ments in control groups facing life-threatening med-
ical conditions. 
(15) As of June 15, 2006, the FDA has not 
promulgated a final version of the June 2004 pro-
posed rule. 
SEC. 3. STATEMENT OF POLICY. 
It is the policy of the United States to control the 
export of test articles which are intended for clinical inves-
tigations involving human participants in order to— 
(1) foster public health and safety; 
(2) prevent injury to the foreign policy of the 
United States; and 
(3) preserve the credibility of the United States 
as a responsible trading partner. 
SEC. 4. MEASURES TO PROTECT THE PUBLIC HEALTH. 
(a) IN GENERAL.—In order to carry out the policy 
set forth in section 3, test articles intended for clinical 
investigations may be exported only pursuant to an export 
license approved by the President. The President may ex-
ercise the authorities of the Export Administration Act of 
1979, as continued in effect pursuant to the International 
Emergency Economic Powers Act, to carry out this sec-
tion. 
(b) CRITERIA FOR EXPORT LICENSE.—In addition to 
any other requirements that may apply, including under 
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the Federal Food, Drug, and Cosmetic Act, the Public 
Health Service Act, and regulations issued under either 
such Act, the President shall require, as a prerequisite for 
approval of an export license for a test article required 
by subsection (a) of this section, that an applicant for such 
license— 
(1) identify each clinical investigation for which 
the test article is intended; 
(2) secure a certification from an institutional 
review board that each of the protocols for every 
clinical investigation identified under paragraph (1) 
has been reviewed by the institutional review board 
and has, at a minimum, met substantially the same 
standards for the protection of the rights and wel-
fare of human subjects as the standards that would 
be required for IRB approval of the protocol if the 
protocol were for a clinical investigation of the test 
article pursuant to the Federal Food, Drug, and 
Cosmetic Act ; and 
(3) submit the certification secured under para-
graph (2) to the President. 
(c) REPORTING REQUIREMENT.—Not later than one 
year after the date of the enactment of this Act, and annu-
ally thereafter, the President shall prepare and submit to 
the appropriate congressional committees a report regard-
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ing the approval of export licenses required by subsection 
(a). Such report shall include— 
(1) the names of the applicants for such export 
licenses; 
(2) the names of approved applicants for such 
export licenses; and 
(3) the destination country or countries for 
each application for such export licenses. 
(d) DEFINITIONS.—In this section: 
(1) APPLICATION
FOR
RESEARCH
OR
MAR-
KETING
PERMIT.—The term ‘‘application for re-
search or marketing permit’’ has the meaning given 
that term in section 56.102(b) of title 21, Code of 
Federal Regulations, or successor regulations. 
(2) APPROPRIATE
CONGRESSIONAL
COMMIT-
TEES.—The term ‘‘appropriate congressional com-
mittees’’ means the Committee on International Re-
lations of the House of Representatives and the 
Committee on Banking, Housing, and Urban Affairs 
of the Senate. 
(3) CLINICAL INVESTIGATION.— 
(A) IN GENERAL.—The term ‘‘clinical in-
vestigation’’ means any experiment that— 
(i) involves a test article and one or 
more human subjects; and 
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(ii)(I) the results of which are in-
tended to be later submitted to, or held for 
inspection by, the Secretary of Health and 
Human Services as part of an application 
for research or marketing permit; or 
(II) must meet the requirements for 
prior submission to such Secretary under 
section 505(i) or 520(g) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
355(i) or 360j(g)). 
(B) EXCLUSION.—The term ‘‘clinical in-
vestigation’’ does not include experiments that 
must meet the requirements of part 58 of title 
21, Code of Federal Regulations, or successor 
regulations, regarding nonclinical laboratory 
studies. 
(4) DESTINATION COUNTRY.—The term ‘‘des-
tination country’’ means the country into which test 
articles are being exported. 
(5) HUMAN SUBJECT.—The term ‘‘human sub-
ject’’ means an individual who is or becomes a par-
ticipant in research, either as a recipient of a test 
article or as a control. A subject may be either a 
healthy individual or a patient. 
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(6) 
INSTITUTION.—The 
term 
‘‘institution’’ 
means any public or private entity or agency (includ-
ing Federal, State, and other agencies), either in the 
United States or other country. 
(7) INSTITUTIONAL REVIEW BOARD; IRB.—The 
terms ‘‘institutional review board’’ and ‘‘IRB’’ mean 
any board, committee, or other group formally des-
ignated by an institution to review, to approve the 
initiation of, and to conduct periodic review of, bio-
medical research involving human subjects. The pri-
mary purpose of such review is to assure the protec-
tion of the rights and welfare of the human subjects. 
(8) IRB APPROVAL.—The term ‘‘IRB approval’’ 
means the determination of an IRB made pursuant 
to part 56 of title 21, Code of Federal Regulations, 
or successor regulations, that a clinical investigation 
has been reviewed and may be conducted at an insti-
tution within the constraints set forth by the IRB 
and by other institutional and Federal requirements. 
(9) TEST
ARTICLE.—The term ‘‘test article’’ 
means any drug for human use, biological product 
for human use, medical device for human use, 
human food additive, color additive, electronic prod-
uct, or any other article that would be subject to 
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regulation under the Federal Food, Drug, and Cos-
metic Act if introduced into interstate commerce. 
Æ 
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