I 

109TH CONGRESS 

1ST SESSION H. R. 3196 

To amend the Public Health Service Act to expand the scope of information 

required for the data bank on clinical trials of drugs, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 30, 2005 

Mr. WAXMAN (for himself, Mr. MARKEY, Mr. BROWN of Ohio, Ms. 

SCHAKOWSKY, Mr. GENE GREEN of Texas, Mr. ALLEN, Mr. GEORGE

MILLER of California, Mr. PALLONE, Mr. BERRY, Ms. SLAUGHTER, Mr. 

STUPAK, Mr. MCDERMOTT, Mr. HINCHEY, Mr. FRANK of Massachusetts, 

Mr. OBERSTAR, Mr. ANDREWS, Mr. MEEKS of New York, Mr. 

DELAHUNT, Mr. MCNULTY, Mr. BERMAN, Mr. WEXLER, Ms. WOOLSEY, 

Ms. HERSETH, Mr. MCGOVERN, Mr. GRIJALVA, Mr. SANDERS, Mr. 

WEINER, Mr. CONYERS, Mr. KUCINICH, Mr. KENNEDY of Rhode Island, 

Mr. OLVER, and Mr. ABERCROMBIE) introduced the following bill; which 

was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Public Health Service Act to expand the 

scope of information required for the data bank on clinical trials of drugs, 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 ‘‘Fair Access to Clinical 

5 Trials Act’’. 
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1 SEC. 2. CLINICAL TRIALS DATA BANK. 

2 (a) IN GENERAL.—Title IV of the Public Health 

3 Service Act (42 U.S.C. 281 et seq.) is amended— 

4 (1) in section 402, by striking subsection (j); 

5 and 

6 (2) by inserting after section 402 the following 

7 section: 

8 ‘‘SEC. 402A. CLINICAL TRIALS DATA BANK. 

9 ‘‘(a) IN GENERAL.— 

10 ‘‘(1) DATA BANK.—The Secretary, acting 

11 through the Director of NIH, shall establish, main12 tain, and operate a data bank of information on clin13 ical trials (including premarket and postmarket 

14 trials) for drugs, biological products, and devices. 

15 The activities of the data bank shall be integrated 

16 and coordinated with related activities of other agen17 cies of the Department of Health and Human Serv18 ices, and to the extent practicable, coordinated with 

19 other data banks containing similar information. 

20 ‘‘(2) CONSULTATION.—The Secretary shall es21 tablish the data bank after consultation with the 

22 Commissioner of Food and Drugs, the directors of 

23 the appropriate agencies of the National Institutes 

24 of Health (including the National Library of Medi25 cine), and the Director of the Centers for Disease 

26 Control and Prevention. 
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1 ‘‘(b) COLLECTION AND DISSEMINATION OF INFORMA2 TION.— 

3 ‘‘(1) COLLECTION.—In carrying out subsection 

4 (a), the Secretary shall collect, catalog, store, and 

5 disseminate the information described in such sub6 section. 

7 ‘‘(2) INCLUSION OF SUBMITTED INFORMA8 TION.—All information on clinical trials required in 

9 this section to be submitted to the Secretary shall be 

10 included in the data bank as soon as practicable 

11 after the Secretary receives the information, subject 

12 to the provisions of this section. 

13 ‘‘(3) DISSEMINATION.—The Secretary shall dis14 seminate information in the data bank through in15 formation systems, which shall include toll-free tele16 phone communications available to members of the 

17 public, to health care providers, and to researchers. 

18 ‘‘(c) TRIALS SUBJECT TO REQUIREMENTS.— 

19 ‘‘(1) TRIALS OF SAFETY AND EFFECTIVE20 NESS.—All clinical trials, whether federally funded 

21 or privately funded, conducted to test the safety or 

22 effectiveness (including comparative effectiveness) of 

23 a drug, biological product, or device (whether clinical 

24 trials of approved products or unapproved products) 
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1 are subject to the requirements of this section, ex2 cept as provided in paragraph (2). 

3 ‘‘(2) EXCEPTIONS.—The requirements of para4 graph (1) do not apply to any of the following: 

5 ‘‘(A) A clinical trial to determine the safe6 ty of a use of a drug if the trial is designed 

7 solely to detect major toxicities in the drug or 

8 to investigate pharmacokinetics, except that the 

9 requirements of such paragraph do apply if the 

10 trial is designed solely to investigate pharmaco11 kinetics in a special population or populations. 

12 ‘‘(B) A small clinical trial to determine the 

13 feasibility of a device, or a trial to test proto14 type devices where the primary focus is feasi15 bility. 

16 ‘‘(3) CERTAIN TRIALS.—The data bank may in17 clude information on a clinical trial described in sub18 paragraph (A) or (B) of paragraph (2) with the con19 sent of the responsible person for the trial. 

20 ‘‘(4) RULE OF CONSTRUCTION.—This section 

21 may not be construed as applying to any classified 

22 information (as defined in subsection (l)). 

23 ‘‘(d) REQUIRED INFORMATION.— 

24 ‘‘(1) REGISTRATION OF TRIAL.— 
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1 ‘‘(A) IN GENERAL.—Before commencing a 

2 clinical trial that is subject to subsection (c)(1), 

3 the responsible person for the trial shall register 

4 the trial with the Secretary. Such a registration 

5 shall be in such form and be submitted in such 

6 manner as the Secretary requires, and shall in7 clude the following information: 

8 ‘‘(i) The medical condition being stud9 ied. 

10 ‘‘(ii) A scientific title for the trial that 

11 includes the name of the intervention, the 

12 condition, and the outcome being studied. 

13 ‘‘(iii) A statement of whether the trial 

14 has undergone research ethics review. The 

15 statement shall provide the date on which 

16 approval was obtained pursuant to such re17 view, or shall provide that such review is 

18 pending. In the case of a pending review, 

19 when approval is obtained, the responsible 

20 person shall provide an update that pro21 vides the date of the approval. 

22 ‘‘(iv) The anticipated start date for 

23 the trial. 
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1 ‘‘(v) The purpose of the trial, includ2 ing a statement of the interventions and 

3 comparisons involved. 

4 ‘‘(vi) The eligibility criteria for par5 ticipation in the clinical trial. 

6 ‘‘(vii) The funding source or sources 

7 of the trial. 

8 ‘‘(viii) A statement that— 

9 ‘‘(I) identifies the product as an 

10 unapproved product or as an approved 

11 product, as applicable; and 

12 ‘‘(II) in the case of an approved 

13 product, identifies the trial as inves14 tigating the approved use of the prod15 uct or an unapproved use of the prod16 uct, as applicable. 

