I 

108TH CONGRESS 

2D SESSION H. R. 5252 

To amend the Public Health Service Act and the Federal Food, Drug, 

and Cosmetic Act with respect to the availability to the public of information on clinical trials to determine the safety and effectiveness of drugs, 

biological products, and devices, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

OCTOBER 7, 2004 

Mr. MARKEY (for himself and Mr. WAXMAN) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Public Health Service Act and the Federal 

Food, Drug, and Cosmetic Act with respect to the availability to the public of information on clinical trials to 

determine the safety and effectiveness of drugs, biological 

products, and devices, 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’’. 
2 

•HR 5252 IH 

1 SEC. 2. REGISTRATION OF CLINICAL TRIALS UNDER PUB2 LIC HEALTH SERVICE ACT. 

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

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

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

6 and 

7 (2) by inserting after section 491 the following 

8 section: 

9 ‘‘SEC. 491A. REGISTRATION OF CLINICAL TRIALS; DATA 

10 BANK. 

11 ‘‘(a) IN GENERAL.— 

12 ‘‘(1) CONDITIONS FOR FINANCIAL AWARDS.— 

13 Except as provided in paragraph (2), an entity may 

14 not receive an award of a grant, contract, or cooper15 ative agreement under this Act for the conduct of a 

16 clinical trial to determine the safety or effectiveness 

17 of a use of a drug or device (referred to in this sec18 tion as a ‘product’) unless the responsible person for 

19 the trial— 

20 ‘‘(A) agrees to register the trial with the 

21 Secretary in accordance with subsection (d)(1); 

22 ‘‘(B) agrees to provide to the Secretary in23 formation on the results of the trial in accord24 ance with subsection (d)(2); 
3 

•HR 5252 IH 

1 ‘‘(C) agrees to the disclosure to the public 

2 of information regarding the trial in accordance 

3 with subsection (e); and 

4 ‘‘(D) agrees to be subject to audits under 

5 subsection (f)(1), and as applicable, to liq6 uidated penalties and the requirement to submit 

7 reports under subsection (g)(1). 

8 ‘‘(2) EXCEPTION.—Paragraph (1) does not 

9 apply to a clinical trial to determine the safety of a 

10 use of a drug if the trial is designed solely to detect 

11 major toxicities in the drug or to investigate phar12 macokinetics, except that such paragraph does apply 

13 if the trial is designed solely to investigate phar14 macokinetics in a special population or populations. 

15 ‘‘(b) DATA BANK.— 

16 ‘‘(1) IN GENERAL.— The Secretary, acting 

17 through the Director of NIH, shall establish, main18 tain, and operate a data bank of information pro19 vided to the Secretary pursuant to subsection (a), 

20 including collecting, cataloging, and storing the in21 formation, and disseminating the information in ac22 cordance with subsection (e). The activities of the 

23 data bank shall be integrated and coordinated with 

24 related activities of other agencies of the Depart25 ment of Health and Human Services, and to the ex-
4 

•HR 5252 IH 

1 tent practicable, coordinated with other data banks 

2 containing similar information. 

3 ‘‘(2) INFORMATION FROM ELECTIVE SUBMIS4 SIONS.— 

5 ‘‘(A) CLINICAL TRIALS REGARDING DRUGS

6 OR DEVICES.—The Secretary may accept for in7 clusion in the data bank information on clinical 

8 trials that are trials to determine the safety or 

9 effectiveness of a use of a product but are not 

10 subject to requirements under subsection (a). 

11 The inclusion of information in the data bank 

12 under the preceding sentence is subject to the 

13 condition that the responsible person for the 

14 clinical trial involved make each of the agree15 ments described in subsection (a)(1). 

16 ‘‘(B) OTHER CLINICAL TRIALS.—The Sec17 retary may accept for inclusion in the data 

18 bank information on clinical trials that do not 

19 involve drugs or devices if the responsible per20 son for the trial involved agrees to such condi21 tions regarding the submission and disclosure of 

22 the information as the Secretary determines to 

23 be appropriate, taking into account the require24 ments of this section for clinical trials that do 

25 involve drugs or devices. 
5 

•HR 5252 IH 

1 ‘‘(3) CONSULTATION.—The Secretary shall op2 erate the data bank in consultation with the Com3 missioner of Food and Drugs, the directors of the 

4 appropriate agencies of the National Institutes of 

5 Health, and the Director of the Centers for Disease 

6 Control and Prevention. 

7 ‘‘(4) NATIONAL LIBRARY OF MEDICINE.—The 

8 Director of NIH shall assign to the National Library 

9 of Medicine the primary responsibility for carrying 

10 out paragraph (1). 

11 ‘‘(5) ENTRY OF INFORMATION.—Information 

12 provided to the Secretary under this section by re13 sponsible persons for clinical trials shall be entered 

14 in the data bank promptly after the Secretary re15 ceives the information, except to the extent that the 

16 Secretary determines that the information has not 

17 been submitted to the Secretary in accordance with 

18 this section, in which case the Secretary shall 

19 promptly inform the responsible person involved that 

20 corrective actions by the person are necessary to 

21 maintain compliance with this section. 

22 ‘‘(6) AUTHORITY OF SECRETARY.— 

23 ‘‘(A) INCLUSION OF STATEMENTS TO

24 AVOID MISINTERPRETATIONS.—The Secretary 

25 may include in the data bank such statements 
6 

•HR 5252 IH 

1 as the Secretary determines to be appropriate 

2 to assist the public in avoiding misinterpreta3 tions of information in the data bank. State4 ments under the preceding sentence may in5 clude statements regarding the data bank in 

6 general and statements regarding particular 

7 items of information submitted to the data 

8 bank. The Secretary may not under the pre9 ceding sentence alter any information as sub10 mitted. 

11 ‘‘(B) FALSE OR MISLEADING INFORMA12 TION.— 

13 ‘‘(i) IN GENERAL.—If under sub14 section (f) the Secretary determines that 

15 information presented or cited in the data 

16 bank is false or misleading, the Secretary 

17 shall, promptly after making such deter18 mination, identify in the data bank the in19 formation as false or misleading (as appli20 cable), and shall, to the extent practicable, 

21 include in the data bank an accurate 

22 version of the information. The Secretary 

23 shall in addition make appropriate public 

24 notification. 
7 

•HR 5252 IH 

1 ‘‘(ii) LIMITATION.—Clause (i) does 

2 not authorize the disclosure of information 

3 if— 

4 ‘‘(I) the disclosure would con5 stitute a clearly unwarranted invasion 

6 of personal privacy; or 

7 ‘‘(II) the information concerns a 

8 method or process that is a trade se9 cret entitled to protection within the 

10 meaning of section 301(j) of the Fed11 eral Food, Drug, and Cosmetic Act. 

