Statement of Organization, Functions, and Delegations of Authority
Published date | 20 May 2019 |
Record Number | 2019-10431 |
Section | Notices |
Court | Food And Drug Administration |
Federal Register, Volume 84 Issue 97 (Monday, May 20, 2019)
[Federal Register Volume 84, Number 97 (Monday, May 20, 2019)] [Notices] [Pages 22854-22858] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2019-10431] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Statement of Organization, Functions, and Delegations of Authority AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA), Office of the Commissioner, Headquarters organizations, and Centers have modified their structures. FOR FURTHER INFORMATION CONTACT: William Tootle, Director, Office of Budget, Office of the Commissioner, Food and Drug Administration, 4041 Powder Mill Rd., Rm. 72094, Beltsville, MD 20705-4304, 301-796-4710. SUPPLEMENTARY INFORMATION: I. Introduction Part D, Chapter D-B, (Food and Drug Administration), the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services (35 FR 3685, February 25, 1970; 60 FR 56606, November 9, 1995; 64 FR 36361, July 6, 1999; 72 FR 50112, August 30, 2007; 74 FR 41713, August 18, 2009; and 76 FR 45270, July 28, 2011) is amended to reflect the reorganization of the Office of the Commissioner/FDA Headquarters and the following Centers: Center for Devices and Radiological Health (CDRH), Center for Drug Evaluation and Research (CDER), Center for Food Safety and Applied Nutrition (CFSAN), Center for Tobacco Products (CTP), and Center for Veterinary Medicine (CVM). The Office of the Commissioner reorganization will transition FDA away from the Directorate structure. Abolishing the current directorate structure and realigning many of those functions to the Centers/Office of Regulatory Affairs (ORA) establishes a direct line of communication between the Centers/ORA and the Commissioner of Food and Drugs. This direct report relationship with the Centers streamlines communications and better positions FDA to support its regulatory programs and mission. The intent is to create a more effective structure that better reflects FDA's priorities and streamlines operations. The CDRH reorganization will more accurately reflect the functions performed by the Center and help to enhance CDRH's ability to advance FDA's mission and streamline operations and support functions. The CDER reorganization changes the organizational structures and revises the functional statements of following organizations: Office of Communication (OCOMM), Office of Compliance (OC), Office of Executive Programs (OEP), Office of Hematology and Oncology Products (OHOP), and Office of New Drugs (OND). The proposed organizational changes will enhance CDER's ability to develop, coordinate, and evaluate public health communication and education activities in support of the following: The CDER Office of Compliance proposed structure change will establish the framework for a stronger regulatory oversight of the compounded human drugs facilities and compounding related activities. The new structure will help ensure the following: That compounding pharmacies operate within the bounds of traditional pharmacy practice (not manufacturing); that outsourcing facilities operate according to the conditions in section 503B; and the new structure will protect patients from unsafe or ineffective compounded drugs. The CDER Office of Communication is planning to expand CDER's communications outreach and educational efforts to inform the conversation among FDA's stakeholders. This will be managed through accessing more communication channels, enhancing FDA's social media presence, and using more innovative tools. The impact of CDER's growth has impacted the volume of information posted on the web as the content management and development of tools used to connect stakeholders with web content are created. As new programs and initiatives are developed by the Center, the web content will increase. The new content management system will provide the Agency with the opportunity to finally have a true publishing tool. This will allow greater speed in posting the content in the web environment. The CDER Office of Executive Programs houses all the executive functions for CDER and ensures the goals and priorities of the Center Director are carried out. These functions range from administrative support for the Center Director's Office, overseeing the Center's learning and organizational development program, to managing the Center's 18 different Advisory Committees. Restructuring these functions into defined organizational structures will improve decision making by promoting the direct flow of information from frontline employees to the managers directly responsible