Congress 108 - HR 2122 - Project BioShield Act of 2003

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

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Summary

Project BioShield Act of 2003 - (Sec. 2) Amends the Public Health Service Act regarding preparations for public health emergencies affecting national security, including a bioterrorist attack.

Makes biocontainment laboratories and specialized research facilities available as needed to the Secretary of Health and Human Services (the Secretary) in public health emergencies affecting national security if the owners of such a facility have entered into a grant, contract, or cooperative agreement with the Secretary under the provisions of this Act pertaining to biomedical countermeasure research and development.

Grants the Secretary certain authority with respect to the research and development of qualified countermeasures, including: (1) expedited procurement authority; (2) expedited peer review authority; (3) authority for personal services contracts; and (4) streamlined personnel authority. Defines a qualified countermeasure as a priority countermeasure that affects national security.

(Sec. 3) Directs the Secretary of Homeland Security, in coordination with the Secretary and the Secretary of Veterans Affairs, to maintain a stockpile of drugs, vaccines (including smallpox vaccine), and other supplies to provide for the emergency health security of the United States in the event of a bioterrorist attack or other public health emergency. Directs the Secretary to: (1) review and revise the contents of the stockpile on a regular basis; (2) award grants to ensure that the stockpile contains an adequate amount of smallpox vaccine; and (3) assess, on an ongoing basis, the potential public health consequences from the use of chemical, biological, radiological, and nuclear agents and determine the agents for which countermeasures are necessary. Permits the Secretary and the Secretary of Homeland Security to jointly submit to the President proposals for the development of needed security countermeasures. Defines security countermeasures as priority countermeasures against a chemical, biological, radiological, or nuclear agent that meet one of certain criteria (including having been approved or cleared under the Federal Food, Drug, and Cosmetic Act as countermeasures against a chemical, biological, radiological, or nuclear agent).

Amends the Homeland Security Act of 2002 to authorize appropriations for: (1) the procurement of security countermeasures; (2) the carrying out of terror threat assessment responsibilities; and (3) the acquisition and deployment of secure intelligence sharing facilities.

(Sec. 4) Amends the Federal Food, Drug, and Cosmetic Act to allow the Secretary to declare a national emergency under specified conditions and authorize the release of a drug, device, or biological product intended for use in an emergency. Directs the Secretary to impose requirements on the authorization, including ensuring that health care professionals administering the product and persons to whom the product is administered are fully informed about the benefits and risks involved and other alternatives. Requires the Secretary to periodically review an authorization under this Act, and authorizes the Secretary to revoke such an authorization if circumstances so warrant. Allows the President, with regard to the Armed Forces, to waive the requirement that individuals be allowed to refuse administration of a countermeasure if complying with such requirement is: (1) not feasible; (2) contrary to the best interests of such individuals; or (3) not in the interests of national security. Allows the Secretary to withhold from members of the Armed Forces information about the benefits and risks of a countermeasure and alternatives to its use if such information is provided to such individuals within 30 days of the administration of the countermeasure and is recorded in the medical records of such members.

Requires: (1) reports from the Secretary regarding authorities under this Act; (2) the Secretary to request the National Academy of Sciences to review biomedical countermeasure research and development activities under this Act; and (3) review by the General Accounting Office.

(Sec. 6) Directs the Secretary to ensure that diverse institutions, including Historically Black Colleges and Universities and those serving other underrepresented populations, are meaningfully aware of research, contracts, cooperative agreements, and development grants and procurements conducted under this Act.

(Sec. 7) Directs the Secretary to determine whether, for any grant, contract, or cooperative agreement awarded under this Act for the research, development, or procurement of a qualified countermeasure or a security countermeasure, the countermeasure involved is subject to existing export-related controls. Allows the Secretary to make a recommendation to the appropriate agency or agencies that a countermeasure should be subject to such controls if it is not already.

(Sec. 8) Directs the Secretary, the Secretary of Homeland Security, and the Secretary of Defense to ensure that the activities of their respective Departments coordinate, complement, and do not unnecessarily duplicate programs designed to protect the homeland from biological, chemical, radiological, and nuclear agents. Directs such Secretaries to each appoint an official to coordinate such programs for their respective Departments.

Actions

Jul 17, 2003

Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 214.
Jul 16, 2003

Considered as unfinished business. (consideration: CR H6947-6948)
Jul 16, 2003

POSTPONED ROLL CALL VOTE - At the conclusion of debate on H.R. 2122, as amended, the Chair put the question on passage of the bill, as amended, and by voice vote, announced that the ayes had prevailed. Mr. Cox demanded the yeas and nays and the Chair postponed further proceedings on the question of passage until later in the legislative day.
Jul 16, 2003

The previous question was ordered pursuant to a previous order of the House. (consideration: CR H6946; text: CR H6946)
Jul 16, 2003

DEBATE - The House proceeded with 90 minutes of debate on H.R. 2122, equally divided and controlled.
Jul 16, 2003

Considered by previous order of the House. (consideration: CR H6908-6941; text as reported in House: CR H6908-6920)
Jul 16, 2003

Consideration initiated by previous order of the House.
Jul 16, 2003

Motion to reconsider laid on the table Agreed to without objection.
Jul 16, 2003

On passage Passed by the Yeas and Nays: 421 - 2 (Roll no. 373).
Jul 16, 2003

Passed/agreed to in House: On passage Passed by the Yeas and Nays: 421 - 2 (Roll no. 373).
Jul 8, 2003

Placed on the Union Calendar, Calendar No. 98.
Jul 8, 2003

Reported (Amended) by the Committee on Homeland Security (Select). H. Rept. 108-147, Part III.
Jun 27, 2003

House Committee on Homeland Security (Select) Granted an extension for further consideration ending not later than July 8, 2003.
Jun 26, 2003

Ordered to be Reported (Amended) by the Yeas and Nays: 29 - 0.
Jun 26, 2003

Committee Consideration and Mark-up Session Held.
Jun 13, 2003

House Committee on Homeland Security (Select) Granted an extension for further consideration ending not later than June 27, 2003.
Jun 12, 2003

Reported (Amended) by the Committee on Government Reform. H. Rept. 108-147, Part II.
Jun 11, 2003

Committee on Armed Services discharged.
Jun 10, 2003

Referred sequentially to the House Committee on Armed Services for a period ending not later than June 11, 2003 pursuant to clause 1(c), rule X.
Jun 10, 2003

House Committee on Homeland Security (Select) Granted an extension for further consideration ending not later than June 13, 2003.
Jun 10, 2003

House Committee on Government Reform Granted an extension for further consideration ending not later than June 13, 2003.
Jun 10, 2003

Reported by the Committee on Energy and Commerce. H. Rept. 108-147, Part I.
May 22, 2003

Ordered to be Reported (Amended) by Voice Vote.
May 22, 2003

Committee Consideration and Mark-up Session Held.
May 15, 2003

Referred to the Committee on Energy and Commerce, and in addition to the Committees on Government Reform, and Homeland Security (Select), for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
May 15, 2003

Introduced in House

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