II 

110TH CONGRESS 

1ST SESSION S. 467 

To amend the Public Health Service Act to expand the clinical trials drug 

data bank. 

IN THE SENATE OF THE UNITED STATES 

JANUARY 31, 2007 

Mr. DODD (for himself, Mr. GRASSLEY, Mr. WYDEN, Mr. BINGAMAN, Mr. 

DURBIN, and Mr. HARKIN) introduced the following bill; which was read 

twice and referred to the Committee on Health, Education, Labor, and 

Pensions 

A BILL 

To amend the Public Health Service Act to expand the 

clinical trials drug data bank. 

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 of 2007’’ or the ‘‘FACT Act’’. 

6 SEC. 2. PURPOSE. 

7 It is the purpose of this Act— 

8 (1) to create a publicly accessible national data 

9 bank of clinical trial information comprised of a clinVerDate Aug 31 2005 00:28 Feb 03, 2007 Jkt 059200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S467.IS S467

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1 ical trial registry and a clinical trial results data2 base; 

3 (2) to foster transparency and accountability in 

4 health-related intervention research and develop5 ment; 

6 (3) to maintain a clinical trial registry acces7 sible to patients and health care practitioners seek8 ing information related to ongoing clinical trials for 

9 serious or life-threatening diseases and conditions; 

10 and 

11 (4) to establish a clinical trials results database 

12 of all publicly and privately funded clinical trial re13 sults regardless of outcome, that is accessible to the 

14 scientific community, health care practitioners, and 

15 members of the public. 

16 SEC. 3. CLINICAL TRIALS DATA BANK. 

17 (a) IN GENERAL.—Subsection (i) of section 402 of 

18 the Public Health Service Act (42 U.S.C. 282), as amend19 ed by Public Law 109–482, is amended— 

20 (1) in paragraph (1)(A), by striking ‘‘for drugs 

21 for serious or life-threatening diseases and condi22 tions’’; 

23 (2) in paragraph (2), by striking ‘‘available to 

24 individuals with serious’’ and all that follows 

25 through the period and inserting ‘‘accessible to paVerDate Aug 31 2005 00:28 Feb 03, 2007 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S467.IS S467

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1 tients, other members of the public, health care 

2 practitioners, researchers and the scientific commu3 nity. In making information about clinical trials pub4 licly available, the Secretary shall seek to be as time5 ly and transparent as possible.’’; 

6 (3) by redesignating paragraphs (4) and (5), as 

7 paragraphs (8) and (9), respectively; 

8 (4) by striking paragraph (3) and inserting the 

9 following: 

10 ‘‘(3) The data bank shall include the following: 

11 ‘‘(A)(i) A registry of clinical trials (in this sub12 paragraph referred to as the ‘registry’) of health-re13 lated interventions (whether federally or privately 

14 funded). 

15 ‘‘(ii) The registry shall include information for 

16 all clinical trials conducted to test the safety or ef17 fectiveness (including comparative effectiveness) of 

18 any drug, biological product, or device (including 

19 those drugs, biological products, or devices approved 

20 or cleared by the Secretary) intended to treat serious 

21 or life-threatening diseases and conditions, except 

22 those Phase I clinical trials conducted to test solely 

23 the safety of an unapproved drug or unlicensed bio24 logical product, or pilot or feasibility studies con25 ducted to confirm the design and operating speciVerDate Aug 31 2005 00:28 Feb 03, 2007 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S467.IS S467

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1 fications of an unapproved or not yet cleared med2 ical device. For purposes of this section, Phase I 

3 clinical trials are trials described in section 

4 313.12(a) of title 21, Code of Federal Regulations 

5 (or any successor regulations). 

6 ‘‘(iii) The registry may include information 

7 for— 

8 ‘‘(I) Phase I clinical trials conducted to 

9 test solely the safety of an unapproved drug or 

10 unlicensed biological product, or pilot or feasi11 bility studies conducted to confirm the design 

12 and operating specifications of an unapproved 

13 or not yet cleared medical device with the con14 sent of the responsible person; and 

15 ‘‘(II) clinical trials of other health-related 

16 interventions with the consent of the responsible 

17 person. 

18 ‘‘(iv) The information to be included in the reg19 istry under this subparagraph shall include the fol20 lowing: 

21 ‘‘(I) Descriptive information, including a 

22 brief title, trial description in lay terminology, 

23 trial phase, trial type, trial purpose, description 

24 of the primary and secondary clinical outcome 

25 measures to be examined in the trial, the time 


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1 at which the outcome measures will be assessed, 

2 and the dates and details of any revisions to 

3 such outcomes. 

4 ‘‘(II) Recruitment information, including 

5 eligibility and exclusion criteria, a description of 

6 whether, and through what procedure, the man7 ufacturer or sponsor of the investigation of a 

8 new drug will respond to requests for protocol 

9 exception, with appropriate safeguards, for sin10 gle-patient and expanded protocol use of the 

11 new drug, particularly in children, a statement 

12 as to whether the trial is closed to enrollment 

13 of new patients, overall trial status, individual 

14 site status, and estimated completion date. For 

15 purposes of this section the term ‘completion 

16 date’ means the date of the last visit by sub17 jects in the trial for the outcomes described in 

18 subclause (I). 

19 ‘‘(III) Location and contact information, 

20 including the identity of the responsible person. 

21 ‘‘(IV) Administrative data, including the 

22 study sponsor and the study funding source. 

23 ‘‘(V) Information pertaining to experi24 mental treatments for serious or life-threatVerDate Aug 31 2005 00:28 Feb 03, 2007 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S467.IS S467

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1 ening diseases and conditions (whether federally 

2 or privately funded) that may be available— 

3 ‘‘(aa) under a treatment investiga4 tional new drug application that has been 

5 submitted to the Secretary under section 

6 360bbb(c) of title 21, Code of Federal 

7 Regulations; or 

8 ‘‘(bb) as a Group C cancer drug (as 

9 defined by the National Cancer Institute). 

10 ‘‘(B)(i) A clinical trial results database (in this 

11 subparagraph referred to as the ‘database’) of 

12 health-related interventions (whether federally or 

13 privately funded). 

14 ‘‘(ii) The database shall include information for 

15 all clinical trials conducted to test the safety or ef16 fectiveness (including comparative effectiveness) of 

17 any drug, biological product, or device (including 

18 those drugs, biological products, or devices approved 

19 or cleared by the Secretary), except those Phase I 

20 clinical trials conducted to test solely the safety of 

21 an unapproved drug or unlicensed biological product, 

22 or pilot or feasibility studies conducted to confirm 

23 the design and operating specifications of an unap24 proved or not yet cleared medical device. 


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1 ‘‘(iii) The database may include information 

2 for— 

3 ‘‘(I) Phase I clinical trials conducted to 

4 test solely the safety of an unapproved drug or 

5 unlicensed biological product, or pilot or feasi6 bility studies conducted to confirm the design 

7 and operating specifications of an unapproved 

8 or not yet cleared medical device with the con9 sent of the responsible person; and 

10 ‘‘(II) clinical trials of other health-related 

11 interventions with the consent of the responsible 

12 person. 