for making decisions and provide clarity to staff roles and responsibilities. Furthermore, the proposed organizational changes permit Office of Executive Programs' managers to better define critical business processes and identify opportunities for streamlining complex tasks, which will facilitate a more efficient and strategic deployment of these resources during public health emergencies and outbreaks. The proposed changes align with Reimagine HHS guiding principle #3--Generating Efficiencies through Streamlined Processes and Reimagine HHS guiding principle #5-- HHS as a More Innovative and Responsive Organization. The CDER Office of Hematology and Oncology Products reorganization is in response to Title III of the 21st Century Cures Act (Cures Act), enacted into law on December 13, 2016, which provides authorities FDA can use to help modernize drug, biological, and device product development and review to create greater efficiencies and predictability in product development and review. Numerous initiatives are currently taking place in the Agency to carry out the plan laid out in the Cures Act and include: Patient Focused Drug Development; Novel Clinical Trial Design; Real World Evidence; Summary-level Review and Inter-Center Institutes; as well as other initiatives. The Office of Hematology and Oncology Products [[Page 22855]] has been an active participant and at times a leader in many of these initiatives. To meet external and internal stakeholders' expectations and to effectively and efficiently carry out these initiatives delineated in the Cures Act, it is necessary to flatten out the organizational structure. The office proposes to expand their clinical review divisions from three to five, create a centralized safety reporting team, and create a labeling team. The office is dedicated in modernizing the drug, biological, and device product development and review and in creating greater efficiencies and predictability in oncology product development and review. With this restructuring, the office, working in partnership with the Oncology Center of Excellence, can ensure that the Agency's initiatives are being worked on in an efficient and cohesive manner so that industry and all other outside groups feel as if we are working with them in the fight against cancer. The CDER Office of Therapeutic Biologics and Biosimilars reorganization is in response to the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which was enacted on March 23, 2010. This law amended the Public Health Service Act (PHS Act) to create an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an already approved FDA-licensed biological product (the reference product). This pathway was established to provide more treatment options, increase access to lifesaving medications, and potentially reduce healthcare costs through increased competition. The current review management and policy development approach for biosimilar and interchangeable products lacks a ``primary owner'' and this impacts CDER's ability to set a singular goal and focus on internal operational requirements and communication similar to new drugs and generic drugs products. Specifically, policy development is fractured between the CDER Office of Medical Policy (OMP), Office of New Drugs (OND), and Office of Regulatory Policy (ORP). Since there is no office that holds primary responsibility for setting policy direction, the drafting and responding to inquiries such as citizen petitions and the development of policy positions is split between the various organizations. Likewise, the communication efforts are split between CDER OMP, OND, and OCOMM. While there is clear evidence of operational efficiencies associated with the review process for biosimilar and interchangeable products, the biggest inefficiency is with policy development. This proposed reorganization will be part of FDA's ongoing efforts to achieve the performance goals agreed to by the Agency in conjunction with the reauthorization of Biosimilar User Fee Act (BsUFA II). The CFSAN reorganization realigns functions and personnel, retitling and establishing of new organizations within the CFSAN offices of: Office of Cosmetics and Colors, Office of Food Additive Safety, and Office of Coordinated Outbreak Response and Evaluation Network, which formalize its organizational components and functions; distinguish operational culture between pre- and post-market review; clarify staff allocation; improve effectiveness; and increase efficiency in the management and leadership for internal and external stakeholders. The CTP Office of Health Communication and Education reorganization establishes the Division of Research and Evaluation; changes the title of the Division of