2017 Report on Scientific Conference with Expenses Over $30,000
21st Century Cures Act Reports on Scientific Conferences
Section 3074 of 21st Century Cures Act requires the FDA to report on scientific conferences hosted, sponsored, co-sponsored, or attendance at non-Federal Scientific Meetings with FDA expenses in excess of $30,000. The following outlines the total expenses for each scientific meeting together with other pertinent information including how the conference advanced the mission of the agency, a description of the conference activities. Section 3074 requires additional information of compelling circumstances for the costs exceeding $150,000.
131st Association of Analytical Chemists (AOAC) Annual Meeting & Exposition
9/24/2017 to 9/27/2017
Atlanta, Georgia
Total Expense: $31,064
Number of Individuals Whose Expense Were Paid By FDA: 17
Meeting Description:
The 2017 Association of Analytical Chemists International Meeting & Expo is the best opportunity to communicate the research findings and interact with food producers and many scientific collaborators in the allergen area.
How meeting advances the mission of FDA:
This meeting advances the mission of FDA by allowing FDA scientific professionals to gain knowledge in the latest advances related specifically to food allergens and food chemistry applied to food processing, analytical chemistry, allergenic proteins, and food safety. .
2017 International Association for Food Protection (IAFP) Annual Meeting
7/9/2017 to 7/12/2017
Tampa, Florida
Total Expense: $315,603
Number of Individuals Whose Expense Were Paid By FDA: 131
Meeting Description:
International Association for Food Protection hosts an Annual Meeting, providing attendees with information on current and emerging food safety issues, the latest science, innovative solutions to new and recurring problems, and the opportunity to network with thousands of food safety professionals from around the globe. The IAFP Annual Meeting is attended by more than 3,400 of the top industry, academic and governmental food safety professionals from six continents. The meeting activities will include exhibits sharing the latest in available technologies; leading experts speaking on a variety of timely topics; and special recognition of outstanding professionals and students for their contributions in the food safety field, committee meetings, social activities and networking opportunities. Attending this conference is a major benefit to the agency and attendees because they receive up to date training and information on protecting the food supply and advancing food safety worldwide. This conference supports FDA's mission of protecting and promoting public health, strengthening science, improving product quality, working with industry, and improving overall interaction and communication.
How meeting advances the mission of FDA:
Attendance at this conference advances FDA's knowledge and leadership in the mission critical area of foodborne C. cayetanensis and to improve understanding of foodborne pathogens, food laws and regulations, allergens, food toxicology, sanitation, and risk assessment.
Exceptional Circumstances for Exceeding $150,000 in Expenses:
IAFP is a widely-attended conference that provides food safety professionals worldwide with a forum to exchange information on protecting the food supply in all fields of food safety within CFSAN. Because of the importance of the meeting, 131 FDA professionals attended causing the cost to exceed $150,000.
International Chinese Statistical Association (ICSA)
6/25/2017 to 6/28/2017
Chicago, Illinois
Total Expense: $88,633
Number of Individuals Whose Expense Were Paid By FDA: 58
Meeting Description:
This meeting is primarily a learning and professional development opportunity, so is beneficial to FDA since it enhances our capability to evaluate clinical trials that use newer methods. It also identifies the duties of the CDRH attendees in support of the Agency's mission. Finally, it supports CDRHs mission by providing FDA statisticians an opportunity to educate industry.
How meeting advances the mission of FDA:
This meeting helped to advance FDA’s mission by providing a forum for Biostatisticians, from the Division of Biostatistics, CDRH, to engage with statistics community, and to learn new, innovative, and cutting-edge statistical methods and tools for their professional development and to apply in their day-to-day review of regulatory pre-and-post market submissions with complex statistical designs.
57th Annual Meeting of the Teratology Society
6/24/2017 to 6/28/2017
Denver, Colorado
Total Expense: $42,709
Number of Individuals Whose Expense Were Paid By FDA: 16
Meeting Description:
Presenting a talk in the Pregnancy Registry symposium, which is directly related to our mission of ensuring the safe use of drugs in pregnancy through issuance of PMRs that involve data collection through pregnancy registries. Topic presented: 1) Including Pregnancy Registry Data in Labeling 2) The Benefits of Breastfeeding
How meeting advances the mission of FDA:
Meeting is critical to the FDA's DPMH's mission of ensuring the safe and effective use of medications and biologics during pregnancy through the exchange of knowledge with researchers, clinicians, industry, and other stakeholders. This scientific exchange is critical to the FDA mission as this information directly affects our work in developing/updating product labeling and safety communications on the risks of medication use in pregnancy and lactation. DPMH led the organization of the 2014 public meeting on post-approval safety studies in pregnant women, and is leading the effort to develop policy and update the 2002 Pregnancy Registry Guidance.
