 

21 ‘‘(D) MISBRANDING.—If the sponsor, with22 in 30 days after receiving a request under sub23 paragraph (C), does not agree to make a label24 ing change requested by the Commissioner, the 

25 Commissioner may deem the drug that is the 
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1 subject of the application or supplement to be 

2 misbranded. 

3 ‘‘(E) NO EFFECT ON AUTHORITY.—Noth4 ing in this subsection limits the authority of the 

5 United States to bring an enforcement action 

6 under this Act when a drug lacks appropriate 

7 pediatric labeling. Neither course of action (the 

8 Pediatric Advisory Committee process or an en9 forcement action referred to in the preceding 

10 sentence) shall preclude, delay, or serve as the 

11 basis to stay the other course of action. 

12 ‘‘(3) OTHER LABELING CHANGES.—If the Sec13 retary makes a determination that a pediatric as14 sessment conducted under this section does or does 

15 not demonstrate that the drug that is the subject of 

16 such assessment is safe and effective, including 

17 whether such assessment results are inconclusive, in 

18 pediatric populations or subpopulations, the Sec19 retary shall order the labeling of such product to in20 clude information about the results of the assess21 ment and a statement of the Secretary’s determina22 tion. 

23 ‘‘(h) DISSEMINATION OF PEDIATRIC INFORMA24 TION.—
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1 ‘‘(1) IN GENERAL.—Not later than 180 days 

2 after the date of submission of a pediatric assess3 ment under this section, the Secretary shall make 

4 available to the public in an easily accessible manner 

5 the medical, statistical, and clinical pharmacology re6 views of such pediatric assessments and shall post 

7 such assessments on the website of the Food and 

8 Drug Administration. 

9 ‘‘(2) DISSEMINATION OF INFORMATION RE10 GARDING LABELING CHANGES.—The Secretary shall 

11 require that the sponsors of the assessments that re12 sult in labeling changes that are reflected in the an13 nual summary developed pursuant to subsection 

14 (f)(4)(H) distribute such information to physicians 

15 and other health care providers. 

16 ‘‘(3) EFFECT OF SUBSECTION.—Nothing in this 

17 subsection shall alter or amend section 301(j) of this 

18 Act or section 552 of title 5, United States Code, or 

19 section 1905 of title 18, United States Code. 

20 ‘‘(i) ADVERSE EVENT REPORTING.—

21 ‘‘(1) REPORTING IN YEAR 1.—During the 1-

22 year period beginning on the date a labeling change 

23 is made pursuant to subsection (g), the Secretary 

24 shall ensure that all adverse event reports that have 

25 been received for such drug (regardless of when such 
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1 report was received) are referred to the Office of Pe2 diatric Therapeutics. In considering such reports, 

3 the Director of such Office shall provide for the re4 view of the report by the Pediatric Advisory Com5 mittee, including obtaining any recommendations of 

6 such committee regarding whether the Secretary 

7 should take action under this Act in response to 

8 such report. 

9 ‘‘(2) REPORTING IN SUBSEQUENT YEARS.—Fol10 lowing the 1-year period described in paragraph (1), 

11 the Secretary shall, as appropriate, refer to the Of12 fice of Pediatric Therapeutics with all pediatric ad13 verse event reports for a drug for which a pediatric 

14 study was conducted under this section. In consid15 ering such reports, the Director of such Office may 

16 provide for the review of such reports by the Pedi17 atric Advisory Committee, including obtaining any 

18 recommendation of such Committee regarding 

19 whether the Secretary should take action in response 

20 to such report. 

21 ‘‘(3) EFFECT.—The requirements of this sub22 section shall supplement, not supplant, other review 

23 of such adverse event reports by the Secretary.’’. 
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1 SEC. 415. MEANINGFUL THERAPEUTIC BENEFIT. 

2 Section 505B(c) of the Federal Food, Drug, and Cos3 metic Act (21 U.S.C. 355c) is amended—

4 (1) by striking ‘‘estimates’’ and inserting ‘‘de5 termines’’; and 

6 (2) by striking ‘‘would’’ and inserting ‘‘could’’. 

7 SEC. 416. REPORTS. 

8 (a) INSTITUTE OF MEDICINE STUDY.—

9 (1) IN GENERAL.—Not later than 3 years after 

10 the date of enactment of this subtitle, the Secretary 

11 shall contract with the Institute of Medicine to con12 duct a study and report to Congress regarding the 

13 pediatric studies conducted pursuant to section 

14 505B of the Federal Food, Drug, and Cosmetic Act 

15 (21 U.S.C. 355c) since 1997. 

16 (2) CONTENT OF STUDY.—The study under 

17 paragraph (1) shall review and assess—

18 (A) pediatric studies conducted pursuant 

19 to section 505B of the Federal Food, Drug, and 

20 Cosmetic Act (21 U.S.C. 355c) since 1997 and 

21 labeling changes made as a result of such stud22 ies; and 

23 (B) the use of extrapolation for pediatric 

24 subpopulations, the use of alternative endpoints 

25 for pediatric populations, neonatal assessment 

26 tools, number and type of pediatric adverse 
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1 events, and ethical issues in pediatric clinical 

2 trials. 

3 (3) REPRESENTATIVE SAMPLE.—The Institute 

4 of Medicine may devise an appropriate mechanism to 

5 review a representative sample of studies conducted 

6 pursuant to section 505B of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 355c) from each 

8 review division within the Center for Drug Evalua9 tion and Research and the Center for Biologics 

10 Evaluation and Research in order to make the re11 quired assessment. 

12 (b) GAO REPORT.—Not later than September 1, 

13 2010, the Comptroller General of the United States, in 

14 consultation with the Secretary of Health and Human 

15 Services, shall submit to Congress a report that addresses 

16 the effectiveness of section 505B of the Federal Food, 

17 Drug, and Cosmetic Act (21 U.S.C. 355a) in ensuring 

18 that medicines used by children are tested and properly 

19 labeled, including—

20 (1) the number and importance of drugs for 

21 children that are being tested as a result of this pro22 vision and the importance for children, health care 

23 providers, parents, and others of labeling changes 

24 made as a result of such testing; 
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1 (2) the number and importance of drugs for 

2 children that are not being tested for their use not3 withstanding the provisions of such section 505B, 

4 and possible reasons for the lack of testing; and 

5 (3) the number of drugs for which testing is 

6 being done and labeling changes required, including 

7 the date labeling changes are made and which label8 ing changes required the use of the dispute resolu9 tion process established under such section 505B, 

10 together with a description of the outcomes of such 

11 process, including a description of the disputes and 

12 the recommendations of the Pediatric Advisory Com13 mittee. 

14 SEC. 417. TECHNICAL CORRECTIONS. 

15 Section 505B(a)(2)(B)(ii) of the Federal Food, Drug, 

16 and Cosmetic Act (21 U.S.C. 355c(a)(2)(B)(ii)) is amend17 ed by striking ‘‘one’’ and inserting ‘‘1’’. 

18 Subtitle C—Pediatric Medical 

19 Devices 

20 SEC. 421. SHORT TITLE. 

21 This subtitle may be cited as the ‘‘Pediatric Medical 

22 Device Safety and Improvement Act of 2007’’. 
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1 SEC. 422. TRACKING PEDIATRIC DEVICE APPROVALS. 

2 Chapter V of the Federal Food, Drug, and Cosmetic 

3 Act (21 U.S.C. 351 et seq.) is amended by inserting after 

4 section 515 the following: 

5 ‘‘SEC. 515A. PEDIATRIC USES OF DEVICES. 

6 ‘‘(a) NEW DEVICES.—

7 ‘‘(1) IN GENERAL.—A person that submits to 

8 the Secretary an application under section 520(m), 

9 or an application (or supplement to an application) 

10 or a product development protocol under section 

11 515, shall include in the application or protocol the 

12 information described in paragraph (2). 

13 ‘‘(2) REQUIRED INFORMATION.—The applica14 tion or protocol described in paragraph (1) shall in15 clude, with respect to the device for which approval 

16 is sought and if readily available—

17 ‘‘(A) a description of any pediatric sub18 populations that suffer from the disease or con19 dition that the device is intended to treat, diag20 nose, or cure; and 

21 ‘‘(B) the number of affected pediatric pa22 tients. 

23 ‘‘(3) ANNUAL REPORT.—Not later than 18 

24 months after the date of enactment of this section, 

25 and annually thereafter, the Secretary shall submit 

26 to the Committee on Health, Education, Labor, and 
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1 Pensions of the Senate and the Committee on En2 ergy and Commerce of the House of Representatives 

3 a report that includes—

4 ‘‘(A) the number of devices approved in the 

5 year preceding the year in which the report is 

6 submitted, for which there is a pediatric sub7 population that suffers from the disease or con8 dition that the device is intended to treat, diag9 nose, or cure; 

10 ‘‘(B) the number of devices approved in 

11 the year preceding the year in which the report 

12 is submitted, labeled for use in pediatric pa13 tients; 

14 ‘‘(C) the number of pediatric devices ap15 proved in the year preceding the year in which 

16 the report is submitted, exempted from a fee 

17 pursuant to section 738(a)(2)(B)(v); and 

18 ‘‘(D) the review time for each device de19 scribed in subparagraphs (A), (B), and (C). 

20 ‘‘(b) DETERMINATION OF PEDIATRIC EFFECTIVE21 NESS BASED ON SIMILAR COURSE OF DISEASE OR CONDI22 TION OR SIMILAR EFFECT OF DEVICE ON ADULTS.—

23 ‘‘(1) IN GENERAL.—If the course of the disease 

24 or condition and the effects of the device are suffi25 ciently similar in adults and pediatric patients, the 
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1 Secretary may conclude that adult data may be used 

2 to support a determination of a reasonable assur3 ance of effectiveness in pediatric populations, as ap4 propriate. 

5 ‘‘(2) EXTRAPOLATION BETWEEN SUBPOPULA6 TIONS.—A study may not be needed in each pedi7 atric subpopulation if data from one subpopulation 

8 can be extrapolated to another subpopulation. 

9 ‘‘(c) PEDIATRIC SUBPOPULATION.—In this section, 

10 the term ‘pediatric subpopulation’ has the meaning given 

11 the term in section 520(m)(6)(E)(ii).’’. 

12 SEC. 423. MODIFICATION TO HUMANITARIAN DEVICE EX13 EMPTION. 

14 (a) IN GENERAL.—Section 520(m) of the Federal 

15 Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) is 

16 amended—

17 (1) in paragraph (3), by striking ‘‘No’’ and in18 serting ‘‘Except as provided in paragraph (6), no’’; 

19 (2) in paragraph (5)—

20 (A) by inserting ‘‘, if the Secretary has 

21 reason to believe that the requirements of para22 graph (6) are no longer met,’’ after ‘‘public 

23 health’’; and 

24 (B) by adding at the end the following: ‘‘If 

25 the person granted an exemption under para-
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1 graph (2) fails to demonstrate continued com2 pliance with the requirements of this sub3 section, the Secretary may suspend or withdraw 

4 the exemption from the effectiveness require5 ments of sections 514 and 515 for a humani6 tarian device only after providing notice and an 

7 opportunity for an informal hearing.’’; 

8 (3) by striking paragraph (6) and inserting the 

9 following: 

10 ‘‘(6)(A) Except as provided in subparagraph (D), the 

11 prohibition in paragraph (3) shall not apply with respect 

12 to a person granted an exemption under paragraph (2) 

13 if each of the following conditions apply: 

14 ‘‘(i)(I) The device with respect to which the ex15 emption is granted is intended for the treatment or 

16 diagnosis of a disease or condition that occurs in pe17 diatric patients or in a pediatric subpopulation, and 

18 such device is labeled for use in pediatric patients or 

19 in a pediatric subpopulation in which the disease or 

20 condition occurs. 

21 ‘‘(II) The device was not previously approved 

22 under this subsection for the pediatric patients or 

23 the pediatric subpopulation described in subclause 

24 (I) prior to the date of enactment of the Pediatric 
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1 Medical Device Safety and Improvement Act of 

2 2007. 

3 ‘‘(ii) During any calendar year, the number of 

4 such devices distributed during that year does not 

5 exceed the annual distribution number specified by 

6 the Secretary when the Secretary grants such ex7 emption. The annual distribution number shall be 

8 based on the number of individuals affected by the 

9 disease or condition that such device is intended to 

10 treat, diagnose, or cure, and of that number, the 

11 number of individuals likely to use the device, and 

12 the number of devices reasonably necessary to treat 

13 such individuals. In no case shall the annual dis14 tribution number exceed the number identified in 

15 paragraph (2)(A). 

16 ‘‘(iii) Such person immediately notifies the Sec17 retary if the number of such devices distributed dur18 ing any calendar year exceeds the annual distribu19 tion number referred to in clause (ii). 

20 ‘‘(iv) The request for such exemption is sub21 mitted on or before October 1, 2012. 

22 ‘‘(B) The Secretary may inspect the records relating 

23 to the number of devices distributed during any calendar 

24 year of a person granted an exemption under paragraph 
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1 (2) for which the prohibition in paragraph (3) does not 

2 apply. 

3 ‘‘(C) A person may petition the Secretary to modify 

4 the annual distribution number specified by the Secretary 

5 under subparagraph (A)(ii) with respect to a device if ad6 ditional information on the number of individuals affected 

7 by the disease or condition arises, and the Secretary may 

8 modify such number but in no case shall the annual dis9 tribution number exceed the number identified in para10 graph (2)(A). 

11 ‘‘(D) If a person notifies the Secretary, or the Sec12 retary determines through an inspection under subpara13 graph (B), that the number of devices distributed during 

14 any calendar year exceeds the annual distribution number, 

15 as required under subparagraph (A)(iii), and modified 

16 under subparagraph (C), if applicable, then the prohibi17 tion in paragraph (3) shall apply with respect to such per18 son for such device for any sales of such device after such 

19 notification. 

20 ‘‘(E)(i) In this subsection, the term ‘pediatric pa21 tients’ means patients who are 21 years of age or younger 

22 at the time of the diagnosis or treatment. 

23 ‘‘(ii) In this subsection, the term ‘pediatric sub24 population’ means 1 of the following populations: 

25 ‘‘(I) Neonates. 
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1 ‘‘(II) Infants. 

2 ‘‘(III) Children. 

3 ‘‘(IV) Adolescents.’’; and 

4 (4) by adding at the end the following: 

5 ‘‘(7) The Secretary shall refer any report of an ad6 verse event regarding a device for which the prohibition 

7 under paragraph (3) does not apply pursuant to para8 graph (6)(A) that the Secretary receives to the Office of 

9 Pediatric Therapeutics, established under section 6 of the 

10 Best Pharmaceuticals for Children Act (Public Law 107–

11 109)). In considering the report, the Director of the Office 

12 of Pediatric Therapeutics, in consultation with experts in 

13 the Center for Devices and Radiological Health, shall pro14 vide for periodic review of the report by the Pediatric Ad15 visory Committee, including obtaining any recommenda16 tions of such committee regarding whether the Secretary 

17 should take action under this Act in response to the re18 port.’’. 

19 (b) REPORT.—Not later than January 1, 2012, the 

20 Comptroller General of the United States shall submit to 

21 the Committee on Health, Education, Labor, and Pen22 sions of the Senate and the Committee on Energy and 

23 Commerce of the House of Representatives a report on 

24 the impact of allowing persons granted an exemption 

25 under section 520(m)(2) of the Federal Food, Drug, and 
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1 Cosmetic Act (21 U.S.C. 360j(m)(2)) with respect to a 

2 device to profit from such device pursuant to section 

3 520(m)(6) of such Act (21 U.S.C. 360j(m)(6)) (as amend4 ed by subsection (a)), including—

5 (1) an assessment of whether such section 

6 520(m)(6) (as amended by subsection (a)) has in7 creased the availability of pediatric devices for condi8 tions that occur in small numbers of children, in9 cluding any increase or decrease in the number of—

10 (A) exemptions granted under such section 

11 520(m)(2) for pediatric devices; and 

12 (B) applications approved under section 

13 515 of such Act (21 U.S.C. 360e) for devices 

14 intended to treat, diagnose, or cure conditions 

15 that occur in pediatric patients or for devices 

16 labeled for use in a pediatric population; 

17 (2) the conditions or diseases the pediatric de18 vices were intended to treat or diagnose and the esti19 mated size of the pediatric patient population for 

20 each condition or disease; 

21 (3) the costs of the pediatric devices, based on 

22 a survey of children’s hospitals; 

23 (4) the extent to which the costs of such devices 

24 are covered by health insurance; 
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1 (5) the impact, if any, of allowing profit on ac2 cess to such devices for patients; 

3 (6) the profits made by manufacturers for each 

4 device that receives an exemption; 

5 (7) an estimate of the extent of the use of the 

6 pediatric devices by both adults and pediatric popu7 lations for a condition or disease other than the con8 dition or disease on the label of such devices; 

9 (8) recommendations of the Comptroller Gen10 eral of the United States regarding the effectiveness 

11 of such section 520(m)(6) (as amended by sub12 section (a)) and whether any modifications to such 

13 section 520(m)(6) (as amended by subsection (a)) 

14 should be made; 

15 (9) existing obstacles to pediatric device devel16 opment; and 

17 (10) an evaluation of the demonstration grants 

18 described in section 425, which shall include an eval19 uation of the number of pediatric medical devices—

20 (A) that have been or are being studied in 

21 children; and 

22 (B) that have been submitted to the Food 

23 and Drug Administration for approval, clear24 ance, or review under such section 520(m) (as 
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1 amended by this Act) and any regulatory ac2 tions taken. 

3 (c) GUIDANCE.—Not later than 180 days after the 

4 date of enactment of this subtitle, the Commissioner of 

5 Food and Drugs shall issue guidance for institutional re6 view committees on how to evaluate requests for approval 

7 for devices for which a humanitarian device exemption 

8 under section 520(m)(2) of the Federal Food, Drug, and 

9 Cosmetic Act (21 U.S.C. 360j(m)(2)) has been granted. 

10 SEC. 424. CONTACT POINT FOR AVAILABLE FUNDING. 

11 Section 402(b) of the Public Health Service Act (42 

12 U.S.C. 282(b)) is amended—

13 (1) in paragraph (21), by striking ‘‘and’’ after 

14 the semicolon at the end; 

15 (2) in paragraph (22), by striking the period at 

16 the end and inserting ‘‘; and’’; and 

17 (3) by inserting after paragraph (22) the fol18 lowing: 

19 ‘‘(23) shall designate a contact point or office 

20 to help innovators and physicians identify sources of 

21 funding available for pediatric medical device devel22 opment.’’. 

23 SEC. 425. DEMONSTRATION GRANTS FOR IMPROVING PEDI24 ATRIC DEVICE AVAILABILITY. 

25 (a) IN GENERAL.—
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1 (1) REQUEST FOR PROPOSALS.—Not later than 

2 90 days after the date of enactment of this subtitle, 

3 the Secretary of Health and Human Services shall 

4 issue a request for proposals for 1 or more grants 

5 or contracts to nonprofit consortia for demonstration 

6 projects to promote pediatric device development. 

7 (2) DETERMINATION ON GRANTS OR CON8 TRACTS.—Not later than 180 days after the date the 

9 Secretary of Health and Human Services issues a 

10 request for proposals under paragraph (1), the Sec11 retary shall make a determination on the grants or 

12 contracts under this section. 

13 (b) APPLICATION.—A nonprofit consortium that de14 sires to receive a grant or contract under this section shall 

15 submit an application to the Secretary of Health and 

16 Human Services at such time, in such manner, and con17 taining such information as the Secretary may require. 

18 (c) USE OF FUNDS.—A nonprofit consortium that re19 ceives a grant or contract under this section shall facilitate 

20 the development, production, and distribution of pediatric 

21 medical devices by—

22 (1) encouraging innovation and connecting 

23 qualified individuals with pediatric device ideas with 

24 potential manufacturers; 
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1 (2) mentoring and managing pediatric device 

2 projects through the development process, including 

3 product identification, prototype design, device devel4 opment, and marketing; 

5 (3) connecting innovators and physicians to ex6 isting Federal and non-Federal resources, including 

7 resources from the Food and Drug Administration, 

8 the National Institutes of Health, the Small Busi9 ness Administration, the Department of Energy, the 

10 Department of Education, the National Science 

11 Foundation, the Department of Veterans Affairs, 

12 the Agency for Healthcare Research and Quality, 

13 and the National Institute of Standards and Tech14 nology; 

15 (4) assessing the scientific and medical merit of 

16 proposed pediatric device projects; and 

17 (5) providing assistance and advice as needed 

18 on business development, personnel training, proto19 type development, postmarket needs, and other ac20 tivities consistent with the purposes of this section. 

21 (d) COORDINATION.—

22 (1) NATIONAL INSTITUTES OF HEALTH.—Each 

23 consortium that receives a grant or contract under 

24 this section shall—
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1 (A) coordinate with the National Institutes 

2 of Health’s pediatric device contact point or of3 fice, designated under section 424; and 

4 (B) provide to the National Institutes of 

5 Health any identified pediatric device needs 

6 that the consortium lacks sufficient capacity to 

7 address or those needs in which the consortium 

8 has been unable to stimulate manufacturer in9 terest. 

10 (2) FOOD AND DRUG ADMINISTRATION.—Each 

11 consortium that receives a grant or contract under 

12 this section shall coordinate with the Commissioner 

13 of Food and Drugs and device companies to facili14 tate the application for approval or clearance of de15 vices labeled for pediatric use. 

16 (3) EFFECTIVENESS AND OUTCOMES.—Each 

17 consortium that receives a grant or contract under 

18 this section shall annually report to the Secretary of 

19 Health and Human Services on—

20 (A) the effectiveness of activities conducted 

21 under subsection (c); 

22 (B) the impact of activities conducted 

23 under subsection (c) on pediatric device devel24 opment; and 
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1 (C) the status of pediatric device develop2 ment that has been facilitated by the consor3 tium. 

4 (e) AUTHORIZATION OF APPROPRIATIONS.—There 

5 are authorized to be appropriated to carry out this section 

6 $6,000,000 for each of fiscal years 2008 through 2012. 

7 SEC. 426. AMENDMENTS TO OFFICE OF PEDIATRIC THERA8 PEUTICS AND PEDIATRIC ADVISORY COM9 MITTEE. 

10 (a) IN GENERAL.—

11 (1) OFFICE OF PEDIATRIC THERAPEUTICS.—

12 Section 6(b) of the Best Pharmaceuticals for Chil13 dren Act (21 U.S.C. 393a(b)) is amended by insert14 ing ‘‘, including increasing pediatric access to med15 ical devices’’ after ‘‘pediatric issues’’. 

16 (2) PLAN FOR PEDIATRIC MEDICAL DEVICE RE17 SEARCH.—

18 (A) IN GENERAL.—Not later than 270 

19 days after the date of enactment of this sub20 title, the Office of Pediatric Therapeutics, in 

21 collaboration with the Director of the National 

22 Institutes of Health and the Director of the 

23 Agency for Healthcare Research and Quality, 

24 shall submit to the Committee on Health, Edu25 cation, Labor, and Pensions of the Senate and 
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1 the Committee on Energy and Commerce of the 

2 House of Representatives a plan for expanding 

3 pediatric medical device research and develop4 ment. In developing such plan, the Commis5 sioner of Food and Drugs shall consult with in6 dividuals and organizations with appropriate ex7 pertise in pediatric medical devices. 

8 (B) CONTENTS.—The plan under subpara9 graph (A) shall include—

10 (i) the current status of federally 

11 funded pediatric medical device research; 

12 (ii) any gaps in such research, which 

13 may include a survey of pediatric medical 

14 providers regarding unmet pediatric med15 ical device needs, as needed; and 

16 (iii) a research agenda for improving 

17 pediatric medical device development and 

18 Food and Drug Administration clearance 

19 or approval of pediatric medical devices, 

20 and for evaluating the short- and long21 term safety and effectiveness of pediatric 

22 medical devices. 

23 (b) PEDIATRIC ADVISORY COMMITTEE.—Section 14 

24 of the Best Pharmaceuticals for Children Act (42 U.S.C. 

25 284m note) is amended—
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1 (1) in subsection (a), by inserting ‘‘(including 

2 drugs and biological products) and medical devices’’ 

3 after ‘‘therapeutics’’; and 

4 (2) in subsection (b)—

5 (A) in paragraph (1), by inserting ‘‘(in6 cluding drugs and biological products) and med7 ical devices’’ after ‘‘therapeutics’’; and 

8 (B) in paragraph (2)—

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

10 ‘‘and 505B’’ and inserting ‘‘505B, 510(k), 

11 515, and 520(m)’’; 

12 (ii) by striking subparagraph (B) and 

13 inserting the following: 

14 ‘‘(B) identification of research priorities re15 lated to therapeutics (including drugs and bio16 logical products) and medical devices for pedi17 atric populations and the need for additional 

18 diagnostics and treatments for specific pediatric 

19 diseases or conditions; and’’; and 

20 (iii) in subparagraph (C), by inserting 

21 ‘‘(including drugs and biological products) 

22 and medical devices’’ after ‘‘therapeutics’’. 
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1 SEC. 427. POSTMARKET SURVEILLANCE. 

2 (a) POSTMARKET SURVEILLANCE.—Section 522 of 

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

4 360l) is amended—

5 (1) by striking subsection (a) and inserting the 

6 following: 

7 ‘‘(a) POSTMARKET SURVEILLANCE.—

8 ‘‘(1) IN GENERAL.—

9 ‘‘(A) CONDUCT.—The Secretary may by 

10 order require a manufacturer to conduct 

11 postmarket surveillance for any device of the 

12 manufacturer that is a class II or class III de13 vice—

14 ‘‘(i) the failure of which would be rea15 sonably likely to have serious adverse 

16 health consequences; 

17 ‘‘(ii) that is expected to have signifi18 cant use in pediatric populations; or 

19 ‘‘(iii) that is intended to be—

20 ‘‘(I) implanted in the human 

21 body for more than 1 year; or 

22 ‘‘(II) a life-sustaining or life-sup23 porting device used outside a device 

24 user facility. 

25 ‘‘(B) CONDITION.—The Secretary may 

26 order a postmarket surveillance under subpara-
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1 graph (A) as a condition to approval or clear2 ance of a device described in subparagraph 

3 (A)(ii). 

4 ‘‘(2) RULE OF CONSTRUCTION.—The provisions 

5 of paragraph (1) shall have no effect on authorities 

6 otherwise provided under the Act or regulations 

7 issued under this Act.’’; and 

8 (2) in subsection (b)—

9 (A) by striking ‘‘(b) SURVEILLANCE AP10 PROVAL.—Each’’ and inserting the following: 

11 ‘‘(b) SURVEILLANCE APPROVAL.—

12 ‘‘(1) IN GENERAL.—Each’’; 

13 (B) by striking ‘‘The Secretary, in con14 sultation’’ and inserting ‘‘Except as provided in 

15 paragraph (2), the Secretary, in consultation’’; 

16 (C) by striking ‘‘Any determination’’ and 

17 inserting ‘‘Except as provided in paragraph (2), 

18 any determination’’; and 

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

20 ‘‘(2) LONGER SURVEILLANCES FOR PEDIATRIC

21 DEVICES.—The Secretary may by order require a 

22 prospective surveillance period of more than 36 

23 months with respect to a device that is expected to 

24 have significant use in pediatric populations if such 

25 period of more than 36 months is necessary in order 
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1 to assess the impact of the device on growth and de2 velopment, or the effects of growth, development, ac3 tivity level, or other factors on the safety of the de4 vice.’’. 

5 TITLE V—OTHER PROVISIONS 

6 SEC. 501. POLICY ON THE REVIEW AND CLEARANCE OF SCI7 ENTIFIC ARTICLES PUBLISHED BY FDA EM8 PLOYEES. 

9 Subchapter A of chapter VII of the Federal Food, 

10 Drug, and Cosmetic Act (21 U.S.C. 371 et seq.), as 

11 amended by section 241, is further amended by adding 

12 at the end the following: 

13 ‘‘SEC. 713. POLICY ON THE REVIEW AND CLEARANCE OF 

14 SCIENTIFIC ARTICLES PUBLISHED BY FDA 

15 EMPLOYEES. 

16 ‘‘(a) DEFINITION.—In this section, the term ‘article’ 

17 means a paper, poster, abstract, book, book chapter, or 

18 other published writing. 

19 ‘‘(b) POLICIES.—The Secretary, through the Com20 missioner of Food and Drugs, shall establish and make 

21 publicly available clear written policies to implement this 

22 section and govern the timely submission, review, clear23 ance, and disclaimer requirements for articles. 

24 ‘‘(c) TIMING OF SUBMISSION FOR REVIEW.—If an of25 ficer or employee, including a Staff Fellow and a con-
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1 tractor who performs staff work, of the Food and Drug 

2 Administration is required by the policies established 

3 under subsection (b) to submit an article to the supervisor 

4 of such officer or employee, or to some other official of 

5 the Food and Drug Administration, for review and clear6 ance before such officer or employee may seek to publish 

7 or present such an article at a conference, such officer 

8 or employee shall submit such article for such review and 

9 clearance not less than 30 days before submitting the arti10 cle for publication or presentation. 

11 ‘‘(d) TIMING FOR REVIEW AND CLEARANCE.—The 

12 supervisor or other reviewing official shall review such ar13 ticle and provide written clearance, or written clearance 

14 on the condition of specified changes being made, to such 

15 officer or employee not later than 30 days after such offi16 cer or employee submitted such article for review. 

17 ‘‘(e) NON-TIMELY REVIEW.—If, 31 days after such 

18 submission under subsection (c), the supervisor or other 

19 reviewing official has not cleared or has not reviewed such 

20 article and provided written clearance, such officer or em21 ployee may consider such article not to have been cleared 

22 and may submit the article for publication or presentation 

23 with an appropriate disclaimer as specified in the policies 

24 established under subsection (b).’’. 
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1 SEC. 502. TECHNICAL AMENDMENTS. 

