Project BioShield Act of 2004

Bill: 108-s-15
Sponsor: Sen. Gregg, Judd [R-NH]
Introduced: 2003-03-11 in the Senate
Policy area: Health
Subjects: AIDS (Disease)
Access to health care
Administrative procedure
Antibiotics
Antitrust law
Appropriations
Armed Forces and National Security
Biological warfare
Black colleges
Brain diseases
Chemical warfare
Child health
Civil actions and liability
Clinical trials
Clinics
Colleges
Commerce
Communication in medicine
Compensation (Law)
Congress
Congressional investigations
Congressional reporting requirements
Counseling
Crime and Law Enforcement
Damages
Department of Health and Human Services
Department of Homeland Security
Drug approvals
Drug industry
Drug resistance in microorganisms
EBB Terrorism
Earnings
Economics and Public Finance
Education
Emergency Management
Emergency medicine
Environmental Protection
Export controls
Families
Federal advisory bodies
Federal employees
Federal officials
Federal preemption
Fines (Penalties)
Fire fighters
Foreign Trade and International Finance
Government Operations and Politics
Government liability
Government procurement
Government publicity
Government trust funds
Governmental investigations
Guardian and ward
Health counseling
Health education
Health warnings
Hepatitis
Higher education
Human immunodeficiency viruses
Influenza
Informed consent (Medical law)
Injunctions
International Affairs
Jurisdiction
Labor and Employment
Laboratories
Law
Law enforcement officers
Legal fees
Liability (Law)
Licenses
Limitation of actions
Medical laboratories
Medical personnel
Medical research
Medical screening
Medical statistics
Medical supplies
Military medicine
Military personnel
Minorities
Minority education
National Institutes of Health (NIH)
Nuclear terrorism
Pharmaceutical research
Police
Preventive medicine
Prisons
Public health administration
Radiation
Radiation victims
Radioactivity
Recruiting of employees
Research and development
Research centers
Research grants
Science, Technology, Communications
Scientists in government
Sexually transmitted diseases
Smallpox
Social Welfare
State laws
Survivors' benefits
Terrorism
Transportation and Public Works
Travel
Travel agents
Vaccination
Vaccines
Workers' compensation

