FDA’s Center for Drug Evaluation and Research Initiatives – Clinical Outcome Assessment Compendium (Pilot version)
Capturing outcomes that are important to patients in clinical trials is a high priority for FDA. The pilot COA Compendium is part of FDA's efforts to foster patient-focused drug development. The COA Compendium is intended to facilitate communication and to provide clarity and transparency to drug developers and the research community by collating and summarizing clinical outcome assessment information for many different diseases and conditions into a single resource. It can be used as a starting point when considering how certain clinical outcome assessments might be utilized in clinical trials and will likely be most informative in early drug development. The public is referred to the following FDA Web sites for additional background information: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM459231.htm and http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM481225.pdf
The COA Compendium has been under development since 2013. Its pilot version was released for public comments on January 14, 2016, and we anticipate continued development work in the next few years. The Compendium is intended to be a living document on the FDA website.
FDA Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA) Program
CDER SBIA’s mission is to engage with small pharmaceutical business and industry by providing timely and accurate information on human drug development and regulation.
Our vision is to ensure that every industry representative can always find the resources they need, allowing for a clear and efficient development process.
CDER SBIA employs several ongoing avenues through which it accomplishes its goals:
Direct Communication Services:
- Dedicated telephone numbers and an email address available for industry, and responds to thousands of emails and phone calls every year.
- CDER SBIA Chronicles, an electronic newsletter, which highlights a specific regulatory issue every other month.
- CDER Small Business and Industry Education Series, web-based learning tutorials as part of a larger platform, CDERLearn, which contains educational tutorials offered by all of CDER.
- CDER Small Business and Industry Assistance LinkedIn Showcase Page, a niche, dedicated page that allows the Agency to provide specific audiences/stakeholders with targeted information.
- Conferences: CDER SBIA hosts several conferences each year, including spring and fall Regulatory Education for Industry (REdI)) conferences (in collaboration with the Center for Devices and Radiological Health), and topic-specific REdI Conferences. Many of these conferences are available for attendance in-person or virtually. Conference presentations are publically available online post event. These events provide open Q&A sessions.
- Exhibits and Presentations: SBIA staff exhibit and speak at several conferences throughout the year.
- Small Biz Buzz, regular email updates to educate industry on new regulations, guidances, and meetings.
- Webinars, including frequent and timely webinars on various topics of interest to industry; highlights on recent regulation, initiatives and guidances. These events provide open Q&A sessions.
- Webpage: Web entry platform customized to the needs of small pharmaceutical entities. The website [www.fda.gov/cdersbia] contains a wealth of information regarding development and other considerations for marketing drug products.
FDA Modernizing Pharmaceutical Manufacturing to Ensure a Safe and Reliable Drug Supply Chain
This initiative facilitates the incorporation of new and emerging manufacturing technology into the pharmaceutical industry to increase the reliability and quality of medications available in the U.S.
Shortages of medications and drug recalls pose a risk to public health by reducing the access to critical treatments, and the FDA determined that an unacceptably large number of shortages are due to flaws in the manufacturing process, leading to poor quality medications. Unfortunately, current production methods often have been in place, largely unchanged, for many decades. Thus, achieving a safe and reliable drug supply chain will demand technical advances in pharmaceutical manufacturing.
In 2014, the Agency created the Emerging Technology Team (ETT) to engage with the pharmaceutical industry and to support the adoption and use of novel and emerging technologies in pharmaceutical development and manufacturing. It is clear that innovative manufacturing technologies (e.g., new dosage forms, new manufacturing processes, or new testing methods) have great potential to increase the efficiency, agility and reliability in the pharmaceutical manufacturing sector. ETT makes every effort to ensure that many companies have the opportunity to participate, and that a wide variety of novel manufacturing technologies are considered.
The Emerging Technology Program takes an innovative, collaborative approach to engagement on the topic, both internally and externally. ETT members are drawn from across FDA and bring a wealth of technical expertise, regulatory insight, and institutional knowledge and experience to the group. Industry participants in the program work with ETT early in the technology development process, discussing progress and challenges and addressing technical and regulatory concerns in advance of submitting drug applications for FDA’s evaluation. Industry partners benefit from the program by drawing upon FDA expertise and by resolving many questions prior before an application is submitted, FDA benefits by learning about new technologies before they first appear in applications for review and inspection, and the public benefits from greater access to high-quality medications.
Recently, ETT issued a formal Draft Guidance for Industry to increase awareness of the project. This augments information about the group in press accounts, in proceedings from technical workshops, in the peer-reviewed literature, and in the Report to the President Accelerating U.S. Advanced Manufacturing from the President’s Council of Advisors on Science and Technology.
