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

Input: Consider Input: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Ban the Box Act''.

SEC. 2. UNLAWFUL EMPLOYMENT PRACTICES RELATED TO CRIMINAL RECORD OF 
              APPLICANTS.

    (a) In General.--Except as provided in subsection (b), it shall be 
an unlawful employment practice for any employer to make inquiries of 
an applicant for employment or otherwise seek information about such an 
applicant (including through the use of any form or application) 
relating to whether such applicant has ever been convicted of a 
criminal offense.
    (b) Exception.--Notwithstanding subsection (a), an employer may 
make inquiries of an applicant or otherwise seek information about the 
applicant relating to whether such applicant has ever been convicted of 
a criminal offense--
            (1) after a conditional offer for employment has been 
        extended to an applicant; or
            (2) where the granting of employment may involve an 
        unreasonable risk to the safety of specific individuals or to 
        the general public.

SEC. 3. RULEMAKING.

    Not later than 1 year after the date of enactment of this Act, the 
Commission shall issue rules--
            (1) defining categories of employment where an individual's 
        past criminal history may involve an unreasonable risk to the 
        safety of specific individuals or to the general public; and
            (2) factors to be considered by employers in assessing 
        whether an individual's past criminal history poses such an 
        unreasonable risk.

SEC. 4. ENFORCEMENT.

