I 

113TH CONGRESS 

1ST SESSION H. R. 2031 

To amend title IV of the Public Health Service Act to expand the clinical 

trial registry data bank, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 16, 2013 

Mr. MARKEY (for himself, Mr. WAXMAN, Ms. DELAURO, and Ms. SCHAKOWSKY) introduced the following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To amend title IV of the Public Health Service Act to 

expand the clinical trial registry data bank, 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 ‘‘Trial and Experi5 mental Studies Transparency Act of 2012’’ or the ‘‘TEST 

6 Act’’. 

7 SEC. 2. EXPANDED CLINICAL TRIAL REGISTRY DATA BANK. 

8 (a) IN GENERAL.—Section 402(j) of the Public 

9 Health Service Act (42 U.S.C. 282(j)) is amended— 


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1 (1) in paragraph (1)(A)— 

2 (A) in clause (ii)— 

3 (i) by amending subclause (I) to read 

4 as follows: 

5 ‘‘(I) an interventional study of a 

6 device subject to section 510(k), 515, 

7 or 520(m) of the Federal Food, Drug, 

8 and Cosmetic Act, including any 

9 interventional study of a device con10 ducted outside of the United States 

11 the results of which are submitted to 

12 the Secretary in support of a PMA 

13 (as such term is defined in section 

14 814.3(e) of title 21, Code of Federal 

15 Regulations); a premarket notification 

16 required under section 510(k) of the 

17 Federal Food, Drug, and Cosmetic 

18 Act; or a HDE (as such term is de19 fined in section 814.3(m) of title 21, 

20 Code of Federal Regulations).’’; and 

21 (ii) in subclause (II)— 

22 (I) by striking ‘‘pediatric’’; and 

23 (II) by inserting ‘‘that involves 

24 data collection from human subjects’’ 

25 before the period at the end; 


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1 (B) by amending clause (iii) to read as fol2 lows: 

3 ‘‘(iii) APPLICABLE DRUG CLINICAL

4 TRIAL.—The term ‘applicable drug clinical 

5 trial’ means an interventional study of a 

6 drug subject to section 505 of the Federal 

7 Food, Drug, and Cosmetic Act or to sec8 tion 351 of this Act, including any inter9 ventional study of a drug conducted out10 side of the United States the results of 

11 which are submitted to the Secretary in 

12 support of— 

13 ‘‘(I) an IND (as such term is de14 fined in section 312.3 of title 21, 

15 Code of Federal Regulations); 

16 ‘‘(II) an application filed under 

17 subsection (b) or (j) of such section 

18 505 of the Federal Food, Drug, and 

19 Cosmetic Act; or 

20 ‘‘(III) an application for a license 

21 under section 351.’’; 

22 (C) by redesignating clauses (iv) through 

23 (ix) as clauses (v) through (x), respectively; 

24 (D) after clause (iii), by inserting the fol25 lowing new clause: 


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1 ‘‘(iv) INTERVENTIONAL STUDY.—For 

2 purposes of clauses (ii) and (iii), the term 

3 ‘interventional study’ means a study in 

4 human beings in which individuals are as5 signed by an investigator, based on a pro6 tocol, to receive specific interventions to 

7 evaluate their effects on biomedical or 

8 health-related outcomes.’’; and 

9 (E) in clause (vi), as redesignated by sub10 paragraph (C)— 

11 (i) in the heading, by inserting ‘‘; PRI12 MARY COMPLETION DATE’’ after ‘‘DATE’’; 

13 and 

14 (ii) by inserting ‘‘, also referred to as 

15 ‘primary completion date’,’’ before 

16 ‘‘means’’; 

17 (2) in paragraph (2)— 

18 (A) in subparagraph (A)(ii)— 

19 (i) by redesignating subclauses (II), 

20 (III), and (IV) as subclauses (III), (IV), 

21 and (V), respectively; 

22 (ii) by inserting after subclause (I) 

23 the following: 

24 ‘‘(II) supporting documents, in25 cluding— 


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1 ‘‘(aa) consent documents 

2 used to enroll subjects into the 

3 trial, as approved by the Institu4 tional Review Board or equiva5 lent committee prior to the start 

6 of the trial; and 

7 ‘‘(bb) protocol documents, as 

8 approved by the Institutional Re9 view Board or equivalent com10 mittee prior to the start of the 

11 trial;’’; and 

12 (iii) in subclause (IV), as so redesig13 nated, in item (cc), by inserting ‘‘(or, in 

14 the case of a location outside of the United 

15 States, other appropriate location informa16 tion)’’ after ‘‘zip code’’; 

17 (B) in subparagraph (C)(ii) by striking 

18 ‘‘21 days after’’ and inserting ‘‘before’’; and 

19 (C) by amending subparagraph (D) to read 

20 as follows: 

