II 

110TH CONGRESS 

1ST SESSION S. 468 

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

safety, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

JANUARY 31, 2007 

Mr. GRASSLEY (for himself, Mr. DODD, Ms. MIKULSKI, and Mr. BINGAMAN) 

introduced the following bill; which was read twice and referred to the 

Committee on Health, Education, Labor, and Pensions 

A BILL 

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

respect to drug safety, 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 Safety Act of 2007’’. 

6 SEC. 2. CENTER FOR POSTMARKET EVALUATION AND RE7 SEARCH FOR DRUGS AND BIOLOGICS. 

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 506C the following: 


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1 ‘‘SEC. 507. DRUG SAFETY. 

2 ‘‘(a) ESTABLISHMENT OF THE CENTER FOR

3 POSTMARKET EVALUATION AND RESEARCH FOR DRUGS

4 AND BIOLOGICS.—There is established within the Food 

5 and Drug Administration a Center for Postmarket Eval6 uation and Research for Drugs and Biologics (referred to 

7 in the section as the ‘Center’). The Director of the Center 

8 shall report directly to the Commissioner of Food and 

9 Drugs. 

10 ‘‘(b) DUTIES OF THE CENTER FOR POSTMARKET

11 EVALUATION AND RESEARCH FOR DRUGS AND BIO12 LOGICS.— 

13 ‘‘(1) RESPONSIBILITIES OF DIRECTOR.—The 

14 Director of the Center, in consultation with the Di15 rector of the Center for Drug Evaluation and Re16 search or the Director of the Center for Biologics 

17 Evaluation and Research, as appropriate, shall— 

18 ‘‘(A) conduct postmarket risk assessment 

19 of drugs approved under section 505 of this Act 

20 and of biological products licensed under section 

21 351 of the Public Health Service Act; 

22 ‘‘(B) conduct and improve postmarket sur23 veillance of approved drugs and licensed biologi24 cal products using postmarket surveillance pro25 grams and activities (including MedWatch), 

26 risk-benefit analyses, adverse event reports, the 


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1 scientific literature, any clinical or observational 

2 studies (including studies required under sub3 section (d) or (e)), and any other resources that 

4 the Director of the Center determines appro5 priate; 

6 ‘‘(C) determine whether a study is required 

7 under subsection (d) or (e) and consult with the 

8 sponsors of drugs and biological products to en9 sure that such studies are completed by the 

10 date, and according to the terms, specified by 

11 the Director of the Center; 

12 ‘‘(D) contract, or require the sponsor of an 

13 application or the holder of an approved appli14 cation or license to contract, with the holders of 

15 domestic and international patient databases to 

16 conduct epidemiologic and other observational 

17 studies; 

18 ‘‘(E) determine, based on postmarket sur19 veillance programs and activities (including 

20 MedWatch), risk-benefit analyses, adverse event 

21 reports, the scientific literature, and any clinical 

22 or observational studies (including studies re23 quired under subsection (d) or (e)), and any 

24 other resources that the Director of the Center 

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1 logical product may present an unreasonable 

2 risk to the health of patients or the general 

3 public, and take corrective action if such an un4 reasonable risk may exist; 

5 ‘‘(F) make information about the safety 

6 and effectiveness of approved drugs and li7 censed biological products available to the pub8 lic and healthcare providers in a timely manner; 

9 and 

10 ‘‘(G) conduct other activities as the Direc11 tor of the Center determines appropriate to en12 sure the safety and effectiveness of all drugs 

13 approved under section 505 and all biological 

14 products licensed under section 351 of the Pub15 lic Health Service Act. 

16 ‘‘(2) DETERMINATION OF UNREASONABLE

17 RISK.—In determining whether a drug or biological 

18 product may present an unreasonable risk to the 

19 health of patients or the general public, the Director 

20 of the Center, in consultation with the Director of 

21 the Center for Drug Evaluation and Research or the 

22 Director of the Center for Biologics Evaluation and 

23 Research, as appropriate, shall consider the risk in 

24 relation to the known benefits of such drug or bio25 logical product. 


