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U.S. Department of Health and Human Services

About FDA

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Office of Business Informatics (OBI)

Provides leadership and coordination of informatics activities across CDER and makes recommendations that support long-term strategic goals.

Builds strategic partnerships with internal clients and conducts joint business planning with CDER offices to systemically assess and prioritize business informatics needs.

Translates business priorities into a single, center-wide portfolio of informatics initiatives that are delivered through strategic partnerships, such as: the FDA Office of Information Management (OIM), and provides overall program management.

Provides business informatics services & solutions across CDER through a network of strategic internal and external partners.

 

Office Leadership

  • Hilmar Hamann, Ph.D., Office Director
  • Gary Gensinger, MBA, Office Deputy Director
  • Mark Gray, Division of Data Management Services & Solutions Director
  • Linda Sigg, MS, Division of Regulatory Review and Drug Safety Services & Solutions Director
  • Binh Ta, PMP, Innovation Management & Architecture Services & Solutions Director
  • William Taylor, Division of Drug Quality and Compliance Services & Solutions Director

 

Descriptions of Organizational Units

Immediate Office

  1. CDER Program Management Office
    Ensures successful delivery of the CDER Informatics Action Plan and evaluates new client requests to assess timing, scope, funding and resources.
  2. Innovation Management & Architecture Services & Solutions
    Ensures successful delivery of the CDER Informatics Action Plan and evaluates new client requests to assess timing, scope, funding and resources.
  3. Center IT Liaison Team
    Coordinates Information Technology (IT) initiatives between CDER and the Office of Information Management (OIM) and facilitates IT processes in support of CDER’s business priorities.

 

Division of Drug Quality and Compliance Services & Solutions

Builds strategic relationships with the Office of Compliance (OC) and the Office of Pharmaceutical Sciences (OPS) and conducts joint business planning to systemically assess and prioritize business informatics needs and establishes a portfolio of Services & Solutions in support of critical drug quality and compliance business needs.

 

Division of Regulatory Review and Drug Safety Services & Solutions

Builds strategic relationships with the Office of New Drugs (OND), Office of Surveillance and Epidemiology (OSE), Office of Translational Sciences (OTS) and the Office of Medical Policy (OMP) and conducts joint business planning to systemically assess and prioritize business informatics needs and establishes a portfolio of Services & Solutions in support of critical regulatory review and drug safety business needs.

 

Division of Business Management Services & Solutions

Builds strategic relationships with the Office of Management (OM), Office of Communications (OCOMM), Office of Executive Programs (OEP), Office of Regulatory Policy (ORP), Office of the Center Director (OCD) and Office of Planning & Informatics (OPI) and conducts joint business planning to systemically assess and prioritize business informatics needs and establishes a portfolio of Enabling Services & Solutions to streamline CDER’s business operations and improve financial stewardship.

 

Division of Data Management Services & Solutions

Provides Data Management Services and Solutions to streamline electronic and traditional submissions and delivers solutions to enable rapid adoption of emerging electronic data standards. Provides accurate and timely guidance on electronic submission issues and supports development of guidance, specifications, and regulations associated with data management issues.

 

Contact Us

Office of Business Informatics
10903 New Hampshire Avenue
White Oak Building 22, Suite 1100
Silver Spring, MD 20993
Phone: 301-796-1000