13 ‘‘(iv) The information to be included in the 

14 database under this subparagraph shall include the 

15 following: 

16 ‘‘(I) Descriptive information, including— 

17 ‘‘(aa) a brief title; 

18 ‘‘(bb) the drug, biological product or 

19 device to be tested; 

20 ‘‘(cc) a trial description in lay termi21 nology; 

22 ‘‘(dd) the trial phase; 

23 ‘‘(ee) the trial type; 

24 ‘‘(ff) the trial purpose; 


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1 ‘‘(gg) demographic data such as age, 

2 gender, or ethnicity of trial participants; 

3 ‘‘(hh) the estimated completion date 

4 for the trial; and 

5 ‘‘(ii) the study sponsor and the study 

6 funding source. 

7 ‘‘(II) A description of the primary and sec8 ondary clinical outcome measures to be exam9 ined in the trial, the time at which the outcome 

10 measures will be assessed, and the dates and 

11 details of any revisions to such outcomes. 

12 ‘‘(III) The actual completion date of the 

13 trial and the reasons for any difference from 

14 such actual date and the estimated completion 

15 date submitted pursuant to subclause (I)(ii). If 

16 the trial is not completed, the termination date 

17 and reasons for such termination. 

18 ‘‘(IV) A summary of the results of the trial 

19 in a standard, non-promotional summary for20 mat (such as ICHE3 template form), including 

21 the trial design and methodology, results of the 

22 primary and secondary outcome measures as 

23 described in subclause (II), summary data ta24 bles with respect to the primary and secondary 

25 outcome measures, including information on the 


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1 statistical significance or lack thereof of such 

2 results. 

3 ‘‘(V) Safety data concerning the trial (in4 cluding a summary of all adverse events speci5 fying the number and type of such events, data 

6 on prespecified adverse events, data on serious 

7 adverse events, and data on overall deaths). 

8 ‘‘(VI) Any publications in peer reviewed 

9 journals relating to the trial. If the trial results 

10 are published in a peer reviewed journal, the 

11 database shall include a citation to and, when 

12 available, a link to the journal article. 

13 ‘‘(VII) A description of the process used to 

14 review the results of the trial, including a state15 ment about whether the results have been peer 

16 reviewed by reviewers independent of the trial 

17 sponsor. 

18 ‘‘(VIII) If the trial addresses the safety, 

19 effectiveness, or benefit of a use not described 

20 in the approved labeling for the drug, biological 

21 product, or device, a statement, as appropriate, 

22 displayed prominently at the beginning of the 

23 data in the registry with respect to the trial, 

24 that the Food and Drug Administration— 


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1 ‘‘(aa) is currently reviewing an appli2 cation for approval of such use to deter3 mine whether the use is safe and effective; 

4 ‘‘(bb) has disapproved an application 

5 for approval of such use; 

6 ‘‘(cc) has reviewed an application for 

7 approval of such use but the application 

8 was withdrawn prior to approval or dis9 approval; or 

10 ‘‘(dd) has not reviewed or approved 

11 such use as safe and effective. 

12 ‘‘(IX) If data from the trial has not been 

13 submitted to the Food and Drug Administra14 tion, an explanation of why it has not been sub15 mitted. 

16 ‘‘(X) A description of the protocol used in 

17 such trial to the extent necessary to evaluate 

18 the results of such trial. 

19 ‘‘(4)(A)(i) Not later than 90 days after the date of 

20 the completion of the review by the Food and Drug Ad21 ministration of information submitted by a sponsor in sup22 port of a new drug application, or a supplemental new 

23 drug application, whether or not approved by the Food 

24 and Drug Administration, the Commissioner of Food and 

25 Drugs shall make available to the public the full reviews 


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1 conducted by the Administration of such application, in2 cluding documentation of significant differences of opinion 

3 and the resolution of those differences. 

4 ‘‘(ii) When submitting information in support of a 

5 new drug application or a supplemental new drug applica6 tion, the sponsor shall certify, in writing, that the informa7 tion submitted to the Food and Drug Administration com8 plies with the requirements of the Federal Food, Drug, 

9 and Cosmetic Act and that such information presented is 

10 accurate. 

11 ‘‘(iii) If the sponsor fails to provide certification as 

12 specified under clause (ii), the Secretary shall transmit to 

13 the sponsor a notice stating that such sponsor shall submit 

14 the certification by the date determined by the Secretary. 

15 If, by the date specified by the Secretary in the notice 

16 under this clause, the Secretary has not received the cer17 tification, the Secretary, after providing the opportunity 

18 for a hearing, shall order such sponsor to pay a civil mone19 tary penalty of $10,000 for each day after such date that 

20 the certification is not submitted. 

21 ‘‘(iv) If the Secretary determines, after notice and op22 portunity for a hearing, that the sponsor knew or should 

23 have known that the information submitted in support of 

24 a new drug application or a supplemental new drug appli25 cation was inaccurate, the Secretary shall order such sponVerDate Aug 31 2005 00:28 Feb 03, 2007 Jkt 059200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S467.IS S467

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1 sor to pay a civil monetary penalty of not less than 

2 $100,000 but not to exceed $2,000,000 for any 30-day 

3 period. 

4 ‘‘(B)(i) The Secretary shall deposit the funds col5 lected under subparagraph (A) into an account and use 

6 such funds, in consultation with the Director of the Agen7 cy for Healthcare Research and Quality, to fund studies 

8 that compare the clinical effectiveness of 2 or more treat9 ments for similar diseases or conditions. 

10 ‘‘(ii) The Secretary shall award funding under clause 

11 (i) based on a priority list established not later than 6 

12 months after the date of enactment of the FACT Act by 

13 the Director of the Agency for Healthcare Research and 

14 Quality and periodically updated as determined appro15 priate by the Director. 

16 ‘‘(C) Not later than 90 days after the date of the 

17 completion of a written consultation on a drug concerning 

18 the drug’s safety conducted by the Office of Surveillance 

19 and Epidemiology, regardless of whether initiated by such 

20 Office or outside of the Office, the Commissioner of Food 

21 and Drugs shall make available to the public a copy of 

22 such consultation in full. 

23 ‘‘(D) Nothing in this paragraph shall be construed 

24 to alter or amend section 301(j) or section 1905 of title 

25 18, United States Code. 


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1 ‘‘(E) This paragraph shall supersede section 552 of 

2 title 5, United States Code. 

3 ‘‘(5) The information described in subparagraphs (A) 

4 and (B) of paragraph (3) shall be in a format that can 

5 be readily accessed and understood by members of the 

6 general public, including patients seeking to enroll as sub7 jects in clinical trials. 

8 ‘‘(6) The Secretary shall assign each clinical trial a 

9 unique identifier to be included in the registry and in the 

10 database described in subparagraphs (A) and (B) of para11 graph (3). To the extent practicable, this identifier shall 

12 be consistent with other internationally recognized and 

13 used identifiers. 

