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CONGRESS SET TO PASS LAW ELIMINATING LIABILITY FOR VACCINE INJURIES
CIA invests in no-fuel power generators

[This is the next-to-last step before complete and total tyranny over your health.

While there has long been a Vaccine Injury Compensation Fund (VICP) to protect pharmaceutical companies from law suits when their vaccines kill or injure children, the Biodefense and Pandemic Vaccine and Drug Development Act of 2005 would make it impossible for anyone to seek compensation or pursue any legal action whatsoever if a drug or vaccine is categorized as a “countermeasure.”

The Homeland Security Act of 2002 provided liability bail-outs for Eli Lilly’s vaccine mercury preservative thimerosal which is contained in every flu vaccine, but this new act gives Big-Pharma the kitchen sink. This unprecedented legislation would establish the Biomedical Advanced Research and Development Agency (BARDA) which will operate secretly, exempt from the Freedom of Information Act. BARDA would decide which vaccines and drugs are considered “countermeasures.”

The legislation goes so far as to say (in legalese) if death occurs because the “countermeasure” (drug or vaccine) administered was mislabeled you still cannot seek compensation. The Model Emergency Health Powers Act (MEHPA) failed to implement similar legislation on the state level back in 2002, but many of its important aspects were rolled into the Homeland Security Act.

The only step left for total health tyranny would be to implement a state of emergency. Under the Homeland Security Act, this would give the Secretary of Health and Human Services the power to implement forced vaccinations and drugging with experimental, untested “countermeasures.” Those who refuse forced administration would be subject to incarceration.

Meanwhile everyone waits for explosive indictments, which serve as the perfect smokescreen for the end-game in health tyranny legislation. – MK]

http://www.nvic.org/PressReleases/101905Burrbill.htm

For immediate release
Wednesday, October 19, 2005

In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes.

CONGRESS SET TO PASS LAW ELIMINATING LIABILITY FOR VACCINE INJURIES

Washington, D.C. - The National Vaccine Information Center (NVIC) is calling the "Biodefense and Pandemic Vaccine and Drug Development Act of 2005"(S. 1873), which passed out of the U.S. Senate HELP Committee one day after it was introduced "a drug company stockholder's dream and a consumer's worst nightmare." The proposed legislation will strip Americans of the right to a trial by jury if harmed by an experimental or licensed drug or vaccine that they are forced by government to take, whenever federal health officials declare a public health emergency.

The legislation's architect, Senator Richard Burr (R-NC), Chairman of the HELP Subcommittee on Bioterrorism and Public Health Preparedness, told the full HELP Committee yesterday that the legislation" creates a true partnership" between the federal government, the pharmaceutical industry and academia to walk the drug companies "through the Valley of Death" in bringing a new vaccine or drug to market. Burr said it will give the Department of Health and Human Services "additional authority and resources to partner with the private sector to rapidly develop drugs and vaccines." The Burr bill gives the Secretary of DHHS the sole authority to decide whether a manufacturer violated laws mandating drug safety and bans citizens from challenging his decision in the civil court system.

The bill establishes the Biomedical Advanced Research and Development Agency (BARDA), as the single point of authority within the government for the advanced research and development of drugs and vaccines in response to bioterrorism and natural disease outbreaks such as the flu. BARDA will operate in secret, exempt from the Freedom of Information Act and the Federal Advisory Committee Act, insuring that no evidence of injuries or deaths caused by drugs and vaccines labeled as "countermeasures" will become public.

Nicknamed "Bioshield Two," the legislation is being pushed rapidly through Congress without time for voters to make their voices heard by their elected representatives. Co-sponsored by Republican Senate Majority Leader Bill Frist (R-TN), Senate Health, Education, Labor and Pensions Committee Chairman Mike Enzi (R-WY), and Senate Budget Committee Chairman Judd Gregg (R-NH), the legislation will eliminate both regulatory and legal safeguards applied to vaccines as well as take away the right of children and adults harmed by vaccines and drugs to present their case in front of a jury in a civil court of law.

