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                FDA Meetings, Conferences and Workshops

FDA Meetings, Conferences and Workshops

                        FDA Meetings, Conferences, and Workshops: Past Events
          FDA Annual Reports on Conferences


                        Public Calendar - Meetings With FDA Officials Home
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          FDA Meetings, Conferences and Workshops
          2023 FDA-Held Conferences With Expenses Over $100,000FDA Meetings, Conferences and Workshops 2023 FDA-Held Conferences With Expenses Over $100,000
  
  	
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The Food and Drug Administration (FDA) hosted, sponsored, or co-sponsored 6 conferences with expenditures greater than $100,000 this fiscal year. The FDA funded the conference, travel and/or other expenses for 27,027 FDA attendees, 414 Federal employees and 26,613 Non-Federal employees. One Conference sponsor concerning the “FDA23 Rapid Response Team Annual Meeting” was the Association of Food and Drug Officials, which were responsible for meeting logistics and planning as a deliverable of their cooperative agreement (please see “FDA23 Rapid Response Team Annual Meeting” below). Conference topics included, but were not limited to, educating outsourcing facility members on relevant policy matters and FDA oversight approaches regarding outsourcing facilities and drug production; disseminating information on FDA's regulatory requirements to legally study and market drugs, medical devices, and biologics in the United States; and reviewing lessons learned from the past years’ responses, projects for the upcoming year, commodity specific trainings/seminars, and other human and animal food safety topics that would improve Rapid Response Teams’ emergency response capability. All conferences funded and attended followed the applicable Federal authorities, policies, and procedures. Furthermore, conferences helped advance the FDA’s mission by the following reasons, but not limited to, providing information sharing between FDA and Outsourcing Facilities to directly support FDA goals of ensuring the sector can provide products of reliable quality as well as effective implementation of federal law on drug compounding overall; engaging senior managers in discussion and planning to lead the implementation of the decisions made to ensure mission success; allowing FDA to hear directly from small business owners about their questions/concerns about the FDA regulatory procedures as well as allowing FDA to share targeted regulatory information to attendees; and allowing FDA Division/District Offices to receive the training, resources, and support from FDA to develop and maintain a mature Rapid Response Team.

Narrative Report

See below for a summation of all conference expenditures for FY **2023**.
Total Conference Net Expenses (in dollars)    $1,329,952.02

Conference Report

**CONF - 05650
Basic Information**    
Conference Title     **FDA23 Center of Excellence on Compounding for Outsourcing Facilities Conference**
Applicable Conference Type    Scientific, FDA Hosted/Sponsored/Co-Sponsored

Conference Location    Virtual
Conference Start Date    09/12/2023
Conference End Date     09/13/2023

**Cost and Attendee Information**
Total agency cost of the conference      $520,944.78
Total number of individuals whose travel expenses were paid by the agency    0

**Explanation of how the conference advanced the mission of the agency**
The purpose of this conference was to educate outsourcing facility members on relevant policy matters and FDA oversight approaches regarding outsourcing facilities and drug production.  CDER’s Office of Compliance, as well as other offices in CDER (such as the Office of Pharmaceutical Quality) and other offices at the FDA (such as the Office of Regulatory Affairs) worked together to advance FDA’s public health mission related to drug compounding. Although compounded drugs can serve an important medical need for certain patients when an approved drug is not medically appropriate, they also present a risk to patients. Compounded drugs are not FDA-approved. Therefore, they do not undergo premarket review by FDA for safety, effectiveness, and quality. The Drug Quality and Security Act of 2013 created “outsourcing facilities” – a new industry sector of drug compounders held to higher quality standards to protect patient health. Outsourcing facilities are intended to offer a more reliable supply of compounded drugs needed by hospitals, clinics, and other providers. To help the outsourcing facility industry meet its intended function, FDA intends to engage in a number of initiatives to address challenges and support advancement. These include the development and provision of practical and virtual training, as well as in-depth research to better understand barriers that impede growth and potential solutions. This conference enabled engagement and information sharing between FDA and Outsourcing Facilities to directly support FDA goals of ensuring the sector can provide products of reliable quality as well as effective implementation of federal law on drug compounding overall.