14 ‘‘(7) To the extent practicable, the Secretary shall en15 sure that where the same information is required for the 

16 registry and the database described in subparagraphs (A) 

17 and (B) of paragraph (3), a process exists to allow the 

18 responsible person to make only one submission.’’; and 

19 (5) by adding at the end the following: 

20 ‘‘(10) In this section, the term ‘clinical trial’ with re21 spect to the registry and the database described in sub22 paragraphs (A) and (B) of paragraph (3) means a re23 search study in human volunteers to answer specific health 

24 questions, including treatment trials, prevention trials, di25 agnostic trials, screening trials, and quality of life trials.’’. 


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1 (b) ACTIONS OF SECRETARY REGARDING CLINICAL

2 TRIALS.—Section 402 of the Public Health Service Act 

3 (42 U.S.C. 282), as amended by Public Law 109–482, is 

4 amended— 

5 (1) by redesignating subsections (j) and (k) as 

6 subsections (o) and (p), respectively; and 

7 (2) by inserting after subsection (i), the fol8 lowing: 

9 ‘‘(j) FEDERALLY SUPPORTED TRIALS.— 

10 ‘‘(1) ALL FEDERALLY SUPPORTED TRIALS.— 

11 With respect to any clinical trial described in sub12 section (i)(3)(B) that is supported solely by a grant, 

13 contract, or cooperative agreement awarded by the 

14 Secretary, the principal investigator of such trial 

15 shall, not later than the date specified in paragraph 

16 (2), submit to the Secretary— 

17 ‘‘(A) the information described in sub18 clauses (II) through (X) of subsection 

19 (i)(3)(B)(iv), and with respect to clinical trials 

20 in progress on the date of enactment of the 

21 FACT Act, the information described in sub22 clause (I) of subsection (i)(3)(B)(iv); or 

23 ‘‘(B) a statement containing information 

24 sufficient to demonstrate to the Secretary that 

25 the information described in subparagraph (A) 


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1 cannot reasonably be submitted, along with an 

2 estimated date of submission of the information 

3 described in such subparagraph. 

4 ‘‘(2) DATE SPECIFIED.—The date specified in 

5 this paragraph shall be the date that is 1 year from 

6 the earlier of— 

7 ‘‘(A) the estimated completion date of the 

8 trial, as submitted under subsection 

9 (i)(3)(B)(vi)(I)(ii); or 

10 ‘‘(B) the actual date of the completion or 

11 termination of the trial. 

12 ‘‘(3) CONDITION OF FEDERAL GRANTS, CON13 TRACTS, AND COOPERATIVE AGREEMENTS.— 

14 ‘‘(A) CERTIFICATION OF COMPLIANCE.— 

15 To be eligible to receive a grant, contract, or 

16 cooperative agreement from the Secretary for 

17 the conduct or support of a clinical trial de18 scribed in subsection (i)(3)(B), the principal in19 vestigator involved shall certify to the Secretary 

20 that— 

21 ‘‘(i) such investigator shall submit 

22 data to the Secretary in accordance with 

23 this subsection; and 

24 ‘‘(ii) such investigator has complied 

25 with the requirements of this subsection 


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1 with respect to other clinical trials con2 ducted by such investigator after the date 

3 of enactment of the FACT Act. 

4 ‘‘(B) FAILURE TO SUBMIT CERTIFI5 CATION.—An investigator that fails to submit a 

6 certification as required under subparagraph 

7 (A) shall not be eligible to receive a grant, con8 tract, or cooperative agreement from the Sec9 retary for the conduct or support of a clinical 

10 trial described in subsection (i)(3)(B). 

11 ‘‘(C) FAILURE TO COMPLY WITH CERTIFI12 CATION.—If, by the date specified in paragraph 

13 (2), the Secretary has not received the informa14 tion or statement described in paragraph (1), 

15 the Secretary shall— 

16 ‘‘(i) transmit to the principal investi17 gator involved a notice specifying the infor18 mation or statement required to be sub19 mitted to the Secretary and stating that 

20 such investigator shall not be eligible to re21 ceive further funding from the Secretary if 

22 such information or statement is not sub23 mitted to the Secretary within 30 days of 

24 the date on which such notice is trans25 mitted; and 


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1 ‘‘(ii) include and prominently display, 

2 until such time as the Secretary receives 

3 the information or statement described in 

4 paragraph (1), as part of the record of 

5 such trial in the database described in sub6 section (i), a notice stating that the results 

7 of such trials have not been reported as re8 quired by law. 

9 ‘‘(D) FAILURE TO COMPLY WITH NO10 TICE.—If by the date that is 30 days after the 

11 date on which the notice described in subpara12 graph (C) is transmitted, the Secretary has not 

13 received from the principal investigator involved 

14 the information or statement required pursuant 

15 to such notice, the Secretary may not award a 

16 grant, contract, cooperative agreement, or any 

17 other award to such principal investigator until 

18 such principal investigator submits to the Sec19 retary the information or statement required 

20 pursuant to such notice. 

21 ‘‘(E) SUBMISSION OF STATEMENT BUT

22 NOT INFORMATION.— 

23 ‘‘(i) IN GENERAL.—If by the date 

24 specified in paragraph (2), the Secretary 

25 has received a statement described in paraVerDate Aug 31 2005 00:28 Feb 03, 2007 Jkt 059200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\S467.IS S467

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1 graph (1)(B) but not the information de2 scribed in paragraph (1)(A), the Secretary 

3 shall transmit to the principal investigator 

4 involved a notice stating that such investi5 gator shall submit such information by the 

6 date determined by the Secretary in con7 sultation with such investigator. 

8 ‘‘(ii) FAILURE TO COMPLY WITH CER9 TIFICATION.—If, by the date specified by 

10 the Secretary in the notice under clause 

11 (i), the Secretary has not received the in12 formation described in paragraph (1)(B), 

13 the Secretary shall— 

14 ‘‘(I) transmit to the principal in15 vestigator involved a notice specifying 

16 the information required to be sub17 mitted to the Secretary and stating 

18 that such investigator shall not be eli19 gible to receive further funding from 

20 the Secretary if such information is 

21 not submitted to the Secretary within 

22 30 days of the date on which such no23 tice is transmitted; and 

24 ‘‘(II) include and prominently 

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1 retary receives the information de2 scribed in paragraph (1)(B), as part 

3 of the record of such trial in the data4 base described in subsection (i), a no5 tice stating that the results of such 

6 trials have not been reported as re7 quired by law. 

8 ‘‘(F) FAILURE TO COMPLY WITH NO9 TICE.—If by the date that is 30 days after the 

10 date on which the notice described in subpara11 graph (E)(ii)(I) is transmitted, the Secretary 

12 has not received from the principal investigator 

13 involved the information required pursuant to 

14 such notice, the Secretary may not award a 

15 grant, contract, cooperative agreement, or any 

16 other award to such principal investigator until 

17 such principal investigator submits to the Sec18 retary the information required pursuant to 

19 such notice. 