2 The Public Health Service Act (42 U.S.C. 201 et 

3 seq.) is amended—

4 (1) in section 319C–2(j)(3)(B), by striking 

5 ‘‘section 319C–1(h)’’ and inserting ‘‘section 319C–

6 1(i)’’; 

7 (2) in section 402(b)(4), by inserting ‘‘minority 

8 and other’’ after ‘‘reducing’’; 

9 (3) in section 403(a)(4)(C)(iv)(III), by inserting 

10 ‘‘and post doctoral training funded through investi11 gator-initiated research grant awards’’ before the 

12 semicolon; and 

13 (4) in section 403C(a)—

14 (A) in the matter preceding paragraph (1), 

15 by inserting ‘‘graduate students supported by 

16 NIH for’’ after ‘‘with respect to’’; 

17 (B) in paragraph (1), by inserting ‘‘such’’ 

18 after ‘‘percentage of’’; and 

19 (C) in paragraph (2), by inserting ‘‘(not 

20 including any leaves of absence)’’ after ‘‘average 

21 time’’. 

22 SEC. 503. SEVERABILITY CLAUSE. 

23 If any provision of this Act, an amendment made this 

24 Act, or the application of such provision or amendment 

25 to any person or circumstance is held to be unconstitu26 tional, the remainder of this Act, the amendments made 
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1 by this Act, and the application of the provisions of such 

2 to any person or circumstances shall not be affected there3 by. 

4 SEC. 504. SENSE OF THE SENATE WITH RESPECT TO FOL5 LOW-ON BIOLOGICS. 

6 (a) FINDINGS.—The Senate finds the following: 

7 (1) The Food and Drug Administration has 

8 stated that it requires legislative authority to review 

9 follow-on biologics. 

10 (2) Business, consumer, and government pur11 chasers require competition and choice to ensure 

12 more affordable prescription drug options. 

13 (3) Well-constructed policies that balance the 

14 needs of innovation and affordability have broad bi15 partisan support. 

16 (b) SENSE OF THE SENATE.—It is the sense of the 

17 Senate that legislation should be enacted to—

18 (1) provide the Food and Drug Administration 

19 with the authority and flexibility to approve bio20 pharmaceuticals subject to an abbreviated approval 

21 pathway; 

22 (2) ensure that patient safety remains para23 mount in the system; 

24 (3) establish a regulatory pathway that is effi25 cient, effective, and scientifically-grounded and that 
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1 also includes measures to ensure timely resolution of 

2 patent disputes; and 

3 (4) provide appropriate incentives to facilitate 

4 the research and development of innovative bio5 pharmaceuticals. 

6 SEC. 505. PRIORITY REVIEW TO ENCOURAGE TREATMENTS 

7 FOR TROPICAL DISEASES. 

8 Subchapter A of chapter V of the Federal Food, 

9 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend10 ed by adding at the end the following: 

11 ‘‘SEC. 524. PRIORITY REVIEW TO ENCOURAGE TREATMENTS 

12 FOR TROPICAL DISEASES. 

13 ‘‘(a) DEFINITIONS.—In this section: 

14 ‘‘(1) AIDS.—The term ‘AIDS’ means the ac15 quired immune deficiency syndrome. 

16 ‘‘(2) AIDS DRUG.—The term ‘AIDS drug’ 

17 means a drug indicated for treating HIV. 

18 ‘‘(3) HIV.—The term ‘HIV’ means the human 

19 immunodeficiency virus, the pathogen that causes 

20 AIDS. 

21 ‘‘(4) NEGLECTED OR TROPICAL DISEASE.—The 

22 term ‘neglected or tropical disease’ means—

23 ‘‘(A) HIV, malaria, tuberculosis, and re24 lated diseases; or 
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1 ‘‘(B) any other infectious disease that dis2 proportionately affects poor and marginalized 

3 populations, including those diseases targeted 

4 by the Special Programme for Research and 

5 Training in Tropical Diseases cosponsored by 

6 the United Nations Development Program, 

7 UNICEF, the World Bank, and the World 

8 Health Organization. 

9 ‘‘(5) PRIORITY REVIEW.—The term ‘priority re10 view’, with respect to a new drug application de11 scribed in paragraph (6), means review and action 

12 by the Secretary on such application not later than 

13 180 days after receipt by the Secretary of such ap14 plication, pursuant to the Manual of Policies and 

15 Procedures of the Food and Drug Administration. 

16 ‘‘(6) PRIORITY REVIEW VOUCHER.—The term 

17 ‘priority review voucher’ means a voucher issued by 

18 the Secretary to the sponsor of a tropical disease 

19 product that entitles such sponsor, or a person de20 scribed under subsection (b)(2), to priority review of 

21 a new drug application submitted under section 

22 505(b)(1) after the date of approval of the tropical 

23 disease product. 

24 ‘‘(7) TROPICAL DISEASE PRODUCT.—The term 

25 ‘tropical disease product’ means a product that—
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1 ‘‘(A) is a new drug, antibiotic drug, bio2 logical product, vaccine, device, diagnostic, or 

3 other tool for treatment of a neglected or trop4 ical disease; and 

5 ‘‘(B) is approved by the Secretary for use 

6 in the treatment of a neglected or tropical dis7 ease. 

8 ‘‘(b) PRIORITY REVIEW VOUCHER.—

9 ‘‘(1) IN GENERAL.—The Secretary shall award 

10 a priority review voucher to the sponsor of a tropical 

11 disease product upon approval by the Secretary of 

12 such tropical disease product. 

13 ‘‘(2) TRANSFERABILITY.—The sponsor of a 

14 tropical disease product that receives a priority re15 view voucher under this section may transfer (in16 cluding by sale) the entitlement to such voucher to 

17 a sponsor of a new drug for which an application 

18 under section 505(b)(1) will be submitted after the 

19 date of the approval of the tropical disease product. 

20 ‘‘(3) LIMITATION.—A sponsor of a tropical dis21 ease product may not receive a priority review 

22 voucher under this section if the tropical disease 

23 product was approved by the Secretary prior to the 

24 date of enactment of this section. 

25 ‘‘(c) PRIORITY REVIEW USER FEE.—
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1 ‘‘(1) IN GENERAL.—The Secretary shall estab2 lish a user fee program under which a sponsor of a 

3 drug that is the subject of a priority review voucher 

4 shall pay to the Secretary a fee determined under 

5 paragraph (2). Such fee shall be in addition to any 

6 fee required to be submitted by the sponsor under 

7 chapter VII. 

8 ‘‘(2) FEE AMOUNT.—The amount of the pri9 ority review user fee shall be determined each fiscal 

10 year by the Secretary and based on the anticipated 

11 costs to the Secretary of implementing this section. 

12 ‘‘(3) ANNUAL FEE SETTING.—The Secretary 

13 shall establish, before the beginning of each fiscal 

14 year beginning after September 30, 2007, for that 

15 fiscal year, the amount of the priority review user 

16 fee. 

17 ‘‘(4) PAYMENT.—

18 ‘‘(A) IN GENERAL.—The fee required by 

19 this subsection shall be due upon the filing of 

20 the new drug application under section 

21 505(b)(1) for which the voucher is used. 

22 ‘‘(B) COMPLETE APPLICATION.—An appli23 cation described under subparagraph (A) for 

24 which the sponsor requests the use of a priority 

25 review voucher shall be considered incomplete if 
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1 the fee required by this subsection is not in2 cluded in such application. 

3 ‘‘(5) OFFSETTING COLLECTIONS.—Fees col4 lected pursuant to this subsection for any fiscal 

5 year—

6 ‘‘(A) shall be deposited and credited as off7 setting collections to the account providing ap8 propriations to the Food and Drug Administra9 tion; and 

10 ‘‘(B) shall not be collected for any fiscal 

11 year except to the extent provided in advance in 

12 appropriation Acts.’’. 

13 SEC. 506. CITIZENS PETITIONS AND PETITIONS FOR STAY 

14 OF AGENCY ACTION. 

15 Section 505 of the Federal Food, Drug, and Cosmetic 

16 Act (21 U.S.C. 355), as amended by this Act, is amended 

17 by adding at the end the following: 

18 ‘‘(s) CITIZEN PETITIONS AND PETITIONS FOR STAY

19 OF AGENCY ACTION.—

20 ‘‘(1) IN GENERAL.—

21 ‘‘(A) NO DELAY OF CONSIDERATION OR

22 APPROVAL.—

23 ‘‘(i) IN GENERAL.—With respect to a 

24 pending application submitted under sub25 section (b)(2) or (j), if a petition is sub-
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1 mitted to the Secretary that seeks to have 

2 the Secretary take, or refrain from taking, 

3 any form of action relating to the approval 

4 of the application, including a delay in the 

5 effective date of the application, clauses 

6 (ii) and (iii) shall apply. 

7 ‘‘(ii) NO DELAY OF CONSIDERATION

8 OR APPROVAL.—Except as provided in 

9 clause (iii), the receipt and consideration of 

10 a petition described in clause (i) shall not 

11 delay consideration or approval of an appli12 cation submitted under subsection (b)(2) 

13 or (j). 

14 ‘‘(iii) NO DELAY OF APPROVAL WITH15 OUT DETERMINATION.—The Secretary 

16 shall not delay approval of an application 

17 submitted under subsection (b)(2) or (j) 

18 while a petition described in clause (i) is 

19 reviewed and considered unless the Sec20 retary determines, not later than 25 busi21 ness days after the submission of the peti22 tion, that a delay is necessary to protect 

23 the public health. 

24 ‘‘(B) DETERMINATION OF DELAY.—With 

25 respect to a determination by the Secretary 
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1 under subparagraph (A)(iii) that a delay is nec2 essary to protect the public health the following 

3 shall apply: 

4 ‘‘(i) Not later than 5 days after mak5 ing such determination, the Secretary shall 

6 publish on the Internet website of the 

7 Food and Drug Administration a detailed 

8 statement providing the reasons underlying 

9 the determination. The detailed statement 

10 shall include a summary of the petition 

11 and comments and supplements, the spe12 cific substantive issues that the petition 

13 raises which need to be considered prior to 

14 approving a pending application submitted 

15 under subsection (b)(2) or (j), and any 

16 clarifications and additional data that is 

17 needed by the Secretary to promptly review 

18 the petition. 

19 ‘‘(ii) Not later than 10 days after 

20 making such determination, the Secretary 

21 shall provide notice to the sponsor of the 

22 pending application submitted under sub23 section (b)(2) or (j) and provide an oppor24 tunity for a meeting with appropriate staff 
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1 as determined by the Commissioner to dis2 cuss the determination. 

3 ‘‘(2) TIMING OF FINAL AGENCY ACTION ON PE4 TITIONS.—

5 ‘‘(A) IN GENERAL.—Notwithstanding a de6 termination made by the Secretary under para7 graph (1)(A)(iii), the Secretary shall take final 

8 agency action with respect to a petition not 

9 later than 180 days of submission of that peti10 tion unless the Secretary determines, prior to 

11 the date that is 180 days after the date of sub12 mission of the petition, that a delay is necessary 

13 to protect the public health. 

14 ‘‘(B) DETERMINATION OF DELAY.—With 

15 respect to a determination by the Secretary 

16 under subparagraph (A) that a delay is nec17 essary to protect the public health the following 

18 shall apply: 

19 ‘‘(i) Not later than 5 days after mak20 ing the determination under subparagraph 

21 (A), the Secretary shall publish on the 

22 Internet website of the Food and Drug Ad23 ministration a detailed statement providing 

24 the reasons underlying the determination. 

25 The detailed statement should include the 
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1 state of the review of the petition, the spe2 cific outstanding issues that still need to 

3 be resolved, a proposed timeframe to re4 solve the issues, and any additional infor5 mation that has been requested by the Sec6 retary of the petitioner or needed by the 

7 Secretary in order to resolve the petition 

8 and not further delay an application filed 

9 under subsection (b)(2) or (j). 

10 ‘‘(ii) Not later than 10 days after 

11 making the determination under subpara12 graph (A), the Secretary shall provide no13 tice to the sponsor of the pending applica14 tion submitted under subsection (b)(2) or 

15 (j) and provide an opportunity for a meet16 ing with appropriate staff as determined 

17 by the Commissioner to discuss the deter18 mination. 

19 ‘‘(3) VERIFICATIONS.—

20 ‘‘(A) PETITIONS FOR REVIEW.—The Sec21 retary shall not accept a petition for review un22 less it is signed and contains the following 

23 verification: ‘I certify that, to my best knowl24 edge and belief: (a) this petition includes all in25 formation and views upon which the petition re-
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1 lies; (b) this petition includes representative 

2 data and/or information known to the petitioner 

3 which are unfavorable to the petition; and (c) 

4 information upon which I have based the action 

5 requested herein first became known to the 

6 party on whose behalf this petition is filed on 

7 or about llllllllll. I received or 

8 expect to receive payments, including cash and 

9 other forms of consideration, from the following 

10 persons or organizations to file this petition: 

11 llllllll. I verify under penalty of 

12 perjury that the foregoing is true and correct.’, 

13 with the date of the filing of such petition and 

14 the signature of the petitioner inserted in the 

15 first and second blank space, respectively. 

16 ‘‘(B) SUPPLEMENTAL INFORMATION.—The 

17 Secretary shall not accept for review any sup18 plemental information or comments on a peti19 tion unless the party submitting such informa20 tion or comments does so in written form and 

21 that the subject document is signed and con22 tains the following verification: ‘I certify that, 

23 to my best knowledge and belief: (a) I have not 

24 intentionally delayed submission of this docu25 ment or its contents; and (b) the information 
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1 upon which I have based the action requested 

2 herein first became known to me on or about 

3 llllllllll. I received or expect to 

4 receive payments, including cash and other 

5 forms of consideration, from the following per6 sons or organizations to submit this information 

7 or its contents: lllll. I verify under pen8 alty of perjury that the foregoing is true and 

9 correct.’, with the date of the submission of 

10 such document and the signature of the peti11 tioner inserted in the first and second blank 

12 space, respectively. 

13 ‘‘(4) ANNUAL REPORT ON DELAYS IN APPROV14 ALS PER PETITION.—The Secretary shall annually 

15 submit to the Congress a report that specifies—

16 ‘‘(A) the number of applications under 

17 subsection (b)(2) and (j) that were approved 

18 during the preceding 1-year period; 

19 ‘‘(B) the number of petitions that were 

20 submitted during such period; 

21 ‘‘(C) the number of applications whose ef22 fective dates were delayed by petitions during 

23 such period and the number of days by which 

24 the applications were so delayed; and 
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1 ‘‘(D) the number of petitions that were 

2 filed under this subsection that were deemed by 

3 the Secretary under paragraph (1)(A)(iii) to re4 quire delaying an application under subsection 

5 (b)(2) or (j) and the number of days by which 

6 the applications were so delayed. 

7 ‘‘(5) EXCEPTION.—This subsection does not 

8 apply to a petition that is made by the sponsor of 

9 the application under subsection (b)(2) or (j) and 

10 that seeks only to have the Secretary take or refrain 

11 from taking any form of action with respect to that 

12 application. 

13 ‘‘(6) REPORT BY INSPECTOR GENERAL.—The 

14 Office of Inspector General of the Department of 

15 Health and Human Services shall issue a report not 

16 later than 2 years after the date of enactment of 

17 this subsection evaluating evidence of the compliance 

18 of the Food and Drug Administration with the re19 quirement that the consideration by the Secretary of 

20 petitions that do not raise public health concerns re21 main separate and apart from the review and ap22 proval of an application submitted under subsection 

23 (b)(2) or (j). 

24 ‘‘(7) DEFINITION.—For purposes of this sub25 section, the term ‘petition’ includes any request for 
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1 an action described in paragraph (1)(A)(i) to the 

2 Secretary, without regard to whether the request is 

3 characterized as a petition.’’. 

4 SEC. 507. PUBLICATION OF ANNUAL REPORTS. 

5 (a) IN GENERAL.—The Commissioner on Food and 

6 Drugs shall annually submit to Congress and publish on 

7 the Internet website of the Food and Drug Administra8 tion, a report concerning the results of the Administra9 tion’s pesticide residue monitoring program, that in10 cludes—

11 (1) information and analysis similar to that 

12 contained in the report entitled ‘‘Food and Drug Ad13 ministration Pesticide Program Residue Monitoring 

14 2003’’ as released in June of 2005; 

15 (2) based on an analysis of previous samples, 

16 an identification of products or countries (for im17 ports) that require special attention and additional 

18 study based on a comparison with equivalent prod19 ucts manufactured, distributed, or sold in the United 

20 States (including details on the plans for such addi21 tional studies), including in the initial report (and 

22 subsequent reports as determined necessary) the re23 sults and analysis of the Ginseng Dietary Supple24 ments Special Survey as described on page 13 of the 
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1 report entitled ‘‘Food and Drug Administration Pes2 ticide Program Residue Monitoring 2003’’; 

3 (3) information on the relative number of inter4 state and imported shipments of each tested com5 modity that were sampled, including recommenda6 tions on whether sampling is statistically significant, 

7 provides confidence intervals or other related statis8 tical information, and whether the number of sam9 ples should be increased and the details of any plans 

10 to provide for such increase; and 

11 (4) a description of whether certain commod12 ities are being improperly imported as another com13 modity, including a description of additional steps 

14 that are being planned to prevent such smuggling. 

15 (b) INITIAL REPORTS.—Annual reports under sub16 section (a) for fiscal years 2004 through 2006 may be 

17 combined into a single report, by not later than June 1, 

18 2008, for purposes of publication under subsection (a). 

19 Thereafter such reports shall be completed by June 1 of 

20 each year for the data collected for the year that was 2-

21 years prior to the year in which the report is published. 

22 (c) MEMORANDUM OF UNDERSTANDING.—The Com23 missioner of Food and Drugs, the Administrator of the 

24 Food Safety and Inspection Service, the Department of 

25 Commerce, and the head of the Agricultural Marketing 
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1 Service shall enter into a memorandum of understanding 

2 to permit inclusion of data in the reports under subsection 

3 (a) relating to testing carried out by the Food Safety and 

4 Inspection Service and the Agricultural Marketing Service 

5 on meat, poultry, eggs, and certain raw agricultural prod6 ucts, respectively. 

7 SEC. 508. HEAD START ACT AMENDMENT IMPOSING PAREN8 TAL CONSENT REQUIREMENT FOR NON9 EMERGENCY INTRUSIVE PHYSICAL EXAMINA10 TIONS. 

11 The Head Start Act (42 U.S.C. 9831 et seq.) is 

12 amended by adding at the end the following: 

13 ‘‘SEC. 657A. PARENTAL CONSENT REQUIREMENT FOR NON14 EMERGENCY INTRUSIVE PHYSICAL EXAMINA15 TIONS. 

16 ‘‘(a) IN GENERAL.—A Head Start agency shall ob17 tain written parental consent before administration of any 

18 nonemergency intrusive physical examination of a child in 

19 connection with participation in a program under this sub20 chapter. 

21 ‘‘(b) DEFINITION.—The term ‘nonemergency intru22 sive physical examination’ means, with respect to a child, 

23 a physical examination that—
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1 ‘‘(1) is not immediately necessary to protect the 

2 health or safety of the child involved or the health 

3 or safety of another individual; and 

4 ‘‘(2) requires incision or is otherwise invasive, 

5 or involves exposure of private body parts. 

6 ‘‘(c) RULE OF CONSTRUCTION.—Nothing in this sec7 tion shall be construed to prohibit agencies from using es8 tablished methods, for handling cases of suspected or 

9 known child abuse and neglect, that are in compliance 

10 with applicable Federal, State, or tribal law.’’. 

11 SEC. 509. SAFETY OF FOOD ADDITIVES. 

12 Not later than 90 days after the date of enactment 

13 of this Act, the Food and Drug Administration shall issue 

14 a report on the question of whether substances used to 

15 preserve the appearance of fresh meat may create any 

16 health risks, or mislead consumers. 

17 SEC. 510. IMPROVING GENETIC TEST SAFETY AND QUALITY. 

18 Not later than 30 days after the date of enactment 

19 of this Act, the Secretary shall enter into a contract with 

20 the Institute of Medicine to conduct a study to assess the 

21 overall safety and quality of genetic tests and prepare a 

22 report that includes recommendations to improve Federal 

23 oversight and regulation of genetic tests. Such study shall 

24 take into consideration relevant reports by the Secretary’s 

25 Advisory Committee on Genetic Testing and other groups 
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1 and shall be completed not later than 1 year after the date 

2 on which the Secretary entered into such contract. 

3 SEC. 511. ORPHAN DISEASE TREATMENT IN CHILDREN. 

4 (a) FINDING.—The Senate finds that parents of chil5 dren suffering from rare genetic diseases known as orphan 

6 diseases face multiple obstacles in obtaining safe and ef7 fective treatment for their children due mainly to the fact 

8 that many Food and Drug Administration-approved drugs 

9 used in the treatment of orphan diseases in children may 

10 not be approved for pediatric indications. 

11 (b) SENSE OF THE SENATE.—It is the sense of the 

12 Senate that the Food and Drug Administration should 

13 enter into a contract with the Institute of Medicine for 

14 the conduct of a study concerning measures that may be 

15 taken to improve the likelihood that Food and Drug Ad16 ministration-approved drugs that are safe and effective in 

17 treating children with orphan diseases are made available 

18 and affordable for pediatric indications. 

19 SEC. 512. COLOR CERTIFICATION REPORTS. 

20 Section 721 of the Federal Food, Drug, and Cosmetic 

21 Act (21 U.S.C. 379e) is amended by adding at the end 

22 the following: 

23 ‘‘(g) COLOR CERTIFICATION REPORTS.—Not later 

24 than—
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1 ‘‘(1) 90 days after the close of a fiscal year in 

2 which color certification fees are collected, the Sec3 retary shall submit to Congress a performance re4 port for such fiscal year on the number of batches 

5 of color additives approved, the average turn around 

6 time for approval, and quantifiable goals for improv7 ing laboratory efficiencies; and 

8 ‘‘(2) 120 days after the close of a fiscal year in 

9 which color certification fees are collected, the Sec10 retary shall submit to Congress a financial report 

11 for such fiscal year that includes all fees and ex12 penses of the color certification program, the balance 

13 remaining in the fund at the end of the fiscal year, 

14 and anticipated costs during the next fiscal year for 

15 equipment needs and laboratory improvements of 

16 such program.’’. 

17 SEC. 513. PROHIBITION ON IMPORTATION FROM A FOR18 EIGN FOOD FACILITY THAT DENIES ACCESS 

19 TO FOOD INSPECTORS. 

20 Notwithstanding any other provision of law, no food 

21 product may be imported into the United States that is 

22 the product of a foreign facility registered under section 

23 415 of the Federal Food, Drug, and Cosmetic Act (21 

24 U.S.C. 350d) that refuses to permit United States inspec-
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1 tors, upon request, to inspect such facility or that unduly 

2 delays access to United States inspectors. 

3 SEC. 514. COUNTERFEIT-RESISTANT TECHNOLOGIES. 

4 Notwithstanding any other provision of this Act, the 

5 requirement that the Secretary of Health and Human 

6 Services certify that the implementation of the title of this 

7 Act relating to the Importation of Prescription Drugs will 

8 pose no additional risk to the public’s health and safety 

9 and will result in a significant reduction in the cost of 

10 covered products to the American consumer shall not 

11 apply to the requirement that the Secretary require that 

12 the packaging of any prescription drug incorporates—

13 (1) not later than 18 months after the date of 

14 enactment of this Act, a standardized numerical 

15 identifier (which, to the extent practicable, shall be 

16 harmonized with international consensus standards 

17 for such an identifier) unique to each package of 

18 such drug, applied at the point of manufacturing 

19 and repackaging (in which case the numerical identi20 fier shall be linked to the numerical identifier ap21 plied at the point of manufacturing); and 

22 (2) not later than 24 months after the date of 

23 enactment of this Act for the 50 prescription drugs 

24 with the highest dollar volume of sales in the United 

25 States, based on the calendar year that ends of De-
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1 cember 31, 2007, and, not later than 30 months 

2 after the date of enactment of this Act for all other 

3 prescription drugs—

4 (A) overt optically variable counterfeit-re5 sistant technologies that—

6 (i) are visible to the naked eye, pro7 viding for visual identification of product 

8 authenticity without the need for readers, 

9 microscopes, lighting devices, or scanners; 

10 (ii) are similar to that used by the 

11 Bureau of Engraving and Printing to se12 cure United States currency; 

13 (iii) are manufactured and distributed 

14 in a highly secure, tightly controlled envi15 ronment; and 

16 (iv) incorporate additional layers of 

17 nonvisible convert security features up to 

18 and including forensic capability; or 

19 (B) technologies that have a function of se20 curity comparable to that described in subpara21 graph (A), as determined by the Secretary. 

22 SEC. 515. ENHANCED AQUACULTURE AND SEAFOOD IN23 SPECTION. 

24 (a) FINDINGS.—Congress finds the following: 
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1 (1) In 2007, there has been an overwhelming 

2 increase in the volume of aquaculture and seafood 

3 that has been found to contain substances that are 

4 not approved for use in food in the United States. 

5 (2) As of May 2007, inspection programs are 

6 not able to satisfactorily accomplish the goals of en7 suring the food safety of the United States. 

8 (3) To protect the health and safety of con9 sumers in the United States, the ability of the Sec10 retary of Health and Human Services to perform in11 spection functions must be enhanced. 

12 (b) HEIGHTENED INSPECTIONS.—The Secretary of 

13 Health and Human Services (referred to in this section 

14 as the ‘‘Secretary’’) is authorized to, by regulation, en15 hance, as necessary, the inspection regime of the Food and 

16 Drug Administration for aquaculture and seafood, con17 sistent with obligations of the United States under inter18 national agreements and United States law. 

19 (c) REPORT TO CONGRESS.—Not later than 90 days 

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

21 submit to Congress a report that—

22 (1) describes the specifics of the aquaculture 

23 and seafood inspection program; 

24 (2) describes the feasibility of developing a 

25 traceability system for all catfish and seafood prod-
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1 ucts, both domestic and imported, for the purpose of 

2 identifying the processing plant of origin of such 

3 products; and 

4 (3) provides for an assessment of the risks as5 sociated with particular contaminants and banned 

6 substances. 

7 (d) PARTNERSHIPS WITH STATES.—Upon the re8 quest by any State, the Secretary may enter into partner9 ship agreements, as soon as practicable after the request 

10 is made, to implement inspection programs regarding the 

11 importation of aquaculture and seafood. 

12 (e) AUTHORIZATION OF APPROPRIATIONS.—There 

13 are authorized to be appropriated such sums as may be 

14 necessary to carry out this section. 

15 SEC. 516. SENSE OF THE SENATE REGARDING CERTAIN 

16 PATENT INFRINGEMENTS. 

17 (a) FINDINGS.—The Senate makes the following 

18 findings: 

19 (1) Innovation in developing life-saving pre20 scription drugs saves millions of lives around the 

21 world each year. 

22 (2) The responsible protection of intellectual 

23 property is vital to the continued development of 

24 new and life-saving drugs and future growth of the 

25 United States economy. 
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1 (3) In order to maintain the global competitive2 ness of the United States, the United States Trade 

3 Representative’s Office of Intellectual Property and 

4 Innovation develops and implements trade policy in 

5 support of vital American innovations, including in6 novation in the pharmaceutical and medical tech7 nology industries. 

8 (4) The United States Trade Representative 

9 also provides trade policy leadership and expertise 

10 across the full range of interagency initiatives to en11 hance protection and enforcement of intellectual 

12 property rights. 

13 (5) Strong and fair intellectual property protec14 tion, including patent, copyright, trademark, and 

15 data protection plays an integral role in fostering 

16 economic growth and development and ensuring pa17 tient access to the most effective medicines around 

18 the world. 

19 (6) There are concerns that certain countries 

20 have engaged in unfair price manipulation and abuse 

21 of compulsory licensing. Americans bear the major22 ity of research and development costs for the world, 

23 which could undermine the value of existing United 

24 States pharmaceutical patents and could impede ac25 cess to important therapies. 
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1 (7) There is a growing global threat of counter2 feit medicines and increased need for the United 

3 States Trade Representative and other United 

4 States agencies to use available trade policy meas5 ures to strengthen laws and enforcement abroad to 

6 prevent harm to United States patients and patients 

7 around the world. 

8 (b) SENSE OF THE SENATE.—It is the sense of the 

9 Senate that—

10 (1) the United States Trade Representative 

11 should use all the tools at the disposal of the Trade 

12 Representative to address violations and other con13 cerns with intellectual property, including through—

14 (A) bilateral engagement with United 

15 States trading partners; 

16 (B) transparency and balance of the an17 nual ‘‘Special 301’’ review and reviews of com18 pliance with the intellectual property require19 ments of countries with respect to which the 

20 United States grants trade preferences; 

21 (C) negotiation of responsible and fair in22 tellectual property provisions as part of bilateral 

23 and regional trade agreements; and 

24 (D) multilateral engagement through the 

25 World Trade Organization (WTO); and 
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1 (2) the United States Trade Representative 

2 should develop and submit to Congress a strategic 

3 plan to address the problem of countries that in4 fringe upon American pharmaceutical intellectual 

5 property rights and the problem of countries that 

6 engage in price manipulation. 

7 SEC. 517. CONSULTATION REGARDING GENETICALLY ENGI8 NEERED SEAFOOD PRODUCTS. 

9 The Commissioner of Food and Drugs shall consult 

10 with the Assistant Administrator of the National Marine 

11 Fisheries Service of the National Oceanic and Atmos12 pheric Administration to produce a report on any environ13 mental risks associated with genetically engineered sea14 food products, including the impact on wild fish stocks. 