Health, Scientific, and Regulatory Communication to the Division of Regulatory Communication; and revises the functional statements of the Office of Health Communication and Education; the Division of Public Health Education; and the Division of Regulatory Communication. The proposed organizational changes will enhance the Center's ability to develop, coordinate, and evaluate public health communication and education activities in support of requirements of the Family Smoking Prevention and Tobacco Control Act. The CVM reorganization affects the Center's Office of Management and Office of New Animal Drug Evaluation. The CVM Office of Management reorganization establishes the Business Informatics Staff; abolishes the Management Logistics Staff; and revises the functional statements of the Office of Management. The organizational changes will enhance CVM's ability to promote information technology guidelines and policies; manage the center's information technology portfolio; and provide capital planning and investment controls to the Department of Health and Human Services. The CVM Office of New Animal Drug Evaluation reorganization establishes the Division of Animal Bioengineering and Cellular Therapies and revises the functional statements of the Office of New Animal Drug Evaluation. The organizational changes will create a dedicated group for the review and approval of biologically derived emerging technologies, such as animal bioengineering and cell and gene therapy products. The Food and Drug Administration, Office of the Commissioner (OC) and Headquarters, Centers, and Offices, have been restructured as follows: DCA. ORGANIZATION. The Office of the Commissioner is headed by the Commissioner of Food and Drugs, and includes the following organizational units: OFFICE OF THE COMMISSIONER Office of the Chief Counsel Office of the Executive Secretariat Freedom of Information Staff Office of the Counselor to the Commissioner DCB. ORGANIZATION. The Center for Biologics Evaluation and Research is headed by the Center Director. CENTER FOR BIOLOGICS EVALUATION AND RESEARCH DCC. ORGANIZATION. The Center for Devices and Radiological Health is headed by the Center Director and includes the following organizational units: CENTER FOR DEVICES AND RADIOLOGICAL HEALTH Office of the Center Director Quality Management Staff Office of Science and Engineering Laboratories Management Support Staff Division of Biomedical Physics Division of Imaging, Diagnostics, and Software Reliability Division of Applied Mechanics Division of Administrative and Laboratory Support Division of Biology, Chemistry and Materials Science Office of Communication and Education Program Management Operations Staff Division of Communication Web and Graphics Branch External Communications Branch Internal Communications Branch Division of Industry and Consumer Education Postmarket and Consumer Branch Premarket Programs Branch Division of Information Disclosure Freedom of Information Branch A Freedom of Information Branch B Division of Employee Training and Development Employee Development Branch Technology and Learning Management Branch Office of Management Planning and Program Analysis Staff Division of Workforce Management Division of Financial Management Division of Management Services Division of Acquisition Services Office of Product Evaluation and Quality Quality and Analytics Staff Clinical and Scientific Policy Staff Strategic Initiatives Staff Regulation, Policy and Guidance Staff Office of Regulatory Programs Division of Regulatory Programs I Division of Regulatory Programs II Division of Regulatory Programs III Office of Clinical Evidence and Analysis [[Page 22856]] Division of Clinical Evidence and Analysis I Division of Clinical Evidence and Analysis II Office of Health Technology I Division of Health Technology I A Division of Health Technology I B Division of Health Technology I C Office of Health Technology II Division of Health Technology II A Division of Health Technology II B Division of Health Technology II C Office of Health Technology III Division of Health Technology III A Division of Health Technology III B Division of Health Technology III C Office of Health Technology IV Division of Health Technology IV A Division of Health Technology IV B Office of Health Technology V Division of Health Technology V A Division of Health Technology V B Office of Health Technology VI Division of Health Technology VI A Division of Health Technology VI B Division of Health Technology VI C Office of In Vitro Diagnostics and Radiological Health Division of Chemistry and Toxicology Devices Chemistry Branch Diabetes Branch Toxicology Branch Cardio-Renal Diagnostics Branch Division of Immunology and Hematology Devices Hematology Branch