20 ‘‘(G) RULE OF CONSTRUCTION.—For pur21 poses of this paragraph, limitations on the 

22 awarding of grants, contracts, cooperative 

23 agreements, or any other awards to principal 

24 investigators for violations of this paragraph 


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1 shall not be construed to include any funding 

2 that supports the clinical trial involved. 

3 ‘‘(4) RULE OF CONSTRUCTION.—Nothing in 

4 this subsection shall be construed to prevent an in5 vestigator other than the investigator described in 

6 paragraph (3)(F) from receiving an ongoing award, 

7 contract, or cooperative agreement. 

8 ‘‘(5) INCLUSION IN REGISTRY.— 

9 ‘‘(A) GENERAL RULE.—The Secretary 

10 shall, pursuant to subsection (i)(5), include— 

11 ‘‘(i) the data described in subsection 

12 (i)(3)(A) and submitted under the amend13 ments made by section 4(a) of the FACT 

14 Act in the registry described in subsection 

15 (i) as soon as practicable after receiving 

16 such data; and 

17 ‘‘(ii) the data described in clause (I) 

18 of subsection (i)(3)(B)(iv) and submitted 

19 under this subsection or the amendments 

20 made by section 4(a) of the FACT Act in 

21 the database described in subsection (i) as 

22 soon as practicable after receiving such 

23 data. 

24 ‘‘(B) OTHER DATA.— 


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1 ‘‘(i) IN GENERAL.—The Secretary 

2 shall, pursuant to subsection (i)(5), include 

3 the data described in subclauses (II) 

4 through (X) of subsection (i)(3)(B)(iv) and 

5 submitted under this section in the data6 base described in subsection (i)— 

7 ‘‘(I) as soon as practicable after 

8 receiving such data; or 

9 ‘‘(II) in the case of data to which 

10 clause (ii) applies, by the date de11 scribed in clause (iii). 

12 ‘‘(ii) DATA DESCRIBED.—This clause 

13 applies to data described in clause (i) if— 

14 ‘‘(I) the principal investigator in15 volved requests a delay in the inclu16 sion in the database of such data in 

17 order to have such data published in 

18 a peer reviewed journal; and 

19 ‘‘(II) the Secretary determines 

20 that an attempt will be made to seek 

21 such publication. 

22 ‘‘(iii) DATE FOR INCLUSION IN REG23 ISTRY.—Subject to clause (iv), the date de24 scribed in this clause is the earlier of— 


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1 ‘‘(I) the date on which the data 

2 involved is published as provided for 

3 in clause (ii); or 

4 ‘‘(II) the date that is 18 months 

5 after the date on which such data is 

6 submitted to the Secretary. 

7 ‘‘(iv) EXTENSION OF DATE.—The 

8 Secretary may extend the 18-month period 

9 described in clause (iii)(II) for an addi10 tional 6 months if the principal investi11 gator demonstrates to the Secretary, prior 

12 to the expiration of such 18-month period, 

13 that the data involved has been accepted 

14 for publication by a journal described in 

15 clause (ii)(I). 

16 ‘‘(v) MODIFICATION OF DATA.—Prior 

17 to including data in the database under 

18 clause (ii) or (iv), the Secretary shall per19 mit the principal investigator to modify the 

20 data involved. 

21 ‘‘(6) MEMORANDUM OF UNDERSTANDING.—Not 

22 later than 6 months after the date of enactment of 

23 the FACT Act, the Secretary shall seek a memo24 randum of understanding with the heads of all other 

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1 clude in the registry and the database clinical trials 

2 sponsored by such agencies that meet the require3 ments of this subsection. 

4 ‘‘(7) APPLICATION TO CERTAIN PERSONS.—The 

5 provisions of this subsection shall apply to a respon6 sible person described in subsections (n)(1)(A)(ii)(II) 

7 or (n)(1)(B)(i)(II). 

8 ‘‘(k) TRIALS WITH NON-FEDERAL SUPPORT.— 

9 ‘‘(1) IN GENERAL.—The responsible person for 

10 a clinical trial described in subsection (i)(3)(B) shall, 

11 not later than the date specified in paragraph (3), 

12 submit to the Secretary— 

13 ‘‘(A) the information described in sub14 clauses (II) through (X) of subsection 

15 (i)(3)(B)(iv), and with respect to clinical trials 

16 in progress on the date of enactment of the 

17 FACT Act, the information described in sub18 clause (I) of subsection (i)(3)(B)(iv); or 

19 ‘‘(B) a statement containing information 

20 sufficient to demonstrate to the Secretary that 

21 the information described in subparagraph (A) 

22 cannot reasonably be submitted, along with an 

23 estimated date of submission of the information 

24 described in such subparagraph. 

25 ‘‘(2) SANCTION IN CASE OF NONCOMPLIANCE.— 


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1 ‘‘(A) INITIAL NONCOMPLIANCE.—If by the 

2 date specified in paragraph (3), the Secretary 

3 has not received the information or statement 

4 required to be submitted to the Secretary under 

5 paragraph (1), the Secretary shall— 

6 ‘‘(i) transmit to the responsible person 

7 for such trial a notice stating that such re8 sponsible person shall be liable for the civil 

9 monetary penalties described in subpara10 graph (B) if the required information or 

11 statement is not submitted to the Sec12 retary within 30 days of the date on which 

13 such notice is transmitted; and 

14 ‘‘(ii) include and prominently display, 

15 until such time as the Secretary receives 

16 the information described in paragraph 

17 (1), as part of the record of such trial in 

18 the database described in subsection (i), a 

19 notice stating that the results of such 

20 trials have not been reported as required 

21 by law. 

22 ‘‘(B) CIVIL MONETARY PENALTIES FOR

23 NONCOMPLIANCE.— 

24 ‘‘(i) IN GENERAL.—If by the date that 

25 is 30 days after the date on which a notice 


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1 described in subparagraph (A) is trans2 mitted, the Secretary has not received from 

3 the responsible person involved the infor4 mation or statement required pursuant to 

5 such notice, the Secretary shall, after pro6 viding the opportunity for a hearing, order 

7 such responsible person to pay a civil pen8 alty of $10,000 for each day after such 

9 date that the information or statement is 

10 not submitted. 

11 ‘‘(ii) WAIVERS.—In any case in which 

12 a responsible person described in clause (i) 

13 is a nonprofit entity, the Secretary may 

14 waive or reduce the penalties applicable 

15 under such clause to such person. 

16 ‘‘(C) SUBMISSION OF STATEMENT BUT

17 NOT INFORMATION.— 

18 ‘‘(i) IN GENERAL.—If by the date 

19 specified in paragraph (3), the Secretary 

20 has received a statement described in para21 graph (1)(B) but not the information de22 scribed in paragraph (1)(A) the Secretary 

23 shall transmit to the responsible person in24 volved a notice stating that such respon25 sible person shall submit such information 


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1 by the date determined by the Secretary in 

2 consultation with such responsible person. 

