Department of Homeland Security Appropriations for Fiscal Year 2006

Total Page:16

File Type:pdf, Size:1020Kb

Department of Homeland Security Appropriations for Fiscal Year 2006 DEPARTMENT OF HOMELAND SECURITY APPROPRIATIONS FOR FISCAL YEAR 2006 THURSDAY, APRIL 28, 2005 U.S. SENATE, SUBCOMMITTEE OF THE COMMITTEE ON APPROPRIATIONS, Washington, DC. The subcommittee met at 10:29 a.m., in room SD–192, Dirksen Senate Office Building, Hon. Judd Gregg (chairman) presiding. Present: Senators Gregg, Cochran, Stevens, Craig, Allard, Byrd, and Inouye. DEPARTMENT OF HOMELAND SECURITY STATEMENT OF DR. PENROSE C. ALBRIGHT, ASSISTANT SECRETARY FOR SCIENCE AND TECHNOLOGY OPENING STATEMENT OF SENATOR JUDD GREGG Senator GREGG. We will convene this hearing. The purpose of this Homeland Security hearing is to review where we stand relative to defending this Nation from biological or chemical attack, which is in my opinion the biggest threat to our country. If you prioritize threat, which is exactly what we should be doing as a Congress and as a Government, you have to put at the top of the list the concerns weapons of mass destruction used against the American population somewhere here in the United States or overseas obviously. We, 2 years ago, began the effort to try to aggressively address this issue, recognizing some fundamental flaws within our struc- ture as a country, the biggest flaw being the pharmaceutical indus- try, which one would presume would naturally pursue ways of being able to respond to a biological attack, was not structured to do so, and the Government was not structured to deal with a chem- ical or a biological attack. BIOSHIELD So we worked very hard, in my prior role as Chairman of the Health Committee, to pass a piece of legislation called BioShield, which was the initiative of the administration. And the purpose of this bill was to reenergize the vaccine industry in this country and to energize the research community within our Nation to pursue ways to respond to various chemical and biological agents which might be used against us. We understand, obviously, there is no market for a product to re- spond to these type of agents. These agents are by definition agents (1) 2 which do not commonly occur, but only occur when we are at- tacked, although smallpox was a problem, but it has been eradi- cated. So we needed to create a structure where there would be not only an atmosphere where creative individuals and scientists would step forward to develop responses to attacks involving threats such as anthrax, smallpox, botulism, and plague, but we also had to cre- ate a monetary system, a market system which would encourage this from a standpoint of making it a reasonable place to invest your money if you were an investor. And that is what BioShield was all about. It basically put the Government in the business of buying antidotes and vaccines for this list of major threats. We are now well into this process. Progress has been made in some areas but there is still a long way to go in other areas. The purpose of this hearing is to discuss what we are doing and what we should be doing that will better produce results. My own personal concern is we have still not stood up a vaccine industry in this country at the level I would like to see it. We still do not have many participants in the production of vaccine, that the research community, especially our academic research commu- nity, has not yet embraced this initiative as well as and as aggres- sively as I would hope, and that there appears to be some incen- tives in the system which are discouraging research in this area, and the question of how we are purchasing products, to the extent it is being brought on line, whether that is chilling competition or participation of other parties in the research and development of creative new ways to address these types of threats. It is a complex issue involving the most cutting-edge levels of science, and it does not have a simple solution. If it did, we would have gotten to it much sooner. But we do have a committed effort to do it, and we have got a committed Government to accomplish it, and I think we have got some good witnesses today to find out where we stand and where we should go. With that, I will yield to the honorable Senator from Virginia, Senator Byrd. STATEMENT OF SENATOR ROBERT C. BYRD Senator BYRD. That is West Virginia. Senator GREGG. I apologize profusely. BIOLOGICAL OR CHEMICAL ATTACK Senator BYRD. Mr. Chairman, first of all, let me thank you for your service. I listened with rapt attention at your remarks. You are well prepared to be the Chairman of this subcommittee and well prepared to probe this very important subject. I welcome the witnesses on both panels for this hearing, and I applaud you, Mr. Chairman, for calling us together for such an im- portant topic. Earlier this year during testimony before the Senate Intelligence Committee, CIA Director Porter Goss warned and I quote ‘‘It is only a matter of time before Al Qaeda or another terrorist group tries to use chemical, biological, radiological, or nuclear weapons in the United States.’’ Mr. Chairman, I believe that. I believe it is ab- solutely the case, and I am not sure that we are prepared. I doubt it because we do not know when, we do not know where this mon- 3 ster will confront us with a bioterror attack, a chemical attack, a nuclear attack, or a radiological attack. With regard to a biological attack, Congress made a serious com- mitment by appropriating $5.6 billion to pursue new vaccines and medications to protect the American public from known biological threats. It is essential the agencies involved in this process be ac- countable for progress in this area. So, I look forward to discussing this and other homeland security efforts, not only to detect and re- spond to a bioterror incident, but what efforts are being made to prevent a biological, chemical, also to examine nuclear terror inci- dent. Thank you, Mr. Chairman. Senator GREGG. Thank you, Senator Byrd. We will turn to the panel now. The first panel will be people in our Government who have first-line responsibility for getting us prepared for a biological or chemical attack and being able to re- spond to it. Our first witness is Dr. Albright who was confirmed as Assistant Secretary of Homeland Security, Plans, Programs, and Budgets on October 3. Our second witness is Mr. Simonson who is the Assistant Secretary for Public Health Emergency Preparedness, United States Department of Health and Human Services. And these two gentlemen have the portfolio and we look forward to hearing how we are doing. So let us start with you, Dr. Albright. STATEMENT OF DR. PENROSE C. ALBRIGHT Dr. ALBRIGHT. Good afternoon, Chairman Gregg, Senator Byrd, and distinguished members of the Subcommittee. I am pleased to appear before you today to discuss the progress the Science and Technology Directorate of the Department of Homeland Security is making in the Nation’s efforts to prevent, protect against, respond to, and recover from acts of bioterrorism against the American peo- ple. President Bush has made strengthening the Nation’s defenses against biological weapons a critical national priority. The Presi- dent’s focus on these issues has resulted in a joint Homeland Secu- rity Presidential Directive/National Security Presidential directive entitled Biodefense for the 21st Century that provides a com- prehensive framework for our Nation’s sustained and focused effort against biological weapons threats. ACCOMPLISHMENTS IN BIODEFENSE The Department of Homeland Security and the Science and Technology Directorate have explicit responsibilities in this inte- grated national effort. In particular, I want to highlight the strat- egy, planning, and accomplishments to date of the Science and Technology Directorate in the area of biodefense and the essential collaborations with key Federal partners, including those rep- resented here today. In 2004 and 2005, the Science and Technology Directorate devel- oped a national architecture and plan for the detection of biological attacks, should they occur, and as initial steps, deployed the BioWatch Environmental Sensor System to protect our Nation’s cit- ies from the threat and ramifications of such an attack and also 4 initiated the design of the National Biosurveillance Integration System as part of an interagency process. We completed the planning and conceptual design of the Na- tional Biodefense Analysis and Countermeasures Center. This cen- ter will focus on, among other things, creating a scientifically based understanding of the biological threat. We established the Biodefense Knowledge Center, which is an operational hub for enabling collaboration and communication within the Homeland Security enterprise. We have certified four material threats and have two additional certifications underway. These material threat determinations are required in order to com- mit BioShield funds. We have established a National Bioforensic Analysis Center to provide a national capability for conducting forensic analysis of evi- dence from biocrimes and terrorism to obtain a biological finger- print to identify perpetrators and determine the origin and method of the attack. In 2006, our expectations are to complete the deployment of the second generation BioWatch system to the top threat cities and to complete test and evaluation of the laboratory prototypes for the third generation of these detection systems. We will also complete the first formal risk assessment that is re- quired under HSPD-10 and close many of the key remaining exper- imental gaps in our knowledge of the classic biological threat agents. We will continue operations of the Plum Island Animal Disease Center and essential upgrades to the facility and initiate the design of the National Bio and Agrodefense Facility.
