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SECTION 1. SHORT TITLE.

This Act may be cited as the ''American Fisheries Advisory
Committee Act''.

SEC. 2. AMERICAN FISHERIES ADVISORY COMMITTEE.

(a) Establishment.--Section 2 of the Act of August 11, 1939 (15
U.S.C. 713c-3), is amended by adding at the end the following:
''(f) American Fisheries Advisory Committee.--
''(1) Definitions.--In this subsection:
''(A) Committee.--The term 'Committee' means the
American Fisheries Advisory Committee established under
paragraph (2).
''(B) Marketing and promotion.--The term 'marketing
and promotion' means an activity aimed at encouraging
the consumption of seafood or expanding or maintaining
commercial markets for seafood.
''(C) Processor.--The term 'processor' means any
person in the business of preparing or packaging
seafood (including seafood of the processor's own
harvesting) for sale.
''(D) Seafood.--The term 'seafood' means farm-
raised and wild-caught fish or shellfish harvested in
the United States or by a United States flagged vessel
for human consumption.
''(E) Seafood industry.--The term 'seafood
industry' means harvesters, marketers, growers,
processors, and persons providing them with goods and
services.
''(2) Establishment.--Not later than 90 days after the date
of the enactment of the American Fisheries Advisory Committee
Act, the Secretary shall establish five regions within the
American Fisheries Advisory Committee as follows:
''(A) Region 1 shall consist of Alaska, Hawaii, the
Commonwealth of the Northern Mariana Islands, and the
territories of Guam and American Samoa.
''(B) Region 2 shall consist of Maine, New
Hampshire, Massachusetts, Rhode Island, Connecticut,
New York, Michigan, Minnesota, Wisconsin, Illinois,
Indiana, Ohio, and Pennsylvania.
''(C) Region 3 shall consist of Texas, Alabama,
Louisiana, Mississippi, Florida, Puerto Rico, and the
territory of the Virgin Islands.
''(D) Region 4 shall consist of California,
Washington, Oregon, and Idaho.
''(E) Region 5 shall consist of New Jersey,
Delaware, Maryland, Virginia, North Carolina, South
Carolina, and Georgia.
''(3) Membership.--The Committee shall be composed of the
following members:
''(A) Regional representation.--Each of the regions
listed in subparagraphs (A) through (E) of paragraph
(2) shall be represented on the Committee by two
members--
''(i) who are appointed by the Secretary;
''(ii) who reside in a State or territory
in the region that the member will represent;
''(iii) of which--
''(I) one shall have experience as
a seafood harvester; and
''(II) one shall have experience as
a processor; and
''(iv) that are selected so that the
members of the Committee have experience or
expertise with as many seafood species as
practicable.
''(B) At-large members.--The Secretary shall
appoint to the Committee at-large members to ensure
that the Committee fairly reflects the expertise and
interest of the seafood industry located in each
region, as follows:
''(i) One individual with experience in
mass market food distribution.
''(ii) One individual with experience in
mass market food retail or food service.
''(iii) One individual with experience in
the marketing of seafood.
''(iv) One individual with experience in
growing seafood.
''(v) One individual who is an employee of
the National Marine Fisheries Service with
expertise in fisheries research.
''(4) Member terms.--The term for a member of the Committee
shall be three years, except that the Secretary shall designate
staggered terms for the members initially appointed to the