21 ‘‘(D) POSTING OF DATA.—The Director of 

22 NIH shall ensure that clinical trial information 

23 for an applicable clinical trial submitted in ac24 cordance with this paragraph is posted pub25 lically in the registry data bank not later than 


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1 30 days after such submission is determined to 

2 meet the quality criteria established by the Di3 rector of NIH.’’; 

4 (3) in paragraph (3)— 

5 (A) in subparagraph (C)— 

6 (i) by striking ‘‘Not later than 1 

7 year’’ and all that follows through the 

8 colon and inserting ‘‘Subject to subpara9 graph (2)(C), the Secretary shall include in 

10 the registry and results data bank the fol11 lowing elements for an applicable clinical 

12 trial:’’; and 

13 (ii) by adding at the end the following 

14 new clause: 

15 ‘‘(v) SUPPORTING DOCUMENTS.— 

16 Final consent and protocol documents, in17 cluding all dated amendments to the initial 

18 version of such documents, as approved by 

19 the Institutional Review Board or equiva20 lent committee.’’; 

21 (B) in subparagraph (D)— 

22 (i) by striking clauses (ii) and (iv); 

23 (ii) in clause (iii)— 

24 (I) by striking subclause (III); 

25 and 


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1 (II) by redesignating subclause 

2 (IV) as subclause (III); and 

3 (iii) by redesignating— 

4 (I) clause (iii) as clause (ii); and 

5 (II) clauses (v) through (vii) as 

6 clauses (iii) through (v), respectively; 

7 (C) in subparagraph (E)— 

8 (i) by striking clauses (i) through (v) 

9 and inserting the following: 

10 ‘‘(i) IN GENERAL.—Except as pro11 vided in clauses (ii) and (iii), the respon12 sible party for an applicable clinical trial 

13 shall submit to the Director of NIH for in14 clusion in the registry and results data 

15 bank the clinical trial information de16 scribed in subparagraph (C) not later than 

17 1 year after the primary completion date 

18 of such trial. 

19 ‘‘(ii) DELAYED SUBMISSION OF RE20 SULTS WITH CERTIFICATION.—If the re21 sponsible party for an applicable clinical 

22 trial submits a certification that an appli23 cable clinical trial involves a drug described 

24 in clause (iii) or a device described in 

25 clause (iv), the responsible party shall subVerDate Mar 15 2010 06:29 May 24, 2013 Jkt 029200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H2031.IH H2031

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1 mit to the Director of NIH, for inclusion 

2 in the registry and results data bank, the 

3 clinical trial information described in sub4 paragraphs (C) and (D) not later than the 

5 earliest of the following: 

6 ‘‘(I) The later of— 

7 ‘‘(aa) 30 days after the drug 

8 or device is approved, licensed, or 

9 cleared, as applicable; or 

10 ‘‘(bb) 1 year after the pri11 mary completion date of the ap12 plicable clinical trial. 

13 ‘‘(II) The date that is 2 years 

14 after the primary completion date of 

15 the applicable clinical trial. 

16 ‘‘(iii) DRUG DESCRIBED.—A drug de17 scribed in this clause is a drug that con18 tains an active ingredient, including any 

19 ester or salt, that has not been an ingre20 dient in a drug approved in any other ap21 plication under section 505 of the Federal 

22 Food, Drug, and Cosmetic Act or licensed 

23 for any use under section 351 of this Act. 

24 ‘‘(iv) DEVICE DESCRIBED.—A device 

25 described in this clause is a device that has 


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1 not been approved or cleared for any use 

2 under section 510(k) or under section 515 

3 or 520(m) of the Federal Food, Drug, and 

4 Cosmetic Act.’’; 

5 (ii) by redesignating clause (vi) as 

6 clause (v); and 

7 (iii) by adding at the end the fol8 lowing: 

9 ‘‘(vi) PUBLIC POSTINGS RELATED TO

10 DELAYS AND EXTENSIONS.—Information 

11 submitted by the responsible party as part 

12 of a certification for delayed submission of 

13 results submitted under clause (ii) or a re14 quest for extension submitted under clause 

15 (v) shall be posted publically in the reg16 istry data bank.’’; 

17 (D) by striking subparagraph (F); 

18 (E) by redesignating subparagraphs (G) 

19 through (I) as subparagraphs (F) through (H), 

20 respectively; and 

21 (F) in subparagraph (F), as so redesig22 nated, by inserting before the period at the end 

23 the following: ‘‘is determined to meet the qual24 ity criteria established by the Director of NIH’’; 

25 and 


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1 (4) in paragraph (4)(B)— 

2 (A) in clause (i)(II), by striking 

3 ‘‘(3)(E)(iii)’’ and inserting ‘‘(3)(E)(ii)’’; and 

4 (B) in clause (ii)(II)— 

5 (i) by striking ‘‘by both’’; and 

6 (ii) by striking ‘‘and paragraph 

7 (3)(D)(ii)(II))’’. 

