Contents

SUBCHAPTER 220 - CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER)

220 - OFFICE OF THE CENTER DIRECTOR

The CBER Director is Jesse Goodman, M.D., M.P.H. This center is responsible for administering the regulation of biological products under the biological product control provisions of the Public Health Services Act (PHS Act) and applicable provisions of the Federal Food Drug and Cosmetic Act (FD&C Act).

Establishes written and physical standards, conducts research, tests products submitted for release, approves licensing of biological manufacturers and biological products, and inspects licensed manufacturers' facilities for compliance with standards. Provides focus in FDA for coordination of the Acquired Immune Deficiency Syndrome (AIDS) program. Works to develop an AIDS vaccine, AIDS diagnostic tests and conducts other AIDS-related activities.

Plans and conducts research on the preparation, preservation, and safety of blood and blood products, the methods of testing safety, purity, potency and efficacy of such products of therapeutic use, and the immunological problems concerned with products, testing, and use of diagnostic reagents employed in grouping and typing blood.

In carrying out these functions, cooperates with other FDA components, other PHS organizations, governmental and international agencies, volunteer health organizations, universities, individual scientists, non-governmental laboratories and manufacturers of biological products.

Office of the Center Director is organized as follows:

1. Deputy Director (Operations), (HFM-2)
   Mark A. Elengold
2. Deputy Director (Medicine), (HFM-6).
3. Associate Director for Quality Assurance (HFM-4),
   Sheryl L. Lard-Whitford, Ph.D.
4. Associate Director for Policy (HFM-10),
   Diane Maloney. JD.
5. Associate Director for Review Management
   (HFM-25), Robert A. Yetter, Ph.D.
6. Associate Director for Research (HFM-20),
   Neil D. Goldman, Ph.D.
7. Associate Director for Medical and International
   Affairs, (HFM-30) Elaine C. Esber, M.D.
8. Senior Policy Advisor (HFM-1)
   Jill H. Warner, J.D.

The Center has seven Offices under the direction of the Center Director, which will be discussed below.

220.01 - Office of Biostatistics and Epidemiology (OBE) (HFM-210)

Susan S. Ellengerg, Ph.D., Director

This office provides oversight and resources for the review of biological products and is responsible for statistical and epidemiological services to the Center, including responsibility for the adverse event reporting system.

The Office of Biostatistics and Epidemiology is organized as follows:

1. Division of Biostatistics (HFM-217)
   Peter A. Lachenbruch, Ph.D, Director
2. Division of Epidemiology (HFM-220)
   M. Miles Braun, MD, MPH, Acting Director

221 - OFFICE OF COMMUNICATION, TRAINING, AND MANUFACTURERS ASSISTANCE (OCTMA) (HFM-40)

MARY T. MEYER, DIRECTOR

This office manages the Center's professional and management training program, career and staff development program, employee orientation program, and related employee development policies. Directs the Center's consumer and professional informational activities in coordination with the other Agency components.

Serves as a liaison with Center components to provide advice and assistance to manufacturers and scientific associations to promote their understanding and compliance with FDA regulations. The Office is responsible for all activities relating to the administration of the Center's central documentation room.

The Office has the following Divisions:

1. Division of Manufacturers Assistance and Training
   (HFM-42) Gail H. Sherman, Director
2. Division of Disclosure and Oversight Management
   (HFM-44) JoAnne C. Binkley, Director

222 - OFFICE OF MANAGEMENT (OM) (HFM-100)

DON R. PETERSON, DIRECTOR

This Office monitors the development and operation of planning systems for Center activities and resource allocations and advises the Center Director on Center administrative policies, guidelines, and information systems and services. Plans and directs Center operations for financial, personnel and administrative management services. Directs and counsels Center managers through program evaluation and technological forecasting. .

Functions as an advisor on contract and grant proposals.

Office of Management is organized as follows:

1. Regulatory Information Management Staff
   (HFM-110) Roger D. Eastep, Director
2. Division of Management Services (HFM-115)
   Gerald L. Anderson, Director
3. Division of Planning, Evaluation and Budget
   (HFM-140) Nancy D. Williams, Director

222.01 - Office of Information Technology Management (OITM) (HFM-160)

Ron D. Connor, Director

This office manages the Center's microcomputer resources and LAN/WAN network architecture, provides oversight and management of CBER's automated information systems and acts as the liaison with Center activities and contract Information Technology vendors.

Develops, implements, and monitors ADP standards and policies for all Center Information Resource activities and maintains the Center-wide Information Resource security program for all legacy data and electronic access. Provides budget execution and contract monitoring of Information Technology resources.

The Office has the following Divisions:

1. Division of Information Technology Operations
   (HFM-165) Ginger Leo, Director
2. Division of Information Technology Development
   (HFM-170) John C. Chang, Director
3. Division of Information Technology Infrastructure

(HFM-180) Vacant Director

223 - OFFICE OF BLOOD RESEARCH AND REVIEW (OBRR) (HFM-300)

JAY S. EPSTEIN, MD, DIRECTOR

OBRR develops policy and procedures governing the pre-market approval review and evaluation of biological blood products in keeping with the provisions of the PHS Act and applicable provisions of the FD&C Act.

Performs the investigational device exemption (IDE) review process for devices related to biological blood products and develops related policy of those products regulated by the Office. Reviews, evaluates and takes appropriate action on investigational new drug applications (INDs) related to biological blood products and amendments or supplements to these applications; product applications submitted by manufacturers of biological blood products, including labeling; and establishment license applications submitted by blood and plasma establishments.

