Project BioShield Act of 2003

Bill: 108-hr-2122
Sponsor: Rep. Tauzin, W. J. (Billy) [R-LA-3]
Introduced: 2003-05-15 in the House
Policy area: Health
Subjects: Administrative procedure
Armed Forces and National Security
Authorization
Biological warfare
Black colleges
Business records
Chemical warfare
Child health
Clinical trials
Commerce
Congress
Congressional investigations
Congressional reporting requirements
Crime and Law Enforcement
Department of Health and Human Services
Drug approvals
Drug industry
Drugs
EBB Terrorism
Economics and Public Finance
Education
Emergency Management
Emergency medicine
Employee selection
Export controls
Families
Federal aid to research
Federal employees
Foreign Trade and International Finance
Government Operations and Politics
Government contractors
Government paperwork
Government procurement
Government publicity
Government service contracts
Higher education
Informed consent (Medical law)
International Affairs
Labeling
Laboratories
Law
Licenses
Medical fees
Medical laboratories
Medical records
Medical research
Medical supplies
Military medicine
Military personnel
Minorities
Minority education
Nuclear terrorism
Peer review organizations (Medicine)
Pharmaceutical research
Prescription pricing
Product safety
Public health
Research and development
Research and development facilities
Research grants
Science, Technology, Communications
Security measures
Smallpox
Storage
Strategic materials
Technological innovations
Terrorism
Vaccines

Summary:
action_date: 2003-05-15
text: Project BioShield Act of 2003 - Amends the Public Health Service Act regarding preparations for public health emergencies affecting national security, including a bioterrorist attack.
Grants the Secretary of Health and Human Services (the Secretary) certain authority with respect to the research and development of qualified countermeasures, including: (1) expedited procurement authority; (2) expedited peer authority; and (3) authority for personal services contracts.
Directs the Secretary of Homeland Security, in coordination with the Secretary and the Secretary of Veterans Affairs, to maintain a stockpile of drugs, vaccines (including smallpox vaccine), and other supplies to provide for the emergency health security of the United States in the event of a bioterrorist attack or other public health emergency. Directs the Secretary to: (1) award grants to ensure that the stockpile contains an adequate amount of smallpox vaccine; and (2) assess, on an ongoing basis, the potential public health consequences from the use of chemical, biological, radiological, and nuclear agents and determine the agents for which countermeasures are necessary.
Amends the Federal Food, Drug, and Cosmetic Act to allow the Secretary to declare a national emergency under specified conditions and authorize the release of a drug or device intended for use in an emergency. Directs the Secretary to impose requirements on the authorization, including ensuring that health care professionals administering the product and persons to whom the product is administered are fully informed about the benefits and risks involved and other alternatives. Requires the Secretary to periodically review an authorization under this Act, and authorizes the Secretary to revoke such an authorization if circumstances so warrant. Allows the President, under specified circumstances in cases involving the Armed Forces, to waive the requirement that individuals be allowed to refuse administration of a countermeasure.
Requires: (1) reports from the Secretary regarding authorities under this Act; (2) the Secretary to request the National Academy of Sciences to review biomedical countermeasure research and development activities under this Act; and (3) review by the General Accounting Office.
action_date: 2003-06-10
text: 

(This measure has not been amended since it was introduced on May 15, 2003. However, because action occurred on the measure, the summary has been expanded.)

 
Project BioShield Act of 2003 - (Sec. 2) Amends the Public Health Service Act regarding preparations for public health emergencies affecting national security, including a bioterrorist attack.
Makes biocontainment laboratories and specialized research facilities available as needed to the Secretary of Health and Human Services (the Secretary) in public health emergencies affecting national security if the owners of such a facility have entered into a grant or cooperative agreement with the Secretary under the provisions of this Act pertaining to biomedical countermeasure research and development.
Grants the Secretary certain authority with respect to the research and development of qualified countermeasures, including: (1) expedited procurement authority; (2) expedited peer review authority; (3) authority for personal services contracts; and (4) streamlined personnel authority. Defines a qualified countermeasure as a priority countermeasure that affects national security. 