Recommended publications
  • GAO-09-878R Project Bioshield Act: HHS Has Supported Development
    United States Government Accountability Office Washington, DC 20548 July 24, 2009 Congressional Committees Subject: Project BioShield Act: HHS Has Supported Development, Procurement, and Emergency Use of Medical Countermeasures to Address Health Threats This report formally transmits the attached briefing in response to section 247d-6c of title 42 of the United States Code. (See the enclosure.) The statute required the Comptroller General to examine the Department of Health and Human Services’ (HHS) support for the development and procurement of and authority for the emergency use of medical countermeasures to address chemical, biological, radiological, and nuclear threats to public health, and provide the results to the congressional committees by July 21, 2009.1 HHS determines priorities for medical countermeasure procurement based on those chemical, biological, radiological, and nuclear agents that have been identified by the Department of Homeland Security as posing a material threat to the U.S. population that could affect national security. We provided the briefing to staff of your committees to satisfy the mandate reporting requirement on July 20, 2009, and July 21, 2009. – – – – – We are sending copies of this report to the Secretary of HHS, the Secretary of Homeland Security, and other interested parties. In addition, the report will be available at no charge on the GAO Web site at http://www.gao.gov. If you or your staff have any questions regarding this report, please contact me at (202) 512- 7114 or bascettac@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report.
    [Show full text]
  • UN Health Update #58
    UN Health Update #58 Multilateral Consulting, LLC November 1, 2017 UN HEALTH UPDATE #58 NOVEMBER 1, 2017 Table of Contents WHO Breaks Precedent with New Leadership Team ............................................... 1 Female majority, inclusion of conservatives in line-up WIPO Showcases Agency’s Work, Highlights IFPMA Project .................................. 5 At Assemblies: committees report, "Pat-INFORMED" presented “Montevideo Roadmap” Issued by Leaders at WHO NCD Confab .......................... 8 High-level attendance at October Uruguay meeting WHO Establishes High-Level NCD Commission ..................................................... 9 Headed by Sania Nishtar, will include Peruvian president WHO Issues GCM/NCD Progress Report ............................................................... 9 Aims to achieve Global Monitoring Framework's 9 targets WHO EURO, LSE Scholars: Hurdles are Prices, IP ............................................... 10 Slams failure to implement HLP recommencations, including "punishment' Comments Submitted on WHO GPW 2019-2023 ................................................... 10 Lays out D-G's vision and priorities; NGOs make suggestions PAHO Elects Carissa Etienne to 2nd Term .............................................................. 12 Directing Council takes up usual list of topics Regional Director Presides Over First/Last EMRO Meeting .................................. 12 Ministers debate range of pressing challenges WPRO Takes Up Broad Range of Issues ...............................................................
    [Show full text]
  • Acquisitions, and Policy Implementation Issues for Congress
    Order Code RL33907 Project BioShield: Appropriations, Acquisitions, and Policy Implementation Issues for Congress March 8, 2007 Frank Gottron Specialist in Science and Technology Policy Resources, Science, and Industry Division Project BioShield: Appropriations, Acquisitions, and Policy Implementation Issues for Congress Summary The Project BioShield Act of 2004 (P.L. 108-276) established a 10-year program to acquire civilian medical countermeasures to chemical, biological, radiological and nuclear (CBRN) agents for the Strategic National Stockpile. Provisions of this act were designed to encourage private companies to develop these countermeasures by guaranteeing a government market for successfully developed countermeasures. Both the Department of Homeland Security (DHS) and the Department of Health and Human Services (HHS) have responsibilities in this program. Funds for this program are appropriated to DHS, while contracts are executed through HHS. The interagency process responsible for deciding which countermeasures to procure has changed multiple times since this program’s inception. The Homeland Security Appropriations Act, 2004 (P.L. 108-90) provided an advance appropriation of $5.6 billion to acquire CBRN countermeasures over a 10- year period (FY2004–FY2013). This act also limited the amount that could be obligated during specified time periods. The Project BioShield Act of 2004 (P.L. 108-276) assigned the $5.6 billion advance appropriation to Project BioShield countermeasure acquisitions. The Consolidated Appropriations Act, 2004 (P.L. 108- 199) and the Consolidated Appropriations Act, 2005 (P.L. 108-447) reduced the total amount available for Project BioShield by a total of $25 million. Congress retains the power to make additional appropriations and rescissions to this account.