17 ‘‘(ix) The estimated completion date 

18 for the trial. For purposes of this section, 

19 the term ‘completion date’ means the date 

20 of the final collection of data from subjects 

21 in the trial for the outcomes described in 

22 clause (vi). 

23 ‘‘(x) A description of the primary and 

24 secondary outcomes to be examined in the 

25 trial, the time at which the primary and 
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1 secondary outcomes will be assessed, and 

2 the dates and details of any revisions to 

3 such outcomes. 

4 ‘‘(xi) A statement of the hypothesis 

5 being tested in the trial. 

6 ‘‘(xii) The total number of subjects 

7 anticipated to participate in the trial. 

8 ‘‘(xiii) Contact information for the 

9 person to whom scientific inquiries regard10 ing the trial should be made. 

11 ‘‘(xiv) Information on— 

12 ‘‘(I) study design; 

13 ‘‘(II) methods; 

14 ‘‘(III) study phase; and 

15 ‘‘(IV) study type. 

16 ‘‘(xv) If the trial will test the effec17 tiveness of the use of a product with re18 spect to a serious or life-threatening dis19 ease or condition, the additional informa20 tion described in subparagraph (B)(i). 

21 ‘‘(xvi) With respect to an individual 

22 who is not an employee of the responsible 

23 person for the trial or of the manufacturer 

24 of the product involved, information on any 

25 agreement that the responsible person or 
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1 manufacturer has entered into with such 

2 individual that restricts in any manner the 

3 ability of the individual to— 

4 ‘‘(I) discuss the results of the 

5 trial at a scientific meeting or any 

6 other public or private forum; or 

7 ‘‘(II) publish the results of the 

8 trial, or a description or discussion of 

9 the results of the trial, in a scientific 

10 or academic journal. 

11 ‘‘(xvii) After the initial submission of 

12 the registration, periodic updates to reflect 

13 changes to information provided under this 

14 subparagraph. Such updates— 

15 ‘‘(I) shall be provided not less 

16 frequently than once every six months 

17 until information on the results of the 

18 trial is submitted under paragraph 

19 (2)(A) or a waiver is provided under 

20 paragraph (2)(D); and 

21 ‘‘(II) shall identify the dates on 

22 which the changes were made. 

23 ‘‘(B) SERIOUS OR LIFE-THREATENING DIS24 EASES.— 
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1 ‘‘(i) IN GENERAL.—For a clinical trial 

2 that will test the effectiveness of the use of 

3 a product with respect to a serious or life4 threatening disease or condition, the addi5 tional information referred to in subpara6 graph (A)(xv) is the following: 

7 ‘‘(I) A brief summary of the trial, 

8 provided in lay language. 

9 ‘‘(II) A description of the loca10 tion of trial sites and the start date of 

11 the trial. 

12 ‘‘(III) A point of contact for indi13 viduals desiring to enroll as subjects 

14 in the trial, including a single point of 

15 contact for all trial sites. 

16 ‘‘(IV) The status of the trial with 

17 respect to the enrollment of subjects, 

18 stated for the trial in general and for 

19 individual trial sites. 

20 ‘‘(V) Information that may be 

21 available— 

22 ‘‘(aa) under a treatment in23 vestigational new drug applica24 tion, or a treatment investiga25 tional device exemption, that has 
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1 been submitted to the Secretary 

2 under section 561(c) of the Fed3 eral Food, Drug, and Cosmetic 

4 Act (relating to expanded access 

5 protocols); or 

6 ‘‘(bb) as a Group C cancer 

7 drug (as defined by the National 

8 Cancer Institute). 

9 ‘‘(ii) FORMATTING FOR GENERAL

10 PUBLIC.—The information provided under 

11 clause (i) shall be in a format that can be 

12 readily accessed and understood by mem13 bers of the general public, including pa14 tients seeking to enroll as subjects in clin15 ical trials. 

16 ‘‘(C) LABELS OF APPROVED PRODUCTS.— 

17 If a clinical trial registered under subparagraph 

18 (A) is investigating an approved product and 

19 the label for such product is included on the 

20 Internet site of the Food and Drug Administra21 tion, the information in the data bank con22 cerning the trial shall include an electronic link 

23 to such label for individuals accessing the data 

24 bank through the Internet. 
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1 ‘‘(D) UNIQUE IDENTIFIER.—The Secretary 

2 shall assign to each clinical trial registered 

3 under subparagraph (A) a unique identifier for 

4 purposes of the data bank. The Secretary shall 

5 seek to ensure that such identifiers comply with 

6 international standards for identifying clinical 

7 trials. 

8 ‘‘(E) MODIFICATIONS REGARDING RE9 QUIRED INFORMATION.—Notwithstanding 

10 clauses (i) through (xvi) of subparagraph (A), 

11 requirements under such clauses may be modi12 fied by the Secretary, and additional require13 ments for the provision of information in reg14 istrations under such subparagraph may be es15 tablished by the Secretary, in order to ensure 

16 the nonmisleading disclosure of important infor17 mation from clinical trials. 

18 ‘‘(2) SUBMISSION OF RESULTS OF TRIAL.— 

19 ‘‘(A) IN GENERAL.—The responsible per20 son for a clinical trial that is subject to sub21 section (c)(1) shall provide to the Secretary in22 formation described in subparagraph (B) on the 

23 results of the trial, subject to subparagraph 

24 (D). The information shall be provided in the 

25 form of a structured abstract and in such man-
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1 ner as the Secretary may require, in a form not 

2 likely to mislead or distort the results. 

3 ‘‘(B) INFORMATION.—For purposes of sub4 paragraph (A), the information described in 

5 this subparagraph on the results of a clinical 

6 trial is the following: 

7 ‘‘(i) The actual completion date of the 

8 trial and the reasons for any difference 

9 from such actual date and the estimated 

10 completion date submitted pursuant to 

11 paragraph (1)(A)(ix), or, if the trial is ter12 minated prior to completion, the termi13 nation date and reasons for such termi14 nation. 

15 ‘‘(ii) Primary and secondary out16 comes, presented succinctly as quantitative 

17 data and as tests of hypotheses. 

18 ‘‘(iii) Information on the number and 

19 type of significant adverse events in sub20 jects that may be associated with the prod21 uct involved, including such events for 

22 which a causal relationship has not been 

23 established. 

24 ‘‘(iv) A citation to each covered article 

25 published in a peer-reviewed scientific or 
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1 academic journal. An article published in 

2 such a journal is a covered article for pur3 poses of this clause if— 

4 ‘‘(I) the article discusses the re5 sults of the trial; 

6 ‘‘(II) the responsible person or 

7 the principal investigator for the clin8 ical trial contributed to the article; 

9 and 

10 ‘‘(III) MEDLINE includes a ci11 tation to the article. 