(Sec. 3) Directs the Secretary of Homeland Security, in coordination with the Secretary and the Secretary of Veterans Affairs, to maintain a stockpile of drugs, vaccines (including smallpox vaccine), and other supplies to provide for the emergency health security of the United States in the event of a bioterrorist attack or other public health emergency. Directs the Secretary to: (1) review and revise the contents of the stockpile on a regular basis; (2) award grants to ensure that the stockpile contains an adequate amount of smallpox vaccine; and (3) assess, on an ongoing basis, the potential public health consequences from the use of chemical, biological, radiological, and nuclear agents and determine the agents for which countermeasures are necessary. Permits the Secretary and the Secretary of Homeland Security to jointly submit to the President proposals for the development of needed security countermeasures. Defines security countermeasures as priority countermeasures against a chemical, biological, radiological, or nuclear agent that meet one of certain criteria (including having been approved or cleared under the Federal Food, Drug, and Cosmetic Act as countermeasures against a chemical, biological, radiological, or nuclear agent). 
Amends the Homeland Security Act of 2002 to authorize appropriations for the procurement of security countermeasures.
(Sec. 4) Amends the Federal Food, Drug, and Cosmetic Act to allow the Secretary to declare a national emergency under specified conditions and authorize the release of a drug or device intended for use in an emergency. Directs the Secretary to impose requirements on the authorization, including ensuring that health care professionals administering the product and persons to whom the product is administered are fully informed about the benefits and risks involved and other alternatives. Requires the Secretary to periodically review an authorization under this Act, and authorizes the Secretary to revoke such an authorization if circumstances so warrant. Allows the President, with regard to the Armed Forces, to waive the requirement that individuals be allowed to refuse administration of a countermeasure if complying with such requirement is: (1) not feasible; (2) contrary to the best interests of such individuals; or (3) not in the interests of national security. Allows the Secretary to withhold from members of the Armed Forces information about the benefits and risks of a countermeasure and alternatives to its use if such information is provided to such individuals within 30 days of the administration of the countermeasure and is recorded in the medical records of such members.
Requires: (1) reports from the Secretary regarding authorities under this Act; (2) the Secretary to request the National Academy of Sciences to review biomedical countermeasure research and development activities under this Act; and (3) review by the General Accounting Office.
action_date: 2003-06-12
text: Project BioShield Act of 2003 - (Sec. 2) Amends the Public Health Service Act regarding preparations for public health emergencies affecting national security, including a bioterrorist attack. 
Makes biocontainment laboratories and specialized research facilities available as needed to the Secretary of Health and Human Services (the Secretary) in public health emergencies affecting national security if the owners of such a facility have entered into a grant or cooperative agreement with the Secretary under the provisions of this Act pertaining to biomedical countermeasure research and development. 
Grants the Secretary certain authority with respect to the research and development of qualified countermeasures, including: (1) expedited procurement authority; (2) expedited peer review authority; (3) authority for personal services contracts; and (4) streamlined personnel authority. Defines a qualified countermeasure as a priority countermeasure that affects national security. Declares that nothing in this section shall affect the authority of interested parties to protest contracting decisions to the contracting agency, the General Accounting Office, or the U.S. Court of Federal Claims. 
(Sec. 3) Directs the Secretary of Homeland Security, in coordination with the Secretary and the Secretary of Veterans Affairs, to maintain a stockpile of drugs, vaccines (including smallpox vaccine), and other supplies to provide for the emergency health security of the United States in the event of a bioterrorist attack or other public health emergency. Directs the Secretary to: (1) review and revise the contents of the stockpile on a regular basis; (2) award grants to ensure that the stockpile contains an adequate amount of smallpox vaccine; and (3) assess, on an ongoing basis, the potential public health consequences from the use of chemical, biological, radiological, and nuclear agents and determine the agents for which countermeasures are necessary. Permits the Secretary and the Secretary of Homeland Security to jointly submit to the President proposals for the development of needed security countermeasures. Defines security countermeasures as priority countermeasures against a chemical, biological, radiological, or nuclear agent that meet one of certain criteria (including having been approved or cleared under the Federal Food, Drug, and Cosmetic Act as countermeasures against a chemical, biological, radiological, or nuclear agent). 
Amends the Homeland Security Act of 2002 to authorize appropriations for the procurement of security countermeasures. 