"It is a sad day for this nation when Congress is frightened and bullied into allowing one profit making industry to destroy the seventh Amendment to the Constitution guaranteeing citizens their day in court in front of a jury of their peers," said Barbara Loe Fisher, president of NVIC. "This proposed legislation, like the power and money grab by federal health officials and industry in the Homeland Security Act of 2002 and the Project Bioshield Act of 2004, is an unconstitutional attempt by some in Congress to give a taxpayer-funded handout to pharmaceutical companies for drugs and vaccines the government can force all citizens to use while absolving everyone connected from any responsibility for injuries and deaths which occur. It means that, if an American is injured by an experimental flu or anthrax vaccine he or she is mandated to take, that citizen will be banned from exercising the Constitutional right to a jury trial even if it is revealed that the vaccine maker engaged in criminal fraud and negligence in the manufacture of the vaccine."

The federal Food and Drug Administration (FDA) is legally responsible for regulating the pharmaceutical industry and ensuring that drugs and vaccines released to the public are safe and effective. Drug companies marketing painkillers, like Vioxx, and anti-depressants, which have resulted in the deaths and injuries of thousands of children and adults, are being held accountable in civil court while the FDA has come under intense criticism for withholding information about the drugs' dangers from the public. Since 1986, vaccine makers have been protected from most liability in civil court through the National Childhood Vaccine Injury Act in which Congress created a federal vaccine injury compensation program (VICP) that offers vaccine victims an alternative to the court system. Even though the program has awarded nearly $2 billion to victims of mandated vaccines, two out of three plaintiffs are turned away.
"The drug companies and doctors got all the liability protection they needed in 1986 but they are greedy and want more," said Fisher. "And the federal health agencies want more power to force citizens to use vaccines without having to worry about properly regulating them. If the Burr bill passes, all economic incentives to insure mandated vaccines are safe will be removed and the American people are facing a future where government can force them to take poorly regulated experimental drugs and vaccines labeled as "countermeasures" or go to jail. The only recourse for citizens will be to strike down mandatory vaccination laws so vaccines will be subject to the law of supply and demand in the marketplace. The health care consumer's cry will be: No liability? No mandates."

The National Vaccine Information Center (NVIC) was founded by parents of vaccine injured children in 1982 and co-founders worked with Congress on the National Childhood Vaccine Injury Act of 1986. 

S.1873

Biodefense and Pandemic Vaccine and Drug Development Act of 2005 (Introduced in Senate)


S 1873 IS

109th CONGRESS
1st Session
S. 1873

To prepare and strengthen the biodefenses of the United States against deliberate, accidental, and natural outbreaks of illness, and for other purposes.

IN THE SENATE OF THE UNITED STATES

October 17, 2005

Mr. BURR (for himself, Mr. ENZI, Mr. GREGG, Mr. FRIST, and Mr. ALEXANDER) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions


A BILL
To prepare and strengthen the biodefenses of the United States against deliberate, accidental, and natural outbreaks of illness, and for other purposes.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the `Biodefense and Pandemic Vaccine and Drug Development Act of 2005'.

SEC. 2. TABLE OF CONTENTS.

The table of contents of this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Biomedical Advanced Research and Development Agency.
Sec. 4. Clarification of countermeasures covered by Project BioShield.
Sec. 5. Orphan drug market exclusivity for countermeasure products.
Sec. 6. Liability protections for pandemics, epidemics, and countermeasures.
Sec. 7. Compensation.
Sec. 8. Rebates and grants for research development, and manufacturing of vaccines, qualified countermeasures and pandemic or epidemic products.
Sec. 9. Technical assistance.
Sec. 10. Animal models for certain diseases.
Sec. 11. Animal Model/Research Tool Scientific Advisory Committee.
Sec. 12. Collaboration and coordination.
Sec. 13. Procurement.
Sec. 14. National Pathology Center.

SEC. 3. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AGENCY.

Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) is amended by inserting after section 319K the following:

`SEC. 319L. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AGENCY.