    [Show full text]
  • Project Bioshield Act of 2004
    PUBLIC LAW 108–276—JULY 21, 2004 118 STAT. 835 Public Law 108–276 108th Congress An Act 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 July 21, 2004 contracting flexibility, infrastructure improvements, and expediting the scientific [S. 15] peer review process, and streamlining the Food and Drug Administration approval process of countermeasures. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, Project BioShield Act of 2004. SECTION 1. SHORT TITLE. 42 USC 201 note. This Act may be cited as the ‘‘Project BioShield Act of 2004’’. SEC. 2. BIOMEDICAL COUNTERMEASURE RESEARCH AND DEVELOP- MENT—AUTHORITIES. (a) IN GENERAL.—Part B of title III of the Public Health Service Act (42 U.S.C. 243 et seq.) is amended by inserting after section 319F the following section: ‘‘SEC. 319F–1. AUTHORITY FOR USE OF CERTAIN PROCEDURES 42 USC 247d–6a. REGARDING QUALIFIED COUNTERMEASURE RESEARCH AND DEVELOPMENT ACTIVITIES. ‘‘(a) IN GENERAL.— ‘‘(1) AUTHORITY.—In conducting and supporting research and development activities regarding countermeasures under section 319F(h), the Secretary may conduct and support such activities in accordance with this section and, in consultation with the Director of the National Institutes of Health, as part of the program under section 446, if the activities concern qualified countermeasures. ‘‘(2) QUALIFIED COUNTERMEASURE.—For purposes of this section, the term ‘qualified countermeasure’ means a drug (as that term is defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
    [Show full text]
  • Avian Influenza Pandemic May Expand the Military Role in Disaster Relief
    USAWC STRATEGY RESEARCH PROJECT AVIAN INFLUENZA PANDEMIC MAY EXPAND THE MILITARY ROLE IN DISASTER RELIEF by Colonel Frank William Sherod II United States Army Colonel Dallas C. Hack Project Adviser This SRP is submitted in partial fulfillment of the requirements of the Master of Strategic Studies Degree. The U.S. Army War College is accredited by the Commission on Higher Education of the Middle States Association of Colleges and Schools, 3624 Market Street, Philadelphia, PA 19104, (215) 662-5606. The Commission on Higher Education is an institutional accrediting agency recognized by the U.S. Secretary of Education and the Council for Higher Education Accreditation. The views expressed in this student academic research paper are those of the author and do not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government. U.S. Army War College CARLISLE BARRACKS, PENNSYLVANIA 17013 Form Approved Report Documentation Page OMB No. 0704-0188 Public reporting burden for the collection of information is estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to Washington Headquarters Services, Directorate for Information Operations and Reports, 1215 Jefferson Davis Highway, Suite 1204, Arlington VA 22202-4302. Respondents should be aware that notwithstanding any other provision of law, no person shall be subject to a penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number.
