|Date||January 22, 2013 (113th Congress, 1st Session)|
|Staff Contact||Ed Bedard|
On January 22, 2013 the House is scheduled to consider H.R. 307, The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, under a suspension of the rules requiring a two-thirds majority for approval. The bill was introduced on January 18, 2013 by Rep. Mike Rogers (MI) and referred to the Committee on Energy & Commerce and the Committee on Veterans Affairs for a time to be determined by the Speaker.
The legislation would facilitate the development of chemical, biological, radioactive, and nuclear (CBRN) medical countermeasures (MCMs) and bolster the nation's public health preparedness infrastructure so the Nation can better respond to public health emergencies and disasters, including those caused by CBRN attack. Also, the bill amends the Public Health Service Act to authorize funding for certain activities carried out by various agencies and offices within the Department of Health and Human Services (HHS) that would support the readiness of the public health system to address public health and medical emergencies.
TITLE I – Strengthening National Preparedness and Response for Public Health Emergencies
Sec. 101. National Health Security Strategy – This section would amend the National Health Security Strategy to include dental care in the goals for medical preparedness. It would also direct the Secretary of the Department of Health & Human Services (HHS) to improve public health emergency preparedness, response, outreach and communication with respect to at-risk individuals, including those with disabilities.
Sec. 102. Assistant Secretary for Preparedness and Response – This section clarifies that the Assistant Secretary for Preparedness and Response (ASPR) has lead policy and coordination responsibilities within HHS with respect to emergency preparedness and response. To this end, H.R. 307 would require the ASPR to take certain actions to increase oversight and improve efficiency of the entire MCM enterprise.
Sec. 103. National Advisory Committee on Children and Disasters – This section would establish a committee to carry on the work previously done by the Children’s HHS Interagency Leadership on Disasters (CHILD) Working Group and the National Commission on Children and Disasters to improve our nation’s ability to care for children in the midst of and affected by disasters.
Sec. 104. Modernization of the National Disaster Medical System – This section reauthorizes the National Disaster Medical System (NDMS), which assists in managing the federal government’s medical response to major emergencies and disasters. The section authorizes $52 million for each FY 2013 – 2017, the same level as was appropriated to the program in FY 2012. This section also directs the Secretary to ensure that the needs of at-risk individuals are taken into account in the NDMS.
Sec. 105. Continuing the Role of the Department of Veterans Affairs – This section of the bill would improve the readiness of Veterans Affairs medical centers and research facilities with respect to a CBRN attack. It would reauthorize $155.3 million for each FY 2013-2017, which is the FY 2012 appropriated level.
TITLE II – Optimizing State and Local All-Hazards Preparedness and Response
Sec. 201. Temporary Redeployment of Federally Funded Personnel During a Public Health Emergency – This section would allow the Secretary, only upon request by a Governor or tribal Chief and only in the event of a public health emergency, to authorize the redeployment of non-Federal employees who are funded in part or in whole through programs reauthorized by this act. This would allow state and tribal agencies to respond more effectively and efficiently to public health emergencies, rather than having to hire new workers. This provision would sunset in five years and calls for a study in four years to determine the effectiveness of this provision in regards to emergency response and saving taxpayer money.
Sec. 202. Improving State and Local Public Health Security – This section would reauthorize the Public Health Emergency Preparedness Cooperative Agreement (PHEP) program administered by the Centers for Disease Control and Prevention. These grants have been critical to improving the ability of public health departments across the country to respond to many public health hazards. The bill would authorize the program at $641.9 million for each FY 2013 – 2017. This level of funding is equal to the program’s FY 2012 appropriated level.
This section would also reauthorize the vaccine tracking and distribution program used during an influenza pandemic. The bill would authorize the program at $30.8 million for each of FY 2013-2017. This level of funding is equal to the program’s FY 2012 appropriated level.
Sec. 203. Hospital Preparedness and Medical Surge Capacity – This section would reauthorize two key programs aimed at training and equipping volunteers to be prepared in the event of a public health emergency: the Medical Reserve Crops (MRC) and the Emergency System for Advance Registration of Volunteer Health Professionals (ESAR-VHP). The section reauthorizes the MRC at $11.2 million and the ESAR-VHP at $5 million for FY 2013 – 2017, both of which are equal to the programs’ respective FY 2012 appropriations.
This section also would reauthorize the Hospital Preparedness Program (HPP). The grants given by the HPP program help state and local governments improve their emergency preparedness and medical surge capacity. The bill would require the Secretary to implement evidence-based metrics to ensure that those receiving awards meet the goals of the National Health Security Strategy.
Lastly, this section would incorporate dentists into the all-hazards public health and medical response curricula and training.
Sec. 204. Enhancing Situational Awareness and Biosurveillance – This section would reauthorize the federal, state and local surveillance and situational awareness capacity program and would make poison control centers to be eligible. The bill would authorize $138.3 million for each of FY 2013 – 2017. This is equal to the program’s FY 2012 appropriated funding.
Sec. 205. Eliminating Duplicative Project BioShield Reports – This section would repeal a report included in the Project BioShield Act of 2004 that is duplicative of parts of the Strategy and Implementation Plan referenced in Section 102.