15 SEC. 518. REPORT ON THE MARKETING OF CERTAIN CRUS16 TACEANS. 

17 Not later than 30 days after the date of enactment 

18 of this Act, the Secretary of Health and Human Services, 

19 in consultation with the Secretary of Commerce, shall sub20 mit to the Health, Education, Labor, and Pensions Com21 mittee and the Committee on Commerce, Science, and 

22 Transportation of the Senate, a report on the differences 

23 between taxonomy of species of lobster in the subfamily 

24 Nephropinae, and species of langostino, specifically from 

25 the infraorder Caridea or Anomura. This report shall also 
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1 describe the differences in consumer perception of such 

2 species, including such factors as taste, quality, and value 

3 of the species. 

4 SEC. 519. CIVIL PENALTIES; DIRECT-TO-CONSUMER ADVER5 TISEMENT. 

6 (a) CIVIL PENALTIES.—Section 303 of the Federal 

7 Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amend8 ed by adding at the end the following: 

9 ‘‘(g)(1) Any applicant (as such term is used in section 

10 505(o)) who disseminates a direct-to-consumer advertise11 ment for a prescription drug that is false or misleading 

12 and a violation of section 502(n) shall be liable to the 

13 United States for a civil penalty in an amount not to ex14 ceed $150,000 for the first such violation in any 3-year 

15 period, and not to exceed $300,000 for each subsequent 

16 violation committed after the applicant has been penalized 

17 under this paragraph any time in the preceding 3-year pe18 riod. For the purposes of this paragraph, repeated dis19 semination of the same or similar advertisement prior to 

20 the receipt of the written notice referred to in paragraph 

21 (2) for such advertisements shall be considered as 1 viola22 tion. 

23 ‘‘(2) A civil penalty under paragraph (1) shall be as24 sessed by the Secretary by an order made on the record 

25 after providing written notice to the applicant to be as-
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1 sessed a civil penalty and an opportunity for a hearing 

2 in accordance with this paragraph and section 554 of title 

3 5, United States Code. If upon receipt of the written no4 tice, the applicant to be assessed a civil penalty objects 

5 and requests a hearing, then in the course of any inves6 tigation related to such hearing, the Secretary may issue 

7 subpoenas requiring the attendance and testimony of wit8 nesses and the production of evidence that relates to the 

9 matter under investigation, including information per10 taining to the factors described in paragraph (3). 

11 ‘‘(3) Upon the request of the applicant to be assessed 

12 a civil penalty, the Secretary, in determining the amount 

13 of a civil penalty, shall take into account the nature, cir14 cumstances, extent, and gravity of the violation or viola15 tions, including the following factors: 

16 ‘‘(A) Whether the applicant submitted the ad17 vertisement or a similar advertisement for review 

18 under section 736A. 

19 ‘‘(B) Whether the applicant submitted the ad20 vertisement for prereview if required under section 

21 505(o)(5)(D). 

22 ‘‘(C) Whether, after submission of the adver23 tisement as described in subparagraph (A) or (B), 

24 the applicant disseminated the advertisement before 

25 the end of the 45-day comment period. 
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1 ‘‘(D) Whether the applicant failed to incor2 porate any comments made by the Secretary with re3 gard to the advertisement or a similar advertisement 

4 into the advertisement prior to its dissemination. 

5 ‘‘(E) Whether the applicant ceased distribution 

6 of the advertisement upon receipt of the written no7 tice referred to in paragraph (2) for such advertise8 ment. 

9 ‘‘(F) Whether the applicant had the advertise10 ment reviewed by qualified medical, regulatory, and 

11 legal reviewers prior to its dissemination. 

12 ‘‘(G) Whether the violations were material. 

13 ‘‘(H) Whether the applicant who created the 

14 advertisement acted in good faith. 

15 ‘‘(I) Whether the applicant who created the ad16 vertisement has been assessed a civil penalty under 

17 this provision within the previous 1-year period. 

18 ‘‘(J) The scope and extent of any voluntary, 

19 subsequent remedial action by the applicant. 

20 ‘‘(K) Such other matters, as justice may re21 quire. 

22 ‘‘(4)(A) Subject to subparagraph (B), no applicant 

23 shall be required to pay a civil penalty under paragraph 

24 (1) if the applicant submitted the advertisement to the 
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1 Secretary and disseminated such advertisement after in2 corporating any comment received from the Secretary. 

3 ‘‘(B) The Secretary may retract or modify any prior 

4 comments the Secretary has provided to an advertisement 

5 submitted to the Secretary based on new information or 

6 changed circumstances, so long as the Secretary provides 

7 written notice to the applicant of the new views of the Sec8 retary on the advertisement and provides a reasonable 

9 time for modification or correction of the advertisement 

10 prior to seeking any civil penalty under paragraph (1). 

11 ‘‘(5) The Secretary may compromise, modify, remit, 

12 with or without conditions, any civil penalty which may 

13 be assessed under paragraph (1). The amount of such pen14 alty, when finally determined, or the amount charged upon 

15 in compromise, may be deducted from any sums owned 

16 by the United States to the applicant charged. 

17 ‘‘(6) Any applicant who requested, in accordance with 

18 paragraph (2), a hearing with respect to the assessment 

19 of a civil penalty and who is aggrieved by an order assess20 ing a civil penalty, may file a petition for de novo judicial 

21 review of such order with the United States Court of Ap22 peals for the District of Columbia Circuit or for any other 

23 circuit in which such applicant resides or transacts busi24 ness. Such a petition may only be filed within the 60-day 
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1 period beginning on the date the order making such as2 sessments was issued. 

3 ‘‘(7) If any applicant fails to pay an assessment of 

4 a civil penalty—

5 ‘‘(A) after the order making the assessment be6 comes final, and if such applicant does not file a pe7 tition for judicial review of the order in accordance 

8 with paragraph (6); or 

9 ‘‘(B) after a court in an action brought under 

10 paragraph (6) has entered a final judgment in favor 

11 of the Secretary, 

12 the Attorney General shall recover the amount assessed 

13 (plus interest at currently prevailing rates from the date 

14 of the expiration of the 60-day period referred to in para15 graph (6) or date of such final judgment, as the case may 

16 be) in an action brought in any appropriate district court 

17 of the United States. In such an action, the validity, 

18 amount, and appropriateness of such penalty shall not be 

19 subject to review.’’. 

20 (b) DIRECT-TO-CONSUMER ADVERTISEMENT.—

21 (1) IN GENERAL.—Section 502(n) of the Fed22 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

23 352(n)) is amended by inserting after the first sen24 tence the following: ‘‘In the case of an advertisement 

25 for a prescription drug presented directly to con-
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1 sumers in television or radio format that states the 

2 name of the drug and its conditions of use, the 

3 major statement relating to side effects, contra4 indications, and effectiveness referred to in the pre5 vious sentence shall be stated in a clear and con6 spicuous (neutral) manner.’’. 

7 (2) REGULATIONS TO DETERMINE NEUTRAL

8 MANNER.—The Secretary of Health and Human 

9 Services shall by regulation establish standards for 

10 determining whether a major statement, relating to 

11 side effects, contraindications, and effectiveness of a 

12 drug, described in section 502(n) of the Federal 

13 Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) 

14 (as amended by paragraph (1)) is presented in the 

15 manner required under such section. 

16 SEC. 520. REPORT BY THE FOOD AND DRUG ADMINISTRA17 TION REGARDING LABELING INFORMATION 

18 ON THE RELATIONSHIP BETWEEN THE USE 

19 OF INDOOR TANNING DEVICES AND DEVEL20 OPMENT OF SKIN CANCER OR OTHER SKIN 

21 DAMAGE. 

22 (a) IN GENERAL.—The Secretary of Health and 

23 Human Services (referred to in this section as the ‘‘Sec24 retary’’), acting through the Commissioner of Food and 

25 Drugs, shall determine—
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1 (1) whether the labeling requirements for in2 door tanning devices, including the positioning re3 quirements, provide sufficient information to con4 sumers regarding the risks that the use of such de5 vices pose for the development of irreversible damage 

6 to the eyes and skin, including skin cancer; and 

7 (2)(A) whether modifying the warning label re8 quired on tanning beds to read, ‘‘Ultraviolet radi9 ation can cause skin cancer’’, or any other additional 

10 warning, would communicate the risks of indoor tan11 ning more effectively; or 

12 (B) whether there is no warning that would be 

13 capable of adequately communicating such risks. 

14 (b) CONSUMER TESTING.—In making the determina15 tions under subsection (a), the Secretary shall conduct ap16 propriate consumer testing, using the best available meth17 ods for determining consumer understanding of label 

18 warnings. 

19 (c) PUBLIC HEARINGS; PUBLIC COMMENT.—The 

20 Secretary shall hold public hearings and solicit comments 

21 from the public in making the determinations under sub22 section (a). 

23 (d) REPORT.—Not later than 1 year after the date 

24 of the enactment of this Act, the Secretary shall submit 

25 to the Congress a report that provides the determinations 
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1 under subsection (a). In addition, the Secretary shall in2 clude in the report the measures being implemented by 

3 the Secretary to significantly reduce the risks associated 

4 with indoor tanning devices. 

5 TITLE VI—FOOD SAFETY 

6 SEC. 601. FINDINGS. 

7 (a) FINDINGS.—Congress finds that—

8 (1) the safety and integrity of the United 

9 States food supply is vital to the public health, to 

10 public confidence in the food supply, and to the suc11 cess of the food sector of the Nation’s economy; 

12 (2) illnesses and deaths of individuals and com13 panion animals caused by contaminated food—

14 (A) have contributed to a loss of public 

15 confidence in food safety; and 

16 (B) have caused significant economic losses 

17 to manufacturers and producers not responsible 

18 for contaminated food items; 

19 (3) the task of preserving the safety of the food 

20 supply of the United States faces tremendous pres21 sures with regard to—

22 (A) emerging pathogens and other con23 taminants and the ability to detect all forms of 

24 contamination; and 
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1 (B) an increasing volume of imported food 

2 from a wide variety of countries; and 

3 (C) a shortage of adequate resources for 

4 monitoring and inspection; 

5 (4) the United States is increasing the amount 

6 of food that it imports such that—

7 (A) from 2003 to the present, the value of 

8 food imports has increased from 

9 $45,600,000,000 to $64,000,000,000; and 

10 (B) imported food accounts for 13 percent 

11 of the average Americans diet including 31 per12 cent of fruits, juices, and nuts, 9.5 percent of 

13 red meat and 78.6 percent of fish and shellfish; 

14 and 

15 (5) the number of full time equivalent Food and 

16 Drug Administration employees conducting inspec17 tions has decreased from 2003 to 2007. 

18 SEC. 602. ENSURING THE SAFETY OF PET FOOD. 

19 (a) PROCESSING AND INGREDIENT STANDARDS.—

20 Not later than 18 months after the date of enactment of 

21 this Act, the Secretary of Health and Human Services (re22 ferred to in this title as the ‘‘Secretary’’), in consultation 

23 with the Association of American Feed Control Officials, 

24 and other relevant stakeholder groups, including veteri25 nary medical associations, animal health organizations, 
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1 and pet food manufacturers, shall by regulation estab2 lish—

3 (1) processing and ingredient standards with 

4 respect to pet food, animal waste, and ingredient 

5 definitions; and 

6 (2) updated standards for the labeling of pet 

7 food that includes nutritional information and ingre8 dient information. 

9 (b) EARLY WARNING SURVEILLANCE SYSTEMS AND

10 NOTIFICATION DURING PET FOOD RECALLS.—Not later 

11 than 180 days after the date of enactment of this Act, 

12 the Secretary shall by regulation establish an early warn13 ing and surveillance system to identify adulteration of the 

14 pet food supply and outbreaks of illness associated with 

15 pet food. In establishing such system, the Secretary 

16 shall—

17 (1) use surveillance and monitoring mechanisms 

18 similar to, or in coordination with, those mechanisms 

19 used by the Centers for Disease Control and Preven20 tion to monitor human health, such as the 

21 Foodborne Diseases Active Surveillance Network 

22 (FoodNet) and PulseNet; 

23 (2) consult with relevant professional associa24 tions and private sector veterinary hospitals; and 
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1 (3) work with the Health Alert Network and 

2 other notification networks to inform veterinarians 

3 and relevant stakeholders during any recall of pet 

4 food. 

5 SEC. 603. ENSURING EFFICIENT AND EFFECTIVE COMMU6 NICATIONS DURING A RECALL. 

7 The Secretary shall, during an ongoing recall of 

8 human or pet food—

9 (1) work with companies, relevant professional 

10 associations, and other organizations to collect and 

11 aggregate information pertaining to the recall; 

12 (2) use existing networks of communication in13 cluding electronic forms of information dissemina14 tion to enhance the quality and speed of communica15 tion with the public; and 

16 (3) post information regarding recalled prod17 ucts on the Internet website of the Food and Drug 

18 Administration in a consolidated, searchable form 

19 that is easily accessed and understood by the public. 

20 SEC. 604. STATE AND FEDERAL COOPERATION. 

21 (a) IN GENERAL.—The Secretary shall work with the 

22 States in undertaking activities and programs that assist 

23 in improving the safety of fresh and processed produce 

24 so that State food safety programs involving the safety 

25 of fresh and processed produce and activities conducted 
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1 by the Secretaries function in a coordinated and cost-effec2 tive manner. With the assistance provided under sub3 section (b), the Secretary shall encourage States to—

4 (1) establish, continue, or strengthen State food 

5 safety programs, especially with respect to the regu6 lation of retail commercial food establishments; and 

7 (2) establish procedures and requirements for 

8 ensuring that processed produce under the jurisdic9 tion of the State food safety programs is not unsafe 

10 for human consumption. 

11 (b) ASSISTANCE.—The Secretary may provide to a 

12 State, for planning, developing, and implementing such a 

13 food safety program—

14 (1) advisory assistance; 

15 (2) technical assistance, training, and labora16 tory assistance (including necessary materials and 

17 equipment); and 

18 (3) financial and other assistance. 

19 (c) SERVICE AGREEMENTS.—The Secretary may, 

20 under an agreement entered into with a Federal, State, 

21 or local agency, use, on a reimbursable basis or otherwise, 

22 the personnel, services, and facilities of the agency to carry 

23 out the responsibilities of the agency under this section. 

24 An agreement entered into with a State agency under this 

25 subsection may provide for training of State employees. 
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1 SEC. 605. ADULTERATED FOOD REGISTRY. 

2 (a) FINDINGS.—Congress makes the following find3 ings: 

4 (1) In 1994, Congress passed the Dietary Sup5 plement Health and Education Act (P.L. 103–417) 

6 to provide the Food and Drug Administration with 

7 the legal framework to ensure that dietary supple8 ments are safe and properly labeled foods. 

9 (2) In 2006, Congress passed the Dietary Sup10 plement and Nonprescription Drug Consumer Pro11 tection Act (P.L. 109–462) to establish a mandatory 

12 reporting system of serious adverse events for non13 prescription drugs and dietary supplements sold and 

14 consumed in the United States. 

15 (3) The adverse event reporting system created 

16 under the Dietary Supplement and Nonprescription 

17 Drug Consumer Protection Act will serve as the 

18 early warning system for any potential public health 

19 issues associated with the use of these food products. 

20 (4) A reliable mechanism to track patterns of 

21 adulteration in food would support efforts by the 

22 Food and Drug Administration to effectively target 

23 limited inspection resources to protect the public 

24 health. 
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1 (b) IN GENERAL.—Chapter IV of the Federal Food, 

2 Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amend3 ed by adding at the end the following: 

4 ‘‘SEC. 417. ADULTERATED FOOD REGISTRY. 

5 ‘‘(a) DEFINITIONS.—In this section: 

6 ‘‘(1) IMPORTER.—The term ‘importer’, with re7 spect to an article of food, means the person who 

8 submitted the notice with respect to such article of 

9 food under section 801(m). 

10 ‘‘(2) RESPONSIBLE PARTY.—The term ‘respon11 sible party’, with respect to an article of food, means 

12 any registered food facility under section 415(a), in13 cluding those responsible for the manufacturing, 

14 processing, packaging or holding of such food for 

15 consumption in the United States. 

16 ‘‘(3) REPORTABLE ADULTERATED FOOD.—The 

17 term ‘reportable adulterated food’ for purposes of 

18 this section means a food that is adulterated or—

19 ‘‘(A) presents a situation in which there is 

20 a reasonable probability that the use of, or ex21 posure to, a violative product will cause serious 

22 adverse health consequences or death as defined 

23 in section 7.3(m)(1) of title, Code of Federal 

24 Regulations (or any successor regulations); or 
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1 ‘‘(B) meets the threshold established in 

2 section 304(h). 

3 ‘‘(b) ESTABLISHMENT.—

4 ‘‘(1) IN GENERAL.—Not later than 180 days 

5 after the date of enactment of this section, the Sec6 retary shall establish within the Food and Drug Ad7 ministration an Adulterated Food Registry to which 

8 instances of reportable adulterated food may be sub9 mitted by the Food and Drug Administration after 

10 receipt of reports of adulteration, via an electronic 

11 portal, from—

12 ‘‘(A) Federal, State, and local public 

13 health officials; 

14 ‘‘(B) an importer; 

15 ‘‘(C) a responsible party; or 

16 ‘‘(D) a consumer or other individual. 

17 ‘‘(2) REVIEW BY SECRETARY.—The Secretary 

18 shall review and determine the validity of the infor19 mation submitted under paragraph (1) for the pur20 poses of identifying adulterated food, submitting en21 tries to the Adulterated Food Registry, acting under 

22 subsection (c), and exercising other existing food 

23 safety authorities under the Act to protect the public 

24 health. 

25 ‘‘(c) ISSUANCE OF AN ALERT BY THE SECRETARY.—
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1 ‘‘(1) IN GENERAL.—The Secretary shall issue 

2 an alert with respect to an adulterated food if the 

3 Adulterated Food Registry shows that the food—

4 ‘‘(A) has been associated with repeated 

5 and separate outbreaks of illness or has been 

6 repeatedly determined to be adulterated; or 

7 ‘‘(B) is a reportable adulterated food. 

8 ‘‘(2) SCOPE OF ALERT.—An alert under para9 graph (1) may apply to a particular food or to food 

10 from a particular producer, manufacturer, shipper, 

11 growing area, or country, to the extent that elements 

12 in subparagraph (A) or (B) of paragraph (1) are as13 sociated with the particular food, producer, manu14 facturer, shipper, growing area, or country. 

15 ‘‘(d) SUBMISSION BY A CONSUMER OR OTHER INDI16 VIDUAL.—A consumer or other individual may submit a 

17 report to the Food and Drug Administration using the 

18 electronic portal data elements described in subsection (e). 

19 Such reports shall be evaluated by the Secretary as speci20 fied in subsection (b)(2). 

21 ‘‘(e) NOTIFICATION AND REPORTING OF ADULTERA22 TION.—

23 ‘‘(1) DETERMINATION BY RESPONSIBLE PARTY

24 OR IMPORTER.—If a responsible party or importer 

25 determines that an article of food it produced, proc-
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1 essed, manufactured, distributed, or otherwise han2 dled is a reportable adulterated food, the responsible 

3 party shall provide the notifications described under 

4 paragraph (2). 

5 ‘‘(2) NOTIFICATION OF ADULTERATION.—

6 ‘‘(A) IN GENERAL.—Not later than 5 days 

7 after a responsible party or importer receives a 

8 notification, the responsible party or importer, 

9 as applicable, shall review whether the food ref10 erenced in the report described in paragraph 

11 (1) is a reportable adulterated food. 

12 ‘‘(B) NOTIFICATION.—If a determination 

13 is made by such responsible party or importer 

14 that the food is a reportable adulterated food, 

15 such responsible party or importer shall, no 

16 later than 2 days after such determination is 

17 made, notify other responsible parties directly 

18 linked in the supply chain to which and from 

19 which the article of reportable adulterated food 

20 was transferred. 

21 ‘‘(3) SUBMISSION OF REPORTS TO THE FOOD

22 AND DRUG ADMINISTRATION BY A RESPONSIBLE

23 PARTY OR IMPORTER.—The responsible party or im24 porter, as applicable, shall submit a report to the 

25 Food and Drug Administration through the elec-
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1 tronic portal using the data elements described in 

2 subsection (f) not later than 2 days after a respon3 sible party or importer—

4 ‘‘(A) makes a notification under paragraph 

5 (2)(B); or 

6 ‘‘(B) determines that an article of food it 

7 produced, processed, manufactured, distributed, 

8 imported, or otherwise handled is a reportable 

9 adulterated food, except that if such adultera10 tion was initiated with such responsible party or 

11 importer, was detected prior to any transfer of 

12 such article of food, and was destroyed, no re13 port is necessary. 

14 ‘‘(f) DATA ELEMENTS IN THE REGISTRY.—A report 

15 submitted to the Food and Drug Administration electronic 

16 portal under subsection (e) shall include the following data 

17 elements: 

18 ‘‘(1) Contact information for the individual or 

19 entity submitting the report. 

20 ‘‘(2) The date on which an article of food was 

21 determined to be adulterated or suspected of being 

22 adulterated. 

23 ‘‘(3) A description of the article of food includ24 ing the quantity or amount. 

25 ‘‘(4) The extent and nature of the adulteration. 
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1 ‘‘(5) The disposition of the article. 

2 ‘‘(6) Product information typically found on 

3 packaging including product codes, use by dates, 

4 and names of manufactures or distributors. 

5 ‘‘(7) Information about the place of purchase or 

6 process by which the consumer or other individual 

7 acquired the article of adulterated food. 

8 ‘‘(8) In the case of a responsible party or an 

9 importer, the elements required for the registration 

10 of food facilities under section 415(a). 

11 ‘‘(9) The contact information for parties di12 rectly linked in the supply chain and notified under 

13 subsection (e)(2). 

14 ‘‘(10) In the case of an importer, the elements 

15 required for the prior notice of imported food ship16 ments under section 801(m). 

17 ‘‘(g) MAINTENANCE AND INSPECTION OF

18 RECORDS.—The responsible person or importer shall 

19 maintain records related to each report received, notifica20 tion made, and report submitted to the Food and Drug 

21 Administration under this section and permit inspection 

22 of such records as provided for in section 414. Such 

23 records shall also be made available during an inspection 

24 under section 704. 
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1 ‘‘(h) REQUEST FOR INFORMATION.—Section 552 of 

2 title 5, United States Code, shall apply to any request for 

3 information regarding a record in the Adulterated Food 

4 Registry. 

5 ‘‘(i) HOMELAND SECURITY NOTIFICATION.—If, after 

6 receiving a report under subsection (e), the Secretary sus7 pects such food may have been deliberately adulterated, 

8 the Secretary shall immediately notify the Secretary of 

9 Homeland Security. The Secretary shall make the data in 

10 the Adulterated Imported Food Registry available to the 

11 Secretary of Homeland Security.’’. 

12 (c) DEFINITION.—Section 201(ff) of the Federal 

13 Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff)) is 

14 amended by striking ‘‘section 201(g)’’ and inserting ‘‘sec15 tions 201(g) and 417’’. 

16 (d) PROHIBITED ACTS.—Section 301 of the Federal 

17 Food, Drug, and Cosmetic Act (21 U.S.C. 331), as 

18 amended by this Act, is further amended by adding at the 

19 end the following: 

20 ‘‘(kk) The failure to provide a report as required 

21 under section 417(e)(3). 

22 ‘‘(ll) The falsification a report as required under sec23 tion 417(e)(3).’’. 

24 (e) SUSPECTED FOOD ADULTERATION REGULA25 TIONS.—The Secretary shall, within 180 days of enact-
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1 ment of this Act, promulgate regulations that establish 

2 standards and thresholds by which importers and respon3 sible parties shall be required and consumers may be able 

4 to, under section 417 of the Federal Food, Drug, and Cos5 metic Act (as added by this section)—

6 (1) report instances of suspected reportable 

7 adulteration of food to the Food and Drug Adminis8 tration for possible inclusion in the Adulterated 

9 Food Registry after evaluation of such report; and 

10 (2) notify, in keeping with subsection (e)(2) of 

11 such section 417, other responsible parties directly 

12 linked in the supply chain, including establishments 

13 as defined in section 415(b) of such Act. 

14 (f) EFFECTIVE DATE.—The requirements of section 

15 417(e) of the Federal Food, Drug, and Cosmetic Act, as 

16 added by subsection (a), shall become effective 180 days 

17 after the date of enactment of this Act. 

18 SEC. 606. SENSE OF THE SENATE. 

19 It is the sense of the Senate that—

20 (1) it is vital for Congress to provide the Food 

21 and Drug Administration with additional resources, 

22 authorities, and direction with respect to ensuring 

23 the safety of the food supply of the United States; 
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1 (2) additional inspectors are required to im2 prove the Food and Drug Administration’s ability to 

3 safeguard the food supply of the United States; 

4 (3) because of the increasing volume of inter5 national trade in food products the Secretary of 

6 Health and Human Services should make it a pri7 ority to enter into agreements with the trading part8 ners of the United States with respect to food safe9 ty; and 

10 (4) the Senate should work to develop a com11 prehensive response to the issue of food safety. 

12 SEC. 607. ANNUAL REPORT TO CONGRESS. 

13 The Secretary shall, on an annual basis, submit to 

14 the Committee on Health, Education, Labor, and Pen15 sions and the Committee on Appropriations of the Senate 

16 and the Committee on Energy and Commerce and the 

17 Committee on Appropriations of the House of Representa18 tives a report that includes, with respect to the preceding 

19 1-year period—

20 (1) the number and amount of food products 

21 regulated by the Food and Drug Administration im22 ported into the United States, aggregated by country 

23 and type of food; 

24 (2) a listing of the number of Food and Drug 

25 Administration inspectors of imported food products 
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1 referenced in paragraph (1) and the number of Food 

2 and Drug Administration inspections performed on 

3 such products; and 

4 (3) aggregated data on the findings of such in5 spections, including data related to violations of the 

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

7 201 et seq.), and enforcement actions used to follow8 up on such findings and violations. 

9 SEC. 608. RULE OF CONSTRUCTION. 

10 Nothing in this title (or an amendment made by this 

11 title) shall be construed to affect—

12 (1) the regulation of dietary supplements under 

13 the Dietary Supplement Health and Education Act; 

14 or 

15 (2) the adverse event reporting system for die16 tary supplements created under the Dietary Supple17 ment and Nonprescription Drug Consumer Protec18 tion Act. 

19 SEC. 609. AUTHORIZATION OF APPROPRIATIONS. 

20 There are authorized to be appropriated to carry out 

21 this title (and the amendments made by this title) such 

22 sums as may be necessary. 
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1 TITLE VII—DOMESTIC PET 

2 TURTLE MARKET ACCESS 

3 SEC. 701. SHORT TITLE. 

4 This title may be cited as the ‘‘Domestic Pet Turtle 

5 Market Access Act of 2007’’. 

6 SEC. 702. FINDINGS. 

7 Congress makes the following findings: 

8 (1) Pet turtles less than 10.2 centimeters in di9 ameter have been banned for sale in the United 

10 States by the Food and Drug Administration since 

11 1975 due to health concerns. 

12 (2) The Food and Drug Administration does 

13 not ban the sale of iguanas or other lizards, snakes, 

14 frogs, or other amphibians or reptiles that are sold 

15 as pets in the United States that also carry sal16 monella bacteria. The Food and Drug Administra17 tion also does not require that these animals be 

18 treated for salmonella bacteria before being sold as 

19 pets. 

20 (3) The technology to treat turtles for sal21 monella, and make them safe for sale, has greatly 

22 advanced since 1975. Treatments exist that can 

23 nearly eradicate salmonella from turtles, and individ24 uals are more aware of the causes of salmonella, how 
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1 to treat salmonella poisoning, and the seriousness 

2 associated with salmonella poisoning. 

3 (4) University research has shown that these 

4 turtles can be treated in such a way that they can 

5 be raised, shipped, and distributed without having a 

6 recolonization of salmonella. 

7 (5) University research has also shown that pet 

8 owners can be equipped with a treatment regiment 

9 that allows the turtle to be maintained safe from sal10 monella. 

11 (6) The Food and Drug Administration should 

12 allow the sale of turtles less than 10.2 centimeters 

13 in diameter as pets as long as the sellers are re14 quired to use proven methods to treat these turtles 

15 for salmonella. 

16 SEC. 703. SALE OF BABY TURTLES. 

17 Notwithstanding any other provision of law, the Food 

18 and Drug Administration shall not restrict the sale by a 

19 turtle farmer, wholesaler, or commercial retail seller of a 

20 turtle that is less than 10.2 centimeters in diameter as 

21 a pet if—

22 (1) the State or territory in which such farmer 

23 is located has developed a regulatory process by 

24 which pet turtle farmers are required to have a 

25 State license to breed, hatch, propagate, raise, grow, 
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1 receive, ship, transport, export, or sell pet turtles or 

2 pet turtle eggs; 

3 (2) such State or territory requires certification 

4 of sanitization that is signed by a veterinarian who 

5 is licensed in the State or territory, and approved by 

6 the State or territory agency in charge of regulating 

7 the sale of pet turtles; 

8 (3) the certification of sanitization requires 

9 each turtle to be sanitized or treated for diseases, in10 cluding salmonella, and is dependant upon using the 

11 Siebeling method, or other such proven non-anti12 biotic method, to make the turtle salmonella-free; 

13 and 

14 (4) the turtle farmer or commercial retail seller 

15 includes, with the sale of such a turtle, a disclosure 

16 to the buyer that includes—

17 (A) information regarding—

18 (i) the possibility that salmonella can 

19 re-colonize in turtles; 

20 (ii) the dangers, including possible se21 vere illness or death, especially for at-risk 

22 people who may be susceptible to sal23 monella poisoning, such as children, preg24 nant women, and others who may have 

25 weak immune systems, that could result if 
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1 the turtle is not properly handled and safe2 ly maintained; 

3 (iii) the proper handling of the turtle, 

4 including an explanation of proper hygiene 

5 such as handwashing after handling a tur6 tle; and 

7 (iv) the proven methods of treatment 

8 that, if properly applied, keep the turtle 

9 safe from salmonella; 

10 (B) a detailed explanation of how to prop11 erly treat the turtle to keep it safe from sal12 monella, using the proven methods of treatment 

13 referred to under subparagraph (A), and how 

14 the buyer can continue to purchase the tools, 

15 treatments, or any other required item to con16 tinually treat the turtle; and 

17 (C) a statement that buyers of pet turtles 

18 should not abandon the turtle or abandon it 

19 outside, as the turtle may become an invasive 

20 species to the local community, but should in21 stead return them to a commercial retail pet 

22 seller or other organization that would accept 

23 turtles no longer wanted as pets. 
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1 SEC. 704. FDA REVIEW OF STATE PROTECTIONS. 