12 ‘‘(c) INSTITUTIONAL REVIEW BOARDS.—For pur13 poses of subsection (a), the Secretary shall amend part 

14 46 of title 45, Code of Federal Regulations, to provide 

15 that— 

16 ‘‘(1) the functions of institutional review boards 

17 under such part include— 

18 ‘‘(A) determining whether clinical trials to 

19 determine the safety or effectiveness of prod20 ucts are registered under subsection (a)(1)(A); 

21 and 

22 ‘‘(B) denying the approval of the boards 

23 for such trials that are not registered under 

24 such subsection; 
8 

•HR 5252 IH 

1 ‘‘(2) any approval of an institutional review 

2 board regarding such a trial is not effective under 

3 such part if the trial is not registered under such 

4 subsection; and 

5 ‘‘(3) upon request of an institutional review 

6 board for such a trial, the Secretary will provide to 

7 the board a copy of the registration for the trial 

8 under such subsection (which copy will be the reg9 istration as submitted to the Secretary, together 

10 with all updates to the registration). 

11 ‘‘(d) SUBMISSION OF REQUIRED INFORMATION.— 

12 ‘‘(1) SUBMISSION OF REGISTRATION INFORMA13 TION.— 

14 ‘‘(A) IN GENERAL.—A registration of a 

15 clinical trial under subsection (a)(1)(A) is in ac16 cordance with this paragraph if, subject to sub17 paragraph (B), the registration is in such form 

18 and is submitted in such manner as the Sec19 retary requires, and the registration contains 

20 such information on the design and goals of the 

21 trial as the Secretary determines to be impor22 tant to clinicians or researchers. Such informa23 tion shall include the following: 

24 ‘‘(i) A brief title for the trial, provided 

25 in lay language. 
9 

•HR 5252 IH 

1 ‘‘(ii) The disease or condition with 

2 which the trial is concerned. 

3 ‘‘(iii) The medical intervention or 

4 interventions being investigated in the 

5 trial. 

6 ‘‘(iv) A statement that— 

7 ‘‘(I) identifies the product as an 

8 unapproved product or as an approved 

9 product, as applicable; and 

10 ‘‘(II) in addition, in the case of 

11 an approved product, identifies the 

12 trial as investigating the approved use 

13 of the product or an unapproved use 

14 of the product, as applicable. 

15 ‘‘(v) The purpose of the trial, includ16 ing a statement of the interventions and 

17 comparisons involved. 

18 ‘‘(vi) A statement of the hypothesis 

19 being tested in the trial. 

20 ‘‘(vii) Information on— 

21 ‘‘(I) study design; 

22 ‘‘(II) methods; 

23 ‘‘(III) study phase; and 

24 ‘‘(IV) study type. 
10 

•HR 5252 IH 

1 ‘‘(viii) The definition of the primary 

2 and secondary outcomes for the trial. 

3 ‘‘(ix) The length of time for which 

4 data on the primary and secondary out5 comes will be collected on each patient. 

6 ‘‘(x) Eligibility criteria for participa7 tion in the trial. 

8 ‘‘(xi) The total number of subjects an9 ticipated to participate in the trial. 

10 ‘‘(xii) The anticipated or actual date 

11 on which the trial will begin. 

12 ‘‘(xiii) The anticipated or actual date 

13 of final data collection from subjects in the 

14 trial on the primary outcome. 

15 ‘‘(xiv) The identity of each responsible 

16 person for the trial. 

17 ‘‘(xv) Sources of funding for the trial 

18 in addition to the award under this Act. 

19 ‘‘(xvi) The identity of the principal in20 vestigator in the trial. 

21 ‘‘(xvii) Contact information for the 

22 principal investigator. 

23 ‘‘(xviii) A unique protocol number 

24 identification number for the trial, which 

25 number shall be assigned by the Secretary. 
11 

•HR 5252 IH 

1 ‘‘(xix) After the initial submission of 

2 the registration, periodic updates to reflect 

3 changes to information provided under this 

4 subparagraph and subparagraph (B), 

5 which updates— 

6 ‘‘(I) are provided not less fre7 quently than once every six months 

8 until the results of the trial are sub9 mitted under paragraph (2)(A)(i) or a 

10 waiver is provided under paragraph 

11 (2)(C); and 

12 ‘‘(II) identify the dates on which 

13 the changes were made. 

14 ‘‘(B) SERIOUS OR LIFE-THREATENING DIS15 EASES; TEST OF EFFECTIVENESS.—In the case 

16 of a registration under subsection (a)(1)(A) of 

17 a clinical trial to test the effectiveness of the 

18 use of a product with respect to a serious or 

19 life-threatening disease or condition, the reg20 istration is in accordance with this paragraph 

21 if, in addition to the information described in 

22 subparagraph (A), the registration provides the 

23 following information: 

24 ‘‘(i) A brief summary of the trial, pro25 vided in lay language. 
12 

•HR 5252 IH 

1 ‘‘(ii) A description of the location of 

2 trial sites. 

3 ‘‘(iii) A point of contact for individ4 uals desiring to enroll as subjects in the 

5 trial, including a single point of contact for 

6 all trial sites. 

7 ‘‘(iv) The status of the trial with re8 spect to the enrollment of subjects, stated 

9 for the trial in general and for individual 

10 trial sites. 

11 ‘‘(v) Information that may be avail12 able— 

13 ‘‘(I) under a treatment investiga14 tional new drug application, or a 

15 treatment investigational device ex16 emption, that has been submitted to 

17 the Secretary under section 561(c) of 

18 the Federal Food, Drug, and Cos19 metic Act (relating to expanded access 

20 protocols); or 

21 ‘‘(II) as a Group C cancer drug 

22 (as defined by the National Cancer 

23 Institute). 

24 ‘‘(2) SUBMISSION OF RESULTS OF TRIAL.— 
13 

•HR 5252 IH 

1 ‘‘(A) IN GENERAL.—For purposes of sub2 section (a)(1)(B), information on the results of 

3 a clinical trial is provided in accordance with 

4 this paragraph if, subject to subparagraphs (B) 

5 and (C), the following conditions are met: 

6 ‘‘(i) The results are submitted— 

7 ‘‘(I) not later than 12 months 

8 after the earlier of the anticipated 

9 date that applies under paragraph 

10 (1)(A)(xiii) or the actual date that ap11 plies under such paragraph; or 

12 ‘‘(II) such later date as may 

13 apply under an extension under sub14 paragraph (B). 