Finally, recognizing that pharmaceutical production and sales occur around the globe, ETT will be sharing the lessons learned at FDA with its sister regulatory agencies in other countries. Collaborations and conversations with European and Asian regulators “spread the word” about the activity and its benefits to industry, regulators, and the public. FDA Emerging Technology Program will be both a catalyst for advancement in production methods today and a stabilizing force for the pharmaceutical market in the future.
FDA Center for Food Safety and Applied Nutrition – Genome Trakr Network
One of the most significant challenges associated with foodborne disease outbreak investigation has been a lack of ability to rapidly identify the source of a contamination event and rapidly eliminate it from the food supply. Despite the best efforts of food safety experts, tools available for tracking and tracing foodborne outbreaks were simply too slow and insufficiently resolved to effectively pinpoint the source of an outbreak, resulting in weeks of effort, and in many cases, preventing identification of its cause. Now, whole genome sequencing (WGS) is being used to distinguish relationships among bacterial pathogens with sufficient certainty that to potentially identify sources of bacterial contamination of the food supply down to the farm level. FDA spearheaded the development of the GenomeTrakr, a sustainable network of public health laboratories using WGS to investigate foodborne illness outbreaks and attribute illnesses to specific food products, processing or farming practices, or geographic regions.
The program is changing the way that foodborne illnesses are investigated, allowing authorities to investigate small illness clusters before there is a chance to sicken large numbers of people. The network is linked by a common, publicly accessible database that uses a common sequencing platform, with common laboratory and quality control procedures, common on-board training and a common metadata (sample information) standard. Since its inception in 2012, the network now includes 12 federal, 16 state and 9 international laboratories. Federal partners collaborating with FDA on Genome Trakr include CDC, USDA, and NIH. Leveraging NIH\NCBI’s IT and bioinformatic resources for analysis and data storage allows FDA to focus its efforts on a rapid expansion of WGS capacity to collaborating state laboratories. The network has built a database of over 47,000 and 10,000 Salmonella and Listeria monocytogenes genomes, respectively, from real time surveillance and historical collections. This database has supported multiple foodborne illness outbreak investigations and is fundamentally changing the way that outbreak investigations are conducted and will be in 21 – 24 state laboratories in fiscal year 2019.
FDA-iRISK®– Increasing Capacity and Collaborations
FDA-iRISK® is a web-based system for modeling food-safety risks and solutions. It is freely available to anyone in the world and currently has more than 2,800 registered users from 141 countries/regions and is used in every continent. The system has been developed to encourage collaboration and sharing, with built-in abilities to share developed modules or entire models with the whole community or with selected partners. FDA has developed and continues to develop a rich repository of food safety models and modules for everyone to use or adapt. The food safety risk assessment modeling system, its features, and its extensive documentation were designed to allow for complete transparency with regard to data, methods, and results generated from any model developed. FDA-iRISK was a finalist in round 6 of the HHSinnovates program and has been granted a registered trademark.
FDA-iRISK mathematically simulates risk scenarios and interventions, using many automated features that reduce the time and labor-intensive process needed for food-safety risk assessment. Government, industry, and others can use the resulting predictions to inform decisions about food-safety priorities and policies. FDA-iRISK also provides a much-needed international, Web-based platform for sharing and collecting information about risks and interventions in the global food supply. This easily accessed tool is available to anyone for free, including entities in countries that export food to the United States.
A peer-reviewed tool with many built-in features and mathematical equations, FDA-iRISK enables users to enter data that represent their respective food-safety issues and to modify those scenarios, to predict the impact that changes to various points in the production chain for a given food will have on foodborne illness. It enables users to predict and compare, not only the number but also the severity (measured in disability-adjusted life years – “DALYs”) of cases of illnesses associated with various food-and-contaminant combinations and scenarios.
Since the initial launch of FDA-iRISK in 2012, FDA has continued to expand the tools capacity. FDA-iRISK 2.0 was made public on FoodRisk.org in March 2015 (http://foodrisk.org/exclusives/fda-irisk-a-comparative-risk-assessment-tool/). FDA is developing new scenarios to examine a variety of food safety questions and to estimate total dietary risk burden of contaminants. FDA is also collaboratively working with industry, the private sector, other U. S. government agencies, and international regulatory bodies to advance these and other kinds of predictive capabilities in FDA-iRISK.