2 The Commissioner of Food and Drugs may, after 

3 providing an opportunity for the affected State to respond, 

4 restrict the sale of a turtle only if the Secretary of Health 

5 and Human Services determines that the actual implemen6 tation of State health protections described in this title 

7 are insufficient to protect consumers against infectious 

8 diseases acquired from such turtle at the time of sale. 

9 TITLE VIII—IMPORTATION OF 

10 PRESCRIPTION DRUGS 

11 SEC. 801. SHORT TITLE. 

12 This title may be cited as the ‘‘Pharmaceutical Mar13 ket Access and Drug Safety Act of 2007’’. 

14 SEC. 802. FINDINGS. 

15 Congress finds that—

16 (1) Americans unjustly pay up to 5 times more 

17 to fill their prescriptions than consumers in other 

18 countries; 

19 (2) the United States is the largest market for 

20 pharmaceuticals in the world, yet American con21 sumers pay the highest prices for brand pharma22 ceuticals in the world; 

23 (3) a prescription drug is neither safe nor effec24 tive to an individual who cannot afford it; 

25 (4) allowing and structuring the importation of 

26 prescription drugs to ensure access to safe and af-
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1 fordable drugs approved by the Food and Drug Ad2 ministration will provide a level of safety to Amer3 ican consumers that they do not currently enjoy; 

4 (5) American spend more than 

5 $200,000,000,000 on prescription drugs every year; 

6 (6) the Congressional Budget Office has found 

7 that the cost of prescription drugs are between 35 

8 to 55 percent less in other highly-developed coun9 tries than in the United States; and 

10 (7) promoting competitive market pricing would 

11 both contribute to health care savings and allow 

12 greater access to therapy, improving health and sav13 ing lives. 

14 SEC. 803. REPEAL OF CERTAIN SECTION REGARDING IM15 PORTATION OF PRESCRIPTION DRUGS. 

16 Chapter VIII of the Federal Food, Drug, and Cos17 metic Act (21 U.S.C. 381 et seq.) is amended by striking 

18 section 804. 

19 SEC. 804. IMPORTATION OF PRESCRIPTION DRUGS; WAIVER 

20 OF CERTAIN IMPORT RESTRICTIONS. 

21 (a) IN GENERAL.—Chapter VIII of the Federal 

22 Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.), 

23 as amended by section 803, is further amended by insert24 ing after section 803 the following: 
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1 ‘‘SEC. 804. COMMERCIAL AND PERSONAL IMPORTATION OF 

2 PRESCRIPTION DRUGS. 

3 ‘‘(a) IMPORTATION OF PRESCRIPTION DRUGS.—

4 ‘‘(1) IN GENERAL.—In the case of qualifying 

5 drugs imported or offered for import into the United 

6 States from registered exporters or by registered im7 porters—

8 ‘‘(A) the limitation on importation that is 

9 established in section 801(d)(1) is waived; and 

10 ‘‘(B) the standards referred to in section 

11 801(a) regarding admission of the drugs are 

12 subject to subsection (g) of this section (includ13 ing with respect to qualifying drugs to which 

14 section 801(d)(1) does not apply). 

15 ‘‘(2) IMPORTERS.—A qualifying drug may not 

16 be imported under paragraph (1) unless—

17 ‘‘(A) the drug is imported by a pharmacy, 

18 group of pharmacies, or a wholesaler that is a 

19 registered importer; or 

20 ‘‘(B) the drug is imported by an individual 

21 for personal use or for the use of a family mem22 ber of the individual (not for resale) from a reg23 istered exporter. 

24 ‘‘(3) RULE OF CONSTRUCTION.—This section 

25 shall apply only with respect to a drug that is im-
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1 ported or offered for import into the United 

2 States—

3 ‘‘(A) by a registered importer; or 

4 ‘‘(B) from a registered exporter to an indi5 vidual. 

6 ‘‘(4) DEFINITIONS.—

7 ‘‘(A) REGISTERED EXPORTER; REG8 ISTERED IMPORTER.—For purposes of this sec9 tion: 

10 ‘‘(i) The term ‘registered exporter’ 

11 means an exporter for which a registration 

12 under subsection (b) has been approved 

13 and is in effect. 

14 ‘‘(ii) The term ‘registered importer’ 

15 means a pharmacy, group of pharmacies, 

16 or a wholesaler for which a registration 

17 under subsection (b) has been approved 

18 and is in effect. 

19 ‘‘(iii) The term ‘registration condition’ 

20 means a condition that must exist for a 

21 registration under subsection (b) to be ap22 proved. 

23 ‘‘(B) QUALIFYING DRUG.—For purposes of 

24 this section, the term ‘qualifying drug’ means a 
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1 drug for which there is a corresponding U.S. 

2 label drug. 

3 ‘‘(C) U.S. LABEL DRUG.—For purposes of 

4 this section, the term ‘U.S. label drug’ means 

5 a prescription drug that—

6 ‘‘(i) with respect to a qualifying drug, 

7 has the same active ingredient or ingredi8 ents, route of administration, dosage form, 

9 and strength as the qualifying drug; 

10 ‘‘(ii) with respect to the qualifying 

11 drug, is manufactured by or for the person 

12 that manufactures the qualifying drug; 

13 ‘‘(iii) is approved under section 

14 505(c); and 

15 ‘‘(iv) is not—

16 ‘‘(I) a controlled substance, as 

17 defined in section 102 of the Con18 trolled Substances Act (21 U.S.C. 

19 802); 

20 ‘‘(II) a biological product, as de21 fined in section 351 of the Public 

22 Health Service Act (42 U.S.C. 262), 

23 including—

24 ‘‘(aa) a therapeutic DNA 

25 plasmid product; 
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1 ‘‘(bb) a therapeutic synthetic 

2 peptide product; 

3 ‘‘(cc) a monoclonal antibody 

4 product for in vivo use; and 

5 ‘‘(dd) a therapeutic recom6 binant DNA-derived product; 

7 ‘‘(III) an infused drug, including 

8 a peritoneal dialysis solution; 

9 ‘‘(IV) an injected drug; 

10 ‘‘(V) a drug that is inhaled dur11 ing surgery; 

12 ‘‘(VI) a drug that is the listed 

13 drug referred to in 2 or more abbre14 viated new drug applications under 

15 which the drug is commercially mar16 keted; or 

17 ‘‘(VII) a sterile opthlamic drug 

18 intended for topical use on or in the 

19 eye. 

20 ‘‘(D) OTHER DEFINITIONS.—For purposes 

21 of this section: 

22 ‘‘(i)(I) The term ‘exporter’ means a 

23 person that is in the business of exporting 

24 a drug to individuals in the United States 

25 from Canada or from a permitted country 
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1 designated by the Secretary under sub2 clause (II), or that, pursuant to submitting 

3 a registration under subsection (b), seeks 

4 to be in such business. 

5 ‘‘(II) The Secretary shall designate a 

6 permitted country under subparagraph (E) 

7 (other than Canada) as a country from 

8 which an exporter may export a drug to in9 dividuals in the United States if the Sec10 retary determines that—

11 ‘‘(aa) the country has statutory 

12 or regulatory standards that are 

13 equivalent to the standards in the 

14 United States and Canada with re15 spect to—

16 ‘‘(AA) the training of phar17 macists; 

18 ‘‘(BB) the practice of phar19 macy; and 

20 ‘‘(CC) the protection of the 

21 privacy of personal medical infor22 mation; and 

23 ‘‘(bb) the importation of drugs to 

24 individuals in the United States from 
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1 the country will not adversely affect 

2 public health. 

3 ‘‘(ii) The term ‘importer’ means a 

4 pharmacy, a group of pharmacies, or a 

5 wholesaler that is in the business of im6 porting a drug into the United States or 

7 that, pursuant to submitting a registration 

8 under subsection (b), seeks to be in such 

9 business. 

10 ‘‘(iii) The term ‘pharmacist’ means a 

11 person licensed by a State to practice 

12 pharmacy, including the dispensing and 

13 selling of prescription drugs. 

14 ‘‘(iv) The term ‘pharmacy’ means a 

15 person that—

16 ‘‘(I) is licensed by a State to en17 gage in the business of selling pre18 scription drugs at retail; and 

19 ‘‘(II) employs 1 or more phar20 macists. 

21 ‘‘(v) The term ‘prescription drug’ 

22 means a drug that is described in section 

23 503(b)(1). 

24 ‘‘(vi) The term ‘wholesaler’—
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1 ‘‘(I) means a person licensed as a 

2 wholesaler or distributor of prescrip3 tion drugs in the United States under 

4 section 503(e)(2)(A); and 

5 ‘‘(II) does not include a person 

6 authorized to import drugs under sec7 tion 801(d)(1). 

8 ‘‘(E) PERMITTED COUNTRY.—The term 

9 ‘permitted country’ means—

10 ‘‘(i) Australia; 

11 ‘‘(ii) Canada; 

12 ‘‘(iii) a member country of the Euro13 pean Union, but does not include a mem14 ber country with respect to which—

15 ‘‘(I) the country’s Annex to the 

16 Treaty of Accession to the European 

17 Union 2003 includes a transitional 

18 measure for the regulation of human 

19 pharmaceutical products that has not 

20 expired; or 

21 ‘‘(II) the Secretary determines 

22 that the requirements described in 

23 subclauses (I) and (II) of clause (vii) 

24 will not be met by the date on which 

25 such transitional measure for the reg-
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1 ulation of human pharmaceutical 

2 products expires; 

3 ‘‘(iv) Japan; 

4 ‘‘(v) New Zealand; 

5 ‘‘(vi) Switzerland; and 

6 ‘‘(vii) a country in which the Sec7 retary determines the following require8 ments are met: 

9 ‘‘(I) The country has statutory or 

10 regulatory requirements—

11 ‘‘(aa) that require the review 

12 of drugs for safety and effective13 ness by an entity of the govern14 ment of the country; 

15 ‘‘(bb) that authorize the ap16 proval of only those drugs that 

17 have been determined to be safe 

18 and effective by experts employed 

19 by or acting on behalf of such en20 tity and qualified by scientific 

21 training and experience to evalu22 ate the safety and effectiveness of 

23 drugs on the basis of adequate 

24 and well-controlled investigations, 

25 including clinical investigations, 
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1 conducted by experts qualified by 

2 scientific training and experience 

3 to evaluate the safety and effec4 tiveness of drugs; 

5 ‘‘(cc) that require the meth6 ods used in, and the facilities and 

7 controls used for the manufac8 ture, processing, and packing of 

9 drugs in the country to be ade10 quate to preserve their identity, 

11 quality, purity, and strength; 

12 ‘‘(dd) for the reporting of 

13 adverse reactions to drugs and 

14 procedures to withdraw approval 

15 and remove drugs found not to 

16 be safe or effective; and 

17 ‘‘(ee) that require the label18 ing and promotion of drugs to be 

19 in accordance with the approval 

20 of the drug. 

21 ‘‘(II) The valid marketing au22 thorization system in the country is 

23 equivalent to the systems in the coun24 tries described in clauses (i) through 

25 (vi). 
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1 ‘‘(III) The importation of drugs 

2 to the United States from the country 

3 will not adversely affect public health. 

4 ‘‘(b) REGISTRATION OF IMPORTERS AND EXPORT5 ERS.—

6 ‘‘(1) REGISTRATION OF IMPORTERS AND EX7 PORTERS.—A registration condition is that the im8 porter or exporter involved (referred to in this sub9 section as a ‘registrant’) submits to the Secretary a 

10 registration containing the following: 

11 ‘‘(A)(i) In the case of an exporter, the 

12 name of the exporter and an identification of all 

13 places of business of the exporter that relate to 

14 qualifying drugs, including each warehouse or 

15 other facility owned or controlled by, or oper16 ated for, the exporter. 

17 ‘‘(ii) In the case of an importer, the name 

18 of the importer and an identification of the 

19 places of business of the importer at which the 

20 importer initially receives a qualifying drug 

21 after importation (which shall not exceed 3 

22 places of business except by permission of the 

23 Secretary). 

24 ‘‘(B) Such information as the Secretary 

25 determines to be necessary to demonstrate that 
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1 the registrant is in compliance with registration 

2 conditions under—

3 ‘‘(i) in the case of an importer, sub4 sections (c), (d), (e), (g), and (j) (relating 

5 to the sources of imported qualifying 

6 drugs; the inspection of facilities of the im7 porter; the payment of fees; compliance 

8 with the standards referred to in section 

9 801(a); and maintenance of records and 

10 samples); or 

11 ‘‘(ii) in the case of an exporter, sub12 sections (c), (d), (f), (g), (h), (i), and (j) 

13 (relating to the sources of exported quali14 fying drugs; the inspection of facilities of 

15 the exporter and the marking of compliant 

16 shipments; the payment of fees; and com17 pliance with the standards referred to in 

18 section 801(a); being licensed as a phar19 macist; conditions for individual importa20 tion; and maintenance of records and sam21 ples). 

22 ‘‘(C) An agreement by the registrant that 

23 the registrant will not under subsection (a) im24 port or export any drug that is not a qualifying 

25 drug. 
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1 ‘‘(D) An agreement by the registrant to—

2 ‘‘(i) notify the Secretary of a recall or 

3 withdrawal of a qualifying drug distributed 

4 in a permitted country that the registrant 

5 has exported or imported, or intends to ex6 port or import, to the United States under 

7 subsection (a); 

8 ‘‘(ii) provide for the return to the reg9 istrant of such drug; and 

10 ‘‘(iii) cease, or not begin, the expor11 tation or importation of such drug unless 

12 the Secretary has notified the registrant 

13 that exportation or importation of such 

14 drug may proceed. 

15 ‘‘(E) An agreement by the registrant to 

16 ensure and monitor compliance with each reg17 istration condition, to promptly correct any 

18 noncompliance with such a condition, and to 

19 promptly report to the Secretary any such non20 compliance. 

21 ‘‘(F) A plan describing the manner in 

22 which the registrant will comply with the agree23 ment under subparagraph (E). 

24 ‘‘(G) An agreement by the registrant to 

25 enforce a contract under subsection (c)(3)(B) 
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•S 1082 ES

1 against a party in the chain of custody of a 

2 qualifying drug with respect to the authority of 

3 the Secretary under clauses (ii) and (iii) of that 

4 subsection. 

5 ‘‘(H) An agreement by the registrant to 

6 notify the Secretary not more than 30 days be7 fore the registrant intends to make the change, 

8 of—

9 ‘‘(i) any change that the registrant in10 tends to make regarding information pro11 vided under subparagraph (A) or (B); and 

12 ‘‘(ii) any change that the registrant 

13 intends to make in the compliance plan 

14 under subparagraph (F). 

15 ‘‘(I) In the case of an exporter—

16 ‘‘(i) An agreement by the exporter 

17 that a qualifying drug will not under sub18 section (a) be exported to any individual 

19 not authorized pursuant to subsection 

20 (a)(2)(B) to be an importer of such drug. 

21 ‘‘(ii) An agreement to post a bond, 

22 payable to the Treasury of the United 

23 States that is equal in value to the lesser 

24 of—
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•S 1082 ES

1 ‘‘(I) the value of drugs exported 

2 by the exporter to the United States 

3 in a typical 4-week period over the 

4 course of a year under this section; or 

5 ‘‘(II) $1,000,000; 

6 ‘‘(iii) An agreement by the exporter to 

7 comply with applicable provisions of Cana8 dian law, or the law of the permitted coun9 try designated under subsection 

10 (a)(4)(D)(i)(II) in which the exporter is lo11 cated, that protect the privacy of personal 

12 information with respect to each individual 

13 importing a prescription drug from the ex14 porter under subsection (a)(2)(B). 

15 ‘‘(iv) An agreement by the exporter to 

16 report to the Secretary—

17 ‘‘(I) not later than August 1 of 

18 each fiscal year, the total price and 

19 the total volume of drugs exported to 

20 the United States by the exporter dur21 ing the 6-month period from January 

22 1 through June 30 of that year; and 

23 ‘‘(II) not later than January 1 of 

24 each fiscal year, the total price and 

25 the total volume of drugs exported to 
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•S 1082 ES

1 the United States by the exporter dur2 ing the previous fiscal year. 

3 ‘‘(J) In the case of an importer, an agree4 ment by the importer to report to the Sec5 retary—

6 ‘‘(i) not later than August 1 of each 

7 fiscal year, the total price and the total 

8 volume of drugs imported to the United 

9 States by the importer during the 6-month 

10 period from January 1 through June 30 of 

11 that fiscal year; and 

12 ‘‘(ii) not later than January 1 of each 

13 fiscal year, the total price and the total 

14 volume of drugs imported to the United 

15 States by the importer during the previous 

16 fiscal year. 

17 ‘‘(K) Such other provisions as the Sec18 retary may require by regulation to protect the 

19 public health while permitting—

20 ‘‘(i) the importation by pharmacies, 

21 groups of pharmacies, and wholesalers as 

22 registered importers of qualifying drugs 

23 under subsection (a); and 

24 ‘‘(ii) importation by individuals of 

25 qualifying drugs under subsection (a). 
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1 ‘‘(2) APPROVAL OR DISAPPROVAL OF REGISTRA2 TION.—

3 ‘‘(A) IN GENERAL.—Not later than 90 

4 days after the date on which a registrant sub5 mits to the Secretary a registration under para6 graph (1), the Secretary shall notify the reg7 istrant whether the registration is approved or 

8 is disapproved. The Secretary shall disapprove 

9 a registration if there is reason to believe that 

10 the registrant is not in compliance with one or 

11 more registration conditions, and shall notify 

12 the registrant of such reason. In the case of a 

13 disapproved registration, the Secretary shall 

14 subsequently notify the registrant that the reg15 istration is approved if the Secretary deter16 mines that the registrant is in compliance with 

17 such conditions. 

18 ‘‘(B) CHANGES IN REGISTRATION INFOR19 MATION.—Not later than 30 days after receiv20 ing a notice under paragraph (1)(H) from a 

21 registrant, the Secretary shall determine wheth22 er the change involved affects the approval of 

23 the registration of the registrant under para24 graph (1), and shall inform the registrant of 

25 the determination. 
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1 ‘‘(3) PUBLICATION OF CONTACT INFORMATION

2 FOR REGISTERED EXPORTERS.—Through the Inter3 net website of the Food and Drug Administration 

4 and a toll-free telephone number, the Secretary shall 

5 make readily available to the public a list of reg6 istered exporters, including contact information for 

7 the exporters. Promptly after the approval of a reg8 istration submitted under paragraph (1), the Sec9 retary shall update the Internet website and the in10 formation provided through the toll-free telephone 

11 number accordingly. 

12 ‘‘(4) SUSPENSION AND TERMINATION.—

13 ‘‘(A) SUSPENSION.—With respect to the 

14 effectiveness of a registration submitted under 

15 paragraph (1): 

16 ‘‘(i) Subject to clause (ii), the Sec17 retary may suspend the registration if the 

18 Secretary determines, after notice and op19 portunity for a hearing, that the registrant 

20 has failed to maintain substantial compli21 ance with a registration condition. 

22 ‘‘(ii) If the Secretary determines that, 

23 under color of the registration, the ex24 porter has exported a drug or the importer 

25 has imported a drug that is not a quali-
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•S 1082 ES

1 fying drug, or a drug that does not comply 

2 with subsection (g)(2)(A) or (g)(4), or has 

3 exported a qualifying drug to an individual 

4 in violation of subsection (i)(2)(F), the 

5 Secretary shall immediately suspend the 

6 registration. A suspension under the pre7 ceding sentence is not subject to the provi8 sion by the Secretary of prior notice, and 

9 the Secretary shall provide to the reg10 istrant an opportunity for a hearing not 

11 later than 10 days after the date on which 

12 the registration is suspended. 

13 ‘‘(iii) The Secretary may reinstate the 

14 registration, whether suspended under 

15 clause (i) or (ii), if the Secretary deter16 mines that the registrant has demonstrated 

17 that further violations of registration con18 ditions will not occur. 

19 ‘‘(B) TERMINATION.—The Secretary, after 

20 notice and opportunity for a hearing, may ter21 minate the registration under paragraph (1) of 

22 a registrant if the Secretary determines that 

23 the registrant has engaged in a pattern or prac24 tice of violating 1 or more registration condi25 tions, or if on 1 or more occasions the Secretary 
380

•S 1082 ES

1 has under subparagraph (A)(ii) suspended the 

2 registration of the registrant. The Secretary 

3 may make the termination permanent, or for a 

4 fixed period of not less than 1 year. During the 

5 period in which the registration is terminated, 

6 any registration submitted under paragraph (1) 

7 by the registrant, or a person that is a partner 

8 in the export or import enterprise, or a prin9 cipal officer in such enterprise, and any reg10 istration prepared with the assistance of the 

11 registrant or such a person, has no legal effect 

12 under this section. 

13 ‘‘(5) DEFAULT OF BOND.—A bond required to 

14 be posted by an exporter under paragraph (1)(I)(ii) 

15 shall be defaulted and paid to the Treasury of the 

16 United States if, after opportunity for an informal 

17 hearing, the Secretary determines that the exporter 

18 has—

19 ‘‘(A) exported a drug to the United States 

20 that is not a qualifying drug or that is not in 

21 compliance with subsection (g)(2)(A), (g)(4), or 

22 (i); or 

23 ‘‘(B) failed to permit the Secretary to con24 duct an inspection described under subsection 

25 (d). 
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•S 1082 ES

1 ‘‘(c) SOURCES OF QUALIFYING DRUGS.—A registra2 tion condition is that the exporter or importer involved 

3 agrees that a qualifying drug will under subsection (a) be 

4 exported or imported into the United States only if there 

5 is compliance with the following: 

6 ‘‘(1) The drug was manufactured in an estab7 lishment—

8 ‘‘(A) required to register under subsection 

9 (h) or (i) of section 510; and 

10 ‘‘(B)(i) inspected by the Secretary; or 

11 ‘‘(ii) for which the Secretary has elected to 

12 rely on a satisfactory report of a good manufac13 turing practice inspection of the establishment 

14 from a permitted country whose regulatory sys15 tem the Secretary recognizes as equivalent 

16 under a mutual recognition agreement, as pro17 vided for under section 510(i)(3), section 803, 

18 or part 26 of title 21, Code of Federal Regula19 tions (or any corresponding successor rule or 

20 regulation). 

21 ‘‘(2) The establishment is located in any coun22 try, and the establishment manufactured the drug 

23 for distribution in the United States or for distribu24 tion in 1 or more of the permitted countries (without 

25 regard to whether in addition the drug is manufac-
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•S 1082 ES

1 tured for distribution in a foreign country that is 

2 not a permitted country). 

3 ‘‘(3) The exporter or importer obtained the 

4 drug—

5 ‘‘(A) directly from the establishment; or 

6 ‘‘(B) directly from an entity that, by con7 tract with the exporter or importer—

8 ‘‘(i) provides to the exporter or im9 porter a statement (in such form and con10 taining such information as the Secretary 

11 may require) that, for the chain of custody 

12 from the establishment, identifies each 

13 prior sale, purchase, or trade of the drug 

14 (including the date of the transaction and 

15 the names and addresses of all parties to 

16 the transaction); 

17 ‘‘(ii) agrees to permit the Secretary to 

18 inspect such statements and related 

19 records to determine their accuracy; 

20 ‘‘(iii) agrees, with respect to the quali21 fying drugs involved, to permit the Sec22 retary to inspect warehouses and other fa23 cilities, including records, of the entity for 

24 purposes of determining whether the facili25 ties are in compliance with any standards 
383

•S 1082 ES

1 under this Act that are applicable to facili2 ties of that type in the United States; and 

3 ‘‘(iv) has ensured, through such con4 tractual relationships as may be necessary, 

5 that the Secretary has the same authority 

6 regarding other parties in the chain of cus7 tody from the establishment that the Sec8 retary has under clauses (ii) and (iii) re9 garding such entity. 

10 ‘‘(4)(A) The foreign country from which the im11 porter will import the drug is a permitted country; 

12 or 

13 ‘‘(B) The foreign country from which the ex14 porter will export the drug is the permitted country 

15 in which the exporter is located. 

16 ‘‘(5) During any period in which the drug was 

17 not in the control of the manufacturer of the drug, 

18 the drug did not enter any country that is not a per19 mitted country. 

20 ‘‘(6) The exporter or importer retains a sample 

21 of each lot of the drug for testing by the Secretary. 

22 ‘‘(d) INSPECTION OF FACILITIES; MARKING OF SHIP23 MENTS.—

24 ‘‘(1) INSPECTION OF FACILITIES.—A registra25 tion condition is that, for the purpose of assisting 
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•S 1082 ES

1 the Secretary in determining whether the exporter 

2 involved is in compliance with all other registration 

3 conditions—

4 ‘‘(A) the exporter agrees to permit the Sec5 retary—

6 ‘‘(i) to conduct onsite inspections, in7 cluding monitoring on a day-to-day basis, 

8 of places of business of the exporter that 

9 relate to qualifying drugs, including each 

10 warehouse or other facility owned or con11 trolled by, or operated for, the exporter; 

12 ‘‘(ii) to have access, including on a 

13 day-to-day basis, to—

14 ‘‘(I) records of the exporter that 

15 relate to the export of such drugs, in16 cluding financial records; and 

17 ‘‘(II) samples of such drugs; 

18 ‘‘(iii) to carry out the duties described 

19 in paragraph (3); and 

20 ‘‘(iv) to carry out any other functions 

21 determined by the Secretary to be nec22 essary regarding the compliance of the ex23 porter; and 

24 ‘‘(B) the Secretary has assigned 1 or more 

25 employees of the Secretary to carry out the 
385

•S 1082 ES

1 functions described in this subsection for the 

2 Secretary randomly, but not less than 12 times 

3 annually, on the premises of places of busi4 nesses referred to in subparagraph (A)(i), and 

5 such an assignment remains in effect on a con6 tinuous basis. 

7 ‘‘(2) MARKING OF COMPLIANT SHIPMENTS.—A 

8 registration condition is that the exporter involved 

9 agrees to affix to each shipping container of quali10 fying drugs exported under subsection (a) such 

11 markings as the Secretary determines to be nec12 essary to identify the shipment as being in compli13 ance with all registration conditions. Markings under 

14 the preceding sentence shall—

15 ‘‘(A) be designed to prevent affixation of 

16 the markings to any shipping container that is 

17 not authorized to bear the markings; and 

18 ‘‘(B) include anticounterfeiting or track19 and-trace technologies, taking into account the 

20 economic and technical feasibility of those tech21 nologies. 

22 ‘‘(3) CERTAIN DUTIES RELATING TO EXPORT23 ERS.—Duties of the Secretary with respect to an ex24 porter include the following: 
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•S 1082 ES

1 ‘‘(A) Inspecting, randomly, but not less 

2 than 12 times annually, the places of business 

3 of the exporter at which qualifying drugs are 

4 stored and from which qualifying drugs are 

5 shipped. 

6 ‘‘(B) During the inspections under sub7 paragraph (A), verifying the chain of custody of 

8 a statistically significant sample of qualifying 

9 drugs from the establishment in which the drug 

10 was manufactured to the exporter, which shall 

11 be accomplished or supplemented by the use of 

12 anticounterfeiting or track-and-trace tech13 nologies, taking into account the economic and 

14 technical feasibility of those technologies, except 

15 that a drug that lacks such technologies from 

16 the point of manufacture shall not for that rea17 son be excluded from importation by an ex18 porter. 

19 ‘‘(C) Randomly reviewing records of ex20 ports to individuals for the purpose of deter21 mining whether the drugs are being imported 

22 by the individuals in accordance with the condi23 tions under subsection (i). Such reviews shall be 

24 conducted in a manner that will result in a sta-
387

•S 1082 ES

1 tistically significant determination of compli2 ance with all such conditions. 

3 ‘‘(D) Monitoring the affixing of markings 

4 under paragraph (2). 

5 ‘‘(E) Inspecting as the Secretary deter6 mines is necessary the warehouses and other fa7 cilities, including records, of other parties in the 

8 chain of custody of qualifying drugs. 

9 ‘‘(F) Determining whether the exporter is 

10 in compliance with all other registration condi11 tions. 