Institute of Food Technologies IFT Annual Meeting
6/23/2017 to 6/29/2017
Las Vegas, Nevada
Total Expense: $42,298
Number of Individuals Whose Expense Were Paid By FDA: 20
Meeting Description:
The goal of the symposium is to focus on the development of new tools, methodologies, and investigation processes to address unexpected, unusual, and urgent safety issues in food production. The format included opportunities for those who work in food production, food safety, quality control and technical services to hear from public health leadership, and to interact and discuss food forensic investigation strategies and the application of forensic science to food problems. The FDA Forensic Chemistry Center (FCC) plays a critical role in the development of approaches to food analyses related to criminal investigations and outbreaks/emergencies involving regulated products, and in the protection of the public health as a supporting laboratory for the Division of Food Defense Targeting.
How meeting advances the mission of FDA:
This conference provides a venue for FDA employees to build contacts for greater communication and potential collaboration. It is necessary for the FDA Forensic Chemistry Center (FCC) to remain current with respect to the research being done that would enhance its ability to support Agency activities. The information that the attendees acquired during the conference were disseminated to the staff of the FCC as a trip report after the meeting to further the impact of attending.
DIA 2017 - Drug Information Association 53rd Annual Meeting
6/18/2017 to 6/22/2017
Chicago, Illinois
Total Expense: $352,722
Number of Individuals Whose Expense Were Paid By FDA: 135
Meeting Description:
The Drug Information Association annual meeting is a widely-attended meeting by professionals in the pharmaceutical and medical device industry, it is the foremost regulatory scientific professional organization in the country. Their entire focus is issues that bring together regulators, industry, academia and now patients in a neutral forum. DIA 2017 is the largest global interdisciplinary event that brings together 7,000+ key thought leaders and innovators from industry, academia, regulatory and government agencies, health, patient, and philanthropic organizations from around the globe - and across all disciplines involved in the discovery, development, and life cycle management of health care products.
How meeting advances the mission of FDA:
This meeting advance the mission of FDA by allowing FDA professionals to interact with a global community of life sciences professionals and exchange information leading to innovation and development of medical products and therapies to patients. Industry, clinicians, patient representatives, and regulatory agencies from around the world will attend and present at this event, as well as exhibits from 450 companies will be available. This meeting provides the opportunity to network and interact with health professionals across multiple disciplines, as well as the opportunity for FDA professionals to receive continuing education.
Exceptional Circumstances for Exceeding $150,000 in Expenses:
The Drug Information Association (DIA) annual meeting is the largest widely attended meeting by FDA's Center for Drug Evaluation and Research (CDER) professionals in the pharmaceutical and medical device industry, it is the foremost regulatory scientific professional organization in the country. Their entire focus is issues that bring together regulators, industry, academia and now patients in a neutral forum. DIA is the largest global interdisciplinary event that brings together key thought leaders and innovators from industry, academia, regulatory and government agencies, health, patient, and philanthropic organizations from around the globe - and across all disciplines involved in the discovery, development, and life cycle management of health care products. The meeting includes about 300 individual tutorials, workshops, learning sessions and discussion forums. CDER sent 125 attendees because the DIA Annual Meeting provides the best opportunity for individuals involved in regulatory and scientific drug discovery activities with an opportunity to learn about the latest developments needed to carry on their scientific responsibilities. Further, DIA allows an outlet for CDER scientist to interact with their peers from around the world, exchange information and ideas and network in an effort to build new relationships.
121st Association of Food and Drug Officials (AFDO) Annual Educational Conference
6/17/2017 to 6/21/2017
Houston, Texas
Total Expense: $104,780
Number of Individuals Whose Expense Were Paid By FDA: 34
Meeting Description:
The FDA is a member of Association of Food and Drug Officials (AFDO) and serves in an advisory role on several committees tasked with educating members consisting of food and drug regulatory officials and industry. This educational conference is an opportunity that allows individuals from government, industry and the public to participate, listen and learn valuable information and develops initiatives concerning food, drug, medical device, cosmetic and product safety issues. FDA attendance fosters collaboration and leveraging of effective public health programs and supports and enhances compliance within regulated industry.