(Sec. 4) Amends the Federal Food, Drug, and Cosmetic Act to allow the Secretary to declare a national emergency under specified conditions and authorize the release of a drug or device intended for use in an emergency. Directs the Secretary to impose requirements on the authorization, including ensuring that health care professionals administering the product and persons to whom the product is administered are fully informed about the benefits and risks involved and other alternatives. Requires the Secretary to periodically review an authorization under this Act, and authorizes the Secretary to revoke such an authorization if circumstances so warrant. Allows the President, with regard to the Armed Forces, to waive the requirement that individuals be allowed to refuse administration of a countermeasure if complying with such requirement is: (1) not feasible; (2) contrary to the best interests of such individuals; or (3) not in the interests of national security. Allows the Secretary to withhold from members of the Armed Forces information about the benefits and risks of a countermeasure and alternatives to its use if such information is provided to such individuals within 30 days of the administration of the countermeasure and is recorded in the medical records of such members.
(Sec. 5) Requires: (1) reports from the Secretary regarding authorities under this Act; (2) the Secretary to request the National Academy of Sciences to review biomedical countermeasure research and development activities under this Act; and (3) review by the General Accounting Office.
action_date: 2003-07-08
text: 
Project BioShield Act of 2003 - (Sec. 2) Amends the Public Health Service Act regarding preparations for public health emergencies affecting national security, including a bioterrorist attack.
 
Makes biocontainment laboratories and specialized research facilities available as needed to the Secretary of Health and Human Services (the Secretary) in public health emergencies affecting national security if the owners of such a facility have entered into a grant or cooperative agreement with the Secretary under the provisions of this Act pertaining to biomedical countermeasure research and development.
Grants the Secretary certain authority with respect to the research and development of qualified countermeasures, including: (1) expedited procurement authority; (2) expedited peer review authority; (3) authority for personal services contracts; and (4) streamlined personnel authority. Defines a qualified countermeasure as a priority countermeasure that affects national security. 
(Sec. 3) Directs the Secretary of Homeland Security, in coordination with the Secretary and the Secretary of Veterans Affairs, to maintain a stockpile of drugs, vaccines (including smallpox vaccine), and other supplies to provide for the emergency health security of the United States in the event of a bioterrorist attack or other public health emergency. Directs the Secretary to: (1) review and revise the contents of the stockpile on a regular basis; (2) award grants to ensure that the stockpile contains an adequate amount of smallpox vaccine; and (3) assess, on an ongoing basis, the potential public health consequences from the use of chemical, biological, radiological, and nuclear agents and determine the agents for which countermeasures are necessary. Permits the Secretary and the Secretary of Homeland Security to jointly submit to the President proposals for the development of needed security countermeasures. Defines security countermeasures as priority countermeasures against a chemical, biological, radiological, or nuclear agent that meet one of certain criteria (including having been approved or cleared under the Federal Food, Drug, and Cosmetic Act as countermeasures against a chemical, biological, radiological, or nuclear agent). 
Amends the Homeland Security Act of 2002 to authorize appropriations for: (1) the procurement of security countermeasures; (2) the carrying out of terror threat assessment responsibilities; (3) the acquisition and deployment of secure intelligence sharing facilities; and (4) the emergency development of security countermeasures. 
(Sec. 4) Amends the Federal Food, Drug, and Cosmetic Act to allow the Secretary to declare a national emergency under specified conditions and authorize the release of a drug or device intended for use in an emergency. Directs the Secretary to impose requirements on the authorization, including ensuring that health care professionals administering the product and persons to whom the product is administered are fully informed about the benefits and risks involved and other alternatives. Requires the Secretary to periodically review an authorization under this Act, and authorizes the Secretary to revoke such an authorization if circumstances so warrant. Allows the President, with regard to the Armed Forces, to waive the requirement that individuals be allowed to refuse administration of a countermeasure if complying with such requirement is: (1) not feasible; (2) contrary to the best interests of such individuals; or (3) not in the interests of national security. Allows the Secretary to withhold from members of the Armed Forces information about the benefits and risks of a countermeasure and alternatives to its use if such information is provided to such individuals within 30 days of the administration of the countermeasure and is recorded in the medical records of such members. 
(Sec. 5) Requires: (1) reports from the Secretary regarding particular exercises of authority; (2) the Secretary to request the National Academy of Sciences to review biomedical countermeasure research and development activities under this Act; and (3) review by the General Accounting Office. 
(Sec. 6) Directs the Secretary to ensure that diverse institutions, including Historically Black Colleges and Universities and those serving other underrepresented populations, are meaningfully aware of research and development grants and procurements conducted under this Act. 
