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In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.

SECTION 1. LIABILITY OF BUSINESS ENTITIES PROVIDING USE OF FACILITIES
TO NONPROFIT ORGANIZATIONS.

(a) Definitions.--In this section:
(1) Business entity.--The term ''business entity'' means a
firm, corporation, association, partnership, consortium, joint
venture, or other form of enterprise.
(2) Facility.--The term ''facility'' means any real
property, including any building, improvement, or appurtenance.
(3) Gross negligence.--The term ''gross negligence'' means
voluntary and conscious conduct by a person with knowledge (at
the time of the conduct) that the conduct is likely to be
harmful to the health or well-being of another person.
(4) Intentional misconduct.--The term ''intentional
misconduct'' means conduct by a person with knowledge (at the
time of the conduct) that the conduct is harmful to the health
or well-being of another person.
(5) Nonprofit organization.--The term ''nonprofit
organization'' means--
(A) any organization described in section 501(c)(3)
of the Internal Revenue Code of 1986 and exempt from
tax under section 501(a) of such Code; or
(B) any not-for-profit organization organized and
conducted for public benefit and operated primarily for
charitable, civic, educational, religious, welfare, or
health purposes.
(6) State.--The term ''State'' means each of the several
States, the District of Columbia, the Commonwealth of Puerto
Rico, the Virgin Islands, Guam, American Samoa, the Northern
Mariana Islands, any other territory or possession of the
United States, or any political subdivision of any such State,
territory, or possession.
(b) Limitation on Liability.--
(1) In general.--Subject to subsection (c), a business
entity shall not be subject to civil liability relating to any
injury or death occurring at a facility of the business entity
in connection with a use of such facility by a nonprofit
organization if--
(A) the use occurs outside of the scope of business
of the business entity;
(B) such injury or death occurs during a period
that such facility is used by the nonprofit
organization; and
(C) the business entity authorized the use of such
facility by the nonprofit organization.
(2) Application.--This subsection shall apply--
(A) with respect to civil liability under Federal
and State law; and
(B) regardless of whether a nonprofit organization
pays for the use of a facility.
(c) Exception for Liability.--Subsection (b) shall not apply to an
injury or death that results from an act or omission of a business
entity that constitutes gross negligence or intentional misconduct,
including any misconduct that--
(1) constitutes a crime of violence (as that term is
defined in section 16 of title 18, United States Code) or act
of international terrorism (as that term is defined in section
2331 of title 18) for which the defendant has been convicted in
any court;
(2) constitutes a hate crime (as that term is used in the
Hate Crime Statistics Act (28 U.S.C. 534 note));
(3) involves a sexual offense, as defined by applicable
State law, for which the defendant has been convicted in any
court; or
(4) involves misconduct for which the defendant has been
found to have violated a Federal or State civil rights law.
(d) Superseding Provision.--
(1) In general.--Subject to paragraph (2) and subsection
(e), this Act preempts the laws of any State to the extent that
such laws are inconsistent with this Act, except that this Act
shall not preempt any State law that provides additional
protection from liability for a business entity for an injury
or death with respect to which conditions under subparagraphs
(A) through (C) of subsection (b)(1) apply.
(2) Limitation.--Nothing in this Act shall be construed to
supersede any Federal or State health or safety law.
(e) Election of State Regarding Nonapplicability.--This Act shall
not apply to any civil action in a State court against a business
entity in which all parties are citizens of the State if such State
enacts a statute--
(1) citing the authority of this subsection;
(2) declaring the election of such State that this Act
shall not apply to such civil action in the State; and
(3) containing no other provision.
Solution: Shields a business entity from civil liability relating to any injury or death occurring at a facility of that entity in connection with a use of such facility by a nonprofit organization if: (1) the use occurs outside the scope of business of the business entity; (2) such injury or death occurs during a period that such facility is used by such organization; and (3) the business entity authorized the use of such facility by the organization.
Makes this Act inapplicable to an injury or death that results from an act or omission of a business entity that constitutes gross negligence or intentional misconduct, including misconduct that: (1) constitutes a hate crime or a crime of violence or act of international terrorism for which the defendant has been convicted in any court; or (2) involves a sexual offense for which the defendant has been convicted in any court or misconduct for which the defendant has been found to have violated a Federal or State civil rights law.
Preempts State laws to the extent that such laws are inconsistent with this Act, except State law that provides additional protection from liability. Specifies that this Act shall not be construed to supersede any Federal or State health or safety law.
Makes this Act inapplicable to any civil action in a State court against a business entity in which all parties are citizens of the State if such State, citing this Act's authority and containing no other provision, enacts a statute declaring the State's election that this Act shall not apply to such action in the State.
Why? This Bill focuses on shielding business entities from civil liability relating to an injury or death depending on the conditions of injury, hence the generated summary is correct.

New input: SECTION 1. SHORT TITLE.

This Act may be cited as the ''Safe Overseas Human Testing Act''.

SEC. 2. FINDINGS.