`(a) Definitions- In this section:

`(1) BARDA- The term `BARDA' means the Biomedical Advanced Research and Development Agency.
`(2) FUND- The term `Fund' means the Biodefense Medical Countermeasure Development Fund established under subsection (d).
`(3) OTHER TRANSACTIONS- The term `other transactions' means transactions, other than procurement contracts, grants, and cooperative agreements, including transactions for prototypes, as provided to the Secretary of Defense under section 2371 of title 10, United States Code.
`(4) QUALIFIED COUNTERMEASURE- The term `qualified countermeasure' has the meaning given such term in section 319F-1.
`(5) QUALIFIED COUNTERMEASURE AND QUALIFIED PANDEMIC OR EPIDEMIC PRODUCT ADVANCED RESEARCH AND DEVELOPMENT-
`(A) IN GENERAL- The term `qualified countermeasure and qualified pandemic or epidemic product advanced research and development' means any applied research, testing, or evaluation (including those conducted on humans or animals), related to the safety or effectiveness, that is required for approval, clearance, or licensing by the Secretary under this Act or the Federal Food, Drug, and Cosmetic Act, of such countermeasure or pandemic or epidemic product to diagnose, mitigate, prevent, or treat harm from a deliberate, accidental, or natural exposure to a chemical, biological, radiological, or nuclear agent, particularly such exposure resulting from an act of terrorism or potential pandemic infectious disease.
`(B) INCLUSION- The term under subparagraph (A) includes any investigation to improve the manufacturing, formulation, finish, fill, delivery, or shelf-life of such qualified countermeasures or qualified pandemic or epidemic products.
`(6) QUALIFIED PANDEMIC OR EPIDEMIC PRODUCT- The term `qualified pandemic or epidemic product' has the meaning given the term in section 319F-3(c)(5).
`(7) SECURITY COUNTERMEASURE- The term `security countermeasure' has the meaning given such term in section 319F-2.
`(8) PERSON- The term `person' includes an individual, partnership, corporation, association, entity, or public or private corporation, including a Federal, State, or local agency or department.