    [Show full text]
  • Biosecurity: a Comprehensive Action Plan Center for American Progress
    Center for American Progress Biosecurity A Comprehensive Action Plan Andrew J. Grotto Jonathan B. Tucker Progressive Ideas for a Strong, Just, and Free America Biosecurity: A Comprehensive Action Plan Center for American Progress Biosecurity A Comprehensive Action Plan Andrew J. Grotto and Jonathan B. Tucker June 2006 After Guantanamo: A Special Tribunal for International Terrorist Suspects 1 Biosecurity: A Comprehensive Action Plan Center for American Progress Table of Contents EXECUTIVE SUMMARY i BIOLOGICAL THREATS FACING THE UNITED STATES 1 PREVENTING BIO-CATASTROPHES: THE NEED FOR A GLOBAL APPROACH 9 PREVENTING THE MISUSE OF THE LIFE SCIENCES 9 RECOMMENDATIONS STRENGTHENING BIOLOGICAL DISARMAMENT MEASURES 14 RECOMMENDATIONS 8 CONTAINING DISEASE OUTBREAKS: AN INTEGRATED PUBLIC HEALTH STRATEGY 21 TIMELY DETECTION OF OUTBREAKS 22 RECOMMENDATIONS 0 RAPID CONTAINMENT OF OUTBREAKS 32 RECOMMENDATIONS 5 DEFENDING AGAINST BIOLOGICAL THREATS: AN INTEGRATED RESEARCH STRATEGY 37 REFORMING THE DRUG DEVELOPMENT PROCESS 38 RECOMMENDATIONS 41 RATIONALIZING BIODEFENSE SPENDING 42 RECOMMENDATIONS 44 GLOSSARY 47 Biosecurity: A Comprehensive Action Plan ACKNOWLEDGMENTS The authors are deeply grateful to the following individuals for their valuable comments and criticisms on earlier drafts of this report: Bob Boorstin, Joseph Cirincione, P. J. Crowley, Richard Ebright, Gerald L. Epstein, Trevor Findlay, Brian Finlay, Elisa D. Harris, David Heyman, Ajey Lele, Dan Matro, Caitriona McLeish, Jonathan Moreno, Peter Ogden, Alan Pearson, Michael Schiffer, Laura Segal, and Bradley Smith. 4 Center for American Progress Executive Summary iological weapons and infectious diseases share several fundamental characteristics that the United States can leverage to counter both Bof these threats more effectively. Both a bioweapons attack and a natural pandemic, such as avian flu, can be detected in similar ways, and the effectiveness of any response to an outbreak of infectious disease, whether natural or caused deliberately by terrorists, hinges on the strength of the U.S.
    [Show full text]
  • The Project Bioshield Act: Issues for the 112Th Congress
    The Project BioShield Act: Issues for the 112th Congress Frank Gottron Specialist in Science and Technology Policy March 13, 2012 Congressional Research Service 7-5700 www.crs.gov R42349 CRS Report for Congress Prepared for Members and Committees of Congress The Project BioShield Act: Issues for the 112th Congress Summary In 2004, Congress passed the Project BioShield Act (P.L. 108-276) to provide the federal government with new authorities related to the development, procurement, and use of medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) terrorism agents. As the expiration of some of these authorities approaches, Congress is considering whether these authorities have sufficiently contributed to national preparedness to merit extension. The Project BioShield Act provides three main authorities: (1) guaranteeing a federal market for new CBRN medical countermeasures, (2) permitting emergency use of countermeasures that are either unapproved or have not been approved for the intended emergency use, and (3) relaxing regulatory requirements for some CBRN terrorism-related spending. The Department of Health and Human Services (HHS) has used each of these authorities. The HHS obligated approximately $2.5 billion to guarantee a government market for countermeasures against anthrax, botulism, radiation, and smallpox. The HHS allowed the emergency use of several unapproved products, including during the 2009 H1N1 influenza pandemic. The HHS used expedited review authorities to approve contracts and grants related to CBRN countermeasure research and development. The Department of Homeland Security (DHS) Appropriations Act, 2004 (P.L. 108-90) advance- appropriated $5.593 billion to acquire CBRN countermeasures through Project BioShield for FY2004-FY2013. Through FY2012, subsequent Congresses have removed $1.876 billion from this account through rescissions and transfers, more than one-third of the advance appropriation.
    [Show full text]
  • Project Bioshield Act Fact Sheet
    ASTHO LEGAL PREPAREDNESS SERIES EMERGENCY USE AUTHORIZATION TOOLKIT Project BioShield Act Fact Sheet Overview With the anthrax and other terrorist attacks of 2001, the federal government determined that it would need new medical countermeasures, such as diagnostic tests, drugs, and vaccines, to respond to an attack using chemical, biological, radiological, or nuclear (CBRN) agents.1 The lack of a significant commercial market for CBRN countermeasures was identified as a reason for the dearth of such countermeasures.1 Since diseases and conditions caused by CBRN agents occur infrequently, the private sector did not have an economic incentive to invest the millions of dollars necessary to research and develop such measures.1 The Project BioShield Act of 20042 was enacted to accelerate the research, development, purchase, and availability of effective medical products against CBRN agents.3 Project BioShield provided the government with the authority and funding to develop, acquire, stockpile, and distribute the medical products needed to protect the United States against weapons of mass destruction.3 Note: As of March 2012, Congress is in the process of reauthorizing the Pandemic and All-Hazards Preparedness Act (PAHPA), which may impact some provisions of the Project BioShield Act. Please see ASTHO EUA Current Issues Winter 2012 for more information about reauthorization and its potential impact on EUAs and related issues. What the Law Does The Project BioShield Act authorizes expedited procurement, streamlined personnel appointments, expedited peer review, biomedical countermeasures procurement, emergency use of medical countermeasures, and other biodefense activities. Liability Protections The Project BioShield Act does not contain any explicit immunity or other liability protections.