15 ‘‘(ii) The results are provided in the 

16 form of a structured abstract and in such 

17 manner as the Secretary may require. 

18 ‘‘(iii) The results consist of informa19 tion determined by the Secretary to be im20 portant to clinicians or researchers, in a 

21 form that ensures that the information is 

22 accurate and not likely to mislead or dis23 tort the results of the trial. Such informa24 tion shall include the following: 
14 

•HR 5252 IH 

1 ‘‘(I) The date on which the trial 

2 commenced. 

3 ‘‘(II) The actual date for the 

4 final collection of data from subjects 

5 in the trial. 

6 ‘‘(III) Primary and secondary 

7 outcomes, presented succinctly as 

8 quantitative data and as tests of 

9 hypotheses. 

10 ‘‘(IV) Basic demographic infor11 mation on subjects. 

12 ‘‘(V) In the group of subjects re13 ceiving the product, and in each com14 parison group of subjects, the percent15 age of individuals who decided to 

16 cease participation as subjects and the 

17 reasons for ceasing participation. 

18 ‘‘(VI) Information on significant 

19 adverse events in subjects that may be 

20 associated with the product involved, 

21 including such events for which a 

22 causal relationship has not been es23 tablished. 

24 ‘‘(iv) If the trial is investigating an 

25 unapproved use of an approved product, a 
15 

•HR 5252 IH 

1 statement is submitted to the data bank 

2 that the Food and Drug Administration, 

3 as applicable— 

4 ‘‘(I) is currently reviewing an ap5 plication for approval of the unap6 proved use; 

7 ‘‘(II) has disapproved such an 

8 application; 

9 ‘‘(III) has reviewed such an ap10 plication, but the application was 

11 withdrawn prior to approval or dis12 approval; or 

13 ‘‘(IV) has not reviewed or ap14 proved such an application. 

15 ‘‘(v) After the initial submission of the 

16 results, periodic updates are submitted to 

17 the data bank to reflect changes in the in18 formation submitted under this subpara19 graph, which updates— 

20 ‘‘(I) are provided not less fre21 quently than once every six months 

22 during the 10-year period beginning 

23 on the date on which the results are 

24 due under clause (i); and 
16 

•HR 5252 IH 

1 ‘‘(II) identify the dates on which 

2 the changes were made. 

3 ‘‘(vi) For each covered article pub4 lished in a peer-reviewed scientific or aca5 demic journal, the responsible person for 

6 the trial submits to the data bank a state7 ment that provides a citation to the article. 

8 An article published in such a journal is a 

9 covered article for purposes of this clause 

10 if— 

11 ‘‘(I) the article discusses the re12 sults of the trial; 

13 ‘‘(II) the responsible person or 

14 the principal investigator for the clin15 ical trial contributed to the article; 

16 and 

17 ‘‘(III) MEDLINE includes a ci18 tation to the article. 

19 ‘‘(vii) If the due date under clause (i) 

20 for the trial is a date that is more than 

21 three years after the date on which the 

22 trial was registered under subsection 

23 (a)(1)(A): 

24 ‘‘(I) Upon the expiration of such 

25 three-year period, the responsible per-
17 

•HR 5252 IH 

1 son for the trial submits to the data 

2 bank a report that describes the 

3 progress being made toward submis4 sion of the results. 

5 ‘‘(II) For each two-year period 

6 that lapses after the submission of the 

7 report under subclause (I), the re8 sponsible person submits to the data 

9 bank an additional report that de10 scribes such progress, except that no 

11 report is required under this sub12 clause after such due date. 

13 ‘‘(B) EXTENSIONS.— 

14 ‘‘(i) IN GENERAL.—The Secretary 

15 may provide an extension of the due date 

16 under subparagraph (A)(i) for the results 

17 of a clinical trial if the responsible person 

18 for the trial submits to the Secretary a 

19 written request that demonstrates good 

20 cause for the extension and provides an es21 timate of the date on which the results will 

22 be submitted. More than one such exten23 sion may be provided by the Secretary for 

24 the clinical trial involved. 
18 

•HR 5252 IH 

1 ‘‘(ii) EXTENSIONS REGARDING JOUR2 NAL PUBLICATION.— 

3 ‘‘(I) ARTICLE UNDER CONSIDER4 ATION FOR PUBLICATION.—The Sec5 retary shall under clause (i) provide 

6 an extension of 18 months regarding 

7 the submission of the results of a clin8 ical trial if— 

9 ‘‘(aa) the request under such 

10 clause demonstrates that an arti11 cle providing the information de12 scribed in subparagraph (A)(iii) 

13 has been submitted to a peer-re14 viewed scientific or academic 

15 journal for which references are 

16 included in MEDLINE, and the 

17 request demonstrates that the ar18 ticle is being considered by the 

19 journal for publication; and 

20 ‘‘(bb) such request is made 

21 before the expiration of the 12- 

22 month period described in sub23 paragraph (A)(i). 

24 ‘‘(II) ARTICLE ACCEPTED FOR

25 PUBLICATION.—If the responsible per-
19 

•HR 5252 IH 

1 son for a clinical trial has received an 

2 extension under subclause (I) for the 

3 trial, the Secretary shall provide an 

4 additional extension of six months, be5 ginning upon the expiration of such 

6 first extension, if the person dem7 onstrates to the Secretary, before the 

8 expiration of the first extension, that 

9 the article involved has been accepted 

10 for publication by a journal referred 

11 to in such subclause. 

12 ‘‘(C) WAIVERS REGARDING RESULTS OF

13 TRIAL.—With respect to the requirement under 

14 subsection (a)(1)(B) to submit to the Secretary 

15 the results of a clinical trial, the Secretary may 

16 waive the requirement upon a written request to 

17 the Secretary by the responsible person for the 

18 trial if the Secretary determines that extraor19 dinary circumstances justify the waiver and 

20 that providing the waiver is in the public inter21 est or consistent with the protection of the pub22 lic health. The Secretary shall ensure that in23 formation on each such waiver is included in 

24 the data bank. 
20 

•HR 5252 IH 

1 ‘‘(3) TRACKING OF CHANGES IN INFORMATION

2 SUBMITTED TO DATA BANK.—The Secretary shall 

3 ensure that updates to the data bank submitted 

4 under paragraphs (1)(A)(xviii) and (2)(A)(v) do not 

5 result in the removal from the data bank of the 

6 original submissions or of any preceding updates, 

7 and that information in the data bank is presented 

8 in a manner that enables users to readily access 

9 each original submission and to track the changes 

10 made by the updates. 

