U.S. Government Documents
on Countermeasure Development

This is our working compendium of biosecurity-related U.S. government documents in the public domain. To recommend a government document for inclusion, please email the Webmaster.

Department of Defense

• 2008 Chemical and Biological Defense Program Annual Report to Congress (2008)
• Joint Service Chemical and Biological Defense Program FY08–09 Overview (2007)
• 2007 Chemical and Biological Defense Program Annual Report to Congress (2007)
• Report on Activities and Programs for Countering Proliferation and NBC Terrorism Volume I Executive Summary (2007)
• 2007 Transformational Medical Technologies Initiative Report to Congress (2007)
• 2006 Chemical and Biological Defense Program Annual Report to Congress (2006)
• Joint Service Chemical & Biological Defense Program Overview (2006)
  

Department of Health and Human Services

• Guidance on Allocating and Targeting Pandemic Influenza Vaccine (2008)
• Project BioShield Annual Report to Congress: August 2006 - July 2007 (2008)
• Pandemic and All-Hazards Preparedness Act Progress Report (2007)
• Draft BARDA Strategic Plan for Medical Countermeasure Research, Development, and Procurement (2007)
• HHS PHEMCE Implementation Plan for Chemical, Biological, Radiological And Nuclear Threats (2007)
• HHS PHEMCE Strategy (2007)
• Project BioShield Annual Report to Congress: July 2004 through July 2006 (2006)

Food and Drug Administration

• Draft Guidance for Industry and FDA Staff: Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses (2008)
• FDA Science and Mission at Risk (2007)
• Guidance Emergency Use Authorization of Medical Products (2007) (external link)
• Guidance for Industry Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention (2007)
• Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines (2007)
• In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path - Guidance for Industry and FDA Staff (2007)
• Reagents for Detection of Specific Novel Influenza A Viruses: Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document (2006)
• Guidance for Industry, Investigators, and Reviewers Exploratory IND Studies (2005)
• Guidance for Industry, Vaccinia Virus — Developing Drugs to Mitigate Complications from Smallpox Vaccination (2004)
• 21 CFR Parts 314 and 601 [Docket No. 98N–0237] RIN 0910–AC05, New Drug and Biological Drug Products; Evidence (2002)
• Guidance for Industry, Inhalational Anthrax (Post Exposure) - Developing Antimicrobial Drugs (2002)

National Institutes of Health/National Institute for Allergy and Infectious Diseases (NIAID)

• The Jordan Report: Accelerated Development of Vaccines (2007)
• NIAID Strategic Plan for Biodefense Research 2007 Update (2007)
• NIAID Biodefense Research Agenda for CDC Category A Agents, 2006 Progress Report (2006)
• NIAID Biodefense Research Agenda for CDC Category A Agents, 2006 Progress Report - Overview and Stories of Discovery (2006)
• NIAID Biodefense Research Agenda for Category B and C Priority Pathogens, Progress Report, June 2004 (2004)
• NIAID Biodefense Research Agenda for Category B and C Priority Pathogens – January 2003 (2003)
• NIAID Biodefense Research Agenda for CDC Category A Agents, Progress Report, August 2003 (2003)
• NIAID Biodefense Research Agenda for CDC Category A Agents – February 2002 (2002)

Government Accountability Office (formerly General Accounting Office)

• Project Bioshield: Actions Needed to Avoid Repeating Past Problems with Procuring New Anthrax Vaccine and Managing the Stockpile of Licensed Vaccine (2007)
• Homeland Security: New Department Could Improve Biomedical R&D Coordination but May Disrupt Dual-Purpose Efforts (2002)
• Anthrax Vaccine: Changes to the Manufacturing Process (2001)
• Anthrax Vaccine: GAO's Survey of Guard and Reserve Pilots and Aircrew (2000)

The White House

• White House FY 2009 Budget Amendment (2008)
• Homeland Security Presidential Directive/HSPD-18 - National Strategy for Medical Countermeasures against Weapons of Mass Destruction (2007) (external link)
• Homeland Security Presidential Directive/HSPD-10 - Biodefense for the 21st Century (2004)

Other

• U.S. Policy Regarding Pandemic Influenza Vaccine (2008)