System Name: Bioresearch Monitoring Information System, HHS/FDA.
Security Classification: None.
System Location(s): This notice applies to clinical investigators who are conducting, or have conducted, clinical investigations of products regulated by FDA.
Categories of Records in the System: The purposes of this system are to:
1. Support regulatory or procedural controls to ensure that clinical investigators meet requirements of the relevant statutes and regulations governing clinical investigations of FDA-regulated products.
2. Support the effective performance of activities necessary for the conduct of the FDA's bioresearch monitoring program.
Routine Uses of Records Maintained in the System, Including Categories of Users and the Purposes of such Uses:
Storage: Files may be maintained in various formats including hard copy paper in manual files, microfilm, magnetic disk or tape, computer disks, hard drives, and file servers and other types of data storage devices.
Retrievability: Records may be indexed by name or code number, but can be retrieved by manual or computer search of the case-tracking system using the name of the individual.
Safeguards:
1. Authorized users: Records in FDA's system are available to the Commissioner of Food and Drugs, FDA's System Managers, and to other appropriate FDA and HHS officials when there is a need to know in the performance of their duties. All authorized users are informed that the records are confidential and are not to be further disclosed.
2. Procedural safeguards: Access is strictly controlled by FDA's System Managers in compliance with the Privacy Act and this system notice. Access to the records is limited to ensure confidentiality. All questions and inquiries from any party should be addressed to FDA's Office of Good Clinical Practice.
3. Physical safeguards: All records (such as diskettes, computer listings, or documents) are kept in a secured area, locked rooms, and locked building. The facility has a 24-hour guard service, and access to the building is further controlled by an operational card key system. Access to the files, which are generally hard copy, are limited to a subset of persons with general access to the building. Access to individual offices is controlled by simplex locks. Records are kept in locked file cabinets in a room that is locked during non-working hours. Access to this room is restricted to specific personnel. Access to computer files is strictly limited through passwords and user-invisible encryption. Special measures commensurate with the sensitivity of the record are taken to prevent unauthorized copying or disclosure of the records.
Retention and Disposal: The records are maintained in accordance with FDA's Records Control Schedule, applicable General Records Schedule (accessions), and disposition schedule approved by the National Archives and Records Administration (cases).
System Manager(s) and Address(es): Division of Inspections and Surveillance, Center for Biologics Evaluation and Research, Office of Compliance and Biologics Quality (refer to http://www.fda.gov for address specifics).
Division of Bioresearch Monitoring, Center for Devices and Radiological Health, Office of Compliance (refer to http://www.fda.gov for address specifics).
Division of Scientific Investigations, Center for Drug Evaluation and Research, Office of Compliance (refer to http://www.fda.gov for address specifics).
Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (refer to http://www.fda.gov for address specifics).
Office of Enforcement, Office of Regulatory Affairs (refer to http://www.fda.gov for address specifics), and Regional Field Offices (refer to http://www.fda.gov for address specifics).
Center for Tobacco Products (refer to http://www.fda.gov for address specifics).
Division of Compliance, Center for Veterinary Medicine, Bioresearch Monitoring Program (refer to http://www.fda.gov for address specifics).
Office of Good Clinical Practice, Office of the Commissioner (refer to http://www.fda.gov for address specifics).
Notification Procedure: In accordance with 21 CFR part 21 subpart D, an individual may submit a request to the FDA Privacy Act Coordinator, with a notarized signature, to confirm whether records exist about that individual. Requests should be directed to the FDA Privacy Act Coordinator (refer to http://www.fda.gov for the address specifics). Investigative records are exempt from this provision (see the following sentences: Records Exempted from Certain Provisions of the Act). In addition, some records may be exempt under 5 U.S.C. 552a(d)(5), if they are "compiled in reasonable anticipation of a civil action or proceeding." See also 21 CFR 21.41. Requests may be mailed to the FDA Privacy Act Coordinator (refer to http://www.fda.gov for the address specifics).
Record Access Procedures: Same as notification procedures. Requesters should specify the record contents being sought. Access to record systems which have been granted an exemption from the Privacy Act access requirement may be made at the discretion of the system manager. If access is denied to requested records, an appeal may be made to the FDA Commissioner. A request can also be made for an accounting of disclosures that have been made of a record, if any.
Contesting Record Procedures: In accordance with 21 CFR 21.50, contact the FDA Privacy Act Coordinator (refer to http://www.fda.gov), and reasonably identify the record, specify the information being contested, the corrective action sought, and your reasons for requesting the correction, along with supporting information to show how the record is inaccurate, incomplete, untimely, or irrelevant. As stated previously, investigative records are exempt from this provision (see the following paragraphs of this document: Records Exempted from Certain Provisions of the Act). In addition, some records may be exempt under 5 U.S.C. 552a(d)(5) if they are "compiled in reasonable anticipation of a civil action or proceeding."
Individual on whom the record is maintained. Some material is obtained from third parties (e.g., a study sponsor, publication, or institutional review board), or is developed by FDA.
Exemptions Claimed for the System: Investigatory records compiled for law enforcement purposes in this system are exempt from the notification, access, correction and amendment provisions of the Privacy Act (21 CFR 21.61).