11 ‘‘(e) PUBLIC DISCLOSURE OF INFORMATION.— 

12 ‘‘(1) IN GENERAL.—The Secretary shall dis13 seminate information in the data bank through in14 formation systems in accordance with this sub15 section. Information required in this section to be 

16 submitted to the data bank shall not be considered 

17 confidential commercial information or trade secrets, 

18 notwithstanding any other provision of law. 

19 ‘‘(2) PROHIBITION AGAINST FEES.— The Sec20 retary may not impose a fee for providing access to 

21 information in the data bank. 

22 ‘‘(3) INTERNET SITES.— 

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

24 operate one or more searchable Internet sites 

25 for purposes of presenting to clinicians and re-
21 

•HR 5252 IH 

1 searchers, and to patients seeking to enroll as 

2 subjects in clinical trials, information in the 

3 data bank that is required in paragraph (5) to 

4 be disclosed. The Secretary shall ensure that— 

5 ‘‘(i) such a site, or a portion of a site, 

6 is designed specifically for use by clinicians 

7 and researchers; and 

8 ‘‘(ii) such a site, or a portion of a site, 

9 is designed specifically for use by patients 

10 seeking to enroll as subjects in clinical 

11 trials. 

12 ‘‘(B) RELATION TO CERTAIN INTERNET

13 SITE.—The Secretary shall ensure that the 

14 Internet site or portion thereof operated under 

15 subparagraph (A)(ii) includes information of 

16 the type that was available on ClinicalTrials.gov 

17 as of the day before the date of the enactment 

18 of the Fair Access to Clinical Trials Act (relat19 ing to serious or life-threatening diseases). This 

20 section may not be construed as requiring the 

21 Secretary to terminate or alter 

22 ClinicalTrials.gov, or as prohibiting the Sec23 retary from terminating or altering such site. 

24 ‘‘(4) SPECIFIC MEANS OF DISCLOSURE.—With 

25 respect to information in the data bank that is re-
22 

•HR 5252 IH 

1 quired in paragraph (5) to be disclosed, all disclo2 sures shall be made through an Internet site or sites 

3 under paragraph (3) and any other means deter4 mined appropriate by the Secretary, except that in 

5 the case of information of the type referred to in 

6 paragraph (3)(B) and intended for patients seeking 

7 to enroll as subjects in clinical trials, the means of 

8 disclosure shall include toll-free telephone commu9 nications. 

10 ‘‘(5) REQUIRED DISCLOSURES; AUTHORITY OF

11 SECRETARY FOR EXCLUSIONS.— 

12 ‘‘(A) CLINICIANS AND RESEARCHERS.— 

13 With respect to means of disclosure under this 

14 subsection that are intended for clinicians and 

15 researchers, the Secretary shall through such 

16 means disclose all information in the data bank, 

17 except that the Secretary may exclude informa18 tion contained in the data bank pursuant to 

19 subsection (d)(1)(B) if the Secretary determines 

20 that such information is not useful to clinicians 

21 and researchers. 

22 ‘‘(B) PATIENTS SEEKING ENROLLMENT AS

23 SUBJECTS IN CLINICAL TRIALS.—With respect 

24 to means of disclosure under this subsection 

25 that are intended for patients seeking to enroll 
23 

•HR 5252 IH 

1 as subjects in clinical trials, the Secretary shall 

2 through such means disclose all information in 

3 the data bank, except that the Secretary may 

4 exclude any information that the Secretary de5 termines is not useful to such patients. The 

6 Secretary may not under the preceding sentence 

7 exclude information of the type referred to in 

8 paragraph (3)(B). 

9 ‘‘(6) REGISTRATION INFORMATION; DATE OF

10 DISCLOSURE.—In the case of information regarding 

11 a clinical trial that is contained in the data bank 

12 pursuant to subparagraph (A) or (B) of subsection 

13 (d)(1), disclosures required in paragraph (5) shall 

14 begin in accordance with the following: 

15 ‘‘(A) All such disclosures shall begin 

16 promptly after the registration involved is sub17 mitted to the Secretary, other than disclosure of 

18 the definitions of the primary and secondary 

19 outcomes. 

20 ‘‘(B) Disclosure of the definition of the pri21 mary and secondary outcomes shall begin at the 

22 same time as disclosure of the results of the 

23 trial begin under paragraph (7)(A). 

24 ‘‘(7) RESULTS OF TRIAL; DATE OF DISCLO25 SURE.— 
24 

•HR 5252 IH 

1 ‘‘(A) IN GENERAL.—In the case of infor2 mation regarding a clinical trial that is con3 tained in the data bank pursuant to subsection 

4 (d)(2), disclosures required in paragraph (5) 

5 shall begin promptly after the information is 

6 submitted to the Secretary, subject to subpara7 graph (B). 

8 ‘‘(B) WAIVER REGARDING RESULTS OF

9 TRIAL.—In the case of information contained in 

10 the data bank on waivers under subsection 

11 (d)(2)(C), disclosures required in paragraph (5) 

12 shall begin promptly after the waiver is pro13 vided. 

14 ‘‘(f) DETERMINATION OF VIOLATIONS.— 

15 ‘‘(1) COMPLIANCE AUDITS.— 

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

17 conduct periodic audits of responsible persons 

18 for clinical trials receiving awards described in 

19 subsection (a)(1) in order to determine whether 

20 the persons have submitted information as re21 quired under agreements under subparagraphs 

22 (A) and (B) of such subsection, including deter23 mining whether any of the information is false 

24 or misleading. 
25 

•HR 5252 IH 

1 ‘‘(B) PRIORITY.—In conducting audits 

2 under subparagraph (A), the Secretary shall 

3 give priority to responsible persons for clinical 

4 trials who have at any time been included on 

5 the list under subsection (g)(1)(A)(i), taking 

6 into account the number and severity of the vio7 lations involved. 

8 ‘‘(2) NOTICE TO RESPONSIBLE PERSONS.— 

9 Promptly after determining that a responsible per10 son for a clinical trial is in violation of a require11 ment under subparagraph (A) or (B) of subsection 

12 (a)(1), the Secretary shall notify the person in writ13 ing of the violation. 