`(b) BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AGENCY-

`(1) ESTABLISHMENT- There is established within the Department of Health and Human Services, the Biomedical Advanced Research and Development Agency.
`(2) PURPOSE- It shall be the purpose of the BARDA to coordinate and oversee activities that support and accelerate qualified countermeasure or qualified pandemic or epidemic product (referred to in this section as `countermeasure or product') advanced research and development by--
`(A) directing and coordinating collaboration among the Department of Health and Human Services, other Federal agencies, relevant industries, academia, and other persons, with respect to such advanced research and development;
`(B) supporting countermeasure and product advanced research and development;
`(C) recommending approaches to modernize and streamline the countermeasure or product development process and reduce regulatory burdens with respect to procurement of security countermeasures and qualified pandemic or epidemic products; and
`(D) supporting innovation to reduce the time and cost of countermeasure and product advanced research and development.
`(3) DIRECTOR- The BARDA shall be headed by a Director (referred to in this section as the `Director') who shall--
`(A) be appointed by the President, with the advice and consent of the Senate;
`(B) report to the Secretary; and
`(C) serve as the principal advisor to the Secretary on countermeasure and product advanced research and development.
`(4) DUTIES OF DIRECTOR-
`(A) COLLABORATION- To carry out the purpose described in paragraph (2)(A), the Secretary, acting through the Director, shall--
`(i) increase appropriate communication between the Federal Government and relevant industries, academia, and other interested persons with respect to countermeasure and product advanced research and development by establishing transparent, expeditious, and direct processes to--
`(I) facilitate regular, ongoing communication regarding the processes established under subparagraph (C)(ii) and new countermeasures or products of interest;
`(II) solicit research and associated data on potential countermeasures and products and related technologies; and
`(III) provide technical assistance with respect to such processes and the Food and Drug Administration approval process;
`(ii) at least annually--
`(I) convene meetings with representatives from relevant industries, academia, other Federal agencies, international agencies, and other interested persons; and
`(II) sponsor relevant biodefense countermeasure technology demonstrations;
`(iii) carry out the activities described in subsection (g) of section 2 of the Clayton Act; and
`(iv) encourage and coordinate countermeasure or product advanced research and development, including by convening working groups as identified in paragraph (5).
`(B) SUPPORT ADVANCED RESEARCH AND DEVELOPMENT- To carry out the purpose described in paragraph (2)(B), the Secretary, acting through the Director, shall--
`(i) conduct continuous searches and support calls for potential countermeasures or products for drugs, biological products, devices, or research tools to diagnose, mitigate, prevent, or treat harm from existing, emerging, or possible chemical, biological, radiological, and nuclear agents or potential pandemic infectious diseases that threaten public health and national security, as identified by the Assistant Secretary for Public Health Emergency Preparedness;
`(ii) direct the countermeasure and product advanced research and development activities of the Department of Health and Human Services, in consultation with the Assistant Secretary for Public Health Emergency Preparedness, the Director of the National Institutes of Health, the Director of the Centers for the Disease Control and Prevention, and the Commissioner of Food and Drugs; and
`(iii) award contracts, grants, cooperative agreements, and enter into other transactions, to include use of simplified acquisition authorities provided under sections 319F-1 and 319F-2(c)(7)(C)(iii), to public and private persons, including for-profit and nonprofit persons, federally funded research and development centers, and universities, to--
`(I) support the cost of countermeasure and product advanced research and development; and
`(II) ensure accelerated development of countermeasures and products.
`(C) STREAMLINE PROCESSES- To carry out the purpose described in paragraph (2)(C), the Secretary, acting through the Director, shall--
`(i) receive from the Assistant Secretary for Public Health Emergency Preparedness, requirements for national civilian biodefense needs, particularly countermeasures or products and other technologies, to diagnose, mitigate, prevent, or treat harm from existing, emerging, or potential chemical, biological, radiological, or nuclear agents or potential pandemic infectious diseases;
`(ii) establish transparent, expeditious, and direct processes for selecting promising countermeasures and products, supporting them through advanced research and development and recommending them for procurement;
`(iii) establish an office within the BARDA, in consultation with the Commissioner of Food and Drugs, to--
`(I) facilitate regular and ongoing communication between the BARDA and the Food and Drug Administration regarding the status of BARDA advanced research and development activities;
`(II) ensure that such activities are coordinated with the approval requirements of the Food and Drug Administration, with the goal of expediting the development and approval of countermeasures and products; and
`(III) connect interested persons with additional technical assistance made available under section 565 of the Federal Food, Drug, and Cosmetic Act;
`(iv) coordinate with the Food and Drug Administration to facilitate regulatory review and approval of promising classes of countermeasures or products through the development of research tools; and