12 ‘‘(v) A description of the process used 

13 to review the results of the trial, including 

14 a statement about whether the results have 

15 been peer reviewed by reviewers inde16 pendent of the sponsor. 

17 ‘‘(vi) If the trial is investigating an 

18 unapproved product or an unapproved use 

19 of an approved product, a statement, as 

20 appropriate, displayed prominently at the 

21 beginning of information in the data bank 

22 concerning the trial, that the Food and 

23 Drug Administration— 

24 ‘‘(I) is currently reviewing an ap25 plication for approval of such product 
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1 or use to determine whether the use is 

2 safe and effective; 

3 ‘‘(II) has disapproved an applica4 tion for approval of such product or 

5 use; 

6 ‘‘(III) has reviewed an applica7 tion for approval of such product or 

8 use but the application was withdrawn 

9 prior to approval or disapproval; or 

10 ‘‘(IV) has not reviewed or ap11 proved such product or use as safe 

12 and effective. 

13 ‘‘(vii) If data from the trial has not 

14 been submitted to the Food and Drug Ad15 ministration, an explanation of why it has 

16 not been submitted. 

17 ‘‘(viii) A statement providing such in18 formation on the protocol for the trial as 

19 may be necessary to evaluate the results of 

20 the trial. Criteria issued by the Secretary 

21 under subsection (k) shall include criteria 

22 regarding information that is required for 

23 purposes of such statements. 

24 ‘‘(ix) In the group of subjects receiv25 ing the product, and in each comparison 
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1 group of subjects, the percentage of indi2 viduals who ceased participation as sub3 jects and the reasons for ceasing participa4 tion. 

5 ‘‘(x) Basic demographic information 

6 on subjects. 

7 ‘‘(xi) With respect to an individual 

8 who is not an employee of the responsible 

9 person for the trial or of the manufacturer 

10 of the product involved, information (to the 

11 extent not submitted under paragraph 

12 (1)(A)(xvi) on any agreement that the re13 sponsible person or manufacturer has en14 tered into with such individual that re15 stricts in any manner the ability of the in16 dividual to— 

17 ‘‘(I) discuss the results of the 

18 trial at a scientific meeting or any 

19 other public or private forum; or 

20 ‘‘(II) publish the results of the 

21 trial, or a description or discussion of 

22 the results of the trial, in a scientific 

23 or academic journal. 

24 ‘‘(xii) After the initial submission of 

25 information on the results, periodic up-
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1 dates to reflect changes in the information 

2 submitted pursuant to this subparagraph. 

3 Such updates— 

4 ‘‘(I) shall be provided not less 

5 frequently than once every six months 

6 during the 10-year period beginning 

7 on the date on which information on 

8 the results is due under subparagraph 

9 (C)(i); and 

10 ‘‘(II) shall identify the dates on 

11 which the changes were made. 

12 ‘‘(C) DUE DATE FOR RESULTS.— 

13 ‘‘(i) IN GENERAL.—Information re14 quired under subparagraph (A) on the re15 sults of a clinical trial shall be submitted 

16 to the Secretary— 

17 ‘‘(I) not later than one year after 

18 the earlier of— 

19 ‘‘(aa) the estimated comple20 tion date of the trial, as sub21 mitted under paragraph 

22 (1)(A)(ix); or 

23 ‘‘(bb) the actual completion 

24 date of the trial, or the actual 

25 date of the termination of the 
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1 trial before completion, as appli2 cable; or 

3 ‘‘(II) by such later date as may 

4 apply under an extension under clause 

5 (iii). 

6 ‘‘(ii) REPORTS REGARDING DUE DATE

7 IN EXCESS OF THREE YEARS.—If the due 

8 date under clause (i) for information on 

9 the results of a clinical trial is a date that 

10 is more than three years after the date on 

11 which the trial was registered under para12 graph (1)(A), the following applies: 

13 ‘‘(I) Upon the expiration of such 

14 three-year period, the responsible per15 son for the trial shall submit to the 

16 Secretary a report that describes the 

17 progress being made toward submis18 sion of the results. 

19 ‘‘(II) For each one-year period 

20 that lapses after the submission of the 

21 report under subclause (I), the re22 sponsible person shall submit to the 

23 Secretary an additional report that 

24 describes such progress, except that 
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1 no report is required under this sub2 clause after such due date. 

3 ‘‘(iii) EXTENSIONS.— 

4 ‘‘(I) IN GENERAL.—The Sec5 retary may provide an extension of 

6 the due date under clause (i)(I) for in7 formation on the results of a clinical 

8 trial if the responsible person for the 

9 trial submits to the Secretary a writ10 ten request that demonstrates good 

11 cause for the extension and provides 

12 an estimate of the date on which in13 formation on the results will be sub14 mitted. More than one such extension 

15 may be provided by the Secretary for 

16 the clinical trial involved. 

17 ‘‘(II) EXTENSIONS REGARDING

18 JOURNAL PUBLICATION.— 

19 ‘‘(aa) ARTICLE UNDER CON20 SIDERATION FOR PUBLICA21 TION.—With respect to the sub22 mission of information on the re23 sults of a clinical trial, the Sec24 retary shall under subclause (I) 

25 provide an extension of 18 
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1 months after the due date under 

2 clause (i)(I) (or if such an exten3 sion previously has been pro4 vided, 18 months beginning upon 

5 the expiration of the most recent 

6 extension) if— 

7 ‘‘(AA) the request 

8 under such subclause dem9 onstrates that an article pro10 viding the information de11 scribed in subparagraph (B) 

12 has been submitted to a 

13 peer-reviewed scientific or 

14 academic journal for which 

15 references are included in 

16 MEDLINE, and the request 

17 demonstrates that the article 

18 is being considered by the 

19 journal for publication; and 

20 ‘‘(BB) such request is 

21 made before the expiration 

22 of the one-year period de23 scribed in clause (i)(I) (or if 

24 such an extension previously 

25 has been provided, before 
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1 the expiration of the most 

2 recent extension). 

3 ‘‘(bb) ARTICLE ACCEPTED

4 FOR PUBLICATION.—If the re5 sponsible person for a clinical 

6 trial has received an extension 

7 under item (aa) regarding the 

8 trial, the Secretary shall provide 

9 an additional extension of six 

10 months, beginning upon the expi11 ration of such first extension, if 

12 the person demonstrates to the 

13 Secretary, before the expiration 

14 of the first extension, that the ar15 ticle involved has been accepted 

16 for publication by a journal re17 ferred to in such item. 