**CONF - 05571
Basic Information**    
Conference Title     **FDA23 ORA Manager Summit**
Applicable Conference Type    Non-Scientific, FDA Hosted/Sponsored/Co-Sponsored

Conference Location    The Westin St. Francis San Francisco on Union Square
335 Powell Street
San Francisco, California, USA, 94102
Conference Start Date    09/19/2023
Conference End Date     09/21/2023

**Cost and Attendee Information**
Total agency cost of the conference      $326,907.10
Total number of individuals whose travel expenses were paid by the agency    139

**Explanation of how the conference advanced the mission of the agency**
ORA senior management generally gathers once a year to discuss different topics or organizational processes and procedures, depending on current needs and plans. This was the first time, since COVID, that management was able to meet in-person. Managers, who attended, represented all areas of ORA. These managers were charged to lead the implementation of the decisions made at this meeting and are key to providing input into the final decisions and implementation plans developed in order to meet the ORA and FDA mission and goals. This face-to-face ORA manager summit was mission critical to ensure ORA was able to operate under the proposed new model for ORA. Without approval, ORA functions including the completion of mission critical activities would have been impacted.  By having this meeting, ORA engaged senior managers in discussion and planning for the future to ensure mission success. It was key that managers have the time to interact with one another and dedicate the time to productive discussions, brainstorming, and developing plans.

**CONF - 05237
Basic Information**   
Conference Title    **FDA23 Small Business Regulatory Education for Industry Annual Conference**
Applicable Conference Type    Scientific, FDA Hosted/Sponsored/Co-Sponsored

Conference Location    Virtual
Conference Start Date    06/05/2023
Conference End Date     06/09/2023

**Cost and Attendee Information**
Total agency cost of the conference      $134,555.19
Total number of individuals whose travel expenses were paid by the agency    0

**Explanation of how the conference advanced the mission of the agency**
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance’s (SBIA’s) mission is to promote productive interaction by assisting regulated domestic and international small pharmaceutical business and industry seeking timely and accurate information relating to development and regulation of human drug products. SBIA outreach activities include hosting events in locations that have been determined to be geographically dense with small pharmaceutical businesses, including the generic and device industries. CDER SBIA helps empower small businesses in their interactions with FDA and aids those businesses in the development of more complete submissions and first-cycle drug approvals.  Attendees to this conference received information on FDA's regulatory requirements to legally study and market drugs, medical devices, and biologics in the United States. This conference was divided amongst 3 tracks: drugs, devices, and biologics.  This meeting was a major element for the CDER Small Business and Industry Assistance (CDER SBIA) program within the Division of Drug Information (DDI) in the CDER Office of Communications (OCOMM). This meeting allowed FDA to hear directly from small business owners about their questions/concerns about the FDA regulatory procedures. It also allowed FDA to share targeted regulatory information to attendees. This in turn will assist in sponsors submitting more complete application to the FDA which should ultimately reduce the review time.

**CONF - 04581
Basic Information**    
Conference Title     **FDA23 Rapid Response Team Annual Meeting**
Applicable Conference Type    Non-Scientific, FDA Hosted/Sponsored/Co-Sponsored

Conference Location    Hyatt Regency Long Beach
200 S Pine Avenue
Long Beach, CA 90802
Conference Start Date    12/05/2022
Conference End Date     12/07/2022

**Cost and Attendee Information**
Total agency cost of the conference      $130,355.50
Total number of individuals whose travel expenses were paid by the agency    81

**Explanation of how the conference advanced the mission of the agency**
This meeting served as a venue for Rapid Response Teams (RRT) and stakeholders (FDA/states/local authority/tribal/municipal) to come together to engage, network, and review progress made by grantees during the past year in light of the Rapid Response Team program's oversight and assistance requirements for the RRT Cooperative Agreement. Additionally, this meeting was a critical part of the oversight and management expectations of grantees for activities related to mentorship, national collaboration, and best practices, all of which are integral components of the cooperative agreement. Specifically, attendees reviewed lessons learned from the past years’ responses, projects for the upcoming year, commodity specific trainings/seminars, and other human and animal food safety topics that would improve RRT emergency response capability. The meeting must be held annually to ensure state programs funded through the cooperative agreement and their corresponding FDA Division/District Offices receive the training, resources, and support from FDA to develop and maintain a mature Rapid Response Team. The Association of Food and Drug Officials was responsible for meeting logistics and planning as a deliverable of their cooperative agreement. The RRT cooperative agreement, funded through FDA ORA Office of Partnerships (OP), addressed the need for improved, integrated rapid response to human and animal food emergencies. Multiple national initiatives such as the FDAA (2007), formation of the President’s Food Safety Working Group (2009) and the passage of FSMA (2011) all point to the priority of this issue for the nation.