Summary:
action_date: 2003-03-11
text: Biodefense Improvement and Treatment for America Act - Smallpox Emergency Personnel Protection Act of 2003 - Amends the Public Health Service Act to entitle eligible individuals to payment by the Secretary of Health and Human Services for medical items and services to treat covered injuries caused by covered countermeasures against smallpox. Subjects cases of death and total disability to a separate payment structure.
Project Bioshield Act of 2003 - Permits the Secretary to conduct and support research and development with respect to biomedical countermeasures.
Directs the Secretary, on an ongoing basis, to assess threats of use of chemical, biological, radiological, and nuclear agents and procure biomedical countermeasures to such threats.
Allows the Secretary to declare a national emergency under specified conditions and authorize the release of a drug or device intended solely for use in an emergency.
Improved Vaccine Affordability and Availability Act - Amends the Public Health Service Act to direct the Secretary to: (1) develop and disseminate information concerning certain diseases and their vaccines, including bacterial meningitis and hepatitis A and B; and (2) maintain a six months supply of prioritized vaccines.
Revises provisions governing the National Vaccine Injury Compensation Program, including provisions regarding: (1) equitable relief; (2) derivative petitions; and (3) an extension of the statute of limitations.
Amends Internal Revenue Code provisions concerning the Vaccine Injury Compensation Trust Fund, including to expand compensated loss for injury or death to include related loss.
Amends the Public Health Service Act to require the Secretary to contract with the Institute of Medicine of the National Academy of Science to conduct an ongoing, comprehensive review of new scientific data on childhood vaccines.
action_date: 2003-03-25
text: Project BioShield Act of 2003 - (Sec. 2) Amends the Public Health Service Act to declare that the National Institute of Allergy and Infectious Diseases shall be the lead institute for performing, administering, or supporting biomedical countermeasure research and development. Defines a biomedical countermeasure as a drug, biological product, or device that is used to treat, identify, or prevent harm from: (1) a biological, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security; or (2) a potentially harmful condition arising from the administering of a drug, biological product, or device in response to such an agent.
Grants the Secretary of Health and Human Services (the Secretary): (1) expedited procurement authority regarding property or services for use in performing, administering, or supporting biomedical countermeasure research or development; (2) the authority to expedite peer review under this section as deemed necessary to obtain a likely contribution to the field of biomedical countermeasure research; and (3) the authority to secure the personal services of experts or consultants with relevant qualifications for the purpose of performing, administering, and supporting biomedical countermeasure research and development.
Classifies a person carrying out a contract under this section, and an officer, employee, or governing board member of such person, to be deemed an employee of the Department of Health and Human Services for purposes of claims under specified law for money damages for personal injury, including death.
(Sec. 3) Directs the Secretary of Homeland Security, on an ongoing basis, to assess threats of use of chemical, biological, radiological, and nuclear agents and determine which threats pose a material risk of use against the United States population. Requires the Secretary of Homeland Security to assess the public health consequences of such potential uses and to determine the agents for which countermeasures are necessary to protect the public health. Authorizes the Secretary and the Secretary of Homeland Security to jointly submit to the President for approval proposals to call for needed countermeasures. Directs the Secretaries to inform persons who may respond to each approved call. Requires the Secretary, in consultation with the Secretary of Homeland Security, to determine countermeasures appropriate for procurement and inclusion in the stockpile under the Public Health and Bioterrorism Preparedness and Response Act of 2002. Directs the Secretary to annually determine and report to the President whether there is a significant commercial market for products identified as appropriate for procurement other than as biomedical countermeasures. Directs the Secretary to procure countermeasures that have been approved by the President.
Authorizes appropriations.
(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 solely for use in an emergency. Directs the Secretary to impose requirements on the authorization to ensure 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. Imposes civil monetary penalties for violation of this section. 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. Applies record keeping requirements under the Act to products authorized under this Act for use in emergencies.
(Sec. 5) Amends Public Health Service Act provisions concerning the administration of smallpox countermeasures by health professionals, including to modify the definitions of covered countermeasure, covered person, and qualified person.
(Sec. 6) Directs the Comptroller General to report to Congress regarding this Act.
action_date: 2004-05-19
text: 
Project BioShield Act of 2004 - (Sec. 2) Amends the Public Health Service Act to authorize the Secretary of Health and Human Services (the Secretary) to: (1) conduct and support research and development activities regarding qualified countermeasures (a drug, biological product, or device to treat, identify, or prevent harm from any biological, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security), including by entering into interagency agreements for research and development; and (2) provide that biocontaminant laboratories and specialized research facilities under such agreements shall be available to the Secretary to respond to public health emergencies affecting national security. 
 
Allows the Secretary to expedite procurement to respond to pressing research and development needs by: (1) using simplified procurement procedures for products and services that cost more than the simplified acquisition threshold; (2) allowing other than full and open competition in certain instances; (3) increasing the micropurchase threshold to allow the Secretary to use those procedures; and (4) limiting review of the Secretary's procurement decisions. 
 
Allows the Secretary to employ other procedures to respond to pressing qualified countermeasure research and development needs, including expediting peer review procedures in certain instances, contracting with experts or consultants, and appointing professional and technical employees to positions at the National Institutes of Health.
 
Requires that appropriate internal controls be instituted for the authority given to the Secretary under this section.
 
Amends the Public Health Service Act to allow the Director of the National Institutes of Health to act through the Director of the National Institute of Allergy and Infectious Diseases (NIAID) to provide grants for the modernization and construction of biomedical and behavioral research facilities. Increases the Federal share of such NIAID-funded projects. 
 