18 ‘‘(cc) PUBLICATION DURING

19 PERIOD OF EXTENSION.—With 

20 respect to an extension under 

21 item (aa) or (bb), if during the 

22 period of extension the article in23 volved is published in a journal 

24 referred to in item (aa)— 
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1 ‘‘(AA) the extension 

2 terminates upon publication 

3 of the article; and 

4 ‘‘(BB) the due date 

5 under clause (i) regarding 

6 the clinical trial involved be7 comes the date of such pub8 lication. 

9 ‘‘(D) WAIVERS REGARDING RESULTS OF

10 TRIAL.—With respect to the requirement under 

11 subparagraph (A) to submit to the Secretary in12 formation on the results of a clinical trial, the 

13 Secretary may waive the requirement upon a 

14 written request to the Secretary by the respon15 sible person for the trial if the Secretary deter16 mines that extraordinary circumstances justify 

17 the waiver and that providing the waiver is in 

18 the public interest or consistent with the protec19 tion of the public health. The Secretary shall 

20 ensure that information on each such waiver is 

21 included in the data bank. 

22 ‘‘(3) UPDATES; TRACKING OF CHANGES IN SUB23 MITTED INFORMATION.—The Secretary shall ensure 

24 that updates submitted to the Secretary under para25 graphs (1)(A)(xvii) and (2)(B)(xii) do not result in 
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1 the removal from the data bank of the original sub2 missions or of any preceding updates, and that in3 formation in the data bank is presented in a manner 

4 that enables users to readily access each original 

5 submission and to track the changes made by the 

6 updates. 

7 ‘‘(e) ENFORCEMENT.— 

8 ‘‘(1) EFFECT OF FAILURE TO PROVIDE INFOR9 MATION.—In the case of a clinical trial that is sub10 ject to subsection (c)(1): 

11 ‘‘(A) Subject to paragraph (2), if the Sec12 retary determines that with respect to the trial 

13 the responsible person is not in compliance with 

14 requirements under subsection (d) to submit in15 formation to the Secretary, the following ap16 plies: 

17 ‘‘(i) Such person is subject to a civil 

18 penalty in accordance with paragraph (3). 

19 ‘‘(ii) The person is, during the period 

20 of such noncompliance, ineligible for any 

21 award from the Secretary of a grant, coop22 erative agreement, or contract for the con23 duct of any trial that is subject to sub24 section (c)(1), including all current awards 
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1 for such trials, except that such period of 

2 ineligibility may not exceed five years. 

3 ‘‘(iii) The person is subject to the 

4 sanction described in paragraph (4) (relat5 ing to the investigational use of products) 

6 if the noncompliance is serious or repeated. 

7 ‘‘(B) The submission to the Secretary of 

8 information under subsection (d) that is false or 

9 misleading constitutes noncompliance for pur10 poses of subparagraph (A). 

11 ‘‘(2) PROCEDURES REGARDING NONCOMPLI12 ANCE.— 

13 ‘‘(A) NOTICE OF NONCOMPLIANCE.—With 

14 respect to a clinical trial that is subject to sub15 section (c)(1), if the Secretary determines that 

16 the responsible person involved has not sub17 mitted information to the Secretary in accord18 ance with subsection (d), the Secretary— 

19 ‘‘(i) shall transmit to such person a 

20 notice specifying the required information 

21 and stating that the person will be subject 

22 to applicable sanctions referred to in para23 graph (1)(A) if the information is not sub24 mitted to the Secretary within 90 days 
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1 after the date on which the notice is trans2 mitted; 

3 ‘‘(ii) shall through the notice inform 

4 the person that under subsection (h) the 

5 person is being identified in the data bank 

6 as a noncompliant person; and 

7 ‘‘(iii) shall through the notice inform 

8 the person of the provisions of paragraph 

9 (8). 

10 ‘‘(B) FAILURE TO CORRECT NONCOMPLI11 ANCE.—Upon the expiration of the 90-day pe12 riod beginning on the date on which the Sec13 retary transmits a notice under subparagraph 

14 (A) to a responsible person, the Secretary shall 

15 impose on such person the sanctions referred to 

16 in clauses (i) and (ii) of paragraph (1)(A) if the 

17 information involved has not been submitted to 

18 the Secretary, except that the Secretary may 

19 elect not to impose such a sanction or sanctions 

20 if the Secretary determines that the noncompli21 ance involved is not serious or repeated. 

22 ‘‘(3) AMOUNT OF CIVIL PENALTY; HEARING

23 PROCEDURES.—With respect to a civil penalty im24 posed under paragraph (1)(A)(i) on a responsible 

25 person: 
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1 ‘‘(A) The amount of the penalty shall be 

2 not more than a total of $15,000 for all viola3 tions adjudicated in a single proceeding in the 

4 case of an individual, and not more than 

5 $10,000 per day until the violation is corrected 

6 in the case of any other person, except that if 

7 the person is a nonprofit entity the penalty may 

8 not exceed a total of $15,000 for all violations 

9 adjudicated in a single proceeding. 

10 ‘‘(B) The provisions of paragraphs (3) 

11 through (5) of section 303(f) of the Federal 

12 Food, Drug, and Cosmetic Act apply to the im13 position of such a penalty to the same extent 

14 and in the same manner as such provisions 

15 apply to a penalty imposed under such section 

16 303(f). 

17 ‘‘(4) ELIGIBILITY FOR INVESTIGATIONAL USE

18 EXEMPTIONS.—In any case in which the noncompli19 ance referred to in paragraph (1)(A) is serious or re20 peated, the Secretary may, upon the expiration of 

21 the 90-day period beginning on the date on which 

22 the Secretary transmits a notice under paragraph 

23 (2)(A) to the responsible person involved, consider 

24 such person to be ineligible for any future exemp25 tions under section 505(i) or 520(g) of the Federal 
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1 Food, Drug, and Cosmetic Act for any investigation 

2 until the violation is corrected, except that such pe3 riod of ineligibility may not exceed five years. The 

4 Secretary may impose such sanction only after no5 tice and an opportunity for a hearing, unless a hear6 ing regarding such noncompliance is held pursuant 

7 to paragraph (3) and through such hearing the Sec8 retary determines that the noncompliance was seri9 ous or repeated. 

10 ‘‘(5) FAILURE TO SUBMIT INFORMATION ON RE11 SULTS; REQUIREMENT OF REPORTS.—In any case in 

12 which the noncompliance referred to in paragraph 

13 (1)(A) is a failure to submit to the Secretary infor14 mation on the results of the trial by the due date 

15 under subsection (d)(2)(C)(i), the Secretary shall 

16 order the responsible person to submit to the Sec17 retary periodic reports on the progress being made 

18 toward submission of information on the results, 

19 which reports shall be submitted not less frequently 

20 that once each year until the information is sub21 mitted to the Secretary. 