14 ‘‘(g) ACTIONS OF SECRETARY REGARDING VIOLA15 TIONS.— 

16 ‘‘(1) IN GENERAL.—If a responsible person for 

17 a clinical trial is in violation of an agreement under 

18 subparagraph (A) or (B) of subsection (a)(1) (in19 cluding submitting information under such a sub20 paragraph that is false or misleading), the following 

21 applies, subject to paragraph (4) of this subsection: 

22 ‘‘(A) In any case in which the violation is 

23 not corrected within 30 days after the Secretary 

24 provides to the responsible person a notice 

25 under subsection (f)(2) regarding the violation: 
26 

•HR 5252 IH 

1 ‘‘(i) Through Internet sites under sub2 section (e)(3) and such other means as the 

3 Secretary determines to be appropriate, the 

4 Secretary shall announce to the public that 

5 the responsible person is in violation of 

6 this section. For purposes of the preceding 

7 sentence, the Secretary shall maintain a 

8 list of responsible persons in violation that 

9 is available to the public. 

10 ‘‘(ii) The responsible person is, pursu11 ant to subsection (a)(1)(D), subject to a 

12 liquidated penalty of not more than a total 

13 of $15,000 for all violations adjudicated in 

14 a single proceeding in the case of an indi15 vidual, and $10,000 per day until the vio16 lation is corrected in the case of any other 

17 person, except that if the person is a non18 profit entity the penalty may not exceed a 

19 total of $15,000 for all violations adju20 dicated in a single proceeding. Paragraphs 

21 (3) through (5) of section 303(f) of the 

22 Federal Food, Drug, and Cosmetic Act 

23 apply to the imposition of such a penalty 

24 to the same extent and in the same man25 ner as such paragraphs apply to a penalty 
27 

•HR 5252 IH 

1 imposed under paragraph (1) or (2) of 

2 such section. 

3 ‘‘(B) In any case in which the violation is 

4 a significant violation and is not corrected with5 in 60 days after the Secretary provides to the 

6 responsible person a notice under subsection 

7 (f)(2) regarding the violation, the Secretary 

8 shall, after notice and an opportunity for a 

9 hearing, consider the person to be ineligible for 

10 any future awards described in subsection 

11 (a)(1) until the violation is corrected, except 

12 that notice and an opportunity for a hearing 

13 are not required if a hearing regarding such 

14 violation was held pursuant to subparagraph 

15 (A)(ii). 

16 ‘‘(C) In any case in which the violation is 

17 a failure to submit to the data bank the results 

18 of the trial by the due date under subsection 

19 (d)(2)(A)(i), the Secretary shall order the re20 sponsible person to submit to the data bank 

21 periodic reports on the progress being made to22 ward submission of the results, which reports 

23 shall be submitted not less frequently that once 

24 every two years until the results are submitted 

25 to the data bank. 
28 

•HR 5252 IH 

1 ‘‘(2) RELATION TO RELATED REQUIRE2 MENTS.—If a responsible person for a clinical trial 

3 is ineligible for purposes of section 565(f)(1)(B) or 

4 566(a)(2) of the Federal Food, Drug, and Cosmetic 

5 Act, the person is ineligible for any award described 

6 in subsection (a)(1) during the period of such ineli7 gibility, without regard to whether the person is in8 eligible under paragraph (1)(B) of this subsection. 

9 ‘‘(3) FALSE OR MISLEADING INFORMATION.—If 

10 the Secretary determines that the responsible person 

11 for a clinical trial has submitted to the data bank 

12 information that is false or misleading, and if on 

13 such basis a civil money has been imposed under 

14 paragraph (1)(A)(ii) on such person or the person 

15 has becomes ineligible within the meaning of para16 graph (1)(B) or (2), the Secretary shall remove the 

17 information from the data bank, subject to any judi18 cial review of such action or actions of the Secretary. 

19 ‘‘(4) WAIVER REGARDING INELIGIBILITY FOR

20 FUNDING.—With respect to a responsible person 

21 who is ineligible for purposes of paragraph (1)(B) or 

22 (2), the Secretary may waive the applicability of 

23 such paragraph in order to provide for a clinical 

24 trial if the Secretary determines that providing the 

25 waiver is in the public interest or consistent with the 
29 

•HR 5252 IH 

1 protection of the public health. Each such deter2 mination of the Secretary shall be published in the 

3 Federal Register. 

4 ‘‘(5) FUNDING OF COMPARATIVE STUDIES.— 

5 Penalties collected by the Secretary under paragraph 

6 (1)(A)(ii) shall be used by the Secretary to make 

7 awards of grants, contracts, or cooperative agree8 ments for the conduct of comparative clinical trials 

9 to determine the safety or relative effectiveness of 

10 products. 

11 ‘‘(h) CRITERIA.—The Secretary shall establish cri12 teria regarding compliance with this section. 

13 ‘‘(i) AWARD FOR CONDUCT OF CLINICAL TRIAL; 

14 COMPLIANCE COSTS AS DIRECT COSTS.—In admin15 istering an award of a grant, contract, or cooperative 

16 agreement that is subject to subsection (a)(1), the Sec17 retary shall consider the costs of complying with require18 ments under such subsection as part of the direct costs 

19 of conducting the clinical trial involved. 

20 ‘‘(j) DEFINITIONS.—For purposes of this section: 

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

22 product that is approved, licensed, or cleared for 

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

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

25 or under section 351 of this Act. 
30 

•HR 5252 IH 

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

2 an approved product, means a use that is an ap3 proved, licensed, or cleared use of the product under 

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

5 ‘‘(3) The term ‘clinical trial’, with respect to a 

6 product, means a clinical investigation within the 

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

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

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

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

11 term does not include such an investigation that 

12 does not prospectively assign human subjects to 

13 intervention or comparison groups to study the caus14 al relationship between a medical intervention and 

15 an outcome. 

16 ‘‘(4) The term ‘data bank’ means the data bank 

17 under subsection (b). 

18 ‘‘(5) The term ‘device’ has the meaning given 

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

20 Drug, and Cosmetic Act. 

21 ‘‘(6) The term ‘drug’ has the meaning given 

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

23 Drug, and Cosmetic Act. Such term includes a bio24 logical product. 
31 

•HR 5252 IH 

1 ‘‘(7) The term ‘MEDLINE’ means the biblio2 graphic electronic data base of references to journal3 published articles that is operated by the National 

4 Library of Medicine and is designated by such Li5 brary as the Medical Literature, Analysis, and Re6 trieval System Online. 

7 ‘‘(8) The term ‘product’ has the meaning indi8 cated for such term in subsection (a)(1). 

9 ‘‘(9) The term ‘researchers’ means individuals 

10 who conduct research on drugs or devices. 

11 ‘‘(10) The term ‘responsible person’, with re12 spect to a clinical trial to determine the safety or ef13 fectiveness of a use of a product, has the following 

14 meaning, as applicable: 

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

16 has been submitted for an exemption under sec17 tion 505(i) or 520(g)(2)(A) with respect to the 

18 trial, such term means the entity who, within 

19 the meaning of such section, is the sponsor of 

20 the trial. 