(Sec. 7) Directs the Secretary, the Secretary of Homeland Security, and the Secretary of Defense to ensure that the activities of their respective Departments coordinate, complement, and do not unnecessarily duplicate programs designed to protect the homeland from biological, chemical, radiological, and nuclear agents. Directs such Secretaries to each appoint an official to coordinate such programs for their respective Departments.
action_date: 2003-07-16
text: 
Project BioShield Act of 2003 - (Sec. 2) Amends the Public Health Service Act regarding preparations for public health emergencies affecting national security, including a bioterrorist attack.
 
Makes biocontainment laboratories and specialized research facilities available as needed to the Secretary of Health and Human Services (the Secretary) in public health emergencies affecting national security if the owners of such a facility have entered into a grant, contract, or cooperative agreement with the Secretary under the provisions of this Act pertaining to biomedical countermeasure research and development. 
Grants the Secretary certain authority with respect to the research and development of qualified countermeasures, including: (1) expedited procurement authority; (2) expedited peer review authority; (3) authority for personal services contracts; and (4) streamlined personnel authority. Defines a qualified countermeasure as a priority countermeasure that affects national security. 
(Sec. 3) Directs the Secretary of Homeland Security, in coordination with the Secretary and the Secretary of Veterans Affairs, to maintain a stockpile of drugs, vaccines (including smallpox vaccine), and other supplies to provide for the emergency health security of the United States in the event of a bioterrorist attack or other public health emergency. Directs the Secretary to: (1) review and revise the contents of the stockpile on a regular basis; (2) award grants to ensure that the stockpile contains an adequate amount of smallpox vaccine; and (3) assess, on an ongoing basis, the potential public health consequences from the use of chemical, biological, radiological, and nuclear agents and determine the agents for which countermeasures are necessary. Permits the Secretary and the Secretary of Homeland Security to jointly submit to the President proposals for the development of needed security countermeasures. Defines security countermeasures as priority countermeasures against a chemical, biological, radiological, or nuclear agent that meet one of certain criteria (including having been approved or cleared under the Federal Food, Drug, and Cosmetic Act as countermeasures against a chemical, biological, radiological, or nuclear agent). 
Amends the Homeland Security Act of 2002 to authorize appropriations for: (1) the procurement of security countermeasures; (2) the carrying out of terror threat assessment responsibilities; and (3) the acquisition and deployment of secure intelligence sharing facilities. 
 
(Sec. 4) Amends the Federal Food, Drug, and Cosmetic Act to allow the Secretary to declare a national emergency under specified conditions and authorize the release of a drug, device, or biological product intended for use in an emergency. Directs the Secretary to impose requirements on the authorization, including ensuring that health care professionals administering the product and persons to whom the product is administered are fully informed about the benefits and risks involved and other alternatives. Requires the Secretary to periodically review an authorization under this Act, and authorizes the Secretary to revoke such an authorization if circumstances so warrant. Allows the President, with regard to the Armed Forces, to waive the requirement that individuals be allowed to refuse administration of a countermeasure if complying with such requirement is: (1) not feasible; (2) contrary to the best interests of such individuals; or (3) not in the interests of national security. Allows the Secretary to withhold from members of the Armed Forces information about the benefits and risks of a countermeasure and alternatives to its use if such information is provided to such individuals within 30 days of the administration of the countermeasure and is recorded in the medical records of such members. 
Requires: (1) reports from the Secretary regarding authorities under this Act; (2) the Secretary to request the National Academy of Sciences to review biomedical countermeasure research and development activities under this Act; and (3) review by the General Accounting Office. 
(Sec. 6) Directs the Secretary to ensure that diverse institutions, including Historically Black Colleges and Universities and those serving other underrepresented populations, are meaningfully aware of research, contracts, cooperative agreements, and development grants and procurements conducted under this Act. 
(Sec. 7) Directs the Secretary to determine whether, for any grant, contract, or cooperative agreement awarded under this Act for the research, development, or procurement of a qualified countermeasure or a security countermeasure, the countermeasure involved is subject to existing export-related controls. Allows the Secretary to make a recommendation to the appropriate agency or agencies that a countermeasure should be subject to such controls if it is not already. 