22 ‘‘(6) RULE OF CONSTRUCTION.—With respect 

23 to a responsible person who is subject to a sanction 

24 referred to in paragraph (1)(A), this subsection may 

25 not be construed as providing that any other person 
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1 associated with the clinical trial involved is subject 

2 to the sanction. 

3 ‘‘(7) USE OF FUNDS.— 

4 ‘‘(A) IN GENERAL.—The Secretary shall 

5 deposit the funds collected under paragraph 

6 (1)(A) into an account and use such funds, in 

7 consultation with the Director of the Agency for 

8 Healthcare Research and Quality, to fund stud9 ies that compare the clinical effectiveness of two 

10 or more treatments for a disease or condition. 

11 ‘‘(B) FUNDING DECISIONS.—The Secretary 

12 shall award funding under subparagraph (A) 

13 based on a priority list established not later 

14 than six months after the date of enactment of 

15 the Fair Access to Clinical Trials Act by the 

16 Director of the Agency for Healthcare Research 

17 and Quality and periodically updated as deter18 mined appropriate by the Director. 

19 ‘‘(8) DISCLOSURE OF CERTAIN INFORMA20 TION.—In the case of a responsible person to whom 

21 a notice under paragraph (2) has been transmitted, 

22 if such person has not submitted the information in23 volved to the Secretary by the expiration of the 180- 

24 day period beginning on the date on which the notice 

25 was transmitted to the person, the following applies: 
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1 ‘‘(A) Notwithstanding section 301(j) of the 

2 Federal Food, Drug, and Cosmetic Act, section 

3 1905 of title 18, United States Code, subsection 

4 (j)(4)(C)(ii) of this section, or any other provi5 sion of law, the Secretary shall begin disclosure 

6 through the data bank of the definitions of the 

7 primary and secondary outcomes for the clinical 

8 trial involved unless the definitions have already 

9 been disclosed pursuant to subsection 

10 (j)(4)(C)(ii). 

11 ‘‘(B) Notwithstanding section 301(j) of the 

12 Federal Food, Drug, and Cosmetic Act, section 

13 1905 of title 18, United States Code, or any 

14 other provision of law, if the responsible person 

15 is the manufacturer or a distributor of the 

16 product involved, the Secretary shall through 

17 the data bank disclose information on the prod18 uct that— 

19 ‘‘(i) is required to be submitted under 

20 subsection (d); and 

21 ‘‘(ii) is included in any FDA applica22 tion for the product (as defined in sub23 section (l)) that the responsible person has 

24 submitted to the Secretary. 
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1 ‘‘(f) TRIALS CONDUCTED OUTSIDE UNITED

2 STATES.— 

3 ‘‘(1) IN GENERAL.—If a covered person submits 

4 to the Secretary an FDA application for a product 

5 (as defined in subsection (l)), and one or more of the 

6 investigations presented to the Secretary by such 

7 person for purposes of the document are covered for8 eign investigations, the person is subject to a civil 

9 penalty— 

10 ‘‘(A) in any case in which information on 

11 the investigation has not, as of the date on 

12 which the application is submitted to the Sec13 retary, been submitted to the data bank to the 

14 same extent as would have been required as of 

15 such date under subsection (d) if the investiga16 tion had been subject to subsection (c)(1); and 

17 ‘‘(B) in any case in which, after such date, 

18 information on the investigation is not sub19 mitted to the data bank to the same extent as 

20 would be required if the investigation were sub21 ject to subsection (c)(1). 

22 ‘‘(2) PROCEDURES.—The provisions of para23 graphs (2), (3), (6), and (7) of subsection (e) apply 

24 to a civil penalty under paragraph (1) to the same 
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1 extent and in the same manner as such provisions 

2 apply to a civil penalty under subsection (e)(1)(A). 

3 ‘‘(3) DEFINITIONS.—With respect to an FDA 

4 application for a product, for purposes of this sub5 section: 

6 ‘‘(A) The term ‘covered foreign investiga7 tion’ means an investigation that was not con8 ducted in any of the States and was not subject 

9 to subsection (c)(1). 

10 ‘‘(B) The term ‘covered person’ means the 

11 person who was the principal investigator or the 

12 responsible person for any of the covered for13 eign investigation or investigations involved. 

14 ‘‘(g) LABELING AND ADVERTISEMENTS.—- 

15 ‘‘(1) IN GENERAL.—If a person disseminates la16 beling, or an advertisement or other descriptive 

17 printed matter, for an approved product for human 

18 use and the labeling, advertisement, or other matter 

19 refers to an investigation that is not subject to sub20 section (c)(1), and if the person was the principal in21 vestigator or the responsible person for the inves22 tigation, the person is subject to a civil penalty— 

23 ‘‘(A) in any case in which information on 

24 the investigation has not, as of the date on 

25 which the labeling, advertisement, or other mat-
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1 ter enters the market, been submitted to the 

2 data bank to the same extent as would have 

3 been required as of such date under subsection 

4 (d) if the investigation had been subject to sub5 section (c)(1); and 

6 ‘‘(B) in any case in which, after such date, 

7 information on the investigation is not sub8 mitted to the data bank to the same extent as 

9 would be required if the investigation were sub10 ject to subsection (c)(1). 

11 ‘‘(2) PROCEDURES.—The provisions of para12 graphs (2), (3), (6), and (7) of subsection (e) apply 

13 to a civil penalty under paragraph (1) to the same 

14 extent and in the same manner as such provisions 

15 apply to a civil penalty under subsection (e)(1)(A). 

16 ‘‘(h) PUBLIC LIST OF NONCOMPLIANT RESPONSIBLE

17 PERSONS.—In any case in which a notice of noncompli18 ance is submitted to a person under subsection (e)(2)(A), 

19 (f)(2), or (g)(2), the Secretary shall include with the infor20 mation in the data bank that concerns the clinical trial 

21 involved a statement, prominently displayed, that such 

22 person has not reported information to the data bank as 

23 required by law, which statement shall remain in the data 

24 bank until the information involved is submitted to the 

25 Secretary. For purposes of the preceding sentence, the 
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1 Secretary shall maintain a list of noncompliant persons 

2 that is available to the public. 

3 ‘‘(i) COMPLIANCE AUDITS.— 

4 ‘‘(1) IN GENERAL.—The Secretary shall con5 duct periodic audits of responsible persons for clin6 ical trials that are subject to subsection (c)(1) in 

7 order to determine whether such persons have sub8 mitted information as required in subsection (d), in9 cluding determining whether any of the information 

10 is false or misleading. 