**CONF - 05171
Basic Information**    
Conference Title     **FDA23 Small Business Regulatory Education for Industry Advancing Generics Forum**
Applicable Conference Type    Scientific, FDA Hosted/Sponsored/Co-Sponsored

Conference Location    Virtual
Conference Start Date    09/01/2023
Conference End Date     09/02/2023

**Cost and Attendee Information**
Total agency cost of the conference      $108,594.74
Total number of individuals whose travel expenses were paid by the agency    0

**Explanation of how the conference advanced the mission of the agency**
The purpose of this science-focused workshop was to communicate to the generic industry how FDA research outcomes guide and facilitate complex generic drug product development. FDA linked GDUFA science and research on complex drug products to product-specific guidance development, discussed pre-ANDA meetings and review, and examined various areas of complex product science. This meeting was a major program element for the CDER Small Business and Industry Assistance (CDER SBIA) program within the Division of Drug Information (DDI) in the CDER Office of Communications (OCOMM). This meeting allowed FDA to hear directly from small business owners about their questions/concerns about the FDA regulatory procedures. This forum allowed FDA to share targeted regulatory information to attendees. This in turn assisted in sponsors submitting more complete application to the FDA which should ultimately reduce the review time.

**CONF - 05048
Basic Information**    
Conference Title     **FDA23 Small Business Regulatory Education for Industry Generic Drugs Forums**
Applicable Conference Type    Scientific, FDA Hosted/Sponsored/Co-Sponsored

Conference Location    Virtual
Conference Start Date    04/12/2023
Conference End Date     04/13/2023

**Cost and Attendee Information**
Total agency cost of the conference      $108,594.71
Total number of individuals whose travel expenses were paid by the agency    0

**Explanation of how the conference advanced the mission of the agency**
The Generic Drugs Forum (GDF) is an annual event that offers attendees the opportunity to hear from FDA subject matter experts from every part of the generic drug assessment program. The goal of the forum was to provide information to aid potential and current applicants by offering practical advice and taking a deep dive into the Abbreviated New Drug Application (ANDA) assessment process. This year’s theme was Celebrating 10 Years of GDF, and presentations focused on hot topics, such as GDUFA III updates, information and technology, and complex generics. The purpose of the meeting was to educate the small business generic pharmaceutical industry on key elements associated with the generic drug development continuum. This meeting also was of invaluable assistance to both CDER and SBIA staff, as it served as reference, providing training material to help directing and in producing relevant material responsive to their audience's inquiries and needs.  This meeting was a major element for the CDER Small Business and Industry Assistance (CDER SBIA) program within the Division of Drug Information (DDI) in the CDER Office of Communications (OCOMM).  It allowed FDA to hear directly from small business owners about their questions/concerns about the FDA regulatory procedures. This forum allowed FDA to share targeted regulatory information to attendees. In turn, this will assist sponsors submitting more complete application to the FDA, which should ultimately reduce the review time.

**NOTE:** For conferences with expenses more than $500,000, in addition to the information required above, the agency approving official will note the expense of the conference is the cost-effective to achieving a compelling purpose and the basis for such approval must be documented in writing by the designated approving official.

Supplemental Information

Reference Authority

21st Century Cures Act, Public Law 114-255, December 2016
	(https://www.congress.gov/bill/114th-congress/house-bill/34/text)
	OMB Memorandum M-17-08, Promoting Efficient Spending to Support Agency Operations, Section 2, November 2016
	(https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/memoranda/2017/m-17-08.pdf)
	HHS Policy on Promoting Efficient Spending: Use of Appropriated Funds for Conferences and Meeting Space, Food, Promotional Items, and Printing and Publications, September 2017
	(https://www.hhs.gov/grants/contracts/contract-policies-regulations/efficient-spending/index.html) ***Note: This link leads to the 2015 version of the policy that is currently listed on the HHS.gov website. Once the 2017 version of the policy has been uploaded to the HHS.gov website, this link must be updated to reflect the 2017 policy.***
	FDA Conference Approval and Public Reporting (CAPR) Staff Manual Guide (SMG) 2350.5**Recipient:** Assistant Secretary of Financial Resources (ASFR)

**Frequency/Submission Date:** Annually / January 31st of each year

**Distribution:** Published to FDA Annual Report on Conference website

                                                                                  Content current as of:
      01/29/2024FDA Meetings, Conferences and Workshops

          
                        FDA Meetings, Conferences, and Workshops: Past Events
          FDA Annual Reports on Conferences


                        Public Calendar - Meetings With FDA Officials
 
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