The Congress finds the following:
(1) Before a manufacturer of a new drug or device can
market its new product, the Food and Drug Administration (in
this section referred to as the ''FDA'') requires that the
manufacturer conduct laboratory and clinical trials to
ascertain the product's safety and effectiveness.
(2) Federal regulations mandate that an Institutional
Review Board (IRB), which is comprised of scientists,
physicians, and lay people, review the protocol or research
plan and the informed consent form of the proposed clinical
trial to ensure, among other things, that the health and safety
of the human participants are not unnecessarily endangered.
(3) Institutional Review Boards also verify that the
manufacturer's clinical researchers implement appropriate
additional safeguards to protect the rights and welfare of
potentially vulnerable populations and persons who are
economically or educationally disadvantaged.
(4) Most importantly, the IRBs help assure the FDA that
manufacturers of new drugs and medical devices adequately
inform human participants of the anticipated risks and the
likelihood of projected benefits derived from their
participation in the clinical trials, and then secure the
voluntary consent of the participants.
(5) For the purpose of supporting the safety and efficacy
of the test article, the FDA, however, may accept the results
of clinical trials with human participants which are conducted
outside of the United States and do not meet United States IRB
and ethical requirements.
(6) Foreign clinical trials involving human participants
only need to conform to either international norms on clinical
investigations or the laws and regulations of the country in
which the research is to be conducted. However, neither
international nor most host-country standards meet the
stringent requirements of the United States.
(7) International and most foreign-country legal
protections do not adequately shield participants in clinical
investigations of a new drug or device from unethical,
dangerous, or unscrupulous research practices.
(8) Some researchers exploit the fragile regulatory
systems, high illiteracy rates, and public health failures of
developing countries to test their experimental drugs and
devices on misinformed and unwilling human participants.
(9) On April 30, 2001, the National Bioethics Advisory
Commission (NBAC) presented to the President a report, entitled
''Ethical and Policy Issues in International Research: Clinical
Trials in Developing Countries'', which discussed the ethical
issues generated by research on human participants in
developing countries and recommended ways to help ensure the
health and safety of these human participants. The NBAC
highlighted the inadequate regulatory protections which are
afforded to human participants in many clinical trials abroad.
(10) In September 2001, the Office of the Inspector General
of the Department of Health and Human Services released the
report entitled ''The Globalization of Clinical Trials: A
Growing Challenge in Protecting Human Subjects''. In the
report, the Inspector General acknowledged that key entities
which oversee or study foreign research, including United
States regulatory agencies and the World Health Organization,
have raised concerns about the lack of experience and
insufficient monitoring practices of many foreign IRBs.
(11) The Inspector General also recommended, among other
things, that the FDA collect more information on the
performance of foreign IRBs and the growth and location of
foreign clinical investigations.
(12) While Federal regulation should accelerate, whenever
possible, the delivery from laboratory to patients of new drugs
which are designed to treat devastating illnesses, existing law
permits manufacturers to profit from the misery and pain of
uniformed, misinformed, and unwilling patients in developing
countries.
(13) On June 10, 2004, the FDA issued a proposed rule that
would, among other things, replace the existing requirement
that foreign clinical studies be conducted in accordance with
the ethical principles which are contained in the Declaration
of Helsinki (described in section 312.120(c) of title 21, Code
of Federal Regulations), with a requirement that such studies
comply with good clinical practice (GCP).
(14) Although pharmaceutical and biotechnology companies
and their lobbyists, in submitted public comment, generally
support the proposed rule, other organizations, such as the
AIDS Vaccine Advocacy Coalition and Public Citizen, have
objected to the proposed deletion of the Declaration of
Helsinki from applicable regulations because the removal may
result in the use of placebos or other drugs which are less
effective than established treatments in control groups facing
life-threatening medical conditions.
(15) As of June 15, 2006, the FDA has not promulgated a
final version of the June 2004 proposed 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 investigations 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 exercise 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 section.
(b) Criteria for Export License.--In addition to any other
requirements that may apply, including under 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 welfare 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 paragraph (2) to
the President.
(c) Reporting Requirement.--Not later than one year after the date
of the enactment of this Act, and annually thereafter, the President
shall prepare and submit to the appropriate congressional committees a
report regarding 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 marketing permit.--The term
''application for research 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 committees.--The term
''appropriate congressional committees'' means the Committee on
International Relations 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
investigation'' means any experiment that--
(i) involves a test article and one or more
human subjects; and
(ii)(I) the results of which are intended
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 investigation''
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 ''destination country''
means the country into which test articles are being exported.
(5) Human subject.--The term ''human subject'' means an
individual who is or becomes a participant 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.
(6) Institution.--The term ''institution'' means any public
or private entity or agency (including 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 designated by an institution
to review, to approve the initiation of, and to conduct
periodic review of, biomedical research involving human
subjects. The primary purpose of such review is to assure the
protection 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 institution 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
product, or any other article that would be subject to
regulation under the Federal Food, Drug, and Cosmetic Act if
introduced into interstate commerce.
Solution:
Safe Overseas Human Testing Act - Allows test articles intended for clinical investigations to be exported only pursuant to an export license approved by the President. Directs the President to require an applicant for such license to: (1) identify each clinical investigation for which the test article is intended; and (2) secure a certification from an institutional review board that each of the protocols for every clinical investigation has been reviewed by the board and has met substantially the same standards for the protection of the rights and welfare of human subjects as would be required if the protocol were for a clinical investigation of the test article pursuant to the Federal Food, Drug, and Cosmetic Act.