Over the next two years, FDA will make available additional features that increase the capacity and collaboration abilities of the risk assessment modeling system, including expanded sharing capacity and features to model cross-contamination, accommodate microbial toxins, and quantitatively evaluate uncertainty. FDA will reach out to industry, academic, government, and international partners to adapt the model interface to better link to relevant existing software tools to simultaneously expand the capacity of the risk assessment modeling system as well as the system’s accessibility to food safety scientists. Also during this period, FDA, working partners in industry, academia, and government agencies around the world, will develop a framework for sustaining and expanding FDA-iRISK in the future, ensuring it continues to reflect state-of-the-art methods and approaches used in food safety quantitative risk assessment.
FDA Center for Tobacco Products Exchange Lab
The Exchange Lab offers free, open and easy access to FDA-created science-based tobacco education content that any organization can place on its website or social media channel to amplify prevention messaging and expand reach to important audiences. The Exchange Lab includes more than 100 content items focused on public health education, tobacco research, retailer information, and tobacco regulations and compliance, with more content added regularly. This information is available in a variety of media formats—including interactive widgets, text with related images, infographics, videos and tweets—all of which can be added to new or existing websites in three quick and easy steps. Material used from the Exchange Lab is automatically updated to ensure that websites always display the most current tobacco regulatory and scientific information.
Office of Partnerships Contracts and Grants File Retrieval and Evaluation Database (F.R.E.D.)
Launched in 2015, F.R.E.D .is a custom-built software application, utilizing Microsoft Access, to create a unified platform capable of tracking in great detail the various aspects of the Office of Partnerships multi-million dollar contracts, grants, and cooperative agreements. This resource will provide a one-stop shop for data storage, standardization, and aggregation regarding a funding vehicle’s specifications, invoices, reports, reporting due dates, and contact information. The F.R.E.D .has also been designed to be scalable. It is capable of adding future programs and reports when needed for particular datasets. This initiative will increase the efficiency in answering data calls and inquiries, as well as provide for improved accuracy in financial analytics.
FDA Scientific Research Impact Initiative
The Scientific Research Impact initiative opens broad new vistas of transparency, participation, and collaboration to the public. The initiative, aligned with HHS public access policy to publications developed from federally-sponsored research programs, establishes for the first time, central management of ORA lab efforts to (1) conduct mission-supportive research; (2) publish/showcase scientific work through professional channels (including peer-reviewed journals and abstracts/posters presented at scientific conferences/meetings); and (3) form public private partnerships (PPP) as well as to establish collaborative training programs designed to educate other regulators on ORA’s regulatory standards. This initiative demonstrates both transparency and participation/collaboration while 1) advancing regulatory science, 2) broadening dissemination of scientific knowledge, 3) informing regulatory decision-making, 4) catalyzing action, and 5) advancing public health. One specific goal of the overarching initiative is to publish ORA scientific/regulatory method papers on FDA’s website to facilitate public access to them. Creation of website links to scientific papers will start in FY2016 and is targeted for completion by the end of FY2018 (Q4). Other key major milestones and anticipated completion dates include FY2017 Q2 posting on FDA’s public- facing web site followed by quarterly updates thru FY2018.
FDA Office of Regulatory Affairs Ombudsman
The position of ORA Ombudsman was created in October 2015. The primary purposes of the position are to: (1) informally and in an unbiased manner, find solutions, when possible, to problems that arise with external partners, including industry, other government agencies, and consumers; and (2) improve communication between ORA employees and stakeholders through outreach and education, helping both sides become more aware of the other’s needs.
FDA Egg Safety Regulatory Program Standards Development
This three-year cooperative agreement is intended to fund the self-assessment of state egg regulatory programs, provide recommendations for national egg regulatory program standards for state programs to adopt, and share egg inspection data and program information between FDA and grantees. The goal of this cooperative agreement program is to facilitate long-term improvements to the national food safety system by strengthening interagency collaboration, improving states' regulatory and surveillance protection programs for eggs, and developing national egg regulatory program standards for states. Under this cooperative agreement, state agencies will make recommendations to establish national egg regulatory program standards for States to adopt. In addition, effective strategies for FDA and the states to share egg inspection data will be identified. Funds will be used to conduct egg program self-assessment, review state/federal laws and regulations pertaining to eggs, and identify or create an electronic system to facilitate sharing of egg inspection information. An ultimate objective of this initiative is to enhance the capacity of egg safety regulatory entities to take appropriate action to protect the public health.
