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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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

1-3 - CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER)
     1-3-1 - Office of Compliance and Biologics Quality (HFM-600)
     1-3-2 - Division of Case Management (HFM-610)
     1-3-3 - Division of Inspections and Surveillance (HFM-650)
     1-3-4 - Division of Manufacturing and Product Quality (HFM-670)
     1-3-5 - Division of Biological Standards and Quality Control (HFM-680)

 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. Ensures the quality of products regulated by CBER over their entire lifecycle through pre-market review and inspection, and post-market review, surveillance, inspection, outreach, and compliance;
  2. Monitors the quality of marketed biological products through surveillance, inspections, and compliance programs; reviews, evaluates and takes appropriate compliance action, in coordination with other Agency components;
  3. Reviews, evaluates and takes action on manufacturing supplements submitted by manufacturers (except blood and plasma establishments), and leads pre-approval and pre-license inspections supporting Biologics License Application submissions and supplements as part of the CBER managed review process;
  4. 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;
  5. Coordinates CBER’s participation in the inspection of biological product manufacturing facilities;
  6. Develops, with other CBER/agency components, policies and compliance standards for biological products including Current Good Manufacturing Practice (CGMP) regulations; ensures the uniform interpretation of standards and evaluates industry’s conformance with CGMP in manufacturing biological products;
  7. Directs CBER’s bioresearch monitoring program, and takes appropriate compliance actions, in coordination with other Agency components;
  8. Develops compliance and surveillance programs for CBER-regulated products, coordinates and directs their field implementation, and advises other CBER components on these programs;
  9. Provides guidance to headquarters and field personnel in the development of evidence to support enforcement actions;
  10. Coordinates all CBER compliance activities with Office of Regulatory Affairs, including planning and field assignments;
  11. Coordinates CBER’s import and export programs;
  12. In coordination with other CBER components, responsible for lot release of biological products including review of protocols submitted for release by manufacturers;
  13. Reviews and evaluates all administrative action recommendations including suspension, revocation, denial of license; disqualification of clinical investigators; and recommended civil and criminal actions, including seizure, injunction, and prosecution based on findings of inspections and investigations;
  14. 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);
  15. Coordinates CBER’s application integrity policy;
  16. Develops, reviews, and analyzes, in coordination with other agency components, policies that apply to products regulated by CBER, including procedures, instructions, guidance documents, regulations, and other written policy statements;
  17. Reviews, evaluates, and takes appropriate compliance actions on advertising and promotional labeling materials for CBER-regulated products to ensure that the information about the risks and benefits of regulated products are communicated in a truthful, accurate, science-based, non-misleading and balanced manner and is in compliance with pertinent federal laws and regulations;
  18. Plans, develops, and implements, in coordination with other agency and CBER components, education programs for Agency staff, industry, health professionals, and consumers, concerning products regulated by CBER;
  19. Manages CBER’s product shortage program, and
  20. In cooperation with other Center components, develops and maintains scientific programs dealing with the preparation and distribution of official U.S. reference preparations used in the control testing of biological products. Collaborates with national and international health agencies on evaluation studies of International Reference Preparations and functions as a World Health Organization/Pan American Health Organization (WHO/PAHO) Reference Laboratory.

There are four Divisions within the Office of Compliance and Biologics Quality:

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

 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, and denial of license. 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 other Agency and CBER components, plans and implements educational programs for Agency staff 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 the Office of Regulatory Affairs (ORA) for issuance of Warning Letters and reviews and evaluates 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 requests for export of unapproved biological products and requests for export certificates;
  9. Provides assessment of the compliance status of regulated establishments within CBER's purview (compliance status checks); and,
  10. Reviews, evaluates, and takes appropriate compliance actions on advertising and promotional labeling materials for CBER-regulated products to ensure that the information about the risks and benefits of regulated products are communicated in a truthful, accurate, science-based, non-misleading and balanced manner, and is in compliance with pertinent laws and regulations.

 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 direction 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 CBER inspection programs;
  3. Develops guidance and other training programs in conjunction with CBER components, to promote industry compliance and for use in training Agency staff, industry, health professionals and consumers concerning products regulated by CBER;
  4. Develops and updates CBER compliance programs;
  5. Directs CBER’s program for biological product deviation reports (including HCT/P deviation reports and medical device reports), and reports of complications of blood collection or transfusion confirmed to be fatal. Coordinates case reviews, as appropriate, by a committee of medical officers;
  6. Plans and directs investigation and surveillance assignments in response to reports regarding product defects, adverse events, complaints, biological product deviations, and allegations of violative activity. Evaluates the related inspection and investigation reports;
  7. Directs CBER’s Bioresearch Monitoring program with oversight of clinical investigators, institutional review boards, and sponsors of clinical research for biological products. Plans and directs inspection assignments, evaluates Establishment Inspection Reports, and takes appropriate compliance actions, in coordination with other Agency components, including Untitled Letters, Warning Letters, and the initiating the disqualification of clinical investigators;
  8. Coordinates office follow-up and response to complaints related to investigational products and clinical trials;
  9. Working with other Agency components, provides guidance to industry, consumers, and other government officials concerning bioresearch monitoring policies and regulations;
  10. Promotes uniformity between CBER and ORA with regard to conducting inspections and the implementation of Current Good Manufacturing Practices (CGMPs) policy;
  11. Provides support for Team Biologics inspections and coordinates participation by qualified product specialists. Serves as CBER’s contact for Team Biologics issues during inspections;
  12. Supports the CBER pre-approval inspection program; and,
  13. Serves as the CBER contact for other federal agencies concerning inspection, surveillance, and enforcement matters, and coordinates review of these matters with other agency components as appropriate.

 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 CBER as part of the managed review process. Performs Chemistry, Manufacturing and Controls (CMC) and Current Good Manufacturing Practice (CGMP) reviews for CBER-regulated products;
  2. Develops and administers the biological products lot release program in coordination with other CBER components; reviews manufacturers’ submissions for licensed biological product lots; receives, maintains, and distributes samples of biological products submitted for testing;
  3. Leads pre-license and pre-approval inspections supporting Biologics License Applications submissions and supplements, as part of the CBER managed review process. Prepares inspection reports as part of an inspection team and evaluates the firm’s corrective actions; and,
  4. Supports enforcement activities by evaluating inspection reports and corrective actions when inspections are performed by other CBER or field components.

 1-3-5 - Division of Biological Standards and Quality Control (HFM-680)

The functional statements for the Division of Biological Standards and Quality Control are:

  1. Develops product testing programs in a secured and controlled environment using appropriately qualified and validated methods for generating data supportive of CBER regulatory activities;
  2. Maintains product testing programs in a manner that meets internationally recognized standards;
  3. Participates in lot release activities by performing testing of submitted samples and review of lot release protocols according to approved testing programs;
  4. Participates in regulatory review activities by contributing expertise to the evaluation of test methods, assessment of acceptability of assay method validation packages, and evaluation of appropriateness of product specifications;
  5. Provides expert scientific and technical advice and assistance to industry, other agency components, and international and academic organizations on issues related to biologics product testing and methods validation;
  6. Prepares, calibrates, holds and distributes official U.S. reference preparations used in the control testing of biological products; and,
  7. Develops and maintains scientific programs for the evaluation and standardization of reagent test kits and related devices in cooperation with other Center components.