(Sec. 8) Directs the Secretary, the Secretary of Homeland Security, and the Secretary of Defense to ensure that the activities of their respective Departments coordinate, complement, and do not unnecessarily duplicate programs designed to protect the homeland from biological, chemical, radiological, and nuclear agents. Directs such Secretaries to each appoint an official to coordinate such programs for their respective Departments.

Legislative actions:
action_date: 2003-07-17
text: Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 214.
action_date: 2003-07-16
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2003-07-16
text: On passage Passed by the Yeas and Nays: 421 - 2 (Roll no. 373).
action_date: 2003-07-16
text: Passed/agreed to in House: On passage Passed by the Yeas and Nays: 421 - 2 (Roll no. 373).
action_date: 2003-07-16
text: Considered as unfinished business. (consideration: CR H6947-6948)
action_date: 2003-07-16
text: POSTPONED ROLL CALL VOTE - At the conclusion of debate on H.R. 2122, as amended, the Chair put the question on passage of the bill, as amended, and by voice vote, announced that the ayes had prevailed. Mr. Cox demanded the yeas and nays and the Chair postponed further proceedings on the question of passage until later in the legislative day.
action_date: 2003-07-16
text: The previous question was ordered pursuant to a previous  order of the House. (consideration: CR H6946; text: CR H6946)
action_date: 2003-07-16
text: DEBATE - The House proceeded with 90 minutes of debate on H.R. 2122, equally divided and controlled.
action_date: 2003-07-16
text: Considered by previous order of the House. (consideration: CR H6908-6941; text as reported in House: CR H6908-6920)
action_date: 2003-07-16
text: Consideration initiated by previous order of the House.
action_date: 2003-07-08
text: Placed on the Union Calendar, Calendar No. 98.
action_date: 2003-07-08
text: Reported (Amended) by the Committee on Homeland Security (Select). H. Rept. 108-147, Part III.
action_date: 2003-07-08
text: Reported (Amended) by the Committee on Homeland Security (Select). H. Rept. 108-147, Part III.
action_date: 2003-06-27
text: House Committee on Homeland Security (Select) Granted an extension for further consideration ending not later than July 8, 2003.
action_date: 2003-06-26
text: Ordered to be Reported (Amended) by the Yeas and Nays: 29 - 0.
action_date: 2003-06-26
text: Committee Consideration and Mark-up Session Held.
action_date: 2003-06-13
text: House Committee on Homeland Security (Select) Granted an extension for further consideration ending not later than June 27, 2003.
action_date: 2003-06-12
text: Reported (Amended) by the Committee on Government Reform. H. Rept. 108-147, Part II.
action_date: 2003-06-12
text: Reported (Amended) by the Committee on Government Reform. H. Rept. 108-147, Part II.
action_date: 2003-06-11
text: Committee on Armed Services discharged.
action_date: 2003-06-11
text: Committee on Armed Services discharged.
action_date: 2003-06-10
text: Referred sequentially to the House Committee on Armed Services for a period ending not later than June 11, 2003 pursuant to clause 1(c), rule X.
action_date: 2003-06-10
text: House Committee on Homeland Security (Select) Granted an extension for further consideration ending not later than June 13, 2003.
action_date: 2003-06-10
text: House Committee on Government Reform Granted an extension for further consideration ending not later than June 13, 2003.
action_date: 2003-06-10
text: Reported by the Committee on Energy and Commerce. H. Rept. 108-147, Part I.
action_date: 2003-06-10
text: Reported by the Committee on Energy and Commerce. H. Rept. 108-147, Part I.
action_date: 2003-05-22
text: Ordered to be Reported (Amended) by Voice Vote.
action_date: 2003-05-22
text: Committee Consideration and Mark-up Session Held.
action_date: 2003-05-15
text: Referred to the Committee on Energy and Commerce, and in addition to the Committees on Government Reform, and Homeland Security (Select), for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
action_date: 2003-05-15
text: Referred to the Committee on Energy and Commerce, and in addition to the Committees on Government Reform, and Homeland Security (Select), for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
action_date: 2003-05-15
text: Referred to the Committee on Energy and Commerce, and in addition to the Committees on Government Reform, and Homeland Security (Select), for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
action_date: 2003-05-15
text: Referred to the Committee on Energy and Commerce, and in addition to the Committees on Government Reform, and Homeland Security (Select), for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
action_date: 2003-05-15
text: Introduced in House
action_date: 2003-05-15
text: Introduced in House