FDA Office of Regulatory Affairs (ORA) Partnership Agreement Initiative
FDA’s ORA has used partnerships as a means of strengthening existing relationships with state agencies. A Partnership Agreement is a formal written document between the FDA and the partner organization, which clearly defines each partner’s activities and responsibilities for accomplishing a specific program objective. Partnership Agreements also produce measurable outcomes related to programmatic objectives and/or operational needs. Over the past two years, ORA’s Office of Partnerships (OP) has revamped the partnership agreement process to ensure partners involved are meeting the goal of maximizing the available resources in the most efficient and effective manner consistent with achieving a high level of consumer protection. Following the development of a Partnership Agreement SOP in February 2015, OP has reviewed, edited and counseled many offices that have drawn up their own valid partnership agreements. For example, in response to the Fukushima emergency, a Partnership Agreement was established between FDA and the Alaska Department of Environmental Conservation (ADEC) in May 2016 enabling ADEC to borrow a portable Gamma-ray analysis system affording the State radio-analytical capacity and expertise and emergency response capability for continued monitoring of Alaskan Coastal water finfish for radionuclides. FDA also has some partnership agreements under development. Partnership Agreements enables FDA and the partner agencies to demonstrate a mutual commitment to shared goals and objectives without obligating fiscal resources.
FDA and State of California Department of Public Health (CDPH) Human Food Mutual Reliance Pilot (MRP)
This new initiative between the California Department of Public Health (CDPH) and FDA’s Office of Regulatory Affairs (ORA) constitutes a further commitment to build the infrastructure and capacity of State, local, territorial, and tribal regulatory agencies to promote a national Integrated Food Safety System (IFSS) mandated by the Food Safety Modernization Act (FSMA). The purpose of this pilot between the FDA’s Los Angeles and San Francisco Districts and CDPH is to better align our food safety regulatory systems, reduce unnecessary duplication, enhance information sharing and, to the extent possible, leverage resources so that the agencies can better meet their public health objectives.
The pilot focuses on the interdependence of the FDA and the CDPH food safety programs. It seeks to achieve comparability in their each program’s food safety inspections, complaint investigations, sample analysis, compliance activities, response activities, and recall-related work such that each program may rely on inspections conducted by the other in meeting its inspectional obligations. Both the FDA participants and CDPH will focus on cooperative completion of the combined inspection workloads for regulated facilities. The pilot is also intended to identify effective methods for utilizing partner agency’s work products to support public health advisories, warning letters, or judicial actions based in whole or in part on the partner agency’s work products.
This initiative spans from April 2015 to September 2016. An evaluation to determine next steps will ensue. During Phase 1 of the pilot (April 2015 – September 2015), each agency provided 100 food inspections that its partner agency was able to count towards completing its inspectional workload. During Phase 2 and 3 of the pilot (October 2015 – present), each agency shared established food inventories and selected firms to inspect with a commitment to share the results with agency partner. By relying on inspectional data from its agency partner, neither agency had to inspect over 250 firms during its inspectional cycle. This has reduced duplication of effort while enhancing the effectiveness of consumer protection.
FDA and California Food Emergency Response Team (CalFERT) Collaborates with California Leafy Greens Marketing Association (CA LGMA)
California continues to be the country’s largest agricultural producer, producing over 52% of the nation’s fresh market vegetables and leafy greens in the nation. With an increased number of foodborne-outbreaks over the years associated with fresh produce, particularly leafy greens, FDA and the State of California have devoted significant resources to reducing the incidence of illness associated with contaminated leafy greens. The CalFERT was first adopted in 1999 as a joint Rapid Response Team (RRT) to respond to investigations of outbreaks associated with leafy greens, with a focus on regulatory actions and intervention strategies designed to prevent them and their contamination sources. CalFERT wanted to expand and share the lessons learned from each outbreak response incident with external produce industry organizations. This grass roots-driven initiative began in 2011, has had several iterations, and in ongoing. This has resulted in CalFERT members’ working with the California Leafy Greens industry to respond more swiftly and collaboratively to remove violative and products contaminated with microorganisms of public health significance.
FDA Rare Disease Annual Training
As part of FDA’s Prescription Drug User Fee Act (PDUFA) V commitments, the Rare Disease Program in the Office of New Drugs provides annual training on rare disease drug development. This training is conducted for review staff and includes extensive participation by other HHS agencies such as NIH and CMS as well as representatives from patient stakeholder groups, families who are caregivers of patients suffering from rare diseases, and the regulated industry. Most recently, this training was attended by over 175 people. This training began in March 2011 and has been held every year since. It is expected to continue at least through 2022 since it is an ongoing commitment under PDUFA VI.
HRSA Addressing HIV Care and Housing Coordination through Data Integration to Improve Health Outcomes along the HIV Care Continuum
The Health Resources and Services Administration (HRSA) and the U.S. Department of Housing and Urban Development (HUD) have partnered on this initiative that seeks to identify models for the electronic integration of housing and HIV care data systems to better coordinate service delivery and enhance patient navigation to improve health outcomes along the HIV Care Continuum. The funded recipients worked to increase the interoperability of HIV data systems, such as the Homeless Management Information System and RWHAP’s CAREWare, to measure housing’s impact on the health outcomes of Housing Opportunities for Persons with AIDS program clients.