12 ‘‘(4) PRIOR NOTICE OF SHIPMENTS.—A reg13 istration condition is that, not less than 8 hours and 

14 not more than 5 days in advance of the time of the 

15 importation of a shipment of qualifying drugs, the 

16 importer involved agrees to submit to the Secretary 

17 a notice with respect to the shipment of drugs to be 

18 imported or offered for import into the United 

19 States under subsection (a). A notice under the pre20 ceding sentence shall include—

21 ‘‘(A) the name and complete contact infor22 mation of the person submitting the notice; 

23 ‘‘(B) the name and complete contact infor24 mation of the importer involved; 
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•S 1082 ES

1 ‘‘(C) the identity of the drug, including the 

2 established name of the drug, the quantity of 

3 the drug, and the lot number assigned by the 

4 manufacturer; 

5 ‘‘(D) the identity of the manufacturer of 

6 the drug, including the identity of the establish7 ment at which the drug was manufactured; 

8 ‘‘(E) the country from which the drug is 

9 shipped; 

10 ‘‘(F) the name and complete contact infor11 mation for the shipper of the drug; 

12 ‘‘(G) anticipated arrival information, in13 cluding the port of arrival and crossing location 

14 within that port, and the date and time; 

15 ‘‘(H) a summary of the chain of custody of 

16 the drug from the establishment in which the 

17 drug was manufactured to the importer; 

18 ‘‘(I) a declaration as to whether the Sec19 retary has ordered that importation of the drug 

20 from the permitted country cease under sub21 section (g)(2)(C) or (D); and 

22 ‘‘(J) such other information as the Sec23 retary may require by regulation. 

24 ‘‘(5) MARKING OF COMPLIANT SHIPMENTS.—A 

25 registration condition is that the importer involved 
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•S 1082 ES

1 agrees, before wholesale distribution (as defined in 

2 section 503(e)) of a qualifying drug that has been 

3 imported under subsection (a), to affix to each con4 tainer of such drug such markings or other tech5 nology as the Secretary determines necessary to 

6 identify the shipment as being in compliance with all 

7 registration conditions, except that the markings or 

8 other technology shall not be required on a drug 

9 that bears comparable, compatible markings or tech10 nology from the manufacturer of the drug. Markings 

11 or other technology under the preceding sentence 

12 shall—

13 ‘‘(A) be designed to prevent affixation of 

14 the markings or other technology to any con15 tainer that is not authorized to bear the mark16 ings; and 

17 ‘‘(B) shall include anticounterfeiting or 

18 track-and-trace technologies, taking into ac19 count the economic and technical feasibility of 

20 such technologies. 

21 ‘‘(6) CERTAIN DUTIES RELATING TO IMPORT22 ERS.—Duties of the Secretary with respect to an im23 porter include the following: 

24 ‘‘(A) Inspecting, randomly, but not less 

25 than 12 times annually, the places of business 
390

•S 1082 ES

1 of the importer at which a qualifying drug is 

2 initially received after importation. 

3 ‘‘(B) During the inspections under sub4 paragraph (A), verifying the chain of custody of 

5 a statistically significant sample of qualifying 

6 drugs from the establishment in which the drug 

7 was manufactured to the importer, which shall 

8 be accomplished or supplemented by the use of 

9 anticounterfeiting or track-and-trace tech10 nologies, taking into account the economic and 

11 technical feasibility of those technologies, except 

12 that a drug that lacks such technologies from 

13 the point of manufacture shall not for that rea14 son be excluded from importation by an im15 porter. 

16 ‘‘(C) Reviewing notices under paragraph 

17 (4). 

18 ‘‘(D) Inspecting as the Secretary deter19 mines is necessary the warehouses and other fa20 cilities, including records of other parties in the 

21 chain of custody of qualifying drugs. 

22 ‘‘(E) Determining whether the importer is 

23 in compliance with all other registration condi24 tions. 

25 ‘‘(e) IMPORTER FEES.—
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•S 1082 ES

1 ‘‘(1) REGISTRATION FEE.—A registration con2 dition is that the importer involved pays to the Sec3 retary a fee of $10,000 due on the date on which 

4 the importer first submits the registration to the 

5 Secretary under subsection (b). 

6 ‘‘(2) INSPECTION FEE.—A registration condi7 tion is that the importer involved pays a fee to the 

8 Secretary in accordance with this subsection. Such 

9 fee shall be paid not later than October 1 and April 

10 1 of each fiscal year in the amount provided for 

11 under paragraph (3). 

12 ‘‘(3) AMOUNT OF INSPECTION FEE.—

13 ‘‘(A) AGGREGATE TOTAL OF FEES.—Not 

14 later than 30 days before the start of each fis15 cal year, the Secretary, in consultation with the 

16 Secretary of Homeland Security and the Sec17 retary of the Treasury, shall establish an aggre18 gate total of fees to be collected under para19 graph (2) for importers for that fiscal year that 

20 is sufficient, and not more than necessary, to 

21 pay the costs for that fiscal year of admin22 istering this section with respect to registered 

23 importers, including the costs associated with—

24 ‘‘(i) inspecting the facilities of reg25 istered importers, and of other entities in 
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•S 1082 ES

1 the chain of custody of a qualifying drug 

2 as necessary, under subsection (d)(6); 

3 ‘‘(ii) developing, implementing, and 

4 operating under such subsection an elec5 tronic system for submission and review of 

6 the notices required under subsection 

7 (d)(4) with respect to shipments of quali8 fying drugs under subsection (a) to assess 

9 compliance with all registration conditions 

10 when such shipments are offered for im11 port into the United States; and 

12 ‘‘(iii) inspecting such shipments as 

13 necessary, when offered for import into the 

14 United States to determine if such a ship15 ment should be refused admission under 

16 subsection (g)(5). 

17 ‘‘(B) LIMITATION.—Subject to subpara18 graph (C), the aggregate total of fees collected 

19 under paragraph (2) for a fiscal year shall not 

20 exceed 2.5 percent of the total price of quali21 fying drugs imported during that fiscal year 

22 into the United States by registered importers 

23 under subsection (a). 

24 ‘‘(C) TOTAL PRICE OF DRUGS.—
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1 ‘‘(i) ESTIMATE.—For the purposes of 

2 complying with the limitation described in 

3 subparagraph (B) when establishing under 

4 subparagraph (A) the aggregate total of 

5 fees to be collected under paragraph (2) 

6 for a fiscal year, the Secretary shall esti7 mate the total price of qualifying drugs im8 ported into the United States by registered 

9 importers during that fiscal year by adding 

10 the total price of qualifying drugs imported 

11 by each registered importer during the 6-

12 month period from January 1 through 

13 June 30 of the previous fiscal year, as re14 ported to the Secretary by each registered 

15 importer under subsection (b)(1)(J). 

16 ‘‘(ii) CALCULATION.—Not later than 

17 March 1 of the fiscal year that follows the 

18 fiscal year for which the estimate under 

19 clause (i) is made, the Secretary shall cal20 culate the total price of qualifying drugs 

21 imported into the United States by reg22 istered importers during that fiscal year by 

23 adding the total price of qualifying drugs 

24 imported by each registered importer dur25 ing that fiscal year, as reported to the Sec-
394

•S 1082 ES

1 retary by each registered importer under 

2 subsection (b)(1)(J). 

3 ‘‘(iii) ADJUSTMENT.—If the total 

4 price of qualifying drugs imported into the 

5 United States by registered importers dur6 ing a fiscal year as calculated under clause 

7 (ii) is less than the aggregate total of fees 

8 collected under paragraph (2) for that fis9 cal year, the Secretary shall provide for a 

10 pro-rata reduction in the fee due from each 

11 registered importer on April 1 of the sub12 sequent fiscal year so that the limitation 

13 described in subparagraph (B) is observed. 

14 ‘‘(D) INDIVIDUAL IMPORTER FEE.—Sub15 ject to the limitation described in subparagraph 

16 (B), the fee under paragraph (2) to be paid on 

17 October 1 and April 1 by an importer shall be 

18 an amount that is proportional to a reasonable 

19 estimate by the Secretary of the semiannual 

20 share of the importer of the volume of quali21 fying drugs imported by importers under sub22 section (a). 

23 ‘‘(4) USE OF FEES.—

24 ‘‘(A) IN GENERAL.—Subject to appropria25 tions Acts, fees collected by the Secretary under 
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•S 1082 ES

1 paragraphs (1) and (2) shall be credited to the 

2 appropriation account for salaries and expenses 

3 of the Food and Drug Administration until ex4 pended (without fiscal year limitation), and the 

5 Secretary may, in consultation with the Sec6 retary of Homeland Security and the Secretary 

7 of the Treasury, transfer some proportion of 

8 such fees to the appropriation account for sala9 ries and expenses of the Bureau of Customs 

10 and Border Protection until expended (without 

11 fiscal year limitation). 

12 ‘‘(B) SOLE PURPOSE.—Fees collected by 

13 the Secretary under paragraphs (1) and (2) are 

14 only available to the Secretary and, if trans15 ferred, to the Secretary of Homeland Security, 

16 and are for the sole purpose of paying the costs 

17 referred to in paragraph (3)(A). 

18 ‘‘(5) COLLECTION OF FEES.—In any case where 

19 the Secretary does not receive payment of a fee as20 sessed under paragraph (1) or (2) within 30 days 

21 after it is due, such fee shall be treated as a claim 

22 of the United States Government subject to sub23 chapter II of chapter 37 of title 31, United States 

24 Code. 

25 ‘‘(f) EXPORTER FEES.—
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•S 1082 ES

1 ‘‘(1) REGISTRATION FEE.—A registration con2 dition is that the exporter involved pays to the Sec3 retary a fee of $10,000 due on the date on which 

4 the exporter first submits that registration to the 

5 Secretary under subsection (b). 

6 ‘‘(2) INSPECTION FEE.—A registration condi7 tion is that the exporter involved pays a fee to the 

8 Secretary in accordance with this subsection. Such 

9 fee shall be paid not later than October 1 and April 

10 1 of each fiscal year in the amount provided for 

11 under paragraph (3). 

12 ‘‘(3) AMOUNT OF INSPECTION FEE.—

13 ‘‘(A) AGGREGATE TOTAL OF FEES.—Not 

14 later than 30 days before the start of each fis15 cal year, the Secretary, in consultation with the 

16 Secretary of Homeland Security and the Sec17 retary of the Treasury, shall establish an aggre18 gate total of fees to be collected under para19 graph (2) for exporters for that fiscal year that 

20 is sufficient, and not more than necessary, to 

21 pay the costs for that fiscal year of admin22 istering this section with respect to registered 

23 exporters, including the costs associated with—

24 ‘‘(i) inspecting the facilities of reg25 istered exporters, and of other entities in 
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•S 1082 ES

1 the chain of custody of a qualifying drug 

2 as necessary, under subsection (d)(3); 

3 ‘‘(ii) developing, implementing, and 

4 operating under such subsection a system 

5 to screen marks on shipments of qualifying 

6 drugs under subsection (a) that indicate 

7 compliance with all registration conditions, 

8 when such shipments are offered for im9 port into the United States; and 

10 ‘‘(iii) screening such markings, and 

11 inspecting such shipments as necessary, 

12 when offered for import into the United 

13 States to determine if such a shipment 

14 should be refused admission under sub15 section (g)(5). 

16 ‘‘(B) LIMITATION.—Subject to subpara17 graph (C), the aggregate total of fees collected 

18 under paragraph (2) for a fiscal year shall not 

19 exceed 2.5 percent of the total price of quali20 fying drugs imported during that fiscal year 

21 into the United States by registered exporters 

22 under subsection (a). 

23 ‘‘(C) TOTAL PRICE OF DRUGS.—

24 ‘‘(i) ESTIMATE.—For the purposes of 

25 complying with the limitation described in 
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•S 1082 ES

1 subparagraph (B) when establishing under 

2 subparagraph (A) the aggregate total of 

3 fees to be collected under paragraph (2) 

4 for a fiscal year, the Secretary shall esti5 mate the total price of qualifying drugs im6 ported into the United States by registered 

7 exporters during that fiscal year by adding 

8 the total price of qualifying drugs exported 

9 by each registered exporter during the 6-

10 month period from January 1 through 

11 June 30 of the previous fiscal year, as re12 ported to the Secretary by each registered 

13 exporter under subsection (b)(1)(I)(iv). 

14 ‘‘(ii) CALCULATION.—Not later than 

15 March 1 of the fiscal year that follows the 

16 fiscal year for which the estimate under 

17 clause (i) is made, the Secretary shall cal18 culate the total price of qualifying drugs 

19 imported into the United States by reg20 istered exporters during that fiscal year by 

21 adding the total price of qualifying drugs 

22 exported by each registered exporter dur23 ing that fiscal year, as reported to the Sec24 retary by each registered exporter under 

25 subsection (b)(1)(I)(iv). 
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•S 1082 ES

1 ‘‘(iii) ADJUSTMENT.—If the total 

2 price of qualifying drugs imported into the 

3 United States by registered exporters dur4 ing a fiscal year as calculated under clause 

5 (ii) is less than the aggregate total of fees 

6 collected under paragraph (2) for that fis7 cal year, the Secretary shall provide for a 

8 pro-rata reduction in the fee due from each 

9 registered exporter on April 1 of the subse10 quent fiscal year so that the limitation de11 scribed in subparagraph (B) is observed. 

12 ‘‘(D) INDIVIDUAL EXPORTER FEE.—Sub13 ject to the limitation described in subparagraph 

14 (B), the fee under paragraph (2) to be paid on 

15 October 1 and April 1 by an exporter shall be 

16 an amount that is proportional to a reasonable 

17 estimate by the Secretary of the semiannual 

18 share of the exporter of the volume of quali19 fying drugs exported by exporters under sub20 section (a). 

21 ‘‘(4) USE OF FEES.—

22 ‘‘(A) IN GENERAL.—Subject to appropria23 tions Acts, fees collected by the Secretary under 

24 paragraphs (1) and (2) shall be credited to the 

25 appropriation account for salaries and expenses 
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1 of the Food and Drug Administration until ex2 pended (without fiscal year limitation), and the 

3 Secretary may, in consultation with the Sec4 retary of Homeland Security and the Secretary 

5 of the Treasury, transfer some proportion of 

6 such fees to the appropriation account for sala7 ries and expenses of the Bureau of Customs 

8 and Border Protection until expended (without 

9 fiscal year limitation). 

10 ‘‘(B) SOLE PURPOSE.—Fees collected by 

11 the Secretary under paragraphs (1) and (2) are 

12 only available to the Secretary and, if trans13 ferred, to the Secretary of Homeland Security, 

14 and are for the sole purpose of paying the costs 

15 referred to in paragraph (3)(A). 

16 ‘‘(5) COLLECTION OF FEES.—In any case where 

17 the Secretary does not receive payment of a fee as18 sessed under paragraph (1) or (2) within 30 days 

19 after it is due, such fee shall be treated as a claim 

20 of the United States Government subject to sub21 chapter II of chapter 37 of title 31, United States 

22 Code. 

23 ‘‘(g) COMPLIANCE WITH SECTION 801(a).—

24 ‘‘(1) IN GENERAL.—A registration condition is 

25 that each qualifying drug exported under subsection 
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1 (a) by the registered exporter involved or imported 

2 under subsection (a) by the registered importer in3 volved is in compliance with the standards referred 

4 to in section 801(a) regarding admission of the drug 

5 into the United States, subject to paragraphs (2), 

6 (3), and (4). 

7 ‘‘(2) SECTION 505; APPROVAL STATUS.—

8 ‘‘(A) IN GENERAL.—A qualifying drug that 

9 is imported or offered for import under sub10 section (a) shall comply with the conditions es11 tablished in the approved application under sec12 tion 505(b) for the U.S. label drug as described 

13 under this subsection. 

14 ‘‘(B) NOTICE BY MANUFACTURER; GEN15 ERAL PROVISIONS.—

16 ‘‘(i) IN GENERAL.—The person that 

17 manufactures a qualifying drug that is, or 

18 will be, introduced for commercial distribu19 tion in a permitted country shall in accord20 ance with this paragraph submit to the 

21 Secretary a notice that—

22 ‘‘(I) includes each difference in 

23 the qualifying drug from a condition 

24 established in the approved applica25 tion for the U.S. label drug beyond—
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1 ‘‘(aa) the variations provided 

2 for in the application; and 

3 ‘‘(bb) any difference in label4 ing (except ingredient labeling); 

5 or 

6 ‘‘(II) states that there is no dif7 ference in the qualifying drug from a 

8 condition established in the approved 

9 application for the U.S. label drug be10 yond—

11 ‘‘(aa) the variations provided 

12 for in the application; and 

13 ‘‘(bb) any difference in label14 ing (except ingredient labeling). 

15 ‘‘(ii) INFORMATION IN NOTICE.—A 

16 notice under clause (i)(I) shall include the 

17 information that the Secretary may require 

18 under section 506A, any additional infor19 mation the Secretary may require (which 

20 may include data on bioequivalence if such 

21 data are not required under section 506A), 

22 and, with respect to the permitted country 

23 that approved the qualifying drug for com24 mercial distribution, or with respect to 
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1 which such approval is sought, include the 

2 following: 

3 ‘‘(I) The date on which the quali4 fying drug with such difference was, 

5 or will be, introduced for commercial 

6 distribution in the permitted country. 

7 ‘‘(II) Information demonstrating 

8 that the person submitting the notice 

9 has also notified the government of 

10 the permitted country in writing that 

11 the person is submitting to the Sec12 retary a notice under clause (i)(I), 

13 which notice describes the difference 

14 in the qualifying drug from a condi15 tion established in the approved appli16 cation for the U.S. label drug. 

17 ‘‘(III) The information that the 

18 person submitted or will submit to the 

19 government of the permitted country 

20 for purposes of obtaining approval for 

21 commercial distribution of the drug in 

22 the country which, if in a language 

23 other than English, shall be accom24 panied by an English translation 

25 verified to be complete and accurate, 
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1 with the name, address, and a brief 

2 statement of the qualifications of the 

3 person that made the translation. 

4 ‘‘(iii) CERTIFICATIONS.—The chief ex5 ecutive officer and the chief medical officer 

6 of the manufacturer involved shall each 

7 certify in the notice under clause (i) that—

8 ‘‘(I) the information provided in 

9 the notice is complete and true; and 

10 ‘‘(II) a copy of the notice has 

11 been provided to the Federal Trade 

12 Commission and to the State attor13 neys general. 

14 ‘‘(iv) FEE.—If a notice submitted 

15 under clause (i) includes a difference that 

16 would, under section 506A, require the 

17 submission of a supplemental application if 

18 made as a change to the U.S. label drug, 

19 the person that submits the notice shall 

20 pay to the Secretary a fee in the same 

21 amount as would apply if the person were 

22 paying a fee pursuant to section 

23 736(a)(1)(A)(ii). Subject to appropriations 

24 Acts, fees collected by the Secretary under 

25 the preceding sentence are available only to 
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1 the Secretary and are for the sole purpose 

2 of paying the costs of reviewing notices 

3 submitted under clause (i). 

4 ‘‘(v) TIMING OF SUBMISSION OF NO5 TICES.—

6 ‘‘(I) PRIOR APPROVAL NO7 TICES.—A notice under clause (i) to 

8 which subparagraph (C) applies shall 

9 be submitted to the Secretary not 

10 later than 120 days before the quali11 fying drug with the difference is intro12 duced for commercial distribution in a 

13 permitted country, unless the country 

14 requires that distribution of the quali15 fying drug with the difference begin 

16 less than 120 days after the country 

17 requires the difference. 

18 ‘‘(II) OTHER APPROVAL NO19 TICES.—A notice under clause (i) to 

20 which subparagraph (D) applies shall 

21 be submitted to the Secretary not 

22 later than the day on which the quali23 fying drug with the difference is intro24 duced for commercial distribution in a 

25 permitted country. 
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1 ‘‘(III) OTHER NOTICES.—A no2 tice under clause (i) to which subpara3 graph (E) applies shall be submitted 

4 to the Secretary on the date that the 

5 qualifying drug is first introduced for 

6 commercial distribution in a permitted 

7 country and annually thereafter. 

8 ‘‘(vi) REVIEW BY SECRETARY.—

9 ‘‘(I) IN GENERAL.—In this para10 graph, the difference in a qualifying 

11 drug that is submitted in a notice 

12 under clause (i) from the U.S. label 

13 drug shall be treated by the Secretary 

14 as if it were a manufacturing change 

15 to the U.S. label drug under section 

16 506A. 

17 ‘‘(II) STANDARD OF REVIEW.—

18 Except as provided in subclause (III), 

19 the Secretary shall review and approve 

20 or disapprove the difference in a no21 tice submitted under clause (i), if re22 quired under section 506A, using the 

23 safe and effective standard for ap24 proving or disapproving a manufac25 turing change under section 506A. 
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1 ‘‘(III) BIOEQUIVALENCE.—If the 

2 Secretary would approve the dif3 ference in a notice submitted under 

4 clause (i) using the safe and effective 

5 standard under section 506A and if 

6 the Secretary determines that the 

7 qualifying drug is not bioequivalent to 

8 the U.S. label drug, the Secretary 

9 shall—

10 ‘‘(aa) include in the labeling 

11 provided under paragraph (3) a 

12 prominent advisory that the 

13 qualifying drug is safe and effec14 tive but is not bioequivalent to 

15 the U.S. label drug if the Sec16 retary determines that such an 

17 advisory is necessary for health 

18 care practitioners and patients to 

19 use the qualifying drug safely 

20 and effectively; or 

21 ‘‘(bb) decline to approve the 

22 difference if the Secretary deter23 mines that the availability of 

24 both the qualifying drug and the 
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1 U.S. label drug would pose a 

2 threat to the public health. 

3 ‘‘(IV) REVIEW BY THE SEC4 RETARY.—The Secretary shall review 

5 and approve or disapprove the dif6 ference in a notice submitted under 

7 clause (i), if required under section 

8 506A, not later than 120 days after 

9 the date on which the notice is sub10 mitted. 

11 ‘‘(V) ESTABLISHMENT INSPEC12 TION.—If review of such difference 

13 would require an inspection of the es14 tablishment in which the qualifying 

15 drug is manufactured—

16 ‘‘(aa) such inspection by the 

17 Secretary shall be authorized; 

18 and 

19 ‘‘(bb) the Secretary may rely 

20 on a satisfactory report of a good 

21 manufacturing practice inspec22 tion of the establishment from a 

23 permitted country whose regu24 latory system the Secretary rec25 ognizes as equivalent under a 
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1 mutual recognition agreement, as 

2 provided under section 510(i)(3), 

3 section 803, or part 26 of title 

4 21, Code of Federal Regulations 

5 (or any corresponding successor 

6 rule or regulation). 

7 ‘‘(vii) PUBLICATION OF INFORMATION

8 ON NOTICES.—

9 ‘‘(I) IN GENERAL.—Through the 

10 Internet website of the Food and 

11 Drug Administration and a toll-free 

12 telephone number, the Secretary shall 

13 readily make available to the public a 

14 list of notices submitted under clause 

15 (i). 

16 ‘‘(II) CONTENTS.—The list under 

17 subclause (I) shall include the date on 

18 which a notice is submitted and 

19 whether—

20 ‘‘(aa) a notice is under re21 view; 

22 ‘‘(bb) the Secretary has or23 dered that importation of the 

24 qualifying drug from a permitted 

25 country cease; or 
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1 ‘‘(cc) the importation of the 

2 drug is permitted under sub3 section (a). 

4 ‘‘(III) UPDATE.—The Secretary 

5 shall promptly update the Internet 

6 website with any changes to the list. 

7 ‘‘(C) NOTICE; DRUG DIFFERENCE REQUIR8 ING PRIOR APPROVAL.—In the case of a notice 

9 under subparagraph (B)(i) that includes a dif10 ference that would, under section 506A(c) or 

11 (d)(3)(B)(i), require the approval of a supple12 mental application before the difference could 

13 be made to the U.S. label drug the following 

14 shall occur: 

15 ‘‘(i) Promptly after the notice is sub16 mitted, the Secretary shall notify reg17 istered exporters, registered importers, the 

18 Federal Trade Commission, and the State 

19 attorneys general that the notice has been 

20 submitted with respect to the qualifying 

21 drug involved. 

22 ‘‘(ii) If the Secretary has not made a 

23 determination whether such a supple24 mental application regarding the U.S. label 

25 drug would be approved or disapproved by 
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1 the date on which the qualifying drug in2 volved is to be introduced for commercial 

3 distribution in a permitted country, the 

4 Secretary shall—

5 ‘‘(I) order that the importation of 

6 the qualifying drug involved from the 

7 permitted country not begin until the 

8 Secretary completes review of the no9 tice; and 

10 ‘‘(II) promptly notify registered 

11 exporters, registered importers, the 

12 Federal Trade Commission, and the 

13 State attorneys general of the order. 

14 ‘‘(iii) If the Secretary determines that 

15 such a supplemental application regarding 

16 the U.S. label drug would not be approved, 

17 the Secretary shall—

18 ‘‘(I) order that the importation of 

19 the qualifying drug involved from the 

20 permitted country cease, or provide 

21 that an order under clause (ii), if any, 

22 remains in effect; 

23 ‘‘(II) notify the permitted coun24 try that approved the qualifying drug 
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1 for commercial distribution of the de2 termination; and 

3 ‘‘(III) promptly notify registered 

4 exporters, registered importers, the 

5 Federal Trade Commission, and the 

6 State attorneys general of the deter7 mination. 

8 ‘‘(iv) If the Secretary determines that 

9 such a supplemental application regarding 

10 the U.S. label drug would be approved, the 

11 Secretary shall—

12 ‘‘(I) vacate the order under 

13 clause (ii), if any; 

14 ‘‘(II) consider the difference to 

15 be a variation provided for in the ap16 proved application for the U.S. label 

17 drug; 

18 ‘‘(III) permit importation of the 

19 qualifying drug under subsection (a); 

20 and 

21 ‘‘(IV) promptly notify registered 

22 exporters, registered importers, the 

23 Federal Trade Commission, and the 

24 State attorneys general of the deter25 mination. 
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1 ‘‘(D) NOTICE; DRUG DIFFERENCE NOT RE2 QUIRING PRIOR APPROVAL.—In the case of a 

3 notice under subparagraph (B)(i) that includes 

4 a difference that would, under section 

5 506A(d)(3)(B)(ii), not require the approval of a 

6 supplemental application before the difference 

7 could be made to the U.S. label drug the fol8 lowing shall occur: 

9 ‘‘(i) During the period in which the 

10 notice is being reviewed by the Secretary, 

11 the authority under this subsection to im12 port the qualifying drug involved continues 

13 in effect. 

14 ‘‘(ii) If the Secretary determines that 

15 such a supplemental application regarding 

16 the U.S. label drug would not be approved, 

17 the Secretary shall—

18 ‘‘(I) order that the importation of 

19 the qualifying drug involved from the 

20 permitted country cease; 

21 ‘‘(II) notify the permitted coun22 try that approved the qualifying drug 

23 for commercial distribution of the de24 termination; and 
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1 ‘‘(III) promptly notify registered 

2 exporters, registered importers, the 

3 Federal Trade Commission, and the 

4 State attorneys general of the deter5 mination. 

6 ‘‘(iii) If the Secretary determines that 

7 such a supplemental application regarding 

8 the U.S. label drug would be approved, the 

9 difference shall be considered to be a vari10 ation provided for in the approved applica11 tion for the U.S. label drug. 

12 ‘‘(E) NOTICE; DRUG DIFFERENCE NOT RE13 QUIRING APPROVAL; NO DIFFERENCE.—In the 

14 case of a notice under subparagraph (B)(i) that 

15 includes a difference for which, under section 

16 506A(d)(1)(A), a supplemental application 

17 would not be required for the difference to be 

18 made to the U.S. label drug, or that states that 

19 there is no difference, the Secretary—

20 ‘‘(i) shall consider such difference to 

21 be a variation provided for in the approved 

22 application for the U.S. label drug; 

23 ‘‘(ii) may not order that the importa24 tion of the qualifying drug involved cease; 

25 and 
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1 ‘‘(iii) shall promptly notify registered 

2 exporters and registered importers. 

3 ‘‘(F) DIFFERENCES IN ACTIVE INGRE4 DIENT, ROUTE OF ADMINISTRATION, DOSAGE

5 FORM, OR STRENGTH.—

6 ‘‘(i) IN GENERAL.—A person who 

7 manufactures a drug approved under sec8 tion 505(b) shall submit an application 

9 under section 505(b) for approval of an10 other drug that is manufactured for dis11 tribution in a permitted country by or for 

12 the person that manufactures the drug ap13 proved under section 505(b) if—

14 ‘‘(I) there is no qualifying drug 

15 in commercial distribution in per16 mitted countries whose combined pop17 ulation represents at least 50 percent 

18 of the total population of all permitted 

19 countries with the same active ingre20 dient or ingredients, route of adminis21 tration, dosage form, and strength as 

22 the drug approved under section 

23 505(b); and 

24 ‘‘(II) each active ingredient of 

25 the other drug is related to an active 
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1 ingredient of the drug approved under 

2 section 505(b), as defined in clause 

3 (v). 

4 ‘‘(ii) APPLICATION UNDER SECTION

5 505(b).—The application under section 

6 505(b) required under clause (i) shall—

7 ‘‘(I) request approval of the other 

8 drug for the indication or indications 

9 for which the drug approved under 

10 section 505(b) is labeled; 

11 ‘‘(II) include the information that 

12 the person submitted to the govern13 ment of the permitted country for 

14 purposes of obtaining approval for 

15 commercial distribution of the other 

16 drug in that country, which if in a 

17 language other than English, shall be 

18 accompanied by an English trans19 lation verified to be complete and ac20 curate, with the name, address, and a 

21 brief statement of the qualifications of 

22 the person that made the translation; 

23 ‘‘(III) include a right of reference 

24 to the application for the drug ap25 proved under section 505(b); and 
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1 ‘‘(IV) include such additional in2 formation as the Secretary may re3 quire. 

4 ‘‘(iii) TIMING OF SUBMISSION OF AP5 PLICATION.—An application under section 

6 505(b) required under clause (i) shall be 

7 submitted to the Secretary not later than 

8 the day on which the information referred 

9 to in clause (ii)(II) is submitted to the gov10 ernment of the permitted country. 