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1 ‘‘(c) SECRETARIAL AUTHORITY.— 

2 ‘‘(1) IN GENERAL.—Approval of a drug under 

3 section 505 of this Act or issuance of a license for 

4 a biological product under section 351 of the Public 

5 Health Service Act may be subject to the require6 ment that the sponsor conduct 1 or more postmarket 

7 studies as described in subsection (d) or (e) of this 

8 section, or other postmarket studies as required by 

9 the Secretary, to validate the safety and effective10 ness of the drug or biological product. 

11 ‘‘(2) DEFINITION.—For purposes of this sec12 tion, the term ‘postmarket’ means— 

13 ‘‘(A) with respect to a drug, after approval 

14 of an application under section 505; and 

15 ‘‘(B) with respect to a biological product, 

16 after licensure under section 351 of the Public 

17 Health Service Act. 

18 ‘‘(d) PREAPPROVAL REVIEW.— 

19 ‘‘(1) REVIEW OF APPLICATION.— 

20 ‘‘(A) IN GENERAL.— 

21 ‘‘(i) REVIEW.—At any time before a 

22 drug is approved under section 505 of this 

23 Act or a biological product is licensed 

24 under section 351 of the Public Health 

25 Service Act, the Director of the Center 


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1 shall review the application (or supplement 

2 to the application), and any analyses asso3 ciated with the application, of such drug or 

4 biological product. 

5 ‘‘(ii) EFFECT OF APPROVAL OR LI6 CENSURE.—The approval of a drug under 

7 section 505 or the licensure of a biological 

8 product under such section 351 shall not 

9 affect the continuation and completion of a 

10 review under clause (i). 

11 ‘‘(B) LIMITATION.—In no case shall the 

12 review under subparagraph (A) delay a decision 

13 with respect to an application for a drug under 

14 section 505 of this Act or for a biological prod15 uct under section 351 of the Public Health 

16 Service Act. 

17 ‘‘(2) RESULT OF REVIEW.—The Director of the 

18 Center may, based on the review under paragraph 

19 (1)— 

20 ‘‘(A) require that the sponsor of the appli21 cation agree to conduct 1 or more postmarket 

22 studies to determine the safety or effectiveness 

23 of a drug or biological product, including such 

24 safety or effectiveness as compared to other 

25 drugs or biological products, to be completed by 


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1 a date, and according to the terms, specified by 

2 the Director of the Center; or 

3 ‘‘(B) contract, or require the sponsor of 

4 the application to contract, with a holder of a 

5 domestic or an international patient database to 

6 conduct 1 or more epidemiologic or other obser7 vational studies. 

8 ‘‘(e) POSTMARKETING STUDIES OF DRUG SAFETY.— 

9 ‘‘(1) IN GENERAL.—At any time after a drug is 

10 approved under section 505 of this Act or a biologi11 cal product is licensed under section 351 of the Pub12 lic Health Service Act, the Director of the Center, 

13 may— 

14 ‘‘(A) require that the holder of an ap15 proved application or license conduct 1 or more 

16 studies to determine the safety or effectiveness 

17 of such drug or biological product, including 

18 such safety and effectiveness as compared to 

19 other drugs or biological products, to be com20 pleted by a date, and according to the terms, 

21 specified by such Director; or 

22 ‘‘(B) contract, or require the holder of the 

23 approved application or license to contract, with 

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1 tient database to conduct 1 or more epidemio2 logic or other observational studies. 

3 ‘‘(2) REVIEW OF OUTSTANDING STUDIES.—Not 

4 later than 90 days after the date of enactment of 

5 the Food and Drug Administration Safety Act of 

6 2007, the Director of the Center shall— 

7 ‘‘(A) review and publish a list in the Fed8 eral Register of any postmarketing studies out9 standing on the date of enactment of the Food 

10 and Drug Administration Safety Act of 2007; 

11 and 

12 ‘‘(B) as the Director determines appro13 priate, require the sponsor of a study described 

14 in subparagraph (A) to conduct such study 

15 under this subsection. 

16 ‘‘(f) PUBLICATION OF PROGRESS REPORTS AND

17 COMPLETED STUDIES.— 

18 ‘‘(1) IN GENERAL.—The Director of the Center 

19 shall require that the sponsor of a study under sub20 section (d) or (e) submit to the Secretary— 

21 ‘‘(A) not less frequently than every 90 

22 days, an up-to-date report describing the 

23 progress of such study; and 

24 ‘‘(B) upon the completion date of such 

25 study, the results of such study. 