NIH Cancer Research Ideas: Engaging the Cancer Community in the Cancer Moonshot
In April 2016, NCI, in consultation with NIH leadership and the White House, created a Blue Ribbon Panel (BRP) as a working group of the National Cancer Advisory Board. The panel, comprised almost entirely of non-Federal experts, was given the charge to lay out the scientific vision, goals, and implementation plan for the Cancer Moonshot. They were also given a firm and aggressive deadline of end of summer 2016 to deliver a report of key recommendations, requiring all 28 members and over 130 members of seven working groups, to dedicate countless personal and professional hours to accomplish what was needed.
To further support the Blue Ribbon Panel, NCI launched Cancer Research Ideas, an on-line ideation tool through which individuals submitted their recommendations for accomplishing the goals of the Cancer Moonshot, on topics ranging from cancer prevention to advancing the understanding of the origins of cancer to reducing cancer health disparities. The community could also submit ideas via email and by calling NCI’s Cancer Information Service. Additionally, the Blue Ribbon Panel conducted listening sessions with two professional organizations. The Cancer Research Ideas website was open for 10 weeks and was promoted through social media (Twitter, Google Hangouts), blog post, and exhibit space at major professional meetings.
When the site closed on July 1, the panel received more than 1,600 ideas and comments. Specifically, 848 ideas and 515 comments were submitted from 1,300 registrants. The ideas ranged from new areas of scientific research to proposed changes in how participants find out about and join clinical trials. This level of engagement, enabled by technology, is unusual in the cancer research community. Members of the BRP working groups reviewed and considered the submitted ideas as they deliberated on the cancer research priorities for the Moonshot. A final report from the BRP will be presented to the National Cancer Advisory Board on September 7, 2016. The ideas and comments are all archived and still available to view on the site.
NIH World RePORT
Over the past decade, global concern about the disproportionate burden of disease and mortality in low-income countries, especially in sub-Saharan Africa, has led to a substantial influx of funding for research by many donor and research agencies. Questions have been raised about whether these international efforts could be better coordinated.
As a first step, the NIH Office of Extramural Research and the Fogarty International Center created World RePORT (the World Research Portfolio Online Reporting Tool), a freely available online resource at http://WorldRePORT.nih.gov that provides access to nine major research funding organizations' portfolio of research activities in sub-Saharan Africa and Southeast Asia. In addition to NIH-funded research, the site includes research funded by a wide array of public and private entities. Each funding organization's projects are plotted geographically and can be searched with keywords in project titles and abstracts, and filtered by year, country, and funding organization. A data-export feature allows the user to build individual datasets for further analyses and customized reporting.
In 2016-2018, World RePORT is being expanded worldwide, to include projects directly or indirectly by the supporting agencies. A goal of World RePORT was to increase the visibility of the indirect research activity -- the foreign component of domestic grants that are undertaken in locations other than where a research grant is funded – as well as direct activity. In fall 2016, a redesigned World RePORT site will be made available that includes worldwide directly-supported projects, and enhanced tools for searching, mapping, and exporting data. By the end of 2017, the funders will be providing enhanced data on worldwide, indirectly-supported projects through the redesigned site.
NIH Open Science Prize
The Open Science Prize is a unique collaborative effort between the National Institutes of Health, UK-based Wellcome Trust, and the Howard Hughes Medical Institute designed to encourage and recognize the development of new tools, products, and services that use open digital content to help solve pressing public health and biomedical research challenges. As a first of its kind international challenge competition between these organizations, it is an example of an innovative funding method that is successfully stimulating international collaborations around open data.
The Open Science Prize was announced in October 2015. Contestants worldwide were invited to submit ideas that could be developed into prototypes of services, tools, or platforms that could enable open content to be discovered, accessed and re-used in ways that will advance research and public health. In order to qualify, each finalist team was required to be an international partnership, composed of at least two or more individuals or entities of which at least one is based in the United States and another is based in another country.
In the first phase of the competition, contestants were invited to submit their ideas. Finalists are being given $80,000 for development of a prototype by December 1, 2016. A grand prize winner, to be selected from among the six finalists, will be announced in early 2017. The grand prize winner will receive $230,000 to advance their winning project.
In total, 96 submissions were received representing 450 innovators from 45 countries across 5 continents. Each proposal selected as a finalist represents an original approach to either synthesizing available data to create new knowledge or creating platforms that allow for the integration of such knowledge.
