[Federal Register: October 19, 1998 (Volume 63, Number 201)]
[Notices]
[Page 55873-55876]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19oc98-54]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0864]


Privacy Act of 1974; Altered System of Records, Including
Addition of Routine Use(s) to an Existing System of Records

AGENCY: Department of Health and Human Services (HHS).

[[Page 55874]]

ACTION: Notification of an altered system of records, including the
addition of a new routine use.

-----------------------------------------------------------------------

SUMMARY:  In accordance with the requirements of the Privacy Act of
1974 (Privacy Act), the Department of Health and Human Services (HHS)
is publishing notice of a proposal to alter Privacy Act System of
Records 09-10-0010 for the ``Bioresearch Monitoring Information System,
HHS/FDA,'' including the addition of a new routine use. The major
purposes of the proposed alterations are to add the names of the Center
for Food Safety and Applied Nutrition (CFSAN), and the Center for
Veterinary Medicine (CVM), and related information regarding these
Centers, to ensure that the system covers all of the Food and Drug
Administration's (FDA's) Centers; update the relevant statutory and
regulatory citations; and modify the routine uses section of the
existing system notice by removing unnecessary routine uses, revising
other routine uses to bring them in conformance with case law, and
adding a new routine use providing for disclosure of covered records to
sponsors and Institutional Review Boards (IRB's) involved with studies
affected by a clinical investigator's violative or potentially
violative conduct.
DATES:  Submit written comments on the proposed alterations, including
the new routine use, by November 18, 1998. HHS sent a Report of Altered
System to the Congress and the Office of Management and Budget (OMB) on
October 19, 1998. The alteration to the system of records will be
effective 40 days from the date submitted to OMB unless HHS receives
comments which would result in a contrary determination.

ADDRESSES:  Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Regulatory Counsel (HFC-230), Office
of Regulatory Affairs, Office of Enforcement, Division of Compliance
Policy, Food and Drug Administration, 12720 Twinbrook Pkwy., suite 517,
Rockville, MD 20852, 301-827-0412.

SUPPLEMENTARY INFORMATION: FDA proposes to alter Privacy Act System of
Records 09-10-0010 for the ``Bioresearch Monitoring Information System,
HHS/FDA.'' The major purposes of the proposed alterations are to: (1)
Add the names of CFSAN, and CVM, and related information regarding
these Centers, to ensure that the system covers all of FDA's Centers;
(2) update the relevant statutory and regulatory citations; and (3)
modify the routine uses section of the existing system notice by
removing unnecessary routine uses, revising other routine uses to bring
them in conformance with case law, and adding a new routine use
providing for disclosure of covered records to sponsors and IRB's
involved with studies affected by a clinical investigator's violative
or potentially violative conduct.
    The records in this system will be maintained in a secure manner
compatible with their content and use. All records are kept in secured
areas, locked rooms, and locked buildings. Manual and computerized
records will be maintained in accordance 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
of the Department's General Administration Manual, and the Department's
Automated Information Systems Security Handbook. Data stored in
computers will be accessed through the use of regularly expiring
passwords and individual ID's known only to authorized users.
    FDA staff will be required to adhere to the provisions of the
Privacy Act (5 U.S.C. 552a) and the HHS Privacy Act regulations (45 CFR
5b). Only authorized users whose official duties require the use of
such information will have regular access to the records in this
system. Authorized users are FDA employees and contractors responsible
for training the individuals who will inspect the facilities of the
clinical investigators, who compile and analyze the inspectional data
and information, or who, as a part of their official duties, routinely
disclose information under the Freedom of Information Act (FOIA) or
conduct other authorized sharing of FDA records. Users will be required
to sign an agreement indicating their cooperation with FDA systems
security and Privacy Act policies.
    The proposed alteration contains a new routine use permitting
disclosure of records in the system to sponsors and IRB's associated
with the clinical investigator's studies. Under the altered system, FDA
may disclose to sponsors and IRB's those records that on their face, or
in conjunction with other records, indicate a violation or potential
violation of the law by clinical investigators that have conducted or
are conducting studies. Disclosure would be made either under a request
from the sponsor or IRB or, in FDA's discretion, without the need for a
request. The purpose of disclosure would be to alert these parties to
inspectional findings indicating violations or potential violations of
the laws enforced by FDA, including the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321 et seq.) and its implementing regulations.
Such disclosure is compatible with the purpose of the system because
the sponsors and IRB's play a significant role in ensuring that
clinical investigators meet the applicable statutory and regulatory
requirements. Disclosure also provides the sponsors and IRB's with
information that is important to meeting their responsibilities under
FDA's regulations, including their responsibility to monitor the data
collected under the study.
    In some cases, evidence of a violation or potential violation may
implicate more than one of the clinical investigator's studies. Where
more than one clinical study is involved, FDA may, where it deems
appropriate, share information concerning a violation or potential
violation with the sponsors and IRB's of any of the clinical
investigator's studies.
    In addition to creating a new routine use, the proposed alteration
will delete as unnecessary two routine uses which provide for
disclosure of records to certain employees of the agency for use in
performance of their duties, thereby duplicating another Privacy Act
exemption, 5 U.S.C. 552a(b)(1). The proposed alteration also will
revise language in the remaining routine uses to bring them in
conformance with recent case law. (See Covert v. Harrington, 876 F.2d
751 (9th Cir. 1989).) Minor editorial revisions also have been made
throughout the system notice to enhance its clarity and specificity,
and to accommodate normal updating changes.
    Interested persons may, on or before (insert date 30 days after
date of publication in the Federal Register), submit to the Dockets
Management Branch (address above) written comments regarding the
revised system notice. Two copies of any comments are to be submitted,
except that individuals may submit one copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
    The following notice is written in the present, rather than the
future tense, to avoid the unnecessary expenditure of public funds to
republish the notice after the alteration and routine use has become
effective. The revised system notice, including the proposed
alterations, is set forth in full below.

[[Page 55875]]

    Dated: October 9, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.

Revised System Notice

09-10-0010

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.

[[Page 55876]]

    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.
[FR Doc. 98-27937 Filed 10-16-98; 8:45 am]
BILLING CODE 4160-01-F