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1 ‘‘(2) COMPLETION DATE.—For purposes of this 

2 section, the completion date of such study shall be 

3 determined by the Director of the Center. 

4 ‘‘(g) DETERMINATIONS BY DIRECTOR.— 

5 ‘‘(1) RESULTS OF STUDY.—The Director of the 

6 Center shall determine, upon receipt of the results of 

7 a study required under subsection (d) or (e)— 

8 ‘‘(A) whether the drug or biological prod9 uct studied may present an unreasonable risk to 

10 the health of patients or the general public; and 

11 ‘‘(B) what, if any, corrective action under 

12 subsection (k) shall be taken to protect patients 

13 and the public health. 

14 ‘‘(2) RESULTS OF EVIDENCE.—The Director of 

15 the Center may, at any time, based on the empirical 

16 evidence from postmarket surveillance programs and 

17 activities (including MedWatch), risk-benefit anal18 yses, adverse event reports, the scientific literature, 

19 any clinical or observational studies (including stud20 ies required under subsection (d) or (e)), or any 

21 other resources that the Director of the Center de22 termines appropriate— 

23 ‘‘(A) make a determination that a drug or 

24 biological product may present an unreasonable 


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1 risk to the health of patients or the general 

2 public; and 

3 ‘‘(B) order a corrective action under sub4 section (k) be taken to protect patients and the 

5 public health. 

6 ‘‘(3) REQUIRED CONSULTATION AND CONSIDER7 ATIONS.—Before making a determination under 

8 paragraph (2), ordering a study under subsection 

9 (d) or (e), or taking a corrective action under sub10 section (k), the Director of the Center shall— 

11 ‘‘(A) consult with the Director of the Cen12 ter for Drug Evaluation and Research or the 

13 Director of the Center for Biologics Evaluation 

14 and Research, as appropriate; and 

15 ‘‘(B) consider— 

16 ‘‘(i) the benefit-to-risk profile of the 

17 drug or biological product; 

18 ‘‘(ii) the effect that a corrective ac19 tion, or failure to take corrective action, 

20 will have on the patient population that re21 lies on the drug or biological product; and 

22 ‘‘(iii) the extent to which the drug or 

23 biological product presents a meaningful 

24 therapeutic benefit as compared to other 

25 available treatments. 


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1 ‘‘(h) PUBLIC INFORMATION.—Periodically, but not 

2 less often than every 90 days, the Secretary shall make 

3 available to the public, by publication in the Federal Reg4 ister and posting on an Internet website, the following in5 formation: 

6 ‘‘(1) Studies required under subsection (d) or 

7 (e) including— 

8 ‘‘(A) the type of study; 

9 ‘‘(B) the nature of the study; 

10 ‘‘(C) the primary and secondary outcomes 

11 of the study; 

12 ‘‘(D) the date the study was required 

13 under subsection (d) or (e) or was agreed to by 

14 the sponsor; 

15 ‘‘(E) the deadline for completion of the 

16 study; and 

17 ‘‘(F) if the study has not been completed 

18 by the deadline under subparagraph (E), a 

19 statement that explains why. 

20 ‘‘(2) The periodic progress reports and results 

21 of completed studies described under subsection (f). 

22 ‘‘(3) Any determinations made by the Director 

23 of the Center under subsection (g), including— 

24 ‘‘(A) reasons for the determination, includ25 ing factual basis for such determination; 


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1 ‘‘(B) reference to supporting empirical 

2 data; and 

3 ‘‘(C) an explanation that describes why 

4 contrary data is insufficient. 

5 ‘‘(i) DRUG ADVISORY COMMITTEE.—The Drug Safe6 ty and Risk Management Advisory Committee within the 

7 Center of the Food and Drug Administration shall— 

8 ‘‘(1) meet not less frequently than every 180 

9 days; and 

10 ‘‘(2) make recommendations to the Director of 

11 the Center with respect to— 

12 ‘‘(A) which drugs and biological products 

13 should be the subject of a study under sub14 section (d) or (e); 

15 ‘‘(B) the design and duration for studies 

16 under subsection (d) or (e); 

17 ‘‘(C) which drugs and biological products 

18 may present an unreasonable risk to the health 

19 of patients or the general public; and 

20 ‘‘(D) appropriate corrective actions under 

21 subsection (k). 