21 ‘‘(B) In any case in which such an applica22 tion has not been submitted, such term means 

23 the entity who is or will be providing the largest 

24 share of the monetary support for the trial 
32 

•HR 5252 IH 

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

2 trial), subject to the following: 

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

4 State is or will be providing the largest 

5 share, such term means the principal in6 vestigator for the trial. 

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

8 will be providing the largest share, such 

9 term means the principal investigator for 

10 the trial in any case in which such entity 

11 and investigator have jointly certified to 

12 the Secretary that the investigator will be 

13 the responsible person for purposes of this 

14 section. 

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

16 equal monetary support for the trial and 

17 no other entity provides a greater amount 

18 of monetary support, such term means 

19 each of the entities providing such equal 

20 support, other than the Federal Govern21 ment or a State. 

22 ‘‘(iv) Notwithstanding clauses (i) 

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

24 Secretary a written request to be the re25 sponsible person for purposes of this sec-
33 

•HR 5252 IH 

1 tion, such term means that entity in any 

2 case in which the Secretary determines 

3 that the entity is or will be providing mon4 etary support for the trial and is respon5 sible for conducting the trial. 

6 ‘‘(11) The term ‘unapproved product’ means a 

7 product that is not an approved product. 

8 ‘‘(12) The term ‘unapproved use’, with respect 

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

10 approved use. 

11 ‘‘(k) AUTHORIZATION OF APPROPRIATIONS.—For the 

12 purpose of carrying out this section, there are authorized 

13 to be appropriated such sums as may be necessary for fis14 cal year 2004 and each subsequent fiscal year. Fees col15 lected under section 736 or 738 of the Federal Food, 

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

17 this section.’’. 

18 (b) CLINICAL INVESTIGATIONS IN PROGRESS.—With 

19 respect to a clinical investigation to determine the safety 

20 or effectiveness of a use of a drug, biological product, or 

21 device, if the final data collection from subjects in the trial 

22 on the primary outcome has not been completed as of the 

23 date of the enactment of this Act, and if the investigation 

24 is being conducted with an award of a grant, contract, 

25 or cooperative agreement under the Public Health Service 
34 

•HR 5252 IH 

1 Act, the investigation becomes subject to section 491A of 

2 such Act (as added by subsection (a) of this section) upon 

3 the expiration of 30 days after the date of the enactment 

4 of this Act, except that registration information required 

5 pursuant to subsection (d)(1) of such section 491A is due 

6 upon the expiration of such 30 days. For purposes of the 

7 preceding sentence, the term ‘‘clinical investigation’’ has 

8 the meaning that applies for purposes of subsection (j)(3) 

9 of such section 491A. 

10 (c) RULE OF CONSTRUCTION REGARDING PRIOR

11 PROVISION.—With respect to the data bank program 

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

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

14 this Act: 

15 (1) Subsection (a) shall be construed as a 

16 transfer and modification of the program, and not as 

17 the termination of the program and the establish18 ment of a different program. 

19 (2) All information contained in the data bank 

20 on such day shall continue to be contained in the 

21 data bank, subject to section 491A of the Public 

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

23 this section) or other applicable provisions of law. 
35 

•HR 5252 IH 

1 SEC. 3. OTHER CONDITIONS REGARDING DATA BANK ON 

2 CLINICAL TRIALS. 

3 (a) INVESTIGATIONAL DRUGS AND DEVICES.— 

4 (1) IN GENERAL.—Subchapter E of chapter V 

5 of the Federal Food, Drug, and Cosmetic Act (21 

6 U.S.C. 360bbb et seq.) is amended by adding at the 

7 end the following section: 

8 ‘‘SEC. 565. INVESTIGATIONAL DRUGS AND DEVICES; CONDI9 TIONS REGARDING DATA BANK ON CLINICAL 

10 TRIALS. 

11 ‘‘(a) IN GENERAL.— 

12 ‘‘(1) CONDITIONS FOR EXEMPTIONS.—Except 

13 as provided in paragraph (2), an exemption under 

14 section 505(i) or 520(g)(2)(A) for an investigation 

15 to determine the safety or effectiveness of the use of 

16 a drug or device (referred to in this section as a 

17 ‘product’) may not be considered to be in effect un18 less— 

19 ‘‘(A) the sponsor of the investigation 

20 agrees to register the investigation with the 

21 Secretary; 

22 ‘‘(B) the sponsor of the investigation 

23 agrees to provide to the Secretary information 

24 on the results of the investigation; and 
36 

•HR 5252 IH 

1 ‘‘(C) the sponsor of the investigation 

2 agrees to the disclosure to the public of infor3 mation regarding the investigation. 

4 ‘‘(2) EXCEPTION.—Paragraph (1) does not 

5 apply to an investigation to determine the safety of 

6 a use of a drug if the trial is designed solely to de7 tect major toxicities in the drug or to investigate 

8 pharmacokinetics, except that such paragraph does 

9 apply if the trial is designed solely to investigate 

10 pharmacokinetics in a special population or popu11 lations. 

12 ‘‘(b) INSTITUTIONAL REVIEW BOARDS.—For pur13 poses of subsection (a), the Secretary shall amend parts 

14 50, 56, and 812 of title 21, Code of Federal Regulations, 

15 to provide that— 

16 ‘‘(1) the functions of institutional review boards 

17 under such parts include— 

18 ‘‘(A) determining whether investigations 

19 are registered under subsection (a)(1)(A); and 

20 ‘‘(B) denying the approval of the boards 

21 for investigations that are not registered under 

22 such subsection; 

23 ‘‘(2) any approval of an institutional review 

24 board regarding an investigation is not effective 
37 

•HR 5252 IH 

1 under such parts if the investigation is not reg2 istered under such subsection; and 

3 ‘‘(3) upon request of an institutional review 

4 board for such an investigation, the Secretary will 

5 provide to the board a copy of the registration for 

6 the investigation under such subsection (which copy 

7 will be the registration as submitted to the Sec8 retary, together with all updates to the registration). 

9 ‘‘(c) CERTAIN EXEMPTIONS.—The reference in sub10 section (a) to an exemption under section 505(i) includes 

11 an exemption described in section 312.2(b) of title 21, 

12 Code of Federal Regulations. The reference in such sub13 section to an exemption under section 520(g)(2)(A) in14 cludes an exemption described in section 812.2(b) of such 

15 title 21. 