Immunology and Flow Cytometry Branch Division of Microbiology Devices Viral Respiratory and Human Papilloma Respiratory Branch General Viral and Hepatitis Branch General Bacterial and Antimicrobial Susceptibility Branch Bacterial Respiratory and Medical Countermeasures Branch Division of Radiological Health Magnetic Resonance and Electronic Products Branch Diagnostic X-Ray Systems Branch Nuclear Medicine and Radiation Therapy Branch Mammography, Ultrasound and Imaging Software Branch Division of Mammography Quality Standards Program Management Branch Information Management Branch Division of Program Operations and Management Division of Molecular Genetics and Pathology Molecular Pathology and Cytology Branch Molecular Genetics Branch Office of Strategic Partnerships and Technology Innovation Division of All Hazards Response, Science and Strategic Partnerships Division of Digital Health Division of Technology and Data Services Office of Policy DCD. ORGANIZATION. The Center for Drug Evaluation and Research is headed by the Director and includes the following organization units: CENTER FOR DRUG EVALUATION AND RESEARCH Office of the Center Director Office of Regulatory Policy Office of Management Office of Communications Office of Compliance Office of Manufacturing Quality Office of Unapproved Drugs and Labeling Compliance Office of Scientific Investigations Office of Program and Regulatory Operations Office of Medical Policy Office of Prescription Drug Promotion Office of Medical Policy Initiatives Office of Translational Sciences Office of Biostatistics Office of Clinical Pharmacology Office of Computational Science Office of Study Integrity and Surveillance Office of Executive Programs Office of Surveillance and Epidemiology Office of Medication Error Prevention and Risk Management Office of Pharmacovigilance and Epidemiology Office of New Drugs Office of Drug Evaluation I Office of Drug Evaluation II Office of Drug Evaluation III Office of Antimicrobial Products Office of Drug Evaluation IV Office of Hematology and Oncology Products Office of Strategic Programs Office of Program and Strategic Analysis Office of Business Informatics Office of Generic Drugs Office of Research Standards Office of Bioequivalence Office of Generic Drug Policy Office of Regulatory Operations Office of Pharmaceutical Quality Office of Biotechnology Products Office of New Drug Products Office of Policy for Pharmaceutical Quality Office of Process and Facilities Office of Surveillance Office of Testing and Research Office of Program and Regulatory Operations Office of Lifecycle Drug Products DCE. ORGANIZATION. The Center for Food Safety and Applied Nutrition is headed by the Center Director. CENTER FOR FOOD SAFETY AND APPLIED NUTRITION DCED. ORGANIZATION. The Office of Food Additive Safety is headed by the Director, Office of Food Additive Safety, and includes the following organizational units: Office of Food Additive Safety Operations Staff Division of Food Contact Substances Toxicology Review Branch Chemistry Review Branch Regulatory Review Branch Division of Food Ingredients Toxicology Review Branch Chemistry Review Branch Regulatory Review Branch Division of Biotechnology, Regulatory Science, and Surveillance Post-Market Review Branch Scientific Support Branch DCEE. ORGANIZATION. The Office of Cosmetics and Colors is headed by the Director, Office of Cosmetics and Colors, and includes the following organizational units: Office of Cosmetics and Colors Division of Cosmetics and Colors Color Certification Branch Color Technology Branch Division of Cosmetics Cosmetics Regulatory Activities Branch Cosmetics Regulatory Science Branch DCEN. ORGANIZATION. The Office of Coordinated Outbreak Response and Evaluation Network is headed by the Director, Office of Coordinated Outbreak Response and Evaluation Network, and includes the following organizational units: Office of Food Additive Safety Signals and Analysis Staff DCF. ORGANIZATION. The Center for Tobacco Products is headed by the Center Director. CENTER FOR TOBACCO PRODUCTS DCFF. ORGANIZATION. The Center for Tobacco Products Office of Health Communication and Education is headed by the Director of Health Communication and Education and includes the following organizational units: Office of Health Communication and Education Division of Public Health Education Division of Regulatory Communication Division of Research and Evaluation DCG. ORGANIZATION. The Center for Veterinary Medicine is headed by the Center Director. CENTER FOR VETERINARY MEDICINE DCGB. ORGANIZATION. The Center for Veterinary Medicine Office of Management is headed by the Associate Director for Management and includes the following organizational units: Budget Planning and Evaluation