3 ‘‘(ii) FAILURE TO COMPLY.—If, by the 

4 date specified by the Secretary in the no5 tice under clause (i), the Secretary has not 

6 received the information described in para7 graph (1)(A), the Secretary shall— 

8 ‘‘(I) transmit to the responsible 

9 person involved a notice specifying the 

10 information required to be submitted 

11 to the Secretary and stating that such 

12 responsible person shall be liable for 

13 the civil monetary penalties described 

14 in subparagraph (D) if such informa15 tion is not submitted to the Secretary 

16 within 30 days of the date on which 

17 such notice is transmitted; and 

18 ‘‘(II) include and prominently 

19 display, until such time as the Sec20 retary receives the information de21 scribed in paragraph (1)(A), as part 

22 of the record of such trial in the data23 base described in subsection (i), a no24 tice stating that the results of such 


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1 trials have not been reported as re2 quired by law. 

3 ‘‘(D) NONCOMPLIANCE.— 

4 ‘‘(i) IN GENERAL.—If by the date that 

5 is 30 days after the date on which a notice 

6 described in subparagraph (C)(ii)(I) is 

7 transmitted, the Secretary has not received 

8 from the responsible person involved the 

9 information required pursuant to such no10 tice, the Secretary, after providing the op11 portunity for a hearing, shall order such 

12 responsible person to pay a civil penalty of 

13 $10,000 for each day after such date that 

14 the information is not submitted. 

15 ‘‘(ii) WAIVERS.—In any case in which 

16 a responsible person described in clause (i) 

17 is a nonprofit entity, the Secretary may 

18 waive or reduce the penalties applicable 

19 under such clause to such person. 

20 ‘‘(E) NOTICE OF PUBLICATION OF DATA.— 

21 If the responsible person is the manufacturer or 

22 distributor of the drug, biological product, or 

23 device involved, the notice under subparagraphs 

24 (A)(i) and (C)(ii)(I) shall include a notice that 

25 the Secretary shall publish the data described 


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1 in subsection (i)(3)(B) in the database if the re2 sponsible person has not submitted the informa3 tion specified in the notice transmitted by the 

4 date that is 6 months after the date of such no5 tice. 

6 ‘‘(F) PUBLICATION OF DATA.—Notwith7 standing section 301(j) of the Federal Food, 

8 Drug, and Cosmetic Act, section 1905 of title 

9 18, United States Code, or any other provision 

10 of law, if the responsible person is the manufac11 turer or distributor of the drug, biological prod12 uct, or device involved, and if the responsible 

13 person has not submitted to the Secretary the 

14 information specified in a notice transmitted 

15 pursuant to subparagraph (A)(i) or (C)(ii)(I) by 

16 the date that is 6 months after the date of such 

17 notice, the Secretary shall publish in the reg18 istry information that— 

19 ‘‘(i) is described in subsection 

20 (i)(3)(B); and 

21 ‘‘(ii) the responsible person has sub22 mitted to the Secretary in any application, 

23 including a supplemental application, for 

24 the drug or device under section 505, 510, 

25 515, or 520 of the Federal Food, Drug, 


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1 and Cosmetic Act or for the biological 

2 product under section 351. 

3 ‘‘(3) DATE SPECIFIED.—The date specified in 

4 this paragraph shall be the date that is 1 year from 

5 the earlier of— 

6 ‘‘(A) the estimated completion date of the 

7 trial, submitted under subsection 

8 (i)(3)(B)(vi)(I)(ii); or 

9 ‘‘(B) the actual date of completion or ter10 mination of the trial. 

11 ‘‘(4) USE OF FUNDS.— 

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

13 deposit the funds collected under paragraph (2) 

14 into an account and use such funds, in con15 sultation with the Director of the Agency for 

16 Healthcare Research and Quality, to fund stud17 ies that compare the clinical effectiveness of 2 

18 or more treatments for similar diseases or con19 ditions. 

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

21 shall award funding under subparagraph (A) 

22 based on a priority list established not later 

23 than 6 months after the date of enactment of 

24 the FACT Act by the Director of the Agency 

25 for Healthcare Research and Quality and periVerDate Aug 31 2005 00:28 Feb 03, 2007 Jkt 059200 PO 00000 Frm 00029 Fmt 6652 Sfmt 6201 E:\BILLS\S467.IS S467

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1 odically updated as determined appropriate by 

2 the Director. 

3 ‘‘(5) INCLUSION IN REGISTRY.— 

4 ‘‘(A) GENERAL RULE.—The Secretary 

5 shall, pursuant to subsection (i)(5), include— 

6 ‘‘(i) the data described in subsection 

7 (i)(3)(A) and submitted under the amend8 ments made by section 4(a) of the FACT 

9 Act in the registry described in subsection 

10 (i) as soon as practicable after receiving 

11 such data; and 

12 ‘‘(ii) the data described in clause (I) 

13 of subsection (i)(3)(B)(iv) and submitted 

14 under this subsection in the database de15 scribed in subsection (i) as soon as prac16 ticable after receiving such data. 

17 ‘‘(B) OTHER DATA.— 

18 ‘‘(i) IN GENERAL.—The Secretary 

19 shall, pursuant to subsection (i)(5), include 

20 the data described in subclauses (II) 

21 through (X) of subsection (i)(3)(B)(iv) and 

22 submitted under this section in the data23 base described in subsection (i)— 

24 ‘‘(I) as soon as practicable after 

25 receiving such data; or 


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1 ‘‘(II) in the case of data to which 

2 clause (ii) applies, by the date de3 scribed in clause (iii). 

4 ‘‘(ii) DATA DESCRIBED.—This clause 

5 applies to data described in clause (i) if— 

6 ‘‘(I) the responsible person in7 volved requests a delay in the inclu8 sion in the database of such data in 

9 order to have such data published in 

10 a peer reviewed journal; and 

11 ‘‘(II) the Secretary determines 

12 that an attempt will be made to seek 

13 such publication. 

14 ‘‘(iii) DATE FOR INCLUSION IN REG15 ISTRY.—Subject to clause (iv), the date de16 scribed in this clause is the earlier of— 

17 ‘‘(I) the date on which the data 

18 involved is published as provided for 

19 in clause (ii); or 

20 ‘‘(II) the date that is 18 months 

21 after the date on which such data is 

22 submitted to the Secretary. 

23 ‘‘(iv) EXTENSION OF DATE.—The 

24 Secretary may extend the 18-month period 

25 described in clause (iii)(II) for an addiVerDate Aug 31 2005 00:28 Feb 03, 2007 Jkt 059200 PO 00000 Frm 00031 Fmt 6652 Sfmt 6201 E:\BILLS\S467.IS S467

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1 tional 6 months if the responsible person 

2 demonstrates to the Secretary, prior to the 

3 expiration of such 18-month period, that 

4 the data involved has been accepted for 

5 publication by a journal described in clause 

6 (ii)(I). 