22 ‘‘(j) PENALTIES.— 

23 ‘‘(1) IN GENERAL.—If the Secretary deter24 mines, after notice and opportunity for an informal 

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1 uct or other entity has failed to complete a study re2 quired under subsection (d) or (e) by the date or to 

3 the terms specified by the Secretary under such sub4 section, the Secretary may order such sponsor or 

5 other entity to— 

6 ‘‘(A) complete the study in a specified 

7 time; 

8 ‘‘(B) revise the study to comply with the 

9 terms specified by the Secretary under sub10 section (d) or (e); or 

11 ‘‘(C) pay a civil penalty. 

12 ‘‘(2) AMOUNT OF PENALTIES.— 

13 ‘‘(A) IN GENERAL.—The civil penalty or14 dered under paragraph (1) shall be $250,000 

15 for the first 30-day period after the date speci16 fied by the Secretary that the study is not com17 pleted, and shall double in amount for every 30- 

18 day period thereafter that the study is not com19 pleted. 

20 ‘‘(B) LIMITATION.—In no case shall a pen21 alty under subparagraph (A) exceed $2,000,000 

22 for any 30-day period. 

23 ‘‘(3) NOTIFICATION OF PENALTY.—The Sec24 retary shall publish in the Federal Register any civil 

25 penalty ordered under this subsection. 


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1 ‘‘(k) RESULT OF DETERMINATION.— 

2 ‘‘(1) IN GENERAL.—If the Director of the Cen3 ter makes a determination that a drug or biological 

4 product may present an unreasonable risk to the 

5 health of patients or the general public under sub6 section (g), such Director shall order a corrective ac7 tion, as described under paragraph (2). 

8 ‘‘(2) CORRECTIVE ACTIONS.—The corrective ac9 tion described under subsection (g)— 

10 ‘‘(A) may include— 

11 ‘‘(i) requiring a change to the drug or 

12 biological product label by a date specified 

13 by the Director of the Center; 

14 ‘‘(ii) modifying the approved indica15 tion of the drug or biological product to re16 strict use to certain patients; 

17 ‘‘(iii) placing restriction on the dis18 tribution of the drug or biological product 

19 to ensure safe use; 

20 ‘‘(iv) requiring the sponsor of the 

21 drug or biological product or license to es22 tablish a patient registry; 

23 ‘‘(v) requiring patients to sign a con24 sent form prior to receiving a prescription 

25 of the drug or biological product; 


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1 ‘‘(vi) requiring the sponsor to monitor 

2 sales and usage of the drug or biological 

3 product to detect unsafe use; 

4 ‘‘(vii) requiring patient or physician 

5 education; and 

6 ‘‘(viii) requiring the establishment of 

7 a risk management plan by the sponsor; 

8 and 

9 ‘‘(B) shall include the requirements with 

10 respect to promotional material under sub11 section (l)(1). 

12 ‘‘(3) PENALTIES.— 

13 ‘‘(A) IN GENERAL.—If the Secretary deter14 mines, after notice and opportunity for an in15 formal hearing, that a sponsor of a drug or bio16 logical product has failed to take the corrective 

17 action ordered by the Director of the Center 

18 under this subsection or has failed to comply 

19 with subsection (l)(2), the Secretary may order 

20 such sponsor to pay a civil penalty. 

21 ‘‘(B) AMOUNT OF PENALTIES.— 

22 ‘‘(i) IN GENERAL.—The civil penalty 

23 ordered under subparagraph (A) shall be 

24 $250,000 for the first 30-day period that 

25 the sponsor does not comply with the order 


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1 under paragraph (1), and shall double in 

2 amount for every 30-day period thereafter 

3 that the order is not complied with. 

4 ‘‘(ii) LIMITATION.—In no case shall a 

5 penalty under clause (i) exceed $2,000,000 

6 for any 30-day period. 

7 ‘‘(C) NOTIFICATION OF PENALTY.—The 

8 Secretary shall publish in the Federal Register 

9 any civil penalty ordered under this paragraph. 