Committee.
''(5) Responsibilities.--The Committee shall be responsible
for--
''(A) identifying needs of the seafood industry
that may be addressed by a project funded with a grant
under subsection (c);
''(B) developing the request for proposals for such
grants;
''(C) reviewing applications for such grants; and
''(D) selecting applications for approval under
subsection (c)(2)(B).
''(6) Chair.--The Committee shall elect a chair by a
majority of those voting, if a quorum is present.
''(7) Quorum.--A simple majority of members of the
Committee shall constitute a quorum, but a lesser number may
hold hearings.
''(8) Meetings.--
''(A) Frequency.--The Committee shall meet not more
than two times each year.
''(B) Location.--The meetings of the Committee
shall rotate between the geographic regions described
under paragraph (2).
''(C) Federal advisory committee act.--The Federal
Advisory Committee Act (5 U.S.C. App.) shall not apply
to the Committee.
''(9) Staff.--The Committee may employ staff as necessary
without regard to the provisions of title 5, United States
Code.
''(10) Per diem and expenses and funding.--
''(A) In general.--A member of the Committee shall
serve without compensation, but shall be reimbursed in
accordance with section 5703 of title 5, United States
Code, for reasonable travel costs and expenses incurred
in performing duties as a member of the Committee.
''(B) Funding.--The reimbursements made under
subparagraph (A) shall be paid with the funds made
available for grants under subsection (c).
''(11) Conflict of interest.--The conflict of interest and
recusal provisions set out in section 302(j) of the Magnuson-
Stevens Fishery Conservation and Management Act (16 U.S.C.
1852(j)) shall apply to any decision by the Committee and to
all members of the Committee as if each member of the Committee
is an affected individual within the meaning of such section
302(j), except that in addition to the disclosure requirements
of section 302(j)(2)(C) of such Act (16 U.S.C. 1852(j)(2)(C)),
each member of the Committee shall disclose any financial
interest or relationship in an organization or with an
individual that is applying for a grant under subsection (c)
held by the member of the Committee, including an interest as
an officer, director, trustee, partner, employee, contractor,
agent, or other representative.''.
(b) Role in Approval of Grants.--Section 2(c)(3) of the Act of
August 11, 1939 (15 U.S.C. 713c-3(c)(3)), is amended to read as
follows:
''(3) No application for a grant under this subsection may be
approved unless--
''(A) the Secretary is satisfied that the applicant has the
requisite technical and financial capability to carry out the
project; and
''(B) the application is selected for funding by the
American Fisheries Advisory Committee under subsection (f).''.
American Fisheries Advisory Committee Act This bill amends the Saltonstall-Kennedy Act to direct the National Oceanic and Atmospheric Administration (NOAA)to establish the American Fisheries Advisory Committee. NOAA must establish five regions within the committee.The committee must consist of members chosen regionally and across all sectors of the fishing industry.Additionally, the committee must: (1)identify the needs of the fishing industry, (2)develop grant proposals to fund projects that address the industry needs, (3)review grant applications, and (4)provide NOAA with grant applicants for approval. NOAA must not approve a grant application unless the application is selected for funding by the committee.

