09-10-0010 Bioresearch Monitoring Information System, HHS/FDA

System name:

Bioresearch Monitoring Information System, HHS/FDA.

Security classification:

None.

System location:

Center for Biologics Evaluation and Research (CBER), Office of Compliance and Biologics Quality, Bioresearch Monitoring Team (HFM–650), 1401 Rockville Pike, Rockville, MD 20852.

Center for Devices and Radiological Health (CDRH), Office of Compliance, Division of Bioresearch Monitoring (HFZ–310), 2094 Gaither Rd., Rockville, MD 20850.

Center for Drug Evaluation and Research (CDER), Office of Compliance, Division of Scientific Investigations (HFD–340), 7520 Standish Pl., Rockville, MD 20855.

Center for Food Safety and Applied Nutrition (CFSAN), Office of Premarket Approval, Division of Product Policy (HFS–205), 200 C St. SW., Washington, DC 20204.

Center for Veterinary Medicine (CVM), Office of Surveillance & Compliance (HFV–234), Division of Compliance, Bioresearch Monitoring Staff, 7500 Standish Pl., Rockville, MD 20855.

Categories of individuals covered by the system:

Clinical investigators who are conducting, or have conducted, clinical studies of new drugs, biologics, and devices under investigational new drug and biologics, and investigational device exemption requests; clinical investigators who are conducting, or have conducted, studies on food or color additives, generally recognized as safe (GRAS) substances, or infant formula; and clinical investigators who are conducting, or have conducted, studies on new animal drugs under investigational new animal drug requests.

Categories of records in the system:

Automated file is maintained on all clinical investigators; contains name, education, professional qualifications and background, Program Oriented Data Systems (PODS) locator code, and information on studies conducted. Manual file contains, in addition to that same information, investigatory material collected by, or developed by, the Food and Drug Administration (FDA), during investigations of possible violations of statutes and regulations governing new drug, biologic, food or color additive, GRAS substance, infant formula, new animal drug, and/or device studies.

Authority for maintenance of the system:

Section 505(i)(3), Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)(3)), 21 CFR part 312 (new drugs and biologics for investigational use); section 520, Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j), 21 CFR part 812 (new devices for investigational use); sections 512(j) and (l)(1), Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(j) and (l)(1)), 21 CFR part 511 (new animal drugs for investigational use); Sections 409 and 721, Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348 and 379e), 21 CFR part 71 (color additive petitions), 21 CFR part 171 (food additive petitions); section 412, Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a) (infant formula requirements); and section 351, Public Health Service Act (42 U.S.C. 262).

Purpose(s):

1. To provide controls to assure that investigators meet requirements of the relevant statutes and regulations governing new drug, biologic, food or color additive, GRAS substance, infant formula, new animal drug, and/or device studies.

2.To serve as a data base for the effective performance of activities necessary for the conduct of the bioresearch monitoring program.

Routine uses of records maintained in the system, including categories of users and the purposes of such uses:

1. Records that, on their face or in conjunction with other records, indicate a violation or potential violation of law, may be: (1) Referred for investigation and possible enforcement action under the applicable Federal, State, or foreign laws to the Department of Justice and other appropriate Federal agencies, an appropriate State food and drug enforcement agency or licensing authority, or the government of a foreign country where studies are being or have been conducted; or (2) disclosed to sponsors or IRB's responsible for initiating, approving, monitoring, or overseeing any studies affected by the violation or potential violation, if the information disclosed is relevant to any enforcement, regulatory, investigative, or prosecutorial responsibility of the receiving entity.

2. Disclosure may be made to a congressional office from the record of an individual in response to an inquiry from the congressional office made at the written request of that individual.

3. The Department of Health and Human Services (HHS) may disclose information from this system of records to the Department of Justice, or to a court or other adjudicative body, when:

(a) HHS, or any component thereof; or

(b) Any HHS employee in his or her official capacity; or

(c) Any HHS employee in his or her individual capacity where the Department of Justice (or HHS, where it is authorized to do so) has agreed to represent the employee; or

(d) The United States or any agency thereof (where HHS determines that the litigation is likely to affect HHS or any of its components),

is a party to litigation or has an interest in such litigation, and HHS determines that the use of such records by the Department of Justice, the court or other adjudicative body, is relevant and necessary to the litigation and would help in the effective representation of the governmental interest, provided, however, that in each case, HHS determines that such disclosure is compatible with the purpose for which the records were collected.

Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system:

Storage:

Manual files of investigatory materials are maintained in letter-size manila folders and on microfilm. Automated files are maintained on magnetic disk or tape.

Retrievability:

Indexed by name or code number.

Safeguards:

1. Authorized users: Personnel in CBER's Bioresearch Monitoring Team and CBER Product Review Offices; Personnel in CDRH's Division of Bioresearch Monitoring; Personnel in CDER's Division of Scientific Investigations, Division of Drug Information Resources, Management and Data Systems Branch; Personnel in CFSAN's Division of Product Policy, Division of Health Effects Evaluation; and Personnel in CVM's Division of Compliance, Bioresearch Monitoring Staff.

2. Physical safeguards: Files are stored in secured areas, locked buildings, locked rooms, locked tape vaults, and lockable data media cabinets.

3. Procedural (or technical) safeguards: Limited access and computer password which is changed periodically.

4. Implementation guidelines: These practices are in compliance with the standards of chapter 45–13 of the HHS General Administration Manual, "Safeguarding Records Contained in Systems of Records," supplementary Chapter PHS hf: 45–13, and the Department's Automated Information System Security Handbook.

Retention and disposal:

Records are retained and disposed of under the authority of the FDA Records Control Schedule transmittal number H:90–1, Departmental number B–331.

System manager(s) and address:

Director, Division of Inspections and Surveillance (HFM–650), Center for Biologics Evaluation and Research, Office of Compliance and Biologics Quality, 1401 Rockville Pike, Rockville, MD 20852.

Director, Division of Bioresearch Monitoring (HFZ–310), Office of Compliance, Center for Devices and Radiological Health, 2094 Gaither Rd., Rockville, MD 20850.

Deputy Director, Division of Scientific Investigation (HFD–341), Center for Drug Evaluation and Research, Office of Compliance, 7520 Standish Pl., Rockville, MD 20855.

Bioresearch Monitoring Project Manager (HFS–207), Center for Food Safety and Applied Nutrition, Office of Premarket Approval, Division of Product Policy, 200 C St. SW., Washington, DC 20204.

Manager, Bioresearch Monitoring Program (HFV–234), Center for Veterinary Medicine, Division of Compliance, 7500 Standish Pl., Rockville, MD 20855.

Notification procedures:

An individual may learn if a record exists about him or her upon written request with notarized signature or certification of identification under penalty of perjury if request is made by mail, or with identification if request is made in person (see also 21 CFR 21.44), directed to:

FDA Privacy Act Coordinator (HFI–30), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.

Record access procedures:

Same as notification procedures. Requesters should also reasonably 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:

Commissioner, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.

You may also request an accounting of disclosures that have been made of your record, if any.

Contesting record procedures:

Contact the official at the address specified under notification procedures above 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.

Record source categories:

Individual on whom the record is maintained. Some material is obtained from third parties, e.g., drug companies, publications, or is developed by FDA.

Systems exempted from certain provisions of the act:

This system is exempt from access and contest and certain other provisions of the Privacy Act (5 U.S.C. 552a(c)(3), (d)(1) to (d)(4), (e)(3), (e)(4)(G) to (e)(4)(H) and (f)) to the extent that it includes investigatory material compiled for law enforcement purposes, where access would be likely to prejudice the conduct of the investigation.