Authorizes appropriations for the National Vaccine Program for FY 2004 and 2005.
 
Adds the Secretary of Homeland Security to the working group on the prevention, preparedness, and response to bioterrorism and other public health emergencies.
 
(Sec. 3) Amends the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 to direct the Secretary to: (1) coordinate with the Secretary of Homeland Security to maintain the Strategic National Stockpile (a stockpile of drugs, vaccines, and medical devices and supplies to provide for the emergency health security of the United States in the event of a bioterrorist attack or other public health emergency); (2) deploy the Stockpile to respond to an actual or potential emergency as required by the Secretary of Homeland Security; and (3) deploy the Stockpile to respond to an actual or potential public health emergency or other situation in which deployment is necessary to protect the public health or safety.
 
Allows security countermeasures to be procured using the special reserve fund (a biodefense countermeasures appropriations account set up pursuant to this Act). Defines &quot;security countermeasure&quot; as a countermeasure that is either authorized for emergency use or that the Secretary determines is a priority, is necessary, and is an approved drug or a drug reasonably likely to be approved within eight years.
 
Provides that in order for a countermeasure to be procured using the special reserve fund: (1) the Secretary of Homeland Security must identify a chemical, biological, radiological or nuclear agent as a material threat to the U.S. population sufficient to affect national security; (2) the Secretary must determine that a countermeasure is necessary to protect the public health; (3) the Secretary must assess the availability and appropriateness of the countermeasure to address the identified material threat; (4) the Secretary of Homeland Security and the Secretary must jointly submit to the President a proposal to issue a call for the development of needed countermeasures that are either not available or cleared only for alternative purposes; (5) the Secretaries must make a commitment that they will recommend that the special reserve fund be made available for the procurement of such a countermeasure; (6) the President must approve the proposal; (7) the Secretaries must make specified information known to persons who may respond to a call for the countermeasure involved, including the specifications of the needed countermeasure; (8) the Secretary must determine which countermeasures can appropriately be procured using the special reserve fund by considering the quantities needed, the feasibility of producing and delivering such a quantity within eight years, and the lack of a commercial market; (9) the Secretaries and the Director of the Office of Management Budget must submit to the President a recommendation that the special reserve fund be used to procure the countermeasure; and (10) the President must approve the recommendation. Requires the Secretary and the Secretary of Homeland Security to notify designated congressional committees promptly that a material threat has been identified for which countermeasures are necessary to protect the public health and that the President has approved a recommendation for countermeasure procurement using the special reserve fund.
 
Amends the Homeland Security Act to change the responsibilities of the Secretary of Homeland Security as they relate to the Stockpile.
 
Authorizes appropriations: (1) for FY 2004 through 2013 for the special reserve fund to procure security countermeasures approved by the President; (2) for FY 2004 through 2006 for the hiring of personnel to carry out terror threat assessments; and (3) for the acquisition and deployment of secure intelligence-sharing facilities. Transfers the functions, personnel, assets, unexpended balances, and liabilities of the Stockpile from the Secretary of Homeland Security to the Secretary. 
 
(Sec. 4) Amends the Federal Food, Drug, and Cosmetic Act to allow the Secretary to authorize the introduction into interstate commerce of a drug, device, or biological product intended for emergency use, specifically allowing the use of unapproved products, or the unapproved use of approved products, upon: (1) a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent; or (2) a determination by the Secretary of a public health emergency that affects, or has a significant potential to affect, national security and that involves a specified biological, chemical, radiological, or nuclear agent or a specified disease or condition that may be attributable to such agent. (Current law allows the Secretary to authorize the use of such emergency products only upon a determination by the Secretary of Defense of a military emergency involving a heightened risk to U.S. forces of an attack.)
 
Amends the National Defense Authorization Act for Fiscal Year 2004 to continue provisions governing the emergency use of products with respect to members of the Armed Forces.
 
(Sec. 5) Requires the Secretary of Health and Human Services to report to Congress on the exercise of authority under this Act and on additional barriers to the procurement of security countermeasures.
 