How meeting advances the mission of FDA:
FDA works in cooperation with other government agencies, foreign counterparts, industry and academia each year at the Association of Food and Drug Officials Educational Conference. It is mission critical that the Agency continue to participate in the conference to further the education of the industry and other regulatory counterparts for a uniform understanding of the laws and regulations, enhance compliance, and strengthen food, drug, and medical device safety systems. .
77th Scientific Sessions (American Diabetes Association)
6/9/2017 to 6/13/2017
San Diego, California
Total Expense: $37,282
Number of Individuals Whose Expense Were Paid By FDA: 13
Meeting Description:
The American Diabetes Association’s Scientific Sessions offers researchers and health care professionals from around the world the unique opportunity to share ideas and learn about the significant advances in diabetes research, treatment, and care.
How meeting advances the mission of FDA:
This meeting advances the mission of FDA by allowing FDA's scientific professionals to obtain independent and collaborative evaluations and reviews to all programs and disciplines the Center for Drug and Evaluation and Research in support of scientific and regulatory review process related to drugs and therapeutic biologics with special attention to the safety and efficacy of these products.
65th Conference on Mass Spectrometry and Allied Topics
6/4/2017 to 6/8/2017
Indianapolis, Indiana
Total Expense: $54,551
Number of Individuals Whose Expense Were Paid By FDA: 25
Meeting Description:
This is the major Scientific Conference for Mass spectrometry in the United States, organized by the American Society of Mass Spectrometry. Experts in the field of Mass Spectrometry from the US and all over the world participate in this event and hundreds of scientific presentations and thousands of posted-presentations are presented during five days.
How meeting advances the mission of FDA:
The meeting topics are directly related to our research and operation and this meeting advances the mission of FDA by furthering FDA scientific professionals the understanding of the field of mass spectrometry. Our mission is to develop sensitive mass spectrometric methods to analyze veterinary residues in animal and human food and furthering our understanding in the field it is critical to achieve that mission.
2017 American Society of Clinical Oncology (ASCO) Annual Meeting
6/2/2017 to 6/6/2017
Chicago, Illinois
Total Expense: $175,094
Number of Individuals Whose Expense Were Paid By FDA: 61
Meeting Description:
The American Society of Clinical Oncology (ASCO) promotes and provides for lifelong learning for oncology professionals; cancer research; an improved environment for oncology practice; access to quality cancer care; a global network of oncology expertise; and educated and informed patients with cancer. ASCO is supported by its affiliate organization, the Conquer Cancer Foundation, which funds ground-breaking research and programs that make a tangible difference in the lives of people with cancer. This meeting provides medical and regulatory professionals with important new knowledge about breakthrough medications including new monoclonal antibodies and novel immune therapeutic approaches in oncology.
How meeting advances the mission of FDA:
Attending this meeting will allow reviewers in FDA/CDRH/OIR/DMGP (The Division of Molecular Genetics and Pathology), to gain in-depth and up-to-date information on basic, translational, and clinical cancer research including biomarker diagnostic development and interpretation. Additionally, information about diagnostics research and implementation in the clinical setting in the area of immunohistochemistry, next-generation sequencing and other important technologies which is critical to FDA's mission for regulatory review and approval of in vitro diagnostic devices. The conference will cover many pertinent areas, including method development, next generation diagnostics in cancer, and new biomarker research and development.
Exceptional Circumstances for Exceeding $150,000 in Expenses:
The ASCO Annual Meeting brings together oncology professionals from around the world. Educational sessions feature world-renowned faculty discussing state-of-the-art treatment modalities, new therapies, and ongoing controversies in the field. Science sessions present the latest ground-breaking research in oral and poster format. Spanning disciplines, disease sites, and treatment approaches, it is our combined knowledge that will shape the future of patient care and research. We must partner with health care professionals and specialists of diverse backgrounds to meet the evolving challenges in providing optimal care to our patients. With exciting advances in big data technology, our collective wisdom will become all the more powerful as new insights will be revealed in seconds, not years. The impact of our wisdom, however, can only be as great as our ability to strengthen the delivery of and access to high-quality cancer care. As medical professionals and as a Society, we must all continue to evolve cancer care and research with each new discovery. If these participants are not in attendance they will miss the opportunity to gain knowledge on the latest cutting-edge research and technology in oncology. CDER sent 54 attendees to this meeting, as attendance to this meeting is mission critical for the CDER Medical Officers to keep current on this rapidly-changing field.