10 ‘‘(l) PROMOTION MATERIAL.— 

11 ‘‘(1) SAFETY ISSUE.—If the Director of the 

12 Center makes a determination that a drug or bio13 logical product may present an unreasonable risk to 

14 the health of patients or the general public under 

15 subsection (g), such Director, in consultation with 

16 the Division of Drug Marketing, Advertising, and 

17 Communications of the Food and Drug Administra18 tion, shall— 

19 ‘‘(A) notwithstanding section 502(n), re20 quire that the sponsor of such drug or biologi21 cal product submit to the Director of the Cen22 ter copies of all promotional material with re23 spect to the drug or biological product not less 

24 than 30 days prior to the dissemination of such 

25 material; and 


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1 ‘‘(B) require that all promotional material 

2 with respect to the drug or biological product 

3 include certain disclosures, which shall be dis4 played prominently and in a manner easily un5 derstood by the general public, including— 

6 ‘‘(i) a statement that describes the 

7 unreasonable risk to the health of patients 

8 or the general public as determined by the 

9 Director of the Center; 

10 ‘‘(ii) a statement that encourages pa11 tients to discuss potential risks and bene12 fits with their healthcare provider; 

13 ‘‘(iii) a description of the corrective 

14 actions required under subsection (k); 

15 ‘‘(iv) where appropriate, a statement 

16 explaining that there may be products 

17 available to treat the same disease or con18 dition that present a more favorable ben19 efit-to-risk profile, and that patients should 

20 talk to their healthcare provider about the 

21 risks and benefits of alternative treat22 ments; 

23 ‘‘(v) a description of any requirements 

24 of outstanding clinical and observational 


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1 studies, including the purpose of each 

2 study; and 

3 ‘‘(vi) contact information to report a 

4 suspected adverse reaction. 

5 ‘‘(2) NEW PRODUCTS; OUTSTANDING STUD6 IES.—For the first 2-year period after a drug is ap7 proved under section 505 of this Act or a biological 

8 product is licensed under section 351 of the Public 

9 Health Service Act, and with respect to drugs and 

10 biological products for which there are outstanding 

11 study requirements under subsection (d) or (e), the 

12 Director of the Center, in consultation with the Divi13 sion of Drug Marketing, Advertising, and Commu14 nications of the Food and Drug Administration, 

15 shall— 

16 ‘‘(A) notwithstanding section 502(n), re17 quire that the sponsor of such drug or biologi18 cal product submit to the Director of the Cen19 ter copies of all promotional material with re20 spect to the drug or biological product not less 

21 than 30 days prior to the dissemination of such 

22 material; and 

23 ‘‘(B) require that all promotional material 

24 with respect to the drug or biological product 

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1 played prominently and in a manner easily un2 derstood by the general public, including— 

3 ‘‘(i) a statement explaining that the 

4 drug or biological product is newly ap5 proved or licensed or the subject of out6 standing clinical or observational studies, 

7 as the case may be, and, as a result, not 

8 all side effects or drug interactions may be 

9 known; 

10 ‘‘(ii) the number of people in which 

11 the drug or biological product has been 

12 studied and the duration of time during 

13 which the drug or biological product has 

14 been studied; 

15 ‘‘(iii) a statement that encourages pa16 tients to discuss the potential risks and 

17 benefits of treatment with their healthcare 

18 provider; 

19 ‘‘(iv) a description of any require20 ments of outstanding clinical and observa21 tional studies, including the purpose of 

22 each study; and 

23 ‘‘(v) contact information to report a 

24 suspected adverse reaction. 


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1 ‘‘(3) EFFECT OF VOLUNTARY SUBMISSION.— 

2 Paragraphs (1)(A) and (2)(A) shall not apply to the 

3 sponsor of a drug or biological product if such spon4 sor has voluntarily submitted to the Division of 

5 Drug Marketing, Advertising, and Communications 

6 of the Food and Drug Administration all pro7 motional material with respect to the drug or bio8 logical product prior to the dissemination of such 

9 material. 