Requires the Comptroller General to: (1) review the Secretary's use of the authorities granted under this Act and make recommendations to improve the utilization or effectiveness of such authorities; (2) assess the adequacy of the internal controls instituted by the Secretary and make recommendations to improve their effectiveness; (3) identify any purchases or procurements that would not have been made or that would have been significantly delayed without the authorities provided to the Secretary; (4) determine to what extent authorized activities under this Act have enhanced the development of biomedical countermeasures affecting national security and recommend improvements; (5) assess the availability of countermeasures to address threats identified by the Secretary of Homeland Security; (6) assess the extent to which programs and activities under this Act will reduce any gap between the threat and the availability of countermeasures to an acceptable level of risk; and (7) assess the threats to national security posed by technology that will enable the development of antibiotic resistant, mutated, or bioengineered strains of biological agents and recommend strategies for addressing such threats.
 
Requires the Secretary and the Secretary of Homeland Security to report jointly on where there is a lack of adequate large scale biocontaminant facilities necessary for the testing of security countermeasures in accordance with Food and Drug Administration requirements.
 
(Sec. 6) Directs the Secretary to ensure that diverse institutions, including Historically Black Colleges and Universities and those serving large proportions of underrepresented populations, are meaningfully aware of available research and development grants, contracts, cooperative agreements, and procurements conducted under this Act.
 
(Sec. 7) Requires the Secretary to determine whether the countermeasures being developed are subject to existing export-related controls and, if not, recommend to appropriate Federal agencies that such countermeasures should be on the list of controlled items subject to such controls.
 
(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.
 
(Sec. 9) Amends title 11 of the Social Security Act to allow the Secretary to waive certain requirements during emergencies, including: (1) requirements pertaining to direction or reallocation of an individual to receive medical screening in an alternate location pursuant to an appropriate State emergency preparedness plan; and (2) sanctions for noncompliance with specified requirements of the Health Insurance Portability and Accountability Act of 1996.

action_date: 2004-07-14
text: 

(This measure has not been amended since it was passed by the Senate on May 19, 2004. The summary of that version is repeated here.)

 
Project BioShield Act of 2004 - (Sec. 2) Amends the Public Health Service Act to authorize the Secretary of Health and Human Services (the Secretary) to: (1) conduct and support research and development activities regarding qualified countermeasures (a drug, biological product, or device to treat, identify, or prevent harm from any biological, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security), including by entering into interagency agreements for research and development; and (2) provide that biocontaminant laboratories and specialized research facilities under such agreements shall be available to the Secretary to respond to public health emergencies affecting national security. 
 
Allows the Secretary to expedite procurement to respond to pressing research and development needs by: (1) using simplified procurement procedures for products and services that cost more than the simplified acquisition threshold; (2) allowing other than full and open competition in certain instances; (3) increasing the micropurchase threshold to allow the Secretary to use those procedures; and (4) limiting review of the Secretary's procurement decisions. 
 
Allows the Secretary to employ other procedures to respond to pressing qualified countermeasure research and development needs, including expediting peer review procedures in certain instances, contracting with experts or consultants, and appointing professional and technical employees to positions at the National Institutes of Health.
 
Requires that appropriate internal controls be instituted for the authority given to the Secretary under this section.
 
Amends the Public Health Service Act to allow the Director of the National Institutes of Health to act through the Director of the National Institute of Allergy and Infectious Diseases (NIAID) to provide grants for the modernization and construction of biomedical and behavioral research facilities. Increases the Federal share of such NIAID-funded projects. 
 
Authorizes appropriations for the National Vaccine Program for FY 2004 and 2005.
 
Adds the Secretary of Homeland Security to the working group on the prevention, preparedness, and response to bioterrorism and other public health emergencies.
 