The goal of the Open Science Prize is to support the development and prototyping of services, tools, and platforms to overcome these hurdles to ensure data can be used to advance discovery and spur innovation. The Open Science Prize is enabling new types of research, new types of knowledge, new types of collaboration, and new ways of thinking. The tools developed by the finalist teams represent the tip of the iceberg in terms of what is, and what could be created, using open digital content.
Innovation Lab and QuBBD Program
The NIH and the National Science Foundation (NSF) are collaborating to encourage collaborations between biomedical scientists and quantitative scientists. Using both extramural grants and Innovation Labs, teams are being developed and supported.
Quantitative Biomedical Big Data (QuBBD) is a competitive extramural grant program that is designed to support research at the intersection of the biomedical and data sciences by encouraging new inter-disciplinary and multi-disciplinary collaborations that focus on innovative and transformative quantitative approaches to address biomedical challenges.
The NIH and the NSF have been jointly sponsoring a series of Innovation Labs. These are intensive, facilitated workshops where new teams of early-career biomedical and quantitative investigators are mentored through the process of building multidisciplinary research programs. The Innovation Lab focused on precision medicine in 2015 and mHealth in 2016.
Breaking Barriers to Give Adults with Hearing Loss Better Access to Affordable Hearing Health Care
Several HHS divisions are joining with other Federal agencies, public advocacy groups, private industry, and the National Academies of Sciences, Engineering, and Medicine (National Academies) to transform hearing health care in the United States. The NIH estimates that 28.8 million adults in the United States have hearing loss significant enough that a hearing aid would help them, yet only one in four has ever used one.
In June 2016, the National Academies released the consensus study report, which includes 12 key recommendations to dramatically enhance consumers’ ability to find and fully use the appropriate, affordable, and high-quality services, technologies, and support they need to manage hearing loss. The recommendations include key institutional, technological, and regulatory changes that would improve access and affordability, expand the range of hearing devices and technologies available to consumers, and increase education and awareness of hearing loss. In addition, the report calls for more evidence-based information for the public and increased transparency of fee structures for devices and services, compatible technologies, and patients’ rights to their hearing health care records so they can make more informed decisions.
The President’s Council of Advisors on Science and Technology (PCAST) also recently called for major changes to America’s hearing health system. In October 2015, PCAST’s letter report to the president, Aging America & Hearing Loss: Imperative of Improved Hearing Technologies, recommended sweeping changes that the federal government can make to simultaneously decrease the cost of hearing aids, spur technology innovation, and increase consumer choice options.
In August 2016, the NIH and other federal agencies will begin prioritizing and implementing key recommendations in partnership with the National Academies and private organizations. Innovative approaches to change the current hearing health system and engage health consumers, professionals, and other stakeholders will remain the focus of our efforts over the coming years.
An Innovative Public Comment Database Provided Public Input for Use in Developing U.S. Dietary Guidelines policy
HHS and USDA jointly release the Dietary Guidelines for Americans (Dietary Guidelines) every 5 years. As part of the process for developing the 2015–2020 Dietary Guidelines, HHS and USDA convened an independent 2015 Dietary Guidelines Advisory Committee (Advisory Committee) that was charged with submitting its findings and recommendations to the Secretaries of HHS and USDA in the Scientific Report of the 2015 Dietary Guidelines Advisory Committee (Advisory Report).
A transparent public comment database was created by ODPHP for the public to have a role in the advisory committee’s process and to comment on its final report. The public was able to submit and read comments online. Categories and topic areas were identified for easy access to upload comments and attachments, including research articles and data reports, petitions and letters, etc., to support public entries. HHS and USDA accepted written public comments for the Advisory Committee throughout the Advisory Committee’s deliberations over 18 months and on its Advisory Report. Over 29,000 public comments were received and these along with federal agency comments informed revisions to the Dietary Guidelines.
The public comment database was uniquely developed in collaboration and participation with cross-agency USDA staff, meeting Federal Advisory Committee Act requirements for transparency, and reaching target audiences in a highly innovative manner, with a product that can be modeled for future advisory committees.
Mid-Course Review of the National Vaccine Plan
The HHS National Vaccine Program Office (NVPO) updated the National Vaccine Plan (NVP) in 2010 with broad input from federal and non-federal partners and guidance from the National Vaccine Advisory Committee (NVAC). The NVP is the nation’s blueprint for our vaccine and immunization enterprise and provides a strategic approach for preventing infectious diseases and improving the public’s health through the optimal use of vaccines. The 2010 NVP provided a comprehensive strategy to enhance all aspects of the vaccine ecosystem, including research and development, supply, financing, distribution, safety, informed decision-making by consumers and health care providers, vaccine-preventable disease surveillance, vaccine effectiveness and coverage monitoring, and global coordination. Anticipating that there were likely to be both scientific and policy changes within the ten-year scope of the 2010 NVP, a mid-course review was built into the 2010 NVP. Since the release of the NVP in 2010, the landscape has changed including the passage of the ACA.