Staff Business Informatics Staff Human Capital Management Staff Program and Resources Management Staff Talent Development Management Staff DCGC. ORGANIZATION. The Center for Veterinary Medicine Office of New Animal Drug Evaluation is headed by the Director of New Animal Drug Evaluation and includes the following organizational units: Division of Animal Bioengineering and Cellular Therapies Division of Business Information Science and Management Division of Generic Animal Drugs Division of Human Food Safety Division of Manufacturing Technologies Division of Production Drugs Division of Scientific Support Division of Therapeutic Drugs for Food Animals Division of Therapeutic Drugs for Non-Food Animals DCH. ORGANIZATION. The Oncology Center of Excellence is headed by the Director and includes the following organizational units: ONCOLOGY CENTER OF EXCELLENCE DCI. ORGANIZATION. The Office of Regulatory Affairs is headed by the Associate Commissioner for Regulatory Affairs. OFFICE OF REGULATORY AFFAIRS DCJ. ORGANIZATION. The Office of Clinical Policy and Programs is headed by the Director, Office of Clinical Policy and [[Page 22857]] Programs, and includes the following organizational units: OFFICE OF CLINICAL POLICY AND PROGRAMS Healthcare Provider Staff Patient Affairs Staff Office of Clinical Policy Good Clinical Practice Staff Office of Combination Products Office of Orphan Products Development Office of Pediatric Therapeutics DCK. ORGANIZATION. The Office of External Affairs is headed by the Associate Commissioner for External Affairs and includes the following organizational units: OFFICE OF EXTERNAL AFFAIRS Operations Staff FDA History Office Stakeholder Engagement Staff Web & Digital Services Staff Office of Media Affairs Office of Editorial and Creative Services DCL. ORGANIZATION. The Office of Food Policy and Response is headed by the Deputy Commissioner for Food Policy and Response, and includes the following organizational units: OFFICE OF FOOD POLICY AND RESPONSE Office of Resource Planning and Strategic Management DCM. ORGANIZATION. The Office of Minority Health and Health Equity is headed by the Assistant Commissioner for Minority Health and Health Equity and includes the following organizational units: OFFICE OF MINORITY HEALTH AND HEALTH EQUITY DCN. ORGANIZATION. The Office of Operations is headed by the Chief Operating Officer and includes the following organizational units: OFFICE OF OPERATIONS Office of Enterprise Management Services Program Effectiveness Staff Division of Compliance and Conflict Prevention Conflict Prevention and Resolution Staff Division of Human Capital Division of Information Governance Dockets Management Staff Division of Resource Management Division of Vendor Management Office of Equal Employment and Opportunity Compliance Staff Office of Ethics and Integrity Office of Facilities, Engineering and Mission Support Services Jefferson Laboratories Complex Staff Facilities Program Staff Employee Safety and Occupational Health Staff Division of Operations Management and Community Relations Logistics and Transportation Management Branch Facilities Maintenance and Operations Branch Auxiliary Program Management Staff Division of Planning, Engineering and Space Management Portfolio and Space Management Branch Engineering Management Branch Office of Finance, Budget, and Acquisitions Business Management Services Staff Office of Acquisitions and Grants Services Division of Acquisition Operations Service Contracts Branch Contracts Operations Branch Division of Acquisition Programs Scientific Support Branch Field Operations Branch Facilities Support Branch Division of State Acquisitions, Agreements and Grants Grants and Assistance Agreements Branch ORA Inspection Branch CTP Inspection Branch Division of Information Technology Acquisitions Information Technology Acquisitions Branch Systems Technology Acquisitions Branch Information Technology Strategic Support Branch Division of Policy, Systems and Program Support Training and Development Branch Acquisitions Policy and Oversight Branch Office of Budget Division of Budget Formulation and Program Alignment Division of Budget Execution and Control Office of Financial Management Financial Systems Support Staff Division of Accounting Division of Controls, Compliance and Oversight Division of Payment Services Division of Travel Services Field Operations Staff Division of User Fees Office of Human Capital Management Business Operations Staff Management and Administrative Inquiries Staff Performance Management and Awards Staff Division of FDA Training and Development Organization Development and Learning Solutions Branch Training Delivery and Program Operations Branch Division of Human Resources Systems and Operations