H.R. 307: Bio-hazards Preparedness Act (Reauthorization)

On Tuesday, January 22, the House of Representatives passed H.R. 307, a bill that prepares for chemical, biological, radiological, and nuclear threats. It passed overwhelmingly with only the Tea Party crowd voting ‘No’. Overall, the bill cuts funding in certain areas, orders special disaster preparedness plans be created to account for children and “at-risk individuals” (it’s not clear who “at-risk individuals” are), and allows unapproved, unlicensed medical products to be sold in case of an emergency. Oh yeah, it also loosens the definition of “emergency”. The bill now moves into the Senate.

H.R. 307- PANDEMIC AND ALL-HAZARDS PREPAREDNESS REAUTHORIZATION ACT OF 2013

TITLE I—STRENGTHENING NATIONAL PREPAREDNESS AND RESPONSE FOR PUBLIC HEALTH EMERGENCIES

SEC. 102. ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE.

  • Gives 6 months for the Secretary to create a plan for responding to chemical, biological, radiological, and nuclear threats.
  • Orders an accounting of contracts and grants issued to “entities” tasked with bio-threat response (but doesn’t require that the entities be identified) who have been given more than $50,000.

SEC. 103. NATIONAL ADVISORY COMMITTEE ON CHILDREN AND DISASTERS.

  • Orders the disaster plan to specifically address the needs of children

SEC. 104. MODERNIZATION OF THE NATIONAL DISASTER MEDICAL SYSTEM.

  • Orders the disaster plan to specifically address the needs of “at-risk” individuals.
  • Changes the funding from “sums as may be necessary” to $52.7 million per year (2013-2017)

TITLE II—OPTIMIZING STATE AND LOCAL ALL-HAZARDS PREPAREDNESS AND RESPONSE

SEC. 202. IMPROVING STATE AND LOCAL PUBLIC HEALTH SECURITY.

(a) COOPERATIVE AGREEMENTS

  • Allows the government to enter contracts with “public and private stakeholders” for health emergency preparedness
  • Lowers funding from $824 million/year to $642 million/year
  • Funds can roll-over from year to year as long as certain benchmarks are achieved.

(1) EMERGENCY SYSTEM FOR ADVANCE REGISTRATION OF VOLUNTEER HEALTH PROFESSIONALS.—

  • Increases funding from $2 million/year to $5 million/year

(2) VOLUNTEERS

  • Cuts funding for training emergency response volunteers in half, from $22 million/year to $11million/year

(2) STRATEGY AND IMPLEMENTATION PLAN.

  • Gives 6 month deadline for crafting a plan to “modernize and enhance biosurveillance activities”
  • ‘‘(h) DEFINITION.—For purposes of this section the term ‘biosurveillance’ means the process of gathering near real-time biological data that relates to human and zoonotic disease activity and threats to human or animal health, in order to achieve early warning and identification of such health threats, early detection and prompt ongoing tracking of health events, and overall situational awareness of disease activity.”
  • The government wants to identify the steps necessary to achieve a “national biosurveillance system for human health, with international connectivity, where appropriate” that “creates a networked system to allow for two-way information flow between and among Federal, State, and local government public health authorities and clinical health care providers.”

TITLE III—ENHANCING MEDICAL COUNTERMEASURE REVIEW

SEC. 302. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMERGENCIES.

  • Loosens the definition of “emergency” to include “threat justifying emergency authorized use”.
  • Allows the use of an unapproved medical devices or products if declared necessary by the government.
  • Replaced the term “manufacturer of the product” with the word “person”.
  • Allows the government to waive “requirements regarding current good manufacturing practice otherwise applicable to the manufacture, processing, packing, or holding of products.”
  • Authorization can be revoked.

(b) EMERGENCY USE OF MEDICAL PRODUCTS.

  • Allows the government to extend the expiration date of medical products and “authorize the introduction or delivery for introduction into interstate commerce” if doing so protects the public health or military preparedness and effectiveness.

SEC. 304. ENHANCING MEDICAL COUNTER-MEASURE ACTIVITIES.

(c) FINAL GUIDANCE ON DEVELOPMENT OF ANIMAL MODELS.

  • Gives the government one year to tell industry what the rules are in regards to animal testing.

TITLE IV—ACCELERATING MEDICAL COUNTERMEASURE ADVANCED RE-SEARCH AND DEVELOPMENT

SEC. 401. BIOSHIELD.

  • Allows the government to enter into contracts that have government pay the cost of a company’s research and development
  • Allows $1.4 billion to be spent on private research and development costs in contracts.

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