11 ‘‘(iv) NOTICE OF DECISION ON APPLI12 CATION.—The Secretary shall promptly no13 tify registered exporters, registered import14 ers, the Federal Trade Commission, and 

15 the State attorneys general of a determina16 tion to approve or to disapprove an appli17 cation under section 505(b) required under 

18 clause (i). 

19 ‘‘(v) RELATED ACTIVE INGREDI20 ENTS.—For purposes of clause (i)(II), 2 

21 active ingredients are related if they are—

22 ‘‘(I) the same; or 

23 ‘‘(II) different salts, esters, or 

24 complexes of the same moiety. 

25 ‘‘(3) SECTION 502; LABELING.—
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1 ‘‘(A) IMPORTATION BY REGISTERED IM2 PORTER.—

3 ‘‘(i) IN GENERAL.—In the case of a 

4 qualifying drug that is imported or offered 

5 for import by a registered importer, such 

6 drug shall be considered to be in compli7 ance with section 502 and the labeling re8 quirements under the approved application 

9 for the U.S. label drug if the qualifying 

10 drug bears—

11 ‘‘(I) a copy of the labeling ap12 proved for the U.S. label drug under 

13 section 505, without regard to wheth14 er the copy bears any trademark in15 volved; 

16 ‘‘(II) the name of the manufac17 turer and location of the manufac18 turer; 

19 ‘‘(III) the lot number assigned by 

20 the manufacturer; 

21 ‘‘(IV) the name, location, and 

22 registration number of the importer; 

23 and 
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1 ‘‘(V) the National Drug Code 

2 number assigned to the qualifying 

3 drug by the Secretary. 

4 ‘‘(ii) REQUEST FOR COPY OF THE LA5 BELING.—The Secretary shall provide such 

6 copy to the registered importer involved, 

7 upon request of the importer. 

8 ‘‘(iii) REQUESTED LABELING.—The 

9 labeling provided by the Secretary under 

10 clause (ii) shall—

11 ‘‘(I) include the established 

12 name, as defined in section 502(e)(3), 

13 for each active ingredient in the quali14 fying drug; 

15 ‘‘(II) not include the proprietary 

16 name of the U.S. label drug or any 

17 active ingredient thereof; 

18 ‘‘(III) if required under para19 graph (2)(B)(vi)(III), a prominent ad20 visory that the qualifying drug is safe 

21 and effective but not bioequivalent to 

22 the U.S. label drug; and 

23 ‘‘(IV) if the inactive ingredients 

24 of the qualifying drug are different 
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1 from the inactive ingredients for the 

2 U.S. label drug, include—

3 ‘‘(aa) a prominent notice 

4 that the ingredients of the quali5 fying drug differ from the ingre6 dients of the U.S. label drug and 

7 that the qualifying drug must be 

8 dispensed with an advisory to 

9 people with allergies about this 

10 difference and a list of ingredi11 ents; and 

12 ‘‘(bb) a list of the ingredi13 ents of the qualifying drug as 

14 would be required under section 

15 502(e). 

16 ‘‘(B) IMPORTATION BY INDIVIDUAL.—

17 ‘‘(i) IN GENERAL.—In the case of a 

18 qualifying drug that is imported or offered 

19 for import by a registered exporter to an 

20 individual, such drug shall be considered to 

21 be in compliance with section 502 and the 

22 labeling requirements under the approved 

23 application for the U.S. label drug if the 

24 packaging and labeling of the qualifying 

25 drug complies with all applicable regula-
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1 tions promulgated under sections 3 and 4 

2 of the Poison Prevention Packaging Act of 

3 1970 (15 U.S.C. 1471 et seq.) and the la4 beling of the qualifying drug includes—

5 ‘‘(I) directions for use by the 

6 consumer; 

7 ‘‘(II) the lot number assigned by 

8 the manufacturer; 

9 ‘‘(III) the name and registration 

10 number of the exporter; 

11 ‘‘(IV) if required under para12 graph (2)(B)(vi)(III), a prominent ad13 visory that the drug is safe and effec14 tive but not bioequivalent to the U.S. 

15 label drug; 

16 ‘‘(V) if the inactive ingredients of 

17 the drug are different from the inac18 tive ingredients for the U.S. label 

19 drug—

20 ‘‘(aa) a prominent advisory 

21 that persons with an allergy 

22 should check the ingredient list 

23 of the drug because the ingredi24 ents of the drug differ from the 
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1 ingredients of the U.S. label 

2 drug; and 

3 ‘‘(bb) a list of the ingredi4 ents of the drug as would be re5 quired under section 502(e); and 

6 ‘‘(VI) a copy of any special label7 ing that would be required by the Sec8 retary had the U.S. label drug been 

9 dispensed by a pharmacist in the 

10 United States, without regard to 

11 whether the special labeling bears any 

12 trademark involved. 

13 ‘‘(ii) PACKAGING.—A qualifying drug 

14 offered for import to an individual by an 

15 exporter under this section that is pack16 aged in a unit-of-use container (as those 

17 items are defined in the United States 

18 Pharmacopeia and National Formulary) 

19 shall not be repackaged, provided that—

20 ‘‘(I) the packaging complies with 

21 all applicable regulations under sec22 tions 3 and 4 of the Poison Preven23 tion Packaging Act of 1970 (15 

24 U.S.C. 1471 et seq.); or 
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1 ‘‘(II) the consumer consents to 

2 waive the requirements of such Act, 

3 after being informed that the pack4 aging does not comply with such Act 

5 and that the exporter will provide the 

6 drug in packaging that is compliant at 

7 no additional cost. 

8 ‘‘(iii) REQUEST FOR COPY OF SPECIAL

9 LABELING AND INGREDIENT LIST.—The 

10 Secretary shall provide to the registered 

11 exporter involved a copy of the special la12 beling, the advisory, and the ingredient list 

13 described under clause (i), upon request of 

14 the exporter. 

15 ‘‘(iv) REQUESTED LABELING AND IN16 GREDIENT LIST.—The labeling and ingre17 dient list provided by the Secretary under 

18 clause (iii) shall—

19 ‘‘(I) include the established 

20 name, as defined in section 502(e)(3), 

21 for each active ingredient in the drug; 

22 and 

23 ‘‘(II) not include the proprietary 

24 name of the U.S. label drug or any 

25 active ingredient thereof. 
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•S 1082 ES

1 ‘‘(4) SECTION 501; ADULTERATION.—A quali2 fying drug that is imported or offered for import 

3 under subsection (a) shall be considered to be in 

4 compliance with section 501 if the drug is in compli5 ance with subsection (c). 

6 ‘‘(5) STANDARDS FOR REFUSING ADMISSION.—

7 A drug exported under subsection (a) from a reg8 istered exporter or imported by a registered importer 

9 may be refused admission into the United States if 

10 1 or more of the following applies: 

11 ‘‘(A) The drug is not a qualifying drug. 

12 ‘‘(B) A notice for the drug required under 

13 paragraph (2)(B) has not been submitted to the 

14 Secretary. 

15 ‘‘(C) The Secretary has ordered that im16 portation of the drug from the permitted coun17 try cease under paragraph (2) (C) or (D). 

18 ‘‘(D) The drug does not comply with para19 graph (3) or (4). 

20 ‘‘(E) The shipping container appears dam21 aged in a way that may affect the strength, 

22 quality, or purity of the drug. 

23 ‘‘(F) The Secretary becomes aware that—

24 ‘‘(i) the drug may be counterfeit; 
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1 ‘‘(ii) the drug may have been pre2 pared, packed, or held under insanitary 

3 conditions; or 

4 ‘‘(iii) the methods used in, or the fa5 cilities or controls used for, the manufac6 turing, processing, packing, or holding of 

7 the drug do not conform to good manufac8 turing practice. 

9 ‘‘(G) The Secretary has obtained an in10 junction under section 302 that prohibits the 

11 distribution of the drug in interstate commerce. 

12 ‘‘(H) The Secretary has under section 

13 505(e) withdrawn approval of the drug. 

14 ‘‘(I) The manufacturer of the drug has in15 stituted a recall of the drug. 

16 ‘‘(J) If the drug is imported or offered for 

17 import by a registered importer without submis18 sion of a notice in accordance with subsection 

19 (d)(4). 

20 ‘‘(K) If the drug is imported or offered for 

21 import from a registered exporter to an indi22 vidual and 1 or more of the following applies: 

23 ‘‘(i) The shipping container for such 

24 drug does not bear the markings required 

25 under subsection (d)(2). 
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1 ‘‘(ii) The markings on the shipping 

2 container appear to be counterfeit. 

3 ‘‘(iii) The shipping container or mark4 ings appear to have been tampered with. 

5 ‘‘(h) EXPORTER LICENSURE IN PERMITTED COUN6 TRY.—A registration condition is that the exporter in7 volved agrees that a qualifying drug will be exported to 

8 an individual only if the Secretary has verified that—

9 ‘‘(1) the exporter is authorized under the law of 

10 the permitted country in which the exporter is lo11 cated to dispense prescription drugs; and 

12 ‘‘(2) the exporter employs persons that are li13 censed under the law of the permitted country in 

14 which the exporter is located to dispense prescription 

15 drugs in sufficient number to dispense safely the 

16 drugs exported by the exporter to individuals, and 

17 the exporter assigns to those persons responsibility 

18 for dispensing such drugs to individuals. 

19 ‘‘(i) INDIVIDUALS; CONDITIONS FOR IMPORTA20 TION.—

21 ‘‘(1) IN GENERAL.—For purposes of subsection 

22 (a)(2)(B), the importation of a qualifying drug by 

23 an individual is in accordance with this subsection if 

24 the following conditions are met: 
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1 ‘‘(A) The drug is accompanied by a copy of 

2 a prescription for the drug, which prescrip3 tion—

4 ‘‘(i) is valid under applicable Federal 

5 and State laws; and 

6 ‘‘(ii) was issued by a practitioner who, 

7 under the law of a State of which the indi8 vidual is a resident, or in which the indi9 vidual receives care from the practitioner 

10 who issues the prescription, is authorized 

11 to administer prescription drugs. 

12 ‘‘(B) The drug is accompanied by a copy 

13 of the documentation that was required under 

14 the law or regulations of the permitted country 

15 in which the exporter is located, as a condition 

16 of dispensing the drug to the individual. 

17 ‘‘(C) The copies referred to in subpara18 graphs (A)(i) and (B) are marked in a manner 

19 sufficient—

20 ‘‘(i) to indicate that the prescription, 

21 and the equivalent document in the per22 mitted country in which the exporter is lo23 cated, have been filled; and 

24 ‘‘(ii) to prevent a duplicative filling by 

25 another pharmacist. 
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•S 1082 ES

1 ‘‘(D) The individual has provided to the 

2 registered exporter a complete list of all drugs 

3 used by the individual for review by the individ4 uals who dispense the drug. 

5 ‘‘(E) The quantity of the drug does not ex6 ceed a 90-day supply. 

7 ‘‘(F) The drug is not an ineligible subpart 

8 H drug. For purposes of this section, a pre9 scription drug is an ‘ineligible subpart H drug’ 

10 if the drug was approved by the Secretary 

11 under subpart H of part 314 of title 21, Code 

12 of Federal Regulations (relating to accelerated 

13 approval), with restrictions under section 520 of 

14 such part to assure safe use, and the Secretary 

15 has published in the Federal Register a notice 

16 that the Secretary has determined that good 

17 cause exists to prohibit the drug from being im18 ported pursuant to this subsection. 

19 ‘‘(2) NOTICE REGARDING DRUG REFUSED AD20 MISSION.—If a registered exporter ships a drug to 

21 an individual pursuant to subsection (a)(2)(B) and 

22 the drug is refused admission to the United States, 

23 a written notice shall be sent to the individual and 

24 to the exporter that informs the individual and the 
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1 exporter of such refusal and the reason for the re2 fusal. 

3 ‘‘(j) MAINTENANCE OF RECORDS AND SAMPLES.—

4 ‘‘(1) IN GENERAL.—A registration condition is 

5 that the importer or exporter involved shall—

6 ‘‘(A) maintain records required under this 

7 section for not less than 2 years; and 

8 ‘‘(B) maintain samples of each lot of a 

9 qualifying drug required under this section for 

10 not more than 2 years. 

11 ‘‘(2) PLACE OF RECORD MAINTENANCE.—The 

12 records described under paragraph (1) shall be 

13 maintained—

14 ‘‘(A) in the case of an importer, at the 

15 place of business of the importer at which the 

16 importer initially receives the qualifying drug 

17 after importation; or 

18 ‘‘(B) in the case of an exporter, at the fa19 cility from which the exporter ships the quali20 fying drug to the United States. 

21 ‘‘(k) DRUG RECALLS.—

22 ‘‘(1) MANUFACTURERS.—A person that manu23 factures a qualifying drug imported from a per24 mitted country under this section shall promptly in25 form the Secretary—
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1 ‘‘(A) if the drug is recalled or withdrawn 

2 from the market in a permitted country; 

3 ‘‘(B) how the drug may be identified, in4 cluding lot number; and 

5 ‘‘(C) the reason for the recall or with6 drawal. 

7 ‘‘(2) SECRETARY.—With respect to each per8 mitted country, the Secretary shall—

9 ‘‘(A) enter into an agreement with the gov10 ernment of the country to receive information 

11 about recalls and withdrawals of qualifying 

12 drugs in the country; or 

13 ‘‘(B) monitor recalls and withdrawals of 

14 qualifying drugs in the country using any infor15 mation that is available to the public in any 

16 media. 

17 ‘‘(3) NOTICE.—The Secretary may notify, as 

18 appropriate, registered exporters, registered import19 ers, wholesalers, pharmacies, or the public of a recall 

20 or withdrawal of a qualifying drug in a permitted 

21 country. 

22 ‘‘(l) DRUG LABELING AND PACKAGING.—

23 ‘‘(1) IN GENERAL.—When a qualifying drug 

24 that is imported into the United States by an im25 porter under subsection (a) is dispensed by a phar-
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1 macist to an individual, the pharmacist shall provide 

2 that the packaging and labeling of the drug complies 

3 with all applicable regulations promulgated under 

4 sections 3 and 4 of the Poison Prevention Packaging 

5 Act of 1970 (15 U.S.C. 1471 et seq.) and shall in6 clude with any other labeling provided to the indi7 vidual the following: 

8 ‘‘(A) The lot number assigned by the man9 ufacturer. 

10 ‘‘(B) The name and registration number of 

11 the importer. 

12 ‘‘(C) If required under paragraph 

13 (2)(B)(vi)(III) of subsection (g), a prominent 

14 advisory that the drug is safe and effective but 

15 not bioequivalent to the U.S. label drug. 

16 ‘‘(D) If the inactive ingredients of the drug 

17 are different from the inactive ingredients for 

18 the U.S. label drug—

19 ‘‘(i) a prominent advisory that persons 

20 with allergies should check the ingredient 

21 list of the drug because the ingredients of 

22 the drug differ from the ingredients of the 

23 U.S. label drug; and 
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1 ‘‘(ii) a list of the ingredients of the 

2 drug as would be required under section 

3 502(e). 

4 ‘‘(2) PACKAGING.—A qualifying drug that is 

5 packaged in a unit-of-use container (as those terms 

6 are defined in the United States Pharmacopeia and 

7 National Formulary) shall not be repackaged, pro8 vided that—

9 ‘‘(A) the packaging complies with all appli10 cable regulations under sections 3 and 4 of the 

11 Poison Prevention Packaging Act of 1970 (15 

12 U.S.C. 1471 et seq.); or 

13 ‘‘(B) the consumer consents to waive the 

14 requirements of such Act, after being informed 

15 that the packaging does not comply with such 

16 Act and that the pharmacist will provide the 

17 drug in packaging that is compliant at no addi18 tional cost. 

19 ‘‘(m) CHARITABLE CONTRIBUTIONS.—Notwith20 standing any other provision of this section, this section 

21 does not authorize the importation into the United States 

22 of a qualifying drug donated or otherwise supplied for free 

23 or at nominal cost by the manufacturer of the drug to 

24 a charitable or humanitarian organization, including the 
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1 United Nations and affiliates, or to a government of a for2 eign country. 

3 ‘‘(n) UNFAIR AND DISCRIMINATORY ACTS AND PRAC4 TICES.—

5 ‘‘(1) IN GENERAL.—It is unlawful for a manu6 facturer, directly or indirectly (including by being a 

7 party to a licensing agreement or other agreement), 

8 to—

9 ‘‘(A) discriminate by charging a higher 

10 price for a prescription drug sold to a registered 

11 exporter or other person in a permitted country 

12 that exports a qualifying drug to the United 

13 States under this section than the price that is 

14 charged, inclusive of rebates or other incentives 

15 to the permitted country or other person, to an16 other person that is in the same country and 

17 that does not export a qualifying drug into the 

18 United States under this section; 

19 ‘‘(B) discriminate by charging a higher 

20 price for a prescription drug sold to a registered 

21 importer or other person that distributes, sells, 

22 or uses a qualifying drug imported into the 

23 United States under this section than the price 

24 that is charged to another person in the United 

25 States that does not import a qualifying drug 
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1 under this section, or that does not distribute, 

2 sell, or use such a drug; 

3 ‘‘(C) discriminate by denying, restricting, 

4 or delaying supplies of a prescription drug to a 

5 registered exporter or other person in a per6 mitted country that exports a qualifying drug to 

7 the United States under this section or to a 

8 registered importer or other person that distrib9 utes, sells, or uses a qualifying drug imported 

10 into the United States under this section; 

11 ‘‘(D) discriminate by publicly, privately, or 

12 otherwise refusing to do business with a reg13 istered exporter or other person in a permitted 

14 country that exports a qualifying drug to the 

15 United States under this section or with a reg16 istered importer or other person that distrib17 utes, sells, or uses a qualifying drug imported 

18 into the United States under this section; 

19 ‘‘(E) knowingly fail to submit a notice 

20 under subsection (g)(2)(B)(i), knowingly fail to 

21 submit such a notice on or before the date spec22 ified in subsection (g)(2)(B)(v) or as otherwise 

23 required under subsection (e) (3), (4), and (5) 

24 of section 4 of the Pharmaceutical Market Ac25 cess and Drug Safety Act of 2007, knowingly 
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1 submit such a notice that makes a materially 

2 false, fictitious, or fraudulent statement, or 

3 knowingly fail to provide promptly any informa4 tion requested by the Secretary to review such 

5 a notice; 

6 ‘‘(F) knowingly fail to submit an applica7 tion required under subsection (g)(2)(F), know8 ingly fail to submit such an application on or 

9 before the date specified in subsection 

10 (g)(2)(F)(ii), knowingly submit such an applica11 tion that makes a materially false, fictitious, or 

12 fraudulent statement, or knowingly fail to pro13 vide promptly any information requested by the 

14 Secretary to review such an application; 

15 ‘‘(G) cause there to be a difference (includ16 ing a difference in active ingredient, route of 

17 administration, dosage form, strength, formula18 tion, manufacturing establishment, manufac19 turing process, or person that manufactures the 

20 drug) between a prescription drug for distribu21 tion in the United States and the drug for dis22 tribution in a permitted country; 

23 ‘‘(H) refuse to allow an inspection author24 ized under this section of an establishment that 

25 manufactures a qualifying drug that is, or will 
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1 be, introduced for commercial distribution in a 

2 permitted country; 

3 ‘‘(I) fail to conform to the methods used 

4 in, or the facilities used for, the manufacturing, 

5 processing, packing, or holding of a qualifying 

6 drug that is, or will be, introduced for commer7 cial distribution in a permitted country to good 

8 manufacturing practice under this Act; 

9 ‘‘(J) become a party to a licensing agree10 ment or other agreement related to a qualifying 

11 drug that fails to provide for compliance with 

12 all requirements of this section with respect to 

13 such drug; 

14 ‘‘(K) enter into a contract that restricts, 

15 prohibits, or delays the importation of a quali16 fying drug under this section; 

17 ‘‘(L) engage in any other action to restrict, 

18 prohibit, or delay the importation of a quali19 fying drug under this section; or 

20 ‘‘(M) engage in any other action that the 

21 Federal Trade Commission determines to dis22 criminate against a person that engages or at23 tempts to engage in the importation of a quali24 fying drug under this section. 
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1 ‘‘(2) REFERRAL OF POTENTIAL VIOLATIONS.—

2 The Secretary shall promptly refer to the Federal 

3 Trade Commission each potential violation of sub4 paragraph (E), (F), (G), (H), or (I) of paragraph 

5 (1) that becomes known to the Secretary. 

6 ‘‘(3) AFFIRMATIVE DEFENSE.—

7 ‘‘(A) DISCRIMINATION.—It shall be an af8 firmative defense to a charge that a manufac9 turer has discriminated under subparagraph 

10 (A), (B), (C), (D), or (M) of paragraph (1) that 

11 the higher price charged for a prescription drug 

12 sold to a person, the denial, restriction, or delay 

13 of supplies of a prescription drug to a person, 

14 the refusal to do business with a person, or 

15 other discriminatory activity against a person, 

16 is not based, in whole or in part, on—

17 ‘‘(i) the person exporting or importing 

18 a qualifying drug into the United States 

19 under this section; or 

20 ‘‘(ii) the person distributing, selling, 

21 or using a qualifying drug imported into 

22 the United States under this section. 

23 ‘‘(B) DRUG DIFFERENCES.—It shall be an 

24 affirmative defense to a charge that a manufac25 turer has caused there to be a difference de-
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1 scribed in subparagraph (G) of paragraph (1) 

2 that—

3 ‘‘(i) the difference was required by the 

4 country in which the drug is distributed; 

5 ‘‘(ii) the Secretary has determined 

6 that the difference was necessary to im7 prove the safety or effectiveness of the 

8 drug; 

9 ‘‘(iii) the person manufacturing the 

10 drug for distribution in the United States 

11 has given notice to the Secretary under 

12 subsection (g)(2)(B)(i) that the drug for 

13 distribution in the United States is not dif14 ferent from a drug for distribution in per15 mitted countries whose combined popu16 lation represents at least 50 percent of the 

17 total population of all permitted countries; 

18 or 

19 ‘‘(iv) the difference was not caused, in 

20 whole or in part, for the purpose of re21 stricting importation of the drug into the 

22 United States under this section. 

23 ‘‘(4) EFFECT OF SUBSECTION.—

24 ‘‘(A) SALES IN OTHER COUNTRIES.—This 

25 subsection applies only to the sale or distribu-
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1 tion of a prescription drug in a country if the 

2 manufacturer of the drug chooses to sell or dis3 tribute the drug in the country. Nothing in this 

4 subsection shall be construed to compel the 

5 manufacturer of a drug to distribute or sell the 

6 drug in a country. 

7 ‘‘(B) DISCOUNTS TO INSURERS, HEALTH

8 PLANS, PHARMACY BENEFIT MANAGERS, AND

9 COVERED ENTITIES.—Nothing in this sub10 section shall be construed to—

11 ‘‘(i) prevent or restrict a manufac12 turer of a prescription drug from providing 

13 discounts to an insurer, health plan, phar14 macy benefit manager in the United 

15 States, or covered entity in the drug dis16 count program under section 340B of the 

17 Public Health Service Act (42 U.S.C. 

18 256b) in return for inclusion of the drug 

19 on a formulary; 

20 ‘‘(ii) require that such discounts be 

21 made available to other purchasers of the 

22 prescription drug; or 

23 ‘‘(iii) prevent or restrict any other 

24 measures taken by an insurer, health plan, 
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1 or pharmacy benefit manager to encourage 

2 consumption of such prescription drug. 

3 ‘‘(C) CHARITABLE CONTRIBUTIONS.—

4 Nothing in this subsection shall be construed 

5 to—

6 ‘‘(i) prevent a manufacturer from do7 nating a prescription drug, or supplying a 

8 prescription drug at nominal cost, to a 

9 charitable or humanitarian organization, 

10 including the United Nations and affili11 ates, or to a government of a foreign coun12 try; or 

13 ‘‘(ii) apply to such donations or sup14 plying of a prescription drug. 

15 ‘‘(5) ENFORCEMENT.—

16 ‘‘(A) UNFAIR OR DECEPTIVE ACT OR PRAC17 TICE.—A violation of this subsection shall be 

18 treated as a violation of a rule defining an un19 fair or deceptive act or practice prescribed 

20 under section 18(a)(1)(B) of the Federal Trade 

21 Commission Act (15 U.S.C. 57a(a)(1)(B)). 

22 ‘‘(B) ACTIONS BY THE COMMISSION.—The 

23 Federal Trade Commission—

24 ‘‘(i) shall enforce this subsection in 

25 the same manner, by the same means, and 
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1 with the same jurisdiction, powers, and du2 ties as though all applicable terms and pro3 visions of the Federal Trade Commission 

4 Act (15 U.S.C. 41 et seq.) were incor5 porated into and made a part of this sec6 tion; and 

7 ‘‘(ii) may seek monetary relief three8 fold the damages sustained, in addition to 

9 any other remedy available to the Federal 

10 Trade Commission under the Federal 

11 Trade Commission Act (15 U.S.C. 41 et 

12 seq.). 

13 ‘‘(6) ACTIONS BY STATES.—

14 ‘‘(A) IN GENERAL.—

15 ‘‘(i) CIVIL ACTIONS.—In any case in 

16 which the attorney general of a State has 

17 reason to believe that an interest of the 

18 residents of that State have been adversely 

19 affected by any manufacturer that violates 

20 paragraph (1), the attorney general of a 

21 State may bring a civil action on behalf of 

22 the residents of the State, and persons 

23 doing business in the State, in a district 

24 court of the United States of appropriate 

25 jurisdiction to—
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1 ‘‘(I) enjoin that practice; 

2 ‘‘(II) enforce compliance with 

3 this subsection; 

4 ‘‘(III) obtain damages, restitu5 tion, or other compensation on behalf 

6 of residents of the State and persons 

7 doing business in the State, including 

8 threefold the damages; or 

9 ‘‘(IV) obtain such other relief as 

10 the court may consider to be appro11 priate. 

12 ‘‘(ii) NOTICE.—

13 ‘‘(I) IN GENERAL.—Before filing 

14 an action under clause (i), the attor15 ney general of the State involved shall 

16 provide to the Federal Trade Commis17 sion—

18 ‘‘(aa) written notice of that 

19 action; and 

20 ‘‘(bb) a copy of the com21 plaint for that action. 

22 ‘‘(II) EXEMPTION.—Subclause 

23 (I) shall not apply with respect to the 

24 filing of an action by an attorney gen25 eral of a State under this paragraph, 
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1 if the attorney general determines 

2 that it is not feasible to provide the 

3 notice described in that subclause be4 fore filing of the action. In such case, 

5 the attorney general of a State shall 

6 provide notice and a copy of the com7 plaint to the Federal Trade Commis8 sion at the same time as the attorney 

9 general files the action. 

10 ‘‘(B) INTERVENTION.—

11 ‘‘(i) IN GENERAL.—On receiving no12 tice under subparagraph (A)(ii), the Fed13 eral Trade Commission shall have the right 

14 to intervene in the action that is the sub15 ject of the notice. 

16 ‘‘(ii) EFFECT OF INTERVENTION.—If 

17 the Federal Trade Commission intervenes 

18 in an action under subparagraph (A), it 

19 shall have the right—

20 ‘‘(I) to be heard with respect to 

21 any matter that arises in that action; 

22 and 

23 ‘‘(II) to file a petition for appeal. 

24 ‘‘(C) CONSTRUCTION.—For purposes of 

25 bringing any civil action under subparagraph 
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1 (A), nothing in this subsection shall be con2 strued to prevent an attorney general of a State 

3 from exercising the powers conferred on the at4 torney general by the laws of that State to—

5 ‘‘(i) conduct investigations; 

6 ‘‘(ii) administer oaths or affirmations; 

7 or 

8 ‘‘(iii) compel the attendance of wit9 nesses or the production of documentary 

10 and other evidence. 

11 ‘‘(D) ACTIONS BY THE COMMISSION.—In 

12 any case in which an action is instituted by or 

13 on behalf of the Federal Trade Commission for 

14 a violation of paragraph (1), a State may not, 

15 during the pendency of that action, institute an 

16 action under subparagraph (A) for the same 

17 violation against any defendant named in the 

18 complaint in that action. 

19 ‘‘(E) VENUE.—Any action brought under 

20 subparagraph (A) may be brought in the dis21 trict court of the United States that meets ap22 plicable requirements relating to venue under 

23 section 1391 of title 28, United States Code. 

24 ‘‘(F) SERVICE OF PROCESS.—In an action 

25 brought under subparagraph (A), process may 
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1 be served in any district in which the defend2 ant—

3 ‘‘(i) is an inhabitant; or 

4 ‘‘(ii) may be found. 

5 ‘‘(G) MEASUREMENT OF DAMAGES.—In 

6 any action under this paragraph to enforce a 

7 cause of action under this subsection in which 

8 there has been a determination that a defend9 ant has violated a provision of this subsection, 

10 damages may be proved and assessed in the ag11 gregate by statistical or sampling methods, by 

12 the computation of illegal overcharges or by 

13 such other reasonable system of estimating ag14 gregate damages as the court in its discretion 

15 may permit without the necessity of separately 

16 proving the individual claim of, or amount of 

17 damage to, persons on whose behalf the suit 

18 was brought. 

19 ‘‘(H) EXCLUSION ON DUPLICATIVE RE20 LIEF.—The district court shall exclude from the 

21 amount of monetary relief awarded in an action 

22 under this paragraph brought by the attorney 

23 general of a State any amount of monetary re24 lief which duplicates amounts which have been 

25 awarded for the same injury. 
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1 ‘‘(7) EFFECT ON ANTITRUST LAWS.—Nothing 

2 in this subsection shall be construed to modify, im3 pair, or supersede the operation of the antitrust 

4 laws. For the purpose of this subsection, the term 

5 ‘antitrust laws’ has the meaning given it in the first 

6 section of the Clayton Act, except that it includes 

7 section 5 of the Federal Trade Commission Act to 

8 the extent that such section 5 applies to unfair 

9 methods of competition. 