`(v) recommend to the Secretary, through the Assistant Secretary for Public Health Emergency Preparedness, procurement of the most promising eligible security countermeasures or qualified pandemic or epidemic products identified in clause (i).
`(D) SUPPORTING INNOVATION- To carry out the purpose described in paragraph (2)(D), the Secretary, acting through the Director, shall award contracts, grants, cooperative agreements, or enter into other transactions, to include use of simplified acquisition authorities provided under sections 319F-1 and 319F-2(c)(7)(C)(iii), to the entities described in subparagraph (B)(iii), to promote innovation in technologies supporting the advanced research and development and production of qualified or security countermeasures or qualified pandemic or epidemic products, such as research tools, manufacturing, countermeasure administration, storage, and bioinformatics and other devices.
`(E) OTHER DUTIES-
`(i) IN GENERAL- The Director may--
`(I) prepare and submit to the President and Congress, an annual budget estimate for qualified countermeasure and pandemic or epidemic product advanced research and development and other BARDA activities, after opportunity for comment by the Secretary; and
`(II) receive from the President and the Office of Management and Budget directly all funds appropriated by Congress for obligation and expenditure by the BARDA.
`(ii) SECRETARY DUTIES- The Secretary, acting through the Director, may--
`(I) enter into such contracts, leases, cooperative agreements, or other transactions, as may be necessary to carry out the functions of BARDA, without regard to section 3648 and 3709 of the Revised Statutes of the United States (31 U.S.C. 3324(a) and (b)), (41 U.S.C. 5), with any public agency, any firm, association, corporation, or educational institution, or any other person;
`(II) support advanced research and development and innovation of potential countermeasures or products by highly qualified foreign nationals outside the United States that may inure to the benefit of the American people and collaborative research involving American and foreign participants;
`(III) administer grants using milestone-based awards and payments; and
`(IV) establish 1 or more federally funded research and development centers or university affiliated research centers in accordance with section 253(c)(3) of title 41, United States Code.
`(5) VULNERABLE POPULATIONS- In carrying out the activities under this section, the Director, in consultation with the Vulnerable Populations Working Group, may give priority to supporting and facilitating advanced research and development of countermeasures or products, and formulations of countermeasures or products, that are likely to be safe and effective for pediatric populations, pregnant women, and other vulnerable populations.
`(6) WORKING GROUPS-
`(A) IDENTIFICATION OF TECHNOLOGIES-
`(i) IN GENERAL- The Director may establish and convene, or enter into a contract with a public or private research institution to convene, one or more working groups that consists of experts on countermeasure technology to identify innovative technologies that have the potential to be developed as countermeasures or products.
`(ii) MEETINGS- A working group established under clause (i) shall participate in regular meetings with sponsors of countermeasures, products, or related technologies to--
`(I) review the scientific evidence or concept of such countermeasures, products, or related technologies;
`(II) provide guidance on research protocols or studies; and
`(III) provide guidance on the regulatory approval process for countermeasures, products, and related technologies.
`(iii) RECOMMENDATIONS- Not later than 30 days after each meeting with a sponsor of a countermeasure, product, or related technology, the working group shall make recommendations to the Director concerning such countermeasure, product, or related technology.
`(iv) CONFIDENTIALITY- Any commercial confidential or proprietary information that is disclosed to the working group in a meeting under this section shall remain confidential and shall not be disclosed other than to the Secretary or the Director, or their designees.
`(v) CONSTRUCTION- Nothing in this subparagraph shall be construed to prohibit a sponsor from meeting with the Director to discuss potential countermeasures, products, or related technologies.
`(B) PUBLIC WORKING GROUP- The Director may establish and convene one or more working groups composed of private citizens and officials of Federal, State, and local governments to advise such Director with respect to the functions of the BARDA and the Director.
`(C) VULNERABLE POPULATIONS WORKING GROUP- The Director shall establish and convene a Vulnerable Populations Working Group composed of experts on pediatric populations, pregnant women, and other vulnerable populations to advise such Director with respect to--
`(i) supporting and facilitating advanced research and development of countermeasures, and formulations of countermeasures, that are safe and effective for such populations; and
`(ii) other activities of the BARDA that effect such populations.
`(7) PERSONNEL AUTHORITIES-
`(A) SPECIALLY QUALIFIED SCIENTIFIC AND PROFESSIONAL PERSONNEL- In hiring personnel for the BARDA, the Director shall have the hiring and management authorities described in section 1101 of the Strom Thurmond National Defense Authorization Act for Fiscal Year 1999 (5 U.S.C. 3104 note; Public Law 105-261). With respect to the personnel of the BARDA, the term of appointments for employees referred to under subsection (c)(1) of that section may not exceed 5 years before the granting of any extension under subsection (c)(2) of that section.
`(B) SPECIAL CONSULTANTS- The Director may accept special consultants as personnel for the BARDA under section 207(f).
`(C) INTERGOVERNMENTAL PERSONNEL ACT- The Director may accept as personnel for the BARDA, employees under subchapter VI of chapter 33 of subpart B of part III of title 5, United States Code.
`(D) OTHER SERVICES- The Director may accept voluntary and uncompensated services.

