199 
for conducting the trial, has access to and con-
trol over the data, has the right to publish the 
results of the trial, and has the responsibility to 
meet all of the requirements under this section 
that are applicable to responsible parties. 
‘‘(b) CLINICAL TRIALS REGISTRY DATABASE.— 
‘‘(1) ESTABLISHMENT.—To enhance patient en-
rollment and provide a mechanism to track subse-
quent progress of clinical trials, the Secretary, act-
ing through the Director of NIH, shall establish and 
administer a clinical trial registry database in ac-
cordance with this section (referred to in this section 
as the ‘registry database’). The Director of NIH 
shall ensure that the registry database is made pub-
licly available through the Internet. 
‘‘(2) CONTENT.—The Secretary shall promul-
gate regulations for the submission to the registry 
database of clinical trial information that— 
‘‘(A) conforms to the International Clinical 
Trials Registry Platform trial registration data 
set of the World Health Organization; 
‘‘(B) includes the city, State, and zip code 
for each clinical trial location or a toll free 
number through which such location informa-
tion may be accessed; 
VerDate Aug 31 2005 
05:37 Jul 12, 2007
Jkt 059200
PO 00000
Frm 00199
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.RH
H2900
bajohnson on PROD1PC77 with BILLS
200 
‘‘(C) includes a statement of the estimated 
completion date for the clinical trial; 
‘‘(D) includes the identity and contact in-
formation of the responsible party; 
‘‘(E) if the drug is not approved under sec-
tion 505 of the Federal Food, Drug, and Cos-
metic Act or licensed under section 351 of this 
Act, or the device is not cleared under section 
510(k) or approved under section 515 of the 
Federal Food, Drug, and Cosmetic Act, speci-
fies whether or not there is expanded access to 
the drug or device under section 561 of the 
Federal Food, Drug, and Cosmetic Act for 
those who do not qualify for enrollment in the 
clinical trial and how to obtain information 
about such access; 
‘‘(F) includes, with respect to any indi-
vidual who is not an employee of the responsible 
party for the clinical trial or of the manufac-
turer of the drug or device involved, information 
on whether the responsible party or manufac-
turer has entered into any agreement with such 
individual that restricts in any manner the abil-
ity of the individual— 
VerDate Aug 31 2005 
05:37 Jul 12, 2007
Jkt 059200
PO 00000
Frm 00200
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.RH
H2900
bajohnson on PROD1PC77 with BILLS
201 
‘‘(i) to discuss the results of the trial 
at a scientific meeting or any other public 
or private forum; or 
‘‘(ii) to publish the results of the trial, 
or a description or discussion of the results 
of the trial, in a scientific or academic 
journal; and 
‘‘(G) requires the inclusion of such other 
data elements to the registry database as ap-
propriate. 
‘‘(3) FORMAT AND STRUCTURE.— 
‘‘(A) SEARCHABLE CATEGORIES.—The Di-
rector of NIH shall ensure that the public may 
search the entries in the registry database by 1 
or more of the following criteria: 
‘‘(i) The indication being studied in 
the clinical trial, using Medical Subject 
Headers (MeSH) descriptors. 
‘‘(ii) The safety issue being studied in 
the clinical trial. 
‘‘(iii) The enrollment status of the 
clinical trial. 
‘‘(iv) The sponsor of the clinical trial. 
‘‘(B) FORMAT.—The Director of the NIH 
shall ensure that the registry database is easily 
VerDate Aug 31 2005 
05:37 Jul 12, 2007
Jkt 059200
PO 00000
Frm 00201
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.RH
H2900
bajohnson on PROD1PC77 with BILLS
202 
used by patients, and that entries are easily 
compared. 
‘‘(4) DATA SUBMISSION.—The responsible party 
for an applicable clinical trial shall submit to the Di-
rector of NIH for inclusion in the registry database 
the clinical trial information described in paragraph 
(2). 
‘‘(5) TRUTHFUL
CLINICAL
TRIAL
INFORMA-
TION.— 
‘‘(A) IN GENERAL.—The clinical trial in-
formation submitted by a responsible party 
under this subsection shall not be false or mis-
leading. 
‘‘(B) EFFECT.—Subparagraph (A) shall 
not have the effect of requiring clinical trial in-
formation to include information from any 
source other than the clinical trial involved. 
‘‘(6) TIMING OF SUBMISSION.—Except as pro-
vided in paragraph (7), the clinical trial information 
for a clinical trial required to be submitted under 
this subsection shall be submitted not later than 14 
days after the first patient is enrolled in such clin-
ical trial. 
‘‘(7) UPDATES.—The responsible party for an 
applicable clinical trial shall submit to the Director 
VerDate Aug 31 2005 
05:37 Jul 12, 2007
Jkt 059200
PO 00000
Frm 00202
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.RH
H2900
bajohnson on PROD1PC77 with BILLS