(Sec. 3) Amends the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 to direct the Secretary to: (1) coordinate with the Secretary of Homeland Security to maintain the Strategic National Stockpile (a stockpile of drugs, vaccines, and medical devices and supplies to provide for the emergency health security of the United States in the event of a bioterrorist attack or other public health emergency); (2) deploy the Stockpile to respond to an actual or potential emergency as required by the Secretary of Homeland Security; and (3) deploy the Stockpile to respond to an actual or potential public health emergency or other situation in which deployment is necessary to protect the public health or safety.
 
Allows security countermeasures to be procured using the special reserve fund (a biodefense countermeasures appropriations account set up pursuant to this Act). Defines &quot;security countermeasure&quot; as a countermeasure that is either authorized for emergency use or that the Secretary determines is a priority, is necessary, and is an approved drug or a drug reasonably likely to be approved within eight years.
 
Provides that in order for a countermeasure to be procured using the special reserve fund: (1) the Secretary of Homeland Security must identify a chemical, biological, radiological or nuclear agent as a material threat to the U.S. population sufficient to affect national security; (2) the Secretary must determine that a countermeasure is necessary to protect the public health; (3) the Secretary must assess the availability and appropriateness of the countermeasure to address the identified material threat; (4) the Secretary of Homeland Security and the Secretary must jointly submit to the President a proposal to issue a call for the development of needed countermeasures that are either not available or cleared only for alternative purposes; (5) the Secretaries must make a commitment that they will recommend that the special reserve fund be made available for the procurement of such a countermeasure; (6) the President must approve the proposal; (7) the Secretaries must make specified information known to persons who may respond to a call for the countermeasure involved, including the specifications of the needed countermeasure; (8) the Secretary must determine which countermeasures can appropriately be procured using the special reserve fund by considering the quantities needed, the feasibility of producing and delivering such a quantity within eight years, and the lack of a commercial market; (9) the Secretaries and the Director of the Office of Management Budget must submit to the President a recommendation that the special reserve fund be used to procure the countermeasure; and (10) the President must approve the recommendation. Requires the Secretary and the Secretary of Homeland Security to notify designated congressional committees promptly that a material threat has been identified for which countermeasures are necessary to protect the public health and that the President has approved a recommendation for countermeasure procurement using the special reserve fund.
 
Amends the Homeland Security Act to change the responsibilities of the Secretary of Homeland Security as they relate to the Stockpile.
 
Authorizes appropriations: (1) for FY 2004 through 2013 for the special reserve fund to procure security countermeasures approved by the President; (2) for FY 2004 through 2006 for the hiring of personnel to carry out terror threat assessments; and (3) for the acquisition and deployment of secure intelligence-sharing facilities. Transfers the functions, personnel, assets, unexpended balances, and liabilities of the Stockpile from the Secretary of Homeland Security to the Secretary. 
 
(Sec. 4) Amends the Federal Food, Drug, and Cosmetic Act to allow the Secretary to authorize the introduction into interstate commerce of a drug, device, or biological product intended for emergency use, specifically allowing the use of unapproved products, or the unapproved use of approved products, upon: (1) a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent; or (2) a determination by the Secretary of a public health emergency that affects, or has a significant potential to affect, national security and that involves a specified biological, chemical, radiological, or nuclear agent or a specified disease or condition that may be attributable to such agent. (Current law allows the Secretary to authorize the use of such emergency products only upon a determination by the Secretary of Defense of a military emergency involving a heightened risk to U.S. forces of an attack.)
 
Amends the National Defense Authorization Act for Fiscal Year 2004 to continue provisions governing the emergency use of products with respect to members of the Armed Forces.
 
(Sec. 5) Requires the Secretary of Health and Human Services to report to Congress on the exercise of authority under this Act and on additional barriers to the procurement of security countermeasures.
 
