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. SCHA-
KOWSKY) introduced the following bill; which was referred to the Com-
mittee 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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Trial and Experi-
mental Studies Transparency Act of 2012’’ or the ‘‘TEST 
Act’’. 
SEC. 2. EXPANDED CLINICAL TRIAL REGISTRY DATA BANK. 
(a) IN GENERAL.—Section 402(j) of the Public 
Health Service Act (42 U.S.C. 282(j)) is amended— 
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(1) in paragraph (1)(A)— 
(A) in clause (ii)— 
(i) by amending subclause (I) to read 
as follows: 
‘‘(I) an interventional study of a 
device subject to section 510(k), 515, 
or 520(m) of the Federal Food, Drug, 
and Cosmetic Act, including any 
interventional study of a device con-
ducted outside of the United States 
the results of which are submitted to 
the Secretary in support of a PMA 
(as such term is defined in section 
814.3(e) of title 21, Code of Federal 
Regulations); a premarket notification 
required under section 510(k) of the 
Federal Food, Drug, and Cosmetic 
Act; or a HDE (as such term is de-
fined in section 814.3(m) of title 21, 
Code of Federal Regulations).’’; and 
(ii) in subclause (II)— 
(I) by striking ‘‘pediatric’’; and 
(II) by inserting ‘‘that involves 
data collection from human subjects’’ 
before the period at the end; 
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(B) by amending clause (iii) to read as fol-
lows: 
‘‘(iii) APPLICABLE
DRUG
CLINICAL 
TRIAL.—The term ‘applicable drug clinical 
trial’ means an interventional study of a 
drug subject to section 505 of the Federal 
Food, Drug, and Cosmetic Act or to sec-
tion 351 of this Act, including any inter-
ventional study of a drug conducted out-
side of the United States the results of 
which are submitted to the Secretary in 
support of— 
‘‘(I) an IND (as such term is de-
fined in section 312.3 of title 21, 
Code of Federal Regulations); 
‘‘(II) an application filed under 
subsection (b) or (j) of such section 
505 of the Federal Food, Drug, and 
Cosmetic Act; or 
‘‘(III) an application for a license 
under section 351.’’; 
(C) by redesignating clauses (iv) through 
(ix) as clauses (v) through (x), respectively; 
(D) after clause (iii), by inserting the fol-
lowing new clause: 
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‘‘(iv) INTERVENTIONAL STUDY.—For 
purposes of clauses (ii) and (iii), the term 
‘interventional study’ means a study in 
human beings in which individuals are as-
signed by an investigator, based on a pro-
tocol, to receive specific interventions to 
evaluate their effects on biomedical or 
health-related outcomes.’’; and 
(E) in clause (vi), as redesignated by sub-
paragraph (C)— 
(i) in the heading, by inserting ‘‘; PRI-
MARY COMPLETION DATE’’ after ‘‘DATE’’; 
and 
(ii) by inserting ‘‘, also referred to as 
‘primary 
completion 
date’,’’ 
before 
‘‘means’’; 
(2) in paragraph (2)— 
(A) in subparagraph (A)(ii)— 
(i) by redesignating subclauses (II), 
(III), and (IV) as subclauses (III), (IV), 
and (V), respectively; 
(ii) by inserting after subclause (I) 
the following: 
‘‘(II) supporting documents, in-
cluding— 
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‘‘(aa) 
consent 
documents 
used to enroll subjects into the 
trial, as approved by the Institu-
tional Review Board or equiva-
lent committee prior to the start 
of the trial; and 
‘‘(bb) protocol documents, as 
approved by the Institutional Re-
view Board or equivalent com-
mittee prior to the start of the 
trial;’’; and 
(iii) in subclause (IV), as so redesig-
nated, in item (cc), by inserting ‘‘(or, in 
the case of a location outside of the United 
States, other appropriate location informa-
tion)’’ after ‘‘zip code’’; 
(B) in subparagraph (C)(ii) by striking 
‘‘21 days after’’ and inserting ‘‘before’’; and 
(C) by amending subparagraph (D) to read 
as follows: 
‘‘(D) POSTING OF DATA.—The Director of 
NIH shall ensure that clinical trial information 
for an applicable clinical trial submitted in ac-
cordance with this paragraph is posted pub-
lically in the registry data bank not later than 
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30 days after such submission is determined to 
meet the quality criteria established by the Di-
rector of NIH.’’; 
(3) in paragraph (3)— 
(A) in subparagraph (C)— 
(i) by striking ‘‘Not later than 1 
year’’ and all that follows through the 
colon and inserting ‘‘Subject to subpara-
graph (2)(C), the Secretary shall include in 
the registry and results data bank the fol-
lowing elements for an applicable clinical 
trial:’’; and 
(ii) by adding at the end the following 
new clause: 
‘‘(v) 
SUPPORTING
DOCUMENTS.— 
Final consent and protocol documents, in-
cluding all dated amendments to the initial 
version of such documents, as approved by 
the Institutional Review Board or equiva-
lent committee.’’; 
(B) in subparagraph (D)— 
(i) by striking clauses (ii) and (iv); 
(ii) in clause (iii)— 
(I) by striking subclause (III); 
and 
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(II) by redesignating subclause 
(IV) as subclause (III); and 
(iii) by redesignating— 
(I) clause (iii) as clause (ii); and 
(II) clauses (v) through (vii) as 
clauses (iii) through (v), respectively; 
(C) in subparagraph (E)— 
(i) by striking clauses (i) through (v) 
and inserting the following: 
‘‘(i) IN
GENERAL.—Except as pro-
vided in clauses (ii) and (iii), the respon-
sible party for an applicable clinical trial 
shall submit to the Director of NIH for in-
clusion in the registry and results data 
bank the clinical trial information de-
scribed in subparagraph (C) not later than 
1 year after the primary completion date 
of such trial. 