10 ‘‘(m) WITHDRAWAL OR SUSPENSION OF APPROVAL

11 OR LICENSURE.— 

12 ‘‘(1) IN GENERAL.—The Director of the Center, 

13 may withdraw or suspend approval of a drug or li14 censure of a biological product using expedited pro15 cedures (as prescribed by the Secretary in regula16 tions promulgated not later than 1 year after the 

17 date of enactment of the Food and Drug Adminis18 tration Safety Act of 2007, which shall include an 

19 opportunity for an informal hearing) after consulta20 tion with the Director of the Center for Drug Eval21 uation and Research or the Director of the Center 

22 for Biologics Evaluation and Research, as appro23 priate, and any other person as determined appro24 priate by the Director of the Center, if— 


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1 ‘‘(A) the Director of the Center makes a 

2 determination that the drug or biological prod3 uct may present an unreasonable risk to the 

4 health of patients or the general public, and 

5 that risk cannot be satisfactorily alleviated by a 

6 corrective action under subsection (k); or 

7 ‘‘(B) the sponsor fails to comply with an 

8 order or requirement under this section. 

9 ‘‘(2) PUBLIC INFORMATION.—The Secretary 

10 shall make available to the public, by publication in 

11 the Federal Register and posting on an Internet 

12 website, the details of the consultation described in 

13 paragraph (1), including— 

14 ‘‘(A) the reason for the determination to 

15 withdraw, suspend, or failure to withdraw or 

16 suspend, approval for the drug or licensure for 

17 the biological product; 

18 ‘‘(B) the factual basis for such determina19 tion; 

20 ‘‘(C) reference to supporting empirical 

21 data; 

22 ‘‘(D) an explanation that describes why 

23 contrary data is insufficient; and 

24 ‘‘(E) the position taken by each individual 

25 consulted. 


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1 ‘‘(n) EFFECT OF SECTION.—The authorities con2 ferred by this section shall be separate from and in addi3 tion to the authorities conferred by section 505B. 

4 ‘‘(o) ADMINISTRATION OF SECTION.—The provisions 

5 of this section shall be carried out by the Secretary, acting 

6 through the Director of the Center.’’. 

7 (b) MISBRANDING.—Section 502 of the Federal 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amend9 ed by inserting after subsection (j) the following: 

10 ‘‘(k) If it is a drug or biological product for which 

11 the sponsor of an application or holder of an approved ap12 plication or license has not complied with an order or re13 quirement under section 507.’’. 

14 (c) REPORT ON DEVICES.—Not later than 6 months 

15 after the date of enactment of this Act, the Secretary of 

16 Health and Human Services, in consultation with the 

17 Commissioner of Food and Drugs, the Director of the 

18 Center for Postmarket Evaluation and Research for Drugs 

19 and Biologics, and the Director of the Center for Devices 

20 and Radiological Health, shall submit to Congress a report 

21 that— 

22 (1) identifies gaps in the current process of 

23 postmarket surveillance of devices approved under 

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

25 U.S.C. 321 et seq.); 


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1 (2) includes recommendations on ways to im2 prove gaps in postmarket surveillance of devices; and 

3 (3) identifies the changes in authority needed to 

4 make those improvements, recognizing the legitimate 

5 differences between devices and other medical prod6 ucts regulated by the Food and Drug Administra7 tion. 

8 (d) TRANSFER OF FUNCTIONS.—The functions and 

9 duties of the Office of Surveillance and Epidemiology, in10 cluding the Drug Safety and Risk Management Advisory 

11 Committee, of the Food and Drug Administration on the 

12 day before the date of enactment of this Act shall be trans13 ferred to the Center for Postmarket Evaluation and Re14 search for Drugs and Biologics established under section 

15 507 of the Federal Food, Drug, and Cosmetic Act (as 

16 added by this section). The Center for Postmarket Evalua17 tion and Research for Drugs and Biologics shall be a sepa18 rate entity within the Food and Drug Administration and 

19 shall not be an administrative office of the Center for 

20 Drug Evaluation and Research or the Center for Biologics 

21 Evaluation and Research. 

22 (e) AUTHORIZATION OF APPROPRIATIONS.—There 

23 are authorized to be appropriated to carry out this Act 

24 (and the amendments made by this Act)— 

25 (1) $50,000,000 for fiscal year 2008; 


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1 (2) $75,000,000 for fiscal year 2009; 

2 (3) $100,000,000 for fiscal year 2010; 

3 (4) $125,000,000 for fiscal year 2011; and 

4 (5) $150,000,000 for fiscal year 2012. 

Æ 


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