Requires the Comptroller General to: (1) review the Secretary's use of the authorities granted under this Act and make recommendations to improve the utilization or effectiveness of such authorities; (2) assess the adequacy of the internal controls instituted by the Secretary and make recommendations to improve their effectiveness; (3) identify any purchases or procurements that would not have been made or that would have been significantly delayed without the authorities provided to the Secretary; (4) determine to what extent authorized activities under this Act have enhanced the development of biomedical countermeasures affecting national security and recommend improvements; (5) assess the availability of countermeasures to address threats identified by the Secretary of Homeland Security; (6) assess the extent to which programs and activities under this Act will reduce any gap between the threat and the availability of countermeasures to an acceptable level of risk; and (7) assess the threats to national security posed by technology that will enable the development of antibiotic resistant, mutated, or bioengineered strains of biological agents and recommend strategies for addressing such threats.
 
Requires the Secretary and the Secretary of Homeland Security to report jointly on where there is a lack of adequate large scale biocontaminant facilities necessary for the testing of security countermeasures in accordance with Food and Drug Administration requirements.
 
(Sec. 6) Directs the Secretary to ensure that diverse institutions, including Historically Black Colleges and Universities and those serving large proportions of underrepresented populations, are meaningfully aware of available research and development grants, contracts, cooperative agreements, and procurements conducted under this Act.
 
(Sec. 7) Requires the Secretary to determine whether the countermeasures being developed are subject to existing export-related controls and, if not, recommend to appropriate Federal agencies that such countermeasures should be on the list of controlled items subject to such controls.
 
(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.
 
(Sec. 9) Amends title 11 of the Social Security Act to allow the Secretary to waive certain requirements during emergencies, including: (1) requirements pertaining to direction or reallocation of an individual to receive medical screening in an alternate location pursuant to an appropriate State emergency preparedness plan; and (2) sanctions for noncompliance with specified requirements of the Health Insurance Portability and Accountability Act of 1996.

action_date: 2004-07-21
text: 

(This measure has not been amended since it was passed by the Senate on May 19, 2004. The summary of that version is repeated here.)

 
Project BioShield Act of 2004 - (Sec. 2) Amends the Public Health Service Act to authorize the Secretary of Health and Human Services (the Secretary) to: (1) conduct and support research and development activities regarding qualified countermeasures (a drug, biological product, or device to treat, identify, or prevent harm from any biological, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security), including by entering into interagency agreements for research and development; and (2) provide that biocontaminant laboratories and specialized research facilities under such agreements shall be available to the Secretary to respond to public health emergencies affecting national security. 
 
Allows the Secretary to expedite procurement to respond to pressing research and development needs by: (1) using simplified procurement procedures for products and services that cost more than the simplified acquisition threshold; (2) allowing other than full and open competition in certain instances; (3) increasing the micropurchase threshold to allow the Secretary to use those procedures; and (4) limiting review of the Secretary's procurement decisions. 
 
Allows the Secretary to employ other procedures to respond to pressing qualified countermeasure research and development needs, including expediting peer review procedures in certain instances, contracting with experts or consultants, and appointing professional and technical employees to positions at the National Institutes of Health.
 
Requires that appropriate internal controls be instituted for the authority given to the Secretary under this section.
 
Amends the Public Health Service Act to allow the Director of the National Institutes of Health to act through the Director of the National Institute of Allergy and Infectious Diseases (NIAID) to provide grants for the modernization and construction of biomedical and behavioral research facilities. Increases the Federal share of such NIAID-funded projects. 
 
Authorizes appropriations for the National Vaccine Program for FY 2004 and 2005.
 
Adds the Secretary of Homeland Security to the working group on the prevention, preparedness, and response to bioterrorism and other public health emergencies.
 
(Sec. 3) Amends the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 to direct the Secretary to: (1) coordinate with the Secretary of Homeland Security to maintain the Strategic National Stockpile (a stockpile of drugs, vaccines, and medical devices and supplies to provide for the emergency health security of the United States in the event of a bioterrorist attack or other public health emergency); (2) deploy the Stockpile to respond to an actual or potential emergency as required by the Secretary of Homeland Security; and (3) deploy the Stockpile to respond to an actual or potential public health emergency or other situation in which deployment is necessary to protect the public health or safety.
 