8 (b) IMPLEMENTATION.—The Secretary of Health and 

9 Human Services shall implement the amendments made 

10 by subsection (a) not later than 6 months after the date 

11 of enactment of this Act. 

12 SEC. 3. REPORTING REQUIREMENT. 

13 Not later than 2 years after the date of the enact14 ment of this Act, and annually thereafter, the Director 

15 of the National Institutes of Health and the Commissioner 

16 of the Food and Drug Administration shall each submit 

17 to the Committee on Energy and Commerce of the House 

18 of Representatives and the Committee on Health, Edu19 cation, Labor, and Pensions of the Senate a report that 

20 includes the following: 

21 (1) Based on information that is readily avail22 able in the data bank described in section 402(j) of 

23 the Public Health Service Act (42 U.S.C. 282(j))— 

24 (A) the number of trials that the Director 

25 or Commissioner, as applicable, has identified 


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1 as trials that are likely to be subject to the re2 porting requirements of such section; 

3 (B) of the trials identified under subpara4 graph (A), the estimated numbers and percent5 ages of such trials— 

6 (i) that have complete registration in7 formation; and 

8 (ii) that have met the result reporting 

9 requirements of section 402(j) of the Pub10 lic Health Service Act; and 

11 (C) whether results of the trials have been 

12 submitted by the responsible party by the due 

13 dates outlined in section 402(j) of the Public 

14 Health Service Act and, if not, whether certifi15 cations for delayed submission of such results, 

16 or requests for extensions, have been submitted 

17 by the responsible party. 

18 For purposes of this paragraph, the Secretary may 

19 use an algorithm or other technique for efficiently 

20 reviewing large amounts of data. 

21 (2) A description of any actions taken to con22 sult with other Federal agencies under 

23 402(j)(5)(A)(iv) of the Public Health Service Act. 

24 (3) In the case of a report submitted by the 

25 Commissioner of the Food and Drug Administration, 


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1 a description of any enforcement actions taken for 

2 violations of section 301(jj) of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 331(jj)), includ4 ing— 

5 (A) warning letters or fines imposed re6 lated to reporting requirements; and 

7 (B) any inquiries made to responsible par8 ties to inform those parties of any potential en9 forcement action. 

10 (4) In the case of a report submitted by the Di11 rector of the National Institutes of Health, a de12 scription of any actions taken to withhold grant 

13 funds from responsible parties that are not compli14 ant with the requirements of this section as indi15 cated in 402(j)(5)(A) of the Public Health Service 

16 Act. 

17 SEC. 4. RULEMAKING RELATED TO FOREIGN CLINICAL 

18 STUDIES. 

19 (a) DRUGS.—Not later than 1 year after the date of 

20 enactment of this Act, the Secretary of Health and 

21 Human Services shall issue final regulations to amend sec22 tion 312.120 of title 21, Code of Federal Regulations (re23 lating to foreign clinical studies not conducted under an 

24 IND) to require that clinical trial information for such a 

25 foreign clinical study be submitted for inclusion in the regVerDate Mar 15 2010 06:29 May 24, 2013 Jkt 029200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H2031.IH H2031

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1 istry and results data bank in accordance with section 

2 402(j) of the Public Health Service Act (42 U.S.C. 

3 282(j)), as amended by this Act, as a condition for the 

4 acceptance of such study as support for an IND (as such 

5 term is defined in section 312.3 of title 21, Code of Fed6 eral Regulations) or application for marketing approval 

7 (an application under section 505 of the Federal Food, 

8 Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 

9 of the Public Health Service Act (42 U.S.C. 262)). 

10 (b) DEVICES.—Not later than 1 year after the date 

11 of enactment of this Act, the Secretary of Health and 

12 Human Services shall issue final regulations (including 

13 regulations amending section 814.15 of title 21, Code of 

14 Federal Regulations (relating to research conducted out15 side the United States)) to require that clinical trial infor16 mation for studies conducted outside the United States be 

17 submitted for inclusion in the registry and results data 

18 bank in accordance with section 402(j) of the Public 

19 Health Service Act (42 U.S.C. 282(j)), as amended by this 

20 Act, as a condition for the acceptance of such studies to 

21 support a PMA (as such term is defined in section 

22 814.3(e) of title 21, Code of Federal Regulations), a pre23 market notification required under section 510(k) of the 

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


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1 360(k)), or HDE (as such term is defined in section 

2 814.3(m) of title 21, Code of Federal Regulations). 

Æ 


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