`(c) National Biodefense Advisory Board-

`(1) IN GENERAL-

`(A) PURPOSE- The National Biodefense Advisory Board shall provide expert advice and guidance to the Secretary on the threats, challenges, and opportunities presented by advances in biological and life sciences and the threat from natural infectious diseases and chemical, biological, radiological, and nuclear threats.

[Here is the most critical section of this legislation – section 6. The entire bill can be found at http://thomas.loc.gov by searching for S 1873 – FTW]

Biodefense and Pandemic Vaccine and Drug Development Act of 2005
(Introduced in Senate)

SEC. 6. LIABILITY PROTECTIONS FOR PANDEMICS, EPIDEMICS, AND COUNTERMEASURES.

Part B of title III of the Public Health Service Act is amended by inserting after section 319F-2 (42 U.S.C. 247d-6b) the following:

`SEC. 319F-3. LIABILITY PROTECTIONS FOR PANDEMIC AND EPIDEMIC PRODUCTS AND SECURITY COUNTERMEASURES.

`(a) Authority- As provided in subsection (b), and subject to subsection (b)(1)(C), a manufacturer, distibutor, or administrator of a security countermeasure, or a qualified pandemic and epidemic product, described in subsection (b)(1)(A) or a health care provider shall be immune from suit or liability caused by or arising out of the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescribing, administration, or use of a security countermeasure, or a qualified pandemic and epidemic product, described in subsection (b)(1)(A).
`(b) Litigation Management-
`(1) LIMITATION ON CAUSE OF ACTION-
`(A) IN GENERAL-
`(i) IN GENERAL- No cause of action shall exist against a person described in subsection (a) for claims for loss of property, personal injury, or death arising out of, reasonably relating to, or resulting from the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescribing, administration, or use of a security countermeasure or qualified pandemic or epidemic product distributed, sold, purchased, donated, dispensed, prescribed, administered, or used in anticipation of and preparation for, in defense against, or in response to, or recovery from an actual or potential public health emergency that is a designated security countermeasure or a qualified pandemic or epidemic product by the Secretary in a declaration described in paragraph (2).
`(ii) RULE OF CONSTRUCTION- For purposes of this section, the phrase `arising out of, reasonably relating to, or resulting from' shall not be construed to apply to loss of property, personal injury, or death that has no alleged or potential causal relationship with the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescribing, administration, or use of a product described in clause (i).
`(B) RULE-
`(i) SUBSEQUENT INJURY- The protections set forth in subsection (a) and subparagraph (A) shall apply to all claims identified in subparagraph (A) that involve products distributed, sold, purchased, donated, dispensed, prescribed, administered, or used during the effective period set forth in the designation provided for in paragraph (2), regardless of the date of alleged injury.
`(ii) PRIVATE DONATION OR SALE- The protections set forth in subsection (a) and subparagraph (A) shall apply to all claims identified in subparagraph (A) that involve security countermeasures or qualified pandemic or epidemic products distributed, sold, purchased, donated, dispensed, prescribed, administered, or used during the effective period set forth in the designation provided for in paragraph (2) by a manufacturer through the commercial market, provided that the security countermeasures or the qualified pandemic or epidemic product are the security countermeasure or qualified pandemic or epidemic product described in a declaration described in paragraph (2) and the Secretary does not specifically prohibit such private donation or sale in such declaration.
`(C) POTENTIAL LIABILITY UPON DETERMINATION-
`(i) IN GENERAL- A manufacturer, distributor, administrator, or health care provider shall not be immune under subsection (a) or exempted from a cause of action under subparagraph (A) if the Secretary makes a determination as provided for in subparagraph (D).
`(ii) INVESTIGATION BY SECRETARY- A party seeking a determination under subparagraph (D) may petition the Secretary to investigate allegations against a manufacturer, distributor, administrator, or health care provider arising out of, relating to, or resulting from the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescribing, administration, or use of products as provided for in subparagraph (A)(i). The decision to undertake such investigation shall be within the Secretary's discretion and shall not be subject to judicial review.
`(iii) RULE OF CONSTRUCTION- Nothing in this section shall be construed to abrogate or limit the application of subtitle II of chapter 5 and chapter 7 of title 5, United States Code (commonly known as the Administrative Procedure Act).
`(D) DETERMINATION BY SECRETARY-
`(i) IN GENERAL- In making a determination under this subparagraph, the Secretary, acting through an administrative law judge, must find clear and convincing evidence that--
`(I) the manufacturer, distributor, administrator, or health care provider violated a provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or this Act; and