    (a) Employees Covered by Title VII of the Civil Rights Act of 
1964.--
            (1) In general.--The powers, procedures, and remedies 
        provided in sections 705, 706, 707, 709, 710, and 711 of the 
        Civil Rights Act of 1964 (42 U.S.C. 2000e-4 et seq.) to the 
        Commission, the Attorney General, or any person, alleging a 
        violation of title VII of that Act (42 U.S.C. 2000e et seq.) 
        shall be the powers, procedures, and remedies this title 
        provides to the Commission, the Attorney General, or any 
        person, respectively, alleging an unlawful employment practice 
        in violation of this title against an employee described in 
        section 5(2)(A), except as provided in paragraphs (2) and (3).
            (2) Costs and fees.--The powers, remedies, and procedures 
        provided in subsections (b) and (c) of section 722 of the 
        Revised Statutes of the United States (42 U.S.C. 1988), shall 
        be the powers, remedies, and procedures this title provides to 
        the Commission, the Attorney General, or any person, alleging 
        such a practice.
            (3) Damages.--The powers, remedies, and procedures provided 
        in section 1977A of the Revised Statutes of the United States 
        (42 U.S.C. 1981a), including the limitations contained in 
        subsection (b)(3) of such section 1977A, shall be the powers, 
        remedies, and procedures this title provides to the Commission, 
        the Attorney General, or any person, alleging such a practice 
        (not an employment practice specifically excluded from coverage 
        under section 1977A(a)(1) of the Revised Statutes of the United 
        States).
    (b) Employees Covered by Congressional Accountability Act of 
1995.--
            (1) In general.--The powers, remedies, and procedures 
        provided in the Congressional Accountability Act of 1995 (2 
        U.S.C. 1301 et seq.) to the Board (as defined in section 101 of 
        that Act (2 U.S.C. 1301)), or any person, alleging a violation 
        of section 201(a)(1) of that Act (2 U.S.C. 1311(a)(1)) shall be 
        the powers, remedies, and procedures this title provides to 
        that Board, or any person, alleging an unlawful employment 
        practice in violation of this title against an employee 
        described in section 5(2)(B), except as provided in paragraphs 
        (2) and (3).
            (2) Costs and fees.--The powers, remedies, and procedures 
        provided in subsections (b) and (c) of section 722 of the 
        Revised Statutes of the United States (42 U.S.C. 1988), shall 
        be the powers, remedies, and procedures this title provides to 
        that Board, or any person, alleging such a practice.
            (3) Damages.--The powers, remedies, and procedures provided 
        in section 1977A of the Revised Statutes of the United States 
        (42 U.S.C. 1981a), including the limitations contained in 
        subsection (b)(3) of such section 1977A, shall be the powers, 
        remedies, and procedures this title provides to that Board, or 
        any person, alleging such a practice (not an employment 
        practice specifically excluded from coverage under section 
        1977A(a)(1) of the Revised Statutes of the United States).
            (4) Other applicable provisions.--With respect to a claim 
        alleging a practice described in paragraph (1), title III of 
        the Congressional Accountability Act of 1995 (2 U.S.C. 1381 et 
        seq.) shall apply in the same manner as such title applies with 
        respect to a claim alleging a violation of section 201(a)(1) of 
        such Act (2 U.S.C. 1311(a)(1)).
    (c) Employees Covered by Chapter 5 of Title 3, United States 
Code.--
            (1) In general.--The powers, remedies, and procedures 
        provided in chapter 5 of title 3, United States Code, to the 
        President, the Commission, the Merit Systems Protection Board, 
        or any person, alleging a violation of section 411(a)(1) of 
        that title, shall be the powers, remedies, and procedures this 
        title provides to the President, the Commission, such Board, or 
        any person, respectively, alleging an unlawful employment 
        practice in violation of this title against an employee 
        described in section 5(2)(C), except as provided in paragraphs 
        (2) and (3).
            (2) Costs and fees.--The powers, remedies, and procedures 
        provided in subsections (b) and (c) of section 722 of the 
        Revised Statutes of the United States (42 U.S.C. 1988), shall 
        be the powers, remedies, and procedures this title provides to 
        the President, the Commission, such Board, or any person, 
        alleging such a practice.
            (3) Damages.--The powers, remedies, and procedures provided 
        in section 1977A of the Revised Statutes of the United States 
        (42 U.S.C. 1981a), including the limitations contained in 
        subsection (b)(3) of such section 1977A, shall be the powers, 
        remedies, and procedures this title provides to the President, 
        the Commission, such Board, or any person, alleging such a 
        practice (not an employment practice specifically excluded from 
        coverage under section 1977A(a)(1) of the Revised Statutes of 
        the United States).
    (d) Employees Covered by Government Employee Rights Act of 1991.--
            (1) In general.--The powers, remedies, and procedures 
        provided in sections 302 and 304 of the Government Employee 
        Rights Act of 1991 (42 U.S.C. 2000e-16b, 2000e-16c) to the 
        Commission, or any person, alleging a violation of section 
        302(a)(1) of that Act (42 U.S.C. 2000e-16b(a)(1)) shall be the 
        powers, remedies, and procedures this title provides to the 
        Commission, or any person, respectively, alleging an unlawful 
        employment practice in violation of this title against an 
        employee described in section 5(2)(D), except as provided in 
        paragraphs (2) and (3).
            (2) Costs and fees.--The powers, remedies, and procedures 
        provided in subsections (b) and (c) of section 722 of the 
        Revised Statutes of the United States (42 U.S.C. 1988), shall 
        be the powers, remedies, and procedures this title provides to 
        the Commission, or any person, alleging such a practice.
            (3) Damages.--The powers, remedies, and procedures provided 
        in section 1977A of the Revised Statutes of the United States 
        (42 U.S.C. 1981a), including the limitations contained in 
        subsection (b)(3) of such section 1977A, shall be the powers, 
        remedies, and procedures this title provides to the Commission, 
        or any person, alleging such a practice (not an employment 
        practice specifically excluded from coverage under section 
        1977A(a)(1) of the Revised Statutes of the United States).
    (e) Employees Covered by Section 717 of the Civil Rights Act of 
1964.--
            (1) In general.--The powers, remedies, and procedures 
        provided in section 717 of the Civil Rights Act of 1964 (42 
        U.S.C. 2000e-16) to the Commission, the Attorney General, the 
        Librarian of Congress, or any person, alleging a violation of 
        that section shall be the powers, remedies, and procedures this 
        title provides to the Commission, the Attorney General, the 
        Librarian of Congress, or any person, respectively, alleging an 
        unlawful employment practice in violation of this title against 
        an employee or applicant described in section 2(2)(E), except 
        as provided in paragraphs (2) and (3).
            (2) Costs and fees.--The powers, remedies, and procedures 
        provided in subsections (b) and (c) of section 722 of the 
        Revised Statutes of the United States (42 U.S.C. 1988), shall 
        be the powers, remedies, and procedures this title provides to 
        the Commission, the Attorney General, the Librarian of 
        Congress, or any person, alleging such a practice.
            (3) Damages.--The powers, remedies, and procedures provided 
        in section 1977A of the Revised Statutes of the United States 
        (42 U.S.C. 1981a), including the limitations contained in 
        subsection (b)(3) of such section 1977A, shall be the powers, 
        remedies, and procedures this title provides to the Commission, 
        the Attorney General, the Librarian of Congress, or any person, 
        alleging such a practice (not an employment practice 
        specifically excluded from coverage under section 1977A(a)(1) 
        of the Revised Statutes of the United States).

