3.0.0 15 2023-01-15T22:48:22Z 2023-01-15T22:48:22Z Senate S S 2003-03-11 108 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Reported by 2003-03-25T16:59:24Z Markup by 2003-03-20T00:52:14Z Referred to 2003-03-11T23:56:28Z Project BioShield Act of 2003 108 2122 HR 2003-07-17 Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 214. Companion bill Senate 2004-07-21 Became Public Law No: 108-276. President E40000 2 House floor actions 2004-07-21 Became Public Law No: 108-276. BecameLaw 36000 9 Library of Congress 2004-07-21 Signed by President. President E30000 2 House floor actions 2004-07-21 Signed by President. BecameLaw 36000 9 Library of Congress 2004-07-16 Presented to President. Floor E20000 2 House floor actions 2004-07-16 Presented to President. President 28000 9 Library of Congress 2004-07-14 18:58:08 Motion to reconsider laid on the table Agreed to without objection. Floor H38310 2 House floor actions 2004-07-14 18:58:04 On passage Passed by the Yeas and Nays: 414 - 2 (Roll no. 376). (text: CR H5721-5729) Floor H37100 2 House floor actions 376 https://clerk.house.gov/evs/2004/roll376.xml House 108 2004-07-14T22:58:04Z 2 2004-07-14 18:58:04 Passed/agreed to in House: On passage Passed by the Yeas and Nays: 414 - 2 (Roll no. 376).(text: CR H5721-5729) Floor 8000 9 Library of Congress 376 https://clerk.house.gov/evs/2004/roll376.xml House 108 2004-07-14T22:58:04Z 2 2004-07-14 18:31:49 The previous question was ordered pursuant to a previous order of the House. (consideration: CR H5740) Floor H35000 2 House floor actions 2004-07-14 17:20:06 DEBATE - Pursuant to a previous order, the House proceeded with ninety minutes of debate on S. 15. Floor H8D000 2 House floor actions 2004-07-14 17:19:57 Considered by a previous order of the House. (consideration: CR H5721-5741) Floor H30000 2 House floor actions 2004-07-14 17:19:41 Consideration initiated by previous order of the House. Floor H30800 2 House floor actions 2004-05-20 18:42:20 Held at the desk. Floor H15000 2 House floor actions 2004-05-20 Senate Message on Senate action sent to the House. Floor 2004-05-20 10:04:24 Received in the House. Floor H14000 2 House floor actions 2004-05-19 Senate Passed Senate with an amendment and an amendment to the Title by Yea-Nay Vote. 99 - 0. Record Vote Number: 99. Floor 99 https://www.senate.gov/legislative/LIS/roll_call_votes/vote1082/vote_108_2_00099.xml Senate 108 2004-05-19T18:15:51Z 2 2004-05-19 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. Floor 17000 9 Library of Congress 99 https://www.senate.gov/legislative/LIS/roll_call_votes/vote1082/vote_108_2_00099.xml Senate 108 2004-05-19T18:15:51Z 2 2004-05-19 Senate The committee substitute as amended agreed to by Unanimous Consent. Floor 2004-05-19 Senate Measure laid before Senate by unanimous consent. (consideration: CR S5744-5767; text of measure as reported in Senate: CR S5744-5760) Floor 2003-03-27 Senate Star Print ordered on the reported bill. Floor 2003-03-25 Senate Placed on Senate Legislative Calendar under General Orders. Calendar No. 53. Calendars 2003-03-25 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Reported by Senator Gregg with an amendment in the nature of a substitute. Without written report. Committee 2003-03-25 Committee on Health, Education, Labor, and Pensions. Reported by Senator Gregg with an amendment in the nature of a substitute. Without written report. Committee 14000 9 Library of Congress sshr00 Health, Education, Labor, and Pensions Committee 2003-03-19 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. Committee 2003-03-11 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2003-03-11 Introduced in Senate IntroReferral 10000 9 Library of Congress G000445 Sen. Gregg, Judd [R-NH] Judd Gregg R NH N F000439 Sen. Frist, William H. [R-TN] WILLIAM FRIST R TN H. 2003-03-11 True A000360 Sen. Alexander, Lamar [R-TN] Lamar Alexander R TN 2003-03-11 True W000154 Sen. Warner, John [R-VA] JOHN WARNER R VA WILLIAM 2003-03-11 True E000285 Sen. Enzi, Michael B. [R-WY] MICHAEL ENZI R WY B. 2003-03-11 True S001141 Sen. Sessions, Jeff [R-AL] Jeff Sessions R AL 2003-03-11 True R000307 Sen. Roberts, Pat [R-KS] PAT ROBERTS R KS 2003-03-11 True G000359 Sen. Graham, Lindsey [R-SC] Lindsey Graham R SC 2003-03-11 True B000611 Sen. Bond, Christopher S. [R-MO] CHRISTOPHER BOND R MO S. 2003-03-12 False I000024 Sen. Inhofe, James M. [R-OK] Jim Inhofe R OK 2003-03-19 False S000888 Sen. Stevens, Ted [R-AK] THEODORE STEVENS R AK F. 2003-03-25 False F000442 Sen. Fitzgerald, Peter [R-IL] PETER FITZGERALD R IL 2003-04-09 False 2003-05-07T04:00:00Z S. 15, Project BioShield Act of 2003 http://www.cbo.gov/publication/14419 <p>Cost estimate for the bill as reported by the Senate Committee on Health, Education, Labor, and Pensions on March 25, 2003</p> 2003-05-07T04:00:00Z S. 15, Project BioShield Act of 2003 https://www.cbo.gov/publication/14419 Cost estimate for the bill as reported by the Senate Committee on Health, Education, Labor, and Pensions on March 25, 2003 Public Law 108-276 Health 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 Health 00 2003-03-11 Introduced in Senate 2006-11-28T17:35:40Z 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.]]>

01 2003-03-25 Reported to Senate with amendment(s) 2006-11-28T17:35:40Z 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.]]>

35 2004-05-19 Passed Senate amended 2004-06-04T17:16:16Z 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 "security countermeasure" 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.