16 ‘‘(d) RELATIONSHIP TO SIMILAR REQUIREMENTS.— 

17 For purposes of subsection (a): 

18 ‘‘(1) The responsibilities of a sponsor of an in19 vestigation, and of the Secretary, are the same as 

20 apply under section 491A of the Public Health Serv21 ice Act with respect to responsible persons, except to 

22 the extent of taking into account that this section 

23 concerns conditions for exemptions referred to in 

24 subsection (a)(1) and section 491A of such Act con-
38 

•HR 5252 IH 

1 cerns conditions for the receipt of an award under 

2 such Act. 

3 ‘‘(2) The Secretary shall administer the pro4 gram under this section and the program under sec5 tion 491A of such Act as substantially a single pro6 gram, shall not require duplicative registrations, and 

7 shall otherwise avoid duplicative activities. 

8 ‘‘(e) DETERMINATION OF VIOLATIONS.— 

9 ‘‘(1) COMPLIANCE AUDITS.— 

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

11 conduct periodic audits of sponsors of investiga12 tions for which exemptions referred to in sub13 section (a)(1) are in effect in order to deter14 mine whether the sponsors have submitted in15 formation as required under agreements under 

16 subparagraphs (A) and (B) of such subsection, 

17 including determining whether any of the infor18 mation is false or misleading. 

19 ‘‘(B) PRIORITY.—In conducting audits 

20 under subparagraph (A), the Secretary shall 

21 give priority to sponsors of investigations who 

22 have at any time been included on the list 

23 under subsection (f)(1)(A)(i), taking into ac24 count the number and severity of the violations 

25 involved. 
39 

•HR 5252 IH 

1 ‘‘(2) NOTICE TO SPONSORS.—Promptly after 

2 determining that a sponsor of an investigation is in 

3 violation of a requirement under subparagraph (A) 

4 or (B) of subsection (a)(1), the Secretary shall no5 tify the sponsor in writing of the violation. 

6 ‘‘(f) ACTIONS OF SECRETARY REGARDING VIOLA7 TIONS.— 

8 ‘‘(1) IN GENERAL.—If a sponsor of an inves9 tigation is in violation of an agreement under sub10 paragraph (A) or (B) of subsection (a)(1) (including 

11 submitting information under such a subparagraph 

12 that is false or misleading), the following applies, 

13 subject to paragraph (2) of this subsection: 

14 ‘‘(A) In any case in which the violation is 

15 not corrected within 30 days after the Secretary 

16 provides to the sponsor a notice under sub17 section (e)(2) regarding the violation: 

18 ‘‘(i) Through Internet sites operated 

19 pursuant to subsection (d) and such other 

20 means as the Secretary determines to be 

21 appropriate, the Secretary shall announce 

22 to the public that the sponsor is in viola23 tion of this section. For purposes of the 

24 preceding sentence, the Secretary shall 
40 

•HR 5252 IH 

1 maintain a list of sponsors in violation that 

2 is available to the public. 

3 ‘‘(ii) The sponsor is subject to a civil 

4 penalty of not more than a total of 

5 $15,000 for all violations adjudicated in a 

6 single proceeding in the case of an indi7 vidual, and $10,000 per day until the vio8 lation is corrected in the case of any other 

9 person, except that if the person is a non10 profit entity the penalty may not exceed a 

11 total of $15,000 for all violations adju12 dicated in a single proceeding. Paragraphs 

13 (3) through (5) of section 303(f) apply to 

14 the imposition of such a penalty to the 

15 same extent and in the same manner as 

16 such paragraphs apply to a penalty im17 posed under paragraph (1) or (2) of such 

18 section. 

19 ‘‘(B) In any case in which the violation is 

20 a significant violation and is not corrected with21 in 60 days after the Secretary provides to the 

22 sponsor a notice under subsection (e)(2) regard23 ing the violation, the Secretary may, after no24 tice and an opportunity for a hearing, consider 

25 the sponsor to be ineligible for any future ex-
41 

•HR 5252 IH 

1 emptions referred to in subsection (a)(1) for 

2 any investigation until the violation is corrected, 

3 except that notice and an opportunity for a 

4 hearing are not required if a hearing regarding 

5 such violation was held pursuant to subpara6 graph (A)(ii). 

7 ‘‘(C) In any case in which the violation is 

8 a failure to submit to the data bank the results 

9 of the investigation by the due date that applies 

10 pursuant to subsection (d), the Secretary shall 

11 order the sponsor of the investigation to submit 

12 to the data bank periodic reports on the 

13 progress being made toward submission of the 

14 results, which reports shall be submitted not 

15 less frequently that once every two years until 

16 the results are submitted to the data bank. 

17 ‘‘(2) FALSE OR MISLEADING INFORMATION.—If 

18 the Secretary determines that the sponsor of an in19 vestigation has submitted to the data bank informa20 tion that is false or misleading, and if on such basis 

21 a civil money has been imposed under paragraph 

22 (1)(A)(ii) on the sponsor or the sponsor has becomes 

23 ineligible within the meaning of paragraph (1)(B), 

24 the Secretary shall remove the information from the 
42 

•HR 5252 IH 

1 data bank, subject to any judicial review of such ac2 tion or actions of the Secretary. 

3 ‘‘(3) WAIVER REGARDING INELIGIBILITY FOR

4 EXEMPTIONS.—With respect to a sponsor who is in5 eligible for purposes of paragraph (1)(B), the Sec6 retary may waive the applicability of such paragraph 

7 in order to provide for an investigation if the Sec8 retary determines that providing the waiver is in the 

9 public interest or consistent with the protection of 

10 the public health. Each such determination of the 

11 Secretary shall be published in the Federal Register. 

12 ‘‘(4) FUNDING OF COMPARATIVE STUDIES.— 

13 Penalties collected by the Secretary under paragraph 

14 (1)(A)(ii) shall be used by the Secretary to make 

15 awards of grants or contracts for the conduct of 

16 comparative investigations to determine the safety or 

17 relative effectiveness of products. 

18 ‘‘(g) DEFINITIONS.— 

19 ‘‘(1) IN GENERAL.—Definitions under section 

20 491A(j) of the Public Health Service Act apply for 

21 purposes of this section, subject to paragraph (2). 

22 ‘‘(2) INVESTIGATION.—For purposes of this 

23 section, the term ‘investigation’ means a clinical in24 vestigation within the meaning of section 505(i) (in 

25 the case of drug), or within the meaning of section 
43 

•HR 5252 IH 

1 520(g) (in the case of a device), as applicable, except 

2 that such term does not include such an investiga3 tion that does not prospectively assign human sub4 jects to intervention or comparison groups to study 

5 the causal relationship between a medical interven6 tion and an outcome.’’. 

