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  5. FDA-TRACK: Significant Accomplishments to Date
  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: Significant Accomplishments to Date

The following are a few examples (not inclusive) of some significant accomplishments since the inception of the FDA-TRACK program.

Agency Vacancy Rate: The FDA uses numerous committees and panels to obtain independent expert advice on scientific, technical, and policy matters. This includes questions related to the development and evaluation of products regulated by FDA. When FDA-TRACK first began, one of the first main cross-agency initiatives was to decrease the vacancy rate on the Advisory Committees. In October 2009, when the FDA started to monitor monthly advisory committee vacancy rates in FDA-TRACK, the Advisory Committee vacancy rate was at 33%. Through monthly FDA-TRACK data analysis, quarterly briefings and subsequent follow-up, the root issues of the Advisory Committee recruitment and selection process that affected vacancy rates were identified and addressed in an effort to reach a 10% target vacancy rate. With increased accountability and oversight through FDA-TRACK, the Agency’s overall vacancy rate in 2018 is at 10%.

    Office of Biostatistics and Epidemiology (OBE), Use of Lot Distribution Data to Estimate Patient Exposure for Epidemiological Analysis of Adverse Event Reports: This measure tracks the number of lot distribution reports received by CBER in the month and uploaded into CBER’s Regulatory Management System – Biologics License Applications database (RMS-BLA) within 7 days. Manufacturers of vaccines and other biological products electronically submit post-marketing lot distribution data to CBER’s Lot Distribution Database (LDD) for use in post-marketing safety surveillance. Previously, this data was primarily submitted to CBER as paper reports. The conversion to electronic submissions provides a standardized and consistent presentation of lot distribution information which improves the accuracy, efficiency, and timeliness. After successfully tracking this measure in FDA-TRACK, this measure was added as a performance goal in CBER’s 2017 budget.

      Promote a Culture of Meaningful Patient Engagement by CDRH Interaction with Patients: CDRH set out to obtain patient input on key premarket and postmarket issues facing CDRH and foster participation of 10 patient groups. By the end of 2016, CDRH staff participated in 21 patient interaction opportunities, involving 34 patient organizations. CDRH also set a 2016 target of 50% for CDRH employees to interact with patients as part of their job duties. CDRH exceeded this target by 18% (68%).

      Increase Use and Transparency of Patient Input as Evidence in CDRH Decision Making: CDRH set an FY 2016 target of 50% for PMA (premarket approval), de novo and HDE (humanitarian device exemption) decisions to include a public summary of available and relevant patient perspective data considered. CDRH exceeded this goal, with 65% of all PMAs, de novo, and HDEs included a public summary of available patient perspective data. Additionally, during FY 2017, CDRH implemented a measure to increase the number of patient perspective studies (e.g., evaluating patient-reported outcomes (PRO) or patient preferences (PPI)) used in support of premarket and postmarket regulatory decisions.

        Office of New Drugs (OND), Number of New Drug Applications (NDAs) and Biologics License Applications (BLAs) submitted: One goal of the Prescription Drug User Fee Act (PDUFA) V is to improve the efficiency and effectiveness of the first cycle review process and to decrease the number of review cycles necessary for approval without changing approval standards. First cycle approval means a drug was approved without requests for additional information that would delay approval and lead to another cycle of review. In July 2012, CDER began tracking the number of NDAs and BLAs approved in the first cycle. In the first fiscal year (FY 2013), 66 NDAs and BLAs were approved in the first cycle. Since this time, the number of first cycle approvals has continued to increase with 99 NDAs and BLAs approved in FY 2016.

          Office of Food Defense, Communication and Emergency Response (OFDCER), FSMA Webpage: One of the main goals for the FDA's Foods and Veterinary Medicine Program  has been providing outreach, education, and resources  to stakeholders on the provisions of the new FDA Food Safety Modernization Act (FSMA).  FDA's Foods and Veterinary Medicine Program achieved its goal  to create and maintain a knowledge portal to promote awareness of the FSMA and its 50 regulations/guidance to  help drive industry compliance and improve public health. The portal  opened on February 15, 2011 and  provides stakeholders (consumers, industry, food safety professionals, Federal/State/local regulators, and international trading partners) information on what the FSMA is, who it impacts, how it’s being implemented, and the opportunities for stakeholders to be involved. FDA-TRACK provided the platform for  FDA to setup the initial portal  to consolidate FSMA-related materials including Frequently Asked Questions in one location, establish and maintain a mailbox for FSMA communications with stakeholders,  establish a subscriber list to receive e-mail updates, and  develop Standard Operating Procedures for maintaining the portal in order to constantly have the most up-to-date information available to stakeholders. Through successful planning, in the first year of its existence, the portal boasts 11, 500 subscribers, 126 Frequently Asked Questions in 12 topic areas, 10 blogs, 4 quarterly progress reports.  Visit the FSMA knowledge portal to see current materials and FSMA timelines.