American Society for Microbiology (ASM) Microbe 2017
6/1/2017 to 6/5/2017
New Orleans, Louisiana
Total Expense: $137,136
Number of Individuals Whose Expense Were Paid By FDA: 51
Meeting Description:
The FDA attendees will serve as subject matter experts (SMEs) at the conference. Several key areas for FDA are discussed at the conference including a pilot program to extend the mandated testing of milk for tetracycline residues. FDA has been working with the NCIMS over the last several conferences to test for drug residues beyond the currently mandated testing for beta-Lactams. FDA SME input is essential to address questions regarding both drug residue issues, and the validity of the drug residue rapid screening tests proposed for use in the expanded program. Improving the safety of the Nation's milk supply is a major FDA initiative.
How meeting advances the mission of FDA:
This mission advances the mission of FDA by protecting and promoting public health, strengthening science, improving product quality, working with industry, and improving overall interaction and communication. FDA scientific professionals also meet with leading scientists from around the world who work on antimicrobial resistance and food safety.
2017 International Council for Harmonization (ICH) Montreal Meeting
5/27/2017 to 6/1/2017
Montreal, Canada
Total Expense: $176,937
Number of Individuals Whose Expense Were Paid By FDA: 43
Meeting Description:
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration.
How meeting advances the mission of FDA:
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use is the key international forum in which the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research negotiate with other international regulatory authorities and industry stakeholders to achieve greater harmonization in significant aspects of the drug regulatory process.
Exceptional Circumstances for Exceeding $150,000 in Expenses:
The meeting of the International Council for Harmonization (ICH) on Technical Requirements for Pharmaceuticals for Human Use provides the best opportunity for FDA scientific professionals to work side-by-side with regulatory and industry experts to make recommendations towards achieving greater harmonization in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration. For fiscal year 2017, 53 FDA scientific professionals attended this meeting. This large number of FDA personnel traveling to Canada along with length of the meeting caused the cost to attend this meeting to exceed $150,000.
ISPOR 22nd Annual International Meeting
5/20/2017 to 5/24/2017
Boston, Massachusetts
Total Expense: $61,316
Number of Individuals Whose Expense Were Paid By FDA: 28
Meeting Description:
The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) during this meeting clinicians and new researchers learn how to incorporate pharmacoeconomics into study design and data analysis. Participants review the basic principles and concepts of health economic evaluations, then discuss how to collect, and calculate the costs of different alternatives, determine the economic impact of clinical outcomes, and how to identify, track, and assign costs to different types of health care resources used
How meeting advances the mission of FDA:
The meeting advances the mission of FDA by allowing FDA scientific professionals to see different pharmacoeconomic models and techniques, including cost-minimization, cost-effectiveness, cost-benefit, cost-utility, and budget impact analysis. Decision analysis, sensitivity analysis, and discounting. The training courses offered at this conference presented recent developments in the mathematical modeling field, which will improve the quantitative analytic skills of FDA staff members.
International Conference on Molluscan Shellfish Safety ICMSS
5/12/2017 to 5/21/2017
Galway, Ireland
Total Expense: $31,524
Number of Individuals Whose Expense Were Paid By FDA: 6
Meeting Description:
This conference offers an important multidisciplinary interface between regulatory, scientific, and industrial representatives of the international molluscan food safety community. It is a biannual forum where unusual, emerging, and novel shellfish risk factors are discussed, offering new information and solutions. As part of the FDA-CEFAS cooperative field studies training. CFSANs presence at this conference allows emphasis on critical data supporting NSSP approach towards addressing discharges of sanitary waste through dilution analysis and establishment of prohibited buffer zones adjacent to point source discharges (absent in current EU regulation but included in an annex if the country chooses to pursue trade with the US).
How meeting advances the mission of FDA:
This meeting allowed SME to deliver critical results to the EU regarding joint FDA-EURL studies indicating the effectiveness and present FDA's application of Whole Genome Sequencing (WGS) in detection of new emergent Vibrio parahaemolyticus clones using a novel core genome multilocus sequence typing (cgMLST) scheme.