7 ‘‘(v) MODIFICATION OF DATA.—Prior 

8 to including data in the database under 

9 clause (ii) or (iv), the Secretary shall per10 mit the responsible person to modify the 

11 data involved. 

12 ‘‘(6) EFFECT.—The information with respect to 

13 a clinical trial submitted to the Secretary under this 

14 subsection, including data published by the Sec15 retary pursuant to paragraph (2)(F), may not be 

16 submitted by a person other than the responsible 

17 person as part of, or referred to in, an application 

18 for approval of a drug or device under section 505, 

19 510, 515, or 520 of the Federal Food, Drug, and 

20 Cosmetic Act or of a biological product under section 

21 351, unless the information is available from a 

22 source other than the registry or database described 

23 in subsection (i). 

24 ‘‘(l) PROCEDURES AND WAIVERS.— 


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1 ‘‘(1) SUBMISSION PRIOR TO NOTICE.—Nothing 

2 in subsections (j) through (k) shall be construed to 

3 prevent a principal investigator or a responsible per4 son from submitting any information required under 

5 this subsection to the Secretary prior to receiving 

6 any notice described in such subsections. 

7 ‘‘(2) ONGOING TRIALS.—A factually accurate 

8 statement that a clinical trial is ongoing shall be 

9 deemed to be information sufficient to demonstrate 

10 to the Secretary that the information described in 

11 subsections (j)(1)(A) and (k)(1)(A) cannot reason12 ably be submitted. 

13 ‘‘(3) INFORMATION PREVIOUSLY SUBMITTED.— 

14 Nothing in subsections (j) through (k) shall be con15 strued to require the Secretary to send a notice to 

16 any principal investigator or responsible person re17 quiring the submission to the Secretary of informa18 tion that has already been submitted. 

19 ‘‘(4) SUBMISSION FORMAT AND TECHNICAL

20 STANDARDS.— 

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

22 to the extent practicable, accept submissions re23 quired under this subsection in an electronic 

24 format and shall establish interoperable tech25 nical standards for such submissions. 


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1 ‘‘(B) CONSISTENCY OF STANDARDS.—To 

2 the extent practicable, the standards established 

3 under subparagraph (A) shall be consistent 

4 with standards adopted by the Consolidated 

5 Health Informatics Initiative (or a successor or6 ganization to such Initiative) to the extent such 

7 Initiative (or successor) is in operation. 

8 ‘‘(5) TRIALS COMPLETED PRIOR TO ENACT9 MENT.—The Secretary shall establish procedures 

10 and mechanisms to allow for the voluntary submis11 sion to the database of the information described in 

12 subsection (i)(3)(B) with respect to clinical trials 

13 completed prior to the date of enactment of the 

14 FACT Act. In cases in which it is in the interest of 

15 public health, the Secretary may require that infor16 mation from such trials be submitted to the data17 base. To the extent practicable, submissions to the 

18 database shall comply with paragraph (4). Failure to 

19 comply with a requirement to submit information to 

20 the database under this paragraph shall be deemed 

21 to be a failure to submit information as required 

22 under this section, and the appropriate remedies and 

23 sanctions under this section shall apply. 

24 ‘‘(6) TRIALS NOT INVOLVING DRUGS, BIOLOGI25 CAL PRODUCTS, OR DEVICES.—The Secretary shall 


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1 establish procedures and mechanisms to allow for 

2 the voluntary submission to the database of the in3 formation described in subsection (i)(3)(B) with re4 spect to clinical trials that do not involve drugs, bio5 logical products, or devices. In cases in which it is 

6 in the interest of public health, the Secretary may 

7 require that information from such trials be sub8 mitted to the database. Failure to comply with such 

9 a requirement shall be deemed to be a failure to sub10 mit information as required under this section, and 

11 the appropriate remedies and sanctions under this 

12 section shall apply. 

13 ‘‘(7) SUBMISSION OF INACCURATE INFORMA14 TION.— 

15 ‘‘(A) IN GENERAL.—If the Secretary deter16 mines that information submitted by a principal 

17 investigator or a responsible person under this 

18 section is factually and substantively inaccurate, 

19 the Secretary shall submit a notice to the inves20 tigator or responsible person concerning such 

21 inaccuracy that includes— 

22 ‘‘(i) a summary of the inaccuracies in23 volved; and 

24 ‘‘(ii) a request for corrected informa25 tion within 30 days. 


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1 ‘‘(B) AUDIT OF INFORMATION.— 

2 ‘‘(i) IN GENERAL.—The Secretary 

3 may conduct audits of any information 

4 submitted under subsection (i). 

5 ‘‘(ii) REQUIREMENT.—Any principal 

6 investigator or responsible person that has 

7 submitted information under subsection (i) 

8 shall permit the Secretary to conduct the 

9 audit described in clause (i). 

10 ‘‘(C) CHANGES TO INFORMATION.—Any 

11 change in the information submitted by a prin12 cipal investigator or a responsible person under 

13 this section shall be reported to the Secretary 

14 within 30 days of the date on which such inves15 tigator or person became aware of the change 

16 for purposes of updating the registry or the 

17 database. 

18 ‘‘(D) FAILURE TO CORRECT.—If a prin19 cipal investigator or a responsible person fails 

20 to permit an audit under subparagraph (B), 

21 provide corrected information pursuant to a no22 tice under subparagraph (A), or provide 

23 changed information under subparagraph (C), 

24 the investigator or responsible person involved 

25 shall be deemed to have failed to submit inforVerDate Aug 31 2005 00:28 Feb 03, 2007 Jkt 059200 PO 00000 Frm 00036 Fmt 6652 Sfmt 6201 E:\BILLS\S467.IS S467

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1 mation as required under this section and the 

2 appropriate remedies and sanction under this 

3 section shall apply. 

4 ‘‘(E) CORRECTIONS.— 

5 ‘‘(i) IN GENERAL.—The Secretary 

6 may correct, through any means deemed 

7 appropriate by the Secretary to protect 

8 public health, any information included in 

9 the registry or the database described in 

10 subsection (i) (including information de11 scribed or contained in a publication re12 ferred to under subclause (VI) of sub13 section (i)(3)(B)(iv)) that is— 

14 ‘‘(I) submitted to the Secretary 

15 for inclusion in the registry or the 

16 database; and 

17 ‘‘(II) factually and substantively 

18 inaccurate or false or misleading. 

19 ‘‘(ii) RELIANCE ON INFORMATION.— 

20 The Secretary may rely on any information 

21 from a clinical trial or a report of an ad22 verse event acquired or produced under the 

23 authority of section 351 of this Act or of 

24 the Federal Food, Drug, and Cosmetic Act 


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1 in determining whether to make correc2 tions as provided for in clause (i). 