]]> 81 2004-07-14 Passed House without amendment 2004-07-21T19:18:45Z (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 "security countermeasure" 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.

]]> 49 2004-07-21 Public Law 2004-07-24T13:30:51Z (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 "security countermeasure" 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.

]]> Project BioShield Act of 2004 Display Title Project BioShield Act of 2004 Official Title as Introduced A bill to amend the Public Health Service Act to provide for the payment of compensation for certain individuals with injuries resulting from the administration of smallpox countermeasures, to provide protections and countermeasures against chemical, radiological, or nuclear agents that may be used in a terrorist attack against the United States, and to improve immunization rates by increasing the distribution of vaccines and improving and clarifying the vaccine injury compensation program. Introduced in Senate IS Short Titles as Reported to Senate Project BioShield Act of 2003 S Senate Short Titles as Passed House Project BioShield Act of 2004 H House Short Titles as Passed Senate Project Bioshield Act of 2004 S Senate Short Titles as Enacted Project BioShield Act of 2004 Official Titles as Amended by Senate A bill to amend the Public Health Service Act to provide protections and countermeasures against chemical, radiological, or nuclear agents that may be used in a terrorist attack against the United States by giving the National Institutes of Health contracting flexibility, infrastructure improvements, and expediting the scientific peer review process, and streamlining the Food and Drug Administration approval process of countermeasures. S Senate Short Titles as Introduced for portions of this bill Project BioShield Act of 2003 Short Titles as Introduced for portions of this bill Smallpox Emergency Personnel Protection Act of 2003 Popular Titles Vaccine Compensation bill 9 Library of Congress Short Titles as Introduced for portions of this bill Improved Vaccine Affordability and Availability Act Short Titles as Introduced Biodefense Improvement and Treatment for America Act 3180 108 SAMDT To amend the title. 2022-02-25T17:33:07Z 2004-05-19 Amendment SA 3180 agreed to in Senate by Unanimous Consent Vote. SA 3180 https://www.congress.gov/amendment/108th-congress/senate-amendment/3180 G000445 Sen. Gregg, Judd [R-NH] Judd Gregg R NH 1 1 K000105 Sen. Kennedy, Edward M. [D-MA] EDWARD KENNEDY D MA MOORE 2004-05-19 True 2004-05-19T04:00:00Z 2004-05-19T04:00:00Z Senate 108 S Senate S 15 Project BioShield Act of 2004 2023-01-15T22:48:22Z 6 2004-05-19 0 Senate Amendment SA 3180 agreed to in Senate by Unanimous Consent Vote. Floor 2004-05-19 0 Senate Amendment SA 3180 proposed by Senator Gregg. (consideration: CR S5767) To amend the title. Floor 2004-05-19 Senate amendment proposed (on the floor): Amendment SA 3180 proposed by Senator Gregg.(consideration: CR S5767) Floor 93000 9 Library of Congress 2004-05-19 Senate amendment agreed to: Amendment SA 3180 agreed to in Senate by Unanimous Consent Vote. Floor 94000 9 Library of Congress 2004-05-19 Senate amendment submitted Floor 91000 9 Library of Congress 3178 108 SAMDT To provide for a complete substitute. 2022-02-25T17:33:07Z 2004-05-19 Amendment SA 3178 agreed to in Senate by Unanimous Consent. SA 3178 https://www.congress.gov/amendment/108th-congress/senate-amendment/3178 G000445 Sen. Gregg, Judd [R-NH] Judd Gregg R NH 1 1 K000105 Sen. Kennedy, Edward M. [D-MA] EDWARD KENNEDY D MA MOORE 2004-05-19 True 2004-05-19T04:00:00Z 2004-05-19T04:00:00Z Senate 108 S Senate S 15 Project BioShield Act of 2004 2023-01-15T22:48:22Z 6 2004-05-19 0 Senate Amendment SA 3178 agreed to in Senate by Unanimous Consent. Floor 2004-05-19 0 Senate Amendment SA 3178 proposed by Senator Gregg. (consideration: CR S5762-5766) To provide for a complete substitute. Floor 2004-05-19 Senate amendment proposed (on the floor): Amendment SA 3178 proposed by Senator Gregg.(consideration: CR S5762-5766) Floor 93000 9 Library of Congress 2004-05-19 Senate amendment agreed to: Amendment SA 3178 agreed to in Senate by Unanimous Consent. Floor 94000 9 Library of Congress 2004-05-19 Senate amendment submitted Floor 91000 9 Library of Congress Enrolled Bill Engrossed in Senate 2004-05-19T04:00:00Z Reported to Senate 2003-03-25T05:00:00Z Introduced in Senate 2003-03-11T05:00:00Z 2004-07-22T03:59:59Z https://www.govinfo.gov/content/pkg/PLAW-108publ276/xml/PLAW-108publ276.xml Public Law 2004-07-21 Became Public Law No: 108-276. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.