11 ‘‘(2) PRIORITY.—In conducting audits under 

12 subparagraph (A), the Secretary shall give priority 

13 to responsible persons for clinical trials who have at 

14 any time been included on the list under subsection 

15 (h), taking into account the number and severity of 

16 the violations involved. 

17 ‘‘(j) GENERAL PROVISIONS.— 

18 ‘‘(1) AUTHORITY OF SECRETARY.— 

19 ‘‘(A) INCLUSION OF STATEMENTS TO

20 AVOID MISINTERPRETATIONS.—The Secretary 

21 may include in the data bank such statements 

22 as the Secretary determines to be appropriate 

23 to assist the public in avoiding misinterpreta24 tions of information in the data bank. State25 ments under the preceding sentence may in-
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1 clude statements regarding the data bank in 

2 general and statements regarding particular 

3 items of information submitted to the data 

4 bank. The Secretary may not under the pre5 ceding sentence alter any information as sub6 mitted. 

7 ‘‘(B) FALSE OR MISLEADING INFORMA8 TION.—If the Secretary determines that infor9 mation presented or cited in the data bank is 

10 false or misleading, the Secretary shall, prompt11 ly after making such determination, identify in 

12 the data bank the information as false or mis13 leading (as applicable), and shall, to the extent 

14 practicable, include in the data bank an accu15 rate version of the information. The Secretary 

16 shall in addition make appropriate public notifi17 cation. 

18 ‘‘(2) LIMITATION ON DISCLOSURES.—This sec19 tion may not be construed as authorizing the disclo20 sure of information through the data bank if— 

21 ‘‘(A) such disclosure would constitute a 

22 clearly unwarranted invasion of personal pri23 vacy; or 

24 ‘‘(B) such information concerns a method 

25 or process which as a trade secret is entitled to 
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1 protection within the meaning of section 301(j) 

2 of the Federal Food, Drug, and Cosmetic Act. 

3 ‘‘(3) INSTITUTIONAL REVIEW BOARDS.—The 

4 Secretary shall amend part 46 of title 45, Code of 

5 Federal Regulations, and parts 50, 56, and 812 of 

6 title 21 of Code, to provide as follows: 

7 ‘‘(A) That the functions of institutional re8 view boards under such parts include— 

9 ‘‘(i) determining whether clinical trials 

10 that are subject to subsection (c)(1) are 

11 registered under subsection (d)(1)(A); and 

12 ‘‘(ii) denying the approval of the 

13 boards for such trials that are not so reg14 istered. 

15 ‘‘(B) That any approval of an institutional 

16 review board regarding such a trial is not effec17 tive under such parts if the trial is not so reg18 istered. 

19 ‘‘(C) That upon request of an institutional 

20 review board for such a trial, the Secretary will 

21 provide to the board a copy of the registration 

22 for the trial under subsection (d)(1)(A) (which 

23 copy will be the registration as submitted to the 

24 Secretary, together with all updates to the reg25 istration). 
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1 ‘‘(4) DISCLOSURE OF INFORMATION.— 

2 ‘‘(A) IN GENERAL.—The Secretary shall 

3 disseminate information in the data bank 

4 through an Internet site or sites under subpara5 graph (B) and through any other means deter6 mined appropriate by the Secretary. Informa7 tion required in this section to be submitted to 

8 the Secretary shall not be considered confiden9 tial commercial information or trade secrets, 

10 notwithstanding any other provision of law. 

11 ‘‘(B) INTERNET SITES.— 

12 ‘‘(i) IN GENERAL.—The Secretary 

13 shall operate one or more searchable Inter14 net sites for purposes of presenting to cli15 nicians and researchers, and to patients 

16 seeking to enroll as subjects in clinical 

17 trials, information in the data bank. The 

18 Secretary shall ensure that— 

19 ‘‘(I) such a site, or a portion of 

20 a site, is designed specifically for use 

21 by clinicians and researchers; and 

22 ‘‘(II) such a site, or a portion of 

23 a site, is designed specifically for use 

24 by patients seeking to enroll as sub25 jects in clinical trials. 
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1 ‘‘(ii) RELATION TO CERTAIN INTER2 NET SITE.—The Secretary shall ensure 

3 that the Internet site or portion thereof op4 erated under clause (i)(II) includes infor5 mation of the type that was available on 

6 ClinicalTrials.gov as of the day before the 

7 date of the enactment of the Fair Access 

8 to Clinical Trials Act (relating to serious 

9 or life-threatening diseases). This section 

10 may not be construed as requiring the Sec11 retary to terminate or alter 

12 ClinicalTrials.gov, or as prohibiting the 

13 Secretary from terminating or altering 

14 such site. 

15 ‘‘(C) REGISTRATION INFORMATION; DATE

16 OF DISCLOSURE.—In the case of information 

17 regarding a clinical trial that is submitted to 

18 the Secretary under subsection (d)(1), disclo19 sures of the information through the data bank 

20 shall, subject to subsection (e)(8), begin in ac21 cordance with the following: 

22 ‘‘(i) All such disclosures shall begin 

23 promptly after the registration involved is 

24 submitted to the Secretary, other than dis-
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1 closure of the definitions of the primary 

2 and secondary outcomes. 

3 ‘‘(ii) Disclosure of the definition of 

4 the primary and secondary outcomes shall 

5 begin at the same time as disclosure of the 

6 results of the trial begin under subpara7 graph (D)(i), unless the responsible person 

8 for the trial requests earlier disclosure, or 

9 unless the Secretary requires earlier disclo10 sure pursuant to subparagraph (E)(ii). 

11 ‘‘(D) RESULTS OF TRIAL; DATE OF DIS12 CLOSURE.— 

13 ‘‘(i) IN GENERAL.—In the case of in14 formation regarding a clinical trial that is 

15 submitted to the Secretary under sub16 section (d)(2)(A), disclosures of the infor17 mation through the data bank shall begin 

18 promptly after the information is sub19 mitted to the Secretary, subject to clause 

20 (ii). 

21 ‘‘(ii) WAIVER REGARDING RESULTS

22 OF TRIAL.—In the case of information on 

23 waivers that is contained in the data bank 

24 under subsection (d)(2)(D), disclosures of 

25 the information through the data bank 
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1 shall begin promptly after the waiver is 

2 provided. 