10 ‘‘(8) MANUFACTURER.—In this subsection, the 

11 term ‘manufacturer’ means any entity, including any 

12 affiliate or licensee of that entity, that is engaged 

13 in—

14 ‘‘(A) the production, preparation, propaga15 tion, compounding, conversion, or processing of 

16 a prescription drug, either directly or indirectly 

17 by extraction from substances of natural origin, 

18 or independently by means of chemical syn19 thesis, or by a combination of extraction and 

20 chemical synthesis; or 

21 ‘‘(B) the packaging, repackaging, labeling, 

22 relabeling, or distribution of a prescription 

23 drug.’’. 

24 (b) PROHIBITED ACTS.—The Federal Food, Drug, 

25 and Cosmetic Act is amended—
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1 (1) in section 301 (21 U.S.C. 331), by striking 

2 paragraph (aa) and inserting the following: 

3 ‘‘(aa)(1) The sale or trade by a pharmacist, or by 

4 a business organization of which the pharmacist is a part, 

5 of a qualifying drug that under section 804(a)(2)(A) was 

6 imported by the pharmacist, other than—

7 ‘‘(A) a sale at retail made pursuant to dis8 pensing the drug to a customer of the pharmacist or 

9 organization; or 

10 ‘‘(B) a sale or trade of the drug to a pharmacy 

11 or a wholesaler registered to import drugs under sec12 tion 804. 

13 ‘‘(2) The sale or trade by an individual of a qualifying 

14 drug that under section 804(a)(2)(B) was imported by the 

15 individual. 

16 ‘‘(3) The making of a materially false, fictitious, or 

17 fraudulent statement or representation, or a material 

18 omission, in a notice under clause (i) of section 

19 804(g)(2)(B) or in an application required under section 

20 804(g)(2)(F), or the failure to submit such a notice or 

21 application. 

22 ‘‘(4) The importation of a drug in violation of a reg23 istration condition or other requirement under section 

24 804, the falsification of any record required to be main25 tained, or provided to the Secretary, under such section, 
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1 or the violation of any registration condition or other re2 quirement under such section.’’; and 

3 (2) in section 303(a) (21 U.S.C. 333(a)), by 

4 striking paragraph (6) and inserting the following: 

5 ‘‘(6) Notwithstanding subsection (a), any person that 

6 knowingly violates section 301(i) (2) or (3) or section 

7 301(aa)(4) shall be imprisoned not more than 10 years, 

8 or fined in accordance with title 18, United States Code, 

9 or both.’’. 

10 (c) AMENDMENT OF CERTAIN PROVISIONS.—

11 (1) IN GENERAL.—Section 801 of the Federal 

12 Food, Drug, and Cosmetic Act (21 U.S.C. 381) is 

13 amended by striking subsection (g) and inserting the 

14 following: 

15 ‘‘(g) With respect to a prescription drug that is im16 ported or offered for import into the United States by an 

17 individual who is not in the business of such importation, 

18 that is not shipped by a registered exporter under section 

19 804, and that is refused admission under subsection (a), 

20 the Secretary shall notify the individual that—

21 ‘‘(1) the drug has been refused admission be22 cause the drug was not a lawful import under sec23 tion 804; 

24 ‘‘(2) the drug is not otherwise subject to a 

25 waiver of the requirements of subsection (a); 
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1 ‘‘(3) the individual may under section 804 law2 fully import certain prescription drugs from export3 ers registered with the Secretary under section 804; 

4 and 

5 ‘‘(4) the individual can find information about 

6 such importation, including a list of registered ex7 porters, on the Internet website of the Food and 

8 Drug Administration or through a toll-free telephone 

9 number required under section 804.’’. 

10 (2) ESTABLISHMENT REGISTRATION.—Section 

11 510(i) of the Federal Food, Drug, and Cosmetic Act 

12 (21 U.S.C. 360(i)) is amended in paragraph (1) by 

13 inserting after ‘‘import into the United States’’ the 

14 following: ‘‘, including a drug that is, or may be, im15 ported or offered for import into the United States 

16 under section 804,’’. 

17 (3) EFFECTIVE DATE.—The amendments made 

18 by this subsection shall take effect on the date that 

19 is 90 days after the date of enactment of this title. 

20 (d) EXHAUSTION.—

21 (1) IN GENERAL.—Section 271 of title 35, 

22 United States Code, is amended—

23 (A) by redesignating subsections (h) and 

24 (i) as (i) and (j), respectively; and 
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1 (B) by inserting after subsection (g) the 

2 following: 

3 ‘‘(h) It shall not be an act of infringement to use, 

4 offer to sell, or sell within the United States or to import 

5 into the United States any patented invention under sec6 tion 804 of the Federal Food, Drug, and Cosmetic Act 

7 that was first sold abroad by or under authority of the 

8 owner or licensee of such patent.’’. 

9 (2) RULE OF CONSTRUCTION.—Nothing in the 

10 amendment made by paragraph (1) shall be con11 strued to affect the ability of a patent owner or li12 censee to enforce their patent, subject to such 

13 amendment. 

14 (e) EFFECT OF SECTION 804.—

15 (1) IN GENERAL.—Section 804 of the Federal 

16 Food, Drug, and Cosmetic Act, as added by sub17 section (a), shall permit the importation of quali18 fying drugs (as defined in such section 804) into the 

19 United States without regard to the status of the 

20 issuance of implementing regulations—

21 (A) from exporters registered under such 

22 section 804 on the date that is 90 days after 

23 the date of enactment of this title; and 

24 (B) from permitted countries, as defined in 

25 such section 804, by importers registered under 
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1 such section 804 on the date that is 1 year 

2 after the date of enactment of this title. 

3 (2) REVIEW OF REGISTRATION BY CERTAIN EX4 PORTERS.—

5 (A) REVIEW PRIORITY.—In the review of 

6 registrations submitted under subsection (b) of 

7 such section 804, registrations submitted by en8 tities in Canada that are significant exporters 

9 of prescription drugs to individuals in the 

10 United States as of the date of enactment of 

11 this title will have priority during the 90 day 

12 period that begins on such date of enactment. 

13 (B) PERIOD FOR REVIEW.—During such 

14 90-day period, the reference in subsection 

15 (b)(2)(A) of such section 804 to 90 days (relat16 ing to approval or disapproval of registrations) 

17 is, as applied to such entities, deemed to be 30 

18 days. 

19 (C) LIMITATION.—That an exporter in 

20 Canada exports, or has exported, prescription 

21 drugs to individuals in the United States on or 

22 before the date that is 90 days after the date 

23 of enactment of this title shall not serve as a 

24 basis, in whole or in part, for disapproving a 
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1 registration under such section 804 from the 

2 exporter. 

3 (D) FIRST YEAR LIMIT ON NUMBER OF

4 EXPORTERS.—During the 1-year period begin5 ning on the date of enactment of this title, the 

6 Secretary of Health and Human Services (re7 ferred to in this section as the ‘‘Secretary’’) 

8 may limit the number of registered exporters 

9 under such section 804 to not less than 50, so 

10 long as the Secretary gives priority to those ex11 porters with demonstrated ability to process a 

12 high volume of shipments of drugs to individ13 uals in the United States. 

14 (E) SECOND YEAR LIMIT ON NUMBER OF

15 EXPORTERS.—During the 1-year period begin16 ning on the date that is 1 year after the date 

17 of enactment of this title, the Secretary may 

18 limit the number of registered exporters under 

19 such section 804 to not less than 100, so long 

20 as the Secretary gives priority to those export21 ers with demonstrated ability to process a high 

22 volume of shipments of drugs to individuals in 

23 the United States. 

24 (F) FURTHER LIMIT ON NUMBER OF EX25 PORTERS.—During any 1-year period beginning 
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1 on a date that is 2 or more years after the date 

2 of enactment of this title, the Secretary may 

3 limit the number of registered exporters under 

4 such section 804 to not less than 25 more than 

5 the number of such exporters during the pre6 vious 1-year period, so long as the Secretary 

7 gives priority to those exporters with dem8 onstrated ability to process a high volume of 

9 shipments of drugs to individuals in the United 

10 States. 

11 (3) LIMITS ON NUMBER OF IMPORTERS.—

12 (A) FIRST YEAR LIMIT ON NUMBER OF IM13 PORTERS.—During the 1-year period beginning 

14 on the date that is 1 year after the date of en15 actment of this title, the Secretary may limit 

16 the number of registered importers under such 

17 section 804 to not less than 100 (of which at 

18 least a significant number shall be groups of 

19 pharmacies, to the extent feasible given the ap20 plications submitted by such groups), so long as 

21 the Secretary gives priority to those importers 

22 with demonstrated ability to process a high vol23 ume of shipments of drugs imported into the 

24 United States. 
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1 (B) SECOND YEAR LIMIT ON NUMBER OF

2 IMPORTERS.—During the 1-year period begin3 ning on the date that is 2 years after the date 

4 of enactment of this title, the Secretary may 

5 limit the number of registered importers under 

6 such section 804 to not less than 200 (of which 

7 at least a significant number shall be groups of 

8 pharmacies, to the extent feasible given the ap9 plications submitted by such groups), so long as 

10 the Secretary gives priority to those importers 

11 with demonstrated ability to process a high vol12 ume of shipments of drugs into the United 

13 States. 

14 (C) FURTHER LIMIT ON NUMBER OF IM15 PORTERS.—During any 1-year period beginning 

16 on a date that is 3 or more years after the date 

17 of enactment of this title, the Secretary may 

18 limit the number of registered importers under 

19 such section 804 to not less than 50 more (of 

20 which at least a significant number shall be 

21 groups of pharmacies, to the extent feasible 

22 given the applications submitted by such 

23 groups) than the number of such importers 

24 during the previous 1-year period, so long as 

25 the Secretary gives priority to those importers 
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1 with demonstrated ability to process a high vol2 ume of shipments of drugs to the United 

3 States. 

4 (4) NOTICES FOR DRUGS FOR IMPORT FROM

5 CANADA.—The notice with respect to a qualifying 

6 drug introduced for commercial distribution in Can7 ada as of the date of enactment of this title that is 

8 required under subsection (g)(2)(B)(i) of such sec9 tion 804 shall be submitted to the Secretary not 

10 later than 30 days after the date of enactment of 

11 this title if—

12 (A) the U.S. label drug (as defined in such 

13 section 804) for the qualifying drug is 1 of the 

14 100 prescription drugs with the highest dollar 

15 volume of sales in the United States based on 

16 the 12 calendar month period most recently 

17 completed before the date of enactment of this 

18 Act; or 

19 (B) the notice is a notice under subsection 

20 (g)(2)(B)(i)(II) of such section 804. 

21 (5) NOTICE FOR DRUGS FOR IMPORT FROM

22 OTHER COUNTRIES.—The notice with respect to a 

23 qualifying drug introduced for commercial distribu24 tion in a permitted country other than Canada as of 

25 the date of enactment of this title that is required 
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1 under subsection (g)(2)(B)(i) of such section 804 

2 shall be submitted to the Secretary not later than 

3 180 days after the date of enactment of this title 

4 if—

5 (A) the U.S. label drug for the qualifying 

6 drug is 1 of the 100 prescription drugs with the 

7 highest dollar volume of sales in the United 

8 States based on the 12 calendar month period 

9 that is first completed on the date that is 120 

10 days after the date of enactment of this title; or 

11 (B) the notice is a notice under subsection 

12 (g)(2)(B)(i)(II) of such section 804. 

13 (6) NOTICE FOR OTHER DRUGS FOR IMPORT.—

14 (A) GUIDANCE ON SUBMISSION DATES.—

15 The Secretary shall by guidance establish a se16 ries of submission dates for the notices under 

17 subsection (g)(2)(B)(i) of such section 804 with 

18 respect to qualifying drugs introduced for com19 mercial distribution as of the date of enactment 

20 of this title and that are not required to be sub21 mitted under paragraph (4) or (5). 

22 (B) CONSISTENT AND EFFICIENT USE OF

23 RESOURCES.—The Secretary shall establish the 

24 dates described under subparagraph (A) so that 

25 such notices described under subparagraph (A) 
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1 are submitted and reviewed at a rate that al2 lows consistent and efficient use of the re3 sources and staff available to the Secretary for 

4 such reviews. The Secretary may condition the 

5 requirement to submit such a notice, and the 

6 review of such a notice, on the submission by a 

7 registered exporter or a registered importer to 

8 the Secretary of a notice that such exporter or 

9 importer intends to import such qualifying drug 

10 to the United States under such section 804. 

11 (C) PRIORITY FOR DRUGS WITH HIGHER

12 SALES.—The Secretary shall establish the dates 

13 described under subparagraph (A) so that the 

14 Secretary reviews the notices described under 

15 such subparagraph with respect to qualifying 

16 drugs with higher dollar volume of sales in the 

17 United States before the notices with respect to 

18 drugs with lower sales in the United States. 

19 (7) NOTICES FOR DRUGS APPROVED AFTER EF20 FECTIVE DATE.—The notice required under sub21 section (g)(2)(B)(i) of such section 804 for a quali22 fying drug first introduced for commercial distribu23 tion in a permitted country (as defined in such sec24 tion 804) after the date of enactment of this title 

25 shall be submitted to and reviewed by the Secretary 
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1 as provided under subsection (g)(2)(B) of such sec2 tion 804, without regard to paragraph (4), (5), or 

3 (6). 

4 (8) REPORT.—Beginning with the first full fis5 cal year after the date of enactment of this title, not 

6 later than 90 days after the end of each fiscal year 

7 during which the Secretary reviews a notice referred 

8 to in paragraph (4), (5), or (6), the Secretary shall 

9 submit a report to Congress concerning the progress 

10 of the Food and Drug Administration in reviewing 

11 the notices referred to in paragraphs (4), (5), and 

12 (6). 

13 (9) USER FEES.—

14 (A) EXPORTERS.—When establishing an 

15 aggregate total of fees to be collected from ex16 porters under subsection (f)(2) of such section 

17 804, the Secretary shall, under subsection 

18 (f)(3)(C)(i) of such section 804, estimate the 

19 total price of drugs imported under subsection 

20 (a) of such section 804 into the United States 

21 by registered exporters during the first fiscal 

22 year in which this title takes effect to be an 

23 amount equal to the amount which bears the 

24 same ratio to $1,000,000,000 as the number of 
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1 days in such fiscal year during which this title 

2 is effective bears to 365. 

3 (B) IMPORTERS.—When establishing an 

4 aggregate total of fees to be collected from im5 porters under subsection (e)(2) of such section 

6 804, the Secretary shall, under subsection 

7 (e)(3)(C)(i) of such section 804, estimate the 

8 total price of drugs imported under subsection 

9 (a) of such section 804 into the United States 

10 by registered importers during—

11 (i) the first fiscal year in which this 

12 title takes effect to be an amount equal to 

13 the amount which bears the same ratio to 

14 $1,000,000,000 as the number of days in 

15 such fiscal year during which this title is 

16 effective bears to 365; and 

17 (ii) the second fiscal year in which 

18 this title is in effect to be $3,000,000,000. 

19 (C) SECOND YEAR ADJUSTMENT.—

20 (i) REPORTS.—Not later than Feb21 ruary 20 of the second fiscal year in which 

22 this title is in effect, registered importers 

23 shall report to the Secretary the total price 

24 and the total volume of drugs imported to 

25 the United States by the importer during 
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1 the 4-month period from October 1 

2 through January 31 of such fiscal year. 

3 (ii) REESTIMATE.—Notwithstanding 

4 subsection (e)(3)(C)(ii) of such section 804 

5 or subparagraph (B), the Secretary shall 

6 reestimate the total price of qualifying 

7 drugs imported under subsection (a) of 

8 such section 804 into the United States by 

9 registered importers during the second fis10 cal year in which this title is in effect. 

11 Such reestimate shall be equal to—

12 (I) the total price of qualifying 

13 drugs imported by each importer as 

14 reported under clause (i); multiplied 

15 by 

16 (II) 3. 

17 (iii) ADJUSTMENT.—The Secretary 

18 shall adjust the fee due on April 1 of the 

19 second fiscal year in which this title is in 

20 effect, from each importer so that the ag21 gregate total of fees collected under sub22 section (e)(2) for such fiscal year does not 

23 exceed the total price of qualifying drugs 

24 imported under subsection (a) of such sec25 tion 804 into the United States by reg-
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1 istered importers during such fiscal year as 

2 reestimated under clause (ii). 

3 (D) FAILURE TO PAY FEES.—Notwith4 standing any other provision of this section, the 

5 Secretary may prohibit a registered importer or 

6 exporter that is required to pay user fees under 

7 subsection (e) or (f) of such section 804 and 

8 that fails to pay such fees within 30 days after 

9 the date on which it is due, from importing or 

10 offering for importation a qualifying drug under 

11 such section 804 until such fee is paid. 

12 (E) ANNUAL REPORT.—

13 (i) FOOD AND DRUG ADMINISTRA14 TION.—Not later than 180 days after the 

15 end of each fiscal year during which fees 

16 are collected under subsection (e), (f), or 

17 (g)(2)(B)(iv) of such section 804, the Sec18 retary shall prepare and submit to the 

19 House of Representatives and the Senate a 

20 report on the implementation of the au21 thority for such fees during such fiscal 

22 year and the use, by the Food and Drug 

23 Administration, of the fees collected for the 

24 fiscal year for which the report is made 
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1 and credited to the Food and Drug Admin2 istration. 

3 (ii) CUSTOMS AND BORDER CON4 TROL.—Not later than 180 days after the 

5 end of each fiscal year during which fees 

6 are collected under subsection (e) or (f) of 

7 such section 804, the Secretary of Home8 land Security, in consultation with the Sec9 retary of the Treasury, shall prepare and 

10 submit to the House of Representatives 

11 and the Senate a report on the use, by the 

12 Bureau of Customs and Border Protection, 

13 of the fees, if any, transferred by the Sec14 retary to the Bureau of Customs and Bor15 der Protection for the fiscal year for which 

16 the report is made. 

17 (10) SPECIAL RULE REGARDING IMPORTATION

18 BY INDIVIDUALS.—

19 (A) IN GENERAL.—Notwithstanding any 

20 provision of this title (or an amendment made 

21 by this title), the Secretary shall expedite the 

22 designation of any additional countries from 

23 which an individual may import a qualifying 

24 drug into the United States under such section 

25 804 if any action implemented by the Govern-
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1 ment of Canada has the effect of limiting or 

2 prohibiting the importation of qualifying drugs 

3 into the United States from Canada. 

4 (B) TIMING AND CRITERIA.—The Sec5 retary shall designate such additional countries 

6 under subparagraph (A)—

7 (i) not later than 6 months after the 

8 date of the action by the Government of 

9 Canada described under such subpara10 graph; and 

11 (ii) using the criteria described under 

12 subsection (a)(4)(D)(i)(II) of such section 

13 804. 

14 (f) IMPLEMENTATION OF SECTION 804.—

15 (1) INTERIM RULE.—The Secretary may pro16 mulgate an interim rule for implementing section 

17 804 of the Federal Food, Drug, and Cosmetic Act, 

18 as added by subsection (a) of this section. 

19 (2) NO NOTICE OF PROPOSED RULEMAKING.—

20 The interim rule described under paragraph (1) may 

21 be developed and promulgated by the Secretary with22 out providing general notice of proposed rulemaking. 

23 (3) FINAL RULE.—Not later than 1 year after 

24 the date on which the Secretary promulgates an in25 terim rule under paragraph (1), the Secretary shall, 
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1 in accordance with procedures under section 553 of 

2 title 5, United States Code, promulgate a final rule 

3 for implementing such section 804, which may incor4 porate by reference provisions of the interim rule 

5 provided for under paragraph (1), to the extent that 

6 such provisions are not modified. 

7 (g) CONSUMER EDUCATION.—The Secretary shall 

8 carry out activities that educate consumers—

9 (1) with regard to the availability of qualifying 

10 drugs for import for personal use from an exporter 

11 registered with and approved by the Food and Drug 

12 Administration under section 804 of the Federal 

13 Food, Drug, and Cosmetic Act, as added by this sec14 tion, including information on how to verify whether 

15 an exporter is registered and approved by use of the 

16 Internet website of the Food and Drug Administra17 tion and the toll-free telephone number required by 

18 this title; 

19 (2) that drugs that consumers attempt to im20 port from an exporter that is not registered with and 

21 approved by the Food and Drug Administration can 

22 be seized by the United States Customs Service and 

23 destroyed, and that such drugs may be counterfeit, 

24 unapproved, unsafe, or ineffective; 
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1 (3) with regard to the suspension and termi2 nation of any registration of a registered importer or 

3 exporter under such section 804; and 

4 (4) with regard to the availability at domestic 

5 retail pharmacies of qualifying drugs imported under 

6 such section 804 by domestic wholesalers and phar7 macies registered with and approved by the Food 

8 and Drug Administration. 

9 (h) EFFECT ON ADMINISTRATION PRACTICES.—Not10 withstanding any provision of this title (and the amend11 ments made by this title), the practices and policies of the 

12 Food and Drug Administration and Bureau of Customs 

13 and Border Protection, in effect on January 1, 2004, with 

14 respect to the importation of prescription drugs into the 

15 United States by an individual, on the person of such indi16 vidual, for personal use, shall remain in effect. 

17 (i) REPORT TO CONGRESS.—The Federal Trade 

18 Commission shall, on an annual basis, submit to Congress 

19 a report that describes any action taken during the period 

20 for which the report is being prepared to enforce the provi21 sions of section 804(n) of the Federal Food, Drug, and 

22 Cosmetic Act (as added by this title), including any pend23 ing investigations or civil actions under such section. 
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1 SEC. 805. DISPOSITION OF CERTAIN DRUGS DENIED ADMIS2 SION INTO UNITED STATES. 

3 (a) IN GENERAL.—Chapter VIII of the Federal 

4 Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.), 

5 as amended by section 804, is further amended by adding 

6 at the end the following section: 

7 ‘‘SEC. 805. DISPOSITION OF CERTAIN DRUGS DENIED AD8 MISSION. 

9 ‘‘(a) IN GENERAL.—The Secretary of Homeland Se10 curity shall deliver to the Secretary a shipment of drugs 

11 that is imported or offered for import into the United 

12 States if—

13 ‘‘(1) the shipment has a declared value of less 

14 than $10,000; and 

15 ‘‘(2)(A) the shipping container for such drugs 

16 does not bear the markings required under section 

17 804(d)(2); or 

18 ‘‘(B) the Secretary has requested delivery of 

19 such shipment of drugs. 

20 ‘‘(b) NO BOND OR EXPORT.—Section 801(b) does 

21 not authorize the delivery to the owner or consignee of 

22 drugs delivered to the Secretary under subsection (a) pur23 suant to the execution of a bond, and such drugs may not 

24 be exported. 

25 ‘‘(c) DESTRUCTION OF VIOLATIVE SHIPMENT.—The 

26 Secretary shall destroy a shipment of drugs delivered by 
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1 the Secretary of Homeland Security to the Secretary 

2 under subsection (a) if—

3 ‘‘(1) in the case of drugs that are imported or 

4 offered for import from a registered exporter under 

5 section 804, the drugs are in violation of any stand6 ard described in section 804(g)(5); or 

7 ‘‘(2) in the case of drugs that are not imported 

8 or offered for import from a registered exporter 

9 under section 804, the drugs are in violation of a 

10 standard referred to in section 801(a) or 801(d)(1). 

11 ‘‘(d) CERTAIN PROCEDURES.—

12 ‘‘(1) IN GENERAL.—The delivery and destruc13 tion of drugs under this section may be carried out 

14 without notice to the importer, owner, or consignee 

15 of the drugs except as required by section 801(g) or 

16 section 804(i)(2). The issuance of receipts for the 

17 drugs, and recordkeeping activities regarding the 

18 drugs, may be carried out on a summary basis. 

19 ‘‘(2) OBJECTIVE OF PROCEDURES.—Procedures 

20 promulgated under paragraph (1) shall be designed 

21 toward the objective of ensuring that, with respect to 

22 efficiently utilizing Federal resources available for 

23 carrying out this section, a substantial majority of 

24 shipments of drugs subject to described in sub25 section (c) are identified and destroyed. 
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1 ‘‘(e) EVIDENCE EXCEPTION.—Drugs may not be de2 stroyed under subsection (c) to the extent that the Attor3 ney General of the United States determines that the 

4 drugs should be preserved as evidence or potential evi5 dence with respect to an offense against the United States. 

6 ‘‘(f) RULE OF CONSTRUCTION.—This section may 

7 not be construed as having any legal effect on applicable 

8 law with respect to a shipment of drugs that is imported 

9 or offered for import into the United States and has a 

10 declared value equal to or greater than $10,000.’’. 

11 (b) PROCEDURES.—Procedures for carrying out sec12 tion 805 of the Federal Food, Drug, and Cosmetic Act, 

13 as added by subsection (a), shall be established not later 

14 than 90 days after the date of the enactment of this title. 

15 (c) EFFECTIVE DATE.—The amendments made by 

16 this section shall take effect on the date that is 90 days 

17 after the date of enactment of this title. 

18 SEC. 806. WHOLESALE DISTRIBUTION OF DRUGS; STATE19 MENTS REGARDING PRIOR SALE, PURCHASE, 

20 OR TRADE. 

21 (a) STRIKING OF EXEMPTIONS; APPLICABILITY TO

22 REGISTERED EXPORTERS.—Section 503(e) of the Federal 

23 Food, Drug, and Cosmetic Act (21 U.S.C. 353(e)) is 

24 amended—

25 (1) in paragraph (1)—
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1 (A) by striking ‘‘and who is not the manu2 facturer or an authorized distributor of record 

3 of such drug’’; 

4 (B) by striking ‘‘to an authorized dis5 tributor of record or’’; and 

6 (C) by striking subparagraph (B) and in7 serting the following: 

8 ‘‘(B) The fact that a drug subject to subsection (b) 

9 is exported from the United States does not with respect 

10 to such drug exempt any person that is engaged in the 

11 business of the wholesale distribution of the drug from 

12 providing the statement described in subparagraph (A) to 

13 the person that receives the drug pursuant to the export 

14 of the drug. 

15 ‘‘(C)(i) The Secretary shall by regulation establish re16 quirements that supersede subparagraph (A) (referred to 

17 in this subparagraph as ‘alternative requirements’) to 

18 identify the chain of custody of a drug subject to sub19 section (b) from the manufacturer of the drug throughout 

20 the wholesale distribution of the drug to a pharmacist who 

21 intends to sell the drug at retail if the Secretary deter22 mines that the alternative requirements, which may in23 clude standardized anti-counterfeiting or track-and-trace 

24 technologies, will identify such chain of custody or the 

25 identity of the discrete package of the drug from which 
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1 the drug is dispensed with equal or greater certainty to 

2 the requirements of subparagraph (A), and that the alter3 native requirements are economically and technically fea4 sible. 

5 ‘‘(ii) When the Secretary promulgates a final rule to 

6 establish such alternative requirements, the final rule in 

7 addition shall, with respect to the registration condition 

8 established in clause (i) of section 804(c)(3)(B), establish 

9 a condition equivalent to the alternative requirements, and 

10 such equivalent condition may be met in lieu of the reg11 istration condition established in such clause (i).’’; 

12 (2) in paragraph (2)(A), by adding at the end 

13 the following: ‘‘The preceding sentence may not be 

14 construed as having any applicability with respect to 

15 a registered exporter under section 804.’’; and 

16 (3) in paragraph (3), by striking ‘‘and sub17 section (d)—’’ in the matter preceding subparagraph 

18 (A) and all that follows through ‘‘the term ‘whole19 sale distribution’ means’’ in subparagraph (B) and 

20 inserting the following: ‘‘and subsection (d), the 

21 term ‘wholesale distribution’ means’’. 

22 (b) CONFORMING AMENDMENT.—Section 503(d) of 

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

24 353(d)) is amended by adding at the end the following: 
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1 ‘‘(4) Each manufacturer of a drug subject to sub2 section (b) shall maintain at its corporate offices a current 

3 list of the authorized distributors of record of such drug. 

4 ‘‘(5) For purposes of this subsection, the term ‘au5 thorized distributors of record’ means those distributors 

6 with whom a manufacturer has established an ongoing re7 lationship to distribute such manufacturer’s products.’’. 

8 (c) EFFECTIVE DATE.—

9 (1) IN GENERAL.—The amendments made by 

10 paragraphs (1) and (3) of subsection (a) and by sub11 section (b) shall take effect on January 1, 2010. 

12 (2) DRUGS IMPORTED BY REGISTERED IMPORT13 ERS UNDER SECTION 804.—Notwithstanding para14 graph (1), the amendments made by paragraphs (1) 

15 and (3) of subsection (a) and by subsection (b) shall 

16 take effect on the date that is 90 days after the date 

17 of enactment of this title with respect to qualifying 

18 drugs imported under section 804 of the Federal 

19 Food, Drug, and Cosmetic Act, as added by section 

20 804. 

21 (3) EFFECT WITH RESPECT TO REGISTERED

22 EXPORTERS.—The amendment made by subsection 

23 (a)(2) shall take effect on the date that is 90 days 

24 after the date of enactment of this title. 
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1 (4) ALTERNATIVE REQUIREMENTS.—The Sec2 retary shall issue regulations to establish the alter3 native requirements, referred to in the amendment 

4 made by subsection (a)(1), that take effect not later 

5 than January 1, 2010. 

6 (5) INTERMEDIATE REQUIREMENTS.—The Sec7 retary shall by regulation require the use of stand8 ardized anti-counterfeiting or track-and-trace tech9 nologies on prescription drugs at the case and pallet 

10 level effective not later than 1 year after the date of 

11 enactment of this title. 