Support Data Quality and Services Management Branch Human Resources Information Systems and Records Branch Human Resources Information Technology Branch Retirement and Benefits Branch Timekeeping and Payroll Services Branch Division of Employee and Labor Relations Employee Relations Branch I Employee Relations Branch II Labor Relations Branch Division of Strategic Talent Management Programs Workforce Support and Development Branch Quality of Work-life Programs Branch Office of Information Management and Technology Office of Information Management Office of Information Security Office of Technology and Delivery Delivery Management and Support Staff Division of Infrastructure Operations Infrastructure Management Services Staff Implementation Branch Infrastructure Engineering Branch Systems Monitoring & Response Branch Systems Operations Branch Network & Communications Operations Branch Division of Application Services Application Management Services Staff Data Management & Operations Branch Medical Products Branch OC/CVM/CTP Branch ORA/CFSAN Branch Enterprise Applications Branch Office of Business & Customer Assurance Division of Business Partnership & Support Internet & Intranet Branch Call Center Branch Regional Support Branch Property, Receiving & Distribution Branch Employee Resource and Information Center Division of Management Services Office of Enterprise Portfolio Management Office of Informatics & Technology Innovation Informatics Staff Knowledge Management Staff Enterprise Architecture Staff Office of Planning and Evaluation Planning Staff Program Evaluation and Process Improvement Staff Office of Security and Emergency Management Office of Security Operations Office of Emergency Management Emergency Planning, Exercises and Evaluation Staff Program Operations and Coordination Staff Office of Emergency Operations Office of Talent Solutions Commission Corps Staff Executive Resources Staff Policy and Accountability Staff Scientific Talent Recruitment Staff Division of Talent Services I CDER Branch A CDER Branch B CDER Branch C Division of Talent Services II CFSAN and CVM Branch OC and National Center for Toxicological Research Branch OO Branch Division of Talent Services III CBER Branch CDRH Branch CTP Branch Division of Talent Services IV ORA Branch A ORA Branch B ORA Branch C Division of Talent Sourcing and Staffing Corporate Recruitment & Title 38 Branch Scientific Staffing & Outreach Branch Customer Care and Data Quality Branch DCO. ORGANIZATION. The Office of Policy, Legislation, and International Affairs is headed by the Deputy Commissioner for Policy, Legislation, and International Affairs and includes the following organizational units: OFFICE OF POLICY, LEGISLATION, AND INTERNATIONAL AFFAIRS Intergovernmental Affairs Staff Management and Operations Staff Office of Congressional Appropriations Office of Economics and Analysis Office of Global Policy and Strategy Office of Global Diplomacy and Partnerships Office of Global Operations [[Page 22858]] Regional Field Office, China Office Regional Field Office, Europe Office Regional Field Office, India Office Regional Field Office, Latin America Office Office of Trade, Mutual Recognition and International Arrangements Office of Legislation Office of Policy Policy Engagement and Coordination Staff Regulations Editorial Staff Regulations Policy and Management Staff DCP. ORGANIZATION. The Office of the Chief Scientist is headed by the Chief Scientist and includes the following organizational units: OFFICE OF THE CHIEF SCIENTIST Advisory Committee Oversight and Management Staff Office of Counter-Terrorism and Emerging Threats Office of Laboratory Safety Office of Regulatory Science and Innovation Office of Scientific Integrity Office of Scientific Professional Development National Center for Toxicological Research DCQ. ORGANIZATION. The Office of Women's Health is headed by the Assistant Commissioner for Women's Health and includes the following organizational units: OFFICE OF WOMEN'S HEALTH II. Delegations of Authority Pending further delegation, directives, or orders by the Commissioner of Food and Drugs, all delegations and redelegations of authority made to officials and employees of affected organizational components will continue in them or their successors pending further redelegations, provided they are consistent with this reorganization. III. Electronic Access This reorganization is reflected in FDA's Staff Manual Guide. Persons interested in seeing the complete Staff Manual Guide can find it on FDA's website at: https://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/default.htm. Authority: 44 U.S.C. 3101. Alex M. Azar, II, Secretary, HHS. [FR Doc. 2019-10431 Filed 5-17-19; 8:45 am] BILLING CODE 4164-01-P