    [Show full text]
  • Failures of Project Bioshield & Congressional Attempts to Remedy It
    DePaul Journal of Health Care Law Volume 10 Issue 3 Spring 2007 Article 8 October 2015 Failures of Project BioShield & Congressional Attempts to Remedy It Megan O'Reilly Follow this and additional works at: https://via.library.depaul.edu/jhcl Recommended Citation Megan O'Reilly, Failures of Project BioShield & Congressional Attempts to Remedy It, 10 DePaul J. Health Care L. 503 (2007) Available at: https://via.library.depaul.edu/jhcl/vol10/iss3/8 This Case Briefs is brought to you for free and open access by the College of Law at Via Sapientiae. It has been accepted for inclusion in DePaul Journal of Health Care Law by an authorized editor of Via Sapientiae. For more information, please contact digitalservices@depaul.edu. CASE BRIEF: THE FAILURES OF PROJECT BIOSHIELD & CONGRESSIONAL ATTEMPTS TO REMEDY IT Megan O'Reilly I. THE THREAT OF A BIOLOGICAL TERROR ATTACK In response to the 2001 terrorist attacks, the United States government began a crash program to develop drugs, vaccine and diagnostic tests to protect the nation from biological terrorism.' As part of this effort, President Bush signed Project BioShield into law on July 21, 2004. The legislation was intended to facilitate a faster process to research, develop, purchase and make bioterrorism countermeasures available to combat bioterrorist threats. 2 However, Project BioShield is not drawing the interest it aimed for. The legislation has faced significant criticism because the law has failed to adequately provide consistent and well-coordinated financing, and sufficient, ensured markets, as well as any liability protection for vaccine developers. 3 The threat of a biological attack is very real.4 To ensure that Project BioShield assists in protecting the nation from future bioterrorist attacks, it is necessary to evaluate the successes and setbacks the initiative has faced.
    [Show full text]
  • It's Getting Ugly out There
    It’s Getting Ugly Out There The Frauds, Bunglers, Liars, and Losers Who Are Hurting America JACK CAFFERTY John Wiley & Sons, Inc. It’s Getting Ugly Out There It’s Getting Ugly Out There The Frauds, Bunglers, Liars, and Losers Who Are Hurting America JACK CAFFERTY John Wiley & Sons, Inc. Copyright © 2007 by Jack Cafferty. All rights reserved Published by John Wiley & Sons, Inc., Hoboken, New Jersey Published simultaneously in Canada Design and composition by Navta Associates, Inc. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, scanning, or otherwise, except as permitted under Section 107 or 108 of the 1976 United States Copy- right Act, without either the prior written permission of the Publisher, or authorization through payment of the appropriate per-copy fee to the Copyright Clearance Center, 222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400, fax (978) 646-8600, or on the web at www.copyright.com. Requests to the Publisher for permission should be addressed to the Permissions Department, John Wiley & Sons, Inc., 111 River Street, Hoboken, NJ 07030, (201) 748-6011, fax (201) 748-6008, or online at http://www.wiley.com/go/permissions. Limit of Liability/Disclaimer of Warranty: While the publisher and the author have used their best efforts in preparing this book, they make no representations or warranties with respect to the accuracy or completeness of the contents of this book and specifically dis- claim any implied warranties of merchantability or fitness for a particular purpose.