SECTION 1. SHORT TITLE.

This Act may be cited as the ''Firefighters Special Operation Task
Force Act''.

SEC. 2. GRANTS FOR FIREFIGHTING TASK FORCES.

The Federal Fire Prevention and Control Act of 1974 (15 U.S.C. 2201
et seq.) is amended by adding at the end the following new section:

''SEC. 37. ASSISTANCE FOR FIREFIGHTING TASK FORCES.

''(a) Definitions.--In this section:
''(1) Critical infrastructure.--The term 'critical
infrastructure' has the meaning given that term in section
1016(e) of the Critical Infrastructures Protection Act of 2001
(42 U.S.C. 5195c(e)).
''(2) Firefighting personnel.--The term 'firefighting
personnel' has the meaning given that term in section 33(a).
''(3) Incident response.--The term 'incident response'
means a response by a task force or task force unit to--
''(A) a terrorist attack, including such an attack
that utilizes a weapon of mass destruction;
''(B) a release of a hazardous material;
''(C) a natural disaster; or
''(D) any other emergency for which a response by a
fire service is appropriate.
''(4) Member.--The term 'member', with respect to a task
force, means a fire service that is a party to the cooperative
agreement establishing the task force.
''(5) Task force.--The term 'task force' means 2 or more
fire services that collectively consist of at least 50
firefighting personnel, operating pursuant to a cooperative
agreement for the purpose of coordinating incident response
among such fire services.
''(b) Grant Authority.--The Administrator may award not more than
100 grants for task forces each fiscal year for the purposes described
in subsection (c).
''(c) Purposes.--A grant awarded under this section shall be used--
''(1) to provide salary and benefits to hire firefighting
personnel or rehire firefighting personnel who have been laid
off to provide services to the task force, including salary and
benefits;
''(2) to pay expenses related to the participation of
firefighting personnel in appropriate training courses;
''(3) to provide training related to incident response to
firefighting personnel;
''(4) to obtain appropriate equipment, including
firefighting vehicles or support systems for members of the
task force;
''(5) to improve the ability of a member of a task force to
communicate with a local police department or hospital, or with
any other appropriate governmental or private sector entity;
and
''(6) to ensure the compatibility and interoperability of
training and equipment with those obtained by other task
forces.
''(d) Application Guidance.--The Administrator shall make available
to potential applicants for assistance under this section a description
of a model task force configuration, which shall include--
''(1) an administrative unit, consisting of 2 chief
officers, 2 captains, and 2 lieutenants, to coordinate training
programs, logistics, and maintenance of equipment, which shall
operate at least 40 hours per week;
''(2) a command unit, consisting of 1 chief officer serving
as the task force commander and 1 firefighter serving as
communications coordinator, which shall operate at all times;
''(3) at least 1 hazardous materials company, consisting of
1 company officer and 5 firefighters, which shall operate at
all times;
''(4) at least 1 rescue company, consisting of 1 company
officer and 5 firefighters, which shall operate at all times;
and
''(5) 6 squad companies, each consisting of 1 company
officer and 5 firefighters, which shall operate at all times,
and which may serve, as appropriate, as a hazardous materials
company or rescue company as described in paragraphs (3) and
(4).
''(e) Application Requirements.--Each task force desiring
assistance under this section shall submit an application to the
Administrator at such time, in such manner, and accompanied by such
information as the Administrator may reasonably require. In order to
qualify for a grant, an applicant's proposal shall provide for--
''(1) prompt incident response;
''(2) a unified command system;
''(3) common training and equipment for task force members;
''(4) maximum coverage in the task force region, taking
into account population, business centers, vital
infrastructures, transportation corridors, and government
centers; and
''(5) preservation during the life of the grant of the
overall personnel level for each fire service, at least at the
level in effect at the time the application was submitted.
''(f) Selection Priority.--In selecting a task force to receive
assistance under this section, the Administrator shall give priority to
task forces that serve a geographic area that--
''(1) has a high population density; or
''(2) is located not more than 50 miles from--
''(A) a facility that produces nuclear power;
''(B) a large facility that produces, treats, or
refines chemicals or petroleum products;
''(C) a business district of national significance;
or
''(D) a location with one or more critical
infrastructures.
''(g) Matching Requirement.--The Administrator may provide
assistance to a Task Force under this section for a fiscal year only if
the task force agrees to obtain from non-Federal sources for such
fiscal year at least 55 percent of the costs of the task force. The
non-Federal contributions may be in-kind contributions, including
personnel, personnel overtime, vehicles, equipment, administrative
costs, fuel, maintenance, contractor services, and rental space.
''(h) Authorization of Appropriations.--There are authorized to be
appropriated to the Administrator to carry out this section such sums
as may be necessary for each of the fiscal years 2008 through 2016.''.
Firefighters Special Operation Task Force Act - Amends the Federal Fire Prevention and Control Act of 1974 to authorize the Administrator of the U.S. Fire Administration to award up to 100 grants for task forces (two or more fire services that collectively consist of at least 50 firefighting personnel, operating under a cooperative agreement to coordinate incident response) each fiscal year for: (1) salary and benefits to hire firefighting personnel; (2) training; (3) equipment or support systems; (4) communications between task force members and a local police department or hospital or with any other appropriate governmental or private sector entity; and (5) compatibility and interoperability of training and equipment.

Requires the Administrator to give priority to task forces serving geographic areas that have a high population density or that are located within 50 miles of: (1) a nuclear power facility; (2) a large facility that produces, treats, or refines chemicals or petroleum products; (3) a business district of national significance; or (4) a location with one or more critical infrastructures.

Requires grantees to obtain non-federal matching funds of at least 55% of the amount awarded by the Administrator for each fiscal year.

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.
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.