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HomeU.S. FDA Guidance › Bioterrorism Act

Public Health Security and Bioterrorism Preparedness and Response Act

Title I - National Preparedness for Bioterrorism and Other Public Health Emergencies
  • Subtitle A: National Preparedness and Response Planning, Coordinating, and Reporting

  • Sec. 101. National preparedness and response
    Sec. 102. Assistant Secretary for Public Health Emergency Prepareness; National Disaster Medical System
    Sec. 103. Improving ability of Centers for Disease Control and Prevention
    Sec. 104. Advisory committees and communications; study regarding communications abilities of public health agencies
    Sec. 105. Education of health care personnel; training regarding pediatric issues
    Sec. 106. Grants regarding shortages of certain health professionals
    Sec. 107. Emergency system for advance registration of health professions volunteers
    Sec. 108. Working group
    Sec. 109. Antimicrobial resistance
    Sec. 110. Supplies and services in lieu of award funds
    Sec. 111. Additional amendments

  • Subtitle B: Strategic National Stockpile; Development of Priority Countermeasures

  • Sec. 121. Strategic national stockpile
    Sec. 122. Accelerated approval of priority countermeasures
    Sec. 123. Issuance of rule on animal trials
    Sec. 124. Security for countermeasure development and production
    Sec. 125. Accelerated countermeasure research and development
    Sec. 126. Evaluation of new and emerging technologies regarding bioterrorist attack and other public health emergencies
    Sec. 127. Potassium iodide

  • Subtitle C: Improving State, Local, and Hospital Preparedness for and Response to Bioterrorism and Other Public Health Emergencies

  • Sec. 131. Grants to improve State, local, and hospital preparedness for and response to bioterrorism and other public health emergencies

  • Subtitle D: Emergenciy Authorities; Additional Provisions

  • Sec. 141. Reporting deadlines
    Sec. 142. Streamlining and clarifying communicable disease quarantine provisions
    Sec. 143. Emergency waiver of Medicare, Medicaid, and SCHIP requirements
    Sec. 144. Provision for expiration of public health emergencies

  • Subtitle E: Additional Provisions

  • Sec. 151. Designated State public emergency announcement plan
    Sec. 152. Expanded research by Secretary of Energy
    Sec. 153. Expanded research on worker health and safety
    Sec. 154. Enhancement of emergency preparedness of Department of Veterans Affairs
    Sec. 155. Reauthorization of existing program
    Sec. 156. Sense of Congress
    Sec. 157. General Accounting Office report
    Sec. 158. Certain awards
    Sec. 159. Public access defibrillaton programs and public access defibrillation demonstration projects

Title II - Enhancing Controls on Dangerous Biological Agents and Toxins
  • Subtitle A: Department of Health and Human Services

  • Sec. 201. Regulation of certain biological agents and toxins
    Sec. 202. Implementation by Department of Health and Human Services
    Sec. 203. Effective dates
    Sec. 204. Conforming amendment

  • Subtitle B: Department of Agriculture

  • Sec. 211. Short title
    Sec. 212. Regulation of certain biological agents and toxins
    Sec. 213. Impementation by Department of Agriculture

  • Subtitle C: Interagency Coordination Regarding Overlap Agents and Toxins

  • Sec. 221. Interagency coordination

  • Subtitle D: Criminal Penalties Regarding Certain Biological Agents and Toxins

  • Sec. 231. Criminal penalties

Title III - Protecting Safety and Security of Food and Drug Supply
  • Subtitle A: Protection of Food Supply

  • Sec. 301. Food safety and security strategy
    Sec. 302. Protection against adulteration of food
    Sec. 303. Administrative detention
    Sec. 304. Debarment for repeated or serious food import violations
    Sec. 305. Registration of food facilities
    Sec. 306. Maintenance and inspection of records for foods
    Sec. 307. Prior notice of imported food shipments
    Sec. 308. Authority to mark articles refused admission into United States
    Sec. 309. Prohibition against port shopping
    Sec. 310. Notices to States regarding import food
    Sec. 311. Grants to States for inspections
    Sec. 312. Surveillance and information grants and authorities
    Sec. 313. Surveillance of zoonotic diseases
    Sec. 314. Authority to commiccion other Federal officials to conduct inspections
    Sec. 315. Rule of construction

  • Subtitle B: Protection of Drug Supply

  • Sec. 321. Annual registration of foreign manufacturers; shipping information, drug and device listing
    Sec. 322. Requirement of additional information regarding import components intended for use in export products

  • Subtitle C: General Provisions Relating to Upgrade of Agricultural Security

  • Sec. 331. Expansion of Animal and Plant Health Inspection Service activities
    Sec. 332. Expansion of Food Safety Inspection Service activities
    Sec. 333. Biosecurity upgrades at the Department of Agriculture
    Sec. 334. Agricultural biosecrity
    Sec. 335. Agricultural bioterrorism research and development
    Sec. 336. Animal enterprise terrorism penalties
Title IV - Drinking Water Security and Safety
  • Sec. 401. Terrorist and other intentional acts
  • Sec. 402. Other Safe Drinking Water Act amendments
  • Sec. 403. Miscellaneous and technical amendments
Title V - Additional Provisions
  • Subtitle A: Prescription Drug User Fees

  • Sec. 501. Short title
    Sec. 502. Findings
    Sec. 503. Definitions
    Sec. 504. Authority to assess and use drug fees
    Sec. 505. Accountability and reports
    Sec. 506. Reports of postmarking studies
    Sec. 507. Savings clause
    Sec. 508. Effective date
    Sec. 509. Sunset clause

  • Subtitle B: Funding Provisions Regarding Food and Drug Administration

  • Sec. 521. Office of Drug Safety
    Sec. 522. Division of Drug Marketing, Advertising, and Communications
    Sec. 523. Office of Generic Drugs

  • Subtitle C: Additional Provisions

  • Sec. 531. Transition to digital television
    Sec. 532. 3-year delay in lock in procedures for Medicare+Choice plans; change in Medicare+Choice reporting deadlines and annual, coordinated election period for 2003, 2004, and 2005


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