2017 National Conference on Interstate Milk Shipments (NCIMS) Conference and FDA Pre-Meeting
5/12/2017 to 5/17/2017
Grand Rapids, Michigan
Total Expense: $101,857
Number of Individuals Whose Expense Were Paid By FDA: 22
Meeting Description:
The National Conference on Interstate Milk Shipments (NCIMS) serves as the representative of the States through the cooperative programs with FDA in the implementation of the Pasteurized Milk Ordnance (PMO). The PMO is a model document setting sanitary standards for “Grade A” milk in the US based on science. At the NCIMS conference, proposals to modify the PMO will be discussed and voted on by the States.
How meeting advances the mission of FDA:
The Center for Veterinary Medicine (CVM) attendees will serve as subject matter experts (SMEs) for FDA at the conference. Several key areas for CVM were discussed at the conference including a pilot program to extend the mandated testing of milk for tetracycline residues. FDA has been working with the NCIMS over the last several conferences to test for drug residues beyond the currently mandated testing for beta-Lactams. CVM SME input is essential to address questions regarding both drug residue issues, and the validity of the drug residue rapid screening tests proposed for use in the expanded program. The Appendix N Committee is charged with implementing an expanded testing program for drug residues in raw milk. The expansion of the program is a major FDA initiative to improve the safety of the Nation's milk supply. The attendees’ expertise is critical to the work of the committee.
49th Annual National Conference on Radiation Control - Conference of Radiation Control Program Directors (CRCPD)
5/8/2017 to 5/11/2017
Scottsdale, Arizona
Total Expense: $33,855
Number of Individuals Whose Expense Were Paid By FDA: 14
Meeting Description:
The Conference of Radiation Control Program Directors' (CRCPD) mission is "to promote consistency in addressing and resolving radiation protection issues, to encourage high standards of quality in radiation protection programs, and to provide leadership in radiation safety and education." FDA personnel attended training that helps keep them abreast of the latest issues in radiological health. It further allowed for personnel to liaise with State counterparts as well as fellow radiological health workers within other federal agencies, including but not limited to the Nuclear Regulatory Commission and Environmental Protection Agency. During the conference, FDA personnel met with multiple State partners to discuss Mammography Quality Standards Act (MQSA) inspection contracts regarding emerging problems, compliance trends, and training and staffing needs. Also, this allowed the personnel to provide information and agency messaging to FDA's State partners.
How meeting advances the mission of FDA:
The 49th Annual National Conference on Radiation Control is critical to the FDA's mission because it provides training opportunities for the Regional Radiological Health Representatives (RRHRs) and Radiation Specialists to stay abreast of current and evolving issues in the FDA-regulated field of radiological health. If employees did not attend, it would be difficult for them to obtain the continuing education requirements for maintaining MQSA inspector certification. Staff could also miss out on emerging trends in radiological health. Further, it would severely hinder communication and consistent messaging to State counterparts if FDA did not attend.
Food and Drug Law Institute (FDLI) 2017 Annual Conference:
5/4/2017 to 5/5/2017
Washington, DC
Total Expense: $53,537
Number of Individuals Whose Expense Were Paid By FDA: 58
Meeting Description:
FDLI’s Annual Conference is the largest and longest-running legal conference for the entire food and drug law community, including every product category regulated by FDA. This two-day conference will cover legal, regulatory, policy and economic issues spanning the broad range of FDA's authority by bringing together experts from the federal government, industry, the private bar, patient, and consumer advocates, consulting organizations and academia. Participants will review the latest regulatory developments and look ahead to future issues on the horizon. The purpose of FDA attending this conference is to emphasize a willingness to learn, engage, and serve as a point of contact to industry. Having an ear to the ground at industry events can provide some valuable insight into how the industry is currently thinking and will give us the opportunity to learn about new products and hear industry’s current concerns firsthand.
How meeting advances the mission of FDA:
Attendance at this conference supports the FDA mission to protect the public health by allowing participants to 1) gather useful information relevant to regulation of regulated products and its manufacture, marketing and sale, 2) to inform FDA staff of any significant information or important issues and perspectives presented at the conference that are relevant to the FDA’s work and mission, and 3) gather useful information about industry and stakeholder opinions and attitudes toward FDA and its activities. Attendance gave FDA attendees a comprehensive overview of industry's and the public's concerns about FDA projects such as pathways to market (e.g., substantial equivalence, PMTA for ENDS), product standards (e.g., child-resistant packaging, safety), and various other rulemakings and guidance. Conference covered the latest in legal, regulatory, and policy issues by bringing together experts from the federal government, industry, the private bar, non-profit, patient and consumer advocates, consulting organizations, and academia.