NVPO led the development of a mid-course review of the NVP with the goal of assessing whether the priorities set in 2010 should be adjusted to ensure that the plan continued to be responsive to current environmental realities. This review is intended to reflect on the priorities and progress toward goals laid out in the NVP.
Stakeholders were engaged including academia, industry, pharmacies and pharmacists, health care providers, philanthropic organizations and consumer groups to provide an independent and balanced vision for moving forward with the NVP. The National Vaccine Advisory Committee, a federal advisory committee made up of non-federal voting members, were also asked to independently evaluate NVPO’s findings and conclusions. The NVAC discussions occur during public meetings held approximately every three months. At the next public meeting in September, NVAC will discuss and vote on its final recommendations.
Administrative Law Judges
The Appellant Climate Survey is used to measure appellant satisfaction with the appeals experience, controlling for appeal outcome. The survey is conducted annually by a third-party vendor using recognized statistical sampling methodologies to ensure a random selection of hearing participants. The contractor conducts the survey and compiles and analyzes the resulting data. Results are used to make program improvements for case processing and identify training needs for staff as well as generally gauge progress made in increasing satisfaction among appellants.
The appellant forum is an open meeting where staff provide updates to appellants on the status of operations; relays information on a number of initiatives designed to mitigate the backlog of claims appeals awaiting adjudication; and provides information on measures that appellants could take to make the administrative appeals process work more efficiently.
Office of the National Coordinator for Health Information Technology (ONC) Tech Lab
The health IT landscape has changed considerably since the Health Information Technology for Economic and Clinical Health (HITECH) Act. The ONC Tech Lab will guide ONC’s work to adapt and evolve ONC’s standards and technology work processes to align and connect to changes in policy and in the industry. In concert with the ONC Health IT Certification Program, this principled approach will provide internal and external stakeholders with common connection points to ONC’s standards and technology efforts. ONC will use the Tech Lab’s organizing structure to help it focus on what ONC can uniquely contribute to improve existing standards and build consensus around those that best serve specific interoperability needs. The Tech Lab will ensure through engagement and testing that standards have been rigorously tested and are consistently implemented. The four focus areas of the Tech Lab are:
(1) Standards Coordination – Working with standards development organizations (SDOs) and industry stakeholders; (2) Testing and Utilities – Testing tools for developers and providers to test their health IT functionality in the field; (3) Pilots – Supporting implementation pilots for standards, including the Interoperability Standards Advisory (ISA); and(4) Innovation – Working with start-up communities, administering challenges, and forward looking standard and technology activities.
FDA Transitions to the Automated Commercial Environment/International Trade Data System (ACE/ITDS)
In February 2014, President Obama signed an executive order calling all government agencies involved in international trade to work together to streamline import and export processes for America’s businesses. The executive order also established the Border Interagency Executive Council (BIEC), an interagency body that provides strategic leadership and policy guidance to improve coordination among agencies with border responsibilities and between the U.S. Government and the trade community. The BIEC includes executives from the Departments of Agriculture, Commerce, Defense, Health and Human Services, Interior, Justice, State, Transportation, and Treasury. National Security Council (NSC) Staff, National Economic Council (NEC) Staff, and representatives from the Office of Management and Budget (OMB) and the United States Trade Representative (USTR) also attend. In response to the Presidential mandate, the Food and Drug Administration (FDA), which chairs the BIEC Risk Management Committee, Customs and Border Protection (CBP), and 46 partner agencies began collaborating to improve technologies and policies that would, in turn, facilitate trade.
Together, the Government developed a fully-electronic processing infrastructure, the Automated Commercial Environment/International Trade Data System (ACE/ITDS). This technology transformed the nation’s import process and allows industry to provide a standardized set of import information to the Government in one “single window” and to receive coordinated Government responses in the same manner. This represents improved processes, as past information was submitted, often redundantly, to multiple Government agencies rather than as one set of harmonized information to one Government agency. A fully-electronic, coordinated system allows the Government to receive information more quickly and process cargo more expeditiously.