SEC. 5. DEFINITIONS.

    As used in this Act--
            (1) the term ``Commission'' means the Equal Employment 
        Opportunity Commission;
            (2) the term ``employer''--
                    (A) has the meaning given such term in section 
                701(b) of the Civil Rights Act of 1964 (42 U.S.C. 
                2000e(b)); and
                    (B) includes--
                            (i) an employing office, as defined in 
                        section 101 of the Congressional Accountability 
                        Act of 1995 (2 U.S.C. 1301) and section 411(c) 
                        of title 3, United States Code;
                            (ii) an entity employing a State employee 
                        described in section 304(a) of the Government 
                        Employee Rights Act of 1991 (12 U.S.C. 
                        1220(a)); and
                            (iii) an entity to which section 717(a) of 
                        the Civil Rights Act of 1964 (42 U.S.C. 2000e-
                        16(a)) applies;
            (3) the term ``employee'' means--
                    (A) an employee (including an applicant), as 
                defined in section 701(f) of the Civil Rights Act of 
                1964 (42 U.S.C. 2000e(f));
                    (B) a covered employee (including an applicant), as 
                defined in section 101 of the Congressional 
                Accountability Act of 1995 (2 U.S.C. 1301);
                    (C) a covered employee (including an applicant), as 
                defined in section 411(c) of title 3, United States 
                Code;
                    (D) a State employee (including an applicant) 
                described in section 304(a) of the Government Employee 
                Rights Act of 1991 (12 U.S.C. 1220(a)); or
                    (E) an employee (including an applicant) to which 
                section 717(a) of the Civil Rights Act of 1964 (42 
                U.S.C. 2000e-16(a)) applies; and
            (4) the term ``person'' has the meaning given such term in 
        section 701(a) of the Civil Rights Act of 1964 (42 U.S.C. 
        2000e(a)).

SEC. 6. EFFECTIVE DATE.

    This Act shall take effect beginning 1 year after the date of the 
enactment of this Act.

Output: Ban the Box Act - Makes it an unlawful employment practice for certain employers to seek information concerning a job applicant's conviction for a criminal offense.

Sets forth exceptions authorizing an employer to seek such information: (1) after a conditional offer for employment has been extended to an applicant, or (2) where the granting of employment may involve an unreasonable risk to the safety of specific individuals or the general public.

Directs the Equal Employment Opportunity Commission (EEOC) to issue rules indentifying factors to be considered by employers in assessing whether an individual's past criminal history poses such an unreasonable risk within defined categories of employment.

Sets forth enforcement procedures and remedies under the Civil Rights Act of 1964, Congressional Accountability Act of 1995, Government Employee Rights Act of 1991, and the rights and protections extended to presidential offices.


Input: Consider Input: SECTION 1. SHORT TITLE.

    This Act may be cited as the ``National Emergency Centers 
Establishment Act''.

SEC. 2. ESTABLISHMENT OF NATIONAL EMERGENCY CENTERS.