2017 American Association of Pharmaceutical Scientists (AAPS) National Biotechnology Conference
5/1/2017 to 5/3/2017
San Diego, California
Total Expense: $45,465
Number of Individuals Whose Expense Were Paid By FDA: 16
Meeting Description:
The Emerging Topics theme will focus on topics with a significant impact on pharmaceutical industry and health care including recent trends in clinical trials and translational medicine. FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human drugs.
How meeting advances the mission of FDA:
The American Association of Pharmaceutical Scientists National Biotechnology Conference will further the mission of the FDA because the tremendous progress in technology, biology, and pharmaceutical sciences provides a great potential in pharmaceutical research and development, and is a driving force in developing new drugs as well as improving patient outcomes and increasing patient access to medicine. .
The 69th Annual AAN Annual Meeting
4/22/2017 to 4/28/2017
Boston, Massachusetts
Total Expense: $58,565
Number of Individuals Whose Expense Were Paid By FDA: 21
Meeting Description:
The American Academy of Neurology (ANN) is the major professional meeting that spans across the fields of neurology such as pain, movement disorders, neurodegeneration, child neurology, neuromuscular disorders, and behavioral neurology. It is the major meeting where continuing medical information is shared and presented regarding research and clinical practice advances and clinical practice parameters and guidelines are shared and explained.
How meeting advances the mission of FDA:
This meeting advances the mission of FDA by allowing FDA clinical reviewers and clinical staff remain up to date on clinical advances and treatment modalities, and to interact with our fellow academic clinicians during the largest professional Neurological Association, attended by Neurologists from across the world.
11th Workshop on Recent Issues in Bioanalysis (WRIB)
4/3/2017 to 4/7/2017
Los Angeles, California
Total Expense: $33,507
Number of Individuals Whose Expense Were Paid By FDA: 14
Meeting Description:
Work on Recent Issues in Bioanalysis is a forum where regulators and industry convene for working together in the field of bioanalysis, biomarkers, and immunogenicity to improve global health.
How meeting advances the mission of FDA:
Work on Recent Issues in Bioanalysis forum will help the FDA develop and implement programs and policies for inspection, compliance, and enforcement of the following regulatory areas: nonclinical studies, bioequivalence studies, and human subject protections in clinical drug product studies.
253rd American Chemical Society (ACS) National Meeting on Advanced Materials, Technologies, Systems & Processes
4/2/2017 to 4/6/2017
San Francisco, California
Total Expense: $65,654
Number of Individuals Whose Expense Were Paid By FDA: 21
Meeting Description:
Attendance at this conference provided FDA employees the opportunity to meet and network with thousands of scientists from industry, government, and academia. They also attended numerous technical sessions which showcased the latest research and developments from leading scientist around the world. This enables FDA employees to stay abreast of cutting edge chemistry research.
How meeting advances the mission of FDA:
Part of FDA's mission is to promote and protect the public's health by ensuring a safe food supply in the United States. This industry, however, has become increasingly complex, with advances made in technologies used in food production and packaging. It is essential for FDA employees to stay well versed in these areas in order to do complete their jobs.
National Conference on Tobacco or Health (NCTOH)
3/22/2017 to 3/24/2017
Austin, Texas
Total Expense: $155,120
Number of Individuals Whose Expense Were Paid By FDA: 73
Meeting Description:
The purpose of the National Conference on Tobacco or Health (NCTOH) is to help improve and sustain the effectiveness and reach of tobacco control programs and activities in the United States. It is the premier gathering of the U.S. tobacco control movement. Since the most recent NCTOH in 2012 the field has evolved considerably, with new challenges to face and new tools and resources available. This conference brings together practitioners from across the country for three days of learning, networking, and strategizing on the impact of and opportunities around reducing tobacco use. The NCTOH is one of the largest, long-standing gatherings of the United States tobacco control movement. It attracts a diverse set of public health professionals to learn about best practices and policies to reduce tobacco use—the leading preventable cause of disease and death in the United States.
How meeting advances the mission of FDA:
This conference meets the Center for Tobacco Product (CTP) mission to protect Americans from tobacco-related death and disease through knowledge sharing, networking, and strategizing on the impact of and opportunities around reducing tobacco use. The conference is attended by tobacco control professionals and researchers, and focuses on effective tobacco control measures and the exchange of valuable ideas with others working in this area. Because of the numerous program areas covered by NCTOH, this conference is applicable to many CTP staff.