3 ‘‘(E) STUDY REGARDING DATE FOR DIS4 CLOSURE OF PRIMARY AND SECONDARY OUT5 COMES; AUTHORITY OF SECRETARY.— 

6 ‘‘(i) IN GENERAL.—The Secretary, in 

7 consultation with appropriate government 

8 agencies, shall conduct a study to deter9 mine whether the delay in disclosure of the 

10 definitions of the primary and secondary 

11 outcomes under clause (ii) of subparagraph 

12 (C), relative to the timing of disclosures 

13 under clause (i) of such subparagraph, is 

14 consistent with the protection of the public 

15 health. Not later than three years after the 

16 date of the enactment of the Fair Access 

17 to Clinical Trials Act, the Secretary shall 

18 complete the study and submit to the ap19 propriate committees of the Congress a re20 port describing the findings of the study. 

21 ‘‘(ii) AUTHORITY OF SECRETARY.—If 

22 on the basis of the study under clause (i) 

23 the Secretary determines that the delay re24 ferred to in such clause is not consistent 

25 with the protection of the public health, 
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1 the Secretary shall by regulation establish 

2 an earlier date for disclosures of the defini3 tions referred to in such clause, which date 

4 may not be earlier than the date of disclo5 sures under subparagraph (C)(i). A final 

6 rule shall be issued under the preceding 

7 sentence not later than one year after the 

8 date on which the report under clause (i) 

9 of this subparagraph is submitted to the 

10 appropriate committees of the Congress. 

11 ‘‘(5) LIMITATION ON USE OF INFORMATION.— 

12 Information on a clinical trial that is disclosed 

13 through the data bank, including information dis14 closed under subsection (e)(8), may not be used by 

15 a person other than the responsible person for the 

16 trial (or an entity acting with the permission of such 

17 person) as part of any FDA application (as defined 

18 in subsection (l)) unless the information is available 

19 in accordance with law from a source other than the 

20 data bank. 

21 ‘‘(6) SUBMISSION FORMAT AND TECHNICAL

22 STANDARDS.— 

23 ‘‘(A) IN GENERAL.—The Secretary shall, 

24 to the extent practicable, accept submissions re25 quired in subsection (d) in an electronic format 
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1 and shall establish interoperable technical 

2 standards for such submissions. 

3 ‘‘(B) CONSISTENCY OF STANDARDS.—To 

4 the extent practicable, the standards established 

5 under subparagraph (A) shall be consistent 

6 with standards adopted by the Consolidated 

7 Health Informatics Initiative (or a successor or8 ganization to such Initiative) to the extent such 

9 Initiative (or successor) is in operation. 

10 ‘‘(7) TRIALS NOT INVOLVING DRUGS, BIOLOGI11 CAL PRODUCTS, OR DEVICES.—The Secretary shall 

12 establish procedures and mechanisms to allow for 

13 the voluntary submission to the Secretary of infor14 mation described in subsection (d)(2)(B) on clinical 

15 trials that are not subject to subsection (c)(1). Infor16 mation received by the Secretary under this para17 graph shall be included in the data bank. In any 

18 case in which it is in the interest of public health, 

19 the Secretary may require that information on such 

20 trials be submitted to the Secretary. Failure to com21 ply with such a requirement shall be deemed to be 

22 a failure to submit information as required under 

23 this section, and the appropriate remedies and sanc24 tions under this section shall apply. 
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1 ‘‘(8) AWARD FOR CONDUCT OF CLINICAL TRIAL; 

2 COMPLIANCE COSTS AS DIRECT COSTS.—In admin3 istering an award of a grant, contract, or coopera4 tive agreement that is subject to subsection (c)(1), 

5 the Secretary shall consider the costs of complying 

6 with requirements under this section as part of the 

7 direct costs of conducting the clinical trial involved. 

8 ‘‘(k) CRITERIA.—The Secretary shall establish cri9 teria regarding compliance with this section. 

10 ‘‘(l) DEFINITIONS.—For purposes of this section: 

11 ‘‘(1) The term ‘approved product’ means a 

12 product that is approved, licensed, or cleared for 

13 commercial distribution under section 505, 510(k), 

14 or 515 of the Federal Food, Drug, and Cosmetic Act 

15 or under section 351 of this Act. 

16 ‘‘(2) The term ‘approved use’, with respect to 

17 an approved product, means a use that is an ap18 proved, licensed, or cleared use of the product under 

19 a provision of law referred to in paragraph (1). 

20 ‘‘(3) The term ‘biological product’ has the 

21 meaning given such term in section 351. 

22 ‘‘(4) The term ‘classified’, with respect to infor23 mation, means information on matters referred to in 

24 section 552(b)(1)(A) of title 5, United States Code. 
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1 ‘‘(5) The term ‘clinical trial’, with respect to a 

2 product, means a clinical investigation within the 

3 meaning of section 505(i) of the Federal Food, 

4 Drug, and Cosmetic Act (in the case of drug), or 

5 within the meaning of section 520(g) of such Act (in 

6 the case of a device), as applicable, except that such 

7 term does not include such an investigation that 

8 does not prospectively assign human subjects to 

9 intervention or comparison groups to study the caus10 al relationship between a medical intervention and 

11 an outcome. 

12 ‘‘(6) The term ‘data bank’ means the data bank 

13 under subsection (a). 

14 ‘‘(7) The term ‘device’ has the meaning given 

15 such term in section 201(h) of the Federal Food, 

16 Drug, and Cosmetic Act. 

17 ‘‘(8) The term ‘drug’ has the meaning given 

18 such term in section 201(g)(1) of the Federal Food, 

19 Drug, and Cosmetic Act. Such term includes a bio20 logical product. 

21 ‘‘(9) The term ‘FDA application’, with respect 

22 to a product, means each of the following: 

23 ‘‘(A) An application or report submitted to 

24 the Secretary for the purpose of seeking a deci25 sion by the Secretary for the product to become 
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1 an approved product (as defined in paragraph 

2 (1)). Such term includes a supplement to such 

3 an application or report. 

4 ‘‘(B) An application for an exemption 

5 under section 505(i) or 520(g) of the Federal 

6 Food, Drug, and Cosmetic Act (relating to in7 vestigational use). 

8 ‘‘(10) The term ‘MEDLINE’ means the biblio9 graphic electronic data base of references to journal10 published articles that is operated by the National 

11 Library of Medicine and is designated by such Li12 brary as the Medical Literature, Analysis, and Re13 trieval System Online. 

14 ‘‘(11) The term ‘postmarket’, with respect to a 

15 clinical trial to investigate a product, means a clin16 ical trial that is conducted after the product has be17 come an approved product. 

18 ‘‘(12) The term ‘product’ means a drug, biologi19 cal product, or device. 

20 ‘‘(13) The term ‘responsible person’, with re21 spect to a clinical trial that is subject to subsection 

22 (c)(1), has the following meaning, as applicable: 

23 ‘‘(A) In any case in which an application 

24 has with respect to the trial been submitted for 

25 an exemption under section 505(i) or 
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1 520(g)(2)(A) of the Federal Food, Drug, and 

2 Cosmetic Act, such term means the entity who, 

3 within the meaning of such section, is the spon4 sor of the trial. 