Plans and conducts research related to the development, manufacture, and testing of biological blood products, including those related to AIDS and those prepared by genetic engineering and synthetic procedures. Develops and maintains a scientific base for establishing standards designed to ensure the continued safety, purity, potency, and effectiveness of biological blood products.

Plans and conducts research on the preparation, preservation, characteristics, action and safety of blood and blood products; the methods of evaluating safety, purity, potency and efficacy of such products; the therapeutic uses of such products; and the testing and use of diagnostic reagents employed in grouping and typing blood, and screening for markers of infectious diseases.

This office has the following Divisions

1. Division of Emerging and Transfusion Transmitted
   Diseases (HFM-310)
   Hira L. Nakhasi, Ph.D., Director
2. Division of Hematology (HFM-330)
   Mark J. Weinstein, Ph.D., Acting Director
3. Division of Blood Applications (HFM-370)
   Vacant, Director, Director

224 - OFFICE OF VACCINES RESEARCH AND REVIEW (OVRR) (HFM-400)

KAREN MIDTHUN, DIRECTOR

OVRR covers vaccines, allergenic products, antigen specific, immunomodulators, and diagnostic antigens.

Reviews, evaluates, and takes appropriate action on INDs related to vaccines and regulated products and amendments or supplements to these applications, including approval or disapproval of research plans and protocols, modifications and restrictions. Performs the IDE review process for devices related to vaccines and related products regulated by CBER. Develops all related policy and procedures governing pre-market approval review and evaluation of vaccines and related products in keeping with the provisions of the PHS Act and applicable provisions of the FD&C Act.

Plans and conducts research related to the development, manufacture, and testing of vaccines and related products, including those related to AIDS and those prepared by genetic engineering and synthetic products. Develops and maintains a scientific base for establishing standards designed to ensure continued safety, purity, potency and effectiveness of vaccines and related products.

In cooperation with other CBER components, tests products submitted for release by manufacturers; evaluates clinical experience and reports of adverse events as necessary; participates in inspection of manufacturing facilities; and takes appropriate action on recommendations concerning denial of license applications for products.

The divisions in this office are:

1. Division of Bacterial, Parasitic, and Allergenic
   Products (HFM-410)
   Richard I Walker, PhD., Director
2. Division of Viral Products (HFM-445)
   Jerry P. Wier, PhD., Director
3. Division of Vaccines & Related Products
   Applications (HFM-475)
   Karen L. Goldenthal, MD, Director

225 - OFFICE OF CELLULAR TISSUE AND GENE THERAPIES

Philip D. Noguchi, M.D., Director

In October 2002, FDA created the Office of Cellular, Tissue, and Gene Therapies (OCTGT) to consolidate regulatory and review activities for tissues, cellular and tissue-based products, gene therapies, and xenotransplantation products. This office includes experts in molecular and cell biology, viral and nonviral gene therapy vectors, nucleic acid chemistry and genomics, proteomics, developmental and reproductive biology, stem cell biology and physiology, tissue and organ regeneration and medical and pharmacology/toxicology. OCTGT evaluates potential shortages to help assure the continued safe supply of needed products. This office works with CDC, NIH and other appropriate organizations to develop standards and methods for cellular therapies and participates in inter-center focus groups for collaborative reviews. Through this centralization of activity and expertise, FDA is working more effectively with our agency partners, conducting outreach, and regulating tissue products to achieve a safe and adequate supply.

The divisions in this office are:

1. Division of Cellular and Gene Therapies (HFM-735)
   Raj K. Puri, M.D., Ph.D., Acting Director
2. Division of Clinical Evaluation and Pharmacology/Toxicology (HFM-755)
   Cynthia A. Rask, M.D., Director
3. Division of Human Tissues (HFM-770)
   Ruth R. Solomon, M.D., Acting Director

226 - OFFICE OF COMPLIANCE AND BIOLOGICS QUALITY (HFM-600)

STEVEN A. MASIELLO, DIRECTOR

OCBQ monitors the quality of marketed biological products through surveillance, inspections, compliance activities, application review, and lot release programs. Advises the Center Director and other Agency officials on FDA's regulatory compliance responsibilities for biological products. Reviews license applications and supplements to determine if the facilities are appropriate for the manufacturing activities. Participates in prelicense and annual inspections and on license application review committees.

Serves as the focal point for all CBER enforcement activities. Provides guidance to Headquarters and field personnel in the development of evidence to support enforcement actions for deviations from the applicable standards. Coordinates Center/field compliance activities, including planning activities and field assignments, with the exception of consumer affairs activities.

Manages the CBER biological product inspection program. Coordinates with other Center Offices and Agency components. Directs the Center's bioresearch monitoring and recall programs for biological products.

Develops biological product compliance and surveillance programs, coordinates field implementation, and advises other Center components on these programs. Evaluates, in coordination with appropriate Agency officials, firms' conformance with CGMP in producing biological products for procurement by Federal and State agencies.

Coordinates the Center's export program and serves as the Center's focal point for import and export issues.

Identifies and recommends appropriate action, in coordination with other FDA components, on the results of continuing surveillance and evaluation of advertising and clinical experience reports submitted by manufacturers and sponsors of products regulated by CBER.

Maintains a reference reagent program, and establishes written and reference standards for biological product establishments (except blood and plasma establishments). In coordination with other CBER components, tests products submitted for release by manufacturers.

This office has three Divisions:

1. Division of Case Management (HFM-610)
   Mary A. Malarkey, Director
2. Division of Inspections and Surveillance (HFM-650)
   Elaine Knowles Cole, Director
3. Division of Manufacturing and Product Quality
   (HFM-670) John A. Eltermann, Jr., Director