1-3 - CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER)

1-3-1 - Office Of Compliance And Biologics Quality (HFM-600)

The functional statements for the Office of Compliance and Biologics Quality are:

1. Monitors the quality of biological products through surveillance, inspections, and compliance programs, and coordinates testing of marketed products with other components of the FDA;
2. Reviews, evaluates and takes action on Investigational New Drug applications (INDs), biologics license applications (BLAs), supplements, and amendments submitted to CBER; performs Chemistry, Manufacturing and Controls (CMC) and Current Good Manufacturing Practice (CGMP) reviews;
3. Advises the center director and other agency officials on emerging and significant compliance issues for biological products and serves as CBER’s focal point for surveillance and enforcement policy;
4. Coordinates CBER’s participation in the inspection of biological product manufacturing facilities;
5. Develops, with other CBER/agency components, compliance standards for biological products, including Current Good Manufacturing Practice (CGMP) regulations, ensures their uniform interpretation and evaluates industry’s conformance with CGMP in manufacturing biological products;
6. Directs CBER’s bioresearch monitoring program, enforcement, and recall programs for biological products;
7. Develops biological product compliance and surveillance programs, coordinates and directs their field implementation, and advises other CBER components on these programs;
8. Provides guidance to headquarters and field personnel in the development of evidence to support enforcement actions;
9. Coordinates all CBER-field compliance activities, including planning and field assignments;
10. Coordinates CBER’s import and export programs;
11. In coordination with other CBER components, responsible for lot release of biological products including testing products and review of protocols submitted for release by manufacturers also maintains a reference reagent program;
12. Reviews, and evaluates all administrative action recommendations including suspension, revocation, denial of license, debarment, disqualification of clinical investigators, and recommended civil and criminal actions, including seizure, injunction, and prosecution based on findings of inspections and investigations;
13. Reviews and evaluates all recommendations for Orders of Retention, Recall, Destruction and Cessation of Manufacturing involving human cells, tissues, and cellular and tissue-based products (HCT/Ps);
14. Coordinates CBER’s application integrity policy;
15. In coordination with other agency components, formulates policy in the areas of compliance and biologics quality including enforcement, good manufacturing practices, and labeling including advertising and promotion, and drafts guidance documents for other agency components and regulated industry on these subjects;
16. Enforces regulations pertaining to product labeling including proprietary names, labels, package inserts, and promotion and advertising material; formulates and establishes policy for the regulation of promotional activities including advertisements, promotional labeling, and promotional practices; and,
17. Plans and develops, in coordination with other agency and CBER components, information and education activities related to biological products.

There are three divisions within the Office of Compliance and Biologics Quality:

1. Division of Case Management;
2. Division of Inspections and Surveillance; and, 
3. Division of Manufacturing and Product Quality.

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1-3-2 - Division Of Case Management (HFM-610)

The functional statements for the Division of Case Management are:

1. Reviews and evaluates administrative action recommendations including suspension, revocation, denial of license and debarment; reviews recommended civil and criminal actions, including seizure, injunction, and prosecution; prepares documents required for such enforcement actions and manages cases after actions are taken;
2. Reviews and evaluates all recommendations for Orders of Retention, Recall, Destruction and Cessation of Manufacturing involving human cells, tissues, and cellular and tissue-based products (HCT/Ps);
3. Coordinates support for ongoing litigation and contested cases with the Office of Chief Counsel and the Department of Justice, including the identification and preparation of expert witnesses;
4. In coordination with the Office of Communications, Training, and Manufacturers Assistance, provides training for CBER and other agency personnel regarding evidence development in support of compliance actions;
5. Provides primary support within the Office of Compliance and Biologics Quality for agency ad hoc committee meetings relating to proposed enforcement action against products, manufacturers or other individuals associated with CBER regulated products;
6. Develops enforcement standards for direct reference authority to FDA district offices for issuance of Warning Letters and reviews and evaluates Team Biologics and district generated recommendations for the issuance of Warning Letters for which direct reference authority has not been granted;
7. Coordinates CBER’s application integrity policy;
8. Directs and coordinates CBER’s import and export programs, including the review of applications for export of unapproved biological products and requests for export certificates;
9. Provides assessment of the compliance status of regulated firms within CBER's purview (compliance status checks); and,
10. Reviews, evaluates, and monitors material associated with promotion, advertising, conferences, exhibits, and similar types of media for all biological products, new drugs, and medical devices approved by CBER;  participates in actions to remedy violative promotion.

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1-3-3 - Division Of Inspections And Surveillance (HFM-650)

The functional statements for the Division of Inspections and Surveillance are:

1. Coordinates and provides support and guidance to district offices for investigations and surveillance inspections;
2. Works with the Office of Regulatory Affairs (ORA) to prepare inspection work plans and allocate resources for the biological product inspection program;
3. Develops guidance and other training programs in conjunction with CBER components, to promote industry compliance and for use in training headquarters and field inspection staffs;
4. Develops and updates compliance programs on behalf of CBER;
5. Manages the biological compliance surveillance activities including review of transfusion-related fatality reports and biological product deviations;
6. Plans and directs investigation and surveillance assignments in response to reports regarding product defects, adverse events, biological product deviations, and allegations of violative activity;  evaluates the related inspection and investigation reports;
7. Manages the Bioresearch Monitoring programs for CBER, including clinical investigator disqualifications;  reviews, evaluates, and classifies establishment inspection reports and prepares Warning Letters; 
8. Coordinates office follow-up and response to complaints related to investigational products and clinical trials;
9. Working with the Office of Communications, Training, and Manufacturers Assistance, provides guidance to industry and government concerning bioresearch monitoring policies and regulations;
10. Manages CBER’s product shortage program;
11. Promotes uniformity between CBER and ORA with regard to conducting inspections and the implementation of Current Good Manufacturing Practices (CGMPs) policy;
12. Serves as CBER’s contact for Team Biologics issues during inspections;
13. Supports the CBER pre-approval inspection program; and,
14. Serves as the CBER contact for other federal agencies concerning enforcement matters, and coordinates review of these matters with other agency components as appropriate.

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1-3-4 - Division Of Manufacturing And Product Quality (HFM-670)

The functional statements for the Division of Manufacturing and Product Quality are:

1. Reviews, evaluates, and takes action on Investigational New Drugs applications (INDs), license applications, supplements, and amendments submitted to the Center for Biologics Evaluation and Research (CBER); performs Chemistry, Manufacturing and Controls (CMC) and Current Good Manufacturing Practice (CGMP) reviews;
2. Develops and administers the biological products lot release program; reviews manufacturers’ submissions for licensed biological product lots; receives, maintains, and distributes samples of biological products submitted for testing;
3. In coordination with the Office of Communications, Training, and Manufacturers Assistance, provides expert technical and regulatory guidance and training to CBER and other agency components, government agencies, and representatives of domestic and foreign biological establishments regarding biological product manufacturing and quality;
4. Leads prelicense and preapproval inspections, and participates in routine GCMP inspections of establishments manufacturing biological products;  participates in the preparation of inspection reports as part of an inspection team and evaluates the firm’s corrective actions; and,
5. Supports enforcement activities by evaluating inspection reports and corrective actions when inspections are performed by other CBER or field components.

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