Allows security countermeasures to be procured using the special reserve fund (a biodefense countermeasures appropriations account set up pursuant to this Act). Defines &quot;security countermeasure&quot; as a countermeasure that is either authorized for emergency use or that the Secretary determines is a priority, is necessary, and is an approved drug or a drug reasonably likely to be approved within eight years.
 
Provides that in order for a countermeasure to be procured using the special reserve fund: (1) the Secretary of Homeland Security must identify a chemical, biological, radiological or nuclear agent as a material threat to the U.S. population sufficient to affect national security; (2) the Secretary must determine that a countermeasure is necessary to protect the public health; (3) the Secretary must assess the availability and appropriateness of the countermeasure to address the identified material threat; (4) the Secretary of Homeland Security and the Secretary must jointly submit to the President a proposal to issue a call for the development of needed countermeasures that are either not available or cleared only for alternative purposes; (5) the Secretaries must make a commitment that they will recommend that the special reserve fund be made available for the procurement of such a countermeasure; (6) the President must approve the proposal; (7) the Secretaries must make specified information known to persons who may respond to a call for the countermeasure involved, including the specifications of the needed countermeasure; (8) the Secretary must determine which countermeasures can appropriately be procured using the special reserve fund by considering the quantities needed, the feasibility of producing and delivering such a quantity within eight years, and the lack of a commercial market; (9) the Secretaries and the Director of the Office of Management Budget must submit to the President a recommendation that the special reserve fund be used to procure the countermeasure; and (10) the President must approve the recommendation. Requires the Secretary and the Secretary of Homeland Security to notify designated congressional committees promptly that a material threat has been identified for which countermeasures are necessary to protect the public health and that the President has approved a recommendation for countermeasure procurement using the special reserve fund.
 
Amends the Homeland Security Act to change the responsibilities of the Secretary of Homeland Security as they relate to the Stockpile.
 
Authorizes appropriations: (1) for FY 2004 through 2013 for the special reserve fund to procure security countermeasures approved by the President; (2) for FY 2004 through 2006 for the hiring of personnel to carry out terror threat assessments; and (3) for the acquisition and deployment of secure intelligence-sharing facilities. Transfers the functions, personnel, assets, unexpended balances, and liabilities of the Stockpile from the Secretary of Homeland Security to the Secretary. 
 
(Sec. 4) Amends the Federal Food, Drug, and Cosmetic Act to allow the Secretary to authorize the introduction into interstate commerce of a drug, device, or biological product intended for emergency use, specifically allowing the use of unapproved products, or the unapproved use of approved products, upon: (1) a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent; or (2) a determination by the Secretary of a public health emergency that affects, or has a significant potential to affect, national security and that involves a specified biological, chemical, radiological, or nuclear agent or a specified disease or condition that may be attributable to such agent. (Current law allows the Secretary to authorize the use of such emergency products only upon a determination by the Secretary of Defense of a military emergency involving a heightened risk to U.S. forces of an attack.)
 
Amends the National Defense Authorization Act for Fiscal Year 2004 to continue provisions governing the emergency use of products with respect to members of the Armed Forces.
 
(Sec. 5) Requires the Secretary of Health and Human Services to report to Congress on the exercise of authority under this Act and on additional barriers to the procurement of security countermeasures.
 
Requires the Comptroller General to: (1) review the Secretary's use of the authorities granted under this Act and make recommendations to improve the utilization or effectiveness of such authorities; (2) assess the adequacy of the internal controls instituted by the Secretary and make recommendations to improve their effectiveness; (3) identify any purchases or procurements that would not have been made or that would have been significantly delayed without the authorities provided to the Secretary; (4) determine to what extent authorized activities under this Act have enhanced the development of biomedical countermeasures affecting national security and recommend improvements; (5) assess the availability of countermeasures to address threats identified by the Secretary of Homeland Security; (6) assess the extent to which programs and activities under this Act will reduce any gap between the threat and the availability of countermeasures to an acceptable level of risk; and (7) assess the threats to national security posed by technology that will enable the development of antibiotic resistant, mutated, or bioengineered strains of biological agents and recommend strategies for addressing such threats.
 