7 (2) CONFORMING AMENDMENTS.—Chapter V of 

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

9 U.S.C. 351 et seq.) is amended— 

10 (A) in section 505(i), by adding at the end 

11 the following paragraph: 

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

13 (1) is subject to section 565 (relating to information on 

14 investigations).’’; and 

15 (B) in section 520(g), by adding at the end 

16 the following paragraph: 

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

18 (2)(A) is subject to section 565 (relating to information 

19 on investigations).’’. 

20 (b) PREMARKET APPLICATION OR REPORT; LABEL21 ING AND ADVERTISING.—Subchapter E of chapter V of 

22 the Federal Food, Drug, and Cosmetic Act, as amended 

23 by subsection (a) of this section, is amended by adding 

24 at the end the following section: 
44 

•HR 5252 IH 

1 ‘‘SEC. 566. PREMARKET APPLICATION OR REPORT; LABEL2 ING AND ADVERTISING; RELATION TO DATA 

3 BANK ON CLINICAL TRIALS. 

4 ‘‘(a) PREMARKET APPLICATION OR REPORT.—If a 

5 person submits to the Secretary an application under sec6 tion 505(b) or 515 or a report under section 510(k), and 

7 one or more of the investigations presented to the Sec8 retary by the person for purposes of the application or 

9 report are investigations that are not subject to require10 ments under section 565 or under section 491A of the 

11 Public Health Service, and if the person was the principal 

12 investigator or the responsible person for the investigation 

13 involved, the following applies: 

14 ‘‘(1) The person is subject to a civil penalty— 

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

16 the investigation has not, as of the date on 

17 which the application or report is submitted to 

18 the Secretary, been submitted to the data bank 

19 described in such section 491A to the same ex20 tent as would have been required as of such 

21 date if the investigation had been subject to 

22 such requirements (without regard to time23 frames for the submission of information that 

24 would have applied before such date under such 

25 section); and 
45 

•HR 5252 IH 

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

2 information on the investigation is not sub3 mitted to the data bank to the same extent as 

4 would be required if the investigation were sub5 ject to such requirements. 

6 ‘‘(2) If the person is subject to a civil penalty 

7 under paragraph (1), the Secretary, in addition to 

8 such penalty, may, after notice and an opportunity 

9 for a hearing, consider the person to be ineligible for 

10 any future exemptions under section 505(i) or 

11 520(g)(2)(A) for any investigation until the informa12 tion involved is submitted to the data bank as de13 scribed in paragraph (1), except that notice and an 

14 opportunity for a hearing are not required if a hear15 ing regarding such violation was held pursuant to 

16 paragraph (1). 

17 ‘‘(b) LABELING AND ADVERTISEMENTS.—If a person 

18 disseminates labeling, or an advertisement or other de19 scriptive printed matter, for a drug or device for human 

20 use and the labeling, advertisement, or other matter refers 

21 to an investigation that is not subject to requirements 

22 under section 565 or under section 491A of the Public 

23 Health Service, and if the person was the principal investi24 gator or the responsible person for the investigation, the 

25 person is subject to a civil penalty— 
46 

•HR 5252 IH 

1 ‘‘(1) in any case in which information on the in2 vestigation has not, as of the date on which the la3 beling, advertisement, or other matter enters the 

4 market, been submitted to the data bank described 

5 in such section 491A to the same extent as would 

6 have been required as of such date if the investiga7 tion had been subject to such requirements (without 

8 regard to timeframes for the submission of informa9 tion that would have applied before such date under 

10 such section); and 

11 ‘‘(2) in any case in which, after such date, in12 formation on the investigation is not submitted to 

13 the data bank to the same extent as would be re14 quired if the investigation were subject to such re15 quirements. 

16 ‘‘(c) AMOUNT OF CIVIL PENALTY; PROCEDURE.—A 

17 civil penalty under subsection (a)(1) or (b) shall be not 

18 more than a total of $15,000 for all violations adjudicated 

19 in a single proceeding in the case of an individual, and 

20 $10,000 per day until the violation is corrected in the case 

21 of any other person, except that if the person is a non22 profit entity the penalty may not exceed a total of $15,000 

23 for all violations adjudicated in a single proceeding. Para24 graphs (3) through (5) of section 303(f) apply to the im25 position of such a penalty to the same extent and in the 
47 

•HR 5252 IH 

1 same manner as such paragraphs apply to a penalty im2 posed under paragraph (1) or (2) of such section. 

3 ‘‘(d) BIOLOGICS LICENSE APPLICATION.—Sub4 sections (a) and (c) apply with respect to a biologics li5 cense application under section 351 of the Public Health 

6 Service Act to the same extent and in the same manner 

7 as such subsections apply with respect to an application 

8 or report referred to in subsection (a). 

9 ‘‘(e) DEFINITIONS.—For purposes of this section: 

10 ‘‘(1) The term ‘investigation’ has the meaning 

11 given such term in section 565(g). 

12 ‘‘(2) The term ‘responsible person’ has the 

13 meaning given such term in section 491A(j) of the 

14 Public Health Service Act. ’’. 

15 (c) CLINICAL INVESTIGATIONS IN PROGRESS.—With 

16 respect to a clinical investigation to determine the safety 

17 or effectiveness of a use of a drug, biological product, or 

18 device, if the final data collection from subjects in the in19 vestigation on the primary outcome has not been com20 pleted as of the date of the enactment of this Act, and 

21 if the investigation is one for which an exemption under 

22 section 505(i) or 520(g)(2)(A) of the Federal Food, Drug, 

23 and Cosmetic Act is in effect, the investigation becomes 

24 subject to section 565 of such Act (as added by subsection 

25 (a) of this section) upon the expiration of 30 days after 
48 

•HR 5252 IH 

1 the date of the enactment of this Act, except that registra2 tion information required pursuant to subsection (d) of 

3 such section 565 is due upon the expiration of such 30 

4 days. For purposes of the preceding sentence, the term 

5 ‘‘clinical investigation’’ has the meaning given such term 

6 in subsection (g)(2) of such section 565. 

7 SEC. 4. RULE OF CONSTRUCTION REGARDING AUTHORITY 

8 OF SECRETARY FOR PUBLIC DISCLOSURE OF 

9 INFORMATION ON CLINICAL TRIALS. 

10 This Act and the amendments made by this Act may 

11 not be construed as limiting the authority of the Secretary 

12 of Health and Human Services to disclose to the public 

13 information on clinical trials to determine the safety or 

14 effectiveness of the use of drugs, which authority was in 

15 effect as of the day before the date of the enactment of 

16 this Act. 

Æ