            Focus on our YouthFDA protects youth from illegal sales of e-cigarettes, e-liquids, and cigars by enforcing restrictions that make it illegal to sell tobacco products to minors. In September 2016, the FDA took action against 55 tobacco retailers by issuing the first warning letters for selling these newly regulated tobacco products to minors. This came about a month after the FDA began enforcing new federal regulations making it illegal nationwide to sell the newly regulated tobacco products to anyone under age 18 in person and online, and requiring retailers to check photo ID of anyone under age 27, among other restrictions. Before the August 8, 2016, final rule that extended the FDA’s authority to all tobacco products, there was no federal prohibition on the sale of these products to children. With this rule and as part of the 2009 Family Smoking Prevention and Tobacco Control Act, FDA closely monitors retailer compliance with federal tobacco laws and regulations and takes corrective action on violations. The agency and/or its contractors conduct inspections in 56 states and territories. For found violations, the FDA generally issues warning letters before pursuing enforcement actions, including civil money penalties and no tobacco sale orders. In FY2016 alone, FDA conducted 165,169 inspections of tobacco product retail establishments, issued 13,940 warning letters to retailers for violating the law, and initiated 3,685 civil money penalty cases

              Office of New Animal Drug Evaluation (ONADE), Pre-AGDUFA Generic New Animal Drug Applications Backlog: In August 2010, CVM eliminated its backlog of generic new animal drug applications, approximately 132 applications, received prior to the Animal Generic Drug User Fee Act (AGDUFA) which was effective October 1, 2008. CVM was able to successfully eliminate this backlog through the monthly tracking and monitoring of these applications via FDA-TRACK. CVM prioritized and planned the review of these applications based upon application complexity to ensure sufficient time was allotted to complete the reviews in FY 2010. With the elimination of this backlog, CVM anticipates it will enhance the cost effectiveness and predictability of new animal drug development. It further expects that the number of generic new animal drug applications submitted to CVM will increase, hopefully leading to an increase in the number of generic new animal drugs available on the market.

                • Office of Management (OM), Workforce Initiative: CVM has recognized a movement across the Federal government from reactive Human Resources Management towards proactive Human Capital Planning to ensure the workforce has the right people, in the right place, at the right time. OM has embarked on this large initiative to better understand the current and emerging issues facing the CVM workforce and design hiring and retention strategies that will ensure CVM’s future workforce has the knowledge and skills necessary to operate as a high-performing organization. Some of these initiatives were managed and tracked in FDA-TRACK and include:
                  • Strategic Human Capital Plan - In June 2011, CVM completed the development of its Strategic Human Capital Plan. The Plan was designed to guide the creation and implementation of the Center's human capital programs from FY2012-2016. It will allow CVM to respond to its current and future scientific and regulatory demands with both innovation and excellence.
                  • Workforce Profiles - In May 2010, CVM completed Workforce Profiles for three Mission Critical Occupations (MCOs): 1) Veterinary Medical Officer; 2) Consumer Safety Officer; and 3) Chemist. This highly valuable information enables the Center's leadership to gain a better understanding of the workforce and project future workforce trends and to identify potential workforce issues.
                  • Attrition Projection Models - In May 2010, CVM completed Attrition Projection Models for three MCOs: 1) Veterinary Medical Officer; 2) Consumer Safety Officer; and 3) Chemist. These models allow the Center to successfully apply valid statistical formulas to CVM's workforce data to anticipate areas of attrition risk.
                  • Competency Models - In April 2010, CVM completed the development of its competency models and utilized these technical competency models to draft competency-based position descriptions (PDs)

              FOIA Backlog: FDA has been working to reduce its backlog of FOIA requests through enhancements to its programs. The number of FOIA requests pending reached an all-time low (2,535 as of FY16 year-end) since tracking this measure in FY09. This was an 8% decrease in the backlog compared to FY15 (2,769 as of FY15 year-end). Meanwhile, the number of FOIA requests received continues to gradually increase each year. Tracking these requests has allowed FOIA to evaluate and rearrange work responsibilities as needed to ensure balanced workloads, train redactors on additional subject matter areas to keep pace with frequently requested records, and set closeout target dates for older FOIA requests.

                Develop and Validate Genetic Biomarkers: NCTR led a cross-Agency effort to develop research techniques to produce new biomarkers and evaluate existing biomarkers. NCTR scientists authored a book chapter for Molecular Toxicology Protocols (Methods in Molecular Biology series) that details methods for conducting the Pig-a gene mutation assay in mice and rats. The Pig-a assay is rapid, relatively inexpensive, and is functional across species (mice-to-human), making it a potentially valuable tool for regulatory safety assessments. Additionally, NCTR researchers developed and tested a simpler, more accurate and sensitive genetic analysis approach that utilizes next-generation sequencing and publically-available bioinformatics approaches to quickly detect and catalog genetic mutations in cells.

                Pediatric Anesthesia Research: In collaboration with the Center for Drug Evaluation and Research (CDER), NCTR scientists defined pathways behind brain damage associated with exposure to general anesthetics, specifically as it relates to early to late stages of infant development. This research increases our knowledge of how the body is affected by various general anesthetics and how these effects can be lessened in the future.

                  Office of the Chief Scientist (OCS), Commissioner’s Fellowship Program: This two-year fellowship program provides an opportunity for health professionals and scientists to receive training and experience at the FDA. The goals of the program are to: 1) attract scientists to the FDA to address a regulatory science issue, 2) train scientists in regulatory science, and 3) serve as a recruiting tool for FDA. Since tracking began in FY13, 81 fellows have participated in the Commissioner’s Fellowship Program. 88% of these fellows have graduated the program, and 77% of these graduates accepted internal offers to work at the FDA. During this, the fellows completed 74 projects and published 63 peer review manuscripts.

                    Voluntary National Retail Food Regulatory Program Standards (Program Standards): FDA has developed the Program Standards to achieve national uniformity among regulatory programs responsible for retail food protection in the United States. The Program Standards are designed to help retail food regulatory programs enhance the services they provide to the public and receive recognition for meeting these standards. In support of this goal, FDA works cooperatively with state, local, territorial and tribal partners using a risk-based approach to leverage limited resources. Program enrollment has increased from 546 agencies at the beginning of FY13 to over 770 agencies and it continues to increase.

                      Note:  The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time.

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