Requires the Secretary and the Secretary of Homeland Security to report jointly on where there is a lack of adequate large scale biocontaminant facilities necessary for the testing of security countermeasures in accordance with Food and Drug Administration requirements.
 
(Sec. 6) Directs the Secretary to ensure that diverse institutions, including Historically Black Colleges and Universities and those serving large proportions of underrepresented populations, are meaningfully aware of available research and development grants, contracts, cooperative agreements, and procurements conducted under this Act.
 
(Sec. 7) Requires the Secretary to determine whether the countermeasures being developed are subject to existing export-related controls and, if not, recommend to appropriate Federal agencies that such countermeasures should be on the list of controlled items subject to such controls.
 
(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.
 
(Sec. 9) Amends title 11 of the Social Security Act to allow the Secretary to waive certain requirements during emergencies, including: (1) requirements pertaining to direction or reallocation of an individual to receive medical screening in an alternate location pursuant to an appropriate State emergency preparedness plan; and (2) sanctions for noncompliance with specified requirements of the Health Insurance Portability and Accountability Act of 1996.


Legislative actions:
action_date: 2004-07-21
text: Became Public Law No: 108-276.
action_date: 2004-07-21
text: Became Public Law No: 108-276.
action_date: 2004-07-21
text: Signed by President.
action_date: 2004-07-21
text: Signed by President.
action_date: 2004-07-16
text: Presented to President.
action_date: 2004-07-16
text: Presented to President.
action_date: 2004-07-14
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2004-07-14
text: On passage Passed by the Yeas and Nays: 414 - 2 (Roll no. 376). (text: CR H5721-5729)
action_date: 2004-07-14
text: Passed/agreed to in House: On passage Passed by the Yeas and Nays: 414 - 2 (Roll no. 376).(text: CR H5721-5729)
action_date: 2004-07-14
text: The previous question was ordered pursuant to a previous  order of the House. (consideration: CR H5740)
action_date: 2004-07-14
text: DEBATE - Pursuant to a previous order, the House proceeded with ninety minutes of debate on S. 15.
action_date: 2004-07-14
text: Considered by a previous order of the House. (consideration: CR H5721-5741)
action_date: 2004-07-14
text: Consideration initiated by previous order of the House.
action_date: 2004-05-20
text: Held at the desk.
action_date: 2004-05-20
text: Message on Senate action sent to the House.
action_date: 2004-05-20
text: Received in the House.
action_date: 2004-05-19
text: Passed Senate with an amendment and an amendment to the Title by Yea-Nay Vote. 99 - 0. Record Vote Number: 99.
action_date: 2004-05-19
text: Passed/agreed to in Senate: Passed Senate with an amendment and an amendment to the Title by Yea-Nay Vote. 99 - 0. Record Vote Number: 99.
action_date: 2004-05-19
text: The committee substitute as amended agreed to by Unanimous Consent.
action_date: 2004-05-19
text: Measure laid before Senate by unanimous consent. (consideration: CR S5744-5767; text of measure as reported in Senate: CR S5744-5760)
action_date: 2003-03-27
text: Star Print ordered on the reported bill.
action_date: 2003-03-25
text: Placed on Senate Legislative Calendar under General Orders. Calendar No. 53.
action_date: 2003-03-25
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Gregg with an amendment in the nature of a substitute. Without written report.
action_date: 2003-03-25
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Gregg with an amendment in the nature of a substitute. Without written report.
action_date: 2003-03-19
text: Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
action_date: 2003-03-11
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2003-03-11
text: Introduced in Senate

Enacted as: number: 108-276