The Act clarifies the authority of different American officials, makes it easier to temporarily reassign personnel to respond to emergency situations, and alters the process for testing and producing medical countermeasures.

For example, the Assistant Secretary's office is required to develop and update annually a five-year budget plan based on medical countermeasures priorities.

The Assistant Secretary will also now be in charge the Medical Reserve Corps and the Emergency System for Advance Registration of Volunteer Health Professionals.

The Assistant Secretary is required to develop the Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan, a coordinated strategy and accompanying implementation plan for medical countermeasures to address chemical, biological, radiological, and nuclear threats.

[4] Section 105 of the Act reauthorizes through Fiscal Year 2018 a program for public health emergency readiness of the Department of Veterans Affairs (VA) medical centers.

[4] Section 202 of the Act revises and reauthorizes for Fiscal Years 2014-2018 a program of cooperative agreements to improve state and local public health security.

[4] Section 203 of the Act adds dental entities among those that may carry out education and training activities to improve responses to public health emergencies.

Likewise, the section reauthorizes for FY2014-FY2018 the Medical Reserve Corps to provide for an adequate supply of volunteers in the case of a public health emergency.

Section 203 also revises and reauthorizes appropriations for FY2014-FY2018 for a program of grants and cooperative agreements to improve surge capacity and enhance community and hospital preparedness.

This section adds poison control centers to the integrated system of public health alert communications and surveillance networks.

[4] Section 204 requires the Secretary to submit to the appropriate congressional committees a coordinated strategy and an accompanying implementation plan that demonstrates the measurable steps the Secretary will carry out to: Section 204 defines "biosurveillance" as 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.

Section 301 amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise requirements about animal testing.

The Secretary is now allowed to make a declaration that the circumstances exist justifying such an authorization and base the determination on: Section 302 outlines the Secretary's new authority to do the following: Section 303 contains official definitions for security countermeasure, qualified countermeasure and qualified pandemic or epidemic product that will be added to the Federal Food, Drug and Cosmetic Act.

The Secretary is required to: The Secretary is required to provide final guidance to industry within one year after enactment of the Act regarding the development of animal models to support approval, clearance, or licensure of countermeasures and epidemic and pandemic products when human efficacy studies are not ethical or feasible.

The Secretary must also establish a procedure by which a sponsor or applicant developing a countermeasure for which human efficacy studies are not ethical or practicable, and that has an approved investigational new drug application or investigational device exemption, may request and receive: (1) a meeting to discuss proposed animal model development activities, and (2) a meeting before initiating pivotal animal studies.

The Act authorizes the Secretary of Health and Human Services to enter into contracts and other agreements that are in the government's best interest in meeting identified security countermeasure needs, including reimbursement of the cost of advanced research and development as a reasonable, allowable, and allocable direct cost of the contract involved.

It requires the Secretary of Health and Human Services to provide a report to Congress when funds available in the SRF go below $1.5 billion.

[4] Section 402 also extends the Freedom of Information Act (FOIA) exemption for specific technical data or scientific information that is created or obtained during countermeasure and product advanced research and development under the Public Health Service Act that reveals significant and not otherwise known vulnerabilities of existing medical or public health defenses against biological, chemical, nuclear, or radiological threats.

Finally, it requires the Board to give any recommendation, finding, or report provided to the Secretary also to the appropriate congressional committees.

[5] Based on information provided by the HHS and the VA, the CBO estimates that implementing the act would cost about $11 billion over the 2014-2018 period, assuming the appropriation of the authorized amounts.

The Consolidated Appropriations Act, 2012, included funding totaling about $2 billion in fiscal year 2012 for activities similar to those that would be authorized by H.R.