    (a) In General.--In accordance with the requirements of this Act, 
the Secretary of Homeland Security shall establish not fewer than 6 
national emergency centers on military installations.
    (b) Purpose of National Emergency Centers.--The purpose of a 
national emergency center shall be to use existing infrastructure--
            (1) to provide temporary housing, medical, and humanitarian 
        assistance to individuals and families dislocated due to an 
        emergency or major disaster;
            (2) to provide centralized locations for the purposes of 
        training and ensuring the coordination of Federal, State, and 
        local first responders;
            (3) to provide centralized locations to improve the 
        coordination of preparedness, response, and recovery efforts of 
        government, private, and not-for-profit entities and faith-
        based organizations; and
            (4) to meet other appropriate needs, as determined by the 
        Secretary of Homeland Security.

SEC. 3. DESIGNATION OF MILITARY INSTALLATIONS AS NATIONAL EMERGENCY 
              CENTERS.

    (a) In General.--Not later than 60 days after the date of the 
enactment of this Act, the Secretary of Homeland Security, in 
consultation with the Secretary of Defense, shall designate not fewer 
than 6 military installations as sites for the establishment of 
national emergency centers.
    (b) Minimum Requirements.--A site designated as a national 
emergency center shall be--
            (1) capable of meeting for an extended period of time the 
        housing, health, transportation, education, and humanitarian 
        needs of a large number of individuals affected by an emergency 
        or major disaster;
            (2) environmentally safe and shall not pose a health risk 
        to individuals who may use the center;
            (3) capable of accommodating major disaster preparedness 
        and response drills, operations, and procedures; and
            (4) easily accessible at all times, including during an 
        emergency or major disaster.
    (c) Location of National Emergency Centers.--There shall be 
established not fewer than one national emergency center in each of the 
following areas:
            (1) The area consisting of Federal Emergency Management 
        Agency Regions I, II, and III.
            (2) The area consisting of Federal Emergency Management 
        Agency Region IV.
            (3) The area consisting of Federal Emergency Management 
        Agency Regions V and VII.
            (4) The area consisting of Federal Emergency Management 
        Agency Region VI.
            (5) The area consisting of Federal Emergency Management 
        Agency Regions VIII and X.
            (6) The area consisting of Federal Emergency Management 
        Agency Region IX.
    (d) Preference for Designation of Closed Military Installations.--
Wherever possible, the Secretary of Homeland Security, in consultation 
with the Secretary of Defense, shall designate a closed military 
installation as a site for a national emergency center. If the 
Secretaries of Homeland Security and Defense jointly determine that 
there is not a sufficient number of closed military installations that 
meet the requirements of subsections (b) and (c), the Secretaries shall 
jointly designate portions of existing military installations other 
than closed military installations as national emergency centers.
    (e) Transfer of Control of Closed Military Installations.--If a 
closed military installation is designated as a national emergency 
center, not later than 180 days after the date of designation, the 
Secretary of Defense shall transfer to the Secretary of Homeland 
Security administrative jurisdiction over such closed military 
installation.
    (f) Cooperative Agreement for Joint Use of Existing Military 
Installations.--If an existing military installation other than a 
closed military installation is designated as a national emergency 
center, not later than 180 days after the date of designation, the 
Secretary of Homeland Security and the Secretary of Defense shall enter 
into a cooperative agreement to provide for the establishment of the 
national emergency center.
    (g) Reports.--
            (1) Preliminary report.-- Not later than 90 days after the 
        date of the enactment of this Act, the Secretary of Homeland 
        Security, acting jointly with the Secretary of Defense, shall 
        submit to Congress a report that contains for each designated 
        site--
                    (A) an outline of the reasons why the site was 
                selected;
                    (B) an outline of the need to construct, repair, or 
                update any existing infrastructure at the site;
                    (C) an outline of the need to conduct any necessary 
                environmental clean-up at the site;
                    (D) an outline of preliminary plans for the 
                transfer of control of the site from the Secretary of 
                Defense to the Secretary of Homeland Security, if 
                necessary under subsection (e); and
                    (E) an outline of preliminary plans for entering 
                into a cooperative agreement for the establishment of a 
                national emergency center at the site, if necessary 
                under subsection (f).
            (2) Update report.--Not later than 120 days after the date 
        of the enactment of this Act, the Secretary of Homeland 
        Security, acting jointly with the Secretary of Defense, shall 
        submit to Congress a report that contains for each designated 
        site--
                    (A) an update on the information contained in the 
                report as required by paragraph (1);
                    (B) an outline of the progress made toward the 
                transfer of control of the site, if necessary under 
                subsection (e);
                    (C) an outline of the progress made toward entering 
                a cooperative agreement for the establishment of a 
                national emergency center at the site, if necessary 
                under subsection (f); and
                    (D) recommendations regarding any authorizations 
                and appropriations that may be necessary to provide for 
                the establishment of a national emergency center at the 
                site.
            (3) Final report.--Not later than 1 year after the date of 
        the enactment of this Act, the Secretary of Homeland Security, 
        acting jointly with the Secretary of Defense, shall submit to 
        Congress a report that contains for each designated site--
                    (A) finalized information detailing the transfer of 
                control of the site, if necessary under subsection (e);
                    (B) the finalized cooperative agreement for the 
                establishment of a national emergency center at the 
                site, if necessary under subsection (f); and
                    (C) any additional information pertinent to the 
                establishment of a national emergency center at the 
                site.
            (4) Additional reports.--The Secretary of Homeland 
        Security, acting jointly with the Secretary of Defense, may 
        submit to Congress additional reports as necessary to provide 
        updates on steps being taken to meet the requirements of this 
        Act.