Exceptional Circumstances for Exceeding $150,000 in Expenses:
NCTOH is attended by FDA's tobacco control professionals and focuses on effective tobacco control measures and the exchange of valuable ideas with others working in this area. Because of the numerous program areas covered by NCTOH, this conference is applicable to many Center for Tobacco Product staff. As a result, 73 staff members across 8 CTP program areas attended because the National Conference on Tobacco or Health is one of the largest, long-standing conferences focusing on tobacco control in the United States and delivered specific and unique information related to this country. This is a rare opportunity for staff to collaborate with others in the field, hear the latest research, and illustrate findings about the ever-changing field of tobacco. This was a much-needed conference because it only is offered once every three years. The last conference was in 2012 and FDA sent 35 people. Since that time, CTP staff has more than doubled the number of employees attending the conference resulting in costs to exceed $150,000.
AAOS 2017 Annual Meeting
3/14/2017 to 3/18/2017
San Diego, California
Total Expense: $39,039
Number of Individuals Whose Expense Were Paid By FDA: 16
Meeting Description:
The American Academy of Orthopedic Surgeons (AAOS) conference is the largest orthopedic conference and one of the largest medical conferences in the world. This conference allows members of the orthopedic devices branches the unique opportunity to attend an international meeting where they will see orthopedic devices that are used in the U.S as well as other countries.
How meeting advances the mission of FDA:
This meeting advances the mission of FDA by allowing FDA scientific professionals stay abreast of the latest developments in orthopedic science and clinical developments, specifically in order to facilitate reviews, develop guidance, and to prepare for sponsor interactions regarding innovative devices. Many joint and spinal devices are introduced first at such an international conference which provides exposure to these unfamiliar devices. In addition to the enormous value of seeing the actual devices that FDA has reviewed and some of the devices that may be presented in future submission for FDA review. This knowledge will aid in FDA review of future orthopedic device submissions.
Society of Toxicology (SOT) 56th Annual Meeting and ToxExpo
3/12/2017 to 3/16/2017
Baltimore, Maryland
Total Expense: $88,879
Number of Individuals Whose Expense Were Paid By FDA: 84
Meeting Description:
The Society of Toxicology (SOT) Annual Meeting is the largest meeting of its kind. This annual event features a broad range of scientific sessions and a thematic program that provides participants with a unique opportunity to deepen their knowledge in topical areas and interact with leaders in their respective disciplines.
How meeting advances the mission of FDA:
Meeting advanced the mission of the FDA by sharing up-to-date FDA research data and technologies relevant to regulatory science and members of SOT, the industry that the FDA regulates. This meeting facilitated the cooperation and creation of collaborative efforts with industry scientists; engaged in the recruitment of talented young scientists for the FDA.
Society for Research on Nicotine and Tobacco (SRNT) 23rd Annual Meeting
3/8/2017 to 3/11/2017
Florence, Italy
Total Expense: $73,077
Number of Individuals Whose Expense Were Paid By FDA: 15
Meeting Description:
The Society for Research on Nicotine and Tobacco (SRNT) is the leading association dedicated to all aspects of research on nicotine and tobacco. The 2017 SRNT Annual Meeting will bring together a diverse range of tobacco and nicotine researchers and tobacco control practitioners to discuss their work and share ideas. The meeting will feature cutting-edge research in nicotine and tobacco basic science, clinical, public health, and policy. In particular, the 2017 SRNT meeting will feature an agenda that focuses on up-to-date research on issues critical to FDA tobacco regulatory policy, including emerging science on Electronic Nicotine Delivery Systems (ENDS) such as e-cigarettes, which CTP started to regulate on August 8, 2016. It will provide an opportunity for CTP staff to meet with tobacco researchers concerning their work, and to discuss research progress and future plans. This is also a key meeting for CTP staff to interact with stakeholders from across the tobacco science field, in order both to learn of developments in the field, and communicate CTP priorities.
How meeting advances the mission of FDA:
This conference advanced the Center for Tobacco Products (CTP) mission to protect Americans from tobacco-related death and disease by providing information on the latest developments in nicotine and tobacco research that will ultimately inform and potentially shape future CTP regulatory policy and strategy. Information obtained from this meeting impacted numerous CTP priorities and projects, from research to rulemaking to enforcement efforts. CTP continues to develop new regulations, and working to advance our strategic priorities. CTP's key staff presented on CTP’s current efforts and priorities, and were able to interact with colleagues from around the world on tobacco research and regulation.
