Annual Performance Plan and Report

Topics on this page: Goal 3. Objective F | Table of Related Performance Measures | Analysis of Results | Plans for the Future | Objective Progress Update Summary

Goal 3. Objective F: Protect Americans’ health and safety during emergencies, and foster resilience to withstand and respond to emergencies

Over the past decade, our Nation has renewed its efforts to address large-scale incidents that have threatened human health, such as natural disasters, disease outbreaks, and terrorism. Working with its federal, state, local, tribal, and international partners, as well as industry in public-private partnerships, HHS has improved and exercised response capabilities and developed medical countermeasures.

Over the next few years, HHS will work to build community resilience and strengthen health and emergency response systems. In alignment with Presidential Policy Directive 8 (PPD-8) — robust systems are essential to a secure and resilient Nation with required capabilities to prevent, protect against, mitigate, respond to, and recover from the threats and hazards that pose the greatest risk. This includes strengthening the federal medical and public health response capability.

Within HHS, improving health security is a shared responsibility. ASPR serves as the Secretary’s principal advisor on matters related to bioterrorism, public health emergencies, and also coordinates interagency activities between HHS, other partners, and officials responsible for emergency preparedness and protection of the civilian population. ACF, ACL, AHRQ, ASA, ASPR, CDC, CMS, FDA, HRSA, NIH, OASH, OCR, and SAMHSA have a role in supporting emergency preparedness. The table below includes performance measures that are indicative of HHS activities to improve the health and safety of Americans during emergencies. The Office of the Secretary led this Objective’s assessment as a part of the Strategic Review.

Goal 3.F: Table of Related Performance Measures

Increase the number of new Chemical, Biological, Radiological, and Nuclear threats (CBRN) and Emerging Infectious Disease (EID) medical countermeasures (MCM) under Emergency Use Authority (EUA) or licensed (Lead Agency - ASPR; Measure ID - 2.4.13)

Influenza vaccine production (Lead Agency - FDA; Measure ID - 234101)

Increase laboratory surge capacity in the event of terrorist attack on the food supply. (Radiological and chemical samples/week). (Lead Agency - FDA; Measure ID - 214305)

Increase the percentage of public health agencies that directly receive CDC Public Health Emergency Preparedness funding that can convene within 60 minutes of notification a team of trained staff that can make decisions about appropriate response and interaction with partners. (Lead Agency - CDC; Measure ID - 13.5.3)

Analysis of Results

HHS is expanding diagnostic, preparation, response, and treatment options to deal with both natural and man-made disasters. To do this, both the FDA and ASPR are striving to have more options available to handle a crisis. For example, through the Office of Biomedical Advanced Research and Development Authority (BARDA), ASPR is working to increase the development of medical countermeasures for pandemic influenza as well as chemical, biological, radiological, and nuclear agents through public-private partnerships. The intent is to develop countermeasures, facilitate licensure of these producers, and build domestic countermeasure manufacturing capacity to address these threats. The establishment of three Centers for Innovation in Advanced Development and Manufacturing in the U.S. in 2012 has greatly impacted the nation’s ability to produce vaccine. A two-fold increase in our domestic pandemic influenza vaccine manufacturing surge capacity was realized in 2013 with the commercial scale production of H7N9 vaccines at Novartis’ cell-based vaccine manufacturing facility in North Carolina, which became a CIADM in 2012. In FY 2014, the program exceeded its target its target, producing 3 EUA and 2 licensed medical countermeasures in the CBRN area and 5 licensed products in the pandemic influenza portfolio.

In March 2013, the first human cases of the novel avian influenza strain, H7N9, were reported in China. As of January 2014, 237 cases have been identified, including 58 deaths. Although H7N9 has not yet reached the United States, scientists have indicated that this strain poses a significant threat. Fortunately, lessons learned from the 2009 H1N1 pandemic have brought about improvements in response and coordination between agencies across the Department, including ASPR/BARDA, CDC, NIH, and FDA. For example, new cell- and recombinant-based influenza vaccines, generated by the need identified in the H1N1 response, have been licensed for use. Also technology improvements in vaccine development and manufacturing have streamlined vaccine seed production, which has provided the ability to develop influenza vaccines quicker. Partnerships with private industry, such as the Centers of Innovation and for Advanced Development and Manufacturing, allowed the Department to quickly pivot and expand capacity for the development and manufacturing of H7N9 vaccines for stockpiling. BARDA has also established the Fill-Finish Network, which is intended to boost the nation’s ability to provide influenza vaccine domestically. Should large-scale distribution of a H7N9 vaccine be necessary, BARDA will be able to engage this network, which is anticipated to increase existing capacity by 20 percent.