‘‘(ii) DELAYED
SUBMISSION
OF
RE-
SULTS
WITH
CERTIFICATION.—If the re-
sponsible party for an applicable clinical 
trial submits a certification that an appli-
cable clinical trial involves a drug described 
in clause (iii) or a device described in 
clause (iv), the responsible party shall sub-
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mit to the Director of NIH, for inclusion 
in the registry and results data bank, the 
clinical trial information described in sub-
paragraphs (C) and (D) not later than the 
earliest of the following: 
‘‘(I) The later of— 
‘‘(aa) 30 days after the drug 
or device is approved, licensed, or 
cleared, as applicable; or 
‘‘(bb) 1 year after the pri-
mary completion date of the ap-
plicable clinical trial. 
‘‘(II) The date that is 2 years 
after the primary completion date of 
the applicable clinical trial. 
‘‘(iii) DRUG DESCRIBED.—A drug de-
scribed in this clause is a drug that con-
tains an active ingredient, including any 
ester or salt, that has not been an ingre-
dient in a drug approved in any other ap-
plication under section 505 of the Federal 
Food, Drug, and Cosmetic Act or licensed 
for any use under section 351 of this Act. 
‘‘(iv) DEVICE DESCRIBED.—A device 
described in this clause is a device that has 
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not been approved or cleared for any use 
under section 510(k) or under section 515 
or 520(m) of the Federal Food, Drug, and 
Cosmetic Act.’’; 
(ii) by redesignating clause (vi) as 
clause (v); and 
(iii) by adding at the end the fol-
lowing: 
‘‘(vi) PUBLIC POSTINGS RELATED TO 
DELAYS
AND
EXTENSIONS.—Information 
submitted by the responsible party as part 
of a certification for delayed submission of 
results submitted under clause (ii) or a re-
quest for extension submitted under clause 
(v) shall be posted publically in the reg-
istry data bank.’’; 
(D) by striking subparagraph (F); 
(E) by redesignating subparagraphs (G) 
through (I) as subparagraphs (F) through (H), 
respectively; and 
(F) in subparagraph (F), as so redesig-
nated, by inserting before the period at the end 
the following: ‘‘is determined to meet the qual-
ity criteria established by the Director of NIH’’; 
and 
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(4) in paragraph (4)(B)— 
(A) 
in 
clause 
(i)(II), 
by 
striking 
‘‘(3)(E)(iii)’’ and inserting ‘‘(3)(E)(ii)’’; and 
(B) in clause (ii)(II)— 
(i) by striking ‘‘by both’’; and 
(ii) 
by 
striking 
‘‘and 
paragraph 
(3)(D)(ii)(II))’’. 
(b) IMPLEMENTATION.—The Secretary of Health and 
Human Services shall implement the amendments made 
by subsection (a) not later than 6 months after the date 
of enactment of this Act. 
SEC. 3. REPORTING REQUIREMENT. 
Not later than 2 years after the date of the enact-
ment of this Act, and annually thereafter, the Director 
of the National Institutes of Health and the Commissioner 
of the Food and Drug Administration shall each submit 
to the Committee on Energy and Commerce of the House 
of Representatives and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate a report that 
includes the following: 
(1) Based on information that is readily avail-
able in the data bank described in section 402(j) of 
the Public Health Service Act (42 U.S.C. 282(j))— 
(A) the number of trials that the Director 
or Commissioner, as applicable, has identified 
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as trials that are likely to be subject to the re-
porting requirements of such section; 
(B) of the trials identified under subpara-
graph (A), the estimated numbers and percent-
ages of such trials— 
(i) that have complete registration in-
formation; and 
(ii) that have met the result reporting 
requirements of section 402(j) of the Pub-
lic Health Service Act; and 
(C) whether results of the trials have been 
submitted by the responsible party by the due 
dates outlined in section 402(j) of the Public 
Health Service Act and, if not, whether certifi-
cations for delayed submission of such results, 
or requests for extensions, have been submitted 
by the responsible party. 
For purposes of this paragraph, the Secretary may 
use an algorithm or other technique for efficiently 
reviewing large amounts of data. 
(2) A description of any actions taken to con-
sult 
with 
other 
Federal 
agencies 
under 
402(j)(5)(A)(iv) of the Public Health Service Act. 
(3) In the case of a report submitted by the 
Commissioner of the Food and Drug Administration, 
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a description of any enforcement actions taken for 
violations of section 301(jj) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 331(jj)), includ-
ing— 
(A) warning letters or fines imposed re-
lated to reporting requirements; and 
(B) any inquiries made to responsible par-
ties to inform those parties of any potential en-
forcement action. 
(4) In the case of a report submitted by the Di-
rector of the National Institutes of Health, a de-
scription of any actions taken to withhold grant 
funds from responsible parties that are not compli-
ant with the requirements of this section as indi-
cated in 402(j)(5)(A) of the Public Health Service 
Act. 
SEC. 4. RULEMAKING RELATED TO FOREIGN CLINICAL 
STUDIES. 
(a) DRUGS.—Not later than 1 year after the date of 
enactment of this Act, the Secretary of Health and 
Human Services shall issue final regulations to amend sec-
tion 312.120 of title 21, Code of Federal Regulations (re-
lating to foreign clinical studies not conducted under an 
IND) to require that clinical trial information for such a 
foreign clinical study be submitted for inclusion in the reg-
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