TITLE III – Enhancing Medical Countermeasure Review
Sec. 301. Special Protocol Assessment – This section would increase regulatory predictability for MCM sponsors by expanding the use of Special Protocol Assessments to animal trials and any associated clinical trials necessary to support licensure of MCMs.
Sec. 302. Authorization for Medical Products for Use in Emergencies – This section would amend the Food and Drug Administration’s (FDA) current Emergency Use Authorization authority to enable the FDA to prepare for and prevent a public health emergency rather than simply responding to it.
To improve our nation’s response to emergencies, this section would also authorize the FDA to do the following: (1) extend the expiration date for MCMs intended to be used for emergency responses; (2) grant waivers of current Good Manufacturing Practices; (3) authorize emergency dispensing of MCMs during an actual emergency without an individual prescription if permitted under State law or permitted by an order of the HHS Secretary; (4) work with other HHS agencies to create and issue emergency use instructions concerning a product’s conditions of use; and (5) authorize FDA to waive a product’s Risk Evaluation and Mitigation Strategy if necessary.
Sec. 303. Definitions - This section would define security countermeasure, qualified countermeasure and qualified pandemic or epidemic product in the Federal Food, Drug and Cosmetic Act.
Sec. 304. Enhancing Medical Countermeasure Activities – This section includes provisions that would provide greater predictability and certainty for MCM sponsors by increasing FDA’s interaction with sponsors and requiring FDA to provide additional clarity around the requirements of the approval, clearance and licensure processes for MCMs.
Sec. 305. Regulatory Management Plans – This section would require FDA to establish a process for frequent scientific feedback and interaction with those sponsors who’s MCMs have been procured through the Special Reserve Fund (SRF) in order to facilitate the approval, clearance and licensure of the MCMs. Under the section, FDA also would have the authority to apply this process to MCMs that are not security countermeasures.
Sec. 306. Report – This section would require FDA to annually report on MCM development and review activities starting six months after the enactment of the bill.
Sec. 307. Pediatric Medical Countermeasures – This section would make improvements to current law in order to better address the needs of children in MCM development.
TITLE IV – Accelerating Medical Countermeasure Advanced Research and Development
Sec. 401. BioShield – This section would reauthorize the Project BioShield Special Reserve Fund (SRF), originally established in 2004. It would reauthorize the SRF at $2.8 billion for FY 2014 – 2018, which is consistent with the original appropriation of $5.6 billion over FY 2004 – 2013.
In addition to reauthorization, this section would also prohibit SRF funds from being used for anything other MCM procurement, research and development. It would require the HHS Secretary to provide a report to Congress when funds available in the SRF go below $1.5 billion. It would also allow the use of up to 50 percent of funds available in the SRF for advanced research and development of medical countermeasures at the Biomedical Advanced Research and Development Authority (BARDA), which would supplement, no supplant, BARDA funding through annual appropriations.
Sec. 402. Biomedical Advanced Research and Development Authority – This section would reauthorize BARDA, which was created in 2006 to help bridge the gap between MCM development and procurement. It would reauthorize BARDA at $415 million for FY 2013 – 2017, which is equal to the program’s FY 2012 appropriated level. The section also would extend limited anti-trust exemptions for meetings regarding MCM development that include national security information.
Sec. 403. Strategic National Stockpile – This section would reauthorize the nation’s Strategic National Stockpile at $533.8 million for FY 2013 – 2017, which is the FY 2012 appropriated level.
Sec. 404. National Biodefense Science Board - This section would add pediatric and state/local expertise to the National Biodefense Science Board.
According to the House Committee on Energy and Commerce, shortly after September 11th, Congress acted to prepare for CBRN (Chemical, Biological, Radiological & Nuclear) attacks by fostering the development and procurement of CBRN medical countermeasures (MCMs). To this end, Congress enacted two pieces of legislation: the Project BioShield Act of 2004, and the Pandemic and All-Hazards Preparedness Act of 2006 (PAHPA). Project BioShield provided secure funding to fund the development and purchase of MCMs. PAHPA created a new position within HHS, the Assistant Secretary for Preparedness and Response, who would lead the Federal government’s preparations and response to CBRN attacks.
H.R. 307 would reauthorize and improve upon Project BioShield and PAHPA in order to increase certainty and predictability, clarify the role of the Assistant Secretary for Preparedness and Response (ASPR) and strengthen our nation’s preparedness infrastructure.
The House passed similar legislation in the 112th Congress: H.R. 2405 on December 6, 2011 by voice vote and H.R. 6672 on December 17, 2012 by a recorded vote 383 - 16 (Roll no. 633). For more information, please read the Legislative Digest for H.R. 6672 here.
There is currently no CBO score for this legislation. However, this bill creates no new programs. CBO’s cost estimate for H.R. 2405 states: “CBO estimates that implementing the bill would cost $395 million in 2012 and $7.9 billion over the 2012-2016 period, assuming the appropriation of the authorized amounts. The funding authorized by H.R. 2405 is similar to the appropriation amounts enacted in recent years for the same activities. Pay-as-you-go procedures do not apply to this legislation because it would not affect direct spending or revenues.”