`(II) in violating such Act, such manufacturer, distributor, administrator, or health care provider acted with willful misconduct.
`(ii) EFFECT OF DETERMINATION- If the Secretary finds such clear and convincing evidence under clause (i), the Secretary shall examine whether such willful misconduct to violate an Act under such clause--
`(I) caused the product to present a significant or unreasonable risk to human health; and
`(II) proximately caused the injury alleged by the party.
`(iii) NOTICE AND HEARING- Prior to the Secretary's making a determination under clause (i), the manufacturer, distributor, administrator, or health care provider shall have notice and a right to a formal hearing in accordance with section 556 of title 5, United States Code.
`(iv) EFFECT OF DETERMINATION- Subject to subsection (c), the sole exception to the immunity from suit and liability of manufacturers, distributors, administrators, or healthcare providers set forth in subsection (a) and subparagraph (A) shall be for actions against a manufacturer, distributor, administrator, or healthcare provider as provided in subparagraph (A).
`(v) JUDICIAL REVIEW- At any time prior to the 90th day following a determination by the Secretary under clause (i), any manufacturer, distributor, administrator, or health care provider named in such determination may file a petition with the United States Court District Court for the District of Columbia, for a judicial review of such determination. A copy of the petition shall be forthwith transmitted by the clerk of the court to the Secretary or other officer designated by the Secretary for that purpose. The Secretary thereupon shall file in the court the record of the findings on which the Secretary based his or her determination. The filing of a petition under this clause shall automatically stay the Secretary's determination for the duration of the judicial proceeding. The sole parties to the judicial proceeding shall be the Secretary and the petitioner. Intervention by third parties in the judicial proceeding shall not be permitted. No subpoenas shall be issued nor shall other compulsory process apply. The court's review of a determination by the Secretary under this clause shall conform to the procedures for judicial review of administrative orders set forth in paragraphs (2) through (6) of section 701(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(f)) to the extent consistent with this section.
`(vi) TOLLING OF STATUTE OF LIMITATIONS- The computation of the statute of limitations for any action against a manufacturer, distributor, administrator, or health care provider described under this subparagraph shall not include any time occurring before the determination by the Secretary under this subparagraph.
`(vii) REGULATORY AUTHORITY- The Secretary, in consultation with the Attorney General, shall promulgate regulations defining what actions by a manufacturer, distributor, administrator, or healthcare provider of a security countermeasure or a qualified pandemic and epidemic product shall be deemed to constitute `willful misconduct' for purposes of clause (i). In promulgating such regulations, the Secretary shall consider the nature of the actual or potential public health emergency, the timing and extent of any vaccination or countermeasure program, and any other circumstances they deem significant, so that any civil actions permitted under this subsection will not adversely affect the public health. The Secretary may specify the period of time for which such regulations apply.
`(viii) EVIDENCE REQUIRED- The Secretary, in consultation with the Attorney General, shall promulgate regulations that require, in order to be a party under this section, that an individual present evidence that reasonably demonstrates that--
`(I) such individual has suffered a loss as a direct result of the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescribing, or administration of a security countermeasure or qualified epidemic or pandemic product; and
`(II) the loss as described in subclause (I) was a direct result of the willful misconduct of the manufacturer, distributor, administrator, or health care provider in violating the Federal Food, Drug, and Cosmetic Act or this Act.
`(E) SCOPE- Subparagraph (C) shall apply regardless of whether the suit or liability described in subsection (a) or the claim described in subparagraph (A) arises from the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescribing, administration, or use by the Federal Government or by any person.
`(2) DECLARATION BY SECRETARY-
`(A) IN GENERAL- The Secretary may issue a declaration, pursuant to this paragraph, that an actual or potential public health emergency makes advisable the distribution, administration, or use of a security countermeasure or qualified pandemic or epidemic product.
`(B) SECURITY COUNTERMEASURE OR QUALIFIED PANDEMIC OR EPIDEMIC PRODUCT- The Secretary shall specify in such declaration the security countermeasures or qualified pandemic or epidemic products to be sold by, purchased from, or donated by a manufacturer or drawn from the Strategic National Stockpile.