The FDA is diversifying flu vaccine production and increasing laboratory surge capacity for testing potentially contaminated foods. The FDA seeks to ensure continued progress in preparation for new influenza strains, to strengthen vaccine safety monitoring, and to advance the detection of possible adverse events of new licensed vaccines through the use of large population databases. As a result, the FDA achieved its FY 2014 target to develop, evaluate, and standardize new methods to produce high-yield influenza vaccine reference strains. Activities to meet this target include the following: FDA continued evaluation and standardization of multiple assays; FDA included a new technology, Virus Counter platform, to quantify the virus particles in the virus preparation; and FDA developed a H7N9 influenza vaccine candidate virus. Also, in the event of a terrorist attack on the food supply, the FDA seeks to increase its ability to rapidly test large numbers of samples of potentially contaminated foods through a focus of laboratory capacity, achieving its target every year since 2010.

The CDC is helping public health agencies rapidly convene key management staff (within 60 minutes of being notified of an emergency) so that they can integrate information, prioritize resources, and effectively coordinate with key response partners. Since FY 2009, the CDC’s 62 grantees (which include states, territories and four major metropolitan U.S. cities) that successfully convened key staff within 60 minutes of notification increased from 68 percent to 98 percent in FY 2013, exceeding the target. CDC will continue to work with grantees to improve results and achieve future targets.

Plans for the Future

For FY 2015, ASPR plans to continue manage the procurement and advanced development of medical countermeasures for chemical, biological, radiological, and nuclear agents (referred to as CBRN); Project BioShield procurements; and the advanced development and procurement of medical countermeasures for pandemic influenza and other emerging infectious diseases, with acquisitions to meet the requirements.

The FDA is planning to maintain laboratory surge capacity for potentially contaminated foods in FY 2015 to perform analysis on at least 2,500 radiological samples and 2,100 chemical samples per week. This effort will have public health value even in non-deliberate food contamination situations because contaminated food products will be identified and removed from the marketplace more quickly. The FDA will also continue to evaluate new methods to produce high-yield influenza vaccine reference strains, to build capacity to respond to seasonal influenza and potential pandemics.

The CDC will work to increase the percentage of public health agencies that can assemble, make key decisions, and quickly respond during an emergency. Because many emergencies provide little to no notice but still require a rapid response, the CDC will continue focusing on improving the percentage of grantees who can convene key staff within 60 minutes of notification, maintaining a goal of 95 percent in FY 2014 - 2016.

Objective Progress Update Summary

The U.S. Department of Health and Human Services, in consultation with the Office of Management and Budget, has determined that performance toward this objective is making noteworthy progress. This progress is demonstrated by the representative performance measures associated with this objective and described in the HHS Annual Performance Plan and Report. Further evidence of progress is described below.

• With the help of the Assistant Secretary for Preparedness and Response’s (ASPR) Biomedical Advanced Research and Development Authority (BARDA) and Project BioShield, our nation has acquired 12 medical countermeasures (MCM) against chemical, biological, radiological, and nuclear (CBRN) threats; pandemic influenza; and emerging infectious diseases. Almost half of these MCMs have a “peacetime” public health use. In addition, when a worrisome new avian influenza strain (H7N9) emerged in China last year, ASPR and its HHS partners supported rapid research, development, and stockpiling of vaccine should the strain ever reach the United States.
• In November 2013, the Food and Drug Administration approved the first adjuvanted vaccine for the prevention of H5N1 influenza, commonly known as avian or bird flu, which has been included within the Strategic National Stockpile for distribution by public health officials as needed.
• In response to the Elk River methylcyclohexanemethanol (MCHM) chemical release in January 2014, West Virginia’s Laboratory Response Network C Level-2 laboratory tested 581 drinking water samples in 30 days, mobilized its public health incident management system, and provided CDC Public Health Emergency Preparedness-funded epidemiology support to enhance public health security for West Virginia residents.
• HRSA, through its Office of Emergency Preparedness and Continuity of Operations and Bureaus/Offices, provided situational awareness and operational status information to federal and other entities related to the following: drought in the Midwest, tornado in Moore, OK, Hurricane Sandy, CDC influenza and immunizations alerts, and the Charleston, WV chemical release.

The Department is continuing to support and execute the programs contributing to this objective, monitoring progress, performance, and program integrity while adjusting to any budgetary constraints or changes to programmatic demands. HHS evaluated the performance of this objective prior to recent notable events involving global health response (such as Ebola) and will reassess this objective as part of the next Strategic Review cycle.  At that time subsequent performance will be taken into account and the performance rating will be reconsidered.