SEC. 4. LIMITATIONS ON STATUTORY CONSTRUCTION.

    This Act does not affect--
            (1) the authority of the Federal Government to provide 
        emergency or major disaster assistance or to implement any 
        disaster mitigation and response program, including any program 
        authorized by the Robert T. Stafford Disaster Relief and 
        Emergency Assistance Act (42 U.S.C. 5121 et seq.); or
            (2) the authority of a State or local government to respond 
        to an emergency.

SEC. 5. AUTHORIZATION OF APPROPRIATIONS.

    There is authorized to be appropriated $125,000,000 for each of 
fiscal years 2006 and 2007 to carry out this Act. Such funds shall 
remain available until expended.

SEC. 6. DEFINITIONS.

    In this Act, the following definitions apply:
            (1) Closed military installation.--The term ``closed 
        military installation'' means a military installation, or 
        portion thereof, approved for closure in 2005 under the Defense 
        Base Closure and Realignment Act of 1990 (part A of title XXIX 
        of Public Law 101-510; 10 U.S.C. 2687 note).
            (2) Emergency.--The term ``emergency'' has the meaning 
        given such term in section 102 of the Robert T. Stafford 
        Disaster Relief and Emergency Assistance Act (42 U.S.C. 5122).
            (3) Major disaster.--The term ``major disaster'' has the 
        meaning given such term in section 102 of the Robert T. 
        Stafford Disaster Relief and Emergency Assistance Act (42 
        U.S.C. 5122).
            (4) Military installation.--The term ``military 
        installation'' has the meaning given such term in section 2910 
        of the Defense Base Closure and Realignment Act of 1990 (part A 
        of title XXIX of Public Law 101-510; 10 U.S.C. 2687 note).

Output: National Emergency Centers Establishment Act - Directs the Secretary of Homeland Security to establish at least six national emergency centers on mililtary installations to provide: (1) temporary housing, medical, and humanitarian assistance to individuals and families dislocated due to an emergency or major disaster; and (2) centralized locations for the training and coordination of federal, state, and local first responders, and to improve coordination of preparedness, response, and recovery efforts of government, private, and not-for-profit entities and faith-based organizations.

Requires the use of such centers to meet other appropriate needs determined by the Secretary.


Input: Consider 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.


Output: 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.