`(C) EFFECTIVE PERIOD- The Secretary shall specify in such declaration the beginning and the ending dates of the effective period of the declaration, which shall be not longer than 6 months. The Secretary may subsequently amend such declaration to shorten or extend such effective period, provided that the new ending data is after the date on which the declaration is amended.
`(D) PUBLICATION- The Secretary shall promptly publish each such declaration and amendment in the Federal Register.
`(c) Actions by the United States- Nothing in this section shall be construed to abrogate or limit any right, remedy, or authority that the United States or any agency thereof may possess under any other provision of law.
`(d) Definitions- In this section:
`(1) ADMINISTRATOR- The term `administrator' means a person employed by the State or local government, or their designee, who supervised or administered a program with respect to the administration, dispensing, distribution, or provision of a security countermeasure or a qualified pandemic or epidemic product, including a person who has established requirements, provided policy guidance, supplied technical or scientific advice or assistance.
`(2) HEALTH CARE PROVIDER- The term `health care provider' means a person, including a volunteer, who distributes, prescribes, administers, dispenses, provides a facility to administer, or supervises or oversees the administration of a security countermeasure or a qualified pandemic or epidemic product, including persons who distribute, prescribe, administer, dispense, or provide a facility to administer in accordance with a designation under subsection (b)(2).
`(3) LOSS- The term `loss' means death, physical injury, or loss of or damage to property, including business interruption loss.
`(4) MANUFACTURER- The term `manufacturer' includes--
`(A) a contractor or subcontractor of a manufacturer;
`(B) a supplier of any product or service, research tool, or component to the manufacturer; and
`(C) any or all of the parents, subsidiaries, affiliates, successors, and assigns of a manufacturer.
`(5) QUALIFIED PANDEMIC OR EPIDEMIC PRODUCT- The term `qualified pandemic or epidemic product' means a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as such term is defined by section 351(i) of this Act) or device (as such term is defined by section 201(h) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(h))) designed, developed, modified, or procured to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic or limit the harm such pandemic or epidemic might otherwise cause or a serious or life-threatening disease or condition caused by such a product, that--
`(A) is approved or cleared under chapter V of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act;
`(B) is a product for which the Secretary determines that sufficient and satisfactory clinical experience or research data (including data, if available, from pre-clinical and clinical trials) support a reasonable conclusion that the product will qualify for approval or licensing within 8 years after the date the Secretary makes a declaration under paragraph (2); or
`(C) is authorized for emergency use section 564 of the Federal Food, Drug, and Cosmetic Act, except that subsection (b) of such section shall not apply.
`(6) PARTY- The term `party' means an individual who can reasonably demonstrate to the Secretary that such individual has suffered a loss (as defined in paragraph (3)) as a direct result of the willful misconduct of a manufacturer, distributor, administrator, or health care provider.
`(7) PERSON- The term `person' includes an individual, partnership, corporation, association, entity, or public or private corporation, including a Federal, State, or local agency or department.
`(8) SECURITY COUNTERMEASURE- The term `security countermeasure' has the meaning given such term in section 319F-2(c)(1)(B).'.

 

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CIA invests in no-fuel power generators

NewsTrack
http://www.upi.com/NewsTrack/view.php?StoryID=20051018-111431-4825r

In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes.

ARLINGTON, Va., Oct. 18 (UPI) -- The U.S. Central Intelligence Agency is reportedly investing in a power unit that can generate substantial electrical energy without using any fuel.

The units manufactured by a small Virginia start-up company -- SkyBuilt Power Inc. -- are so rugged they can be dropped by parachute from an airplane and operate so simply, two people could have a unit running in just a few hours, the Christian Science Monitor reported Tuesday.

The generators are fueled by solar and wind energy, with a battery backup for use during the night or when winds are calm. And the units are designed to run for years with little maintenance, the newspaper said.

Depending upon its configuration, SkyBuilt's Mobile Power Station can generate up to 150 kilowatts of electricity.

And now privately owned, SkyBuilt has a new investor -- In-Q-Tel -- a venture capital firm owned by the CIA. The "Q" in In-Q-Tel is a reference to the fictional character "Q" who supplies James Bond with scientific gadgets.

Although no models for homes are yet available, SkyBuilt says its mobile power station can help meet critical power needs, such as during disasters, terrorist attacks, military operations or meteorological emergencies.

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