3 ‘‘(iii) DETERMINATIONS RELATING TO

4 MISLEADING INFORMATION.—For purposes 

5 of clause (i)(II), in determining whether 

6 information is misleading, the Secretary 

7 shall use the standard described in section 

8 201(n) of the Federal Food, Drug, and 

9 Cosmetic Act that is used to determine 

10 whether labeling or advertising is mis11 leading. 

12 ‘‘(iv) RULE OF CONSTRUCTION.—This 

13 subparagraph shall not be construed to au14 thorize the disclosure of information if— 

15 ‘‘(I) such disclosure would con16 stitute an invasion of personal pri17 vacy; 

18 ‘‘(II) such information concerns a 

19 method or process which as a trade 

20 secret is entitled to protection within 

21 the meaning of section 301(j) of the 

22 Federal Food, Drug, and Cosmetic 

23 Act; 

24 ‘‘(III) such disclosure would dis25 close confidential commercial informaVerDate Aug 31 2005 00:28 Feb 03, 2007 Jkt 059200 PO 00000 Frm 00038 Fmt 6652 Sfmt 6201 E:\BILLS\S467.IS S467

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1 tion or a trade secret, other than a 

2 trade secret described in subclause 

3 (II), unless such disclosure is nec4 essary— 

5 ‘‘(aa) to make a correction 

6 as provided for under clause (i); 

7 and 

8 ‘‘(bb) protect the public 

9 health; or 

10 ‘‘(IV) such disclosure relates to a 

11 biological product for which no license 

12 is in effect under section 351, a drug 

13 for which no approved application is 

14 in effect under section 505(c) of the 

15 Federal Food, Drug, and Cosmetic 

16 Act, or a device that is not cleared 

17 under section 510(k) of such Act or 

18 for which no application is in effect 

19 under section 515 of such Act. 

20 ‘‘(v) NOTICE.—In the case of a disclo21 sure under clause (iv)(III), the Secretary 

22 shall notify the manufacturer or distributor 

23 of the drug, biological product, or device 

24 involved— 


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1 ‘‘(I) at least 30 days prior to 

2 such disclosure; or 

3 ‘‘(II) if immediate disclosure is 

4 necessary to protect the public health, 

5 concurrently with such disclosure. 

6 ‘‘(8) WAIVERS REGARDING CLINICAL TRIAL RE7 SULTS.—The Secretary may waive the requirements 

8 of subsections (j)(1) and (k)(1) that the results of 

9 clinical trials be submitted to the Secretary, upon a 

10 written request from the responsible person if the 

11 Secretary determines that extraordinary cir12 cumstances justify the waiver and that providing the 

13 waiver is in the public interest, consistent with the 

14 protection of public health, or in the interest of na15 tional security. Not later than 30 days after any 

16 part of a waiver is granted, the Secretary shall no17 tify, in writing, the appropriate committees of Con18 gress of the waiver and provide an explanation for 

19 why the waiver was granted. 

20 ‘‘(m) TRIALS CONDUCTED OUTSIDE OF THE UNITED

21 STATES.— 

22 ‘‘(1) IN GENERAL.—With respect to clinical 

23 trials described in paragraph (2), the responsible 

24 person shall submit to the Secretary the information 

25 required under subclauses (II) through (X) of subVerDate Aug 31 2005 00:28 Feb 03, 2007 Jkt 059200 PO 00000 Frm 00040 Fmt 6652 Sfmt 6201 E:\BILLS\S467.IS S467

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1 section (i)(3)(B)(iv). The Secretary shall ensure that 

2 the information described in the preceding sentence 

3 is made available in the database under subsection 

4 (i) in a timely manner. Submissions to the database 

5 shall comply with subsection (l)(4) to the extent 

6 practicable. The Secretary shall include the informa7 tion described in the preceding sentence in the data8 base under subsection (i) as soon as practicable after 

9 receiving such information. Failure to comply with 

10 this paragraph shall be deemed to be a failure to 

11 submit information as required under this section, 

12 and the appropriate remedies and sanctions under 

13 this section shall apply. 

14 ‘‘(2) CLINICAL TRIAL DESCRIBED.—A clinical 

15 trial is described in this paragraph if— 

16 ‘‘(A) such trial is conducted outside of the 

17 United States; and 

18 ‘‘(B) the data from such trial is— 

19 ‘‘(i) submitted to the Secretary as 

20 part of an application, including a supple21 mental application, for a drug or device 

22 under section 505, 510, 515, or 520 of the 

23 Federal Food, Drug, and Cosmetic Act or 

24 for the biological product under section 

25 351; or 


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1 ‘‘(ii) used in advertising or labeling to 

2 make a claim about the drug, device, or bi3 ological product involved. 

4 ‘‘(n) DEFINITIONS; INDIVIDUAL LIABILITY.— 

5 ‘‘(1) RESPONSIBLE PERSON.— 

6 ‘‘(A) IN GENERAL.—In this section, the 

7 term ‘responsible person’ with respect to a clin8 ical trial, means— 

9 ‘‘(i) if such clinical trial is the subject 

10 of an investigational new drug application 

11 or an application for an investigational de12 vice exemption, the sponsor of such inves13 tigational new drug application or such ap14 plication for an investigational device ex15 emption; or 

16 ‘‘(ii) except as provided in subpara17 graph (B), if such clinical trial is not the 

18 subject of an investigational new drug ap19 plication or an application for an investiga20 tional device exemption— 

21 ‘‘(I) the person that provides the 

22 largest share of the monetary support 

23 (such term does not include in-kind 

24 support) for the conduct of such trial; 

25 or 


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1 ‘‘(II) in the case in which the 

2 person described in subclause (I) is a 

3 Federal or State agency, the principal 

4 investigator of such trial. 

5 ‘‘(B) NONPROFIT ENTITIES AND REQUEST6 ING PERSONS.— 

7 ‘‘(i) NONPROFIT ENTITIES.—For pur8 poses of subparagraph (A)(ii)(I), if the 

9 person that provides the largest share of 

10 the monetary support for the conduct of 

11 the clinical trial involved is a nonprofit en12 tity, the responsible person for purposes of 

13 this section shall be— 

14 ‘‘(I) the nonprofit entity; or 

15 ‘‘(II) if the nonprofit entity and 

16 the principal investigator of such trial 

17 jointly certify to the Secretary that 

18 the principal investigator will be re19 sponsible for submitting the informa20 tion described in subsection (i)(3)(B) 

21 for such trial, the principal investi22 gator. 

23 ‘‘(ii) REQUESTING PERSONS.—For 

24 purposes of subparagraph (A)(ii)(I), if a 

25 person— 


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1 ‘‘(I) has submitted a request to 

2 the Secretary that the Secretary rec3 ognize the person as the responsible 

4 person for purposes of this section; 

5 and 

6 ‘‘(II) the Secretary determines 

7 that such person— 

8 ‘‘(aa) provides monetary 

9 support for the conduct of such 

10 trial; 

11 ‘‘(bb) is responsible for the 

12 conduct of such trial; and 

13 ‘‘(cc) will be responsible for 

14 submitting the information de15 scribed in subsection (i)(3)(B) 

16 for such trial; 

17 such person shall be the responsible person 

18 for purposes of this section. 