6th Manufactured Food Regulatory Program (MFRPS) Alliance meeting and 3rd Governmental Food and Feed Laboratories Accreditation Meeting
1/24/2017 to 1/26/2017
St. Petersburg, Florida
Total Expense: $141,029
Number of Individuals Whose Expense Were Paid By FDA: 84
Meeting Description:
This meeting helps State programs advance conformance with the Manufactured Food Regulatory Program Standards (MFRPS) and Lab ISO Accreditation. The meeting consists of presentations and breakout sessions. The elements of the MFRPS and ISO Accreditation describe the best practices of a high quality regulatory program and encourage continuous improvement and innovation. Achieving conformance with the MFRPS by State manufactured food regulatory programs is critical for advancing an integrated national food safety system, as mandated by the Food Safety Modernization Act (FSMA), and improving public health outcomes.
How meeting advances the mission of FDA:
This meeting helps fulfill FDA's oversight and assistance requirements. FDA's cooperative agreement has clear goals and expectations (requirements) for activities related to national collaboration and best practices, and this annual meeting is important in fulfilling this goal. Contributing content to the meeting and attending the meeting is a requirement under the cooperative agreement. The meeting must be held annually to ensure programs funded through the cooperative agreement receive the training, resources, and support from FDA to achieve the significant to full conformance with the MFRPS within 5 years. The sharing of best practices between States and support from the Districts, Office of Partnerships, and across FDA will be essential for this to occur.
2017 Association of American Feed Control Officers (AAFCO) Mid-Year Meeting
1/15/2017 to 1/18/2017
Mobile, Alabama
Total Expense: $57,038
Number of Individuals Whose Expense Were Paid By FDA: 29
Meeting Description:
FDA participates on the Training and Education Committee on training related issues. The primary mission at this mid-year meeting is to work with the organization on a continuation of Animal Feed Regulatory Program Standards (AFRPS) Standard 2 in building out the Feed curriculum framework, developing the 25 general education domains, completing the feed curriculum framework competencies and begin development of the entry level feed work towards the end of next year. Time was scheduled during the meeting for FDA participants to meet with States enrolled in the AFRPS under the AFRPS Cooperative Agreement (CA), to provide an opportunity to interact and provide information regarding AFRPS implementation to the 20-state regulatory agencies and partnering laboratories that are the AFRPS CA grantees. The AFRPS CA grantees are members of the AAFCO. The mid-year meeting is a good venue to announce and promote the FDA Office of Regulatory Affairs (ORA) Office of Partnership's intention to provide an opportunity for additional States that maintain an animal food contract to apply for funding under an expanded AFRPS CA.
How meeting advances the mission of FDA:
Attendance of Office of Regulatory Affairs (ORA) staff allows for direct face-to-face communication with State partners who are currently implementing the AFRPS and performing work under contracts or cooperative agreements for Animal Feed and Tissue Residue Programs, that will aid the migration toward a nationally integrated feed safety system. Currently, those states that are officially implementing the AFRPS are doing so by utilizing funds allotted via their FDA Feed Contract or the AFRPS Cooperative Agreement. Non-attendance by ORA staff to this AAFCO seminar could send a message that FDA is not supportive of AAFCO events. AAFCO membership consists of State agencies that are awardees of FDA contracts and Cooperative Agreements that include Feed contracts and Cooperative Agreements. Non-attendance would deprive enrolled and potentially interested States that would like to know more and/or ask questions about the implementation of the AFRPS to have this face-to-face encounter with FDA employees.
Conference on Global Food Safety and Administration and Antimicrobial
11/7/2016 to 11/23/2016
Hong Kong, Hong Kong
Total Expense: $33,636
Number of Individuals Whose Expense Were Paid By FDA: 7
Meeting Description:
The Conference on Global Food Safety and Administration and Antimicrobial Resistance (GFSAR) is aiming to bring together leading scientists in the areas of food safety and antimicrobial resistance from around the world to share their experiences on enhancing global food safety and combating global antimicrobial resistance. This international exchange will promote basic and applied research in these areas, facilitate important global collaborations, enhance overall safety of a global food supply, and reduce global antimicrobial resistance.
How meeting advances the mission of FDA:
This meeting advances the mission of FDA by allowing FDA scientific professionals to identify obstacles associated with the detection, surveillance, and control as well as to promote international collaborative research to better address the scientific challenges associated with global food safety and antimicrobial resistance