    [Show full text]
  • Public Law 108–276 108Th Congress An
    PUBLIC LAW 108–276—JULY 21, 2004 118 STAT. 835 Public Law 108–276 108th Congress An Act 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 July 21, 2004 contracting flexibility, infrastructure improvements, and expediting the scientific [S. 15] peer review process, and streamlining the Food and Drug Administration approval process of countermeasures. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, Project BioShield Act of 2004. SECTION 1. SHORT TITLE. 42 USC 201 note. This Act may be cited as the ‘‘Project BioShield Act of 2004’’. SEC. 2. BIOMEDICAL COUNTERMEASURE RESEARCH AND DEVELOP- MENT—AUTHORITIES. (a) IN GENERAL.—Part B of title III of the Public Health Service Act (42 U.S.C. 243 et seq.) is amended by inserting after section 319F the following section: ‘‘SEC. 319F–1. AUTHORITY FOR USE OF CERTAIN PROCEDURES 42 USC 247d–6a. REGARDING QUALIFIED COUNTERMEASURE RESEARCH AND DEVELOPMENT ACTIVITIES. ‘‘(a) IN GENERAL.— ‘‘(1) AUTHORITY.—In conducting and supporting research and development activities regarding countermeasures under section 319F(h), the Secretary may conduct and support such activities in accordance with this section and, in consultation with the Director of the National Institutes of Health, as part of the program under section 446, if the activities concern qualified countermeasures. ‘‘(2) QUALIFIED COUNTERMEASURE.—For purposes of this section, the term ‘qualified countermeasure’ means a drug (as that term is defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
    [Show full text]
  • Can Bioshield Effectively Procure Medical
    CAN BIOSHIELD EFFECTIVELY PROCURE MEDICAL COUNTERMEASURES THAT SAFEGUARD THE NATION? HEARING BEFORE THE SUBCOMMITTEE ON EMERGING THREATS, CYBERSECURITY AND SCIENCE AND TECHNOLOGY OF THE COMMITTEE ON HOMELAND SECURITY HOUSE OF REPRESENTATIVES ONE HUNDRED TENTH CONGRESS FIRST SESSION APRIL 18, 2007 Serial No. 110–23 Printed for the use of the Committee on Homeland Security Available via the World Wide Web: http://www.gpoaccess.gov/congress/index.html U.S. GOVERNMENT PRINTING OFFICE 43–559 PDF WASHINGTON : 2009 For sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512–1800; DC area (202) 512–1800 Fax: (202) 512–2104 Mail: Stop IDCC, Washington, DC 20402–0001 VerDate Nov 24 2008 10:52 Jun 11, 2009 Jkt 000000 PO 00000 Frm 00001 Fmt 5011 Sfmt 5011 H:\DOCS\110-HRGS\110-23\43559.TXT HSEC PsN: DIANE Congress.#13 COMMITTEE ON HOMELAND SECURITY BENNIE G. THOMPSON, Mississippi, Chairman LORETTA SANCHEZ, California, PETER T. KING, New York EDWARD J. MARKEY, Massachusetts LAMAR SMITH, Texas NORMAN D. DICKS, Washington CHRISTOPHER SHAYS, Connecticut JANE HARMAN, California MARK E. SOUDER, Indiana PETER A. DEFAZIO, Oregon TOM DAVIS, Virginia NITA M. LOWEY, New York DANIEL E. LUNGREN, California ELEANOR HOLMES NORTON, District of MIKE ROGERS, Alabama Columbia BOBBY JINDAL, Louisiana ZOE LOFGREN, California DAVID G. REICHERT, Washington SHEILA JACKSON LEE, Texas MICHAEL T. MCCAUL, Texas DONNA M. CHRISTENSEN, U.S. Virgin CHARLES W. DENT, Pennsylvania Islands GINNY BROWN-WAITE, Florida BOB ETHERIDGE, North Carolina MARSHA BLACKBURN, Tennessee JAMES R. LANGEVIN, Rhode Island GUS M. BILIRAKIS, Florida HENRY CUELLAR, Texas DAVID DAVIS, Tennessee CHRISTOPHER P.
    [Show full text]