19 ‘‘(2) DRUG, DEVICE, BIOLOGICAL PRODUCT.— 

20 In this section— 

21 ‘‘(A) the terms ‘drug’ and ‘device’ have the 

22 meanings given such terms in section 201 of 

23 the Federal Food, Drug, and Cosmetic Act; and 


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1 ‘‘(B) the term ‘biological product’ has the 

2 meaning given such term in section 351 of this 

3 Act. 

4 ‘‘(3) INDIVIDUAL LIABILITY.— 

5 ‘‘(A) LIMITATION ON LIABILITY OF INDI6 VIDUALS.—No individual shall be liable for any 

7 civil monetary penalty under this section. 

8 ‘‘(B) INDIVIDUALS WHO ARE RESPONSIBLE

9 PERSONS.—If a responsible person under sub10 paragraph (A) or (B) of paragraph (1) is an in11 dividual, such individual shall be subject to the 

12 procedures and conditions described in sub13 section (j).’’. 

14 (c) AUTHORIZATION OF APPROPRIATIONS.—Section 

15 402 of the Public Health Service Act (42 U.S.C. 282), 

16 as amended by this section, is further amended by adding 

17 at the end the following: 

18 ‘‘(q) AUTHORIZATION OF APPROPRIATIONS.—There 

19 are authorized to be appropriated such sums as may be 

20 necessary to carry out this section.’’. 

21 (d) CONFORMING AMENDMENT.—Section 

22 402(c)(1)(D) of the Public Health Service Act (42 U.S.C. 

23 282(c)(1)(D)), as amended by Public Law 109–482, is 

24 amended by striking ‘‘402(k)’’ and inserting ‘‘402(p)’’. 


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1 SEC. 4. REVIEW AND APPROVAL OF PROPOSALS FOR RE2 SEARCH. 

3 (a) AMENDMENTS.—Section 492A(a) of the Public 

4 Health Service Act (42 U.S.C. 289a–1(a)) is amended— 

5 (1) in paragraph (1)(A), by striking ‘‘unless’’ 

6 and all that follows through the period and inserting 

7 the following: ‘‘unless— 

8 ‘‘(i) the application has undergone re9 view in accordance with such section and 

10 has been recommended for approval by a 

11 majority of the members of the Board con12 ducting the review; 

13 ‘‘(ii) such Board has submitted to the 

14 Secretary a notification of such approval; 

15 and 

16 ‘‘(iii) with respect to an application 

17 involving a clinical trial to which section 

18 402(i) applies, the principal investigator 

19 who has submitted such application has 

20 submitted to the Secretary for inclusion in 

21 the registry and the database described in 

22 section 402(i) the information described in 

23 paragraph (3)(A) and subclause (I) of 

24 paragraph (3)(B)(iv) of such section.’’; and 

25 (2) by adding at the end the following: 


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1 ‘‘(3) COST RECOVERY.—Nonprofit entities may 

2 recover the full costs associated with compliance 

3 with the requirements of paragraph (1) from the 

4 Secretary as a direct cost of research.’’. 

5 (b) REGULATIONS.—The Secretary of Health and 

6 Human Services shall modify the regulations promulgated 

7 at part 46 of title 45, Code of Federal Regulations, part 

8 50 of title 21, Code of Federal Regulations, and part 56 

9 of title 21, Code of Federal Regulations, to reflect the 

10 amendments made by subsection (a). 

11 (c) CONFORMING AMENDMENT.—Section 492A(a)(2) 

12 of the Public Health Service Act (42 U.S.C. 289a– 

13 1(a)(2)), as amended by Public Law 109–482, is amended 

14 by striking ‘‘402(k)’’ and inserting ‘‘402(p)’’. 

15 SEC. 5. PROHIBITED ACTS. 

16 Section 301 of the Federal Food, Drug, and Cosmetic 

17 Act (21 U.S.C. 331) is amended by adding at the end the 

18 following: 

19 ‘‘(ii)(1) The entering into of a contract or other 

20 agreement by a responsible person or a manufacturer of 

21 a drug, biological product, or device with an individual 

22 who is not an employee of such responsible person or man23 ufacturer, or the performance of any other act by such 

24 a responsible person or manufacturer, that prohibits, limVerDate Aug 31 2005 00:28 Feb 03, 2007 Jkt 059200 PO 00000 Frm 00047 Fmt 6652 Sfmt 6201 E:\BILLS\S467.IS S467

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1 its, or imposes unreasonable delays on the ability of such 

2 individual to— 

3 ‘‘(A) discuss the results of a clinical trial at a 

4 scientific meeting or any other public or private 

5 forum; or 

6 ‘‘(B) publish the results of a clinical trial or a 

7 description or discussion of the results of a clinical 

8 trial in a scientific journal or any other publication. 

9 ‘‘(2) The entering into a contract or other agreement 

10 by a responsible person or a manufacturer of a drug, bio11 logical product, or device with an academic institution or 

12 a health care facility, or the performance of any other act 

13 by such a responsible person or manufacturer, that pro14 hibits, limits, or imposes unreasonable delays on the abil15 ity of an individual who is not an employee of such respon16 sible person or manufacturer to— 

17 ‘‘(A) discuss the results of a clinical trial at a 

18 scientific meeting or any other public or private 

19 forum; or 

20 ‘‘(B) publish the results of a clinical trial or a 

21 description or discussion of the results of a clinical 

22 trial in a scientific journal or any other publica23 tion.’’. 


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1 SEC. 6. REPORTS. 

2 (a) IMPLEMENTATION REPORT.—Not later than 1 

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

4 of Health and Human Services shall submit to the appro5 priate committees of Congress a report on the status of 

6 the implementation of the requirements of the amend7 ments made by section 3 that includes a description of 

8 the number and types of clinical trials for which informa9 tion has been submitted under such amendments. 

10 (b) DATA COLLECTION.— 

11 (1) IN GENERAL.—The Secretary of Health and 

12 Human Services shall enter into a contract with the 

13 Institute of Medicine for the conduct of a study con14 cerning the extent to which data submitted to the 

15 registry under section 402(i) of the Public Health 

16 Service Act (42 U.S.C. 282(i)) has impacted the 

17 public health. 

18 (2) REPORT.—Not later than 6 months after 

19 the date on which a contract is entered into under 

20 paragraph (1), the Institute of Medicine shall submit 

21 to the Secretary of Health and Human Services a 

22 report on the results of the study conducted under 

23 such paragraph. Such report shall include rec24 ommendations for changes to the registry, the dataVerDate Aug 31 2005 00:28 Feb 03, 2007 Jkt 059200 PO 00000 Frm 00049 Fmt 6652 Sfmt 6201 E:\BILLS\S467.IS S467

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1 base, and the data submission requirements that 

2 would benefit the public health. 

Æ 


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