12 (6) ADDITIONAL REQUIREMENTS.—

13 (A) IN GENERAL.—Notwithstanding any 

14 other provision of this section, the Secretary 

15 shall, not later than 18 months after the date 

16 of enactment of this title, require that the pack17 aging of any prescription drug incorporates—

18 (i) a standardized numerical identifier 

19 unique to each package of such drug, ap20 plied at the point of manufacturing and re21 packaging (in which case the numerical 

22 identifier shall be linked to the numerical 

23 identifier applied at the point of manufac24 turing); and 
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1 (ii)(I) overt optically variable counter2 feit-resistant technologies that—

3 (aa) are visible to the naked eye, 

4 providing for visual identification of 

5 product authenticity without the need 

6 for readers, microscopes, lighting de7 vices, or scanners; 

8 (bb) are similar to that used by 

9 the Bureau of Engraving and Printing 

10 to secure United States currency; 

11 (cc) are manufactured and dis12 tributed in a highly secure, tightly 

13 controlled environment; and 

14 (dd) incorporate additional layers 

15 of nonvisible convert security features 

16 up to and including forensic capa17 bility, as described in subparagraph 

18 (B); or 

19 (II) technologies that have a function 

20 of security comparable to that described in 

21 subclause (I), as determined by the Sec22 retary. 

23 (B) STANDARDS FOR PACKAGING.—For 

24 the purpose of making it more difficult to coun25 terfeit the packaging of drugs subject to this 
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1 paragraph, the manufacturers of such drugs 

2 shall incorporate the technologies described in 

3 subparagraph (A) into at least 1 additional ele4 ment of the physical packaging of the drugs, in5 cluding blister packs, shrink wrap, package la6 bels, package seals, bottles, and boxes. 

7 SEC. 807. INTERNET SALES OF PRESCRIPTION DRUGS. 

8 (a) IN GENERAL.—Chapter V of the Federal Food, 

9 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend10 ed by inserting after section 503A the following: 

11 ‘‘SEC. 503B. INTERNET SALES OF PRESCRIPTION DRUGS. 

12 ‘‘(a) REQUIREMENTS REGARDING INFORMATION ON

13 INTERNET SITE.—

14 ‘‘(1) IN GENERAL.—A person may not dispense 

15 a prescription drug pursuant to a sale of the drug 

16 by such person if—

17 ‘‘(A) the purchaser of the drug submitted 

18 the purchase order for the drug, or conducted 

19 any other part of the sales transaction for the 

20 drug, through an Internet site; 

21 ‘‘(B) the person dispenses the drug to the 

22 purchaser by mailing or shipping the drug to 

23 the purchaser; and 

24 ‘‘(C) such site, or any other Internet site 

25 used by such person for purposes of sales of a 
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1 prescription drug, fails to meet each of the re2 quirements specified in paragraph (2), other 

3 than a site or pages on a site that—

4 ‘‘(i) are not intended to be accessed 

5 by purchasers or prospective purchasers; or 

6 ‘‘(ii) provide an Internet information 

7 location tool within the meaning of section 

8 231(e)(5) of the Communications Act of 

9 1934 (47 U.S.C. 231(e)(5)). 

10 ‘‘(2) REQUIREMENTS.—With respect to an 

11 Internet site, the requirements referred to in sub12 paragraph (C) of paragraph (1) for a person to 

13 whom such paragraph applies are as follows: 

14 ‘‘(A) Each page of the site shall include ei15 ther the following information or a link to a 

16 page that provides the following information: 

17 ‘‘(i) The name of such person. 

18 ‘‘(ii) Each State in which the person 

19 is authorized by law to dispense prescrip20 tion drugs. 

21 ‘‘(iii) The address and telephone num22 ber of each place of business of the person 

23 with respect to sales of prescription drugs 

24 through the Internet, other than a place of 
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1 business that does not mail or ship pre2 scription drugs to purchasers. 

3 ‘‘(iv) The name of each individual who 

4 serves as a pharmacist for prescription 

5 drugs that are mailed or shipped pursuant 

6 to the site, and each State in which the in7 dividual is authorized by law to dispense 

8 prescription drugs. 

9 ‘‘(v) If the person provides for medical 

10 consultations through the site for purposes 

11 of providing prescriptions, the name of 

12 each individual who provides such con13 sultations; each State in which the indi14 vidual is licensed or otherwise authorized 

15 by law to provide such consultations or 

16 practice medicine; and the type or types of 

17 health professions for which the individual 

18 holds such licenses or other authorizations. 

19 ‘‘(B) A link to which paragraph (1) applies 

20 shall be displayed in a clear and prominent 

21 place and manner, and shall include in the cap22 tion for the link the words ‘licensing and con23 tact information’. 

24 ‘‘(b) INTERNET SALES WITHOUT APPROPRIATE

25 MEDICAL RELATIONSHIPS.—
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1 ‘‘(1) IN GENERAL.—Except as provided in para2 graph (2), a person may not dispense a prescription 

3 drug, or sell such a drug, if—

4 ‘‘(A) for purposes of such dispensing or 

5 sale, the purchaser communicated with the per6 son through the Internet; 

7 ‘‘(B) the patient for whom the drug was 

8 dispensed or purchased did not, when such 

9 communications began, have a prescription for 

10 the drug that is valid in the United States; 

11 ‘‘(C) pursuant to such communications, the 

12 person provided for the involvement of a practi13 tioner, or an individual represented by the per14 son as a practitioner, and the practitioner or 

15 such individual issued a prescription for the 

16 drug that was purchased; 

17 ‘‘(D) the person knew, or had reason to 

18 know, that the practitioner or the individual re19 ferred to in subparagraph (C) did not, when 

20 issuing the prescription, have a qualifying med21 ical relationship with the patient; and 

22 ‘‘(E) the person received payment for the 

23 dispensing or sale of the drug. 
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1 For purposes of subparagraph (E), payment is re2 ceived if money or other valuable consideration is re3 ceived. 

4 ‘‘(2) EXCEPTIONS.—Paragraph (1) does not 

5 apply to—

6 ‘‘(A) the dispensing or selling of a pre7 scription drug pursuant to telemedicine prac8 tices sponsored by—

9 ‘‘(i) a hospital that has in effect a 

10 provider agreement under title XVIII of 

11 the Social Security Act (relating to the 

12 Medicare program); or 

13 ‘‘(ii) a group practice that has not 

14 fewer than 100 physicians who have in ef15 fect provider agreements under such title; 

16 or 

17 ‘‘(B) the dispensing or selling of a pre18 scription drug pursuant to practices that pro19 mote the public health, as determined by the 

20 Secretary by regulation. 

21 ‘‘(3) QUALIFYING MEDICAL RELATIONSHIP.—

22 ‘‘(A) IN GENERAL.—With respect to 

23 issuing a prescription for a drug for a patient, 

24 a practitioner has a qualifying medical relation-
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1 ship with the patient for purposes of this sec2 tion if—

3 ‘‘(i) at least one in-person medical 

4 evaluation of the patient has been con5 ducted by the practitioner; or 

6 ‘‘(ii) the practitioner conducts a med7 ical evaluation of the patient as a covering 

8 practitioner. 

9 ‘‘(B) IN-PERSON MEDICAL EVALUATION.—

10 A medical evaluation by a practitioner is an in11 person medical evaluation for purposes of this 

12 section if the practitioner is in the physical 

13 presence of the patient as part of conducting 

14 the evaluation, without regard to whether por15 tions of the evaluation are conducted by other 

16 health professionals. 

17 ‘‘(C) COVERING PRACTITIONER.—With re18 spect to a patient, a practitioner is a covering 

19 practitioner for purposes of this section if the 

20 practitioner conducts a medical evaluation of 

21 the patient at the request of a practitioner who 

22 has conducted at least one in-person medical 

23 evaluation of the patient and is temporarily un24 available to conduct the evaluation of the pa25 tient. A practitioner is a covering practitioner 
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1 without regard to whether the practitioner has 

2 conducted any in-person medical evaluation of 

3 the patient involved. 

4 ‘‘(4) RULES OF CONSTRUCTION.—

5 ‘‘(A) INDIVIDUALS REPRESENTED AS

6 PRACTITIONERS.—A person who is not a practi7 tioner (as defined in subsection (e)(1)) lacks 

8 legal capacity under this section to have a 

9 qualifying medical relationship with any patient. 

10 ‘‘(B) STANDARD PRACTICE OF PHAR11 MACY.—Paragraph (1) may not be construed as 

12 prohibiting any conduct that is a standard prac13 tice in the practice of pharmacy. 

14 ‘‘(C) APPLICABILITY OF REQUIRE15 MENTS.—Paragraph (3) may not be construed 

16 as having any applicability beyond this section, 

17 and does not affect any State law, or interpre18 tation of State law, concerning the practice of 

19 medicine. 

20 ‘‘(c) ACTIONS BY STATES.—

21 ‘‘(1) IN GENERAL.—Whenever an attorney gen22 eral of any State has reason to believe that the in23 terests of the residents of that State have been or 

24 are being threatened or adversely affected because 

25 any person has engaged or is engaging in a pattern 
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1 or practice that violates section 301(l), the State 

2 may bring a civil action on behalf of its residents in 

3 an appropriate district court of the United States to 

4 enjoin such practice, to enforce compliance with such 

5 section (including a nationwide injunction), to obtain 

6 damages, restitution, or other compensation on be7 half of residents of such State, to obtain reasonable 

8 attorneys fees and costs if the State prevails in the 

9 civil action, or to obtain such further and other relief 

10 as the court may deem appropriate. 

11 ‘‘(2) NOTICE.—The State shall serve prior writ12 ten notice of any civil action under paragraph (1) or 

13 (5)(B) upon the Secretary and provide the Secretary 

14 with a copy of its complaint, except that if it is not 

15 feasible for the State to provide such prior notice, 

16 the State shall serve such notice immediately upon 

17 instituting such action. Upon receiving a notice re18 specting a civil action, the Secretary shall have the 

19 right—

20 ‘‘(A) to intervene in such action; 

21 ‘‘(B) upon so intervening, to be heard on 

22 all matters arising therein; and 

23 ‘‘(C) to file petitions for appeal. 

24 ‘‘(3) CONSTRUCTION.—For purposes of bring25 ing any civil action under paragraph (1), nothing in 
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1 this chapter shall prevent an attorney general of a 

2 State from exercising the powers conferred on the 

3 attorney general by the laws of such State to con4 duct investigations or to administer oaths or affir5 mations or to compel the attendance of witnesses or 

6 the production of documentary and other evidence. 

7 ‘‘(4) VENUE; SERVICE OF PROCESS.—Any civil 

8 action brought under paragraph (1) in a district 

9 court of the United States may be brought in the 

10 district in which the defendant is found, is an inhab11 itant, or transacts business or wherever venue is 

12 proper under section 1391 of title 28, United States 

13 Code. Process in such an action may be served in 

14 any district in which the defendant is an inhabitant 

15 or in which the defendant may be found. 

16 ‘‘(5) ACTIONS BY OTHER STATE OFFICIALS.—

17 ‘‘(A) Nothing contained in this section 

18 shall prohibit an authorized State official from 

19 proceeding in State court on the basis of an al20 leged violation of any civil or criminal statute of 

21 such State. 

22 ‘‘(B) In addition to actions brought by an 

23 attorney general of a State under paragraph 

24 (1), such an action may be brought by officers 

25 of such State who are authorized by the State 
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1 to bring actions in such State on behalf of its 

2 residents. 

3 ‘‘(d) EFFECT OF SECTION.—This section shall not 

4 apply to a person that is a registered exporter under sec5 tion 804. 

6 ‘‘(e) GENERAL DEFINITIONS.—For purposes of this 

7 section: 

8 ‘‘(1) The term ‘practitioner’ means a practi9 tioner referred to in section 503(b)(1) with respect 

10 to issuing a written or oral prescription. 

11 ‘‘(2) The term ‘prescription drug’ means a drug 

12 that is described in section 503(b)(1). 

13 ‘‘(3) The term ‘qualifying medical relationship’, 

14 with respect to a practitioner and a patient, has the 

15 meaning indicated for such term in subsection (b). 

16 ‘‘(f) INTERNET-RELATED DEFINITIONS.—

17 ‘‘(1) IN GENERAL.—For purposes of this sec18 tion: 

19 ‘‘(A) The term ‘Internet’ means collectively 

20 the myriad of computer and telecommunications 

21 facilities, including equipment and operating 

22 software, which comprise the interconnected 

23 world-wide network of networks that employ the 

24 transmission control protocol/internet protocol, 

25 or any predecessor or successor protocols to 
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1 such protocol, to communicate information of 

2 all kinds by wire or radio. 

3 ‘‘(B) The term ‘link’, with respect to the 

4 Internet, means one or more letters, words, 

5 numbers, symbols, or graphic items that appear 

6 on a page of an Internet site for the purpose 

7 of serving, when activated, as a method for exe8 cuting an electronic command—

9 ‘‘(i) to move from viewing one portion 

10 of a page on such site to another portion 

11 of the page; 

12 ‘‘(ii) to move from viewing one page 

13 on such site to another page on such site; 

14 or 

15 ‘‘(iii) to move from viewing a page on 

16 one Internet site to a page on another 

17 Internet site. 

18 ‘‘(C) The term ‘page’, with respect to the 

19 Internet, means a document or other file 

20 accessed at an Internet site. 

21 ‘‘(D)(i) The terms ‘site’ and ‘address’, with 

22 respect to the Internet, mean a specific location 

23 on the Internet that is determined by Internet 

24 Protocol numbers. Such term includes the do25 main name, if any. 
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1 ‘‘(ii) The term ‘domain name’ means a 

2 method of representing an Internet address 

3 without direct reference to the Internet Protocol 

4 numbers for the address, including methods 

5 that use designations such as ‘.com’, ‘.edu’, 

6 ‘.gov’, ‘.net’, or ‘.org’. 

7 ‘‘(iii) The term ‘Internet Protocol num8 bers’ includes any successor protocol for deter9 mining a specific location on the Internet. 

10 ‘‘(2) AUTHORITY OF SECRETARY.—The Sec11 retary may by regulation modify any definition 

12 under paragraph (1) to take into account changes in 

13 technology. 

14 ‘‘(g) INTERACTIVE COMPUTER SERVICE; ADVER15 TISING.—No provider of an interactive computer service, 

16 as defined in section 230(f)(2) of the Communications Act 

17 of 1934 (47 U.S.C. 230(f)(2)), or of advertising services 

18 shall be liable under this section for dispensing or selling 

19 prescription drugs in violation of this section on account 

20 of another person’s selling or dispensing such drugs, pro21 vided that the provider of the interactive computer service 

22 or of advertising services does not own or exercise cor23 porate control over such person.’’. 

24 (b) INCLUSION AS PROHIBITED ACT.—Section 301 of 

25 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
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1 331) is amended by inserting after paragraph (k) the fol2 lowing: 

3 ‘‘(l) The dispensing or selling of a prescription drug 

4 in violation of section 503B.’’. 

5 (c) INTERNET SALES OF PRESCRIPTION DRUGS; 

6 CONSIDERATION BY SECRETARY OF PRACTICES AND PRO7 CEDURES FOR CERTIFICATION OF LEGITIMATE BUSI8 NESSES.—In carrying out section 503B of the Federal 

9 Food, Drug, and Cosmetic Act (as added by subsection 

10 (a) of this section), the Secretary of Health and Human 

11 Services shall take into consideration the practices and 

12 procedures of public or private entities that certify that 

13 businesses selling prescription drugs through Internet 

14 sites are legitimate businesses, including practices and 

15 procedures regarding disclosure formats and verification 

16 programs. 

17 (d) REPORTS REGARDING INTERNET-RELATED VIO18 LATIONS OF FEDERAL AND STATE LAWS ON DISPENSING

19 OF DRUGS.—

20 (1) IN GENERAL.—The Secretary of Health and 

21 Human Services (referred to in this subsection as 

22 the ‘‘Secretary’’) shall, pursuant to the submission 

23 of an application meeting the criteria of the Sec24 retary, make an award of a grant or contract to the 

25 National Clearinghouse on Internet Prescribing (op-
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1 erated by the Federation of State Medical Boards) 

2 for the purpose of—

3 (A) identifying Internet sites that appear 

4 to be in violation of Federal or State laws con5 cerning the dispensing of drugs; 

6 (B) reporting such sites to State medical 

7 licensing boards and State pharmacy licensing 

8 boards, and to the Attorney General and the 

9 Secretary, for further investigation; and 

10 (C) submitting, for each fiscal year for 

11 which the award under this subsection is made, 

12 a report to the Secretary describing investiga13 tions undertaken with respect to violations de14 scribed in subparagraph (A). 

15 (2) AUTHORIZATION OF APPROPRIATIONS.—For 

16 the purpose of carrying out paragraph (1), there is 

17 authorized to be appropriated $100,000 for each of 

18 the first 3 fiscal years in which this section is in ef19 fect. 

20 (e) EFFECTIVE DATE.—The amendments made by 

21 subsections (a) and (b) take effect 90 days after the date 

22 of enactment of this title, without regard to whether a 

23 final rule to implement such amendments has been pro24 mulgated by the Secretary of Health and Human Services 

25 under section 701(a) of the Federal Food, Drug, and Cos-
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1 metic Act. The preceding sentence may not be construed 

2 as affecting the authority of such Secretary to promulgate 

3 such a final rule. 

4 SEC. 808. PROHIBITING PAYMENTS TO UNREGISTERED 

5 FOREIGN PHARMACIES. 

6 (a) IN GENERAL.—Section 303 of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 333) is amended by 

8 adding at the end the following: 

9 ‘‘(g) RESTRICTED TRANSACTIONS.—

10 ‘‘(1) IN GENERAL.—The introduction of re11 stricted transactions into a payment system or the 

12 completion of restricted transactions using a pay13 ment system is prohibited. 

14 ‘‘(2) PAYMENT SYSTEM.—

15 ‘‘(A) IN GENERAL.—The term ‘payment 

16 system’ means a system used by a person de17 scribed in subparagraph (B) to effect a credit 

18 transaction, electronic fund transfer, or money 

19 transmitting service that may be used in con20 nection with, or to facilitate, a restricted trans21 action, and includes—

22 ‘‘(i) a credit card system; 

23 ‘‘(ii) an international, national, re24 gional, or local network used to effect a 

25 credit transaction, an electronic fund 
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1 transfer, or a money transmitting service; 

2 and 

3 ‘‘(iii) any other system that is cen4 trally managed and is primarily engaged in 

5 the transmission and settlement of credit 

6 transactions, electronic fund transfers, or 

7 money transmitting services. 

8 ‘‘(B) PERSONS DESCRIBED.—A person re9 ferred to in subparagraph (A) is—

10 ‘‘(i) a creditor; 

11 ‘‘(ii) a credit card issuer; 

12 ‘‘(iii) a financial institution; 

13 ‘‘(iv) an operator of a terminal at 

14 which an electronic fund transfer may be 

15 initiated; 

16 ‘‘(v) a money transmitting business; 

17 or 

18 ‘‘(vi) a participant in an international, 

19 national, regional, or local network used to 

20 effect a credit transaction, electronic fund 

21 transfer, or money transmitting service. 

22 ‘‘(3) RESTRICTED TRANSACTION.—The term 

23 ‘restricted transaction’ means a transaction or trans24 mittal, on behalf of an individual who places an un25 lawful drug importation request to any person en-
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1 gaged in the operation of an unregistered foreign 

2 pharmacy, of—

3 ‘‘(A) credit, or the proceeds of credit, ex4 tended to or on behalf of the individual for the 

5 purpose of the unlawful drug importation re6 quest (including credit extended through the 

7 use of a credit card); 

8 ‘‘(B) an electronic fund transfer or funds 

9 transmitted by or through a money transmit10 ting business, or the proceeds of an electronic 

11 fund transfer or money transmitting service, 

12 from or on behalf of the individual for the pur13 pose of the unlawful drug importation request; 

14 ‘‘(C) a check, draft, or similar instrument 

15 which is drawn by or on behalf of the individual 

16 for the purpose of the unlawful drug importa17 tion request and is drawn on or payable at or 

18 through any financial institution; or 

19 ‘‘(D) the proceeds of any other form of fi20 nancial transaction (identified by the Board by 

21 regulation) that involves a financial institution 

22 as a payor or financial intermediary on behalf 

23 of or for the benefit of the individual for the 

24 purpose of the unlawful drug importation re25 quest. 
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1 ‘‘(4) UNLAWFUL DRUG IMPORTATION RE2 QUEST.—The term ‘unlawful drug importation re3 quest’ means the request, or transmittal of a re4 quest, made to an unregistered foreign pharmacy for 

5 a prescription drug by mail (including a private car6 rier), facsimile, phone, or electronic mail, or by a 

7 means that involves the use, in whole or in part, of 

8 the Internet. 

9 ‘‘(5) UNREGISTERED FOREIGN PHARMACY.—

10 The term ‘unregistered foreign pharmacy’ means a 

11 person in a country other than the United States 

12 that is not a registered exporter under section 804. 

13 ‘‘(6) OTHER DEFINITIONS.—

14 ‘‘(A) CREDIT; CREDITOR; CREDIT CARD.—

15 The terms ‘credit’, ‘creditor’, and ‘credit card’ 

16 have the meanings given the terms in section 

17 103 of the Truth in Lending Act (15 U.S.C. 

18 1602). 

19 ‘‘(B) ACCESS DEVICE; ELECTRONIC FUND

20 TRANSFER.—The terms ‘access device’ and 

21 ‘electronic fund transfer’—

22 ‘‘(i) have the meaning given the term 

23 in section 903 of the Electronic Fund 

24 Transfer Act (15 U.S.C. 1693a); and 
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1 ‘‘(ii) the term ‘electronic fund trans2 fer’ also includes any fund transfer covered 

3 under Article 4A of the Uniform Commer4 cial Code, as in effect in any State. 

5 ‘‘(C) FINANCIAL INSTITUTION.—The term 

6 ‘financial institution’—

7 ‘‘(i) has the meaning given the term 

8 in section 903 of the Electronic Transfer 

9 Fund Act (15 U.S.C. 1693a); and 

10 ‘‘(ii) includes a financial institution 

11 (as defined in section 509 of the Gramm12 Leach-Bliley Act (15 U.S.C. 6809)). 

13 ‘‘(D) MONEY TRANSMITTING BUSINESS; 

14 MONEY TRANSMITTING SERVICE.—The terms 

15 ‘money transmitting business’ and ‘money 

16 transmitting service’ have the meaning given 

17 the terms in section 5330(d) of title 31, United 

18 States Code. 

19 ‘‘(E) BOARD.—The term ‘Board’ means 

20 the Board of Governors of the Federal Reserve 

21 System. 

22 ‘‘(7) POLICIES AND PROCEDURES REQUIRED TO

23 PREVENT RESTRICTED TRANSACTIONS.—

24 ‘‘(A) REGULATIONS.—The Board shall 

25 promulgate regulations requiring—
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1 ‘‘(i) an operator of a credit card sys2 tem; 

3 ‘‘(ii) an operator of an international, 

4 national, regional, or local network used to 

5 effect a credit transaction, an electronic 

6 fund transfer, or a money transmitting 

7 service; 

8 ‘‘(iii) an operator of any other pay9 ment system that is centrally managed and 

10 is primarily engaged in the transmission 

11 and settlement of credit transactions, elec12 tronic transfers or money transmitting 

13 services where at least one party to the 

14 transaction or transfer is an individual; 

15 and 

16 ‘‘(iv) any other person described in 

17 paragraph (2)(B) and specified by the 

18 Board in such regulations, 

19 to establish policies and procedures that are 

20 reasonably designed to prevent the introduction 

21 of a restricted transaction into a payment sys22 tem or the completion of a restricted trans23 action using a payment system 
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1 ‘‘(B) REQUIREMENTS FOR POLICIES AND

2 PROCEDURES.—In promulgating regulations 

3 under subparagraph (A), the Board shall—

4 ‘‘(i) identify types of policies and pro5 cedures, including nonexclusive examples, 

6 that shall be considered to be reasonably 

7 designed to prevent the introduction of re8 stricted transactions into a payment sys9 tem or the completion of restricted trans10 actions using a payment system; and 

11 ‘‘(ii) to the extent practicable, permit 

12 any payment system, or person described 

13 in paragraph (2)(B), as applicable, to 

14 choose among alternative means of pre15 venting the introduction or completion of 

16 restricted transactions. 

17 ‘‘(C) NO LIABILITY FOR BLOCKING OR RE18 FUSING TO HONOR RESTRICTED TRANS19 ACTION.—

20 ‘‘(i) IN GENERAL.—A payment sys21 tem, or a person described in paragraph 

22 (2)(B) that is subject to a regulation 

23 issued under this subsection, and any par24 ticipant in such payment system that pre25 vents or otherwise refuses to honor trans-
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1 actions in an effort to implement the poli2 cies and procedures required under this 

3 subsection or to otherwise comply with this 

4 subsection shall not be liable to any party 

5 for such action. 

6 ‘‘(ii) COMPLIANCE.—A person de7 scribed in paragraph (2)(B) meets the re8 quirements of this subsection if the person 

9 relies on and complies with the policies and 

10 procedures of a payment system of which 

11 the person is a member or in which the 

12 person is a participant, and such policies 

13 and procedures of the payment system 

14 comply with the requirements of the regu15 lations promulgated under subparagraph 

16 (A). 

17 ‘‘(D) ENFORCEMENT.—

18 ‘‘(i) IN GENERAL.—This section shall 

19 be enforced by the Federal functional regu20 lators and the Federal Trade Commission 

21 under applicable law in the manner pro22 vided in section 505(a) of the Gramm23 Leach-Bliley Act (15 U.S.C. 6805(a)). 

24 ‘‘(ii) FACTORS TO BE CONSIDERED.—

25 In considering any enforcement action 
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1 under this subsection against a payment 

2 system or person described in paragraph 

3 (2)(B), the Federal functional regulators 

4 and the Federal Trade Commission shall 

5 consider the following factors: 

6 ‘‘(I) The extent to which the pay7 ment system or person knowingly per8 mits restricted transactions. 

9 ‘‘(II) The history of the payment 

10 system or person in connection with 

11 permitting restricted transactions. 

12 ‘‘(III) The extent to which the 

13 payment system or person has estab14 lished and is maintaining policies and 

15 procedures in compliance with regula16 tions prescribed under this subsection. 

17 ‘‘(8) TRANSACTIONS PERMITTED.—A payment 

18 system, or a person described in paragraph (2)(B) 

19 that is subject to a regulation issued under this sub20 section, is authorized to engage in transactions with 

21 foreign pharmacies in connection with investigating 

22 violations or potential violations of any rule or re23 quirement adopted by the payment system or person 

24 in connection with complying with paragraph (7). A 

25 payment system, or such a person, and its agents 
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1 and employees shall not be found to be in violation 

2 of, or liable under, any Federal, State or other law 

3 by virtue of engaging in any such transaction. 

4 ‘‘(9) RELATION TO STATE LAWS.—No require5 ment, prohibition, or liability may be imposed on a 

6 payment system, or a person described in paragraph 

7 (2)(B) that is subject to a regulation issued under 

8 this subsection, under the laws of any state with re9 spect to any payment transaction by an individual 

10 because the payment transaction involves a payment 

11 to a foreign pharmacy. 

12 ‘‘(10) TIMING OF REQUIREMENTS.—A payment 

13 system, or a person described in paragraph (2)(B) 

14 that is subject to a regulation issued under this sub15 section, must adopt policies and procedures reason16 ably designed to comply with any regulations re17 quired under paragraph (7) within 60 days after 

18 such regulations are issued in final form.’’. 

19 (b) EFFECTIVE DATE.—The amendment made by 

20 this section shall take effect on the day that is 90 days 

21 after the date of enactment of this Act. 

22 (c) IMPLEMENTATION.—The Board of Governors of 

23 the Federal Reserve System shall promulgate regulations 

24 as required by subsection (g)(7) of section 303 of the Fed25 eral Food, Drug, and Cosmetic Act (21 U.S.C. 333), as 
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1 added by subsection (a), not later than 90 days after the 

2 date of enactment of this title. 

3 SEC. 809. IMPORTATION EXEMPTION UNDER CONTROLLED 

4 SUBSTANCES IMPORT AND EXPORT ACT. 

5 Section 1006(a)(2) of the Controlled Substances Im6 port and Export Act (21 U.S.C. 956(a)(2)) is amended 

7 by striking ‘‘not import the controlled substance into the 

8 United States in an amount that exceeds 50 dosage units 

9 of the controlled substance.’’ and inserting ‘‘import into 

10 the United States not more than 10 dosage units com11 bined of all such controlled substances.’’. 

12 SEC. 810. SEVERABILITY. 

13 If any provision of this title, an amendment by this 

14 title, or the application of such provision or amendment 

15 to any person or circumstance is held to be unconstitu16 tional, the remainder of this title, the amendments made 

17 by this title, and the application of the provisions of such 

18 to any person or circumstance shall not affected thereby. 

19 SEC. 811. PROTECTION OF HEALTH AND SAFETY. 

20 This title, and the amendments made by this title, 

21 shall become effective only if the Secretary of Health and 

22 Human Services certifies to Congress that the implemen23 tation of this title (and amendments) will—

24 (1) pose no additional risk to the public’s health 

25 and safety; and 
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1 (2) result in a significant reduction in the cost 

2 of covered products to the American consumer. 

Passed the Senate May 9, 2007. 

Attest:

Secretary. 
110TH CONGRESS 

1ST SESSION S. 1082

AN ACT

To amend the Federal Food, Drug, and Cosmetic 

poses.safety of medical products, and for other purthorize drug and device user fees and ensure the Act and the Public Health Service Act to reau-