With more than 35 million lines of FDA-declared shipments in 2015 representing approximately 20% of the nation’s total imports, FDA played a key role in this streamlining initiative and demonstrated ongoing transparency, participation, and collaboration to accomplish this task. FDA worked closely with CBP to develop requirements and build a new interface in which FDA would receive entry-related data and send responses. FDA also modernized its systems to be able to receive and process new information. In addition to working with Government partners, FDA worked closely and consistently with the Trade Support Network and brokers, importers, and software developers nationwide to collaboratively construct a standardized set of requirements. FDA has issued a Federal Register Notice regarding a proposed rule related to the submission of FDA import data in ACE. FDA made information more accessible by creating a DUNS portal and making updates to public websites. FDA hosted more than 700 outreach events and technical assistance sessions to engage and educate trade partners on changes to the import process. FDA also implemented a 24/7 help desk in order to provide around-the-clock support and assistance to industry during this transition.
After a successful pilot, ACE became the official system of record for all imports in July 2016. FDA completed its milestones on time and within budget. As of July 2016, FDA successfully processed approximately 9 million import transactions. Industry participation is currently at 99%. Throughout the next few years, FDA will continue to partner with industry and other agencies to improve processes and implement additional functionality, updates, and capabilities that further streamline the process.
FDA Office of Partnerships Grant Funding Objective Review Board Panel Member Recruitment Initiative
When making grant funding awards, the Objective Review Board (ORB) process is required to have unbiased and qualified objective reviewers undertake a comprehensive review of all grant applications. In the past individual grant program managers identifying qualified individuals. ORA’s Office of Partnerships, Contracts and Grants Staff has developed an ORB panel member recruitment strategy that broadened the target reviewer pool beyond individuals within ORA or another FDA Center to include reviewers from CDC, USDA, HHS, as well as association and industry leaders. This recruitment process also streamlined the ORB reviewer assignment process by centralizing it and directly providing grant program managers directly with names of qualified individuals to choose from, creating a more efficient process. This process further benefited FDA by providing over 40 qualified objective reviewers for the FDA’s largest grant program ever awarded at over $21 million dollars.
FDA Improving Enforcement Efficacy by Leveraging Advanced Technology and Expertise
In September 2012, FDA unveiled a handheld Counterfeit Detection (CD3) device, developed by FDA scientists, which seeks to improve enforcement effectiveness by leveraging advanced technology and expertise. The CD3 device can be used to rapidly screen suspected products and packaging, such as counterfeit pharmaceuticals. This portable unit has been deployed at various ports in the U.S. as well as overseas. FDA continues to refine this low-cost device, which enables users to quickly visualize differences between suspect and authentic products. The goal is to put an affordable tool for fighting pharmaceutical crime in the hands of global regulatory, law enforcement and public health officials.
In FY 2016, a presentation describing the development and application of the CDx against counterfeit products was given at the American Association of Pharmaceutical Scientists convention. FDA conducted and received an award for Operation Pill Pusher, an operation that used the CDx to screen potential counterfeit products and develop a library of diverted or counterfeit products for use in future drug screenings. Based on successful use, demonstrated applications, and the need for additional devices, the Forensic Chemistry Center collaborated with the Division of Budget Formulation and Execution and the Office of Acquisition and Grants Services to develop a contract to develop and manufacture the more advanced CD5 counterfeit device. This collaborative team hosted FDA’s first Industry Day. Presentations were given to industry on the evolution of the device, demonstration of the variety of its applications, and future needs for the CD5 device. Based on the feedback received from Industry Day, the team generated an acquisition plan and solicitation to be posted for industry bidding.
FDA Office of Regulatory Science (ORS) Public Private Partnerships (PPPs) Initiative
ORA initially developed PPPs with industry and academia in response to the FSMA mandate to “identify new and rapid analytical techniques, including commercially-available techniques that can be employed at ports of entry.” This initiative has been central to FDA’s efforts to broaden participation and collaboration with academia and industry and aligns well with the HHS’ public access policy regarding publications developed from federally-sponsored research programs. These PPPs have yielded innovative rapid detection systems that can be used to probe various FDA regulated products for contamination and/or adulteration. In FY2012, ORS began a four-year partnership with the Oak Ridge Institute for Science and Education (ORISE), and seven ORISE Fellows are currently working on seven scientific projects with ORS principal investigators (PIs), serving as linkages to academic or industry partner Co-principal investigators. These PPPs has heavily relied on and benefited tremendously from utilization of fellowship programs as a cornerstone in ORA’s formation of PPPs. ORS has received a number of testimonials from its partners extolling the virtues of the ORISE program. ORS believes, with sustainable funding either thru grants, Broad Agency Announcements (BAAs), or other mechanisms, its will be successful in leveraging PPPs now and into the future.