5 ‘‘(B) In any case in which such an applica6 tion has not been submitted, such term means 

7 the entity who is or will be providing the largest 

8 share of the monetary support for the trial 

9 (without regard to any in-kind support for the 

10 trial), subject to the following: 

11 ‘‘(i) If the Federal Government or a 

12 State is or will be providing the largest 

13 share, such term means the principal in14 vestigator for the trial. 

15 ‘‘(ii) If a nonprofit private entity is or 

16 will be providing the largest share, such 

17 term means the principal investigator for 

18 the trial in any case in which such entity 

19 and investigator have jointly certified to 

20 the Secretary that the investigator will be 

21 the responsible person for purposes of this 

22 section. 

23 ‘‘(iii) If two or more entities provide 

24 equal monetary support for the trial and 

25 no other entity provides a greater amount 
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1 of monetary support, such term means 

2 each of the entities providing such equal 

3 support, other than the Federal Govern4 ment or a State. 

5 ‘‘(iv) Notwithstanding clauses (i) 

6 through (iii), if an entity submits to the 

7 Secretary a written request to be the re8 sponsible person for purposes of this sec9 tion, such term means that entity in any 

10 case in which the Secretary determines 

11 that the entity is responsible for con12 ducting the trial, has access to and control 

13 over the data, has the right to publish the 

14 results of the trial, and has the responsi15 bility to meet all of the requirements under 

16 this section that are applicable to respon17 sible persons. 

18 ‘‘(14) The term ‘unapproved product’ means a 

19 product that is not an approved product. 

20 ‘‘(15) The term ‘unapproved use’, with respect 

21 to an approved product, means a use that is not an 

22 approved use. 

23 ‘‘(m) AUTHORIZATION OF APPROPRIATIONS.—For 

24 the purpose of carrying out this section, there are author25 ized to be appropriated such sums as may be necessary 
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1 for fiscal year 2005 and each subsequent fiscal year. Fees 

2 collected under section 736 or 738 of the Federal Food, 

3 Drug, and Cosmetic Act shall not be used in carrying out 

4 this section.’’. 

5 (b) APPLICABILITY.—With respect to section 402A of 

6 the Public Health Service Act (as added by subsection (a) 

7 of this section): 

8 (1) Subject to paragraphs (2) and (3), such 

9 section 402A applies to all clinical trials that are 

10 commenced on or after the date of the enactment of 

11 this Act, or are in progress as of such date, to the 

12 extent the trials are described in subsection (c)(1) of 

13 such section and not within an exception under sub14 section (c)(2) of such section. 

15 (2) For purposes of paragraph (1), such section 

16 402A applies to a trial that is in progress only if the 

17 final data collection from subjects in the trial on the 

18 primary outcome has not been completed as of the 

19 date of the enactment of this Act. Such a trial be20 comes subject to such section upon the expiration of 

21 30 days after such date of enactment, except that 

22 registration information required pursuant to sub23 section (d)(1) of such section is due upon the expira24 tion of such 30 days. 
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1 (3) The Secretary of Health and Human Serv2 ices (referred to in this paragraph as the ‘‘Sec3 retary’’) shall establish procedures and mechanisms 

4 to allow for the voluntary submission to the Sec5 retary of information described in subsection 

6 (d)(2)(B) of such section 402A on clinical trials that 

7 were completed prior to such date of enactment, or 

8 were in progress as of such date but not subject to 

9 paragraph (2). Information received by the Sec10 retary under this paragraph shall be included in the 

11 data bank. In any case in which it is in the interest 

12 of public health, the Secretary may require that in13 formation on such trials be submitted to the Sec14 retary. Failure to comply with such a requirement 

15 shall be deemed to be a failure to submit informa16 tion as required under such section, and the appro17 priate remedies and sanctions under such section 

18 shall apply. 

19 (4) Definitions applicable to such section 402A 

20 apply for purposes of this subsection. 

21 (c) RULE OF CONSTRUCTION REGARDING PRIOR

22 PROVISION.—With respect to the data bank program 

23 under section 402(j) of the Public Health Service Act as 

24 in effect on the day before the date of the enactment of 

25 this Act: 
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1 (1) Subsection (a) shall be construed as a 

2 transfer and modification of the program, and not as 

3 the termination of the program and the establish4 ment of a different program. 

5 (2) All information contained in the data bank 

6 on such day shall continue to be contained in the 

7 data bank, subject to section 402A of the Public 

8 Health Service Act (as added by subsection (a) of 

9 this section) or other applicable provisions of law. 

10 (d) CONFORMING AMENDMENTS.—Chapter V of the 

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

12 et seq.) is amended— 

13 (1) in section 505(i), by adding at the end the 

14 following paragraph: 

15 ‘‘(5) The provision of an exemption under paragraph 

16 (1) is subject to section 402A(e)(4) of the Public Health 

17 Service Act (relating to a data bank on clinical trials).’’; 

18 and 

19 (2) in section 520(g), by adding at the end the 

20 following paragraph: 

21 ‘‘(8) The provision of an exemption under paragraph 

22 (2)(A) is subject to section 402A(e)(4) of the Public 

23 Health Service Act (relating to a data bank on clinical 

24 trials).’’. 
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1 SEC. 3. REPORTS. 

2 (a) IMPLEMENTATION REPORT.—Not later than one 

3 year after the date of enactment of this Act, the Secretary 

4 of Health and Human Services (referred to in this section 

5 as the ‘‘Secretary’’) shall submit to the appropriate com6 mittees of the Congress a report on the status of the im7 plementation of the requirements of the amendments 

8 made by section 2 that includes a description of the num9 ber and types of clinical trials for which information has 

10 been submitted under such amendments. 

11 (b) DATA COLLECTION.— 

12 (1) IN GENERAL.—The Secretary shall request 

13 the Institute of Medicine to enter into a contract 

14 with the Secretary for the conduct of a study con15 cerning the extent to which information submitted to 

16 the data bank under section 402A of the Public 

17 Health Service Act (as added by section 2(a)) has 

18 impacted the public health. 

19 (2) REPORT.—The Secretary shall ensure that 

20 the contract under paragraph (1) provides that, not 

21 later than six months after the date on which a con22 tract is entered into, the Institute of Medicine will 

23 submit to the Secretary a report on the results of 

24 the study under such paragraph, and that the report 

25 may include any recommendations of the Institute 

26 for changes to the program carried out under the 
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1 section referred to in such paragraph that the Insti2 tute considers appropriate to benefit the public 

3 health. 

Æ